CN111526834B - Surgical drainage sensing and generator control - Google Patents

Surgical drainage sensing and generator control Download PDF

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Publication number
CN111526834B
CN111526834B CN201880084525.4A CN201880084525A CN111526834B CN 111526834 B CN111526834 B CN 111526834B CN 201880084525 A CN201880084525 A CN 201880084525A CN 111526834 B CN111526834 B CN 111526834B
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Prior art keywords
surgical
sensor
smoke
filter
fluid
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CN201880084525.4A
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CN111526834A (en
Inventor
F·E·谢尔顿四世
D·C·耶茨
J·L·哈里斯
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Ethicon LLC
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Ethicon LLC
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Priority claimed from US16/024,149 external-priority patent/US11602393B2/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
    • A61B18/14Probes or electrodes therefor
    • A61B18/1402Probes for open surgery
    • 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
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00589Coagulation
    • 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
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00595Cauterization
    • 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
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601Cutting
    • 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
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00607Coagulation and cutting with the same instrument
    • 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
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00619Welding
    • 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
    • A61B2018/00642Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • 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
    • 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
    • A61B2018/00702Power or energy
    • 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
    • A61B2018/00994Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00General characteristics of surgical instruments
    • A61B2217/002Auxiliary appliance
    • A61B2217/005Auxiliary appliance with suction drainage system
    • 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

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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

Surgical systems may include an evacuation system for evacuating smoke, fluids, and/or particulates from a surgical site. The surgical evacuation system may be intelligent and may include one or more sensors for detecting one or more characteristics of, for example, the surgical system, the evacuation system, the surgical procedure, the surgical site, and/or patient tissue.

Description

Surgical drainage sensing and generator control
Cross Reference to Related Applications
This patent application claims priority from U.S. provisional patent application serial No. 62/691,219 entitled, "SURGICAL EVACUATION SENSING AND MOTOR CONTROL," filed on 6/28, 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 Ser. No. 62/650,887, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES," U.S. provisional patent application Ser. No. 62/650,877, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROL," U.S. provisional patent application Ser. No. 62/650,882, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM," U.S. provisional patent application Ser. No. 62/650,882, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS," U.S. provisional patent application Ser. No. 62/650,898, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS," U.S. Patent, U.S. provisional patent application Ser. No. 62/650,898, entitled "35 CONTROL," U.S. Patent No. 62/877, U.S. 3, 30, and "3, 30, of the United states code 35.
This patent application also claims the benefit of priority from U.S. provisional patent application serial No. 62/640,417 entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR" filed 3/8/2018, and provisional patent application serial No. 62/640,415 entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR" filed 3/8/2018, in accordance with the rules of clause 119 (e) of the united states code, volume 35, the disclosure of each of which is incorporated herein by reference in its entirety.
The present patent application also claims the priority of U.S. provisional patent application Ser. No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM", filed on Ser. No. 62/611,341, filed on Ser. No. 62/340, entitled "CLOUD-BASED MEDICAL ANALYTICS, filed on Ser. No. 28, and U.S. provisional patent application Ser. No. 62/611,339, entitled" ROBOT ASSISTED SURGICAL PLATFORM ", filed on Ser. No. 62/611,339, filed on Ser. No. 28, 12, 2017, volume 35, the disclosures of each of which are hereby incorporated by reference in their entirety.
Background
The invention relates to a surgical system and an exhauster thereof. The surgical smoke extractor is configured to extract smoke, fluids, and/or particulates from the surgical site. For example, during a surgical procedure involving an energy device, smoke may be generated at the surgical site.
Disclosure of Invention
In various embodiments, a surgical system including a surgical evacuation system is disclosed. The surgical evacuation system includes a pump, a motor operably coupled to the pump, a flow path fluidly coupled to the pump, and a sensor positioned along the flow path. The sensor is configured to monitor a parameter of a fluid flowing along the flow path. The surgical system also includes a generator operably configured to supply an energy waveform to the electrosurgical instrument. The surgical system also includes a control circuit configured to receive the parameter from the sensor and adjust the energy waveform supplied by the generator in response to the parameter received from the sensor.
In various embodiments, a surgical system including a surgical evacuation system is disclosed. The surgical evacuation system includes a pump, a motor operably coupled to the pump, a flow path fluidly coupled to the pump, and a sensor positioned along the flow path. The sensor is configured to monitor a parameter of a fluid flowing along the flow path. The surgical system also includes a generator operably configured to supply power to the electrosurgical instrument. The surgical system also includes a control circuit configured to receive the parameter from the sensor and to selectively adjust the power supplied by the generator based on the parameter received from the sensor.
In various embodiments, a non-transitory computer-readable medium storing computer-readable instructions is disclosed. The instructions, when executed, cause the machine to receive a parameter detected by a sensor. The sensor is positioned along a flow path of the surgical evacuation system and is configured to monitor a parameter of fluid flowing along the flow path. The surgical evacuation system also includes a pump fluidly coupled to the flow path and a motor operably coupled to the pump. The computer readable instructions, when executed, further cause the machine to selectively adjust power supplied by the generator to the electrosurgical instrument based on the parameter detected by the sensor.
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 perspective view of a exhauster housing for a surgical evacuation system in accordance with at least one aspect of the present disclosure.
Fig. 2 is a perspective view of a surgical evacuation electrosurgical tool in accordance with at least one aspect of the present disclosure.
Fig. 3 is an elevation view of a surgical drainage tool releasably secured to an electrosurgical pencil in accordance with at least one aspect of the present disclosure.
Fig. 4 is a schematic diagram illustrating internal components within an exhauster housing for a surgical evacuation system in accordance with at least one aspect of the present disclosure.
Fig. 5 is a schematic view of an electrosurgical system including a smoke extractor in accordance with at least one aspect of the present disclosure.
Fig. 6 is a schematic view of a surgical drainage system according to at least one aspect of the present disclosure.
Fig. 7 is a perspective view of a surgical system including a surgical evacuation system in accordance with at least one aspect of the present disclosure.
Fig. 8 is a perspective view of an ejector housing of the surgical extraction system of fig. 7 in accordance with at least one aspect of the present disclosure.
Fig. 9 is an elevational cross-sectional view of a socket in the exhauster housing of fig. 8 along the plane shown in fig. 8 in accordance with at least one aspect of the present disclosure.
Fig. 10 is a perspective view of a filter for a drainage system according to at least one aspect of the present disclosure.
Fig. 11 is a perspective cross-sectional view of the filter of fig. 10 taken along a central longitudinal plane of the filter in accordance with at least one aspect of the present disclosure.
Fig. 12 is a pump for a surgical evacuation system, such as the surgical evacuation system of fig. 7, in accordance with at least one aspect of the present disclosure.
Fig. 13 is a perspective view of a portion of a surgical drainage system in accordance with at least one aspect of the present disclosure.
Fig. 14 is a front perspective view of a fluid catcher of the surgical drainage system of fig. 13 in accordance with at least one aspect of the present disclosure.
Fig. 15 is a rear perspective view of the fluid trap of fig. 14 in accordance with at least one aspect of the present disclosure.
Fig. 16 is a front cross-sectional view of the fluid trap of fig. 14, in accordance with at least one aspect of the present disclosure.
Fig. 17 is a front cross-sectional view of the fluid trap of fig. 14, with portions removed for clarity, and showing liquid captured within the fluid trap and smoke flowing through the fluid trap, in accordance with at least one aspect of the present disclosure.
Fig. 18 is a schematic view of a exhauster housing of a exhauster system according to at least one aspect of the present disclosure.
Fig. 19 is a schematic view of a exhauster housing of another exhauster system according to at least one aspect of the present disclosure.
Fig. 20 is a schematic view of a photoelectric sensor for a surgical drainage system in accordance with at least one aspect of the present disclosure.
Fig. 21 is a schematic view of another photosensor for a surgical drainage system in accordance with at least one aspect of the present disclosure.
Fig. 22 is a schematic view of an ionization sensor for a surgical evacuation system in accordance with at least one aspect of the present disclosure.
FIG. 23 is a graphical representation of (A) particle count over time and (B) motor speed over time of a surgical evacuation system in accordance with at least one aspect of the present disclosure.
Fig. 24A is a cross-sectional view of a diverter valve for a surgical drainage system, showing the diverter valve in a first position, in accordance with at least one aspect of the present disclosure.
FIG. 24B is a cross-sectional view of the diverter valve of FIG. 24A in a second position in accordance with at least one aspect of the present disclosure.
FIG. 25 is a graphical representation of (A) airflow fluid content over time and (B) duty cycle over time of a surgical evacuation system in accordance with at least one aspect of the present disclosure.
Fig. 26 is a flow chart illustrating an adjustment algorithm for a surgical evacuation system in accordance with at least one aspect of the present disclosure.
Fig. 27 is a flow chart illustrating an adjustment algorithm for a surgical evacuation system in accordance with at least one aspect of the present disclosure.
Fig. 28 is a flow chart illustrating an adjustment algorithm for a surgical evacuation system in accordance with at least one aspect of the present disclosure.
Fig. 29 is a flow chart illustrating an adjustment algorithm for a surgical system in accordance with at least one aspect of the present disclosure.
Fig. 30 is a perspective view of a surgical system in accordance with at least one aspect of the present disclosure.
FIG. 31 is a flow chart illustrating an algorithm for displaying efficiency data of a surgical evacuation system in accordance with at least one aspect of the present disclosure.
Fig. 32 is a flow chart illustrating an adjustment algorithm for a surgical evacuation system in accordance with at least one aspect of the present disclosure.
Fig. 33 is a graphical representation of (a) particle count over time and (B) RF current to voltage ratio over time for a surgical system in accordance with at least one aspect of the present disclosure.
Fig. 34 is a flow chart illustrating an adjustment algorithm for a surgical system in accordance with at least one aspect of the present disclosure.
Fig. 35 is a flow chart for controlling a motor based on at least one of a first signal received from a first sensor of a drainage system and a second signal received from a second sensor of the drainage system in accordance with at least one aspect of the present disclosure.
FIG. 36 is a graphical representation of (A) particle count over time, (B) power and voltage of the generator over time, and (C) motor speed over time for a drainage system in accordance with at least one aspect of the present disclosure.
FIG. 37 is a graphical representation of a ratio of pressure detected at a first sensor to pressure detected at a second sensor and a pulse width modulated duty cycle of a motor of a drainage system over time in accordance with at least one aspect of the present disclosure.
FIG. 38 is a graphical representation of (A) particle count over time and (C) airflow velocity over time for a drainage system in accordance with at least one aspect of the present disclosure.
Fig. 39 is a block diagram of a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure.
Fig. 40 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. 41 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. 42 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. 43 is a perspective view of a combined generator module having bipolar, ultrasonic and monopolar contacts and a smoke evacuation member in accordance with at least one aspect of the present disclosure.
Fig. 44 illustrates a single power bus attachment for multiple lateral docking ports of a lateral modular housing configured to be able to receive multiple modules in accordance with at least one aspect of the present disclosure.
Fig. 45 illustrates a vertical modular housing configured to be able to receive a plurality of modules in accordance with at least one aspect of the present disclosure.
Fig. 46 illustrates a surgical data network including a modular communication hub configured to enable connection of a modular device 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. 47 is a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure.
Fig. 48 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. 49 illustrates one aspect of a Universal Serial Bus (USB) hub device in accordance with at least one aspect of the present disclosure.
Fig. 50 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. 51 illustrates control circuitry configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.
FIG. 52 illustrates a combinational logic circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.
FIG. 53 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. 54 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. 55 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. 56 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. 57 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. 58 is a simplified block diagram of a generator configured to provide, among other benefits, inductor-less tuning in accordance with at least one aspect of the present disclosure.
Fig. 59 illustrates an example of a generator in accordance with at least one aspect of the present disclosure, which is one form of the generator of fig. 20.
Fig. 60 is a timeline showing situational awareness of a surgical hub in accordance with an aspect of the present disclosure.
Detailed Description
The applicant of the present patent application owns the following U.S. patent applications filed on date 29 of 2018, 6, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. patent application Ser. No. __________, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS", attorney docket number END8542USNP/170755;
U.S. patent application Ser. No. __________, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS", attorney docket number END8543USNP/170760;
U.S. patent application Ser. No. __________, entitled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION", attorney docket number END8543USNP1/170760-1;
U.S. patent application Ser. No. __________, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING", attorney docket number END8543USNP2/170760-2;
U.S. patent application Ser. No. __________, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING", attorney docket number END8543USNP3/170760-3;
U.S. patent application Ser. No. __________, entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES", attorney docket number END8543USNP4/170760-4;
U.S. patent application Ser. No. __________, entitled "SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE", attorney docket number END8543USNP5/170760-5;
U.S. patent application Ser. No. __________, entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES", attorney docket number END8543USNP6/170760-6;
U.S. patent application Ser. No. __________, entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY", attorney docket number END8543USNP7/170760-7;
U.S. patent application Ser. No. __________, entitled "URGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE", attorney docket number END8544USNP/170761;
U.S. patent application Ser. No. __________, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT", attorney docket number END8544USNP1/170761-1;
U.S. patent application Ser. No. __________, entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY", attorney docket number END8544USNP2/170761-2;
U.S. patent application Ser. No. __________, titled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES", attorney docket number END8544USNP3/170761-3;
U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL", attorney docket number END8545USNP/170762;
U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS", attorney docket number END8545USNP1/170762-1;
U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION FLOW PATHS", attorney docket number END8545USNP2/170762-2;
U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION SENSING AND DISPLAY", attorney docket number END8545USNP4/170762-4;
U.S. patent application Ser. No. __________, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM", attorney docket number END8546USNP/170763;
U.S. patent application Ser. No. __________, entitled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM", attorney docket number END8546USNP1/170763-1;
U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE", attorney docket number END8547USNP/170764; and
U.S. patent application Ser. No. __________, entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS", attorney docket number END8548USNP/170765.
The applicant of the present patent application owns the following U.S. provisional patent applications filed on 28 th 2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. provisional patent application Ser. No. 62/691,228, entitled "A Method of using reinforced flex circuits with multiple sensors with electrosurgical device";
U.S. provisional patent application Ser. No. 62/691,227, entitled "controlLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETER";
U.S. provisional patent application Ser. No. 62/691,230, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTROD";
U.S. provisional patent application Ser. No. 62/691,219, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL";
U.S. provisional patent application Ser. No. 62/691,257, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM";
U.S. provisional patent application Ser. No. 62/691,262, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE"; and
U.S. provisional patent application Ser. No. 62/691,251, entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS";
the applicant of the present patent application owns the following U.S. patent applications filed on date 29 of 3.2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. patent application Ser. No. 15/940,641, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES";
U.S. patent application Ser. No. 15/940,648, entitled "INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIS";
U.S. patent application Ser. No. 15/940,656, entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES";
U.S. patent application Ser. No. 15/940,666, entitled "SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS;
U.S. patent application Ser. No. 15/940,670, entitled "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 ARRANGEMENTS";
U.S. patent application Ser. No. 15/940,632, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD";
U.S. patent application Ser. No. 15/940,640, entitled "COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS";
U.S. patent application Ser. No. 15/940,645 entitled "SELF describe DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT";
U.S. patent application Ser. No. 15/940,649, entitled "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME";
U.S. patent application Ser. No. 15/940,654, entitled "SURGICAL HUB SITUATIONAL AWARENESS";
U.S. patent application Ser. No. 15/940,663, entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING";
U.S. patent application Ser. No. 15/940,668, entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA";
U.S. patent application Ser. No. 15/940,671, entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER";
U.S. patent application Ser. No. 15/940,686, entitled "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 DISPLAYS";
U.S. patent application Ser. No. 15/940,629, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
U.S. patent application Ser. No. 15/940,704, entitled "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 "CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY"; and
U.S. patent application Ser. No. 15/940,742, entitled "DUAL CMOS ARRAY IMAGING";
the applicant of the present patent application owns the following U.S. patent applications filed on date 29 of 3.2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. patent application Ser. No. 15/940,636, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
U.S. patent application Ser. No. 15/940,653, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS";
U.S. patent application Ser. No. 15/940,660, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER";
U.S. patent application Ser. No. 15/940,679, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET";
U.S. patent application Ser. No. 15/940,694, entitled "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 ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";
U.S. patent application Ser. No. 15/940,706, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK"; and
U.S. patent application Ser. No. 15/940,675, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES";
the applicant of the present patent application owns the following U.S. patent applications filed on date 29 of 3.2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. patent application Ser. No. 15/940,627, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. patent application Ser. No. 15/940,637, entitled "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. patent application Ser. No. 15/940,642, entitled "CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. patent application Ser. No. 15/940,676, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. patent application Ser. No. 15/940,680, entitled "CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. patent application Ser. No. 15/940,683, entitled "COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. patent application Ser. No. 15/940,690, entitled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; and
U.S. patent application Ser. No. 15/940,711, entitled "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 SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES";
U.S. provisional patent application Ser. No. 62/649,294, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD";
U.S. patent application Ser. No. 62/649,300, entitled "SURGICAL HUB SITUATIONAL AWARENESS";
U.S. provisional patent application Ser. No. 62/649,309, titled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER";
U.S. patent application Ser. No. 62/649,310, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
U.S. provisional patent application Ser. No. 62/649291, entitled "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 UPDATES FOR SURGICAL DEVICES";
U.S. provisional patent application Ser. No. 62/649,333, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER";
U.S. provisional patent application Ser. No. 62/649,327, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";
U.S. provisional patent application Ser. No. 62/649,315, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK";
U.S. patent application Ser. No. 62/649,313, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES";
U.S. patent application Ser. No. 62/649,320, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. provisional patent application Ser. No. 62/649,307, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; and
U.S. provisional patent application Ser. No. 62/649,323, entitled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS".
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 "METHOD OF HUB COMMUNICATION";
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.
Energy device and smoke exhaust
The present disclosure relates to energy devices and intelligent surgical evacuation systems for evacuating smoke and/or other fluids and/or particulates from a surgical site. Smoke is typically generated during surgery using one or more energy devices. The energy device uses energy to affect tissue. In an energy device, energy is supplied by a generator. Energy devices include devices having tissue contacting electrodes, such as electrosurgical devices having one or more Radio Frequency (RF) electrodes, and devices having vibrating surfaces, such as ultrasonic devices having ultrasonic blades. For electrosurgical devices, the generator is configured to generate an oscillating current to energize the electrodes. For an ultrasonic device, the generator is configured to generate ultrasonic vibrations to energize the ultrasonic blade. The generator is further described herein.
Ultrasonic energy may be used to coagulate and cut tissue. Ultrasonic energy coagulates and cuts tissue by vibrating an energy delivery surface (e.g., an ultrasonic blade) in contact with the tissue. The ultrasonic blade may be coupled to a waveguide that transmits vibratory energy from an ultrasonic transducer that produces mechanical vibrations and is powered by a generator. At high frequency vibrations (e.g., 55,500 times per second), the ultrasonic blade generates friction and heat between the blade and the tissue (i.e., at the blade-tissue interface), which denatures proteins in the tissue to form viscous coagulum. The pressure exerted by the knife surface on the tissue collapses the blood vessel and allows the clot to form a hemostatic seal. The accuracy of the cutting and coagulation can be controlled by the clinician's technique and by adjusting, for example, the power level, blade edge, tissue traction, and blade pressure.
Ultrasonic surgical instruments are increasingly used in surgery by virtue of the unique performance characteristics of such instruments. Depending on the particular instrument configuration and operating parameters, ultrasonic surgical instruments are capable of substantially simultaneously performing cutting of tissue and hemostasis by coagulation, which can advantageously minimize patient trauma. The cutting action is typically accomplished by an end effector or knife tip at the distal end of the ultrasonic instrument. The ultrasonic end effector transmits ultrasonic energy to tissue in contact with the end effector. Ultrasonic instruments of this nature may be configured for open surgical use, laparoscopic surgery, or endoscopic surgery, including, for example, robotic-assisted surgery.
Electrical energy may also be used for coagulation and/or cutting. Electrosurgical devices generally include a handpiece, an instrument with an end effector (e.g., one or more electrodes) mounted distally. The end effector may be positioned against and/or adjacent tissue such that electrical current is introduced into the tissue. Electrosurgical is widely used and offers many advantages, including both coagulation and cutting with a single surgical instrument.
The electrosurgical device electrode or tip is small at the point of contact with the patient to produce RF current with high current density to produce a surgical effect of coagulating and/or cutting tissue by cauterization. After the return electrode passes through the patient, the return electrode carries the same RF signal back to the electrosurgical generator, thereby providing a return path for the RF signal.
The electrosurgical device may be configured for bipolar or monopolar operation. During bipolar operation, current is introduced into and returned from the tissue through the active and return electrodes of the end effector, respectively. During monopolar operation, current is introduced into tissue through the active electrode of the end effector and returned through a return electrode (e.g., a ground pad) that is positioned alone on or against the patient's body. The heat generated by the current flowing through the tissue may form a hemostatic seal within and/or between the tissues and may thus be particularly useful, for example, in sealing blood vessels. The end effector of the electrosurgical device may also include a cutting member that is movable relative to tissue and electrodes to transect the tissue.
In application, the electrosurgical device may transmit a low frequency RF current through the tissue, which may cause ionic oscillations or friction (effectively causing resistive heating), thereby raising the temperature of the tissue. Because of the boundary formed between the affected tissue and the surrounding tissue, the clinician is able to operate with high accuracy and control without damaging adjacent non-target tissue. The low operating temperature of the RF energy may be used to remove, shrink, or remodel soft tissue while sealing the vessel. RF energy can be particularly well suited for connective tissue, which is composed primarily of collagen and contracts when exposed to heat. Other electrosurgical instruments include, but are not limited to, irreversible and/or reversible electroporation, and/or microwave techniques, among others. The techniques disclosed herein may be applicable to ultrasound, bipolar and/or monopolar RF (electrosurgical), irreversible and/or reversible electroporation, and/or microwave-based surgical instruments, among others.
The electrical energy applied by the electrosurgical device may be transmitted from the generator to the instrument. The generator is configured to convert the electrical power into a high frequency waveform comprised of an oscillating current that is transmitted to the electrodes to affect the tissue. The current is passed through the tissue to cauterize (a form of coagulation in which an arc of current on the tissue produces charring of the tissue), desiccate (direct energy application driving cellular water) and/or cut (indirect energy application causing cellular fluid to evaporate causing cellular explosion) the tissue. The response of tissue to current varies depending on the resistance of the tissue, the current density through the tissue, the power output, and the duration of the current application. In some cases, as further described herein, the current waveform may be adjusted to affect different surgical functions and/or to accommodate tissues of different characteristics. For example, different types of tissue (vascular tissue, neural tissue, muscle, skin, fat, and/or bone) may respond differently to the same waveform.
The electrical energy may be in the form of RF energy, which may be in the frequency range described in EN60601-2-2:2009+a11:2011, definition 201.3.218-high frequency. For example, frequencies in monopolar RF applications are typically limited to less than 5MHz to minimize problems associated with high frequency leakage currents. Monopolar applications may typically use frequencies above 200kHz in order to avoid undesirable stimulation of nerves and muscles due to the use of low frequency currents.
In bipolar RF applications, the frequency can be almost any value. In some cases, such as if risk analysis shows that the likelihood of neuromuscular stimulation has been reduced to an acceptable level, lower frequencies may be used for bipolar techniques. It is generally considered that 10mA is the lower threshold for tissue heating effects. In the case of bipolar technology, higher frequencies may also be used.
In some cases, the generator may be configured to digitally generate and provide an output waveform to the surgical device such that the surgical device may use the waveform for various tissue effects. The generator may be a monopolar generator, a bipolar generator and/or an ultrasonic generator. For example, a single generator may supply energy to a monopolar device, a bipolar device, an ultrasonic device, or a combined electrosurgical/ultrasonic device. The generator may facilitate tissue-specific effects via waveform formation and/or may drive RF and ultrasonic energy simultaneously and/or sequentially to a single surgical instrument or multiple surgical instruments.
In one instance, the surgical system can include a generator and various surgical instruments that can be used therewith, including ultrasonic surgical instruments, RF electrosurgical instruments, and combined ultrasonic/RF electrosurgical instruments. The generator may be configured for use with a variety of surgical instruments as further described in U.S. patent application 15/265,279 entitled "TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS" filed on date 2016, 9 and 14 (now U.S. patent application publication 2017/0086914), which is incorporated herein by reference in its entirety.
As described herein, medical procedures that cut tissue and/or cauterize blood vessels are typically performed by utilizing RF electrical energy generated by a generator and transmitted to the tissue of a patient through electrodes operated by a clinician. The electrodes deliver the electrical discharge to cellular material of the patient's body adjacent to the electrodes. The electrical discharge causes the cellular material to warm up to cut tissue and/or cauterize blood vessels.
The high temperatures involved in electrosurgery can cause thermal necrosis of tissue adjacent to the electrode. The longer the tissue is exposed to the high temperatures involved in electrosurgery, the more likely the tissue is to suffer thermal necrosis. In some cases, thermal necrosis of the tissue can reduce the speed of cutting the tissue and increase postoperative complications, eschar generation and healing time, as well as increase the incidence of thermal damage to tissue located away from the cutting site.
The concentration of the RF energy discharge affects both the efficiency with which the electrode can cut tissue and the likelihood of tissue damage away from the cutting site. For standard electrode geometries, the RF energy tends to be uniformly distributed over a relatively large area adjacent to the intended incision site. The substantially uniform distribution of RF energy discharge increases the likelihood of external charge loss into the surrounding tissue, which may increase the likelihood of unwanted tissue damage in the surrounding tissue.
Typical electrosurgical generators produce RF electrical energy and output power levels at various operating frequencies. The particular operating frequency and power output of the generator varies based on the particular electrosurgical generator used and the needs of the physician during the electrosurgical procedure. The particular operating frequency and power output level may be manually adjusted on the generator by a clinician or other operating room personnel. Proper adjustment of these various settings requires a great deal of knowledge, skill and attention from the clinician or other staff. Once the clinician makes the desired adjustments to the various settings on the generator, the generator can maintain these output parameters during the electrosurgical procedure. Typically, wave generators for electrosurgery are adapted to generate RF waves with an output power in the range of 1-300W in cutting mode and 1-120W in coagulation mode and a frequency in the range of 300-600kHz. A typical wave generator is adapted to maintain a selected setting during electrosurgical procedures. For example, if the clinician were to set the output power level of the generator to 50W and then touch the electrodes to the patient to perform the electrosurgical procedure, the power level of the generator would quickly rise and remain at 50W. While setting the power level to a specific setting (such as 50W) will allow the clinician to cut through the patient's tissue, maintaining such a high power level increases the likelihood of thermal necrosis of the patient's tissue.
In some forms, the generator is configured to provide sufficient power to effectively perform electrosurgical procedures in conjunction with electrodes that increase the concentration of RF energy discharge, while at the same time limiting unwanted tissue damage, reducing postoperative complications, and facilitating faster healing. For example, the waveform from the generator may be optimized by the control circuitry throughout the surgical procedure. However, the claimed subject matter is not limited to aspects that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is provided to illustrate only one example of a technical field in which some aspects described herein may be practiced.
As provided herein, the energy device delivers mechanical and/or electrical energy to the target tissue in order to treat the tissue (e.g., cut tissue, cauterize blood vessels, and/or coagulate tissue within and/or near the target tissue). Cutting, cauterizing and/or coagulating tissue may result in the release of fluids and/or particulates into the air. Such fluids and/or particles expelled during surgery may constitute smoke, which may include, for example, carbon particles and/or other particles suspended in air. In other words, the fluid may include smoke and/or other fluid substances. Approximately 90% of endoscopic and open surgical procedures produce a certain level of smoke. Smoke may cause discomfort to the sense of smell of the clinician, assistant, and/or patient, may prevent the clinician from viewing the surgical site, and may be inhaled in some instances, to the detriment of health. For example, fumes generated during electrosurgery may contain toxic chemicals including acrolein, acetonitrile, acrylonitrile, acetylene, alkylbenzenes, benzene, butadiene, butylene, carbon monoxide, cresol, ethane, ethylene, formaldehyde, free radicals, hydrogen cyanide, isobutylene, methane, phenol, polycyclic aromatic hydrocarbons, propylene (propylene), propylene, pyridine, pyrrole (pyriden), styrene, toluene, and xylenes, as well as dead and living cellular material (including blood fragments) and viruses. Certain materials that have been identified in surgical smoke have been identified as known carcinogens. It is estimated that one gram of tissue burned during electrosurgery may be equivalent to toxins and carcinogens of six unfiltered cigarettes. In addition, exposure to smoke released during electrosurgery has been reported to cause eye and lung irritation to healthcare workers.
In addition to the toxicity and odor associated with materials in surgical smoke, the size of particulates in surgical smoke can be detrimental to the clinician, assistant, and/or respiratory system of the patient. In some cases, the particles may be extremely small. In some cases, repeated inhalation of very small particulate matter can lead to acute and chronic respiratory conditions.
Many electrosurgical systems employ a surgical evacuation system that captures the resulting smoke from the surgical procedure and directs the captured smoke away from the clinician and/or away from the patient through a filter and an exhaust port. For example, the evacuation system may be configured to evacuate smoke generated during electrosurgical procedures. The reader will appreciate that such evacuation systems may be referred to as "smoke evacuation systems," but such evacuation systems may be configured to evacuate more than just smoke from the surgical site. Throughout this disclosure, "smoke" exhausted by the exhaust system is not limited to only smoke. Rather, the smoke evacuation systems disclosed herein may be used to evacuate a variety of fluids, including liquids, gases, vapors, fumes, vapors, or combinations thereof. The fluid may be of biological origin and/or may be introduced to the surgical site from an external source during surgery. The fluid may include, for example, water, saline, lymph, blood, exudates, and/or purulent effluents. Further, the fluid may include particulates or other matter (e.g., porous matter or debris) that is evacuated by the evacuation system. For example, such particles may be suspended in a fluid.
Drainage systems typically include a pump and a filter. The pump produces suction that draws the smoke into the filter. For example, aspiration may be configured to draw smoke from a surgical site into a catheter opening, through an evacuation catheter, and into an exhauster housing of an evacuation system. An exhauster housing 50018 for a surgical exhauster system 50000 is shown in fig. 1. In one aspect of the disclosure, the pump and filter are positioned within the exhauster housing 50018. The smoke drawn into the ejector housing 50018 travels to the filter via the suction conduit 50036 and the harmful toxins and pungent odors are filtered from the smoke as it moves through the filter. Aspiration conduits may also be referred to as, for example, vacuum and/or evacuation conduits and/or tubes. The filtered air may then exit the surgical evacuation system as exhaust. In some cases, the various drainage systems disclosed herein may also be configured to deliver fluid to a desired location, such as a surgical site.
Referring now to fig. 2, the suction conduit 50036 from the ejector housing 50018 (fig. 1) can terminate at a handpiece, such as handpiece 50032. The handpiece 50032 includes an electrosurgical instrument including an electrode tip 50034 and a drainage catheter opening adjacent and/or near the electrode tip 50034. The evacuation catheter opening is configured to capture fluids and/or particulates released during a surgical procedure. In such a case, the drainage system 50000 is integrated into the electrosurgical instrument 50032. Still referring to fig. 2, the smoke S is drawn into the suction duct 50036.
In some cases, the evacuation system 50000 can include a separate surgical tool including a catheter opening and configured to aspirate smoke into the system. In still other cases, a tool including a drainage catheter and an opening may be snap-fit onto an electrosurgical tool, as shown in fig. 3. For example, a portion of the aspiration catheter 51036 may be positioned about (or adjacent to) the electrode tip 51034. In one instance, the aspiration catheter 51036 can be releasably secured to a handpiece 51032 of an electrosurgical tool including an electrode tip 51034 with a clamp or other fastener.
Various internal components of the ejector housing 50518 are shown in fig. 4. In various cases, the internal components of fig. 4 may also be incorporated into the ejector housing 50018 of fig. 1. Referring primarily to fig. 4, the evacuation system 50500 includes an evacuation housing 50518, a filter 50502, an exhaust mechanism 5059, and a pump 50506. The extraction system 50500 defines a flow path 50504 through an extractor housing 50518 having an inlet port 50522 and an outlet port 50524. The filter 50502, exhaust mechanism 50520, and pump 50506 are sequentially arranged in line with the flow path 50504 through the ejector housing 50518 between the inlet port 50522 and the outlet port 50524. The inlet port 50522 can be fluidly coupled to an aspiration catheter, such as aspiration catheter 50036 in fig. 1, which can include a distal catheter opening positionable at a surgical site.
Pump 50506 is configured to be capable of creating a pressure differential in flow path 50504 through mechanical action. The pressure differential is configured to draw smoke 50508 from the surgical site into the inlet port 50522 and along the flow path 50504. After the smoke 50508 has moved through the filter 50502, the smoke 50508 may be considered filtered smoke or air 50510, which may continue through the flow path 50504 and exit through the outlet port 50524. The flow path 50504 includes a first region 50514 and a second region 50506. The first zone 50514 is located upstream of the pump 50506; the second section 50506 is downstream of the pump 50506. The pump 50506 is configured to pressurize the fluid in the flow path 50504 such that the fluid in the second zone 50506 has a higher pressure than the fluid in the first zone 50514. Motor 50512 drives pump 50506. Various suitable motors are further described herein. The exhaust mechanism 50520 is a mechanism that can control the speed, direction, and/or other characteristics of the filtered smoke 50510 exiting the exhaust system 50500 at the outlet port 50524.
The flow path 50504 through the drainage system 50500 may be comprised of a tube or other conduit that substantially contains and/or isolates fluid moving through the flow path 50504 from fluid outside of the flow path 50504. For example, the first region 50514 of the flow path 50504 can comprise a tube through which the flow path 50504 extends between the filter 50502 and the pump 50506. The second region 50506 of the flow path 50504 may also include a tube through which the flow path 50504 extends between the pump 50506 and the exhaust mechanism 5059. The flow path 50504 also extends through the filter 50502, pump 50506, and exhaust mechanism 5059 such that the flow path 50504 extends from the inlet port 50522 to the outlet port 50524.
In operation, smoke 50508 may flow into the filter 50502 at the inlet port 50522 and may be pumped through the flow path 50504 by the pump 50506 such that the smoke 50508 is drawn into the filter 50502. The filtered smoke 50510 may then be pumped through the exhaust 50520 and out the outlet port 50524 of the drainage system 50500. The filtered smoke 50510 exiting the exhaust system 50500 at the outlet port 50524 is exhaust gas and may consist of filtered gas that has passed through the exhaust system 50500.
In various instances, the drainage systems disclosed herein (e.g., drainage system 50000 and drainage system 50500) may be incorporated into, for example, a computer-implemented interactive surgical system, such as system 100 (fig. 39) or system 200 (fig. 47). In one aspect of the present disclosure, for example, the computer-implemented surgical system 100 may include at least one hub 106 and a cloud 104. Referring primarily to fig. 41, the hub 106 includes a smoke evacuation module 126. Operation of smoke evacuation module 126 may be controlled by hub 106 based on its situational awareness and/or feedback from its components and/or based on information from cloud 104. Computer-implemented surgical systems 100 and 200 and situational awareness thereof are further described herein.
Situational awareness encompasses the ability of some aspects of the surgical system to determine or infer information related to a surgical procedure from data received from databases and/or instruments. The information may include the type of surgery being performed, the type of tissue being operated on, or the body cavity being the subject of the surgery. With context information associated with the surgical procedure, the surgical system may, for example, improve the manner in which it controls the modular device (e.g., smoke evacuation system) connected thereto, and provide the clinician with the context information or advice during the course of the surgical procedure. Situational awareness is further described in U.S. provisional patent application serial No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed 12/28 in 2017, which is incorporated herein by reference in its entirety.
In various instances, the surgical systems and/or evacuation systems disclosed herein may include a processor. The processor may be programmed to control one or more operating parameters of the surgical system and/or evacuation system based on, for example, sensed and/or aggregated data and/or one or more user inputs. Fig. 5 is a schematic diagram of an electrosurgical system 50300 including a processor 50308. Electrosurgical system 50300 is powered by an AC source 50302 that provides 120V or 240V alternating current. The voltage supplied by AC source 50302 is directed to AC/DC converter 50304, which converts 120V or 240V AC power to 360V DC power. The 360V dc power is then directed to a power converter 50306 (e.g., a buck converter). The power converter 50306 is a step-down DC-DC converter. The power converter 50306 is adapted to step down the input 360V to a desired level in the range of 0-150V.
The processor 50308 may be programmed to adjust various aspects, functions, and parameters of the electrosurgical system 50300. For example, the processor 50308 may determine a desired output power level at the electrode tip 50334, which may be similar in many respects to the electrode tip 50034 in fig. 2 and/or the electrode tip 51034 in fig. 3, for example, and direct the power converter 50306 to step down the voltage to a specified level in order to provide the desired output power. The processor 50308 is coupled to a memory 50310, which is configured to store machine-executable instructions to operate the electrosurgical system 50300 and/or subsystems thereof.
Connected between the processor 50308 and the power converter 50306 is a digital-to-analog converter ("DAC") 50312.DAC 50312 is adapted to convert digital codes generated by processor 50308 into analog signals (current, voltage or charge) that control the voltage step down performed by power converter 50306. Once the power converter 50306 steps down 360V to a level that the processor 50308 has determined will provide the desired output power level, the stepped down voltage is directed to the electrode tip 50334 to effect electrosurgical treatment of the patient tissue and then to the return or ground electrode 50335. The voltage sensor 50314 and the current sensor 50316 are adapted to detect the voltage and current present in the electrosurgical circuit and communicate the detected parameters to the processor 50308 so that the processor 50308 can determine whether to adjust the output power level. As described herein, a typical wave generator is adapted to maintain a selected setting throughout the electrosurgical procedure. In other cases, the operating parameters of the generator may be optimized based on one or more inputs to the processor 5308 (such as inputs from a surgical hub, cloud, and/or situational awareness module), for example, during surgery, as described further herein.
The processor 50308 is coupled to a communication device 50318 for communication over a network. The communication device includes a transceiver 50320 configured to be able to communicate by physical wire or wirelessly. The communication device 50318 may also include one or more additional transceivers. The transceiver may include, but is not limited to, a cellular modem, a wireless mesh network transceiver,A transceiver, a Low Power Wide Area (LPWA) transceiver, and/or a near field communication transceiver (NFC). The communication device 50318 may include or be configured to be able to communicate with:mobile phones, sensor systems (e.g., environments, locations, sports, etc.), and/or sensor networks (wired and/or wireless), computing systems (e.g., server, workstation computer, desktop computer, laptop computer, tablet computer (e.g.,/-)>Galaxy />Etc.), ultra-portable computers, ultra-mobile computers, netbook computers, and/or mini-notebook computers), etc. In at least one aspect of the present disclosure, one of the devices may be a coordinator node.
The transceiver 50320 may be configured to receive serial transmission data from the processor 50308 via a respective UART to modulate the serial transmission data onto an RF carrier to generate a transmission RF signal and transmit the transmission RF signal via a respective antenna. The transceiver is further configured to be able to receive the received RF signals via respective antennas comprising RF carriers modulated with the serial received data, demodulate the received RF signals to extract the serial received data and provide the serial received data to respective UARTs for provision to the processor. Each RF signal has an associated carrier frequency and an associated channel bandwidth. The channel bandwidth is associated with carrier frequencies, transmission data, and/or reception data. Each RF carrier frequency and channel bandwidth is associated with a frequency range of transceiver 50320. Each channel bandwidth is further related to a wireless communication standard and/or protocol that transceiver 50320 may adhere to. In other words, each transceiver 50320 may correspond to a particular implementation of a selected wireless communication standard and/or protocol, e.g., for IEEE 802.11a/b/g/n and/or IEEE 802.15.4 for wireless mesh networks using Zigbee routing.
The processor 50308 is coupled to a sensing and intelligent control device 50324 that is coupled to a fume extractor 50326. The fume extractor 50326 may include one or more sensors 50327 and may also include a pump and pump motor controlled by a motor driver 50328. The motor driver 50328 is communicatively coupled to the processor 50308 and the pump motor in the fume extractor 50326. The sensing and intelligent control device 50324 includes a sensor algorithm 50321 and a communication algorithm 50322 that facilitate communication between the smoke extractor 50326 and other devices to accommodate its control program. The sensing and intelligent control device 50324 is configured to be able to evaluate the fluid, particles, and gas extracted via the evacuation conduit 50336 to improve smoke extraction and/or reduce device smoke output, for example, as described further herein. In certain instances, the sensing and intelligent control device 50324 is communicatively coupled to one or more sensors 50327 in the fume extractor 50326, one or more internal sensors 50330 of the electrosurgical system 50300, and/or one or more external sensors 50332.
In some cases, the processor may be located within an ejector housing of the surgical extraction system. For example, referring to fig. 6, the processor 50408 and its memory 50410 are positioned within the exhauster housing 50440 of the surgical exhauster system 50400. The processor 50408 is in signal communication with a motor driver 50428, various internal sensors 50430, a display 50442, a memory 50410, and a communication device 50418. The communication device 50418 is similar in many respects to the communication device 50318 described above with respect to fig. 5. The communication device 50418 may allow the processor 50408 in the surgical evacuation system 50400 to communicate with other devices within the surgical system. For example, the communication device 50418 may allow for wired and/or wireless communication with one or more external sensors 50432, one or more surgical devices 50444, one or more hubs 50448, one or more clouds 50446, and/or one or more additional surgical systems and/or tools. The reader will readily appreciate that in some instances, the surgical drainage system 50400 of fig. 6 may be incorporated into the electrosurgical system 50300 of fig. 5. The surgical evacuation system 50400 also includes a pump 50450 (including its pump motor 50451), an evacuation conduit 50436, and a vent 50452. Various pumps, evacuation conduits, and vents are further described herein. The surgical evacuation system 50400 can also include sensing and intelligent control devices, which can be similar in many respects to, for example, sensing and intelligent control device 50324. For example, such sensing and intelligent control devices may be in signal communication with one or more of the sensors 50430 and/or external sensors 50432 and/or the processor 50408.
The electrosurgical system 50300 (fig. 5) and/or the surgical evacuation system 50400 (fig. 6) may be programmed to monitor one or more parameters of the surgical system and may affect the surgical function based on one or more algorithms stored in memory in signal communication with the processor 50308 and/or 50408. For example, various exemplary aspects disclosed herein may be implemented by such algorithms.
In one aspect of the disclosure, a processor and sensor system, such as processors 50308 and 50408 and corresponding sensor systems (fig. 5 and 6) in communication therewith, are configured to be able to sense the airflow through the vacuum source in order to adjust parameters of, for example, the smoke evacuation system and/or external devices and/or systems used in series with the smoke evacuation system, such as an electrosurgical system, an energy device, and/or a generator. In one aspect of the present disclosure, the sensor system may include a plurality of sensors positioned along the airflow path of the surgical evacuation system. The sensors may measure a pressure differential within the evacuation system in order to detect a condition or state of the system between the sensors. For example, the system between the two sensors may be a filter, and the pressure differential may be used to increase the speed of the pump motor as the flow through the filter decreases, so as to maintain flow through the system. As another example, the system may be a fluid trap of a drainage system, and the pressure differential may be used to determine an airflow path through the drainage system. In yet another example, the system may be an inlet and an outlet (or exhaust) of the extraction system, and the pressure differential may be used to determine a maximum extraction load in the extraction system in order to maintain the maximum extraction load below a threshold.
In one aspect of the present disclosure, a processor and sensor system, such as processors 50308 and 50408 and corresponding sensor systems in communication therewith (fig. 5 and 6), are configured to detect a ratio of aerosol or carbonized particles (i.e., smoke) in fluid extracted from a surgical site. For example, the sensing system may include a sensor that detects the size and/or composition of the particles, which is used to select the airflow path through the evacuation system. In such cases, the drainage system may include a first filter path or first filter state, and a second filter path or second filter state, which may have different characteristics. In one case, the first path includes only the particulate filter, and the second path includes both the fluid filter and the particulate filter. In some cases, the first path includes a particulate filter and the second path includes a particulate filter and a finer particulate filter arranged in series. Additional and/or alternative filtering paths are also contemplated.
In one aspect of the present disclosure, processors and sensor systems, such as processors 50308 and 50408 and corresponding sensor systems in communication therewith (fig. 5 and 6), are configured to be capable of performing chemical analysis on particles expelled from the abdominal cavity of a patient. For example, the sensing and intelligent control device 50324 can sense particle count and type in order to adjust the power level of the ultrasonic generator to cause the ultrasonic blade to produce less smoke. In another example, the sensor system may include a sensor for detecting a particle count, temperature, fluid content, and/or percentage of contamination of the evacuated fluid, and the detected one or more characteristics may be communicated to the generator to adjust its output. For example, the smoke extractor 50326 and/or its sensing and intelligent control 50324 may be configured to adjust the extraction flow and/or the motor speed of the pump and, at a predetermined particulate content, may be operable to affect the output power or waveform of the generator to reduce smoke generated by the end effector.
In one aspect of the present disclosure, processors and sensor systems, such as processors 50308 and 50408, and their respective sensor systems (fig. 5 and 6) are configured to be able to evaluate particle counts and contamination in an operating room by evaluating one or more characteristics of ambient air and/or exhaust from an exhauster housing. The particle count and/or air quality may be displayed, for example, on the smoke evacuation system, such as on the extractor housing, to communicate information to a clinician and/or to determine the effectiveness of the smoke evacuation system and its filters.
In one aspect of the disclosure, a processor, such as processor 50308 or processor 50408 (fig. 5 and 6), for example, is configured to be able to compare a sample rate image obtained from an endoscope with an ejector particle count from a sensing system (e.g., sensing and intelligent control device 50324) in order to determine a correlation and/or adjust the rate of Revolutions Per Minute (RPM) of the pump. In one case, activation of the generator may be communicated to the smoke extractor so that the desired smoke extraction rate may be achieved. The generator activation may be communicated to the surgical evacuation system through, for example, a surgical hub, a cloud communication system, and/or a direct connection.
In one aspect of the present disclosure, a sensor system and algorithm for a fume extractor system (see, e.g., fig. 5 and 6) may be configured to be able to control the fume extractor and may adjust its motor parameters to adjust the fume extractor's filtration efficiency based on the needs of the surgical field at a given time. In one case, an adaptive airflow pump speed algorithm is provided to automatically vary the motor pump speed based on sensed particles entering the inlet of the smoke extractor and/or exiting the outlet or exhaust of the smoke extractor. For example, the sensing and intelligent control device 50324 (fig. 5) can include, for example, a user selectable speed and an automatic mode speed. At the automatic mode speed, the airflow through the exhaust system may be scaled based on the lack of smoke entering the exhaust system and/or filter particles exiting the exhaust system. In some cases, the automatic mode speed may provide automatic sensing and compensation for the laparoscopic mode.
In one aspect of the invention, the drainage system may include an electrical and communication architecture (see, e.g., fig. 5 and 6) that provides data collection and communication features to improve interactivity with the surgical hub and cloud. In one example, a surgical evacuation system and/or a processor thereof, such as processor 50308 (fig. 5) and processor 50408 (fig. 6), for example, may include a segmented control circuit that is energized in a staged approach to check the system for errors, shorts, and/or safety checks. The segment control circuit may also be configured to be capable of having a powered portion and a non-powered portion until the powered portion performs the first function. The segment control circuit may include circuit elements to identify a status update and display the status update to a user of the attachment component. The segmented control circuit further comprises circuit elements for operating the motor in a first state in which the motor is activated by the user and in a second state in which the motor has not been activated by the user, but rather operates the pump in a quieter manner and at a slower rate. For example, the segment control circuit may allow the smoke extractor to be energized in stages.
The electrical and communication architecture for the drainage system (see, e.g., fig. 5 and 6) may also provide interconnectivity of the smoke extractor with other components within the surgical hub to facilitate interaction and data transfer with the cloud. The transmission of surgical evacuation system parameters to the surgical wheel hub and/or cloud may be provided to affect the output or operation of other attachment devices. The parameter may be operational or sensed. Operational parameters include airflow, differential pressure, and air quality. Sensed parameters include particle concentration, aerosol percentage and chemical analysis.
In one aspect of the present disclosure, a drainage system (such as surgical drainage system 50400) may also include a housing and replaceable components, controls, and displays. Circuit elements for communicating a secure Identification (ID) between such replaceable components are provided. For example, communication between the filter and the fume extraction electronics may be provided to verify the authenticity, remaining life of the component, update parameters in the component, record errors, and/or limit the number and/or type of components that may be identified by the system. In various cases, the communication circuit may authenticate features for enabling and/or disabling configuration parameters. The communication circuitry may employ encryption and/or error handling schemes to manage the secure and proprietary relationship between the components and the smoke evacuation electronics. In some cases, disposable/reusable components are included.
In one aspect of the present disclosure, the drainage system may provide fluid management and extraction filters and airflow configurations. For example, a surgical drainage system is provided that includes a fluid capture mechanism having a first set of extraction or airflow control features and a second set of extraction or airflow control features that are connected in series with each other to extract large and small droplets, respectively. In some cases, the airflow path may include a recirculation channel or secondary fluid channel from the exhaust port downstream of the primary fluid management chamber back to the primary reservoir.
In one aspect of the present disclosure, the propulsion pad may be coupled to an electrosurgical system. For example, the ground electrode 50335 of the electrosurgical system 50300 (fig. 5) may include a push pad with local sensing integrated into the pad while maintaining capacitive coupling. For example, the capacitively coupled return path pad may have small separable array elements that can be used to sense nerve control signals and/or select movement of anatomical locations in order to detect the proximity of the monopolar tip to the nerve bundle.
The electrosurgical system may include a signal generator, an electrosurgical instrument, a return electrode, and a surgical evacuation system. The generator may be an RF wave generator that generates RF power. Attached to the electrosurgical instrument is a utility catheter. The utility conduit includes a cable that transmits electrical energy from the signal generator to the electrosurgical instrument. The utility conduit also includes a vacuum hose that conveys the captured/collected smoke and/or fluid away from the surgical site. Such an exemplary electrosurgical system 50601 is shown in fig. 7. More specifically, electrosurgical system 50601 includes generator 50640, electrosurgical instrument 50630, return electrode 50646, and evacuation system 50600. The electrosurgical instrument 50630 includes a handle 50632 and a distal catheter opening 50634 that is fluidly coupled to an aspiration hose 50636 of the evacuation system 50600. The electrosurgical instrument 50630 also includes electrodes that are powered by the generator 50640. A first electrical connection 50642 (e.g., a wire) extends from the electrosurgical instrument 50630 to the generator 50640. A second electrical connection 50644 (e.g., a lead) extends from the electrosurgical instrument 50630 to the electrode, i.e., the return electrode 50646. In other cases, the electrosurgical instrument 50630 may be a bipolar electrosurgical instrument. The distal catheter opening 50634 on the electrosurgical instrument 50630 is fluidly coupled to an aspiration hose 50636 that extends to a filter end cap 50603 of a filter that is mounted in an exhauster housing 50618 of the exhauster system 50600.
In other cases, the distal catheter opening 50634 of the drainage system 50600 can be located on a handpiece or tool separate from the electrosurgical instrument 50630. For example, drainage system 50600 can include surgical tools that are not coupled to generator 50640 and/or that do not include tissue energizing surfaces. In some cases, the distal catheter opening 50634 of the drainage system 50600 can be releasably attached to an electrosurgical tool. For example, the drainage system 50600 can include a clip or snap type catheter that terminates at a distal catheter opening, the catheter being releasably attachable to a surgical tool (see, e.g., fig. 3).
The electrosurgical instrument 50630 is configured to deliver electrical energy to target tissue of a patient to cut tissue and/or cauterize blood vessels within and/or adjacent to the target tissue, as described herein. Specifically, an electrical discharge is provided to the patient by the electrode tip to heat cellular material of the patient in close contact with or near the electrode tip. Tissue heating occurs at a suitably high temperature to allow the electrosurgical instrument 50630 to be used to perform electrosurgery. The return electrode 50646 is applied to the patient or placed in close proximity to the patient (depending on the type of return electrode) in order to complete the circuit and provide a return electrical path to the generator 50640 for the energy delivered into the patient.
Heating the patient's cellular material through the electrode tip, or cauterizing the blood vessel to prevent bleeding, typically results in the release of smoke where cauterization occurs, as further described herein. In such cases, because the evacuation conduit opening 50634 is proximate to the electrode tip, the evacuation system 50600 is configured to capture smoke released during surgery. Vacuum suction may draw smoke through the electrosurgical instrument 50630 into the catheter opening 50634 and into the aspiration hose 50636 toward the exhauster housing 50618 of the fume evacuation system 50600.
Referring now to fig. 8, a exhauster housing 50618 of the exhauster system 50600 (fig. 7) is shown. The exhauster housing 50618 includes a socket 50620 sized and configured to receive a filter. The exhauster housing 50618 can completely or partially enclose the internal components of the exhauster housing 50618. The socket 50620 includes a first receiver 50622 and a second receiver 50624. The transition surface 50626 extends between the first receiver 50622 and the second receiver 50624.
Referring now primarily to fig. 9, a socket 50620 is shown along the cross-sectional plane of fig. 8. The socket 50620 includes a first end 50621 that opens to receive a filter and a second end 50623 that communicates with the flow path 50699 through the ejector housing 50618. The filter 50670 (fig. 10 and 11) can be removably positioned with the socket 50620. For example, the filter 50670 can be inserted and removed from the first end 50621 of the socket 50620. The second receiver 50624 is configured to receive a connection fitting of the filter 50670.
Surgical evacuation systems typically use filters to remove unwanted contaminants from the smoke before the smoke is released as exhaust. In some cases, the filter may be replaceable. The reader will appreciate that the filter 50670 shown in fig. 10 and 11 may be used with the various drainage systems disclosed herein. The filter 50670 can be a replaceable and/or disposable filter.
The filter 50670 includes a front cover 50672, a rear cover 50674, and a filter body 50676 disposed therebetween. The front cover 50672 includes a filter inlet 50678 that, in some cases, is configured to receive smoke directly from a suction hose 50636 (fig. 7) or other smoke source. In some aspects of the disclosure, the front cover 50672 can be replaced by a fluid trap (e.g., the fluid trap 50760 shown in fig. 14-17) that directs smoke directly from the smoke source and, after removing at least a portion of the fluid therefrom, passes the partially treated smoke into the filter body 50676 for further processing. For example, the filter inlet 50678 can be configured to receive smoke via a fluid trap exhaust port (such as port 50766 in fluid trap 50760) (fig. 14-17) to deliver partially treated smoke into the filter 50670.
Once the smoke enters the filter 50670, the smoke may be filtered by components housed within the filter body 50676. The filtered smoke may then exit the filter 50670 through a filter vent 50680 defined in the rear cover 50674 of the filter 50670. When the filter 50670 is associated with a drainage system, suction generated in the exhauster housing 50618 of the drainage system 50600 can be transferred to the filter 50670 through the filter vent 50680 to draw smoke through the internal filtering components of the filter 50670. The filters generally include a particulate filter and a charcoal filter. The particulate filter may be, for example, a High Efficiency Particulate Air (HEPA) filter or an Ultra Low Permeability Air (ULPA) filter. ULPA filtration utilizes a depth filter similar to a maze. Particles may be filtered using at least one of the following methods: direct interception (where particles exceeding 1.0 micron are captured because they are too large to pass through the fibers of the media filter), inertial impaction (where particles between 0.5 and 1.0 micron collide with the fibers and remain there), and diffuse interception (where particles less than 0.5 micron are captured by the effect of brownian random thermal motion as they "search out" the fibers and attach to them).
The charcoal filter is configured to remove toxic gases and/or odors generated by surgical smoke. In various instances, the charcoal may be "activated" meaning that it has been treated with a heating process to expose the effective absorption sites. Charcoal may be derived from, for example, activated natural coconut shells.
Referring now to fig. 11, the filter 50670 includes a coarse media filter layer 50684 followed by a fine particle filter layer 50686. In other cases, the filter 50670 can be comprised of a single type of filter. In still other cases, the filter 50670 can include more than two filter layers and/or more than two different types of filter layers. After the filter layers 50684 and 50686 remove particulate matter, the smoke is drawn through the carbon reservoir 50688 in the filter 50670 to remove, for example, gaseous contaminants, such as volatile organic compounds, within the smoke. In various cases, the carbon reservoir 50688 may include a charcoal filter. The filtered smoke, now substantially free of particulate and gaseous contaminants, is drawn through the filter vent 50680 and into the drainage system 50600 for further processing and/or elimination.
The filter 50670 includes a plurality of baffles between components of the filter body 50676. For example, the first baffle 50690 is positioned, for example, intermediate the filter inlet 50678 (fig. 10) and a first particulate filter, such as a coarse media filter 50684. The second baffle 50692 is positioned, for example, intermediate a second particulate filter (such as the fine particulate filter 50686) and the carbon reservoir 50688. In addition, a third baffle 50694 is positioned intermediate the carbon reservoir 50688 and the filter vent 50680. The baffles 50690, 50692, and 50694 may include gaskets or O-rings configured to prevent movement of components within the filter body 50676. In various circumstances, the size and shape of the baffles 50690, 50692, and 50694 may be selected to prevent expansion of the filter member in the direction of the applied suction.
The coarse media filter 50684 may include a low air resistance filter material, such as fiberglass, polyester, and/or pleated filter, configured to remove a majority of particulate matter, for example, greater than 10 μm. In some aspects of the disclosure, this includes removing at least 85% of the particulate matter greater than 10 μm, greater than 90% of the particulate matter greater than 10 μm, greater than 95% of the particulate matter greater than 10 μm, greater than 99% of the particulate matter greater than 10 μm, greater than 99.9% of the particulate matter greater than 10 μm, or greater than 99.99% of the particulate matter greater than 10 μm.
Additionally or alternatively, the coarse media filter 50684 may include a low air resistance filter that removes a majority of particulate matter greater than 1 μm. In some aspects of the disclosure, this includes removing at least 85% of the particulate matter greater than 1 μm, greater than 90% of the particulate matter greater than 1 μm, greater than 95% of the particulate matter greater than 1 μm, greater than 99% of the particulate matter greater than 1 μm, greater than 99.9% of the particulate matter greater than 1 μm, or greater than 99.99% of the particulate matter greater than 1 μm.
The fine particulate filter 50686 may include any filter that is more efficient than the coarse media filter 50684. This includes, for example, filters capable of filtering a higher percentage of particles of the same size as the coarse media filter 50684 and/or capable of filtering particles of a smaller size than the coarse media filter 50684. In some aspects of the disclosure, the fine particulate filter 50686 can comprise a HEPA filter or a ULPA filter. Additionally or alternatively, the fine particulate filter 50686 may be pleated to increase its surface area. In some aspects of the disclosure, the coarse media filter 50684 comprises a pleated HEPA filter and the fine particulate filter 50686 comprises a pleated ULPA filter.
After particulate filtration, the smoke enters a downstream section of filter 50670, which includes a carbon reservoir 50688. The carbon reservoir 50688 is defined by porous partitions 50696 and 50698 disposed between the intermediate baffle 50692 and the end baffle 50694, respectively. In some aspects of the present disclosure, the porous partitions 50696 and 50698 are rigid and/or inflexible and define a constant spatial volume of the carbon reservoir 50688.
The carbon reservoir 50688 may include additional sorbents that act cumulatively with or independently of the carbon particles to remove gaseous contaminants. The additional adsorbent may include, for example, an adsorbent such as magnesium oxide and/or copper oxide, which may be used to adsorb gaseous contaminants such as carbon monoxide, ethylene oxide, and/or ozone. In some aspects of the disclosure, additional adsorbent is dispersed throughout reservoir 50688 and/or positioned in different layers above, below, or within reservoir 50688.
Referring again to fig. 4, the evacuation system 50500 includes a pump 50506 within an ejector housing 50518. Similarly, the evacuation system 50600 shown in fig. 7 can include a pump in the exhauster housing 50618 that can create suction to draw smoke from the surgical site through the aspiration hose 50636 and through the filter 50670 (fig. 10 and 11). In operation, the pump may create a pressure differential within the exhauster housing 50618 that causes the smoke to travel into the filter 50670 and exit the exhaust mechanism (e.g., exhaust mechanism 50520 in fig. 4) at the outlet of the flow path. The filter 50670 is configured to extract harmful, contaminated or otherwise unwanted particulates from the smoke.
The pump may be disposed in line with the flow path through the exhauster housing 50618 such that gas flowing through the exhauster housing 50618 enters the pump at one end and exits the pump at the other end. The pump may provide a sealed positive displacement flow path. In various cases, the pump may create a sealed positive displacement flow path by trapping (sealing) a first volume of gas and reducing that volume to a second, smaller volume as the gas moves past the pump. Reducing the volume of trapped gas increases the pressure of the gas. The second pressurized volume of gas may be released from the pump at the pump outlet. For example, the pump may be a compressor. More specifically, the pump may include a hybrid regenerative blower, a claw pump, a cam compressor, and/or a scroll compressor. The positive displacement compressor may provide improved compression ratio and operating pressure while limiting vibration and noise generated by the displacement system 50600. Additionally or alternatively, the drainage system 50600 can include a fan for moving fluid therethrough.
An example of a positive displacement compressor (e.g., scroll compressor pump 50650) is shown in fig. 12. The scroll compressor pump 50650 includes a stator scroll 50652 and a moving scroll 50654. The stator scroll 50652 can be fixed in place while the orbiting scroll 50654 orbits eccentrically. For example, the orbiting scroll 50654 may orbit eccentrically such that it rotates about the central longitudinal axis of the stator scroll 50652. As shown in fig. 12, the central longitudinal axes of the stator scroll 50652 and the orbiting scroll 50654 extend perpendicular to the viewing planes of the scrolls 50652, 50654. The stator scroll 50652 and the moving scroll 50654 are interleaved with each other to form discrete sealed compression chambers 50656.
In use, gas may enter the scroll compressor pump 50650 at inlet 50658. When the orbiting scroll 50654 orbits relative to the stator scroll 50652, inlet gas is first trapped in the compression chamber 50656. The compression chamber 50656 is configured to move discrete volumes of gas along the spiral profile of the scrolls 50652 and 50654 toward the center of the scroll compressor pump 50650. The compression chamber 50656 defines a sealed space in which the gas resides. In addition, as the moving scroll 50654 moves the trapped gas toward the center of the stator scroll 50652, the volume of the compression chamber 50656 decreases. This volume reduction increases the pressure of the gas inside the compression chamber 50656. As the volume decreases, the gas inside the sealed compression chamber 50656 is trapped, thereby pressurizing the gas. Once the pressurized gas reaches the center of the scroll compressor pump 50650, the pressurized gas is released through the outlet 50659.
Referring now to fig. 13, a portion of a drainage system 50700 is shown. The drainage system 50700 may be similar in many respects to the drainage system 50600 (fig. 7). For example, the evacuation system 50700 includes an evacuation housing 50618 and a suction hose 50636. Referring again to fig. 7, the evacuation system 50600 is configured to create suction to draw smoke from the distal end of the suction hose 50636 into the ejector housing 50618 for treatment. Notably, the suction hose 50636 is not connected to the ejector housing 50618 by the filter end cap 50603 of fig. 13. Instead, the suction hose 50636 is connected to the ejector housing 50618 through a fluid trap 50760. A filter similar to filter 50670 may be positioned within a socket of the ejector housing 50618 behind the fluid catcher 50760.
The fluid trap 50760 is a first treatment point that extracts and retains at least a portion of a fluid (e.g., liquid) from the fume before relaying the partially treated fume to the drainage system 50700 for further treatment and filtration. The evacuation system 50700 is configured to process, filter, and otherwise clean smoke to reduce or eliminate unpleasant odors or other problems associated with smoke generation in a surgical room (or other surgical environment), as described herein. In some cases, the fluid trap 50760 (among other things) may increase the efficiency of the drainage system 50700 and/or increase the life of filters associated therewith by extracting droplets and/or aerosols from the smoke before the smoke is further processed by the drainage system 50700.
Referring primarily to fig. 14-17, the fluid trap 50760 is shown separated from the ejector housing 50618 (fig. 13). The fluid trap 50760 includes an inlet port 50762 defined in a front cover or surface 50764 of the fluid trap 50760. The inlet port 50762 may be configured to releasably receive a suction hose 50636 (fig. 13). For example, the end of the suction hose 50636 can be at least partially inserted into the inlet port 50762 and can be secured with an interference fit therebetween. In various cases, the interference fit may be a fluid-tight and/or airtight fit such that substantially all of the smoke passing through the suction hose 50636 is transferred into the fluid trap 50760. In some cases, other mechanisms for coupling or engaging the suction hose 50636 to the inlet port 50762 may be employed, such as a latch-based compression fitting, an O-ring seal that threadably couples the suction hose 50636 to the inlet port 50762, and/or other coupling mechanisms.
In various circumstances, the fluid-tight and/or airtight fit between the suction hose 50636 and the fluid trap 50760 is configured to prevent fluid and/or other materials in the evacuated smoke from leaking at or near the junction of these components. In some cases, suction hose 50636 can be associated with inlet port 50762 by an intermediate coupling device (such as an O-ring and/or adapter) to further ensure a gas-tight and/or fluid-tight connection between suction hose 50636 and fluid trap 50760.
As described above, the fluid trap 50760 includes an exhaust port 50766. The exhaust port extends away from a rear cover or surface 50768 of the fluid catcher 50760. The exhaust port 50766 defines an open channel between the interior chamber 50770 of the fluid trap 50760 and the external environment. In some cases, the vent port 50766 is sized and shaped to be closely associated with a surgical evacuation system or component thereof. For example, the exhaust port 50766 can be sized and shaped to be associated with at least partially treated smoke from the fluid trap 50760 and deliver it to a filter housed within the exhauster housing 50618 (fig. 13). In some cases, the exhaust port 50766 can extend away from a front plate, top surface, or side surface of the fluid trap 50760.
In some cases, the exhaust port 50766 includes a membrane that spaces the exhaust port 50766 from the ejector housing 50618. Such a membrane may be used to prevent water or other liquids collected in the fluid trap 50760 from passing through the exhaust port 50766 and into the ejector housing 50618, while allowing air, water, and/or vapor to pass freely into the ejector housing 50618. For example, high flow microporous Polytetrafluoroethylene (PTFE) may be positioned downstream of the vent 50766 and upstream of the pump to protect the pump or other components of the evacuation system 50700 from damage and/or contamination.
The fluid trap 50760 also includes a gripping region 50772 that is positioned and sized to assist a user in gripping the fluid trap 50760 and/or connecting the fluid trap 50760 to the suction hose 50636 and/or the ejector housing 50618. The gripping area 50772 is shown as an elongated recess; however, the reader will readily appreciate that the gripping area 50772 can comprise, for example, at least one groove, channel, protrusion, ear of grain, and/or ring that can be sized and shaped to accommodate a user's finger or otherwise provide a gripping surface.
Referring now primarily to fig. 16 and 17, an interior chamber 50770 of a fluid trap 50760 is shown. The relative positioning of the inlet port 50762 and the exhaust port 50766 is configured to facilitate extraction and retention of fluid from smoke as smoke enters the fluid trap 50760. In some cases, the inlet port 50762 may include a notched cylindrical shape, which may direct smoke and accompanying fluid toward the fluid reservoir 50774 of the fluid trap 50760, or otherwise directed away from the exhaust port 50766. An example of such fluid flow is shown in fig. 17 with arrows A, B, C, D and E.
As shown, smoke enters fluid trap 50760 through inlet port 50762 (shown by arrow a) and exits fluid trap 50760 through exhaust port 50766 (shown by arrow E). Due at least in part to the geometry of the inlet port (e.g., the longer upper side wall 50761 and the shorter lower side wall 50763), smoke entering the inlet port 50762 is initially directed primarily downward into the fluid reservoir 50774 of the fluid trap 50760 (shown by arrow B). As the smoke continues to pull downwardly into the fluid trap 50760 along arrows a and B, the initially downwardly directed smoke rolls down and laterally away from its source to travel in a substantially opposite but parallel path toward the upper portion of the fluid trap 50760 and out of the exhaust port 50766 (shown by arrows D and E).
The directional flow of mist through fluid trap 50760 may ensure that liquid within the mist is extracted and retained within a lower portion of fluid trap 50760 (e.g., fluid reservoir 50774). Further, when the fluid trap 50760 is in the upright position, the relative positioning of the exhaust port 50766 vertically above the inlet port 50762 is configured to prevent liquid from being inadvertently carried through the exhaust port 50766 by the flow of smoke while not substantially impeding the flow of fluid into and out of the fluid trap 50760. Additionally, in some cases, the configuration of the inlet port 50762 and the outlet port 50766 and/or the size and shape of the fluid trap 50760 itself may enable the fluid trap 50760 to resist spillage.
In various cases, the drainage system may include a plurality of sensors and intelligent controls, as further described herein with respect to, for example, fig. 5 and 6. In one aspect of the present disclosure, the evacuation system may include one or more temperature sensors, one or more fluid detection sensors, one or more pressure sensors, one or more particulate sensors, and/or one or more chemical sensors. The temperature sensor may be positioned to detect a temperature of fluid at the surgical site that moves through the surgical evacuation system and/or is discharged from the surgical evacuation system into the surgical room. The pressure sensor may be positioned to detect pressure within the evacuation system, such as pressure within the enclosure of the exhauster. For example, the pressure sensor may be positioned upstream of the filter, between the filter and the pump, and/or downstream of the pump. In some cases, the pressure sensor may be positioned to detect pressure in the ambient environment external to the evacuation system. Similarly, particle sensors may be positioned to detect particles within the evacuation system, such as particles within the exhauster housing. The particle sensor may be upstream of the filter, between the filter and the pump, and/or downstream of the pump, for example. In various cases, the particle sensor may be positioned to detect particles in the surrounding environment in order to determine, for example, the air quality in a surgical room.
A exhauster housing 50818 for a exhauster system 50800 is schematically illustrated in fig. 18. The exhauster housing 50818 can be similar in many respects to, for example, the exhauster housings 50018 and/or 50618 and/or can be incorporated into the various exhauster systems disclosed herein. The ejector housing 50818 includes a number of sensors, which are further described herein. The reader will appreciate that some exhauster housings may not include each of the sensors shown in fig. 18 and/or may include additional sensors. Similar to the exhauster housings 50018 and 50618 disclosed herein, the exhauster housing 50818 of fig. 18 includes an inlet 50822 and an outlet 50824. The fluid trap 50860, filter 50870, and pump 50806 are sequentially aligned between the inlet 50822 and the outlet 50824 along a flow path 50804 through the ejector housing 50818.
The exhauster housing can include modular and/or replaceable components, as further described herein. For example, the exhauster housing may include a socket or receptacle 50871 sized to receive a modular fluid trap and/or replaceable filter. In some cases, the fluid trap and filter may be incorporated into a single interchangeable module 50859, as shown in fig. 18. More specifically, the fluid trap 50860 and the filter 50870 form an interchangeable module 50859 that may be modular and/or replaceable and removably mountable in a receiver 50871 in the ejector housing 50818. In other cases, the fluid trap 50860 and the filter 50870 may be separate and distinct modular components that may be assembled together and/or separately mounted in the exhauster housing 50818.
Still referring to the ejector housing 50818, the ejector housing 50818 includes a plurality of sensors for detecting various parameters therein and/or parameters of the surrounding environment. Additionally or alternatively, one or more modular components mounted in the ejector housing 50818 may include one or more sensors. For example, referring still to fig. 18, the interchangeable module 50859 includes a plurality of sensors for detecting various parameters therein.
In various cases, the exhauster housing 50818 and/or modular components compatible with the exhauster housing 50818 may include a processor, such as processors 50308 and 50408 (fig. 5 and 6, respectively), configured to be able to receive inputs from one or more sensors and/or transmit outputs to one or more systems and/or drivers. Various processors for use with the ejector housing 50818 are further described herein.
In operation, smoke from a surgical site may be drawn into the inlet 50822 of the ejector housing 50818 via the fluid trap 50860. The flow path 50804 through the exhauster housing 50818 in fig. 18 can include sealed conduits or tubes 50805 extending between various embedded components. In various circumstances, smoke may flow through the fluid detection sensor 50830 and the chemical sensor 50832 to the shunt valve 50834, which is further described herein. A fluid detection sensor, such as sensor 50830, may detect fluid particles in smoke. In one instance, the fluid detection sensor 50830 can be a continuity sensor. For example, the fluid detection sensor 50830 can include two spaced apart electrodes and a sensor for detecting the degree of continuity therebetween. When no fluid is present, the continuity may be, for example, zero or substantially zero. The chemical sensor 50832 can detect chemical characteristics of the smoke.
At the diverter valve 50834, the fluid may be directed into the condenser 50835 of the fluid trap 50860, and the smoke may continue toward the filter 50870. A deflector 50864 is positioned within condenser 50835 to facilitate condensation of droplets from the mist into a reservoir in fluid trap 50860. The fluid detection sensor 50836 may ensure that any fluid in the ejector housing is completely or at least substantially captured within the fluid trap 50860.
Still referring to fig. 18, the smoke may then be directed to flow into a filter 50870 of the interchangeable module 50859. At the inlet to the filter 50870, the smoke may flow through the particle sensor 50838 and the pressure sensor 50840. In one form, the particle sensor 50838 may include a laser particle counter, as further described herein. The smoke may be filtered through a pleated Ultra Low Permeability Air (ULPA) filter 50842 and a charcoal filter 50844, as shown in fig. 18.
After exiting the filter, the filtered smoke may flow through the pressure sensor 50846 and may then continue along the flow path 50804 within the ejector housing 50818 toward the pump 50806. After moving through the pump 50806, the filtered smoke may flow past the particle sensor 50848 and the pressure sensor 50850 at the outlet to the ejector housing 50818. In one form, the particle sensor 50848 can comprise a laser particle counter, as further described herein. The exhauster housing 50818 in fig. 18 also includes an air quality particle sensor 50852 and a surrounding pressure sensor 50854 to detect various characteristics of the surrounding environment, such as the environment in a surgical operating room. The air quality particle sensor or external/ambient air particle sensor 50852 may comprise at least one form of laser particle counter. Various sensors shown in fig. 18 are further described herein. Further, in various circumstances, alternative sensing devices may be used in the smoke evacuation systems disclosed herein. For example, alternative sensors for counting particles and/or determining the concentration of particles in a fluid are further disclosed herein.
In various circumstances, the fluid trap 50860 shown in fig. 18 can be configured to prevent spillage and/or leakage of the captured fluid. For example, the geometry of the fluid trap 50860 can be selected to prevent the captured fluid from spilling and/or leaking. In some cases, the fluid trap 50860 can include a deflector and/or a splash screen (such as screen 50862) for preventing the captured fluid from splashing the fluid trap 50860. In one or more cases, the fluid trap 50860 can include a sensor for detecting the volume of fluid within the fluid trap and/or determining whether the fluid trap 50860 is filled to capacity. The fluid trap 50860 can include a valve for emptying fluid therefrom. The reader will readily appreciate that a variety of alternative fluid trap arrangements and geometries may be employed to capture fluid drawn into the ejector housing 50818.
In some cases, filter 50870 may include additional and/or fewer filtration levels. For example, filter 50870 may include one or more filtration layers selected from the following filter groups: coarse media filters, fine media filters, and adsorbent-based filters. The coarse media filter may be a low air resistance filter, which may be constructed of, for example, fiberglass, polyester, and/or pleated filters. The fine media filter may be a High Efficiency Particulate Air (HEPA) filter and/or a ULPA filter. The adsorbent-based filter may be, for example, an activated carbon filter. The reader will readily appreciate that a variety of alternative filter arrangements and geometries may be employed to filter smoke drawn along the flow path through the exhauster housing 50818.
In one or more cases, the pump 50806 shown in fig. 18 can be replaced by and/or used in conjunction with another compressor and/or pump (such as a hybrid regenerative blower, claw pump, and/or cam compressor), for example. The reader will readily appreciate that a variety of alternative pumping arrangements and geometries may be employed to create suction within the flow path 50804 to draw smoke into the ejector housing 50818.
Various sensors in the evacuation system, such as the sensor shown in fig. 18, may be in communication with the processor. The processor may be incorporated into the evacuation system and/or may be a component of another surgical instrument and/or surgical hub. Various processors are further described herein. The onboard processor may be configured to adjust one or more operating parameters of the ejector system (e.g., the motor of pump 50806) based on input from the sensor. Additionally or alternatively, the on-board processor may be configured to adjust one or more operating parameters of another device (such as an electrosurgical tool and/or an imaging device) based on input from the sensor.
Referring now to fig. 19, another exhauster housing 50918 for a exhauster system 50900 is shown. The exhauster housing 50918 of fig. 19 can be similar in many respects to the exhauster housing 50818 of fig. 18. For example, the ejector housing 50918 defines a flow path 50904 between an inlet 50922 of the ejector housing 50918 and an outlet 50924 of the ejector housing 50918. A fluid trap 50960, a filter 50970, and a pump 50906 are disposed in sequence intermediate the inlet 50922 and the outlet 50924. The exhauster housing 50918 can include a socket or receptacle 50971, for example, sized to receive a modular fluid trap and/or replaceable filter, similar to the receptacle 50871. At the diverter valve 50934, the fluid may be directed into the condenser 50935 of the fluid trap 50960, and the fumes may continue toward the filter 50970. In some cases, fluid trap 50960 can include, for example, a baffle (such as baffle 50964) and/or a splash screen (such as screen 50962) for preventing captured fluid from splashing fluid trap 50960. The filter 50970 includes a pleated Ultra Low Permeability Air (ULPA) filter 50942 and a charcoal filter 50944. A sealed conduit or tube 50905 extends between the various embedded components. The ejector housing 50918 also includes sensors 50830, 50832, 50836, 50838, 50840, 50846, 50848, 50850, 50852, and 50854, which are further described herein and illustrated in fig. 18 and 19.
Still referring to fig. 19, the ejector housing 50918 further includes a centrifugal blower device 50980 and a recirculation valve 50990. Recirculation valve 50990 can be selectively opened and closed to recirculate fluid through fluid trap 50960. For example, if fluid detection sensor 50836 detects fluid, recirculation valve 50990 can be opened such that fluid is directed back away from filter 50970 and back into fluid trap 50960. If the fluid detection sensor 50836 does not detect fluid, the valve 50990 can be closed such that smoke is directed into the filter 50970. As the fluid is recirculated via recirculation valve 50990, the fluid may be drawn in through recirculation conduit 50982. The centrifugal blower device 50980 engages with the recirculation conduit 50982 to create a recirculation suction in the recirculation conduit 50982. More specifically, when recirculation valve 50990 is open and pump 50906 is activated, the suction force generated by pump 50906 downstream of filter 50970 may generate a rotation of first centrifugal blower or squirrel cage 50984, which may be transferred to second centrifugal blower or squirrel cage 50986, which draws the recirculated fluid through recirculation valve 50990 and into fluid trap 50960.
In various aspects of the present disclosure, the control schematic of fig. 5 and 6 may be used with the various sensor systems and exhauster housings of fig. 18 and 19.
The smoke emitted from the surgical site may comprise liquid, aerosol, and/or gas, and/or may comprise materials having different chemical and/or physical properties, such as particulates and particles having different sizes and/or densities, for example. Different types of materials being aspirated from the surgical site can affect the efficiency of the surgical evacuation system and its pump. Furthermore, certain types of materials may require the pump to draw excessive power and/or may risk damaging the pump's motor.
The power supplied to the pump may be modulated based on input from one or more sensors along the flow path to control the flow of smoke through the evacuation system. The output from the sensor may be indicative of, for example, the state or quality of the smoke evacuation system and/or one or more characteristics of the smoke being evacuated, such as the type and ratio of substances, chemical characteristics, density, and/or particle size. In one aspect of the disclosure, the pressure differential between two pressure sensors in the evacuation system may be indicative of, for example, the state of an area therebetween, such as the state of a filter, fluid trap, and/or the overall system. Based on the sensor input, an operating parameter of the motor of the pump may be adjusted by varying the current and/or duty cycle supplied to the motor, the operating parameter being configured to be capable of varying the motor speed.
In one aspect of the present disclosure, by modulating the flow of smoke through the evacuation system, the efficiency of the filter may be increased and/or the motor prevented from burning out.
The surgical evacuation system may include one or more particle counters or particle sensors for detecting the size and/or concentration of particles within the smoke. Referring again to fig. 18 and 19, particle sensors 50838 and 50848 are shown. The reader will readily understand that various particle measurement devices are possible. For example, the particle sensor may be an optical sensor, a laser sensor, a photosensor, an ionization sensor, an electrostatic sensor, and/or combinations thereof. Various particle sensors are further described herein.
In various circumstances, the speed of the motor, and thus the speed of the pump, may be adjusted based on the concentration of particles detected by one or more particle sensors in the surgical evacuation system. For example, when the particle sensor detects an increased concentration of particles in the flow path (which may correspond to an increased amount of smoke in the flow path), the speed of the motor may be increased to increase the speed of the pump and draw more fluid from the surgical site into the smoke evacuation system. Similarly, when the particle sensor detects a reduced concentration of particles in the flow path (which may correspond to a reduced amount of smoke in the flow path), the speed of the motor may be reduced to reduce the speed of the pump and reduce aspiration from the surgical site. Additional and alternative adjustment algorithms for surgical drainage systems are further described herein. Furthermore, in some cases, based on sensor data from the fume evacuation system, a generator in the surgical system may be controlled to adjust the amount of fume generated at the surgical site, as further described herein.
In addition to particle sensors positioned along the flow path of the surgical evacuation system, the system may also include one or more sensors for detecting particle concentration in the surrounding room (e.g., in an operating room or surgical operating room). Referring again to fig. 18 and 19, an air quality particle sensor 50852 is mounted on the outer surface of the ejector housing 50818. Alternative locations for the air mass particle sensor 50852 are also contemplated.
In at least one instance, the particulate sensor may be positioned downstream of the filter, and in some instances, may be positioned at or near the outlet of the filter. For example, the particulate sensor 50848 is positioned downstream of the filter 50870 and pump 50806 in the smoke evacuation system 50800 and downstream of the filter 50970 and pump 50906 in the smoke evacuation system 50900. Because the particle sensor 50848 is positioned downstream of the filters 50870, 50970, the particle sensor is configured to be able to confirm that the filters 50870, 50970 have removed sufficient particles from the smoke. In various instances, such sensors may be adjacent to the exhaust outlets 50824, 50924 of the ejector housings 50818, 50918, respectively. In one aspect of the present disclosure, an electrostatic particle sensor may be utilized. For example, the exhaust outlets 50824, 50924 may include electrostatic particle sensors that sense the flow of exhaust gas downstream of the filtration system and then discharged into the surgical room.
The concentration of particles detected by one or more sensors of the surgical evacuation system may be communicated to the clinician in a number of different ways. For example, the exhauster housings 50818, 50918 and/or the exhauster device (e.g., the electrosurgical instrument 50032 in fig. 2) can include an indicator, such as one or more lights and/or a display screen. For example, LEDs on the exhauster housings 50818, 50819 may change color (e.g., from blue to red) based on the volume of particles detected by the sensor. In other cases, the indicator may include an alarm or alert, which may be, for example, tactile, audible, and/or visual. In such cases, a clinician in the surgical room may be notified by the indicator when the concentration of particles in the ambient air detected by the air quality sensor (e.g., particle sensor 50852) exceeds a threshold amount.
In some cases, the surgical evacuation system may include an optical sensor. The optical sensor may comprise an electronic sensor that converts light or a change in light into an electrical signal. The optical sensor may use a light scattering method to detect and count particles in the smoke to determine the concentration of particles in the smoke. In each case, the light is laser-based. For example, in one case, the laser source is configured to illuminate the particles as they move through the detection chamber. As the particles pass through the laser beam, the light source becomes blurred, redirected and/or absorbed. Scattered light is recorded by a photodetector and the recorded light is analyzed. For example, the recorded light may be converted into an electrical signal indicative of the size and number of particles, which corresponds to the concentration of particles in the smoke. The concentration of particles in the smoke may be calculated in real time, for example by means of a laser optical sensor. In one aspect of the present disclosure, at least one of the particle sensors 50838, 50848, 50852 is a laser optical sensor.
The photo-sensor for detecting particles in the smoke may be a through-beam sensor, a reflective sensor or a diffuse sensor. Reflective photosensor 51000 is shown in fig. 20. Referring to fig. 20, a reflective photosensor 51000 is a light scattering sensor in which a light beam 51002 emitted from a light source 51006 through a lens 51012 is offset from a photodetector or photocell 51004. For example, photodetector 51004 in fig. 20 is offset 90 degrees from light source 51006. When the smoke S obscures the light beam 51002 intermediate the light source 51006 and the light trap 51008, the light is reflected and the reflected light 51010 is scattered toward the lens 51014 and onto the light detector 51004. The photodetector 51004 converts the light into an electrical signal (current) corresponding to the concentration of particles in the smoke S. The output signal may be provided to a processor 51016, which may be similar in many ways to the processors 50308 and/or 50408 shown in fig. 5 and 6, respectively, which may affect the operating parameters of the motor based on the electrical signal and the corresponding particle concentration. For example, the output signal from the reflective photosensor 51000 can be an input to a control algorithm of the motor and/or an input to a surgical hub.
A through photosensor 51100 is shown in fig. 21. As shown in fig. 21, a line of sight extends between the light source 51102 and the light detector 51104. In such a case, the intensity of light reaching the light detector 51104 may be converted into an electrical signal (current) corresponding to the concentration of particles in the smoke S. The output signal may be provided to a processor 51106 coupled to a 24V dc power supply, which may be similar in many respects to the processors 50308 and/or 50408 shown in fig. 5 and 6. The processor 51106 can influence the operating parameters of the motor based on the electrical signals and the corresponding particle concentrations. For example, the output signal from the photosensor 51100 can be an input to a control algorithm of the motor and/or an input to a surgical hub.
In a photosensor for a surgical drainage system, such as sensor 51000 in fig. 20 and/or sensor 51100 in fig. 21, the wavelength of light can be selected to tune the sensor 51000 for a particular type of smoke while ignoring other types of smoke. In some cases, multiple sensors and/or multiple wavelengths may be used to dial the sensor 51000 into the correct combination. Water vapor, even concentrated water vapor, absorbs light of a specific wavelength. For example, water vapor absorbs infrared light rather than reflecting infrared light. Due to these absorption characteristics of water vapor, infrared light can be used to accurately count particles in a fluid in a surgical evacuation system in the presence of water vapor.
In some cases, ionization sensors may be used to detect particles in smoke. The ionization sensor includes two electrodes and a radioactive material that converts air molecules into positive and negative ions. Positive ions move toward the negative electrode and negative ions move toward the positive electrode. If smoke passes between the electrodes, the smoke combines with ions, which breaks the circuit. The drop in current through the circuit can be converted into an electrical signal (current) corresponding to the volume of smoke passing between the electrodes.
An ionization sensor 51200 is shown in fig. 22. The ionization sensor 51200 utilizes americium-241 to ionize air in a restricted area. The sensor 51200 includes a small ionization chamber 51202 with two electrodes 51204 spaced apart. The ionization chamber 51202 can be made of, for example, polyvinyl chloride or polystyrene, and the electrodes 51204 can be spaced about 1cm apart within the ionization chamber 51202, for example. Americium-241 source 51208 may provide americium-241 to ionization chamber 51202. For example, about 0.3 μg of americium-241 may be embedded in a gold foil matrix sandwiched between a silver backing and a 2 micron thick palladium laminate layer. Americium-241 may have a half-life of 432 years and decay by emitting alpha rays 51206. The gold foil matrix is configured to retain the radioactive material while still allowing the alpha rays 51206 to pass through. In each case, alpha rays are preferred over beta rays and gamma waves because they tend to ionize air particles, have low penetrating power, and can be easily accommodated.
During ionization, electrons are knocked out of oxygen and nitrogen molecules, which create charged ions. The charged ions are attracted to the oppositely charged electrodes, thereby forming an electrical current in the chamber. Because the smoke particles 51210 are larger than the air molecules, the ionized particles collide with and combine with the smoke particles. The combined particles act as recombination centers and neutralize ions, which reduces the amount of ionized particles in the ionization chamber 51202 and reduces the total current. The drop in current may be converted to an electrical signal corresponding to the volume of smoke passing between the electrodes 51204. The output signals may be provided to a processor, such as processor 50308 and/or processor 50408 shown in fig. 5 and 6, respectively, which may affect the operating parameters of the motor. For example, the output signal from the ionization sensor 51200 can be an input to a control algorithm of the motor and/or an input to a surgical hub, as further described herein.
In various cases, dual ionization chambers may be used. The first chamber, which acts as a sensing chamber, may be open to the atmosphere and affected by particulate matter, humidity and atmospheric pressure. The second chamber may be isolated from smoke and particulate matter. Although positioned outside the smoke flow path, the second chamber is still subject to humidity and atmospheric pressure. By using two chambers, humidity and barometric pressure changes can be minimized because the outputs from the two chambers are equally affected and cancel each other out. Since the humidity and pressure may vary significantly during surgery (depending on, for example, the type of surgery, the surgical device employed, and the type of tissue encountered), the dual ionization chamber may help the smoke evacuation system compensate for the pressure and humidity variations.
In some cases, a combination method may be utilized to determine the concentration of particles in the smoke. For example, a variety of different types of smoke detectors or sensors may be utilized. Such sensors may be arranged in series with the flow path. For example, a plurality of particle sensors may be positioned along flow path 50804 in fig. 18 and/or flow path 50904 in fig. 19. Various sensors may provide inputs to a pump motor control algorithm, such as the various adjustment algorithms described herein.
In some cases, the surgical evacuation system may be configured to tune the sensor parameters to more accurately detect particles within the smoke. The adjustment of the sensor parameters may depend on the type of surgical device, the type of surgical procedure, and/or the type of tissue. Surgical devices typically produce a predictable type of smoke. For example, in some procedures, the predictable type of smoke may be smoke with a high water vapor content. In such cases, an infrared photosensor may be employed because infrared light is substantially absorbed by water vapor and is not reflected by water vapor. Additionally or alternatively, the predictable type of smoke may be smoke having particles of a particular size or concentration. Based on the expected size of the particles, the sensor may be tuned to more accurately determine the concentration of particles in the smoke.
In some cases, situational awareness may facilitate tuning of sensor parameters. Information related to situational awareness may be provided to the surgical evacuation system by a clinician, an intelligent electrosurgical instrument in signal communication with the surgical evacuation system, a robotic system, a hub, and/or a cloud. For example, the hub may include a situational awareness module that may aggregate data from various sensor systems and/or input systems (including, for example, fume extraction systems). Sensors and/or inputs in the overall computer-implemented interactive surgical system may be used to determine and/or confirm, for example, the surgical device used in the surgery, the type and/or steps of the surgery, and/or the type of tissue. In some cases, situational awareness may predict the type of smoke that will be generated at a particular time. For example, the situational awareness module may determine the type of surgery and the steps therein to determine which smoke will likely be generated. The sensor may be tuned based on the expected type of smoke.
In some cases, one or more of the particle sensors disclosed herein may be a fluid detection sensor. For example, the particle sensor may be positioned and configured to be able to determine whether aerosols and/or droplets are present in the evacuated smoke. In one aspect of the disclosure, the size and/or concentration of the detected particles may correspond to aerosols, droplets, solid matter, and/or combinations thereof. In some cases, situational awareness may determine and/or confirm whether the detected particles are aerosols or solid matter. For example, a situational awareness module in signal communication with a processor (e.g., processor 50308 in fig. 5 and/or processor 50408 in fig. 6) may inform the identification of particles in the fluid.
Referring now to fig. 23, a graphical representation of, for example, a surgical evacuation system, such as particle count 51300 and motor speed 51302 over time of surgical evacuation system 50400 (fig. 6), is shown. The target motor speed 51304 can be predefined and stored in a memory of a processor in signal communication with the motor (see, e.g., fig. 5 and 6). In various circumstances, the processor may be configured to maintain the target motor speed 51304 under normal operating conditions. For example, the target motor speed 51304 may be stored in the memory 50410 (fig. 6), and the processor 50408 (fig. 6) may be configured to be able to maintain the target motor speed 51304 under normal operating conditions. In such cases, when the surgical evacuation system 50400 (fig. 6) is activated, the motor 50451 can be operated at the target motor speed 51304 and can continue to operate at the target motor speed 51304 unless one or more conditions are detected and/or communicated to the processor 50408.
In some cases, the processor 50408 can be in signal communication with a particle sensor configured to be able to detect the concentration of particles in the intake smoke in real time. Various examples of particle concentration sensors, such as laser particle counter sensors, are described herein. In one aspect of the disclosure, a particle sensor 50838 (fig. 18 and 19) positioned at an inlet to the filter 50870 in fig. 18 and an inlet to the filter 50970 in fig. 19 may be in signal communication with the processor 50408 (fig. 6). For example, the laser particle sensor 50838 may correspond to one of the sensors 50430 in fig. 6.
In each case, when the particle sensor50838 When (fig. 18 and 19) the particle concentration (e.g., parts per million of particles in the fluid) is detected to drop below the threshold amount 51306, the processor 50408 can direct the motor driver 50428 to reduce the speed of the motor 50451. For example, at time t in fig. 23 1 At this point, the particle count or particle concentration 51300 drops below the threshold amount 51306. Because the particle count 51300 has fallen below the threshold amount 51306, the motor speed 51302 can be reduced below the target motor speed 51304. Then, if the particle sensor 50838 (fig. 18 and 19) detects that the particle count 51300 again exceeds the threshold amount 51306, such as at time t 2 At that point, the processor 50408 can direct the motor driver 50428 to increase the speed of the motor 50451 to resume the target motor speed 51304. The concentration of particles may correspond to the size of the particles in the smoke. For example, smoke may be present at time t 1 And time t 2 Including smaller particles. By reducing the speed of motor 50451, the suction created by pump 50450 can be reduced, which can ensure that smaller particles are not sucked through the filter of surgical evacuation system 50400. For example, reducing the motor speed or reducing the pressure of the pump may ensure that the filtration system has sufficient time and capacity to trap particulates and that the fine media filter may trap smaller particulates. In other words, the slower speed may improve the filtration efficiency of the surgical drainage system 50400.
In some cases, the speed of the motor 50451 driving the pump 50450 can be adjusted based on a particle sensor positioned downstream of the filter. For example, referring again to fig. 18 and 19, the particle sensor 50848 is positioned downstream of the filter 50870 in fig. 18 and downstream of the filter 50970 in fig. 19. Because the particulate sensor 50848 is positioned downstream of the filter assembly, the particulate sensor 50848 is configured to detect particulates in the exhaust gas from, for example, the surgical evacuation system 50800 or the evacuation system 50900. In other words, such particle sensor 50848 is configured to be able to detect particles that have passed through the ejector housing 50818, 50918 and been expelled into ambient air. The particle sensor 50848 is positioned to the ejector housing 50818, 50918 adjacent the outlets 50824, 50924, respectively. In one case, the processor 50308 (fig. 5) and/or the processor 50408 (fig. 6) may implement the pump adjustment when the concentration of particulates in the exhaust gas (e.g., the concentration of particulates detected by the particulate sensor 50848) exceeds a predefined threshold amount. For example, referring again to fig. 6, the speed of the motor 50451 can be adjusted to increase the filtration efficiency of the surgical drainage system 50400.
The motor speed may be adjusted by limiting the current supplied to the motor and/or varying the duty cycle of the motor. For example, the pulse modulation circuit may employ pulse width modulation and/or pulse frequency modulation to adjust the length and/or frequency of the pulses.
Additionally or alternatively, if the particle count in the vent exceeds a defined threshold amount that may be dangerous or harmful to operators and clinicians in the operating room, the expelled fluid may be redirected through one or more filters in the surgical evacuation system. For example, if the particle sensor 50838 detects that the particle count in the exhaust gas is above a threshold amount, the processor 50308 (fig. 5) and/or the processor 50408 (fig. 6) may open a valve downstream of the filter that may recirculate the exhaust gas and inject the recirculated exhaust gas into a flow path upstream of the filter. In some cases, the valve may inject recirculated exhaust gas into an alternative flow path that includes, for example, one or more additional and/or different filters.
In some cases, the surgical evacuation system may include an override option in which the evacuation system continues to operate and/or continues to operate at a predefined power level despite exceeding a set threshold. For example, in the override mode, the surgical evacuation system may continue to operate and evacuate particulates even if the particulate sensor downstream of the filter detects a concentration of particulates that exceeds a threshold amount. For example, an operator in a surgical room may activate an override feature or mode by activating a switch, toggle switch, button or other actuator on the ejector housing and/or input to the surgical hub.
Referring now to fig. 27, a flow chart depicting an adjustment algorithm 52300 for a surgical drainage system is shown. The various surgical drainage systems disclosed herein may utilize the adjustment algorithm 52300 of fig. 27. Furthermore, the reader will readily appreciate that in some cases, the adjustment algorithm 52300 may be combined with one or more additional adjustment algorithms described herein. Adjustment of the surgical evacuation system may be accomplished by a processor in signal communication with a motor of an ejector pump (see, e.g., the processor and pump of fig. 5 and 6). For example, the processor 50408 can implement the adjustment algorithm 52300. Such a processor may also be in signal communication with one or more sensors in the surgical evacuation system.
In various circumstances, the surgical evacuation system may initially be operated in a standby mode 52302, as shown in fig. 27, in which the motor is operated at low power, as shown in block 52310, to sample fluid from the surgical site. For example, in standby mode 52302, the surgical evacuation system can evacuate a small sample of fluid from the surgical site. The standby mode 52302 can be a default mode of the drainage system.
If the particle sensor upstream of the filter (e.g., particle sensor 50838) detects a particle count or particle concentration greater than a threshold X, as indicated in block 52312, the surgical evacuation system may enter an automatic evacuation mode 52304. In the automatic evacuation mode 52304, the motor speed can be increased at block 52314 to evacuate additional smoke from the surgical site. For example, the particle count or particle concentration may increase above a threshold amount X when electrosurgical operation begins or when a particular electrosurgical power level is activated. In some cases, the speed of the motor may be adjusted during the automatic drain mode 52304 based on the detected particle concentration. For example, as the concentration of particles detected by the particle sensor 50838 increases, the motor speed may correspondingly increase. In some cases, the predefined motor speed may correspond to a predefined range of particle concentrations detected by the particle sensor 50838.
Still referring to fig. 27, if a particle sensor downstream of the filter (e.g., particle sensor 50848) detects a particle count or concentration less than a threshold amount Y at block 52316, the motor may resume the low power mode at block 52310 and/or be further adjusted at block 52314, as specified herein. Further, if the downstream particle sensor 50848 detects a particle count or concentration greater than the threshold amount Y and less than the threshold amount Z at block 52318, the motor speed may be reduced at block 52320 to increase the efficiency of the filter. For example, the concentration of particles detected by the particle sensor 50848 between the thresholds Y and Z may correspond to small particles passing through a filter of the fume exhaust system.
Still referring to fig. 27, if the particle sensor 50848 downstream of the filter detects a particle count greater than a threshold amount Z at block 52318, the motor may be turned off at block 52322 to terminate the evacuation procedure and the surgical evacuation system may enter override mode 52306. For example, the threshold Z may correspond to an air quality risk for a clinician and/or other personnel in the surgical room. In some cases, the operator may selectively override the shutdown function, as further specified herein, such that the motor continues to operate at block 52310. For example, the surgical evacuation system may return to the standby mode 52302 in which a fluid sample is evacuated from the surgical site and monitored by the surgical evacuation system.
In some cases, the power level of the pump may be a function of a pressure differential across at least a portion of the surgical evacuation system. For example, the surgical evacuation system may include at least two pressure sensors. Referring again to fig. 18 and 19, the ambient pressure sensor 50854 is configured to be able to detect pressure in an ambient room. The pressure sensor 50840 is configured to detect pressure in the flow path 50804 intermediate the fluid trap 50860 and the filter or filtration system 50870 of fig. 18, and to detect pressure in the flow path 50904 intermediate the fluid trap 50960 and the filter system 50970 of fig. 19. In addition, the pressure sensor 50846 is configured to detect pressure in the flow path 50804 intermediate the filter system 50870 and the pump 50806 in fig. 18, and the flow path 50904 intermediate the filter system 50970 and the pump 50906 in fig. 19. Finally, the pressure sensor 50850 is configured to be able to detect the pressure in the flow paths 50804 and 50904 at the exhaust ports or outlets 50824 and 50924, respectively. The reader will readily appreciate that certain fume evacuation systems may include fewer or more than the four pressure sensors 50840, 50846, 50850, and 50854 shown in fig. 18 and 19. Further, the pressure sensor may be positioned at alternative locations throughout the surgical evacuation system. For example, one or more pressure sensors may be positioned in, for example, a fume extractor device along a fume extraction conduit extending between the fume extractor and the housing, and positioned within the housing, such as upstream of the fluid trap and/or intermediate of the different layers of the filtration system.
Referring now to fig. 28, a flow chart depicting an adjustment algorithm 52400 for a surgical drainage system is shown. In various instances, the surgical drainage systems disclosed herein may utilize the adjustment algorithm of fig. 28. Furthermore, the reader will readily appreciate that in some cases, the adjustment algorithm 52400 of fig. 28 may be combined with one or more additional adjustment algorithms described herein. Adjustment of the surgical evacuation system may be accomplished by a processor in signal communication with a motor of an ejector pump (see, e.g., the processor and pump of fig. 5 and 6). For example, the processor 50408 can implement the adjustment algorithm 52400. The processor may also be in signal communication with one or more pressure sensors in the surgical evacuation system.
In various cases, the processor 50408 is configured to be able to obtain a pressure measurement P1 from the first pressure sensor at block 52402 and a second pressure measurement P2 from the second pressure sensor at block 52404. The first pressure sensor and the second pressure sensor may be provided by, for example, sensor 50430 in fig. 6. The processor 50408 is configured to be able to compare the measurements P1 and P2 at block 52406 to determine a pressure differential between the first and second pressure sensors. In one case, if the pressure differential is less than or equal to a threshold amount X, such as at block 52408, the speed of the pump may be maintained. Conversely, if the pressure differential is greater than a threshold amount X, such as at block 52410, the speed of the pump may be adjusted. Adjustment of the operating parameters of the motor is configured to enable adjustment of the speed of the pump. The adjustment algorithm 52400 may be repeated continuously and/or at regular intervals. In some cases, the clinician may trigger the implementation of the adjustment algorithm 52400.
The flow of smoke through the evacuation system may be a function of the pressure differential. In one case, if the pressure differential across the extraction system increases significantly, the flow through the system may also increase. The actual flow may be predicted based on the differential pressure and the motor speed. Thus, by monitoring the differential pressure, the flow rate may be more accurately determined.
Additionally, a blockage in the flow path may correspond to an increase in the pressure differential. For example, when the filter captures particulates from smoke, the pressure differential across the filter may increase for a given pump speed. In response to a predefined pressure drop across the filter, the speed of the motor and the corresponding speed of the pump may be increased to maintain the flow of smoke through the system, regardless of clogging in the filter. For example, referring again to fig. 18 and 19, a first pressure sensor may be positioned upstream of the filter (e.g., pressure sensor 50840) and a second pressure sensor may be positioned downstream of the filter (e.g., pressure sensor 50846). The pressure differential between pressure sensor 50840 and pressure sensor 50846 may correspond to a pressure drop across the filter. When the filter captures particles in the smoke, the captured particles may block the flow path, which may increase the pressure differential across the filter. In response to the increased pressure differential, the processor may adjust an operating parameter of the motor to maintain flow throughout the system. For example, the speed of the motor and the corresponding speed of the pump may be increased to compensate for a partially blocked filter in the flow path.
In other cases, the predefined pressure drop may correspond to a blockage in the evacuation conduit. In one example, to avoid tissue damage when the evacuation catheter is blocked by tissue, for example, the speed of the motor and corresponding speed of the pump may be reduced. Reducing the speed of the pump in such cases may be configured to avoid potential tissue trauma.
In another case, the first pressure sensor may be positioned upstream of the fluid trap and the second pressure sensor may be positioned downstream of the fluid trap (e.g., pressure sensor 50840). The pressure differential between the sensors may correspond to a pressure drop across the fluid trap, which may correspond to a flow rate and/or flow path through the fluid trap. The pressure differential across the fluid trap may also be estimated by other sensors in the fluid evacuation system. In some cases, it is desirable to reduce the flow through the fluid trap to ensure that liquid is adequately removed from the smoke before it enters the downstream filter and pump. In such cases, the pressure differential may be reduced by reducing the speed of the motor and the corresponding speed of the pump.
In other cases, the first pressure sensor may be positioned at an inlet to the surgical evacuation system or its exhauster housing, and the second pressure sensor may be positioned at an outlet to the surgical evacuation system (e.g., pressure sensor 50850). The pressure differential between the sensors may correspond to a pressure drop across the surgical evacuation system. In some cases, the maximum pumping load of the system may be kept below a threshold by monitoring the pressure drop across the system. When the pressure drop exceeds a threshold amount, the processor may adjust an operating parameter of the motor (e.g., slow the motor) to reduce the pressure difference.
In one instance, for example, chemical sensor 50832 can detect the pH of a substance (such as a fluid sputtered onto sensor 50832) that is in physical contact with the sensor, for example. In one aspect of the present disclosure, the chemical sensor 50832 can detect glucose and/or oxygen content in the fluid. The chemical sensor 50382 may be configured to be able to detect cancerous byproducts in certain circumstances. If cancerous byproducts are detected, parameters of the evacuation system may be adjusted to reduce the likelihood of such byproducts entering the surgical room. In one case, the pump speed may be reduced to increase the efficiency of a filter in, for example, a drainage system. In other cases, the evacuation system may be de-energized to ensure that cancerous byproducts are not discharged into the surgical room.
The fluid extracted from the surgical site by the surgical evacuation system may include liquids and various particulates. The combination of different types and/or states of substances in the evacuated fluid may make the evacuated fluid difficult to filter. Additionally or alternatively, certain types and/or states of matter may be detrimental to certain filters. For example, the presence of droplets in the smoke may damage certain filters, and the presence of larger particles in the smoke may block certain fine particle filters.
The sensor may be configured to detect a parameter of fluid moving through the evacuation system. Based on the parameters detected by the sensors, the surgical evacuation system may direct the evacuated fluid along an appropriate flow path. For example, a fluid containing a percentage of droplets above a particular threshold parameter may be directed through a fluid trap. As another example, fluid containing particles above a threshold size may be directed through the coarse media filter, and fluid containing particles below a threshold size may bypass the coarse media filter and be directed to the fine media filter.
By providing an alternative flow path through the surgical drainage system, the surgical drainage system and its filters may operate more efficiently and be less prone to damage and/or clogging. The service life of the filter can also be prolonged. As provided herein, a filter may include one or more filtration layers, and in some cases, a filtration system may include one or more filters.
The diverter valve 52934 for a surgical drainage system is shown in detail in fig. 24A and 24B. In one aspect of the present disclosure, the shunt valves 50834 and 50934 shown in the surgical drainage systems 50800 and 50900 in fig. 18 and 19, respectively, may comprise a shunt valve 52934. The diverter valve 52934 includes a ball valve 52396 operably configured to direct fluid from an inlet path 52942 along either the first path 52940 or the second path 52938. In various circumstances, the ball valve 52396 can be an electrically actuated ball valve that includes a controller. For example, a processor for a surgical evacuation system, such as processor 50408 (fig. 6), may send a signal to the ball valve controller to initiate rotation of the ball valve 52396 to alter the flow path of smoke therethrough. When the diverter valve 52934 is in the first position (fig. 24A), the smoke intake through the diverter valve 52934 is directed along the first path 52940. When the diverter valve 52934 is in the second position (fig. 24B), the smoke intake through the diverter valve 52934 is directed along the second path 52938.
The first path 52940 may correspond to a flow path when no liquid is detected within the smoke or when a detected liquid to gas ratio or aerosol percentage is below a threshold. The second path 52938 may correspond to a flow path when a liquid (e.g., aerosol) has been detected within the smoke, or when the detected liquid to gas ratio or aerosol percentage is equal to or above a threshold. In certain aspects of the disclosure, the first path 52940 may bypass the fluid trap and the second path 52938 may direct smoke through the fluid trap to capture fluid from the smoke before the smoke is directed into the filter. By selecting a flow path based on the percentage of aerosol, the efficiency of the surgical evacuation system may be improved.
In other cases, the diverter valve 52934 can include more than two fluid path outlets. Further, the fluid path may bypass/recirculate fluid relative to the fluid trap and/or direct smoke along different filter paths including different arrangements of the fluid trap, condenser, and/or particulate filter according to detected fluid parameters.
Referring again to fig. 18 and 19, the fluid detection sensor 50830 is configured to be able to detect the presence of aerosols or liquid to gas ratios in the smoke. For example, the fluid detection sensor 50830 in fig. 18 is positioned at the inlet 50822 to the ejector housing 50818. In other cases, the fluid detection sensor 50830 can be positioned adjacent to the inlet 50822 and/or at a location upstream of the filter 50870 and/or a socket for receiving the filter 50870. Examples of fluid detection sensors are further described herein. For example, the fluid detection sensor 50830 may include one or more of the particle sensors further disclosed herein. Additionally or alternatively, in one aspect of the present disclosure, the fluid detection sensor 50830 comprises a continuity sensor.
In one case, if the fluid detection sensor 50830 detects a liquid to gas ratio equal to or above a threshold, the intake air may be diverted into the condenser prior to entering the particulate filter. The condenser may be configured to be capable of condensing droplets in the flow path. In various cases, the condenser may comprise a honeycomb structure. The condenser may include a plurality of baffles or other structures upon which the liquid is configured to condense. As the mist flows through the condenser, the liquid may condense on baffles in the condenser and may be directed downward into the fluid reservoir.
Referring primarily to fig. 18, a diverter valve 50834 is positioned to direct the smoke intake to bypass the condenser 50835 so that the smoke flows directly to the filter 50870. While bypassing the condenser 50835, the surgical drain system 50800 may require less power from the motor driving the pump (see, e.g., motor 50451 and pump 50450 in fig. 6). Referring now to fig. 19, diverter valve 50934 is positioned to direct smoke into condenser 50935 within fluid trap 50960 before smoke flows into filter 50970. Conversely, if the fluid detection sensor 50830 detects a liquid to gas ratio below the threshold, the intake air may bypass the condenser 50935 and be directed directly to the filter 50970.
In various circumstances, the fluid detection sensor 50830 can detect the presence of smoke in the flow path. For example, the fluid detection sensor 50830 can comprise a particle sensor. The detection of particles or the detection of a concentration of particles above a threshold value may be indicative of smoke being present in the flow path. In some cases, the fluid detection sensor may not distinguish between solid particles (e.g., carbon) and aerosol particles. In other cases, the fluid detection sensor 50830 can also detect the presence of aerosols. For example, the fluid detection sensor may include a continuity sensor, which, as described herein, may determine, for example, whether the detected particles are aerosols.
In various instances, the surgical evacuation system may include additional or alternative flow paths. For example, the surgical evacuation system may include a high-particle flow path and a low-particle flow path. For example, when a particle sensor, such as particle sensor 50838 (fig. 18 and 19), detects a particle concentration equal to or above a threshold, the intake smoke may be diverted into the particle filter. Conversely, if the laser particle sensor detects a particle concentration below a threshold, the intake smoke may bypass the particle filter. Similarly, different flow paths may correspond to different sizes and/or types of particles. For example, if the particle sensor 50838 detects larger particles, smoke may be directed along a different path than when smaller particles are detected. For example, surgical drainage systems may include different types of particulate filters (e.g., large media filters and fine media filters), and different filtering methods may be used based on detected particle size (or size range), such as direct interception, inertial impaction, and diffusion interception. Different flow paths may be selected to optimize fluid extraction and/or particulate filtration of the smoke while minimizing power consumption and/or stress on the motor. In some cases, the default flow path may be a more direct flow path, and upon detection of a fluid parameter exceeding a threshold limit, the fluid may be diverted to a less direct flow path. Less direct flow paths may require more power.
In various circumstances, a motor for a surgical evacuation system may be adjusted based on characteristics of the intake smoke and/or a filter installed in the surgical evacuation system. Referring again to the schematic diagram shown in fig. 6, the processor 50408 is in signal communication with a motor driver 50428 that is coupled to a motor 50451 of the pump 50450. The processor 50408 can be configured to adjust the motor 50451 based on characteristics of the smoke and/or installed filter. In one instance, the processor 50408 can receive an input corresponding to a volume of liquid within the flow path, including a volume of aerosol suspended within smoke and/or a volume of liquid droplets contacting or resting on a tube of the surgical evacuation system. Various sensors, such as continuity sensors, for detecting the fluid density of intake air smoke are further described herein.
The liquid to gas ratio of the smoke can affect the efficiency of the smoke pump. For example, the compressibility of the liquid within the smoke may be less than the gas within the smoke, which may affect the efficiency of the pump. In addition, different types of pumps may behave differently in the presence of aerosols. In some cases, the pump speed may be accelerated, and in other cases, the pump speed may be decelerated. To optimize the efficiency of the pump for the respective liquid to gas ratio, the processor may be configured to be able to adjust the motor driving the pump. In other words, the control program for the motor may be operable to adjust the pump speed based on the detected liquid to gas ratio in the flow path.
Some pumps can effectively handle fluids with high liquid to gas ratios such that the efficiency of the pump remains the same or increases. For example, some scroll pumps may process aerosols in the smoke path. In such cases, the rotational speed of the pump may decrease with incompressible (or less compressible) fluid, thereby increasing the air handling of the vacuum. Other pumps may be more sensitive to fluids having high liquid to gas ratios and thus may be slowed to limit the pressure differential across the fluid trap.
In various instances, the sensor may be configured to detect flow through the surgical evacuation system. For example, the optical sensor may be configured to measure the flow of particulates within the surgical evacuation system. In some cases, the detected flow through the surgical evacuation system may be used to manage the aspiration rate of the compressor. An algorithm may determine an appropriate pumping rate based on one or more detected parameters of flow and/or smoke (e.g., particle concentration, liquid to gas ratio, etc.). For example, when smoke having a high liquid to gas ratio enters the surgical evacuation system, the motor speed may be reduced to reduce the flow through the surgical evacuation system including its fluid trap so that more liquid may be extracted from the smoke before it enters the pump. The liquid may damage some pumps. For example, if liquid in the smoke is allowed in, the lobe pump and the regenerative blower may be damaged.
Fig. 25 illustrates a graphical representation of airflow fluid content and duty cycle over time of a surgical drainage system, such as surgical drainage system 50800 (fig. 18) and/or 50900 (fig. 19). The fluid content may include aerosols and droplets within the evacuation system and may be detected, for example, by fluid detection sensors 50830 and 50836 (fig. 18 and 19). Referring again to fig. 25, at the beginning of the procedure, fluid detection sensors 50830 and 50836 detect the same or substantially the same fluid content in the smoke. In other words, the fluid content upstream of the respective fluid trap 50860, 50960 is the same or substantially the same as the fluid content downstream of the respective fluid trap 50860, 50960. The fluid content detected by sensors 50830 and 50836 continues to rise as the procedure continues.
At time t 1 Where the fluid content detected by sensors 50830 and 50836 exceeds a fluid content threshold (C T ) 52102, and to prevent damage to the filtration system, the smoke is redirected through a fluid trap, such as fluid traps 50860 and/or 50960. Threshold value of fluid content C T 52102 may correspond to a volume of fluid and/or a percentage of aerosol that would be detrimental to the filtration system. Referring primarily to the extraction system 50900 in fig. 19, the recirculation valve 50990 may Is opened (as shown in fig. 19) so that the fluid can be redirected back into the condenser 50935 of the fluid catcher 50960 before entering the filter 50970. By recirculating the fluid, additional droplets can be removed therefrom. Thus, referring again to fig. 25, the fluid content detected by the fluid detection sensor 50836 positioned upstream of the filter 50970 may be reduced below the fluid quantity threshold C T 52102. In each case, at time t, by the airflow path through the ejector housing 1 The duty cycle of the motor is maintained by adjusting the position, as shown in fig. 25.
Still referring to the graphical representation in fig. 25, as the mist is recirculated through the fluid trap (which captures some of the aerosol and/or droplets), the downstream fluid detection sensor 50836 begins to detect a lesser liquid content in the mist. However, the upstream fluid detection sensor 50830 continues to detect an increased amount of liquid in the mist. Further, at time t 2 At this point, the downstream fluid detection sensor 50836 again detects that the fluid content threshold C is exceeded T 52102 fluid content. To address the increased fluid content, the duty cycle of the pump motor is at time t, although smoke is recirculated through the fluid trap 2 Is reduced to reduce the speed of the pump so that more liquid can be extracted from the smoke before it enters the pump. When the pump is adjusted to a reduced duty cycle, the fluid trap may more effectively trap aerosols and/or droplets within the aerosol, and the fluid content detected by the fluid detection sensor 50836 eventually begins to decrease below the fluid content threshold C T 52102。
In some cases, the fluid volume in the fluid trap and/or the levelness of the housing may be used to determine whether the fluid level therein is approaching a threshold limit, which may correspond to reaching the anti-overflow baffle and/or the fluid trap to the outlet port of the particulate filter. The liquid may damage the particulate filter and/or reduce its efficiency, as further described herein. To prevent liquid from entering the particulate filter, the processor may adjust the motor to minimize the likelihood of liquid being drawn into the particulate filter. For example, the processor may direct the motor to slow down when a predefined volume of liquid enters the fluid trap and/or when the liquid within the trap reaches a set mark or level within the housing that exceeds a predefined safety level.
In various circumstances, the control program of the motor may be further affected by using the pressure differential between pressure sensors in the evacuation system, such as pressure sensors 50840 and 50846 in surgical evacuation system 50900 (fig. 19). For example, based on the pressure differential across filter 50970 and the speed of the motor of pump 50906, the processor of surgical drain system 50900 may be configured to be able to predict the actual flow through filter 50970. In addition, the flow rate may be adjusted (e.g., by adjusting the motor speed) to limit the flow rate and reduce the likelihood that fluid will be drawn out of the reservoir in the fluid trap 50960 and into the filter 50970.
As described herein, the surgical evacuation system may include one or more sensors configured to detect the presence of aerosols (e.g., liquid to gas ratio) within the smoke, and one or more sensors configured to detect the presence of carbonized particles (e.g., parts per million measurements) within the smoke. By determining whether the extracted fluid is primarily steam, primarily smoke, and/or a corresponding ratio of each, the surgical evacuation system may provide valuable information to a clinician, a smart electrosurgical instrument, a robotic system, a hub, and/or a cloud. For example, the ratio of steam to smoke may be indicative of the extent of tissue welding and/or collagen cauterization. In various cases, the energy algorithm of the electrosurgical instrument and its generator may be tuned based on the ratio of steam to smoke.
In one aspect of the present disclosure, the processor may adjust the amplitude and/or power of an ultrasonic generator, such as generator 800 (fig. 58), when the extracted fluid is predominantly steam or has a high aerosol percentage. For example, a processor for a fume extraction system may be communicatively coupled to the generator 800. In one case, when the power is too high for a particular surgical scene, an excess of steam or aerosol may be generated. In such cases, the power level of the generator may be reduced to reduce the vapor/aerosol generated by the energy tool. In other cases, the processor may adjust the power level of the generator for higher particle ratios. For example, for particle ratios above a threshold, the power level may be reduced. In some cases, the voltage may be adjusted to reduce particles generated by the energy tool.
Referring now to fig. 26, an adjustment algorithm 52200 for a surgical drainage system is shown. The various surgical drainage systems disclosed herein may utilize an adjustment algorithm 52200. Furthermore, the reader will readily appreciate that in some cases, the adjustment algorithm 52200 may be combined with one or more additional adjustment algorithms described herein. Adjustment of the surgical evacuation system may be accomplished by a processor in signal communication with a motor of an ejector pump (see, e.g., the processor and pump of fig. 5 and 6). For example, the adjustment algorithm 52200 can be implemented by a processor 50408 in signal communication with a motor driver 50428 and/or a controller of a shunt valve, as further described herein. The processor is configured to monitor characteristics of the smoke being emitted using various sensors. In one aspect of the disclosure, referring to fig. 26, the processor is configured to be able to determine whether the intake air smoke includes particles and aerosols above a threshold.
At the beginning of the adjustment algorithm 52200, a standard flow may begin at block 52202 and one or more characteristics of the intake air smoke may be monitored at block 52204. At block 52206, the sensor can be configured to be capable of inspecting particles in the fluid. If the sensor does not detect particles, the standard flow and/or power level may be maintained at block 52202. In one case, the standard flow rate may be a minimum flow rate or an idle flow rate, as further described herein. If a particle is detected at block 52206 and it is determined at block 52208 that the particle is not an aerosol particle, a first adjustment to the flow and/or power level may be implemented at block 52210. For example, the flow and power level may be increased to increase the evacuation of particles (i.e., smoke) from the surgical site. In some cases, the second adjustment may be implemented if the particles are determined to be aerosol particles at block 52208, or if a portion of the particles are aerosol particles.
In one aspect of the disclosure, the second adjustment may be dependent on the percentage of aerosol in the smoke. For example, if it is determined in block 52212 of fig. 26 that the aerosol percentage is greater than a first threshold amount, such as x%, then smoke may be directed to the fluid trap at block 52214. Conversely, if the aerosol concentration in the smoke is less than or equal to the threshold amount x%, the smoke may be directed around the fluid trap at block 52216. Conduits and valves for directing fluid flow within a fume extraction system are further described herein. In some cases, the flow and/or power level may be adjusted to adequately draw fluid along, for example, a selected flow path, such as toward and/or around the fluid trap. In one aspect of the present disclosure, additional power and/or suction may be required to draw fluid into the fluid trap.
Still referring to fig. 26, after exiting the fluid trap, if aerosol particles are still detected in the smoke at block 52218, and if the aerosol concentration is greater than a second threshold amount, such as Y% in fig. 26, at block 52220, the flow may be reduced at block 52224 to ensure adequate extraction of aerosol from the smoke. Conversely, if the aerosol concentration downstream of the fluid trap is less than or equal to the second threshold amount Y, then the flow may be maintained at block 52222. As shown in fig. 26, after redirecting the flow path and/or adjusting and/or maintaining the flow in the adjustment algorithm 52200, the adjustment algorithm may return to block 52204 to continue monitoring one or more parameters of the fume exhaust system. In some cases, the adjustment algorithm 52200 can be continuously cycled such that smoke characteristics are continuously monitored and/or transmitted to the processor in real-time or near real-time. In other cases, the adjustment algorithm 52200 can be repeated for a predefined time and/or interval.
In some instances, the surgical drainage system may also include a chemical sensor, such as chemical sensor 50832 (fig. 18 and 19). Chemical sensors 50832 are located near inlet 50822 to surgical evacuation system 50800 and near inlet 50922 to surgical evacuation system 50900. The chemical sensor 50832 is configured to detect a chemical characteristic of particles being aspirated by the surgical evacuation system. For example, the chemical sensor 50832 can identify the chemical composition of particles in smoke evacuated from the patient's abdominal cavity during an electrosurgical procedure. Different types of chemical sensors may be utilized to determine the type of material extracted by the surgical evacuation system. In some cases, the smoke evacuation system may be controlled based on content extracted from the surgical site (such as by content detected by chemical sensor 50832).
Chemical analysis of the extracted fluid and/or particles may be used to adjust generator functions, such as the function of generator 800 (fig. 58). For example, generator function may be adjusted based on detection of cancerous material by chemical sensor 50832. In some cases, when the chemical sensor 50832 no longer detects cancerous material, the clinician may be alerted that all cancerous material has been removed and/or the generator may cease operation of the energy device. Alternatively, when the chemical sensor 50832 detects cancerous material, the clinician may be alerted and the generator may optimize operation of the energy device to remove the cancerous material.
In some cases, the generator function may be adjusted based on tissue characteristics detected by the surgical system. Referring primarily to fig. 29, a flow chart depicting an adjustment algorithm 52500 for a surgical system is shown. The various surgical systems disclosed herein may utilize an adjustment algorithm 52500. Furthermore, the reader will readily appreciate that in some cases, the adjustment algorithm 52500 may be combined with one or more additional adjustment algorithms described herein. Adjustment of the surgical system may be effected by a processor (see, e.g., processor 50308 in fig. 5). In various aspects of the disclosure, to determine the type of tissue, the processor 50308 (fig. 5) may be configured to be capable of receiving information from a plurality of sources.
Still referring to fig. 29, one or more sensors 52502 in the surgical evacuation system may provide information to the processor 50308 (fig. 5). Still referring primarily to fig. 28, the particulate sensor 52502a, chemical sensor 52502b, and/or fluid detection sensor 52502c (which may be similar to the sensors shown in fig. 18 and 19) of the surgical drainage system, for example, may provide data indicative of tissue type to the processor 50308. In addition, an external sensor 52504 can provide information to the processor 50308. The external sensor 52504 can be remote from the surgical evacuation system, but positioned on other surgical devices associated with the surgical procedure. For example, one or more external sensors 52504 can be positioned on a surgical instrument, robotic tool, and/or endoscope. In some cases, the internal sensor 52502 and the external sensor 52504 can provide information to a situational awareness module or surgical hub that can provide situational awareness 52506 to the various sensors 52502, 52504. Further, situational awareness 52506 can inform processor 50308 about various sensor data. Based on situational awareness 52506 and data from the sensors 52502, 52504, a tissue type may be determined by the processor 50308 (fig. 5) at block 52510.
In some cases, the elastin to collagen ratio of the extracted material may be determined by the tissue type. For example, elastin may correspond to a first melting temperature, and collagen may correspond to a second melting temperature that is higher than the first melting temperature. In the case where the external sensor 52504 is configured to be able to detect the speed of the gripping arm and/or a parameter of the electric motor corresponding to the gripping speed, the external sensor 52504 may indicate the melting temperature of the tissue and, thus, the elastin to collagen ratio. Elastin and collagen also define different refractive indices and absorptivity. In some cases, infrared spectrometer and/or refractive camera sensors may be utilized to determine and/or confirm tissue type.
In some cases, the energy modality may be adjusted based on the detected tissue type (elastin, collagen, and/or elastin to collagen ratio). For example, some energy devices are more efficient at melting collagen than elastin, but can be tuned by tuning the energy modality to better melt elastin. In other cases, it may be advantageous to melt the collagen and retain the elastin. Additionally or alternatively, the elastin to collagen ratio may indicate the type of physical structure, such as a vein or artery, which may inform the situational awareness 52506 of the system. For example, if collagen is detected at block 52510, energy modality a may be implemented at block 52512. In other cases, if elastin is detected at block 52510, energy modality C may be implemented at block 52516. In still other cases, when a combination of collagen and elastin is detected at block 52510, energy modality B may be implemented at block 52514. The reader will readily appreciate that additional and/or alternative energy modalities are contemplated. For example, different modalities may be used depending on the particular ratio of elastin to collagen and/or based on the surgical procedure being performed and/or steps thereof.
In various surgical procedures employing an energy device to treat tissue, fluids and/or particulates may be released, thereby contaminating the atmosphere in and/or around the surgical site, as further described herein. For example, to improve the visibility of the atmosphere in a surgical site, contaminants may be drawn into the fume extraction system. Furthermore, as contaminants are directed along the airflow path in the fume extraction system, the suspension fluid and/or particles may be filtered out to improve air quality. Depending on the efficiency of the smoke evacuation system and/or the amount of smoke and/or contaminants generated after activation of the electrosurgical instrument, smoke may accumulate in the atmosphere at and/or around the surgical site. Such accumulation of contaminants may, for example, prevent a clinician from being able to view the surgical site.
In one aspect of the present disclosure, a surgical system may include a fume evacuation system including a particle sensor, an electrosurgical instrument, and a generator. Such a smoke evacuation system may monitor particle concentration as the electrosurgical instrument applies energy to tissue during surgery. For example, when a clinician requests power to be supplied to an electrosurgical instrument, the generator is configured to provide the requested power. A processor within the surgical system is configured to analyze the monitored particle concentration and the power requested by the clinician from the generator. The processor may prevent the generator from supplying the requested power if the clinician requested power generates contaminants that drive the particle concentration above a predetermined threshold. Conversely, in such cases, the generator may supply power at a level that returns the particle concentration to below a predetermined threshold.
In such cases, in response, the clinician and/or assistant does not have to monitor particle concentration and adjust the energy modality separately. Rather, the instruments and devices of the surgical system may communicate with each other to direct the generator to supply a particular power level under particular conditions based on inputs from sensors in the smoke evacuation system. The reader will readily understand that situational awareness can further inform the decision making process of the generator. Various algorithms for implementing the foregoing monitoring processes and/or adjustments are also disclosed herein.
The surgical system may include an electrosurgical device, a generator configured to supply power to the electrosurgical device, and a smoke evacuation system. The fume extraction system may include a sensor system configured to monitor the size and/or concentration of particulates within the fume and/or air intake extraction duct. Referring now to fig. 18 and 19, a particle sensor 50838 is shown. The particle sensor 50838 is an internal sensor located at a position along the flow path 50804 (fig. 18) and the flow path 50904 (fig. 19). In various cases, the particle sensor 50838 is positioned at a point on the flow paths 50804, 50904, respectively, before being filtered by the filter systems 50870, 50970; however, the internal particle sensor 50838 may be positioned at any suitable location along the flow paths 50804, 50904 to monitor the contaminated air flowing from the surgical site. In various cases, the fume evacuation system 50800 and/or 50900 can include more than one internal particulate sensor 50838 positioned at various locations along the flow path 50804 and/or 50904, respectively. The reader will readily understand that various particle measurement devices are possible. For example, the particle concentration sensor may be an optical sensor, a laser sensor, a photosensor, an ionization sensor, an electrostatic sensor, and/or any suitable combination thereof. Various sensors are further described herein.
Electrosurgical generators are critical components in electrosurgical circuits because they produce electrosurgical waveforms. The generator is configured to convert the electrical power into a high frequency waveform and to generate a voltage for flow of electrosurgical current. In various cases, the generator is configured to generate various waveforms, where each waveform has a different effect on the tissue. The "cutting current" will cut the tissue but provide little hemostasis. The "coagulation current" provides coagulation with limited tissue dissection and produces an increased heating depth. The "mixed current" is an intermediate current between the cutting current and the coagulating current, however, the mixed current is typically not a combination of the cutting current and the coagulating current. Conversely, the mixed current may be a cutting current, wherein the time for which the current actually flows is reduced from 100% to about 50% of that time. In various circumstances, the generator may automatically monitor tissue impedance and adjust power output to the energy device in order to reduce tissue damage, thereby producing an effective and accurate cutting effect at the lowest possible setting.
An additional electrosurgical cutting mode, known as Advanced Cutting Effect (ACE), provides a clinician with a scalpel-like cutting effect that provides little to no thermal necrosis and does not provide hemostasis. When the generator is placed in ACE mode, a constant voltage is maintained at the tip of the electrode on the end effector. An active electrode on the end of the end effector delivers RF current from the generator to the surgical site. By utilizing ACE mode, clinicians have the following capabilities: the electrosurgical device is used on the skin and achieves equivalent wound healing results without the use of certain surgical instruments, such as scalpels, needles, and/or any surgical instrument that can cause a wound and/or puncture to the patient and/or any person responsible for them in general.
In various aspects of the disclosure, the electrosurgical device includes an ACE cutting system.
Contaminants and/or fumes may be generated during the entire duration of the surgical procedure. If the atmosphere at and/or around the surgical site is not effectively filtered by the fume evacuation system, contaminants accumulate in the atmosphere, making it difficult for the clinician and/or assistant to see the surgical site. Additional problems with smoke in the surgical suite are also disclosed herein. In various cases, a processor within the surgical system may store information in a memory that is specific to the amount of smoke and/or contaminants generated when a clinician uses a particular surgical instrument for a particular duration. Such information may be stored directly in the memory of the processor, in a centralized hub, and/or in the cloud. In various cases, the processors and memory shown in fig. 5 and 6 may be used to store such information.
In various instances, a communication path is established between the smoke evacuation system and the generator in order to control the power supplied to the electrosurgical instrument. Such power is controlled so as to effectively cause the electrosurgical instrument to produce less smoke and/or release less contaminants, and to allow the surgical site to be effectively filtered. In various circumstances, components of the surgical system may communicate directly with each other. In various instances, components of the surgical system communicate with each other through a centralized hub, as further described herein with respect to, for example, fig. 39-60. The reader will readily appreciate that any suitable communication pathway may be used.
When the surgical procedure begins and the electrosurgical instrument is activated, sensors within the smoke evacuation system are configured to monitor parameters related to air quality. Such parameters may include, for example, particle count and/or concentration, temperature, fluid content, and/or percent contamination. The sensor is configured to communicate the monitored parameter to the processor. In various cases, the sensor automatically transmits the monitored parameter after detection. In various cases, the sensor communicates the monitored parameter to the processor after the sensor has been interrogated; however, the reader will appreciate that any suitable manner of conveying the monitored information may be used. In each case, the sensor continuously communicates the monitored information to the processor; however, the reader will appreciate that any suitable sampling rate may be used. The monitored information may be transmitted, for example, in real time or near real time.
In various cases, the processor stores information about a predetermined threshold. The predetermined threshold value varies based on parameters monitored by sensors of the fume extraction system. For example, such a threshold may indicate a level of particles within the surgical site atmosphere that effectively and/or unsafe obstructs a clinician's view within the surgical site when the sensor is monitoring particle counts and/or concentrations. In other cases, the threshold may correspond to a filtration system in the exhauster housing and the ability of the filtration system to adequately filter particulates. For example, if the particle concentration exceeds a certain threshold, the filtration may not adequately filter particles from the smoke, and toxins may pass through the drainage system and/or clog and/or plug its filter. When the processor receives information about the monitored parameter from the sensors of the fume extraction system, the processor is configured to be able to compare the monitored parameter to a predetermined threshold to ensure that the threshold is not exceeded.
In various circumstances, the processor may control various motor functions of the smoke evacuation system if the processor recognizes that a predetermined threshold has been exceeded and/or is approaching exceeded. The processor may adjust the flow of the smoke evacuation system by increasing or decreasing the speed of the motor to more effectively filter contaminants from the surgical site. For example, if the sensor communicates to the processor information suggesting that the particle threshold has been reached, the processor may increase the speed of the motor to draw more fluid and possibly more contaminants from the surgical site into the smoke evacuation system for filtration.
In various circumstances, if the processor recognizes that a predetermined threshold has been exceeded and/or is nearing exceeded, the processor may vary the power supplied by the generator to the electrosurgical instrument. For example, if the sensor transmits information to the processor suggesting that the particle threshold has been reached, the processor will prevent the generator from supplying any additional requested power to the handheld electrosurgical instrument. When the fume extraction system filters out contaminants from the atmosphere to a level below the particle threshold, the processor may then allow the generator to supply the requested power to the handheld electrosurgical instrument.
FIG. 33 is a graphical representation of the correlation between particle count and power level detected over a period of time during surgery. The top graph 53300 represents the particle count and/or particle concentration detected by the internal particle sensor 50838 (fig. 18 and 19) as particles and contaminants are filtered from the surgical site into the smoke evacuation system 50800 and/or 50900. Particle concentration C T Representing a predetermined particle count and/or concentration threshold within the volume of fluid being pumped. The bottom graph 53302 represents the power levels achieved during surgery, including the power requested by the clinician through the hand-held electrosurgical instrument (dashed line), as well as the power actually supplied by the generator of the surgical system (solid line). The power level is defined as the ratio of the RF current to the voltage of the electrosurgical system.
At time t<t 1 Baseline particle concentration is detected 53304 prior to the beginning of the surgical procedure. When the clinician and/or assistant at time t 1 When the electrosurgical instrument is activated, the clinician and/or assistant requests that a particular power level be supplied in order to perform a particular function. Such functionsIncluding dissection and/or cutting through tissue within a surgical site. For example, applying power to tissue may generate smoke and/or contaminants that may be directed into the smoke evacuation system to enhance visibility within the surgical site. At time t 1 Where the generator supplies the requested power. The detected particle concentration is below threshold C T The method comprises the steps of carrying out a first treatment on the surface of the However, at time t 1 After activating the electrosurgical instrument, the internal particle sensor 50838 is at time t 2 Where an increase in particle concentration is detected.
In the graphical representation of FIG. 33, the clinician has reached time t 3 Additional power is requested. For example, t 1 And t 3 The "off" time 53306 of (c) may allow the tissue to cool, thereby creating a degree of hemostasis. As can be seen in fig. 33, the detected particle concentration and power level are at time t 2 And time t 3 And the space therebetween is reduced. At time t 3 At this point, the clinician requests a high power level, which when supplied by the generator, is at time t 4 Where an increase in particle concentration occurs. Finally, the clinician requested power level at time t 5 Where an increase of about a predetermined threshold C is generated T Is a particle concentration of (2). In some cases, threshold C is exceeded T Low visibility within the surgical site due to accumulation of contaminants and/or particulates, inefficient smoke evacuation systems, and/or inoperable smoke evacuation systems may be indicated.
At time t in response to particle concentration 5 At exceeding the particle threshold C T The processor of the surgical system is configured to adjust the supply power of the generator to bring the particle concentration back below the particle threshold C T . As shown in fig. 33, when the particle threshold C is reached and/or exceeded due to high handpiece requested power T When the power supplied by the generator is different from the power requested by the handpiece. When the particle concentration returns to the threshold value C T And/or fall below threshold C T At a time such as at time t 6 Where the generator again supplies the power level requested by the hand-held electrosurgical instrument. Furthermore, as the handpiece requests power at time t 6 Then descend by particle sensor 50838The concentration of particles detected also decreases.
Fig. 34 shows a representation of instructions 53400 stored, for example, by a memory of a surgical system, such as the memory of fig. 5 and 6. In various instances, the surgical systems disclosed herein may utilize instructions 53400. For example, the instructions 53400 can include an adjustment algorithm for the surgical system. Furthermore, the reader will readily appreciate that in some cases, instructions 53400 may be combined with one or more additional algorithms and/or instructions described herein. The instructions 53400 may be implemented, for example, by a processor, such as the processor 50308 in fig. 5.
At block 53402 in instruction 53400, the processor may receive a request for power from the electrosurgical instrument. For example, the electrosurgical instrument may include a handheld device and/or a robotic tool. The requested power may be provided by a user via, for example, a control and/or console. As described above, the sensor is configured to monitor a parameter related to fluid passing through the drainage system. Such parameters may include, for example, particle size, temperature, fluid content, and/or percent contamination. The processor is configured to be able to receive the monitored parameter from the sensor. In various cases, the processor receives such information in response to interrogating the sensor, as indicated by block 53404. In each case, the sensor automatically transmits information after detection. The processor then determines whether the received information exceeds a predetermined threshold at block 53406. At block 53408, if the threshold has been exceeded and/or the threshold is nearly exceeded, the processor is configured to prevent the generator from supplying any or all of the requested power to the electrosurgical instrument. In other cases, at block 53410, the generator waveform can be adjusted to reduce smoke generated by the surgical device, as further described herein.
In various cases, the generator may not cause a level of supply power that exceeds a threshold. At block 53410, if the threshold has not been exceeded, the processor is configured to allow the generator to supply the requested power to the electrosurgical instrument. In various cases, the processor is configured to receive information from the sensors of the smoke evacuation system for the entire duration of the surgical procedure, or at least as long as the processor is receiving a request from the electrosurgical instrument for delivery of power.
In various surgical procedures, radio Frequency (RF) power may be used to cut tissue and coagulate bleeding. When RF power is used to treat tissue, fluids and/or particulates may be released, thereby contaminating the air in and/or around the surgical site. For example, to improve the visibility of the surgical site to the clinician, contaminated air inside the surgical site may be drawn into the fume extraction system. When the contaminated air is directed along the airflow path, the suspension fluid and/or particles may be filtered out of the contaminated air. The filtered air eventually exits the smoke evacuation system through an outlet and is released into the operating room atmosphere. Depending on the efficiency and/or efficacy of the fume extraction system, the filtered air may still contain fluids and/or particulates when released into the operating room atmosphere. The remaining contaminants may, for example, cause discomfort to the sense of smell of the clinician, assistant and/or patient, and inhalation of the contaminants may be unhealthy in some circumstances.
The fume extraction system may include a sensor system configured to monitor the size and/or concentration of particles in the air detected at various points along the airflow path, including locations external to the fume extraction system and internal to the fume extraction system. In one aspect of the disclosure, the fume extraction system may determine the efficiency of the fume extraction system based on comparing the concentration of particulates external to the fume extraction system and internal to the fume extraction system and/or by monitoring the concentration of particulates over time. In addition, the fume evacuation system may alert the clinician to contaminated air in the operating room via a display.
The clinician may be made aware of the level of contaminants such as fluids and/or particulates suspended in the operating room atmosphere. The indication of contaminants in the air may indicate the air quality in the operating room and alert the clinician and/or assistant that the smoke evacuation system needs adjustment and/or maintenance.
The fume extraction system may include a sensor system configured to monitor the size and/or concentration of particles within the air. Referring again to fig. 18 and 19, particle sensors 50838 and 50852 are shown. The particle sensor 50838 is an internal sensor located at a position along the flow path. In various cases, the particle sensor 50838 is positioned at a point on the flow path 50804 (fig. 18), 50904 (fig. 19) prior to filtration; however, the internal particle sensor 50838 may be positioned at any suitable location along the respective flow paths 50804, 50904 to monitor the contaminated air flowing from the surgical site. In various cases, the fume evacuation system 50800, 50900 can include more than one internal particulate sensor 50838 positioned at various locations along the flow paths 50804, 50904, respectively.
The particle sensor 50852 is an external sensor positioned on the outer surface of the fume extraction systems 50800 (fig. 18), 50900 (fig. 19). In various cases, the fume extraction system 50800, 50900 can include more than one external particle sensor 50852. In each case, the external particle sensor 50852 is located within a recess of the housing of the fume extraction systems 50800, 50900; however, the external particle sensor 50852 can be positioned on any suitable surface to detect air quality in an operating room. In each case, an external particulate sensor 50852 is located near the inlet 50822 (fig. 18), 50922 (fig. 19) of the fume evacuation systems 50800, 50900, respectively, to ensure that unfiltered air does not leak from the surgical site into the operating room atmosphere. In each case, an external particle sensor 50852 is located near the outlet ports 50824 (fig. 18), 50924 (fig. 19) of the fume exhaust systems 50800, 50900, respectively, to analyze the air flowing out of the fume exhaust systems 50800, 50900.
The reader will readily appreciate that the external particle sensor 50852 may be located at any suitable location to properly monitor the operating room atmosphere. Furthermore, the reader will readily understand that various particle measurement devices are possible. For example, the particle sensor 50852 can be any suitable particle concentration sensor, such as an optical sensor, a laser sensor, a photoelectric sensor, an ionization sensor, an electrostatic sensor, and/or any suitable combination thereof. Various sensors are further described herein.
In various cases, a sensor system for a fume evacuation system is configured to be able to evaluate the granularity and/or concentration of operating room contaminants and display the detected air quality. The display of such information may convey, for example, the effectiveness of the fume extraction system. In various cases, the transmitted information includes detailed information about filters within the fume evacuation system, and may prevent the accumulation of contaminated air and/or fumes in the operating room atmosphere. The fume evacuation system may be configured to sense, for example, particle concentration, temperature, fluid content, and/or percentage of pollution, and communicate it to a generator to adjust its output, as further described herein. In one aspect of the disclosure, the fume extraction system may be configured to adjust its flow rate and/or motor speed and, at a predefined particulate level, operatively affect the output power or waveform of the generator to reduce the amount of fume generated by the end effector.
In various cases, as described herein, the sensor system may be used to detect whether a filter in a fume extraction system is properly and effectively removing pollutants and/or fumes from the air. By detecting the air quality level of the operating room, the fume evacuation system is configured to prevent high levels of contaminants from accumulating in the operating room atmosphere. The parameters monitored by the sensor system may be used to inform a clinician whether the smoke evacuation system is running and/or performing its intended purpose. In various circumstances, the clinician and/or assistant may use the monitored parameters to determine that a filter within the fume extraction system needs repair and/or replacement. For example, if the external sensor 50852 (fig. 18 and 19) detects that the contaminant particle size and/or concentration is above a predetermined and/or acceptable threshold, the clinician is directed to check whether repair and/or replacement of a filter within the fume system is required.
In various cases, as described above, a processor within the fume exhaust system compares the parameters detected by the external sensors with the parameters detected by the internal sensors. In various cases, the fume extraction system includes a plurality of internal sensors located, for example, at various points along the flow path (such as after each individual filter). The reader should appreciate that the internal sensor may be positioned at any point throughout the flow path to provide a meaningful comparison of filtration efficiency. Using this detected information, the clinician can determine that the filter at a particular location is not effective in removing contaminants and/or fumes from the air. In such cases, the clinician is guided to the precise location of the filter (or filter layer) that requires repair and/or replacement.
In various cases, the sensor system is configured to be able to evaluate dilution of contaminants and/or particles within the atmosphere of the operating room. As described herein, the internal sensor may be located at any suitable location along the flow path. When the internal sensor is located near the outlet port of the fume exhaust system and downstream of the filter, the internal sensor is effectively measuring the size and/or concentration of particles discharged into the operating system atmosphere. In other words, the internal sensor is configured to be able to detect particles and/or contaminants that are not captured during the filtration process. The external sensor is configured to be able to monitor the concentration and/or size of particles diluted throughout the atmosphere of the operating room. The difference between the readings of the internal sensor and the external sensor may be important to determine the air quality of a particular operating room.
The size and/or concentration of particles discharged into the atmosphere may have different effects on the air quality in the operating room based on, for example, parameters such as the size of the operating room and/or ventilation of the operating room. In one case, if discharged in a smaller operating room, the size and/or concentration of the discharged particles has a greater adverse effect on air quality than the same size and/or concentration of particles discharged in a larger operating room. In various circumstances, the presence and/or efficiency of a ventilation system in an operating room can affect how the air quality fluctuates in response to emissions of particulates from the fume extraction system. For example, in an operating room without a ventilation system or an operating room with an inefficient ventilation system, particles discharged from the fume exhaust system may accumulate to potentially harmful levels more quickly, thereby creating unsatisfactory air quality in the operating room.
In various cases, the information detected by the sensor system may be used to control one or more motor functions of the smoke evacuation system. An external sensor may detect an initial air quality level before the surgical procedure begins. Air quality can be continuously monitored throughout the surgical procedure; however, the reader should understand that air quality may be monitored at any suitable rate. The external sensor communicates the detected information to a processor of the fume extraction system (e.g., processors 50308 and 50408 in fig. 5 and 6, respectively). The processor uses the initial air quality level as a baseline to compare with continuously detected air quality levels. When the processor determines that the air quality level detected by the external sensor 50852 shows signs of higher contaminant granularity and/or concentration in the operating room atmosphere, the processor directs the motor to operate at the higher level. As the motor is operated at increased speeds, more contaminated air and/or smoke is pulled from the surgical site into the smoke evacuation system 50800, 50900 for filtration. In various circumstances, when the internal sensor 50838 determines that the cautery device and/or other electrosurgical device producing smoke is active, the processor stores instructions to increase the flow of contaminated air and/or smoke directed into the smoke evacuation system 50800, 50900 during the procedure. By detecting activation of the smoke producing surgical device, the smoke evacuation system 50800, 50900 prevents high levels of contaminants from accumulating in the operating room atmosphere through motor control.
In various cases, the motor speed level is automatically controlled when the processor determines that the operating room atmosphere has an unacceptable air quality level. In various circumstances, the motor speed level is automatically controlled when the processor determines that the smoke-producing surgical device has been activated. For example, the processor may automatically direct the motor to operate at a faster rate when the external sensor 50852 detects that the level of contamination in the operating room atmosphere exceeds a predetermined threshold. The processor then automatically reduces the speed of the motor when the external sensor 50852 detects a drop in contamination level below a predetermined threshold. In various cases, the motor speed level is manually controlled after the clinician is notified of an unacceptable air quality level. In various cases, the motor speed level is manually controlled after the clinician activates the smoke generating surgical device. The reader will appreciate that any suitable combination of automatic and/or manual control may be implemented and/or incorporated into the control algorithm of the fume evacuation system 50800, 50900.
In various circumstances, the processor of the fume evacuation system may identify when the external sensor 50852 detects an unacceptable and/or increased level of contamination of the operating room atmosphere. Such detection indicates inefficiency of the smoke evacuation system 50800, 50900. The detected inefficiency may be indicative of one or more filters failing and/or needing to be replaced. When the clinician is notified that the filter is malfunctioning, the clinician may ensure that the replacement filter is in stock for future maintenance, thereby preventing delays.
In various instances, the smoke evacuation system may be used in conjunction with a camera mirror during surgery to effectively manage contaminant and/or smoke evacuation from the surgical site. For example, smoke evacuation systems 50800, 50900 may be used in conjunction with imaging module 238 and endoscope 239 (fig. 47). In one aspect of the present disclosure, a surgical hub, such as hub 206 (fig. 48), may coordinate communication between, for example, an imaging module 238 and a surgical evacuation system, such as a smoke extractor 226 (fig. 48). The camera mirror is configured to be able to monitor visual occlusion in air by capturing a series of images at a particular sampling rate. The collected images are sent to a processor (e.g., processors 50308, 50408 in fig. 5 and 6, respectively) for evaluation. In various cases, the processor is further configured to be capable of receiving monitoring data from a sensor system, which may include an internal sensor 50838 and/or an external sensor 50852, as described herein. The processor is configured to compare the image received from the camera mirror with the particle count and/or concentration received from the sensor system to determine a correlation, thereby improving the efficiency of evacuation of smoke and/or contaminants from the surgical site and/or the operating room atmosphere.
In such cases, the visual mask determined by the camera mirror is compared to the particle count and/or concentration determined by the sensor system in order to tune the particle count metric to the motor speed of the fume evacuation system. After comparing the data collected from the sensor system and the camera mirror, the processor may take any of a number of steps. For example, based on the comparison, the processor may decide to: switching on a smoke discharging system; increasing the motor speed of the fume extraction system; reducing the motor speed of the fume extraction system; and/or disconnect the fume extraction system. In each case, the comparison is done automatically; however, the reader will appreciate that such comparison may be performed after manual activation.
In various cases, the image captured by the camera mirror and the particle count and/or concentration detected by the sensor system may be stored in memory as a baseline comparison. In future surgical procedures, the clinician and/or assistant may use the images acquired by the camera mirror alone to confirm smoke and/or contaminant density. In such cases, the visual obscuration detected by the camera mirror is associated with a particular particle count and/or concentration. After the processor analyzes the air, the processor may take any of a number of steps. For example, based on comparing the analysis images captured by the camera mirrors from the stored baseline, the processor may decide to: switching on a smoke discharging system; increasing the motor speed of the fume extraction system; reducing the motor speed of the fume extraction system; and/or disconnect the fume extraction system.
In various cases, situational awareness may further inform the decision process described herein. For example, images from the mirror may be meaningful in the context of a particular surgical procedure and/or step thereof, which may be configured and/or determined based on situational awareness of a smoke evacuation system and/or hub in communication therewith. For example, during certain surgical procedures and/or certain steps thereof and/or when treating certain types of tissue, it is expected that there may be more smoke.
In various instances, the smoke evacuation system communicates wirelessly with other surgical devices and/or hubs located in the operating room to increase the efficiency of smoke evacuation during surgery. For example, activation of the generator of the surgical device may be transmitted to a centralized hub that forwards the information onto the smoke evacuation system. The centralized hub may detect a change in current through the surgical energy device and/or power consumption of the sense generator for delivery to the smoke evacuation system. In various instances, the centralized hub may store information related to the surgical procedure and/or the activated surgical device. Such information may include, for example, an expected amount of smoke generated during a particular surgical procedure, and the expected amount may be determined using the particular surgical device and/or information related to tissue composition of a particular patient. Receiving such information may allow the smoke evacuation system to anticipate a particular smoke evacuation rate to more effectively remove smoke and/or contaminants from the surgical site. The reader will appreciate that various surgical devices may communicate information directly to the smoke evacuation system and/or indirectly through a centralized hub. The centralized hub may be, for example, a surgical hub, such as surgical hub 206 (fig. 48).
In various instances, the smoke evacuation system is in wired communication with other surgical devices and/or hubs located in the operating room to increase the efficiency of smoke evacuation during surgery. Such wired communication may be established through a cable interconnection between the generator and the smoke evacuation system for generator activated communication. For example, an activation indication signal cable may be connected between the generator of the surgical device and the smoke evacuation system. The smoke evacuation system is automatically activated when the generator is activated and a signal is received via a wired connection.
Wireless and/or wired communication between the generator of the surgical device and/or the centralized hub and/or the smoke evacuation system may include information about the activated surgical device. Such information may include, for example, current operating mode of the surgical device and/or information regarding the particular energy setting and/or intensity of delivery. In various cases, once such information is transmitted from the surgical device, the memory of the centralized hub and/or smoke evacuation system is configured to be able to store such information for future use. For example, a centralized hub may store information regarding surgical devices used during a particular procedure as well as average smoke and/or contaminant counts and/or concentrations. In future surgical procedures, when the same (or similar) surgical device is activated in the same (or similar) surgical procedure that is treating the same (or similar) type of tissue, the centralized hub may communicate such information to the smoke evacuation system prior to smoke and/or contaminant accumulation.
In various cases, the fume evacuation system is configured to be able to notify a clinician of a level of pollution detected in the atmosphere of an operating room. The fume extraction system may utilize a sensor system to monitor a difference between particle sizes and/or concentrations of particles detected by the first internal sensor and the second external sensor. In various cases, the monitored parameters of the sensor system may be used to alert a clinician and/or an assistant when the detected contamination level exceeds a predetermined threshold.
In various cases, the processor directs the display to display the parameter monitored by the sensor system. In each case, the display is located on the exterior of the housing of the smoke evacuation system. The processor may also communicate the monitored parameters with other surgical instruments and/or hubs located in the operating room to aid in situational awareness of the interactive surgical system. In this way, other surgical instruments and/or hubs may be more effectively used together. In the case of transmitting the monitored parameters throughout the operating room, the clinician and/or assistant may see the contamination alarm from various displays around the operating room. In addition to the display on the fume extraction system, the monitored parameters may be displayed on multiple monitors in the operating room. The reader will appreciate that any suitable combination of displays may be used to convey the air quality detected in the operating room.
Fig. 30 illustrates a smoke evacuation system 53000 configured to monitor air quality of the operating room atmosphere and alert a clinician when the detected air quality exceeds a predetermined threshold and/or becomes potentially harmful. The fume evacuation system 53000 is similar in many respects to fume evacuation system 50600 (fig. 7). For example, the smoke evacuation system 53000 includes a generator 50640, a first electrical connector 50642, a surgical instrument 50630, and a suction hose 50636. As shown in fig. 30, in various cases, the fume evacuation system 53000 includes a display or air quality index screen 53002. The air quality index screen 53002 is configured to be able to display information detected by a sensor system, such as a sensor system including one or more of the sensors 50830, 50832, 50836, 50838, 50840, 50846, 50848, 50850, 50852, which are further described herein and shown in fig. 18 and 19. A processor, such as processor 50308 and/or 50408 (fig. 5 and 6), may be in signal communication with the sensor system and the air quality index screen 53002. In various cases, the air quality index screen 53002 is configured to display the contaminant particle count monitored by the external sensor 50852 to verify that the contaminant is not circulating into the operating room atmosphere at a dangerous level.
In various instances, the smoke evacuation system 53000 includes a latch door 53004 that is accessible to a clinician to replace and/or exchange a filter housed in the extractor housing of the smoke evacuation system 53000. For example, by monitoring the concentration of particulates passing through the fume extraction system 53000, its processor may determine that one or more filters are substantially blocked and near the end of their useful life and thus need to be replaced. In such cases, the clinician may open the latch door 53004 to replace one or more filters. As further described herein, based on the relative placement of the internal sensors in the fume extraction system 53000, a particular filter and/or a filter that needs replacement may be identified.
In various cases, a processor, such as processor 50308 and/or 50408 (fig. 5 and 6), is configured to be able to communicate smoke parameters, such as detected particle size and/or concentration, to display 53002. The display 53002 is configured to display such detected information in any suitable manner. For example, the display 53002 may display the level of contamination detected by each sensor (internal and external) throughout the sensor system. In various cases, the display 53002 is configured to display information only if the air quality does not meet a predetermined threshold. In various cases, the display 53002 includes a touch screen that allows the clinician to determine what information to display and/or where to display the information.
In various cases, the display 53002 includes a graphical interface, an LCD screen, and/or a touch screen. The reader will appreciate that any suitable means of displaying the sensed information and/or combinations thereof may be used in the fume extraction system 53000. For example, an LED lamp may be used as the display 53002. When the processor 50308 and/or 50408 (fig. 5 and 6) determines that an unacceptable air quality is present in the operating room, the processor 50308 and/or 50408 is configured to activate the LED light.
Fig. 31 shows a representation of instructions 53100 stored, for example, by a memory of a surgical evacuation system, such as memories 50310 and 50410 in fig. 5 and 6. In various instances, the surgical evacuation system disclosed herein may utilize instructions 53100 of fig. 31. Furthermore, the reader will readily appreciate that in some cases, instructions 53100 of fig. 31 may be combined with one or more additional algorithms and/or instructions described herein. The instructions 53100 stored in the memory may be implemented by, for example, a processor, such as the processors 50308 and/or 50408 in fig. 5 and 6.
Still referring to fig. 31, as described above, internal sensors, such as sensor 50838 (fig. 18 and 19), are configured to be able to monitor internal parameters, such as particle size and/or concentration of a fluid. As the fluid flows through the flow path, particulates and/or contaminants are filtered out before the fluid exits the surgical drainage system. An external sensor, such as sensor 50852 (fig. 18 and 19), located on the external housing of the surgical drainage system is configured to monitor an external parameter as filtered fluid exits the surgical drainage system. Such external parameters include, for example, the particle size and/or concentration of particles in the atmosphere in the operating room.
At block 53102 in instruction 53100, the processor is configured to be capable of interrogating the internal sensor and the external sensor for the detected internal parameter and the detected external parameter, respectively. In each case, the processor continuously interrogates the internal sensor and the external sensor for this information; however, any suitable sampling rate may be used. The processor is then configured to analyze the information received from the internal and external sensors to determine an efficiency level of the surgical evacuation system at block 53104. After determining the efficiency level of the surgical evacuation system, at block 53106, the processor is configured to display the determined efficiency level on a display. Such a display may include raw information received from the internal and external sensors, an efficiency level determined by the processor, and/or an alert to a clinician if the efficiency level falls below a predetermined threshold. Falling below a predetermined threshold may indicate, for example, that the filter needs to be replaced and/or that particles are not effectively filtered out and accumulate in the operating room atmosphere.
Fig. 32 shows a representation of instructions 53200 stored by a memory of a surgical evacuation system similar to those shown in fig. 31. In various instances, the surgical evacuation systems disclosed herein may utilize the instructions of fig. 32. Furthermore, the reader will readily appreciate that the instructions of FIG. 32 may be combined with one or more additional algorithms and/or instructions described herein in some cases. The instructions may be stored in a memory and executed by a processor, such as memory 50310 and/or 50410 and/or processor 50308 and/or 50408 in fig. 5 and 6, for example.
Still referring to fig. 32, prior to initiating a surgical procedure, at block 53202, the processor is configured to be able to interrogate an external sensor, such as sensor 50852 (fig. 18 and 19), for a baseline air quality parameter. The baseline air quality parameter indicates the air quality of the operating room prior to surgery. At block 53204, the processor is configured to continuously interrogate the internal sensors to identify the surgical procedure being performed. After the processor has determined that surgery is being performed, the processor continuously interrogates the external sensors at block 53206. When the processor determines that the air quality detected by the external sensor is deteriorating, such as at block 53208, for example, the processor is configured to increase the speed of the motor to direct more fluid into the surgical evacuation system at block 53210. If the detected air quality is the same as the baseline air quality, such as at block 53212, the processor is configured to be able to maintain the speed of the motor at block 53214. If the detected air quality has improved from a baseline air quality, such as block 53216, the processor is configured to be able to maintain or reduce the speed of the motor at block 53218. In each case, the processor continuously interrogates the internal sensor and the external sensor for information; however, any suitable sampling rate may be used.
Smoke evacuation systems play an important role in electrosurgical systems by removing harmful toxins and/or pungent odors from the surgical operating room. However, control and adjustability of certain fume extraction systems may be lacking, which may result in reduced motor life and/or poor filter life, for example.
In one aspect of the present disclosure, the sensor may be positioned and configured to detect the presence of particles in the fluid moving past various points in the flow path of the evacuation system. In some aspects of the disclosure, the control circuit may be operable to modify a speed of a motor driving a pump of the evacuation system based on the concentration of particles detected at various points along the flow path. Additionally or alternatively, the control circuit may be used to modify the speed of the motor based on the pressures detected at various points in the flow path.
Effective adjustment of the motor speed of the drainage system may increase the life of the motor and/or increase the filter life. Additional benefits include, for example, potential energy savings and less noise in the surgical room.
As described herein, the electrosurgical instrument may deliver energy to target tissue of a patient to cut tissue and/or cauterize blood vessels within and/or adjacent to the target tissue. Cutting and cauterization may result in smoke release into the air. In various circumstances, smoke can be uncomfortable, obstruct the view of the physician, and inhale, which is harmful to health, as described further herein. The electrosurgical system may employ an evacuation system that captures the resulting smoke, directs the captured smoke through one or more filters, and expels the filtered smoke. More specifically, the smoke may travel through the evacuation system via a vacuum tube. As the smoke moves through one or more of the filters in the evacuation system, the harmful toxins and pungent odors may be filtered out of the smoke. The filtered air may then exit the exhaust extraction system as exhaust through the exhaust port.
In various aspects of the present disclosure, the drainage system includes a filter receiver or socket. The filter receiver is configured to receive a filter. The drainage system also includes a pump having a sealed positive displacement flow path and a motor driving the pump. The sealed positive displacement flow path of the pump may include one or more circulation paths of fluid within the pump. In one aspect of the disclosure, the pump has a first operating pressure and a second operating pressure. In some cases, the pump may compress the incoming fluid to create a pressure differential along the flow path, as further described herein.
As shown in fig. 4, the drainage system 50500 includes a pump 50506 coupled to and driven by a motor 50512. As described herein, pump 50506 may be, for example, a positive displacement pump, such as a reciprocating positive displacement pump, a rotary positive displacement pump, or a linear positive displacement pump. In various cases, pump 50506 may be, for example, a hybrid regenerative blower, a claw pump, a cam compressor, or a scroll compressor. In one aspect of the present disclosure, motor 50512 can be a permanent magnet synchronous Direct Current (DC) motor. Some aspects may include a brushless DC motor.
According to aspects of the present disclosure, motor 50512 may be regulated and/or controlled for a variety of reasons, including, for example, maintaining flow, increasing motor efficiency, increasing motor life, increasing pump life, increasing filter life, and/or saving energy. Once the control circuitry of the drainage system (see, e.g., the control schematic in fig. 5 and 6) knows certain conditions, such as blockage in the flow path, undesirable pressure, and/or undesirable particle count, for example, the control circuitry can adjust the motor 50512 to adjust or maintain flow, which can, for example, increase motor efficiency, increase motor life, increase pump life, increase filter life, and/or save energy.
In one aspect of the present disclosure, referring to fig. 6, the processor may be located inside the evacuation system. For example, the processor 50408 can be located inside the exhauster housing 50618 in fig. 7. In other aspects of the disclosure, the processor may be located external to the evacuation system 50600. An external processor 50308 is shown, for example, in fig. 5. The external processor may be a processor of a surgical hub. In another aspect, the internal processor and the external processor can communicate to cooperatively control the motor 50512.
According to one aspect of the present disclosure, motor 50512 may be regulated by a control circuit to increase motor efficiency. For example, referring to the drainage system in fig. 18 and 19, a fluid detection sensor 50830 is positioned upstream of the filter and upstream of the filter receiver. In various cases, the fluid detection sensor 50830 is configured to be able to detect fluid upstream of the filter. For example, the fluid detection sensor 50830 is configured to be able to detect whether aerosols or droplets are present in the evacuated smoke. Based on the output from the fluid detection sensor 50830, the control circuit may, for example, adjust control parameters of the fume exhaust system, such as adjusting the power of the valve and/or motor.
In some cases, the evacuation system may detect whether a fluid (e.g., smoke) is present in the flow path. In some cases, the fluid detection sensor 50830 may automatically scan for fluid or a particular type of fluid, for example, when a clinician begins to treat patient tissue with an electrosurgical instrument, such as when the electrosurgical instrument 50630 (fig. 7) is activated by the generator 50640 (fig. 7). Alternatively or in combination with the fluid detection sensor 50830, a separate sensor may be configured to detect fluid at a surgical site, such as an end effector of a surgical instrument or imaging device, for example. In one instance, a separate sensor may be positioned near the tip of the electrosurgical instrument 50630. When the fluid detected at the one or more fluid detection sensors is below a threshold, the control circuit may adjust the motor speed of the pump to a level sufficient to monitor the presence of the fluid or a particular type of fluid. The motor speed in such cases may be a minimum motor speed or an idle motor speed that allows for accurate readings at the fluid detection sensor. Alternatively, the motor speed may be reduced to zero and periodically increased to a minimum motor speed or idle motor speed to monitor for the presence of a fluid or a particular type of fluid.
Upon detection of fluid by the fluid detection sensor or a fluid level above a threshold, the control circuitry may adjust the speed of motor 50512 to a level sufficient to completely drain fluid from the surgical site. In one example, a cloud, such as cloud 104 (fig. 39) and/or cloud 204 (fig. 46), may track and/or store motor speed levels determined to be sufficient to effectively drain fluid for the same or similar surgical procedure. In such examples, when setting the appropriate motor speed level for the surgical procedure, the control circuitry may access and/or reference the historical motor speed level stored in the cloud.
Additionally or alternatively, the speed of the motor may be adjusted based on the concentration of particles detected along the flow path. For example, referring again to fig. 18 and 19, drainage systems 50800 and 50900 include laser particle sensors 50838 and 50848 along respective flow paths 50804 and 50904. The particle sensor 50838 is positioned upstream of the filters 50842, 50844 and receiver 50871 in the surgical drainage system 50800, and upstream of the filters 50942, 50944 and receiver 50971 in the surgical drainage system 50900. The particle sensor 50838 is configured to detect and/or count particles upstream of the filter. The particle sensor 50848 is positioned downstream of the filters 50842, 50844 and the receiver 50871 in the surgical evacuation system 50800, and downstream of the filters 50942, 50944 and the receiver 50971 in the surgical evacuation system 50900. The particle sensor 50848 is configured to detect and/or count particles downstream of the filter.
In such cases, the evacuation system 50800, 50900 may detect (e.g., via a laser particle counter sensor) the presence of a fluid (e.g., smoke containing particulate matter). For example, the sensor may detect the concentration of particles in the smoke. In some cases, for example, when a physician begins to treat patient tissue with an electrosurgical instrument, such as when electrosurgical instrument 50630 is activated by generator 50640, a laser particle counter sensor may automatically scan and count particles.
When the particle concentration detected by the particle sensor 50838 is below a threshold, the control circuit may adjust the motor speed to a level sufficient to sample the particle concentration of the flow path. For example, the motor speed may be set to a minimum or idle motor speed that allows for accurate readings at the sensor. In alternative aspects, the motor speed may be reduced to zero and periodically increased to a minimum or idle motor speed level sufficient to monitor for the presence of fluid (e.g., the concentration of particles in the smoke is above a threshold). In such aspects, upon detecting a concentration of particles above a threshold, the control circuitry may adjust the speed of motor 50512 (fig. 4) to a level sufficient to completely evacuate smoke and filter particles from the surgical site. Likewise, the cloud may track and/or store motor speed levels determined to be sufficient to effectively drain fluid for the same or similar surgical procedure based on the concentration of particles detected by the sensor. In such examples, when an appropriate motor speed level is set for the surgical procedure, the control circuitry may access and/or reference such historical motor speed levels.
In one aspect of the present disclosure, motor 50512 is more efficient in that it will shut down (i.e., zero motor speed) or operate at a predetermined minimum or idle speed unless fluid and/or threshold particle concentration is detected. In such cases, energy may be saved and noise in the surgical room may be minimized. Further, if fluid and/or threshold particle concentrations are detected, motor 50512 may be operated at an effective motor speed, i.e., a motor speed determined to be sufficient to effectively drain fluid and/or particles based on historical data. This is an improvement over other manual methods of setting the motor speed level based on subjective assessment (e.g., experience of a particular clinician) and/or turning on the evacuation system only under visual and/or olfactory cues (e.g., seeing and/or smelling smoke) and/or increasing the motor speed level.
According to various aspects of the present disclosure, motor parameters, such as the speed of the motor, may be adapted to adjust (e.g., increase) the efficiency of the drainage system and its filters based on the needs at the surgical site. As described herein, if the smoke detected at the surgical site is below a threshold, the evacuation system may be ineffective in filtering the air volume unnecessarily. In such a case, the motor speed may be reduced, reduced to zero, or kept at zero, such that the volume of air filtered by the draw box is reduced, reduced to zero, or kept at zero, respectively. Efficient use of the drainage system ultimately extends the useful life of the drainage system and/or its components (e.g., fluid traps, filters, motors, pumps, etc.) and reduces the associated repair and/or replacement costs of the drainage system and/or its components. Stresses and wear caused by running the motor at full speed or above sufficient speed at all times are avoided. In addition, the motor driving the pump in the extraction system may generate various levels of operational and/or vibration noise. Such operational and/or vibration noise may be undesirable in, for example, a surgical operating room and/or environment because it may inhibit communication between and/or disturb and/or distract the surgical personnel.
In some cases, it may not be desirable to reduce the motor speed to zero. An electric motor (such as a permanent magnet synchronous DC motor), for example, may require a large starting torque from a complete stop state for use with the various pumps described herein. Here, referring again to fig. 4, pump 50506 creates a pressure differential between fluid entering pump 50506 and fluid exiting pump 50506. This pressure differential or compression ratio of pump 50506 may result in a high starting torque of motor 50512 to activate motor 50512 to rotate pump 50506. In one example, pump 50506 can include a blower (e.g., a hybrid regenerative blower). In such aspects, the blower may be operated at a compression ratio of between about 1.1 and 1.2 to deliver a higher amount of fluid (e.g., relative to a fan or compressor) at an operating pressure of, for example, between about 1.5psig and 1.72 psig. In another example, pump 50506 can include a compressor (e.g., scroll compressor pump 50650 in fig. 12). In such aspects, the compressor may be operated at a compression ratio of greater than about 2 to deliver a lower amount of fluid (e.g., relative to a fan or blower) at an operating pressure of, for example, greater than about 2.72 psig.
Aspects of the present disclosure relate to systems and methods for improving filter assembly life. The filter assembly may include a plurality of filter layers. For example, referring again to fig. 11, the filter assembly includes a coarse media filter 50684, a fine particulate filter 50686, and a carbon reservoir 50688.
According to various aspects of the disclosure, a first pressure sensor (e.g., pressure sensor 50840 in fig. 18 and 19) may be positioned upstream of the filter receiver within the flow path, and a second pressure sensor (e.g., pressure sensor 50846 in fig. 18 and 19) may be positioned downstream of the filter receiver within the flow path. In such cases, the first pressure sensor is configured to detect the first pressure and transmit a signal indicative of the first pressure to the control circuit. Similarly, the second pressure sensor is configured to detect the second pressure and transmit a signal indicative of the second pressure to the control circuit. Further, the control circuit receiving the signal indicative of the first pressure and the signal indicative of the second pressure is configured to be able to calculate a pressure difference between the first pressure sensor and the second pressure sensor. The control circuit may utilize the calculated differential pressure in various ways. In the first case, the control circuit may adjust the motor speed based on the pressure differential. In the second case, the control circuit may indicate that maintenance is required based on the pressure differential. For example, the indicator may be present on the evacuation system interface and/or the surgical hub interface. The control circuitry may calculate the pressure differential continuously, in real time, periodically, or as system computing resources are available.
Referring again to fig. 4, in some cases, particles entering the flow path 50504 of the evacuation system 50500 may cause a blockage therein. For example, the particles may at least partially block and/or clog a portion of the flow path 50504. In one instance, the filter 50502 may be clogged with particulates. When the drainage system is operated, clogging may occur suddenly or over time. The blockage within the drainage system 50500 can cause the pressure differential in the flow path 50504 to rise as the flow is impeded. To maintain the desired flow and compensate for the blockage, pump 50506 and/or motor 50512 may require more power and/or increased speed. However, increased speed and/or power may decrease the efficiency of motor 50512 and/or pump 50506. In addition, operating motor 50512 and/or pump 50506 at increased speeds to compensate for the blockage may shorten its life. In other cases, to compensate for the blockage, the control circuit may adjust motor 50512, as further described herein.
In one aspect of the disclosure, the control circuit can send a drive signal to supply the regulated current to the motor 50512. The desired current supply may be achieved by varying the pulse width modulated duty cycle of the electrical input to motor 50512. In such aspects, increasing the duty cycle of the current input to the motor may increase the motor speed, and decreasing the duty cycle of the current input to the motor may decrease the motor speed.
In one aspect of the present disclosure, the extraction system may include a relief valve within the flow path to relieve excess drag pressure in the extraction system. For example, the relief valve may be in fluid communication with the ambient environment. Relieving excessive resistance pressure via such a relief valve may prevent motor 50512 from having to or attempting to compensate for the excessive resistance pressure. In various aspects of the present disclosure, such safety valves are configured to operate (e.g., open and/or closed) upon receiving a signal from the control circuit.
In various aspects of the present disclosure, the control circuit may learn of a blockage based on a sensor positioned within the evacuation system. For example, referring again to fig. 18 and 19, pressure sensor 50840 is positioned and configured to detect pressure upstream of one or more filters, and pressure sensor 50846 is positioned and configured to detect pressure downstream of one or more filters. The pressure sensor 50840 is further configured to be capable of transmitting a signal indicative of the detected pressure to the control circuit. Similarly, the pressure sensor 50846 is configured to be capable of transmitting a signal indicative of the detected pressure to the control circuit. In such a case, the control circuit may determine that a portion of the filter assembly is at least partially occluded based on the pressure detected at 50846 and/or the pressure differential calculated between 50840 and 50846. In various aspects of the disclosure, the control circuitry may determine that the filter assembly is clogged if, for example, (a) the pressure detected at pressure sensor 50846 is above a particular threshold, (B) the calculated pressure differential between pressure sensor 50840 and pressure sensor 50846 is above a particular threshold, (C) the pressure detected at pressure sensor 50846 is above a particular threshold determined for the filter, and/or (D) the calculated pressure differential between pressure sensor 50840 and pressure sensor 50846 is above a particular threshold determined for the filter. In one case, the control circuitry is configured to be able to access and/or reference the expected pressure of the filter based on historical data stored in a cloud, such as cloud 104 (fig. 39) and/or cloud 204 (fig. 46).
Referring again to fig. 18 and 19, the pressure sensor 50850 is positioned and configured to detect pressure at or near the outlet of the evacuation system. In addition, the pressure sensor 50850 is configured to be capable of transmitting a signal indicative of the pressure detected at or near the outlet to the control circuit. In such cases, the control circuit may determine that the flow path through the drainage system downstream of the filter is at least partially blocked based on the pressure detected at the pressure sensor 50846 and/or the pressure differential calculated between the pressure sensor 50846 and the pressure sensor 50850. In various aspects of the disclosure, the control circuitry may determine that the flow path is blocked if, for example, the pressure detected at the pressure sensor 50846 is above a particular threshold and/or the pressure differential between the pressure sensor 50846 and the pressure sensor 50850 is above a particular threshold. When comparing the pressure differences of the pressure sensor 50846 and the pressure sensor 50850, the pressure difference generated by the pump can be considered. In one case, the control circuit may access and/or reference the expected pressure of the flow path based on historical data stored in a cloud, such as cloud 104 (fig. 39) and/or cloud 204 (fig. 46).
The speed of motor 50512 may correspond to the current supplied to motor 50512. In one aspect of the disclosure, the control circuit can reduce a Pulse Width Modulation (PWM) duty cycle of the current input to the motor 50512 to reduce the rotational speed of the pump 50506 and/or can increase the PWM duty cycle of the current input to the motor 50512 to increase the rotational speed of the pump 50506. As described herein, the adjustment of the PWM duty cycle may be configured to be able to maintain a flow rate that is substantially constant over a range of inlet pressures (e.g., measured at pressure sensor 50840) and/or over a range of outlet pressures (e.g., measured at pressure sensor 50850).
Referring now to fig. 37, the control circuit may track and/or plot the ratio of the pressure detected at the upstream pressure sensor 50840 to the pressure detected at the downstream pressure sensor 50846 (upstream to downstream pressure ratio) over time. For example, control circuitry including processors 50308 and/or 50408 (fig. 5 and 6) may determine a pressure ratio and make various adjustments to the surgical evacuation system based on the pressure ratio.
In one instance, referring to graphical representation 54200 in fig. 37, the pressure differential between upstream pressure sensor 50840 and downstream pressure sensor 50846 may increase as the filter becomes clogged. In one aspect of the disclosure, the pressure ratio may increase as the downstream pressure measured by pressure sensor 50846 decreases and/or the upstream pressure measured by pressure sensor 50840 increases. The pressure at pressure sensor 50840 may be equal or substantially equal to the pressure at the surgical site (e.g., within the patient). The pressure at the pressure sensor 50846 can be the pressure pumped by the pump. The increase in pressure ratio may correspond to a blockage between the downstream pressure sensor 50846 and the upstream pressure sensor 50840, such as a blockage in a filter. For example, when the filter is plugged, the pressure at pressure sensor 50840 may remain the same or substantially the same (pressure at the surgical site), and the pressure at pressure sensor 50846 may decrease as the pump continues to draw a vacuum.
The ratio of upstream to downstream pressure may be indicative of filter life. For example, a low ratio may indicate that the filter does not need to be replaced, and a high ratio may indicate that the filter needs to be replaced.
The slave time t is shown in FIG. 37 0 New and non-blocking filter to time t 2 Most of the filters that were clogged. As shown in fig. 37, the ratio of upstream to downstream pressure (pressure at upstream pressure sensor 50840 to pressure at downstream pressure sensor 50846) begins at a non-zero ratio, which may be due to the baseline pressure differential of the air flow through the filter components and materials. From time t 0 To just time t 1 Previously, this ratio remained relatively constant. At time t 1 Where the upstream to downstream pressure ratio increases at a relatively steady rate, with a slope α, until the upstream to downstream pressure ratio reaches a displacement ratio R). After reaching and/or exceeding the displacement ratio R ", the filter is considered to be substantially blocked and should be replaced to avoid damage to, for example, the motor and/or pump. In one case, the control circuit may access and/or reference the replacement ratio R of a given filter installed or positioned in the filter receiver of the drainage system via the cloud. For example, the permutation ratio R "may be stored in a memory 50410 accessible to the processor 50408 in fig. 6. Alternatively, the replacement ratio R "may be user-defined and/or based on a history of local and/or global pressure data in the cloud. In various aspects of the present disclosure, the control circuitry may display the filter life metric (e.g., 40% remaining) on the drainage system and/or surgical hub user interface using the tracked and/or drawn ratios.
Still referring to fig. 37, the control circuit may further track and/or map the Pulse Width Modulation (PWM) duty cycle of the motor of the evacuation system over time. For example, when the filter is considered to be at time t 0 After which it is up to just time t 1 When relatively new, the PWM duty cycle of the motor is set to a relatively low constant duty cycle or percentage. At time t corresponding to the partial blockage ratio R 1 Where the control circuit is configured to increase the PWM duty cycle of the motor at a relatively steady rate, the slope being alpha 1 . The increased duty cycle may be selected to compensate for filter clogging. The blockage in the filter continues during useWhen accumulated, the duty cycle may be increased accordingly to compensate for filter clogging. In each case, the slope α 1 The slope α may be tracked as shown in fig. 37. The control circuitry may access and/or reference, via a cloud, such as cloud 104 (fig. 39) and/or cloud 204 (fig. 46), the partial blockage ratio associated with a given filter installed in the filter receiver of the drainage system. Alternatively, the partial occlusion ratio may be user defined and/or based on a history of local and/or global pressure data in the cloud.
In one aspect of the present disclosure, increasing the duty cycle of the motor may increase the pump speed such that the pump draws more air through the exhaust system. In other words, an increase in pressure differential across the filter may trigger a corresponding increase in PWM duty cycle of the pump's motor.
Pumps for drainage systems are configured to be able to transfer or affect movement of fluid along a flow path through mechanical action. In operation, the pump may increase the pressure of the fluid as it moves. The pump may have more than one operating pressure. In one aspect of the disclosure, the pump may be operated at a first operating pressure resulting in a first flow of fluid through the flow path, and the pump may be operated at a second operating pressure resulting in a second flow of fluid through the flow path. The first and second flow rates of fluid through the flow path may be the same or substantially similar, regardless of the difference in the first and second operating pressures of the pump. In one case, the pump may operate at a higher operating pressure to maintain a constant flow rate as the blockage builds up within the flow path.
Still referring to graphical representation 54200 in fig. 37, the control circuit may increase the PWM duty cycle of the motor to increase the current supplied to the motor and increase the operating pressure of the pump. For example, the control circuit may adjust the duty cycle based on, for example, the detected pressure, the pressure differential, and/or the ratio of the detected pressures. The increased operating pressure may be configured to be able to compensate for the blockage, such as at time t in FIG. 37 1 A blockage in the filter that begins nearby, while maintaining a constant flow of fluid through the flow path. In such cases, the control circuit can control the pump, for example, when the filter is clogged with particlesIs a load of (a).
In various aspects of the present disclosure, the control circuit may increase the current supplied to the motor up to a determined motor current threshold. In one aspect, the control circuit may increase the determined motor current threshold to achieve the pressure differential required to maintain the desired flow. For example, a pressure differential and desired flow rate may be maintained despite the presence of a blockage in the flow path.
In another aspect of the present disclosure, the control circuit may reduce the determined motor current threshold for various reasons. For example, the control circuit may decrease the determined motor current threshold to prevent inadvertent tissue damage at the surgical site. For example, when the surgical port is blocked by patient tissue, the control circuit may reduce the motor current to reduce the pressure in the system and the suction force applied to the tissue. In one case, the control circuit may access and/or reference the determined motor current threshold via a cloud, such as cloud 104 (fig. 39) and/or cloud 204 (fig. 46). Alternatively, the determined motor current threshold may be user-defined and/or based on a history of local and/or global data in the cloud.
In various aspects of the present disclosure, the control circuit may provide increased power and/or motor speed for a limited period of time based on feedback from the pressure sensor. During this time, an indication of pressure and/or obstruction may be communicated to the user via, for example, an interface in the surgical room. In one case, the clinician may address the occlusion, for example, by clearing the occlusion and/or changing one or more filters in the filter receiver. The limited period of time may be determined based on data stored in the cloud, such as historical data regarding operational cycles at increased power levels and/or speeds prior to motor and/or pump failure, for example. After a limited period of time, the power and/or speed may be reduced, as further described herein, until the occlusion is properly resolved.
According to various aspects of the present disclosure, a control circuit for a pumping system may send a drive signal to supply an increasing or decreasing current to a motor of the pumping system in order to adjust the speed of the motor and/or the speed of the pump. In one case, the control circuit may send a drive signal to achieve burst speed at start-up of the pumping system and/or at transitions between power levels. For example, the burst speed may be configured to be able to pump the pumping system up to a specified level at the beginning of the active pumping mode. The specified level may correspond to, for example, a specified flow and/or a specified pressure. In various cases, burst speeds may be effective to pump the evacuation system to a specified level in an energy efficient manner.
In one case, the burst speed setting via the control circuit is different from the constant operating speed setting via the control circuit. For example, after an initial start-up of the extraction system and/or after an increased power level is set for the extraction system, the control circuit may send a drive signal to supply an increased current to the motor to increase the motor speed to a burst speed in a short period of time. The burst speed may be, for example, a motor speed at least 20% higher than a constant motor speed required to achieve the desired flow rate. In one aspect of the present disclosure, the burst speed is at least 50% or at least 100% higher than the constant motor speed required to achieve the desired flow.
Referring now to the graphical representation 54300 in fig. 38, the airflow rate and particle count over time of a surgical evacuation system is shown. The control circuitry of the surgical evacuation systems 50800 and 50900 (fig. 18 and 19) can adjust the air flow rate as shown graphically in fig. 38, for example. More specifically, the airflow rate includes burst speeds 54302 and 54304 of the motor of the surgical evacuation system. For example, the burst speed may be a motor speed required to achieve an airflow speed higher than a desired airflow speed in a short period of time. As shown in fig. 38, the burst speed 54302 can be, for example, at time t 1 And time t 2 A ratio of implementation in a portion (e.g., 1/5) of the period between 1 And time t 2 Desired airflow velocity V in between 1 A motor speed required at least 20% higher than the air flow speed. Similarly, burst speed 54304 can be, for example, at time t 2 And time t 3 A ratio achieved within a portion (e.g., 1/4) of the period between 2 And time t 3 Desired airflow velocity V in between 2 A motor speed required at least 20% higher than the air flow speed. In the case of a variety of situations, such as a wide variety of situations,the airflow velocity may depend on the particle count within the evacuation system, as further described herein.
According to various aspects of the present disclosure, the transition of the extraction system from the first air flow rate to the second air flow rate may be accompanied by an increase in air flow rate just before or just after the transition and before the adjustment to the second air flow rate. For example, the first air flow and the second air flow may correspond to a constant or substantially constant motor speed and to a constant or substantially constant airflow speed. See again the graphical display in fig. 38 except at time t, respectively 1 And time t 2 In addition to the burst speeds 54302 and 54304 shortly thereafter, the air flow speed is at time t 1 And time t 2 Between and also at time t 2 And time t 3 Is substantially constant. The substantially constant airflow rates shown in fig. 38 may correspond to respective constant motor speeds in respective modes of operation of the extraction system.
Still referring to FIG. 38, at time t 0 Where the air flow velocity may be V 0 And V 1 A non-zero value in between, which may correspond to the motor speed of the "quiet" mode 54310. In the "quiet" mode 54310, the evacuation system may be configured to sample fluid from a surgical site. The sampled fluid may be used to determine the operational state of another component of, for example, a smoke evacuation system, an energy device, and/or a surgical system. At time t 1 At this point, the evacuation system may enter an "active" mode 54312. In some cases, the "active" mode 54312 may be triggered by one or more sensors in the evacuation system, as further described herein. The air flow rate increases to time t 1 Velocity V at 1 And/or to time t 2 Velocity V at 2 May be accompanied by an additional increase in airflow velocity just after the transition or start up to the new velocity level. More specifically, the air flow velocity is shown in FIG. 38 at time t 1 Shortly thereafter and at time t 2 The spike occurs before the subsequent adjustment at that point. In addition, in the second "active" mode 54314, when the airflow is from velocity v 1 Conversion to speed v 2 At the time of the air flow velocity at time t 2 The tip appears soon afterA peak.
Additionally or alternatively, the decrease in power level of the evacuation system from the first airflow rate to the second airflow rate may be accompanied by an initial increase in airflow rate just prior to the decrease. For example, when the airflow rate decreases from a first constant or substantially constant level to a second constant or substantially constant level, the airflow rate may experience airflow rate spikes similar to those shown in fig. 38. In one case, the control circuit may directly affect the airflow velocity spike before returning from the "active mode" to the constant "quiet mode" motor velocity. In various circumstances, for example, the burst speed prior to the quiet mode may flush the surgical system and/or the smoke evacuation system.
In accordance with aspects of the present disclosure, various particle sensors, such as particle sensors 50838 and 50848 in fig. 18 and 19, for example, may be positioned and configured to be able to count particles flowing through and/or within evacuation systems 50800 and 50900. Similarly, air quality particle sensors, such as particle sensor 50852 in fig. 18 and 19, for example, may be positioned and configured to count particles in ambient air around evacuation systems 50800 and 50900 and/or in the surgical room. The various particle sensors (e.g., particle sensors 50838, 50848, 50852, etc.) may be further configured to be able to transmit a signal indicative of the concentration of particles to, for example, a control circuit in order to adjust the airflow rate.
Referring again to fig. 38, a motor for the extraction system may be at time t 0 And time t 1 And is operated in a constant "quiet" mode 54310. At time t 0 And time t 1 In between, at least one particle sensor (e.g., particle sensor 50838 and/or 50848) may actively count particles flowing through the evacuation system. In some cases, at least one particle sensor (e.g., particle sensor 50852) may actively count particles in the ambient air. In at least one instance, the control circuitry may compare the particles counted at particle sensor 50838 and/or particle sensor 50848 to the particles counted at particle sensor 50852. The control circuitry may determine, for example, by particle sensors 50838 and 50And/or the particle concentration detected by the particle sensor 50848 exceeds a first threshold, such as threshold C in FIG. 38 1 . Threshold C 1 May correspond to, for example, particle concentration levels and/or ratios of particles counted at various sensors along the flow path. In response to the particle concentration exceeding a first threshold C 1 The control circuit may control the operation of the circuit at time t 1 Where the motor speed is increased from the "quiet" mode 54310 speed associated with the first non-zero airflow speed to a second airflow speed (e.g., V 1 ) An associated second motor speed or "active" mode 54312. As described above, an increase in airflow velocity may be accompanied by a time t 1 Shortly after the airflow velocity spike or burst 54302.
Still referring to fig. 38, the control circuit may continue to detect the concentration of particles from at least one of the particle sensors 50838, 50848, and/or 50852, while from time t 1 By time t 2 Maintaining and air-flow velocity V 1 An associated motor speed. At time t 2 At this point, the control circuitry may determine that the concentration and/or ratio of particles detected by at least one of the particle sensors 50838, 50848, and/or 50852 exceeds a secondary threshold, such as threshold C in FIG. 38 2 . Threshold C 2 A ratio of particles, which may correspond to a particle concentration level and/or counted at various sensors along the flow path, that is greater than a first threshold C 1 . Responsive to at time t 2 Is beyond a second threshold C 2 The control circuit is configured to be able to adjust the motor speed from the air flow speed V 1 Or the motor speed associated with the first "active" mode 54314 is increased to an increased air flow speed V 2 Or a second "active" mode 54314. Also from the air flow velocity V 1 To the air flow velocity V 2 Can be accompanied by time t 2 Shortly after the airflow velocity spike or burst 54304.
In various circumstances, the control circuit may continue to receive input indicative of the concentration of the particles, such as through the particle sensors 50838, 50848, and/or 50852, while at time t 2 And time t 3 Maintain the velocity V of the air flow between 2 An associated motor speed. At time t 3 At the position of the first part,the control circuitry may determine that the concentration and/or ratio of particles detected by at least one of the particle sensors 50838, 50848, and/or 50852 has fallen below a first threshold C 1 . In response, the control circuit may adjust the motor speed from the air flow speed V 2 The associated motor speed is reduced back to the "quiet" mode speed associated with the first non-zero airflow speed. As described above, in some cases, from the air flow velocity V 2 The reduction back to non-zero airflow velocity may be accompanied by a time t 3 Shortly after the airflow velocity spike. The control circuit may, for example, continue to detect and/or compare the concentration of particles detected by the particle sensors 50838, 50848, and/or 50852, while at time t 3 And then maintain a "quiet" mode speed.
In various aspects of the disclosure, the motor may be a variable speed motor. For example, motor 50512 (fig. 4) may be a variable speed motor. In such a case, the speed of the motor may be controlled based on externally measured parameters. For example, the speed of the variable speed motor may be increased, decreased, or maintained based on parameters measured external to the extraction system.
According to aspects of the present disclosure, motor 50512 (fig. 4) may be adjusted by varying the current supply to motor 50512. For example, a first amount of current may be supplied to motor 50512 to cause motor 50512 to operate at a first operating level. Alternatively, a second amount of current may be supplied to motor 50512 to cause motor 50512 to operate at a second level of operation. More specifically, the varying current supply may be achieved by varying a Pulse Width Modulation (PWM) duty cycle of the electrical input to motor 50512. In other aspects, the current may be varied by adjusting the frequency of the current supplied to the motor. In various aspects of the disclosure, the motor 50512 is coupled to a rotation mechanism or pump 50506 (e.g., a compressor, blower, etc., as described herein) such that decreasing the duty cycle or frequency of the current input to the motor 50512 decreases the rotational speed of the pump 50506. In a similar manner, the duty cycle or frequency of the current input to motor 50512 can increase the rotational speed of pump 50506.
In various aspects of the present disclosure, a lower level of operation of motor 50512 may be more advantageous than completely switching motor 50512 off when evacuation and/or suction is not required, and then switching motor 50512 back on when suction is required. For example, a clinician may only need to use aspiration intermittently during a long surgical cycle. In such aspects, switching motor 50512 on from a fully off state requires a high starting torque in order to overcome the stationary inertia of motor 50512. Repeatedly switching motor 50512 on from the full off mode in this manner is inefficient and may shorten the life of motor 50512. Alternatively, employing a lower operating level allows motor 50512 to remain on during intermittent use of the drainage system during surgery, and can be adjusted to a higher operating level (e.g., when additional aspiration is needed) without the need for higher torque required to overcome the stationary inertia of the motor.
In various aspects of the present disclosure, a series of changes may be determined or predetermined for motor parameters. In one example, the motor speed range may be predetermined for a variable speed motor. In various aspects, as described above, the control circuitry may determine that a particular flow rate or an increase or decrease in flow rate is required at the surgical site based on feedback from one or more sensors. For example, the processor 50308 and/or 50408 in the control circuit may be configured to receive input from one or more sensors and to enable adjustment of the flow based at least in part on the sensor input. The adjustment may be determined in real time or near real time.
In one aspect, the control circuit may determine the need to adjust the motor based on measurements detected by sensors in the surgical system, such as at least one sensor positioned and configured to detect fluid (e.g., fluid detection sensor 50830 in fig. 18 and 19), and/or particles in the fluid (e.g., particle sensors 50838 and/or 50848 in fig. 18 and 19), and/or a separate sensor on the electrosurgical instrument that is positionable at/near the surgical site (e.g., electrosurgical instrument 50630 in fig. 7). In response to the determined need, the control circuit may send a drive signal to supply drive current to the motor 50512 (fig. 4) to adjust its speed to the adjusted motor speed. The adjusted motor speed may correspond to a particular flow rate desired.
Alternatively, in response to a determined need, the control circuit may send a drive signal to supply drive current to the motor 50512 to increase or decrease the motor speed to a speed within a predetermined motor speed range. In such cases, the control circuit limits the speed increase or decrease of the variable speed motor to within a predetermined motor speed range. The adjusted motor speed may or may not correspond to a desired adjusted flow rate. For example, due to a predetermined motor speed range, the control circuit may not be able to adjust the motor speed to achieve the desired flow rate.
In another aspect of the present disclosure, such as when the motor is operated in manual mode, a clinician in the surgical room may select the motor speed. For example, the clinician may manually change the variable speed motor to a desired motor speed via a user interface. The user interface may be on, for example, the housing of the evacuation system and/or the surgical hub interface. In various aspects, the user interface may display external measurement parameters (e.g., the amount of smoke and/or particles measured via sensors at or near the surgical site) to the clinician, and the clinician may manually set the motor speed based on the external measurement parameters. In such aspects, the user interface may send a drive signal to supply drive current to the motor to set, increase, or decrease the motor speed to the selected motor speed.
In one aspect of the present disclosure, the control circuit may change the first drive signal to the second drive signal based on pressure conditions detected and/or measured within the evacuation system. For example, referring again to fig. 18 and 19, pressure sensors 50840, 50846, 50850, and 50854 may transmit their respective pressures to a control circuit, which may change the first drive signal to the second drive signal based on one or more of the detected pressures. It is noted that in such an aspect, the actual motor speed may not be equal to the motor speed selected by the user via the user interface. For example, if the pressure measured within the evacuation system exceeds a threshold pressure, allowing an increase in motor speed associated with the user-selected motor speed may damage the motor and/or other components of the evacuation system. Accordingly, the control circuit may override the user selected motor speed to prevent damage to the evacuation system and its components.
In another aspect of the present disclosure, the motor speed may be automatically selected by the control circuit, such as when the motor is operating in an automatic mode. In such aspects, the control circuit may send a drive signal to supply a drive current to the motor to set, increase, or decrease the motor speed to an appropriate motor speed based on an external measured parameter (e.g., the amount of smoke and/or particles measured at or near the surgical site). In an alternative aspect, the control circuit may send a drive signal to supply drive current to the motor to set, increase, or decrease the motor speed based on parameters measured within the evacuation system, including at least one of pressure and particulate concentration detected by various sensors therein. In one example, pressure sensors 50840, 50846, 50850, and 50854 may communicate their respective sensed and/or measured pressures to a control circuit. Additionally or alternatively, the particle sensors 50838, 50848, and 50852 may transmit their respective detected and/or measured particle counts to the control circuit.
Referring now to fig. 35, an adjustment algorithm 54000 for a surgical evacuation system is illustrated. The various surgical drainage systems disclosed herein may utilize the adjustment algorithm 54000 of fig. 35. Furthermore, the reader will readily appreciate that in some cases, the adjustment algorithm 54000 may be combined with one or more additional adjustment algorithms described herein. Adjustment of the surgical evacuation system may be accomplished by a processor in signal communication with a motor of an ejector pump (see, e.g., the processor and pump of fig. 5 and 6). For example, the processor 50408 can implement the adjustment algorithm 54000. Such a processor may also be in signal communication with one or more sensors in the surgical evacuation system.
In one instance, the control circuit 54008 can be communicatively coupled to a first particle sensor 54010 (which can be similar to the particle sensor 50838 in fig. 18 and 19) and can transmit a first signal including a detected and/or measured particle count thereof at block 54002. In addition, the control circuit 54008 can be coupled to a second particle sensor 54012 (which can be similar in many respects to the particle sensor 50848 of fig. 18 and 19) and can transmit a second signal including the detected and/or measured particle count thereof to the control circuit at block 54004. The control circuit 54008 can then transmit a drive signal at block 54006 to apply the determined drive current to the displacement system motor at block 54016. For example, the control circuit 54008 can be similar in many respects to the control schematic in fig. 5 and 6 and can include a processor communicatively coupled to a memory. In another aspect, any combination of sensors 50840, 50846, 50850, 50854, 50838, 50848, and 50852 (fig. 18 and 19) may communicate their respective sensed and/or measured parameters to control circuit 54008. In such alternative aspects, the control circuit may determine the appropriate motor speed based on internally measured parameters. In either case, the user interface may display the current motor speed in various situations.
In various aspects of the present disclosure, the appropriate motor speed may be an ideal motor speed determined based on historical data stored in a cloud, such as cloud 104 (fig. 39) and/or cloud 204 (fig. 46). For example, given measured external and/or internal parameters, the ideal motor speed may be the most efficient speed. In other aspects, the appropriate motor speed may be an ideal motor speed that is determined such that all measured pressures are below the threshold pressure. In other words, for example, damage to exhaust system components is avoided and particle concentrations (such as those measured at the particle sensor 50848) are minimized. In a further aspect, the motor speed automatically selected by the control circuit may be manually adjusted. In such a manual override mode, the user may select a desired motor speed that is different from the automatically selected motor speed. In such an aspect, the user interface may display the selected motor speed. In further aspects of the disclosure, the user interface may display the desired motor speed determined by the control circuit such that the user is notified that less than (or greater than) the desired motor speed and/or flow has been set and/or selected.
In another aspect of the present disclosure, the external measured parameter supplied to the control circuit may include a power level of an electrosurgical signal supplied by a generator to an electrosurgical instrument (such as the electrosurgical instrument 50630 supplied by the generator 50640 in fig. 6). In such aspects, the control circuit may increase the motor speed in proportion to the increase in power level. For example, various increased power levels may be associated with increased smoke levels in the cloud database. In a similar manner, the control circuit may reduce the motor speed in proportion to the reduction in power level. Here, in alternative aspects, the motor speed may be set (e.g., automatically and/or manually as described herein) at the evacuation system. Further, in such aspects, the power level set at generator 50640 can affect the set motor speed. In one aspect, the manually set motor speed may be changed based on the power level set at the generator 50640. In another aspect, the automatically set motor speed may be changed based on the power level set at the generator 50640.
Fig. 36 shows a graphical display 54100 of, for example, particle count, power, voltage, and motor speed for surgical evacuation systems such as evacuation systems 50800 and 50900. The control circuit of the evacuation system is configured to be able to adjust the motor speed based on the external measured parameter and the internal measured parameter. In one aspect of the present disclosure, the control circuits in fig. 5 and 6 may implement the depicted motor speed adjustment. In fig. 36, the external measured parameter is the power level of an electrosurgical signal supplied to an electrosurgical instrument (e.g., electrosurgical instrument 50630 by generator 50640 in fig. 7) by a generator used in surgery. The internal measurement parameter is, for example, a particle count detected by a pump down system, such as laser particle count counter 50838 in fig. 18 and 19. The reader will readily appreciate that in some cases, motor speed may be adjusted based on one of the external or internal measured parameters. In some cases, additional internal or external parameters may be utilized to adjust motor speed.
At time t 0 Where the motor speed is zero, the power level supplied to the electrosurgical instrument is zero, and the particle count detected by the particle sensor 50838 is zero. At time t 1 Where a first power level is supplied by a generator to the electrosurgical instrument. In one example, a first power electricThe flat may correspond to a coagulation mode. At time t 1 At or shortly after the increase in power level, the control circuit sends a drive signal to supply a starting current to the motor. The starting current is at t for the motor 1 And t 2 Leading to a burst 54102 of motor speed before settling to a baseline (e.g., idle) motor speed 54104. The baseline motor speed 54104 can correspond to, for example, a minimum torque required to turn the pump. For example, when the time approaches t 2 When the motor speed may correspond to a sleep or quiet mode in which the smoke extractor is powered in anticipation of smoke generation. At time t 1 Where the particle sensor 50838 does not affect motor speed.
At time t 2 At this point, the particle sensor 50838 detects a first spike 54106 in particle concentration that increases the particle count above a minimum threshold 54110, which corresponds to an "active" mode of smoke evacuation. In response to the first spike 54106, at time t 2 Shortly thereafter, the control circuit sends a second drive signal to supply an increased current to the motor to increase the flow through the evacuation system from, for example, a "quiet" mode to an "active" mode. In response to the increased flow, the concentration of particles counted by particle sensor 50838 at time t 2 And time t 3 And the middle begins to drop. The control circuit actively monitors the output from the particle sensor 50838 and, as the particle concentration drops, sends a third drive signal to supply a reduced current to the motor 50512 proportional to the reduced particle concentration detected by the particle sensor 50838. In other words, time t 2 And time t 3 The motor speed in between is proportional to the concentration of particles detected by the particle sensor 50838.
At time t 3 At time t supplied by generator 50640 1 And t 3 The first power level, which remains relatively constant, increases from the first power level 54112 to the second power level 54114. In one example, the second power level 54114 can correspond to a cutting mode. In response to an increase in the power level of the generator, at time t 3 Shortly thereafter, the control circuit sends a third drive signal to supply an increased current to the motor, thereby again The flow through the evacuation system is increased a second time. For example, motor speed may be responsive to time t 3 The waveform at which changes. Additionally, due to the increased power level, the particle sensor 50838 detects the second spike 54108 in the counted particles. The third drive signal may address an increased concentration of particles in the smoke. In response to increasing motor speed, the particles counted by particle sensor 50838 are at time t 3 And t 4 And the number of the steps is reduced. Likewise, the control circuit actively monitors the particle sensor 50838 and sends a fourth drive signal to provide a reduced current to the motor proportional to the reduction in particle concentration detected by the particle sensor 50838.
At time t 4 At time t supplied by the generator 3 And t 4 A second power level 54114 which remains relatively constant therebetween at time t 4 And t 5 And decreases at a steady rate. In response, at time t 4 Thereafter, the concentration of particles detected by the particle sensor 50838 also decreases. In fact, the particle concentration is at time t 4 And time t 5 Falling to a level slightly below the minimum threshold 54110 and above the closure threshold 54118, and at a time approaching the closure threshold 54118 to a time t 5 Remain relatively constant. In one instance, this may correspond to evacuating residual smoke from the surgical site. The control circuit at time t 4 And t 5 Continuing to monitor the particle sensor 50838 and sending a subsequent drive signal to and from time t 4 And time t 5 The decrease in particle concentration in between decreases proportionally to the current to the motor.
At time t 5 At this point, a third spike 54116 in particle concentration may be detected by the particle sensor 50838, which again increases the particle count above the minimum threshold 54110. In one instance, additional smoke generated during surgery and detected by particle sensor 50838 may be a result of the tissue condition. For example, additional smoke may be generated when the tissue dries during surgery. Responsive to at time t 5 Where smoke is added, the generator waveform is automatically adjusted to minimize smoke. For example, the third power level may be supplied by the generator. Further, at time t 1 And time t 5 A voltage maintained at a relatively constant first level therebetween at time t 5 Then falls to a relatively constant second level until time t 6 . At time t of power increase and voltage decrease 5 The waveform adjustment 54122 at this point may be configured to be able to generate less smoke in some cases.
Responsive to at time t 5 Where the power level of the generator is adjusted, the concentration of particles detected by particle sensor 50838 is at time t 5 And t 6 The space therebetween is steadily decreased. At time t 6 Where, for example, the power level and voltage of the generator is reduced to zero, such as after completion of a surgical procedure, corresponding to a power-off state. In addition, the concentration of particles detected by particle sensor 50838 at time t 6 Falls below the shutdown threshold 54118. In response, the control circuit sends a drive signal to supply a reduced current to the motor to reduce the motor speed to the sleep or quiet mode 54120.
In various cases, the drainage system may automatically sense and compensate for laparoscopic use. For example, the drainage system may automatically detect a laparoscopic mode of the surgical system. For laparoscopic surgery, a patient's body cavity is insufflated with a gas (e.g., carbon dioxide) to expand the body cavity and create a working and/or viewing space for a physician during the surgery. Expanding the body cavity creates a pressurized cavity. In such cases, as disclosed herein, the evacuation system may be configured to be able to sense, for example, the pressurized cavity and adjust a parameter of the evacuation system parameter, such as motor speed, in response to the pressurized cavity parameter.
For example, referring again to fig. 18 and 19, pressure sensor 50840 may detect a pressure above a particular threshold pressure, which may correspond to the pressure conventionally used for insufflation. In such cases, the control circuitry may initially determine whether the surgical procedure being performed is laparoscopic. In some cases, the control circuitry of the smoke evacuation system (e.g., processors 50308 and/or 50408 in fig. 5 and 6) can query the communicatively coupled surgical hub and/or cloud to determine whether laparoscopic surgery is being performed. For example, as further described herein, situational awareness may determine and/or confirm whether laparoscopic surgery is being performed.
In some cases, an external control circuit (such as a control circuit associated with a surgical hub) may query the communicatively coupled cloud. In another aspect, a user interface of the evacuation system may receive input from a physician. The control circuitry may receive a signal from the user interface indicating that the surgical procedure being performed is a laparoscopic surgical procedure. If not laparoscopic surgery, the control circuitry may determine if the filter is clogged and/or partially clogged, as described herein. If it is a laparoscopic surgery, the control circuit may adjust the pressure detected at the pressure sensor 50840 by a predetermined amount to achieve a laparoscopically adjusted pressure at the sensor 50840. Such laparoscopically adjusted pressure at sensor 50840 may be utilized in place of the actual pressure detected at sensor 50840 according to aspects described herein. In such aspects, this may avoid improper and/or premature indication that the filter is clogged and/or partially clogged. In addition, the foregoing adjustments may avoid unnecessary motor speed adjustments.
According to various aspects, in response to determining that the surgical procedure being performed is a laparoscopic surgical procedure, the evacuation system may further sense such a pressurized cavity and adjust an evacuation system parameter (e.g., motor speed). In such aspects, after a pressure sensor (such as pressure sensor 50840), for example, detects that the evacuation system is being used within a pressurized environment, the control circuitry may send a drive signal to change one or more operating parameters of the motor to an effective evacuation rate for laparoscopic surgery. In one example, the baseline (e.g., idle) motor speed and/or the upper motor speed may be adjusted downward to compensate for the added pressure supplied by the pressurized cavity (e.g., see fig. 7, through the tip of the surgical instrument 50630 and distal catheter opening 50634 near the aspiration hose 50636). In such cases, after a pressure sensor (such as pressure sensor 50840) detects that the evacuation system is being used within the pressurized environment, the control circuitry may set a secondary threshold value relative to the pressure loss at the pressure sensor and/or monitor the established secondary threshold value.
If the pressure detected at pressure sensor 50840 drops below such a secondary threshold, the evacuation system may adversely affect insufflation of the surgical site. For example, an adjustment to the motor speed may cause the pressure at pressure sensor 50840 to drop below a secondary threshold. In some cases, a separate pressure sensor may be positioned on the electrosurgical instrument (i.e., such that it is positioned within the body cavity during laparoscopic surgery) to initially detect the pressurized cavity and/or monitor the pressure within the body cavity during laparoscopic surgery. In such aspects, such pressure sensors will send signals to the control circuitry to appropriately adjust the pumping system parameters (e.g., motor speed), as described herein.
The reader will readily appreciate that the various surgical evacuation systems and components described herein may be incorporated into computer-implemented interactive surgical systems, surgical hubs, and/or robotic systems. For example, the surgical evacuation system may transmit data to and/or may receive data from a surgical hub, a robotic system, and/or a computer-implemented interactive surgical system. Various examples of computer-implemented interactive surgical systems, robotic systems, and surgical hubs are further described below.
Computer-implemented interactive surgical system
Referring to fig. 39, 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. 39, 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. 40 shows an example of a surgical system 102 for performing a surgical procedure on a patient lying on an operating table 114 in a surgical room 116. Robotic system 110 is used as part of surgical system 102 during surgery. 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 "ROBOT ASSISTED SURGICAL PLATFORM," filed on date 28 at 12 in 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-base MEDICAL ANALYTICS," filed on 12/28 at 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 optical components 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 minimally invasive surgery. 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. The use of multispectral imaging is described in more detail under the heading "Advanced Imaging Acquisition Module" of U.S. provisional patent application serial No. 62/611,341, filed on date 28 of 2017, 12, 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 a "surgical theatre" (i.e., operating theatre or treatment theatre) 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 components. 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 surgery. 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. 40. 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" of U.S. provisional patent application serial No. 62/611,341, filed on 28 of 12 in 2017, the disclosure of which is incorporated herein by reference in its entirety.
As shown in fig. 40, the main display 119 is positioned in the sterile field to be visible to the 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 perform, for example, diagnostic steps associated with 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. 40, a surgical instrument 112 is used in a surgical procedure as part of the surgical system 102. Hub 106 is also configured to coordinate the flow of information to the display of surgical instrument 112. For example, U.S. provisional patent application Ser. No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed on month 12, 28, 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 heading Surgical Instrument Hardware of U.S. provisional patent application serial No. 62/611,341, filed on 12 months 28 in 2017, the disclosure of which is incorporated herein by reference in its entirety.
Referring now to fig. 41, hub 106 is shown 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. 41, the hub 106 further includes a smoke evacuation module 126 and/or a suction/irrigation module 128.
During surgery, the application of energy 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 surgery. Solving this problem during surgery 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 component, a bipolar RF energy generator component, and a monopolar RF energy generator component that are housed in a single unit. In one aspect, the combination generator module further comprises a smoke evacuation component for connecting the combination generator module to at least one energy delivery cable of the surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluids and/or particulates generated by application of therapeutic energy to tissue, and a fluid line extending from the remote surgical site to the smoke evacuation component.
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 mount 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. 41-45, 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. 43, the generator module 140 may be a generator module with integrated monopolar, bipolar and ultrasonic components supported in a single housing unit 139 slidably inserted into the hub modular housing 136. As shown in fig. 42, 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. 43 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. 43.
In various aspects, smoke evacuation module 126 includes a fluid line 154, which fluid line 154 conveys trapped/collected smoke and/or fluid from the surgical site 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 flexible tubing that terminates at the smoke evacuation module 126. The common conduit and fluid lines define a fluid path extending toward the smoke evacuation module 126 received 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. 42, combined generator module 145 includes 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 received 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. 43, 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. 44 illustrates a single power bus attachment for multiple lateral docking ports of a lateral modular housing 160 configured to receive multiple modules of a surgical hub 206. The lateral modular housing 160 is configured to laterally receive and interconnect the modules 161. The modules 161 are slidably inserted into 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. 44, 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. 45 illustrates a vertical modular housing 164 configured to receive a plurality of modules 165 of the surgical hub 106. The modules 165 are slidably inserted into 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 arranged vertically, in some cases, the vertical modular housing 164 may include drawers that are arranged laterally. Further, the modules 165 may interact with each other through the docking ports of the vertical modular housing 164. In the example of fig. 45, 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 surgery. 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 surgery, it may be inefficient to remove the surgical device from the 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 field.
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 for snap-fit engagement with the first channel. The second channel is configured to slidably receive a light source module, which may be configured for snap-fit engagement 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," published 8.9.2011, which is incorporated herein by reference in its entirety. Furthermore, U.S. patent 7,982,776, entitled "SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD," published 7.19 in 2011, 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. In addition, U.S. patent application publication 2011/0306840 entitled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS" published 12/15 2011 and U.S. patent application publication 2014/0243597 entitled "SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE published 8/28 2014, each of which are incorporated herein by reference in their entirety.
Fig. 46 shows a surgical data network 201 including a modular communication hub 203 configured to enable connection of a modular device located in one or more operating rooms of a medical facility or any room in a medical facility specifically equipped for surgery 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 to be 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 the 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 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 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 receiving 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 a network hub, a network switch, and a network router 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 into 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, storage devices, and applications) are delivered to modular communication hub 203 and/or computer system 210 located in a surgical operating 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 number of computations based on data collected by the intelligent surgical instrument, 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 storage devices.
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 result analysis processing 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) to transmit the device data. Only one of the devices 1a-1n may send 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. 47) 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. 47 shows 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. 48, modular control tower 236 includes a modular communication hub 203 coupled to computer system 210. As shown in the example of fig. 47, modular control tower 236 is coupled to an imaging module 238 coupled to endoscope 239, a 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, intelligent device/appliance 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. 48 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. 48, 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. 48, each of the hubs/switches in the modular communication 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 Spatial Awareness Within an Operating Room" in U.S. provisional patent application serial No. 62/611,341, filed on day 12/28 in 2017, the disclosure of 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 the bluetooth pairing distance limit. The laser-based non-contact sensor module scans the operating room by emitting laser pulses, receiving laser pulses that bounce off the enclosure of the operating room, and comparing the phase of the emitted 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, a 9-bit bus, an Industry Standard Architecture (ISA), a micro-chamdel architecture (MSA), an Extended ISA (EISA), an Intelligent Drive Electronics (IDE), a VESA Local Bus (VLB), a Peripheral Component Interconnect (PCI), a USB, an Advanced Graphics Port (AGP), a personal computer memory card international association bus (PCMCIA), a 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 under the trade name ARM Cortex. In one aspect, the processor may be a processor available from, for example, texas Instruments LM F230H5QR ARM Cortex-M4F processor core including 256KB of single-cycle flash memory or other non-volatile memory (up to 40 MHz) on-chip memory, prefetch buffer for improving performance above 40MHz, 32KB single-cycle Sequential Random Access Memory (SRAM), load with stillases 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, processor 244 may include a security controller comprising two controller-based families (such as TMS570 and RM4 x), known under the trade name Hercules ARM Cortex R4, also produced by Texas Instruments. The security controller may be configured to be capable of being dedicated to 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. Further, the RAM may be available in various forms such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double 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 devices include, but are 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. Further, the disk storage device 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 components described herein can be implemented with various operating systems or combinations of operating systems.
A user enters commands or information into the computer system 210 through input 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 input devices are connected to the processor through the system bus via other interface ports. Interface ports include, for example, serial ports, parallel ports, game ports, and USB. The output device uses the same type of port as the input device. 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 a cloud computer, or local computers. Other remote cloud computers may be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices or public 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 with remote computers are shown. The remote computer is logically connected to the computer system through a network interface and then physically connected via communication connection. 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 of fig. 48, the imaging module 238, and/or the visualization system 208 of fig. 48, and/or the processor module 232 of fig. 47 and 48 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.
Communication connection refers to hardware/software for connecting a network interface to a 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. 49 illustrates a functional block diagram of one aspect of a USB hub 300 device according to one aspect of the present disclosure. In the illustrated aspect, the USB hub device 300 employs a TUSB2036 integrated circuit hub of 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 to be capable of being 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 through port logic circuitry 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 standardized four-wire cables that provide both communication and power distribution. The power is configured in a bus power mode and a self-powered mode. 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. 50 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 a motor drive 492, is operably coupled to the longitudinally movable displacement member to drive the I-beam knife element. The tracking system 480 is configured to determine a position of a longitudinally movable displacement member. The position information is provided to a processor 462, which may be programmed or configured to determine the position of the longitudinally movable drive member and the position of the firing member, firing bar, and I-beam knife element. Additional motors may be provided at the tool driver interface to control I-beam firing, closure tube travel, shaft rotation, and articulation. 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 or multi-core processor, such as those known under the trade name ARM Cortex, produced by Texas Instruments. In one aspect, the microcontroller 461 may be an LM4F230H5QR ARM Cortex-M4F processor core available from, for example, 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, a load with stillrisInternal 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 secure controller comprising two controller-based families (such as TMS570 and RM4 x), known under the trade name Hercules ARM Cortex R4, also produced by Texas Instruments. The security controller may be configured to be capable of being dedicated to 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 precise control of the speed and position of the knife and articulation system. 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. 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 "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT" published at 10, month 19 of 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. In at least one example, the battery cell may be a lithium ion battery that may be coupled to and decoupled from the power assembly.
The driver 492 may be a3941 available from Allegro Microsystems, inc. A3941492 is a full bridge controller for use with external N-channel power Metal Oxide Semiconductor Field Effect Transistors (MOSFETs) specifically designed for inductive loads such as 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 or low-side FETs. 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 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 to include a rack of drive teeth. In another aspect, the displacement member represents a firing bar or I-beam, each of which may be adapted and configured as a rack that can include drive teeth. Thus, as used herein, the term displacement member is generally used to refer to any movable member of a surgical instrument or tool, such as a drive member, firing bar, I-beam, or any element that can be displaced. In one aspect, a longitudinally movable drive member is coupled to the firing member, the firing bar, and the I-beam. Thus, the absolute positioning system may actually track the linear displacement of the I-beam by tracking the linear displacement of the longitudinally movable drive member. In various other aspects, the displacement member may be coupled to any position sensor 472 adapted to measure linear displacement. Thus, a longitudinally movable drive member, firing bar, or I-beam, or 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 operably 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 operably 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, a firing bar, an I-beam, or a combination thereof.
The single rotation of the sensor element associated with position sensor 472 is equivalent to a longitudinal linear displacement d1 of the displacement member, where d1 is the longitudinal linear distance the displacement member moves from point "a" to point "b" after the single rotation of the sensor element coupled to the displacement member. The sensor arrangement may be connected via gear reduction that causes the position sensor 472 to complete 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 applies logic to determine a unique position signal corresponding to the longitudinal linear displacement d1+d2+ … dn of the displacement member. 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 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 component 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 QFN16 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 locations measured by the location sensor 472, other sensors may be provided to measure physical parameters of the physical system. In some aspects, other sensors may include sensor arrangements such as those described in U.S. patent 9,345,481 to 2016, 5/24, entitled "STAPLE CARTRIDGE tisset THICKNESS," which is incorporated herein by reference in its entirety; U.S. patent application publication 2014/0263552 entitled "STAPLE CARTRIDGE TISSUE THICKNES", published at 9.18 of 2014, which is incorporated herein by reference in its entirety; and U.S. patent application Ser. No. 15/628,175 entitled "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 to the anvil by the closure drive system. A sensor 476, such as, for example, a load sensor, may measure the firing force applied to the I-beam during the firing stroke of the surgical system or tool. The I-beam is configured to engage a wedge sled configured to cam the staple drivers upward to push staples out into deforming contact with the anvil. The I-beam also includes a sharp cutting edge that can be used to sever tissue when the I-beam is advanced distally through the firing bar. Alternatively, a current sensor 478 may be employed to measure the current drawn by the motor 482. The force required to advance the firing 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 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. A magnetic field sensor may be employed to measure the thickness of the captured 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 case, 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. 50.
Fig. 51 illustrates a 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. 52 illustrates a combinational logic circuit 510 configured to control aspects of a surgical instrument or tool according to one aspect of the present disclosure. 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. 53 illustrates a sequential logic circuit 520 configured to control 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. 51) 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. 52) and sequential logic circuitry 520.
FIG. 54 illustrates a surgical instrument or tool including multiple motors that can 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 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 operably coupled to a firing motor drive assembly 604, which may be configured to transmit firing motions generated by the motor 602 to the end effector, and in particular for displacing the I-beam elements. In some instances, the firing motion generated by the motor 602 may cause, for example, staples to be deployed from a staple cartridge into tissue captured by the end effector and/or cause the cutting edge of the I-beam member to be advanced to cut the captured tissue. The I-beam element may be retracted by reversing the direction of motor 602.
In some cases, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operably coupled to a closure motor drive assembly 605, 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 closing motion may cause, for example, the end effector to transition 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 operably coupled to respective articulation motor drive assemblies 608a, 608b that 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 the closure tube and I-beam elements, 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 decoupled 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 operably engaging the articulation motors 606a, 606b and operably engaging the firing motor 602 or the closure motor 603. In at least one example, as shown in fig. 54, the switch 614 may be movable or transitionable 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 closure 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 a 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. 54, the common control module 610 may include a motor driver 626, which may include one or more H-bridge 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 some cases, power source 628 may be used, for example, to supply power to 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. A processor 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 case, 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. In some cases, microcontroller 620 may be, for example, LM4F230H5QR purchased from 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 with StellarisInternal 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. Other microcontrollers could be easily replaced for use with module 4410. Accordingly, the present disclosure should not be limited in this context.
In some instances, 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 may use program instructions associated with firing the I-beam of the end effector when the switch 614 is detected in the first position 616, for example, by the sensor 630; 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. 55 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 individually control the firing member, the closure member, the shaft member, and/or one or more articulation members. The surgical instrument 700 includes a control circuit 710 configured to control a motor-driven firing member, a closure member, a shaft member, and/or one or more articulation members.
In one aspect, the robotic surgical instrument 700 includes a control circuit 710 configured to control the anvil 716 and I-beam 714 (including sharp cutting edges) portions of the end effector 702, the removable staple cartridge 718, the shaft 740, and one or more articulation members 742a, 742b via a plurality of motors 704a-704 e. The position sensor 734 may be configured to provide position feedback of the I-beam 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, a 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 I-beam 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 I-beam 714 at a particular time (t) relative to a starting position or at a time (t) when the I-beam 714 is in a particular position relative to the starting position. 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, 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 may control the closure force applied to the tissue by the anvil 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 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 I-beam 714, anvil 716, shaft 740, articulation 742a, and articulation 742b via respective transmissions 706a-706 e. The transmissions 706a-706e may include one or more gears or other linkage members to couple the motors 704a-704e to movable mechanical elements. The position sensor 734 may sense the position of the I-beam 714. The position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of the I-beam 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 I-beam 714 translates distally and proximally. The control circuit 710 may track the pulses to determine the position of the I-beam 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 I-beam 714. Also, in some examples, the position sensor 734 may be omitted. Where any of motors 704a-704e is a stepper motor, control circuit 710 may track the position of I-beam 714 by aggregating the number and direction of steps that motor 704 has been commanded 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 an I-beam 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 a transmission 706a that is coupled to the I-beam 714. The transmission 706a includes movable mechanical elements such as rotary elements and firing members to control movement of the I-beam 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 I-beam 714. The position sensor 734 may be configured to provide the position of the I-beam 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 firing member is translated distally, the I-beam 714 with the cutting element positioned at the distal end is advanced distally to cut tissue between the staple cartridge 718 and the anvil 716.
In one aspect, the control circuit 710 is configured to drive a closure member, such as an anvil 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. The torque sensor 744b is coupled to a transmission 706b that is coupled to the anvil 716. The transmission 706b includes movable mechanical elements such as rotary elements and closure members to control movement of the anvil 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 indicative of the closing force applied to the anvil 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 anvil 716 is positioned opposite the staple cartridge 718. When ready for use, control circuit 710 may provide a close signal to motor control 708 b. In response to the closure signal, motor 704b advances the closure member to grasp tissue between anvil 716 and staple cartridge 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 a transmission 706c that is coupled to a shaft 740. The transmission 706c includes a movable mechanical element, such as a rotating element, to control the rotation of the shaft 740 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 that is 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. An output shaft of motor 704d is coupled to torque sensor 744d. The torque sensor 744d is coupled to the transmission 706d, which is coupled to the articulation member 742a. 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 disks on a robotic interface (rack) 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 from Austria Microsystems, AG. Position sensor 734 may interface 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, provided to implement a simple and efficient algorithm for computing hyperbolic and trigonometric functions that require only addition, subtraction, digital displacement 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. The sensor 738 can be located on the deck of the staple cartridge 718 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 staple cartridge 718 having tissue thereon, and (4) the load and position on the two articulation bars.
In one aspect, the one or more sensors 738 may include a strain gauge, such as a micro-strain gauge, configured to measure the magnitude of the strain in the anvil 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 anvil 716 and the staple cartridge 718. The sensor 738 may be configured to detect an impedance of a tissue section located between the anvil 716 and the staple cartridge 718 that is indicative of the thickness and/or integrity of the 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 anvil 716. For example, one or more sensors 738 may be located at the point of interaction between the closure tube and the anvil 716 to detect the closing force applied by the closure tube to the anvil 716. The force exerted on the anvil 716 may be indicative of the tissue compression experienced by the section of tissue captured between the anvil 716 and the staple cartridge 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 anvil 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 in real-time the closing force applied to anvil 716.
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 I-beams 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 control circuit 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 I-beam 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 VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT," filed on even 29 at 2017, which is incorporated herein by reference in its entirety.
Fig. 56 illustrates a block diagram of a surgical instrument 750 programmed to control distal translation of a displacement member in accordance with an aspect of the present disclosure. In one aspect, the surgical instrument 750 is programmed to control distal translation of a displacement member, such as an I-beam 764. The surgical instrument 750 includes an end effector 752, which may include an anvil 766, an I-beam 764 (including a sharp cutting edge), and a removable staple cartridge 768.
The position, motion, displacement, and/or translation of a linear displacement member, such as an I-beam 764, may be measured by an absolute positioning system, sensor arrangement, and position sensor 784. Since the I-beam 764 is coupled to the longitudinally movable drive member, the position of the I-beam 764 may be determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Thus, in the following description, the position, displacement, and/or translation of the I-beam 764 may be achieved by the position sensor 784 as described herein. The control circuit 760 may be programmed to control translation of a displacement member, such as an I-beam 764. In some examples, the control circuitry 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 I-beam 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 I-beam 764 as determined by position sensor 784 with the output of timer/counter 781 so that control circuit 760 can determine the position of I-beam 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.
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 an I-beam 764 via a transmission 756. The transmission 756 may include one or more gears or other linkage members to couple the motor 754 to the I-beam 764. The position sensor 784 may sense the position of the I-beam 764. The position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of the I-beam 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 I-beam 764 translates distally and proximally. The control circuit 760 may track the pulses to determine the position of the I-beam 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 I-beam 764. Also, in some examples, the position sensor 784 may be omitted. Where motor 754 is a stepper motor, control circuitry 760 may track the position of I-beam 764 by aggregating the number and direction of steps that 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.
The one or more sensors 788 may include a strain gauge, such as a micro-strain gauge, configured to measure a magnitude of strain in the anvil 766 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. Sensor 788 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between anvil 766 and cartridge 768. The sensor 788 may be configured to detect an impedance of a tissue segment located between the anvil 766 and the staple cartridge 768 that is indicative of a thickness and/or completeness of tissue located therebetween.
The sensor 788 may be configured to measure the force exerted by the closure drive system on the anvil 766. For example, one or more sensors 788 may be located at an interaction point between the closure tube and the anvil 766 to detect a closing force applied by the closure tube to the anvil 766. The force exerted on the anvil 766 may be indicative of the tissue compression experienced by the section of tissue captured between the anvil 766 and the staple cartridge 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 to the anvil 766 by the closure drive system. The one or more sensors 788 may be sampled in real time by the processor of the control circuit 760 during a clamping operation. Control circuitry 760 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to anvil 766 in real-time.
A current sensor 786 may be employed to measure the current drawn by the motor 754. The force required to advance the I-beam 764 corresponds to the current consumed by the motor 754, for example. 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 I-beam 764 in the end effector 752 at or near a 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 a displacement member, cutting member, or I-beam 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 exemplary aspects relate to a surgical instrument 750 that includes an end effector 752 with a motor-driven surgical sealing and cutting tool. For example, motor 754 may drive the displacement member distally and proximally along a longitudinal axis of end effector 752. The end effector 752 may include a pivotable anvil 766 and, when configured for use, the staple cartridge 768 is positioned opposite the anvil 766. The clinician may grasp tissue between the anvil 766 and the staple cartridge 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 the 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 I-beam 764 with the cutting element positioned at the distal end may cut tissue between the staple cartridge 768 and the anvil 766.
In various examples, surgical instrument 750 may include control circuitry 760 programmed to control distal translation of a displacement member, such as I-beam 764, for example, based on one or more tissue conditions. The control circuit 760 may be programmed to directly or indirectly sense a tissue condition, such as thickness, as described herein. The control circuit 760 may be programmed to select a firing control routine based on the tissue condition. 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 760 may be programmed to translate the displacement member at a lower speed and/or with lower power. When thinner tissue is present, control circuitry 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 stroke. 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 METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT," filed on publication No. 9/29 at 2017, which is incorporated herein by reference in its entirety.
Fig. 57 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 an I-beam 764. Surgical instrument 790 includes an end effector 792 that may comprise an anvil 766, an I-beam 764, and a removable staple cartridge 768 that is interchangeable with an RF cartridge 796 (shown in phantom).
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 an AS5055EQFT monolithic magnetic rotational position sensor implemented AS available from 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, provided to implement a simple and efficient algorithm for computing hyperbolic and trigonometric functions that require only addition, subtraction, digital displacement and table lookup operations.
In one aspect, the I-beam 764 may be implemented as a knife member including a knife body that operably supports a tissue cutting knife thereon, and may further include an anvil engagement tab or feature and a channel engagement feature or foot. In one aspect, staple cartridge 768 can be implemented as a standard (mechanical) surgical fastener cartridge. In one aspect, the RF bin 796 may be implemented as an RF bin. These and other sensor arrangements are described in commonly owned U.S. patent application Ser. No. 15/628,175 entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT," filed on even date 20 at 6 of 2017, which is incorporated herein by reference in its entirety.
The position, movement, displacement, and/or translation of a linear displacement member, such as an I-beam 764, may be measured by an absolute positioning system, a sensor arrangement, and a position sensor, represented as position sensor 784. Since the I-beam 764 is coupled to the longitudinally movable drive member, the position of the I-beam 764 may be determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Thus, in the following description, the position, displacement, and/or translation of the I-beam 764 may be achieved by the position sensor 784 as described herein. The control circuit 760 may be programmed to control translation of a displacement member, such as an I-beam 764, as described herein. In some examples, the control circuitry 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 I-beam 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 I-beam 764 as determined by position sensor 784 with the output of timer/counter 781 so that control circuit 760 can determine the position of I-beam 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.
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 an I-beam 764 via a transmission 756. The transmission 756 may include one or more gears or other linkage members to couple the motor 754 to the I-beam 764. The position sensor 784 may sense the position of the I-beam 764. The position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of the I-beam 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 I-beam 764 translates distally and proximally. The control circuit 760 may track the pulses to determine the position of the I-beam 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 I-beam 764. Also, in some examples, the position sensor 784 may be omitted. Where motor 754 is a stepper motor, control circuitry 760 may track the position of I-beam 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 one or more sensors 788 may include a strain gauge, such as a micro-strain gauge, configured to measure a magnitude of strain in the anvil 766 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. Sensor 788 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between anvil 766 and cartridge 768. The sensor 788 may be configured to detect an impedance of a tissue segment located between the anvil 766 and the staple cartridge 768 that is indicative of a thickness and/or completeness of tissue located therebetween.
The sensor 788 may be configured to measure the force exerted by the closure drive system on the anvil 766. For example, one or more sensors 788 may be located at an interaction point between the closure tube and the anvil 766 to detect a closing force applied by the closure tube to the anvil 766. The force exerted on the anvil 766 may be indicative of the tissue compression experienced by the section of tissue captured between the anvil 766 and the staple cartridge 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 to the anvil 766 by the closure drive system. The one or more sensors 788 may be sampled in real time by the processor portion of the control circuit 760 during a clamping operation. Control circuitry 760 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to anvil 766 in real-time.
A current sensor 786 may be employed to measure the current drawn by the motor 754. The force required to advance the I-beam 764 corresponds to the current consumed by the motor 754, for example. The force is converted to a digital signal and provided to control circuitry 760.
When an RF cartridge 796 is loaded in the end effector 792 in place of the staple cartridge 768, an RF energy source 794 is coupled to the end effector 792 and applied to the RF cartridge 796. Control circuitry 760 controls the delivery of RF energy to RF bin 796.
Additional details are disclosed in U.S. patent application Ser. No. 15/636,096, filed on 6/28 at 2017, entitled "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
Fig. 58 is a simplified block diagram of a generator 800 configured to provide, among other benefits, inductor-less tuning. Additional details of the generator 800 are described in U.S. patent 9,060,775, entitled "SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES," published 23, 6, 2015, which is incorporated herein by reference in its entirety. The generator 800 may include a patient isolation station 802 that communicates with a non-isolation station 804 via a power transformer 806. The secondary winding 808 of the power transformer 806 is contained in the isolation stage 802 and may include a tapped configuration (e.g., a center-tapped or non-center-tapped configuration) to define drive signal outputs 810a, 810b, 810c for delivering drive signals to different surgical instruments, such as, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and multi-functional surgical instruments including an ultrasonic energy mode and an RF energy mode that can be delivered separately or simultaneously. Specifically, the drive signal outputs 810a, 810c may output an ultrasonic drive signal (e.g., a 420V Root Mean Square (RMS) drive signal) to the ultrasonic surgical instrument, and the drive signal outputs 810b, 810c may output an RF electrosurgical drive signal (e.g., a 100V RMS drive signal) to the RF electrosurgical instrument, where the drive signal output 810b corresponds to a center tap of the power transformer 806.
In some forms, the ultrasonic drive signal and the electrosurgical drive signal may be provided simultaneously to different surgical instruments and/or to a single surgical instrument, such as a multi-functional surgical instrument, that has the ability to transmit both ultrasonic energy and electrosurgical energy to tissue. It should be appreciated that the electrosurgical signals provided to the dedicated electrosurgical instrument and/or the combined multifunctional ultrasonic/electrosurgical instrument may be treatment level signals or sub-treatment level signals, wherein the sub-treatment signals may be used, for example, to monitor tissue or instrument conditions and provide feedback to the generator. For example, the ultrasound signal and the RF signal may be delivered separately or simultaneously from a generator having a single output port in order to provide the desired output signal to the surgical instrument, as will be discussed in more detail below. Thus, the generator may combine ultrasonic energy and electrosurgical RF energy and deliver the combined energy to the multi-functional ultrasonic/electrosurgical instrument. The bipolar electrode may be placed on one or both jaws of the end effector. In addition to electrosurgical RF energy, one jaw may be simultaneously driven by ultrasonic energy. Ultrasonic energy may be used to dissect tissue, while electrosurgical RF energy may be used for vascular sealing.
The non-isolated stage 804 may include a power amplifier 812 having an output connected to a primary winding 814 of the power transformer 806. In some forms, the power amplifier 812 may include a push-pull amplifier. For example, non-isolated stage 804 may also include logic device 816 for providing digital outputs to digital-to-analog converter (DAC) circuit 818, which in turn provides corresponding analog signals to the input of power amplifier 812. In some forms, for example, logic 816 may include a Programmable Gate Array (PGA), an FPGA, a Programmable Logic Device (PLD), among other logic circuits. Thus, by controlling the input of power amplifier 812 via DAC circuit 818, logic device 816 may control any of a plurality of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signal that appear at drive signal outputs 810a, 810b, 810 c. In some forms, as described below, logic 816 in conjunction with a processor (e.g., a DSP described below) may implement a plurality of DSP-based algorithms and/or other control algorithms to control parameters of the drive signals output by generator 800.
Power may be supplied to the power rail of the power amplifier 812 by a switch mode regulator 820 (e.g., a power converter). In some forms, the switch mode regulator 820 may comprise an adjustable buck regulator, for example. For example, the non-isolated stage 804 may also include a first processor 822, which in one form may include a DSP processor, such as the Analog Devices ADSP-21469SHARC DSP available from Analog Devices, norwood, mass., although any suitable processor may be employed in various forms. In some forms, DSP processor 822 may control the operation of switch-mode power regulator 820 in response to voltage feedback data received by DSP processor 822 from power amplifier 812 via ADC circuit 824. In one form, for example, DSP processor 822 may receive as input, via ADC circuit 824, the waveform envelope of the signal (e.g., RF signal) amplified by power amplifier 812. Subsequently, the DSP processor 822 can control the switch mode regulator 820 (e.g., via a PWM output) such that the rail voltage provided to the power amplifier 812 tracks the waveform envelope of the amplified signal. By dynamically modulating the rail voltage of the power amplifier 812 based on the waveform envelope, the efficiency of the power amplifier 812 may be significantly increased relative to a fixed rail voltage amplifier scheme.
In some forms, logic 816 in conjunction with DSP processor 822 may implement digital synthesis circuitry, such as a direct digital synthesizer control scheme, to control the waveform shape, frequency, and/or amplitude of the drive signals output by generator 800. In one form, for example, logic device 816 may implement the DDS control algorithm by recalling waveform samples stored in a dynamically updated look-up table (LUT) (such as a RAM LUT), which may be embedded in the FPGA. The control algorithm is particularly useful in ultrasound applications in which an ultrasound transducer (such as an ultrasound transducer) 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 800 is affected by the various sources of distortion present in the output drive circuit (e.g., power transformer 806, power amplifier 812), the voltage and current feedback data based on the drive signal can be input into an algorithm (e.g., an error control algorithm implemented by DSP processor 822) that compensates for the distortion by pre-distorting or modifying the waveform samples stored in the LUT as appropriate in a dynamic traveling manner (e.g., in real time). In one form, the amount or degree of pre-distortion applied to the LUT samples may be dependent on the 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 a form, when distortion effects are considered, the LUT waveform samples will not exhibit the desired waveform shape of the drive signal, but rather exhibit a waveform shape that requires the desired waveform shape of the dynamic arm drive signal to be ultimately produced.
The non-isolated stage 804 may also include first and second ADC circuits 826, 828 coupled to the output of the power transformer 806 via respective isolation transformers 830, 832 for sampling the voltage and current, respectively, of the drive signal output by the generator 800. In some forms, the ADC circuits 826, 828 may be configured to be capable of sampling at high speeds (e.g., 80 Mega Samples Per Second (MSPS)) to enable oversampling of the drive signals. In one form, for example, the sampling rate of the ADC circuits 826, 828 may enable over-sampling of the drive signal by a factor of about 200 (depending on frequency). In some forms, the sampling operation of the ADC circuits 826, 828 may be performed by a single ADC circuit that receives the input voltage signal and the current signal via a two-way multiplexer. By using high-speed sampling in the form of generator 800, among other things, computation of complex currents flowing through the dynamic legs (which in some forms may be used to implement the DDS-based waveform shape control described above), accurate digital filtering of the sampled signal, and computation of actual power consumption with high accuracy may be achieved. The voltage and current feedback data output by the ADC circuits 826, 828 may be received and processed (e.g., first-in-first-out (FIFO) buffers, multiplexers) by the logic device 816 and stored in a data memory for subsequent retrieval by, for example, the DSP processor 822. 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 some forms, when voltage and current feedback data pairs are collected, it may be desirable to index each stored voltage and current feedback data pair based on or otherwise associated with a corresponding LUT sample output by logic device 816. Synchronizing LUT samples and voltage and current feedback data in this manner helps in the accurate timing and stability of the predistortion algorithm.
In some forms, 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 form, for example, voltage and current feedback data may be used to determine the impedance phase. 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 frequency control signals may be implemented in DSP processor 822, for example, with the frequency control signals provided as inputs to a DDS control algorithm implemented by logic device 816.
In another form, the current feedback data may be monitored, for example, 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 some forms, control of the current amplitude may be achieved by a control algorithm in the DSP processor 822, 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 logic device 816 and/or full scale output voltages via DAC circuit 818 of DAC circuit 834, which supplies the input to power amplifier 812.
The non-isolated station 804 may also include a second processor 836 for providing, among other things, user Interface (UI) functions. In one form, the UI processor 836 may comprise, for example, an Atmel AT91SAM9263 processor with ARM926EJ-S core available from Atmel Corporation, san Jose, california. Examples of UI functions supported by UI processor 836 may include audible and visual user feedback, communication with peripheral devices (e.g., via a USB interface), communication with foot switches, communication with input devices (e.g., a touch screen display), and communication with output devices (e.g., speakers). The UI processor 836 may communicate with the DSP processor 822 and the logic device 816 (e.g., via an SPI bus). Although UI processor 836 may support primarily UI functions, in some forms it may also cooperate with DSP processor 822 to enable risk mitigation. For example, the UI processor 836 may be programmed to monitor various aspects of user input and/or other inputs (e.g., touch screen input, foot switch input, temperature sensor input) and deactivate the drive output of the generator 800 when an error condition is detected.
In some forms, for example, DSP processor 822 and UI processor 836 may determine and monitor an operational state of generator 800. For DSP processor 822, the operating state of generator 800 may, for example, indicate which control and/or diagnostic processes are being implemented by DSP processor 822. For UI processor 836, the operating state of generator 800 may, for example, indicate: which elements of the UI (e.g., display, sound) may be presented to the user. The respective DSP processors 822 and UI processor 836 may independently maintain the current operating state of the generator 800 and identify and evaluate possible transitions of the current operating state. DSP processor 822 may act as the subject in this relationship and determine when a transition between operating states will occur. The UI processor 836 may note the valid transitions between operating states and may verify that the particular transition is appropriate. For example, when DSP processor 822 instructs UI processor 836 to transition to a particular state, UI processor 836 may verify that the requested transition is valid. In the event that the UI processor 836 determines that the required inter-state transition is invalid, the UI processor 836 may cause the generator 800 to enter an invalid mode.
The non-isolated stage 804 may also include a controller 838 for monitoring input devices (e.g., capacitive touch sensors, capacitive touch screens for turning the generator 800 on and off). In some forms, the controller 838 may include at least one processor and/or other controller device in communication with the UI processor 836. In one form, for example, the controller 838 may include a processor (e.g., a Meg168 bit controller available from Atmel) configured to monitor user input provided by one or more capacitive touch sensors. In one form, the controller 838 may include a touch screen controller (e.g., QT5480 touch screen controller available from Atmel) to control and manage the acquisition of touch data from a capacitive touch screen.
In some forms, the controller 838 may continue to receive operating power (e.g., via a line from a power source of the generator 800, such as the power source 854 described below) while the generator 800 is in the "power off" state. In this manner, the controller 838 may continue to monitor an input device (e.g., a capacitive touch sensor located on the front panel of the generator 800) for turning the generator 800 on and off. When the generator 800 is in a power off state, the controller 838 may wake up the power source (e.g., enable operation of one or more DC/DC voltage converters 856 of the power source 854) if activation of a user "on/off input device is detected. The controller 838 may thus begin a sequence that transitions the generator 800 to the "power on" state. Conversely, when the generator 800 is in the power on state, if activation of the "on/off input device is detected, the controller 838 may begin a sequence that transitions the generator 800 to the power off state. In some forms, for example, the controller 838 may report activation of an "on/off" input device to the UI processor 836, which in turn implements a desired sequence of processes to transition the generator 800 to a power-off state. In such forms, the controller 838 may not have the independent ability to remove power from the generator 800 after the power-on state is established.
In some forms, the controller 838 may cause the generator 800 to provide audible or other sensory feedback to alert the user that a power on or power off sequence has begun. Such alerts may be provided at the beginning of a power-on or power-off sequence and prior to the beginning of other processes associated with the sequence.
In some forms, isolation station 802 may include instrument interface circuitry 840, for example, to provide a communication interface between control circuitry of a surgical instrument and components of non-isolation station 804, such as logic device 816, DSP processor 822, and/or UI processor 836. Instrument interface circuit 840 may exchange information with components of non-isolated station 804 via a communication link (such as an IR-based communication link) that maintains a suitable degree of electrical isolation between isolated station 802 and non-isolated station 804. For example, instrument interface circuit 840 may be supplied with power using a low drop voltage regulator powered by an isolation transformer, which is driven from non-isolation stage 804.
In one form, instrument interface circuit 840 may include logic 842 (e.g., logic, programmable logic, PGA, FPGA, PLD) in communication with signal conditioning circuit 844. The signal conditioning circuit 844 may be configured to receive a periodic signal (e.g., a 2kHz square wave) from the logic circuit 842 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 signals may be transmitted to the surgical instrument control circuit (e.g., through the use of conductive pairs in a cable connecting the generator 800 to the surgical instrument) and monitored to determine the state or configuration of the control circuit. 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 identified based on the one or more characteristics. In one form, for example, the signal conditioning circuit 844 may include an ADC circuit for generating samples of a voltage signal that appears in the control circuit input as a result of an interrogation signal passing through the control circuit. Subsequently, the logic circuit 842 (or a component of the non-isolation station 804) may determine a state or configuration of the control circuit based on the ADC circuit samples.
In one form, instrument interface circuit 840 may include a first data circuit interface 846 to enable exchange of information between logic circuit 842 (or other elements of instrument interface circuit 840) and first data circuits disposed in or otherwise associated with a surgical instrument. In some forms, for example, the first data circuit may be provided in a cable integrally attached to the surgical instrument handpiece, or in an adapter for interfacing a particular surgical instrument type or model with the generator 800. The first data circuit may be implemented in any suitable manner and may communicate with the generator according to any suitable protocol including, for example, those described herein with respect to the first data circuit. In some forms, the first data circuit may include a non-volatile memory device, such as an EEPROM device. In some forms, the first data circuit interface 846 may be implemented separately from the logic circuit 842 and include suitable circuitry (e.g., discrete logic devices, processors) to enable communication between the logic circuit 842 and the first data circuit. In other forms, the first data circuit interface 846 may be integral with the logic circuit 842.
In some forms, the first data circuit may store information related to a particular surgical instrument with which it is associated. Such information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument has been used, and/or any other type of information. This information may be read by instrument interface circuit 840 (e.g., by logic circuit 842), transmitted to components of non-isolated stage 804 (e.g., to logic device 816, DSP processor 822, and/or UI processor 836), for presentation to a user via an output device, and/or to control the function or operation of generator 800. In addition, any type of information may be transferred to the first data circuit via the first data circuit interface 846 (e.g., using logic 842) for storage therein. Such information may include, for example, the number of updates of the operation in which the surgical instrument has been used and/or the date and/or time of its use.
As previously discussed, the surgical instrument may be detachable from the handpiece (e.g., the multi-function surgical instrument may be detachable from the handpiece) to facilitate instrument interchangeability and/or disposability. In such cases, the ability of the conventional generator 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 instrument. For example, designing a surgical instrument 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. The form of instrument described herein addresses these problems by using a data circuit that can be economically implemented in existing surgical instruments with minimal design changes to maintain compatibility of the surgical instrument with the current generator platform.
In addition, the form of the generator 800 may enable communication with an instrument-based data circuit. For example, the generator 800 may be configured to communicate with a second data circuit included in an instrument (e.g., a multifunction surgical instrument). In some forms, the second data circuit may be implemented in a manner similar to the first data circuit described herein. The instrument interface circuit 840 may include a second data circuit interface 848 for enabling this communication. In one form, the second data circuit interface 848 may comprise a tri-state digital interface, although other interfaces may be used. In some forms, the second data circuit may generally be any circuit for transmitting and/or receiving data. In one form, for example, the second data circuit may 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.
In some forms, the second data circuit may store information regarding electrical and/or ultrasonic characteristics of an associated ultrasonic transducer, end effector, or ultrasonic drive system. For example, the first data circuit may indicate an aging frequency slope, as described herein. Additionally or alternatively, any type of information may be transferred to the second data circuit for storage therein via the second data circuit interface 848 (e.g., using the logic circuit 842). 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 some forms, the second data circuit may transmit data collected by one or more sensors (e.g., instrument-based temperature sensors). In some forms, the second data circuit may receive data from the generator 800 and provide an indication (e.g., a light emitting diode indication or other visual indication) to the user based on the received data.
In some forms, the second data circuit and the second data circuit interface 848 may be configured to enable communication between the logic circuit 842 and the second data circuit without providing additional conductors for this (e.g., dedicated conductors of a cable connecting the handpiece to the generator 800). In one form, for example, information may be sent to and from the second data circuit using a single bus communication scheme implemented on an existing cable, such as one of the conductors for transmitting interrogation signals from the signal conditioning circuit 844 to the control circuit in the handpiece. In this way, design changes or modifications of the surgical instrument that might otherwise be necessary are minimized or reduced. Furthermore, because the different types of communications implemented on the common physical channel may be band separated, the presence of the second data circuit may be "stealth" to the generator that does not have the requisite data reading functionality, thus enabling backward compatibility of the surgical instrument.
In some forms, isolation station 802 may include at least one blocking capacitor 850-1 connected to drive signal output 810b 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 form, a second blocking capacitor 850-2 may be provided in series with blocking capacitor 850-1, wherein current leakage occurring from a point between blocking capacitors 850-1, 850-2 is monitored, such as by ADC circuit 852, to sample the voltage induced by the leakage current. These samples may be received, for example, by logic 842. Based on the change in leakage current (as indicated by the voltage samples), the generator 800 may determine when at least one of the blocking capacitors 850-1, 850-2 fails, providing benefits over a single capacitor design with a single point of failure.
In some forms, non-isolated stage 804 may include a power source 854 for delivering DC power at an appropriate voltage and current. The power source may include, for example, a 400W power source for outputting a 48VDC system voltage. The power source 854 may also include one or more DC/DC voltage converters 856 for receiving an output of the power source to generate a DC output at voltages and currents required by the various components of the generator 800. As described above in connection with the controller 838, one or more of the DC/DC voltage converters 856 may receive input from the controller 838 when the controller 838 detects that a user activates an "on/off" input device to enable operation of the DC/DC voltage converter or to wake up the DC/DC voltage converter 856.
Fig. 59 shows an example of a generator 900, which is one form of generator 800 (fig. 58). 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 regulated 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 sides through a power transformer 908. A first signal of a first ENERGY modality is provided to the surgical instrument between terminals labeled enable 1 and RETURN. A second signal of a second ENERGY modality is coupled across capacitor 910 and provided to the surgical instrument between terminals labeled enable 2 and 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 Energyn terminals may be provided, where n is a positive integer greater than 1. It should also be appreciated that up to "n" return paths RETURNn may be provided without departing from the scope of the present disclosure.
The first voltage sensing circuit 912 is coupled across terminals labeled ENERGY1 and RETURN paths to measure the output voltage therebetween. A second voltage sensing circuit 924 is coupled across terminals labeled enable 2 and RETURN paths 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 the processor 902 by dividing the output of a first voltage sensing circuit 912 coupled across a terminal labeled enable 1/RETURN or a second voltage sensing circuit 924 coupled across a terminal labeled enable 2/RETURN by the output of a current sensing circuit 914 disposed 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, the first ENERGY modality enary 1 may be ultrasonic ENERGY and the second ENERGY modality enary 2 may be RF ENERGY. However, other energy modalities besides ultrasound and bipolar or monopolar RF energy modalities also include irreversible and/or reversible electroporation and/or microwave energy, and the like. Moreover, while the example shown in fig. 59 illustrates that a single RETURN path RETURN may be provided for two or more energy modes, in other aspects, multiple RETURN paths RETURN may be provided for each energy mode enalgyn. 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. 59, 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 a lower current to drive an ultrasound transducer, a lower voltage and a 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 between the outputs labeled ENERGY1 and RETURN, as shown in FIG. 59. In one example, the connection of the RF bipolar electrode to the output of generator 900 will preferably be between the outputs labeled enable 2 and RETURN. In the case of monopolar output, the preferred connection would be an active electrode (e.g., pencil or other probe) at the ENERGY2 output and a suitable RETURN pad connected to the RETURN output.
Additional details are disclosed in U.S. patent application publication 2017/0086914 entitled "TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS," published 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 components 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 components. 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 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, comprising: 256KB single cycle flash memory or other non-volatile memoryOn-chip memory for memory (up to 40 MHz), prefetch buffer for improving performance beyond 40MHz, 32KB single cycle Serial Random Access Memory (SRAM), load with stillrisInternal 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 under the trade name Hercules ARM Cortex R4. The security controller may be configured to be capable of being dedicated to 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 receivable within a surgical hub (as described in connection with, for example, fig. 41 and 48) and a surgical device or instrument that is connectable 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.
Situational awareness
Situational awareness is the ability of aspects of a surgical system to determine or infer information related to a surgical procedure from data received from databases and/or instruments. The information may include the type of surgery being performed, the type of tissue being operated on, or the body cavity being the subject of the surgery. With context information associated with the surgical procedure, the surgical system may, for example, improve the manner in which it controls the modular devices (e.g., robotic arms and/or robotic surgical tools) connected thereto, and provide the surgeon with the context information or advice during the course of the surgical procedure.
Referring now to fig. 60, 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 the surgical procedure and the surgical hubs 106, 206 can derive background information from data received from the data sources at 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 resection 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 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 may receive this data from the paired modular devices and other data sources and continually derive inferences about the procedure being performed (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 procedure, a hospital staff member retrieves an Electronic Medical Record (EMR) of a patient from an EMR database of the hospital. Based on selected patient data in the EMR, the surgical hub 106, 206 determines that the procedure to be performed is a thoracic procedure.
In a second step 5204, the staff member scans the incoming medical supplies for the procedure. The surgical hubs 106, 206 cross-reference the scanned supplies with a list of supplies used in various types of surgery and confirm that the supplied mixture corresponds to chest surgery. In addition, the surgical hubs 106, 206 can also determine that the procedure is not a wedge procedure (because the incoming supplies lack some of the supplies required for, or otherwise do not correspond to, a chest wedge procedure).
Third, 5206, the medical personnel scans the patient belt via a scanner communicatively connected to the surgical hub 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 auxiliary equipment utilized may vary depending on the type of surgery 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 with it during this preoperative 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 particular procedure that the surgical team will perform. Once the surgical hub 106, 206 knows what particular procedure is being performed, the surgical hub 106, 206 may retrieve the procedure from memory or the cloud and then cross-reference the data it subsequently receives from the connected data sources (e.g., modular devices and patient monitoring devices) to infer what procedure is being performed by the surgical team.
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 completed 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 step of the procedure (which may be previously accessed or retrieved) to determine that collapsing the lung is the 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 wedge-shaped procedures have been excluded based on the surgical hub 106, 206 based on data received at the second step 5204 of the procedure). The data from the medical imaging device 124 (fig. 40) may 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 a vat segmental resection 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 may thus determine the particular type of surgery being performed and/or the technique used for the particular type of surgery.
Ninth step 5218, the surgical team begins the dissection step 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 completion of the previously discussed surgical step) corresponds to the anatomical step. In some cases, the energy instrument may be an energy tool mounted to a robotic arm of a 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 a segmental resection portion of the procedure is being performed.
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 hubs 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 step 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. The surgeon may alternate between, for example, 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 postoperative portion of the procedure begins.
Thirteenth step 5226, the patient is reversed from anesthesia. 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 may 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," filed on 12/28 at 2017, the disclosure of 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 components and/or based on information from cloud 104.
Examples
Various aspects of the subject matter described herein are set forth in the following numbered embodiments.
Example 1-a surgical system comprising a surgical evacuation system. The surgical evacuation system includes a pump, a motor operably coupled to the pump, a flow path fluidly coupled to the pump, and a sensor positioned along the flow path. The sensor is configured to monitor a parameter of a fluid flowing along the flow path. The surgical system also includes a generator operably configured to supply an energy waveform to the electrosurgical instrument. The surgical system also includes a control circuit configured to receive the parameter from the sensor and adjust the energy waveform supplied by the generator in response to the parameter received from the sensor.
Embodiment 2-the surgical system of embodiment 1, wherein the parameter is selected from the list of parameters consisting of: temperature, particle concentration, aerosol percentage and percent contamination.
Embodiment 3-the surgical system of embodiment 1, wherein the control circuit is configured to adjust the speed of the motor when the parameter includes a concentration of particles that exceeds a threshold concentration.
Embodiment 4-the surgical system of embodiments 1, 2, or 3, wherein the control circuit comprises a processor and a memory communicatively coupled to the processor, and wherein the memory stores instructions executable by the processor, and wherein the processor is in signal communication with the sensor and the motor.
Embodiment 5-the surgical system of embodiments 1, 2, 3, or 4, wherein the control circuit is configured to adjust the energy waveform supplied by the generator when the parameter includes a concentration of particles that exceeds a threshold.
Embodiment 6-the surgical system of embodiment 5, further comprising a surgical hub comprising a situational awareness module, wherein the control circuit is configured to determine the threshold in a plurality of steps of the surgical procedure based on input from the situational awareness module.
Embodiment 7-the surgical system of embodiments 1, 2, 3, 4, or 5, further comprising an electrosurgical instrument, wherein the electrosurgical instrument comprises an actuator configured to receive an input corresponding to the requested energy level, and wherein the energy waveform supplied by the generator corresponds to the requested energy level unless the parameter exceeds a threshold.
Embodiment 8-the surgical system of embodiments 1, 2, 3, 4, 5, 6, or 7, further comprising a surgical hub comprising a control circuit, wherein the surgical hub further comprises a situational awareness module, and wherein the control circuit is configured to determine the tissue type based on inputs from the situational awareness module and the sensor.
Example 9-a surgical system comprising a surgical evacuation system. The surgical evacuation system includes a pump, a motor operably coupled to the pump, a flow path fluidly coupled to the pump, and a sensor positioned along the flow path. The sensor is configured to monitor a parameter of a fluid flowing along the flow path. The surgical system also includes a generator operably configured to supply power to the electrosurgical instrument. The surgical system also includes a control circuit configured to receive the parameter from the sensor and to selectively adjust the power supplied by the generator based on the parameter received from the sensor.
Embodiment 10-the surgical system of embodiment 9, wherein the parameter is selected from the list of parameters consisting of: temperature, particle concentration, aerosol percentage and percent contamination.
Embodiment 11-the surgical system of embodiment 9, wherein the control circuit is configured to adjust the power supplied by the generator to reduce the volume of smoke generated by the electrosurgical instrument when the parameter includes a concentration of particles that exceeds a threshold.
Embodiment 12-the surgical system of embodiment 11, further comprising a surgical hub comprising a situational awareness module, and wherein the control circuit is configured to determine the threshold in a plurality of steps of the surgical procedure based on input from the situational awareness module.
Embodiment 13-the surgical system of embodiments 9, 10, 11, or 12, further comprising a surgical hub comprising a situational awareness module, wherein the control circuit is configured to determine an energy modality of the generator based on input from the situational awareness module.
Example 14-the surgical system of example 13, wherein the selected energy modality corresponds to a collagen to elastin ratio of tissue in the flow path.
Embodiment 15-a non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to receive a parameter detected by a sensor. The sensor is positioned along a flow path of the surgical evacuation system and is configured to monitor a parameter of fluid flowing along the flow path. The surgical evacuation system also includes a pump fluidly coupled to the flow path and a motor operably coupled to the pump. The computer readable instructions, when executed, further cause the machine to selectively adjust power supplied by the generator to the electrosurgical instrument based on the parameter detected by the sensor.
Embodiment 16-the non-transitory computer-readable medium of embodiment 15, wherein the parameter is selected from the following list of parameters: temperature, particle concentration, aerosol percentage and percent contamination.
Embodiment 17-the non-transitory computer-readable medium of embodiment 15, wherein the computer-readable instructions, when executed, cause the machine to adjust the power supplied by the generator when the parameter includes a concentration of particles that exceeds a threshold.
Embodiment 18-the non-transitory computer-readable medium of embodiment 17, wherein the computer-readable instructions, when executed, cause the machine to determine the threshold in a plurality of steps of the surgical procedure based on input from the situational awareness module.
Embodiment 19-the non-transitory computer-readable medium of embodiments 15, 16, 17, or 18, wherein the computer-readable instructions, when executed, cause the machine to determine an energy modality of the generator based on the input from the situational awareness module.
Embodiment 20-the non-transitory computer-readable medium of embodiment 19, wherein the selected energy modality corresponds to a collagen to elastin ratio of tissue in the flow path.
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 storage device. 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 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, communication switch, or 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 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 "component," "system," "module," and the like can 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/operable", "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," and "lower" 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.
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. In addition, although a plurality of operational flow diagrams are listed in other orders, it should be understood that the plurality of operations may be performed in an order different from that shown, or may be performed simultaneously. 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.

Claims (20)

1. A surgical system, comprising:
a first control circuit comprising a situational awareness module, wherein the situational awareness module receives data from a plurality of sources, and wherein the situational awareness module is configured to infer an expected amount of smoke in real time; and
an intelligent surgical drainage system, the intelligent surgical drainage system comprising:
a pump;
a motor operatively coupled to the pump;
a housing, wherein the pump and the motor are positioned within the housing;
a flow path fluidly coupled to the pump; and
a sensor positioned along the flow path, wherein the sensor is configured to monitor a parameter of a fluid flowing along the flow path;
a second control circuit located within the housing, wherein the second control circuit includes sensing and intelligent control circuitry; and
a generator operably configured to supply an energy waveform to an electrosurgical instrument;
wherein the sensing and intelligent control circuitry is configured to:
receiving the parameter from the sensor;
receiving input from the situational awareness module indicative of the expected amount of smoke;
Evaluating the parameter; and is also provided with
Signals are selectively transmitted to cause the generator to adjust the energy waveform supplied by the generator in response to the parameters received from the sensor and input from the situational awareness module.
2. The surgical system of claim 1, wherein the parameter is selected from the following list of parameters: temperature, particle concentration, aerosol percentage and percent contamination.
3. The surgical system of claim 1, wherein the sensing and intelligent control circuitry is configured to adjust the speed of the motor when the parameter includes a concentration of particles exceeding a threshold concentration.
4. The surgical system of claim 3, wherein the sensing and intelligent control circuit comprises a processor and a memory communicatively coupled to the processor, and wherein the memory stores instructions executable by the processor, and wherein the processor is in signal communication with the sensor and the motor.
5. The surgical system of claim 1, wherein the sensing and intelligent control circuitry is configured to adjust the energy waveform supplied by the generator when the parameter includes a concentration of particles exceeding a threshold.
6. The surgical system of claim 5, further comprising a surgical hub comprising the first control circuit and the situational awareness module, wherein the second control circuit is configured to determine the threshold in a plurality of steps of a surgical procedure based on input from the situational awareness module.
7. The surgical system of claim 1, further comprising the electrosurgical instrument, wherein the electrosurgical instrument comprises an actuator configured to receive an input corresponding to the requested energy level, and wherein the energy waveform supplied by the generator corresponds to the requested energy level unless the parameter exceeds a threshold.
8. The surgical system of claim 1, further comprising a surgical hub, wherein the surgical hub further comprises the first control circuit and the situational awareness module, and wherein the second control circuit is configured to determine a tissue type based on inputs from the situational awareness module and the sensor.
9. A surgical system, comprising:
a first control circuit comprising a situational awareness module, wherein the situational awareness module receives data from a plurality of sources, and wherein the situational awareness module is configured to infer an expected amount of smoke in real time; and
An intelligent surgical drainage system, the intelligent surgical drainage system comprising:
a pump;
a motor operatively coupled to the pump;
a housing, wherein the pump and the motor are positioned within the housing;
a flow path fluidly coupled to the pump; and
a sensor positioned along the flow path, wherein the sensor is configured to monitor a parameter of a fluid flowing along the flow path;
a second control circuit located within the housing, wherein the second control circuit includes sensing and intelligent control circuitry; and
a generator operably configured to supply power to an electrosurgical instrument; and
wherein the sensing and intelligent control circuitry is configured to:
receiving the parameter from the sensor;
receiving input from the situational awareness module indicative of the expected amount of smoke;
evaluating the parameter; and is also provided with
Signals are selectively transmitted to cause the generator to adjust the power supplied by the generator based on the parameters received from the sensor and input from the situational awareness module.
10. The surgical system of claim 9, wherein the parameter is selected from the following list of parameters: temperature, particle concentration, aerosol percentage and percent contamination.
11. The surgical system of claim 9, wherein the sensing and intelligent control circuitry is configured to adjust the power supplied by the generator to reduce a volume of smoke generated by the electrosurgical instrument when the parameter includes a concentration of particles that exceeds a threshold.
12. The surgical system of claim 11, further comprising a surgical hub comprising the first control circuit and the situational awareness module, and wherein the second control circuit is configured to determine the threshold in a plurality of steps of a surgical procedure based on input from the situational awareness module.
13. The surgical system of claim 9, further comprising a surgical hub comprising the first control circuit and the situational awareness module, wherein the second control circuit is configured to determine an energy modality of the generator based on input from the situational awareness module.
14. The surgical system of claim 13, wherein the selected energy modality corresponds to a collagen to elastin ratio of tissue in the flow path.
15. A non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to:
Communicatively coupled to a control circuit comprising a situational awareness module, wherein the situational awareness module is configured to infer an expected amount of smoke in real time;
receiving user input corresponding to a user demand energy level;
transmitting a signal corresponding to the real-time user demand energy level to a generator for the electrosurgical instrument;
receiving a parameter detected by a sensor, wherein the sensor is positioned along a flow path of a surgical evacuation system and configured to monitor the parameter of fluid flowing along the flow path, and wherein the surgical evacuation system further comprises a pump fluidly coupled to the flow path and a motor operably coupled to the pump;
selectively overriding the user demand energy level supplied by the generator when the parameter exceeds a threshold; and
the threshold is determined based on input from the situational awareness module, wherein the input is indicative of an expected amount of smoke.
16. The non-transitory computer readable medium of claim 15, wherein the parameter is selected from the following list of parameters: temperature, particle concentration, aerosol percentage and percent contamination.
17. The non-transitory computer readable medium of claim 15, wherein the computer readable instructions, when executed, cause the machine to adjust the user demand energy level supplied by the generator when the parameter includes a particle concentration that exceeds a threshold.
18. The non-transitory computer readable medium of claim 17, wherein the computer readable instructions, when executed, cause the machine to determine the threshold in a plurality of steps of a surgical procedure based on input from a situational awareness module.
19. The non-transitory computer readable medium of claim 15, wherein the computer readable instructions, when executed, cause the machine to determine an energy modality of the generator based on input from a situational awareness module.
20. The non-transitory computer readable medium of claim 19, wherein the selected energy modality corresponds to a collagen to elastin ratio of tissue in the flow path.
CN201880084525.4A 2017-12-28 2018-10-23 Surgical drainage sensing and generator control Active CN111526834B (en)

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US201762611340P 2017-12-28 2017-12-28
US201762611339P 2017-12-28 2017-12-28
US201762611341P 2017-12-28 2017-12-28
US62/611,340 2017-12-28
US62/611,341 2017-12-28
US62/611,339 2017-12-28
US201862691219P 2018-06-28 2018-06-28
US62/691,219 2018-06-28
US16/024,149 US11602393B2 (en) 2017-12-28 2018-06-29 Surgical evacuation sensing and generator control
US16/024,149 2018-06-29
PCT/IB2018/058272 WO2019130120A1 (en) 2017-12-28 2018-10-23 Surgical evacuation sensing and generator control

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