MULTIPLE LEVEL THRESHOLDS TO MODIFY OPERATION OF POWERED SURGICAL INSTRUMENTS

• US 20160256185A1
• Filed: 03/06/2015
• Published: 09/08/2016
• Est. Priority Date: 03/06/2015
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery LLC (Johnson & Johnson)
• Inventors: Shelton, Frederick E. IV, Yates, David C., Harris, Jason L.
• Granted Patent: US 10,441,279 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/295 combined with cutting implements
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/00132 Setting operation time of a device A61B2017/00123 takes precedence
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/0803 Counting the number of times an instrument is used
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 2090/702 Devices for testing the cleaning process, e.g. test soils

Abstract

Thresholds can be assigned for one or more parameters in connection with the operation of a surgical device. An ultimate threshold can trigger a desired action, including cessation of operations or modification of operations, if the ultimate threshold is reached, or predicted to be reached. In addition, a marginal threshold can trigger a desired action, including improving operations such as slowing operations where the value of a parameter is measured to be between the values defined by a marginal threshold and an ultimate threshold. Multiple thresholds, based on multiple parameters, can be defined, further enabling calibrated usage, such as slowing operations based on exceeding both a marginal threshold based on number of sterilization cycles and exceeding a marginal threshold based on extent to which current draw exceeds a certain value.

Claims

1. A surgical cutting and stapling instrument comprising at least one processor and operatively associated memory, the instrument configured to:

identify a parameter;

identify a value of an ultimate threshold for the parameter; and

identify a value of a marginal threshold for the parameter.

2. The instrument of claim 1, wherein operations of the instrument are adjusted based on a determination that a measured value of the parameter exceeds the value of the ultimate threshold.

3. The instrument of claim 1, wherein operations of the instrument are adjusted based on a determination that a measured value of the parameter exceeds the value of the marginal threshold.

4. The instrument of claim 1, wherein a modified rate of change of the value of the parameter is calculated based on a determination that a predicted rate of change of the value of the parameter will result in a value that will exceed the value of the ultimate threshold.

5. The instrument of claim 4, wherein operations of the instrument are adjusted based on the calculated modified rate of change of the parameter.

6. The instrument of claim 5, wherein the adjustment is based on a stepped function.

7. The instrument of claim 5, wherein the adjustment is based on a ramped function.

8. The instrument of claim 5, wherein the value of the calculated rate of change comprises a set of values located between the value of the marginal threshold and the value of the ultimate threshold.

9. The instrument of claim 1, wherein the value of the marginal threshold is approximately 75% of the value of the ultimate threshold.

10. The instrument of claim 1, wherein the parameter comprises current drawn by a battery associated with the instrument.

11. The instrument of claim 1, wherein the parameter comprises voltage of a battery associated with the instrument.

12. The instrument of claim 1, wherein the parameter comprises speed of a knife fired by the instrument.

13. The instrument of claim 1, wherein the parameter comprises a number of sterilization cycles associated with the surgical instrument.

14. The instrument of claim 1, wherein the parameter comprises a measured behavior of a clinician during operation of the instrument.

15. A surgical cutting and stapling instrument comprising at least one processor and operatively associated memory, the surgical instrument configured to:

identify a first parameter;

identify a second parameter; and

identify a specified threshold, the specified threshold comprising one or more of;

a value of an ultimate threshold for the first parameter;

a value of a marginal threshold for the first parameter;

a value of an ultimate threshold for the second parameter; and

a value of a marginal threshold for the second parameter.

16. The instrument of claim 15, further configured to adjust operations upon a determination that a specified threshold has been exceeded.

17. The instrument of claim 15, further configured to store an overlaying threshold, the overlaying threshold based on a mathematical relationship between, on one hand, the value of the first ultimate threshold or the value of the first marginal threshold, and, on the other hand, the value of the second ultimate threshold or the value of the second marginal threshold.

18. The instrument of claim 15 wherein the first parameter comprises speed of a motor of the instrument, and the second parameter comprises a number of sterilization cycles of the instrument.

19. The instrument of claim 15 wherein the first parameter comprises a speed of a knife deployed by the instrument, and the second parameter is a number of sterilization cycles of the instrument.

20. The instrument of claim 15, wherein a third threshold is identified based on a determination that the instrument has exceeded a value of a specified threshold.