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EP-4739241-A1 - ELECTROSURGICAL INSTRUMENT AND METHOD OF DETECTING TISSUE ACCUMULATION ON END EFFECTOR

EP4739241A1EP 4739241 A1EP4739241 A1EP 4739241A1EP-4739241-A1

Abstract

A surgical instrument includes an end effector and a controller. The end effector includes a first jaw, a second jaw, and an electrode associated with the first jaw. The first jaw and the second jaw can move between an open position and a clamped position in order to grasp tissue. Further, the electrode emits a therapeutic energy cycle to seal the grasped tissue. The controller can measure an impedance parameter associated with the end effector and compare the measured impedance parameter with an upper predetermined threshold. Further the controller can generate a cleaning instruction or alter an energy delivery algorithm of the RF therapeutic energy cycle if the measured impedance parameter is greater than the upper predetermined threshold.

Inventors

  • BRADY, JOHN E.
  • MCLAIN, Carmen D.
  • BOGUSZEWSKI, Daniel V.
  • MAPLES, CURTIS A.
  • RUPP, KIP M.
  • LUSK, Meredith N.
  • BOUDREAUX, CHAD P.
  • Vanosdoll, Madison K.
  • BORONYAK, STEVEN M.
  • MAHER, David J.
  • PARFETT, RAYMOND E.

Assignees

  • Cilag GmbH International

Dates

Publication Date
20260513
Application Date
20250722

Claims (20)

  1. 1. A surgical instrument comprising: (a) an end effector including: (i) a first jaw, (ii) a second jaw, wherein the first jaw and the second jaw are configured to move relative to each other between an open position and a clamped position in order to grasp tissue between the first jaw and the second jaw in the clamped position, and (iii) an electrode associated with the first jaw, wherein the electrode is configured to engage the grasped tissue while the first jaw and the second jaw are in the clamped position, wherein the electrode is configured to emit an RF therapeutic energy cycle to the grasped tissue in the clamped position to thereby seal the grasped tissue; and (b) a controller configured to measure and analyze an impedance parameter associated with the end effector, wherein the controller is configured to compare the measured impedance parameter with an upper predetermined threshold, wherein the controller is configured to generate a cleaning instruction or alter an energy delivery algorithm of the RF therapeutic energy cycle if the measured impedance parameter is greater than the upper predetermined threshold.
  2. 2. The surgical instrument of claim 1, wherein the end effector is configured to emit non-therapeutic energy, wherein the impedance parameter comprises an impedance magnitude in response to the emitted non-therapeutic energy.
  3. 3. The surgical instrument of claim 2, wherein the controller is configured to only measure the impedance magnitude of the impedance parameter while the first jaw and the second jaw are in the open position.
  4. 4. The surgical instrument of any preceding claim, wherein the electrode is configured to emit non-therapeutic energy.
  5. 5. The surgical instrument of any preceding claim, wherein the impedance parameter comprises an impedance magnitude in response to the electrode emitting the RF therapeutic energy cycle.
  6. 6. The surgical instrument of claim 5, wherein the impedance magnitude comprises a minimum impedance magnitude of the RF therapeutic energy cycle.
  7. 7. The surgical instrument of any preceding claim, wherein the impedance parameter comprises a mean impedance magnitude calculated from a plurality of RF therapeutic energy cycles.
  8. 8. The surgical instrument of claim 7, wherein the mean impedance magnitude is calculated from an average impedance magnitude of each RF therapeutic energy cycle of the plurality of RF therapeutic energy cycles.
  9. 9. The surgical instrument of any preceding claim, wherein the controller is configured to generate a cleaning instruction or alter an energy delivery algorithm of the RF therapeutic energy cycle if the measured impedance parameter is lower than a lower predetermined threshold.
  10. 10. A surgical instrument comprising: (a) an end effector including: (i) a first jaw, (ii) a second jaw, wherein the first jaw and the second jaw are configured to move relative to each other between an open position and a clamped position in order to grasp tissue between the first jaw and the second jaw in the clamped position, and (iii) an electrode associated with the first jaw, wherein the electrode is configured to engage the grasped tissue while the first jaw and the second jaw are in the clamped position, wherein the electrode is configured to emit an RF therapeutic energy cycle to the grasped tissue in the clamped position to thereby seal the grasped tissue; (b) a sensor configured to measure a jaw opening rate of either the first jaw or the second jaw as the first jaw and the second jaw move from the clamped position to the open position; and (c) a controller in communication with the sensor, wherein the controller is configured to compare the measured jaw opening rate with a predetermined threshold, wherein the controller is configured to generate a cleaning instruction or alter an energy delivery algorithm of the RF therapeutic energy cycle if the measured jaw opening rate is below the predetermined threshold.
  11. 11. The surgical instrument of claim 10, further comprising a shaft assembly extending proximally from the electrode, wherein the sensor is associated with the shaft assembly.
  12. 12. The surgical instrument of claim 10 or 11, wherein the first jaw and the second jaw are pivotally coupled to each other, wherein the sensor comprises an inclinometer.
  13. 13. A surgical instrument comprising: (a) an end effector including: (i) a first jaw, (ii) a second jaw, wherein the first jaw and the second jaw are configured to move relative to each other between an open position and a clamped position in order to grasp tissue between the first jaw and the second jaw in the clamped position, and (iii) an electrode associated with the first jaw, wherein the electrode is configured to engage the grasped tissue while the first jaw and the second jaw are in the clamped position, wherein the electrode is configured to emit an RF therapeutic energy cycle to the grasped tissue in the clamped position to thereby seal the grasped tissue; (b) a sensor configured to measure a jaw gap between the first jaw and the second jaw in the clamped position; and (c) a controller in communication with the sensor, wherein the controller is configured to compare the measured jaw gap with a predetermined threshold, wherein the controller is configured to generate a cleaning instruction or alter an energy delivery algorithm of the RF therapeutic energy cycle if the measured jaw gap is above the predetermined threshold.
  14. 14. The surgical instrument of any preceding claim, further comprising a waveform generator configured to activate the electrode with RF therapeutic energy.
  15. 15. The surgical instrument of claim 14, wherein the controller is located within the waveform generator.
  16. 16. The surgical instrument of any preceding claim, wherein the end effector comprises a second electrode associated with the second jaw.
  17. 17. The surgical instrument of any of claims 1 to 15, further comprising a second electrode associated with the second jaw, wherein the first electrode and the second electrode are configured to emit bipolar RF therapeutic energy.
  18. 18. The surgical instrument of any preceding claim, further comprising a handle, wherein the controller is located within the handle.
  19. 19. The surgical instrument of any preceding claim, further comprising a clamp sensor in commutation with the controller, wherein the clamp sensor is configured to detect when the first jaw and the second jaw are in the clamped position.
  20. 20. The surgical instrument of claim 19, wherein the clamp sensor is in communication with the controller.

Description

ELECTROSURGICAL INSTRUMENT AND METHOD OF DETECTING TISSUE ACCUMULATION ON END EFFECTOR BACKGROUND [0001] A variety of surgical instruments include a tissue cutting element and one or more elements that transmit radio frequency (RF) energy to tissue (e.g., to coagulate or seal the tissue). An example of such an electrosurgical instrument is the ENSEAL® Tissue Sealing Device by Ethicon Endo-Surgery, Inc., of Cincinnati, Ohio. [0002] Buildup of surgical debris on the end-effector of an advanced bipolar device can result in worse sticking performance, premature termination of energy delivery algorithms, and shunting energy away from the tissue to be sealed onto other tissue on the jaw. These results pose a risk to seal quality. Accumulation of surgical debris on a jaw may also limit the capability of sensing technologies implemented in the jaw, such as bioimpedance spectroscopy, or optical sensing modalities, as the sensor measurements will be influences by material built up on the electrodes in addition to the target tissue to seal. A surgeon will use their own experience and judgement of when buildup of surgical debris on jaws has reached a threshold that requires cleaning of the jaws. [0003] While a variety of surgical instruments have been made and used, it is believed that no one prior to the inventors has made or used the invention described in the appended claims. SUMMARY OF THE INVENTION The present invention provides surgical instruments as recited in the independent claims. Optional features are recited in the dependent claims. BRIEF DESCRIPTION OF THE DRAWINGS [0004] While the specification concludes with claims which particularly point out and distinctly claim this technology, it is believed this technology will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which: [0005] FIG. 1 depicts a perspective view of an exemplary electrosurgical instrument; [0006] FIG. 2 depicts a perspective view of an exemplary articulation assembly and end effector of the electrosurgical instrument of FIG. 1; [0007] FIG. 3 depicts an exploded view of the articulation assembly and end effector of FIG. 2; [0008] FIG. 4 depicts a perspective view of the end effector that of FIG. 2; [0009] FIG. 5 depicts an exploded perspective view of the end effector of FIG. 2; [0010] FIG. 6 depicts an illustrative impedance triangle; [0011] FIG. 7 depicts a set of illustrative example waveforms; [0012] FIG. 8 depicts another set of illustrative example waveforms; [0013] FIG. 9 depicts another illustrative example waveform; [0014] FIG. 10 depicts another illustrative example waveform; [0015] FIG. 11 depicts another set of illustrative example waveforms; [0016] FIG. 12 depicts another illustrative example waveform; [0017] FIG. 13 depicts another illustrative example waveform; [0018] FIG. 14A depicts a cross-sectional view of the end effector of FIG. 2, wherein the jaws are in the open position prior to initial use; [0019] FIG. 14B depicts a cross-sectional view of the end effector of FIG. 2, wherein the jaws are in the open position after a plurality of activations; [0020] FIG. 15 depicts a graph of impedance measurements of an end effector in the open position over the course a plurality of activations; [0021] FIG. 16 depicts a flowchart of an illustrative method utilizing subtherapeutic impedance sensing while jaws of an end effector are in an open position to determine if the end effector needs to be cleaned; [0022] FIG. 17A depicts an elevational side view of an alterative end effector, wherein a pair of jaws of the end effector are in a closed position with eschar; [0023] FIG. 17B depicts an elevational side view of the end effector of FIG. 17A, wherein the jaws are in an open position with eschar; [0024] FIG. 18 depicts a flowchart of an illustrative method utilizing the opening rate of change of jaws of an end effector to determine if the end effector needs to be cleaned; [0025] FIG. 19 depicts a cross-sectional view of the end effector of FIG. 17A, with the pair of jaws in closed position with no eschar; [0026] FIG. 20 depicts a cross-sectional view of the end effector of FIG. 17A, with the pair of jaws in closed position with eschar; [0027] FIG. 21 depicts a flowchart of an illustrative method of utilizing a measured jaw gap in the clamped position to determine if the end effector needs to be cleaned; [0028] FIG. 22 depicts a scatter plot of minimum impedance over a series of activations during illustrative use; [0029] FIG. 23 depicts a flowchart of an illustrative method of utilizing an impedance value during a therapeutic energy activation cycle to determine if the end effector needs to be cleaned; and [0030] FIG. 24 depicts a flowchart of an illustrative method of utilizing a mean impedance value of multiple therapeutic energy activation cycles to determine if the end effector needs