WO2019130111A1 - Interruption of energy due to inadvertent capacitive coupling - Google Patents

Interruption of energy due to inadvertent capacitive coupling Download PDF

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Publication number
WO2019130111A1
WO2019130111A1 PCT/IB2018/057943 IB2018057943W WO2019130111A1 WO 2019130111 A1 WO2019130111 A1 WO 2019130111A1 IB 2018057943 W IB2018057943 W IB 2018057943W WO 2019130111 A1 WO2019130111 A1 WO 2019130111A1
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WO
WIPO (PCT)
Prior art keywords
surgical
energy
generator
sensor
tissue
Prior art date
Application number
PCT/IB2018/057943
Other languages
French (fr)
Inventor
David C. Yates
Iv Frederick E. Shelton
Original Assignee
Ethicon Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US16/115,249 external-priority patent/US11291495B2/en
Application filed by Ethicon Llc filed Critical Ethicon Llc
Priority to BR112020012520-2A priority Critical patent/BR112020012520A2/en
Priority to CN201880083568.0A priority patent/CN111511299B/en
Priority to JP2020535200A priority patent/JP7263364B2/en
Publication of WO2019130111A1 publication Critical patent/WO2019130111A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B18/1233—Generators therefor with circuits for assuring patient safety
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1402—Probes for open surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1442—Probes having pivoting end effectors, e.g. forceps
    • A61B18/1445—Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/148—Probes or electrodes therefor having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00779—Power or energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00892—Voltage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00898—Alarms or notifications created in response to an abnormal condition

Definitions

  • This disclosure is related, generally and in various aspects, to surgical systems utilizing radio frequency (RF) energy in electrosurgery.
  • RF radio frequency
  • Electrosurgical systems typically utilize a generator to supply electrosurgical energy (e.g., alternating current at radiofrequency levels) to an active electrode that applies the electrosurgical energy to a surgical site of a patient’s body.
  • the surgical instrument may utilize the energy to perform various types of surgery, such as cutting tissue or coagulating tissue, depending on the need.
  • Monopolar electrosurgery involves applying the surgical instrument to the patient tissue using a single active electrode, and completes the electrical circuit through the patient by a patient return electrode. This return electrode is typically connected back to the monopolar energy generator.
  • capacitive coupling is an ever present problem in this system, and may potentially cause undesired burns at initially unknown locations on the patient’s body. It is desirable to take into account the capacitive coupling so as to minimize or eliminate unintended patient damage.
  • a surgical system configured to limit or prevent capacitive coupling and its effects.
  • the surgical system may include: an energy generator; a surgical instrument electrically coupled to the energy generator and configured to transmit
  • electrosurgical energy to tissue of a patient at a surgical site at least one sensor configured to detect energy an energy anomaly; and at least one processor communicatively coupled to the at least one sensor, and configured to: receive data from the at least one sensor that energy is being emitted at an unintended location within the surgical system; transmit an alert indicating that parasitic capacitive coupling is occurring; and transmit an interrupt to the energy generator to temporarily interrupt energy generation.
  • the surgical system further includes an energy dissipating pad electrically coupled to a neutral electrode in the energy generator, wherein the energy dissipating pad is configured to conductively connect to the patient and dissipate energy away from the patient when energy is applied to the patient tissue by the surgical instrument.
  • the neutral electrode is configured to passively shunt energy away from the patient during a capacitive coupling event.
  • the surgical instrument comprises: an end effector comprising a pair of jaws; and a shaft electrically coupled to the end effector and configured to deliver energy to the end effector from the energy generator.
  • the jaws comprise rounded tips configured to reduce peak voltage spikes as the jaws come into contact with tissue of the patient.
  • the shaft comprises interrupting insulator elements configured to prevent capacitive coupling from transmitting long distance within the shaft.
  • the surgical instrument comprises a triangular one-sided blade with a thin standing upper blade element configured to reduce inductive energy transmission beyond the upper blade element.
  • the end effector comprises one or more electrodes located on the inside portion of the jaws and configured to channel excess energy away from tissue of the patient.
  • FIG. 1 is a block diagram of a computer-implemented interactive surgical system, in accordance with at least one aspect of the present disclosure.
  • FIG. 2 is a surgical system being used to perform a surgical procedure in an operating room, in accordance with at least one aspect of the present disclosure.
  • FIG. 3 is a surgical hub paired with a visualization system, a robotic system, and an intelligent instrument, in accordance with at least one aspect of the present disclosure.
  • FIG. 4 is a partial perspective view of a surgical hub enclosure, and of a combo generator module slidably receivable in a drawer of the surgical hub enclosure, in accordance with at least one aspect of the present disclosure.
  • FIG. 5 is a perspective view of a combo generator module with bipolar, ultrasonic, and monopolar contacts and a smoke evacuation component, in accordance with at least one aspect of the present disclosure.
  • FIG. 6 illustrates individual power bus attachments for a plurality of lateral docking ports of a lateral modular housing configured to receive a plurality of modules, in accordance with at least one aspect of the present disclosure.
  • FIG. 7 illustrates a vertical modular housing configured to receive a plurality of modules, in accordance with at least one aspect of the present disclosure.
  • FIG. 8 illustrates a surgical data network comprising a modular communication hub configured to connect modular devices located in one or more operating theaters of a healthcare facility, or any room in a healthcare facility specially equipped for surgical operations, to the cloud, in accordance with at least one aspect of the present disclosure.
  • FIG. 9 illustrates a computer-implemented interactive surgical system, in accordance with at least one aspect of the present disclosure.
  • FIG. 10 illustrates a surgical hub comprising a plurality of modules coupled to the modular control tower, in accordance with at least one aspect of the present disclosure.
  • FIG. 1 1 illustrates one aspect of a Universal Serial Bus (USB) network hub device, in accordance with at least one aspect of the present disclosure.
  • USB Universal Serial Bus
  • FIG. 12 illustrates a logic diagram of a control system of a surgical instrument or tool, in accordance with at least one aspect of the present disclosure.
  • FIG. 13 illustrates a control circuit configured to control aspects of the surgical instrument or tool, in accordance with at least one aspect of the present disclosure.
  • FIG. 14 illustrates a combinational logic circuit configured to control aspects of the surgical instrument or tool, in accordance with at least one aspect of the present disclosure.
  • FIG. 15 illustrates a sequential logic circuit configured to control aspects of the surgical instrument or tool, in accordance with at least one aspect of the present disclosure.
  • FIG. 16 illustrates a surgical instrument or tool comprising a plurality of motors which can be activated to perform various functions, in accordance with at least one aspect of the present disclosure.
  • FIG. 17 is a schematic diagram of a robotic surgical instrument configured to operate a surgical tool described herein, in accordance with at least one aspect of the present disclosure.
  • FIG. 18 illustrates a block diagram of a surgical instrument programmed to control the distal translation of a displacement member, in accordance with at least one aspect of the present disclosure.
  • FIG. 19 is a schematic diagram of a surgical instrument configured to control various functions, in accordance with at least one aspect of the present disclosure.
  • FIG. 20 is a system configured to execute adaptive ultrasonic blade control algorithms in a surgical data network comprising a modular communication hub, in accordance with at least one aspect of the present disclosure.
  • FIG. 21 illustrates an example of a generator, in accordance with at least one aspect of the present disclosure.
  • FIG. 22 is a surgical system comprising a generator and various surgical instruments usable therewith, in accordance with at least one aspect of the present disclosure.
  • FIG. 23 is an end effector, in accordance with at least one aspect of the present disclosure.
  • FIG. 24 is a diagram of the surgical system of FIG. 22, in accordance with at least one aspect of the present disclosure.
  • FIG. 25 is a model illustrating motional branch current, in accordance with at least one aspect of the present disclosure.
  • FIG. 26 is a structural view of a generator architecture, in accordance with at least one aspect of the present disclosure.
  • FIGS. 27A-27C are functional views of a generator architecture, in accordance with at least one aspect of the present disclosure.
  • FIGS. 28A-28B are structural and functional aspects of a generator, in accordance with at least one aspect of the present disclosure.
  • FIG. 29 provides a diagram showing an example system with means for detecting capacitive coupling, in accordance with at least one aspect of the present disclosure.
  • FIG. 30 is a logic flow diagram depicting a control program or a logic configuration of an example methodology for limiting the effects of capacitive coupling in a surgical system is disclosed, in accordance with at least one aspect of the present disclosure.
  • FIG. 31 is a logic flow diagram depicting a control program or a logic configuration of an example methodology that may be performed by the surgical system utilizing monopolar energy generation to determine whether to take advantage of parasitic capacitive coupling, in accordance with at least one aspect of the present disclosure.
  • FIG. 32 is a timeline depicting situational awareness of a surgical hub, in accordance with at least one aspect of the present disclosure.
  • ultrasonic surgical devices can be configured for transecting and/or coagulating tissue during surgical procedures, for example.
  • Aspects of the electrosurgical devices can be configured for transecting, coagulating, scaling, welding and/or desiccating tissue during surgical procedures, for example.
  • a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., the cloud 104 that may include a remote server 1 13 coupled to a storage device 105).
  • Each surgical system 102 includes at least one surgical hub 106 in communication with the cloud 104 that may include a remote server 1 13.
  • the surgical system 102 includes a visualization system 108, a robotic system 1 10, and a handheld intelligent surgical instrument 1 12, which are configured to communicate with one another and/or the hub 106.
  • a surgical system 102 may include an M number of hubs 106, an N number of visualization systems 108, an O number of robotic systems 1 10, and a P number of handheld intelligent surgical instruments 1 12, where M, N, O, and P are integers greater than or equal to one.
  • FIG. 3 depicts an example of a surgical system 102 being used to perform a surgical procedure on a patient who is lying down on an operating table 1 14 in a surgical operating room 1 16.
  • a robotic system 1 10 is used in the surgical procedure as a part of the surgical system 102.
  • the robotic system 1 10 includes a surgeon’s console 1 18, a patient side cart 120 (surgical robot), and a surgical robotic hub 122.
  • the patient side cart 120 can manipulate at least one removably coupled surgical tool 1 17 through a minimally invasive incision in the body of the patient while the surgeon views the surgical site through the surgeon’s console 1 18.
  • An image of the surgical site can be obtained by a medical imaging device 124, which can be manipulated by the patient side cart 120 to orient the imaging device 124.
  • the robotic hub 122 can be used to process the images of the surgical site for subsequent display to the surgeon through the surgeon’s console 1 18.
  • the imaging device 124 includes at least one image sensor and one or more optical components.
  • Suitable image sensors include, but are not limited to, Charge- Coupled Device (CCD) sensors and Complementary Metal-Oxide Semiconductor (CMOS) sensors.
  • the optical components of the imaging device 124 may include one or more illumination sources and/or one or more lenses.
  • the one or more illumination sources may be directed to illuminate portions of the surgical field.
  • the one or more image sensors may receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and/or surgical instruments.
  • the one or more illumination sources may be configured to radiate electromagnetic energy in the visible spectrum as well as the invisible spectrum.
  • the visible spectrum sometimes referred to as the optical spectrum or luminous spectrum, is that portion of the electromagnetic spectrum that is visible to (i.e., can be detected by) the human eye and may be referred to as visible light or simply light.
  • a typical human eye will respond to wavelengths in air that are from about 380 nm to about 750 nm.
  • the invisible spectrum i.e., the non-luminous spectrum
  • the invisible spectrum is that portion of the electromagnetic spectrum that lies below and above the visible spectrum (i.e., wavelengths below about 380 nm and above about 750 nm).
  • the invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the red visible spectrum, and they become invisible infrared (IR), microwave, and radio electromagnetic radiation.
  • Wavelengths less than about 380 nm are shorter than the violet spectrum, and they become invisible ultraviolet, x-ray, and gamma ray electromagnetic radiation.
  • the imaging device 124 is configured for use in a minimally invasive procedure.
  • imaging devices suitable for use with the present disclosure include, but not limited to, an arthroscope, angioscope, bronchoscope, choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope (gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope, sigmoidoscope, thoracoscope, and ureteroscope.
  • the imaging device employs multi-spectrum monitoring to discriminate topography and underlying structures.
  • a multi-spectral image is one that captures image data within specific wavelength ranges across the electromagnetic spectrum. The wavelengths may be separated by filters or by the use of instruments that are sensitive to particular wavelengths, including light from frequencies beyond the visible light range, e.g., IR and ultraviolet. Spectral imaging can allow extraction of additional information the human eye fails to capture with its receptors for red, green, and blue.
  • the use of multi-spectral imaging is described in greater detail under the heading“Advanced Imaging Acquisition Module” in U.S. Provisional Patent Application Serial No. 62/61 1 ,341 , titled INTERACTIVE SURGICAL PLATFORM, filed
  • Multi-spectrum monitoring can be a useful tool in relocating a surgical field after a surgical task is completed to perform one or more of the previously described tests on the treated tissue.
  • the sterile field may be considered a specified area, such as within a tray or on a sterile towel, that is considered free of microorganisms, or the sterile field may be considered an area, immediately around a patient, who has been prepared for a surgical procedure.
  • the sterile field may include the scrubbed team members, who are properly attired, and all furniture and fixtures in the area.
  • the visualization system 108 includes one or more imaging sensors, one or more image-processing units, one or more storage arrays, and one or more displays that are strategically arranged with respect to the sterile field, as illustrated in FIG. 2.
  • the visualization system 108 includes an interface for HL7, PACS, and EMR.
  • a primary display 1 19 is positioned in the sterile field to be visible to an operator at the operating table 1 14.
  • a visualization tower 1 1 1 is positioned outside the sterile field.
  • the visualization tower 1 1 1 includes a first non-sterile display 107 and a second non-sterile display 109, which face away from each other.
  • the visualization system 108 guided by the hub 106, is configured to utilize the displays 107, 109, and 1 19 to coordinate information flow to operators inside and outside the sterile field.
  • the hub 106 may cause the visualization system 108 to display a snapshot of a surgical site, as recorded by an imaging device 124, on a non-sterile display 107 or 109, while maintaining a live feed of the surgical site on the primary display 1 19.
  • the snapshot on the non-sterile display 107 or 109 can permit a non-sterile operator to perform a diagnostic step relevant to the surgical procedure, for example.
  • the hub 106 is also configured to route a diagnostic input or feedback entered by a non-sterile operator at the visualization tower 1 1 1 to the primary display 1 19 within the sterile field, where it can be viewed by a sterile operator at the operating table.
  • the input can be in the form of a modification to the snapshot displayed on the non- sterile display 107 or 109, which can be routed to the primary display 1 19 by the hub 106.
  • a surgical instrument 1 12 is being used in the surgical procedure as part of the surgical system 102.
  • the hub 106 is also configured to coordinate information flow to a display of the surgical instrument 1 12.
  • a diagnostic input or feedback entered by a non-sterile operator at the visualization tower 1 1 1 can be routed by the hub 106 to the surgical instrument display 1 15 within the sterile field, where it can be viewed by the operator of the surgical instrument 1 12.
  • Example surgical instruments that are suitable for use with the surgical system 102 are described under the heading“Surgical Instrument Hardware” and in U.S. Provisional Patent Application Serial No. 62/61 1 ,341 , titled
  • a hub 106 is depicted in communication with a visualization system 108, a robotic system 1 10, and a handheld intelligent surgical instrument 1 12.
  • the hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a
  • the hub 106 further includes a smoke evacuation module 126 and/or a suction/irrigation module 128.
  • the surgical hub includes a hub enclosure and a combo generator module slidably receivable in a docking station of the hub enclosure.
  • the docking station includes data and power contacts.
  • the combo generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component that are housed in a single unit.
  • the combo generator module also includes a smoke evacuation component, at least one energy delivery cable for connecting the combo generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and/or particulates generated by the application of therapeutic energy to the tissue, and a fluid line extending from the remote surgical site to the smoke evacuation component.
  • the fluid line is a first fluid line and a second fluid line extends from the remote surgical site to a suction and irrigation module slidably received in the hub enclosure.
  • the hub enclosure comprises a fluid interface.
  • Certain surgical procedures may require the application of more than one energy type to the tissue.
  • One energy type may be more beneficial for cutting the tissue, while another different energy type may be more beneficial for sealing the tissue.
  • a bipolar generator can be used to seal the tissue while an ultrasonic generator can be used to cut the sealed tissue.
  • a hub modular enclosure 136 is configured to accommodate different generators, and facilitate an interactive communication therebetween.
  • One of the advantages of the hub modular enclosure 136 is enabling the quick removal and/or replacement of various modules.
  • the modular surgical enclosure includes a first energy-generator module, configured to generate a first energy for application to the tissue, and a first docking station comprising a first docking port that includes first data and power contacts, wherein the first energy-generator module is slidably movable into an electrical engagement with the power and data contacts and wherein the first energy-generator module is slidably movable out of the electrical engagement with the first power and data contacts,
  • the modular surgical enclosure also includes a second energy- generator module configured to generate a second energy, different than the first energy, for application to the tissue, and a second docking station comprising a second docking port that includes second data and power contacts, wherein the second energy-generator module is slidably movable into an electrical engagement with the power and data contacts, and wherein the second energy-generator module is slidably movable out of the electrical engagement with the second power and data contacts.
  • a second energy- generator module configured to generate a second energy, different than the first energy, for application to the tissue
  • a second docking station comprising a second docking port that includes second data and power contacts
  • the modular surgical enclosure also includes a communication bus between the first docking port and the second docking port, configured to facilitate
  • the generator module 140 can be a generator module with integrated monopolar, bipolar, and ultrasonic components supported in a single housing unit 139 slidably insertable into the hub modular enclosure 136.
  • the generator module 140 can be configured to connect to a monopolar device 146, a bipolar device 147, and an ultrasonic device 148.
  • the generator module 140 may comprise a series of monopolar, bipolar, and/or ultrasonic generator modules that interact through the hub modular enclosure 136.
  • the hub modular enclosure 136 can be configured to facilitate the insertion of multiple generators and interactive communication between the generators docked into the hub modular enclosure 136 so that the generators would act as a single generator.
  • the hub modular enclosure 136 comprises a modular power and communication backplane 149 with external and wireless communication headers to enable the removable attachment of the modules 140, 126, 128 and interactive communication
  • the hub modular enclosure 136 includes docking stations, or drawers, 151 , herein also referred to as drawers, which are configured to slidably receive the modules 140, 126, 128.
  • FIG. 4 illustrates a partial perspective view of a surgical hub enclosure 136, and a combo generator module 145 slidably receivable in a docking station 151 of the surgical hub enclosure 136.
  • a docking port 152 with power and data contacts on a rear side of the combo generator module 145 is configured to engage a corresponding docking port 150 with power and data contacts of a corresponding docking station 151 of the hub modular enclosure 136 as the combo generator module 145 is slid into position within the corresponding docking station 151 of the hub module enclosure 136.
  • the combo generator module 145 includes a bipolar, ultrasonic, and monopolar module and a smoke evacuation module integrated together into a single housing unit 139, as illustrated in FIG. 5.
  • the smoke evacuation module 126 includes a fluid line 154 that conveys captured/collected smoke and/or fluid away from a surgical site and to, for example, the smoke evacuation module 126.
  • Vacuum suction originating from the smoke evacuation module 126 can draw the smoke into an opening of a utility conduit at the surgical site.
  • the utility conduit coupled to the fluid line, can be in the form of a flexible tube terminating at the smoke evacuation module 126.
  • the utility conduit and the fluid line define a fluid path extending toward the smoke evacuation module 126 that is received in the hub enclosure 136.
  • the suction/irrigation module 128 is coupled to a surgical tool comprising an aspiration fluid line and a suction fluid line.
  • the aspiration and suction fluid lines are in the form of flexible tubes extending from the surgical site toward the suction/irrigation module 128.
  • One or more drive systems can be configured to cause irrigation and aspiration of fluids to and from the surgical site.
  • the surgical tool includes a shaft having an end effector at a distal end thereof and at least one energy treatment associated with the end effector, an aspiration tube, and an irrigation tube.
  • the aspiration tube can have an inlet port at a distal end thereof and the aspiration tube extends through the shaft.
  • an irrigation tube can extend through the shaft and can have an inlet port in proximity to the energy deliver implement.
  • the energy deliver implement is configured to deliver ultrasonic and/or RF energy to the surgical site and is coupled to the generator module 140 by a cable extending initially through the shaft.
  • the irrigation tube can be in fluid communication with a fluid source, and the aspiration tube can be in fluid communication with a vacuum source.
  • the fluid source and/or the vacuum source can be housed in the suction/irrigation module 128.
  • the fluid source and/or the vacuum source can be housed in the hub enclosure 136 separately from the suction/irrigation module 128.
  • a fluid interface can be configured to connect the suction/irrigation module 128 to the fluid source and/or the vacuum source.
  • the modules 140, 126, 128 and/or their corresponding docking stations on the hub modular enclosure 136 may include alignment features that are configured to align the docking ports of the modules into engagement with their counterparts in the docking stations of the hub modular enclosure 136.
  • the combo generator module 145 includes side brackets 155 that are configured to slidably engage with
  • the drawers 151 of the hub modular enclosure 136 are the same, or substantially the same size, and the modules are adjusted in size to be received in the drawers 151 .
  • the side brackets 155 and/or 156 can be larger or smaller depending on the size of the module.
  • the drawers 151 are different in size and are each designed to accommodate a particular module.
  • the contacts of a particular module can be keyed for engagement with the contacts of a particular drawer to avoid inserting a module into a drawer with mismatching contacts.
  • the docking port 150 of one drawer 151 can be coupled to the docking port 150 of another drawer 151 through a communications link 157 to facilitate an interactive communication between the modules housed in the hub modular enclosure 136.
  • the docking ports 150 of the hub modular enclosure 136 may alternatively, or additionally, facilitate a wireless interactive communication between the modules housed in the hub modular enclosure 136. Any suitable wireless communication can be employed, such as for example Air Titan-Bluetooth.
  • FIG. 6 illustrates individual power bus attachments for a plurality of lateral docking ports of a lateral modular housing 160 configured to receive a plurality of modules of a surgical hub 206.
  • the lateral modular housing 160 is configured to laterally receive and interconnect the modules 161 .
  • the modules 161 are slidably inserted into docking stations 162 of lateral modular housing 160, which includes a backplane for interconnecting the modules 161 .
  • the modules 161 are arranged laterally in the lateral modular housing 160.
  • the modules 161 may be arranged vertically in a lateral modular housing.
  • FIG. 7 illustrates a vertical modular housing 164 configured to receive a plurality of modules 165 of the surgical hub 106.
  • the modules 165 are slidably inserted into docking stations, or drawers, 167 of vertical modular housing 164, which includes a backplane for interconnecting the modules 165.
  • the drawers 167 of the vertical modular housing 164 are arranged vertically, in certain instances, a vertical modular housing 164 may include drawers that are arranged laterally.
  • the modules 165 may interact with one another through the docking ports of the vertical modular housing 164.
  • a display 177 is provided for displaying data relevant to the operation of the modules 165.
  • the vertical modular housing 164 includes a master module 178 housing a plurality of sub-modules that are slidably received in the master module 178.
  • the imaging module 138 comprises an integrated video processor and a modular light source and is adapted for use with various imaging devices.
  • the imaging device is comprised of a modular housing that can be assembled with a light source module and a camera module.
  • the housing can be a disposable housing.
  • the disposable housing is removably coupled to a reusable controller, a light source module, and a camera module.
  • the light source module and/or the camera module can be selectively chosen depending on the type of surgical procedure.
  • the camera module comprises a CCD sensor.
  • the camera module comprises a CMOS sensor.
  • the camera module is configured for scanned beam imaging.
  • the light source module can be configured to deliver a white light or a different light, depending on the surgical procedure.
  • the module imaging device of the present disclosure is configured to permit the replacement of a light source module or a camera module midstream during a surgical procedure, without having to remove the imaging device from the surgical field.
  • the imaging device comprises a tubular housing that includes a plurality of channels.
  • a first channel is configured to slidably receive the camera module, which can be configured for a snap-fit engagement with the first channel.
  • a second channel is configured to slidably receive the light source module, which can be configured for a snap-fit engagement with the second channel.
  • the camera module and/or the light source module can be rotated into a final position within their respective channels.
  • a threaded engagement can be employed in lieu of the snap-fit engagement.
  • multiple imaging devices are placed at different positions in the surgical field to provide multiple views.
  • the imaging module 138 can be configured to switch between the imaging devices to provide an optimal view.
  • the imaging module 138 can be configured to integrate the images from the different imaging device.
  • FIG. 8 illustrates a surgical data network 201 comprising a modular communication hub 203 configured to connect modular devices located in one or more operating theaters of a healthcare facility, or any room in a healthcare facility specially equipped for surgical operations, to a cloud-based system (e.g., the cloud 204 that may include a remote server 213 coupled to a storage device 205).
  • the modular communication hub 203 comprises a network hub 207 and/or a network switch 209 in communication with a network router.
  • the modular communication hub 203 also can be coupled to a local computer system 210 to provide local computer processing and data manipulation.
  • the surgical data network 201 may be configured as passive, intelligent, or switching.
  • a passive surgical data network serves as a conduit for the data, enabling it to go from one device (or segment) to another and to the cloud computing resources.
  • An intelligent surgical data network includes additional features to enable the traffic passing through the surgical data network to be monitored and to configure each port in the network hub 207 or network switch 209.
  • An intelligent surgical data network may be referred to as a manageable hub or switch.
  • a switching hub reads the destination address of each packet and then forwards the packet to the correct port.
  • Modular devices 1 a-1 n located in the operating theater may be coupled to the modular communication hub 203.
  • the network hub 207 and/or the network switch 209 may be coupled to a network router 21 1 to connect the devices 1 a-1 n to the cloud 204 or the local computer system 210.
  • Data associated with the devices 1 a-1 n may be transferred to cloud-based computers via the router for remote data processing and manipulation.
  • Data associated with the devices 1 a-1 n also may be transferred to the local computer system 210 for local data processing and manipulation.
  • Modular devices 2a-2m located in the same operating theater also may be coupled to a network switch 209.
  • the network switch 209 may be coupled to the network hub 207 and/or the network router 21 1 to connect to the devices 2a-2m to the cloud 204.
  • Data associated with the devices 2a-2n may be transferred to the cloud 204 via the network router 21 1 for data processing and manipulation.
  • Data associated with the devices 2a- 2m also may be transferred to the local computer system 210 for local data processing and manipulation.
  • the surgical data network 201 may be expanded by interconnecting multiple network hubs 207 and/or multiple network switches 209 with multiple network routers 21 1.
  • the modular communication hub 203 may be contained in a modular control tower configured to receive multiple devices 1 a-1 n/2a-2m.
  • the local computer system 210 also may be contained in a modular control tower.
  • the modular communication hub 203 is connected to a display 212 to display images obtained by some of the devices 1 a-1 n/2a-2m, for example during surgical procedures.
  • the devices 1 a-1 n/2a-2m may include, for example, various modules such as an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, a suction/irrigation module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device coupled to a display, and/or a non-contact sensor module, among other modular devices that may be connected to the modular communication hub 203 of the surgical data network 201 .
  • various modules such as an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, a suction/irrigation module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device coupled to a display, and/or a non-contact sensor module, among other modular devices that may be connected to the modular communication hub 203 of the surgical data network 201 .
  • the surgical data network 201 may comprise a combination of network hub(s), network switch(es), and network router(s) connecting the devices 1 a-1 n/2a-2m to the cloud. Any one of or all of the devices 1 a-1 n/2a-2m coupled to the network hub or network switch may collect data in real time and transfer the data to cloud computers for data processing and manipulation. It will be appreciated that cloud computing relies on sharing computing resources rather than having local servers or personal devices to handle software applications.
  • the word“cloud” may be used as a metaphor for“the Internet,” although the term is not limited as such. Accordingly, the term“cloud computing” may be used herein to refer to“a type of Internet-based computing,” where different services— such as servers, storage, and
  • the cloud infrastructure may be maintained by a cloud service provider.
  • the cloud service provider may be the entity that coordinates the usage and control of the devices 1 a-1 n/2a-2m located in one or more operating theaters.
  • the cloud computing services can perform a large number of calculations based on the data gathered by smart surgical instruments, robots, and other computerized devices located in the operating theater.
  • the hub hardware enables multiple devices or connections to be connected to a computer that communicates with the cloud computing resources and storage.
  • the surgical data network provides improved surgical outcomes, reduced costs, and improved patient satisfaction.
  • At least some of the devices 1 a-1 n/2a-2m may be employed to view tissue states to assess leaks or perfusion of sealed tissue after a tissue sealing and cutting procedure.
  • At least some of the devices 1 a-1 n/2a-2m may be employed to identify pathology, such as the effects of diseases, using the cloud-based computing to examine data including images of samples of body tissue for diagnostic purposes. This includes localization and margin confirmation of tissue and phenotypes.
  • At least some of the devices 1 a- 1 n/2a-2m may be employed to identify anatomical structures of the body using a variety of sensors integrated with imaging devices and techniques such as overlaying images captured by multiple imaging devices.
  • the data gathered by the devices 1 a-1 n/2a-2m, including image data, may be transferred to the cloud 204 or the local computer system 210 or both for data processing and manipulation including image processing and manipulation.
  • the data may be analyzed to improve surgical procedure outcomes by determining if further treatment, such as the application of endoscopic intervention, emerging technologies, a targeted radiation, targeted intervention, and precise robotics to tissue-specific sites and conditions, may be pursued.
  • Such data analysis may further employ outcome analytics processing, and using standardized approaches may provide beneficial feedback to either confirm surgical treatments and the behavior of the surgeon or suggest modifications to surgical treatments and the behavior of the surgeon.
  • the operating theater devices 1 a-1 n may be connected to the modular communication hub 203 over a wired channel or a wireless channel depending on the configuration of the devices 1 a-1 n to a network hub.
  • the network hub 207 may be implemented, in one aspect, as a local network broadcast device that works on the physical layer of the Open System Interconnection (OSI) model.
  • the network hub provides connectivity to the devices l a i n located in the same operating theater network.
  • the network hub 207 collects data in the form of packets and sends them to the router in half duplex mode.
  • the network hub 207 does not store any media access control/Internet Protocol (MAC/IP) to transfer the device data.
  • MAC/IP media access control/Internet Protocol
  • the network hub 207 has no routing tables or intelligence regarding where to send information and broadcasts all network data across each connection and to a remote server 213 (FIG. 9) over the cloud 204.
  • the network hub 207 can detect basic network errors such as collisions, but having all information broadcast to multiple ports can be a security risk and cause bottlenecks.
  • the operating theater devices 2a-2m may be connected to a network switch 209 over a wired channel or a wireless channel.
  • the network switch 209 works in the data link layer of the OSI model.
  • the network switch 209 is a multicast device for connecting the devices 2a-2m located in the same operating theater to the network.
  • the network switch 209 sends data in the form of frames to the network router 21 1 and works in full duplex mode.
  • Multiple devices 2a-2m can send data at the same time through the network switch 209.
  • the network switch 209 stores and uses MAC addresses of the devices 2a-2m to transfer data.
  • the network hub 207 and/or the network switch 209 are coupled to the network router 21 1 for connection to the cloud 204.
  • the network router 21 1 works in the network layer of the OSI model.
  • the network router 21 1 creates a route for transmitting data packets received from the network hub 207 and/or network switch 21 1 to cloud-based computer resources for further processing and manipulation of the data collected by any one of or all the devices 1 a-1 n/2a-2m.
  • the network router 21 1 may be employed to connect two or more different networks located in different locations, such as, for example, different operating theaters of the same healthcare facility or different networks located in different operating theaters of different healthcare facilities.
  • the network router 21 1 sends data in the form of packets to the cloud 204 and works in full duplex mode. Multiple devices can send data at the same time.
  • the network router 21 1 uses IP addresses to transfer data.
  • the network hub 207 may be implemented as a USB hub, which allows multiple USB devices to be connected to a host computer.
  • the USB hub may expand a single USB port into several tiers so that there are more ports available to connect devices to the host system computer.
  • the network hub 207 may include wired or wireless capabilities to receive information over a wired channel or a wireless channel.
  • a wireless USB short-range, high-bandwidth wireless radio communication protocol may be employed for communication between the devices 1 a-1 n and devices 2a-2m located in the operating theater.
  • the operating theater devices 1 a-1 n/2a-2m may communicate to the modular communication hub 203 via Bluetooth wireless technology standard for exchanging data over short distances (using short-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz) from fixed and mobile devices and building personal area networks (PANs).
  • PANs personal area networks
  • the operating theater devices 1 a-1 n/2a-2m may communicate to the modular communication hub 203 via a number of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.1 1 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivatives thereof, as well as any other wireless and wired protocols that are designated as 3G, 4G, 5G, and beyond.
  • the computing module may include a plurality of communication modules.
  • a first communication module may be dedicated to shorter-range wireless communications such as Wi-Fi and Bluetooth, and a second communication module may be dedicated to longer-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, and others.
  • the modular communication hub 203 may serve as a central connection for one or all of the operating theater devices 1 a-1 n/2a-2m and handles a data type known as frames.
  • Frames carry the data generated by the devices 1 a-1 n/2a-2m.
  • a frame is received by the modular communication hub 203, it is amplified and transmitted to the network router 21 1 , which transfers the data to the cloud computing resources by using a number of wireless or wired communication standards or protocols, as described herein.
  • the modular communication hub 203 can be used as a standalone device or be connected to compatible network hubs and network switches to form a larger network.
  • the modular communication hub 203 is generally easy to install, configure, and maintain, making it a good option for networking the operating theater devices 1 a-1 n/2a-2m.
  • FIG. 9 illustrates a computer-implemented interactive surgical system 200.
  • the computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100.
  • the computer- implemented interactive surgical system 200 includes one or more surgical systems 202, which are similar in many respects to the surgical systems 102.
  • Each surgical system 202 includes at least one surgical hub 206 in communication with a cloud 204 that may include a remote server 213.
  • the computer-implemented interactive surgical system 200 comprises a modular control tower 236 connected to multiple operating theater devices such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating theater. As shown in FIG.
  • the modular control tower 236 comprises a modular communication hub 203 coupled to a computer system 210.
  • the modular control tower 236 is coupled to an imaging module 238 that is coupled to an endoscope 239, a generator module 240 that is coupled to an energy device 241 , a smoke evacuator module 226, a suction/irrigation module 228, a communication module 230, a processor module 232, a storage array 234, a smart device/instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242.
  • the operating theater devices are coupled to cloud computing resources and data storage via the modular control tower 236.
  • a robot hub 222 also may be connected to the modular control tower 236 and to the cloud computing resources.
  • the devices/instruments 235, visualization systems 208, among others, may be coupled to the modular control tower 236 via wired or wireless communication standards or protocols, as described herein.
  • the modular control tower 236 may be coupled to a hub display 215 (e.g., monitor, screen) to display and overlay images received from the imaging module, device/instrument display, and/or other visualization systems 208.
  • the hub display also may display data received from devices connected to the modular control tower in conjunction with images and overlaid images.
  • FIG. 10 illustrates a surgical hub 206 comprising a plurality of modules coupled to the modular control tower 236.
  • the modular control tower 236 comprises a modular communication hub 203, e.g., a network connectivity device, and a computer system 210 to provide local processing, visualization, and imaging, for example.
  • the modular communication hub 203 may be connected in a tiered configuration to expand the number of modules (e.g., devices) that may be connected to the modular communication hub 203 and transfer data associated with the modules to the computer system 210, cloud computing resources, or both.
  • each of the network hubs/switches in the modular communication hub 203 includes three downstream ports and one upstream port.
  • the upstream network hub/switch is connected to a processor to provide a communication connection to the cloud computing resources and a local display 217. Communication to the cloud 204 may be made either through a wired or a wireless communication channel.
  • the surgical hub 206 employs a non-contact sensor module 242 to measure the dimensions of the operating theater and generate a map of the surgical theater using either ultrasonic or laser-type non-contact measurement devices.
  • An ultrasound-based non-contact sensor module scans the operating theater by transmitting a burst of ultrasound and receiving the echo when it bounces off the perimeter walls of an operating theater as described under the heading“Surgical Hub Spatial Awareness Within an Operating Room” in U.S. Provisional Patent Application Serial No. 62/61 1 ,341 , titled INTERACTIVE SURGICAL PLATFORM, filed
  • a laser-based non-contact sensor module scans the operating theater by transmitting laser light pulses, receiving laser light pulses that bounce off the perimeter walls of the operating theater, and comparing the phase of the transmitted pulse to the received pulse to determine the size of the operating theater and to adjust Bluetooth pairing distance limits, for example.
  • the computer system 210 comprises a processor 244 and a network interface 245.
  • the processor 244 is coupled to a communication module 247, storage 248, memory 249, non volatile memory 250, and input/output interface 251 via a system bus.
  • the system bus can be any of several types of bus structure(s) including the memory bus or memory controller, a peripheral bus or external bus, and/or a local bus using any variety of available bus architectures including, but not limited to, 9-bit bus, Industrial Standard Architecture (ISA), Micro-Charmel Architecture (MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association bus (PCMCIA), Small Computer Systems Interface (SCSI), or any other proprietary bus.
  • ISA Industrial Standard Architecture
  • MSA Micro-Charmel Architecture
  • EISA Extended ISA
  • IDE Intelligent Drive Electronics
  • VLB VESA Local Bus
  • PCI Peripheral Component Interconnect
  • USB Advanced Graphics Port
  • AGP Advanced Graphics Port
  • the processor 244 may be any single-core or multicore processor such as those known under the trade name ARM Cortex by Texas Instruments.
  • the processor may be an LM4F230H5QR ARM Cortex-M4F Processor Core, available from Texas
  • Instruments for example, comprising an on-chip memory of 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB single-cycle serial random access memory (SRAM), an internal read-only memory (ROM) loaded with Stel laris Ware® software, a 2 KB electrically erasable
  • EEPROM programmable read-only memory
  • PWM pulse width modulation
  • QEI quadrature encoder inputs
  • ADCs 12-bit analog-to-digital converters
  • the processor 244 may comprise a safety controller comprising two controller-based families such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4, also by Texas Instruments.
  • the safety controller may be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.
  • the system memory includes volatile memory and non-volatile memory.
  • the basic input/output system (BIOS) containing the basic routines to transfer information between elements within the computer system, such as during start-up, is stored in non-volatile memory.
  • the non-volatile memory can include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory.
  • Volatile memory includes random-access memory (RAM), which acts as external cache memory.
  • RAM random-access memory
  • RAM is available in many forms such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and direct Rambus RAM (DRRAM).
  • DRAM dynamic RAM
  • SDRAM synchronous DRAM
  • DDR SDRAM double data rate SDRAM
  • ESDRAM enhanced SDRAM
  • SLDRAM Synchlink DRAM
  • DRRAM direct Rambus RAM
  • the computer system 210 also includes removable/non-removable, volatile/non volatile computer storage media, such as for example disk storage.
  • the disk storage includes, but is not limited to, devices like a magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zip drive, LS-60 drive, flash memory card, or memory stick.
  • the disk storage can include storage media separately or in combination with other storage media including, but not limited to, an optical disc drive such as a compact disc ROM device (CD-ROM), compact disc recordable drive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or a digital versatile disc ROM drive (DVD-ROM).
  • CD-ROM compact disc ROM
  • CD-R Drive compact disc recordable drive
  • CD-RW Drive compact disc rewritable drive
  • DVD-ROM digital versatile disc ROM drive
  • a removable or non-removable interface may be employed.
  • the computer system 210 includes software that acts as an intermediary between users and the basic computer resources described in a suitable operating environment.
  • Such software includes an operating system.
  • the operating system which can be stored on the disk storage, acts to control and allocate resources of the computer system.
  • System applications take advantage of the management of resources by the operating system through program modules and program data stored either in the system memory or on the disk storage. It is to be appreciated that various components described herein can be implemented with various operating systems or combinations of operating systems.
  • a user enters commands or information into the computer system 210 through input device(s) coupled to the I/O interface 251.
  • the input devices include, but are not limited to, a pointing device such as a mouse, trackball, stylus, touch pad, keyboard, microphone, joystick, game pad, satellite dish, scanner, TV tuner card, digital camera, digital video camera, web camera, and the like.
  • These and other input devices connect to the processor through the system bus via interface port(s).
  • the interface port(s) include, for example, a serial port, a parallel port, a game port, and a USB.
  • the output device(s) use some of the same types of ports as input device(s).
  • a USB port may be used to provide input to the computer system and to output information from the computer system to an output device.
  • An output adapter is provided to illustrate that there are some output devices like monitors, displays, speakers, and printers, among other output devices that require special adapters.
  • the output adapters include, by way of illustration and not limitation, video and sound cards that provide a means of connection between the output device and the system bus. It should be noted that other devices and/or systems of devices, such as remote computer(s), provide both input and output capabilities.
  • the computer system 210 can operate in a networked environment using logical connections to one or more remote computers, such as cloud computer(s), or local computers.
  • the remote cloud computer(s) can be a personal computer, server, router, network PC, workstation, microprocessor-based appliance, peer device, or other common network node, and the like, and typically includes many or all of the elements described relative to the computer system. For purposes of brevity, only a memory storage device is illustrated with the remote computer(s).
  • the remote computer(s) is logically connected to the computer system through a network interface and then physically connected via a communication connection.
  • the network interface encompasses communication networks such as local area networks (LANs) and wide area networks (WANs).
  • LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE 802.5 and the like.
  • WAN technologies include, but are not limited to, point-to-point links, circuit- switching networks like Integrated Services Digital Networks (ISDN) and variations thereon, packet switching networks, and Digital Subscriber Lines (DSL).
  • ISDN Integrated Services Digital Networks
  • DSL Digital Subscriber Lines
  • the computer system 210 of FIG. 10, the imaging module 238 and/or visualization system 208, and/or the processor module 232 of FIGS. 9-10 may comprise an image processor, image-processing engine, media processor, or any specialized digital signal processor (DSP) used for the processing of digital images.
  • the image processor may employ parallel computing with single instruction, multiple data (SIMD) or multiple instruction, multiple data (MIMD) technologies to increase speed and efficiency.
  • SIMD single instruction, multiple data
  • MIMD multiple instruction, multiple data
  • the digital image- processing engine can perform a range of tasks.
  • the image processor may be a system on a chip with multicore processor architecture.
  • the communication connection(s) refers to the hardware/software employed to connect the network interface to the bus. While the communication connection is shown for illustrative clarity inside the computer system, it can also be external to the computer system 210.
  • the hardware/software necessary for connection to the network interface includes, for illustrative purposes only, internal and external technologies such as modems, including regular telephone-grade modems, cable modems, and DSL modems, ISDN adapters, and Ethernet cards.
  • FIG. 1 1 illustrates a functional block diagram of one aspect of a USB network hub 300 device, in accordance with at least one aspect of the present disclosure.
  • the USB network hub device 300 employs a TUSB2036 integrated circuit hub by Texas Instruments.
  • the USB network hub 300 is a CMOS device that provides an upstream USB transceiver port 302 and up to three downstream USB transceiver ports 304, 306, 308 in compliance with the USB 2.0 specification.
  • the upstream USB transceiver port 302 is a differential root data port comprising a differential data minus (DM0) input paired with a differential data plus (DP0) input.
  • DM0 differential data minus
  • DP0 differential data plus
  • the three downstream USB transceiver ports 304, 306, 308 are differential data ports where each port includes differential data plus (DP1 -DP3) outputs paired with differential data minus (DM1 -DM3) outputs.
  • the USB network hub 300 device is implemented with a digital state machine instead of a microcontroller, and no firmware programming is required. Fully compliant USB
  • the USB network hub 300 device may be configured either in bus-powered or self-powered mode and includes a hub power logic 312 to manage power.
  • the USB network hub 300 device includes a serial interface engine 310 (SIE).
  • SIE 310 is the front end of the USB network hub 300 hardware and handles most of the protocol described in chapter 8 of the USB specification.
  • the SIE 310 typically comprehends signaling up to the transaction level.
  • the functions that it handles could include: packet recognition, transaction sequencing, SOP, EOP, RESET, and RESUME signal detection/generation, clock/data separation, non-return-to-zero invert (NRZI) data encoding/decoding and bit-stuffing, CRC generation and checking (token and data), packet ID (PID) generation and
  • the 310 receives a clock input 314 and is coupled to a suspend/resume logic and frame timer 316 circuit and a hub repeater circuit 318 to control communication between the upstream USB transceiver port 302 and the downstream USB transceiver ports 304, 306, 308 through port logic circuits 320, 322, 324.
  • the SIE 310 is coupled to a command decoder 326 via interface logic to control commands from a serial EEPROM via a serial EEPROM interface 330.
  • the USB network hub 300 can connect 127 functions configured in up to six logical layers (tiers) to a single computer. Further, the USB network hub 300 can connect to all peripherals using a standardized four-wire cable that provides both
  • the power configurations are bus-powered and self- powered modes.
  • the USB network hub 300 may be configured to support four modes of power management: a bus-powered hub, with either individual-port power management or ganged-port power management, and the self-powered hub, with either individual-port power management or ganged-port power management.
  • the USB network hub 300, the upstream USB transceiver port 302 is plugged into a USB host controller, and the downstream USB transceiver ports 304, 306, 308 are exposed for connecting USB compatible devices, and so forth.
  • FIG. 12 illustrates a logic diagram of a control system 470 of a surgical instrument or tool in accordance with one or more aspects of the present disclosure.
  • the system 470 comprises a control circuit.
  • the control circuit includes a microcontroller 461 comprising a processor 462 and a memory 468.
  • One or more of sensors 472, 474, 476 for example, provide real-time feedback to the processor 462.
  • a tracking system 480 is configured to determine the position of the longitudinally movable displacement member.
  • the position information is provided to the processor 462, which can be programmed or configured to determine the position of the longitudinally movable drive member as well as the position of the closure member. Additional motors may be provided at the tool driver interface to control closure tube travel, shaft rotation, articulation, or clamp arm closure, or a combination of the above.
  • a display 473 displays a variety of operating conditions of the instruments and may include touch screen functionality for data input. Information displayed on the display 473 may be overlaid with images acquired via endoscopic imaging modules.
  • the microcontroller 461 may be any single-core or multicore processor such as those known under the trade name ARM Cortex by Texas Instruments.
  • the main microcontroller 461 may be an LM4F230H5QR ARM Cortex-M4F Processor Core, available from Texas Instruments, for example, comprising an on-chip memory of 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB single-cycle SRAM, and internal ROM loaded with StellarisWare® software, a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and/or one or more 12-bit ADCs with 12 analog input channels, details of which are available for the product datasheet.
  • the microcontroller 461 may comprise a safety controller comprising two controller-based families such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4, also by Texas Instruments.
  • the safety controller may be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.
  • the microcontroller 461 may be programmed to perform various functions such as precise control over the speed and position of the knife, articulation systems, clamp arm, or a combination of the above.
  • the microcontroller 461 includes a processor 462 and a memory 468.
  • the electric motor 482 may be a brushed direct current (DC) motor with a gearbox and mechanical links to an articulation or knife system.
  • a motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers may be readily substituted for use in the tracking system 480 comprising an absolute positioning system. A detailed description of an absolute positioning system is described in U.S. Patent Application Publication No. 2017/0296213, titled SYSTEMS AND METHODS FOR
  • the microcontroller 461 may be programmed to provide precise control over the speed and position of displacement members and articulation systems.
  • the microcontroller 461 may be configured to compute a response in the software of the microcontroller 461.
  • the computed response is compared to a measured response of the actual system to obtain an“observed” response, which is used for actual feedback decisions.
  • the observed response is a favorable, tuned value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect outside influences on the system.
  • the motor 482 may be controlled by the motor driver 492 and can be employed by the firing system of the surgical instrument or tool.
  • the motor 482 may be a brushed DC driving motor having a maximum rotational speed of approximately 25,000 RPM.
  • the motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor.
  • the motor driver 492 may comprise an H-bridge driver comprising field-effect transistors (FETs), for example.
  • FETs field-effect transistors
  • the motor 482 can be powered by a power assembly releasably mounted to the handle assembly or tool housing for supplying control power to the surgical instrument or tool.
  • the power assembly may comprise a battery which may include a number of battery cells connected in series that can be used as the power source to power the surgical instrument or tool.
  • the battery cells of the power assembly may be replaceable and/or rechargeable battery cells.
  • the battery cells can be lithium-ion batteries which can be couplable to and separable from the power assembly.
  • the motor driver 492 may be an A3941 available from Allegro Microsystems, Inc.
  • the A3941 492 is a full-bridge controller for use with external N-channel power metal-oxide semiconductor field-effect transistors (MOSFETs) specifically designed for inductive loads, such as brush DC motors.
  • the driver 492 comprises a unique charge pump regulator that provides full (>10 V) gate drive for battery voltages down to 7 V and allows the A3941 to operate with a reduced gate drive, down to 5.5 V.
  • a bootstrap capacitor may be employed to provide the above battery supply voltage required for N-channel MOSFET s.
  • An internal charge pump for the high- side drive allows DC (100% duty cycle) operation.
  • the full bridge can be driven in fast or slow decay modes using diode or synchronous rectification.
  • current recirculation can be through the high-side or the low-side FETs.
  • the power FETs are protected from shoot-through by resistor-adjustable dead time.
  • Integrated diagnostics provide indications of undervoltage, overtemperature, and power bridge faults and can be configured to protect the power MOSFETs under most short circuit conditions.
  • Other motor drivers may be readily substituted for use in the tracking system 480 comprising an absolute positioning system.
  • the tracking system 480 comprises a controlled motor drive circuit arrangement comprising a position sensor 472 according to one aspect of this disclosure.
  • the position sensor 472 for an absolute positioning system provides a unique position signal corresponding to the location of a displacement member.
  • the displacement member represents a longitudinally movable drive member comprising a rack of drive teeth for meshing engagement with a corresponding drive gear of a gear reducer assembly.
  • the displacement member represents the firing member, which could be adapted and configured to include a rack of drive teeth.
  • the displacement member represents a longitudinal displacement member to open and close a clamp arm, which can be adapted and configured to include a rack of drive teeth.
  • the displacement member represents a clamp arm closure member configured to close and to open a clamp arm of a stapler, ultrasonic, or electrosurgical device, or combinations of the above.
  • the term displacement member is used generically to refer to any movable member of the surgical instrument or tool such as the drive member, the clamp arm, or any element that can be displaced. Accordingly, the absolute positioning system can, in effect, track the displacement of the clamp arm by tracking the linear displacement of the longitudinally movable drive member.
  • the absolute positioning system can be configured to track the position of a clamp arm in the process of closing or opening.
  • the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement.
  • the longitudinally movable drive member, or clamp arm, or combinations thereof may be coupled to any suitable linear displacement sensor.
  • Linear displacement sensors may include contact or non-contact displacement sensors.
  • Linear displacement sensors may comprise linear variable differential transformers (LVDT), differential variable reluctance transducers (DVRT), a slide potentiometer, a magnetic sensing system comprising a movable magnet and a series of linearly arranged Hall effect sensors, a magnetic sensing system comprising a fixed magnet and a series of movable, linearly arranged Hall effect sensors, an optical sensing system comprising a movable light source and a series of linearly arranged photo diodes or photo detectors, an optical sensing system comprising a fixed light source and a series of movable linearly, arranged photo diodes or photo detectors, or any combination thereof.
  • LVDT linear variable differential transformers
  • DVRT differential variable reluctance transducers
  • slide potentiometer a magnetic sensing system comprising a movable magnet and a series of linearly arranged Hall effect sensors
  • a magnetic sensing system comprising a fixed magnet and a series of movable, linearly arranged Hall effect sensors
  • the electric motor 482 can include a rotatable shaft that operably interfaces with a gear assembly that is mounted in meshing engagement with a set, or rack, of drive teeth on the displacement member.
  • a sensor element may be operably coupled to a gear assembly such that a single revolution of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member.
  • An arrangement of gearing and sensors can be connected to the linear actuator, via a rack and pinion arrangement, or a rotary actuator, via a spur gear or other connection.
  • a power source supplies power to the absolute positioning system and an output indicator may display the output of the absolute positioning system.
  • the displacement member represents the longitudinally movable drive member comprising a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of the gear reducer assembly.
  • the displacement member represents the longitudinally movable firing member to open and close a clamp arm.
  • a single revolution of the sensor element associated with the position sensor 472 is equivalent to a longitudinal linear displacement di of the of the displacement member, where di is the longitudinal linear distance that the displacement member moves from point“a” to point “b” after a single revolution of the sensor element coupled to the displacement member.
  • the sensor arrangement may be connected via a gear reduction that results in the position sensor 472 completing one or more revolutions for the full stroke of the displacement member.
  • the position sensor 472 may complete multiple revolutions for the full stroke of the displacement member.
  • a series of switches where n is an integer greater than one, may be employed alone or in combination with a gear reduction to provide a unique position signal for more than one revolution of the position sensor 472. The state of the switches are fed back to the
  • the microcontroller 461 that applies logic to determine a unique position signal corresponding to the longitudinal linear displacement di + d 2 + ... d n of the displacement member.
  • the output of the position sensor 472 is provided to the microcontroller 461 .
  • the position sensor 472 of the sensor arrangement may comprise a magnetic sensor, an analog rotary sensor like a potentiometer, or an array of analog Hall-effect elements, which output a unique combination of position signals or values.
  • the position sensor 472 may comprise any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or the vector components of the magnetic field.
  • magnetic sensing elements such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or the vector components of the magnetic field.
  • the techniques used to produce both types of magnetic sensors encompass many aspects of physics and electronics.
  • the technologies used for magnetic field sensing include search coil, fluxgate, optically pumped, nuclear precession, SQUID, Hall-effect, anisotropic magnetoresistance, giant
  • magnetostrictive/piezoelectric composites magnetostrictive/piezoelectric composites, magnetodiode, magnetotransistor, fiber-optic, magneto-optic, and microelectromechanical systems-based magnetic sensors, among others.
  • the position sensor 472 for the tracking system 480 comprising an absolute positioning system comprises a magnetic rotary absolute positioning system.
  • the position sensor 472 may be implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG.
  • the position sensor 472 is interfaced with the microcontroller 461 to provide an absolute positioning system.
  • the position sensor 472 is a low-voltage and low-power component and includes four Hall-effect elements in an area of the position sensor 472 that is located above a magnet.
  • a high-resolution ADC and a smart power management controller are also provided on the chip.
  • a coordinate rotation digital computer (CORDIC) processor also known as the digit-by-digit method and Volder’s algorithm, is provided to implement a simple and efficient algorithm to calculate hyperbolic and
  • the angle position, alarm bits, and magnetic field information are transmitted over a standard serial communication interface, such as a serial peripheral interface (SPI) interface, to the microcontroller 461 .
  • SPI serial peripheral interface
  • the position sensor 472 provides 12 or 14 bits of resolution.
  • the position sensor 472 may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85mm package.
  • the tracking system 480 comprising an absolute positioning system may comprise and/or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller.
  • a power source converts the signal from the feedback controller into a physical input to the system: in this case the voltage.
  • Other examples include a PWM of the voltage, current, and force.
  • Other sensor(s) may be provided to measure physical parameters of the physical system in addition to the position measured by the position sensor 472.
  • the other sensor(s) can include sensor arrangements such as those described in U.S. Patent No.
  • an absolute positioning system is coupled to a digital data acquisition system where the output of the absolute positioning system will have a finite resolution and sampling frequency.
  • the absolute positioning system may comprise a compare-and-combine circuit to combine a computed response with a measured response using algorithms, such as a weighted average and a theoretical control loop, that drive the computed response towards the measured response.
  • the computed response of the physical system takes into account properties like mass, inertia, viscous friction, inductance resistance, etc., to predict what the states and outputs of the physical system will be by knowing the input.
  • the absolute positioning system provides an absolute position of the displacement member upon power-up of the instrument, without retracting or advancing the displacement member to a reset (zero or home) position as may be required with conventional rotary encoders that merely count the number of steps forwards or backwards that the motor 482 has taken to infer the position of a device actuator, drive bar, knife, or the like.
  • a sensor 474 such as, for example, a strain gauge or a micro-strain gauge, is configured to measure one or more parameters of the end effector, such as, for example, the amplitude of the strain exerted on the anvil during a clamping operation, which can be indicative of the closure forces applied to the anvil.
  • the measured strain is converted to a digital signal and provided to the processor 462.
  • a sensor 476 such as, for example, a load sensor, can measure the closure force applied by the closure drive system to the anvil in a stapler or a clamp arm in an ultrasonic or electrosurgical instrument.
  • the sensor 476 such as, for example, a load sensor, can measure the firing force applied to a closure member coupled to a clamp arm of the surgical instrument or tool or the force applied by a clamp arm to tissue located in the jaws of an ultrasonic or electrosurgical instrument.
  • a current sensor 478 can be employed to measure the current drawn by the motor 482.
  • the displacement member also may be configured to engage a clamp arm to open or close the clamp arm.
  • the force sensor may be configured to measure the clamping force on tissue. The force required to advance the displacement member can correspond to the current drawn by the motor 482, for example. The measured force is converted to a digital signal and provided to the processor 462.
  • the strain gauge sensor 474 can be used to measure the force applied to the tissue by the end effector.
  • a strain gauge can be coupled to the end effector to measure the force on the tissue being treated by the end effector.
  • a system for measuring forces applied to the tissue grasped by the end effector comprises a strain gauge sensor 474, such as, for example, a micro-strain gauge, that is configured to measure one or more parameters of the end effector, for example.
  • the strain gauge sensor 474 can measure the amplitude or magnitude of the strain exerted on a jaw member of an end effector during a clamping operation, which can be indicative of the tissue compression. The measured strain is converted to a digital signal and provided to a processor 462 of the microcontroller 461 .
  • a load sensor 476 can measure the force used to operate the knife element, for example, to cut the tissue captured between the anvil and the staple cartridge.
  • a load sensor 476 can measure the force used to operate the clamp arm element, for example, to capture tissue between the clamp arm and an ultrasonic blade or to capture tissue between the clamp arm and a jaw of an electrosurgical instrument.
  • a magnetic field sensor can be employed to measure the thickness of the captured tissue. The measurement of the magnetic field sensor also may be converted to a digital signal and provided to the processor 462.
  • a memory 468 may store a technique, an equation, and/or a lookup table which can be employed by the microcontroller 461 in the assessment.
  • control system 470 of the surgical instrument or tool also may comprise wired or wireless communication circuits to communicate with the modular communication hub as shown in FIGS. 8-1 1 .
  • FIG. 13 illustrates a control circuit 500 configured to control aspects of the surgical instrument or tool according to one aspect of this disclosure.
  • the control circuit 500 can be configured to implement various processes described herein.
  • the control circuit 500 may comprise a microcontroller comprising one or more processors 502 (e.g., microprocessor, microcontroller) coupled to at least one memory circuit 504.
  • the memory circuit 504 stores machine-executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions to implement various processes described herein.
  • the processor 502 may be any one of a number of single-core or multicore processors known in the art.
  • the memory circuit 504 may comprise volatile and non-volatile storage media.
  • the processor 502 may include an instruction processing unit 506 and an arithmetic unit 508.
  • the instruction processing unit may be configured to receive instructions from the memory circuit 504 of this disclosure.
  • FIG. 14 illustrates a combinational logic circuit 510 configured to control aspects of the surgical instrument or tool according to one aspect of this disclosure.
  • the combinational logic circuit 510 can be configured to implement various processes described herein.
  • combinational logic circuit 510 may comprise a finite state machine comprising a combinational logic 512 configured to receive data associated with the surgical instrument or tool at an input 514, process the data by the combinational logic 512, and provide an output 516.
  • FIG. 15 illustrates a sequential logic circuit 520 configured to control aspects of the surgical instrument or tool according to one aspect of this disclosure.
  • the sequential logic circuit 520 or the combinational logic 522 can be configured to implement various processes described herein.
  • the sequential logic circuit 520 may comprise a finite state machine.
  • the sequential logic circuit 520 may comprise a combinational logic 522, at least one memory circuit 524, and a clock 529, for example.
  • the at least one memory circuit 524 can store a current state of the finite state machine.
  • the sequential logic circuit 520 may be synchronous or asynchronous.
  • the combinational logic 522 is configured to receive data associated with the surgical instrument or tool from an input 526, process the data by the combinational logic 522, and provide an output 528.
  • the circuit may comprise a combination of a processor (e.g., processor 502, FIG. 13) and a finite state machine to implement various processes herein.
  • the finite state machine may comprise a combination of a combinational logic circuit (e.g., combinational logic circuit 510, FIG. 14) and the sequential logic circuit 520.
  • FIG. 16 illustrates a surgical instrument or tool comprising a plurality of motors which can be activated to perform various functions.
  • a first motor can be activated to perform a first function
  • a second motor can be activated to perform a second function
  • a third motor can be activated to perform a third function
  • a fourth motor can be activated to perform a fourth function, and so on.
  • the plurality of motors of robotic surgical instrument 600 can be individually activated to cause firing, closure, and/or articulation motions in the end effector. The firing, closure, and/or articulation motions can be transmitted to the end effector through a shaft assembly, for example.
  • the surgical instrument system or tool may include a firing motor 602.
  • the firing motor 602 may be operably coupled to a firing motor drive assembly 604 which can be configured to transmit firing motions, generated by the motor 602 to the end effector, in particular to displace the clamp arm closure member.
  • the closure member may be retracted by reversing the direction of the motor 602, which also causes the clamp arm to open.
  • the surgical instrument or tool may include a closure motor 603.
  • the closure motor 603 may be operably coupled to a closure motor drive assembly 605 which can be configured to transmit closure motions, generated by the motor 603 to the end effector, in particular to displace a closure tube to close the anvil and compress tissue between the anvil and the staple cartridge.
  • the closure motor 603 may be operably coupled to a closure motor drive assembly 605 which can be configured to transmit closure motions, generated by the motor 603 to the end effector, in particular to displace a closure tube to close the clamp arm and compress tissue between the clamp arm and either an ultrasonic blade or jaw member of an electrosurgical device.
  • the closure motions may cause the end effector to transition from an open configuration to an approximated configuration to capture tissue, for example.
  • the end effector may be transitioned to an open position by reversing the direction of the motor 603.
  • the surgical instrument or tool may include one or more articulation motors 606a, 606b, for example.
  • the motors 606a, 606b may be operably coupled to respective articulation motor drive assemblies 608a, 608b, which can be configured to transmit articulation motions generated by the motors 606a, 606b to the end effector.
  • the articulation motions may cause the end effector to articulate relative to the shaft, for example.
  • the surgical instrument or tool may include a plurality of motors which may be configured to perform various independent functions.
  • the plurality of motors of the surgical instrument or tool can be individually or separately activated to perform one or more functions while the other motors remain inactive.
  • the articulation motors 606a, 606b can be activated to cause the end effector to be articulated while the firing motor 602 remains inactive.
  • the firing motor 602 can be activated to fire the plurality of staples, and/or to advance the cutting edge, while the articulation motor 606 remains inactive.
  • the closure motor 603 may be activated simultaneously with the firing motor 602 to cause the closure tube or closure member to advance distally as described in more detail hereinbelow.
  • the surgical instrument or tool may include a common control module 610 which can be employed with a plurality of motors of the surgical instrument or tool.
  • the common control module 610 may accommodate one of the plurality of motors at a time.
  • the common control module 610 can be couplable to and separable from the plurality of motors of the robotic surgical instrument individually.
  • a plurality of the motors of the surgical instrument or tool may share one or more common control modules such as the common control module 610.
  • a plurality of motors of the surgical instrument or tool can be individually and selectively engaged with the common control module 610.
  • the common control module 610 can be selectively switched from interfacing with one of a plurality of motors of the surgical instrument or tool to interfacing with another one of the plurality of motors of the surgical instrument or tool.
  • the common control module 610 can be selectively switched between operable engagement with the articulation motors 606a, 606b and operable
  • a switch 614 can be moved or transitioned between a plurality of positions and/or states. In a first position 616, the switch 614 may electrically couple the common control module 610 to the firing motor 602; in a second position 617, the switch 614 may electrically couple the common control module 610 to the closure motor 603; in a third position 618a, the switch 614 may electrically couple the common control module 610 to the first articulation motor 606a; and in a fourth position 618b, the switch 614 may electrically couple the common control module 610 to the second articulation motor 606b, for example.
  • separate common control modules 610 can be electrically coupled to the firing motor 602, the closure motor 603, and the articulations motor 606a, 606b at the same time.
  • the switch 614 may be a mechanical switch, an electromechanical switch, a solid- state switch, or any suitable switching mechanism.
  • Each of the motors 602, 603, 606a, 606b may comprise a torque sensor to measure the output torque on the shaft of the motor.
  • the force on an end effector may be sensed in any conventional manner, such as by force sensors on the outer sides of the jaws or by a torque sensor for the motor actuating the jaws.
  • the common control module 610 may comprise a motor driver 626 which may comprise one or more H-Bridge FETs.
  • the motor driver 626 may modulate the power transmitted from a power source 628 to a motor coupled to the common control module 610 based on input from a microcontroller 620 (the“controller”), for example.
  • the microcontroller 620 can be employed to determine the current drawn by the motor, for example, while the motor is coupled to the common control module 610, as described above.
  • the microcontroller 620 may include a microprocessor 622 (the “processor”) and one or more non-transitory computer-readable mediums or memory units 624 (the“memory”).
  • the memory 624 may store various program instructions, which when executed may cause the processor 622 to perform a plurality of functions and/or calculations described herein.
  • one or more of the memory units 624 may be coupled to the processor 622, for example.
  • the microcontroller 620 may communicate over a wired or wireless channel, or combinations thereof.
  • the power source 628 can be employed to supply power to the microcontroller 620, for example.
  • the power source 628 may comprise a battery (or“battery pack” or“power pack”), such as a lithium-ion battery, for example.
  • the battery pack may be configured to be releasably mounted to a handle for supplying power to the surgical instrument 600.
  • a number of battery cells connected in series may be used as the power source 628.
  • the power source 628 may be replaceable and/or rechargeable, for example.
  • the processor 622 may control the motor driver 626 to control the position, direction of rotation, and/or velocity of a motor that is coupled to the common control module 610. In certain instances, the processor 622 can signal the motor driver 626 to stop and/or disable a motor that is coupled to the common control module 610.
  • the term“processor” as used herein includes any suitable microprocessor, microcontroller, or other basic computing device that incorporates the functions of a computer’s central processing unit (CPU) on an integrated circuit or, at most, a few integrated circuits.
  • the processor 622 is a multipurpose, programmable device that accepts digital data as input, processes it according to instructions stored in its memory, and provides results as output. It is an example of sequential digital logic, as it has internal memory. Processors operate on numbers and symbols represented in the binary numeral system.
  • the processor 622 may be any single-core or multicore processor such as those known under the trade name ARM Cortex by Texas Instruments.
  • the microcontroller 620 may be an LM 4F230H5QR, available from Texas Instruments, for example.
  • the Texas Instruments LM4F230H5QR is an ARM Cortex- M4F Processor Core comprising an on-chip memory of 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB single-cycle SRAM, an internal ROM loaded with StellarisWare® software, a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, one or more 12-bit ADCs with 12 analog input channels, among other features that are readily available for the product datasheet.
  • Other microcontrollers may be readily substituted for use with the module 4410. Accordingly, the present disclosure should not be limited in this context.
  • the memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that are couplable to the common control module 610.
  • the memory 624 may include program instructions for controlling the firing motor 602, the closure motor 603, and the articulation motors 606a, 606b.
  • Such program instructions may cause the processor 622 to control the firing, closure, and articulation functions in accordance with inputs from algorithms or control programs of the surgical instrument or tool.
  • one or more mechanisms and/or sensors such as, for example, sensors 630 can be employed to alert the processor 622 to the program instructions that should be used in a particular setting.
  • the sensors 630 may alert the processor 622 to use the program instructions associated with firing, closing, and articulating the end effector.
  • the sensors 630 may comprise position sensors which can be employed to sense the position of the switch 614, for example.
  • the processor 622 may use the program instructions associated with firing the closure member coupled to the clamp arm of the end effector upon detecting, through the sensors 630 for example, that the switch 614 is in the first position 616; the processor 622 may use the program instructions associated with closing the anvil upon detecting, through the sensors 630 for example, that the switch 614 is in the second position 617; and the processor 622 may use the program instructions associated with articulating the end effector upon detecting, through the sensors 630 for example, that the switch 614 is in the third or fourth position 618a, 618b.
  • FIG. 17 is a schematic diagram of a robotic surgical instrument 700 configured to operate a surgical tool described herein according to one aspect of this disclosure.
  • the robotic surgical instrument 700 may be programmed or configured to control distal/proximal translation of a displacement member, distal/proximal displacement of a closure tube, shaft rotation, and articulation, either with single or multiple articulation drive links.
  • the surgical instrument 700 may be programmed or configured to individually control a firing member, a closure member, a shaft member, or one or more articulation members, or combinations thereof.
  • the surgical instrument 700 comprises a control circuit 710 configured to control motor- driven firing members, closure members, shaft members, or one or more articulation members, or combinations thereof.
  • the robotic surgical instrument 700 comprises a control circuit 710 configured to control a clamp arm 716 and a closure member 714 portion of an end effector 702, an ultrasonic blade 718 coupled to an ultrasonic transducer 719 excited by an ultrasonic generator 721 , a shaft 740, and one or more articulation members 742a, 742b via a plurality of motors 704a-704e.
  • a position sensor 734 may be configured to provide position feedback of the closure member 714 to the control circuit 710.
  • Other sensors 738 may be configured to provide feedback to the control circuit 710.
  • a timer/counter 731 provides timing and counting information to the control circuit 710.
  • An energy source 712 may be provided to operate the motors 704a- 704e, and a current sensor 736 provides motor current feedback to the control circuit 710.
  • the motors 704a-704e can be operated individually by the control circuit 710 in an open-loop or closed-loop feedback control.
  • control circuit 710 may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the processor or processors to perform one or more tasks.
  • a timer/counter 731 provides an output signal, such as the elapsed time or a digital count, to the control circuit 710 to correlate the position of the closure member 714 as determined by the position sensor 734 with the output of the timer/counter 731 such that the control circuit 710 can determine the position of the closure member 714 at a specific time (t) relative to a starting position or the time (t) when the closure member 714 is at a specific position relative to a starting position.
  • the timer/counter 731 may be configured to measure elapsed time, count external events, or time external events.
  • control circuit 710 may be programmed to control functions of the end effector 702 based on one or more tissue conditions.
  • the control circuit 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein.
  • the control circuit 710 may be programmed to select a firing control program or closure control program based on tissue conditions.
  • a firing control program may describe the distal motion of the displacement member. Different firing control programs may be selected to better treat different tissue conditions. For example, when thicker tissue is present, the control circuit 710 may be programmed to translate the displacement member at a lower velocity and/or with lower power. When thinner tissue is present, the control circuit 710 may be programmed to translate the displacement member at a higher velocity and/or with higher power.
  • a closure control program may control the closure force applied to the tissue by the clamp arm 716. Other control programs control the rotation of the shaft 740 and the articulation members 742a, 742b.
  • control circuit 710 may generate motor set point signals.
  • the motor set point signals may be provided to various motor controllers 708a-708e.
  • the motor controllers 708a-708e may comprise one or more circuits configured to provide motor drive signals to the motors 704a-704e to drive the motors 704a-704e as described herein.
  • the motors 704a-704e may be brushed DC electric motors.
  • the velocity of the motors 704a-704e may be proportional to the respective motor drive signals.
  • the motors 704a-704e may be brushless DC electric motors, and the respective motor drive signals may comprise a PWM signal provided to one or more stator windings of the motors 704a-704e. Also, in some examples, the motor controllers 708a-708e may be omitted and the control circuit 710 may generate the motor drive signals directly.
  • control circuit 710 may initially operate each of the motors 704a- 704e in an open-loop configuration for a first open-loop portion of a stroke of the displacement member. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the stroke, the control circuit 710 may select a firing control program in a closed-loop configuration.
  • the response of the instrument may include a translation distance of the displacement member during the open-loop portion, a time elapsed during the open-loop portion, the energy provided to one of the motors 704a-704e during the open-loop portion, a sum of pulse widths of a motor drive signal, etc.
  • the control circuit 710 may implement the selected firing control program for a second portion of the displacement member stroke. For example, during a closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e based on translation data describing a position of the displacement member in a closed-loop manner to translate the displacement member at a constant velocity.
  • the motors 704a-704e may receive power from an energy source 712.
  • the energy source 712 may be a DC power supply driven by a main alternating current power source, a battery, a super capacitor, or any other suitable energy source.
  • the motors 704a- 704e may be mechanically coupled to individual movable mechanical elements such as the closure member 714, clamp arm 716, shaft 740, articulation 742a, and articulation 742b via respective transmissions 706a-706e.
  • the transmissions 706a-706e may include one or more gears or other linkage components to couple the motors 704a-704e to movable mechanical elements.
  • a position sensor 734 may sense a position of the closure member 714.
  • the position sensor 734 may be or include any type of sensor that is capable of generating position data that indicate a position of the closure member 714.
  • the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuit 710 as the closure member 714 translates distally and proximally.
  • the control circuit 710 may track the pulses to determine the position of the closure member 714.
  • Other suitable position sensors may be used, including, for example, a proximity sensor.
  • Other types of position sensors may provide other signals indicating motion of the closure member 714.
  • the position sensor 734 may be omitted.
  • the control circuit 710 may track the position of the closure member 714 by aggregating the number and direction of steps that the motor 704 has been instructed to execute.
  • the position sensor 734 may be located in the end effector 702 or at any other portion of the instrument.
  • the outputs of each of the motors 704a-704e include a torque sensor 744a-744e to sense force and have an encoder to sense rotation of the drive shaft.
  • control circuit 710 is configured to drive a firing member such as the closure member 714 portion of the end effector 702.
  • the control circuit 710 provides a motor set point to a motor control 708a, which provides a drive signal to the motor 704a.
  • the output shaft of the motor 704a is coupled to a torque sensor 744a.
  • the torque sensor 744a is coupled to a transmission 706a which is coupled to the closure member 714.
  • the transmission 706a comprises movable mechanical elements such as rotating elements and a firing member to control the movement of the closure member 714 distally and proximally along a longitudinal axis of the end effector 702.
  • the motor 704a may be coupled to the knife gear assembly, which includes a knife gear reduction set that includes a first knife drive gear and a second knife drive gear.
  • a torque sensor 744a provides a firing force feedback signal to the control circuit 710.
  • the firing force signal represents the force required to fire or displace the closure member 714.
  • a position sensor 734 may be configured to provide the position of the closure member 714 along the firing stroke or the position of the firing member as a feedback signal to the control circuit 710.
  • the end effector 702 may include additional sensors 738 configured to provide feedback signals to the control circuit 710. When ready to use, the control circuit 710 may provide a firing signal to the motor control 708a.
  • the motor 704a may drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal stroke start position to a stroke end position distal to the stroke start position.
  • the clamp arm 716 closes towards the ultrasonic blade 718.
  • control circuit 710 is configured to drive a closure member such as the clamp arm 716 portion of the end effector 702.
  • the control circuit 710 provides a motor set point to a motor control 708b, which provides a drive signal to the motor 704b.
  • the output shaft of the motor 704b is coupled to a torque sensor 744b.
  • the torque sensor 744b is coupled to a transmission 706b which is coupled to the clamp arm 716.
  • the transmission 706b comprises movable mechanical elements such as rotating elements and a closure member to control the movement of the clamp arm 716 from the open and closed positions.
  • the motor 704b is coupled to a closure gear assembly, which includes a closure reduction gear set that is supported in meshing engagement with the closure spur gear.
  • the torque sensor 744b provides a closure force feedback signal to the control circuit 710.
  • the closure force feedback signal represents the closure force applied to the clamp arm 716.
  • the position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. Additional sensors 738 in the end effector 702 may provide the closure force feedback signal to the control circuit 710.
  • the pivotable clamp arm 716 is positioned opposite the ultrasonic blade 718.
  • the control circuit 710 may provide a closure signal to the motor control 708b.
  • the motor 704b advances a closure member to grasp tissue between the clamp arm 716 and the ultrasonic blade 718.
  • control circuit 710 is configured to rotate a shaft member such as the shaft 740 to rotate the end effector 702.
  • the control circuit 710 provides a motor set point to a motor control 708c, which provides a drive signal to the motor 704c.
  • the output shaft of the motor 704c is coupled to a torque sensor 744c.
  • the torque sensor 744c is coupled to a transmission 706c which is coupled to the shaft 740.
  • the transmission 706c comprises movable mechanical elements such as rotating elements to control the rotation of the shaft 740 clockwise or counterclockwise up to and over 360°.
  • the motor 704c is coupled to the rotational transmission assembly, which includes a tube gear segment that is formed on (or attached to) the proximal end of the proximal closure tube for operable engagement by a rotational gear assembly that is operably supported on the tool mounting plate.
  • the torque sensor 744c provides a rotation force feedback signal to the control circuit 710.
  • the rotation force feedback signal represents the rotation force applied to the shaft 740.
  • the position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. Additional sensors 738 such as a shaft encoder may provide the rotational position of the shaft 740 to the control circuit 710.
  • control circuit 710 is configured to articulate the end effector 702.
  • the control circuit 710 provides a motor set point to a motor control 708d, which provides a drive signal to the motor 704d.
  • the output shaft of the motor 704d is coupled to a torque sensor 744d.
  • the torque sensor 744d is coupled to a transmission 706d which is coupled to an articulation member 742a.
  • the transmission 706d comprises movable mechanical elements such as articulation elements to control the articulation of the end effector 702 ⁇ 65°.
  • the motor 704d is coupled to an articulation nut, which is rotatably journaled on the proximal end portion of the distal spine portion and is rotatably driven thereon by an articulation gear assembly.
  • the torque sensor 744d provides an articulation force feedback signal to the control circuit 710.
  • the articulation force feedback signal represents the articulation force applied to the end effector 702.
  • Sensors 738 such as an articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710.
  • the articulation function of the robotic surgical system 700 may comprise two articulation members, or links, 742a, 742b. These articulation members 742a,
  • each of articulation links 742a, 742b are driven by separate disks on the robot interface (the rack) which are driven by the two motors 708d, 708e.
  • each of articulation links 742a, 742b can be antagonistically driven with respect to the other link in order to provide a resistive holding motion and a load to the head when it is not moving and to provide an articulation motion as the head is articulated.
  • the articulation members 742a, 742b attach to the head at a fixed radius as the head is rotated. Accordingly, the mechanical advantage of the push-and-pull link changes as the head is rotated. This change in the mechanical advantage may be more pronounced with other articulation link drive systems.
  • the one or more motors 704a-704e may comprise a brushed DC motor with a gearbox and mechanical links to a firing member, closure member, or articulation member.
  • Another example includes electric motors 704a-704e that operate the movable mechanical elements such as the displacement member, articulation links, closure tube, and shaft.
  • An outside influence is an unmeasured, unpredictable influence of things like tissue, surrounding bodies, and friction on the physical system. Such outside influence can be referred to as drag, which acts in opposition to one of electric motors 704a-704e.
  • the outside influence, such as drag may cause the operation of the physical system to deviate from a desired operation of the physical system.
  • the position sensor 734 may be implemented as an absolute positioning system.
  • the position sensor 734 may comprise a magnetic rotary absolute positioning system implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG.
  • the position sensor 734 may interface with the control circuit 710 to provide an absolute positioning system.
  • the position may include multiple Hall-effect elements located above a magnet and coupled to a CORDIC processor, also known as the digit-by-digit method and Volder’s algorithm, that is provided to implement a simple and efficient algorithm to calculate hyperbolic and trigonometric functions that require only addition, subtraction, bitshift, and table lookup operations.
  • CORDIC processor also known as the digit-by-digit method and Volder’s algorithm
  • the control circuit 710 may be in communication with one or more sensors 738.
  • the sensors 738 may be positioned on the end effector 702 and adapted to operate with the robotic surgical instrument 700 to measure the various derived parameters such as the gap distance versus time, tissue compression versus time, and anvil strain versus time.
  • the sensors 738 may comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a load cell, a pressure sensor, a force sensor, a torque sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor for measuring one or more parameters of the end effector 702.
  • the sensors 738 may include one or more sensors.
  • the sensors 738 may be located on the clamp arm 716 to determine tissue location using segmented electrodes.
  • the torque sensors 744a- 744e may be configured to sense force such as firing force, closure force, and/or articulation force, among others. Accordingly, the control circuit 710 can sense (1 ) the closure load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) what portion of the ultrasonic blade 718 has tissue on it, and (4) the load and position on both articulation rods.
  • the one or more sensors 738 may comprise a strain gauge, such as a micro-strain gauge, configured to measure the magnitude of the strain in the clamp arm 716 during a clamped condition.
  • the strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain.
  • the sensors 738 may comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the clamp arm 716 and the ultrasonic blade 718.
  • the sensors 738 may be configured to detect impedance of a tissue section located between the clamp arm 716 and the ultrasonic blade 718 that is indicative of the thickness and/or fullness of tissue located therebetween.
  • the sensors 738 may be implemented as one or more limit switches, electromechanical devices, solid-state switches, Hall-effect devices, magneto-resistive (MR) devices, giant magneto-resistive (GMR) devices, magnetometers, among others.
  • the sensors 738 may be implemented as solid-state switches that operate under the influence of light, such as optical sensors, IR sensors, ultraviolet sensors, among others.
  • the switches may be solid-state devices such as transistors (e.g., FET, junction FET, MOSFET, bipolar, and the like).
  • the sensors 738 may include electrical conductorless switches, ultrasonic switches, accelerometers, and inertial sensors, among others.
  • the sensors 738 may be configured to measure forces exerted on the clamp arm 716 by the closure drive system.
  • one or more sensors 738 can be at an interaction point between the closure tube and the clamp arm 716 to detect the closure forces applied by the closure tube to the clamp arm 716.
  • the forces exerted on the clamp arm 716 can be representative of the tissue compression experienced by the tissue section captured between the clamp arm 716 and the ultrasonic blade 718.
  • the one or more sensors 738 can be positioned at various interaction points along the closure drive system to detect the closure forces applied to the clamp arm 716 by the closure drive system.
  • the one or more sensors 738 may be sampled in real time during a clamping operation by the processor of the control circuit 710.
  • the control circuit 710 receives real-time sample measurements to provide and analyze time-based information and assess, in real time, closure forces applied to the clamp arm 716.
  • a current sensor 736 can be employed to measure the current drawn by each of the motors 704a-704e.
  • the force required to advance any of the movable mechanical elements such as the closure member 714 corresponds to the current drawn by one of the motors 704a-704e.
  • the force is converted to a digital signal and provided to the control circuit 710.
  • the control circuit 710 can be configured to simulate the response of the actual system of the instrument in the software of the controller.
  • a displacement member can be actuated to move the closure member 714 in the end effector 702 at or near a target velocity.
  • the robotic surgical instrument 700 can include a feedback controller, which can be one of any feedback controllers, including, but not limited to a PID, a state feedback, a linear-quadratic (LQR), and/or an adaptive controller, for example.
  • the robotic surgical instrument 700 can include a power source to convert the signal from the feedback controller into a physical input such as case voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force, for example. Additional details are disclosed in U.S. Patent Application Serial No. 15/636,829, titled CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT, filed June 29, 2017, which is herein incorporated by reference in its entirety.
  • FIG. 18 illustrates a schematic diagram of a surgical instrument 750 configured to control the distal translation of a displacement member according to one aspect of this disclosure.
  • the surgical instrument 750 is programmed to control the distal translation of a displacement member such as the closure member 764.
  • the surgical instrument 750 comprises an end effector 752 that may comprise a clamp arm 766, a closure member 764, and an ultrasonic blade 768 coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771 .
  • the position, movement, displacement, and/or translation of a linear displacement member can be measured by an absolute positioning system, sensor arrangement, and position sensor 784. Because the closure member 764 is coupled to a longitudinally movable drive member, the position of the closure member 764 can be determined by measuring the position of the longitudinally movable drive member employing the position sensor 784. Accordingly, in the following description, the position, displacement, and/or translation of the closure member 764 can be achieved by the position sensor 784 as described herein.
  • a control circuit 760 may be programmed to control the translation of the displacement member, such as the closure member 764.
  • the control circuit 760 may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the processor or processors to control the displacement member, e.g., the closure member 764, in the manner described.
  • a timer/counter 781 provides an output signal, such as the elapsed time or a digital count, to the control circuit 760 to correlate the position of the closure member 764 as determined by the position sensor 784 with the output of the timer/counter 781 such that the control circuit 760 can determine the position of the closure member 764 at a specific time (t) relative to a starting position.
  • the timer/counter 781 may be configured to measure elapsed time, count external events, or time external events.
  • the control circuit 760 may generate a motor set point signal 772.
  • the motor set point signal 772 may be provided to a motor controller 758.
  • the motor controller 758 may comprise one or more circuits configured to provide a motor drive signal 774 to the motor 754 to drive the motor 754 as described herein.
  • the motor 754 may be a brushed DC electric motor.
  • the velocity of the motor 754 may be proportional to the motor drive signal 774.
  • the motor 754 may be a brushless DC electric motor and the motor drive signal 774 may comprise a PWM signal provided to one or more stator windings of the motor 754.
  • the motor controller 758 may be omitted, and the control circuit 760 may generate the motor drive signal 774 directly.
  • the motor 754 may receive power from an energy source 762.
  • the energy source 762 may be or include a battery, a super capacitor, or any other suitable energy source.
  • the motor 754 may be mechanically coupled to the closure member 764 via a transmission 756.
  • the transmission 756 may include one or more gears or other linkage components to couple the motor 754 to the closure member 764.
  • a position sensor 784 may sense a position of the closure member 764.
  • the position sensor 784 may be or include any type of sensor that is capable of generating position data that indicate a position of the closure member 764.
  • the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 as the closure member 764 translates distally and proximally.
  • the control circuit 760 may track the pulses to determine the position of the closure member 764.
  • Other suitable position sensors may be used, including, for example, a proximity sensor. Other types of position sensors may provide other signals indicating motion of the closure member 764.
  • the position sensor 784 may be omitted.
  • the control circuit 760 may track the position of the closure member 764 by aggregating the number and direction of steps that the motor 754 has been instructed to execute.
  • the position sensor 784 may be located in the end effector 752 or at any other portion of the instrument.
  • the control circuit 760 may be in communication with one or more sensors 788.
  • the sensors 788 may be positioned on the end effector 752 and adapted to operate with the surgical instrument 750 to measure the various derived parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time.
  • the sensors 788 may comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor for measuring one or more parameters of the end effector 752.
  • the sensors 788 may include one or more sensors.
  • the one or more sensors 788 may comprise a strain gauge, such as a micro-strain gauge, configured to measure the magnitude of the strain in the clamp arm 766 during a clamped condition.
  • the strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain.
  • the sensors 788 may comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the clamp arm 766 and the ultrasonic blade 768.
  • the sensors 788 may be configured to detect impedance of a tissue section located between the clamp arm 766 and the ultrasonic blade 768 that is indicative of the thickness and/or fullness of tissue located therebetween.
  • the sensors 788 may be is configured to measure forces exerted on the clamp arm 766 by a closure drive system.
  • one or more sensors 788 can be at an interaction point between a closure tube and the clamp arm 766 to detect the closure forces applied by a closure tube to the clamp arm 766.
  • the forces exerted on the clamp arm 766 can be
  • the one or more sensors 788 can be positioned at various interaction points along the closure drive system to detect the closure forces applied to the clamp arm 766 by the closure drive system.
  • the one or more sensors 788 may be sampled in real time during a clamping operation by a processor of the control circuit 760.
  • the control circuit 760 receives real-time sample measurements to provide and analyze time-based information and assess, in real time, closure forces applied to the clamp arm 766.
  • a current sensor 786 can be employed to measure the current drawn by the motor 754.
  • the force required to advance the closure member 764 corresponds to the current drawn by the motor 754.
  • the force is converted to a digital signal and provided to the control circuit 760.
  • the control circuit 760 can be configured to simulate the response of the actual system of the instrument in the software of the controller.
  • a displacement member can be actuated to move a closure member 764 in the end effector 752 at or near a target velocity.
  • the surgical instrument 750 can include a feedback controller, which can be one of any feedback controllers, including, but not limited to a PID, a state feedback, LQR, and/or an adaptive controller, for example.
  • the surgical instrument 750 can include a power source to convert the signal from the feedback controller into a physical input such as case voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force, for example.
  • the actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member, or closure member 764, by a brushed DC motor with gearbox and mechanical links to an articulation and/or knife system.
  • a brushed DC motor with gearbox and mechanical links to an articulation and/or knife system.
  • the electric motor 754 that operates the displacement member and the articulation driver, for example, of an interchangeable shaft assembly.
  • An outside influence is an unmeasured, unpredictable influence of things like tissue, surrounding bodies and friction on the physical system. Such outside influence can be referred to as drag which acts in opposition to the electric motor 754.
  • the outside influence, such as drag may cause the operation of the physical system to deviate from a desired operation of the physical system.
  • a surgical instrument 750 comprising an end effector 752 with motor-driven surgical sealing and cutting implements.
  • a motor 754 may drive a displacement member distally and proximally along a longitudinal axis of the end effector 752.
  • the end effector 752 may comprise a pivotable clamp arm 766 and, when configured for use, an ultrasonic blade 768 positioned opposite the clamp arm 766.
  • a clinician may grasp tissue between the clamp arm 766 and the ultrasonic blade 768, as described herein.
  • the clinician may provide a firing signal, for example by depressing a trigger of the instrument 750.
  • the motor 754 may drive the displacement member distally along the longitudinal axis of the end effector 752 from a proximal stroke begin position to a stroke end position distal of the stroke begin position.
  • the closure member 764 with a cutting element positioned at a distal end may cut the tissue between the ultrasonic blade 768 and the clamp arm 766.
  • the surgical instrument 750 may comprise a control circuit 760 programmed to control the distal translation of the displacement member, such as the closure member 764, for example, based on one or more tissue conditions.
  • the control circuit 760 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein.
  • the control circuit 760 may be programmed to select a control program based on tissue conditions.
  • a control program may describe the distal motion of the displacement member. Different control programs may be selected to better treat different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a lower velocity and/or with lower power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher velocity and/or with higher power.
  • the control circuit 760 may initially operate the motor 754 in an open loop configuration for a first open loop portion of a stroke of the displacement member. Based on a response of the instrument 750 during the open loop portion of the stroke, the control circuit 760 may select a firing control program.
  • the response of the instrument may include, a translation distance of the displacement member during the open loop portion, a time elapsed during the open loop portion, energy provided to the motor 754 during the open loop portion, a sum of pulse widths of a motor drive signal, etc.
  • the control circuit 760 may implement the selected firing control program for a second portion of the displacement member stroke.
  • control circuit 760 may modulate the motor 754 based on translation data describing a position of the displacement member in a closed loop manner to translate the displacement member at a constant velocity. Additional details are disclosed in U.S. Patent Application Serial No.
  • FIG. 19 is a schematic diagram of a surgical instrument 790 configured to control various functions according to one aspect of this disclosure.
  • the surgical instrument 790 is programmed to control distal translation of a displacement member such as the closure member 764.
  • the surgical instrument 790 comprises an end effector 792 that may comprise a clamp arm 766, a closure member 764, and an ultrasonic blade 768 which may be interchanged with or work in conjunction with one or more RF electrodes 796 (shown in dashed line).
  • the ultrasonic blade 768 is coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771 .
  • sensors 788 may be implemented as a limit switch, electromechanical device, solid-state switches, Hall-effect devices, MR devices, GMR devices, magnetometers, among others.
  • the sensors 638 may be solid-state switches that operate under the influence of light, such as optical sensors, IR sensors, ultraviolet sensors, among others.
  • the switches may be solid-state devices such as transistors (e.g., FET, junction FET, MOSFET, bipolar, and the like).
  • the sensors 788 may include electrical conductorless switches, ultrasonic switches, accelerometers, and inertial sensors, among others.
  • the position sensor 784 may be implemented as an absolute positioning system comprising a magnetic rotary absolute positioning system implemented as an
  • the position sensor 784 may interface with the control circuit 760 to provide an absolute positioning system.
  • the position may include multiple Hall-effect elements located above a magnet and coupled to a CORDIC processor, also known as the digit-by-digit method and Volder’s algorithm, that is provided to implement a simple and efficient algorithm to calculate hyperbolic and trigonometric functions that require only addition, subtraction, bitshift, and table lookup operations.
  • CORDIC processor also known as the digit-by-digit method and Volder’s algorithm
  • the position sensor 784 may be omitted.
  • the control circuit 760 may track the position of the closure member 764 by aggregating the number and direction of steps that the motor has been instructed to execute.
  • the position sensor 784 may be located in the end effector 792 or at any other portion of the instrument.
  • the control circuit 760 may be in communication with one or more sensors 788.
  • the sensors 788 may be positioned on the end effector 792 and adapted to operate with the surgical instrument 790 to measure the various derived parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time.
  • the sensors 788 may comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor for measuring one or more parameters of the end effector 792.
  • the sensors 788 may include one or more sensors.
  • An RF energy source 794 is coupled to the end effector 792 and is applied to the RF electrode 796 when the RF electrode 796 is provided in the end effector 792 in place of the ultrasonic blade 768 or to work in conjunction with the ultrasonic blade 768.
  • the ultrasonic blade is made of electrically conductive metal and may be employed as the return path for electrosurgical RF current.
  • the control circuit 760 controls the delivery of the RF energy to the RF electrode 796.
  • smart ultrasonic energy devices may comprise adaptive algorithms to control the operation of the ultrasonic blade.
  • the ultrasonic blade adaptive control algorithms are configured to identify tissue type and adjust device parameters.
  • the ultrasonic blade control algorithms are configured to parameterize tissue type.
  • An algorithm to detect the collagen/elastic ratio of tissue to tune the amplitude of the distal tip of the ultrasonic blade is described in the following section of the present disclosure.
  • FIGS. 1-94 Various aspects of smart ultrasonic energy devices are described herein in connection with FIGS. 1-94, for example. Accordingly, the following description of adaptive ultrasonic blade control algorithms should be read in conjunction with FIGS. 1-94 and the description associated therewith.
  • adaptive ultrasonic blade control algorithms may be employed to adjust the parameters of the ultrasonic device based on the type of tissue in contact with the ultrasonic blade.
  • the parameters of the ultrasonic device may be adjusted based on the location of the tissue within the jaws of the ultrasonic end effector, for example, the location of the tissue between the clamp arm and the ultrasonic blade.
  • the impedance of the ultrasonic transducer may be employed to differentiate what percentage of the tissue is located in the distal or proximal end of the end effector.
  • the reactions of the ultrasonic device may be based on the tissue type or compressibility of the tissue.
  • the parameters of the ultrasonic device may be adjusted based on the identified tissue type or parameterization.
  • the mechanical displacement amplitude of the distal tip of the ultrasonic blade may be tuned based on the ration of collagen to elastin tissue detected during the tissue identification procedure.
  • the ratio of collagen to elastin tissue may be detected used a variety of techniques including infrared (IR) surface reflectance and emissivity.
  • IR infrared
  • the force applied to the tissue by the clamp arm and/or the stroke of the clamp arm to produce gap and compression. Electrical continuity across a jaw equipped with electrodes may be employed to determine what percentage of the jaw is covered with tissue.
  • the generator module 240 is configured to execute the adaptive ultrasonic blade control algorithm(s) 802 as described herein with reference to FIGS. 53-105.
  • the device/instrument 235 is configured to execute the adaptive ultrasonic blade control algorithm(s) 804 as described herein with reference to FIGS. 53-105.
  • both the device/instrument 235 and the device/instrument 235 are configured to execute the adaptive ultrasonic blade control algorithms 802, 804 as described herein with reference to FIGS. 53-105.
  • the generator module 240 may comprise a patient isolated stage in communication with a non-isolated stage via a power transformer.
  • a secondary winding of the power transformer is contained in the isolated stage and may comprise a tapped configuration (e.g., a center-tapped or a non-center-tapped configuration) to define drive signal outputs for delivering drive signals to different surgical instruments, such as, for example, an ultrasonic surgical instrument, an RF electrosurgical instrument, and a multifunction surgical instrument which includes ultrasonic and RF energy modes that can be delivered alone or simultaneously.
  • the drive signal outputs may output an ultrasonic drive signal (e.g., a 420V root- mean-square (RMS) drive signal) to an ultrasonic surgical instrument 241
  • the drive signal outputs may output an RF electrosurgical drive signal (e.g., a 100V RMS drive signal) to an RF electrosurgical instrument 241 .
  • RMS root- mean-square
  • RF electrosurgical drive signal e.g., a 100V RMS drive signal
  • the generator module 240 or the device/instrument 235 or both are coupled to the modular control tower 236 connected to multiple operating theater devices such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating theater, as described with reference to FIGS. 8-1 1 , for example.
  • FIG. 21 illustrates an example of a generator 900, which is one form of a generator configured to couple to an ultrasonic instrument and further configured to execute adaptive ultrasonic blade control algorithms in a surgical data network comprising a modular
  • the generator 900 is configured to deliver multiple energy modalities to a surgical instrument.
  • the generator 900 provides RF and ultrasonic signals for delivering energy to a surgical instrument either independently or simultaneously.
  • the RF and ultrasonic signals may be provided alone or in combination and may be provided simultaneously.
  • at least one generator output can deliver multiple energy modalities (e.g., ultrasonic, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, among others) through a single port, and these signals can be delivered separately or simultaneously to the end effector to treat tissue.
  • the generator 900 comprises a processor 902 coupled to a waveform generator 904.
  • the processor 902 and waveform generator 904 are configured to generate a variety of signal waveforms based on information stored in a memory coupled to the processor 902, not shown for clarity of disclosure.
  • the digital information associated with a waveform is provided to the waveform generator 904 which includes one or more DAC circuits to convert the digital input into an analog output.
  • the analog output is fed to an amplifier 1 106 for signal conditioning and amplification.
  • the conditioned and amplified output of the amplifier 906 is coupled to a power transformer 908.
  • the signals are coupled across the power transformer 908 to the secondary side, which is in the patient isolation side.
  • a first signal of a first energy modality is provided to the surgical instrument between the terminals labeled ENERGYi and RETURN.
  • a second signal of a second energy modality is coupled across a capacitor 910 and is provided to the surgical instrument between the terminals labeled ENERGY 2 and RETURN.
  • n is a positive integer greater than 1 . It also will be appreciated that up to“n” return paths RETURN n may be provided without departing from the scope of the present disclosure.
  • a first voltage sensing circuit 912 is coupled across the terminals labeled ENERGYi and the RETURN path to measure the output voltage therebetween.
  • a second voltage sensing circuit 924 is coupled across the terminals labeled ENERGY 2 and the RETURN path to measure the output voltage therebetween.
  • a current sensing circuit 914 is disposed in series with the RETURN leg of the secondary side of the power transformer 908 as shown to measure the output current for either energy modality. If different return paths are provided for each energy modality, then a separate current sensing circuit should be provided in each return leg.
  • the outputs of the first and second voltage sensing circuits 912, 924 are provided to respective isolation transformers 916, 922 and the output of the current sensing circuit 914 is provided to another isolation transformer 918.
  • the outputs of the isolation transformers 916, 928, 922 in the on the primary side of the power transformer 908 (non-patient isolated side) are provided to a one or more ADC circuit 926.
  • the digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and computation.
  • the output voltages and output current feedback information can be employed to adjust the output voltage and current provided to the surgical instrument and to compute output impedance, among other parameters.
  • Input/output communications between the processor 902 and patient isolated circuits is provided through an interface circuit 920. Sensors also may be in electrical communication with the processor 902 by way of the interface circuit 920.
  • the impedance may be determined by the processor 902 by dividing the output of either the first voltage sensing circuit 912 coupled across the terminals labeled ENERGYi/RETURN or the second voltage sensing circuit 924 coupled across the terminals labeled ENERGY 2 /RETURN by the output of the current sensing circuit 914 disposed in series with the RETURN leg of the secondary side of the power transformer 908.
  • the outputs of the first and second voltage sensing circuits 912, 924 are provided to separate isolations transformers 916, 922 and the output of the current sensing circuit 914 is provided to another isolation transformer 916.
  • the digitized voltage and current sensing measurements from the ADC circuit 926 are provided the processor 902 for computing impedance.
  • the first energy modality ENERGYi may be ultrasonic energy and the second energy modality ENERGY 2 may be RF energy.
  • other energy modalities include irreversible and/or reversible
  • the ultrasonic transducer impedance may be measured by dividing the output of the first voltage sensing circuit 912 by the current sensing circuit 914 and the tissue impedance may be measured by dividing the output of the second voltage sensing circuit 924 by the current sensing circuit 914.
  • the generator 900 comprising at least one output port can include a power transformer 908 with a single output and with multiple taps to provide power in the form of one or more energy modalities, such as ultrasonic, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, among others, for example, to the end effector depending on the type of treatment of tissue being performed.
  • the generator 900 can deliver energy with higher voltage and lower current to drive an ultrasonic transducer, with lower voltage and higher current to drive RF electrodes for sealing tissue, or with a coagulation waveform for spot coagulation using either monopolar or bipolar RF electrosurgical electrodes.
  • the output waveform from the generator 900 can be steered, switched, or filtered to provide the frequency to the end effector of the surgical instrument.
  • the connection of an ultrasonic transducer to the generator 900 output would be preferably located between the output labeled ENERGYi and RETURN as shown in FIG. 21.
  • a connection of RF bipolar electrodes to the generator 900 output would be preferably located between the output labeled ENERGY 2 and RETURN.
  • the preferred connections would be active electrode (e.g., pencil or other probe) to the ENERGY 2 output and a suitable return pad connected to the RETURN output.
  • wireless and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communications channels, etc., that may communicate data through the use of modulated electromagnetic radiation through a non-solid medium. The term does not imply that the associated devices do not contain any wires, although in some aspects they might not.
  • the communication module may implement any of a number of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.1 1 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long term evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as any other wireless and wired protocols that are designated as 3G, 4G, 5G, and beyond.
  • the computing module may include a plurality of communication modules.
  • a first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and Bluetooth and a second communication module may be dedicated to longer range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, and others.
  • processor or processing unit is an electronic circuit which performs operations on some external data source, usually memory or some other data stream.
  • the term is used herein to refer to the central processor (central processing unit) in a system or computer systems (especially systems on a chip (SoCs)) that combine a number of specialized “processors.”
  • SoC system on a chip or system on chip
  • SOC system on chip
  • IC integrated circuit
  • a SoC integrates a microcontroller (or microprocessor) with advanced peripherals like graphics processing unit (GPU), Wi-Fi module, or coprocessor.
  • a SoC may or may not contain built-in memory.
  • a microcontroller or controller is a system that integrates a
  • a microcontroller may be implemented as a small computer on a single integrated circuit. It may be similar to a SoC; an SoC may include a microcontroller as one of its components.
  • a microcontroller may contain one or more core processing units (CPUs) along with memory and programmable input/output peripherals.
  • Program memory in the form of Ferroelectric RAM,
  • NOR flash or OTP ROM is also often included on chip, as well as a small amount of RAM.
  • Microcontrollers may be employed for embedded applications, in contrast to the
  • microprocessors used in personal computers or other general purpose applications consisting of various discrete chips.
  • controller or microcontroller may be a stand-alone 1C or chip device that interfaces with a peripheral device. This may be a link between two parts of a computer or a controller on an external device that manages the operation of (and connection with) that device.
  • any of the processors or microcontrollers described herein may be implemented by any single core or multicore processor such as those known under the trade name ARM Cortex by Texas Instruments.
  • the processor may be an LM4F230H5QR ARM Cortex- M4F Processor Core, available from Texas Instruments, for example, comprising on-chip memory of 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with Stel laris Ware® software, 2 KB electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder inputs (QEI) analog, one or more 12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels, details of which are available for the product datasheet.
  • SRAM serial random access memory
  • the processor may comprise a safety controller comprising two controller-based families such as TMS570 and RM4x known under the trade name Hercules ARM Cortex R4, also by Texas Instruments.
  • the safety controller may be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.
  • Modular devices include the modules (as described in connection with FIGS. 3 and 9, for example) that are receivable within a surgical hub and the surgical devices or instruments that can be connected to the various modules in order to connect or pair with the corresponding surgical hub.
  • the modular devices include, for example, intelligent surgical instruments, medical imaging devices, suction/irrigation devices, smoke evacuators, energy generators, ventilators, insufflators, and displays.
  • the modular devices described herein can be controlled by control algorithms.
  • the control algorithms can be executed on the modular device itself, on the surgical hub to which the particular modular device is paired, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture).
  • the modular devices’ control algorithms control the devices based on data sensed by the modular device itself (i.e., by sensors in, on, or connected to the modular device). This data can be related to the patient being operated on (e.g., tissue properties or insufflation pressure) or the modular device itself (e.g., the rate at which a knife is being advanced, motor current, or energy levels).
  • a control algorithm for a surgical stapling and cutting instrument can control the rate at which the instrument’s motor drives its knife through tissue according to resistance encountered by the knife as it advances.
  • FIG. 22 illustrates one form of a surgical system 1000 comprising a generator 1 100 and various surgical instruments 1 104, 1 106, 1 108 usable therewith, where the surgical instrument 1 104 is an ultrasonic surgical instrument, the surgical instrument 1 106 is an RF electrosurgical instrument, and the multifunction surgical instrument 1 108 is a combination ultrasonic/RF electrosurgical instrument.
  • the generator 1 100 is configurable for use with a variety of surgical instruments. According to various forms, the generator 1 100 may be configurable for use with different surgical instruments of different types including, for example, ultrasonic surgical instruments 1 104, RF electrosurgical instruments 1 106, and multifunction surgical instruments 1 108 that integrate RF and ultrasonic energies delivered simultaneously from the generator 1 100.
  • the generator 1 100 is shown separate from the surgical instruments 1 104, 1 106, 1 108 in one form, the generator 1 100 may be formed integrally with any of the surgical instruments 1 104, 1 106, 1 108 to form a unitary surgical system.
  • the generator 1 100 comprises an input device 1 1 10 located on a front panel of the generator 1 100 console.
  • the input device 1 1 10 may comprise any suitable device that generates signals suitable for programming the operation of the generator 1 100.
  • the generator 1 100 may be configured for wired or wireless communication.
  • the generator 1 100 is configured to drive multiple surgical instruments 1 104, 1 106, 1 108.
  • the first surgical instrument is an ultrasonic surgical instrument 1 104 and comprises a handpiece 1 105 (HP), an ultrasonic transducer 1 120, a shaft 1 126, and an end effector 1 122.
  • the end effector 1 122 comprises an ultrasonic blade 1 128 acoustically coupled to the ultrasonic transducer 1 120 and a clamp arm 1 140.
  • the handpiece 1 105 comprises a trigger 1 143 to operate the clamp arm 1 140 and a combination of the toggle buttons 1 134a, 1 134b, 1 134c to energize and drive the ultrasonic blade 1 128 or other function.
  • the toggle buttons 1 134a, 1 134b, 1 134c can be configured to energize the ultrasonic transducer 1 120 with the generator 1 100.
  • the generator 1 100 also is configured to drive a second surgical instrument 1 106.
  • the second surgical instrument 1 106 is an RF electrosurgical instrument and comprises a handpiece 1 107 (HP), a shaft 1 127, and an end effector 1 124.
  • the end effector 1 124 comprises electrodes in clamp arms 1 142a, 1 142b and return through an electrical conductor portion of the shaft 1 127.
  • the electrodes are coupled to and energized by a bipolar energy source within the generator 1 100.
  • the handpiece 1 107 comprises a trigger 1 145 to operate the clamp arms 1 142a, 1 142b and an energy button 1 135 to actuate an energy switch to energize the electrodes in the end effector 1 124.
  • the generator 1 100 also is configured to drive a multifunction surgical instrument 1 108.
  • the multifunction surgical instrument 1 108 comprises a handpiece 1 109 (HP), a shaft 1 129, and an end effector 1 125.
  • the end effector 1 125 comprises an ultrasonic blade 1 149 and a clamp arm 1 146.
  • the ultrasonic blade 1 149 is acoustically coupled to the ultrasonic transducer 1 120.
  • the handpiece 1 109 comprises a trigger 1 147 to operate the clamp arm 1 146 and a combination of the toggle buttons 1 137a, 1 137b, 1 137c to energize and drive the ultrasonic blade 1 149 or other function.
  • the toggle buttons 1 137a, 1 137b, 1 137c can be configured to energize the ultrasonic transducer 1 120 with the generator 1 100 and energize the ultrasonic blade 1 149 with a bipolar energy source also contained within the generator 1 100.
  • the generator 1 100 is configurable for use with a variety of surgical instruments. According to various forms, the generator 1 100 may be configurable for use with different surgical instruments of different types including, for example, the ultrasonic surgical instrument 1 104, the RF electrosurgical instrument 1 106, and the multifunction surgical instrument 1 108 that integrates RF and ultrasonic energies delivered simultaneously from the generator 1 100. Although in the form of FIG. 22 the generator 1 100 is shown separate from the surgical instruments 1 104, 1 106, 1 108, in another form the generator 1 100 may be formed integrally with any one of the surgical instruments 1 104, 1 106, 1 108 to form a unitary surgical system.
  • the generator 1 100 comprises an input device 1 1 10 located on a front panel of the generator 1 100 console.
  • the input device 1 1 10 may comprise any suitable device that generates signals suitable for programming the operation of the generator 1 100.
  • the generator 1 100 also may comprise one or more output devices 1 1 12. Further aspects of generators for digitally generating electrical signal waveforms and surgical instruments are described in US patent publication US-2017-0086914-A1 , which is herein incorporated by reference in its entirety.
  • FIG. 23 is an end effector 1 122 of the example ultrasonic device 1 104, in accordance with at least one aspect of the present disclosure.
  • the end effector 1 122 may comprise a blade 1 128 that may be coupled to the ultrasonic transducer 1 120 via a wave guide.
  • the end effector 1 122 When driven by the ultrasonic transducer 1 120, the blade 1 128 may vibrate and, when brought into contact with tissue, may cut and/or coagulate the tissue, as described herein.
  • the end effector 1 122 also may comprise a clamp arm 1 140 that may be configured for cooperative action with the blade 1 128 of the end effector 1 122.
  • the clamp arm 1 140 With the blade 1 128, the clamp arm 1 140 may comprise a set of jaws.
  • the clamp arm 1 140 may be pivotally connected at a distal end of a shaft 1 126 of the instrument portion 1 104.
  • the clamp arm 1 140 may include a clamp arm tissue pad 1 163, which may be formed from TEFLON® or other suitable low-friction material.
  • the pad 1 163 may be mounted for cooperation with the blade 1 128, with pivotal movement of the clamp arm 1 140 positioning the clamp pad 1 163 in substantially parallel relationship to, and in contact with, the blade 1 128.
  • the tissue pad 1 163 may be provided with a sawtooth-like configuration including a plurality of axially spaced, proximally extending gripping teeth 1 161 to enhance the gripping of tissue in cooperation with the blade 1 128.
  • the clamp arm 1 140 may transition from the open position shown in FIG. 23 to a closed position (with the clamp arm 1 140 in contact with or proximity to the blade 1 128) in any suitable manner.
  • the handpiece 1 105 may comprise a jaw closure trigger. When actuated by a clinician, the jaw closure trigger may pivot the clamp arm 1 140 in any suitable manner.
  • the generator 1 100 may be activated to provide the drive signal to the ultrasonic transducer 1 120 in any suitable manner.
  • the generator 1 100 may comprise a foot switch 1430 (FIG. 24) coupled to the generator 1 100 via a footswitch cable 1432.
  • a clinician may activate the ultrasonic transducer 1 120, and thereby the ultrasonic transducer 1 120 and blade 1 128, by depressing the foot switch 1430.
  • some aspects of the device 1 104 may utilize one or more switches positioned on the handpiece 1 105 that, when activated, may cause the generator 1 100 to activate the ultrasonic transducer 1 120.
  • the one or more switches may comprise a pair of toggle buttons 1 134a, 1 134b, 1 134c (FIG. 22), for example, to determine an operating mode of the device 1 104.
  • the toggle button 1 134a When the toggle button 1 134a is depressed, for example, the ultrasonic generator 1 100 may provide a maximum drive signal to the ultrasonic transducer 1 120, causing it to produce maximum ultrasonic energy output.
  • Depressing toggle button 1 134b may cause the ultrasonic generator 1 100 to provide a user-selectable drive signal to the ultrasonic transducer 1 120, causing it to produce less than the maximum ultrasonic energy output.
  • the device 1 104 additionally or alternatively may comprise a second switch to, for example, indicate a position of a jaw closure trigger for operating the jaws via the clamp arm 1 140 of the end effector 1 122.
  • the ultrasonic generator 1 100 may be activated based on the position of the jaw closure trigger, (e.g., as the clinician depresses the jaw closure trigger to close the jaws via the clamp arm 1 140, ultrasonic energy may be applied).
  • the one or more switches may comprise a toggle button 1 134c that, when depressed, causes the generator 1 100 to provide a pulsed output (FIG. 22).
  • the pulses may be provided at any suitable frequency and grouping, for example.
  • the power level of the pulses may be the power levels associated with toggle buttons 1 134a, 1 134b (maximum, less than maximum), for example.
  • a device 1 104 may comprise any combination of the toggle buttons 1 134a, 1 134b, 1 134c (FIG. 22).
  • the device 1 104 could be configured to have only two toggle buttons: a toggle button 1 134a for producing maximum ultrasonic energy output and a toggle button 1 134c for producing a pulsed output at either the maximum or less than maximum power level per.
  • the drive signal output configuration of the generator 1 100 could be five continuous signals, or any discrete number of individual pulsed signals (1 , 2, 3, 4, or 5).
  • the specific drive signal configuration may be controlled based upon, for example, EEPROM settings in the generator 1 100 and/or user power level selection(s).
  • a two-position switch may be provided as an alternative to a toggle button 1 134c (FIG. 22).
  • a device 1 104 may include a toggle button 1 134a for producing a continuous output at a maximum power level and a two-position toggle button 1 134b. In a first detented position, toggle button 1 134b may produce a continuous output at a less than maximum power level, and in a second detented position the toggle button 1 134b may produce a pulsed output (e.g., at either a maximum or less than maximum power level, depending upon the EEPROM settings).
  • the RF electrosurgical end effector 1 124, 1 125 also may comprise a pair of electrodes.
  • the electrodes may be in communication with the generator 1 100, for example, via a cable.
  • the electrodes may be used, for example, to measure an impedance of a tissue bite present between the clamp arm 1 142a, 1 146 and the blade 1 142b, 1 149.
  • the generator 1 100 may provide a signal (e.g., a non-therapeutic signal) to the electrodes.
  • the impedance of the tissue bite may be found, for example, by monitoring the current, voltage, etc. of the signal.
  • the generator 1 100 may comprise several separate functional elements, such as modules and/or blocks, as shown in FIG.
  • an ultrasonic generator module may drive an ultrasonic device, such as the ultrasonic device 1 104.
  • An electrosurgery/RF generator module may drive the electrosurgical device 1 106.
  • the modules may generate respective drive signals for driving the surgical devices 1 104, 1 106, 1 108.
  • the ultrasonic generator module and/or the electrosurgery/RF generator module each may be formed integrally with the generator 1 100.
  • one or more of the modules may be provided as a separate circuit module electrically coupled to the generator 1 100. (The modules are shown in phantom to illustrate this option.)
  • the electrosurgery/RF generator module may be formed integrally with the ultrasonic generator module, or vice versa.
  • the ultrasonic generator module may produce a drive signal or signals of particular voltages, currents, and frequencies (e.g. 55,500 cycles per second, or Hz).
  • the drive signal or signals may be provided to the ultrasonic device 1 104, and specifically to the transducer 1 120, which may operate, for example, as described above.
  • the generator 1 100 may be configured to produce a drive signal of a particular voltage, current, and/or frequency output signal that can be stepped with high resolution, accuracy, and repeatability.
  • the electrosurgery/RF generator module may generate a drive signal or signals with output power sufficient to perform bipolar electrosurgery using radio frequency (RF) energy.
  • the drive signal may be provided, for example, to the electrodes of the electrosurgical device 1 106, for example, as described above.
  • the generator 1 100 may be configured for therapeutic purposes by applying electrical energy to the tissue sufficient for treating the tissue (e.g., coagulation, cauterization, tissue welding, etc.).
  • the generator 1 100 may comprise an input device 2150 (FIG. 27B) located, for example, on a front panel of the generator 1 100 console.
  • the input device 2150 may comprise any suitable device that generates signals suitable for programming the operation of the generator 1 100. In operation, the user can program or otherwise control operation of the generator 1 100 using the input device 2150.
  • the input device 2150 may comprise any suitable device that generates signals that can be used by the generator (e.g., by one or more processors contained in the generator) to control the operation of the generator 1 100 (e.g., operation of the ultrasonic generator module and/or electrosurgery/RF generator module).
  • the input device 2150 includes one or more of: buttons, switches, thumbwheels, keyboard, keypad, touch screen monitor, pointing device, remote connection to a general purpose or dedicated computer.
  • the input device 2150 may comprise a suitable user interface, such as one or more user interface screens displayed on a touch screen monitor, for example. Accordingly, by way of the input device 2150, the user can set or program various operating parameters of the generator, such as, for example, current (I), voltage (V), frequency (f), and/or period (T) of a drive signal or signals generated by the ultrasonic generator module and/or electrosurgery/RF generator module.
  • the generator 1 100 also may comprise an output device 2140 (FIG. 27B) located, for example, on a front panel of the generator 1 100 console.
  • the output device 2140 includes one or more devices for providing a sensory feedback to a user.
  • Such devices may comprise, for example, visual feedback devices (e.g., an LCD display screen, LED indicators), audio feedback devices (e.g., a speaker, a buzzer) or tactile feedback devices (e.g., haptic actuators).
  • modules and/or blocks of the generator 1 100 may be described by way of example, it can be appreciated that a greater or lesser number of modules and/or blocks may be used and still fall within the scope of the aspects. Further, although various aspects may be described in terms of modules and/or blocks to facilitate description, such modules and/or blocks may be implemented by one or more hardware components, e.g., processors, Digital Signal Processors (DSPs), Programmable Logic Devices (PLDs), Application Specific
  • ASICs Integrated Circuits
  • registers e.g., registers and/or software components, e.g., programs, subroutines, logic and/or combinations of hardware and software components.
  • the ultrasonic generator drive module and electrosurgery/RF drive module 1 1 10 may comprise one or more embedded applications implemented as firmware, software, hardware, or any combination thereof.
  • the modules may comprise various executable modules such as software, programs, data, drivers, application program interfaces (APIs), and so forth.
  • the firmware may be stored in nonvolatile memory (NVM), such as in bit- masked read-only memory (ROM) or flash memory. In various implementations, storing the firmware in ROM may preserve flash memory.
  • the NVM may comprise other types of memory including, for example, programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), or battery backed random-access memory (RAM) such as dynamic RAM (DRAM), Double-Data-Rate DRAM (DDRAM), and/or synchronous DRAM (SDRAM).
  • PROM programmable ROM
  • EPROM erasable programmable ROM
  • EEPROM electrically erasable programmable ROM
  • RAM battery backed random-access memory
  • DRAM dynamic RAM
  • DDRAM Double-Data-Rate DRAM
  • SDRAM synchronous DRAM
  • the modules comprise a hardware component implemented as a processor for executing program instructions for monitoring various measurable characteristics of the devices 1 104, 1 106, 1 108 and generating a corresponding output drive signal or signals for operating the devices 1 104, 1 106, 1 108.
  • the drive signal may drive the ultrasonic transducer 1 120 in cutting and/or coagulation operating modes. Electrical characteristics of the device 1 104 and/or tissue may be measured and used to control operational aspects of the generator 1 100 and/or provided as feedback to the user.
  • the drive signal may supply electrical energy (e.g., RF energy) to the end effector 1 124 in cutting, coagulation and/or desiccation modes. Electrical characteristics of the device 1 106 and/or tissue may be measured and used to control operational aspects of the generator 1 100 and/or provided as feedback to the user.
  • the hardware components may be implemented as DSP, PLD, ASIC, circuits, and/or registers.
  • the processor may be configured to store and execute computer software program instructions to generate the step function output signals for driving various components of the devices 1 104, 1 106, 1 108, such as the ultrasonic transducer 1 120 and the end effectors 1 122, 1 124, 1 125.
  • An electromechanical ultrasonic system includes an ultrasonic transducer, a waveguide, and an ultrasonic blade.
  • the electromechanical ultrasonic system has an initial resonant frequency defined by the physical properties of the ultrasonic transducer, the waveguide, and the ultrasonic blade.
  • the ultrasonic transducer is excited by an alternating voltage V g (t) and current l g (t) signal equal to the resonant frequency of the electromechanical ultrasonic system.
  • V g (t) and current l g (t) signal equal to the resonant frequency of the electromechanical ultrasonic system.
  • the compliance of the ultrasonic blade causes the resonant frequency of the electromechanical ultrasonic system to shift.
  • the inductive impedance is no longer equal to the capacitive impedance causing a mismatch between the drive frequency and the resonant frequency of the electromechanical ultrasonic system.
  • the system is now operating“off-resonance.”
  • the mismatch between the drive frequency and the resonant frequency is manifested as a phase difference between the voltage V g (t) and current l g (t) signals applied to the ultrasonic transducer.
  • the generator electronics can easily monitor the phase difference between the voltage V g (t) and current l g (t) signals and can continuously adjust the drive frequency until the phase difference is once again zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasonic system.
  • the change in phase and/or frequency can be used as an indirect measurement of the ultrasonic blade temperature.
  • the electromechanical properties of the ultrasonic transducer may be modeled as an equivalent circuit comprising a first branch having a static capacitance and a second“motional” branch having a serially connected inductance, resistance and capacitance that define the electromechanical properties of a resonator.
  • Known ultrasonic generators may include a tuning inductor for tuning out the static capacitance at a resonant frequency so that substantially all of generator’s drive signal current flows into the motional branch. Accordingly, by using a tuning inductor, the generator’s drive signal current represents the motional branch current, and the generator is thus able to control its drive signal to maintain the ultrasonic transducer’s resonant frequency.
  • the tuning inductor also may transform the phase impedance plot of the ultrasonic transducer to improve the generator’s frequency lock capabilities.
  • the tuning inductor must be matched with the specific static capacitance of an ultrasonic transducer at the operational resonance frequency.
  • a different ultrasonic transducer having a different static capacitance requires a different tuning inductor.
  • FIG. 25 illustrates an equivalent circuit 1500 of an ultrasonic transducer, such as the ultrasonic transducer 1 120, according to one aspect.
  • the circuit 1500 comprises a first “motional” branch having a serially connected inductance L s , resistance R s and capacitance C s that define the electromechanical properties of the resonator, and a second capacitive branch having a static capacitance C 0 .
  • Drive current l g (t) may be received from a generator at a drive voltage V g (t), with motional current l m (t) flowing through the first branch and current l g (t)-l m (t) flowing through the capacitive branch.
  • Control of the electromechanical properties of the ultrasonic transducer may be achieved by suitably controlling l g (t) and V g (t).
  • known generator architectures may include a tuning inductor U (shown in phantom in FIG. 25) in a parallel resonance circuit for tuning out the static capacitance C 0 at a resonant frequency so that substantially all of the generator’s current output l g (t) flows through the motional branch. In this way, control of the motional branch current l m (t) is achieved by controlling the generator current output l g (t).
  • the tuning inductor L t is specific to the static capacitance C 0 of an ultrasonic transducer, however, and a different ultrasonic transducer having a different static capacitance requires a different tuning inductor L t . Moreover, because the tuning inductor U is matched to the nominal value of the static capacitance C 0 at a single resonant frequency, accurate control of the motional branch current l m (t) is assured only at that frequency. As frequency shifts down with transducer temperature, accurate control of the motional branch current is compromised. [0251] Various aspects of the generator 1 100 may not rely on a tuning inductor L t to monitor the motional branch current l m (t).
  • the generator 1 100 may use the measured value of the static capacitance C 0 in between applications of power for a specific ultrasonic surgical device 1 104 (along with drive signal voltage and current feedback data) to determine values of the motional branch current l m (t) on a dynamic and ongoing basis (e.g., in real-time).
  • Such aspects of the generator 1 100 are therefore able to provide virtual tuning to simulate a system that is tuned or resonant with any value of static capacitance C 0 at any frequency, and not just at a single resonant frequency dictated by a nominal value of the static capacitance C 0 .
  • FIG. 26 is a simplified block diagram of one aspect of the generator 1 100 for providing inductorless tuning as described above, among other benefits.
  • FIGS. 27A-27C illustrate an architecture of the generator 1 100 of FIG. 26 according to one aspect.
  • the generator 1 100 may comprise a patient isolated stage 1520 in communication with a non-isolated stage 1540 via a power transformer 1560.
  • a secondary winding 1580 of the power transformer 1560 is contained in the isolated stage 1520 and may comprise a tapped configuration (e.g., a center-tapped or non-center tapped configuration) to define drive signal outputs 1600a, 1600b, 1600c for outputting drive signals to different surgical devices, such as, for example, an ultrasonic surgical device 1 104 and an electrosurgical device 1 106.
  • drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 420V RMS drive signal) to an ultrasonic surgical device 1 104
  • drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 100V RMS drive signal) to an electrosurgical device 1 106, with output 1600b corresponding to the center tap of the power transformer 1560
  • the non-isolated stage 1540 may comprise a power amplifier 1620 having an output connected to a primary winding 1640 of the power transformer 1560.
  • the power amplifier 1620 may comprise a push-pull amplifier, for example.
  • the non-isolated stage 1540 may further comprise a programmable logic device 1660 for supplying a digital output to a digital-to-analog converter (DAC) 1680, which in turn supplies a corresponding analog signal to an input of the power amplifier 1620.
  • the programmable logic device 1660 may comprise a field-programmable gate array (FPGA), for example.
  • FPGA field-programmable gate array
  • the programmable logic device 1660 by virtue of controlling the power amplifier’s 1620 input via the DAC 1680, may therefore control any of a number of parameters (e.g., frequency, waveform shape, waveform amplitude) of drive signals appearing at the drive signal outputs 1600a, 1600b, 1600c.
  • the programmable logic device 1660 in conjunction with a processor (e.g., processor 1740 discussed below), may implement a number of digital signal processing (DSP)- based and/or other control algorithms to control parameters of the drive signals output by the generator 1 100.
  • DSP digital signal processing
  • Power may be supplied to a power rail of the power amplifier 1620 by a switch-mode regulator 1700.
  • the switch-mode regulator 1700 may comprise an adjustable buck regulator, for example.
  • the non-isolated stage 1540 may further comprise a processor 1740, which in one aspect may comprise a DSP processor such as an ADSP-21469 SHARC DSP, available from Analog Devices, Norwood, Mass., for example.
  • the processor 1740 may control operation of the switch-mode power converter 1700 responsive to voltage feedback data received from the power amplifier 1620 by the processor 1740 via an analog-to-digital converter (ADC) 1760.
  • ADC analog-to-digital converter
  • the processor 1740 may receive as input, via the ADC 1760, the waveform envelope of a signal (e.g., an RF signal) being amplified by the power amplifier 1620.
  • the processor 1740 may then control the switch-mode regulator 1700 (e.g., via a pulse-width modulated (PWM) output) such that the rail voltage supplied to the power amplifier 1620 tracks the waveform envelope of the amplified signal.
  • PWM pulse-width modulated
  • the processor 1740 may be configured for wired or wireless communication.
  • the programmable logic device 1660 in conjunction with the processor 1740, may implement a direct digital synthesizer (DDS) control scheme to control the waveform shape, frequency and/or amplitude of drive signals output by the generator 1 100.
  • DDS direct digital synthesizer
  • the programmable logic device 1660 may implement a DDS control algorithm 2680 (FIG. 28A) by recalling waveform samples stored in a dynamically-updated look-up table (LUT), such as a RAM LUT which may be embedded in an FPGA.
  • LUT dynamically-updated look-up table
  • This control algorithm is particularly useful for ultrasonic applications in which an ultrasonic transducer, such as the ultrasonic transducer 1 120, may be driven by a clean sinusoidal current at its resonant frequency. Because other frequencies may excite parasitic resonances, minimizing or reducing the total distortion of the motional branch current may correspondingly minimize or reduce undesirable resonance effects.
  • voltage and current feedback data based on the drive signal may be input into an algorithm, such as an error control algorithm implemented by the processor 1740, which compensates for distortion by suitably pre-distorting or modifying the waveform samples stored in the LUT on a dynamic, ongoing basis (e.g., in real-time).
  • the amount or degree of pre-distortion applied to the LUT samples may be based on the error between a computed motional branch current and a desired current waveform shape, with the error being determined on a sample-by sample basis.
  • the pre-distorted LUT samples when processed through the drive circuit, may result in a motional branch drive signal having the desired waveform shape (e.g., sinusoidal) for optimally driving the ultrasonic transducer.
  • the LUT waveform samples will therefore not represent the desired waveform shape of the drive signal, but rather the waveform shape that is required to ultimately produce the desired waveform shape of the motional branch drive signal when distortion effects are taken into account.
  • the non-isolated stage 1540 may further comprise an ADC 1780 and an ADC 1800 coupled to the output of the power transformer 1560 via respective isolation transformers 1820, 1840 for respectively sampling the voltage and current of drive signals output by the generator 1 100.
  • the ADCs 1780, 1800 may be configured to sample at high speeds (e.g., 80 Msps) to enable oversampling of the drive signals.
  • the sampling speed of the ADCs 1780, 1800 may enable approximately 200X (depending on drive frequency) oversampling of the drive signals.
  • the sampling operations of the ADCs 1780, 1800 may be performed by a single ADC receiving input voltage and current signals via a two-way multiplexer.
  • the use of high-speed sampling in aspects of the generator 1 100 may enable, among other things, calculation of the complex current flowing through the motional branch (which may be used in certain aspects to implement DDS-based waveform shape control described above), accurate digital filtering of the sampled signals, and calculation of real power consumption with a high degree of precision.
  • Voltage and current feedback data output by the ADCs 1780, 1800 may be received and processed (e.g., FIFO buffering, multiplexing) by the programmable logic device 1660 and stored in data memory for subsequent retrieval by, for example, the processor 1740.
  • voltage and current feedback data may be used as input to an algorithm for pre-distorting or modifying LUT waveform samples on a dynamic and ongoing basis.
  • each stored voltage and current feedback data pair may be indexed based on, or otherwise associated with, a corresponding LUT sample that was output by the programmable logic device 1660 when the voltage and current feedback data pair was acquired. Synchronization of the LUT samples and the voltage and current feedback data in this manner contributes to the correct timing and stability of the pre-distortion algorithm.
  • the voltage and current feedback data may be used to control the frequency and/or amplitude (e.g., current amplitude) of the drive signals.
  • voltage and current feedback data may be used to determine impedance phase, e.g., the phase difference between the voltage and current drive signals. The frequency of the drive signal may then be controlled to minimize or reduce the difference between the determined impedance phase and an impedance phase setpoint (e.g., 0°), thereby minimizing or reducing the effects of harmonic distortion and correspondingly enhancing impedance phase
  • phase impedance and a frequency control signal may be implemented in the processor 1740, for example, with the frequency control signal being supplied as input to a DDS control algorithm implemented by the programmable logic device 1660.
  • the impedance phase may be determined through Fourier analysis.
  • the phase difference between the generator voltage V g (t) and generator current l g (t) driving signals may be determined using the Fast Fourier Transform (FFT) or the Discrete Fourier Transform (DFT) as follows:
  • f is the phase angle
  • f is the frequency
  • t is time
  • Another technique for determining the phase difference between the voltage V g (t) and current l g (t) signals is the zero-crossing method and produces highly accurate results.
  • each negative to positive zero crossing of voltage signal V g (t) triggers the start of a pulse
  • each negative to positive zero crossing of current signal l g (t) triggers the end of the pulse.
  • the result is a pulse train with a pulse width proportional to the phase angle between the voltage signal and the current signal.
  • the pulse train may be passed through an averaging filter to yield a measure of the phase difference.
  • the analog voltage V g (t) and current l g (t) signals are converted to digital signals that are high if the analog signal is positive and low if the analog signal is negative. High accuracy phase estimates require sharp transitions between high and low.
  • a Schmitt trigger along with an RC stabilization network may be employed to convert the analog signals into digital signals.
  • an edge triggered RS flip-flop and ancillary circuitry may be employed.
  • the zero-crossing technique may employ an exclusive OR (XOR) gate.
  • phase difference between the voltage and current signals include Lissajous figures and monitoring the image; methods such as the three- voltmeter method, the crossed-coil method, vector voltmeter and vector impedance methods; and using phase standard instruments, phase-locked loops, and other techniques as described in Phase Measurement, Peter O’Shea, 2000 CRC Press LLC, ⁇ http://www.engnetbase.com>, which is incorporated herein by reference.
  • the current feedback data may be monitored in order to maintain the current amplitude of the drive signal at a current amplitude setpoint.
  • the current amplitude setpoint may be specified directly or determined indirectly based on specified voltage amplitude and power setpoints.
  • control of the current amplitude may be implemented by control algorithm, such as, for example, a proportional-integral-derivative (PID) control algorithm, in the processor 1740.
  • PID proportional-integral-derivative
  • Variables controlled by the control algorithm to suitably control the current amplitude of the drive signal may include, for example, the scaling of the LUT waveform samples stored in the programmable logic device 1660 and/or the full-scale output voltage of the DAC 1680 (which supplies the input to the power amplifier 1620) via a DAC 1860.
  • the non-isolated stage 1540 may further comprise a processor 1900 for providing, among other things, user interface (Ul) functionality.
  • the processor 1900 may comprise an Atmel AT91 SAM9263 processor having an ARM 926EJ-S core, available from Atmel Corporation, San Jose, Calif., for example.
  • Ul functionality supported by the processor 1900 may include audible and visual user feedback, communication with peripheral devices (e.g., via a Universal Serial Bus (USB) interface), communication with a foot switch 1430, communication with an input device 2150 (e.g., a touch screen display) and
  • USB Universal Serial Bus
  • the processor 1900 may communicate with the processor 1740 and the programmable logic device (e.g., via a serial peripheral interface (SPI) bus). Although the processor 1900 may primarily support Ul functionality, it also may coordinate with the processor 1740 to implement hazard mitigation in certain aspects. For example, the processor 1900 may be programmed to monitor various aspects of user input and/or other inputs (e.g., touch screen inputs 2150, foot switch 1430 inputs, temperature sensor inputs 2160) and may disable the drive output of the generator 1 100 when an erroneous condition is detected.
  • SPI serial peripheral interface
  • both the processor 1740 (FIG. 26, 27A) and the processor 1900 (FIG. 26, 27B) may determine and monitor the operating state of the generator 1 100.
  • the operating state of the generator 1 100 may dictate, for example, which control and/or diagnostic processes are implemented by the processor 1740.
  • the operating state of the generator 1 100 may dictate, for example, which elements of a user interface (e.g., display screens, sounds) are presented to a user.
  • the 1900 may independently maintain the current operating state of the generator 1 100 and recognize and evaluate possible transitions out of the current operating state.
  • the processor 1740 may function as the master in this relationship and determine when transitions between operating states are to occur.
  • the processor 1900 may be aware of valid transitions between operating states and may confirm if a particular transition is appropriate. For example, when the processor 1740 instructs the processor 1900 to transition to a specific state, the processor 1900 may verify that the requested transition is valid. In the event that a requested transition between states is determined to be invalid by the processor 1900, the processor 1900 may cause the generator 1 100 to enter a failure mode.
  • the non-isolated stage 1540 may further comprise a controller 1960 (FIG. 26, 27B) for monitoring input devices 2150 (e.g., a capacitive touch sensor used for turning the generator 1 100 on and off, a capacitive touch screen).
  • the controller 1960 may comprise at least one processor and/or other controller device in communication with the processor 1900.
  • the controller 1960 may comprise a processor (e.g., a Mega168 8-bit controller available from Atmel) configured to monitor user input provided via one or more capacitive touch sensors.
  • the controller 1960 may comprise a touch screen controller (e.g., a QT5480 touch screen controller available from Atmel) to control and manage the acquisition of touch data from a capacitive touch screen.
  • a touch screen controller e.g., a QT5480 touch screen controller available from Atmel
  • the controller 1960 may continue to receive operating power (e.g., via a line from a power supply of the generator 1 100, such as the power supply 21 10 (FIG. 26) discussed below). In this way, the controller 1960 may continue to monitor an input device 2150 (e.g., a capacitive touch sensor located on a front panel of the generator 1 100) for turning the generator 1 100 on and off.
  • an input device 2150 e.g., a capacitive touch sensor located on a front panel of the generator 1 100
  • the controller 1960 may wake the power supply (e.g., enable operation of one or more DC/DC voltage converters 2130 (FIG. 26) of the power supply 21 10) if activation of the“on/off input device 2150 by a user is detected.
  • the controller 1960 may therefore initiate a sequence for transitioning the generator 1 100 to a“power on” state.
  • the controller 1960 may initiate a sequence for transitioning the generator 1 100 to the“power off’ state if activation of the“on/off” input device 2150 is detected when the generator 1 100 is in the“power on” state.
  • the controller 1960 may report activation of the“on/off” input device 2150 to the processor 1900, which in turn implements the necessary process sequence for transitioning the generator 1 100 to the“power off’ state.
  • the controller 1960 may have no independent ability for causing the removal of power from the generator 1 100 after its“power on” state has been established.
  • the controller 1960 may cause the generator 1 100 to provide audible or other sensory feedback for alerting the user that a“power on” or“power off” sequence has been initiated. Such an alert may be provided at the beginning of a“power on” or “power off” sequence and prior to the commencement of other processes associated with the sequence.
  • the isolated stage 1520 may comprise an instrument interface circuit 1980 to, for example, provide a communication interface between a control circuit of a surgical device (e.g., a control circuit comprising handpiece switches) and components of the non-isolated stage 1540, such as, for example, the programmable logic device 1660, the processor 1740 and/or the processor 1900.
  • the instrument interface circuit 1980 may exchange information with components of the non-isolated stage 1540 via a communication link that maintains a suitable degree of electrical isolation between the stages 1520, 1540, such as, for example, an infrared (IR)-based communication link.
  • Power may be supplied to the instrument interface circuit 1980 using, for example, a low-dropout voltage regulator powered by an isolation transformer driven from the non-isolated stage 1540.
  • the instrument interface circuit 1980 may comprise a programmable logic device 2000 (e.g., an FPGA) in communication with a signal conditioning circuit 2020 (FIG. 26 and FIG. 27C).
  • the signal conditioning circuit 2020 may be configured to receive a periodic signal from the programmable logic device 2000 (e.g., a 2 kHz square wave) to generate a bipolar interrogation signal having an identical frequency.
  • the interrogation signal may be generated, for example, using a bipolar current source fed by a differential amplifier.
  • the interrogation signal may be communicated to a surgical device control circuit (e.g., by using a conductive pair in a cable that connects the generator 1 100 to the surgical device) and monitored to determine a state or configuration of the control circuit.
  • control circuit may comprise a number of switches, resistors and/or diodes to modify one or more characteristics (e.g., amplitude, rectification) of the interrogation signal such that a state or configuration of the control circuit is uniquely discernible based on the one or more characteristics (e.g., amplitude, rectification) of the interrogation signal such that a state or configuration of the control circuit is uniquely discernible based on the one or more characteristics (e.g., amplitude, rectification) of the interrogation signal such that a state or configuration of the control circuit is uniquely discernible based on the one or more
  • the signal conditioning circuit 2020 may comprise an ADC for generating samples of a voltage signal appearing across inputs of the control circuit resulting from passage of interrogation signal therethrough.
  • the programmable logic device 2000 (or a component of the non-isolated stage 1540) may then determine the state or configuration of the control circuit based on the ADC samples.
  • the instrument interface circuit 1980 may comprise a first data circuit interface 2040 to enable information exchange between the programmable logic device 2000 (or other element of the instrument interface circuit 1980) and a first data circuit disposed in or otherwise associated with a surgical device.
  • a first data circuit 2060 may be disposed in a cable integrally attached to a surgical device handpiece, or in an adaptor for interfacing a specific surgical device type or model with the generator 1 100.
  • the first data circuit may comprise a non-volatile storage device, such as an electrically erasable programmable read-only memory (EEPROM) device.
  • EEPROM electrically erasable programmable read-only memory
  • the first data circuit interface 2040 may be implemented separately from the programmable logic device 2000 and comprise suitable circuitry (e.g., discrete logic devices, a processor) to enable communication between the programmable logic device 2000 and the first data circuit. In other aspects, the first data circuit interface 2040 may be integral with the programmable logic device 2000.
  • the first data circuit 2060 may store information pertaining to the particular surgical device with which it is associated. Such information may include, for example, a model number, a serial number, a number of operations in which the surgical device has been used, and/or any other type of information. This information may be read by the instrument interface circuit 1980 (e.g., by the programmable logic device 2000), transferred to a component of the non-isolated stage 1540 (e.g., to programmable logic device 1660, processor 1740 and/or processor 1900) for presentation to a user via an output device 2140 and/or for controlling a function or operation of the generator 1 100.
  • the instrument interface circuit 1980 e.g., by the programmable logic device 2000
  • a component of the non-isolated stage 1540 e.g., to programmable logic device 1660, processor 1740 and/or processor 1900
  • any type of information may be communicated to first data circuit 2060 for storage therein via the first data circuit interface 2040 (e.g., using the programmable logic device 2000).
  • Such information may comprise, for example, an updated number of operations in which the surgical device has been used and/or dates and/or times of its usage.
  • a surgical instrument may be detachable from a handpiece (e.g., instrument 1 106 may be detachable from handpiece 1 107) to promote instrument interchangeability and/or disposability.
  • known generators may be limited in their ability to recognize particular instrument configurations being used and to optimize control and diagnostic processes accordingly.
  • the addition of readable data circuits to surgical device instruments to address this issue is problematic from a compatibility standpoint, however. For example, it may be impractical to design a surgical device to maintain backward compatibility with generators that lack the requisite data reading functionality due to, for example, differing signal schemes, design complexity and cost.
  • Other aspects of instruments address these concerns by using data circuits that may be implemented in existing surgical instruments economically and with minimal design changes to preserve compatibility of the surgical devices with current generator platforms.
  • aspects of the generator 1 100 may enable communication with instrument-based data circuits.
  • the generator 1 100 may be configured to communicate with a second data circuit (e.g., a data circuit) contained in an instrument (e.g., instrument 1 104, 1 106 or 1 108) of a surgical device.
  • the instrument interface circuit 1980 may comprise a second data circuit interface 2100 to enable this communication.
  • the second data circuit interface 2100 may comprise a tri-state digital interface, although other interfaces also may be used.
  • the second data circuit may generally be any circuit for transmitting and/or receiving data.
  • the second data circuit may store information pertaining to the particular surgical instrument with which it is associated.
  • Such information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument has been used, and/or any other type of information. Additionally or alternatively, any type of information may be communicated to the second data circuit for storage therein via the second data circuit interface 2100 (e.g., using the
  • the second data circuit may transmit data acquired by one or more sensors (e.g., an instrument-based temperature sensor).
  • the second data circuit may receive data from the generator 1 100 and provide an indication to a user (e.g., an LED indication or other visible indication) based on the received data.
  • the second data circuit and the second data circuit interface 2100 may be configured such that communication between the programmable logic device 2000 and the second data circuit can be effected without the need to provide additional conductors for this purpose (e.g., dedicated conductors of a cable connecting a handpiece to the generator 1 100).
  • information may be communicated to and from the second data circuit using a one-wire bus communication scheme implemented on existing cabling, such as one of the conductors used transmit interrogation signals from the signal conditioning circuit 2020 to a control circuit in a handpiece. In this way, design changes or modifications to the surgical device that might otherwise be necessary are minimized or reduced.
  • the presence of a second data circuit may be“invisible” to generators that do not have the requisite data reading functionality, thus enabling backward compatibility of the surgical device instrument.
  • the isolated stage 1520 may comprise at least one blocking capacitor 2960-1 (FIG. 27C) connected to the drive signal output 1600b to prevent passage of DC current to a patient.
  • a single blocking capacitor may be required to comply with medical regulations or standards, for example. While failure in single-capacitor designs is relatively uncommon, such failure may nonetheless have negative consequences.
  • a second blocking capacitor 2960-2 may be provided in series with the blocking capacitor 2960-1 , with current leakage from a point between the blocking capacitors 2960-1 , 2960-2 being monitored by, for example, an ADC 2980 for sampling a voltage induced by leakage current.
  • the samples may be received by the programmable logic device 2000, for example. Based on changes in the leakage current (as indicated by the voltage samples in the aspect of FIG. 26), the generator 1 100 may determine when at least one of the blocking capacitors 2960-1 , 2960-2 has failed. Accordingly, the aspect of FIG. 26 may provide a benefit over single-capacitor designs having a single point of failure.
  • the non-isolated stage 1540 may comprise a power supply 21 10 for outputting DC power at a suitable voltage and current.
  • the power supply may comprise, for example, a 400 W power supply for outputting a 48 VDC system voltage.
  • the power supply 21 10 may further comprise one or more DC/DC voltage converters 2130 for receiving the output of the power supply to generate DC outputs at the voltages and currents required by the various components of the generator 1 100.
  • one or more of the DC/DC voltage converters 2130 may receive an input from the controller 1960 when activation of the“on/off input device 2150 by a user is detected by the controller 1960 to enable operation of, or wake, the DC/DC voltage converters 2130.
  • FIGS. 28A-28B illustrate certain functional and structural aspects of one aspect of the generator 1 100.
  • Feedback indicating current and voltage output from the secondary winding 1580 of the power transformer 1560 is received by the ADCs 1780, 1800, respectively.
  • the ADCs 1780, 1800 may be implemented as a 2-channel ADC and may sample the feedback signals at a high speed (e.g., 80 Msps) to enable oversampling (e.g., approximately 200x oversampling) of the drive signals.
  • the current and voltage feedback signals may be suitably conditioned in the analog domain (e.g., amplified, filtered) prior to processing by the ADCs 1780, 1800.
  • the programmable logic device 1660 comprises an FPGA.
  • the multiplexed current and voltage feedback samples may be received by a parallel data acquisition port (PDAP) implemented within block 2144 of the processor 1740.
  • the PDAP may comprise a packing unit for implementing any of a number of methodologies for correlating the multiplexed feedback samples with a memory address.
  • feedback samples corresponding to a particular LUT sample output by the programmable logic device 1660 may be stored at one or more memory addresses that are correlated or indexed with the LUT address of the LUT sample.
  • feedback samples corresponding to a particular LUT sample output by the programmable logic device 1660 may be stored, along with the LUT address of the LUT sample, at a common memory location.
  • the feedback samples may be stored such that the address of the LUT sample from which a particular set of feedback samples originated may be subsequently ascertained. As discussed above, synchronization of the LUT sample addresses and the feedback samples in this way contributes to the correct timing and stability of the pre-distortion algorithm.
  • a direct memory access (DMA) controller implemented at block 2166 of the processor 1740 may store the feedback samples (and any LUT sample address data, where applicable) at a designated memory location 2180 of the processor 1740 (e.g., internal RAM).
  • DMA direct memory access
  • Block 2200 of the processor 1740 may implement a pre-distortion algorithm for pre distorting or modifying the LUT samples stored in the programmable logic device 1660 on a dynamic, ongoing basis.
  • pre-distortion of the LUT samples may compensate for various sources of distortion present in the output drive circuit of the generator 1 100.
  • the pre-distorted LUT samples, when processed through the drive circuit, will therefore result in a drive signal having the desired waveform shape (e.g., sinusoidal) for optimally driving the ultrasonic transducer.
  • the current through the motional branch of the ultrasonic transducer is determined.
  • the motional branch current may be determined using Kirchhoffs Current Law based on, for example, the current and voltage feedback samples stored at memory location 2180 (which, when suitably scaled, may be representative of l g and V g in the model of FIG. 25 discussed above), a value of the ultrasonic transducer static capacitance C 0 (measured or known a priori) and a known value of the drive frequency.
  • a motional branch current sample for each set of stored current and voltage feedback samples associated with a LUT sample may be determined.
  • each motional branch current sample determined at block 2220 is compared to a sample of a desired current waveform shape to determine a difference, or sample amplitude error, between the compared samples.
  • the sample of the desired current waveform shape may be supplied, for example, from a waveform shape LUT 2260 containing amplitude samples for one cycle of a desired current waveform shape.
  • the particular sample of the desired current waveform shape from the LUT 2260 used for the comparison may be dictated by the LUT sample address associated with the motional branch current sample used in the comparison. Accordingly, the input of the motional branch current to block 2240 may be synchronized with the input of its associated LUT sample address to block 2240.
  • the LUT samples stored in the programmable logic device 1660 and the LUT samples stored in the waveform shape LUT 2260 may therefore be equal in number.
  • the desired current waveform shape represented by the LUT samples stored in the waveform shape LUT 2260 may be a fundamental sine wave.
  • Other waveform shapes may be desirable. For example, it is contemplated that a fundamental sine wave for driving main longitudinal motion of an ultrasonic transducer superimposed with one or more other drive signals at other frequencies, such as a third order harmonic for driving at least two mechanical resonances for beneficial vibrations of transverse or other modes, could be used.
  • Each value of the sample amplitude error determined at block 2240 may be transmitted to the LUT of the programmable logic device 1660 (shown at block 2280 in FIG. 28A) along with an indication of its associated LUT address. Based on the value of the sample amplitude error and its associated address (and, optionally, values of sample amplitude error for the same LUT address previously received), the LUT 2280 (or other control block of the programmable logic device 1660) may pre-distort or modify the value of the LUT sample stored at the LUT address such that the sample amplitude error is reduced or minimized.
  • Current and voltage amplitude measurements, power measurements and impedance measurements may be determined at block 2300 of the processor 1740 based on the current and voltage feedback samples stored at memory location 2180.
  • the feedback samples may be suitably scaled and, in certain aspects, processed through a suitable filter 2320 to remove noise resulting from, for example, the data acquisition process and induced harmonic components.
  • the filtered voltage and current samples may therefore substantially represent the fundamental frequency of the generator’s drive output signal.
  • the filter 2320 may be a finite impulse response (FIR) filter applied in the frequency domain.
  • FFT Fast Fourier Transform
  • the resulting frequency spectrum may be used to provide additional generator functionality.
  • the ratio of the second and/or third order harmonic component relative to the fundamental frequency component may be used as a diagnostic indicator.
  • a root mean square (RMS) calculation may be applied to a sample size of the current feedback samples representing an integral number of cycles of the drive signal to generate a measurement l rm s representing the drive signal output current.
  • RMS root mean square
  • a root mean square (RMS) calculation may be applied to a sample size of the voltage feedback samples representing an integral number of cycles of the drive signal to determine a measurement V rm s representing the drive signal output voltage.
  • RMS root mean square
  • the current and voltage feedback samples may be multiplied point by point, and a mean calculation is applied to samples representing an integral number of cycles of the drive signal to determine a measurement P r of the generator’s real output power.
  • measurement P a of the generator’s apparent output power may be determined as the product V rm s lrms.
  • measurement Z m of the load impedance magnitude may be determined as the quotient Vrms/lrms.
  • the quantities l rms , V rms , P r , P a and Z m determined at blocks 2340, 2360, 2380, 2400 and 2420 may be used by the generator 1 100 to implement any of a number of control and/or diagnostic processes.
  • any of these quantities may be communicated to a user via, for example, an output device 2140 integral with the generator 1 100 or an output device 2140 connected to the generator 1 100 through a suitable communication interface (e.g., a USB interface).
  • Various diagnostic processes may include, without limitation, handpiece integrity, instrument integrity, instrument attachment integrity, instrument overload, approaching instrument overload, frequency lock failure, over-voltage condition, over-current condition, over power condition, voltage sense failure, current sense failure, audio indication failure, visual indication failure, short circuit condition, power delivery failure, or blocking capacitor failure, for example.
  • Block 2440 of the processor 1740 may implement a phase control algorithm for determining and controlling the impedance phase of an electrical load (e.g., the ultrasonic transducer) driven by the generator 1 100.
  • an electrical load e.g., the ultrasonic transducer
  • Block 2440 of the processor 1740 may implement a phase control algorithm for determining and controlling the impedance phase of an electrical load (e.g., the ultrasonic transducer) driven by the generator 1 100.
  • an impedance phase setpoint e.g., 0°
  • the phase control algorithm receives as input the current and voltage feedback samples stored in the memory location 2180.
  • the feedback samples may be suitably scaled and, in certain aspects, processed through a suitable filter 2460 (which may be identical to filter 2320) to remove noise resulting from the data acquisition process and induced harmonic components, for example.
  • the filtered voltage and current samples may therefore substantially represent the fundamental frequency of the generator’s drive output signal.
  • the current through the motional branch of the ultrasonic transducer is determined. This determination may be identical to that described above in connection with block 2220 of the pre-distortion algorithm.
  • the output of block 2480 may thus be, for each set of stored current and voltage feedback samples associated with a LUT sample, a motional branch current sample.
  • impedance phase is determined based on the synchronized input of motional branch current samples determined at block 2480 and corresponding voltage feedback samples. In certain aspects, the impedance phase is determined as the average of the impedance phase measured at the rising edge of the waveforms and the impedance phase measured at the falling edge of the waveforms. [0293] At block 2520 of the of the phase control algorithm, the value of the impedance phase determined at block 2220 is compared to phase setpoint 2540 to determine a difference, or phase error, between the compared values.
  • a frequency output for controlling the frequency of the drive signal is determined.
  • the value of the frequency output may be continuously adjusted by the block 2560 and transferred to a DDS control block 2680 (discussed below) in order to maintain the impedance phase determined at block 2500 at the phase setpoint (e.g., zero phase error).
  • the impedance phase may be regulated to a 0° phase setpoint. In this way, any harmonic distortion will be centered about the crest of the voltage waveform, enhancing the accuracy of phase impedance determination.
  • Block 2580 of the processor 1740 may implement an algorithm for modulating the current amplitude of the drive signal in order to control the drive signal current, voltage and power in accordance with user specified setpoints, or in accordance with requirements specified by other processes or algorithms implemented by the generator 1 100. Control of these quantities may be realized, for example, by scaling the LUT samples in the LUT 2280 and/or by adjusting the full-scale output voltage of the DAC 1680 (which supplies the input to the power amplifier 1620) via a DAC 1860.
  • Block 2600 (which may be implemented as a PID controller in certain aspects) may receive, as input, current feedback samples (which may be suitably scaled and filtered) from the memory location 2180.
  • the current feedback samples may be compared to a“current demand” l d value dictated by the controlled variable (e.g., current, voltage or power) to determine if the drive signal is supplying the necessary current.
  • the current demand l d may be specified directly by a current setpoint 2620A (l sp ). For example, an RMS value of the current feedback data
  • LUT scaling and/or the full-scale output voltage of the DAC 1680 may be adjusted by the block 2600 such that the drive signal current is increased. Conversely, block 2600 may adjust LUT scaling and/or the full-scale output voltage of the DAC 1680 to decrease the drive signal current when the current feedback data indicates an RMS value greater than the current setpoint l sp .
  • the current demand l may be specified indirectly, for example, based on the current required to maintain a desired voltage setpoint 2620B ( V sp ) given the load impedance magnitude Z m measured at block 2420 (e.g. I d V sp /Z m ).
  • Block 2680 may implement a DDS control algorithm for controlling the drive signal by recalling LUT samples stored in the LUT 2280.
  • the DDS control algorithm may be a numerically-controlled oscillator (NCO) algorithm for generating samples of a waveform at a fixed clock rate using a point (memory location)-skipping technique.
  • the NCO algorithm may implement a phase accumulator, or frequency-to-phase converter, that functions as an address pointer for recalling LUT samples from the LUT 2280.
  • the phase accumulator may be a D step size, modulo N phase accumulator, where D is a positive integer representing a frequency control value, and N is the number of LUT samples in the LUT 2280.
  • the phase accumulator may skip addresses in the LUT 2280, resulting in a waveform output having a higher frequency. Accordingly, the frequency of the waveform generated by the DDS control algorithm may therefore be controlled by suitably varying the frequency control value.
  • the frequency control value may be determined based on the output of the phase control algorithm implemented at block 2440.
  • the output of block 2680 may supply the input of DAC 1680, which in turn supplies a corresponding analog signal to an input of the power amplifier 1620.
  • Block 2700 of the processor 1740 may implement a switch-mode converter control algorithm for dynamically modulating the rail voltage of the power amplifier 1620 based on the waveform envelope of the signal being amplified, thereby improving the efficiency of the power amplifier 1620.
  • characteristics of the waveform envelope may be determined by monitoring one or more signals contained in the power amplifier 1620.
  • characteristics of the waveform envelope may be determined by monitoring the minima of a drain voltage (e.g., a MOSFET drain voltage) that is modulated in accordance with the envelope of the amplified signal.
  • a minima voltage signal may be generated, for example, by a voltage minima detector coupled to the drain voltage.
  • the minima voltage signal may be sampled by ADC 1760, with the output minima voltage samples being received at block 2720 of the switch-mode converter control algorithm. Based on the values of the minima voltage samples, block 2740 may control a PWM signal output by a PWM generator 2760, which, in turn, controls the rail voltage supplied to the power amplifier 1620 by the switch-mode regulator 1700. In certain aspects, as long as the values of the minima voltage samples are less than a minima target 2780 input into block 2720, the rail voltage may be modulated in accordance with the waveform envelope as characterized by the minima voltage samples.
  • block 2740 may cause a low rail voltage to be supplied to the power amplifier 1620, with the full rail voltage being supplied only when the minima voltage samples indicate maximum envelope power levels.
  • block 2740 may cause the rail voltage to be maintained at a minimum value suitable for ensuring proper operation of the power amplifier 1620.
  • the surgical instrument may include means for limiting capacitive coupling to improve monopolar isolation for use independently or in cooperation with another advanced energy modality.
  • Capacitive coupling occurs generally when there is a transfer of energy between nodes, induced by an electric field. During surgery, capacitive coupling may occur when two or more electrical surgical instruments are being used in or around a patient. While in some cases capacitive coupling may be desirable, as additional devices may be powered inductively by capacitive coupling, having capacitive coupling occur accidentally during surgery or around a patient generally can have extremely deleterious consequences. Parasitic or accidental capacitive coupling may occur in unknown or unpredictable locations, causing energy to be applied to unintended areas. When the patient is under anesthesia and unable to provide any response, parasitic capacitive coupling can burn a patient while the surgeon would not know it is even occurring. It is therefore desirable to limit the parasitic or accidental capacitive coupling in surgical instruments and during surgery generally.
  • a system including a surgical instrument and a generator may be configured to interrupt the transmission of energy from the generator to the surgical instrument when capacitive coupling has been detected.
  • One or more safety fuses, sensors, controls, and/or algorithms may be in place to automatically trigger an interruption of the generator in these scenarios.
  • Alerts, including audio signals, vibrations, and visual messages may issue to inform the surgery team that the generator was interrupted due to the detection of capacitive coupling.
  • the system includes means for detecting that a capacitive coupling event has occurred. For example, an algorithm that includes inputs from one or more sensors for monitoring events around the system may apply situational awareness and other programmatic means to conclude that capacitive coupling is occurring somewhere within the system and react accordingly.
  • a system having situational awareness means that the system may be configured to anticipate scenarios that may arise based on present environmental and system data and determining that the present conditions follow a pattern that gives rise to predictable next steps.
  • the system may apply situational awareness in the context of handling capacitive coupling events by recalling instances in similarly situated surgeries where various sensor data is detected.
  • the sensor data may indicate an increase in current at two particular locations along a closed loop electrosurgical system, that based on previous data of similarly situated surgeries, indicates a high likelihood that a capacitive coupling event is imminent.
  • the surgical instruments may be modified in structure to limit the occurrence of capacitive coupling, or in other cases reduce the collateral damage caused by capacitive coupling.
  • additional insulation placed strategically in or around the surgical instrument may help limit the incidence of capacitive coupling.
  • the end effector of the surgical instrument may include modified structures that reduce the incidence of current displacement, such as rounding the tips of the end effector or specifically shaping the blade of the end effector to behave more like a monopolar blade while still acting as a bipolar device.
  • the system may include passive means for mitigating or limiting the effects of the capacitive coupling.
  • the system may include leads that can shunt the energy to a neutral node through conductive passive components.
  • any and all of these aspects may be combined or included in a single system to address the challenges posed by multiple electrical components liable to cause capacitive coupling during patient surgery.
  • FIG. 29 provides a diagram showing an example system 134000 with means for detecting capacitive coupling, in accordance with at least one aspect of the present disclosure.
  • the system 134000 includes a monopolar ESU generator 134002 that is electrically coupled to a surgical instrument 134008.
  • the surgical instrument 134008 is used to perform surgery on a patient, where patient tissue 134016 is shown to represent the surgical site of the patient where surgery is being performed.
  • the surgical instrument 134008 may include means for applying electrosurgical or ultrasonic energy to an end effector, and in some cases may include a blade and/or a pair of jaws to grasp or clamp onto tissue.
  • the energy powered by the ESU generator 134002 may touch the patient through the end effector, via any of the possible various components of the end effector. At least a portion of the patient may rest on a return path pad 134014, such as a Smart Megasoft PadTM , for example, that is configured to divert excess energy away from the patient when the surgical instrument 134008 touches the patient and applies electro
  • multiple smart sensors or monitors such as CT 1 (134006), CT2 (134010), and CT3 (134012) smart sensors may be integrated into the electrosurgical system as indicators to determine whether excess or inductive energy is radiating outside the one or more of the electrical sources. As shown in FIG. 29, the smart sensors CT 1 (134006), CT2 (134010) and CT3 (134012) are placed at likely locations where energy may inductively radiate.
  • the sensors or monitors may be configured to detect capacitance, and if placed at strategic locations within the system, a reading of capacitance may imply that capacitive leakage is occurring near the sensor or monitor. Coupled with knowledge of other sensors nearby or throughout the system not indicating a reading of capacitance, one may conclude that capacitive leakage is occurring in close proximity to the sensor or monitor that is providing a positive indication. Other sensors may be used, such as capacitive leakage monitors or detectors. These sensors may be configured to provide an alert, such as lighting up or delivering a noise or transmitting a signal ultimately to a display monitor.
  • the monopolar ESU 134002 may be configured to automatically trigger an interruption in energy generation to stop any further capacitive coupling from occurring.
  • a neutral electrode 134004 may be included in the monopolar ESU 1340002 and may be electrically coupled to the return path pad 134014, such as a Smart Megasoft Pad®, for example, as another solution to reduce capacitive coupling.
  • Energy can reach the neutral node 134004 conductively as the electrosurgical instrument 134008 touches the patient, the patient is touching the return path pad 134014, and the pad is conductively connected to the neutral electrode 134004.
  • energy can be diverted to the neutral node 134004 from the monopolar ESU 134002 or the surgical instrument 134008 and thereby reduce the incidence of capacitive coupling.
  • a cloud analytics system communicatively coupled to the monopolar ESU, such as through a medical hub may be configured to employ situational awareness that can help anticipate when capacitive coupling may occur during surgery.
  • the cloud analytics system and/or the medical hub may utilize a capacitive coupling algorithm to monitor the incidence of energy flowing through the surgical system, and based on previous data about the state of energy in the system for a similar situated procedure, may conclude there is a likelihood that capacitive coupling may occur if no additional action is taken.
  • the cloud analytics module may draw from previous surgeries of the same and note that capacitive coupling has a stronger likelihood to occur after a particular step in the surgery.
  • the cloud analytics system may deliver an alert that indicates this is likely to cause capacitive coupling.
  • the surgeon may be given the option to reduce peak voltage in the surgical instrument 134008 or interrupt the power generation by the monopolar ESU 134002, or the cloud analytics module may automatically cause the medical hub to take these measures. This may lead to eliminating the possibility of capacitive coupling before it has a chance to occur, or at least may limit any unintended effects caused by a momentary occurrence of capacitive coupling.
  • the surgical instrument as shown in FIG. 29 may include structural means for reducing or preventing capacitive coupling.
  • insulation in the shaft of the surgical instrument 134008 may reduce the incidence of inductance.
  • the monopolar wire connecting the monopolar ESU 134002 to the surgical instrument 134008 may be shielded.
  • interrupting plastic elements within the shaft may be intermittently present to prevent capacitive coupling from transmitting long distance within the shaft.
  • Other insulator-type elements may be used to achieve similar effects.
  • the monopolar wire electrically connecting the surgical instrument 134008 to the generator 134002 may be shielded to also reduce the incidence of capacitive coupling.
  • the structure of the end effector may be modified to reduce the effects of capacitive coupling as the end effector makes contact with the patient.
  • the jaws of the end effector may be designed to have only one side of the each of the jaws directed to deliver energy, thereby causing the end effector to act like a monopolar blade while still actually functionally structured as a bipolar device.
  • the ends or tips of the end effector may be shaped like a duck bill, with rounded ends to reduce any voltage peaks that might arise out of pointed ends. The direction of energy in the end effector may still be directed to an area or a point along the duck billed ends, but the dispersion of any excess energy may be blunted by the duck billed end.
  • the blade may be structured to be slightly thicker on one side, such as having a triangular cross-sectional area, and having a thin standing upper blade element on the opposite. This may allow any energy being delivered to the blade to be focused to a point, which may help the surgical instrument act like a monopolar blade while still being a bipolar device. In this way, energy will not be dispersed that would make the surgical instrument more prone to causing capacitive coupling.
  • the jaws of the surgical instrument may have electrodes placed on the inside of the end effector, allowing the outer portions of the end effector to act like a shield to ward against capacitive coupling. The electrodes may still be placed sufficiently to contact the tissue of the patient during a surgery, while having one or more edges of the end effector shield the energy from dispersing beyond the focused surgical area.
  • FIG. 30 is a logic flow diagram 134100 depicting a control program or a logic configuration of an example methodology for limiting the effects of capacitive coupling in a surgical system is disclosed, according to some aspects.
  • the example methodology may be consistent with the descriptions above regarding several enumerated means for limiting capacitive coupling or mitigating its effects during surgery using one or more surgical instruments.
  • the methodology 134100 may start with the surgical system being configured to monitor 134102 energy generation.
  • multiple sensors may be placed strategically at potential vulnerable points more liable to leak energy that can cause capacitive coupling. These sensors may be configured to deliver an alert when an energy anomaly occurs.
  • the sensors or other detecting means may detect 134104 a voltage anomaly, such as a voltage peak or voltage spike, at one or more locations along the surgical system that would not normally be expected to produce such energy production.
  • the system may be configured to conclude these scenarios may give rise to parasitic capacitive coupling, potentially burning the patient unbeknownst to the surgery team in the absence of any alerts.
  • an alert or message may be delivered indicating the energy anomaly and the danger of capacitive coupling occurring.
  • situational awareness also may be used to anticipate 134106 when capacitive coupling is more likely to occur during the usual course of a surgery.
  • Situational awareness may be used to refer back to past surgical operations of similar type or circumstances to identify what variables may be present when capacitive coupling was determined to have occurred. If there are certain steps in the procedure that are more likely to cause capacitive coupling, the system may anticipate these situations by particularly monitoring the sensors at these times, and/or taking preemptive measures to reduce the incidences of capacitive coupling.
  • capacitive coupling is detected or believed to be imminent, based on the above the methodology 134100 executed by the surgical system, measures taken to reduce, eliminate, or mitigate the effects of capacitive coupling can include to automatically interrupt 134108 energy generation at the monopolar energy generator, according to some aspects. It is noted that some loss in surgical operation may occur momentarily at the time this interruption is enabled, but preventing unintended damage to the patient would be paramount in any case. The surgery can continue as planned after a brief moment of interruption.
  • the presence of parasitic capacitive coupling can be harnessed to perform energy coagulation or energy cautery.
  • a conductive return pad 134014 such as the Smart Megasoft Pad® (see FIG. 29)
  • the pad may be defective or worn, such that the conductivity of the return pad 134014 is not sufficient to draw the current of the electrosurgical instrument (e.g., 134008) through the body of the patient.
  • the current may lack a sufficient ground for the energy to travel to, effectively making the body of the patient act like a short circuit. This may render the electrosurgery ineffective, as the energy delivered by the surgical instrument 134008 will not pass through the tissue of the patient and therefore not heat the tissue as intended.
  • a similar situation may occur when there is no return pad at all. That is, without a conductive return pad 134014, such as the Smart Megasoft Pad®, to provide a wide conductive return path, there may be no ground available that is connected to the patient. This also may lead to the patient acting as a short circuit if energy from the surgical instrument were applied to the patient.
  • the monopolar energy generation may be increased to a very high frequency, such as 500Khz to 3-4Mhz, to take advantage of parasitic patient leakage to do padless electrosurgery (or electrosurgery with insufficient conductivity in the pad).
  • a very high frequency such as 500Khz to 3-4Mhz
  • the parasitic leakage current will increase.
  • the stronger leakage current can then more effectively radiatively traverse through the body of the patient.
  • the leakage current of the capacitive coupling may be more effectively radiatively coupled to a ground state as a result, which may effectively drive the current radiatively into another object that acts as ground.
  • the AC frequency is high enough, the current leakage may reach the monopolar generator grounding terminal.
  • the return path may be formed by the radiative current leakage caused by capacitive coupling. To help ensure that the radiative return path reaches a ground plane, the energy of the surgical instrument may be increased to a very high frequency.
  • the poorly conducting return pad may be connected purposely to an earth ground, or table, or to a closest support surface, while the return connector on the generator may be connected to earth ground as well. This will divert the circuit to flow through the radiative return path, rather than have any energy attempt to travel through the poorly conducting return pad and back to the generator, which may cause burns on the patient.
  • the typical monopolar circuit that drives the current through the body and into the return pad may be a preferred method. In these cases, it may be useful to build isolation barriers to the externally connected power source, such as the energy generator 134002 (see FIG. 29). Alternatively, battery powered instruments may be the more ideal system for reducing the leakage current that will help isolate the energy path through the conductive return pad.
  • the surgical system may include a detection circuit configured to determine the capacity of the return path pad. The detection circuit may then provide information as to whether it would be better to utilize the radiative current leakage to complete the circuit, rather than try to rely on a poorly conducting return path pad, or simply no pad at all.
  • the detection circuit may measure an amount of conductivity in the return path pad. If the measure of conductivity satisfies a predetermined threshold, the system may determine that the return path pad may be used to perform the surgery and provide a return path for the monopolar energy.
  • the detection circuit may be configured to send a signal to the system, such as at a processor in the surgical hub or the monopolar generator, that the frequency of the monopolar energy should be increased drastically and the return path pad should be eliminated or at least isolated from consideration. Increasing the frequency will then complete the monopolar circuit through creating a radiative return path.
  • the monopolar generator may include one or more control circuits coupled to one or more sensors that are configured to determine if the current leakage has reached the grounding terminal of the monopolar generator.
  • the sensor combined with the detection circuit and a control circuit of the monopolar generator may be used to create a closed feedback loop system that may automatically adjust the frequency to create a sufficient return path based on high leakage current.
  • the detection circuit may determine if there is sufficient conductivity in the return path pad. If not, the control circuit of the monopolar generator may cause the energy generation to increase the AC frequency.
  • the sensor at the monopolar generator may continuously monitor if any radiative current leakage has reached the ground terminal of the monopolar generator, based on the increased frequency.
  • the control circuit may gradually increase the frequency until it is detected that the radiative current leakage has reached the ground terminal. Therefore, the surgical system may rely on a predetermined frequency threshold if it is determined there is no return path pad or an insufficient conductivity in the pad, or a closed feedback system may be used to find a sufficiently high frequency that can create a return path through radiative coupling.
  • FIG. 31 is a logic flow diagram 134200 depicting a control program or a logic
  • a detection circuit as part of the surgical system may be configured to measure 134202 a level of conductivity in the return path of a monopolar electrosurgical setup.
  • the return path may originally be identified to go through a conductive pad, such as a Soft Megasoft Pad® or other return path conductive pad.
  • the conductivity of the pad may offer poor conductivity.
  • no pad may exist as part of the surgery setup. This may cause the patient body to act as a short circuit of the monopolar circuit, which would reduce or eliminate the effectiveness of trying to apply monopolar energy to a surgical site at the patient.
  • the detection circuit may determine 134204 that the measure of conductivity falls below a predetermined threshold, indicating that the level of conductivity in the return path is sufficiently poor, which prevents completion of the monopolar circuit.
  • the surgical system may cause the generator to increase 134206 the current leakage by increasing the frequency of the alternating current in the monopolar generator.
  • the surgical system may instead utilize the radiative current leakage to create a return path.
  • the frequency is increased, the current leakage will also increase, which thereby increases the reach of the radiative current leakage to reach a ground plane and complete the circuit.
  • the increase in leakage may be determined based on a closed feedback sensor system that adjusts the frequency until it is determined that the radiative current leakage has reached the ground terminal at the monopolar generator.
  • the surgical system also may provide an instruction to isolate 134208 any return path pads and to attach the return connector of the monopolar generator to an earth ground. These measures may be taken to eliminate other alternative return paths that may inadvertently cause burns at undesirable locations in the patient.
  • a timeline 5200 depicting situational awareness of a hub such as the surgical hub 106 or 206, for example.
  • the timeline 5200 is an illustrative surgical procedure and the contextual information that the surgical hub 106, 206 can derive from the data received from the data sources at each step in the surgical procedure.
  • the timeline 5200 depicts the typical steps that would be taken by the nurses, surgeons, and other medical personnel during the course of a lung segmentectomy procedure, beginning with setting up the operating theater and ending with transferring the patient to a post-operative recovery room.
  • the situationally aware surgical hub 106, 206 receives data from the data sources throughout the course of the surgical procedure, including data generated each time medical personnel utilize a modular device that is paired with the surgical hub 106, 206.
  • the surgical hub 106, 206 can receive this data from the paired modular devices and other data sources and continually derive inferences (i.e. , contextual information) about the ongoing procedure as new data is received, such as which step of the procedure is being performed at any given time.
  • the situational awareness system of the surgical hub 106, 206 is able to, for example, record data pertaining to the procedure for generating reports, verify the steps being taken by the medical personnel, provide data or prompts (e.g., via a display screen) that may be pertinent for the particular procedural step, adjust modular devices based on the context (e.g., activate monitors, adjust the field of view (FOV) of the medical imaging device, or change the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and take any other such action described above.
  • record data pertaining to the procedure for generating reports verify the steps being taken by the medical personnel, provide data or prompts (e.g., via a display screen) that may be pertinent for the particular procedural step, adjust modular devices based on the context (e.g., activate monitors, adjust the field of view (FOV) of the medical imaging device, or change the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and take any other such action described above.
  • FOV field of view
  • the hospital staff members retrieve the patient’s EMR from the hospital’s EMR database. Based on select patient data in the EMR, the surgical hub 106, 206 determines that the procedure to be performed is a thoracic procedure.
  • Second step 5204 the staff members scan the incoming medical supplies for the procedure.
  • the surgical hub 106, 206 cross-references the scanned supplies with a list of supplies that are utilized in various types of procedures and confirms that the mix of supplies corresponds to a thoracic procedure. Further, the surgical hub 106, 206 is also able to determine that the procedure is not a wedge procedure (because the incoming supplies either lack certain supplies that are necessary for a thoracic wedge procedure or do not otherwise correspond to a thoracic wedge procedure).
  • Third step 5206 the medical personnel scan the patient band via a scanner that is communicably connected to the surgical hub 106, 206.
  • the surgical hub 106, 206 can then confirm the patient’s identity based on the scanned data.
  • auxiliary equipment can vary according to the type of surgical procedure and the techniques to be used by the surgeon, but in this illustrative case they include a smoke evacuator, insufflator, and medical imaging device.
  • the auxiliary equipment that are modular devices can automatically pair with the surgical hub 106, 206 that is located within a particular vicinity of the modular devices as part of their initialization process.
  • the surgical hub 106, 206 can then derive contextual information about the surgical procedure by detecting the types of modular devices that pair with it during this pre-operative or initialization phase.
  • the surgical hub 106, 206 determines that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices. Based on the combination of the data from the patient’s EMR, the list of medical supplies to be used in the procedure, and the type of modular devices that connect to the hub, the surgical hub 106, 206 can generally infer the specific procedure that the surgical team will be performing. Once the surgical hub 106, 206 knows what specific procedure is being performed, the surgical hub 106, 206 can then retrieve the steps of that procedure from a memory or from the cloud and then cross-reference the data it subsequently receives from the connected data sources (e.g., modular devices and patient monitoring devices) to infer what step of the surgical procedure the surgical team is performing.
  • the connected data sources e.g., modular devices and patient monitoring devices
  • the staff members attach the EKG electrodes and other patient monitoring devices to the patient.
  • the EKG electrodes and other patient monitoring devices are able to pair with the surgical hub 106, 206.
  • the surgical hub 106, 206 begins receiving data from the patient monitoring devices, the surgical hub 106, 206 thus confirms that the patient is in the operating theater.
  • Sixth step 5212 the medical personnel induce anesthesia in the patient.
  • the surgical hub 106, 206 can infer that the patient is under anesthesia based on data from the modular devices and/or patient monitoring devices, including EKG data, blood pressure data, ventilator data, or combinations thereof, for example.
  • the pre operative portion of the lung segmentectomy procedure is completed and the operative portion begins.
  • the patient’s lung that is being operated on is collapsed (while ventilation is switched to the contralateral lung).
  • the surgical hub 106, 206 can infer from the ventilator data that the patient’s lung has been collapsed, for example.
  • the operative portion of the procedure has commenced as it can compare the detection of the patient’s lung collapsing to the expected steps of the procedure (which can be accessed or retrieved previously) and thereby determine that collapsing the lung is the first operative step in this particular procedure.
  • the medical imaging device e.g., a scope
  • receives the medical imaging device data i.e., video or image data
  • the surgical hub 106, 206 can determine that the laparoscopic portion of the surgical procedure has commenced. Further, the surgical hub 106, 206 can determine that the particular procedure being performed is a segmentectomy, as opposed to a lobectomy (note that a wedge procedure has already been discounted by the surgical hub 106, 206 based on data received at the second step 5204 of the procedure).
  • the data from the medical imaging device 124 (FIG.
  • one technique for performing a VATS lobectomy places the camera in the lower anterior corner of the patient’s chest cavity above the diaphragm, whereas one technique for performing a VATS segmentectomy places the camera in an anterior intercostal position relative to the segmental fissure.
  • the situational awareness system can be trained to recognize the positioning of the medical imaging device according to the visualization of the patient’s anatomy.
  • one technique for performing a VATS lobectomy utilizes a single medical imaging device, whereas another technique for performing a VATS
  • segmentectomy utilizes multiple cameras.
  • one technique for performing a VATS segmentectomy utilizes an infrared light source (which can be
  • the surgical hub 106, 206 can thereby determine the specific type of surgical procedure being performed and/or the technique being used for a particular type of surgical procedure.
  • the surgical team begins the dissection step of the procedure.
  • the surgical hub 106, 206 can infer that the surgeon is in the process of dissecting to mobilize the patient’s lung because it receives data from the RF or ultrasonic generator indicating that an energy instrument is being fired.
  • the surgical hub 106, 206 can cross-reference the received data with the retrieved steps of the surgical procedure to determine that an energy instrument being fired at this point in the process (i.e., after the completion of the previously discussed steps of the procedure) corresponds to the dissection step.
  • the energy instrument can be an energy tool mounted to a robotic arm of a robotic surgical system.
  • Tenth step 5220 the surgical team proceeds to the ligation step of the procedure.
  • the surgical hub 106, 206 can infer that the surgeon is ligating arteries and veins because it receives data from the surgical stapling and cutting instrument indicating that the instrument is being fired. Similarly to the prior step, the surgical hub 106, 206 can derive this inference by cross-referencing the receipt of data from the surgical stapling and cutting instrument with the retrieved steps in the process.
  • the surgical instrument can be a surgical tool mounted to a robotic arm of a robotic surgical system.
  • the segmentectomy portion of the procedure is performed.
  • the surgical hub 106, 206 can infer that the surgeon is transecting the parenchyma based on data from the surgical stapling and cutting instrument, including data from its cartridge.
  • the cartridge data can correspond to the size or type of staple being fired by the instrument, for example.
  • the cartridge data can thus indicate the type of tissue being stapled and/or transected.
  • the type of staple being fired is utilized for parenchyma (or other similar tissue types), which allows the surgical hub 106, 206 to infer that the segmentectomy portion of the procedure is being performed.
  • Twelfth step 5224 the node dissection step is then performed.
  • the surgical hub 106, 206 can infer that the surgical team is dissecting the node and performing a leak test based on data received from the generator indicating that an RF or ultrasonic instrument is being fired.
  • an RF or ultrasonic instrument being utilized after parenchyma was transected corresponds to the node dissection step, which allows the surgical hub 106, 206 to make this inference.
  • surgeons regularly switch back and forth between surgical stapling/cutting instruments and surgical energy (i.e. , RF or ultrasonic) instruments depending upon the particular step in the procedure because different instruments are better adapted for particular tasks. Therefore, the particular sequence in which the stapling/cutting instruments and surgical energy instruments are used can indicate what step of the procedure the surgeon is performing.
  • robotic tools can be utilized for one or more steps in a surgical procedure and/or handheld surgical instruments can be utilized for one or more steps in the surgical procedure. The surgeon(s) can alternate between robotic tools and handheld surgical instruments and/or can use the devices concurrently, for example.
  • the patient’s anesthesia is reversed.
  • the surgical hub 106, 206 can infer that the patient is emerging from the anesthesia based on the ventilator data (i.e., the patient’s breathing rate begins increasing), for example.
  • the fourteenth step 5228 is that the medical personnel remove the various patient monitoring devices from the patient.
  • the surgical hub 106, 206 can thus infer that the patient is being transferred to a recovery room when the hub loses EKG, BP, and other data from the patient monitoring devices.
  • the surgical hub 106, 206 can determine or infer when each step of a given surgical procedure is taking place according to data received from the various data sources that are communicably coupled to the surgical hub 106, 206.
  • a machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to, floppy diskettes, optical disks, compact disc, read-only memory (CD-ROMs), and magneto-optical disks, read-only memory (ROMs), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable
  • the non-transitory computer-readable medium includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).
  • wireless and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communications channels, etc., that may communicate data through the use of modulated electromagnetic radiation through a non-solid medium. The term does not imply that the associated devices do not contain any wires, although in some aspects they might not.
  • the communication module may implement any of a number of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.1 1 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long term evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as any other wireless and wired protocols that are designated as 3G, 4G, 5G, and beyond.
  • the computing module may include a plurality of communication modules. For instance, a first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and Bluetooth and a second
  • communication module may be dedicated to longer range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, and others.
  • control circuit may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor comprising one or more individual instruction processing cores, processing unit, processor, microcontroller,
  • microcontroller unit controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic array (PLA), or field programmable gate array (FPGA)), state machine circuitry, firmware that stores instructions executed by programmable circuitry, and any combination thereof.
  • DSP digital signal processor
  • PLD programmable logic device
  • PLA programmable logic array
  • FPGA field programmable gate array
  • state machine circuitry firmware that stores instructions executed by programmable circuitry, and any combination thereof.
  • the control circuit may, collectively or individually, be embodied as circuitry that forms part of a larger system, for example, an integrated circuit (IC), an application- specific integrated circuit (ASIC), a system on-chip (SoC), desktop computers, laptop computers, tablet computers, servers, smart phones, etc.
  • IC integrated circuit
  • ASIC application-specific integrated circuit
  • SoC system on-chip
  • control circuit includes, but is not limited to, electrical circuitry having at least one discrete electrical circuit, electrical circuitry having at least one integrated circuit, electrical circuitry having at least one application specific integrated circuit, electrical circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program which at least partially carries out processes and/or devices described herein, or a microprocessor configured by a computer program which at least partially carries out processes and/or devices described herein), electrical circuitry forming a memory device (e.g., forms of random access memory), and/or electrical circuitry forming a
  • communications device e.g., a modem, communications switch, or optical-electrical equipment.
  • processor or processing unit is an electronic circuit which performs operations on some external data source, usually memory or some other data stream.
  • the term is used herein to refer to the central processor (central processing unit) in a system or computer systems (especially systems on a chip (SoCs)) that combine a number of specialized “processors.”
  • SoC system on a chip or system on chip
  • SoC is an integrated circuit (also known as an“IC” or“chip”) that integrates all components of a computer or other electronic systems. It may contain digital, analog, mixed-signal, and often radio-frequency functions— all on a single substrate.
  • a SoC integrates a microcontroller (or microprocessor) with advanced peripherals like graphics processing unit (GPU), Wi-Fi module, or coprocessor.
  • a SoC may or may not contain built-in memory.
  • a microcontroller or controller is a system that integrates a
  • microprocessor with peripheral circuits and memory.
  • a microcontroller or MCU for controlling
  • microcontroller unit may be implemented as a small computer on a single integrated circuit. It may be similar to a SoC; an SoC may include a microcontroller as one of its components.
  • a microcontroller may contain one or more core processing units (CPUs) along with memory and programmable input/output peripherals.
  • Program memory in the form of Ferroelectric RAM,
  • NOR flash or OTP ROM is also often included on chip, as well as a small amount of RAM.
  • Microcontrollers may be employed for embedded applications, in contrast to the
  • microprocessors used in personal computers or other general purpose applications consisting of various discrete chips.
  • controller or microcontroller may be a stand-alone IC or chip device that interfaces with a peripheral device. This may be a link between two parts of a computer or a controller on an external device that manages the operation of (and connection with) that device.
  • any of the processors or microcontrollers described herein may be implemented by any single core or multicore processor such as those known under the trade name ARM Cortex by Texas Instruments.
  • the processor may be an LM4F230H5QR ARM Cortex-M4F Processor Core, available from Texas Instruments, for example, comprising on-chip memory of 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder inputs (QEI) analog, one or more 12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels, details of which are available for the product datasheet.
  • SRAM serial random access memory
  • ROM
  • the processor may comprise a safety controller comprising two controller- based families such as TMS570 and RM4x known under the trade name Hercules ARM Cortex R4, also by Texas Instruments.
  • the safety controller may be configured specifically for I EC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.
  • logic may refer to an app, software, firmware and/or circuitry configured to perform any of the aforementioned operations.
  • Software may be embodied as a software package, code, instructions, instruction sets and/or data recorded on non-transitory computer readable storage medium.
  • Firmware may be embodied as code, instructions or instruction sets and/or data that are hard-coded (e.g., nonvolatile) in memory devices.
  • the terms“component,”“system,”“module” and the like can refer to a computer-related entity, either hardware, a combination of hardware and software, software, or software in execution.
  • an“algorithm” refers to a self-consistent sequence of steps leading to a desired result, where a“step” refers to a manipulation of physical quantities and/or logic states which may, though need not necessarily, take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It is common usage to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and/or states.
  • a network may include a packet switched network.
  • the communication devices may be capable of communicating with each other using a selected packet switched network communications protocol.
  • One example communications protocol may include an Ethernet communications protocol which may be capable permitting communication using a
  • the Ethernet protocol may comply or be compatible with the Ethernet standard published by the Institute of Electrical and Electronics Engineers (IEEE) titled“IEEE 802.3 Standard”, published in December, 2008 and/or later versions of this standard.
  • the communication devices may be capable of communicating with each other using an X.25 communications protocol.
  • the X.25 communications protocol may comply or be compatible with a standard promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T).
  • ITU-T International Telecommunication Union-Telecommunication Standardization Sector
  • the communication devices may be capable of communicating with each other using a frame relay communications protocol.
  • the frame relay communications protocol may comply or be compatible with a standard promulgated by Consultative Committee for International Circuit and Telephone (CCITT) and/or the American National Standards Institute (ANSI).
  • the transceivers may be capable of
  • ATM Asynchronous Transfer Mode
  • the ATM communications protocol may comply or be compatible with an ATM standard published by the ATM Forum titled“ATM-MPLS Network Interworking 2.0” published August 2001 , and/or later versions of this standard.
  • ATM Forum titled“ATM-MPLS Network Interworking 2.0” published August 2001 , and/or later versions of this standard.
  • connection-oriented network communication protocols are equally contemplated herein.
  • One or more components may be referred to herein as“configured to,”“configurable to,” “operable/operative to,”“adapted/adaptable,”“able to,”“conformable/conformed to,” etc.
  • “configured to” can generally encompass active-state components and/or inactive-state components and/or standby-state components, unless context requires otherwise.
  • proximal and distal are used herein with reference to a clinician
  • proximal refers to the portion closest to the clinician and the term“distal” refers to the portion located away from the clinician.
  • distal refers to the portion located away from the clinician.
  • Modular devices include the modules (as described in connection with FIGS. 3 and 9, for example) that are receivable within a surgical hub and the surgical devices or instruments that can be connected to the various modules in order to connect or pair with the corresponding surgical hub.
  • the modular devices include, for example, intelligent surgical instruments, medical imaging devices, suction/irrigation devices, smoke evacuators, energy generators, ventilators, insufflators, and displays.
  • the modular devices described herein can be controlled by control algorithms.
  • the control algorithms can be executed on the modular device itself, on the surgical hub to which the particular modular device is paired, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture).
  • the modular devices’ control algorithms control the devices based on data sensed by the modular device itself (i.e., by sensors in, on, or connected to the modular device). This data can be related to the patient being operated on (e.g., tissue properties or insufflation pressure) or the modular device itself (e.g., the rate at which a knife is being advanced, motor current, or energy levels).
  • a control algorithm for a surgical stapling and cutting instrument can control the rate at which the instrument’s motor drives its knife through tissue according to resistance encountered by the knife as it advances.
  • any reference to“one aspect,”“an aspect,”“an exemplification,” “one exemplification,” and the like means that a particular feature, structure, or characteristic described in connection with the aspect is included in at least one aspect.
  • Example 1 A surgical system comprising: an energy generator; a surgical instrument electrically coupled to the energy generator and configured to transmit electrosurgical energy to tissue of a patient at a surgical site; at least one sensor configured to detect energy an energy anomaly; and at least one processor communicatively coupled to the at least one sensor, and configured to: receive data from the at least one sensor that energy is being emitted at an unintended location within the surgical system; transmit an alert indicating that parasitic capacitive coupling is occurring; and transmit an interrupt to the energy generator to temporarily interrupt energy generation.
  • Example 2 A surgical system comprising: an energy generator; a surgical instrument electrically coupled to the energy generator and configured to transmit electrosurgical energy to tissue of a patient at a surgical site; at least one sensor configured to detect energy an energy anomaly; and at least one processor communicatively coupled to the at least one sensor, and configured to: receive data from the at least one sensor that energy is being emitted at an unintended location within the surgical system; transmit an alert indicating that parasitic capacitive coupling is occurring; and transmit
  • Example 1 The surgical system of Example 1 , further comprising an energy dissipating pad electrically coupled to a neutral electrode in the energy generator, wherein the energy dissipating pad is configured to conductively connect to the patient and dissipate energy away from the patient when energy is applied to the patient tissue by the surgical instrument.
  • Example 3 The surgical system of any one of Examples 1 or 2, wherein the neutral electrode is configured to passively shunt energy away from the patient during a capacitive coupling event.
  • Example 4 The surgical system of any one of Examples 1 -3, wherein the surgical instrument comprises: an end effector comprising a pair of jaws; and a shaft electrically coupled to the end effector and configured to deliver energy to the end effector from the energy generator.
  • Example 5 The surgical system Example 4, wherein the jaws comprise rounded tips configured to reduce peak voltage spikes as the jaws come into contact with tissue of the patient.
  • Example 6 The surgical system of Example 4, wherein the shaft comprises interrupting insulator elements configured to prevent capacitive coupling from transmitting long distance within the shaft.
  • Example 7 The surgical system of Example 4, wherein the surgical instrument comprises a triangular one-sided blade with a thin standing upper blade element configured to reduce inductive energy transmission beyond the upper blade element.
  • Example 8 The surgical system of Example 4, wherein the end effector comprises one or more electrodes located on the inside portion of the jaws and configured to channel excess energy away from tissue of the patient.
  • Example 9 A method of a surgical system for detecting parasitic capacitive coupling, the surgical system comprising an energy generator, a surgical instrument, and at least one sensor for detecting an energy anomaly, the method comprising: receiving data from the at least one sensor that energy is being emitted at an unintended location within the surgical system;
  • Example 10 A surgical instrument configured to mitigate parasitic capacitive coupling during surgery, comprising: an electrical input configured to be electrically coupled to an energy generator; a shaft; an end effector at a distal end of the shaft; at least one sensor configured to detect energy an energy anomaly; and at least one processor communicatively coupled to the at least one sensor, and configured to: receive data from the at least one sensor that energy is being emitted at an unintended location within the surgical system; transmit an alert indicating that parasitic capacitive coupling is occurring; and transmit an interrupt to the energy generator to temporarily interrupt energy generation.
  • Example 1 1 The surgical instrument of Example 10, wherein the end effector comprises a pair of jaws, and the jaws comprise rounded tips configured to reduce peak voltage spikes as the jaws come into contact with tissue of the patient.
  • Example 12 The surgical instrument of Example 10 or 1 1 , wherein the shaft comprises interrupting insulator elements configured to prevent capacitive coupling from transmitting long distance within the shaft.
  • Example 13 The surgical instrument of any one of Examples 10-12, furthering comprising a triangular one-sided blade with a thin standing upper blade element configured to reduce inductive energy transmission beyond the upper blade element.
  • Example 14 The surgical instrument of any one of Examples 10-13, wherein the end effector comprises one or more electrodes located on an inside portion of the jaws and configured to channel excess energy away from tissue of the patient.

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Abstract

In some aspects, a surgical system configured to limit or prevent capacitive coupling and its effects is presented. The surgical system may include: an energy generator; a surgical instrument electrically coupled to the energy generator and configured to transmit electrosurgical energy to tissue of a patient at a surgical site; at least one sensor configured to detect energy an energy anomaly; and at least one processor communicatively coupled to the at least one sensor, and configured to: receive data from the at least one sensor that energy is being emitted at an unintended location within the surgical system; transmit an alert indicating that parasitic capacitive coupling is occurring; and transmit an interrupt to the energy generator to temporarily interrupt energy generation.

Description

TITLE
INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING
CROSS REFERENCES TO RELATED APPLICATIONS
[0001] The present application claims priority under 35 U.S.C. § 1 19(e) to U.S. Provisional Patent Application No. 62/721 ,995, titled CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION, filed on August 23, 2018, the disclosure of which is herein incorporated by reference in its entirety.
[0002] The present application claims priority under 35 U.S.C. § 1 19(e) to U.S. Provisional Patent Application No. 62/721 ,998, titled SITUATIONAL AWARENESS OF
ELECTROSURGICAL SYSTEMS, filed on August 23, 2018, the disclosure of which is herein incorporated by reference in its entirety.
[0003] The present application claims priority under 35 U.S.C. § 1 19(e) to U.S. Provisional Patent Application No. 62/721 ,999, titled INTERRUPTION OF ENERGY DUE TO
INADVERTENT CAPACITIVE COUPLING, filed on August 23, 2018, the disclosure of which is herein incorporated by reference in its entirety.
[0004] The present application claims priority under 35 U.S.C. § 1 19(e) to U.S. Provisional Patent Application No. 62/721 ,994, titled BIPOLAR COMBINATION DEVICE THAT
AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY, filed on August 23, 2018, the disclosure of which is herein incorporated by reference in its entirety.
[0005] The present application claims priority under 35 U.S.C. § 1 19(e) to U.S. Provisional Patent Application No. 62/721 ,996, titled RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS, filed on August 23, 2018, the disclosure of which is herein incorporated by reference in its entirety.
[0006] The present application also claims priority under 35 U.S.C. § 1 19(e) to U.S.
Provisional Patent Application No. 62/692,747, titled SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE, filed on June 30, 2018, to U.S. Provisional Patent Application No. 62/692,748, titled SMART ENERGY ARCHITECTURE, filed on June 30, 2018, and to U.S. Provisional Patent Application No. 62/692,768, titled SMART ENERGY DEVICES, filed on June 30, 2018, the disclosure of each of which is herein incorporated by reference in its entirety.
[0007] This application also claims the benefit of priority under 35 U.S.C. § 1 19(e) to U. S. Provisional Patent Application No. 62/650,898 filed on March 30, 2018, titled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS, to U.S. Provisional Patent Application Serial No. 62/650,887, titled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES, filed March 30, 2018, to U.S. Provisional Patent Application Serial No. 62/650,882, titled SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM, filed March 30, 2018, and to U.S. Provisional Patent Application Serial No.
62/650,877, titled SURGICAL SMOKE EVACUATION SENSING AND CONTROLS, filed March 30, 2018, the disclosure of each of which is herein incorporated by reference in its entirety.
[0008] This application also claims the benefit of priority under 35 U.S.C. § 1 19(e) to U.S. Provisional Patent Application Serial No. 62/61 1 ,341 , titled INTERACTIVE SURGICAL
PLATFORM, filed December 28, 2017, to U.S. Provisional Patent Application Serial No.
62/61 1 ,340, titled CLOUD-BASED MEDICAL ANALYTICS, filed December 28, 2017, and to U.S. Provisional Patent Application Serial No. 62/61 1 ,339, titled ROBOT ASSISTED SURGICAL PLATFORM, filed December 28, 2017, the disclosure of each of which is herein incorporated by reference in its entirety.
BACKGROUND
[0009] This disclosure is related, generally and in various aspects, to surgical systems utilizing radio frequency (RF) energy in electrosurgery.
[0010] Electrosurgical systems typically utilize a generator to supply electrosurgical energy (e.g., alternating current at radiofrequency levels) to an active electrode that applies the electrosurgical energy to a surgical site of a patient’s body. The surgical instrument may utilize the energy to perform various types of surgery, such as cutting tissue or coagulating tissue, depending on the need. Monopolar electrosurgery involves applying the surgical instrument to the patient tissue using a single active electrode, and completes the electrical circuit through the patient by a patient return electrode. This return electrode is typically connected back to the monopolar energy generator. However, capacitive coupling is an ever present problem in this system, and may potentially cause undesired burns at initially unknown locations on the patient’s body. It is desirable to take into account the capacitive coupling so as to minimize or eliminate unintended patient damage.
SUMMARY
[0011] In some aspects, a surgical system configured to limit or prevent capacitive coupling and its effects is presented. The surgical system may include: an energy generator; a surgical instrument electrically coupled to the energy generator and configured to transmit
electrosurgical energy to tissue of a patient at a surgical site; at least one sensor configured to detect energy an energy anomaly; and at least one processor communicatively coupled to the at least one sensor, and configured to: receive data from the at least one sensor that energy is being emitted at an unintended location within the surgical system; transmit an alert indicating that parasitic capacitive coupling is occurring; and transmit an interrupt to the energy generator to temporarily interrupt energy generation.
[0012] In some aspects, the surgical system further includes an energy dissipating pad electrically coupled to a neutral electrode in the energy generator, wherein the energy dissipating pad is configured to conductively connect to the patient and dissipate energy away from the patient when energy is applied to the patient tissue by the surgical instrument.
[0013] In some aspects of the surgical system, the neutral electrode is configured to passively shunt energy away from the patient during a capacitive coupling event.
[0014] In some aspects of the surgical system, the surgical instrument comprises: an end effector comprising a pair of jaws; and a shaft electrically coupled to the end effector and configured to deliver energy to the end effector from the energy generator.
[0015] In some aspects of the surgical system, the jaws comprise rounded tips configured to reduce peak voltage spikes as the jaws come into contact with tissue of the patient.
[0016] In some aspects of the surgical system, the shaft comprises interrupting insulator elements configured to prevent capacitive coupling from transmitting long distance within the shaft.
[0017] In some aspects of the surgical system, the surgical instrument comprises a triangular one-sided blade with a thin standing upper blade element configured to reduce inductive energy transmission beyond the upper blade element.
[0018] In some aspects of the surgical system, the end effector comprises one or more electrodes located on the inside portion of the jaws and configured to channel excess energy away from tissue of the patient.
FIGURES
[0019] The features of various aspects are set forth with particularity in the appended claims. The various aspects, however, both as to organization and methods of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings as follows.
[0020] FIG. 1 is a block diagram of a computer-implemented interactive surgical system, in accordance with at least one aspect of the present disclosure.
[0021 ] FIG. 2 is a surgical system being used to perform a surgical procedure in an operating room, in accordance with at least one aspect of the present disclosure. [0022] FIG. 3 is a surgical hub paired with a visualization system, a robotic system, and an intelligent instrument, in accordance with at least one aspect of the present disclosure.
[0023] FIG. 4 is a partial perspective view of a surgical hub enclosure, and of a combo generator module slidably receivable in a drawer of the surgical hub enclosure, in accordance with at least one aspect of the present disclosure.
[0024] FIG. 5 is a perspective view of a combo generator module with bipolar, ultrasonic, and monopolar contacts and a smoke evacuation component, in accordance with at least one aspect of the present disclosure.
[0025] FIG. 6 illustrates individual power bus attachments for a plurality of lateral docking ports of a lateral modular housing configured to receive a plurality of modules, in accordance with at least one aspect of the present disclosure.
[0026] FIG. 7 illustrates a vertical modular housing configured to receive a plurality of modules, in accordance with at least one aspect of the present disclosure.
[0027] FIG. 8 illustrates a surgical data network comprising a modular communication hub configured to connect modular devices located in one or more operating theaters of a healthcare facility, or any room in a healthcare facility specially equipped for surgical operations, to the cloud, in accordance with at least one aspect of the present disclosure.
[0028] FIG. 9 illustrates a computer-implemented interactive surgical system, in accordance with at least one aspect of the present disclosure.
[0029] FIG. 10 illustrates a surgical hub comprising a plurality of modules coupled to the modular control tower, in accordance with at least one aspect of the present disclosure.
[0030] FIG. 1 1 illustrates one aspect of a Universal Serial Bus (USB) network hub device, in accordance with at least one aspect of the present disclosure.
[0031] FIG. 12 illustrates a logic diagram of a control system of a surgical instrument or tool, in accordance with at least one aspect of the present disclosure.
[0032] FIG. 13 illustrates a control circuit configured to control aspects of the surgical instrument or tool, in accordance with at least one aspect of the present disclosure.
[0033] FIG. 14 illustrates a combinational logic circuit configured to control aspects of the surgical instrument or tool, in accordance with at least one aspect of the present disclosure.
[0034] FIG. 15 illustrates a sequential logic circuit configured to control aspects of the surgical instrument or tool, in accordance with at least one aspect of the present disclosure.
[0035] FIG. 16 illustrates a surgical instrument or tool comprising a plurality of motors which can be activated to perform various functions, in accordance with at least one aspect of the present disclosure. [0036] FIG. 17 is a schematic diagram of a robotic surgical instrument configured to operate a surgical tool described herein, in accordance with at least one aspect of the present disclosure.
[0037] FIG. 18 illustrates a block diagram of a surgical instrument programmed to control the distal translation of a displacement member, in accordance with at least one aspect of the present disclosure.
[0038] FIG. 19 is a schematic diagram of a surgical instrument configured to control various functions, in accordance with at least one aspect of the present disclosure.
[0039] FIG. 20 is a system configured to execute adaptive ultrasonic blade control algorithms in a surgical data network comprising a modular communication hub, in accordance with at least one aspect of the present disclosure.
[0040] FIG. 21 illustrates an example of a generator, in accordance with at least one aspect of the present disclosure.
[0041] FIG. 22 is a surgical system comprising a generator and various surgical instruments usable therewith, in accordance with at least one aspect of the present disclosure.
[0042] FIG. 23 is an end effector, in accordance with at least one aspect of the present disclosure.
[0043] FIG. 24 is a diagram of the surgical system of FIG. 22, in accordance with at least one aspect of the present disclosure.
[0044] FIG. 25 is a model illustrating motional branch current, in accordance with at least one aspect of the present disclosure.
[0045] FIG. 26 is a structural view of a generator architecture, in accordance with at least one aspect of the present disclosure.
[0046] FIGS. 27A-27C are functional views of a generator architecture, in accordance with at least one aspect of the present disclosure.
[0047] FIGS. 28A-28B are structural and functional aspects of a generator, in accordance with at least one aspect of the present disclosure.
[0048] FIG. 29 provides a diagram showing an example system with means for detecting capacitive coupling, in accordance with at least one aspect of the present disclosure.
[0049] FIG. 30 is a logic flow diagram depicting a control program or a logic configuration of an example methodology for limiting the effects of capacitive coupling in a surgical system is disclosed, in accordance with at least one aspect of the present disclosure.
[0050] FIG. 31 is a logic flow diagram depicting a control program or a logic configuration of an example methodology that may be performed by the surgical system utilizing monopolar energy generation to determine whether to take advantage of parasitic capacitive coupling, in accordance with at least one aspect of the present disclosure.
[0051] FIG. 32 is a timeline depicting situational awareness of a surgical hub, in accordance with at least one aspect of the present disclosure.
DESCRIPTION
[0052] Applicant of the present application owns the following U.S. Patent Applications, filed on August 28, 2018, the disclosure of each of which is herein incorporated by reference in its entirety:
• U.S. Patent Application Docket No. END8536USNP2/180107-2, titled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR;
• U.S. Patent Application Docket No. END8560USNP2/180106-2, titled TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR;
• U.S. Patent Application Docket No. END8561 USNP1/180144-1 , titled RADIO
FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS;
• U.S. Patent Application Docket No. END8563USNP1/180139-1 , titled CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION;
• U.S. Patent Application Docket No. END8563USNP2/180139-2, titled CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE;
• U.S. Patent Application Docket No. END8563USNP3/180139-3, titled DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM;
• U.S. Patent Application Docket No. END8563USNP4/180139-4, titled DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT;
• U.S. Patent Application Docket No. END8563USNP5/180139-5, titled DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR;
• U.S. Patent Application Docket No. END8564USNP1/180140-1 , titled SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS;
• U.S. Patent Application Docket No. END8564USNP2/180140-2, titled MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT; • U.S. Patent Application Docket No. END8564USNP3/180140-3, titled DETECTION OF END EFFECTOR IMMERSION IN LIQUID;
• U.S. Patent Application Docket No. END8565USNP2/180142-2, titled INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP;
• U.S. Patent Application Docket No. END8566USNP1/180143-1 , titled BIPOLAR
COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY; and
• U.S. Patent Application Docket No. END8573USNP1/180145-1 , titled ACTIVATION OF ENERGY DEVICES.
[0053] Applicant of the present application owns the following U.S. Patent Applications, filed on August 23, 2018, the disclosure of each of which is herein incorporated by reference in its entirety:
• U.S. Provisional Patent Application No. 62/721 ,995, titled CONTROLLING AN
ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION;
• U.S. Provisional Patent Application No. 62/721 ,998, titled SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS;
• U.S. Provisional Patent Application No. 62/721 ,999, titled INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;
• U.S. Provisional Patent Application No. 62/721 ,994, titled BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY; and
• U.S. Provisional Patent Application No. 62/721 ,996, titled RADIO FREQUENCY
ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS.
[0054] Applicant of the present application owns the following U.S. Patent Applications, filed on June 30, 2018, the disclosure of each of which is herein incorporated by reference in its entirety:
• U.S. Provisional Patent Application No. 62/692,747, titled SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE;
• U.S. Provisional Patent Application No. 62/692,748, titled SMART ENERGY
ARCHITECTURE; and
• U.S. Provisional Patent Application No. 62/692,768, titled SMART ENERGY DEVICES.
[0055] Applicant of the present application owns the following U.S. Patent Applications, filed on June 29, 2018, the disclosure of each of which is herein incorporated by reference in its entirety: • U.S. Patent Application Serial No. 16/024,090, titled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS;
• U.S. Patent Application Serial No. 16/024,057, titled CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS;
• U.S. Patent Application Serial No. 16/024,067, titled SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION;
• U.S. Patent Application Serial No. 16/024,075, titled SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING;
• U.S. Patent Application Serial No. 16/024,083, titled SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING;
• U.S. Patent Application Serial No. 16/024,094, titled SURGICAL SYSTEMS FOR
DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES;
• U.S. Patent Application Serial No. 16/024,138, titled SYSTEMS FOR DETECTING
PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE;
• U.S. Patent Application Serial No. 16/024,150, titled SURGICAL INSTRUMENT
CARTRIDGE SENSOR ASSEMBLIES;
• U.S. Patent Application Serial No. 16/024,160, titled VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY;
• U.S. Patent Application Serial No. 16/024, 124, titled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;
• U.S. Patent Application Serial No. 16/024, 132, titled SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT;
• U.S. Patent Application Serial No. 16/024,141 , titled SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY;
• U.S. Patent Application Serial No. 16/024,162, titled SURGICAL SYSTEMS WITH
PRIORITIZED DATA TRANSMISSION CAPABILITIES;
• U.S. Patent Application Serial No. 16/024,066, titled SURGICAL EVACUATION
SENSING AND MOTOR CONTROL;
• U.S. Patent Application Serial No. 16/024,096, titled SURGICAL EVACUATION
SENSOR ARRANGEMENTS;
• U.S. Patent Application Serial No. 16/024,1 16, titled SURGICAL EVACUATION FLOW PATHS; • U.S. Patent Application Serial No. 16/024,149, titled SURGICAL EVACUATION SENSING AND GENERATOR CONTROL;
• U.S. Patent Application Serial No. 16/024,180, titled SURGICAL EVACUATION
SENSING AND DISPLAY;
• U.S. Patent Application Serial No. 16/024,245, titled COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM;
• U.S. Patent Application Serial No. 16/024,258, titled SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM;
• U.S. Patent Application Serial No. 16/024,265, titled SURGICAL EVACUATION
SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE; and
• U.S. Patent Application Serial No. 16/024,273, titled DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.
[0056] Applicant of the present application owns the following U.S. Provisional Patent Applications, filed on June 28, 2018, the disclosure of each of which is herein incorporated by reference in its entirety:
• U.S. Provisional Patent Application Serial No. 62/691 ,228, titled A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES;
• U.S. Provisional Patent Application Serial No. 62/691 ,227, titled CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS;
• U.S. Provisional Patent Application Serial No. 62/691 ,230, titled SURGICAL
INSTRUMENT HAVING A FLEXIBLE ELECTRODE;
• U.S. Provisional Patent Application Serial No. 62/691 ,219, titled SURGICAL
EVACUATION SENSING AND MOTOR CONTROL;
• U.S. Provisional Patent Application Serial No. 62/691 ,257, titled COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM;
• U.S. Provisional Patent Application Serial No. 62/691 ,262, titled SURGICAL
EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE; and U.S. Provisional Patent Application Serial No. 62/691 ,251 , titled DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.
[0057] Applicant of the present application owns the following U.S. Provisional Patent Application, filed on April 19, 2018, the disclosure of each of which is herein incorporated by reference in its entirety:
• U.S. Provisional Patent Application Serial No. 62/659,900, titled METHOD OF HUB COMMUNICATION.
[0058] Applicant of the present application owns the following U.S. Provisional Patent Applications, filed on March 30, 2018, the disclosure of each of which is herein incorporated by reference in its entirety:
• U. S. Provisional Patent Application No. 62/650,898 filed on March 30, 2018, titled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS;
• U.S. Provisional Patent Application Serial No. 62/650,887, titled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES;
• U.S. Provisional Patent Application Serial No. 62/650,882, titled SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM; and
• U.S. Provisional Patent Application Serial No. 62/650,877, titled SURGICAL SMOKE EVACUATION SENSING AND CONTROLS
[0059] Applicant of the present application owns the following U.S. Patent Applications, filed on March 29, 2018, the disclosure of each of which is herein incorporated by reference in its entirety:
• U.S. Patent Application Serial No. 15/940,641 , titled INTERACTIVE SURGICAL
SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;
• U.S. Patent Application Serial No. 15/940,648, titled INTERACTIVE SURGICAL
SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES;
• U.S. Patent Application Serial No. 15/940,656, titled SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES;
• U.S. Patent Application Serial No. 15/940,666, titled SPATIAL AWARENESS OF
SURGICAL HUBS IN OPERATING ROOMS;
• U.S. Patent Application Serial No. 15/940,670, titled COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS; • U.S. Patent Application Serial No. 15/940,677, titled SURGICAL HUB CONTROL ARRANGEMENTS;
• U.S. Patent Application Serial No. 15/940,632, titled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD;
• U.S. Patent Application Serial No. 15/940,640, titled COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS;
• U.S. Patent Application Serial No. 15/940,645, titled SELF DESCRIBING DATA
PACKETS GENERATED AT AN ISSUING INSTRUMENT;
• U.S. Patent Application Serial No. 15/940,649, titled DATA PAIRING TO
INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME;
• U.S. Patent Application Serial No. 15/940,654, titled SURGICAL HUB SITUATIONAL AWARENESS;
• U.S. Patent Application Serial No. 15/940,663, titled SURGICAL SYSTEM
DISTRIBUTED PROCESSING;
• U.S. Patent Application Serial No. 15/940,668, titled AGGREGATION AND REPORTING OF SURGICAL HUB DATA;
• U.S. Patent Application Serial No. 15/940,671 , titled SURGICAL HUB SPATIAL
AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;
• U.S. Patent Application Serial No. 15/940,686, titled DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;
• U.S. Patent Application Serial No. 15/940,700, titled STERILE FIELD INTERACTIVE CONTROL DISPLAYS;
• U.S. Patent Application Serial No. 15/940,629, titled COMPUTER IMPLEMENTED
INTERACTIVE SURGICAL SYSTEMS;
• U.S. Patent Application Serial No. 15/940,704, titled USE OF LASER LIGHT AND RED- GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT;
• U.S. Patent Application Serial No. 15/940,722, titled CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT
REFRACTIVITY; and
• U.S. Patent Application Serial No. 15/940,742, titled DUAL CMOS ARRAY IMAGING. • U.S. Patent Application Serial No. 15/940,636, titled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;
• U.S. Patent Application Serial No. 15/940,653, titled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS;
• U.S. Patent Application Serial No. 15/940,660, titled CLOUD-BASED MEDICAL
ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER;
• U.S. Patent Application Serial No. 15/940,679, titled CLOUD-BASED MEDICAL
ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET;
• U.S. Patent Application Serial No. 15/940,694, titled CLOUD-BASED MEDICAL
ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION;
• U.S. Patent Application Serial No. 15/940,634, titled CLOUD-BASED MEDICAL
ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES;
• U.S. Patent Application Serial No. 15/940,706, titled DATA HANDLING AND
PRIORITIZATION IN A CLOUD ANALYTICS NETWORK; and
• U.S. Patent Application Serial No. 15/940,675, titled CLOUD INTERFACE FOR
COUPLED SURGICAL DEVICES.
• U.S. Patent Application Serial No. 15/940,627, titled DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;
• U.S. Patent Application Serial No. 15/940,637, titled COMMUNICATION
ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;
• U.S. Patent Application Serial No. 15/940,642, titled CONTROLS FOR ROBOT- ASSISTED SURGICAL PLATFORMS;
• U.S. Patent Application Serial No. 15/940,676, titled AUTOMATIC TOOL
ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;
• U.S. Patent Application Serial No. 15/940,680, titled CONTROLLERS FOR ROBOT- ASSISTED SURGICAL PLATFORMS;
• U.S. Patent Application Serial No. 15/940,683, titled COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;
• U.S. Patent Application Serial No. 15/940,690, titled DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and • U.S. Patent Application Serial No. 15/940,71 1 , titled SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.
[0060] Applicant of the present application owns the following U.S. Provisional Patent Applications, filed on March 28, 2018, the disclosure of each of which is herein incorporated by reference in its entirety:
• U.S. Provisional Patent Application Serial No. 62/649,302, titled INTERACTIVE
SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;
• U.S. Provisional Patent Application Serial No. 62/649,294, titled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD;
• U.S. Provisional Patent Application Serial No. 62/649,300, titled SURGICAL HUB
SITUATIONAL AWARENESS;
• U.S. Provisional Patent Application Serial No. 62/649,309, titled SURGICAL HUB
SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;
• U.S. Provisional Patent Application Serial No. 62/649,310, titled COMPUTER
IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;
• U.S. Provisional Patent Application Serial No. 62/649,291 , titled USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT;
• U.S. Provisional Patent Application Serial No. 62/649,296, titled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;
• U.S. Provisional Patent Application Serial No. 62/649,333, titled CLOUD-BASED
MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER;
• U.S. Provisional Patent Application Serial No. 62/649,327, titled CLOUD-BASED
MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES;
• U.S. Provisional Patent Application Serial No. 62/649,315, titled DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;
• U.S. Provisional Patent Application Serial No. 62/649,313, titled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;
• U.S. Provisional Patent Application Serial No. 62/649,320, titled DRIVE
ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; • U.S. Provisional Patent Application Serial No. 62/649,307, titled AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and
• U.S. Provisional Patent Application Serial No. 62/649,323, titled SENSING
ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.
[0061] Applicant of the present application owns the following U.S. Provisional Patent Applications, filed on March 8, 2018, the disclosure of each of which is herein incorporated by reference in its entirety:
• U.S. Provisional Patent Application Serial No. 62/640,417, titled TEMPERATURE
CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR; and
• U. S. Provisional Patent Application Serial No. 62/640,415, titled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR.
[0062] Applicant of the present application owns the following U.S. Provisional Patent Applications, filed on December 28, 2017, the disclosure of each of which is herein incorporated by reference in its entirety:
• U.S. Provisional Patent Application Serial No. U.S. Provisional Patent Application Serial No. 62/61 1 ,341 , titled INTERACTIVE SURGICAL PLATFORM;
• U.S. Provisional Patent Application Serial No. 62/61 1 ,340, titled CLOUD-BASED
MEDICAL ANALYTICS; and
• U.S. Provisional Patent Application Serial No. 62/61 1 ,339, titled ROBOT ASSISTED SURGICAL PLATFORM.
[0063] Before explaining various aspects of surgical devices and generators in detail, it should be noted that the illustrative examples are not limited in application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative examples may be implemented or incorporated in other aspects, variations and modifications, and may be practiced or carried out in various ways. Further, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the illustrative examples for the convenience of the reader and are not for the purpose of limitation thereof. Also, it will be appreciated that one or more of the following- described aspects, expressions of aspects, and/or examples, can be combined with any one or more of the other following-described aspects, expressions of aspects and/or examples.
[0064] Various aspects are directed to improved ultrasonic surgical devices, electrosurgical devices and generators for use therewith. Aspects of the ultrasonic surgical devices can be configured for transecting and/or coagulating tissue during surgical procedures, for example. Aspects of the electrosurgical devices can be configured for transecting, coagulating, scaling, welding and/or desiccating tissue during surgical procedures, for example.
[0065] Referring to FIG. 1 , a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., the cloud 104 that may include a remote server 1 13 coupled to a storage device 105). Each surgical system 102 includes at least one surgical hub 106 in communication with the cloud 104 that may include a remote server 1 13. In one example, as illustrated in FIG. 1 , the surgical system 102 includes a visualization system 108, a robotic system 1 10, and a handheld intelligent surgical instrument 1 12, which are configured to communicate with one another and/or the hub 106. In some aspects, a surgical system 102 may include an M number of hubs 106, an N number of visualization systems 108, an O number of robotic systems 1 10, and a P number of handheld intelligent surgical instruments 1 12, where M, N, O, and P are integers greater than or equal to one.
[0066] FIG. 3 depicts an example of a surgical system 102 being used to perform a surgical procedure on a patient who is lying down on an operating table 1 14 in a surgical operating room 1 16. A robotic system 1 10 is used in the surgical procedure as a part of the surgical system 102. The robotic system 1 10 includes a surgeon’s console 1 18, a patient side cart 120 (surgical robot), and a surgical robotic hub 122. The patient side cart 120 can manipulate at least one removably coupled surgical tool 1 17 through a minimally invasive incision in the body of the patient while the surgeon views the surgical site through the surgeon’s console 1 18. An image of the surgical site can be obtained by a medical imaging device 124, which can be manipulated by the patient side cart 120 to orient the imaging device 124. The robotic hub 122 can be used to process the images of the surgical site for subsequent display to the surgeon through the surgeon’s console 1 18.
[0067] Other types of robotic systems can be readily adapted for use with the surgical system 102. Various examples of robotic systems and surgical tools that are suitable for use with the present disclosure are described in U.S. Provisional Patent Application Serial No. 62/61 1 ,339, titled ROBOT ASSISTED SURGICAL PLATFORM, filed December 28, 2017, the disclosure of which is herein incorporated by reference in its entirety.
[0068] Various examples of cloud-based analytics that are performed by the cloud 104, and are suitable for use with the present disclosure, are described in U.S. Provisional Patent Application Serial No. 62/61 1 ,340, titled CLOUD-BASED MEDICAL ANALYTICS, filed
December 28, 2017, the disclosure of which is herein incorporated by reference in its entirety. [0069] In various aspects, the imaging device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, Charge- Coupled Device (CCD) sensors and Complementary Metal-Oxide Semiconductor (CMOS) sensors.
[0070] The optical components of the imaging device 124 may include one or more illumination sources and/or one or more lenses. The one or more illumination sources may be directed to illuminate portions of the surgical field. The one or more image sensors may receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and/or surgical instruments.
[0071] The one or more illumination sources may be configured to radiate electromagnetic energy in the visible spectrum as well as the invisible spectrum. The visible spectrum, sometimes referred to as the optical spectrum or luminous spectrum, is that portion of the electromagnetic spectrum that is visible to (i.e., can be detected by) the human eye and may be referred to as visible light or simply light. A typical human eye will respond to wavelengths in air that are from about 380 nm to about 750 nm.
[0072] The invisible spectrum (i.e., the non-luminous spectrum) is that portion of the electromagnetic spectrum that lies below and above the visible spectrum (i.e., wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the red visible spectrum, and they become invisible infrared (IR), microwave, and radio electromagnetic radiation.
Wavelengths less than about 380 nm are shorter than the violet spectrum, and they become invisible ultraviolet, x-ray, and gamma ray electromagnetic radiation.
[0073] In various aspects, the imaging device 124 is configured for use in a minimally invasive procedure. Examples of imaging devices suitable for use with the present disclosure include, but not limited to, an arthroscope, angioscope, bronchoscope, choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope (gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope, sigmoidoscope, thoracoscope, and ureteroscope.
[0074] In one aspect, the imaging device employs multi-spectrum monitoring to discriminate topography and underlying structures. A multi-spectral image is one that captures image data within specific wavelength ranges across the electromagnetic spectrum. The wavelengths may be separated by filters or by the use of instruments that are sensitive to particular wavelengths, including light from frequencies beyond the visible light range, e.g., IR and ultraviolet. Spectral imaging can allow extraction of additional information the human eye fails to capture with its receptors for red, green, and blue. The use of multi-spectral imaging is described in greater detail under the heading“Advanced Imaging Acquisition Module” in U.S. Provisional Patent Application Serial No. 62/61 1 ,341 , titled INTERACTIVE SURGICAL PLATFORM, filed
December 28, 2017, the disclosure of which is herein incorporated by reference in its entirety. Multi-spectrum monitoring can be a useful tool in relocating a surgical field after a surgical task is completed to perform one or more of the previously described tests on the treated tissue.
[0075] It is axiomatic that strict sterilization of the operating room and surgical equipment is required during any surgery. The strict hygiene and sterilization conditions required in a “surgical theater,” i.e., an operating or treatment room, necessitate the highest possible sterility of all medical devices and equipment. Part of that sterilization process is the need to sterilize anything that comes in contact with the patient or penetrates the sterile field, including the imaging device 124 and its attachments and components. It will be appreciated that the sterile field may be considered a specified area, such as within a tray or on a sterile towel, that is considered free of microorganisms, or the sterile field may be considered an area, immediately around a patient, who has been prepared for a surgical procedure. The sterile field may include the scrubbed team members, who are properly attired, and all furniture and fixtures in the area.
[0076] In various aspects, the visualization system 108 includes one or more imaging sensors, one or more image-processing units, one or more storage arrays, and one or more displays that are strategically arranged with respect to the sterile field, as illustrated in FIG. 2. In one aspect, the visualization system 108 includes an interface for HL7, PACS, and EMR.
Various components of the visualization system 108 are described under the heading “Advanced Imaging Acquisition Module” in U.S. Provisional Patent Application Serial No.
62/61 1 ,341 , titled INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017, the disclosure of which is herein incorporated by reference in its entirety.
[0077] As illustrated in FIG. 2, a primary display 1 19 is positioned in the sterile field to be visible to an operator at the operating table 1 14. In addition, a visualization tower 1 1 1 is positioned outside the sterile field. The visualization tower 1 1 1 includes a first non-sterile display 107 and a second non-sterile display 109, which face away from each other. The visualization system 108, guided by the hub 106, is configured to utilize the displays 107, 109, and 1 19 to coordinate information flow to operators inside and outside the sterile field. For example, the hub 106 may cause the visualization system 108 to display a snapshot of a surgical site, as recorded by an imaging device 124, on a non-sterile display 107 or 109, while maintaining a live feed of the surgical site on the primary display 1 19. The snapshot on the non-sterile display 107 or 109 can permit a non-sterile operator to perform a diagnostic step relevant to the surgical procedure, for example.
[0078] In one aspect, the hub 106 is also configured to route a diagnostic input or feedback entered by a non-sterile operator at the visualization tower 1 1 1 to the primary display 1 19 within the sterile field, where it can be viewed by a sterile operator at the operating table. In one example, the input can be in the form of a modification to the snapshot displayed on the non- sterile display 107 or 109, which can be routed to the primary display 1 19 by the hub 106.
[0079] Referring to FIG. 2, a surgical instrument 1 12 is being used in the surgical procedure as part of the surgical system 102. The hub 106 is also configured to coordinate information flow to a display of the surgical instrument 1 12. For example, in U.S. Provisional Patent Application Serial No. 62/61 1 ,341 , titled INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017, the disclosure of which is herein incorporated by reference in its entirety. A diagnostic input or feedback entered by a non-sterile operator at the visualization tower 1 1 1 can be routed by the hub 106 to the surgical instrument display 1 15 within the sterile field, where it can be viewed by the operator of the surgical instrument 1 12. Example surgical instruments that are suitable for use with the surgical system 102 are described under the heading“Surgical Instrument Hardware” and in U.S. Provisional Patent Application Serial No. 62/61 1 ,341 , titled
INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017, the disclosure of which is herein incorporated by reference in its entirety, for example.
[0080] Referring now to FIG. 3, a hub 106 is depicted in communication with a visualization system 108, a robotic system 1 10, and a handheld intelligent surgical instrument 1 12. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a
communication module 130, a processor module 132, and a storage array 134. In certain aspects, as illustrated in FIG. 3, the hub 106 further includes a smoke evacuation module 126 and/or a suction/irrigation module 128.
[0081] During a surgical procedure, energy application to tissue, for sealing and/or cutting, is generally associated with smoke evacuation, suction of excess fluid, and/or irrigation of the tissue. Fluid, power, and/or data lines from different sources are often entangled during the surgical procedure. Valuable time can be lost addressing this issue during a surgical procedure. Detangling the lines may necessitate disconnecting the lines from their respective modules, which may require resetting the modules. The hub modular enclosure 136 offers a unified environment for managing the power, data, and fluid lines, which reduces the frequency of entanglement between such lines. [0082] Aspects of the present disclosure present a surgical hub for use in a surgical procedure that involves energy application to tissue at a surgical site. The surgical hub includes a hub enclosure and a combo generator module slidably receivable in a docking station of the hub enclosure. The docking station includes data and power contacts. The combo generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component that are housed in a single unit. In one aspect, the combo generator module also includes a smoke evacuation component, at least one energy delivery cable for connecting the combo generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and/or particulates generated by the application of therapeutic energy to the tissue, and a fluid line extending from the remote surgical site to the smoke evacuation component.
[0083] In one aspect, the fluid line is a first fluid line and a second fluid line extends from the remote surgical site to a suction and irrigation module slidably received in the hub enclosure. In one aspect, the hub enclosure comprises a fluid interface.
[0084] Certain surgical procedures may require the application of more than one energy type to the tissue. One energy type may be more beneficial for cutting the tissue, while another different energy type may be more beneficial for sealing the tissue. For example, a bipolar generator can be used to seal the tissue while an ultrasonic generator can be used to cut the sealed tissue. Aspects of the present disclosure present a solution where a hub modular enclosure 136 is configured to accommodate different generators, and facilitate an interactive communication therebetween. One of the advantages of the hub modular enclosure 136 is enabling the quick removal and/or replacement of various modules.
[0085] Aspects of the present disclosure present a modular surgical enclosure for use in a surgical procedure that involves energy application to tissue. The modular surgical enclosure includes a first energy-generator module, configured to generate a first energy for application to the tissue, and a first docking station comprising a first docking port that includes first data and power contacts, wherein the first energy-generator module is slidably movable into an electrical engagement with the power and data contacts and wherein the first energy-generator module is slidably movable out of the electrical engagement with the first power and data contacts,
[0086] Further to the above, the modular surgical enclosure also includes a second energy- generator module configured to generate a second energy, different than the first energy, for application to the tissue, and a second docking station comprising a second docking port that includes second data and power contacts, wherein the second energy-generator module is slidably movable into an electrical engagement with the power and data contacts, and wherein the second energy-generator module is slidably movable out of the electrical engagement with the second power and data contacts.
[0087] In addition, the modular surgical enclosure also includes a communication bus between the first docking port and the second docking port, configured to facilitate
communication between the first energy-generator module and the second energy-generator module.
[0088] Referring to FIGS. 3-7, aspects of the present disclosure are presented for a hub modular enclosure 136 that allows the modular integration of a generator module 140, a smoke evacuation module 126, and a suction/irrigation module 128. The hub modular enclosure 136 further facilitates interactive communication between the modules 140, 126, 128. As illustrated in FIG. 5, the generator module 140 can be a generator module with integrated monopolar, bipolar, and ultrasonic components supported in a single housing unit 139 slidably insertable into the hub modular enclosure 136. As illustrated in FIG. 5, the generator module 140 can be configured to connect to a monopolar device 146, a bipolar device 147, and an ultrasonic device 148. Alternatively, the generator module 140 may comprise a series of monopolar, bipolar, and/or ultrasonic generator modules that interact through the hub modular enclosure 136. The hub modular enclosure 136 can be configured to facilitate the insertion of multiple generators and interactive communication between the generators docked into the hub modular enclosure 136 so that the generators would act as a single generator.
[0089] In one aspect, the hub modular enclosure 136 comprises a modular power and communication backplane 149 with external and wireless communication headers to enable the removable attachment of the modules 140, 126, 128 and interactive communication
therebetween.
[0090] In one aspect, the hub modular enclosure 136 includes docking stations, or drawers, 151 , herein also referred to as drawers, which are configured to slidably receive the modules 140, 126, 128. FIG. 4 illustrates a partial perspective view of a surgical hub enclosure 136, and a combo generator module 145 slidably receivable in a docking station 151 of the surgical hub enclosure 136. A docking port 152 with power and data contacts on a rear side of the combo generator module 145 is configured to engage a corresponding docking port 150 with power and data contacts of a corresponding docking station 151 of the hub modular enclosure 136 as the combo generator module 145 is slid into position within the corresponding docking station 151 of the hub module enclosure 136. In one aspect, the combo generator module 145 includes a bipolar, ultrasonic, and monopolar module and a smoke evacuation module integrated together into a single housing unit 139, as illustrated in FIG. 5. [0091] In various aspects, the smoke evacuation module 126 includes a fluid line 154 that conveys captured/collected smoke and/or fluid away from a surgical site and to, for example, the smoke evacuation module 126. Vacuum suction originating from the smoke evacuation module 126 can draw the smoke into an opening of a utility conduit at the surgical site. The utility conduit, coupled to the fluid line, can be in the form of a flexible tube terminating at the smoke evacuation module 126. The utility conduit and the fluid line define a fluid path extending toward the smoke evacuation module 126 that is received in the hub enclosure 136.
[0092] In various aspects, the suction/irrigation module 128 is coupled to a surgical tool comprising an aspiration fluid line and a suction fluid line. In one example, the aspiration and suction fluid lines are in the form of flexible tubes extending from the surgical site toward the suction/irrigation module 128. One or more drive systems can be configured to cause irrigation and aspiration of fluids to and from the surgical site.
[0093] In one aspect, the surgical tool includes a shaft having an end effector at a distal end thereof and at least one energy treatment associated with the end effector, an aspiration tube, and an irrigation tube. The aspiration tube can have an inlet port at a distal end thereof and the aspiration tube extends through the shaft. Similarly, an irrigation tube can extend through the shaft and can have an inlet port in proximity to the energy deliver implement. The energy deliver implement is configured to deliver ultrasonic and/or RF energy to the surgical site and is coupled to the generator module 140 by a cable extending initially through the shaft.
[0094] The irrigation tube can be in fluid communication with a fluid source, and the aspiration tube can be in fluid communication with a vacuum source. The fluid source and/or the vacuum source can be housed in the suction/irrigation module 128. In one example, the fluid source and/or the vacuum source can be housed in the hub enclosure 136 separately from the suction/irrigation module 128. In such example, a fluid interface can be configured to connect the suction/irrigation module 128 to the fluid source and/or the vacuum source.
[0095] In one aspect, the modules 140, 126, 128 and/or their corresponding docking stations on the hub modular enclosure 136 may include alignment features that are configured to align the docking ports of the modules into engagement with their counterparts in the docking stations of the hub modular enclosure 136. For example, as illustrated in FIG. 4, the combo generator module 145 includes side brackets 155 that are configured to slidably engage with
corresponding brackets 156 of the corresponding docking station 151 of the hub modular enclosure 136. The brackets cooperate to guide the docking port contacts of the combo generator module 145 into an electrical engagement with the docking port contacts of the hub modular enclosure 136. [0096] In some aspects, the drawers 151 of the hub modular enclosure 136 are the same, or substantially the same size, and the modules are adjusted in size to be received in the drawers 151 . For example, the side brackets 155 and/or 156 can be larger or smaller depending on the size of the module. In other aspects, the drawers 151 are different in size and are each designed to accommodate a particular module.
[0097] Furthermore, the contacts of a particular module can be keyed for engagement with the contacts of a particular drawer to avoid inserting a module into a drawer with mismatching contacts.
[0098] As illustrated in FIG. 4, the docking port 150 of one drawer 151 can be coupled to the docking port 150 of another drawer 151 through a communications link 157 to facilitate an interactive communication between the modules housed in the hub modular enclosure 136. The docking ports 150 of the hub modular enclosure 136 may alternatively, or additionally, facilitate a wireless interactive communication between the modules housed in the hub modular enclosure 136. Any suitable wireless communication can be employed, such as for example Air Titan-Bluetooth.
[0099] FIG. 6 illustrates individual power bus attachments for a plurality of lateral docking ports of a lateral modular housing 160 configured to receive a plurality of modules of a surgical hub 206. The lateral modular housing 160 is configured to laterally receive and interconnect the modules 161 . The modules 161 are slidably inserted into docking stations 162 of lateral modular housing 160, which includes a backplane for interconnecting the modules 161 . As illustrated in FIG. 6, the modules 161 are arranged laterally in the lateral modular housing 160. Alternatively, the modules 161 may be arranged vertically in a lateral modular housing.
[0100] FIG. 7 illustrates a vertical modular housing 164 configured to receive a plurality of modules 165 of the surgical hub 106. The modules 165 are slidably inserted into docking stations, or drawers, 167 of vertical modular housing 164, which includes a backplane for interconnecting the modules 165. Although the drawers 167 of the vertical modular housing 164 are arranged vertically, in certain instances, a vertical modular housing 164 may include drawers that are arranged laterally. Furthermore, the modules 165 may interact with one another through the docking ports of the vertical modular housing 164. In the example of FIG. 7, a display 177 is provided for displaying data relevant to the operation of the modules 165. In addition, the vertical modular housing 164 includes a master module 178 housing a plurality of sub-modules that are slidably received in the master module 178.
[0101] In various aspects, the imaging module 138 comprises an integrated video processor and a modular light source and is adapted for use with various imaging devices. In one aspect, the imaging device is comprised of a modular housing that can be assembled with a light source module and a camera module. The housing can be a disposable housing. In at least one example, the disposable housing is removably coupled to a reusable controller, a light source module, and a camera module. The light source module and/or the camera module can be selectively chosen depending on the type of surgical procedure. In one aspect, the camera module comprises a CCD sensor. In another aspect, the camera module comprises a CMOS sensor. In another aspect, the camera module is configured for scanned beam imaging.
Likewise, the light source module can be configured to deliver a white light or a different light, depending on the surgical procedure.
[0102] During a surgical procedure, removing a surgical device from the surgical field and replacing it with another surgical device that includes a different camera or a different light source can be inefficient. Temporarily losing sight of the surgical field may lead to undesirable consequences. The module imaging device of the present disclosure is configured to permit the replacement of a light source module or a camera module midstream during a surgical procedure, without having to remove the imaging device from the surgical field.
[0103] In one aspect, the imaging device comprises a tubular housing that includes a plurality of channels. A first channel is configured to slidably receive the camera module, which can be configured for a snap-fit engagement with the first channel. A second channel is configured to slidably receive the light source module, which can be configured for a snap-fit engagement with the second channel. In another example, the camera module and/or the light source module can be rotated into a final position within their respective channels. A threaded engagement can be employed in lieu of the snap-fit engagement.
[0104] In various examples, multiple imaging devices are placed at different positions in the surgical field to provide multiple views. The imaging module 138 can be configured to switch between the imaging devices to provide an optimal view. In various aspects, the imaging module 138 can be configured to integrate the images from the different imaging device.
[0105] Various image processors and imaging devices suitable for use with the present disclosure are described in U.S. Patent No. 7,995,045, titled COMBINED SBI AND
CONVENTIONAL IMAGE PROCESSOR, which issued on August 9, 201 1 , which is herein incorporated by reference in its entirety. In addition, U.S. Patent No. 7,982,776, titled SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD, which issued on July 19, 201 1 , which is herein incorporated by reference in its entirety, describes various systems for removing motion artifacts from image data. Such systems can be integrated with the imaging module 138. Furthermore, U.S. Patent Application Publication No. 201 1/0306840, titled CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS, which published on December 15, 201 1 , and U.S. Patent Application Publication No. 2014/0243597, titled SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, which published on August 28, 2014, each of which is herein incorporated by reference in its entirety.
[0106] FIG. 8 illustrates a surgical data network 201 comprising a modular communication hub 203 configured to connect modular devices located in one or more operating theaters of a healthcare facility, or any room in a healthcare facility specially equipped for surgical operations, to a cloud-based system (e.g., the cloud 204 that may include a remote server 213 coupled to a storage device 205). In one aspect, the modular communication hub 203 comprises a network hub 207 and/or a network switch 209 in communication with a network router. The modular communication hub 203 also can be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switching. A passive surgical data network serves as a conduit for the data, enabling it to go from one device (or segment) to another and to the cloud computing resources. An intelligent surgical data network includes additional features to enable the traffic passing through the surgical data network to be monitored and to configure each port in the network hub 207 or network switch 209. An intelligent surgical data network may be referred to as a manageable hub or switch. A switching hub reads the destination address of each packet and then forwards the packet to the correct port.
[0107] Modular devices 1 a-1 n located in the operating theater may be coupled to the modular communication hub 203. The network hub 207 and/or the network switch 209 may be coupled to a network router 21 1 to connect the devices 1 a-1 n to the cloud 204 or the local computer system 210. Data associated with the devices 1 a-1 n may be transferred to cloud-based computers via the router for remote data processing and manipulation. Data associated with the devices 1 a-1 n also may be transferred to the local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating theater also may be coupled to a network switch 209. The network switch 209 may be coupled to the network hub 207 and/or the network router 21 1 to connect to the devices 2a-2m to the cloud 204. Data associated with the devices 2a-2n may be transferred to the cloud 204 via the network router 21 1 for data processing and manipulation. Data associated with the devices 2a- 2m also may be transferred to the local computer system 210 for local data processing and manipulation.
[0108] It will be appreciated that the surgical data network 201 may be expanded by interconnecting multiple network hubs 207 and/or multiple network switches 209 with multiple network routers 21 1. The modular communication hub 203 may be contained in a modular control tower configured to receive multiple devices 1 a-1 n/2a-2m. The local computer system 210 also may be contained in a modular control tower. The modular communication hub 203 is connected to a display 212 to display images obtained by some of the devices 1 a-1 n/2a-2m, for example during surgical procedures. In various aspects, the devices 1 a-1 n/2a-2m may include, for example, various modules such as an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, a suction/irrigation module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device coupled to a display, and/or a non-contact sensor module, among other modular devices that may be connected to the modular communication hub 203 of the surgical data network 201 .
[0109] In one aspect, the surgical data network 201 may comprise a combination of network hub(s), network switch(es), and network router(s) connecting the devices 1 a-1 n/2a-2m to the cloud. Any one of or all of the devices 1 a-1 n/2a-2m coupled to the network hub or network switch may collect data in real time and transfer the data to cloud computers for data processing and manipulation. It will be appreciated that cloud computing relies on sharing computing resources rather than having local servers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for“the Internet,” although the term is not limited as such. Accordingly, the term“cloud computing” may be used herein to refer to“a type of Internet-based computing,” where different services— such as servers, storage, and
applications— are delivered to the modular communication hub 203 and/or computer system 210 located in the surgical theater (e.g., a fixed, mobile, temporary, or field operating room or space) and to devices connected to the modular communication hub 203 and/or computer system 210 through the Internet. The cloud infrastructure may be maintained by a cloud service provider. In this context, the cloud service provider may be the entity that coordinates the usage and control of the devices 1 a-1 n/2a-2m located in one or more operating theaters. The cloud computing services can perform a large number of calculations based on the data gathered by smart surgical instruments, robots, and other computerized devices located in the operating theater. The hub hardware enables multiple devices or connections to be connected to a computer that communicates with the cloud computing resources and storage.
[0110] Applying cloud computer data processing techniques on the data collected by the devices 1 a-1 n/2a-2m, the surgical data network provides improved surgical outcomes, reduced costs, and improved patient satisfaction. At least some of the devices 1 a-1 n/2a-2m may be employed to view tissue states to assess leaks or perfusion of sealed tissue after a tissue sealing and cutting procedure. At least some of the devices 1 a-1 n/2a-2m may be employed to identify pathology, such as the effects of diseases, using the cloud-based computing to examine data including images of samples of body tissue for diagnostic purposes. This includes localization and margin confirmation of tissue and phenotypes. At least some of the devices 1 a- 1 n/2a-2m may be employed to identify anatomical structures of the body using a variety of sensors integrated with imaging devices and techniques such as overlaying images captured by multiple imaging devices. The data gathered by the devices 1 a-1 n/2a-2m, including image data, may be transferred to the cloud 204 or the local computer system 210 or both for data processing and manipulation including image processing and manipulation. The data may be analyzed to improve surgical procedure outcomes by determining if further treatment, such as the application of endoscopic intervention, emerging technologies, a targeted radiation, targeted intervention, and precise robotics to tissue-specific sites and conditions, may be pursued. Such data analysis may further employ outcome analytics processing, and using standardized approaches may provide beneficial feedback to either confirm surgical treatments and the behavior of the surgeon or suggest modifications to surgical treatments and the behavior of the surgeon.
[0111] In one implementation, the operating theater devices 1 a-1 n may be connected to the modular communication hub 203 over a wired channel or a wireless channel depending on the configuration of the devices 1 a-1 n to a network hub. The network hub 207 may be implemented, in one aspect, as a local network broadcast device that works on the physical layer of the Open System Interconnection (OSI) model. The network hub provides connectivity to the devices l a i n located in the same operating theater network. The network hub 207 collects data in the form of packets and sends them to the router in half duplex mode. The network hub 207 does not store any media access control/Internet Protocol (MAC/IP) to transfer the device data. Only one of the devices 1 a-1 n can send data at a time through the network hub 207. The network hub 207 has no routing tables or intelligence regarding where to send information and broadcasts all network data across each connection and to a remote server 213 (FIG. 9) over the cloud 204. The network hub 207 can detect basic network errors such as collisions, but having all information broadcast to multiple ports can be a security risk and cause bottlenecks.
[0112] In another implementation, the operating theater devices 2a-2m may be connected to a network switch 209 over a wired channel or a wireless channel. The network switch 209 works in the data link layer of the OSI model. The network switch 209 is a multicast device for connecting the devices 2a-2m located in the same operating theater to the network. The network switch 209 sends data in the form of frames to the network router 21 1 and works in full duplex mode. Multiple devices 2a-2m can send data at the same time through the network switch 209. The network switch 209 stores and uses MAC addresses of the devices 2a-2m to transfer data.
[0113] The network hub 207 and/or the network switch 209 are coupled to the network router 21 1 for connection to the cloud 204. The network router 21 1 works in the network layer of the OSI model. The network router 21 1 creates a route for transmitting data packets received from the network hub 207 and/or network switch 21 1 to cloud-based computer resources for further processing and manipulation of the data collected by any one of or all the devices 1 a-1 n/2a-2m. The network router 21 1 may be employed to connect two or more different networks located in different locations, such as, for example, different operating theaters of the same healthcare facility or different networks located in different operating theaters of different healthcare facilities. The network router 21 1 sends data in the form of packets to the cloud 204 and works in full duplex mode. Multiple devices can send data at the same time. The network router 21 1 uses IP addresses to transfer data.
[0114] In one example, the network hub 207 may be implemented as a USB hub, which allows multiple USB devices to be connected to a host computer. The USB hub may expand a single USB port into several tiers so that there are more ports available to connect devices to the host system computer. The network hub 207 may include wired or wireless capabilities to receive information over a wired channel or a wireless channel. In one aspect, a wireless USB short-range, high-bandwidth wireless radio communication protocol may be employed for communication between the devices 1 a-1 n and devices 2a-2m located in the operating theater.
[0115] In other examples, the operating theater devices 1 a-1 n/2a-2m may communicate to the modular communication hub 203 via Bluetooth wireless technology standard for exchanging data over short distances (using short-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz) from fixed and mobile devices and building personal area networks (PANs). In other aspects, the operating theater devices 1 a-1 n/2a-2m may communicate to the modular communication hub 203 via a number of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.1 1 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivatives thereof, as well as any other wireless and wired protocols that are designated as 3G, 4G, 5G, and beyond. The computing module may include a plurality of communication modules. For instance, a first communication module may be dedicated to shorter-range wireless communications such as Wi-Fi and Bluetooth, and a second communication module may be dedicated to longer-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, and others.
[0116] The modular communication hub 203 may serve as a central connection for one or all of the operating theater devices 1 a-1 n/2a-2m and handles a data type known as frames.
Frames carry the data generated by the devices 1 a-1 n/2a-2m. When a frame is received by the modular communication hub 203, it is amplified and transmitted to the network router 21 1 , which transfers the data to the cloud computing resources by using a number of wireless or wired communication standards or protocols, as described herein.
[0117] The modular communication hub 203 can be used as a standalone device or be connected to compatible network hubs and network switches to form a larger network. The modular communication hub 203 is generally easy to install, configure, and maintain, making it a good option for networking the operating theater devices 1 a-1 n/2a-2m.
[0118] FIG. 9 illustrates a computer-implemented interactive surgical system 200. The computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100. For example, the computer- implemented interactive surgical system 200 includes one or more surgical systems 202, which are similar in many respects to the surgical systems 102. Each surgical system 202 includes at least one surgical hub 206 in communication with a cloud 204 that may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 comprises a modular control tower 236 connected to multiple operating theater devices such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating theater. As shown in FIG. 10, the modular control tower 236 comprises a modular communication hub 203 coupled to a computer system 210. As illustrated in the example of FIG. 9, the modular control tower 236 is coupled to an imaging module 238 that is coupled to an endoscope 239, a generator module 240 that is coupled to an energy device 241 , a smoke evacuator module 226, a suction/irrigation module 228, a communication module 230, a processor module 232, a storage array 234, a smart device/instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242. The operating theater devices are coupled to cloud computing resources and data storage via the modular control tower 236. A robot hub 222 also may be connected to the modular control tower 236 and to the cloud computing resources. The devices/instruments 235, visualization systems 208, among others, may be coupled to the modular control tower 236 via wired or wireless communication standards or protocols, as described herein. The modular control tower 236 may be coupled to a hub display 215 (e.g., monitor, screen) to display and overlay images received from the imaging module, device/instrument display, and/or other visualization systems 208. The hub display also may display data received from devices connected to the modular control tower in conjunction with images and overlaid images.
[0119] FIG. 10 illustrates a surgical hub 206 comprising a plurality of modules coupled to the modular control tower 236. The modular control tower 236 comprises a modular communication hub 203, e.g., a network connectivity device, and a computer system 210 to provide local processing, visualization, and imaging, for example. As shown in FIG. 10, the modular communication hub 203 may be connected in a tiered configuration to expand the number of modules (e.g., devices) that may be connected to the modular communication hub 203 and transfer data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in FIG. 10, each of the network hubs/switches in the modular communication hub 203 includes three downstream ports and one upstream port. The upstream network hub/switch is connected to a processor to provide a communication connection to the cloud computing resources and a local display 217. Communication to the cloud 204 may be made either through a wired or a wireless communication channel.
[0120] The surgical hub 206 employs a non-contact sensor module 242 to measure the dimensions of the operating theater and generate a map of the surgical theater using either ultrasonic or laser-type non-contact measurement devices. An ultrasound-based non-contact sensor module scans the operating theater by transmitting a burst of ultrasound and receiving the echo when it bounces off the perimeter walls of an operating theater as described under the heading“Surgical Hub Spatial Awareness Within an Operating Room” in U.S. Provisional Patent Application Serial No. 62/61 1 ,341 , titled INTERACTIVE SURGICAL PLATFORM, filed
December 28, 2017, which is herein incorporated by reference in its entirety, in which the sensor module is configured to determine the size of the operating theater and to adjust Bluetooth-pairing distance limits. A laser-based non-contact sensor module scans the operating theater by transmitting laser light pulses, receiving laser light pulses that bounce off the perimeter walls of the operating theater, and comparing the phase of the transmitted pulse to the received pulse to determine the size of the operating theater and to adjust Bluetooth pairing distance limits, for example.
[0121] The computer system 210 comprises a processor 244 and a network interface 245.
The processor 244 is coupled to a communication module 247, storage 248, memory 249, non volatile memory 250, and input/output interface 251 via a system bus. The system bus can be any of several types of bus structure(s) including the memory bus or memory controller, a peripheral bus or external bus, and/or a local bus using any variety of available bus architectures including, but not limited to, 9-bit bus, Industrial Standard Architecture (ISA), Micro-Charmel Architecture (MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association bus (PCMCIA), Small Computer Systems Interface (SCSI), or any other proprietary bus.
[0122] The processor 244 may be any single-core or multicore processor such as those known under the trade name ARM Cortex by Texas Instruments. In one aspect, the processor may be an LM4F230H5QR ARM Cortex-M4F Processor Core, available from Texas
Instruments, for example, comprising an on-chip memory of 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB single-cycle serial random access memory (SRAM), an internal read-only memory (ROM) loaded with Stel laris Ware® software, a 2 KB electrically erasable
programmable read-only memory (EEPROM), and/or one or more pulse width modulation (PWM) modules, one or more quadrature encoder inputs (QEI) analogs, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which are available for the product datasheet.
[0123] In one aspect, the processor 244 may comprise a safety controller comprising two controller-based families such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4, also by Texas Instruments. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.
[0124] The system memory includes volatile memory and non-volatile memory. The basic input/output system (BIOS), containing the basic routines to transfer information between elements within the computer system, such as during start-up, is stored in non-volatile memory. For example, the non-volatile memory can include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random-access memory (RAM), which acts as external cache memory. Moreover,
RAM is available in many forms such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and direct Rambus RAM (DRRAM).
[0125] The computer system 210 also includes removable/non-removable, volatile/non volatile computer storage media, such as for example disk storage. The disk storage includes, but is not limited to, devices like a magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zip drive, LS-60 drive, flash memory card, or memory stick. In addition, the disk storage can include storage media separately or in combination with other storage media including, but not limited to, an optical disc drive such as a compact disc ROM device (CD-ROM), compact disc recordable drive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or a digital versatile disc ROM drive (DVD-ROM). To facilitate the connection of the disk storage devices to the system bus, a removable or non-removable interface may be employed.
[0126] It is to be appreciated that the computer system 210 includes software that acts as an intermediary between users and the basic computer resources described in a suitable operating environment. Such software includes an operating system. The operating system, which can be stored on the disk storage, acts to control and allocate resources of the computer system. System applications take advantage of the management of resources by the operating system through program modules and program data stored either in the system memory or on the disk storage. It is to be appreciated that various components described herein can be implemented with various operating systems or combinations of operating systems.
[0127] A user enters commands or information into the computer system 210 through input device(s) coupled to the I/O interface 251. The input devices include, but are not limited to, a pointing device such as a mouse, trackball, stylus, touch pad, keyboard, microphone, joystick, game pad, satellite dish, scanner, TV tuner card, digital camera, digital video camera, web camera, and the like. These and other input devices connect to the processor through the system bus via interface port(s). The interface port(s) include, for example, a serial port, a parallel port, a game port, and a USB. The output device(s) use some of the same types of ports as input device(s). Thus, for example, a USB port may be used to provide input to the computer system and to output information from the computer system to an output device. An output adapter is provided to illustrate that there are some output devices like monitors, displays, speakers, and printers, among other output devices that require special adapters. The output adapters include, by way of illustration and not limitation, video and sound cards that provide a means of connection between the output device and the system bus. It should be noted that other devices and/or systems of devices, such as remote computer(s), provide both input and output capabilities.
[0128] The computer system 210 can operate in a networked environment using logical connections to one or more remote computers, such as cloud computer(s), or local computers. The remote cloud computer(s) can be a personal computer, server, router, network PC, workstation, microprocessor-based appliance, peer device, or other common network node, and the like, and typically includes many or all of the elements described relative to the computer system. For purposes of brevity, only a memory storage device is illustrated with the remote computer(s). The remote computer(s) is logically connected to the computer system through a network interface and then physically connected via a communication connection. The network interface encompasses communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE 802.5 and the like. WAN technologies include, but are not limited to, point-to-point links, circuit- switching networks like Integrated Services Digital Networks (ISDN) and variations thereon, packet switching networks, and Digital Subscriber Lines (DSL).
[0129] In various aspects, the computer system 210 of FIG. 10, the imaging module 238 and/or visualization system 208, and/or the processor module 232 of FIGS. 9-10, may comprise an image processor, image-processing engine, media processor, or any specialized digital signal processor (DSP) used for the processing of digital images. The image processor may employ parallel computing with single instruction, multiple data (SIMD) or multiple instruction, multiple data (MIMD) technologies to increase speed and efficiency. The digital image- processing engine can perform a range of tasks. The image processor may be a system on a chip with multicore processor architecture.
[0130] The communication connection(s) refers to the hardware/software employed to connect the network interface to the bus. While the communication connection is shown for illustrative clarity inside the computer system, it can also be external to the computer system 210. The hardware/software necessary for connection to the network interface includes, for illustrative purposes only, internal and external technologies such as modems, including regular telephone-grade modems, cable modems, and DSL modems, ISDN adapters, and Ethernet cards.
[0131] FIG. 1 1 illustrates a functional block diagram of one aspect of a USB network hub 300 device, in accordance with at least one aspect of the present disclosure. In the illustrated aspect, the USB network hub device 300 employs a TUSB2036 integrated circuit hub by Texas Instruments. The USB network hub 300 is a CMOS device that provides an upstream USB transceiver port 302 and up to three downstream USB transceiver ports 304, 306, 308 in compliance with the USB 2.0 specification. The upstream USB transceiver port 302 is a differential root data port comprising a differential data minus (DM0) input paired with a differential data plus (DP0) input. The three downstream USB transceiver ports 304, 306, 308 are differential data ports where each port includes differential data plus (DP1 -DP3) outputs paired with differential data minus (DM1 -DM3) outputs. [0132] The USB network hub 300 device is implemented with a digital state machine instead of a microcontroller, and no firmware programming is required. Fully compliant USB
transceivers are integrated into the circuit for the upstream USB transceiver port 302 and all downstream USB transceiver ports 304, 306, 308. The downstream USB transceiver ports 304, 306, 308 support both full-speed and low-speed devices by automatically setting the slew rate according to the speed of the device attached to the ports. The USB network hub 300 device may be configured either in bus-powered or self-powered mode and includes a hub power logic 312 to manage power.
[0133] The USB network hub 300 device includes a serial interface engine 310 (SIE). The SIE 310 is the front end of the USB network hub 300 hardware and handles most of the protocol described in chapter 8 of the USB specification. The SIE 310 typically comprehends signaling up to the transaction level. The functions that it handles could include: packet recognition, transaction sequencing, SOP, EOP, RESET, and RESUME signal detection/generation, clock/data separation, non-return-to-zero invert (NRZI) data encoding/decoding and bit-stuffing, CRC generation and checking (token and data), packet ID (PID) generation and
checking/decoding, and/or serial-parallel/parallel-serial conversion. The 310 receives a clock input 314 and is coupled to a suspend/resume logic and frame timer 316 circuit and a hub repeater circuit 318 to control communication between the upstream USB transceiver port 302 and the downstream USB transceiver ports 304, 306, 308 through port logic circuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326 via interface logic to control commands from a serial EEPROM via a serial EEPROM interface 330.
[0134] In various aspects, the USB network hub 300 can connect 127 functions configured in up to six logical layers (tiers) to a single computer. Further, the USB network hub 300 can connect to all peripherals using a standardized four-wire cable that provides both
communication and power distribution. The power configurations are bus-powered and self- powered modes. The USB network hub 300 may be configured to support four modes of power management: a bus-powered hub, with either individual-port power management or ganged-port power management, and the self-powered hub, with either individual-port power management or ganged-port power management. In one aspect, using a USB cable, the USB network hub 300, the upstream USB transceiver port 302 is plugged into a USB host controller, and the downstream USB transceiver ports 304, 306, 308 are exposed for connecting USB compatible devices, and so forth.
Surgical Instrument Hardware [0135] FIG. 12 illustrates a logic diagram of a control system 470 of a surgical instrument or tool in accordance with one or more aspects of the present disclosure. The system 470 comprises a control circuit. The control circuit includes a microcontroller 461 comprising a processor 462 and a memory 468. One or more of sensors 472, 474, 476, for example, provide real-time feedback to the processor 462. A motor 482, driven by a motor driver 492, operably couples a longitudinally movable displacement member to drive a clamp arm closure member. A tracking system 480 is configured to determine the position of the longitudinally movable displacement member. The position information is provided to the processor 462, which can be programmed or configured to determine the position of the longitudinally movable drive member as well as the position of the closure member. Additional motors may be provided at the tool driver interface to control closure tube travel, shaft rotation, articulation, or clamp arm closure, or a combination of the above. A display 473 displays a variety of operating conditions of the instruments and may include touch screen functionality for data input. Information displayed on the display 473 may be overlaid with images acquired via endoscopic imaging modules.
[0136] In one aspect, the microcontroller 461 may be any single-core or multicore processor such as those known under the trade name ARM Cortex by Texas Instruments. In one aspect, the main microcontroller 461 may be an LM4F230H5QR ARM Cortex-M4F Processor Core, available from Texas Instruments, for example, comprising an on-chip memory of 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB single-cycle SRAM, and internal ROM loaded with StellarisWare® software, a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and/or one or more 12-bit ADCs with 12 analog input channels, details of which are available for the product datasheet.
[0137] In one aspect, the microcontroller 461 may comprise a safety controller comprising two controller-based families such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4, also by Texas Instruments. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.
[0138] The microcontroller 461 may be programmed to perform various functions such as precise control over the speed and position of the knife, articulation systems, clamp arm, or a combination of the above. In one aspect, the microcontroller 461 includes a processor 462 and a memory 468. The electric motor 482 may be a brushed direct current (DC) motor with a gearbox and mechanical links to an articulation or knife system. In one aspect, a motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers may be readily substituted for use in the tracking system 480 comprising an absolute positioning system. A detailed description of an absolute positioning system is described in U.S. Patent Application Publication No. 2017/0296213, titled SYSTEMS AND METHODS FOR
CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT, which published on October 19, 2017, which is herein incorporated by reference in its entirety.
[0139] The microcontroller 461 may be programmed to provide precise control over the speed and position of displacement members and articulation systems. The microcontroller 461 may be configured to compute a response in the software of the microcontroller 461. The computed response is compared to a measured response of the actual system to obtain an“observed” response, which is used for actual feedback decisions. The observed response is a favorable, tuned value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect outside influences on the system.
[0140] In one aspect, the motor 482 may be controlled by the motor driver 492 and can be employed by the firing system of the surgical instrument or tool. In various forms, the motor 482 may be a brushed DC driving motor having a maximum rotational speed of approximately 25,000 RPM. In other arrangements, the motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may comprise an H-bridge driver comprising field-effect transistors (FETs), for example. The motor 482 can be powered by a power assembly releasably mounted to the handle assembly or tool housing for supplying control power to the surgical instrument or tool. The power assembly may comprise a battery which may include a number of battery cells connected in series that can be used as the power source to power the surgical instrument or tool. In certain circumstances, the battery cells of the power assembly may be replaceable and/or rechargeable battery cells. In at least one example, the battery cells can be lithium-ion batteries which can be couplable to and separable from the power assembly.
[0141] The motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. The A3941 492 is a full-bridge controller for use with external N-channel power metal-oxide semiconductor field-effect transistors (MOSFETs) specifically designed for inductive loads, such as brush DC motors. The driver 492 comprises a unique charge pump regulator that provides full (>10 V) gate drive for battery voltages down to 7 V and allows the A3941 to operate with a reduced gate drive, down to 5.5 V. A bootstrap capacitor may be employed to provide the above battery supply voltage required for N-channel MOSFET s. An internal charge pump for the high- side drive allows DC (100% duty cycle) operation. The full bridge can be driven in fast or slow decay modes using diode or synchronous rectification. In the slow decay mode, current recirculation can be through the high-side or the low-side FETs. The power FETs are protected from shoot-through by resistor-adjustable dead time. Integrated diagnostics provide indications of undervoltage, overtemperature, and power bridge faults and can be configured to protect the power MOSFETs under most short circuit conditions. Other motor drivers may be readily substituted for use in the tracking system 480 comprising an absolute positioning system.
[0142] The tracking system 480 comprises a controlled motor drive circuit arrangement comprising a position sensor 472 according to one aspect of this disclosure. The position sensor 472 for an absolute positioning system provides a unique position signal corresponding to the location of a displacement member. In one aspect, the displacement member represents a longitudinally movable drive member comprising a rack of drive teeth for meshing engagement with a corresponding drive gear of a gear reducer assembly. In other aspects, the displacement member represents the firing member, which could be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a longitudinal displacement member to open and close a clamp arm, which can be adapted and configured to include a rack of drive teeth. In other aspects, the displacement member represents a clamp arm closure member configured to close and to open a clamp arm of a stapler, ultrasonic, or electrosurgical device, or combinations of the above. Accordingly, as used herein, the term displacement member is used generically to refer to any movable member of the surgical instrument or tool such as the drive member, the clamp arm, or any element that can be displaced. Accordingly, the absolute positioning system can, in effect, track the displacement of the clamp arm by tracking the linear displacement of the longitudinally movable drive member.
[0143] In other aspects, the absolute positioning system can be configured to track the position of a clamp arm in the process of closing or opening. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Thus, the longitudinally movable drive member, or clamp arm, or combinations thereof, may be coupled to any suitable linear displacement sensor. Linear displacement sensors may include contact or non-contact displacement sensors. Linear displacement sensors may comprise linear variable differential transformers (LVDT), differential variable reluctance transducers (DVRT), a slide potentiometer, a magnetic sensing system comprising a movable magnet and a series of linearly arranged Hall effect sensors, a magnetic sensing system comprising a fixed magnet and a series of movable, linearly arranged Hall effect sensors, an optical sensing system comprising a movable light source and a series of linearly arranged photo diodes or photo detectors, an optical sensing system comprising a fixed light source and a series of movable linearly, arranged photo diodes or photo detectors, or any combination thereof.
[0144] The electric motor 482 can include a rotatable shaft that operably interfaces with a gear assembly that is mounted in meshing engagement with a set, or rack, of drive teeth on the displacement member. A sensor element may be operably coupled to a gear assembly such that a single revolution of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. An arrangement of gearing and sensors can be connected to the linear actuator, via a rack and pinion arrangement, or a rotary actuator, via a spur gear or other connection. A power source supplies power to the absolute positioning system and an output indicator may display the output of the absolute positioning system. The displacement member represents the longitudinally movable drive member comprising a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of the gear reducer assembly. The displacement member represents the longitudinally movable firing member to open and close a clamp arm.
[0145] A single revolution of the sensor element associated with the position sensor 472 is equivalent to a longitudinal linear displacement di of the of the displacement member, where di is the longitudinal linear distance that the displacement member moves from point“a” to point “b” after a single revolution of the sensor element coupled to the displacement member. The sensor arrangement may be connected via a gear reduction that results in the position sensor 472 completing one or more revolutions for the full stroke of the displacement member. The position sensor 472 may complete multiple revolutions for the full stroke of the displacement member.
[0146] A series of switches, where n is an integer greater than one, may be employed alone or in combination with a gear reduction to provide a unique position signal for more than one revolution of the position sensor 472. The state of the switches are fed back to the
microcontroller 461 that applies logic to determine a unique position signal corresponding to the longitudinal linear displacement di + d2 + ... dn of the displacement member. The output of the position sensor 472 is provided to the microcontroller 461 . The position sensor 472 of the sensor arrangement may comprise a magnetic sensor, an analog rotary sensor like a potentiometer, or an array of analog Hall-effect elements, which output a unique combination of position signals or values.
[0147] The position sensor 472 may comprise any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or the vector components of the magnetic field. The techniques used to produce both types of magnetic sensors encompass many aspects of physics and electronics. The technologies used for magnetic field sensing include search coil, fluxgate, optically pumped, nuclear precession, SQUID, Hall-effect, anisotropic magnetoresistance, giant
magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance,
magnetostrictive/piezoelectric composites, magnetodiode, magnetotransistor, fiber-optic, magneto-optic, and microelectromechanical systems-based magnetic sensors, among others.
[0148] In one aspect, the position sensor 472 for the tracking system 480 comprising an absolute positioning system comprises a magnetic rotary absolute positioning system. The position sensor 472 may be implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 472 is interfaced with the microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low-voltage and low-power component and includes four Hall-effect elements in an area of the position sensor 472 that is located above a magnet. A high-resolution ADC and a smart power management controller are also provided on the chip. A coordinate rotation digital computer (CORDIC) processor, also known as the digit-by-digit method and Volder’s algorithm, is provided to implement a simple and efficient algorithm to calculate hyperbolic and
trigonometric functions that require only addition, subtraction, bitshift, and table lookup operations. The angle position, alarm bits, and magnetic field information are transmitted over a standard serial communication interface, such as a serial peripheral interface (SPI) interface, to the microcontroller 461 . The position sensor 472 provides 12 or 14 bits of resolution. The position sensor 472 may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85mm package.
[0149] The tracking system 480 comprising an absolute positioning system may comprise and/or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller. A power source converts the signal from the feedback controller into a physical input to the system: in this case the voltage. Other examples include a PWM of the voltage, current, and force. Other sensor(s) may be provided to measure physical parameters of the physical system in addition to the position measured by the position sensor 472. In some aspects, the other sensor(s) can include sensor arrangements such as those described in U.S. Patent No. 9,345,481 , titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, which issued on May 24, 2016, which is herein incorporated by reference in its entirety; U.S. Patent Application Publication No. 2014/0263552, titled STAPLE CARTRIDGE TISSUE
THICKNESS SENSOR SYSTEM, which published on September 18, 2014, which is herein incorporated by reference in its entirety; and U.S. Patent Application Serial No. 15/628, 175, titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT, filed June 20, 2017, which is herein incorporated by reference in its entirety. In a digital signal processing system, an absolute positioning system is coupled to a digital data acquisition system where the output of the absolute positioning system will have a finite resolution and sampling frequency. The absolute positioning system may comprise a compare-and-combine circuit to combine a computed response with a measured response using algorithms, such as a weighted average and a theoretical control loop, that drive the computed response towards the measured response. The computed response of the physical system takes into account properties like mass, inertia, viscous friction, inductance resistance, etc., to predict what the states and outputs of the physical system will be by knowing the input.
[0150] The absolute positioning system provides an absolute position of the displacement member upon power-up of the instrument, without retracting or advancing the displacement member to a reset (zero or home) position as may be required with conventional rotary encoders that merely count the number of steps forwards or backwards that the motor 482 has taken to infer the position of a device actuator, drive bar, knife, or the like.
[0151] A sensor 474, such as, for example, a strain gauge or a micro-strain gauge, is configured to measure one or more parameters of the end effector, such as, for example, the amplitude of the strain exerted on the anvil during a clamping operation, which can be indicative of the closure forces applied to the anvil. The measured strain is converted to a digital signal and provided to the processor 462. Alternatively, or in addition to the sensor 474, a sensor 476, such as, for example, a load sensor, can measure the closure force applied by the closure drive system to the anvil in a stapler or a clamp arm in an ultrasonic or electrosurgical instrument. The sensor 476, such as, for example, a load sensor, can measure the firing force applied to a closure member coupled to a clamp arm of the surgical instrument or tool or the force applied by a clamp arm to tissue located in the jaws of an ultrasonic or electrosurgical instrument.
Alternatively, a current sensor 478 can be employed to measure the current drawn by the motor 482. The displacement member also may be configured to engage a clamp arm to open or close the clamp arm. The force sensor may be configured to measure the clamping force on tissue. The force required to advance the displacement member can correspond to the current drawn by the motor 482, for example. The measured force is converted to a digital signal and provided to the processor 462.
[0152] In one form, the strain gauge sensor 474 can be used to measure the force applied to the tissue by the end effector. A strain gauge can be coupled to the end effector to measure the force on the tissue being treated by the end effector. A system for measuring forces applied to the tissue grasped by the end effector comprises a strain gauge sensor 474, such as, for example, a micro-strain gauge, that is configured to measure one or more parameters of the end effector, for example. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of the strain exerted on a jaw member of an end effector during a clamping operation, which can be indicative of the tissue compression. The measured strain is converted to a digital signal and provided to a processor 462 of the microcontroller 461 . A load sensor 476 can measure the force used to operate the knife element, for example, to cut the tissue captured between the anvil and the staple cartridge. A load sensor 476 can measure the force used to operate the clamp arm element, for example, to capture tissue between the clamp arm and an ultrasonic blade or to capture tissue between the clamp arm and a jaw of an electrosurgical instrument. A magnetic field sensor can be employed to measure the thickness of the captured tissue. The measurement of the magnetic field sensor also may be converted to a digital signal and provided to the processor 462.
[0153] The measurements of the tissue compression, the tissue thickness, and/or the force required to close the end effector on the tissue, as respectively measured by the sensors 474, 476, can be used by the microcontroller 461 to characterize the selected position of the firing member and/or the corresponding value of the speed of the firing member. In one instance, a memory 468 may store a technique, an equation, and/or a lookup table which can be employed by the microcontroller 461 in the assessment.
[0154] The control system 470 of the surgical instrument or tool also may comprise wired or wireless communication circuits to communicate with the modular communication hub as shown in FIGS. 8-1 1 .
[0155] FIG. 13 illustrates a control circuit 500 configured to control aspects of the surgical instrument or tool according to one aspect of this disclosure. The control circuit 500 can be configured to implement various processes described herein. The control circuit 500 may comprise a microcontroller comprising one or more processors 502 (e.g., microprocessor, microcontroller) coupled to at least one memory circuit 504. The memory circuit 504 stores machine-executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions to implement various processes described herein. The processor 502 may be any one of a number of single-core or multicore processors known in the art. The memory circuit 504 may comprise volatile and non-volatile storage media. The processor 502 may include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of this disclosure.
[0156] FIG. 14 illustrates a combinational logic circuit 510 configured to control aspects of the surgical instrument or tool according to one aspect of this disclosure. The combinational logic circuit 510 can be configured to implement various processes described herein. The
combinational logic circuit 510 may comprise a finite state machine comprising a combinational logic 512 configured to receive data associated with the surgical instrument or tool at an input 514, process the data by the combinational logic 512, and provide an output 516.
[0157] FIG. 15 illustrates a sequential logic circuit 520 configured to control aspects of the surgical instrument or tool according to one aspect of this disclosure. The sequential logic circuit 520 or the combinational logic 522 can be configured to implement various processes described herein. The sequential logic circuit 520 may comprise a finite state machine. The sequential logic circuit 520 may comprise a combinational logic 522, at least one memory circuit 524, and a clock 529, for example. The at least one memory circuit 524 can store a current state of the finite state machine. In certain instances, the sequential logic circuit 520 may be synchronous or asynchronous. The combinational logic 522 is configured to receive data associated with the surgical instrument or tool from an input 526, process the data by the combinational logic 522, and provide an output 528. In other aspects, the circuit may comprise a combination of a processor (e.g., processor 502, FIG. 13) and a finite state machine to implement various processes herein. In other aspects, the finite state machine may comprise a combination of a combinational logic circuit (e.g., combinational logic circuit 510, FIG. 14) and the sequential logic circuit 520.
[0158] FIG. 16 illustrates a surgical instrument or tool comprising a plurality of motors which can be activated to perform various functions. In certain instances, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, a third motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In certain instances, the plurality of motors of robotic surgical instrument 600 can be individually activated to cause firing, closure, and/or articulation motions in the end effector. The firing, closure, and/or articulation motions can be transmitted to the end effector through a shaft assembly, for example.
[0159] In certain instances, the surgical instrument system or tool may include a firing motor 602. The firing motor 602 may be operably coupled to a firing motor drive assembly 604 which can be configured to transmit firing motions, generated by the motor 602 to the end effector, in particular to displace the clamp arm closure member. The closure member may be retracted by reversing the direction of the motor 602, which also causes the clamp arm to open.
[0160] In certain instances, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operably coupled to a closure motor drive assembly 605 which can be configured to transmit closure motions, generated by the motor 603 to the end effector, in particular to displace a closure tube to close the anvil and compress tissue between the anvil and the staple cartridge. The closure motor 603 may be operably coupled to a closure motor drive assembly 605 which can be configured to transmit closure motions, generated by the motor 603 to the end effector, in particular to displace a closure tube to close the clamp arm and compress tissue between the clamp arm and either an ultrasonic blade or jaw member of an electrosurgical device. The closure motions may cause the end effector to transition from an open configuration to an approximated configuration to capture tissue, for example. The end effector may be transitioned to an open position by reversing the direction of the motor 603.
[0161] In certain instances, the surgical instrument or tool may include one or more articulation motors 606a, 606b, for example. The motors 606a, 606b may be operably coupled to respective articulation motor drive assemblies 608a, 608b, which can be configured to transmit articulation motions generated by the motors 606a, 606b to the end effector. In certain instances, the articulation motions may cause the end effector to articulate relative to the shaft, for example.
[0162] As described above, the surgical instrument or tool may include a plurality of motors which may be configured to perform various independent functions. In certain instances, the plurality of motors of the surgical instrument or tool can be individually or separately activated to perform one or more functions while the other motors remain inactive. For example, the articulation motors 606a, 606b can be activated to cause the end effector to be articulated while the firing motor 602 remains inactive. Alternatively, the firing motor 602 can be activated to fire the plurality of staples, and/or to advance the cutting edge, while the articulation motor 606 remains inactive. Furthermore, the closure motor 603 may be activated simultaneously with the firing motor 602 to cause the closure tube or closure member to advance distally as described in more detail hereinbelow.
[0163] In certain instances, the surgical instrument or tool may include a common control module 610 which can be employed with a plurality of motors of the surgical instrument or tool.
In certain instances, the common control module 610 may accommodate one of the plurality of motors at a time. For example, the common control module 610 can be couplable to and separable from the plurality of motors of the robotic surgical instrument individually. In certain instances, a plurality of the motors of the surgical instrument or tool may share one or more common control modules such as the common control module 610. In certain instances, a plurality of motors of the surgical instrument or tool can be individually and selectively engaged with the common control module 610. In certain instances, the common control module 610 can be selectively switched from interfacing with one of a plurality of motors of the surgical instrument or tool to interfacing with another one of the plurality of motors of the surgical instrument or tool.
[0164] In at least one example, the common control module 610 can be selectively switched between operable engagement with the articulation motors 606a, 606b and operable
engagement with either the firing motor 602 or the closure motor 603. In at least one example, as illustrated in FIG. 16, a switch 614 can be moved or transitioned between a plurality of positions and/or states. In a first position 616, the switch 614 may electrically couple the common control module 610 to the firing motor 602; in a second position 617, the switch 614 may electrically couple the common control module 610 to the closure motor 603; in a third position 618a, the switch 614 may electrically couple the common control module 610 to the first articulation motor 606a; and in a fourth position 618b, the switch 614 may electrically couple the common control module 610 to the second articulation motor 606b, for example. In certain instances, separate common control modules 610 can be electrically coupled to the firing motor 602, the closure motor 603, and the articulations motor 606a, 606b at the same time. In certain instances, the switch 614 may be a mechanical switch, an electromechanical switch, a solid- state switch, or any suitable switching mechanism.
[0165] Each of the motors 602, 603, 606a, 606b may comprise a torque sensor to measure the output torque on the shaft of the motor. The force on an end effector may be sensed in any conventional manner, such as by force sensors on the outer sides of the jaws or by a torque sensor for the motor actuating the jaws.
[0166] In various instances, as illustrated in FIG. 16, the common control module 610 may comprise a motor driver 626 which may comprise one or more H-Bridge FETs. The motor driver 626 may modulate the power transmitted from a power source 628 to a motor coupled to the common control module 610 based on input from a microcontroller 620 (the“controller”), for example. In certain instances, the microcontroller 620 can be employed to determine the current drawn by the motor, for example, while the motor is coupled to the common control module 610, as described above.
[0167] In certain instances, the microcontroller 620 may include a microprocessor 622 (the “processor”) and one or more non-transitory computer-readable mediums or memory units 624 (the“memory”). In certain instances, the memory 624 may store various program instructions, which when executed may cause the processor 622 to perform a plurality of functions and/or calculations described herein. In certain instances, one or more of the memory units 624 may be coupled to the processor 622, for example. In various aspects, the microcontroller 620 may communicate over a wired or wireless channel, or combinations thereof.
[0168] In certain instances, the power source 628 can be employed to supply power to the microcontroller 620, for example. In certain instances, the power source 628 may comprise a battery (or“battery pack” or“power pack”), such as a lithium-ion battery, for example. In certain instances, the battery pack may be configured to be releasably mounted to a handle for supplying power to the surgical instrument 600. A number of battery cells connected in series may be used as the power source 628. In certain instances, the power source 628 may be replaceable and/or rechargeable, for example.
[0169] In various instances, the processor 622 may control the motor driver 626 to control the position, direction of rotation, and/or velocity of a motor that is coupled to the common control module 610. In certain instances, the processor 622 can signal the motor driver 626 to stop and/or disable a motor that is coupled to the common control module 610. It should be understood that the term“processor” as used herein includes any suitable microprocessor, microcontroller, or other basic computing device that incorporates the functions of a computer’s central processing unit (CPU) on an integrated circuit or, at most, a few integrated circuits. The processor 622 is a multipurpose, programmable device that accepts digital data as input, processes it according to instructions stored in its memory, and provides results as output. It is an example of sequential digital logic, as it has internal memory. Processors operate on numbers and symbols represented in the binary numeral system.
[0170] In one instance, the processor 622 may be any single-core or multicore processor such as those known under the trade name ARM Cortex by Texas Instruments. In certain instances, the microcontroller 620 may be an LM 4F230H5QR, available from Texas Instruments, for example. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex- M4F Processor Core comprising an on-chip memory of 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB single-cycle SRAM, an internal ROM loaded with StellarisWare® software, a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, one or more 12-bit ADCs with 12 analog input channels, among other features that are readily available for the product datasheet. Other microcontrollers may be readily substituted for use with the module 4410. Accordingly, the present disclosure should not be limited in this context. [0171] In certain instances, the memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that are couplable to the common control module 610. For example, the memory 624 may include program instructions for controlling the firing motor 602, the closure motor 603, and the articulation motors 606a, 606b. Such program instructions may cause the processor 622 to control the firing, closure, and articulation functions in accordance with inputs from algorithms or control programs of the surgical instrument or tool.
[0172] In certain instances, one or more mechanisms and/or sensors such as, for example, sensors 630 can be employed to alert the processor 622 to the program instructions that should be used in a particular setting. For example, the sensors 630 may alert the processor 622 to use the program instructions associated with firing, closing, and articulating the end effector. In certain instances, the sensors 630 may comprise position sensors which can be employed to sense the position of the switch 614, for example. Accordingly, the processor 622 may use the program instructions associated with firing the closure member coupled to the clamp arm of the end effector upon detecting, through the sensors 630 for example, that the switch 614 is in the first position 616; the processor 622 may use the program instructions associated with closing the anvil upon detecting, through the sensors 630 for example, that the switch 614 is in the second position 617; and the processor 622 may use the program instructions associated with articulating the end effector upon detecting, through the sensors 630 for example, that the switch 614 is in the third or fourth position 618a, 618b.
[0173] FIG. 17 is a schematic diagram of a robotic surgical instrument 700 configured to operate a surgical tool described herein according to one aspect of this disclosure. The robotic surgical instrument 700 may be programmed or configured to control distal/proximal translation of a displacement member, distal/proximal displacement of a closure tube, shaft rotation, and articulation, either with single or multiple articulation drive links. In one aspect, the surgical instrument 700 may be programmed or configured to individually control a firing member, a closure member, a shaft member, or one or more articulation members, or combinations thereof. The surgical instrument 700 comprises a control circuit 710 configured to control motor- driven firing members, closure members, shaft members, or one or more articulation members, or combinations thereof.
[0174] In one aspect, the robotic surgical instrument 700 comprises a control circuit 710 configured to control a clamp arm 716 and a closure member 714 portion of an end effector 702, an ultrasonic blade 718 coupled to an ultrasonic transducer 719 excited by an ultrasonic generator 721 , a shaft 740, and one or more articulation members 742a, 742b via a plurality of motors 704a-704e. A position sensor 734 may be configured to provide position feedback of the closure member 714 to the control circuit 710. Other sensors 738 may be configured to provide feedback to the control circuit 710. A timer/counter 731 provides timing and counting information to the control circuit 710. An energy source 712 may be provided to operate the motors 704a- 704e, and a current sensor 736 provides motor current feedback to the control circuit 710. The motors 704a-704e can be operated individually by the control circuit 710 in an open-loop or closed-loop feedback control.
[0175] In one aspect, the control circuit 710 may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the processor or processors to perform one or more tasks. In one aspect, a timer/counter 731 provides an output signal, such as the elapsed time or a digital count, to the control circuit 710 to correlate the position of the closure member 714 as determined by the position sensor 734 with the output of the timer/counter 731 such that the control circuit 710 can determine the position of the closure member 714 at a specific time (t) relative to a starting position or the time (t) when the closure member 714 is at a specific position relative to a starting position. The timer/counter 731 may be configured to measure elapsed time, count external events, or time external events.
[0176] In one aspect, the control circuit 710 may be programmed to control functions of the end effector 702 based on one or more tissue conditions. The control circuit 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuit 710 may be programmed to select a firing control program or closure control program based on tissue conditions. A firing control program may describe the distal motion of the displacement member. Different firing control programs may be selected to better treat different tissue conditions. For example, when thicker tissue is present, the control circuit 710 may be programmed to translate the displacement member at a lower velocity and/or with lower power. When thinner tissue is present, the control circuit 710 may be programmed to translate the displacement member at a higher velocity and/or with higher power. A closure control program may control the closure force applied to the tissue by the clamp arm 716. Other control programs control the rotation of the shaft 740 and the articulation members 742a, 742b.
[0177] In one aspect, the control circuit 710 may generate motor set point signals. The motor set point signals may be provided to various motor controllers 708a-708e. The motor controllers 708a-708e may comprise one or more circuits configured to provide motor drive signals to the motors 704a-704e to drive the motors 704a-704e as described herein. In some examples, the motors 704a-704e may be brushed DC electric motors. For example, the velocity of the motors 704a-704e may be proportional to the respective motor drive signals. In some examples, the motors 704a-704e may be brushless DC electric motors, and the respective motor drive signals may comprise a PWM signal provided to one or more stator windings of the motors 704a-704e. Also, in some examples, the motor controllers 708a-708e may be omitted and the control circuit 710 may generate the motor drive signals directly.
[0178] In one aspect, the control circuit 710 may initially operate each of the motors 704a- 704e in an open-loop configuration for a first open-loop portion of a stroke of the displacement member. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the stroke, the control circuit 710 may select a firing control program in a closed-loop configuration. The response of the instrument may include a translation distance of the displacement member during the open-loop portion, a time elapsed during the open-loop portion, the energy provided to one of the motors 704a-704e during the open-loop portion, a sum of pulse widths of a motor drive signal, etc. After the open-loop portion, the control circuit 710 may implement the selected firing control program for a second portion of the displacement member stroke. For example, during a closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e based on translation data describing a position of the displacement member in a closed-loop manner to translate the displacement member at a constant velocity.
[0179] In one aspect, the motors 704a-704e may receive power from an energy source 712. The energy source 712 may be a DC power supply driven by a main alternating current power source, a battery, a super capacitor, or any other suitable energy source. The motors 704a- 704e may be mechanically coupled to individual movable mechanical elements such as the closure member 714, clamp arm 716, shaft 740, articulation 742a, and articulation 742b via respective transmissions 706a-706e. The transmissions 706a-706e may include one or more gears or other linkage components to couple the motors 704a-704e to movable mechanical elements. A position sensor 734 may sense a position of the closure member 714. The position sensor 734 may be or include any type of sensor that is capable of generating position data that indicate a position of the closure member 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuit 710 as the closure member 714 translates distally and proximally. The control circuit 710 may track the pulses to determine the position of the closure member 714. Other suitable position sensors may be used, including, for example, a proximity sensor. Other types of position sensors may provide other signals indicating motion of the closure member 714. Also, in some examples, the position sensor 734 may be omitted. Where any of the motors 704a-704e is a stepper motor, the control circuit 710 may track the position of the closure member 714 by aggregating the number and direction of steps that the motor 704 has been instructed to execute. The position sensor 734 may be located in the end effector 702 or at any other portion of the instrument. The outputs of each of the motors 704a-704e include a torque sensor 744a-744e to sense force and have an encoder to sense rotation of the drive shaft.
[0180] In one aspect, the control circuit 710 is configured to drive a firing member such as the closure member 714 portion of the end effector 702. The control circuit 710 provides a motor set point to a motor control 708a, which provides a drive signal to the motor 704a. The output shaft of the motor 704a is coupled to a torque sensor 744a. The torque sensor 744a is coupled to a transmission 706a which is coupled to the closure member 714. The transmission 706a comprises movable mechanical elements such as rotating elements and a firing member to control the movement of the closure member 714 distally and proximally along a longitudinal axis of the end effector 702. In one aspect, the motor 704a may be coupled to the knife gear assembly, which includes a knife gear reduction set that includes a first knife drive gear and a second knife drive gear. A torque sensor 744a provides a firing force feedback signal to the control circuit 710. The firing force signal represents the force required to fire or displace the closure member 714. A position sensor 734 may be configured to provide the position of the closure member 714 along the firing stroke or the position of the firing member as a feedback signal to the control circuit 710. The end effector 702 may include additional sensors 738 configured to provide feedback signals to the control circuit 710. When ready to use, the control circuit 710 may provide a firing signal to the motor control 708a. In response to the firing signal, the motor 704a may drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal stroke start position to a stroke end position distal to the stroke start position. As the closure member 714 translates distally, the clamp arm 716 closes towards the ultrasonic blade 718.
[0181] In one aspect, the control circuit 710 is configured to drive a closure member such as the clamp arm 716 portion of the end effector 702. The control circuit 710 provides a motor set point to a motor control 708b, which provides a drive signal to the motor 704b. The output shaft of the motor 704b is coupled to a torque sensor 744b. The torque sensor 744b is coupled to a transmission 706b which is coupled to the clamp arm 716. The transmission 706b comprises movable mechanical elements such as rotating elements and a closure member to control the movement of the clamp arm 716 from the open and closed positions. In one aspect, the motor 704b is coupled to a closure gear assembly, which includes a closure reduction gear set that is supported in meshing engagement with the closure spur gear. The torque sensor 744b provides a closure force feedback signal to the control circuit 710. The closure force feedback signal represents the closure force applied to the clamp arm 716. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. Additional sensors 738 in the end effector 702 may provide the closure force feedback signal to the control circuit 710. The pivotable clamp arm 716 is positioned opposite the ultrasonic blade 718. When ready to use, the control circuit 710 may provide a closure signal to the motor control 708b. In response to the closure signal, the motor 704b advances a closure member to grasp tissue between the clamp arm 716 and the ultrasonic blade 718.
[0182] In one aspect, the control circuit 710 is configured to rotate a shaft member such as the shaft 740 to rotate the end effector 702. The control circuit 710 provides a motor set point to a motor control 708c, which provides a drive signal to the motor 704c. The output shaft of the motor 704c is coupled to a torque sensor 744c. The torque sensor 744c is coupled to a transmission 706c which is coupled to the shaft 740. The transmission 706c comprises movable mechanical elements such as rotating elements to control the rotation of the shaft 740 clockwise or counterclockwise up to and over 360°. In one aspect, the motor 704c is coupled to the rotational transmission assembly, which includes a tube gear segment that is formed on (or attached to) the proximal end of the proximal closure tube for operable engagement by a rotational gear assembly that is operably supported on the tool mounting plate. The torque sensor 744c provides a rotation force feedback signal to the control circuit 710. The rotation force feedback signal represents the rotation force applied to the shaft 740. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. Additional sensors 738 such as a shaft encoder may provide the rotational position of the shaft 740 to the control circuit 710.
[0183] In one aspect, the control circuit 710 is configured to articulate the end effector 702. The control circuit 710 provides a motor set point to a motor control 708d, which provides a drive signal to the motor 704d. The output shaft of the motor 704d is coupled to a torque sensor 744d. The torque sensor 744d is coupled to a transmission 706d which is coupled to an articulation member 742a. The transmission 706d comprises movable mechanical elements such as articulation elements to control the articulation of the end effector 702 ±65°. In one aspect, the motor 704d is coupled to an articulation nut, which is rotatably journaled on the proximal end portion of the distal spine portion and is rotatably driven thereon by an articulation gear assembly. The torque sensor 744d provides an articulation force feedback signal to the control circuit 710. The articulation force feedback signal represents the articulation force applied to the end effector 702. Sensors 738, such as an articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710. [0184] In another aspect, the articulation function of the robotic surgical system 700 may comprise two articulation members, or links, 742a, 742b. These articulation members 742a,
742b are driven by separate disks on the robot interface (the rack) which are driven by the two motors 708d, 708e. When the separate firing motor 704a is provided, each of articulation links 742a, 742b can be antagonistically driven with respect to the other link in order to provide a resistive holding motion and a load to the head when it is not moving and to provide an articulation motion as the head is articulated. The articulation members 742a, 742b attach to the head at a fixed radius as the head is rotated. Accordingly, the mechanical advantage of the push-and-pull link changes as the head is rotated. This change in the mechanical advantage may be more pronounced with other articulation link drive systems.
[0185] In one aspect, the one or more motors 704a-704e may comprise a brushed DC motor with a gearbox and mechanical links to a firing member, closure member, or articulation member. Another example includes electric motors 704a-704e that operate the movable mechanical elements such as the displacement member, articulation links, closure tube, and shaft. An outside influence is an unmeasured, unpredictable influence of things like tissue, surrounding bodies, and friction on the physical system. Such outside influence can be referred to as drag, which acts in opposition to one of electric motors 704a-704e. The outside influence, such as drag, may cause the operation of the physical system to deviate from a desired operation of the physical system.
[0186] In one aspect, the position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may comprise a magnetic rotary absolute positioning system implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 734 may interface with the control circuit 710 to provide an absolute positioning system. The position may include multiple Hall-effect elements located above a magnet and coupled to a CORDIC processor, also known as the digit-by-digit method and Volder’s algorithm, that is provided to implement a simple and efficient algorithm to calculate hyperbolic and trigonometric functions that require only addition, subtraction, bitshift, and table lookup operations.
[0187] In one aspect, the control circuit 710 may be in communication with one or more sensors 738. The sensors 738 may be positioned on the end effector 702 and adapted to operate with the robotic surgical instrument 700 to measure the various derived parameters such as the gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 738 may comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a load cell, a pressure sensor, a force sensor, a torque sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor for measuring one or more parameters of the end effector 702. The sensors 738 may include one or more sensors. The sensors 738 may be located on the clamp arm 716 to determine tissue location using segmented electrodes. The torque sensors 744a- 744e may be configured to sense force such as firing force, closure force, and/or articulation force, among others. Accordingly, the control circuit 710 can sense (1 ) the closure load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) what portion of the ultrasonic blade 718 has tissue on it, and (4) the load and position on both articulation rods.
[0188] In one aspect, the one or more sensors 738 may comprise a strain gauge, such as a micro-strain gauge, configured to measure the magnitude of the strain in the clamp arm 716 during a clamped condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensors 738 may comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the clamp arm 716 and the ultrasonic blade 718. The sensors 738 may be configured to detect impedance of a tissue section located between the clamp arm 716 and the ultrasonic blade 718 that is indicative of the thickness and/or fullness of tissue located therebetween.
[0189] In one aspect, the sensors 738 may be implemented as one or more limit switches, electromechanical devices, solid-state switches, Hall-effect devices, magneto-resistive (MR) devices, giant magneto-resistive (GMR) devices, magnetometers, among others. In other implementations, the sensors 738 may be implemented as solid-state switches that operate under the influence of light, such as optical sensors, IR sensors, ultraviolet sensors, among others. Still, the switches may be solid-state devices such as transistors (e.g., FET, junction FET, MOSFET, bipolar, and the like). In other implementations, the sensors 738 may include electrical conductorless switches, ultrasonic switches, accelerometers, and inertial sensors, among others.
[0190] In one aspect, the sensors 738 may be configured to measure forces exerted on the clamp arm 716 by the closure drive system. For example, one or more sensors 738 can be at an interaction point between the closure tube and the clamp arm 716 to detect the closure forces applied by the closure tube to the clamp arm 716. The forces exerted on the clamp arm 716 can be representative of the tissue compression experienced by the tissue section captured between the clamp arm 716 and the ultrasonic blade 718. The one or more sensors 738 can be positioned at various interaction points along the closure drive system to detect the closure forces applied to the clamp arm 716 by the closure drive system. The one or more sensors 738 may be sampled in real time during a clamping operation by the processor of the control circuit 710. The control circuit 710 receives real-time sample measurements to provide and analyze time-based information and assess, in real time, closure forces applied to the clamp arm 716.
[0191] In one aspect, a current sensor 736 can be employed to measure the current drawn by each of the motors 704a-704e. The force required to advance any of the movable mechanical elements such as the closure member 714 corresponds to the current drawn by one of the motors 704a-704e. The force is converted to a digital signal and provided to the control circuit 710. The control circuit 710 can be configured to simulate the response of the actual system of the instrument in the software of the controller. A displacement member can be actuated to move the closure member 714 in the end effector 702 at or near a target velocity. The robotic surgical instrument 700 can include a feedback controller, which can be one of any feedback controllers, including, but not limited to a PID, a state feedback, a linear-quadratic (LQR), and/or an adaptive controller, for example. The robotic surgical instrument 700 can include a power source to convert the signal from the feedback controller into a physical input such as case voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force, for example. Additional details are disclosed in U.S. Patent Application Serial No. 15/636,829, titled CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT, filed June 29, 2017, which is herein incorporated by reference in its entirety.
[0192] FIG. 18 illustrates a schematic diagram of a surgical instrument 750 configured to control the distal translation of a displacement member according to one aspect of this disclosure. In one aspect, the surgical instrument 750 is programmed to control the distal translation of a displacement member such as the closure member 764. The surgical instrument 750 comprises an end effector 752 that may comprise a clamp arm 766, a closure member 764, and an ultrasonic blade 768 coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771 .
[0193] The position, movement, displacement, and/or translation of a linear displacement member, such as the closure member 764, can be measured by an absolute positioning system, sensor arrangement, and position sensor 784. Because the closure member 764 is coupled to a longitudinally movable drive member, the position of the closure member 764 can be determined by measuring the position of the longitudinally movable drive member employing the position sensor 784. Accordingly, in the following description, the position, displacement, and/or translation of the closure member 764 can be achieved by the position sensor 784 as described herein. A control circuit 760 may be programmed to control the translation of the displacement member, such as the closure member 764. The control circuit 760, in some examples, may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the processor or processors to control the displacement member, e.g., the closure member 764, in the manner described. In one aspect, a timer/counter 781 provides an output signal, such as the elapsed time or a digital count, to the control circuit 760 to correlate the position of the closure member 764 as determined by the position sensor 784 with the output of the timer/counter 781 such that the control circuit 760 can determine the position of the closure member 764 at a specific time (t) relative to a starting position. The timer/counter 781 may be configured to measure elapsed time, count external events, or time external events.
[0194] The control circuit 760 may generate a motor set point signal 772. The motor set point signal 772 may be provided to a motor controller 758. The motor controller 758 may comprise one or more circuits configured to provide a motor drive signal 774 to the motor 754 to drive the motor 754 as described herein. In some examples, the motor 754 may be a brushed DC electric motor. For example, the velocity of the motor 754 may be proportional to the motor drive signal 774. In some examples, the motor 754 may be a brushless DC electric motor and the motor drive signal 774 may comprise a PWM signal provided to one or more stator windings of the motor 754. Also, in some examples, the motor controller 758 may be omitted, and the control circuit 760 may generate the motor drive signal 774 directly.
[0195] The motor 754 may receive power from an energy source 762. The energy source 762 may be or include a battery, a super capacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the closure member 764 via a transmission 756. The transmission 756 may include one or more gears or other linkage components to couple the motor 754 to the closure member 764. A position sensor 784 may sense a position of the closure member 764. The position sensor 784 may be or include any type of sensor that is capable of generating position data that indicate a position of the closure member 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 as the closure member 764 translates distally and proximally. The control circuit 760 may track the pulses to determine the position of the closure member 764. Other suitable position sensors may be used, including, for example, a proximity sensor. Other types of position sensors may provide other signals indicating motion of the closure member 764. Also, in some examples, the position sensor 784 may be omitted. Where the motor 754 is a stepper motor, the control circuit 760 may track the position of the closure member 764 by aggregating the number and direction of steps that the motor 754 has been instructed to execute. The position sensor 784 may be located in the end effector 752 or at any other portion of the instrument.
[0196] The control circuit 760 may be in communication with one or more sensors 788. The sensors 788 may be positioned on the end effector 752 and adapted to operate with the surgical instrument 750 to measure the various derived parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 788 may comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor for measuring one or more parameters of the end effector 752. The sensors 788 may include one or more sensors.
[0197] The one or more sensors 788 may comprise a strain gauge, such as a micro-strain gauge, configured to measure the magnitude of the strain in the clamp arm 766 during a clamped condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensors 788 may comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the clamp arm 766 and the ultrasonic blade 768. The sensors 788 may be configured to detect impedance of a tissue section located between the clamp arm 766 and the ultrasonic blade 768 that is indicative of the thickness and/or fullness of tissue located therebetween.
[0198] The sensors 788 may be is configured to measure forces exerted on the clamp arm 766 by a closure drive system. For example, one or more sensors 788 can be at an interaction point between a closure tube and the clamp arm 766 to detect the closure forces applied by a closure tube to the clamp arm 766. The forces exerted on the clamp arm 766 can be
representative of the tissue compression experienced by the tissue section captured between the clamp arm 766 and the ultrasonic blade 768. The one or more sensors 788 can be positioned at various interaction points along the closure drive system to detect the closure forces applied to the clamp arm 766 by the closure drive system. The one or more sensors 788 may be sampled in real time during a clamping operation by a processor of the control circuit 760. The control circuit 760 receives real-time sample measurements to provide and analyze time-based information and assess, in real time, closure forces applied to the clamp arm 766.
[0199] A current sensor 786 can be employed to measure the current drawn by the motor 754. The force required to advance the closure member 764 corresponds to the current drawn by the motor 754. The force is converted to a digital signal and provided to the control circuit 760. [0200] The control circuit 760 can be configured to simulate the response of the actual system of the instrument in the software of the controller. A displacement member can be actuated to move a closure member 764 in the end effector 752 at or near a target velocity. The surgical instrument 750 can include a feedback controller, which can be one of any feedback controllers, including, but not limited to a PID, a state feedback, LQR, and/or an adaptive controller, for example. The surgical instrument 750 can include a power source to convert the signal from the feedback controller into a physical input such as case voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force, for example.
[0201] The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member, or closure member 764, by a brushed DC motor with gearbox and mechanical links to an articulation and/or knife system. Another example is the electric motor 754 that operates the displacement member and the articulation driver, for example, of an interchangeable shaft assembly. An outside influence is an unmeasured, unpredictable influence of things like tissue, surrounding bodies and friction on the physical system. Such outside influence can be referred to as drag which acts in opposition to the electric motor 754. The outside influence, such as drag, may cause the operation of the physical system to deviate from a desired operation of the physical system.
[0202] Various example aspects are directed to a surgical instrument 750 comprising an end effector 752 with motor-driven surgical sealing and cutting implements. For example, a motor 754 may drive a displacement member distally and proximally along a longitudinal axis of the end effector 752. The end effector 752 may comprise a pivotable clamp arm 766 and, when configured for use, an ultrasonic blade 768 positioned opposite the clamp arm 766. A clinician may grasp tissue between the clamp arm 766 and the ultrasonic blade 768, as described herein. When ready to use the instrument 750, the clinician may provide a firing signal, for example by depressing a trigger of the instrument 750. In response to the firing signal, the motor 754 may drive the displacement member distally along the longitudinal axis of the end effector 752 from a proximal stroke begin position to a stroke end position distal of the stroke begin position. As the displacement member translates distally, the closure member 764 with a cutting element positioned at a distal end, may cut the tissue between the ultrasonic blade 768 and the clamp arm 766.
[0203] In various examples, the surgical instrument 750 may comprise a control circuit 760 programmed to control the distal translation of the displacement member, such as the closure member 764, for example, based on one or more tissue conditions. The control circuit 760 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuit 760 may be programmed to select a control program based on tissue conditions. A control program may describe the distal motion of the displacement member. Different control programs may be selected to better treat different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a lower velocity and/or with lower power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher velocity and/or with higher power.
[0204] In some examples, the control circuit 760 may initially operate the motor 754 in an open loop configuration for a first open loop portion of a stroke of the displacement member. Based on a response of the instrument 750 during the open loop portion of the stroke, the control circuit 760 may select a firing control program. The response of the instrument may include, a translation distance of the displacement member during the open loop portion, a time elapsed during the open loop portion, energy provided to the motor 754 during the open loop portion, a sum of pulse widths of a motor drive signal, etc. After the open loop portion, the control circuit 760 may implement the selected firing control program for a second portion of the displacement member stroke. For example, during the closed loop portion of the stroke, the control circuit 760 may modulate the motor 754 based on translation data describing a position of the displacement member in a closed loop manner to translate the displacement member at a constant velocity. Additional details are disclosed in U.S. Patent Application Serial No.
15/720,852, titled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A
SURGICAL INSTRUMENT, filed September 29, 2017, which is herein incorporated by reference in its entirety.
[0205] FIG. 19 is a schematic diagram of a surgical instrument 790 configured to control various functions according to one aspect of this disclosure. In one aspect, the surgical instrument 790 is programmed to control distal translation of a displacement member such as the closure member 764. The surgical instrument 790 comprises an end effector 792 that may comprise a clamp arm 766, a closure member 764, and an ultrasonic blade 768 which may be interchanged with or work in conjunction with one or more RF electrodes 796 (shown in dashed line). The ultrasonic blade 768 is coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771 .
[0206] In one aspect, sensors 788 may be implemented as a limit switch, electromechanical device, solid-state switches, Hall-effect devices, MR devices, GMR devices, magnetometers, among others. In other implementations, the sensors 638 may be solid-state switches that operate under the influence of light, such as optical sensors, IR sensors, ultraviolet sensors, among others. Still, the switches may be solid-state devices such as transistors (e.g., FET, junction FET, MOSFET, bipolar, and the like). In other implementations, the sensors 788 may include electrical conductorless switches, ultrasonic switches, accelerometers, and inertial sensors, among others.
[0207] In one aspect, the position sensor 784 may be implemented as an absolute positioning system comprising a magnetic rotary absolute positioning system implemented as an
AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 784 may interface with the control circuit 760 to provide an absolute positioning system. The position may include multiple Hall-effect elements located above a magnet and coupled to a CORDIC processor, also known as the digit-by-digit method and Volder’s algorithm, that is provided to implement a simple and efficient algorithm to calculate hyperbolic and trigonometric functions that require only addition, subtraction, bitshift, and table lookup operations.
[0208] In some examples, the position sensor 784 may be omitted. Where the motor 754 is a stepper motor, the control circuit 760 may track the position of the closure member 764 by aggregating the number and direction of steps that the motor has been instructed to execute. The position sensor 784 may be located in the end effector 792 or at any other portion of the instrument.
[0209] The control circuit 760 may be in communication with one or more sensors 788. The sensors 788 may be positioned on the end effector 792 and adapted to operate with the surgical instrument 790 to measure the various derived parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 788 may comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor for measuring one or more parameters of the end effector 792. The sensors 788 may include one or more sensors.
[0210] An RF energy source 794 is coupled to the end effector 792 and is applied to the RF electrode 796 when the RF electrode 796 is provided in the end effector 792 in place of the ultrasonic blade 768 or to work in conjunction with the ultrasonic blade 768. For example, the ultrasonic blade is made of electrically conductive metal and may be employed as the return path for electrosurgical RF current. The control circuit 760 controls the delivery of the RF energy to the RF electrode 796.
[0211] Additional details are disclosed in U.S. Patent Application Serial No. 15/636,096, titled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, filed June 28, 2017, which is herein incorporated by reference in its entirety.
Generator Hardware
Adaptive Ultrasonic Blade Control Algorithms
[0212] In various aspects smart ultrasonic energy devices may comprise adaptive algorithms to control the operation of the ultrasonic blade. In one aspect, the ultrasonic blade adaptive control algorithms are configured to identify tissue type and adjust device parameters. In one aspect, the ultrasonic blade control algorithms are configured to parameterize tissue type. An algorithm to detect the collagen/elastic ratio of tissue to tune the amplitude of the distal tip of the ultrasonic blade is described in the following section of the present disclosure. Various aspects of smart ultrasonic energy devices are described herein in connection with FIGS. 1-94, for example. Accordingly, the following description of adaptive ultrasonic blade control algorithms should be read in conjunction with FIGS. 1-94 and the description associated therewith.
Tissue Type Identification And Device Parameter Adjustments
[0213] In certain surgical procedures it would be desirable to employ adaptive ultrasonic blade control algorithms. In one aspect, adaptive ultrasonic blade control algorithms may be employed to adjust the parameters of the ultrasonic device based on the type of tissue in contact with the ultrasonic blade. In one aspect, the parameters of the ultrasonic device may be adjusted based on the location of the tissue within the jaws of the ultrasonic end effector, for example, the location of the tissue between the clamp arm and the ultrasonic blade. The impedance of the ultrasonic transducer may be employed to differentiate what percentage of the tissue is located in the distal or proximal end of the end effector. The reactions of the ultrasonic device may be based on the tissue type or compressibility of the tissue. In another aspect, the parameters of the ultrasonic device may be adjusted based on the identified tissue type or parameterization. For example, the mechanical displacement amplitude of the distal tip of the ultrasonic blade may be tuned based on the ration of collagen to elastin tissue detected during the tissue identification procedure. The ratio of collagen to elastin tissue may be detected used a variety of techniques including infrared (IR) surface reflectance and emissivity. The force applied to the tissue by the clamp arm and/or the stroke of the clamp arm to produce gap and compression. Electrical continuity across a jaw equipped with electrodes may be employed to determine what percentage of the jaw is covered with tissue. [0214] FIG. 20 is a system 800 configured to execute adaptive ultrasonic blade control algorithms in a surgical data network comprising a modular communication hub, in accordance with at least one aspect of the present disclosure. In one aspect, the generator module 240 is configured to execute the adaptive ultrasonic blade control algorithm(s) 802 as described herein with reference to FIGS. 53-105. In another aspect, the device/instrument 235 is configured to execute the adaptive ultrasonic blade control algorithm(s) 804 as described herein with reference to FIGS. 53-105. In another aspect, both the device/instrument 235 and the device/instrument 235 are configured to execute the adaptive ultrasonic blade control algorithms 802, 804 as described herein with reference to FIGS. 53-105.
[0215] The generator module 240 may comprise a patient isolated stage in communication with a non-isolated stage via a power transformer. A secondary winding of the power transformer is contained in the isolated stage and may comprise a tapped configuration (e.g., a center-tapped or a non-center-tapped configuration) to define drive signal outputs for delivering drive signals to different surgical instruments, such as, for example, an ultrasonic surgical instrument, an RF electrosurgical instrument, and a multifunction surgical instrument which includes ultrasonic and RF energy modes that can be delivered alone or simultaneously. In particular, the drive signal outputs may output an ultrasonic drive signal (e.g., a 420V root- mean-square (RMS) drive signal) to an ultrasonic surgical instrument 241 , and the drive signal outputs may output an RF electrosurgical drive signal (e.g., a 100V RMS drive signal) to an RF electrosurgical instrument 241 . Aspects of the generator module 240 are described herein with reference to FIGS. 21 -28B.
[0216] The generator module 240 or the device/instrument 235 or both are coupled to the modular control tower 236 connected to multiple operating theater devices such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating theater, as described with reference to FIGS. 8-1 1 , for example.
[0217] FIG. 21 illustrates an example of a generator 900, which is one form of a generator configured to couple to an ultrasonic instrument and further configured to execute adaptive ultrasonic blade control algorithms in a surgical data network comprising a modular
communication hub as shown in FIG. 20. The generator 900 is configured to deliver multiple energy modalities to a surgical instrument. The generator 900 provides RF and ultrasonic signals for delivering energy to a surgical instrument either independently or simultaneously.
The RF and ultrasonic signals may be provided alone or in combination and may be provided simultaneously. As noted above, at least one generator output can deliver multiple energy modalities (e.g., ultrasonic, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, among others) through a single port, and these signals can be delivered separately or simultaneously to the end effector to treat tissue. The generator 900 comprises a processor 902 coupled to a waveform generator 904. The processor 902 and waveform generator 904 are configured to generate a variety of signal waveforms based on information stored in a memory coupled to the processor 902, not shown for clarity of disclosure. The digital information associated with a waveform is provided to the waveform generator 904 which includes one or more DAC circuits to convert the digital input into an analog output. The analog output is fed to an amplifier 1 106 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 906 is coupled to a power transformer 908. The signals are coupled across the power transformer 908 to the secondary side, which is in the patient isolation side. A first signal of a first energy modality is provided to the surgical instrument between the terminals labeled ENERGYi and RETURN. A second signal of a second energy modality is coupled across a capacitor 910 and is provided to the surgical instrument between the terminals labeled ENERGY2 and RETURN. It will be appreciated that more than two energy modalities may be output and thus the subscript“n” may be used to designate that up to n ENERGYn terminals may be provided, where n is a positive integer greater than 1 . It also will be appreciated that up to“n” return paths RETURNn may be provided without departing from the scope of the present disclosure.
[0218] A first voltage sensing circuit 912 is coupled across the terminals labeled ENERGYi and the RETURN path to measure the output voltage therebetween. A second voltage sensing circuit 924 is coupled across the terminals labeled ENERGY2 and the RETURN path to measure the output voltage therebetween. A current sensing circuit 914 is disposed in series with the RETURN leg of the secondary side of the power transformer 908 as shown to measure the output current for either energy modality. If different return paths are provided for each energy modality, then a separate current sensing circuit should be provided in each return leg. The outputs of the first and second voltage sensing circuits 912, 924 are provided to respective isolation transformers 916, 922 and the output of the current sensing circuit 914 is provided to another isolation transformer 918. The outputs of the isolation transformers 916, 928, 922 in the on the primary side of the power transformer 908 (non-patient isolated side) are provided to a one or more ADC circuit 926. The digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and computation. The output voltages and output current feedback information can be employed to adjust the output voltage and current provided to the surgical instrument and to compute output impedance, among other parameters. Input/output communications between the processor 902 and patient isolated circuits is provided through an interface circuit 920. Sensors also may be in electrical communication with the processor 902 by way of the interface circuit 920.
[0219] In one aspect, the impedance may be determined by the processor 902 by dividing the output of either the first voltage sensing circuit 912 coupled across the terminals labeled ENERGYi/RETURN or the second voltage sensing circuit 924 coupled across the terminals labeled ENERGY2/RETURN by the output of the current sensing circuit 914 disposed in series with the RETURN leg of the secondary side of the power transformer 908. The outputs of the first and second voltage sensing circuits 912, 924 are provided to separate isolations transformers 916, 922 and the output of the current sensing circuit 914 is provided to another isolation transformer 916. The digitized voltage and current sensing measurements from the ADC circuit 926 are provided the processor 902 for computing impedance. As an example, the first energy modality ENERGYi may be ultrasonic energy and the second energy modality ENERGY2 may be RF energy. Nevertheless, in addition to ultrasonic and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and/or reversible
electroporation and/or microwave energy, among others. Also, although the example illustrated in FIG. 21 shows a single return path RETURN may be provided for two or more energy modalities, in other aspects, multiple return paths RETURNn may be provided for each energy modality ENERGYn. Thus, as described herein, the ultrasonic transducer impedance may be measured by dividing the output of the first voltage sensing circuit 912 by the current sensing circuit 914 and the tissue impedance may be measured by dividing the output of the second voltage sensing circuit 924 by the current sensing circuit 914.
[0220] As shown in FIG. 21 , the generator 900 comprising at least one output port can include a power transformer 908 with a single output and with multiple taps to provide power in the form of one or more energy modalities, such as ultrasonic, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, among others, for example, to the end effector depending on the type of treatment of tissue being performed. For example, the generator 900 can deliver energy with higher voltage and lower current to drive an ultrasonic transducer, with lower voltage and higher current to drive RF electrodes for sealing tissue, or with a coagulation waveform for spot coagulation using either monopolar or bipolar RF electrosurgical electrodes. The output waveform from the generator 900 can be steered, switched, or filtered to provide the frequency to the end effector of the surgical instrument. The connection of an ultrasonic transducer to the generator 900 output would be preferably located between the output labeled ENERGYi and RETURN as shown in FIG. 21. In one example, a connection of RF bipolar electrodes to the generator 900 output would be preferably located between the output labeled ENERGY2 and RETURN. In the case of monopolar output, the preferred connections would be active electrode (e.g., pencil or other probe) to the ENERGY2 output and a suitable return pad connected to the RETURN output.
[0221] Additional details are disclosed in U.S. Patent Application Publication No.
2017/0086914, titled TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS, which published on March 30, 2017, which is herein incorporated by reference in its entirety.
[0222] As used throughout this description, the term“wireless” and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communications channels, etc., that may communicate data through the use of modulated electromagnetic radiation through a non-solid medium. The term does not imply that the associated devices do not contain any wires, although in some aspects they might not. The communication module may implement any of a number of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.1 1 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long term evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as any other wireless and wired protocols that are designated as 3G, 4G, 5G, and beyond. The computing module may include a plurality of communication modules. For instance, a first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and Bluetooth and a second communication module may be dedicated to longer range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, and others.
[0223] As used herein a processor or processing unit is an electronic circuit which performs operations on some external data source, usually memory or some other data stream. The term is used herein to refer to the central processor (central processing unit) in a system or computer systems (especially systems on a chip (SoCs)) that combine a number of specialized “processors.”
[0224] As used herein, a system on a chip or system on chip (SoC or SOC) is an integrated circuit (also known as an“IC” or“chip”) that integrates all components of a computer or other electronic systems. It may contain digital, analog, mixed-signal, and often radio-frequency functions— all on a single substrate. A SoC integrates a microcontroller (or microprocessor) with advanced peripherals like graphics processing unit (GPU), Wi-Fi module, or coprocessor. A SoC may or may not contain built-in memory.
[0225] As used herein, a microcontroller or controller is a system that integrates a
microprocessor with peripheral circuits and memory. A microcontroller (or MCU for microcontroller unit) may be implemented as a small computer on a single integrated circuit. It may be similar to a SoC; an SoC may include a microcontroller as one of its components. A microcontroller may contain one or more core processing units (CPUs) along with memory and programmable input/output peripherals. Program memory in the form of Ferroelectric RAM,
NOR flash or OTP ROM is also often included on chip, as well as a small amount of RAM.
Microcontrollers may be employed for embedded applications, in contrast to the
microprocessors used in personal computers or other general purpose applications consisting of various discrete chips.
[0226] As used herein, the term controller or microcontroller may be a stand-alone 1C or chip device that interfaces with a peripheral device. This may be a link between two parts of a computer or a controller on an external device that manages the operation of (and connection with) that device.
[0227] Any of the processors or microcontrollers described herein, may be implemented by any single core or multicore processor such as those known under the trade name ARM Cortex by Texas Instruments. In one aspect, the processor may be an LM4F230H5QR ARM Cortex- M4F Processor Core, available from Texas Instruments, for example, comprising on-chip memory of 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with Stel laris Ware® software, 2 KB electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder inputs (QEI) analog, one or more 12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels, details of which are available for the product datasheet.
[0228] In one aspect, the processor may comprise a safety controller comprising two controller-based families such as TMS570 and RM4x known under the trade name Hercules ARM Cortex R4, also by Texas Instruments. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.
[0229] Modular devices include the modules (as described in connection with FIGS. 3 and 9, for example) that are receivable within a surgical hub and the surgical devices or instruments that can be connected to the various modules in order to connect or pair with the corresponding surgical hub. The modular devices include, for example, intelligent surgical instruments, medical imaging devices, suction/irrigation devices, smoke evacuators, energy generators, ventilators, insufflators, and displays. The modular devices described herein can be controlled by control algorithms. The control algorithms can be executed on the modular device itself, on the surgical hub to which the particular modular device is paired, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). In some exemplifications, the modular devices’ control algorithms control the devices based on data sensed by the modular device itself (i.e., by sensors in, on, or connected to the modular device). This data can be related to the patient being operated on (e.g., tissue properties or insufflation pressure) or the modular device itself (e.g., the rate at which a knife is being advanced, motor current, or energy levels). For example, a control algorithm for a surgical stapling and cutting instrument can control the rate at which the instrument’s motor drives its knife through tissue according to resistance encountered by the knife as it advances.
[0230] FIG. 22 illustrates one form of a surgical system 1000 comprising a generator 1 100 and various surgical instruments 1 104, 1 106, 1 108 usable therewith, where the surgical instrument 1 104 is an ultrasonic surgical instrument, the surgical instrument 1 106 is an RF electrosurgical instrument, and the multifunction surgical instrument 1 108 is a combination ultrasonic/RF electrosurgical instrument. The generator 1 100 is configurable for use with a variety of surgical instruments. According to various forms, the generator 1 100 may be configurable for use with different surgical instruments of different types including, for example, ultrasonic surgical instruments 1 104, RF electrosurgical instruments 1 106, and multifunction surgical instruments 1 108 that integrate RF and ultrasonic energies delivered simultaneously from the generator 1 100. Although in the form of FIG. 22 the generator 1 100 is shown separate from the surgical instruments 1 104, 1 106, 1 108 in one form, the generator 1 100 may be formed integrally with any of the surgical instruments 1 104, 1 106, 1 108 to form a unitary surgical system. The generator 1 100 comprises an input device 1 1 10 located on a front panel of the generator 1 100 console. The input device 1 1 10 may comprise any suitable device that generates signals suitable for programming the operation of the generator 1 100. The generator 1 100 may be configured for wired or wireless communication.
[0231] The generator 1 100 is configured to drive multiple surgical instruments 1 104, 1 106, 1 108. The first surgical instrument is an ultrasonic surgical instrument 1 104 and comprises a handpiece 1 105 (HP), an ultrasonic transducer 1 120, a shaft 1 126, and an end effector 1 122. The end effector 1 122 comprises an ultrasonic blade 1 128 acoustically coupled to the ultrasonic transducer 1 120 and a clamp arm 1 140. The handpiece 1 105 comprises a trigger 1 143 to operate the clamp arm 1 140 and a combination of the toggle buttons 1 134a, 1 134b, 1 134c to energize and drive the ultrasonic blade 1 128 or other function. The toggle buttons 1 134a, 1 134b, 1 134c can be configured to energize the ultrasonic transducer 1 120 with the generator 1 100.
[0232] The generator 1 100 also is configured to drive a second surgical instrument 1 106. The second surgical instrument 1 106 is an RF electrosurgical instrument and comprises a handpiece 1 107 (HP), a shaft 1 127, and an end effector 1 124. The end effector 1 124 comprises electrodes in clamp arms 1 142a, 1 142b and return through an electrical conductor portion of the shaft 1 127. The electrodes are coupled to and energized by a bipolar energy source within the generator 1 100. The handpiece 1 107 comprises a trigger 1 145 to operate the clamp arms 1 142a, 1 142b and an energy button 1 135 to actuate an energy switch to energize the electrodes in the end effector 1 124.
[0233] The generator 1 100 also is configured to drive a multifunction surgical instrument 1 108. The multifunction surgical instrument 1 108 comprises a handpiece 1 109 (HP), a shaft 1 129, and an end effector 1 125. The end effector 1 125 comprises an ultrasonic blade 1 149 and a clamp arm 1 146. The ultrasonic blade 1 149 is acoustically coupled to the ultrasonic transducer 1 120. The handpiece 1 109 comprises a trigger 1 147 to operate the clamp arm 1 146 and a combination of the toggle buttons 1 137a, 1 137b, 1 137c to energize and drive the ultrasonic blade 1 149 or other function. The toggle buttons 1 137a, 1 137b, 1 137c can be configured to energize the ultrasonic transducer 1 120 with the generator 1 100 and energize the ultrasonic blade 1 149 with a bipolar energy source also contained within the generator 1 100.
[0234] The generator 1 100 is configurable for use with a variety of surgical instruments. According to various forms, the generator 1 100 may be configurable for use with different surgical instruments of different types including, for example, the ultrasonic surgical instrument 1 104, the RF electrosurgical instrument 1 106, and the multifunction surgical instrument 1 108 that integrates RF and ultrasonic energies delivered simultaneously from the generator 1 100. Although in the form of FIG. 22 the generator 1 100 is shown separate from the surgical instruments 1 104, 1 106, 1 108, in another form the generator 1 100 may be formed integrally with any one of the surgical instruments 1 104, 1 106, 1 108 to form a unitary surgical system. As discussed above, the generator 1 100 comprises an input device 1 1 10 located on a front panel of the generator 1 100 console. The input device 1 1 10 may comprise any suitable device that generates signals suitable for programming the operation of the generator 1 100. The generator 1 100 also may comprise one or more output devices 1 1 12. Further aspects of generators for digitally generating electrical signal waveforms and surgical instruments are described in US patent publication US-2017-0086914-A1 , which is herein incorporated by reference in its entirety. [0235] FIG. 23 is an end effector 1 122 of the example ultrasonic device 1 104, in accordance with at least one aspect of the present disclosure. The end effector 1 122 may comprise a blade 1 128 that may be coupled to the ultrasonic transducer 1 120 via a wave guide. When driven by the ultrasonic transducer 1 120, the blade 1 128 may vibrate and, when brought into contact with tissue, may cut and/or coagulate the tissue, as described herein. According to various aspects, and as illustrated in FIG. 23, the end effector 1 122 also may comprise a clamp arm 1 140 that may be configured for cooperative action with the blade 1 128 of the end effector 1 122. With the blade 1 128, the clamp arm 1 140 may comprise a set of jaws. The clamp arm 1 140 may be pivotally connected at a distal end of a shaft 1 126 of the instrument portion 1 104. The clamp arm 1 140 may include a clamp arm tissue pad 1 163, which may be formed from TEFLON® or other suitable low-friction material. The pad 1 163 may be mounted for cooperation with the blade 1 128, with pivotal movement of the clamp arm 1 140 positioning the clamp pad 1 163 in substantially parallel relationship to, and in contact with, the blade 1 128. By this construction, a tissue bite to be clamped may be grasped between the tissue pad 1 163 and the blade 1 128. The tissue pad 1 163 may be provided with a sawtooth-like configuration including a plurality of axially spaced, proximally extending gripping teeth 1 161 to enhance the gripping of tissue in cooperation with the blade 1 128. The clamp arm 1 140 may transition from the open position shown in FIG. 23 to a closed position (with the clamp arm 1 140 in contact with or proximity to the blade 1 128) in any suitable manner. For example, the handpiece 1 105 may comprise a jaw closure trigger. When actuated by a clinician, the jaw closure trigger may pivot the clamp arm 1 140 in any suitable manner.
[0236] The generator 1 100 may be activated to provide the drive signal to the ultrasonic transducer 1 120 in any suitable manner. For example, the generator 1 100 may comprise a foot switch 1430 (FIG. 24) coupled to the generator 1 100 via a footswitch cable 1432. A clinician may activate the ultrasonic transducer 1 120, and thereby the ultrasonic transducer 1 120 and blade 1 128, by depressing the foot switch 1430. In addition, or instead of the foot switch 1430, some aspects of the device 1 104 may utilize one or more switches positioned on the handpiece 1 105 that, when activated, may cause the generator 1 100 to activate the ultrasonic transducer 1 120. In one aspect, for example, the one or more switches may comprise a pair of toggle buttons 1 134a, 1 134b, 1 134c (FIG. 22), for example, to determine an operating mode of the device 1 104. When the toggle button 1 134a is depressed, for example, the ultrasonic generator 1 100 may provide a maximum drive signal to the ultrasonic transducer 1 120, causing it to produce maximum ultrasonic energy output. Depressing toggle button 1 134b may cause the ultrasonic generator 1 100 to provide a user-selectable drive signal to the ultrasonic transducer 1 120, causing it to produce less than the maximum ultrasonic energy output. The device 1 104 additionally or alternatively may comprise a second switch to, for example, indicate a position of a jaw closure trigger for operating the jaws via the clamp arm 1 140 of the end effector 1 122. Also, in some aspects, the ultrasonic generator 1 100 may be activated based on the position of the jaw closure trigger, (e.g., as the clinician depresses the jaw closure trigger to close the jaws via the clamp arm 1 140, ultrasonic energy may be applied).
[0237] Additionally or alternatively, the one or more switches may comprise a toggle button 1 134c that, when depressed, causes the generator 1 100 to provide a pulsed output (FIG. 22). The pulses may be provided at any suitable frequency and grouping, for example. In certain aspects, the power level of the pulses may be the power levels associated with toggle buttons 1 134a, 1 134b (maximum, less than maximum), for example.
[0238] It will be appreciated that a device 1 104 may comprise any combination of the toggle buttons 1 134a, 1 134b, 1 134c (FIG. 22). For example, the device 1 104 could be configured to have only two toggle buttons: a toggle button 1 134a for producing maximum ultrasonic energy output and a toggle button 1 134c for producing a pulsed output at either the maximum or less than maximum power level per. In this way, the drive signal output configuration of the generator 1 100 could be five continuous signals, or any discrete number of individual pulsed signals (1 , 2, 3, 4, or 5). In certain aspects, the specific drive signal configuration may be controlled based upon, for example, EEPROM settings in the generator 1 100 and/or user power level selection(s).
[0239] In certain aspects, a two-position switch may be provided as an alternative to a toggle button 1 134c (FIG. 22). For example, a device 1 104 may include a toggle button 1 134a for producing a continuous output at a maximum power level and a two-position toggle button 1 134b. In a first detented position, toggle button 1 134b may produce a continuous output at a less than maximum power level, and in a second detented position the toggle button 1 134b may produce a pulsed output (e.g., at either a maximum or less than maximum power level, depending upon the EEPROM settings).
[0240] In some aspects, the RF electrosurgical end effector 1 124, 1 125 (FIG. 22) also may comprise a pair of electrodes. The electrodes may be in communication with the generator 1 100, for example, via a cable. The electrodes may be used, for example, to measure an impedance of a tissue bite present between the clamp arm 1 142a, 1 146 and the blade 1 142b, 1 149. The generator 1 100 may provide a signal (e.g., a non-therapeutic signal) to the electrodes. The impedance of the tissue bite may be found, for example, by monitoring the current, voltage, etc. of the signal. In various aspects, the generator 1 100 may comprise several separate functional elements, such as modules and/or blocks, as shown in FIG. 24, a diagram of the surgical system 1000 of FIG. 22. Different functional elements or modules may be configured for driving the different kinds of surgical devices 1 104, 1 106, 1 108. For example an ultrasonic generator module may drive an ultrasonic device, such as the ultrasonic device 1 104. An electrosurgery/RF generator module may drive the electrosurgical device 1 106. The modules may generate respective drive signals for driving the surgical devices 1 104, 1 106, 1 108. In various aspects, the ultrasonic generator module and/or the electrosurgery/RF generator module each may be formed integrally with the generator 1 100. Alternatively, one or more of the modules may be provided as a separate circuit module electrically coupled to the generator 1 100. (The modules are shown in phantom to illustrate this option.) Also, in some aspects, the electrosurgery/RF generator module may be formed integrally with the ultrasonic generator module, or vice versa.
[0241] In accordance with the described aspects, the ultrasonic generator module may produce a drive signal or signals of particular voltages, currents, and frequencies (e.g. 55,500 cycles per second, or Hz). The drive signal or signals may be provided to the ultrasonic device 1 104, and specifically to the transducer 1 120, which may operate, for example, as described above. In one aspect, the generator 1 100 may be configured to produce a drive signal of a particular voltage, current, and/or frequency output signal that can be stepped with high resolution, accuracy, and repeatability.
[0242] In accordance with the described aspects, the electrosurgery/RF generator module may generate a drive signal or signals with output power sufficient to perform bipolar electrosurgery using radio frequency (RF) energy. In bipolar electrosurgery applications, the drive signal may be provided, for example, to the electrodes of the electrosurgical device 1 106, for example, as described above. Accordingly, the generator 1 100 may be configured for therapeutic purposes by applying electrical energy to the tissue sufficient for treating the tissue (e.g., coagulation, cauterization, tissue welding, etc.).
[0243] The generator 1 100 may comprise an input device 2150 (FIG. 27B) located, for example, on a front panel of the generator 1 100 console. The input device 2150 may comprise any suitable device that generates signals suitable for programming the operation of the generator 1 100. In operation, the user can program or otherwise control operation of the generator 1 100 using the input device 2150. The input device 2150 may comprise any suitable device that generates signals that can be used by the generator (e.g., by one or more processors contained in the generator) to control the operation of the generator 1 100 (e.g., operation of the ultrasonic generator module and/or electrosurgery/RF generator module). In various aspects, the input device 2150 includes one or more of: buttons, switches, thumbwheels, keyboard, keypad, touch screen monitor, pointing device, remote connection to a general purpose or dedicated computer. In other aspects, the input device 2150 may comprise a suitable user interface, such as one or more user interface screens displayed on a touch screen monitor, for example. Accordingly, by way of the input device 2150, the user can set or program various operating parameters of the generator, such as, for example, current (I), voltage (V), frequency (f), and/or period (T) of a drive signal or signals generated by the ultrasonic generator module and/or electrosurgery/RF generator module.
[0244] The generator 1 100 also may comprise an output device 2140 (FIG. 27B) located, for example, on a front panel of the generator 1 100 console. The output device 2140 includes one or more devices for providing a sensory feedback to a user. Such devices may comprise, for example, visual feedback devices (e.g., an LCD display screen, LED indicators), audio feedback devices (e.g., a speaker, a buzzer) or tactile feedback devices (e.g., haptic actuators).
[0245] Although certain modules and/or blocks of the generator 1 100 may be described by way of example, it can be appreciated that a greater or lesser number of modules and/or blocks may be used and still fall within the scope of the aspects. Further, although various aspects may be described in terms of modules and/or blocks to facilitate description, such modules and/or blocks may be implemented by one or more hardware components, e.g., processors, Digital Signal Processors (DSPs), Programmable Logic Devices (PLDs), Application Specific
Integrated Circuits (ASICs), circuits, registers and/or software components, e.g., programs, subroutines, logic and/or combinations of hardware and software components.
[0246] In one aspect, the ultrasonic generator drive module and electrosurgery/RF drive module 1 1 10 (FIG. 22) may comprise one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. The modules may comprise various executable modules such as software, programs, data, drivers, application program interfaces (APIs), and so forth. The firmware may be stored in nonvolatile memory (NVM), such as in bit- masked read-only memory (ROM) or flash memory. In various implementations, storing the firmware in ROM may preserve flash memory. The NVM may comprise other types of memory including, for example, programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), or battery backed random-access memory (RAM) such as dynamic RAM (DRAM), Double-Data-Rate DRAM (DDRAM), and/or synchronous DRAM (SDRAM).
[0247] In one aspect, the modules comprise a hardware component implemented as a processor for executing program instructions for monitoring various measurable characteristics of the devices 1 104, 1 106, 1 108 and generating a corresponding output drive signal or signals for operating the devices 1 104, 1 106, 1 108. In aspects in which the generator 1 100 is used in conjunction with the device 1 104, the drive signal may drive the ultrasonic transducer 1 120 in cutting and/or coagulation operating modes. Electrical characteristics of the device 1 104 and/or tissue may be measured and used to control operational aspects of the generator 1 100 and/or provided as feedback to the user. In aspects in which the generator 1 100 is used in conjunction with the device 1 106, the drive signal may supply electrical energy (e.g., RF energy) to the end effector 1 124 in cutting, coagulation and/or desiccation modes. Electrical characteristics of the device 1 106 and/or tissue may be measured and used to control operational aspects of the generator 1 100 and/or provided as feedback to the user. In various aspects, as previously discussed, the hardware components may be implemented as DSP, PLD, ASIC, circuits, and/or registers. In one aspect, the processor may be configured to store and execute computer software program instructions to generate the step function output signals for driving various components of the devices 1 104, 1 106, 1 108, such as the ultrasonic transducer 1 120 and the end effectors 1 122, 1 124, 1 125.
[0248] An electromechanical ultrasonic system includes an ultrasonic transducer, a waveguide, and an ultrasonic blade. The electromechanical ultrasonic system has an initial resonant frequency defined by the physical properties of the ultrasonic transducer, the waveguide, and the ultrasonic blade. The ultrasonic transducer is excited by an alternating voltage Vg(t) and current lg(t) signal equal to the resonant frequency of the electromechanical ultrasonic system. When the electromechanical ultrasonic system is at resonance, the phase difference between the voltage Vg(t) and current lg(t) signals is zero. Stated another way, at resonance the inductive impedance is equal to the capacitive impedance. As the ultrasonic blade heats up, the compliance of the ultrasonic blade (modeled as an equivalent capacitance) causes the resonant frequency of the electromechanical ultrasonic system to shift. Thus, the inductive impedance is no longer equal to the capacitive impedance causing a mismatch between the drive frequency and the resonant frequency of the electromechanical ultrasonic system. The system is now operating“off-resonance.” The mismatch between the drive frequency and the resonant frequency is manifested as a phase difference between the voltage V g(t) and current lg(t) signals applied to the ultrasonic transducer. The generator electronics can easily monitor the phase difference between the voltage Vg(t) and current lg(t) signals and can continuously adjust the drive frequency until the phase difference is once again zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasonic system. The change in phase and/or frequency can be used as an indirect measurement of the ultrasonic blade temperature.
[0249] As shown in FIG. 25, the electromechanical properties of the ultrasonic transducer may be modeled as an equivalent circuit comprising a first branch having a static capacitance and a second“motional” branch having a serially connected inductance, resistance and capacitance that define the electromechanical properties of a resonator. Known ultrasonic generators may include a tuning inductor for tuning out the static capacitance at a resonant frequency so that substantially all of generator’s drive signal current flows into the motional branch. Accordingly, by using a tuning inductor, the generator’s drive signal current represents the motional branch current, and the generator is thus able to control its drive signal to maintain the ultrasonic transducer’s resonant frequency. The tuning inductor also may transform the phase impedance plot of the ultrasonic transducer to improve the generator’s frequency lock capabilities.
However, the tuning inductor must be matched with the specific static capacitance of an ultrasonic transducer at the operational resonance frequency. In other words, a different ultrasonic transducer having a different static capacitance requires a different tuning inductor.
[0250] FIG. 25 illustrates an equivalent circuit 1500 of an ultrasonic transducer, such as the ultrasonic transducer 1 120, according to one aspect. The circuit 1500 comprises a first “motional” branch having a serially connected inductance Ls, resistance Rs and capacitance Cs that define the electromechanical properties of the resonator, and a second capacitive branch having a static capacitance C0. Drive current lg(t) may be received from a generator at a drive voltage Vg(t), with motional current lm(t) flowing through the first branch and current lg(t)-lm(t) flowing through the capacitive branch. Control of the electromechanical properties of the ultrasonic transducer may be achieved by suitably controlling lg(t) and Vg(t). As explained above, known generator architectures may include a tuning inductor U (shown in phantom in FIG. 25) in a parallel resonance circuit for tuning out the static capacitance C0 at a resonant frequency so that substantially all of the generator’s current output lg(t) flows through the motional branch. In this way, control of the motional branch current lm(t) is achieved by controlling the generator current output lg(t). The tuning inductor Lt is specific to the static capacitance C0 of an ultrasonic transducer, however, and a different ultrasonic transducer having a different static capacitance requires a different tuning inductor Lt. Moreover, because the tuning inductor U is matched to the nominal value of the static capacitance C0 at a single resonant frequency, accurate control of the motional branch current lm(t) is assured only at that frequency. As frequency shifts down with transducer temperature, accurate control of the motional branch current is compromised. [0251] Various aspects of the generator 1 100 may not rely on a tuning inductor Lt to monitor the motional branch current lm(t). Instead, the generator 1 100 may use the measured value of the static capacitance C0 in between applications of power for a specific ultrasonic surgical device 1 104 (along with drive signal voltage and current feedback data) to determine values of the motional branch current lm(t) on a dynamic and ongoing basis (e.g., in real-time). Such aspects of the generator 1 100 are therefore able to provide virtual tuning to simulate a system that is tuned or resonant with any value of static capacitance C0 at any frequency, and not just at a single resonant frequency dictated by a nominal value of the static capacitance C0.
[0252] FIG. 26 is a simplified block diagram of one aspect of the generator 1 100 for providing inductorless tuning as described above, among other benefits. FIGS. 27A-27C illustrate an architecture of the generator 1 100 of FIG. 26 according to one aspect. With reference to FIG.
26, the generator 1 100 may comprise a patient isolated stage 1520 in communication with a non-isolated stage 1540 via a power transformer 1560. A secondary winding 1580 of the power transformer 1560 is contained in the isolated stage 1520 and may comprise a tapped configuration (e.g., a center-tapped or non-center tapped configuration) to define drive signal outputs 1600a, 1600b, 1600c for outputting drive signals to different surgical devices, such as, for example, an ultrasonic surgical device 1 104 and an electrosurgical device 1 106. In particular, drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 420V RMS drive signal) to an ultrasonic surgical device 1 104, and drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 100V RMS drive signal) to an electrosurgical device 1 106, with output 1600b corresponding to the center tap of the power transformer 1560. The non-isolated stage 1540 may comprise a power amplifier 1620 having an output connected to a primary winding 1640 of the power transformer 1560. In certain aspects the power amplifier 1620 may comprise a push-pull amplifier, for example. The non-isolated stage 1540 may further comprise a programmable logic device 1660 for supplying a digital output to a digital-to-analog converter (DAC) 1680, which in turn supplies a corresponding analog signal to an input of the power amplifier 1620. In certain aspects the programmable logic device 1660 may comprise a field-programmable gate array (FPGA), for example. The programmable logic device 1660, by virtue of controlling the power amplifier’s 1620 input via the DAC 1680, may therefore control any of a number of parameters (e.g., frequency, waveform shape, waveform amplitude) of drive signals appearing at the drive signal outputs 1600a, 1600b, 1600c. In certain aspects and as discussed below, the programmable logic device 1660, in conjunction with a processor (e.g., processor 1740 discussed below), may implement a number of digital signal processing (DSP)- based and/or other control algorithms to control parameters of the drive signals output by the generator 1 100.
[0253] Power may be supplied to a power rail of the power amplifier 1620 by a switch-mode regulator 1700. In certain aspects the switch-mode regulator 1700 may comprise an adjustable buck regulator, for example. As discussed above, the non-isolated stage 1540 may further comprise a processor 1740, which in one aspect may comprise a DSP processor such as an ADSP-21469 SHARC DSP, available from Analog Devices, Norwood, Mass., for example. In certain aspects the processor 1740 may control operation of the switch-mode power converter 1700 responsive to voltage feedback data received from the power amplifier 1620 by the processor 1740 via an analog-to-digital converter (ADC) 1760. In one aspect, for example, the processor 1740 may receive as input, via the ADC 1760, the waveform envelope of a signal (e.g., an RF signal) being amplified by the power amplifier 1620. The processor 1740 may then control the switch-mode regulator 1700 (e.g., via a pulse-width modulated (PWM) output) such that the rail voltage supplied to the power amplifier 1620 tracks the waveform envelope of the amplified signal. By dynamically modulating the rail voltage of the power amplifier 1620 based on the waveform envelope, the efficiency of the power amplifier 1620 may be significantly improved relative to a fixed rail voltage amplifier scheme. The processor 1740 may be configured for wired or wireless communication.
[0254] In certain aspects and as discussed in further detail in connection with FIGS. 28A-28B, the programmable logic device 1660, in conjunction with the processor 1740, may implement a direct digital synthesizer (DDS) control scheme to control the waveform shape, frequency and/or amplitude of drive signals output by the generator 1 100. In one aspect, for example, the programmable logic device 1660 may implement a DDS control algorithm 2680 (FIG. 28A) by recalling waveform samples stored in a dynamically-updated look-up table (LUT), such as a RAM LUT which may be embedded in an FPGA. This control algorithm is particularly useful for ultrasonic applications in which an ultrasonic transducer, such as the ultrasonic transducer 1 120, may be driven by a clean sinusoidal current at its resonant frequency. Because other frequencies may excite parasitic resonances, minimizing or reducing the total distortion of the motional branch current may correspondingly minimize or reduce undesirable resonance effects. Because the waveform shape of a drive signal output by the generator 1 100 is impacted by various sources of distortion present in the output drive circuit (e.g., the power transformer 1560, the power amplifier 1620), voltage and current feedback data based on the drive signal may be input into an algorithm, such as an error control algorithm implemented by the processor 1740, which compensates for distortion by suitably pre-distorting or modifying the waveform samples stored in the LUT on a dynamic, ongoing basis (e.g., in real-time). In one aspect, the amount or degree of pre-distortion applied to the LUT samples may be based on the error between a computed motional branch current and a desired current waveform shape, with the error being determined on a sample-by sample basis. In this way, the pre-distorted LUT samples, when processed through the drive circuit, may result in a motional branch drive signal having the desired waveform shape (e.g., sinusoidal) for optimally driving the ultrasonic transducer. In such aspects, the LUT waveform samples will therefore not represent the desired waveform shape of the drive signal, but rather the waveform shape that is required to ultimately produce the desired waveform shape of the motional branch drive signal when distortion effects are taken into account.
[0255] The non-isolated stage 1540 may further comprise an ADC 1780 and an ADC 1800 coupled to the output of the power transformer 1560 via respective isolation transformers 1820, 1840 for respectively sampling the voltage and current of drive signals output by the generator 1 100. In certain aspects, the ADCs 1780, 1800 may be configured to sample at high speeds (e.g., 80 Msps) to enable oversampling of the drive signals. In one aspect, for example, the sampling speed of the ADCs 1780, 1800 may enable approximately 200X (depending on drive frequency) oversampling of the drive signals. In certain aspects, the sampling operations of the ADCs 1780, 1800 may be performed by a single ADC receiving input voltage and current signals via a two-way multiplexer. The use of high-speed sampling in aspects of the generator 1 100 may enable, among other things, calculation of the complex current flowing through the motional branch (which may be used in certain aspects to implement DDS-based waveform shape control described above), accurate digital filtering of the sampled signals, and calculation of real power consumption with a high degree of precision. Voltage and current feedback data output by the ADCs 1780, 1800 may be received and processed (e.g., FIFO buffering, multiplexing) by the programmable logic device 1660 and stored in data memory for subsequent retrieval by, for example, the processor 1740. As noted above, voltage and current feedback data may be used as input to an algorithm for pre-distorting or modifying LUT waveform samples on a dynamic and ongoing basis. In certain aspects, this may require each stored voltage and current feedback data pair to be indexed based on, or otherwise associated with, a corresponding LUT sample that was output by the programmable logic device 1660 when the voltage and current feedback data pair was acquired. Synchronization of the LUT samples and the voltage and current feedback data in this manner contributes to the correct timing and stability of the pre-distortion algorithm. [0256] In certain aspects, the voltage and current feedback data may be used to control the frequency and/or amplitude (e.g., current amplitude) of the drive signals. In one aspect, for example, voltage and current feedback data may be used to determine impedance phase, e.g., the phase difference between the voltage and current drive signals. The frequency of the drive signal may then be controlled to minimize or reduce the difference between the determined impedance phase and an impedance phase setpoint (e.g., 0°), thereby minimizing or reducing the effects of harmonic distortion and correspondingly enhancing impedance phase
measurement accuracy. The determination of phase impedance and a frequency control signal may be implemented in the processor 1740, for example, with the frequency control signal being supplied as input to a DDS control algorithm implemented by the programmable logic device 1660.
[0257] The impedance phase may be determined through Fourier analysis. In one aspect, the phase difference between the generator voltage Vg(t) and generator current lg(t) driving signals may be determined using the Fast Fourier Transform (FFT) or the Discrete Fourier Transform (DFT) as follows:
Figure imgf000077_0002
[0258] Evaluating the Fourier T ransform at the frequency of the sinusoid yields:
arg F(/0) = yc
Figure imgf000077_0001
arg /(/o) = f2
[0259] Other approaches include weighted least-squares estimation, Kalman filtering, and space-vector-based techniques. Virtually all of the processing in an FFT or DFT technique may be performed in the digital domain with the aid of the 2-channel high speed ADC 1780, 1800, for example. In one technique, the digital signal samples of the voltage and current signals are Fourier transformed with an FFT or a DFT. The phase angle f at any point in time can be calculated by:
f = 2 nft + f0
Where f is the phase angle, f is the frequency, t is time, and f0 is the phase at t = 0.
[0260] Another technique for determining the phase difference between the voltage Vg(t) and current lg(t) signals is the zero-crossing method and produces highly accurate results. For voltage Vg(t) and current lg(t) signals having the same frequency, each negative to positive zero crossing of voltage signal Vg(t) triggers the start of a pulse, while each negative to positive zero crossing of current signal lg(t) triggers the end of the pulse. The result is a pulse train with a pulse width proportional to the phase angle between the voltage signal and the current signal. In one aspect, the pulse train may be passed through an averaging filter to yield a measure of the phase difference. Furthermore, if the positive to negative zero crossings also are used in a similar manner, and the results averaged, any effects of DC and harmonic components can be reduced. In one implementation, the analog voltage Vg(t) and current lg(t) signals are converted to digital signals that are high if the analog signal is positive and low if the analog signal is negative. High accuracy phase estimates require sharp transitions between high and low. In one aspect, a Schmitt trigger along with an RC stabilization network may be employed to convert the analog signals into digital signals. In other aspects, an edge triggered RS flip-flop and ancillary circuitry may be employed. In yet another aspect, the zero-crossing technique may employ an exclusive OR (XOR) gate.
[0261] Other techniques for determining the phase difference between the voltage and current signals include Lissajous figures and monitoring the image; methods such as the three- voltmeter method, the crossed-coil method, vector voltmeter and vector impedance methods; and using phase standard instruments, phase-locked loops, and other techniques as described in Phase Measurement, Peter O’Shea, 2000 CRC Press LLC, <http://www.engnetbase.com>, which is incorporated herein by reference.
[0262] In another aspect, for example, the current feedback data may be monitored in order to maintain the current amplitude of the drive signal at a current amplitude setpoint. The current amplitude setpoint may be specified directly or determined indirectly based on specified voltage amplitude and power setpoints. In certain aspects, control of the current amplitude may be implemented by control algorithm, such as, for example, a proportional-integral-derivative (PID) control algorithm, in the processor 1740. Variables controlled by the control algorithm to suitably control the current amplitude of the drive signal may include, for example, the scaling of the LUT waveform samples stored in the programmable logic device 1660 and/or the full-scale output voltage of the DAC 1680 (which supplies the input to the power amplifier 1620) via a DAC 1860.
[0263] The non-isolated stage 1540 may further comprise a processor 1900 for providing, among other things, user interface (Ul) functionality. In one aspect, the processor 1900 may comprise an Atmel AT91 SAM9263 processor having an ARM 926EJ-S core, available from Atmel Corporation, San Jose, Calif., for example. Examples of Ul functionality supported by the processor 1900 may include audible and visual user feedback, communication with peripheral devices (e.g., via a Universal Serial Bus (USB) interface), communication with a foot switch 1430, communication with an input device 2150 (e.g., a touch screen display) and
communication with an output device 2140 (e.g., a speaker). The processor 1900 may communicate with the processor 1740 and the programmable logic device (e.g., via a serial peripheral interface (SPI) bus). Although the processor 1900 may primarily support Ul functionality, it also may coordinate with the processor 1740 to implement hazard mitigation in certain aspects. For example, the processor 1900 may be programmed to monitor various aspects of user input and/or other inputs (e.g., touch screen inputs 2150, foot switch 1430 inputs, temperature sensor inputs 2160) and may disable the drive output of the generator 1 100 when an erroneous condition is detected.
[0264] In certain aspects, both the processor 1740 (FIG. 26, 27A) and the processor 1900 (FIG. 26, 27B) may determine and monitor the operating state of the generator 1 100. For processor 1740, the operating state of the generator 1 100 may dictate, for example, which control and/or diagnostic processes are implemented by the processor 1740. For processor 1900, the operating state of the generator 1 100 may dictate, for example, which elements of a user interface (e.g., display screens, sounds) are presented to a user. The processors 1740,
1900 may independently maintain the current operating state of the generator 1 100 and recognize and evaluate possible transitions out of the current operating state. The processor 1740 may function as the master in this relationship and determine when transitions between operating states are to occur. The processor 1900 may be aware of valid transitions between operating states and may confirm if a particular transition is appropriate. For example, when the processor 1740 instructs the processor 1900 to transition to a specific state, the processor 1900 may verify that the requested transition is valid. In the event that a requested transition between states is determined to be invalid by the processor 1900, the processor 1900 may cause the generator 1 100 to enter a failure mode.
[0265] The non-isolated stage 1540 may further comprise a controller 1960 (FIG. 26, 27B) for monitoring input devices 2150 (e.g., a capacitive touch sensor used for turning the generator 1 100 on and off, a capacitive touch screen). In certain aspects, the controller 1960 may comprise at least one processor and/or other controller device in communication with the processor 1900. In one aspect, for example, the controller 1960 may comprise a processor (e.g., a Mega168 8-bit controller available from Atmel) configured to monitor user input provided via one or more capacitive touch sensors. In one aspect, the controller 1960 may comprise a touch screen controller (e.g., a QT5480 touch screen controller available from Atmel) to control and manage the acquisition of touch data from a capacitive touch screen. [0266] In certain aspects, when the generator 1 100 is in a“power off’ state, the controller 1960 may continue to receive operating power (e.g., via a line from a power supply of the generator 1 100, such as the power supply 21 10 (FIG. 26) discussed below). In this way, the controller 1960 may continue to monitor an input device 2150 (e.g., a capacitive touch sensor located on a front panel of the generator 1 100) for turning the generator 1 100 on and off. When the generator 1 100 is in the“power off” state, the controller 1960 may wake the power supply (e.g., enable operation of one or more DC/DC voltage converters 2130 (FIG. 26) of the power supply 21 10) if activation of the“on/off input device 2150 by a user is detected. The controller 1960 may therefore initiate a sequence for transitioning the generator 1 100 to a“power on” state. Conversely, the controller 1960 may initiate a sequence for transitioning the generator 1 100 to the“power off’ state if activation of the“on/off” input device 2150 is detected when the generator 1 100 is in the“power on” state. In certain aspects, for example, the controller 1960 may report activation of the“on/off” input device 2150 to the processor 1900, which in turn implements the necessary process sequence for transitioning the generator 1 100 to the“power off’ state. In such aspects, the controller 1960 may have no independent ability for causing the removal of power from the generator 1 100 after its“power on” state has been established.
[0267] In certain aspects, the controller 1960 may cause the generator 1 100 to provide audible or other sensory feedback for alerting the user that a“power on” or“power off” sequence has been initiated. Such an alert may be provided at the beginning of a“power on” or “power off” sequence and prior to the commencement of other processes associated with the sequence.
[0268] In certain aspects, the isolated stage 1520 may comprise an instrument interface circuit 1980 to, for example, provide a communication interface between a control circuit of a surgical device (e.g., a control circuit comprising handpiece switches) and components of the non-isolated stage 1540, such as, for example, the programmable logic device 1660, the processor 1740 and/or the processor 1900. The instrument interface circuit 1980 may exchange information with components of the non-isolated stage 1540 via a communication link that maintains a suitable degree of electrical isolation between the stages 1520, 1540, such as, for example, an infrared (IR)-based communication link. Power may be supplied to the instrument interface circuit 1980 using, for example, a low-dropout voltage regulator powered by an isolation transformer driven from the non-isolated stage 1540.
[0269] In one aspect, the instrument interface circuit 1980 may comprise a programmable logic device 2000 (e.g., an FPGA) in communication with a signal conditioning circuit 2020 (FIG. 26 and FIG. 27C). The signal conditioning circuit 2020 may be configured to receive a periodic signal from the programmable logic device 2000 (e.g., a 2 kHz square wave) to generate a bipolar interrogation signal having an identical frequency. The interrogation signal may be generated, for example, using a bipolar current source fed by a differential amplifier. The interrogation signal may be communicated to a surgical device control circuit (e.g., by using a conductive pair in a cable that connects the generator 1 100 to the surgical device) and monitored to determine a state or configuration of the control circuit. For example, the control circuit may comprise a number of switches, resistors and/or diodes to modify one or more characteristics (e.g., amplitude, rectification) of the interrogation signal such that a state or configuration of the control circuit is uniquely discernible based on the one or more
characteristics. In one aspect, for example, the signal conditioning circuit 2020 may comprise an ADC for generating samples of a voltage signal appearing across inputs of the control circuit resulting from passage of interrogation signal therethrough. The programmable logic device 2000 (or a component of the non-isolated stage 1540) may then determine the state or configuration of the control circuit based on the ADC samples.
[0270] In one aspect, the instrument interface circuit 1980 may comprise a first data circuit interface 2040 to enable information exchange between the programmable logic device 2000 (or other element of the instrument interface circuit 1980) and a first data circuit disposed in or otherwise associated with a surgical device. In certain aspects, for example, a first data circuit 2060 may be disposed in a cable integrally attached to a surgical device handpiece, or in an adaptor for interfacing a specific surgical device type or model with the generator 1 100. In certain aspects, the first data circuit may comprise a non-volatile storage device, such as an electrically erasable programmable read-only memory (EEPROM) device. In certain aspects and referring again to FIG. 26, the first data circuit interface 2040 may be implemented separately from the programmable logic device 2000 and comprise suitable circuitry (e.g., discrete logic devices, a processor) to enable communication between the programmable logic device 2000 and the first data circuit. In other aspects, the first data circuit interface 2040 may be integral with the programmable logic device 2000.
[0271] In certain aspects, the first data circuit 2060 may store information pertaining to the particular surgical device with which it is associated. Such information may include, for example, a model number, a serial number, a number of operations in which the surgical device has been used, and/or any other type of information. This information may be read by the instrument interface circuit 1980 (e.g., by the programmable logic device 2000), transferred to a component of the non-isolated stage 1540 (e.g., to programmable logic device 1660, processor 1740 and/or processor 1900) for presentation to a user via an output device 2140 and/or for controlling a function or operation of the generator 1 100. Additionally, any type of information may be communicated to first data circuit 2060 for storage therein via the first data circuit interface 2040 (e.g., using the programmable logic device 2000). Such information may comprise, for example, an updated number of operations in which the surgical device has been used and/or dates and/or times of its usage.
[0272] As discussed previously, a surgical instrument may be detachable from a handpiece (e.g., instrument 1 106 may be detachable from handpiece 1 107) to promote instrument interchangeability and/or disposability. In such cases, known generators may be limited in their ability to recognize particular instrument configurations being used and to optimize control and diagnostic processes accordingly. The addition of readable data circuits to surgical device instruments to address this issue is problematic from a compatibility standpoint, however. For example, it may be impractical to design a surgical device to maintain backward compatibility with generators that lack the requisite data reading functionality due to, for example, differing signal schemes, design complexity and cost. Other aspects of instruments address these concerns by using data circuits that may be implemented in existing surgical instruments economically and with minimal design changes to preserve compatibility of the surgical devices with current generator platforms.
[0273] Additionally, aspects of the generator 1 100 may enable communication with instrument-based data circuits. For example, the generator 1 100 may be configured to communicate with a second data circuit (e.g., a data circuit) contained in an instrument (e.g., instrument 1 104, 1 106 or 1 108) of a surgical device. The instrument interface circuit 1980 may comprise a second data circuit interface 2100 to enable this communication. In one aspect, the second data circuit interface 2100 may comprise a tri-state digital interface, although other interfaces also may be used. In certain aspects, the second data circuit may generally be any circuit for transmitting and/or receiving data. In one aspect, for example, the second data circuit may store information pertaining to the particular surgical instrument with which it is associated. Such information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument has been used, and/or any other type of information. Additionally or alternatively, any type of information may be communicated to the second data circuit for storage therein via the second data circuit interface 2100 (e.g., using the
programmable logic device 2000). Such information may comprise, for example, an updated number of operations in which the instrument has been used and/or dates and/or times of its usage. In certain aspects, the second data circuit may transmit data acquired by one or more sensors (e.g., an instrument-based temperature sensor). In certain aspects, the second data circuit may receive data from the generator 1 100 and provide an indication to a user (e.g., an LED indication or other visible indication) based on the received data.
[0274] In certain aspects, the second data circuit and the second data circuit interface 2100 may be configured such that communication between the programmable logic device 2000 and the second data circuit can be effected without the need to provide additional conductors for this purpose (e.g., dedicated conductors of a cable connecting a handpiece to the generator 1 100). In one aspect, for example, information may be communicated to and from the second data circuit using a one-wire bus communication scheme implemented on existing cabling, such as one of the conductors used transmit interrogation signals from the signal conditioning circuit 2020 to a control circuit in a handpiece. In this way, design changes or modifications to the surgical device that might otherwise be necessary are minimized or reduced. Moreover, because different types of communications can be implemented over a common physical channel (either with or without frequency-band separation), the presence of a second data circuit may be“invisible” to generators that do not have the requisite data reading functionality, thus enabling backward compatibility of the surgical device instrument.
[0275] In certain aspects, the isolated stage 1520 may comprise at least one blocking capacitor 2960-1 (FIG. 27C) connected to the drive signal output 1600b to prevent passage of DC current to a patient. A single blocking capacitor may be required to comply with medical regulations or standards, for example. While failure in single-capacitor designs is relatively uncommon, such failure may nonetheless have negative consequences. In one aspect, a second blocking capacitor 2960-2 may be provided in series with the blocking capacitor 2960-1 , with current leakage from a point between the blocking capacitors 2960-1 , 2960-2 being monitored by, for example, an ADC 2980 for sampling a voltage induced by leakage current.
The samples may be received by the programmable logic device 2000, for example. Based on changes in the leakage current (as indicated by the voltage samples in the aspect of FIG. 26), the generator 1 100 may determine when at least one of the blocking capacitors 2960-1 , 2960-2 has failed. Accordingly, the aspect of FIG. 26 may provide a benefit over single-capacitor designs having a single point of failure.
[0276] In certain aspects, the non-isolated stage 1540 may comprise a power supply 21 10 for outputting DC power at a suitable voltage and current. The power supply may comprise, for example, a 400 W power supply for outputting a 48 VDC system voltage. As discussed above, the power supply 21 10 may further comprise one or more DC/DC voltage converters 2130 for receiving the output of the power supply to generate DC outputs at the voltages and currents required by the various components of the generator 1 100. As discussed above in connection with the controller 1960, one or more of the DC/DC voltage converters 2130 may receive an input from the controller 1960 when activation of the“on/off input device 2150 by a user is detected by the controller 1960 to enable operation of, or wake, the DC/DC voltage converters 2130.
[0277] FIGS. 28A-28B illustrate certain functional and structural aspects of one aspect of the generator 1 100. Feedback indicating current and voltage output from the secondary winding 1580 of the power transformer 1560 is received by the ADCs 1780, 1800, respectively. As shown, the ADCs 1780, 1800 may be implemented as a 2-channel ADC and may sample the feedback signals at a high speed (e.g., 80 Msps) to enable oversampling (e.g., approximately 200x oversampling) of the drive signals. The current and voltage feedback signals may be suitably conditioned in the analog domain (e.g., amplified, filtered) prior to processing by the ADCs 1780, 1800. Current and voltage feedback samples from the ADCs 1780, 1800 may be individually buffered and subsequently multiplexed or interleaved into a single data stream within block 2120 of the programmable logic device 1660. In the aspect of FIGS. 28A-28B, the programmable logic device 1660 comprises an FPGA.
[0278] The multiplexed current and voltage feedback samples may be received by a parallel data acquisition port (PDAP) implemented within block 2144 of the processor 1740. The PDAP may comprise a packing unit for implementing any of a number of methodologies for correlating the multiplexed feedback samples with a memory address. In one aspect, for example, feedback samples corresponding to a particular LUT sample output by the programmable logic device 1660 may be stored at one or more memory addresses that are correlated or indexed with the LUT address of the LUT sample. In another aspect, feedback samples corresponding to a particular LUT sample output by the programmable logic device 1660 may be stored, along with the LUT address of the LUT sample, at a common memory location. In any event, the feedback samples may be stored such that the address of the LUT sample from which a particular set of feedback samples originated may be subsequently ascertained. As discussed above, synchronization of the LUT sample addresses and the feedback samples in this way contributes to the correct timing and stability of the pre-distortion algorithm. A direct memory access (DMA) controller implemented at block 2166 of the processor 1740 may store the feedback samples (and any LUT sample address data, where applicable) at a designated memory location 2180 of the processor 1740 (e.g., internal RAM).
[0279] Block 2200 of the processor 1740 may implement a pre-distortion algorithm for pre distorting or modifying the LUT samples stored in the programmable logic device 1660 on a dynamic, ongoing basis. As discussed above, pre-distortion of the LUT samples may compensate for various sources of distortion present in the output drive circuit of the generator 1 100. The pre-distorted LUT samples, when processed through the drive circuit, will therefore result in a drive signal having the desired waveform shape (e.g., sinusoidal) for optimally driving the ultrasonic transducer.
[0280] At block 2220 of the pre-distortion algorithm, the current through the motional branch of the ultrasonic transducer is determined. The motional branch current may be determined using Kirchhoffs Current Law based on, for example, the current and voltage feedback samples stored at memory location 2180 (which, when suitably scaled, may be representative of lg and Vg in the model of FIG. 25 discussed above), a value of the ultrasonic transducer static capacitance C0 (measured or known a priori) and a known value of the drive frequency. A motional branch current sample for each set of stored current and voltage feedback samples associated with a LUT sample may be determined.
[0281] At block 2240 of the pre-distortion algorithm, each motional branch current sample determined at block 2220 is compared to a sample of a desired current waveform shape to determine a difference, or sample amplitude error, between the compared samples. For this determination, the sample of the desired current waveform shape may be supplied, for example, from a waveform shape LUT 2260 containing amplitude samples for one cycle of a desired current waveform shape. The particular sample of the desired current waveform shape from the LUT 2260 used for the comparison may be dictated by the LUT sample address associated with the motional branch current sample used in the comparison. Accordingly, the input of the motional branch current to block 2240 may be synchronized with the input of its associated LUT sample address to block 2240. The LUT samples stored in the programmable logic device 1660 and the LUT samples stored in the waveform shape LUT 2260 may therefore be equal in number. In certain aspects, the desired current waveform shape represented by the LUT samples stored in the waveform shape LUT 2260 may be a fundamental sine wave. Other waveform shapes may be desirable. For example, it is contemplated that a fundamental sine wave for driving main longitudinal motion of an ultrasonic transducer superimposed with one or more other drive signals at other frequencies, such as a third order harmonic for driving at least two mechanical resonances for beneficial vibrations of transverse or other modes, could be used.
[0282] Each value of the sample amplitude error determined at block 2240 may be transmitted to the LUT of the programmable logic device 1660 (shown at block 2280 in FIG. 28A) along with an indication of its associated LUT address. Based on the value of the sample amplitude error and its associated address (and, optionally, values of sample amplitude error for the same LUT address previously received), the LUT 2280 (or other control block of the programmable logic device 1660) may pre-distort or modify the value of the LUT sample stored at the LUT address such that the sample amplitude error is reduced or minimized. It will be appreciated that such pre-distortion or modification of each LUT sample in an iterative manner across the entire range of LUT addresses will cause the waveform shape of the generator’s output current to match or conform to the desired current waveform shape represented by the samples of the waveform shape LUT 2260.
[0283] Current and voltage amplitude measurements, power measurements and impedance measurements may be determined at block 2300 of the processor 1740 based on the current and voltage feedback samples stored at memory location 2180. Prior to the determination of these quantities, the feedback samples may be suitably scaled and, in certain aspects, processed through a suitable filter 2320 to remove noise resulting from, for example, the data acquisition process and induced harmonic components. The filtered voltage and current samples may therefore substantially represent the fundamental frequency of the generator’s drive output signal. In certain aspects, the filter 2320 may be a finite impulse response (FIR) filter applied in the frequency domain. Such aspects may use the Fast Fourier Transform (FFT) of the output drive signal current and voltage signals. In certain aspects, the resulting frequency spectrum may be used to provide additional generator functionality. In one aspect, for example, the ratio of the second and/or third order harmonic component relative to the fundamental frequency component may be used as a diagnostic indicator.
[0284] At block 2340 (FIG. 28B), a root mean square (RMS) calculation may be applied to a sample size of the current feedback samples representing an integral number of cycles of the drive signal to generate a measurement lrms representing the drive signal output current.
[0285] At block 2360, a root mean square (RMS) calculation may be applied to a sample size of the voltage feedback samples representing an integral number of cycles of the drive signal to determine a measurement Vrms representing the drive signal output voltage.
[0286] At block 2380, the current and voltage feedback samples may be multiplied point by point, and a mean calculation is applied to samples representing an integral number of cycles of the drive signal to determine a measurement Pr of the generator’s real output power.
[0287] At block 2400, measurement Pa of the generator’s apparent output power may be determined as the product Vrms lrms.
[0288] At block 2420, measurement Zm of the load impedance magnitude may be determined as the quotient Vrms/lrms. In certain aspects, the quantities lrms, Vrms, Pr, Pa and Zm determined at blocks 2340, 2360, 2380, 2400 and 2420 may be used by the generator 1 100 to implement any of a number of control and/or diagnostic processes. In certain aspects, any of these quantities may be communicated to a user via, for example, an output device 2140 integral with the generator 1 100 or an output device 2140 connected to the generator 1 100 through a suitable communication interface (e.g., a USB interface). Various diagnostic processes may include, without limitation, handpiece integrity, instrument integrity, instrument attachment integrity, instrument overload, approaching instrument overload, frequency lock failure, over-voltage condition, over-current condition, over power condition, voltage sense failure, current sense failure, audio indication failure, visual indication failure, short circuit condition, power delivery failure, or blocking capacitor failure, for example.
[0289] Block 2440 of the processor 1740 may implement a phase control algorithm for determining and controlling the impedance phase of an electrical load (e.g., the ultrasonic transducer) driven by the generator 1 100. As discussed above, by controlling the frequency of the drive signal to minimize or reduce the difference between the determined impedance phase and an impedance phase setpoint (e.g., 0°), the effects of harmonic distortion may be minimized or reduced, and the accuracy of the phase measurement increased.
[0290] The phase control algorithm receives as input the current and voltage feedback samples stored in the memory location 2180. Prior to their use in the phase control algorithm, the feedback samples may be suitably scaled and, in certain aspects, processed through a suitable filter 2460 (which may be identical to filter 2320) to remove noise resulting from the data acquisition process and induced harmonic components, for example. The filtered voltage and current samples may therefore substantially represent the fundamental frequency of the generator’s drive output signal.
[0291] At block 2480 of the phase control algorithm, the current through the motional branch of the ultrasonic transducer is determined. This determination may be identical to that described above in connection with block 2220 of the pre-distortion algorithm. The output of block 2480 may thus be, for each set of stored current and voltage feedback samples associated with a LUT sample, a motional branch current sample.
[0292] At block 2500 of the phase control algorithm, impedance phase is determined based on the synchronized input of motional branch current samples determined at block 2480 and corresponding voltage feedback samples. In certain aspects, the impedance phase is determined as the average of the impedance phase measured at the rising edge of the waveforms and the impedance phase measured at the falling edge of the waveforms. [0293] At block 2520 of the of the phase control algorithm, the value of the impedance phase determined at block 2220 is compared to phase setpoint 2540 to determine a difference, or phase error, between the compared values.
[0294] At block 2560 (FIG. 28A) of the phase control algorithm, based on a value of phase error determined at block 2520 and the impedance magnitude determined at block 2420, a frequency output for controlling the frequency of the drive signal is determined. The value of the frequency output may be continuously adjusted by the block 2560 and transferred to a DDS control block 2680 (discussed below) in order to maintain the impedance phase determined at block 2500 at the phase setpoint (e.g., zero phase error). In certain aspects, the impedance phase may be regulated to a 0° phase setpoint. In this way, any harmonic distortion will be centered about the crest of the voltage waveform, enhancing the accuracy of phase impedance determination.
[0295] Block 2580 of the processor 1740 may implement an algorithm for modulating the current amplitude of the drive signal in order to control the drive signal current, voltage and power in accordance with user specified setpoints, or in accordance with requirements specified by other processes or algorithms implemented by the generator 1 100. Control of these quantities may be realized, for example, by scaling the LUT samples in the LUT 2280 and/or by adjusting the full-scale output voltage of the DAC 1680 (which supplies the input to the power amplifier 1620) via a DAC 1860. Block 2600 (which may be implemented as a PID controller in certain aspects) may receive, as input, current feedback samples (which may be suitably scaled and filtered) from the memory location 2180. The current feedback samples may be compared to a“current demand” ld value dictated by the controlled variable (e.g., current, voltage or power) to determine if the drive signal is supplying the necessary current. In aspects in which drive signal current is the control variable, the current demand ld may be specified directly by a current setpoint 2620A (lsp). For example, an RMS value of the current feedback data
(determined as in block 2340) may be compared to user-specified RMS current setpoint lsp to determine the appropriate controller action. If, for example, the current feedback data indicates an RMS value less than the current setpoint lsp, LUT scaling and/or the full-scale output voltage of the DAC 1680 may be adjusted by the block 2600 such that the drive signal current is increased. Conversely, block 2600 may adjust LUT scaling and/or the full-scale output voltage of the DAC 1680 to decrease the drive signal current when the current feedback data indicates an RMS value greater than the current setpoint lsp.
[0296] In aspects in which the drive signal voltage is the control variable, the current demand l may be specified indirectly, for example, based on the current required to maintain a desired voltage setpoint 2620B ( Vsp ) given the load impedance magnitude Zm measured at block 2420 (e.g. Id Vsp/Zm). Similarly, in aspects in which drive signal power is the control variable, the current demand ld may be specified indirectly, for example, based on the current required to maintain a desired power setpoint 2620C (Psp) given the voltage V, ms measured at blocks 2360 (e.g. Id = P spIVrms)·
[0297] Block 2680 (FIG. 28A) may implement a DDS control algorithm for controlling the drive signal by recalling LUT samples stored in the LUT 2280. In certain aspects, the DDS control algorithm may be a numerically-controlled oscillator (NCO) algorithm for generating samples of a waveform at a fixed clock rate using a point (memory location)-skipping technique. The NCO algorithm may implement a phase accumulator, or frequency-to-phase converter, that functions as an address pointer for recalling LUT samples from the LUT 2280. In one aspect, the phase accumulator may be a D step size, modulo N phase accumulator, where D is a positive integer representing a frequency control value, and N is the number of LUT samples in the LUT 2280. A frequency control value of D=1 , for example, may cause the phase accumulator to sequentially point to every address of the LUT 2280, resulting in a waveform output replicating the waveform stored in the LUT 2280. When D>1 , the phase accumulator may skip addresses in the LUT 2280, resulting in a waveform output having a higher frequency. Accordingly, the frequency of the waveform generated by the DDS control algorithm may therefore be controlled by suitably varying the frequency control value. In certain aspects, the frequency control value may be determined based on the output of the phase control algorithm implemented at block 2440. The output of block 2680 may supply the input of DAC 1680, which in turn supplies a corresponding analog signal to an input of the power amplifier 1620.
[0298] Block 2700 of the processor 1740 may implement a switch-mode converter control algorithm for dynamically modulating the rail voltage of the power amplifier 1620 based on the waveform envelope of the signal being amplified, thereby improving the efficiency of the power amplifier 1620. In certain aspects, characteristics of the waveform envelope may be determined by monitoring one or more signals contained in the power amplifier 1620. In one aspect, for example, characteristics of the waveform envelope may be determined by monitoring the minima of a drain voltage (e.g., a MOSFET drain voltage) that is modulated in accordance with the envelope of the amplified signal. A minima voltage signal may be generated, for example, by a voltage minima detector coupled to the drain voltage. The minima voltage signal may be sampled by ADC 1760, with the output minima voltage samples being received at block 2720 of the switch-mode converter control algorithm. Based on the values of the minima voltage samples, block 2740 may control a PWM signal output by a PWM generator 2760, which, in turn, controls the rail voltage supplied to the power amplifier 1620 by the switch-mode regulator 1700. In certain aspects, as long as the values of the minima voltage samples are less than a minima target 2780 input into block 2720, the rail voltage may be modulated in accordance with the waveform envelope as characterized by the minima voltage samples. When the minima voltage samples indicate low envelope power levels, for example, block 2740 may cause a low rail voltage to be supplied to the power amplifier 1620, with the full rail voltage being supplied only when the minima voltage samples indicate maximum envelope power levels. When the minima voltage samples fall below the minima target 2780, block 2740 may cause the rail voltage to be maintained at a minimum value suitable for ensuring proper operation of the power amplifier 1620.
Limiting Capacitive Coupling and its Effects
[0299] Aspects of the present disclosure are presented for a surgical instrument with improved device capabilities for reducing undesired operational side effects. In particular, the surgical instrument may include means for limiting capacitive coupling to improve monopolar isolation for use independently or in cooperation with another advanced energy modality.
Capacitive coupling occurs generally when there is a transfer of energy between nodes, induced by an electric field. During surgery, capacitive coupling may occur when two or more electrical surgical instruments are being used in or around a patient. While in some cases capacitive coupling may be desirable, as additional devices may be powered inductively by capacitive coupling, having capacitive coupling occur accidentally during surgery or around a patient generally can have extremely deleterious consequences. Parasitic or accidental capacitive coupling may occur in unknown or unpredictable locations, causing energy to be applied to unintended areas. When the patient is under anesthesia and unable to provide any response, parasitic capacitive coupling can burn a patient while the surgeon would not know it is even occurring. It is therefore desirable to limit the parasitic or accidental capacitive coupling in surgical instruments and during surgery generally.
[0300] In some aspects, a system including a surgical instrument and a generator may be configured to interrupt the transmission of energy from the generator to the surgical instrument when capacitive coupling has been detected. One or more safety fuses, sensors, controls, and/or algorithms may be in place to automatically trigger an interruption of the generator in these scenarios. Alerts, including audio signals, vibrations, and visual messages may issue to inform the surgery team that the generator was interrupted due to the detection of capacitive coupling. [0301] In some aspects, the system includes means for detecting that a capacitive coupling event has occurred. For example, an algorithm that includes inputs from one or more sensors for monitoring events around the system may apply situational awareness and other programmatic means to conclude that capacitive coupling is occurring somewhere within the system and react accordingly. A system having situational awareness means that the system may be configured to anticipate scenarios that may arise based on present environmental and system data and determining that the present conditions follow a pattern that gives rise to predictable next steps. As an example, the system may apply situational awareness in the context of handling capacitive coupling events by recalling instances in similarly situated surgeries where various sensor data is detected. The sensor data may indicate an increase in current at two particular locations along a closed loop electrosurgical system, that based on previous data of similarly situated surgeries, indicates a high likelihood that a capacitive coupling event is imminent.
[0302] In some aspects, the surgical instruments may be modified in structure to limit the occurrence of capacitive coupling, or in other cases reduce the collateral damage caused by capacitive coupling. For example, additional insulation placed strategically in or around the surgical instrument may help limit the incidence of capacitive coupling. In other cases, the end effector of the surgical instrument may include modified structures that reduce the incidence of current displacement, such as rounding the tips of the end effector or specifically shaping the blade of the end effector to behave more like a monopolar blade while still acting as a bipolar device.
[0303] In some aspects, the system may include passive means for mitigating or limiting the effects of the capacitive coupling. For example, the system may include leads that can shunt the energy to a neutral node through conductive passive components. In general, any and all of these aspects may be combined or included in a single system to address the challenges posed by multiple electrical components liable to cause capacitive coupling during patient surgery.
[0304] FIG. 29 provides a diagram showing an example system 134000 with means for detecting capacitive coupling, in accordance with at least one aspect of the present disclosure. The system 134000 includes a monopolar ESU generator 134002 that is electrically coupled to a surgical instrument 134008. The surgical instrument 134008 is used to perform surgery on a patient, where patient tissue 134016 is shown to represent the surgical site of the patient where surgery is being performed. The surgical instrument 134008 may include means for applying electrosurgical or ultrasonic energy to an end effector, and in some cases may include a blade and/or a pair of jaws to grasp or clamp onto tissue. The energy powered by the ESU generator 134002 may touch the patient through the end effector, via any of the possible various components of the end effector. At least a portion of the patient may rest on a return path pad 134014, such as a Smart Megasoft Pad™, for example, that is configured to divert excess energy away from the patient when the surgical instrument 134008 touches the patient and applies electrosurgical energy.
[0305] Because of the multiple electrical sources near the patient, parasitic capacitive coupling is ever present and always a danger to harm the patient during surgery. Because the patient is not expected to express any reaction during surgery, if unknown or unpredicted capacitive coupling occurs, the patient may experience burns in unintended places as a result.
In general, energy anomalies like capacitive coupling should be minimized or otherwise corrected in order to improve patient safety. To limit the occurrence of capacitive coupling or other types of energy anomalies, multiple smart sensors or monitors, such as CT 1 (134006), CT2 (134010), and CT3 (134012) smart sensors may be integrated into the electrosurgical system as indicators to determine whether excess or inductive energy is radiating outside the one or more of the electrical sources. As shown in FIG. 29, the smart sensors CT 1 (134006), CT2 (134010) and CT3 (134012) are placed at likely locations where energy may inductively radiate. The sensors or monitors may be configured to detect capacitance, and if placed at strategic locations within the system, a reading of capacitance may imply that capacitive leakage is occurring near the sensor or monitor. Coupled with knowledge of other sensors nearby or throughout the system not indicating a reading of capacitance, one may conclude that capacitive leakage is occurring in close proximity to the sensor or monitor that is providing a positive indication. Other sensors may be used, such as capacitive leakage monitors or detectors. These sensors may be configured to provide an alert, such as lighting up or delivering a noise or transmitting a signal ultimately to a display monitor. In addition, the monopolar ESU 134002 may be configured to automatically trigger an interruption in energy generation to stop any further capacitive coupling from occurring.
[0306] In some aspects, a neutral electrode 134004 may be included in the monopolar ESU 1340002 and may be electrically coupled to the return path pad 134014, such as a Smart Megasoft Pad®, for example, as another solution to reduce capacitive coupling. Energy can reach the neutral node 134004 conductively as the electrosurgical instrument 134008 touches the patient, the patient is touching the return path pad 134014, and the pad is conductively connected to the neutral electrode 134004. Thus, energy can be diverted to the neutral node 134004 from the monopolar ESU 134002 or the surgical instrument 134008 and thereby reduce the incidence of capacitive coupling. [0307] In some aspects, a cloud analytics system communicatively coupled to the monopolar ESU, such as through a medical hub, may be configured to employ situational awareness that can help anticipate when capacitive coupling may occur during surgery. The cloud analytics system and/or the medical hub may utilize a capacitive coupling algorithm to monitor the incidence of energy flowing through the surgical system, and based on previous data about the state of energy in the system for a similar situated procedure, may conclude there is a likelihood that capacitive coupling may occur if no additional action is taken. For example, during a surgery involving prescribed methods for how to the surgical instrument and how much power should be employed during particular steps in the surgery, the cloud analytics module may draw from previous surgeries of the same and note that capacitive coupling has a stronger likelihood to occur after a particular step in the surgery. While monitoring the steps in the surgery, when the same or very similar energy profiles occur during or just before the expected step that tends to induce capacitive coupling, the cloud analytics system may deliver an alert that indicates this is likely to cause capacitive coupling. The surgeon may be given the option to reduce peak voltage in the surgical instrument 134008 or interrupt the power generation by the monopolar ESU 134002, or the cloud analytics module may automatically cause the medical hub to take these measures. This may lead to eliminating the possibility of capacitive coupling before it has a chance to occur, or at least may limit any unintended effects caused by a momentary occurrence of capacitive coupling.
[0308] In some aspects, the surgical instrument as shown in FIG. 29 may include structural means for reducing or preventing capacitive coupling. For example, insulation in the shaft of the surgical instrument 134008 may reduce the incidence of inductance. In other cases, the monopolar wire connecting the monopolar ESU 134002 to the surgical instrument 134008 may be shielded. As another example, interrupting plastic elements within the shaft may be intermittently present to prevent capacitive coupling from transmitting long distance within the shaft. Other insulator-type elements may be used to achieve similar effects. In some aspects, the monopolar wire electrically connecting the surgical instrument 134008 to the generator 134002 may be shielded to also reduce the incidence of capacitive coupling.
[0309] In some aspects, the structure of the end effector may be modified to reduce the effects of capacitive coupling as the end effector makes contact with the patient. As one example, the jaws of the end effector may be designed to have only one side of the each of the jaws directed to deliver energy, thereby causing the end effector to act like a monopolar blade while still actually functionally structured as a bipolar device. In one example of this, the ends or tips of the end effector may be shaped like a duck bill, with rounded ends to reduce any voltage peaks that might arise out of pointed ends. The direction of energy in the end effector may still be directed to an area or a point along the duck billed ends, but the dispersion of any excess energy may be blunted by the duck billed end. As another example, the blade may be structured to be slightly thicker on one side, such as having a triangular cross-sectional area, and having a thin standing upper blade element on the opposite. This may allow any energy being delivered to the blade to be focused to a point, which may help the surgical instrument act like a monopolar blade while still being a bipolar device. In this way, energy will not be dispersed that would make the surgical instrument more prone to causing capacitive coupling. As a final example, the jaws of the surgical instrument may have electrodes placed on the inside of the end effector, allowing the outer portions of the end effector to act like a shield to ward against capacitive coupling. The electrodes may still be placed sufficiently to contact the tissue of the patient during a surgery, while having one or more edges of the end effector shield the energy from dispersing beyond the focused surgical area.
[0310] FIG. 30 is a logic flow diagram 134100 depicting a control program or a logic configuration of an example methodology for limiting the effects of capacitive coupling in a surgical system is disclosed, according to some aspects. The example methodology may be consistent with the descriptions above regarding several enumerated means for limiting capacitive coupling or mitigating its effects during surgery using one or more surgical instruments.
[0311] As shown and consistent with the examples discussed above, the methodology 134100 may start with the surgical system being configured to monitor 134102 energy generation. For example, multiple sensors may be placed strategically at potential vulnerable points more liable to leak energy that can cause capacitive coupling. These sensors may be configured to deliver an alert when an energy anomaly occurs.
[0312] Continuing on, the sensors or other detecting means may detect 134104 a voltage anomaly, such as a voltage peak or voltage spike, at one or more locations along the surgical system that would not normally be expected to produce such energy production. The system may be configured to conclude these scenarios may give rise to parasitic capacitive coupling, potentially burning the patient unbeknownst to the surgery team in the absence of any alerts. As a result, an alert or message may be delivered indicating the energy anomaly and the danger of capacitive coupling occurring.
[0313] In some aspects, situational awareness also may be used to anticipate 134106 when capacitive coupling is more likely to occur during the usual course of a surgery. Situational awareness may be used to refer back to past surgical operations of similar type or circumstances to identify what variables may be present when capacitive coupling was determined to have occurred. If there are certain steps in the procedure that are more likely to cause capacitive coupling, the system may anticipate these situations by particularly monitoring the sensors at these times, and/or taking preemptive measures to reduce the incidences of capacitive coupling.
[0314] If capacitive coupling is detected or believed to be imminent, based on the above the methodology 134100 executed by the surgical system, measures taken to reduce, eliminate, or mitigate the effects of capacitive coupling can include to automatically interrupt 134108 energy generation at the monopolar energy generator, according to some aspects. It is noted that some loss in surgical operation may occur momentarily at the time this interruption is enabled, but preventing unintended damage to the patient would be paramount in any case. The surgery can continue as planned after a brief moment of interruption.
[0315] Measuring the energy out relative to energy in, taking advantage of parasitic leakage to improve pad contact, or turn power off, generator knows how much current it’s generating, and you’re measuring the energy that is put out.
Increasing Frequency in the Presence of Capacitive Coupling
[0316] In some aspects, the presence of parasitic capacitive coupling can be harnessed to perform energy coagulation or energy cautery. In certain instances, it may be desirable to increase the energy generation of the electrosurgical instrument in order to drive the monopolar circuit to ground, through the body of the patient. While there may be a number of instances where the monopolar circuit is completed through the conductivity drawn by a conductive return pad 134014, such as the Smart Megasoft Pad® (see FIG. 29), in some cases the pad may be defective or worn, such that the conductivity of the return pad 134014 is not sufficient to draw the current of the electrosurgical instrument (e.g., 134008) through the body of the patient. In such cases, the current may lack a sufficient ground for the energy to travel to, effectively making the body of the patient act like a short circuit. This may render the electrosurgery ineffective, as the energy delivered by the surgical instrument 134008 will not pass through the tissue of the patient and therefore not heat the tissue as intended. A similar situation may occur when there is no return pad at all. That is, without a conductive return pad 134014, such as the Smart Megasoft Pad®, to provide a wide conductive return path, there may be no ground available that is connected to the patient. This also may lead to the patient acting as a short circuit if energy from the surgical instrument were applied to the patient. [0317] To adjust for these situations, in some aspects, the monopolar energy generation may be increased to a very high frequency, such as 500Khz to 3-4Mhz, to take advantage of parasitic patient leakage to do padless electrosurgery (or electrosurgery with insufficient conductivity in the pad). By increasing the alternating current frequency, the parasitic leakage current will increase. The stronger leakage current can then more effectively radiatively traverse through the body of the patient. After reaching through the body of the patient, the leakage current of the capacitive coupling may be more effectively radiatively coupled to a ground state as a result, which may effectively drive the current radiatively into another object that acts as ground. For example, if the AC frequency is high enough, the current leakage may reach the monopolar generator grounding terminal. This will help to remove the short circuit effect of the patient, thereby allowing for the energy coagulation to take place. Therefore, in the situations where there is a non-padded system, or a system with poor conductivity in a pad, it may be desirable to increase current leakage in order to take advantage of higher leakage return that can be used to complete the monopolar circuit. That is, in some cases, the return path may be formed by the radiative current leakage caused by capacitive coupling. To help ensure that the radiative return path reaches a ground plane, the energy of the surgical instrument may be increased to a very high frequency.
[0318] In some cases, the poorly conducting return pad may be connected purposely to an earth ground, or table, or to a closest support surface, while the return connector on the generator may be connected to earth ground as well. This will divert the circuit to flow through the radiative return path, rather than have any energy attempt to travel through the poorly conducting return pad and back to the generator, which may cause burns on the patient.
[0319] It is noted that when there is a padded system, and the pad provides sufficient conductivity under the patient, the typical monopolar circuit that drives the current through the body and into the return pad may be a preferred method. In these cases, it may be useful to build isolation barriers to the externally connected power source, such as the energy generator 134002 (see FIG. 29). Alternatively, battery powered instruments may be the more ideal system for reducing the leakage current that will help isolate the energy path through the conductive return pad.
[0320] In some aspects, the surgical system may include a detection circuit configured to determine the capacity of the return path pad. The detection circuit may then provide information as to whether it would be better to utilize the radiative current leakage to complete the circuit, rather than try to rely on a poorly conducting return path pad, or simply no pad at all. The detection circuit may measure an amount of conductivity in the return path pad. If the measure of conductivity satisfies a predetermined threshold, the system may determine that the return path pad may be used to perform the surgery and provide a return path for the monopolar energy. If the conductivity is below the threshold, then the detection circuit may be configured to send a signal to the system, such as at a processor in the surgical hub or the monopolar generator, that the frequency of the monopolar energy should be increased drastically and the return path pad should be eliminated or at least isolated from consideration. Increasing the frequency will then complete the monopolar circuit through creating a radiative return path.
[0321] In some aspects, the monopolar generator may include one or more control circuits coupled to one or more sensors that are configured to determine if the current leakage has reached the grounding terminal of the monopolar generator. The sensor, combined with the detection circuit and a control circuit of the monopolar generator may be used to create a closed feedback loop system that may automatically adjust the frequency to create a sufficient return path based on high leakage current. For example, the detection circuit may determine if there is sufficient conductivity in the return path pad. If not, the control circuit of the monopolar generator may cause the energy generation to increase the AC frequency. The sensor at the monopolar generator may continuously monitor if any radiative current leakage has reached the ground terminal of the monopolar generator, based on the increased frequency. The control circuit may gradually increase the frequency until it is detected that the radiative current leakage has reached the ground terminal. Therefore, the surgical system may rely on a predetermined frequency threshold if it is determined there is no return path pad or an insufficient conductivity in the pad, or a closed feedback system may be used to find a sufficiently high frequency that can create a return path through radiative coupling.
[0322] FIG. 31 is a logic flow diagram 134200 depicting a control program or a logic
configuration of an example methodology that may be performed by the surgical system utilizing monopolar energy generation to determine whether to take advantage of parasitic capacitive coupling. Consistent with the descriptions above, a detection circuit as part of the surgical system may be configured to measure 134202 a level of conductivity in the return path of a monopolar electrosurgical setup. The return path may originally be identified to go through a conductive pad, such as a Soft Megasoft Pad® or other return path conductive pad. In some cases, the conductivity of the pad may offer poor conductivity. In other cases, no pad may exist as part of the surgery setup. This may cause the patient body to act as a short circuit of the monopolar circuit, which would reduce or eliminate the effectiveness of trying to apply monopolar energy to a surgical site at the patient. [0323] The detection circuit may determine 134204 that the measure of conductivity falls below a predetermined threshold, indicating that the level of conductivity in the return path is sufficiently poor, which prevents completion of the monopolar circuit. As a result, the surgical system may cause the generator to increase 134206 the current leakage by increasing the frequency of the alternating current in the monopolar generator. The surgical system may instead utilize the radiative current leakage to create a return path. When the frequency is increased, the current leakage will also increase, which thereby increases the reach of the radiative current leakage to reach a ground plane and complete the circuit. Thus, by increasing the frequency, the poor conductivity of the return path pad 134014 - or even lack of any pad at all - may be subverted. In some cases, the increase in leakage may be determined based on a closed feedback sensor system that adjusts the frequency until it is determined that the radiative current leakage has reached the ground terminal at the monopolar generator.
[0324] In some aspects, the surgical system also may provide an instruction to isolate 134208 any return path pads and to attach the return connector of the monopolar generator to an earth ground. These measures may be taken to eliminate other alternative return paths that may inadvertently cause burns at undesirable locations in the patient.
Situational Awareness
[0325] Referring now to FIG. 32, a timeline 5200 depicting situational awareness of a hub, such as the surgical hub 106 or 206, for example, is depicted. The timeline 5200 is an illustrative surgical procedure and the contextual information that the surgical hub 106, 206 can derive from the data received from the data sources at each step in the surgical procedure. The timeline 5200 depicts the typical steps that would be taken by the nurses, surgeons, and other medical personnel during the course of a lung segmentectomy procedure, beginning with setting up the operating theater and ending with transferring the patient to a post-operative recovery room.
[0326] The situationally aware surgical hub 106, 206 receives data from the data sources throughout the course of the surgical procedure, including data generated each time medical personnel utilize a modular device that is paired with the surgical hub 106, 206. The surgical hub 106, 206 can receive this data from the paired modular devices and other data sources and continually derive inferences (i.e. , contextual information) about the ongoing procedure as new data is received, such as which step of the procedure is being performed at any given time. The situational awareness system of the surgical hub 106, 206 is able to, for example, record data pertaining to the procedure for generating reports, verify the steps being taken by the medical personnel, provide data or prompts (e.g., via a display screen) that may be pertinent for the particular procedural step, adjust modular devices based on the context (e.g., activate monitors, adjust the field of view (FOV) of the medical imaging device, or change the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and take any other such action described above.
[0327] As the first step 5202 in this illustrative procedure, the hospital staff members retrieve the patient’s EMR from the hospital’s EMR database. Based on select patient data in the EMR, the surgical hub 106, 206 determines that the procedure to be performed is a thoracic procedure.
[0328] Second step 5204, the staff members scan the incoming medical supplies for the procedure. The surgical hub 106, 206 cross-references the scanned supplies with a list of supplies that are utilized in various types of procedures and confirms that the mix of supplies corresponds to a thoracic procedure. Further, the surgical hub 106, 206 is also able to determine that the procedure is not a wedge procedure (because the incoming supplies either lack certain supplies that are necessary for a thoracic wedge procedure or do not otherwise correspond to a thoracic wedge procedure).
[0329] Third step 5206, the medical personnel scan the patient band via a scanner that is communicably connected to the surgical hub 106, 206. The surgical hub 106, 206 can then confirm the patient’s identity based on the scanned data.
[0330] Fourth step 5208, the medical staff turns on the auxiliary equipment. The auxiliary equipment being utilized can vary according to the type of surgical procedure and the techniques to be used by the surgeon, but in this illustrative case they include a smoke evacuator, insufflator, and medical imaging device. When activated, the auxiliary equipment that are modular devices can automatically pair with the surgical hub 106, 206 that is located within a particular vicinity of the modular devices as part of their initialization process. The surgical hub 106, 206 can then derive contextual information about the surgical procedure by detecting the types of modular devices that pair with it during this pre-operative or initialization phase. In this particular example, the surgical hub 106, 206 determines that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices. Based on the combination of the data from the patient’s EMR, the list of medical supplies to be used in the procedure, and the type of modular devices that connect to the hub, the surgical hub 106, 206 can generally infer the specific procedure that the surgical team will be performing. Once the surgical hub 106, 206 knows what specific procedure is being performed, the surgical hub 106, 206 can then retrieve the steps of that procedure from a memory or from the cloud and then cross-reference the data it subsequently receives from the connected data sources (e.g., modular devices and patient monitoring devices) to infer what step of the surgical procedure the surgical team is performing.
[0331] Fifth step 5210, the staff members attach the EKG electrodes and other patient monitoring devices to the patient. The EKG electrodes and other patient monitoring devices are able to pair with the surgical hub 106, 206. As the surgical hub 106, 206 begins receiving data from the patient monitoring devices, the surgical hub 106, 206 thus confirms that the patient is in the operating theater.
[0332] Sixth step 5212, the medical personnel induce anesthesia in the patient. The surgical hub 106, 206 can infer that the patient is under anesthesia based on data from the modular devices and/or patient monitoring devices, including EKG data, blood pressure data, ventilator data, or combinations thereof, for example. Upon completion of the sixth step 5212, the pre operative portion of the lung segmentectomy procedure is completed and the operative portion begins.
[0333] Seventh step 5214, the patient’s lung that is being operated on is collapsed (while ventilation is switched to the contralateral lung). The surgical hub 106, 206 can infer from the ventilator data that the patient’s lung has been collapsed, for example. The surgical hub 106,
206 can infer that the operative portion of the procedure has commenced as it can compare the detection of the patient’s lung collapsing to the expected steps of the procedure (which can be accessed or retrieved previously) and thereby determine that collapsing the lung is the first operative step in this particular procedure.
[0334] Eighth step 5216, the medical imaging device (e.g., a scope) is inserted and video from the medical imaging device is initiated. The surgical hub 106, 206 receives the medical imaging device data (i.e., video or image data) through its connection to the medical imaging device. Upon receipt of the medical imaging device data, the surgical hub 106, 206 can determine that the laparoscopic portion of the surgical procedure has commenced. Further, the surgical hub 106, 206 can determine that the particular procedure being performed is a segmentectomy, as opposed to a lobectomy (note that a wedge procedure has already been discounted by the surgical hub 106, 206 based on data received at the second step 5204 of the procedure). The data from the medical imaging device 124 (FIG. 2) can be utilized to determine contextual information regarding the type of procedure being performed in a number of different ways, including by determining the angle at which the medical imaging device is oriented with respect to the visualization of the patient’s anatomy, monitoring the number or medical imaging devices being utilized (i.e., that are activated and paired with the surgical hub 106, 206), and monitoring the types of visualization devices utilized. For example, one technique for performing a VATS lobectomy places the camera in the lower anterior corner of the patient’s chest cavity above the diaphragm, whereas one technique for performing a VATS segmentectomy places the camera in an anterior intercostal position relative to the segmental fissure. Using pattern recognition or machine learning techniques, for example, the situational awareness system can be trained to recognize the positioning of the medical imaging device according to the visualization of the patient’s anatomy. As another example, one technique for performing a VATS lobectomy utilizes a single medical imaging device, whereas another technique for performing a VATS
segmentectomy utilizes multiple cameras. As yet another example, one technique for performing a VATS segmentectomy utilizes an infrared light source (which can be
communicably coupled to the surgical hub as part of the visualization system) to visualize the segmental fissure, which is not utilized in a VATS lobectomy. By tracking any or all of this data from the medical imaging device, the surgical hub 106, 206 can thereby determine the specific type of surgical procedure being performed and/or the technique being used for a particular type of surgical procedure.
[0335] Ninth step 5218, the surgical team begins the dissection step of the procedure. The surgical hub 106, 206 can infer that the surgeon is in the process of dissecting to mobilize the patient’s lung because it receives data from the RF or ultrasonic generator indicating that an energy instrument is being fired. The surgical hub 106, 206 can cross-reference the received data with the retrieved steps of the surgical procedure to determine that an energy instrument being fired at this point in the process (i.e., after the completion of the previously discussed steps of the procedure) corresponds to the dissection step. In certain instances, the energy instrument can be an energy tool mounted to a robotic arm of a robotic surgical system.
[0336] Tenth step 5220, the surgical team proceeds to the ligation step of the procedure. The surgical hub 106, 206 can infer that the surgeon is ligating arteries and veins because it receives data from the surgical stapling and cutting instrument indicating that the instrument is being fired. Similarly to the prior step, the surgical hub 106, 206 can derive this inference by cross-referencing the receipt of data from the surgical stapling and cutting instrument with the retrieved steps in the process. In certain instances, the surgical instrument can be a surgical tool mounted to a robotic arm of a robotic surgical system.
[0337] Eleventh step 5222, the segmentectomy portion of the procedure is performed. The surgical hub 106, 206 can infer that the surgeon is transecting the parenchyma based on data from the surgical stapling and cutting instrument, including data from its cartridge. The cartridge data can correspond to the size or type of staple being fired by the instrument, for example. As different types of staples are utilized for different types of tissues, the cartridge data can thus indicate the type of tissue being stapled and/or transected. In this case, the type of staple being fired is utilized for parenchyma (or other similar tissue types), which allows the surgical hub 106, 206 to infer that the segmentectomy portion of the procedure is being performed.
[0338] Twelfth step 5224, the node dissection step is then performed. The surgical hub 106, 206 can infer that the surgical team is dissecting the node and performing a leak test based on data received from the generator indicating that an RF or ultrasonic instrument is being fired.
For this particular procedure, an RF or ultrasonic instrument being utilized after parenchyma was transected corresponds to the node dissection step, which allows the surgical hub 106, 206 to make this inference. It should be noted that surgeons regularly switch back and forth between surgical stapling/cutting instruments and surgical energy (i.e. , RF or ultrasonic) instruments depending upon the particular step in the procedure because different instruments are better adapted for particular tasks. Therefore, the particular sequence in which the stapling/cutting instruments and surgical energy instruments are used can indicate what step of the procedure the surgeon is performing. Moreover, in certain instances, robotic tools can be utilized for one or more steps in a surgical procedure and/or handheld surgical instruments can be utilized for one or more steps in the surgical procedure. The surgeon(s) can alternate between robotic tools and handheld surgical instruments and/or can use the devices concurrently, for example. Upon completion of the twelfth step 5224, the incisions are closed up and the post-operative portion of the procedure begins.
[0339] Thirteenth step 5226, the patient’s anesthesia is reversed. The surgical hub 106, 206 can infer that the patient is emerging from the anesthesia based on the ventilator data (i.e., the patient’s breathing rate begins increasing), for example.
[0340] Lastly, the fourteenth step 5228 is that the medical personnel remove the various patient monitoring devices from the patient. The surgical hub 106, 206 can thus infer that the patient is being transferred to a recovery room when the hub loses EKG, BP, and other data from the patient monitoring devices. As can be seen from the description of this illustrative procedure, the surgical hub 106, 206 can determine or infer when each step of a given surgical procedure is taking place according to data received from the various data sources that are communicably coupled to the surgical hub 106, 206.
[0341] Situational awareness is further described in U.S. Provisional Patent Application Serial No. 62/61 1 ,341 , titled INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017, which is herein incorporated by reference in its entirety. In certain instances, operation of a robotic surgical system, including the various robotic surgical systems disclosed herein, for example, can be controlled by the hub 106, 206 based on its situational awareness and/or feedback from the components thereof and/or based on information from the cloud 102.
[0342] While several forms have been illustrated and described, it is not the intention of the applicant to restrict or limit the scope of the appended claims to such detail. Numerous modifications, variations, changes, substitutions, combinations, and equivalents to those forms may be implemented and will occur to those skilled in the art without departing from the scope of the present disclosure. Moreover, the structure of each element associated with the described forms can be alternatively described as a means for providing the function performed by the element. Also, where materials are disclosed for certain components, other materials may be used. It is therefore to be understood that the foregoing description and the appended claims are intended to cover all such modifications, combinations, and variations as falling within the scope of the disclosed forms. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications, and equivalents.
[0343] The foregoing detailed description has set forth various forms of the devices and/or processes via the use of block diagrams, flowcharts, and/or examples. Insofar as such block diagrams, flowcharts, and/or examples contain one or more functions and/or operations, it will be understood by those within the art that each function and/or operation within such block diagrams, flowcharts, and/or examples can be implemented, individually and/or collectively, by a wide range of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will recognize that some aspects of the forms disclosed herein, in whole or in part, can be equivalently implemented in integrated circuits, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as virtually any
combination thereof, and that designing the circuitry and/or writing the code for the software and or firmware would be well within the skill of one of skill in the art in light of this disclosure. In addition, those skilled in the art will appreciate that the mechanisms of the subject matter described herein are capable of being distributed as one or more program products in a variety of forms, and that an illustrative form of the subject matter described herein applies regardless of the particular type of signal bearing medium used to actually carry out the distribution.
[0344] Instructions used to program logic to perform various disclosed aspects can be stored within a memory in the system, such as dynamic random access memory (DRAM), cache, flash memory, or other storage. Furthermore, the instructions can be distributed via a network or by way of other computer readable media. Thus a machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to, floppy diskettes, optical disks, compact disc, read-only memory (CD-ROMs), and magneto-optical disks, read-only memory (ROMs), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable
programmable read-only memory (EEPROM), magnetic or optical cards, flash memory, or a tangible, machine-readable storage used in the transmission of information over the Internet via electrical, optical, acoustical or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Accordingly, the non-transitory computer-readable medium includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).
[0345] As used throughout this description, the term“wireless” and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communications channels, etc., that may communicate data through the use of modulated electromagnetic radiation through a non-solid medium. The term does not imply that the associated devices do not contain any wires, although in some aspects they might not. The communication module may implement any of a number of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.1 1 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long term evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as any other wireless and wired protocols that are designated as 3G, 4G, 5G, and beyond. The computing module may include a plurality of communication modules. For instance, a first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and Bluetooth and a second
communication module may be dedicated to longer range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, and others.
[0346] As used in any aspect herein, the term“control circuit” may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor comprising one or more individual instruction processing cores, processing unit, processor, microcontroller,
microcontroller unit, controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic array (PLA), or field programmable gate array (FPGA)), state machine circuitry, firmware that stores instructions executed by programmable circuitry, and any combination thereof. The control circuit may, collectively or individually, be embodied as circuitry that forms part of a larger system, for example, an integrated circuit (IC), an application- specific integrated circuit (ASIC), a system on-chip (SoC), desktop computers, laptop computers, tablet computers, servers, smart phones, etc. Accordingly, as used herein“control circuit” includes, but is not limited to, electrical circuitry having at least one discrete electrical circuit, electrical circuitry having at least one integrated circuit, electrical circuitry having at least one application specific integrated circuit, electrical circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program which at least partially carries out processes and/or devices described herein, or a microprocessor configured by a computer program which at least partially carries out processes and/or devices described herein), electrical circuitry forming a memory device (e.g., forms of random access memory), and/or electrical circuitry forming a
communications device (e.g., a modem, communications switch, or optical-electrical equipment). Those having skill in the art will recognize that the subject matter described herein may be implemented in an analog or digital fashion or some combination thereof.
[0347] As used herein a processor or processing unit is an electronic circuit which performs operations on some external data source, usually memory or some other data stream. The term is used herein to refer to the central processor (central processing unit) in a system or computer systems (especially systems on a chip (SoCs)) that combine a number of specialized “processors.”
[0348] As used herein, a system on a chip or system on chip (SoC or SOC) is an integrated circuit (also known as an“IC” or“chip”) that integrates all components of a computer or other electronic systems. It may contain digital, analog, mixed-signal, and often radio-frequency functions— all on a single substrate. A SoC integrates a microcontroller (or microprocessor) with advanced peripherals like graphics processing unit (GPU), Wi-Fi module, or coprocessor.
A SoC may or may not contain built-in memory.
[0349] As used herein, a microcontroller or controller is a system that integrates a
microprocessor with peripheral circuits and memory. A microcontroller (or MCU for
microcontroller unit) may be implemented as a small computer on a single integrated circuit. It may be similar to a SoC; an SoC may include a microcontroller as one of its components. A microcontroller may contain one or more core processing units (CPUs) along with memory and programmable input/output peripherals. Program memory in the form of Ferroelectric RAM,
NOR flash or OTP ROM is also often included on chip, as well as a small amount of RAM.
Microcontrollers may be employed for embedded applications, in contrast to the
microprocessors used in personal computers or other general purpose applications consisting of various discrete chips.
[0350] As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with a peripheral device. This may be a link between two parts of a computer or a controller on an external device that manages the operation of (and connection with) that device.
[0351] Any of the processors or microcontrollers described herein, may be implemented by any single core or multicore processor such as those known under the trade name ARM Cortex by Texas Instruments. In one aspect, the processor may be an LM4F230H5QR ARM Cortex-M4F Processor Core, available from Texas Instruments, for example, comprising on-chip memory of 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder inputs (QEI) analog, one or more 12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels, details of which are available for the product datasheet.
[0352] In one aspect, the processor may comprise a safety controller comprising two controller- based families such as TMS570 and RM4x known under the trade name Hercules ARM Cortex R4, also by Texas Instruments. The safety controller may be configured specifically for I EC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.
[0353] As used in any aspect herein, the term“logic” may refer to an app, software, firmware and/or circuitry configured to perform any of the aforementioned operations. Software may be embodied as a software package, code, instructions, instruction sets and/or data recorded on non-transitory computer readable storage medium. Firmware may be embodied as code, instructions or instruction sets and/or data that are hard-coded (e.g., nonvolatile) in memory devices.
[0354] As used in any aspect herein, the terms“component,”“system,”“module” and the like can refer to a computer-related entity, either hardware, a combination of hardware and software, software, or software in execution.
[0355] As used in any aspect herein, an“algorithm” refers to a self-consistent sequence of steps leading to a desired result, where a“step” refers to a manipulation of physical quantities and/or logic states which may, though need not necessarily, take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It is common usage to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and/or states.
[0356] A network may include a packet switched network. The communication devices may be capable of communicating with each other using a selected packet switched network communications protocol. One example communications protocol may include an Ethernet communications protocol which may be capable permitting communication using a
Transmission Control Protocol/Internet Protocol (TCP/IP). The Ethernet protocol may comply or be compatible with the Ethernet standard published by the Institute of Electrical and Electronics Engineers (IEEE) titled“IEEE 802.3 Standard”, published in December, 2008 and/or later versions of this standard. Alternatively or additionally, the communication devices may be capable of communicating with each other using an X.25 communications protocol. The X.25 communications protocol may comply or be compatible with a standard promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices may be capable of communicating with each other using a frame relay communications protocol. The frame relay communications protocol may comply or be compatible with a standard promulgated by Consultative Committee for International Telegraph and Telephone (CCITT) and/or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be capable of
communicating with each other using an Asynchronous Transfer Mode (ATM) communications protocol. The ATM communications protocol may comply or be compatible with an ATM standard published by the ATM Forum titled“ATM-MPLS Network Interworking 2.0” published August 2001 , and/or later versions of this standard. Of course, different and/or after-developed connection-oriented network communication protocols are equally contemplated herein.
[0357] Unless specifically stated otherwise as apparent from the foregoing disclosure, it is appreciated that, throughout the foregoing disclosure, discussions using terms such as “processing,”“computing,”“calculating,”“determining,”“displaying,” or the like, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.
[0358] One or more components may be referred to herein as“configured to,”“configurable to,” “operable/operative to,”“adapted/adaptable,”“able to,”“conformable/conformed to,” etc. Those skilled in the art will recognize that“configured to” can generally encompass active-state components and/or inactive-state components and/or standby-state components, unless context requires otherwise.
[0359] The terms“proximal” and“distal” are used herein with reference to a clinician
manipulating the handle portion of the surgical instrument. The term“proximal” refers to the portion closest to the clinician and the term“distal” refers to the portion located away from the clinician. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical”,“horizontal”,“up”,“down”,“left” and“right” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
[0360] Modular devices include the modules (as described in connection with FIGS. 3 and 9, for example) that are receivable within a surgical hub and the surgical devices or instruments that can be connected to the various modules in order to connect or pair with the corresponding surgical hub. The modular devices include, for example, intelligent surgical instruments, medical imaging devices, suction/irrigation devices, smoke evacuators, energy generators, ventilators, insufflators, and displays. The modular devices described herein can be controlled by control algorithms. The control algorithms can be executed on the modular device itself, on the surgical hub to which the particular modular device is paired, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). In some exemplifications, the modular devices’ control algorithms control the devices based on data sensed by the modular device itself (i.e., by sensors in, on, or connected to the modular device). This data can be related to the patient being operated on (e.g., tissue properties or insufflation pressure) or the modular device itself (e.g., the rate at which a knife is being advanced, motor current, or energy levels). For example, a control algorithm for a surgical stapling and cutting instrument can control the rate at which the instrument’s motor drives its knife through tissue according to resistance encountered by the knife as it advances.
[0361] Those skilled in the art will recognize that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as“open” terms (e.g., the term“including” should be interpreted as“including but not limited to,” the term “having” should be interpreted as“having at least,” the term“includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases“at least one” and“one or more” to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles“a” or“an” limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrases“one or more” or“at least one” and indefinite articles such as“a” or“an” (e.g.,“a” and/or“an” should typically be interpreted to mean“at least one” or “one or more”); the same holds true for the use of definite articles used to introduce claim recitations.
[0362] In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of“two recitations,” without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to“at least one of A, B, and C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g.,“a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to“at least one of A, B, or C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g.,“a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone,
C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that typically a disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms unless context dictates otherwise. For example, the phrase“A or B” will be typically understood to include the possibilities of“A” or“B” or“A and B.”
[0363] With respect to the appended claims, those skilled in the art will appreciate that recited operations therein may generally be performed in any order. Also, although various operational flow diagrams are presented in a sequence(s), it should be understood that the various operations may be performed in other orders than those which are illustrated, or may be performed concurrently. Examples of such alternate orderings may include overlapping, interleaved, interrupted, reordered, incremental, preparatory, supplemental, simultaneous, reverse, or other variant orderings, unless context dictates otherwise. Furthermore, terms like “responsive to,”“related to,” or other past-tense adjectives are generally not intended to exclude such variants, unless context dictates otherwise. [0364] It is worthy to note that any reference to“one aspect,”“an aspect,”“an exemplification,” “one exemplification,” and the like means that a particular feature, structure, or characteristic described in connection with the aspect is included in at least one aspect. Thus, appearances of the phrases“in one aspect,”“in an aspect,”“in an exemplification,” and“in one
exemplification” in various places throughout the specification are not necessarily all referring to the same aspect. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner in one or more aspects.
[0365] Any patent application, patent, non-patent publication, or other disclosure material referred to in this specification and/or listed in any Application Data Sheet is incorporated by reference herein, to the extent that the incorporated materials is not inconsistent herewith. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
[0366] In summary, numerous benefits have been described which result from employing the concepts described herein. The foregoing description of the one or more forms has been presented for purposes of illustration and description. It is not intended to be exhaustive or limiting to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The one or more forms were chosen and described in order to illustrate principles and practical application to thereby enable one of ordinary skill in the art to utilize the various forms and with various modifications as are suited to the particular use contemplated. It is intended that the claims submitted herewith define the overall scope.
[0367] Various aspects of the subject matter described herein are set out in the following numbered examples.
[0368] Example 1 . A surgical system comprising: an energy generator; a surgical instrument electrically coupled to the energy generator and configured to transmit electrosurgical energy to tissue of a patient at a surgical site; at least one sensor configured to detect energy an energy anomaly; and at least one processor communicatively coupled to the at least one sensor, and configured to: receive data from the at least one sensor that energy is being emitted at an unintended location within the surgical system; transmit an alert indicating that parasitic capacitive coupling is occurring; and transmit an interrupt to the energy generator to temporarily interrupt energy generation. [0369] Example 2. The surgical system of Example 1 , further comprising an energy dissipating pad electrically coupled to a neutral electrode in the energy generator, wherein the energy dissipating pad is configured to conductively connect to the patient and dissipate energy away from the patient when energy is applied to the patient tissue by the surgical instrument.
[0370] Example 3. The surgical system of any one of Examples 1 or 2, wherein the neutral electrode is configured to passively shunt energy away from the patient during a capacitive coupling event.
[0371] Example 4. The surgical system of any one of Examples 1 -3, wherein the surgical instrument comprises: an end effector comprising a pair of jaws; and a shaft electrically coupled to the end effector and configured to deliver energy to the end effector from the energy generator.
[0372] Example 5. The surgical system Example 4, wherein the jaws comprise rounded tips configured to reduce peak voltage spikes as the jaws come into contact with tissue of the patient.
[0373] Example 6. The surgical system of Example 4, wherein the shaft comprises interrupting insulator elements configured to prevent capacitive coupling from transmitting long distance within the shaft.
[0374] Example 7. The surgical system of Example 4, wherein the surgical instrument comprises a triangular one-sided blade with a thin standing upper blade element configured to reduce inductive energy transmission beyond the upper blade element.
[0375] Example 8. The surgical system of Example 4, wherein the end effector comprises one or more electrodes located on the inside portion of the jaws and configured to channel excess energy away from tissue of the patient.
[0376] Example 9. A method of a surgical system for detecting parasitic capacitive coupling, the surgical system comprising an energy generator, a surgical instrument, and at least one sensor for detecting an energy anomaly, the method comprising: receiving data from the at least one sensor that energy is being emitted at an unintended location within the surgical system;
transmitting an alert indicating that parasitic capacitive coupling is occurring; and transmitting an interrupt to the energy generator to temporarily interrupt energy generation.
[0377] Example 10. A surgical instrument configured to mitigate parasitic capacitive coupling during surgery, comprising: an electrical input configured to be electrically coupled to an energy generator; a shaft; an end effector at a distal end of the shaft; at least one sensor configured to detect energy an energy anomaly; and at least one processor communicatively coupled to the at least one sensor, and configured to: receive data from the at least one sensor that energy is being emitted at an unintended location within the surgical system; transmit an alert indicating that parasitic capacitive coupling is occurring; and transmit an interrupt to the energy generator to temporarily interrupt energy generation.
[0378] Example 1 1 . The surgical instrument of Example 10, wherein the end effector comprises a pair of jaws, and the jaws comprise rounded tips configured to reduce peak voltage spikes as the jaws come into contact with tissue of the patient.
[0379] Example 12. The surgical instrument of Example 10 or 1 1 , wherein the shaft comprises interrupting insulator elements configured to prevent capacitive coupling from transmitting long distance within the shaft.
[0380] Example 13. The surgical instrument of any one of Examples 10-12, furthering comprising a triangular one-sided blade with a thin standing upper blade element configured to reduce inductive energy transmission beyond the upper blade element.
[0381] Example 14. The surgical instrument of any one of Examples 10-13, wherein the end effector comprises one or more electrodes located on an inside portion of the jaws and configured to channel excess energy away from tissue of the patient.

Claims

1. A surgical system comprising:
an energy generator;
a surgical instrument electrically coupled to the energy generator and configured to transmit electrosurgical energy to tissue of a patient at a surgical site;
at least one sensor configured to detect energy an energy anomaly; and
at least one processor communicatively coupled to the at least one sensor, and configured to:
receive data from the at least one sensor that energy is being emitted at an unintended location within the surgical system;
transmit an alert indicating that parasitic capacitive coupling is occurring; and transmit an interrupt to the energy generator to temporarily interrupt energy generation.
2. The surgical system of claim 1 , further comprising an energy dissipating pad electrically coupled to a neutral electrode in the energy generator, wherein the energy dissipating pad is configured to conductively connect to the patient and dissipate energy away from the patient when energy is applied to the patient tissue by the surgical instrument.
3. The surgical system of claim 2, wherein the neutral electrode is configured to passively shunt energy away from the patient during a capacitive coupling event.
4. The surgical system of claim 1 , wherein the surgical instrument comprises:
an end effector comprising a pair of jaws; and
a shaft electrically coupled to the end effector and configured to deliver energy to the end effector from the energy generator.
5. The surgical system of claim 4, wherein the jaws comprise rounded tips configured to reduce peak voltage spikes as the jaws come into contact with tissue of the patient.
6. The surgical system of claim 4, wherein the shaft comprises interrupting insulator elements configured to prevent capacitive coupling from transmitting long distance within the shaft.
7. The surgical system of claim 4, wherein the surgical instrument comprises a triangular one sided blade with a thin standing upper blade element configured to reduce inductive energy transmission beyond the upper blade element.
8. The surgical system of claim 4, wherein the end effector comprises one or more electrodes located on the inside portion of the jaws and configured to channel excess energy away from tissue of the patient.
9. A method of a surgical system for detecting parasitic capacitive coupling, the surgical system comprising an energy generator, a surgical instrument, and at least one sensor for detecting an energy anomaly, the method comprising:
receiving data from the at least one sensor that energy is being emitted at an unintended location within the surgical system;
transmitting an alert indicating that parasitic capacitive coupling is occurring; and transmitting an interrupt to the energy generator to temporarily interrupt energy generation.
10. A surgical instrument configured to mitigate parasitic capacitive coupling during surgery, comprising:
an electrical input configured to be electrically coupled to an energy generator;
a shaft;
an end effector at a distal end of the shaft;
at least one sensor configured to detect energy an energy anomaly; and
at least one processor communicatively coupled to the at least one sensor, and configured to:
receive data from the at least one sensor that energy is being emitted at an unintended location within the surgical system;
transmit an alert indicating that parasitic capacitive coupling is occurring; and transmit an interrupt to the energy generator to temporarily interrupt energy generation.
1 1 . The surgical instrument of claim 10, wherein the end effector comprises a pair of jaws, and the jaws comprise rounded tips configured to reduce peak voltage spikes as the jaws come into contact with tissue of the patient.
12. The surgical instrument of claim 10, wherein the shaft comprises interrupting insulator elements configured to prevent capacitive coupling from transmitting long distance within the shaft.
13. The surgical instrument of claim 10, furthering comprising a triangular one-sided blade with a thin standing upper blade element configured to reduce inductive energy transmission beyond the upper blade element.
14. The surgical instrument of claim 10, wherein the end effector comprises one or more electrodes located on an inside portion of the jaws and configured to channel excess energy away from tissue of the patient.
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