System and method to track usage of surgical instrument

Patent metadata

Field	Value
Publication number	US-11864786-B2
Application number	US-202016801400-A
Country	US
Kind code	B2
Filing date	Feb 26, 2020
Priority date	May 20, 2016
Publication date	Jan 9, 2024
Grant date	Jan 9, 2024

Abstract

Systems, devices, and methods are operable to track usage of a surgical instrument and modify the performance of the surgical instrument based on the prior usage of the surgical instrument. Some surgical instruments are designed to have a limited service life beginning at their first use, or a limit to their overall usage in order to ensure safe use of the sensitive instruments. However, a lack of ability to track usage characteristics when the instrument is separated from an external power supply allows for user abuse and avoidance of such safety mechanisms. Adding a battery or capacitor to the instrument may allow for an ability to track usage when the instrument is separated from an external power supply. Implementing special user prompts, device use ratios, and device use half-life upon powering down of an instrument may additionally be used to prevent circumvention of safety features.

First claim

We claim:

1. An apparatus, comprising:
(a) a surgical instrument, the surgical instrument comprising:
(i) an end effector, wherein the end effector comprises a surgical feature,
(ii) a generator connection,
(iii) a user input, wherein the user input is operable to activate the surgical feature of the end effector,
(iv) a processor, and
(v) an instrument memory, wherein the instrument memory is configured to store a set of device life management characteristics, wherein the processor is configured to enable or disable the surgical feature based upon the set of device life management characteristics; and

(b) a generator, the generator comprising:
(i) a display,
(ii) a generator memory configured to store a list of unique identifiers, wherein each unique identifier is associated with a used surgical instrument, and wherein the generator is configured to disable the surgical feature when the surgical instrument is represented in the list of unique identifiers, and
(iii) a generator user input,
wherein the generator is configured to:
(A) prevent the surgical instrument from being added to the list of unique identifiers when the surgical instrument is disconnected from the generator as a result of a generator error,
(B) add the surgical instrument to the list of unique identifiers when the surgical instrument is disconnected from the generator as a result of a generator power loss, and
(C) add the surgical instrument to the list of unique identifiers in response to receiving an indication via the generator user input that a use of the surgical instrument is complete.

2. The apparatus of claim 1 , wherein the surgical instrument further includes a timer feature configured to generate a value signal that changes at a predetermined rate, and wherein at least one of the device life management characteristics is based at least in part on the value signal from the timer feature.

3. The apparatus of claim 2 , wherein the timer feature further includes a timing battery circuit, and wherein the processor is configured to disable the surgical feature based on a signal from the timing battery circuit.

4. The apparatus of claim 2 , wherein the timer feature further includes a timing circuit, wherein the timing circuit comprises a capacitor and a discharge load feature.

5. The apparatus of claim 4 , wherein the generator connection is configured to supply power to the timing circuit and charge the capacitor to an initial charge when the surgical instrument is connected to the generator.

6. The apparatus of claim 1 , further comprising an external timer configured to maintain a present time indicator.

7. The apparatus of claim 6 , wherein the external timer includes a timer processor, a timer memory, and a battery.

8. The apparatus of claim 7 , wherein the generator is configured to charge the battery.

9. The apparatus of claim 8 , wherein the generator memory is further configured to retrieve the present time indicator from the external timer and write the present time indicator to the generator memory.

10. The apparatus of claim 9 , wherein the generator is further configured to associate the surgical instrument with the present time indicator when the surgical instrument is connected to the generator.

11. The apparatus of claim 10 , wherein the generator is further configured to disable the surgical feature when two or more present time indicators associated with the surgical instrument indicate that the surgical instrument has exceeded a usable life.

12. The apparatus of claim 11 , wherein the usable life is between about 4 and about 24 hours.

13. The apparatus of claim 1 , wherein the processor is configured to:
(A) determine a total generator connection time based upon the set of device life management characteristics, wherein the total generator connection time indicates a total duration of time that the surgical instrument has been connected to the generator,
(B) determine a total activation time based upon the set of device life management characteristics, wherein the total activation time indicates the total duration of time that the end effector has been in use,
(C) determine a usage ratio of the total generator connection time to the total activation time, and
(D) disable the surgical feature when the usage ratio exceeds an upper abnormal use threshold or when the ratio falls short of a lower abnormal use threshold.

14. The apparatus of claim 1 , wherein the processor is configured to:
(A) determine a total generator connection time based upon the device life management characteristics, wherein the total generator connection time indicates the duration of time that the surgical instrument has been connected to the generator,
(B) disable the surgical feature when the total generator connection time exceeds a connection time threshold, and
(C) reduce the connection time threshold each time the surgical instrument is disconnected from the generator.

15. The apparatus of claim 14 , wherein the connection threshold is 12 hours, and wherein the processor is configured to reduce the connection threshold to 6 hours after a first disconnection from the generator, to 3 hours after a second disconnection from the generator, and to 1.5 hours after a third disconnection from the generator.

16. The apparatus of claim 1 , wherein the generator is configured to operate the surgical instrument at a reduced functionality when the surgical instrument is represented on the list of unique identifiers.

17. An apparatus, comprising:
(a) a generator configured to connect to a surgical instrument having an end effector with a surgical feature, the generator comprising:
(i) a display,
(ii) a generator memory configured to store a list of unique identifiers, wherein each unique identifier is associated with a used surgical instrument, and wherein the generator is configured to disable the surgical feature when the surgical instrument is represented in the list of unique identifiers, and
(iii) a generator user input,
wherein the generator is configured to:
(A) prevent the surgical instrument from being added to the list of unique identifiers when the surgical instrument is disconnected from the generator as a result of a generator error,
(B) add the surgical instrument to the list of unique identifiers when the surgical instrument is disconnected from the generator as a result of a generator power loss, and
(C) add the surgical instrument to the list of unique identifiers in response to receiving an indication via the generator user input that a use of the surgical instrument is complete.

18. The apparatus of claim 17 , further comprising an external timer configured to maintain a present time indicator, and wherein the generator is further configured to retrieve the present time indicator from the external timer and write the present time indicator to the generator memory.

19. The apparatus of claim 17 , wherein the generator is configured to operate the surgical instrument at a reduced functionality when the surgical instrument is represented on the list of unique identifiers.

Assignees

• Cilag Gmbh Int

Inventors

• Faller Craig N
• Dickerson Benjamin D
• Aldridge Jeffrey L
• Bullock Jeffrey A
• Timm Richard W
• Asher Ryan M
• Holland Timothy S
• Davis Craig T
• Hough Christina M
• Kimball Cory G
• Madan Ashvani K
• Yates David C
• Wan Shan
• Gee Jacob S
• Hollo Joseph E
• Boudreaux Chad P
• Schulte John B
• Muhlenkamp Tylor C
• Black Brian D

Classifications

• A61B17/320092 Primary

  with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw · CPC title

• A61B17/320068 Primary

  using mechanical vibrations, e.g. ultrasonic (A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745) · CPC title

• A61B18/04

  by heating (by applying electromagnetic radiation A61B18/18) · CPC title

• A61B90/08

  Accessories or related features not otherwise provided for · CPC title

• A61N7/02

  Localised ultrasound hyperthermia · CPC title