SYSTEM AND METHOD TO ENABLE RE-USE OF SURGICAL INSTRUMENT

• US 20170284860A1
• Filed: 04/01/2016
• Published: 10/05/2017
• Est. Priority Date: 04/01/2016
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery LLC (Johnson & Johnson)
• Inventors: Dickerson, Benjamin D.
• Granted Patent: US 10,175,096 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/320092 with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
• CPC Class Codes: A61B 18/1445 at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00725 Calibration or performance testing
• CPC Class Codes: A61B 2017/320094 additional movable means performing clamping operation
• CPC Class Codes: A61B 2017/320095 with sealing or cauterizing means
• CPC Class Codes: A61B 2018/00988 Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/0803 Counting the number of times an instrument is used
• CPC Class Codes: A61B 2090/0809 Indication of cracks or breakages
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: B06B 3/00 Methods or apparatus specially adapted for transmitting mechanical vibrations of infrasonic, sonic, or ultrasonic frequency

Abstract

Some surgical instruments become partially or fully disabled at a device firmware level after being used in a surgical procedure in order to prevent overuse or abuse of the surgical instrument that could create patient safety concerns. A reconditioning device may be used by the end user of such a surgical instrument to perform diagnostics and reconditioning of the surgical instrument so that the surgical instrument may be placed back into service without the direct intervention of the manufacturer. The reconditioning device provides power to the surgical instrument, analyzes device usage history, activates and tests the surgical instrument cutting and gripping functions, and measures electrical characteristics and mechanical characteristics of the surgical instrument. Gathered data is used to determine if the surgical instrument may be safely reconditioned for further use. If reconditioning is possible, the device will be reconfigured for safe use, reactivated, and then sterilized for subsequent re-use.

Claims

1. A system comprising:

(a) a generator configured to be coupled with a generator connection of a used surgical instrument, wherein the generator is configured to;

(i) provide power to the used surgical instrument,

(ii) receive data from the used surgical instrument, and

(iii) transmit data to the used surgical instrument;

(b) a surgical instrument actuator configured to cause the used surgical instrument to activate one or more of a set of surgical instrument modes;

(c) a memory, wherein the memory is configured to store a set of instructions; and

(d) a processor, wherein the processor is configured to execute the instructions to;

(i) receive a set of usage data from the used surgical instrument,

(ii) cause the input actuator to activate the used surgical instrument in a first mode,

(iii) while the first mode is active, measure a set of electrical characteristics of the used surgical instrument,

(iv) based upon the set of usage data and the set of electrical characteristics, create a reconditioning profile that may be applied to the used surgical instrument.

2. The system of claim 1, further comprising an imaging device positioned to capture an image of an end effector of the used surgical instrument, wherein the processor is further configured to execute instructions to:

(i) capture a set of image data for the end effector via the imaging device, and

(ii) based upon the set of usage data, the set of electrical characteristics, and the set of image data, create a reconditioning profile that may be applied to the used surgical instrument.

3. The system of claim 2, wherein the set of image data comprises one or more images of a feature of the used surgical instrument, and wherein the processor is further configured to:

(i) when a thickness of the feature meets a safety threshold, determine the reconditioning profile,

(ii) when the thickness of the feature falls short of the safety threshold by a first measurement value, determine the reconditioning profile and include in the reconditioning profile a surgical instrument reconfiguration that allows the thickness of the feature to meet the safety threshold, and

(iii) when the thickness of the feature falls short of the safety threshold by a second measurement value, not create the reconditioning profile, wherein the second measurement value is greater than the first measurement value.

4. The system of claim 2, wherein the configuration to create a reconditioning profile further comprises instructions that may be executed by the processor to compare the set of image data to a set of new device image data and determine a level of deformity of the end effector of used surgical instrument.

5. The system of claim 1, further comprising a load cell configured to receive the end effector, wherein the configuration to create a reconditioning profile further comprises instructions that may be executed by the processor to cause:

(i) an end effector of the surgical instrument to activate and apply a force to the load cell, and

(ii) the load cell to measure the force.

6. The system of claim 1, wherein the surgical instrument actuator is configured to physically actuate a user input of the used surgical instrument.

7. The system of claim 1, wherein the surgical instrument actuator is configured to transmit a signal to the used surgical instrument.

8. The system of claim 1, further comprising a display, wherein display is configured to display the reconditioning profile, and wherein the processor is further configured to receive a user selection indicating that the reconditioning profile should be applied to the used surgical instrument.

9. The system of claim 8, further comprising a network device in communication with a remote server, wherein the network device is configured to transmit the user selection to the remote server, and wherein the network device is further configured to transmit a notification to the remote server when one or more of the set of surgical instrument modes are enabled.

10. The system of claim 1, wherein the set of usage data comprises one or more of:

(A) a surgical instrument activation count associated with the used surgical instrument,

(B) a surgical instrument activation duration count associated with the used surgical instrument,

(C) a surgical instrument generator connection duration count associated with the used surgical instrument, or

(D) a surgical instrument close cycle count associated with the used surgical instrument; and

wherein the set of electrical characteristics comprises one or more of;

(A) capacitance associated with the used surgical instrument,

(B) power consumption associated with the used surgical instrument, or

(C) phase margin associated with the used surgical instrument.

11. The system of claim 1, wherein the reconditioning profile comprises:

(A) a surgical instrument reconfiguration, wherein the surgical instrument reconfiguration is configured to be written to a memory of the used surgical instrument to modify operation of the used surgical instrument, and

(B) a surgical instrument activation dataset, wherein the surgical instrument activation dataset is configured to be written to the memory of the used surgical instrument to enable one or more of the set of surgical instrument modes.

12. A method comprising:

(a) at a reconditioning device, reading a set of usage data from a used surgical instrument;

(b) activating one or more of a set of surgical instrument modes of the used surgical instrument via an input actuator of the reconditioning device and measuring a set of electrical characteristics of the used surgical instrument;

(c) measuring a set of mechanical characteristics of the used surgical instrument via the reconditioning device;

(d) creating, based upon the set of usage data, the set of electrical characteristics, and the set of mechanical characteristics, a reconditioning profile that may be applied to the used surgical instrument by the reconditioning device;

(e) receiving a user input indicating that the reconditioning profile should be applied to the used surgical instrument; and

(f) applying the reconditioning profile to the used surgical instrument in response to the user input, wherein applying the reconditioning profile to the used surgical instrument enables one or more of the set of surgical instrument modes.

13. The method of claim 12, wherein the step of measuring the set of electrical characteristics of the used surgical instrument comprises one or more of the following acts:

(i) measuring acoustic impedance of an ultrasonic blade of the used surgical instrument,

(ii) measuring the conductivity of an activation circuit of the used surgical instrument, or

(iii) measuring at least one of capacitance, power consumption, or phase shift margin of a transducer of the used surgical instrument.

14. The method of claim 12, wherein the reconditioning profile comprises a surgical instrument reconfiguration, the method further comprising writing the surgical instrument reconfiguration to a memory of the used surgical instrument to modify the electrical characteristics of the used surgical instrument during activation.

15. The method of claim 12, wherein the step of measuring the set of mechanical characteristics of the used surgical instrument comprises one or more of the following acts:

(i) measuring force applied by an end effector of the used surgical instrument to a load cell of the reconditioning device,

(ii) measuring thickness of a clamp pad of the end effector with an imaging device of the reconditioning device, or

(iii) measuring deformity of the end effector with an imaging device of the reconditioning device.

16. The method of claim 15, further comprising the steps of, if the force applied by the end effector the load cell does not fall between a minimum force threshold and a maximum force threshold:

(a) terminating the creation of the reconditioning profile; and

(b) indicating to a user that reconditioning of the surgical instrument is not possible.

17. The method of claim 15, further comprising the steps of, if the thickness of the clamp pad of the end effector does not fall between a minimum thickness threshold and a maximum thickness threshold:

(a) terminating the creation of the reconditioning profile; and

(b) indicating to a user that reconditioning of the surgical instrument is not possible.

18. The method of claim 15, further comprising the steps of, if the end effector displays unsafe deformity relative to a new end effector:

(a) terminating the creation of the reconditioning profile; and

(b) indicating to a user that reconditioning of the surgical instrument is not possible.

19. The method of claim 12, further comprising the steps:

(a) displaying the reconditioning profile to a user via a display of the reconditioning device;

(b) displaying a set of conditions to the user via the display, the set of conditions indicating a cost associated with applying the reconditioning profile to the used surgical instrument; and

(c) after receiving the user input indicating that the reconditioning profile should be applied to the used surgical instrument, sending a purchase signal to a remote server via a network device of the reconditioning device identifying the user, the used surgical instrument, and the reconditioning profile.

20. A system comprising:

(a) a used surgical instrument comprising;

(i) an activation input,

(ii) an end effector, the end effector comprising an ultrasonic blade and a clamp arm, the clamp having a clamp pad,

(iii) a generator connection, and

(iv) a surgical instrument body, and

(b) a reconditioning device comprising;

(i) a surgical instrument holder, wherein the surgical instrument holder is configured to hold the surgical instrument body,

(ii) a generator configured to couple with the generator connection, wherein the generator is configured to;

(A) provide power to the used surgical instrument,

(B) receive data from the used surgical instrument, and

(C) transmit data to the used surgical instrument,

(iii) a surgical instrument actuator configured to actuate the activation input and thereby activate the end effector,

(iv) an imaging device positioned to capture an image of the end effector,

(v) a load cell configured to receive and measure a clamping force of the clamp arm, and

(vi) a memory, wherein the memory is configured to store a set of instructions, and

(vii) a processor, wherein the processor is configured to execute the instructions to;

(A) receive a set of usage data from the used surgical instrument,

(B) cause the input actuator to activate the used surgical instrument in a first mode,

(C) while the first mode is active, measure a set of electrical characteristics of the used surgical instrument,

(D) based upon the set of usage data, the set of electrical characteristics, end effector structural characteristics as visualized by the imaging device, and the clamping force, create a reconditioning profile that may be applied to the used surgical instrument,

(E) apply the reconditioning profile to the used surgical instrument, thereby enabling at least one operational mode of the used surgical instrument.