Multiple level thresholds to modify operation of powered surgical instruments

• US 10,441,279 B2
• Filed: 03/06/2015
• Issued: 10/15/2019
• Est. Priority Date: 03/06/2015
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon, LLC (Johnson & Johnson)
• Inventors: Shelton, IV, Frederick E., Yates, David C., Harris, Jason L.
• Primary Examiner(s): Gerrity, Stephen F.
• Assistant Examiner(s): Kotis, Joshua G
• Application Number:
  US14/640,795
• Publication Number:
  US 20160256185A1
• Time in Patent Office: 1,684 Days
• Field of Search: 2271751-1821
• 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;

a first sensor, wherein the first sensor is coupled to the at least one processor;

a second sensor, wherein the second sensor is coupled to the at least one processor; and

a motor, wherein function of the motor is controlled by the at least one processor;

wherein the surgical instrument is configured to;

identify a first parameter associated with the surgical cutting and stapling instrument;

identify a second parameter associated with the surgical cutting and stapling instrument;

measure, by the first sensor, a first present value for the first parameter;

measure, by the second sensor, a second present value for the second parameter;

define a first ultimate threshold for the first parameter;

define a first marginal threshold for the first parameter;

define a second ultimate threshold for the second parameter;

define a second marginal threshold for the second parameter;

compare, by the at least one processor, the measured first present value of the first parameter with the first marginal threshold and the first ultimate threshold;

compare, by the at least one processor, the measured second present value of the second parameter with the second marginal threshold and the second ultimate threshold;

slow a first rate of operation of the surgical cutting and stapling instrument at which the first present value of the first parameter approaches the first ultimate threshold for the first parameter when the measured first present value for the first parameter exceeds the first marginal threshold for the first parameter;

slow a second rate of operation of the surgical cutting and stapling instrument when the measured second present value for the second parameter exceeds the second marginal threshold for the second parameter;

return a knife to a pre-fired position or cease operation of the surgical cutting and stapling instrument when the measured first present value of the first parameter exceeds the first ultimate threshold for the first parameter; and

return the knife to the pre-fired position or cease operation of the surgical cutting and stapling instrument when the measured second present value of the second parameter exceeds the second ultimate threshold for the second parameter,

store an overlaying threshold, the overlaying threshold based on a mathematical relationship between the value of the first ultimate threshold or the value of the first marginal threshold, and the value of the second ultimate threshold or the value of the second marginal threshold, wherein there is an interactive association between the value of the first ultimate threshold or the value of the first marginal threshold, and the value of the second ultimate threshold or the value of the second marginal threshold,

wherein the surgical cutting and stapling instrument is further configured to adjust the second marginal threshold if the measured first present value for the first parameter exceeds the first marginal threshold for the first parameter.

2. The instrument of claim 1, further configured to adjust operations upon a determination that at least one of the first marginal threshold, the first ultimate threshold, the second marginal threshold, and the second ultimate threshold has been exceeded.

3. The instrument of claim 1 wherein the first parameter comprises speed of the motor of the instrument, and the second parameter comprises a number of sterilization cycles of the instrument.

4. The instrument of claim 1 wherein the first parameter comprises a speed of the knife deployed by the instrument, and the second parameter is a number of sterilization cycles of the instrument.

5. The instrument of claim 1, wherein a third threshold is identified based on a determination that the instrument has exceeded a value of at least one of the first marginal threshold, the first ultimate threshold, the second marginal threshold, and the second ultimate threshold.

6. The instrument of claim 1, wherein at least one of the first and second parameters represents quantities, amounts, states, or events.

7. The instrument of claim 6, wherein at least one of the first and second parameters is at least one of closure clamp loads, current draw, pressure, firing load, torque, sterilization cycles, voltage, speed of the knife fired, tissue pressure, tissue thickness, tissue gap, jaw closure rate, tissue creep rate, knife thickness, battery usage, and battery charge.

8. A method of operating a surgical cutting and stapling instrument, the method comprising:

identifying a first parameter associated with the surgical cutting and stapling instrument;

identifying a second parameter associated with the surgical cutting and stapling instrument;

measuring, by a first sensor coupled to at least one processor of the surgical cutting and stapling instrument, a first present value for the first parameter;

measuring, by a second sensor coupled to at least one processor of the surgical cutting and stapling instrument, a second present value for the second parameter;

defining a first ultimate threshold for the first parameter;

defining a first marginal threshold for the first parameter;

defining a second ultimate threshold for the second parameter;

defining a second marginal threshold for the second parameter;

comparing, by the at least one processor, the measured first present value of the first parameter with the first marginal threshold and the first ultimate threshold;

comparing, by the at least one processor, the measured second present value of the second parameter with the second marginal threshold and the second ultimate threshold;

slowing a first rate of operation of the surgical cutting and stapling instrument at which the first present value of the first parameter approaches the first ultimate threshold for the first parameter when the measured first present value for the first parameter exceeds the first marginal threshold for the first parameter;

slowing a second rate of operation of the surgical cutting and stapling instrument when the measured second present value for the second parameter exceeds the second marginal threshold for the second parameter;

returning a knife to a pre-fired position or ceasing operation of the surgical cutting and stapling instrument when the measured first present value of the first parameter exceeds the first ultimate threshold for the first parameter; and

returning the knife to the pre-fired position or ceasing operation of the surgical cutting and stapling instrument when the measured second present value of the second parameter exceeds the second ultimate threshold for the second parameter;

storing an overlaying threshold, the overlaying threshold based on a mathematical relationship between the value of the first ultimate threshold or the value of the first marginal threshold, and the value of the second ultimate threshold or the value of the second marginal threshold, wherein there is an interactive association between the value of the first ultimate threshold or the value of the first marginal threshold, and the value of the second ultimate threshold or the value of the second marginal threshold; and

adjusting the second marginal threshold if the measured first present value for the first parameter exceeds the first marginal threshold for the first parameter.

9. The method of claim 8, further comprising adjusting operations upon a determination that at least one of the first marginal threshold, the first ultimate threshold, the second marginal threshold, and the second ultimate threshold has been exceeded.

10. The method of claim 8, 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.

11. The method of claim 8, wherein the first parameter comprises a speed of the knife deployed by the instrument, and the second parameter is a number of sterilization cycles of the instrument.

12. The method of claim 8, wherein a third threshold is identified based on a determination that the instrument has exceeded a value of at least one of the first marginal threshold, the first ultimate threshold, the second marginal threshold, and the second ultimate threshold.

13. The method of claim 8, wherein at least one of the first and second parameters represents quantities, amounts, states, or events.

14. The method of claim 13, wherein at least one of the first and second parameters is at least one of closure clamp loads, current draw, pressure, firing load, torque, sterilization cycles, voltage, speed of the knife fired, tissue pressure, tissue thickness, tissue gap, jaw closure rate, tissue creep rate, knife thickness, battery usage, and battery charge.