CN111511300B - Increasing radio frequency to create a non-pad monopole loop - Google Patents

Increasing radio frequency to create a non-pad monopole loop Download PDF

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Publication number
CN111511300B
CN111511300B CN201880083612.8A CN201880083612A CN111511300B CN 111511300 B CN111511300 B CN 111511300B CN 201880083612 A CN201880083612 A CN 201880083612A CN 111511300 B CN111511300 B CN 111511300B
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Prior art keywords
surgical
generator
sensor
control
monopolar
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CN201880083612.8A
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CN111511300A (en
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D·C·耶茨
F·E·谢尔顿四世
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Ethicon LLC
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Ethicon LLC
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Priority claimed from US16/115,256 external-priority patent/US11253315B2/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/1206Generators therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/1206Generators therefor
    • A61B18/1233Generators therefor with circuits for assuring patient safety
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00172Connectors and adapters therefor
    • A61B2018/00178Electrical connectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00666Sensing and controlling the application of energy using a threshold value
    • A61B2018/00672Sensing and controlling the application of energy using a threshold value lower
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/00732Frequency
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00875Resistance or impedance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/1206Generators therefor
    • A61B2018/1246Generators therefor characterised by the output polarity
    • A61B2018/1253Generators therefor characterised by the output polarity monopolar
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/007Aspiration
    • A61B2218/008Aspiration for smoke evacuation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30Surgical robots
    • A61B34/37Master-slave robots

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

In some aspects, the present disclosure presents a surgical system that utilizes capacitive coupling. The surgical system may include: a monopolar energy generator; a surgical instrument configured to transmit electrosurgical energy through the electrode to tissue of a patient at a surgical site; and at least one detection circuit configured to be capable of: measuring the amount of electrical conduction in the return path of the electrosurgical energy; determining that the amount of electrical conduction in the return path falls below a predetermined threshold; and transmitting a signal to cause the monopolar generator to increase current leakage in the surgical system by increasing the frequency of alternating current in the electrosurgical energy generation. The monopolar energy generator may further include a sensor configured to determine that a monopolar energy circuit is complete by detecting that the current leak has reached a ground terminal in the monopolar energy generator.

Description

Increasing radio frequency to create a non-pad monopole loop
RELATED APPLICATIONSCross-reference to (C)
This patent application claims priority from U.S. provisional patent application 62/721,995 entitled control of ultrasonic surgical instruments (CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION) according to tissue location, filed on publication No. 35, clause 119 (e), clause 2018, 8, 23, the disclosure of which is incorporated herein by reference in its entirety.
This patent application claims priority from U.S. provisional patent application 62/721,998 entitled situation awareness (SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS) to electrosurgical System filed on day 23, 8, 35 of the United states code, clause 119 (e), which is incorporated herein by reference in its entirety.
This patent application claims priority from U.S. provisional patent application 62/721,999 entitled energy interruption due to unintentional capacitive COUPLING (INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING), filed on clause 119 (e) of the united states code, volume 35, the disclosure of which is incorporated herein by reference in its entirety.
This patent application claims priority from U.S. provisional patent application 62/721,994 entitled bipolar combination device (BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY) for automatically adjusting pressure based on energy modality, filed on even date 8, 23, clause 119 (e) of the united states code, volume 35, the disclosure of which is incorporated herein by reference in its entirety.
This patent application claims priority from U.S. provisional patent application 62/721,996 entitled RADIO FREQUENCY energy device (RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS) for delivering combined electrical signals, filed on clause 119 (e) of the united states code, 35, the disclosure of which is incorporated herein by reference in its entirety.
The present patent application also requires priority from U.S. provisional patent application 62/692,747 entitled intelligent energy device (SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE) filed on U.S. provisional patent application 62/692,748 entitled intelligent energy ARCHITECTURE (SMART ENERGY architure) filed on U.S. provisional patent application 62/692,748 entitled intelligent energy device (SMART ENERGY DEVICES) filed on U.S. edition of act 35, clause 119 (e), 30, and U.S. provisional patent application 62/692,768 filed on U.S. edition of act 6, 30, each of which is incorporated herein by reference in its entirety.
The present patent application also claims the benefit of U.S. provisional patent application serial No. 62/650,898, filed on U.S. code 35, clause 119 (e), entitled capacitive coupled return path pad with SEPARABLE array elements (CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS), U.S. provisional patent application serial No. 62/650,887, filed on 3, 30, 2018, entitled SURGICAL system with optimized sensing capability (surgecal SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES), U.S. provisional patent application serial No. 62/650,882, 882, filed on 3, 30, 2018, entitled smoke evacuation module (SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM) for an interactive SURGICAL platform, filed on 3, 30, 2018, entitled SURGICAL smoke sensing and control (SURGICAL SMOKE EVACUATION SENSING AND control), the disclosure of each of these provisional patent applications being incorporated herein by reference in its entirety.
The present patent application also claims the benefit of priority from U.S. provisional patent application Ser. No. 62/611,341, filed on U.S. code 35, clause 119 (e), and entitled interactive surgical platform (INTERACTIVE SURGICAL PLATFORM) at 12, 28, and U.S. provisional patent application Ser. No. 62/611,340, filed on 12, 28, and entitled robotic assisted surgical platform (ROBOT ASSISTED SURGICAL PLATFORM) at 35, filed on 28, and entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS), the disclosure of each of which is incorporated herein by reference in its entirety.
Background
The present disclosure relates generally and in various aspects to surgical systems that utilize Radio Frequency (RF) energy in electrosurgery.
Electrosurgical systems typically utilize a generator to supply electrosurgical energy (e.g., alternating current at a radio frequency level) to an active electrode that applies the electrosurgical energy to a surgical site of a patient's body. The surgical instrument can utilize this energy as needed to perform various types of surgical procedures, such as cutting tissue or coagulating tissue. Monopolar electrosurgery involves applying a surgical instrument to patient tissue using a single active electrode and completing a circuit through the patient via the patient return electrode. The return electrode is typically connected back to the monopolar energy generator. However, capacitive coupling is a constant problem in this system and can potentially cause unwanted burns at locations on the patient's body that are initially unknown. It is desirable to consider capacitive coupling to minimize or eliminate unintended harm to the patient.
Disclosure of Invention
In some aspects, a surgical system is presented. The surgical system may include: a monopolar energy generator; a surgical instrument electrically coupled to a monopolar energy generator comprising an electrode and configured to transmit electrosurgical energy through the electrode to tissue of a patient at a surgical site; at least one detection circuit configured to be capable of: measuring the amount of electrical conduction in the return path of the electrosurgical energy; determining that the amount of electrical conduction in the return path falls below a predetermined threshold; and transmitting a signal to cause the monopolar generator to increase current leakage in the surgical system by increasing the frequency of alternating current in the electrosurgical energy generation; wherein the monopolar energy generator comprises a sensor configured to be able to determine that a monopolar energy circuit is complete by detecting that the current leakage has reached a ground terminal in the monopolar energy generator.
In some aspects of the surgical system, increasing current leakage allows monopolar electrosurgery of the patient to be performed using the surgical instrument.
In some aspects of the surgical system, the monopolar energy generator further comprises a control circuit configured to: receiving an indication from the sensor that the current leakage has not reached the ground terminal in the monopolar energy generator; and in response to the indication, further increasing the alternating current frequency.
In some aspects of the surgical system, the control circuit is further configured to: receiving a second indication from the sensor that the current leakage has reached the ground terminal in the monopolar energy generator in response to further increasing the alternating current frequency; and in response to the second indication, stopping increasing the alternating current frequency.
In some aspects of the surgical system, the surgical system is further configured to provide instructions to isolate any return path pad away from the surgical system to minimize electrical conductivity through any return path pad.
In some aspects of the surgical system, increasing the frequency includes increasing the frequency to a range of 500KHz to 4 MHz.
Drawings
The features of the various aspects are particularly described in the appended claims. The various aspects (related to surgical organization and methods) and further objects and advantages thereof, however, may best be understood by reference to the following description taken in conjunction with the accompanying drawings.
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 for performing 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, robotic system, and intelligent instrument, in accordance with at least one aspect of the present disclosure.
Fig. 4 is a partial perspective view of a surgical hub housing and a combined generator module slidably received in a drawer of the surgical hub housing in accordance with at least one aspect of the present disclosure.
Fig. 5 is a perspective view of a combined generator module with bipolar, ultrasonic and monopolar contacts and smoke evacuation means in accordance with at least one aspect of the present disclosure.
Fig. 6 illustrates a single power bus attachment for a plurality of lateral docking ports of a lateral modular housing configured to be able to house a plurality of modules in accordance with at least one aspect of the present disclosure.
Fig. 7 illustrates a vertical modular housing configured to be able to house a plurality of modules in accordance with at least one aspect of the present disclosure.
Fig. 8 illustrates a surgical data network including a modular communication hub configured to enable connection of modular devices located in one or more operating rooms of a medical facility or any room in a medical facility dedicated to surgical operations to a cloud in accordance with at least one aspect of the present disclosure.
Fig. 9 is a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure.
Fig. 10 illustrates a surgical hub including a plurality of modules coupled to a modular control tower in accordance with at least one aspect of the present disclosure.
Fig. 11 illustrates one aspect of a Universal Serial Bus (USB) hub device in accordance with at least one aspect of the present disclosure.
Fig. 12 illustrates a logic diagram of a control system for 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 various aspects of a 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 various aspects of a 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 a surgical instrument or tool in accordance with at least one aspect of the present disclosure.
Fig. 16 illustrates a surgical instrument or tool including multiple motors that can be activated to perform various functions in accordance with at least one aspect of the present disclosure.
Fig. 17 is a schematic view 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 distal translation of a displacement member in accordance with at least one aspect of the present disclosure.
Fig. 19 is a schematic view 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 an adaptive ultrasonic blade control algorithm in a surgical data network including 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 including a generator and various surgical instruments that may be used therewith in accordance with at least one aspect of the present disclosure.
Fig. 23 is an end effector according to at least one aspect of the present disclosure.
Fig. 24 is an illustration of the surgical system of fig. 22 in accordance with at least one aspect of the present disclosure.
Fig. 25 is a model illustrating dynamic leg 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.
Fig. 27A-27C are functional views of a generator architecture in accordance with at least one aspect of the present disclosure.
Fig. 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 illustrating an exemplary system having 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 logic configuration of an exemplary method for limiting the effects of capacitive coupling in a disclosed surgical system in accordance with at least one aspect of the present disclosure.
Fig. 31 is a logic flow diagram depicting a control program or logic configuration of an exemplary method that may be performed by a surgical system utilizing monopolar energy generation to determine whether to utilize parasitic capacitive coupling in accordance with at least one aspect of the present disclosure.
Description
The applicant of the present patent application owns the following U.S. patent applications filed on 28 of 2018, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. patent application Ser. No. END8536USNP2/180107-2 entitled estimated state of an ultrasonic END effector and control system therefor (ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR);
U.S. patent application Ser. No. END8560USNP2/180106-2 entitled ultrasonic END effector temperature control and control system (TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR);
U.S. patent application Ser. No. END8561USNP1/180144-1 entitled RADIO FREQUENCY energy device (RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS) for delivering combined electrical signals;
U.S. patent application Ser. No. END8563USNP1/180139-1 entitled control of an ultrasonic surgical instrument according to tissue location (CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION);
U.S. patent application Ser. No. END8563USNP2/180139-2 entitled control OF the activation OF an ultrasonic surgical instrument according to the presence OF TISSUE (CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE);
U.S. patent application Ser. No. END8563USNP3/180139-3, entitled determination of tissue composition via ultrasound System (DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM);
U.S. patent application Ser. No. END8563USNP4/180139-4 entitled determining the status of an ultrasonic electro-mechanical system based on frequency shift (DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEMACCORDINGTO FREQUENCY SHIFT);
U.S. patent application Ser. No. END8563USNP5/180139-5 entitled determining the status of an ultrasonic END effector (DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR);
U.S. patent application Ser. No. END8564USNP1/180140-1 entitled situation awareness of electrosurgical systems (SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS);
U.S. patent application Ser. No. END8564USNP2/180140-2 entitled mechanism (MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT) for controlling different electromechanical systems of an electrosurgical instrument;
U.S. patent application Ser. No. END8564USNP3/180140-3 entitled detection of END effector immersion in liquid (DETECTION OF END EFFECTOR IMMERSION IN LIQUID);
U.S. patent application Ser. No. END8565USNP1/180142-1 entitled energy interruption due to improper capacitive COUPLING (INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING);
U.S. patent application Ser. No. END8566USNP1/180143-1 entitled bipolar combination device (BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY) for automatically adjusting pressure based on energy modality; and
U.S. patent application Ser. No. END8573USNP1/180145-1, titled ACTIVATION energy device (ACTIVATION OF ENERGY DEVICES).
The applicant of the present patent application owns the following U.S. patent applications filed on date 2018, 8, 23, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. provisional patent application 62/721,995 entitled control of an ultrasonic surgical instrument (CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION) according to tissue location;
U.S. provisional patent application 62/721,998 entitled situation awareness of electrosurgical systems (SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS);
U.S. provisional patent application 62/721,999 entitled energy interruption due to unintentional capacitive COUPLING (INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING);
U.S. provisional patent application 62/721,994 entitled bipolar combination device (BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY) for automatically adjusting pressure based on energy modality; and
U.S. provisional patent application 62/721,996 entitled RADIO FREQUENCY energy device (RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS) for delivering combined electrical signals.
The applicant of the present patent application owns the following U.S. patent applications filed on date 30 and 6 in 2018, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. provisional patent application 62/692,747 entitled intelligent activation of an energy device by another device (SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE);
U.S. provisional patent application 62/692,748 entitled intelligent energy architecture (SMART ENERGY ARCHITURE); and
U.S. provisional patent application 62/692,768 entitled intelligent energy device (SMART ENERGY DEVICES).
The applicant of the present patent application owns the following U.S. patent applications filed on date 29 of 2018, 6, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. patent application Ser. No. 16/024,090, entitled capacitively coupled return path pad with SEPARABLE array elements (CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS);
U.S. patent application Ser. No. 16/024,057, entitled control of surgical instruments (CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS) based on sensed closure parameters;
U.S. patent application Ser. No. 16/024,067, entitled System (SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION) for adjusting end effector parameters based on information during surgery;
U.S. patent application Ser. No. 16/024,075 entitled safety System for Intelligent powered surgical stapling (SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING);
U.S. patent application Ser. No. 16/024,083 entitled safety System for Intelligent powered surgical stapling (SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING);
U.S. patent application Ser. No. 16/024,094 entitled surgical System (SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES) for detecting end effector tissue maldistribution;
U.S. patent application Ser. No. 16/024,138, entitled system (SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE) for detecting the proximity of a surgical end effector to cancerous tissue;
U.S. patent application Ser. No. 16/024,150, entitled surgical instrument cartridge sensor assembly (SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES);
U.S. patent application Ser. No. 16/024,160, entitled variable output cartridge sensor assembly (VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY);
U.S. patent application Ser. No. 16/024,124, entitled surgical instrument (SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE) with flexible electrode;
U.S. patent application Ser. No. 16/024,132 entitled surgical device with Flexible Circuit
A machine (SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT); U.S. patent application Ser. No. 16/024,141, entitled surgical instrument (SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY) with tissue marking assembly;
U.S. patent application Ser. No. 16/024,162 entitled SURGICAL System with priority data transmission capability (SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES);
U.S. patent application Ser. No. 16/024,066, entitled surgical drainage sensing and MOTOR CONTROL (SURGICAL EVACUATION SENSING AND MOTOR CONTROL);
U.S. patent application Ser. No. 16/024,096 entitled surgical drainage sensor arrangement (SURGICAL EVACUATION SENSOR ARRANGEMENTS);
U.S. patent application Ser. No. 16/024,116, entitled surgical drainage flow path (SURGICAL EVACUATION FLOW PATHS);
U.S. patent application Ser. No. 16/024,149 entitled surgical drainage sensing and generator control (SURGICAL EVACUATION SENSING AND GENERATOR CONTROL);
U.S. patent application Ser. No. 16/024,180, entitled surgical drainage sensing and display (SURGICAL EVACUATION SENSING ANDDISPLAY);
U.S. patent application serial No. 16/024,245, entitled delivery of smoke evacuation system parameters to a hub or cloud (COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM) in a smoke evacuation module for an interactive surgical platform;
U.S. patent application Ser. No. 16/024,258 entitled smoke evacuation system (SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM) including a segmented control circuit for an interactive surgical platform;
U.S. patent application Ser. No. 16/024,265 entitled surgical drainage system (SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE) with communication circuitry for communication between a filter and a fume extractor; and
U.S. patent application Ser. No. 16/024,273, entitled DUAL tandem large DROPLET filter and small DROPLET filter (DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS).
The applicant of the present patent application owns the following U.S. provisional patent applications filed on 28 th 2018, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. provisional patent application Ser. No. 62/691,228 entitled method (A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES) of using an enhanced flex circuit with multiple sensors with electrosurgical devices;
U.S. provisional patent application Ser. No. 62/691,227, entitled control of a surgical instrument (CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS) based on sensed closure parameters;
U.S. provisional patent application Ser. No. 62/691,230 entitled surgical instrument (SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE) with flexible electrode;
U.S. provisional patent application Ser. No. 62/691,219 entitled surgical drainage sensing and MOTOR CONTROL (SURGICAL EVACUATION SENSING AND MOTOR CONTROL);
U.S. provisional patent application serial No. 62/691,257 entitled delivery of smoke evacuation system parameters to a hub or cloud (COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM) in a smoke evacuation module for an interactive surgical platform;
U.S. provisional patent application serial No. 62/691,262 entitled surgical evacuation system (SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE) having communication circuitry for communication between the filter and the fume extractor; and
U.S. provisional patent application Ser. No. 62/691,251 entitled DUAL inline large DROPLET filter and small DROPLET filter (DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS);
the applicant of the present patent application owns the following U.S. provisional patent applications filed on date 19 of 2018, 4, the disclosures of which are incorporated herein by reference in their entirety:
U.S. provisional patent application Ser. No. 62/659,900, entitled hub communication method (METHOD OF HUB COMMUNICATION);
the applicant of the present patent application owns the following U.S. provisional patent applications filed on 3.30.2018, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. provisional patent application 62/650,898 filed on 3/30 of 2018, entitled capacitively coupled return path pad with SEPARABLE array elements (CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS);
U.S. provisional patent application Ser. No. 62/650,887 entitled SURGICAL System with optimized sensing capability (SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES);
U.S. patent application Ser. No. 62/650,882, entitled smoke evacuation module (SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM) for an interactive surgical platform; and
U.S. patent application Ser. No. 62/650,877 entitled surgical Smoke sensing and control (SURGICAL SMOKE EVACUATION SENSING AND CONTROL)
The applicant of the present patent application owns the following U.S. patent applications filed on date 29 of 3.2018, the disclosures of which are incorporated herein by reference in their entirety:
U.S. patent application Ser. No. 15/940,641 entitled interactive surgical System (INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES) with encrypted communication capability;
U.S. patent application Ser. No. 15/940,648 entitled interactive surgical System (INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA Capobilities) with conditional processing apparatus and data CAPABILITIES;
U.S. patent application Ser. No. 15/940,656 entitled surgical hub coordination of operating room device control and communication (SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES);
U.S. patent application Ser. No. 15/940,666 entitled spatial perception of surgical hubs in operating theatres (SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS);
U.S. patent application Ser. No. 15/940,670, entitled cooperative utilization of data exported from a secondary source by a smart surgical hub (COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS);
U.S. patent application Ser. No. 15/940,677, entitled surgical hub control arrangement;
U.S. patent application Ser. No. 15/940,632, entitled data stripping method (DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD) for querying patient records for data and creating anonymous records;
U.S. patent application Ser. No. 15/940,640 entitled communication hub and storage device (COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS) for storing parameters and conditions of surgical devices to be shared with CLOUD-BASED analysis systems; U.S. patent application Ser. No. 15/940,645 entitled SELF-DESCRIBING data packet (SELF describe DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT) generated at an issuing instrument;
U.S. patent application Ser. No. 15/940,649, entitled data pairing (DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME) for interconnecting device measurement parameters with results;
U.S. patent application Ser. No. 15/940,654 entitled surgical hub situational awareness (SURGICAL HUB SITUATIONAL AWARENESS);
U.S. patent application Ser. No. 15/940,663, entitled surgical System distributed processing (SURGICAL SYSTEM DISTRIBUTED PROCESSING);
U.S. patent application Ser. No. 15/940,668 entitled aggregation and reporting of surgical hub data (AGGREGATION AND REPORTING OF SURGICAL HUB DATA);
U.S. patent application Ser. No. 15/940,671, entitled SURGICAL HUB space perception (SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER) for determining devices in an operating room;
U.S. patent application Ser. No. 15/940,686, entitled TO display alignment of staple cartridge with previous linear staple lines (DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE);
U.S. patent application Ser. No. 15/940,700, entitled sterile field interactive CONTROL display (STERILE FIELD INTERACTIVE CONTROL display);
U.S. patent application Ser. No. 15/940,629, entitled COMPUTER-implemented Interactive SURGICAL System (COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS);
U.S. patent application Ser. No. 15/940,704, entitled determination OF the characteristics OF backscattered light using laser and red-GREEN-blue color development (USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT);
U.S. patent application Ser. No. 15/940,722, entitled tissue irregularities characterized by using monochromatic light refractive index (CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY); and
U.S. patent application Ser. No. 15/940,742 entitled Dual Complementary Metal Oxide Semiconductor (CMOS) array imaging (DUAL CMOS ARRAY IMAGING);
U.S. patent application Ser. No. 15/940,636 entitled adaptive control program update for surgical devices (ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES);
U.S. patent application Ser. No. 15/940,653, entitled adaptive control program update for surgical hubs (ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS);
U.S. patent application Ser. No. 15/940,660, entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER) for customization and recommendation to users;
U.S. patent application Ser. No. 15/940,679 entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET) for linking local usage trends with resource acquisition behaviors of larger datasets;
U.S. patent application Ser. No. 15/940,694 entitled CLOUD-BASED medical analysis of medical facilities FOR personalizing instrument function segments (CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION);
U.S. patent application Ser. No. 15/940,634 entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES) for security and authentication trend and reactivity measurements;
U.S. patent application Ser. No. 15/940,706, entitled data processing and priority (DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK) in a cloud analysis network; and
U.S. patent application Ser. No. 15/940,675, entitled cloud interface (CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES) for coupled surgical devices;
U.S. patent application Ser. No. 15/940,627, entitled drive arrangement FOR robotic-assisted surgical platform (DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);
U.S. patent application Ser. No. 15/940,637 entitled communication arrangement for robotic-assisted surgical platforms (COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);
U.S. patent application Ser. No. 15/940,642, entitled control for robotic-assisted surgical platforms (CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);
U.S. patent application Ser. No. 15/940,676, entitled automatic tool adjustment for robotic-assisted surgical platforms (AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);
U.S. patent application Ser. No. 15/940,680, entitled controller for robotic-assisted surgical platform (CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);
U.S. patent application Ser. No. 15/940,683, entitled cooperative surgical action for robotic-assisted surgical platform (COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);
U.S. patent application Ser. No. 15/940,690 entitled display arrangement FOR robotic-assisted surgical platform (DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS); and
U.S. patent application Ser. No. 15/940,711, entitled sensing arrangement FOR robotic-assisted surgical platform (SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS).
The applicant of the present patent application owns the following U.S. provisional patent applications filed on day 28, 3, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. provisional patent application Ser. No. 62/649,302 entitled interactive surgical System (INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES) with encrypted communication capability;
U.S. provisional patent application Ser. No. 62/649,294 entitled data stripping method (DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD) for querying patient records and creating anonymous records;
U.S. patent application Ser. No. 62/649,300, entitled surgical hub situational awareness (SURGICAL HUB SITUATIONAL AWARENESS);
U.S. provisional patent application Ser. No. 62/649,309, entitled SURGICAL HUB space perception (SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER) for determining devices in an operating room;
U.S. patent application Ser. No. 62/649,310, entitled COMPUTER-implemented Interactive SURGICAL System (COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS);
U.S. provisional patent application Ser. No. 62/649291, entitled determination OF the characteristics OF backscattered light using laser and red-GREEN-blue color development (USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT);
U.S. patent application Ser. No. 62/649,296, entitled adaptive control program update for surgical devices (ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES);
U.S. provisional patent application Ser. No. 62/649,333 entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER) for customization and recommendation to a user;
U.S. provisional patent application Ser. No. 62/649,327 entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES) for security and authentication trend and reactivity measurements;
U.S. provisional patent application Ser. No. 62/649,315, entitled data processing and priority in a cloud analysis network (DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK);
U.S. patent application Ser. No. 62/649,313, entitled cloud interface (CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES) for coupled surgical devices;
U.S. patent application Ser. No. 62/649,320, entitled drive arrangement FOR robotic-assisted surgical platform (DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);
U.S. provisional patent application Ser. No. 62/649,307 entitled automatic tool adjustment for robotic-assisted surgical platforms (AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS); and
U.S. provisional patent application Ser. No. 62/649,323, entitled sensing arrangement FOR robotic-assisted surgical platform (SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS).
The applicant of the present patent application owns the following U.S. provisional patent applications filed on day 3, 8 of 2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. provisional patent application serial No. 62/640,417 entitled temperature control in an ultrasound device and control system therefor (TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR); and
U.S. provisional patent application Ser. No. 62/640,415, entitled to estimate the status of an ultrasonic end effector and control system therefor (ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR).
The applicant of the present patent application owns the following U.S. provisional patent applications filed on date 28 of 12 of 2017, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. provisional patent application Ser. No. 62/611,341, entitled interactive surgical platform (INTERACTIVE SURGICAL PLATFORM);
U.S. provisional patent application Ser. No. 62/611,340, entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS); and
U.S. patent application Ser. No. 62/611,339, entitled robotic-assisted surgical platform (ROBOT ASSISTED SURGICAL PLATFORM);
before explaining aspects of the surgical device and generator in detail, it should be noted that the exemplary embodiment is not limited in its 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 alone or in combination with other aspects, variations and modifications and may be practiced or carried out in various ways. Furthermore, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the illustrative embodiments for the convenience of the reader and are not for the purpose of limitation. Moreover, it is to be understood that the expression of one or more of the aspects, and/or examples described below may be combined with any one or more of the expression of other aspects, and/or examples described below.
Aspects relate to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Aspects of the ultrasonic surgical device may be configured to transect and/or coagulate tissue, for example, during a surgical procedure. Aspects of the electrosurgical device may be configured for transecting, coagulating, scaling, welding, and/or desiccating tissue, for example, during a surgical procedure.
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., may include a cloud 104 coupled to a remote server 113 of a storage device 105). Each surgical system 102 includes at least one surgical hub 106 in communication with a cloud 104, which may include a remote server 113. In one example, as shown in fig. 1, the surgical system 102 includes a visualization system 108, a robotic system 110, and a hand-held intelligent surgical instrument 112 configured to communicate with each other and/or with the hub 106. In some aspects, the surgical system 102 may include M number of hubs 106, N number of visualization systems 108, O number of robotic systems 110, and P number of hand-held intelligent surgical instruments 112, where M, N, O and P are integers greater than or equal to one.
Fig. 3 illustrates an example of a surgical system 102 for performing a surgical procedure on a patient lying on an operating table 114 in a surgical operating room 116. The robotic system 110 is used as part of the surgical system 102 in a surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robotic hub 122. When the surgeon views the surgical site through the surgeon's console 120, the patient-side cart 117 may manipulate at least one removably coupled surgical tool 118 through a minimally invasive incision in the patient. Images of the surgical site may be obtained by a medical imaging device 124 that may be maneuvered by the patient side cart 120 to orient the imaging device 124. The robotic hub 122 may be used to process images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.
Other types of robotic systems may be readily adapted for use with the surgical system 102. Various examples of robotic systems and surgical tools suitable for use in the present disclosure are described in U.S. provisional patent application serial No. 62/611,339 entitled robotic-assisted surgical platform (ROBOT ASSISTED SURGICAL PLATFORM), filed on date 28 of 2017, the disclosure of which is incorporated herein by reference in its entirety.
Various examples of CLOUD-BASED analysis performed by the CLOUD 104 and suitable for use in the present disclosure are described in U.S. provisional patent application serial No. 62/611,340 entitled "CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS)" filed on date 12, 2017, the disclosure of which is incorporated herein by reference in its entirety.
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.
The optics of the imaging device 124 may include one or more illumination sources and/or one or more lenses. One or more illumination sources may be directed to illuminate multiple 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 the luminescence spectrum) is that portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye, and may be referred to as visible light or simple light. A typical human eye will respond to wavelengths in the air of about 380nm to about 750 nm.
The invisible spectrum (i.e., the non-emission spectrum) is the portion of the electromagnetic spectrum that lies below and above the visible spectrum (i.e., wavelengths below about 380nm and above about 750 nm). The human eye cannot detect the invisible spectrum. Wavelengths greater than about 750nm are longer than the red visible spectrum, and they become invisible Infrared (IR), microwave, and radio electromagnetic radiation. Wavelengths less than about 380nm are shorter than the violet spectrum and they become invisible ultraviolet, x-ray and gamma-ray electromagnetic radiation.
In various aspects, the imaging device 124 is configured for use in a minimally invasive procedure. Examples of imaging devices suitable for use in the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, choledochoscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophageal-duodenal scopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngeal-renal endoscopes, sigmoidoscopes, thoracoscopes, and hysteroscopes.
In one aspect, the imaging device employs multispectral monitoring to distinguish between topography and underlying structures. Multispectral images are images that capture image data in a particular range of wavelengths across the electromagnetic spectrum. Wavelengths may be separated by filters or by using instruments that are sensitive to specific wavelengths, including light from frequencies outside the visible range, such as IR and ultraviolet. Spectral imaging may allow extraction of additional information that the human eye fails to capture with its red, green and blue receptors. Use of multispectral imaging is described in more detail under the heading "advanced imaging acquisition module (Advanced Imaging Acquisition Module)" of U.S. provisional patent application serial No. 62/611,341 entitled "interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on month 12, 2017, the disclosure of which is incorporated herein by reference in its entirety. After completing a surgical task to perform one or more of the previously described tests on the treated tissue, multispectral monitoring may be a useful tool for repositioning the surgical site.
It is self-evident that the operating room and surgical equipment need to be strictly sterilized during any surgical procedure. The stringent sanitary and sterilization conditions required in the "surgery room" (i.e., operating or treatment room) require the highest possible sterility of all medical devices and equipment. Part of this sterilization process is the need to sterilize the patient or any substance penetrating the sterile field, including the imaging device 124 and its attachments and devices. It should be understood that a sterile field may be considered a designated area that is considered to be free of microorganisms, such as within a tray or within a sterile towel, or a sterile field may be considered an area surrounding a patient that is ready for a surgical procedure. The sterile field may include scrubbing team members that are properly worn, as well as all furniture and fixtures in the area.
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 strategically placed with respect to the sterile field, as shown in fig. 2. In one aspect, the visualization system 108 includes interfaces for HL7, PACS, and EMR. Various components of the visualization system 108 are described under the heading "advanced imaging acquisition module (Advanced Imaging Acquisition Module)" of U.S. provisional patent application serial No. 62/611,341 entitled "interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on date 28 of 2017, the disclosure of which is incorporated herein by reference in its entirety.
As shown in fig. 2, the main display 119 is positioned in the sterile field to be visible to an operator at the operating table 114. Furthermore, the visualization tower 111 is positioned outside the sterile field. The visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 facing away from each other. The visualization system 108, guided by the hub 106, is configured to be able to coordinate the information flow to operators inside and outside the sterile field using the displays 107, 109 and 119. For example, hub 106 may cause imaging system 108 to display a snapshot of the surgical site recorded by imaging device 124 on non-sterile display 107 or 109 while maintaining a real-time feed of the surgical site on main display 119. The snapshot on the non-sterile display 107 or 109 may allow a non-sterile operator to, for example, perform diagnostic steps related to a surgical procedure.
In one aspect, the hub 106 is further configured to be able to route diagnostic inputs or feedback entered by a non-sterile operator at the visualization tower 111 to a main display 119 within the sterile field, where it is viewable by a sterile operator on the console. In one example, the input may be a modification to a snapshot displayed on the non-sterile display 107 or 109, which may be routed through the hub 106 to the main display 119.
Referring to fig. 2, a surgical instrument 112 is used in a surgical procedure as part of the surgical system 102. The hub 106 is further configured to coordinate the flow of information to the display of the surgical instrument 112. For example, U.S. provisional patent application Ser. No. 62/611,341 entitled "Interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on month 12, 2017, the disclosure of which is incorporated herein by reference in its entirety. Diagnostic inputs or feedback entered by a non-sterile operator at the visualization tower 111 may be routed by the hub 106 to a surgical instrument display 115 within the sterile field, where the inputs or feedback may be observed by an operator of the surgical instrument 112. An exemplary surgical instrument suitable for use in surgical system 102 is described under the heading "surgical instrument hardware (Surgical Instrument Hardware)" of U.S. provisional patent application serial No. 62/611,341 entitled "interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on date 12/28 in 2017, the disclosure of which is incorporated herein by reference in its entirety.
Referring now to fig. 3, hub 106 is depicted in communication with visualization system 108, robotic system 110, and hand-held intelligent surgical instrument 112. 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 memory array 134. In certain aspects, as shown in fig. 3, the hub 106 further includes a smoke evacuation module 126 and/or a suction/irrigation module 128.
During surgical procedures, energy application to tissue for sealing and/or cutting is often associated with smoke evacuation, aspiration of excess fluid, and/or irrigation of tissue. Fluid lines, power lines, and/or data lines from different sources are often entangled during a surgical procedure. Solving this problem during a surgical procedure can lose valuable time. Disconnecting the pipeline may require disconnecting the pipeline from its respective module, which may require resetting the module. The hub modular housing 136 provides a unified environment for managing power, data, and fluid lines, which reduces the frequency of entanglement between such lines.
Aspects of the present disclosure provide a surgical hub for a surgical procedure involving the application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combination generator module slidably received in a docking bay of the hub housing. The docking station includes a data contact and a power contact. The combined generator module includes two or more of an ultrasonic energy generator device, a bipolar RF energy generator device, and a monopolar RF energy generator device that are housed in a single unit. In one aspect, the combination generator module further comprises smoke evacuation means for connecting the combination generator module to at least one energy delivery cable of the surgical instrument, at least one smoke evacuation means configured to evacuate smoke, fluid and/or particles generated by application of therapeutic energy to tissue, and a fluid line extending from the remote surgical site to the smoke evacuation means.
In one aspect, the fluid line is a first fluid line and the second fluid line extends from the remote surgical site to an aspiration and irrigation module slidably received in the hub housing. In one aspect, the hub housing includes a fluid interface.
Certain surgical procedures may require more than one type of energy to be applied to tissue. One energy type may be more advantageous for cutting tissue, while a different energy type may be more advantageous for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut the sealed tissue. Aspects of the present disclosure provide a solution in which the hub modular housing 136 is configured to house different generators and facilitate interactive communication therebetween. One of the advantages of the hub modular housing 136 is the ability to quickly remove and/or replace various modules.
Aspects of the present disclosure provide a modular surgical housing for use in a surgical procedure involving the application of energy to tissue. The modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue, and a first docking station including a first docking port including a first data and power contact, wherein the first energy generator module is slidably movable into electrical engagement with the power and data contact, and wherein the first energy generator module is slidably movable out of electrical engagement with the first power and data contact,
Further to the above, the modular surgical housing further comprises a second energy generator module configured to generate a second energy different from the first energy for application to the tissue, and a second docking station comprising a second docking port comprising a second data and power contact, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contact, and wherein the second energy generator is slidably movable out of electrical contact with the second power and data contact.
In addition, the modular surgical housing further 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.
Referring to fig. 3-7, aspects of the present disclosure are presented as a hub modular housing 136 that allows for modular integration of the generator module 140, smoke evacuation module 126, and suction/irrigation module 128. The hub modular housing 136 also facilitates interactive communication between the modules 140, 126, 128. As shown in fig. 5, the generator module 140 may be a generator module with integrated monopolar, bipolar and ultrasonic devices supported in a single housing unit 139 slidably inserted into the hub modular housing 136. As shown in fig. 5, the generator module 140 may be configured to be connectable to a monopolar device 146, a bipolar device 147, and an ultrasound device 148. Alternatively, the generator module 140 may include a series of monopolar generator modules, bipolar generator modules, and/or an ultrasound generator module that interact through the hub modular housing 136. The hub modular housing 136 may be configured to facilitate interactive communication between the insertion and docking of multiple generators into the hub modular housing 136 such that the generators will act as a single generator.
In one aspect, the hub modular housing 136 includes a modular power and communication backplane 149 having external and wireless communication connectors to enable removable attachment of the modules 140, 126, 128 and interactive communication therebetween.
In one aspect, the hub modular housing 136 includes a docking bay or drawer 151 (also referred to herein as a drawer) configured to slidably receive the modules 140, 126, 128. Fig. 4 shows a partial perspective view of the surgical hub housing 136 and the combined generator module 145 slidably received in the docking cradle 151 of the surgical hub housing 136. Docking ports 152 having power and data contacts on the back of the combination generator module 145 are configured to engage the corresponding docking ports 150 with the power and data contacts of the corresponding docking bays 151 of the hub module housing 136 when the combination generator module 145 is slid into place within the corresponding docking bays 151 of the hub module housing 136. In one aspect, the combined generator module 145 includes a bipolar, ultrasound and monopolar module and a smoke evacuation module integrated together into a single housing unit 139, as shown in fig. 5.
In various aspects, smoke evacuation module 126 includes a fluid line 154, which fluid line 154 conveys the trapped/collected smoke and/or fluid away from the surgical site and to, for example, smoke evacuation module 126. Vacuum suction from smoke evacuation module 126 may draw smoke into the opening of the common conduit at the surgical site. The common conduit coupled to the fluid lines may be in the form of a flexible tube terminating at the smoke evacuation module 126. The common conduit and fluid lines define a fluid path that extends toward the smoke evacuation module 126 housed in the hub housing 136.
In various aspects, the aspiration/irrigation module 128 is coupled to a surgical tool that includes an aspiration fluid line and an aspiration fluid line. In one example, the aspiration and aspiration fluid lines are in the form of flexible tubing extending from the surgical site toward the aspiration/irrigation module 128. The one or more drive systems may be configured to flush fluid to and aspirate fluid from the surgical site.
In one aspect, a 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, a draft tube, and an irrigation tube. The draft tube may have an inlet at its distal end and the draft tube extends through the shaft. Similarly, the draft tube may extend through the shaft and may have an inlet adjacent the energy delivery tool. The energy delivery tool is configured to deliver ultrasonic energy and/or RF energy to the surgical site and is coupled to the generator module 140 by a cable that initially extends through the shaft.
The flush tube may be in fluid communication with a fluid source and the draft tube may be in fluid communication with a vacuum source. A fluid source and/or a vacuum source may be housed in the suction/irrigation module 128. In one example, a fluid source and/or a vacuum source may be housed in the hub housing 136 independently of the suction/irrigation module 128. In such examples, the fluid interface can connect the aspiration/irrigation module 128 to a fluid source and/or a vacuum source.
In one aspect, the modules 140, 126, 128 and/or their corresponding docking bays on the hub modular housing 136 may include alignment features configured to align the docking ports of the modules into engagement with their corresponding ports in the docking bays of the hub modular housing 136. For example, as shown in fig. 4, combined generator module 145 includes side brackets 155, side brackets 155 configured to slidably engage corresponding brackets 156 of corresponding docking bays 151 of hub module housing 136. The brackets cooperate to guide the mating port contacts of the combined generator module 145 into electrical engagement with the mating port contacts of the hub modular housing 136.
In some aspects, the drawers 151 of the hub modular housing 136 are the same or substantially the same size, and the size of the modules are adjusted to be housed in the drawers 151. For example, side brackets 155 and/or 156 may be larger or smaller depending on the size of the module. In other aspects, the drawers 151 are sized differently and each is designed to accommodate a particular module.
In addition, the contacts of a particular module may be keyed to engage the contacts of a particular drawer to avoid inserting the module into a drawer having unmatched contacts.
As shown in fig. 4, the docking port 150 of one drawer 151 may be coupled to the docking port 150 of another drawer 151 by a communication link 157 to facilitate interactive communication between modules housed in the hub modular housing 136. Alternatively or additionally, the docking port 150 of the hub modular housing 136 may facilitate wireless interactive communication between modules housed in the hub modular housing 136. Any suitable wireless communication may be employed, such as, for example, air titanium-Bluetooth.
Fig. 6 illustrates a single power bus attachment for multiple lateral docking ports of a lateral modular housing 160, the lateral modular housing 160 configured to house multiple modules of a surgical hub 206. The lateral modular housing 160 is configured to laterally house and interconnect the modules 161. The modules 161 are slidably inserted into the docking base 162 of the lateral modular housing 160, which lateral modular housing 160 includes a floor for interconnecting the modules 161. As shown in fig. 6, the modules 161 are laterally disposed in a lateral modular housing 160. Alternatively, the modules 161 may be arranged vertically in a lateral modular housing.
Fig. 7 shows a vertical modular housing 164 configured to house a plurality of modules 165 of the surgical hub 106. The modules 165 are slidably inserted into a docking bay or drawer 167 of a vertical modular housing 164, the vertical modular housing 164 including a floor for interconnecting the modules 165. Although the drawers 167 of the vertical modular housing 164 are vertically arranged, in some cases, the vertical modular housing 164 may include drawers that are laterally arranged. Further, the modules 165 may interact with each other through the docking ports of the vertical modular housing 164. In the example of fig. 7, a display 177 for displaying data related to the operation of module 165 is provided. Further, the vertical modular housing 164 includes a main module 178 that houses a plurality of sub-modules slidably received in the main module 178.
In various aspects, the imaging module 138 includes an integrated video processor and modular light source and is adapted for use with various imaging devices. In one aspect, an imaging device is constructed of a modular housing that may be fitted with a light source module and a camera module. The housing may be a disposable housing. In at least one example, the disposable housing is removably coupled to the reusable controller, the light source module, and the camera module. The light source module and/or the camera module may be selectively selected according to the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module includes a CMOS sensor. In another aspect, the camera module is configured for scanning beam imaging. Also, the light source module may be configured to deliver white light or different lights, depending on the surgical procedure.
During a surgical procedure, it may be inefficient to remove a surgical device from a surgical field and replace the surgical device with another surgical device that includes a different camera or a different light source. Temporary loss of vision from the surgical field can have undesirable consequences. The modular imaging apparatus of the present disclosure is configured to allow for flow replacement of the light source module or the camera module during a surgical procedure without having to remove the imaging apparatus from the surgical site.
In one aspect, an imaging device includes a tubular housing including a plurality of channels. The first channel is configured to slidably receive a camera module, which may be configured to be snap-fit engageable with the first channel. The second channel is configured to slidably receive a light source module, which may be configured to be snap-fit engageable with the second channel. In another example, the camera module and/or the light source module may be rotated within their respective channels to a final position. Instead of a snap-fit engagement, a threaded engagement may be employed.
In various examples, multiple imaging devices are placed at different locations in a surgical field to provide multiple views. The imaging module 138 may be configured to be capable of switching between imaging devices to provide an optimal view. In various aspects, the imaging module 138 may be configured to be capable of integrating images from different imaging devices.
Various image processors and imaging devices suitable for use in the present disclosure are described in U.S. patent 7,995,045, entitled combined SBI and conventional image processor (COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR), published 8.8.9 2011, which is incorporated by reference herein in its entirety. Furthermore, U.S. patent 7,982,776, entitled SBI motion artifact removal apparatus and method (SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD), published in 2011, 7, 19, which is incorporated herein by reference in its entirety, describes various systems for removing motion artifacts from image data. Such a system may be integrated with the imaging module 138. Further, U.S. patent application publication 2011/0306840 entitled controllable magnetic source (CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS) to a fastener body internal device published on 12/15 2011 and U.S. patent application publication 2014/0243597 entitled system for performing minimally invasive surgical procedures (SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE) published on 8/2014, each of which is incorporated herein by reference in its entirety.
Fig. 8 illustrates a surgical data network 201 including a modular communication hub 203, the modular communication hub 203 configured to enable connection of modular devices located in one or more operating rooms of a medical facility or any room in a medical facility specifically equipped for surgical procedures to a cloud-based system (e.g., cloud 204, which may include remote server 213 coupled to storage device 205). In one aspect, modular communication hub 203 includes a network hub 207 and/or a network switch 209 in communication with a network router. Modular communication hub 203 may also 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 switched. The passive surgical data network acts as a conduit for data, enabling it to be transferred from one device (or segment) to another device (or segment) and cloud computing resources. The intelligent surgical data network includes additional features to enable monitoring of traffic through the surgical data network and configuring each port in the hub 207 or network switch 209. The intelligent surgical data network may be referred to as a manageable hub or switch. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.
Modular devices 1a-1n located in an operating room may be coupled to a modular communication hub 203. The hub 207 and/or the network switch 209 may be coupled to a network router 211 to connect the devices 1a-1n to the cloud 204 or to a local computer system 210. The data associated with the devices 1a-1n may be transmitted via routers to cloud-based computers for remote data processing and manipulation. Data associated with the devices 1a-1n may also be transmitted to the local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to network switch 209. Network switch 209 may be coupled to network hub 207 and/or network router 211 to connect devices 2a-2m to cloud 204. Data associated with the devices 2a-2n may be transmitted to the cloud 204 via the network router 211 for data processing and manipulation. The data associated with the devices 2a-2m may also be transmitted to the local computer system 210 for local data processing and manipulation.
It should be appreciated that the surgical data network 201 may be extended by interconnecting a plurality of network hubs 207 and/or a plurality of network switches 209 with a plurality of network routers 211. Modular communication hub 203 may be included in a modular control tower configured to be capable of housing a plurality of devices 1a-1n/2a-2m. Local computer system 210 may also be contained in a modular control tower. Modular communication hub 203 is connected to display 212 to display images obtained by some of devices 1a-1n/2a-2m, for example, during a surgical procedure. In various aspects, the devices 1a-1n/2a-2m may include, for example, various modules such as a non-contact sensor module in an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, an aspiration/irrigation module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device connected to a display, and/or other modular devices that may be connected to a modular communication hub 203 of a surgical data network 201.
In one aspect, the surgical data network 201 may include a combination of one or more hubs, one or more network switches, and one or more network routers that connect the devices 1a-1n/2a-2m to the cloud. Any or all of the devices 1a-1n/2a-2m coupled to the hub or switch may collect data in real time and transmit the data to the cloud computer for data processing and manipulation. It should be appreciated that cloud computing relies on shared computing resources, rather than using local servers or personal devices to process software applications. The term "cloud" may be used as a metaphor for "internet," although the term is not so limited. Thus, the term "cloud computing" may be used herein to refer to "types of internet-based computing" in which different services (such as servers, memory, and applications) are delivered to modular communication hub 203 and/or computer system 210 located in a surgical room (e.g., stationary, mobile, temporary, or in-situ operating room or space) and devices connected to 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 case, the cloud service provider may be an entity that coordinates the use and control of devices 1a-1n/2a-2m located in one or more operating rooms. The cloud computing service may perform a large amount of computation based on data collected by intelligent surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware enables multiple devices or connections to connect to a computer that communicates with cloud computing resources and memory.
Applying cloud computer data processing techniques to the data collected by the devices 1a-1n/2a-2m, the surgical data network provides improved surgical results, reduced costs, and improved patient satisfaction. At least some of the devices 1a-1n/2a-2m may be employed to observe tissue conditions to assess leakage or perfusion of sealed tissue following tissue sealing and cutting procedures. At least some of the devices 1a-1n/2a-2m may be employed to identify pathologies, such as the effects of a disease, and data including images of body tissue samples for diagnostic purposes may be examined using cloud-based computing. This includes localization and marginal confirmation of tissue and phenotype. At least some of the devices 1a-1n/2a-2m may be employed to identify anatomical structures of the body using various sensors integrated with imaging devices and techniques, such as overlapping images captured by multiple imaging devices. The data (including image data) collected by the devices 1a-1n/2a-2m may be transmitted to the cloud 204 or the local computer system 210 or both for data processing and manipulation, including image processing and manipulation. Such data analysis may further employ a result analysis process and may provide beneficial feedback using standardized methods to confirm or suggest modification of surgical treatment and surgeon behavior.
In one implementation, operating room devices 1a-1n may be connected to modular communication hub 203 via a wired channel or a wireless channel, depending on the configuration of devices 1a-1n to the hub. In one aspect, hub 207 may be implemented as a local network broadcaster operating on the physical layer of the Open Systems Interconnection (OSI) model. The hub provides a connection to the devices 1a-1n located in the same operating room network. The hub 207 collects the data in the form of packets and sends it to the router in half duplex mode. The hub 207 does not store any media access control/internet protocol (MAC/IP) for transmitting device data. Only one of the devices 1a-1n may transmit data through the hub 207 at a time. The hub 207 has no routing tables or intelligence about where to send information and broadcast all network data on each connection and all network data to the remote server 213 (fig. 9) through the cloud 204. Hub 207 may detect basic network errors such as collisions, but broadcasting all information to multiple ports may pose a security risk and cause bottlenecks.
In another implementation, the operating room devices 2a-2m may be connected to the network switch 209 via a wired channel or a wireless channel. The network switch 209 operates 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 room to a network. The network switch 209 sends data to the network router 211 in the form of frames and operates in full duplex mode. Multiple devices 2a-2m may transmit data simultaneously through network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to transmit data.
The hub 207 and/or the network switch 209 are coupled to a network router 211 to connect to the cloud 204. The network router 211 operates in the network layer of the OSI model. Network router 211 creates a route for transmitting data packets received from network hub 207 and/or network switch 211 to cloud-based computer resources to further process and manipulate data collected by any or all of devices 1a-1n/2a-2 m. Network router 211 may be employed to connect two or more different networks located at different locations, such as, for example, different operating rooms at the same medical facility or different networks located at different operating rooms at different medical facilities. The network router 211 sends data in packets to the cloud 204 and operates in full duplex mode. Multiple devices may transmit data simultaneously. The network router 211 uses the IP address to transmit data.
In one example, the hub 207 may be implemented as a USB hub that allows multiple USB devices to connect to a host. USB hubs can extend a single USB port to multiple tiers so that more ports are available to connect devices to a host system computer. Hub 207 may include wired or wireless capabilities for receiving information over a wired or wireless channel. In one aspect, a wireless USB short-range, high-bandwidth wireless radio communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located in an operating room.
In other examples, operating room devices 1a-1n/2a-2m may communicate with modular communication hub 203 via bluetooth wireless technology standards for exchanging data from stationary devices and mobile devices and constructing Personal Area Networks (PANs) over short distances (using short wavelength UHF radio waves of 2.4 to 2.485GHz in the ISM band). In other aspects, the operating room devices 1a-1n/2a-2m may communicate with the modular communication hub 203 via a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 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 designated 3G, 4G, 5G, and above. The computing module may include a plurality of communication modules. For example, 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, etc.
The modular communication hub 203 may serve as a central connection for one or all of the operating room devices 1a-1n/2a-2m and handle a type of data called frames. The frames carry data generated by the devices 1a-1n/2a-2 m. When the modular communication hub 203 receives the frame, it is amplified and transmitted to the network router 211, which network router 211 transmits the data to the cloud computing resources using a plurality of wireless or wired communication standards or protocols as described herein.
Modular communication hub 203 may be used as a stand-alone device or connected to a compatible hub and network switch to form a larger network. Modular communication hub 203 is generally easy to install, configure, and maintain, making it a good option for networking operating room devices 1a-1n/2a-2 m.
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 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 in communication with a cloud 204, which may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236, the modular control tower 236 being connected to a plurality of operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in an operating room. As shown in fig. 10, modular control tower 236 includes a modular communication hub 203 coupled to computer system 210. As shown in the example of fig. 9, modular control tower 236 is coupled to imaging module 238 coupled to endoscope 239, generator module 240 coupled to energy device 241, smoke extractor module 226, aspiration/irrigation module 228, communication module 230, processor module 232, storage array 234, smart device/instrument 235 optionally coupled to display 237, and non-contact sensor module 242. The operating room devices are coupled to cloud computing resources and data storage via modular control tower 236. The robotic hub 222 may also be connected to a modular control tower 236 and cloud computing resources. The devices/instruments 235, visualization system 208, etc. may be coupled to the modular control tower 236 via a wired or wireless communication standard or protocol, as described herein. The modular control tower 236 may be coupled to the hub display 215 (e.g., monitor, screen) to display and overlay images received from the imaging module, device/instrument display, and/or other visualization system 208. The hub display may also combine the images and the overlay images to display data received from devices connected to the modular control tower.
Fig. 10 illustrates a surgical hub 206 including a plurality of modules coupled to a modular control tower 236. The modular control tower 236 includes a modular communication hub 203 (e.g., a network connectivity device) and a computer system 210 to provide, for example, local processing, visualization, and imaging. As shown in fig. 10, modular communication hub 203 may be hierarchically configured to connect to expand the number of modules (e.g., devices) that may be connected to modular communication hub 203 and transmit data associated with the modules to computer system 210, cloud computing resources, or both. As shown in fig. 10, each of the hubs/switches in modular communications hub 203 includes three downstream ports and one upstream port. The upstream hub/switch is connected to the processor to provide a communication connection with the cloud computing resources and the local display 217. Communication with cloud 204 may be through a wired or wireless communication channel.
The surgical hub 206 employs a non-contact sensor module 242 to measure the size of the operating room and uses ultrasonic or laser type non-contact measurement devices to generate a map of the surgical room. The ultrasound-based non-contact sensor module scans the operating room by transmitting a burst of ultrasound waves and receiving echoes as it bounces off the operating room's perimeter wall, as described under the heading "surgical hub space perception in operating room (Surgical Hub Spatial Awareness Within an Operating Room)" in U.S. provisional patent application serial No. 62/611,341 entitled "interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on day 12, 2017, which is incorporated herein by reference in its entirety, wherein the sensor module is configured to be able to determine the size of the operating room and adjust bluetooth pairing distance limits. The laser-based non-contact sensor module scans the operating room by transmitting laser pulses, receiving laser pulses that bounce off the enclosure of the operating room, and comparing the phase of the transmitted pulses with the received pulses to determine the size of the operating room and adjust the bluetooth pairing distance limit.
Computer system 210 includes a processor 244 and a network interface 245. The processor 244 is coupled via a system bus to a communication module 247, a storage 248, a memory 249, a non-volatile memory 250, and an input/output interface 251. The system bus may be any of several types of bus structure including a 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, industry Standard Architecture (ISA), micro-chamdel 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 System Interface (SCSI), or any other peripheral bus.
The controller 244 may be any single or multi-core processor, such as those provided by Texas instruments (Texas Instruments) under the trade name ARM Cortex. In one aspect, the processor may be an on-chip memory available from, for example, texas instruments (Texas Instruments) LM4F230H5QR ARM Cortex-M4F processor core including 256KB of single-cycle flash memory or other non-volatile memory (up to 40 MHz), a prefetch buffer for improving performance above 40MHz, 32KB single-cycle Sequential Random Access Memory (SRAM), loaded with Internal read-only memory (ROM) of software, 2KB electrically erasable programmable read-only memory (EEPROM), and/or 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, the details of which can be seen in the product data sheet.
In one aspect, the processor 244 may include a security controller comprising two controller-based families such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4 also produced by texas instruments (Texas Instruments). The security controller may be configured specifically for IEC 61508 and ISO 26262 security critical applications, etc. to provide advanced integrated security features while delivering scalable performance, connectivity, and memory options.
The system memory includes volatile memory and nonvolatile memory. A 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 nonvolatile memory. For example, the non-volatile memory may 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. In addition, RAM is available in a variety of forms, such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), dual data rate SDRAM (DDR SDRAM) Enhanced SDRAM (ESDRAM), synchronous Link DRAM (SLDRAM), and Direct Rambus RAM (DRRAM).
Computer system 210 also includes removable/non-removable, volatile/nonvolatile computer storage media such as, for example, magnetic disk storage. Disk storage includes, but is not limited to, devices such as magnetic disk drives, floppy disk drives, tape drives, jaz drives, zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, the disk storage can include storage media separately or in combination with other storage media including, but not limited to, an optical disk drive such as a compact disk ROM device (CD-ROM), compact disk recordable drive (CD-R drive), compact disk rewritable drive (CD-RW drive) or a digital versatile disk ROM drive (DVD-ROM). To facilitate connection of the disk storage devices to the system bus, a removable or non-removable interface may be used.
It is to be appreciated that computer system 210 includes software that acts as an intermediary between users and the basic computer resources described in suitable operating environment. Such software includes an operating system. An operating system, which may be stored on disk storage, is used to control and allocate resources of the computer system. System applications utilize the operating system to manage resources through program modules and program data stored either in system memory or on disk storage. It is to be appreciated that the various devices 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 one or more input devices coupled to the I/O interface 251. 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 are connected to the processor through the system bus via one or more interface ports. The one or more interface ports include, for example, serial ports, parallel ports, game ports, and USB. The one or more output devices use the same type of ports as the one or more input devices. Thus, for example, a USB port may be used to provide input to a computer system and to output information from the computer system to an output device. Output adapters are provided to illustrate that there are some output devices (e.g., monitors, displays, speakers, and printers) that require special adapters among other output devices.
Computer system 210 may operate in a networked environment using logical connections to one or more remote computers, such as one or more cloud computers, or local computers. The one or more remote cloud computers may be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices or other common network nodes, or the like, and typically include many or all of the elements described relative to the computer system. For simplicity, only memory storage devices having one or more remote computers are shown. One or more remote computers are logically connected to the computer system through a network interface and then physically connected via communication connections. The network interface encompasses communication networks such as local-area networks (LAN) and wide-area networks (WAN). 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).
In various aspects, the computer system 210, imaging module 238 and/or visualization system 208 of fig. 10, and/or the processor module 232 of fig. 9-10 may include an image processor, an image processing engine, a media processor, or any special purpose Digital Signal Processor (DSP) for processing digital images. The image processor may employ parallel computation with single instruction, multiple data (SIMD) or multiple instruction, multiple data (MIMD) techniques to increase speed and efficiency. The digital image processing engine may perform a series of tasks. The image processor may be a system on a chip having a multi-core processor architecture.
One or more communication connections refer to the hardware/software used to connect the network interface to the bus. Although shown as a communication connection for exemplary clarity within a computer system, it can also be external to computer system 210. The hardware/software necessary for connection to the network interface includes, for exemplary 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. 11 illustrates a functional block diagram of one aspect of a USB hub 300 device in accordance with at least one aspect of the present disclosure. In the illustrated aspect, USB hub device 300 employs a TUSB2036 integrated circuit hub of texas instruments (Texas Instruments). The USB 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 according to the USB 2.0 specification. The upstream USB transceiver port 302 is a differential root data port that includes a differential data negative (DP 0) input paired with a differential data positive (DM 0) input. The three downstream USB transceiver ports 304, 306, 308 are differential data ports, with each port including differential data positive (DP 1-DP 3) outputs paired with differential data negative (DM 1-DM 3) outputs.
The USB hub 300 device is implemented with a digital state machine rather than a microcontroller and does not require firmware programming. Fully compatible USB transceivers are integrated into the circuitry for the upstream USB transceiver port 302 and all of the 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 port. The USB hub 300 device may be configured in a bus power mode or a self-powered mode and include hub power logic 312 for managing power.
The USB hub 300 device includes a serial interface engine 310 (SIE). SIE 310 is the front end of the USB hub 300 hardware and handles most of the protocols described in chapter 8 of the USB specification. SIE 310 generally includes signaling up to the transaction level. The processing functions thereof can include: packet identification, transaction ordering, SOP, EOP, RESET and RESUME signal detection/generation, clock/data separation, non return to zero inversion (NRZI) data encoding/decoding and digit stuffing, CRC generation and checking (token and data), packet ID (PID) generation and checking/decoding, and/or serial-parallel/parallel-serial conversion. 310 receives a clock input 314 and is coupled to pause/resume logic and frame timer 316 circuitry and hub repeater circuitry 318 to control communications between the upstream USB transceiver port 302 and the downstream USB transceiver ports 304, 306, 308 via port logic circuits 320, 322, 324. SIE 310 is coupled to command decoder 326 via interface logic to control commands from a serial EEPROM via serial EEPROM interface 330.
In various aspects, the USB hub 300 may connect 127 functions configured in up to six logical layers (tiers) to a single computer. Further, the USB hub 300 may be connected to all external devices using a standardized four-wire cable that provides both communication and power distribution. The power is configured in a bus power mode and a self-powered mode. The USB hub 300 may be configured to support four power management modes: bus-powered hubs with individual port power management or ganged port power management, and self-powered hubs with individual port power management or ganged port power management. In one aspect, the USB hub 300, the upstream USB transceiver port 302, are plugged into a USB host controller using USB cables, and the downstream USB transceiver ports 304, 306, 308 are exposed for connection to USB compatible devices, etc.
Surgical instrument hardware
Fig. 12 illustrates a logic diagram of a control system 470 for a surgical instrument or tool in accordance with one or more aspects of the present disclosure. The system 470 includes control circuitry. The control circuit includes a microcontroller 461 that includes a processor 462 and memory 468. For example, one or more of the sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482 driven by motor drive 492 is operatively coupled to the longitudinally movable displacement member to drive the clamp arm closing member. The tracking system 480 is configured to determine a position of the longitudinally movable displacement member. The position information is provided to a processor 462, which processor 462 may be programmed or configured to be able 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 thereof. The display 473 displays various operating conditions of the instrument and may include touch screen functionality for data input. The information displayed on the display 473 may be superimposed with the image acquired via the endoscopic imaging module.
In one aspect, microprocessor 461 may be any single core or multiple coresA core processor such as those known under the trade name ARM Cortex produced by texas instruments (Texas Instruments). In one aspect, the microcontroller 461 may be an LM4F230H5QR ARM Cortex-M4F processor core available from, for example, texas instruments Inc. (Texas Instruments), which includes 256KB of single-cycle flash memory or other non-volatile memory (up to 40 MHz) on-chip memory, a prefetch buffer for improving performance above 40MHz, 32KB single-cycle SRAM, loaded withInternal ROM for software, 2KB electrical EEPROM, one or more PWM modules, one or more QEI simulations, one or more 12-bit ADCs with 12 analog input channels, the details of which can be seen in the product data sheet.
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 produced by texas instruments (Texas Instruments). The security controller may be configured specifically for IEC 61508 and ISO 26262 security critical applications, etc. to provide advanced integrated security features while delivering scalable performance, connectivity, and memory options.
The microcontroller 461 can be programmed to perform various functions such as precisely controlling the speed and position of the knife, articulation system, clamp arm, or a combination thereof. In one aspect, the microcontroller 461 includes a processor 462 and memory 468. The electric motor 482 may be a brushed Direct Current (DC) motor having a gear box and a mechanical link to an articulation or knife system. In one aspect, the motor drive 492 may be a3941 available from Allegro microsystems, inc (Allegro Microsystems, inc). Other motor drives may be readily replaced for use in tracking system 480, including an absolute positioning system. A detailed description of absolute positioning systems is described in U.S. patent application publication 2017/0296213, entitled system and method for controlling surgical stapling and severing instrument (SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT), published at 10 and 19 in 2017, which is incorporated herein by reference in its entirety.
The microcontroller 461 can be programmed to provide precise control of the speed and position of the displacement member and articulation system. The microcontroller 461 may be configured to be able to calculate responses in the software of the microcontroller 461. The calculated response is compared to the measured response of the actual system to obtain an "observed" response, which is used in the actual feedback decision. The observed response is an advantageous tuning value that equalizes the smooth continuous nature of the simulated response with the measured response, which can detect external effects on the system.
In one aspect, the motor 482 can be controlled by a motor drive 492 and can be employed by a firing system of the surgical instrument or tool. In various forms, the motor 482 may be a brushed DC drive motor having a maximum rotational speed of about 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 include, for example, an H-bridge driver including a Field Effect Transistor (FET). The motor 482 may 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 include a battery that may include a plurality of battery cells connected in series that may be used as a power source to provide power to a surgical instrument or tool. In some cases, the battery cells of the power assembly may be replaceable and/or rechargeable battery cells. In at least one example, the battery cell may be a lithium ion battery, which may be coupled to and separable from the power component.
Driver 492 may be a3941 available from Allegro microsystems, inc (Allegro Microsystems, inc). A3941 492 is a full bridge controller for use with an external N-channel power Metal Oxide Semiconductor Field Effect Transistor (MOSFET) specifically designed for inductive loads, such as brushed DC motors. The driver 492 includes a unique charge pump regulator that provides full (> 10V) gate drive for battery voltages as low as 7V and allows a3941 to operate with reduced gate drive as low as 5.5V. A bootstrap capacitor may be employed to provide the above-described battery supply voltage required for an N-channel MOSFET. The internal charge pump of the high side drive allows dc (100% duty cycle) operation. Diodes or synchronous rectification may be used to drive the full bridge in either a fast decay mode or a slow decay mode. In slow decay mode, current recirculation may pass through either the high-side FET or the low-side FET. The dead time, which is adjustable by a resistor, protects the power FET from breakdown. The overall diagnostics provide indications of brown-out, over-temperature, and power bridge faults, and may be configured to be able to protect the power MOSFET under most short circuit conditions. Other motor drives may be readily replaced for use in tracking system 480, including an absolute positioning system.
Tracking system 480 includes a controlled motor drive circuit arrangement including a position sensor 472 in accordance with an aspect of the present disclosure. A position sensor 472 for the absolute positioning system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents a longitudinally movable drive member that includes a rack of drive teeth for meshing engagement with a corresponding drive gear of the gear reducer assembly. In other aspects, the displacement member represents a firing member that may be adapted and configured as a rack that includes drive teeth. In a further aspect, the displacement member represents a longitudinal displacement member for opening and closing the clamping arm, which longitudinal displacement member may be adapted and configured as a rack comprising drive teeth. In other aspects, the displacement member represents a clamp arm closure member configured to close and open a clamp arm of a stapler, a clamp arm of an ultrasonic or electrosurgical device, or a combination thereof. Thus, as used herein, the term displacement member is used generically to refer to any movable member of a surgical instrument or tool, such as a drive member, a clamping arm, or any element that may be displaced. Thus, the absolute positioning system can actually track the displacement of the clamping arm by tracking the linear displacement of the longitudinally movable drive member.
In other aspects, the absolute positioning system may be configured to track the position of the clamp arm during closing or opening. In various other aspects, the displacement member may be coupled to any position sensor 472 adapted to measure linear displacement. Thus, the longitudinally movable drive member, or the clamping arm, or a combination thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may comprise a contact type displacement sensor or a non-contact type displacement sensor. The linear displacement sensor may comprise a Linear Variable Differential Transformer (LVDT), a Differential Variable Reluctance Transducer (DVRT), a sliding 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 photodiodes or photodetectors, an optical sensing system comprising a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.
The electric motor 482 may include a rotatable shaft operatively interfacing with a gear assembly mounted on the displacement member in meshing engagement with a set or rack of drive teeth. The sensor element may be operatively coupled to the gear assembly such that a single rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The gearing and sensor arrangement may be connected to the linear actuator via a rack and pinion arrangement, or to the rotary actuator via a spur gear or other connection. The power source powers the absolute positioning system and the output indicator may display an output of the absolute positioning system. The displacement member represents a longitudinally movable drive member that includes racks of drive teeth formed thereon for meshing engagement with corresponding drive gears of the gear reducer assembly. The displacement member represents a longitudinally movable firing member for opening and closing the clamping arms.
A single rotation of the sensor element associated with the position sensor 472 is equivalent to the longitudinal linear displacement d of the displacement member 1 Wherein d is 1 Is the longitudinal linear distance that the displacement member moves from point "a" to point "b" after a single rotation of the sensor element coupled to the displacement member. The sensor arrangement being connectable via gear reduction, the teethThe wheel decelerates such that the position sensor 472 completes only one or more rotations for the full stroke of the displacement member. The position sensor 472 may complete multiple rotations for a 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 gear reduction to provide a unique position signal for more than one revolution of the position sensor 472. The state of the switch is fed back to the microcontroller 461, which microcontroller 461 applies logic to determine the longitudinal linear displacement d corresponding to the displacement member 1 +d 2 +…d n Is provided. The output of the position sensor 472 is provided to a microcontroller 461. The position sensor 472 of the sensor arrangement may include a magnetic sensor, an analog rotation sensor (e.g., a potentiometer), an array of analog hall effect elements that output a unique combination of position signals or values.
The position sensor 472 may include any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or vector component of the magnetic field. Technologies for producing the two types of magnetic sensors described above cover a number of aspects of physics and electronics. Techniques for magnetic field sensing include probe coils, fluxgates, optical pumps, nuclear spin, superconducting quantum interferometers (SQUIDs), hall effects, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoresistance, magnetostriction/piezoelectric composites, magneto-sensitive diodes, magneto-sensitive transistors, optical fibers, magneto-optical, and microelectromechanical system based magnetic sensors, among others.
In one aspect, the position sensor 472 for the tracking system 480 including an absolute positioning system includes a magnetic rotational absolute positioning system. The position sensor 472 may be implemented AS an AS5055EQFT monolithic magnetic rotation position sensor, which is commercially available from australian microelectronics company (Austria Microsystems, AG). The position sensor 472 interfaces with the microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low voltage and low power device and includes four hall effect elements located in the area of the position sensor 472 on the magnet. A high resolution ADC and intelligent power management controller are also provided on the chip. A coordinate rotation digital computer (CORDIC) processor (also known as a bitwise and Volder algorithm) is provided to perform simple and efficient algorithms to calculate hyperbolic and trigonometric functions, which require only addition, subtraction, digital displacement and table lookup operations. The angular position, alarm bits, and magnetic field information are transmitted to the microcontroller 461 through a standard serial communication interface, such as a Serial Peripheral Interface (SPI) interface. The position sensor 472 provides 12 or 14 bit resolution. The site sensor 472 may be an AS5055 chip provided in a small QFN 16 pin 4 x 0.85mm package.
The tracking system 480, including an absolute positioning system, may include and/or may be programmed to implement feedback controllers such as PID, status feedback, and adaptive controllers. The power source converts the signal from the feedback controller into a physical input to the system: in this case a voltage. Other examples include PWM of voltage, current, and force. In addition to the location measured by the location sensor 472, one or more other sensors may be provided to measure physical parameters of the physical system. In some aspects, the one or more other sensors may include a sensor arrangement such as those described in U.S. patent 9,345,481 to a cartridge TISSUE THICKNESS sensor system (STAPLE CARTRIDGE tissu THICKNESS) issued at month 5 and 24 of 2016, which is incorporated herein by reference in its entirety; U.S. patent application publication 2014/0263552 entitled staple cartridge TISSUE THICKNESS sensor system (STAPLE CARTRIDGE tissu THICKNESS), published at 9, 18, 2014, which is incorporated herein by reference in its entirety; and U.S. patent application Ser. No. 15/628,175, entitled technique for adaptive control of motor speed for surgical stapling and cutting instruments (TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT), filed on 6/20 of 2017, which is incorporated herein by reference in its entirety. In a digital signal processing system, an absolute positioning system is coupled to a digital data acquisition system, wherein the output of the absolute positioning system will have a limited resolution and sampling frequency. The absolute positioning system may include a comparison and combination circuit to combine the calculated response with the measured response using an algorithm (such as a weighted average and a theoretical control loop) that drives the calculated response toward the measured response. The calculated response of the physical system takes into account characteristics such as mass, inertia, viscous friction, inductance and resistance to predict the state and output of the physical system by knowing the inputs.
Thus, the absolute positioning system provides an absolute position of the displacement member upon power-up of the instrument and does not retract or advance the displacement member to a reset (clear or home) position as may be required by conventional rotary encoders that merely count the number of forward or backward steps taken by the motor 482 to infer the position of the device actuator, drive rod, knife, or the like.
The 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 magnitude of the strain exerted on the anvil during a clamping operation, which may be indicative of the closing force 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) may measure the closing force applied by the closure drive system to the stapler or anvil in the clamping arm in an ultrasonic or electrosurgical instrument. A sensor 476 (such as, for example, a load sensor) may measure the firing force applied to a closure member coupled to a clamping arm of a surgical instrument or tool or the force applied by the clamping arm to tissue located in the jaws of an ultrasonic or electrosurgical instrument. Alternatively, a current sensor 478 may be employed to measure the current drawn by the motor 482. The displacement member may also be configured to engage the clamp arm to open or close the clamp arm. The force sensor may be configured to measure a clamping force on tissue. The force required to advance the displacement member may correspond to, for example, the current consumed by the motor 482. The measured force is converted to a digital signal and provided to the processor 462.
In one form, the strain gauge sensor 474 may be used to measure the force applied to tissue by the end effector. A strain gauge may be coupled to the end effector to measure forces on tissue being treated by the end effector. A system for measuring force applied to tissue grasped by an end effector includes a strain gauge sensor 474, such as, for example, a microstrain gauge, configured to be able to measure one or more parameters of the end effector, for example. In one aspect, the strain gauge sensor 474 can measure an amplitude or magnitude of strain applied to the jaw member of the end effector during a clamping operation, which can be indicative of tissue compression. The measured strain is converted to a digital signal and provided to a processor 462 of the microcontroller 461. Load sensor 476 may measure a force used to operate a knife element, for example, to cut tissue captured between an anvil and a staple cartridge. The load sensor 476 may measure a force used to operate the clamp arm element, for example, to capture tissue between the clamp arm and the ultrasonic blade or to capture tissue between the clamp arm and the jaws of the electrosurgical instrument. A magnetic field sensor may be employed to measure the thickness of the trapped tissue. The measurements of the magnetic field sensors may also be converted to digital signals and provided to the processor 462.
The microcontroller 461 can use measurements of tissue compression, tissue thickness, and/or force required to close the end effector, as measured by the sensors 474, 476, respectively, to characterize corresponding values of the selected position of the firing member and/or the speed of the firing member. In one example, the memory 468 may store techniques, formulas, and/or look-up tables that may be employed by the microcontroller 461 in the evaluation.
The control system 470 of the surgical instrument or tool may also include wired or wireless communication circuitry to communicate with a modular communication hub, as shown in fig. 8-11.
Fig. 13 illustrates a control circuit 500, the control circuit 500 configured to control aspects of a surgical instrument or tool according to one aspect of the present disclosure. The control circuit 500 may be configured to enable the various processes described herein. The circuit 500 may include a microcontroller including 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 the various processes described herein. The processor 502 may be any of a variety of single-core or multi-core processors known in the art. Memory circuit 504 may include volatile storage media and nonvolatile 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 the present disclosure.
Fig. 14 illustrates a combinational logic circuit 510, the combinational logic circuit 510 configured to control aspects of a surgical instrument or tool according to one aspect of the present disclosure. The combinational logic circuit 510 may be configured to enable the various processes described herein. The combinational logic circuit 510 may comprise a finite state machine comprising combinational logic 512, the combinational logic 512 being configured to receive data associated with a surgical instrument or tool at input 514, process the data through the combinational logic 512 and provide output 516.
Fig. 15 illustrates a sequential logic circuit 520 configured to control various aspects of a surgical instrument or tool in accordance with an aspect of the present disclosure. Sequential logic 520 or combinational logic 522 may be configured to enable the various processes described herein. Sequential logic circuit 520 may include a finite state machine. Sequential logic circuit 520 may include, for example, combinational logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 may store the current state of the finite state machine. In some cases, sequential logic circuit 520 may be synchronous or asynchronous. The combinational logic 522 is configured to receive data associated with a surgical instrument or tool from the input 526, process the data through the combinational logic 522 and provide the output 528. In other aspects, the circuitry may include a combination of a processor (e.g., processor 502, fig. 13) and a finite state machine to implement the various processes herein. In other embodiments, the finite state machine may comprise a combination of combinational logic circuitry (e.g., combinational logic circuitry 510, fig. 14) and sequential logic circuitry 520.
Fig. 16 illustrates a surgical instrument or tool including multiple motors that may be activated to perform various functions. In some cases, a first motor may be activated to perform a first function, a second motor may be activated to perform a second function, and a third motor may be activated to perform a third function. In some instances, multiple motors of the robotic surgical instrument 600 may be individually activated to cause firing motions, closing motions, and/or articulation in the end effector. Firing motions, closing motions, and/or articulation motions may be transmitted to the end effector, for example, through a shaft assembly.
In some instances, a surgical instrument system or tool may include a firing motor 602. The firing motor 602 is operatively coupled to a firing motor drive assembly 604, which firing motor drive assembly 604 may be configured to transmit firing motions generated by the motor 602 to the end effector, particularly for displacing the clamp arm closure member. The closure member may be retracted by reversing the direction of the motor 602, which also causes the clamp arms to open.
In some cases, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operatively coupled to a closure motor drive assembly 605, the closure motor drive assembly 605 being configured to transmit a closure motion generated by the motor 603 to the end effector, in particular for displacing a closure tube to close the anvil and compress tissue between the anvil and the staple cartridge. The closure motor 603 may be operatively coupled to a closure motor drive assembly 605 configured to transmit a closure motion generated by the motor 603 to the end effector, particularly for displacing a closure tube to close the clamping arm and compress tissue between the clamping arm and an ultrasonic blade or jaw member of the electrosurgical device. The closing motion may transition, for example, the end effector from an open configuration to an approximated configuration to capture tissue. The end effector may be transitioned to the open position by reversing the direction of the motor 603.
In some instances, the surgical instrument or tool may include, for example, one or more articulation motors 606a, 606b. The motors 606a, 606b may be operatively coupled to respective articulation motor drive assemblies 608a, 608b, which may be configured to transmit articulation generated by the motors 606a, 606b to the end effector. In some cases, articulation may cause the end effector to articulate relative to a shaft, for example.
As described above, a surgical instrument or tool may include multiple motors that may be configured to perform various independent functions. In some cases, multiple motors of a surgical instrument or tool may be activated individually or independently to perform one or more functions while other motors remain inactive. For example, the articulation motors 606a, 606b may be activated to articulate the end effector while the firing motor 602 remains inactive. Alternatively, the firing motor 602 may be activated to fire a plurality of staples and/or advance a cutting edge while the articulation motor 606 remains inactive. Further, the closure motor 603 may be activated simultaneously with the firing motor 602 to distally advance a closure tube or closure member, as described in more detail below.
In some instances, a surgical instrument or tool may include a common control module 610, which common control module 610 may be used with multiple motors of the surgical instrument or tool. In some cases, the common control module 610 may adjust one of the plurality of motors at a time. For example, the common control module 610 may be individually coupled to and separable from multiple motors of the surgical instrument. In some instances, multiple motors of a surgical instrument or tool may share one or more common control modules, such as common control module 610. In some instances, multiple motors of a surgical instrument or tool may independently and selectively engage a common control module 610. In some cases, the common control module 610 may switch from interfacing with one of the plurality of motors of the surgical instrument or tool to interfacing with another of the plurality of motors of the surgical instrument or tool.
In at least one example, the common control module 610 can be selectively switched between operatively engaging the articulation motors 606a, 606b and operatively engaging the firing motor 602 or the closure motor 603. In at least one example, as shown in fig. 16, the switch 614 may move or transition between a plurality of positions and/or states. In the first position 616, the switch 614 may electrically couple the common control module 610 to the firing motor 602; in the second position 617, the switch 614 may electrically couple the common control module 610 to the close motor 603; in the third position 618a, the switch 614 may electrically couple the common control module 610 to the first articulation motor 606a; and in the fourth position 618b, the switch 614 may electrically couple the common control module 610 to, for example, the second articulation motor 606b. In some instances, a separate common control module 610 may be electrically coupled to the firing motor 602, the closure motor 603, and the articulation motors 606a, 606b simultaneously. In some cases, 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 include a torque sensor to measure the output torque on the shaft of the motor. The force on the end effector can be sensed in any conventional manner, such as by a force sensor on the outside of the jaws or by a torque sensor of a motor for actuating the jaws.
In various cases, as shown in fig. 16, the common control module 610 may include a motor driver 626, which motor driver 626 may include one or more H-bridge field effect FETs. The motor driver 626 may regulate power transmitted from a power source 628 to a motor coupled to the common control module 610, e.g., based on input from the microcontroller 620 ("controller"). In some cases, when the motors are coupled to the common control module 610, the microcontroller 620 may be employed, for example, to determine the current consumed by the motors, as described above.
In some cases, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or storage units 624 ("memory"). In some cases, memory 624 may store various program instructions that, when executed, may cause processor 622 to perform the various functions and/or computations described herein. In some cases, one or more of the memory units 624 may be coupled to the processor 622, for example. In various aspects, microcontroller 620 may communicate over a wired or wireless channel or a combination thereof.
In some cases, power source 628 may be used, for example, to power microcontroller 620. In some cases, power source 628 may include a battery (or "battery pack" or "power pack"), such as a lithium-ion battery, for example. In some instances, the battery pack may be configured to be releasably mountable to the handle for powering the surgical instrument 600. A plurality of series-connected battery cells may be used as the power source 628. In some cases, the power source 628 may be, for example, replaceable and/or rechargeable.
In various circumstances, the processor 622 may control the motor driver 626 to control the position, rotational direction, and/or speed of the motor coupled to the common controller 610. In some cases, the processor 622 may signal the motor driver 626 to stop and/or deactivate the motor coupled to the common controller 610. It should be appreciated that the term "processor" as used herein includes any suitable microprocessor, microcontroller, or other basic computing device that incorporates the functionality of the Central Processing Unit (CPU) of a computer on one integrated circuit or at most a few integrated circuits. Processor 622 is a versatile programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and then provides the result as output. Because the processor has internal memory, this is an example of sequential digital logic. The objects of operation of the processor are numbers and symbols represented in a binary digital system.
In one example, the processor 622 may be any single or multi-core processor, such as those known under the trade name ARM Cortex, produced by Texas instruments Inc. (Texas Instruments). In some cases, microcontroller 620 may be, for example, LM4F230H5QR, available from texas instruments (Texas Instruments). In at least one example, texas Instruments LM F230H5QR is an ARM Cortex-M4F processor core, comprising: on-chip memory of 256KB single-cycle flash memory or other non-volatile memory (up to 40 MHz), prefetch buffer for improving performance above 40MHz, 32KB single-cycle SRAM, loaded withInternal ROM for software, 2KB EEPROM, one or more PWM modules, one or more QEI simulations, one or more 12-bit ADCs with 12 analog input channels, and other features that are readily available. Can be easily usedOther microcontrollers are replaced for use with the module 4410. Accordingly, the present disclosure should not be limited in this context. />
In some cases, the memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that may be coupled to the common controller 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, 606 b. Such program instructions may cause the processor 622 to control firing, closing, and articulation functions in accordance with inputs from algorithms or control programs for the surgical instrument or tool.
In some cases, one or more mechanisms and/or sensors, such as sensor 630, may be used to alert the processor 622 of program instructions that should be used in a particular setting. For example, the sensor 630 may alert the processor 622 to use program instructions associated with firing, closing, and articulation end effectors. In some cases, the sensor 630 may include, for example, a position sensor that may be used to sense the position of the switch 614. Thus, the processor 622 can use program instructions associated with firing a closure member coupled to a clamp arm of the end effector upon detecting, for example, by the sensor 630 that the switch 614 is in the first position 616; processor 622 may use program instructions associated with closing the anvil upon detecting, for example, by sensor 630 that switch 614 is in second position 617; and the processor 622 may use program instructions associated with articulating the end effector when it is detected, for example by the sensor 630, that the switch 614 is in the third position 618a or the fourth position 618 b.
Fig. 17 is a schematic view of a robotic surgical instrument 700 configured to operate a surgical tool described herein, according to one aspect of the present disclosure. The robotic surgical instrument 700 may be programmed or configured to control distal/proximal translation of the displacement member, distal/proximal displacement of the closure tube, shaft rotation, and articulation with a single or multiple articulation drive links. In one aspect, the surgical instrument 700 can be programmed or configured to control the firing member, closure member, shaft member, or one or more articulation members, or a combination thereof, individually. The surgical instrument 700 includes a control circuit 710, the control circuit 710 configured to control a motor-driven firing member, a closure member, a shaft member, or one or more articulation members, or a combination thereof.
In one aspect, the robotic surgical instrument 700 includes a control circuit 710, the control circuit 710 configured to control the clamp arm 716 and closure member 714 portions of the end effector 702, the ultrasonic blade 718 coupled to the ultrasonic transducer 719 excited by the ultrasonic generator 721, the shaft 740, and one or more articulation members 742a, 742b via the plurality of motors 704a-704 e. The 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. Timer/counter 731 provides timing and count information to 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. Motors 704a-704e may be individually operated in open loop or closed loop feedback control by control circuit 710.
In one aspect, control circuitry 710 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause one or more processors to perform one or more tasks. In one aspect, the timer/counter 731 provides an output signal, such as a 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 to the output of the timer/counter 731 so that the control circuit 710 can determine the position of the closure member 714 at a particular time (t) relative to the starting position or a time (t) when the closure member 714 is in a particular position relative to the starting position. The timer/counter 731 may be configured to be able to measure elapsed time, count external events, or time external events.
In one aspect, the control circuitry 710 may be programmed to control the function of the end effector 702 based on one or more tissue conditions. Control circuitry 710 may be programmed to directly or indirectly sense tissue conditions, such as thickness, as described herein. The control circuit 710 may be programmed to select a firing control routine or a closure control routine based on tissue conditions. The firing control procedure may describe distal movement of the displacement member. Different firing control procedures may be selected to better address 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 speed and/or with lower power. When thinner tissue is present, control circuit 710 may be programmed to translate the displacement member at a higher speed and/or with a higher power. The closure control program can control the closing force applied to the tissue by the clamp arm 716. Other control programs control rotation of the shaft 740 and the articulation members 742a, 742 b.
In one aspect, the control circuit 710 may generate a motor set point signal. The motor set point signals may be provided to various motor controllers 708a-708e. The motor controllers 708a-708e may include 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, motors 704a-704e may be brushed DC electric motors. For example, the speed of motors 704a-704e may be proportional to the corresponding motor drive signal. In some examples, the motors 704a-704e may be brushless DC motors, and the respective motor drive signals may include PWM signals provided to one or more stator windings of the motors 704a-704 e. Also, in some examples, motor controllers 708a-708e may be omitted and control circuit 710 may directly generate motor drive signals.
In some examples, control circuit 710 may initially operate each of motors 704a-704e in an open loop configuration for a first open loop portion of the travel 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 routine in a closed loop configuration. The response of the instrument may include the translational distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy provided to one of the motors 704a-704e during the open loop portion, the sum of the pulse widths of the motor drive signals, and the like. After the open loop portion, the control circuit 710 may implement a selected firing control routine for a second portion of the displacement member travel. For example, during a closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e to translate the displacement member at a constant speed based on translation data describing the position of the displacement member in a closed-loop manner.
In one aspect, motors 704a-704e may receive power from an energy source 712. The energy source 712 may be a DC power source driven by a main alternating current power source, a battery, a super capacitor, or any other suitable energy source. Motors 704a-704e may be mechanically coupled to individual movable mechanical elements, such as closure member 714, clamp arm 716, shaft 740, articulation 742a, and articulation 742b via respective transmissions 706a-706 e. The actuators 706a-706e may include one or more gears or other linkage devices to couple the motors 704a-704e to the movable mechanical elements. The position sensor 734 may sense the position of the closure member 714. The position sensor 734 may be or include any type of sensor capable of generating position data indicative of the 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, proximity sensors. Other types of position sensors may provide other signals indicative of the movement of the closure member 714. Also, in some examples, the position sensor 734 may be omitted. Where motors 704a-704e are stepper motors, control circuit 710 may track the position of closure member 714 by aggregating the number and direction of steps that motor 704 has been instructed to perform. The position sensor 734 may be located in the end effector 702 or at any other portion of the instrument. The output of each of the motors 704a-704e includes a torque sensor 744a-744e for sensing force and has an encoder for sensing rotation of the drive shaft.
In one aspect, the control circuit 710 is configured to drive a firing member, such as a closure member 714 portion of the end effector 702. Control circuit 710 provides a motor setpoint to motor control 708a, which provides a drive signal to motor 704 a. An output shaft of motor 704a is coupled to torque sensor 744a. The torque sensor 744a is coupled to the transmission 706a, and the transmission 706a is coupled to the closure member 714. The transmission 706a includes movable mechanical elements such as rotary elements and firing members to control the movement of the closure member 714 distally and proximally along the longitudinal axis of the end effector 702. In one aspect, motor 704a may be coupled to a knife gear assembly that includes a knife gear reduction set that includes a first knife drive gear and a second knife drive gear. Torque sensor 744a provides a firing force feedback signal to control circuit 710. The firing force signal is indicative of the force required to fire or displace the closure member 714. The 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 for use, the control circuit 710 may provide a firing signal to the motor control 708 a. 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 an end-of-stroke position distal to the stroke start position. As the closure member 714 translates distally, the clamp arm 716 closes toward the ultrasonic blade 718.
In one aspect, the control circuit 710 is configured to drive a closure member, such as a clamp arm 716 portion of the end effector 702. The control circuit 710 provides a motor set point to the motor control 708b, which motor control 708b provides a drive signal to the motor 704 b. An output shaft of motor 704b is coupled to torque sensor 744b. Torque sensor 744b is coupled to transmission 706b that is coupled to clamp arm 716. The actuator 706b includes movable mechanical elements such as rotating elements and closure members to control movement of the clamp arm 716 from the open and closed positions. In one aspect, motor 704b is coupled to a closure gear assembly that includes a closure reduction gear set supported in meshing engagement with a closure spur gear. The torque sensor 744b provides a closing force feedback signal to the control circuit 710. The closing force feedback signal is representative of the closing 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. An additional sensor 738 in the end effector 702 may provide a closing force feedback signal to the control circuit 710. The pivotable clamp arm 716 is positioned opposite the ultrasonic blade 718. When ready for use, control circuit 710 may provide a close signal to motor control 708 b. In response to the closure signal, the motor 704b advances the closure member to grasp tissue between the clamp arm 716 and the ultrasonic blade 718.
In one aspect, the control circuit 710 is configured to enable rotation of a shaft member, such as the shaft 740, to rotate the end effector 702. The control circuit 710 provides a motor set point to the motor control 708c, which motor control 708c provides a drive signal to the motor 704 c. An output shaft of motor 704c is coupled to torque sensor 744c. The torque sensor 744c is coupled to the transmission 706c that is coupled to the shaft 740. The actuator 706c includes a movable mechanical element, such as a rotating element, to control the shaft 740 to rotate more than 360 degrees clockwise or counterclockwise. In one aspect, the motor 704c is coupled to a rotary transmission assembly that includes a tube gear section formed on (or attached to) a proximal end of the proximal closure tube for operative engagement by a rotary gear assembly operatively supported on the tool mounting plate. Torque sensor 744c provides a rotational force feedback signal to control circuit 710. The rotational force feedback signal is indicative of the rotational 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. An additional sensor 738, such as a shaft encoder, may provide the rotational position of the shaft 740 to the control circuit 710.
In one aspect, the control circuitry 710 is configured to enable articulation of the end effector 702. The control circuit 710 provides a motor set point to the motor control 708d, which motor control 708d provides a drive signal to the motor 704 d. The output of motor 704d is coupled to torque sensor 744d. The torque sensor 744d is coupled to the transmission 706d that is coupled to the articulation member 742 a. The transmission 706d includes movable mechanical elements, such as articulation elements, to control articulation of the end effector 702 + -65 deg.. In one aspect, the motor 704d is coupled to an articulation nut rotatably journaled on the proximal end portion of the distal spine and 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 is representative of the articulation force applied to the end effector 702. A sensor 738, such as an articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710.
In another aspect, the articulation function of the robotic surgical system 700 may include two articulation members or links 742a, 742b. These articulation members 742a, 742b are driven by separate discs on the robotic interface (rack) that are driven by the two motors 708d, 708 e. When a separate firing motor 704a is provided, each of the articulation links 742a, 742b may be antagonistic driven relative to the other link to provide resistance preserving motion and load to the head when the head is not moving and articulation when the head is articulating. The articulation members 742a, 742b attach to the head at a fixed radius as the head rotates. Thus, the mechanical advantage of the push-pull link changes as the head rotates. This variation in mechanical advantage may be more pronounced for other articulation link drive systems.
In one aspect, one or more of the motors 704a-704e can include a brushed DC motor with a gear box and a mechanical link with a firing member, a closure member, or an articulation member. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, articulation links, closure tubes, and shafts. External influences are unmeasured, unpredictable effects of things such as tissue, surrounding body and friction on a physical system. Such external effects may be referred to as drag forces, which act against one of the electric motors 704a-704e. External influences such as drag forces may cause the operation of the physical system to deviate from the desired operation of the physical system.
In one aspect, the position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may include a magnetic rotational absolute positioning system implemented AS an AS5055EQFT monolithic magnetic rotational position sensor, which is commercially available from australian microelectronics (Austria Microsystems, AG). Position sensor 734 interfaces with controller 710 to provide an absolute positioning system. The location may include a hall effect element located above the magnet and coupled to a CORDIC processor, also known as a bitwise method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions that require only addition operations, subtraction operations, digital displacement operations and table lookup operations.
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 various derived parameters, such as gap distance versus time, tissue compression and time, and anvil strain and time. The sensors 738 may include magnetic sensors, magnetic field sensors, strain gauges, load sensors, pressure sensors, force sensors, torque sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensor for measuring one or more parameters of the end effector 702. The sensor 738 may include one or more sensors. A sensor 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 forces such as firing forces, closing forces, and/or articulation forces, and the like. Thus, 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) the portion of the ultrasonic blade 718 having tissue thereon, and (4) the load and position on the two articulation rods.
In one aspect, the one or more sensors 738 may include a strain gauge, such as a micro-strain gauge, configured to be able to measure the magnitude of strain in the clamp arm 716 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 738 may comprise a pressure sensor configured to detect pressure generated by the presence of compressed tissue between the clamp arm 716 and the ultrasonic blade 718. The sensor 738 may be configured to detect an impedance of a tissue section located between the clamp arm 716 and the ultrasonic blade 718, which is indicative of a thickness and/or a degree of filling of tissue located therebetween.
In one aspect, the sensor 738 may be implemented as one or more limit switches, electromechanical devices, solid state switches, hall effect devices, magnetoresistive (MR) devices, giant Magnetoresistive (GMR) devices, magnetometers, and the like. In other implementations, the sensor 738 may be implemented as a solid state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and so forth. Also, the switch may be a solid state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar transistor, etc.). In other implementations, the sensors 738 may include non-electrical conductor switches, ultrasonic switches, accelerometers, inertial sensors, and the like.
In one aspect, the sensor 738 may be configured to measure the force exerted by the closure drive system on the clamp arm 716. For example, one or more sensors 738 may be located at the point of interaction between the closure tube and the clamp arm 716 to detect the closing force applied by the closure tube to the clamp arm 716. The force exerted on the clamping arm 716 may be indicative of the tissue compression experienced by the section of tissue captured between the clamping arm 716 and the ultrasonic blade 718. One or more sensors 738 may be positioned at various points of interaction along the closure drive system to detect the closing force applied to the clamp arm 716 by the closure drive system. The one or more sensors 738 may be sampled in real time by the processor of the control circuit 710 during the clamping operation. Control circuitry 710 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to clamp arm 716 in real-time.
In one aspect, a current sensor 736 may be used to measure the current consumed by each of the motors 704a-704 e. The force required to advance any of the movable mechanical elements, such as the closure member 714, corresponds to the current consumed by one of the motors 704a-704 e. The force is converted to a digital signal and provided to the processor 710. Control circuitry 710 may be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member may be actuated to move the closure member 714 in the end effector 702 at or near a target speed. Robotic surgical system 700 may include a feedback controller, which may be one of any feedback controllers including, but not limited to, for example, PID, state feedback, linear square (LQR), and/or adaptive controllers. The robotic surgical instrument 700 may include a power source to convert signals from a feedback controller into physical inputs, such as housing voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force, for example. Additional details are disclosed in U.S. patent application Ser. No. 15/636,829, entitled closed loop speed control technique for robotic surgical instruments (CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT), filed on publication No. 6/29, 2017, which is incorporated herein by reference in its entirety.
Fig. 18 illustrates a schematic view of a surgical instrument 750 configured to control distal translation of a displacement member, according to one aspect of the present disclosure. In one aspect, the surgical instrument 750 is programmed to control distal translation of a displacement member, such as the closure member 764. The surgical instrument 750 includes an end effector 752, which end effector 752 can include 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, such as the closure member 764, may be measured by an absolute positioning system, a sensor arrangement, and a position sensor 784. Since the closure member 764 is coupled to the longitudinally movable drive member, the position of the closure member 764 can be determined by measuring the position of the longitudinally movable drive member with the position sensor 784. Thus, in the following description, the position, displacement, and/or translation of the closure member 764 may be achieved by the position sensor 784 described herein. The control circuit 760 may be programmed to control translation of a displacement member, such as the closure member 764. In some examples, the control circuit 760 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the one or more processors to control the displacement member (e.g., the closure member 764) in the manner described. In one aspect, timer/counter 781 provides an output signal, such as a time elapsed or a digital count, to control circuit 760 to correlate the position of closure member 764 as determined by position sensor 784 with the output of timer/counter 781 so that control circuit 760 can determine the position of closure member 764 at a particular time (t) relative to the starting position. Timer/counter 781 may be configured to be able to measure elapsed time, count external events, or time external events.
Control circuit 760 may generate motor set point signal 772. The motor set point signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to provide motor drive signals 774 to the motor 754 to drive the motor 754, as described herein. In some examples, motor 754 may be a brushed DC electric motor. For example, the speed of motor 754 may be proportional to motor drive signal 774. In some examples, motor 754 may be a brushless DC electric motor and motor drive signal 774 may include a PWM signal provided to one or more stator windings of motor 754. Also, in some examples, the motor controller 758 may be omitted and the control circuit 760 may directly generate the motor drive signal 774.
The motor 754 may receive power from an energy source 762. The energy source 762 may be or include a battery, supercapacitor, 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 devices to couple the motor 754 to the closure member 764. The position sensor 784 may sense the position of the closure member 764. The position sensor 784 may be or include any type of sensor capable of generating position data indicative of the 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, proximity sensors. Other types of position sensors may provide other signals indicative of the movement of the closure member 764. Also, in some examples, the position sensor 784 may be omitted. In the case 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 perform. The position sensor 784 may be located in the end effector 752 or at any other portion of the instrument.
Control circuitry 760 can be in communication with one or more sensors 788. The sensor 788 may be positioned on the end effector 752 and adapted to operate with the surgical instrument 750 to measure various derived parameters such as gap distance and time, tissue compression and time, and anvil strain and time. The sensor 788 may include, for example, 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 sensor 788 may include one or more sensors.
In some cases, the one or more sensors 788 may include a strain gauge, such as a micro-strain gauge, configured to be able to measure a magnitude of strain in the clamp arm 766 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 788 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between the clamp arm 766 and the ultrasonic blade 768. The sensor 788 may be configured to detect an impedance of a tissue segment located between the clamp arm 766 and the ultrasonic blade 768 that is indicative of a thickness and/or a degree of filling of tissue located therebetween.
The sensor 788 may be configured to measure the force exerted by the closure drive system on the clamp arm 766. For example, one or more sensors 788 may be located at an interaction point between the closure tube and the clamp arm 766 to detect a closing force applied by the closure tube to the clamp arm 766. The force exerted on the clamp arm 766 may be indicative of the tissue compression experienced by the section of tissue captured between the clamp arm 766 and the ultrasonic blade 768. One or more sensors 788 may be positioned at various points of interaction along the closure drive system to detect the closing force applied by the closure drive system to the clamp arm 766. The one or more sensors 788 may be sampled in real time by the processor of the control circuit 760 during a clamping operation. The control circuit 760 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to the clamp arm 766 in real-time.
The current sensor 786 may be used to measure the current drawn by the motor 754. The force required to advance the closure member 764 may correspond to, for example, the current consumed by the motor 754. The force is converted to a digital signal and provided to control circuitry 760.
The control circuitry 760 may be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member may be actuated to move the closure member 764 in the end effector 752 at or near the target speed. Surgical instrument 750 may include a feedback controller, which may be one of any feedback controllers including, but not limited to, for example, PID, status feedback, LQR, and/or adaptive controllers. The surgical instrument 750 may include a power source to convert signals from a feedback controller into physical inputs, such as housing 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 through a brushed DC motor having a gear box and mechanical link with an articulation and/or knife system. Another example is an electric motor 754 that operates a displacement member and an articulation driver, such as an interchangeable shaft assembly. External influences are unmeasured, unpredictable effects of things such as tissue, surrounding body and friction on a physical system. Such external effects may be referred to as drag forces acting against the electric motor 754. External influences such as drag forces may cause the operation of the physical system to deviate from the desired operation of the physical system.
Various example aspects relate to a surgical instrument 750 that includes an end effector 752 having a motor-driven surgical seal and cut implementation. For example, the motor 754 may drive the displacement member distally and proximally along a longitudinal axis of the end effector 752. The end effector 752 may include a pivotable clamp arm 766 and, when configured for use, the ultrasonic blade 768 is positioned opposite the clamp arm 766. The clinician may grasp tissue between the clamp arm 766 and the ultrasonic blade 768 as described herein. When the instrument 750 is ready to be used, 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 a longitudinal axis of the end effector 752 from a proximal stroke start position to an end-of-stroke position distal of the stroke start position. As the displacement member translates distally, the closure member 764 with the cutting element positioned at the distal end may cut tissue between the ultrasonic blade 768 and the clamp arm 766.
In various examples, the surgical instrument 750 may include a control circuit 760, which control circuit 760 is programmed to control distal translation of a displacement member (such as the closure member 764) based on one or more tissue conditions. The control circuit 760 may be programmed to directly or indirectly sense tissue conditions, such as thickness, as described herein. Control circuitry 760 may be programmed to select a control program based on tissue conditions. The control program may describe distal movement of the displacement member. Different control programs may be selected to better address 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 speed 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 speed and/or with a higher power.
In some examples, control circuit 760 may operate motor 754 initially in an open loop configuration for a first open loop portion of the travel of the displacement member. Based on the response of the instrument 750 during the open loop portion of the stroke, the control circuit 760 may select a firing control routine. The response of the instrument may include the sum of the translational distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy provided to the motor 754 during the open loop portion, the pulse width of the motor drive signal, and the like. After the open loop portion, the control circuit 760 may implement a selected firing control routine for a second portion of the displacement member travel. For example, during a closed-loop portion of the stroke, the control circuit 760 may adjust the motor 754 based on translation data describing the position of the displacement member in a closed-loop manner to translate the displacement member at a constant speed. Additional details are disclosed in U.S. patent application Ser. No. 15/720,852, entitled System and method for controlling a display of a surgical instrument (SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT), filed on publication No. 9/29 of 2017, which is incorporated herein by reference in its entirety.
Fig. 19 is a schematic view of a surgical instrument 790 configured to control various functions in accordance with an aspect of the present 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 includes an end effector 792, which end effector 792 may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768, which ultrasonic blade 768 may be interchanged with or work in conjunction with one or more RF electrodes 796 (shown in phantom). The ultrasonic blade 768 is coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.
In one aspect, the sensor 788 may be implemented as a limit switch, an electromechanical device, a solid state switch, a hall effect device, an MR device, a GMR device, a magnetometer, or the like. In other implementations, the sensor 638 may be implemented as a solid state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and so forth. Also, the switch may be a solid state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar transistor, etc.). In other implementations, the sensor 788 may include a no-electrical-conductor switch, an ultrasonic switch, an accelerometer, an inertial sensor, and so forth.
In one aspect, the position sensor 784 may be implemented AS an absolute positioning system including a single-piece magnetic rotational position sensor implemented AS5055EQFT, which is available from australian microelectronics (Austria Microsystems, AG). Position sensor 784 may interface with controller 760 to provide an absolute positioning system. The location may include a hall effect element located above the magnet and coupled to a CORDIC processor, also known as a bitwise method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions that require only addition operations, subtraction operations, digital displacement operations and table lookup operations.
In some examples, the position sensor 784 may be omitted. In the case 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 perform. The position sensor 784 may be located in the end effector 792 or at any other portion of the instrument.
Control circuitry 760 can be in communication with one or more sensors 788. The sensor 788 may be positioned on the end effector 792 and adapted to operate with the surgical instrument 790 to measure various derived parameters, such as gap distance and time, tissue compression and time, and anvil strain and time. The sensor 788 may include, for example, 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 sensor 788 may include one or more sensors.
The RF energy source 794 is coupled to the end effector 792 and the RF energy source 794 is applied to the RF electrode 796 when the RF electrode 796 is disposed in the end effector 792 to replace the ultrasonic blade 768 or work in conjunction with the ultrasonic blade 768. For example, ultrasonic blades are made of conductive metal and can be used as a return path for electrosurgical RF current. Control circuitry 760 controls the delivery of RF energy to RF electrode 796.
Additional details are disclosed in U.S. patent application Ser. No. 15/636,096, filed on 6/28 at 2017, entitled surgical System coupleable with a staple cartridge and a RADIO FREQUENCY cartridge, and methods of use thereof (SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME), which is incorporated herein by reference in its entirety.
Generator hardware
Adaptive ultrasonic blade control algorithm
In various aspects, the intelligent ultrasonic energy apparatus may include an adaptive algorithm for controlling the operation of the ultrasonic blade. In one aspect, the ultrasonic blade adaptive control algorithm is configured to be able to identify tissue type and adjust device parameters. In one aspect, the ultrasonic blade control algorithm is configured to be capable of parameterizing tissue types. The following section of the present disclosure describes an algorithm for detecting the collagen/elastic ratio of tissue to tune the amplitude of the distal tip of an ultrasonic blade. Various aspects of the intelligent ultrasonic energy apparatus are described herein in connection with, for example, fig. 1-94. Accordingly, the following description of the adaptive ultrasonic blade control algorithm should be read in connection with FIGS. 1-94 and the description associated therewith.
Tissue type identification and device parameter adjustment
In certain surgical procedures, it is desirable to employ an adaptive ultrasonic blade control algorithm. In one aspect, an adaptive ultrasonic blade control algorithm may be employed to adjust parameters of the ultrasonic device based on the type of tissue in contact with the ultrasonic blade. In one aspect, parameters of the ultrasonic device may be adjusted based on the position of tissue within the jaws of the ultrasonic end effector (e.g., the position of tissue between the clamp arm and the ultrasonic blade). The impedance of the ultrasonic transducer can be used to distinguish the percentage of tissue in the distal or proximal end of the end effector. The response of the ultrasound device may be based on the tissue type or the compressibility of the tissue. In another aspect, parameters of the ultrasound device may be adjusted based on the identified tissue type or parameterization. For example, the amplitude of the mechanical displacement of the distal tip of the ultrasonic blade may be tuned based on the ratio of collagen to elastin tissue detected during the tissue identification process. The ratio of collagen to elastin tissue can be measured using a variety of techniques, including Infrared (IR) surface reflectance and emissivity. The force applied to the tissue by the clamping arm and/or the stroke of the clamping arm creates a gap and compression. Electrical continuity across the electrode-equipped jaws may be employed to determine the percentage of jaws covered by tissue.
Fig. 20 is a system 800 configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including 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 be capable of executing one or more adaptive ultrasonic blade control algorithms 802 as described herein with reference to fig. 20. In another aspect, the device/instrument 235 is configured to be capable of executing one or more adaptive ultrasonic blade control algorithms 804 as described herein with reference to fig. 20. In another aspect, both the device/instrument 235 and the device/instrument 235 are configured to be capable of executing the adaptive ultrasonic blade control algorithms 802, 804 as described herein with reference to fig. 20.
The generator module 240 may include a patient isolation stage in communication with a non-isolation stage via a power transformer. The secondary windings of the power transformer are contained in the isolation stage and may include a tap configuration (e.g., a center-tap or non-center-tap configuration) to define drive signal outputs for delivering drive signals to different surgical instruments, such as, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and multi-functional surgical instruments including ultrasonic energy modes and RF energy modes that can be delivered separately or simultaneously. Specifically, the drive signal output may output an ultrasonic drive signal (e.g., 420V Root Mean Square (RMS) drive signal) to the ultrasonic surgical instrument 241, and the drive signal output may output an RF electrosurgical drive signal (e.g., 100V RMS drive signal) to the RF electrosurgical instrument 241. Aspects of the generator module 240 are described herein with reference to fig. 21-28B.
The generator module 240 or the device/instrument 235 or both are coupled to a modular control tower 236, which modular control tower 236 is connected to a plurality of operating room devices such as, for example, intelligent surgical instruments, robots, and other computerized devices located in an operating room, as described with reference to fig. 8-11, for example.
FIG. 21 shows a hairAn example of a generator 900 is one form of a generator configured to be coupled to an ultrasonic instrument and further configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub, as shown in fig. 20. Generator 900 is configured to deliver a plurality of energy modalities to a surgical instrument. Generator 900 provides an RF signal and an ultrasonic signal for delivering energy to the surgical instrument independently or simultaneously. The RF signal and the ultrasonic signal may be provided separately or in combination, and may be provided simultaneously. As described above, at least one generator output may deliver multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation and/or microwave energy, etc.) through a single port, and these signals may be delivered separately or simultaneously to an end effector to treat tissue. Generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and the waveform generator 904 are configured to be able to generate various signal waveforms based on information stored in a memory coupled to the processor 902, which is not shown for clarity of this disclosure. The digital information associated with the waveform is provided to a waveform generator 904, which waveform generator 904 includes one or more DAC circuits to convert the digital input to an analog output. The analog output is fed to an amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 906 is coupled to a power transformer 908. The signal is coupled to a secondary side of the patient isolated side through a power transformer 908. A first signal of a first ENERGY modality is provided to a signal labeled ENERGY 1 And a surgical instrument between the terminals of RETURN. A second signal of a second ENERGY modality is coupled across capacitor 910 and provided to a capacitor labeled enable 2 And a surgical instrument between the terminals of RETURN. It should be appreciated that more than two ENERGY modes may be output, and thus the subscript "n" may be used to designate that up to n ENERGY may be provided n A terminal, wherein n is a positive integer greater than 1. It should also be appreciated that up to n RETURN paths RETURN may be provided without departing from the scope of the present disclosure n
First voltage sense circuit 912 is coupled to a voltage source labeled ENERGY 1 And both ends of the terminal of the RETURN path to measure the output voltage therebetween. Second voltage sensing circuit 924 is coupled to a voltage source labeled ENERGY 2 And both ends of the terminal of the RETURN path to measure the output voltage therebetween. As shown, a current sensing circuit 914 is provided in series with the RETURN leg on the secondary side of the power transformer 908 to measure the output current of either energy mode. If a different return path is provided for each energy modality, a separate current sensing circuit should be provided in each return branch. 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 the other isolation transformer 918. The output of the isolation transformers 916, 928, 922 on the primary side of the power transformer 908 (non-patient isolated side) is provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and computation. Output voltage and output current feedback information may be used to adjust the output voltage and current provided to the surgical instrument and calculate output impedance, among other parameters. Input/output communications between the processor 902 and patient isolation circuitry are provided through interface circuitry 920. The sensor may also be in electrical communication with the processor 902 through the interface 920.
In one aspect, the impedance may be determined by processor 902 by coupling a signal labeled ENERGY 1 First voltage sensing circuit 912 across the terminals of RETURN or coupled to a voltage source labeled ENERGY 2 The output of the second voltage sensing circuit 924 across the terminals of RETURN is divided by the output of the current sensing circuit 914 placed in series with the RETURN leg on the secondary side of the power transformer 908. The outputs of the first and second voltage sensing circuits 912, 924 are provided to separate isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to the other isolation transformer 916. The digitized voltage and current sense measurements from ADC circuit 926 are provided to processor 902 for use in calculating impedance. For example, a first ENERGY modality ENERGY 1 Can be ultrasonic ENERGY, and a second ENERGY mode ENERGY 2 May be RF energy. However, in addition to ultrasound and bipolar or monopolar RF energy modesOther energy modalities include, among others, irreversible and/or reversible electroporation and/or microwave energy. Moreover, while the example shown in fig. 21 illustrates that a single RETURN path RETURN may be provided for two or more ENERGY modes, in other aspects, ENERGY may be provided for each ENERGY mode n Providing multiple RETURN paths n . Thus, as described herein, the ultrasound transducer impedance may be measured by dividing the output of the first voltage sensing circuit 912 by the output of 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 output of the current sensing circuit 914.
As shown in fig. 21, a generator 900 including at least one output port may include a power transformer 908 having a single output and multiple taps to provide power to the end effector in one or more energy modes (such as ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, etc.), for example, depending on the type of tissue treatment being performed. For example, generator 900 may deliver energy with a higher voltage and lower current to drive an ultrasound transducer, a lower voltage and higher current to drive an RF electrode for sealing tissue, or a coagulation waveform for use with monopolar or bipolar RF electrosurgical electrodes. The output waveform from generator 900 may be manipulated, switched, or filtered to provide a frequency to the end effector of the surgical instrument. The connection of the ultrasound transducer to the output of generator 900 will preferably be located at what is labeled ENERGY 1 And the output of RETURN, as shown in fig. 21. In one example, the connection of the RF bipolar electrode to the generator 900 output will preferably be located at what is labeled ENERGY 2 And the output of RETURN. In the case of monopolar output, the preferred connection would be an active electrode (e.g., cone of light (pencil) or other probe) to ENERGY 2 And a suitable RETURN pad output and connected to the RETURN output.
Additional details are disclosed in U.S. patent application publication 2017/0086914 entitled techniques for operating a generator and housing instrument for digitally generating electrical signal waveforms (TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS), published at 30/3/2017, which is incorporated herein by reference in its entirety.
As used throughout this specification, 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 mean that the associated organizations do not contain any wires, although in some aspects they may not. The communication module may implement any of a variety of wireless or wired communication standards or protocols, including, but not limited to, wi-Fi (IEEE 802.11 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, and ethernet derivatives thereof, and any other wireless and wired protocol computing modules designated 3G, 4G, 5G, and above, may include a plurality of communication modules. For example, 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, etc.
As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source (typically memory or some other data stream). The term as used herein refers to a central processor (central processing unit) in one or more systems, especially a system on a chip (SoC), that combine multiple specialized "processors".
As used herein, a system-on-chip or system-on-chip (SoC or SoC) is an integrated circuit (also referred to as an "IC" or "chip") that integrates all of the devices of a computer or other electronic system. It may contain digital, analog, mixed signal and typically radio frequency functions-all on a single substrate. The SoC integrates a microcontroller (or microprocessor) with advanced peripheral devices such as a Graphics Processing Unit (GPU), wi-Fi module, or coprocessor. The SoC may or may not contain built-in memory.
As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuitry and memory. The microcontroller (or MCU of the microcontroller unit) may be implemented as a small computer on a single integrated circuit. It may be similar to a SoC; the SoC may include a microcontroller as one of its devices. The microcontroller may include one or more Core Processing Units (CPUs), memory and programmable input/output peripherals. Program memory in the form of ferroelectric RAM, NOR flash memory or OTP ROM, as well as small amounts of RAM are often included on the chip. Microcontrollers may be used in embedded applications, as opposed to microprocessors used in personal computers or other general purpose applications consisting of various discrete chips.
As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with peripheral devices. This may be a link between two components of a computer or a controller on an external device for managing the operation of (and connection to) the device.
Any of the processors or microcontrollers as described herein may be any single or multi-core processor, such as those provided by texas instruments (Texas Instruments) under the trade name ARM Cortex. In one aspect, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from texas instruments (Texas Instruments), comprising: on-chip memory of 256KB single-cycle flash memory or other non-volatile memory (up to 40 MHz), prefetch buffer for improving performance beyond 40MHz, 32KB single-cycle Serial Random Access Memory (SRAM), load withInternal read-only memory (ROM) of software, electrically erasable programmable read-only memory (EEPROM) of 2KB, one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Input (QEI) analog, one or more 12-bit analog-to-digital converters (ADC) with 12 analog input channels, and other features that are readily available.
In one example, the processor may include a security controller that includes two controller-based families, such as TMS570 and RM4x, also provided by texas instruments (Texas Instruments) under the trade name Hercules ARM Cortex R4. The security controller may be configured specifically for IEC 61508 and ISO 26262 security critical applications, etc. to provide advanced integrated security features while delivering scalable performance, connectivity, and memory options.
The modular device includes modules (as described in connection with fig. 3 and 9) that may be housed within a surgical hub and a surgical device or instrument that may be connected to various modules for connection or mating with a corresponding surgical hub. Modular devices include, for example, smart surgical instruments, medical imaging devices, aspiration/irrigation devices, smoke ventilators, energy generators, ventilators, insufflators, and displays. The modular device described herein may be controlled by a control algorithm. The control algorithm may be executed on the modular device itself, on a surgical hub paired with a particular modular device, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). In some examples, the control algorithm of the modular device controls the device based on data sensed by the modular device itself (i.e., through sensors in, on, or connected to the modular device). The data may be related to the patient being operated on (e.g., tissue characteristics or insufflation pressure) or the modular device itself (e.g., rate at which the knife is advanced, motor current or energy level). For example, control algorithms for surgical stapling and severing instruments may control the rate at which a motor of the instrument drives its knife through tissue based on the resistance encountered by the knife as it advances.
Fig. 22 illustrates one form of a surgical system 1000 that includes a generator 1100 and various surgical instruments 1104, 1106, 1108 that may be used therewith, wherein the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multifunctional surgical instrument 1108 is a combination of ultrasonic/RF electrosurgical instruments. The generator 1100 may be configured for use with a variety of surgical devices. According to various forms, the generator 1100 may be configured for use with different surgical instruments of different types, including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multi-functional surgical instrument 1108 that integrates both RF energy and ultrasonic energy delivered simultaneously from the generator 1100. Although in the form of fig. 22, the generator 1100 is shown separate from the surgical instruments 1104, 1106, 1108, in one form the generator 1100 may be integrally formed with any of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. The generator 1100 includes an input device 1110 located on the front panel of the generator 1100 console. Input device 1110 may include any suitable device that generates signals suitable for programming the operation of generator 1100. The generator 1100 may be configured for wired or wireless communication.
The generator 1100 is configured to drive a plurality of surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104 and includes a handpiece 1105 (HP), an ultrasonic transducer 1120, a shaft 1126, and an end effector 1122. The end effector 1122 includes an ultrasonic blade 1128 and a clamp arm 1140 that are acoustically coupled to an ultrasonic transducer 1120. The handpiece 1105 includes a combination of a trigger 1143 for operating the clamp arm 1140 and switch buttons 1134a, 1134b, 1134c for powering the ultrasonic blade 1128 and driving the ultrasonic blade 1128 or other functions. The toggle buttons 1134a, 1134b, 1134c may be configured to enable the ultrasound transducer 1120 to be powered by the generator 1100.
Generator 1100 is further configured to drive a second surgical instrument 1106. The second surgical instrument 1106 is an RF electrosurgical instrument and includes a handpiece 1107 (HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in the clamp arms 1142a, 1142b and returns through the electrical conductor portion of the shaft 1127. These electrodes are coupled to and energized by a bipolar energy source within the generator 1100. The handpiece 1107 includes a trigger 1145 for operating the clamp arms 1142a, 1142b and an energy button 1135 for actuating an energy switch to energize electrodes in the end effector 1124.
The generator 1100 is further configured to drive a multi-function surgical instrument 1108. The multifunction surgical instrument 1108 includes a handpiece 1109 (HP), a shaft 1129, and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. Ultrasonic blade 1149 is acoustically coupled to ultrasonic transducer 1120. The handpiece 1109 includes a combination of a trigger 1147 for operating the clamp arm 1146 and switch buttons 1137a, 1137b, 1137c for powering the ultrasonic blade 1149 and driving the ultrasonic blade 1149 or other functions. The toggle buttons 1137a, 1137b, 1137c may be configured to power the ultrasonic transducer 1120 with the generator 1100 and the ultrasonic blade 1149 with a bipolar energy source also contained within the generator 1100.
The generator 1100 may be configured for use with a variety of surgical devices. According to various forms, the generator 1100 may be configured for use with different surgical instruments of different types, including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multi-functional surgical instrument 1108 that integrates RF energy and ultrasonic energy simultaneously delivered from the generator 1100. Although in the form of fig. 22, the generator 1100 is shown separate from the surgical instruments 1104, 1106, 1108, in another form, the generator 1100 may be integrally formed with any of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. As discussed above, the generator 1100 includes an input device 1110 located on the front panel of the generator 1100 console. Input device 1110 may include any suitable device that generates signals suitable for programming the operation of generator 1100. The generator 1100 may also include one or more output devices 1112. Additional aspects of generators and surgical instruments for digitally generating electrical signal waveforms are described in U.S. patent publication US-2017-0086914-A1, which is incorporated herein by reference in its entirety.
Fig. 23 is an end effector 1122 of an example ultrasound device 1104 in accordance with at least one aspect of the present disclosure. The end effector 1122 may include a blade 1128, which blade 1128 may be coupled to an ultrasonic transducer 1120 via a waveguide. Blade 1128 may vibrate when driven by ultrasonic transducer 1120 and may cut and/or coagulate tissue when in contact with tissue, as described herein. According to various aspects, and as shown in fig. 23, the end effector 1122 may further comprise a clamp arm 1140 that may be configured to act in concert with the blade 1128 of the end effector 1122. With the blade 1128, the clamping arm 1140 can include a set of jaws. The clamping arm 1140 mayPivotally connected at a distal end of shaft 1126 of instrument portion 1104. The clamp arm 1140 may include a clamp arm tissue pad 1163, the clamp arm tissue pad 1163 may be formed fromOr other suitable low friction material. The pad 1163 may be mounted for cooperation with the knife 1128, wherein pivotal movement of the clamp arm 1140 positions the clamp pad 1163 generally parallel to and in contact with the knife 1128. With this configuration, tissue to be clamped may be grasped between the tissue pad 1163 and the blade 1128. The tissue pad 1163 may have a serrated configuration including a plurality of axially spaced proximally extending grasping teeth 1161 to cooperate with the blades 1128 to enhance grasping of tissue. The clamp arm 1140 may be transitioned from the open position shown in fig. 23 to the closed position (with the clamp arm 1140 in contact with the blade 1128 or in proximity to the blade 1128) in any suitable manner. For example, the handpiece 1105 may include a jaw closure trigger. The jaw closure trigger, when actuated by the clinician, may pivot the clamping arm 1140 in any suitable manner.
The generator 1100 may be activated to provide a drive signal to the transducer 1120 in any suitable manner. For example, the generator 1100 may include a foot switch 1430 (fig. 24), the foot switch 1430 being coupled to the generator 1100 via a foot switch cable 1432. The clinician may activate the ultrasound transducer 1120 by depressing the foot switch 1430 and thereby activate the ultrasound transducer 1120 and blade 1128. In addition to, or in lieu of, the foot switch 1430, some aspects of the device 1104 may utilize one or more switches positioned on the handpiece 1105 that, when activated, may cause the generator 1100 to activate the transducer 1120. In one aspect, for example, the one or more switches may include a pair of switch buttons 1134a, 1134b, 1134c (fig. 22), for example, to determine the mode of operation of the device 1104. When the toggle button 1134a is depressed, for example, the ultrasonic generator 1100 can provide a maximum drive signal to the transducer 1120, causing it to produce a maximum ultrasonic energy output. Depressing the toggle button 1134b may cause the ultrasonic generator 1100 to provide a user-selectable drive signal to the ultrasonic transducer 1120, causing it to produce an ultrasonic energy output that is less than a maximum value. Additionally or alternatively, the device 1104 can include a second switch to indicate, for example, a position of a jaw closure trigger for operating the jaws via the clamping arm 1140 of the end effector 1122. Further, in some aspects, the ultrasonic generator 1100 can be activated based on the position of the jaw closure trigger (e.g., ultrasonic energy can be applied when a clinician depresses the jaw closure trigger to close the jaws via the clamping arm 1140).
Additionally or alternatively, one or more switches may include a toggle button 1134c that, when depressed, causes the generator 1100 to provide a pulsed output (fig. 22). The pulses may be provided, for example, at any suitable frequency and grouping. In certain aspects, for example, the power level of the pulse may be the power level (maximum, less than maximum) associated with the toggle buttons 1134a, 1134b.
It should be appreciated that the device 1104 may include any combination of toggle buttons 1134a, 1134b, 1134c (fig. 22). For example, the device 1104 may be configured to have only two toggle buttons: a toggle button 1134a for generating a maximum ultrasonic energy output and a toggle button 1134c for generating a pulsed output at or below a maximum power level. Thus, the drive signal output configuration of the generator 1100 may be five continuous signals, or any discrete number of single pulse signals (1, 2, 3, 4, or 5). In certain aspects, the particular drive signal configuration may be controlled, for example, based on EEPROM settings and/or one or more user power level selections in generator 1100.
In certain aspects, a two-position switch may be provided in place of toggle button 1134c (fig. 22). For example, the device 1104 may include a toggle button 1134a and a two-position toggle button 1134b for generating a continuous output at a maximum power level. In the first detent position, the toggle button 1134b may generate a continuous output that is less than the maximum power level, and in the second detent position, the toggle button 1134b may generate a pulsed output (e.g., at or less than the maximum power level, depending on the EEPROM setting).
In some aspects, the RF electrosurgical end effectors 1124, 1125 (fig. 22) may also include a pair of electrodes. The electrodes may be in communication with the generator 1100, for example, via a cable. The electrodes may be used, for example, to measure the impedance of tissue bite existing between the clamp arms 1142a, 1146 and the blades 1142b, 1149. The generator 1100 may provide a signal (e.g., a non-therapeutic signal) to the electrode. For example, the impedance of tissue occlusion may be found by monitoring the current, voltage, etc. of the signal.
In various aspects, the generator 1100 may include several independent functional elements, such as modules and/or blocks, as shown in the illustrations of the surgical system 1000 of fig. 24, 22. Different functional elements or modules may be configured to drive different kinds of surgical devices 1104, 1106, 1108. For example, the ultrasonic generator module may drive an ultrasonic device, such as ultrasonic surgical device 1104. The electrosurgical/RF generator module may drive the electrosurgical device 1106. For example, the modules may generate respective drive signals for driving the surgical devices 1104, 1106, 1108. In various aspects, the ultrasound generator module and/or the electrosurgical/RF generator module may each be integrally formed with the generator 1100. Alternatively, one or more of the modules may be provided as separate circuit modules electrically coupled to the generator 1100. (the modules are shown in phantom to illustrate this portion.) furthermore, in some aspects, the electrosurgical/RF generator module may be integrally formed with the ultrasound generator module, or vice versa.
According to the aspects, the ultrasonic generator module may generate one or more drive signals of a particular voltage, current, and frequency (e.g., 55,500 cycles per second or Hz). The one or more drive signals may be provided to the ultrasound device 1104, particularly the transducer 1120, which may operate, for example, as described above. In one aspect, the generator 1100 may be configured to generate a drive signal capable of generating a particular voltage, current, and/or frequency output signal that may be modified in terms of high resolution, accuracy, and reproducibility.
According to the aspects, the electrosurgical/RF generator module may generate one or more drive signals having an output power sufficient to perform bipolar electrosurgery using Radio Frequency (RF) energy. In bipolar electrosurgical applications, a drive signal may be provided to, for example, the electrodes of the electrosurgical device 1106, as described above. Thus, the generator 1100 can be configured for therapeutic purposes by applying electrical energy to tissue sufficient to treat tissue (e.g., coagulate, cauterize, tissue weld, etc.).
The generator 1100 may include an input device 2150 (fig. 27B) located on a front panel of, for example, a console of the generator 1100. Input device 2150 may include any suitable device that generates signals suitable for programming the operation of generator 1100. In operation, a user may program or otherwise control the operation of generator 1100 using input device 2150. The input device 2150 may include any suitable device that generates signals that may be used by the generator (e.g., by one or more processors included in the generator) to control the operation of the generator 1100 (e.g., the operation of the ultrasound generator module and/or the electrosurgical/RF generator module). In various aspects, the input device 2150 includes one or more of the following: buttons, switches, thumbwheels, keyboards, keypads, touch screen monitors, pointing devices, remote connections to general purpose or special purpose computers. In other aspects, the input device 2150 may include, for example, a suitable user interface such as one or more user interface screens displayed on a touch screen monitor, for example. Thus, through the input device 2150, a 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 one or more drive signals generated by the ultrasound generator module and/or the electrosurgical/RF generator module.
The generator 1100 may also include an input device 2140 (fig. 27B) located on a front panel of, for example, the generator 1100 console. The output device 2140 includes one or more devices for providing sensory feedback to a user. Such devices may include, for example, visual feedback devices (e.g., LCD display screens, LED indicators), audio feedback devices (e.g., speakers, buzzers), or haptic feedback devices (e.g., haptic actuators).
While certain modules and/or blocks of the generator 1100 may be described by way of example, it is to be understood that a greater or lesser number of modules and/or blocks may be used and still fall within the scope of the described aspects. Moreover, while various aspects may be described in terms of modules and/or blocks for ease of illustration, such modules and/or blocks may be implemented by one or more hardware devices (e.g., processors, digital Signal Processors (DSPs), programmable Logic Devices (PLDs), application Specific Integrated Circuits (ASICs), circuits, registers) and/or software devices (e.g., programs, subroutines, logic), and/or combinations of hardware and software devices.
In one aspect, the ultrasound generator drive module and the electrosurgical/RF drive module 1110 (fig. 22) can include one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. The modules may include various executable modules, such as software, programs, data, drivers, application Program Interfaces (APIs), and the like. The firmware may be stored in a non-volatile memory (NVM), such as bit-masked Read Only Memory (ROM) or flash memory. In various implementations, storing the firmware in ROM may protect the flash memory. The NVM may include 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).
In one aspect, the module includes a hardware device implemented as a processor for executing program instructions for monitoring various measurable characteristics of the devices 1104, 1106, 1108 and generating corresponding output drive signals for operating the devices 1104, 1106, 1108. In aspects in which the generator 1100 is used in conjunction with the device 1104, the drive signals may drive the ultrasonic transducer 1120 in a cutting and/or coagulating mode of operation. The electrical characteristics of the device 1104 and/or tissue may be measured and used to control operational aspects of the generator 1100 and/or may be provided as feedback to a user. In aspects in which the generator 1100 is used in conjunction with the device 1106, the drive signal can supply electrical energy (e.g., RF energy) to the end effector 1124 in a cutting, coagulation, and/or dehydration mode. The electrical characteristics of the device 1106 and/or tissue may be measured and used to control an operational aspect of the generator 1100 and/or may be provided as feedback to a user. In various aspects, as described above, the hardware devices 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 step function output signals for driving the various components of the devices 1104, 1106, 1108 (e.g., the ultrasonic transducer 1120 and the end effectors 1122, 1124, 1125).
An electromechanical ultrasound system includes an ultrasound transducer, a waveguide, and an ultrasound blade. The electromechanical ultrasound system has an initial resonant frequency defined by the physical characteristics of the ultrasound transducer, the waveguide, and the ultrasonic blade. The ultrasonic transducer being excited by an alternating voltage V g (t) Signal and Current I g The resonant frequency of the (t) signal is equal to the electromechanical ultrasound system. When the ultrasonic electromechanical system is at resonance, voltage V g (t) Signal and Current I g The phase difference between the (t) signals is zero. In other words, 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 equivalent capacitance) causes the resonant frequency of the electro-mechanical ultrasonic system to shift. Thus, the inductive impedance is no longer equal to the capacitive impedance, resulting in a mismatch between the driving frequency and the resonant frequency of the electromechanical ultrasound system. The system now runs "off-resonance". The mismatch between the drive frequency and the resonance frequency is manifested by a voltage V applied to the ultrasound transducer g (t) Signal and Current I g (t) phase differences between the signals. The generator electronics can easily monitor the voltage V g (t) and current I g (t) phase difference between the signals and the drive frequency can be continuously adjusted until the phase difference is again zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasound system. The change in phase and/or frequency may be used as an indirect measurement of the ultrasonic blade temperature.
As shown in fig. 25, the electromechanical properties of an ultrasound transducer can be modeled as an equivalent circuit comprising a first branch having a static capacitance and a second "dynamic" branch having series-connected inductance, resistance, and capacitance defining the electromechanical properties of the resonator. Known ultrasonic generators may include a tuning inductor for detuning a static capacitance at a resonant frequency such that substantially all of the drive signal current of the generator flows into the dynamic leg. Thus, by using a tuning inductor, the drive signal current of the generator is representative of the dynamic branch current, and thus the generator is able to control its drive signal to maintain the resonant frequency of the ultrasound transducer. Tuning the inductor may also transform the phase-impedance diagram of the ultrasound transducer to improve the frequency locking capability of the generator. However, the tuning inductor must be matched to the particular static capacitance of the ultrasound transducer at the operating resonant frequency. In other words, different ultrasound transducers with different static capacitances require different tuning inductors.
Fig. 25 illustrates an equivalent circuit 1500 of an ultrasound transducer, such as ultrasound transducer 1120, according to an aspect. The circuit 1500 includes a series connected inductor L with an electromechanical characteristic defining a resonator s Resistance R s And capacitor C s A first "dynamic" branch of (C) and a second capacitive branch with static capacitance C 0 . Can be at the driving voltage V g Receiving a drive current I from the generator at (t) g (t) wherein the dynamic current I m (t) flow through the first branch and current I g (t)-I m (t) flow through the capacitive branch. By appropriately controlling I g (t) and V g (t) effecting control of the electromechanical properties of the ultrasound transducer. As described above, known generator architectures may include a tuning inductor L in a parallel resonant circuit t (shown in phantom in fig. 25) for coupling the static capacitance C 0 Tuned to a resonant frequency such that substantially the current output I of the generator g All flow in (t) passes through the dynamic leg. In this way, by controlling the generator current output I g (t) implementing the dynamic branch current I m Control of (t). However, tuning inductor L t Static capacitance C for ultrasonic transducer 0 Is specific and different ultrasound transducers with different static capacitances require different tuning inductors L t . In addition, because of the tuning inductor L t At a single resonant frequency with static capacitance C 0 So that the dynamic branch current I is ensured only at this frequency m (t)And (5) accurately controlling. As the frequency shifts downward with the passage of transducer temperature, precise control of the dynamic arm current is compromised.
Various aspects of the generator 1100 may not rely on tuning the inductor L t To monitor dynamic branch current I m (t). Conversely, the generator 1100 may use an electrostatic capacitance C between the application of power for a particular ultrasonic surgical device 1104 0 To determine the dynamic branch current I on a dynamic travel basis (e.g., in real time) m The value of (t). Thus, such aspects of the generator 1100 can provide virtual tuning to simulate a tuned system or to interact with the capacitance C at any frequency 0 Any value of (2) resonates, not just at static capacitance C 0 Is resonant at a single resonant frequency indicated by the nominal value of (c).
Fig. 26 is a simplified block diagram of one aspect of a generator 1100 that provides for inductor-less tuning, among other benefits, as described above. Fig. 27A-27C illustrate an architecture of the generator 1100 of fig. 26, according to an aspect. Referring to fig. 26, the generator 1100 may include a patient isolation stage 1520 that communicates with a non-isolation stage 1540 via a power transformer 1560. Secondary windings 1580 of power transformers 1560 are included in isolation stage 1520 and may include a tap configuration (e.g., a center-tap or non-center-tap configuration) to define drive signal outputs 1600a, 1600b, 1600c for outputting drive signals to different surgical devices (such as, for example, ultrasonic surgical device 1104 and electrosurgical device 1106). Specifically, the drive signal outputs 1600a, 1600b, 1600c may output drive signals (e.g., 420V RMS drive signals) to the ultrasonic surgical device 1104, and the drive signal outputs 1600a, 1600b, 1600c may output drive signals (e.g., 100V RMS drive signals) to the electrosurgical device 1106, with the output 1060b corresponding to a center tap of the power transformer 1560. The non-isolated stage 1540 may include a power amplifier 1620, the power amplifier 1620 having an output connected to a primary winding 1640 of a power transformer 1560. In certain aspects, the power amplifier 1620 may comprise, for example, a push-pull amplifier. The non-isolated stage 1540 may further include a programmable logic device 1660, the programmable logic device 1660 being configured to supply 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, programmable logic device 1660 may comprise, for example, a Field Programmable Gate Array (FPGA). Because the input of power amplifier 1620 is controlled via DAC 1680, programmable logic device 1660 can thus control any of a plurality of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signals that appear at drive signal outputs 1600a, 1600b, 1600 c. In certain aspects and as described below, programmable logic device 1660, in conjunction with a processor (e.g., processor 1740 described below), can implement a plurality of Digital Signal Processing (DSP) based algorithms and/or other control algorithms to control parameters of the drive signals output by generator 1100.
Power may be supplied to the power rail of the power amplifier 1620 by the switch mode regulator 1700. In certain aspects, the switch mode regulator 1700 may comprise, for example, an adjustable buck regulator. As described above, the non-isolated stage 1540 may further include a processor 1740, which processor 1740 may include, in one aspect, a DSP processor such as an ADSP-21469SHARC DSP, available from Analog Devices, norwood, mass, for example, norwood, ma. In certain aspects, the processor 1740 may control operation of the switch-mode power converter 1700 in response to voltage feedback data received by the processor 1740 from the power amplifier 1620 via an analog-to-digital converter (ADC) 1760. In one aspect, for example, the processor 1740 may receive as input the waveform envelope of a signal (e.g., an RF signal) being amplified by the power amplifier 1620 via the ADC 1760. Processor 1740 may then control the switch-mode regulator 1700 (e.g., via Pulse Width Modulation (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 increased relative to a fixed rail voltage amplifier scheme. Processor 1740 may be configured for wired or wireless communication.
In certain aspects and as discussed in greater detail in connection with fig. 28A-28B, programmable logic device 1660, in conjunction with processor 1740, can implement a Direct Digital Synthesizer (DDS) control scheme to control the waveform shape, frequency, and/or amplitude of the drive signals output by generator 1100. In one aspect, for example, programmable logic device 1660 may implement DDS control algorithm 2680 (fig. 28A) by retrieving (retrieving) waveform samples stored in a dynamically updated look-up table (LUT), such as a RAM LUT that may be embedded in an FPGA. The control algorithm is particularly useful in ultrasound applications in which an ultrasound transducer, such as ultrasound transducer 1120, may be driven by a purely sinusoidal current at its resonant frequency. Minimizing or reducing the total distortion of the dynamic branch current may accordingly minimize or reduce adverse resonance effects, as other frequencies may excite parasitic resonances. Because the waveform shape of the drive signal output by the generator 1100 is affected by the various sources of distortion present in the output drive circuitry (e.g., power transformer 1560, power amplifier 1620), the voltage and current feedback data based on the drive signal may be input into an algorithm (such as an error control algorithm implemented by processor 1740) that compensates for the distortion by predistorting or modifying the waveform samples stored in the LUT on a dynamic travel basis as appropriate (e.g., in real time). In one form, the amount or degree of predistortion applied to the LUT samples may be based on an error between the calculated dynamic branch current and the desired current waveform shape, where the error may be determined on a sample-by-sample basis. In this manner, the predistorted LUT samples, when processed by the drive circuitry, may cause the dynamic arm drive signal to have a desired waveform shape (e.g., sinusoidal shape) to optimally drive the ultrasound transducer. Thus, in such aspects, when considering the distortion effects, the LUT waveform samples will thus not represent the desired waveform shape of the drive signal, but rather the waveform shape required to ultimately produce the desired waveform shape of the dynamic arm drive signal.
The non-isolated stage 1540 may further include an ADC 1780 and an ADC 1800, the ADC 1780 and ADC 1800 coupled to the output of the power transformer 1560 via respective isolation transformers 1820, 1840 for sampling the voltage and current, respectively, of the drive signal output by the generator 1100. In certain aspects, the ADCs 1780, 1800 may be configured to be capable of sampling at high speeds (e.g., 80 Msps) to enable oversampling of the drive signals. In one aspect, for example, the sampling rate of the ADCs 1780, 1800 may enable over-sampling of the drive signal by about 200X (depending on frequency). In certain aspects, the sampling operation of the ADCs 1780, 1800 may be performed by a single ADC that receives the input voltage signal and the current signal via a two-way multiplexer. By using high-speed sampling in aspects of the generator 1100, among other things, computation of complex currents flowing through the dynamic legs (which in some aspects may be used to implement the DDS-based waveform shape control described above), accurate digital filtering of the sampled signals, and computation of actual power consumption with high accuracy may be achieved. The voltage and current feedback data output by the ADCs 1780, 1800 may be received and processed (e.g., FIFO buffered, multiplexed) by the programmable logic device 1660 and stored in a data memory for subsequent retrieval by, for example, the DSP processor 1740. As described above, the voltage and current feedback data can be used as inputs to the algorithm for pre-distorting or modifying LUT waveform samples in a dynamic progression manner. In certain aspects, when voltage and current feedback data pairs are collected, this may entail indexing each stored voltage and current feedback data pair based on or otherwise associated with a corresponding LUT sample output by programmable logic device 1660. Synchronizing LUT samples and voltage and current feedback data in this manner helps in the accurate timing and stability of the predistortion algorithm.
In certain aspects, voltage and current feedback data may be used to control the frequency and/or amplitude (e.g., current amplitude) of the drive signal. In one aspect, for example, voltage and current feedback data may be used to determine an impedance phase, such as a phase difference between voltage and current drive signals. Subsequently, the frequency of the drive signal may be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0 °), thereby minimizing or reducing the effects of harmonic distortion and correspondingly improving the impedance phase measurement accuracy. The determination of the phase impedance and the frequency control signal may be implemented in the processor 1740, for example, with the frequency control signal supplied as input to a DDS control algorithm implemented by the programmable logic device 1660.
The impedance phase may be determined by fourier analysis. In one aspect, the generator voltage V may be determined using a Fast Fourier Transform (FFT) or a Discrete Fourier Transform (DFT) as follows g (t) drive signal and generator current I g (t) phase difference between drive signals:
evaluating the fourier transform at sinusoidal frequencies yields:
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other methods include weighted least squares estimation, kalman filtering, and space vector based techniques. For example, almost all of the processing in FFT or DFT techniques may be performed in the digital domain with the assistance of, for example, 2-channel high speed ADCs 1780, 1800. In one technique, digital signal samples of the voltage signal and the current signal are fourier transformed with an FFT or DFT. Can be calculated by the following formula Phase angle at any point in time
Wherein the method comprises the steps ofIs the phase angle, f is the frequency, t is the time, and +.>Is the phase at t=0.
For determining voltage V g (t) Signal and Current I g Another technique for the phase difference between (t) signals is the zero crossing method and produces very accurate results. For voltages V having the same frequency g (t) Signal and Current I g (t) signal, voltage signal V g Each of (t) negative to positive zero crossing triggers the onset of pulse, and current signal I g And (t) each negative-to-positive zero crossing triggers the end of the pulse. The result is a pulse train having 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 obtain a measure of the phase difference. Furthermore, if positive to negative zero crossings are also used in a similar manner, and the result averaged, any effect of DC and harmonic components can be reduced. In one implementation, the analog voltage V g (t) Signal and Current I g The (t) signal is converted into a digital signal which is high in the case that the analog signal is positive and low in the case that the analog signal is negative. High precision phase estimation requires sharp transitions between high and low values. In one aspect, a Schmitt trigger and an RC stabilization network may be employed to convert analog signals to digital signals. In other aspects, an edge-triggered RS flip-flop (flip-flop) and auxiliary circuitry may be employed. In yet another aspect, a zero crossing technique Exclusive or (XOR) gates may be used.
Other techniques for determining the phase difference between the voltage signal and the current signal include Lissajous diagrams and monitoring of the images; methods such as a three volt method, a cross coil method, a vector voltmeter, and a vector impedance method; and "phase measurements" using phase standard instruments, phase locked loops, and < http:// www.engnetbase.com > such as Peter O' Shea,2000CRC Press LLC, < http:// www.engnetbase.com >, incorporated herein by reference.
In another aspect, for example, the current feedback data may be monitored to maintain the current amplitude of the drive signal at a current amplitude set point. The current amplitude set point may be specified directly or determined indirectly based on a particular voltage amplitude and power set point. In certain aspects, control of the current amplitude may be achieved by a control algorithm in the processor 1740, such as, for example, a proportional-integral-derivative (PID) control algorithm. Variables that the control algorithm controls in order to properly control the current amplitude of the drive signal may include, for example, scaling of LUT waveform samples stored in programmable logic device 1660 and/or full-scale output voltage via DAC 1680 of DAC 1860 (which supplies the input to power amplifier 1620).
The non-isolated stage 1540 may further include a processor 1900 for providing, among other things, user Interface (UI) functionality. In one aspect, processor 1900 may comprise, for example, an Atmel AT91 SAM9263 processor with an ARM 926EJ-S core available from altmeyer company (Atmel Corporation, san Jose, calif.) of San Jose, california. Examples of UI functions supported by processor 1900 may include audible and visual user feedback, communication with peripheral devices (e.g., via a Universal Serial Bus (USB) interface), communication with foot switch 1430, communication with input device 2150 (e.g., a touch screen display), and communication with output device 2140 (e.g., a speaker). Processor 1900 may be in communication with processor 1740 and a programmable logic device (e.g., via a Serial Peripheral Interface (SPI) bus). Although processor 1900 may support primarily UI functions, in some aspects it may also cooperate with processor 1740 to achieve risk mitigation. For example, the processor 1900 may be programmed to monitor various aspects of user inputs and/or other inputs (e.g., touch screen inputs 2150, foot switch 1430 inputs, temperature sensor inputs 2160) and deactivate the drive output of the generator 1100 when an error condition is detected.
In certain aspects, processor 1740 (fig. 26, 27A) and processor 1900 (fig. 26, 27B) may determine and monitor the operational state of generator 1100. For processor 1740, the operating state of generator 1100 may, for example, indicate which control and/or diagnostic processes are implemented by processor 1740. For processor 1900, the operating state of generator 1100 may indicate, for example, which elements of the user interface (e.g., display, sound) are presented to the user. Processors 1740, 1900 may independently maintain the current operating state of generator 1100 and identify and evaluate possible transitions of the current operating state. Processor 1740 may serve as a host in this relationship and determine when a transition between operating states will occur. Processor 1900 may note the valid transitions between operating states and may verify that a particular transition is appropriate. For example, when processor 1740 instructs processor 1900 to transition to a particular state, processor 1900 may verify that the requested transition is valid. In the event that processor 1900 determines that the requested inter-state transition is invalid, processor 1900 may cause generator 1100 to enter a failure mode.
The non-isolated stage 1540 may further include a controller 1960 (fig. 26, 27B) for monitoring the input device 2150 (e.g., capacitive touch sensor, capacitive touch screen for turning the generator 1100 on and off). In certain aspects, the controller 1960 may include at least one processor and/or other controller device in communication with the processor 1900. In one aspect, for example, the controller 1960 may include a processor (e.g., a Mega168 bit controller available from Atmel corporation (Atemel)) configured to be able to monitor user inputs provided via one or more capacitive touch sensors. In one aspect, the controller 1960 can include a touch screen controller (e.g., QT5480 touch screen controller available from Atmel corporation (Atemel)) to control and manage the acquisition of touch data from a capacitive touch screen.
In certain aspects, the controller 1960 may continue to receive operating power (e.g., via a pipeline from a power source of the generator 1100, such as the power source 2110 (fig. 26) discussed below) when the generator 1100 is in a "power off state. In this way, the controller 1960 may continue to monitor the input device 2150 (e.g., a capacitive touch sensor located on the front panel of the generator 1100) for switching the generator 1100 on and off. When the generator 1100 is in the "power off" state, if activation of the user "on/off" input 2150 is detected, the controller 1960 may wake up the power source (e.g., enable operation of one or more DC/DC voltage converters 2130 (fig. 26) of the power source 2110). The controller 1960 may begin a sequence that transitions the generator 1100 to a "power on" state. Conversely, when the generator 1100 is in the "power on" state, if activation of the "on/off" input 2150 is detected, the controller 1960 may begin a sequence that transitions the generator 1100 to the "power off" state. In certain aspects, for example, the controller 1960 may report to the processor 1900 activation of the "on/off" input 2150, which in turn the processor 1900 implements the required process sequence to transition the generator 1100 to the "power off" state. In such an aspect, the controller 1960 may not have the independent ability to remove power from the generator 1100 after the "power off" state has been established.
In certain aspects, the controller 1960 may cause the generator 1100 to provide audible or other sensory feedback for alerting a user that a "power on" or "power off" sequence has begun. This alert may be provided at the beginning of a "power on" or "power off" sequence and before other processes associated with the sequence begin.
In certain aspects, isolation stage 1520 can include instrument interface circuitry 1980 to provide a communication interface between, for example, control circuitry of the surgical device (e.g., control circuitry including a handpiece switch) and devices of non-isolation stage 1540 (such as, for example, programmable logic device 1660, processor 1740, and/or processor 1900). The instrument interface circuit 1980 may exchange information with devices of the non-isolation stage 1540 via a communication link (such as, for example, an Infrared (IR) based communication link) that maintains a suitable degree of electrical isolation between the stages 1520, 1540. For example, instrument interface circuit 1980 may be powered using a low drop-out voltage regulator powered by an isolation transformer, which is driven from non-isolation stage 1540.
In one aspect, instrument interface circuit 1980 may include programmable logic device 2000 in communication with signal conditioning circuit 2020 (fig. 26 and 27C). The signal conditioning circuit 2020 may be configured to receive a periodic signal (e.g., a 2kHz square wave) from the programmable logic circuit 2000 to generate bipolar interrogation signals having the same frequency. For example, the interrogation signal may be generated using a bipolar current source fed by a differential amplifier. The interrogation signal may be sent to the surgical device control circuitry (e.g., through the use of conductive pairs in a cable connecting the generator 1100 to the surgical device) and monitored to determine the status or configuration of the control circuitry. For example, the control circuit may include a plurality of switches, resistors, and/or diodes to modify one or more characteristics (e.g., amplitude, correction) of the interrogation signal such that a state or configuration of the control circuit may be uniquely discerned based on the one or more characteristics. In one aspect, for example, the signal conditioning circuit 2020 may include an ADC for generating samples of the voltage signal that are present in the input of the control circuit as a result of the interrogation signal passing through the control circuit. The programmable logic device 2000 (or a device of the non-isolation stage 1540) may then determine the state or configuration of the control circuit based on the ADC samples.
In one aspect, instrument interface circuit 1980 may include a first data circuit interface 2040 to enable information exchange between programmable logic device 2000 (or other elements of instrument interface circuit 1980) and first data circuits disposed in or otherwise associated with a surgical device. In certain aspects, for example, the first data circuit 2060 can be disposed in a cable integrally attached to the surgical device handpiece, or an adapter for interfacing a particular surgical device type or model with the generator 1100. In certain aspects, the first data circuit may include a non-volatile memory 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 include suitable circuitry (e.g., discrete logic devices, processors) 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 logic device 2000.
In certain aspects, the first data circuit 2060 may store information related to the particular surgical device 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 instrument interface circuit 1980 (e.g., by programmable logic device 2000), transferred to devices of non-isolated stage 1540 (e.g., to programmable logic device 1660, processor 1740, and/or processor 1900) for presentation to a user via output device 2140 and/or to control functions or operations of generator 1100. In addition, any type of information may be sent to the 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 include, for example, an updated number of operations in which the surgical device is used and/or a date and/or time of its use.
As previously discussed, the surgical instrument can be detachable from the handpiece (e.g., instrument 1106 can be detachable from handpiece 1107) to facilitate instrument interchangeability and/or disposability. In such cases, the ability of the known generators to identify the particular instrument configuration used and to optimize the control and diagnostic process accordingly may be limited. However, from a compatibility perspective, it is problematic to address this problem by adding readable data circuits to the surgical device instrument. For example, designing a surgical device to maintain backward compatibility with a generator lacking the requisite data reading functionality may be impractical due to, for example, different signal schemes, design complexity, and costs. Other aspects of the instrument address these issues by using a data circuit that can be economically implemented in existing surgical instruments with minimal design changes to maintain compatibility of the surgical device with current generator platforms.
Additionally, aspects of the generator 1100 may enable communication with instrument-based data circuits. For example, the generator 1100 may be configured to communicate with a second data circuit contained in an instrument (e.g., instrument 1104, 1106, or 1108) of the surgical device. The instrument interface circuit 1980 may include a second data circuit interface 2100 for enabling this communication. In one aspect, the second data circuit interface 2100 may comprise a tri-state digital interface, although other interfaces may be used. In certain aspects, the second data circuit may generally be any circuit for transmitting and/or receiving data. In one aspect, the second data circuit can store information related to the particular surgical instrument 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 sent 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 include, for example, the number of updates to the operation in which the surgical instrument was used and/or the date and/or time of its use. In certain aspects, the second data circuit may transmit data collected by one or more sensors (e.g., instrument-based temperature sensors). In certain aspects, the second data circuit may receive data from the generator 1100 and provide an indication (e.g., an LED indication or other visual indication) to the user based on the received data.
In certain aspects, the second data circuit and the second data circuit interface 2100 may be configured to enable communication between the programmable logic device 2000 and the second data circuit without providing additional conductors for this (e.g., dedicated conductors of a cable connecting the handpiece to the generator 1100). In one aspect, for example, information may be transferred to and from the second data circuit using a single bus communication scheme implemented on an existing cable, such as one of the conductors used to transfer interrogation signals from the signal conditioning circuit 2020 to the control circuit in the hand piece. In this way, design changes or modifications of the surgical device that may otherwise be necessary may be minimized or reduced. Furthermore, because different types of communications may be implemented on a common physical channel (with or without frequency band separation), the presence of the second data circuit may be "stealth" to a generator that does not have the requisite data reading functionality, thus enabling backward compatibility of the surgical device instrument.
In certain aspects, the isolation stage 1520 may include at least one blocking capacitor 2960-1 (fig. 27C) connected to the drive signal output 1600b to prevent DC current from flowing to the patient. For example, the signal blocking capacitor may be required to comply with medical regulations or standards. Although relatively few errors occur in single capacitor designs, such errors can have adverse consequences. In one aspect, a second blocking capacitor 2960-2 may be provided in series with blocking capacitor 2960-1, wherein current leakage occurring from a point between blocking capacitors 2960-1, 2960-2 is detected by, for example, ADC 2980 for sampling the voltage induced by the leakage current. The sample may be received, for example, by programmable logic device 2000. Based on the change in leakage current (as indicated by the voltage samples in the aspect of fig. 26), the generator 1100 may determine when at least one of the blocking capacitors 2960-1, 2960-2 fails. Thus, the aspect of fig. 26 has benefits over a single capacitor design with a single point of failure.
In certain aspects, the non-isolated stage 1540 may include a power source 2110 for outputting DC power at an appropriate voltage and current. The power source may include, for example, a 400W power source for outputting a system voltage of 48 VDC. As described above, the power source 2110 may further include one or more DC/DC voltage converters 2130 for receiving the output of the power source to generate a DC output at the voltages and currents required by the various devices of the generator 1100. As described above in connection with the controller 1960, one or more of the DC/DC voltage converters 2130 may receive input from the controller 1960 when the controller 1960 detects that a user activates the on/off input device 2150 to enable operation of the DC/DC voltage converter 2130 or wakes up the DC/DC voltage converter 2130.
Fig. 28A-28B illustrate certain functional and structural aspects of one aspect of the generator 1100. Feedback indicative of 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 2-channel ADCs and may sample the feedback signal at a high speed (e.g., 80 Msps) to allow the drive signal to be oversampled (e.g., about 200x oversampling). The current feedback signal and the voltage feedback signal may be appropriately conditioned (e.g., amplified, filtered) in the analog domain prior to processing by the ADCs 1780, 1800. The current and voltage feedback samples from the ADCs 1780, 1800 may be buffered separately and then multiplexed or interleaved into a single data stream within the block 2120 of the programmable logic device 1660. In the aspect of fig. 28A-28B, 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 processor 1740. The PDAP may include an encapsulation unit for implementing any of a variety of methods for associating the multiplexed feedback samples with the memory address. In one aspect, for example, feedback samples corresponding to a particular LUT sample output by programmable logic device 1660 may be stored at one or more memory addresses associated with or indexed by the LUT address of the LUT sample. In another aspect, feedback samples corresponding to a particular LUT sample output by programmable logic device 1660 may be stored at a common memory location along with the LUT address of the LUT sample. In any case, 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 determined. Synchronizing the LUT sample address and feedback samples in this manner, as described above, aids in the proper timing and stability of the predistortion algorithm. A Direct Memory Access (DMA) controller implemented at block 2166 of processor 1740 may store feedback samples (and, where applicable, any LUT sample address data) at designated memory location 2180 (e.g., internal RAM) of processor 1740.
The block 2200 of the processor 1740 may implement a predistortion algorithm for predistorting or modifying LUT samples stored in the programmable logic device 1660 on a dynamic traveling basis. As described above, predistortion of LUT samples may compensate for various distortion sources present in the output driver circuit of generator 1100. The predistorted LUT samples, when processed by the drive circuit, will thus give the drive signal a desired waveform shape (e.g., sinusoidal shape) to optimally drive the ultrasound transducer.
At block 2220 of the predistortion algorithm, the current through the dynamic leg of the ultrasound transducer is determined. May be based on, for example, current and voltage feedback samples stored at memory location 2180 (which, when properly scaled, may represent I in the model of fig. 25 discussed above) g And V g ) Static capacitance C of ultrasonic transducer 0 And a known value of the drive frequency, using kirchhoff's current law. A dynamic branch current sample for each set of stored current and voltage feedback samples associated with the LUT sample may be determined.
At block 2240 of the predistortion algorithm, each dynamic branch current sample determined at block 2220 is compared to a sample of the desired current waveform shape to determine a difference or sample amplitude error between the compared samples. For this determination, samples of the desired current waveform shape may be supplied, for example, from waveform shape LUT 2260, the waveform shape LUT 2260 containing amplitude samples of one cycle of the desired current waveform shape. The particular sample of the desired current waveform shape from LUT 2260 for comparison may be determined by the LUT sample address associated with the dynamic branch current sample for comparison. Thus, the input of the moving branch current to block 2240 may be synchronized to the input of its associated LUT sample address to block 2240. Accordingly, the number of LUT samples stored in programmable logic device 1660 and LUT samples stored in waveform shape LUT 2260 may be equal. In certain aspects, the desired current waveform shape represented by the LUT samples stored in 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 the primary longitudinal motion of an ultrasound transducer superimposed with one or more other driving signals at other frequencies may be used, such as third order harmonics for driving at least two mechanical resonances for the advantageous vibrations of the transverse or other modes.
Each value of the sample amplitude error determined at block 2240 is transmitted to the LUT of 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 the value of the sample amplitude error of the same LUT address previously received), LUT 2280 (or other control block of programmable logic device 1660) may predistort 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 predistortion or modification of each LUT sample in an iterative manner throughout the LUT address range will result in the waveform shape of the output current of the generator matching or conforming to the desired current waveform shape represented by the samples of waveform shape LUT 2260.
The current and voltage amplitude measurements, power measurements, and impedance measurements may be determined at block 2300 of processor 1740 based on current and voltage feedback samples stored at memory location 2180. Before determining these quantities, the feedback samples may be appropriately scaled and, in some aspects, processed through a suitable filter 2320 to remove noise generated by, for example, the data acquisition process and the induced harmonic components. Thus, the filtered voltage and current samples may substantially represent the fundamental frequency of the drive output signal of the generator. In certain aspects, the filter 2320 may be a Finite Impulse Response (FIR) filter applied to the frequency domain. Such aspects may use a Fast Fourier Transform (FFT) of the output drive signal current and voltage signals. In certain aspects, the resulting spectrum may be used to provide additional generator functionality. In one aspect, for example, the ratio of the second order harmonic component and/or the third order harmonic component relative to the fundamental frequency component may be used as a diagnostic indicator.
At block 2340 (fig. 28B), a Root Mean Square (RMS) calculation may be applied to the current feedback samples representing a sample size of the drive signal for an integer cycle to generate a measurement I representing the drive signal output current rms
At block 2360, a Root Mean Square (RMS) calculation may be applied to the voltage feedback samples representing a sample size of the drive signal for an integer cycle to determine a measurement V representing the drive signal output voltage rms
At block 2380, the current and voltage feedback samples may be point-wise multiplied and samples representing the drive signal for an integer cycle may be averaged to determine a measure P of the true output power of the generator r
At block 2400, a measurement P of the apparent output power of the generator a Can be determined as the product V rms ·I rms
At block 2420, a measurement Z of the load resistance magnitude m Can be determined as quotient V rms /I rms
In certain aspects, the amount I determined at blocks 2340, 2360, 2380, 2400, and 2420 rms 、V rms 、P r 、P a And Z m May be used by the generator 1100 to implement any of a number of control and/or diagnostic processes. In certain aspects, any of these quantities may be communicated to the user via, for example, an output 2140 integral to the generator 1100 or an output 2140 connected to the generator 1100 by a suitable communication interface (e.g., USB interface). For example, various diagnostic processes may include, but are not limited to, handpiece integrity, instrument attachment integrity, instrument overload, proximity instrument overload, frequency lock failure, 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.
Block 2440 of processor 1740 can implement a phase control algorithm for determining and controlling the impedance phase of an electrical load (e.g., an ultrasound transducer) driven by generator 1100. As described above, by controlling the frequency of the drive signal to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0 °), the effects of harmonic distortion can be minimized or reduced, and the accuracy of the phase measurement is increased.
The phase control algorithm receives as input current and voltage feedback samples stored in memory location 2180. Before the feedback samples are used in the phase control algorithm, the feedback samples may be appropriately scaled and in some aspects processed through a suitable filter 2460 (which may be the same as filter 2320) to remove noise generated by, for example, the data acquisition process and the induced harmonic components. Thus, the filtered voltage and current samples may substantially represent the fundamental frequency of the drive output signal of the generator.
At block 2480 of the phase control algorithm, the current through the dynamic leg of the ultrasound transducer is determined. This determination may be the same as the determination described above in connection with block 2220 of the predistortion algorithm. Thus, for each set of stored current and voltage feedback samples associated with a LUT sample, the output of block 2480 may be a dynamic branch current sample.
At block 2500 of the phase control algorithm, an impedance phase is determined based on the synchronous input of the dynamic branch current samples and the corresponding voltage feedback samples determined at block 2480. In certain aspects, the impedance phase is determined as an average of the impedance phase measured at the rising edge of the waveform and the impedance phase measured at the falling edge of the waveform.
At block 2520 of the phase control algorithm, the impedance phase value determined at block 2220 is compared to phase set point 2540 to determine a difference or phase error between the compared values.
At block 2560 (fig. 28A) of the phase control algorithm, a frequency output for controlling the frequency of the drive signal is determined based on the value of the phase error determined at block 2520 and the magnitude of the impedance determined at block 2420. The value of the frequency output may be continuously adjusted by block 2560 and transmitted to DDS control block 2680 (discussed below) to maintain the impedance phase determined at block 2500 at a phase set point (e.g., zero phase error). In certain aspects, the impedance phase may be adjusted to a 0 ° phase set point. In this way, any harmonic distortion will be centered around the peak of the voltage waveform, enhancing the accuracy of the phase impedance determination.
Block 2580 of processor 1740 may implement an algorithm for modulating the current amplitude of the drive signal to control the drive signal current, voltage and power according to a user-specified set point or according to requirements specified by other processes or algorithms implemented by generator 1100. Examples of control of these quantitiesSuch as by scaling LUT samples in LUT 2280 and/or by adjusting the full-scale output voltage of DAC 1680 (which supplies input to power amplifier 1620) via DAC 1860. Block 2600 (which may be implemented in some aspects as a PID controller) may receive as input current feedback samples (which may be appropriately scaled and filtered) from memory location 2180. The current feedback sample may be combined with a "current demand" I specified by a controlled variable (e.g., current, voltage, or power) d The values are compared to determine if the drive signal supplies the necessary current. In terms of drive signal current as a control variable, current demand I d Can be controlled by the current set point 2620A (I sp ) Direct assignment. For example, the RMS value of the current feedback data (as determined in block 2340) may be compared to a user-specified RMS current setpoint I sp A comparison is made to determine the appropriate controller action. For example, if the current feedback data indicates that the RMS value is less than the current set point I sp The LUT scaling and/or full scale output voltage of DAC 1680 may be adjusted by block 2600 such that the drive signal current increases. Conversely, when the current feedback data indicates that the RMS value is greater than the current set point I sp Block 2600, in turn, may adjust the LUT scaling and/or full scale output voltage of DAC 1680 to reduce the drive signal current.
In terms of drive signal voltage as control variable, current demand I d May be based, for example, on maintaining the load impedance magnitude Z measured at block 2420 m Given the desired voltage set point 2620B (V sp ) The required current is indirectly specified (e.g., I d =V sp /Z m ). Similarly, in terms of drive signal power as a control variable, current demand I d May be based, for example, on the voltage V measured at block 2360 rms Given the desired set point 2620C (P sp ) The required current is indirectly specified (e.g., I d =P sp /V rms )。
Block 2680 (fig. 28A) may implement a DDS control algorithm for controlling the drive signals by retrieving LUT samples stored in LUT 2280. In certain aspects, the DDS control algorithm may be a Numerically Controlled Oscillator (NCO) algorithm for generating samples of waveforms at a fixed clock rate using a point (memory location) -skip technique. The NCO algorithm may implement a phase accumulator or frequency-to-phase converter that is used as an address pointer for retrieving LUT samples from LUT 2280. In one aspect, the phase accumulator may be a D-step, modulus N phase accumulator, where D is a positive integer representing the frequency control value and N is the number of LUT samples in LUT 2280. For example, a frequency control value of d=1 may cause the phase accumulator to sequentially point to each address of LUT 2280, resulting in a waveform output that replicates the waveform stored in LUT 2280. When D >1, the phase accumulator may skip addresses in LUT 2280, producing a waveform output with a higher frequency. Accordingly, the frequency of the waveform generated by the DDS control algorithm can thus be controlled by appropriately changing 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 DAC 1680 supplies the corresponding analog signal to the input of power amplifier 1620.
Block 2700 of processor 1740 may implement a switch mode converter control algorithm for dynamically modulating the rail voltage of power amplifier 1620 based on the waveform envelope of the amplified signal, thereby improving the efficiency of power amplifier 1620. In certain aspects, the 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, the characteristics of the waveform envelope may be determined by monitoring a minimum value of a drain voltage (e.g., a MOSFET drain voltage) modulated according to the envelope of the amplified signal. The minimum voltage signal may be generated, for example, by a voltage minimum detector coupled to the drain voltage. The minimum voltage signal may be sampled by the ADC 1760, with the output minimum voltage sample received at block 2720 of the switch-mode converter control algorithm. Based on the value of the minimum voltage sample, block 2740 may control the PWM signal output by PWM generator 2760, which PWM generator 2760 in turn controls the rail voltage supplied by switch mode regulator 1700 to power amplifier 1620. In certain aspects, as long as the value of the minimum voltage sample is less than the minimum target 2780 input into block 2720, the rail voltage may be modulated according to the waveform envelope characterized by the minimum voltage sample. For example, block 2740 may result in supplying a low rail voltage to power amplifier 1620 when the minimum voltage sample indicates a low envelope power level, wherein a full rail voltage is supplied only when the minimum voltage sample indicates a maximum envelope power level. When the minimum voltage sample falls below the minimum target 2780, the block 2740 may cause the rail voltage to remain at a minimum value suitable to ensure proper operation of the power amplifier 1620.
Limiting capacitive coupling and its effects
Aspects of the present disclosure are directed to a surgical instrument having improved device capabilities for reducing unwanted operational side effects. In particular, the surgical instrument may include means for limiting capacitive coupling to improve monopolar isolation for use alone or with another advanced energy mode. Capacitive coupling generally occurs when there is an energy transfer between nodes caused by an electric field. During surgery, capacitive coupling may occur when two or more powered surgical instruments are used in or around a patient. While capacitive coupling may be desirable in some circumstances, because the add-on device may be inductively powered by the capacitive coupling, the consequences of the capacitive coupling occurring accidentally during surgery or around the patient may often be extremely detrimental. Parasitic or unexpected capacitive coupling may occur at unknown or unpredictable locations, resulting in energy being applied to unintended areas. When the patient is under anesthesia and no response is provided, parasitic capacitive coupling may burn the patient, and the surgeon is not even aware that this has occurred. It is therefore desirable to limit parasitic or accidental capacitive coupling in surgical instruments and generally during surgery.
In some aspects, a system including a surgical instrument and a generator can be configured to interrupt transmission of energy from the generator to the surgical instrument when capacitive coupling has been detected. In these cases, one or more safety fuses, sensors, controllers, and/or algorithms may be in place to automatically trigger an interrupt to the generator. Alarms may be issued, including audio signals, vibrations, and visual messages, to inform the surgical team to interrupt the generator due to the detection of capacitive coupling.
In some aspects, the system includes means for detecting that a capacitive coupling event has occurred. For example, algorithms that include inputs from one or more sensors for detecting events surrounding the system may apply situational awareness and other programming means to infer that capacitive coupling is occurring somewhere within the system and react accordingly. A system with situational awareness means that the system can be configured to predict what is likely to occur based on the current environment and system data and determine that the current conditions follow a pattern that causes a predictable next step. For example, the system may apply situational awareness in the context of handling capacitively coupled events by recalling instances in a similar surgical procedure in which various sensor data are detected. The sensor data may indicate an increase in current at two particular locations along the closed loop electrosurgical system that indicates a high likelihood of impending capacitive coupling events based on previous data of a similar-location surgical procedure.
In some aspects, the surgical instrument may be structurally modified to limit the occurrence of capacitive coupling or otherwise reduce collateral damage caused by capacitive coupling. For example, additional insulation strategically placed in or around the surgical instrument may help limit capacitive coupling from occurring. In other cases, the end effector of the surgical instrument may include improved structures that reduce the occurrence of current displacement, such as rounding the end of the end effector or, in particular, shaping the blade of the end effector to behave more like a monopolar blade while still functioning as a bipolar device.
In some aspects, the system may include passive means for mitigating or limiting the effects of capacitive coupling. For example, the system may include a lead that may shunt energy to a neutral node through a conductive passive component. In general, any or all of these aspects may be combined or included in a single system to address challenges presented by multiple electronic components that are susceptible to capacitive coupling during patient surgery.
FIG. 29 provides an exemplary system having means for detecting capacitive coupling in accordance with at least one aspect of the present disclosure134000. The system 134000 includes a monopolar ESU generator 134002 electrically coupled to the surgical instrument 134008. The surgical instrument 134008 is used to perform a surgical procedure on a patient, wherein patient tissue 134016 is shown representing a surgical site of the patient undergoing the surgical procedure. The surgical instrument 134008 can include means for applying electrosurgical or ultrasonic energy to the end effector and in some cases can include a blade and/or a pair of jaws to grasp or clamp on tissue. The energy supplied by ESU generator 134002 can contact the patient through the end effector via any of the various possible components of the end effector. At least a portion of the patient may rest on a return path pad 134014 such as Smart Megasoft Pad TM The return path pad is configured to transfer excess energy away from the patient when the surgical instrument 134008 contacts the patient and electrosurgical energy is applied, for example.
Because of the multiple power sources in the vicinity of the patient, parasitic capacitive coupling is always present and there is always a risk of injury to the patient during the surgical procedure. Because the patient is not expected to express any response during surgery, if an unknown or unpredictable capacitive coupling occurs, the patient may therefore experience burns where it is not expected. Generally, energy anomalies such as capacitive coupling should be minimized or otherwise corrected to improve patient safety. To limit capacitive coupling or other types of energy anomalies from occurring, multiple smart sensors or monitors, such as CT1 (134006), CT2 (134010), and CT3 (134012) smart sensors, may be integrated into the electrosurgical system as indicators to determine if excess or inductive energy is radiating outside of one or more power sources. As shown in fig. 29, the smart sensors CT1 (134006), CT2 (134010), and CT3 (134012) are placed in possible locations where energy may be induced to radiate. The sensor or monitor may be configured to be able to detect capacitance and if placed at a strategic location within the system, the reading of the capacitance may suggest that a capacitance leak is occurring in the vicinity of the sensor or monitor. In combination with knowledge of other sensors near or throughout the system that are not indicative of capacitance readings, it can be inferred that capacitance leakage is occurring near the location of the sensor or monitor that is providing the forward indication. Other sensors may be used, such as capacitive leak monitors or detectors. These sensors may be configured to provide an alarm, such as lighting or delivering noise or ultimately transmitting a signal to a display monitor. In addition, the monopolar ESU 134002 can be configured to automatically trigger an energy break to prevent any further capacitive coupling from occurring.
In some aspects, a neutral electrode 134004 may be included in the monopolar ESU 1340002 and may be electrically coupled to a return path pad 134014 such as Smart MegasoftFor example as another solution to reduce capacitive coupling. When the electrosurgical instrument 134008 contacts the patient, the patient is contacting the return path pad 134014, and the pad is conductively connected to the neutral electrode 134004, energy can conductively reach the neutral node 134004. Thus, energy may be transferred from the monopolar ESU 134002 or the surgical instrument 134008 to the neutral node 134004, thereby reducing the occurrence of capacitive coupling.
In some aspects, a cloud analysis system, such as communicatively coupled to a monopolar ESU through a medical hub, may be configured to be able to employ situational awareness that may help predict when capacitive coupling may occur during surgery. The cloud analysis system and/or medical hub may utilize a capacitive coupling algorithm to monitor the incidence of energy flowing through the surgical system and, based on previous data regarding the energy status in the system for a similarly situated protocol, may infer that capacitive coupling is likely to occur if no additional measures are taken. For example, during a surgical procedure involving how a surgical instrument is used during a particular step in the surgical procedure and the prescribed method of how much power should be employed, the cloud analysis module may extract this information from the previous surgical procedure and note that capacitive coupling is more likely to occur after the particular step in the surgical procedure. In monitoring steps in surgery, when the same or very similar energy distribution occurs during or before the expected step that tends to induce capacitive coupling, the cloud analysis system may deliver an alert that this is likely to cause capacitive coupling. The surgeon may be provided with the option of reducing peak voltages in the surgical instrument 134008 or interrupting power generation through the monopolar ESU 134002, or the cloud analysis module may automatically cause the medical hub to take these measures. This may lead to the possibility of eliminating the capacitive coupling before it has an opportunity to occur, or at least may limit any unintended effects due to the temporary occurrence of capacitive coupling.
In some aspects, a surgical instrument such as that 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 can reduce the occurrence of inductance. In other cases, the monopolar lead connecting the monopolar ESU 134002 to the surgical instrument 134008 may be shielded. As another example, there may be intermittent breaks in the plastic elements within the shaft to prevent capacitive coupling from transmitting long distances within the shaft. Other insulator type elements may be used to achieve a similar effect. In some aspects, monopolar wires electrically connecting the surgical instrument 134008 to the generator 134002 can be shielded to also reduce the occurrence of capacitive coupling.
In some aspects, the structure of the end effector may be modified to reduce the effects of capacitive coupling when the end effector is in contact with a patient. For example, the jaws of the end effector may be designed such that only one side of each jaw is used to deliver energy, thereby causing the end effector to function like a monopolar blade, while still being functionally configured as a bipolar device. In one example of such a situation, the end or tip of the end effector may be shaped like a duckbill with a rounded end to reduce any voltage peaks that may result from a pointed tip. The direction of energy in the end effector may still be directed toward the region or point of the duckbill end, but any excess energy dispersion may be passivated by the duckbill end. As another example, the blade may be configured to be slightly thicker on one side, such as having a triangular cross-sectional area, and having a thin upstanding upper blade element on the opposite side. This may allow any energy 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 dissipated, which will make the surgical instrument more prone to capacitive coupling. As a final example, the jaws of the surgical instrument can have electrodes placed on the inside of the end effector, allowing the outside of the end effector to act like a shield to prevent capacitive coupling from occurring. The electrodes may still be placed sufficiently to contact the patient's tissue during the surgical procedure while shielding one or more edges of the end effector from energy that is dispersed outside the focused surgical field.
Fig. 30 is a logic flow diagram 134100 depicting a control program or logic configuration of an exemplary method for limiting the effects of capacitive coupling in the disclosed surgical system, in accordance with some aspects. This exemplary method may be consistent with the description above of several enumeration means for limiting capacitive coupling or mitigating the effects thereof during a surgical procedure using one or more surgical instruments.
As shown in the above examples and consistent therewith, the method 134100 may begin with the surgical system being configured to monitor 134102 for energy generation. For example, multiple sensors may be strategically placed at potentially vulnerable points that are more prone to leakage of energy that could result in capacitive coupling. These sensors may be configured to deliver an alarm when an energy anomaly occurs.
Continuing, a sensor or other detection device may detect 134104 voltage anomalies, such as voltage peaks or voltage spikes, at one or more locations along the surgical system, often where such energy is not desired. The system may be configured to be able to infer that these conditions may cause parasitic capacitive coupling, which may burn the patient without any alarm and without the knowledge of the surgical team. As a result, an alarm or message may be delivered indicating that an energy anomaly and a capacitive coupling hazard are occurring.
In some aspects, situational awareness may also be used to predict when 134106 is more likely to capacitively couple during the routine course of a surgical procedure. Situational awareness can be used to review past types or conditions of similar surgical procedures to identify which variables may exist in determining when capacitive coupling occurs. If certain steps in the protocol are more likely to cause capacitive coupling, the system can predict these conditions by specifically monitoring the sensor at these times and/or taking preemptive measures to reduce the occurrence of capacitive coupling.
If capacitive coupling is detected or deemed imminent based on the above-described method 134100 performed by the surgical system, according to some aspects, measures taken to reduce, eliminate, or mitigate the effects of capacitive coupling may include automatically interrupting 134108 the energy generation at the monopolar energy generator. It should be noted that some loss of surgical operation may occur temporarily when the interruption is enabled, but in any event, it is of paramount importance to prevent unintended damage to the patient. After a brief interruption, the surgical procedure may continue as planned.
The relationship between the output energy and the input energy is measured, parasitic leakage is used to improve pad contact or shut down power, and the generator knows how much current it generates and how much output energy is being measured.
Increasing frequency in the presence of capacitive coupling
In some aspects, the presence of parasitic capacitive coupling may be utilized to perform energy coagulation or energy cauterization. In some cases, it may be desirable to increase the energy generation of the electrosurgical instrument to drive the monopolar circuit through the patient's body to ground. Although in many cases the conductive return pad (such as Smart Megasoft134014, see fig. 29) to complete a unipolar circuit, but in some cases the pad may be defective or worn such that the pad 134014 is not sufficiently conductive to draw current through the patient's body of the electrosurgical instrument (e.g., 134008). In such cases, the current may lack sufficient ground for energy to propagate, effectively causing the patient's body to act like a short circuit. This may render electrosurgical ineffective because the energy delivered by the surgical instrument 134008 does not pass through the patient's tissue and therefore does not heat the tissue as intended. A similar situation may occur when no pad is returned at all. That is, in the absence of a conductive return pad such as Smart Megasoft->134014 provides a wide conductive return path, there may be no available ground to connect with the patient. This may also cause the patient to act like a short circuit when energy from the surgical instrument is applied to the patient.
To accommodate these situations, in some aspects, monopolar energy generation can be increased to very high frequencies, such as 500Khz to 3-4Mhz, to take advantage of parasitic patient leakage to perform cushionless electrosurgery (or electrosurgery with insufficient conductivity in the cushion). By increasing the ac frequency, the parasitic leakage current will increase. The stronger leakage current may then radiate more effectively through the patient's body. After reaching through the patient's body, the capacitively coupled leakage current may be more effectively radiation coupled to the ground state, as a result of which it may be effective to drive current radiation into another object that acts as ground. For example, if the AC frequency is high enough, current leakage may reach the monopole generator ground terminal. This will help to eliminate the short circuit effect of the patient so that energy clotting can occur. Thus, in the presence of non-pad systems or less conductive systems in the pad, it may be desirable to increase current leakage to take advantage of the higher leakage return that may be used to complete the monopolar circuit. That is, in some cases, the return path may be formed by radiation current leakage caused by capacitive coupling. To help ensure that the radiation return path reaches the ground plane, the energy of the surgical instrument can be increased to very high frequencies.
In some cases, the less conductive return pad may be intentionally connected to ground, a countertop, or the nearest support surface, while the return connector on the generator may also be connected to ground. This causes the transfer circuit to flow through the radiation return path rather than causing any energy to attempt to travel through the less conductive return pad and back to the generator (which may cause the patient to be burned).
It should be noted that a typical monopolar circuit that drives current through the body and into the return pad may be the preferred method when a pad system is present and the pad provides sufficient conductivity under the patient. In these cases, it may be useful to establish an isolation barrier for an externally connected power source, such as the energy generator 134002 (see fig. 29). Alternatively, a battery powered instrument may be a more ideal system for reducing leakage current, which would help isolate the energy path through the conductive return pad.
In some aspects, the surgical system can include a detection circuit configured to determine the volume of the return path pad. The detection circuit may then provide information about whether the circuit is better to complete with radiation current leakage, rather than attempting to rely on less conductive return path pads or no pads at all. The detection circuit may measure an amount of conductivity in the return path pad. If the measured value of conductivity meets a predetermined threshold, the system may determine that the return path pad is available to perform the surgical procedure and provide a return path for monopolar energy. If the conductivity is below the threshold, the detection circuit may be configured to be able to send a signal to the system, such as at the processor of the surgical hub or monopolar generator, that should significantly increase the frequency of the monopolar energy and that should eliminate or at least disregard the return path pad. Increasing the frequency will then complete the monopole circuit by creating a return path for the radiation.
In some aspects, the monopole generator may include one or more control circuits coupled to the one or more sensors, the one or more control circuits configured to be able to determine whether a current leak has reached a ground terminal of the monopole generator. The sensor in combination with the detection circuit and control circuit of the monopole generator can be used to create a closed feedback loop system that can automatically adjust the frequency based on high leakage current to create a sufficient return path. For example, the detection circuit may determine whether there is sufficient conductivity in the return path pad. If not, the control circuitry of the monopole generator may cause energy to occur to increase the AC frequency. The sensor at the monopole generator may continuously monitor whether any radiation current leakage has reached the ground terminal of the monopole generator based on the increased frequency. The control circuit may gradually increase the frequency until it is detected that the radiation current leakage has reached the ground terminal. Thus, if it is determined that there is no return path pad or insufficient conductivity in the pad, the surgical system may rely on a predetermined frequency threshold, or a closed feedback system may be used to find a sufficiently high frequency that a return path may be created by radiation coupling.
Fig. 31 is a logic flow diagram 134200 depicting a control program or logic configuration of an exemplary method that may be performed by a surgical system utilizing monopolar energy generation to determine whether to utilize parasitic capacitive coupling. Consistent with the description above, a detection circuit as part of the surgical system may be configured to measure the conductivity level in the return path of the 134202 monopolar electrosurgical setting. The return path may be initially determined to pass through a conductive pad, such as Soft MegasoftOr other return path conductive pad. In some cases, the conductivity in the pad may provide poor conductivity. In other cases, there may be no pad as part of the surgical setup. This may result in the patient's body acting as a short circuit to the monopolar circuit, which will reduce or eliminate the effectiveness of attempting to apply monopolar energy to the surgical site of the patient.
The detection circuit may determine 134204 that the measured value of conductivity falls below a predetermined threshold, indicating that the conductivity level in the return path is sufficiently poor to prevent completion of the monopolar circuit. As a result, the surgical system may increase 134206 current leakage from the generator by increasing the frequency of the alternating current in the monopolar generator. The surgical system may alternatively utilize radiation current leakage to create a return path. As the frequency increases, the current leakage will also increase, thereby increasing the range of radiation leakage current to the ground plane and completing the circuit. Thus, by increasing the frequency, the poor conductivity of the return path pad can be overridden or even no pad at all. In some cases, the leakage increase may be determined based on a closed feedback sensor system that may adjust the frequency until it is determined that the radiation current leakage has reached a ground terminal at the monopole generator.
In some aspects, the surgical system may also provide instructions to isolate 134208 any return path pads and attach the return connector of the monopolar generator to ground. These measures can be taken to eliminate other alternative return paths that may inadvertently cause burns at undesirable patient locations.
Situational awareness
Referring now to fig. 32, a time axis 5200 depicting situational awareness of a hub, such as surgical hub 106 or 206, is shown. The timeline 5200 is illustrative of a surgical procedure and background information that the surgical hub 106, 206 may derive from data received from a data source for each step in the surgical procedure. The time axis 5200 depicts typical steps that nurses, surgeons and other medical personnel will take during a lung segment removal procedure, starting from the establishment of an operating room and until the patient is transferred to a post-operative recovery room.
The situation awareness surgical hubs 106, 206 receive data from the data sources throughout the surgical procedure, including data generated each time a medical professional utilizes a modular device paired with the surgical hubs 106, 206. The surgical hubs 106, 206 can receive this data from the paired modular device and other data sources and continually derive inferences about the ongoing procedure (i.e., background information) as new data is received, such as which step of the procedure to perform at any given time. The situational awareness system of the surgical hubs 106, 206 can, for example, record data related to the procedure used to generate the report, verify steps that medical personnel are taking, provide data or cues that may be related to particular procedure steps (e.g., via a display screen), adjust modular devices based on context (e.g., activate monitors, adjust the field of view (FOV) of a 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.
As a first step 5202 in this exemplary protocol, a hospital staff retrieves the patient's EMR from the hospital's EMR database. Based on the selected patient data in the EMR, the surgical hub 106, 206 determines that the procedure to be performed is a chest procedure.
In a second step 5204, the staff member scans the incoming medical supplies for the protocol. The surgical hubs 106, 206 cross-reference the scanned supplies with the list of supplies used in the various types of protocols and confirm that the supplied mixture corresponds to the chest protocol. In addition, the surgical hubs 106, 206 can also determine that the procedure is not a wedge procedure (because the incoming supplies lack certain supplies required for, or otherwise do not correspond to, a chest wedge procedure).
Third step 5206, the medical personnel scans the patient belt via a scanner communicatively connected to the surgical hub hubs 106, 206. The surgical hub 106, 206 may then confirm the identity of the patient based on the scanned data.
Fourth step 5208, the medical staff opens the auxiliary equipment. The ancillary equipment utilized may vary depending on the type of surgical procedure and the technique to be used by the surgeon, but in this exemplary case they include smoke evacuators, insufflators and medical imaging devices. When activated, the auxiliary equipment as a modular device may automatically pair with a surgical hub 106, 206 located in a specific vicinity of the modular device as part of its initialization process. The surgical hub 106, 206 may then derive background information about the surgical procedure by detecting the type of modular device paired therewith during the 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 data from the patient's EMR, the list of medical supplies used in the procedure and the type of modular device connected to the hub, the surgical hub 106, 206 can generally infer the specific procedure that the surgical team will perform. Once the surgical hub 106, 206 knows what specific procedure is being performed, the surgical hub 106, 206 can retrieve the steps of the procedure from memory or the cloud and then cross-reference the data it subsequently receives from the connected data sources (e.g., modular device and patient monitoring device) to infer what steps of the surgical procedure the surgical team is performing.
Fifth step 5210, the staff member attaches the EKG electrode and other patient monitoring devices to the patient. EKG electrodes and other patient monitoring devices can be paired with the surgical hubs 106, 206. When the surgical hub 106, 206 begins to receive data from the patient monitoring device, the surgical hub 106, 206 thus confirms that the patient is in the operating room.
Sixth step 5212, the medical personnel induce anesthesia in the patient. The surgical hubs 106, 206 may infer that the patient is under anesthesia based on data from the modular device and/or the patient monitoring device, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. At the completion of the sixth step 5212, the preoperative portion of the lung segmental resection procedure is complete and the operative portion begins.
Seventh step 5214, the patient's lungs being operated on are folded (while ventilation is switched to the contralateral lung). For example, the surgical hub 106, 206 may infer from the ventilator data that the patient's lungs have collapsed. The surgical hub 106, 206 may infer that the surgical portion of the procedure has begun because it may compare the detection of the patient's lung collapse to the expected steps of the procedure (which may be previously accessed or retrieved), thereby determining that collapsing the lung is a surgical step in that particular procedure.
Eighth step 5216, a medical imaging device (e.g., an endoscope) is inserted and video from the medical imaging device is activated. The surgical hubs 106, 206 receive medical imaging device data (i.e., video or image data) through their connection to the medical imaging device. After receiving the medical imaging device data, the surgical hub 106, 206 may determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 106, 206 may determine that the particular procedure being performed is a segmental resection, rather than a leaf resection (note that the wedge procedure has been excluded based on the surgical hub 106, 206 based on the data received at the second step 5204 of the procedure). The data from the medical imaging device 124 (fig. 2) can be used to determine background information related to the type of procedure being performed in a number of different ways, including by determining the angle of the visual orientation of the medical imaging device relative to the patient's anatomy, monitoring the number of medical imaging devices utilized (i.e., activated and paired with the surgical hub 106, 206), and monitoring the type of visualization device utilized. For example, one technique for performing a vat lobectomy places the camera in the lower anterior corner of the patient's chest over the septum, while one technique for performing a vat segmented resection places the camera in an anterior intercostal position relative to the segmented slit. For example, using pattern recognition or machine learning techniques, the situational awareness system may be trained to recognize the positioning of the medical imaging device from the visualization of the patient anatomy. As another example, one technique for performing a vat lobectomy utilizes a single medical imaging apparatus, while another technique for performing a vat segmented excision utilizes multiple cameras. As another example, a technique for performing vat segmental resections utilizes an infrared light source (which may be communicatively coupled to a surgical hub as part of a visualization system) to visualize segmental slots that are not used in vat pulmonary resections. By tracking any or all of this data from the medical imaging device, the surgical hub 106, 206 can thus determine the particular type of surgical procedure being performed and/or the technique used for the particular type of surgical procedure.
Ninth step 5218, the surgical team begins the anatomical steps of the procedure. The surgical hub 106, 206 may infer that the surgeon is dissecting to mobilize the patient's lungs because it receives data from the RF generator or the ultrasound generator indicating that the energy instrument is being fired. The surgical hub 106, 206 may cross the received data with the retrieval step of the surgical procedure to determine that the energy instrument fired at that point in the procedure (i.e., after the previously discussed procedure steps are completed) corresponds to an anatomical step. In some cases, the energy instrument may be an energy tool mounted to a robotic arm of the robotic surgical system.
Tenth step 5220, the surgical team proceeds with the ligation step of the procedure. The surgical hubs 106, 206 can infer that the surgeon is ligating arteries and veins because they receive data from the surgical stapling and severing instrument indicating that the instrument is being fired. Similar to the previous steps, the surgical hubs 106, 206 can derive this inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the retrieval steps in the process. In some cases, the surgical instrument may be a surgical tool mounted to a robotic arm of a robotic surgical system.
Eleventh step 5222, a segmental resection portion of the procedure is performed. The surgical hubs 106, 206 can infer that the surgeon is transecting soft tissue based on data from the surgical stapling and severing instrument, including data from its cartridge. The cartridge data may correspond to, for example, the size or type of staples fired by the instrument. Since different types of staples are used for different types of tissue, the cartridge data can be indicative of the type of tissue being stapled and/or transected. In this case, the type of staples being fired is used for soft tissue (or other similar tissue type), which allows the surgical hub 106, 206 to infer that the segmental resection portion of the procedure is in progress.
In a twelfth step 5224, a node dissection step is performed. The surgical hub 106, 206 may infer that the surgical team is dissecting nodes and performing leak tests based on data received from the generator indicating that the RF or ultrasonic instrument is being fired. For this particular procedure, the RF or ultrasonic instrument used after transecting the soft tissue corresponds to a node dissection step that allows the surgical hub 106, 206 to make such inferences. It should be noted that the surgeon switches back and forth between surgical stapling/cutting instruments and surgical energy (i.e., RF or ultrasonic) instruments periodically, depending on the particular steps in the procedure, as the different instruments are better suited for the particular task. Thus, the particular sequence in which the stapling/severing instrument and the surgical energy instrument are used may dictate the steps of the procedure that the surgeon is performing. Further, in some cases, robotic tools may be used for one or more steps in a surgical procedure, and/or hand-held surgical instruments may be used for one or more steps in a surgical procedure. One or more surgeons may, for example, alternate between robotic tools and hand-held surgical instruments and/or may use the devices simultaneously. At the completion of the twelfth step 5224, the incision is closed and the post-operative portion of the procedure begins.
Thirteenth step 5226, the patient is reverse anesthetized. For example, the surgical hub 106, 206 may infer that the patient is waking from anesthesia based on, for example, ventilator data (i.e., the patient's respiration rate begins to increase).
Finally, a fourteenth step 5228 is for the medical personnel to remove the various patient monitoring devices from the patient. Thus, when the hub loses EKG, BP, and other data from the patient monitoring device, the surgical hub 106, 206 may infer that the patient is being transferred to the recovery room. As can be seen from the description of this exemplary procedure, the surgical hub 106, 206 can determine or infer when each step of a given surgical procedure occurs from data received from various data sources communicatively coupled to the surgical hub 106, 206.
Situational awareness is further described in U.S. provisional patent application serial No. 62/611,341 entitled interactive surgical platform (INTERACTIVE SURGICAL PLATFORM) filed on month 12, 2017, which is incorporated herein by reference in its entirety. In some cases, operation of robotic surgical systems (including the various robotic surgical systems disclosed herein) may be controlled by hubs 106, 206 based on their situational awareness and/or feedback from their devices and/or based on information from cloud 102.
While various 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. Many modifications, variations, changes, substitutions, combinations, and equivalents of these forms may be made by one skilled in the art without departing from the scope of the disclosure. Furthermore, the structure of each element associated with the described form may alternatively be described as a means for providing the function performed by the element. In addition, where materials for certain components are disclosed, other materials may be used. It is, therefore, to be understood that the foregoing detailed description and the appended claims are intended to cover all such modifications, combinations, and variations as falling within the scope of the disclosed forms of the invention. The appended claims are intended to cover all such modifications, changes, variations, substitutions, modifications and equivalents.
The foregoing detailed description has set forth various forms of the apparatus and/or methods 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, 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 may 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 electronic circuitry and/or writing the code for the software and/or hardware 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 a program product or 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 media used to actually carry out the distribution.
Instructions for programming logic to perform the various disclosed aspects can be stored within a memory within a system, such as a Dynamic Random Access Memory (DRAM), cache, flash memory, or other memory. Furthermore, the instructions may be distributed via a network or by other computer readable media. Thus, a machine-readable medium may include, but is not limited to, a mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), a floppy disk, an optical disk, a compact disk, a read-only memory (CD-ROM), a magneto-optical disk, a read-only memory (ROM), a Random Access Memory (RAM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), a magnetic or optical card, a flash memory, or a tangible, machine-readable storage device for use in transmitting information over the internet via electrical, optical, acoustic, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Thus, a 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).
As used throughout this specification, 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 mean that the associated organizations do not contain any wires, although in some aspects they may not. The communication module may implement any of a variety of wireless or wired communication standards or protocols, including, but not limited to, wi-Fi (IEEE 802.11 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, and ethernet derivatives thereof, and any other wireless and wired protocol computing modules designated 3G, 4G, 5G, and above, may include a plurality of communication modules. For example, 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, etc.
As used in any aspect herein, the term "control circuitry" may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more individual instruction processing cores, processing units, processors, microcontrollers, microcontroller units, controllers, digital Signal Processors (DSPs), programmable Logic Devices (PLDs), programmable Logic Arrays (PLAs), field Programmable Gate Arrays (FPGAs)), state machine circuitry, firmware storing instructions executed by the programmable circuitry, and any combination thereof. The control circuitry may be implemented collectively or individually as circuitry forming part of a larger system, such as an Integrated Circuit (IC), an Application Specific Integrated Circuit (ASIC), a system-on-a-chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smart phone, or the like. Thus, as used herein, "control circuitry" includes, but is not limited to, electronic circuitry having at least one discrete circuit, electronic circuitry having at least one integrated circuit, electronic circuitry having at least one application specific integrated circuit, electronic circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program that at least partially implements the methods and/or apparatus described herein, or a microprocessor configured by a computer program that at least partially implements the methods and/or apparatus described herein), electronic circuitry forming a memory device (e.g., forming a random access memory), and/or electronic circuitry forming a communication device (e.g., a modem, a communication switch, or an optoelectronic device). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital fashion, or some combination thereof.
As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source (typically memory or some other data stream). The term as used herein refers to a central processor (central processing unit) in one or more systems, especially a system on a chip (SoC), that combine multiple specialized "processors".
As used herein, a system-on-chip or system-on-chip (SoC or SoC) is an integrated circuit (also referred to as an "IC" or "chip") that integrates all of the devices of a computer or other electronic system. It may contain digital, analog, mixed signal and typically radio frequency functions-all on a single substrate. The SoC integrates a microcontroller (or microprocessor) with advanced peripheral devices such as a Graphics Processing Unit (GPU), wi-Fi module, or coprocessor. The SoC may or may not contain built-in memory.
As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuitry and memory. The microcontroller (or MCU of the microcontroller unit) may be implemented as a small computer on a single integrated circuit. It may be similar to a SoC; the SoC may include a microcontroller as one of its devices. The microcontroller may include one or more Core Processing Units (CPUs), memory and programmable input/output peripherals. Program memory in the form of ferroelectric RAM, NOR flash memory or OTP ROM, as well as small amounts of RAM are often included on the chip. Microcontrollers may be used in embedded applications, as opposed to microprocessors used in personal computers or other general purpose applications consisting of various discrete chips.
As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with peripheral devices. This may be a link between two components of a computer or a controller on an external device for managing the operation of (and connection to) the device.
Any of the processors or microcontrollers as described herein may be any single or multi-core processor, such as those provided by texas instruments (Texas Instruments) under the trade name ARM Cortex. In one aspect, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from texas instruments (Texas Instruments), comprising: on-chip memory of 256KB single-cycle flash memory or other non-volatile memory (up to 40 MHz), prefetch buffer for improving performance beyond 40MHz, 32KB single-cycle Serial Random Access Memory (SRAM), load withInternal read-only memory (ROM) of software, electrically erasable programmable read-only memory (EEPROM) of 2KB, one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Input (QEI) analog, one or more 12-bit analog-to-digital converters (ADC) with 12 analog input channels, and other features that are readily available.
In one example, the processor may include a security controller that includes two controller-based families, such as TMS570 and RM4x, also provided by texas instruments (Texas Instruments) under the trade name Hercules ARM Cortex R4. The security controller may be configured specifically for IEC 61508 and ISO 26262 security critical applications, etc. to provide advanced integrated security features while delivering scalable performance, connectivity, and memory options.
As used in any aspect herein, the term "logic" may refer to an application, software, firmware, and/or circuitry configured to be capable of performing any of the foregoing operations. The software may be embodied as software packages, code, instructions, instruction sets, and/or data recorded on a non-transitory computer readable storage medium. The firmware may be embodied as code, instructions or a set of instructions and/or data that are hard-coded (e.g., non-volatile) in a memory device.
As used in any aspect herein, the terms "device," "system," "module," and the like may refer to a computer-related entity, hardware, a combination of hardware and software, or software in execution.
As used in any aspect herein, an "algorithm" refers to an organized sequence of steps leading to a desired result, wherein "step" refers to the manipulation of physical quantities and/or logical states that may, but need not, take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. Are often used to refer to signals such 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 conditions.
The network may comprise a packet switched network. The communication devices may be capable of communicating with each other using the selected packet switched network communication protocol. One exemplary communication protocol may include an ethernet communication protocol that may allow for communication using transmission control protocol/internet protocol (TCP/IP). The ethernet protocol may conform to or be compatible with an ethernet standard known as the "IEEE 802.3 standard" published by the Institute of Electrical and Electronics Engineers (IEEE) at month 12 of 2008 and/or a higher version of the standard. Alternatively or additionally, the communication devices may be capable of communicating with each other using an x.25 communication protocol. The x.25 communication protocol may conform to or conform to standards promulgated by the international telecommunications union telecommunication standardization sector (ITU-T). Alternatively or additionally, the communication devices may be capable of communicating with each other using a frame relay communication protocol. The frame relay communication protocol may conform to or conform to standards promulgated by the international committee for telephone and telephone negotiations (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) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard promulgated by the ATM forum at month 8 of 2001 under the name "ATM-MPLS network interworking 2.0" and/or a higher version of the standard. Of course, different and/or later developed connection oriented network communication protocols are likewise contemplated herein.
Unless specifically stated otherwise as apparent from the above disclosure, it is appreciated that throughout the above disclosure, discussions utilizing 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.
One or more components may be referred to herein as "configured to be capable of", "configurable to be capable of", "operable/operative", "adapted/adaptable", "capable of", "conformable/conformable", and the like. Those skilled in the art will recognize that "configured to be capable of" may generally encompass active and/or inactive and/or standby components unless the context indicates otherwise.
The terms "proximal" and "distal" are used herein with respect to a clinician manipulating a handle portion of a 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 also be appreciated that for simplicity and clarity, spatial terms such as "vertical," "horizontal," "upper," "lower," "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.
The modular device includes modules (as described in connection with fig. 3 and 9) that may be housed within a surgical hub and a surgical device or instrument that may be connected to various modules for connection or mating with a corresponding surgical hub. Modular devices include, for example, smart surgical instruments, medical imaging devices, aspiration/irrigation devices, smoke ventilators, energy generators, ventilators, insufflators, and displays. The modular device described herein may be controlled by a control algorithm. The control algorithm may be executed on the modular device itself, on a surgical hub paired with a particular modular device, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). In some examples, the control algorithm of the modular device controls the device based on data sensed by the modular device itself (i.e., through sensors in, on, or connected to the modular device). The data may be related to the patient being operated on (e.g., tissue characteristics or insufflation pressure) or the modular device itself (e.g., rate at which the knife is advanced, motor current or energy level). For example, control algorithms for surgical stapling and severing instruments may control the rate at which a motor of the instrument drives its knife through tissue based on the resistance encountered by the knife as it advances.
Those skilled in the art will recognize that, in general, terms used herein, and particularly in the appended claims (e.g., bodies of the appended claims) are generally intended to be "open" terms (e.g., the term "including" should be construed as "including but not limited to," the term "having" should be construed as "having at least," the term "comprising" should be construed as "including but not limited to," etc.). It will be further understood by those with skill in 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(s). 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.
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). Moreover, 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 having only a, only B, only C, 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 "A, B or at least one of 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" shall include but not be limited to systems having only a, only B, only C, 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, in general, unless the context indicates otherwise, disjunctive words and/or phrases presenting two or more alternative terms in the detailed description, claims, or drawings should be understood to encompass the possibility of including one of the terms, either of the terms, or both. For example, the phrase "a or B" will generally be understood to include the possibility of "a" or "B" or "a and B".
For the purposes of the appended claims, those skilled in the art will understand that the operations recited therein can generally be performed in any order. Additionally, while a plurality of operational flow diagrams are listed in one or more orders, it should be understood that the plurality of operations may be performed in an order other than that shown, or may be performed concurrently. Examples of such alternative ordering may include overlapping, staggered, interrupted, reordered, incremental, preparatory, supplemental, simultaneous, reverse, or other altered ordering unless the context dictates otherwise. Moreover, unless the context dictates otherwise, terms such as "responsive to," "related to," or other past-type adjectives are generally not intended to exclude such variants.
It should be appreciated that any reference to "one aspect," "an example," or "an example" means that a particular feature, structure, or characteristic described in connection with the aspect is included in at least one aspect. Thus, the appearances of the phrases "in one aspect," "in an example," and "in an example" in various places throughout this 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.
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 herein by reference, as if the incorporated material was not inconsistent herewith. Accordingly, 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.
In summary, many of the benefits resulting from employing the concepts described herein have been described. The foregoing detailed description of one or more forms has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations of the present invention are possible in light of the above teachings. One or more of the forms selected and described are chosen to illustrate principles and practical application to thereby enable one of ordinary skill in the art to utilize the various forms and various modifications as are suited to the particular use contemplated. The claims filed herewith are intended to define the full scope.
Various aspects of the subject matter described herein are set forth in the following numbered embodiments:
example 1: a surgical system, comprising: a monopolar energy generator; a surgical instrument electrically coupled to a monopolar energy generator comprising an electrode and configured to transmit electrosurgical energy through the electrode to tissue of a patient at a surgical site; at least one detection circuit configured to be capable of: measuring the amount of electrical conduction in the return path of the electrosurgical energy; determining that the amount of electrical conduction in the return path falls below a predetermined threshold; and transmitting a signal to cause the monopolar generator to increase current leakage in the surgical system by increasing the frequency of alternating current in the electrosurgical energy generation; wherein the monopolar energy generator comprises a sensor configured to be able to determine that a monopolar energy circuit is complete by detecting that the current leakage has reached a ground terminal in the monopolar energy generator.
Example 2: the surgical system of embodiment 1, wherein increasing the current leakage allows monopolar electrosurgical operation of the patient to be performed using the surgical instrument.
Example 3: the surgical system of embodiment 1 or 2, wherein the monopolar energy generator further comprises a control circuit configured to: receiving an indication from the sensor that the current leakage has not reached the ground terminal in the monopolar energy generator; and in response to the indication, further increasing the alternating current frequency.
Example 4: the surgical system of embodiment 3, wherein the control circuit is further configured to: receiving a second indication from the sensor that the current leakage has reached the ground terminal in the monopolar energy generator in response to further increasing the alternating current frequency; and in response to the second indication, stopping increasing the alternating current frequency.
Example 5: the surgical system of any of embodiments 1-4, wherein the surgical system is further configured to provide instructions to isolate any return path pad from the surgical system to minimize electrical conductivity flowing through any of the return path pads.
Example 6: the surgical system of any of embodiments 1-5, wherein increasing the frequency comprises increasing the frequency to a range of 500KHz to 4 MHz.
Example 7: a monopolar energy generator of a surgical system, the monopolar energy generator coupled to a surgical instrument configured to transmit electrosurgical energy to tissue of a patient at a surgical site, the energy generator comprising: a power source configured to generate monopolar electrosurgical energy; completing a circuit sensor; a control circuit; a ground terminal; wherein the control circuit is configured to: receiving a signal from a detection circuit that the amount of conduction in the return path of the monopolar electrosurgical energy falls below a predetermined threshold; and responsive to the signal; causing the power source to increase current leakage by increasing the alternating current frequency; wherein the completion circuit sensor is configured to determine that a monopolar energy circuit is complete by detecting that the current leakage has reached the ground terminal.
Example 8: the monopolar energy generator of embodiment 7, wherein increasing said current leakage allows monopolar electrosurgery of said patient to be performed using said surgical instrument.
Example 9: the monopolar energy generator of embodiment 7 or 8, wherein the control circuit is further configured to: receiving an indication from the completed circuit sensor that the current leakage has not reached the ground terminal; and in response to the indication, further increasing the alternating current frequency.
Example 10: the monopolar energy generator of embodiment 9, wherein said control circuit is further configured to enable: receiving a second indication from the sensor that the current leakage has reached the ground terminal in the monopolar energy generator in response to further increasing the alternating current frequency; and in response to the second indication, stopping increasing the alternating current frequency.
Example 11: the monopolar energy generator of any of embodiments 7-10, further configured to provide instructions to isolate any return path pad from the surgical system to minimize conductivity flowing through any return path pad.
Example 12: the monopolar energy generator of any of embodiments 7-10, wherein increasing said frequency comprises increasing said frequency to a range of 500KHz to 4 MHz.
Example 13: a closed loop method of a surgical system including a monopolar energy generator, a surgical instrument coupled to the energy generator, and a detection circuit communicatively coupled to the energy generator, the method comprising: generating electrosurgical energy for the surgical instrument by the energy generator; delivering electrosurgical energy to tissue of a patient at a surgical site by the surgical instrument through an electrode; measuring, by the detection circuit, an amount of conduction in a return path of the electrosurgical energy; determining, by the detection circuit, that the amount of electrical conduction in the return path falls below a predetermined threshold; transmitting, by the detection circuit, a signal to the monopolar energy generator to cause the energy generator to increase current leakage in the surgical system by increasing the frequency of alternating current in the electrosurgical energy generation; and determining, by a sensor in the monopolar energy generator, that a monopolar energy circuit is complete by detecting that the current leak has reached a ground terminal in the monopolar energy generator.
Example 14: the method of embodiment 13, wherein increasing the current leakage allows monopolar electrosurgery of the patient to be performed using the surgical instrument.
Example 15: the method of embodiment 13 or 14, further comprising: receiving an indication from the sensor that the current leakage has not reached the ground terminal in the monopolar energy generator; and in response to the indication, further increasing the alternating current frequency.
Example 16: the method of embodiment 15, further comprising: receiving a second indication from the sensor that the current leakage has reached the ground terminal in the monopolar energy generator in response to further increasing the alternating current frequency; and in response to the second indication, stopping increasing the alternating current frequency.
Example 17: the method of any of embodiments 13-16, further comprising providing instructions to isolate any return path pad from the surgical system to minimize electrical conductivity flowing through any of the return path pads.
Example 18: the method of any of embodiments 13-17 wherein increasing the frequency comprises increasing the frequency to a range of 500KHz to 4 MHz.

Claims (12)

1. A surgical system, comprising:
a monopolar energy generator;
a surgical instrument electrically coupled to a monopolar energy generator comprising an electrode and configured to transmit electrosurgical energy through the electrode to tissue of a patient at a surgical site;
at least one detection circuit configured to be capable of:
measuring an amount of conduction in a return path of the electrosurgical energy;
determining that the amount of electrical conduction in the return path falls below a predetermined threshold; and
transmitting a signal to cause the monopolar energy generator to increase current leakage in the surgical system by increasing the frequency of alternating current in the electrosurgical energy generation;
wherein the monopolar energy generator comprises a sensor configured to be able to determine that a monopolar energy circuit is complete by detecting that the current leakage has reached a ground terminal in the monopolar energy generator.
2. The surgical system of claim 1, wherein increasing the current leakage allows monopolar electrosurgical procedures of the patient to be performed using the surgical instrument.
3. The surgical system of claim 1, wherein the monopolar energy generator further comprises a control circuit configured to:
Receiving an indication from the sensor that the current leakage has not reached the ground terminal in the monopolar energy generator; and
in response to the indication, the alternating current frequency is further increased.
4. The surgical system of claim 3, wherein the control circuit is further configured to:
receiving a second indication from the sensor that the current leakage has reached the ground terminal in the monopolar energy generator in response to further increasing the alternating current frequency; and
in response to the second indication, stopping increasing the alternating current frequency.
5. The surgical system of claim 1, wherein the surgical system is further configured to provide instructions to isolate any return path pad from the surgical system to minimize electrical conductivity flowing through any of the return path pads.
6. The surgical system of claim 1, wherein increasing the frequency comprises increasing the frequency to a range of 500KHz to 4 MHz.
7. A monopolar energy generator of a surgical system, the monopolar energy generator coupled to a surgical instrument configured to transmit electrosurgical energy to tissue of a patient at a surgical site, the energy generator comprising:
A power source configured to generate monopolar electrosurgical energy;
completing a circuit sensor;
a control circuit; and
a ground terminal;
wherein the control circuit is configured to:
receiving a signal from a detection circuit that the amount of conduction in the return path of the monopolar electrosurgical energy falls below a predetermined threshold; and
responsive to the signal; causing the power source to increase current leakage by increasing the alternating current frequency;
wherein the completion circuit sensor is configured to determine that a monopolar energy circuit is complete by detecting that the current leakage has reached the ground terminal.
8. The monopolar energy generator of claim 7, wherein increasing the current leakage allows monopolar electrosurgery of the patient to be performed using the surgical instrument.
9. The monopolar energy generator of claim 7, wherein the control circuit is further configured to enable:
receiving an indication from the completed circuit sensor that the current leakage has not reached the ground terminal; and
in response to the indication, the alternating current frequency is further increased.
10. The monopolar energy generator of claim 9, wherein the control circuit is further configured to enable:
Receiving a second indication from the sensor that the current leakage has reached the ground terminal in the monopolar energy generator in response to further increasing the alternating current frequency; and
in response to the second indication, stopping increasing the alternating current frequency.
11. The monopolar energy generator of claim 7 further configured to provide instructions to isolate any return path pad from the surgical system to minimize electrical conductivity flowing through any of the return path pads.
12. The monopolar energy generator of claim 7 wherein increasing the frequency comprises increasing the frequency to a range of 500KHz to 4 MHz.
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US16/115,256 US11253315B2 (en) 2017-12-28 2018-08-28 Increasing radio frequency to create pad-less monopolar loop
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