System and method to track usage of surgical instrument

Patent metadata

Field	Value
Publication number	US-10624667-B2
Application number	US-201715491139-A
Country	US
Kind code	B2
Filing date	Apr 19, 2017
Priority date	May 20, 2016
Publication date	Apr 21, 2020
Grant date	Apr 21, 2020

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 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,
(v) a timer feature configured to generate a value signal that changes at a predetermined rate, and
(vi) a memory, wherein the memory is configured to store a set of device life management characteristics, wherein at least one of the device life management characteristics is based at least in part on the value signal from the timer feature, and
wherein the processor is configured to enable or disable the surgical feature based upon the set of device life management characteristics.

2. The apparatus of claim 1 , 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.

3. The apparatus of claim 2 , wherein the timing battery circuit comprises a battery, a discharge load feature, and an activation switch, wherein the generator connection is configured to close the activation switch when the surgical instrument is connected to a generator.

4. The apparatus of claim 3 , wherein the discharge load feature comprises a resistor configured to discharge the battery at a predetermined discharge rate.

5. The apparatus of claim 4 , wherein the processor is further configured to disable the surgical feature when the battery charge falls below a disable threshold, wherein the predetermined discharge rate is selected to result in the battery charge falling below the disable threshold between about 4 hours and about 24 hours after the activation switch is closed.

6. The apparatus of claim 3 , wherein the discharge load feature comprises a light emitting diode configured to discharge the battery at a predetermined discharge rate.

7. The apparatus of claim 1 , wherein the timer feature further includes a timing circuit, wherein the timing circuit comprises a capacitor and a discharge load feature.

8. The apparatus of claim 7 , wherein the generator connection is configured to supply power to the timing circuit and charge the capacitor to an initial charge when the surgical instrumented is connected to a generator.

9. The apparatus of claim 8 , wherein the discharge load feature is configured to provide a predetermined discharge rate for the capacitor, and wherein the surgical feature is disabled when the capacitor charge falls below a disable threshold.

10. The apparatus of claim 9 , wherein the memory is configured to receive a charge bit in response to the capacitor reaching the initial charge, and wherein the processor is further configured to cease charging the capacitor when the charge bit is present on the memory.

11. The apparatus of claim 1 , further comprising a generator, the generator comprising:
(i) a display, and
(ii) a generator user input, wherein the generator is 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.

12. The apparatus of claim 11 , wherein the generator is configured to 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.

13. The apparatus of claim 11 , wherein the generator is configured to add the surgical instrument to the list of unique identifiers when the surgical instrument disconnected from the generator as a result of a generator power loss.

14. The apparatus of claim 11 , wherein the generator is configured to 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.

15. The apparatus of claim 1 , further comprising:
(a) a generator, comprising a generator memory; and
(b) an external timer, comprising a timer processor, a timer memory, and a battery,
wherein the external timer is configured to maintain a present time indicator, and
wherein the generator is configured to:
(i) charge the battery,
(ii) retrieve the present time indicator from the external timer and write the present time indicator to the generator memory,
(iii) associate the surgical instrument with the present time indicator when the surgical instrument is connected to the generator, and
(iv) 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.

16. 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 a 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.

17. 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 a 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.

18. The apparatus of claim 17 , wherein the connection threshold is about 12 hours, and wherein the processor is configured to reduce the connection threshold to about 6 hours after a first disconnection from the generator, to about 3 hours after a second disconnection from the generator, and to about 1.5 hours after a third disconnection from the generator.

19. 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,
(v) a memory, wherein the memory is configured to store a set of device life management characteristics, and

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, comprising:
(i) a display, and
(ii) a generator user input, wherein the generator is 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.

Assignees

• Ethicon Llc

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

• A61B2017/320095

  with sealing or cauterizing means · CPC title

• A61B18/12

  by passing a current through the tissue to be heated, e.g. high-frequency current · CPC title

• A61B2090/0807

  Indication means · CPC title

• A61B2017/0011

  piezoelectric · CPC title

• A61B90/90

  Identification means for patients or instruments, e.g. tags · CPC title