# US 2016/0256185 A1 · Multiple level thresholds to modify operation of powered surgical instruments

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- Number: US 2016/0256185 A1
- Document ID: US20160256185A1
- Status: Published application
- Kind: A1
- Application number: 14/640,795
- Filed: 2015-03-06
- Published: 2016-09-08
- Earliest claimed: 2015-03-06
- Assignees: Ethicon Endo-Surgery, Inc.
- Applicants: Ethicon Endo-Surgery, LLC
- Inventors: Frederick E. Shelton, IV; David C. Yates; Jason L. Harris
- Web page: https://patentgrep.com/patent/US20160256185A1

## CPC

- A61B 17/295: combined with cutting implements
- A61B 17/068: Surgical staplers {, e.g. containing multiple staples or clamps}({staplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105;} for performing anastomosis A61B17/115; {staplers in general B25C5/00})
- A61B 17/07207: {the staples being applied sequentially}
- A61B 2017/00017: {Electrical control of surgical instruments}
- A61B 2017/00022: {Sensing or detecting at the treatment site}
- A61B 2017/00123: {and automatic shutdown}
- A61B 2017/00132: {Setting operation time of a device (A61B2017/00123 takes precedence)}
- A61B 2017/00398: {using powered actuators, e.g. stepper motors, solenoids}
- A61B 2018/00648: {using more than one sensed parameter}
- A61B 2018/00666: {using a threshold value}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/0803: {Counting the number of times an instrument is used}
- A61B 2090/0807: {Indication means}
- A61B 2090/702: {Devices for testing the cleaning process, e.g. test soils}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 4)

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

### Claim 6 (depends on 5)

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

### Claim 7 (depends on 5)

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

### Claim 8 (depends on 5)

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.

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 1)

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

### Claim 11 (depends on 1)

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

### Claim 12 (depends on 1)

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

### Claim 13 (depends on 1)

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

### Claim 14 (depends on 1)

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

### Claim 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.

### Claim 16 (depends on 15)

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

### Claim 17 (depends on 15)

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.

### Claim 18 (depends on 15)

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.

### Claim 19 (depends on 15)

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.

### Claim 20 (depends on 15)

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.
