# US 2021/0275053 A1 · Time dependent evaluation of sensor data to determine stability, creep, and viscoelastic elements of measures

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- Number: US 2021/0275053 A1
- Document ID: US20210275053A1
- Status: Published application
- Kind: A1
- Application number: 17/205,510
- Filed: 2021-03-18
- Published: 2021-09-09
- Earliest claimed: 2015-03-06
- Assignees: Ethicon, Inc.
- Applicants: Ethicon LLC
- Inventors: Frederick E. Shelton, IV; Jason L. Harris; Brett E. Swensgard; Richard L. Leimbach; Shane R. Adams; Mark D. Overmyer
- Web page: https://patentgrep.com/patent/US20210275053A1

## CPC

- A61B 5/0538: invasively, e.g. using a catheter
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/6847: {mounted on an invasive device}
- 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 17/105: {Wound clamp magazines (for packaging sharps A61B50/3001)}
- A61B 17/295: combined with cutting implements
- A61B 17/3209: Incision instruments
- A61B 18/1445: {at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod}
- A61B 2017/00017: {Electrical control of surgical instruments}
- A61B 2017/00022: {Sensing or detecting at the treatment site}
- A61B 2017/00026: {Conductivity or impedance, e.g. of tissue}
- A61B 2017/00075: {Motion}
- A61B 2017/00123: {and automatic shutdown}
- A61B 2017/00353: {one mechanical instrument performing multiple functions, e.g. cutting and grasping}
- A61B 2017/00398: {using powered actuators, e.g. stepper motors, solenoids}
- A61B 2017/0046: {with a releasable handle; with handle and operating part separable}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00734: {battery operated}
- A61B 2017/00876: {magnetic}
- A61B 2017/07228: {Arrangement of the staples}
- A61B 2017/07271: {characterised by its cartridge}
- A61B 2017/2927: {the angular position of the head being adjustable with respect to the shaft}
- A61B 2018/00607: {Coagulation and cutting with the same instrument}
- A61B 2018/0063: {Sealing}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/1455: {having a moving blade for cutting tissue grasped by the jaws}
- A61B 2090/061: {for measuring dimensions, e.g. length}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61B 2090/0803: {Counting the number of times an instrument is used}
- A61B 2090/0811: {for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument}
- A61B 2560/0468: Built-in electrodes
- A61B 2560/0475: Special features of memory means, e.g. removable memory cards
- A61B 2562/0223: Magnetic field sensors
- A61B 2562/0247: Pressure sensors
- A61B 2562/0261: Strain gauges
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A powered surgical cutting and stapling instrument is disclosed. The instrument includes at least one sensor to measure at least one parameter associated with the instrument, at least one processor, and a memory operatively associated with the processor. The memory includes machine executable instructions that when executed by the processor cause the processor to monitor the at least one sensor over a predetermined time period and determine a rate of change of the measured parameter.

## Claims

### Claim 1

A powered surgical cutting and stapling instrument comprising:
at least one sensor to measure at least one parameter associated with the instrument
at least one processor; and
a memory operatively associated with the processor, the memory including machine executable instructions that when executed by the processor cause the processor to:
monitor the at least one sensor over a predetermined time period; and
determine a rate of change of the measured parameter.

### Claim 2 (depends on 1)

The powered surgical cutting and stapling instrument of claim 1, comprising an end effector comprising a first jaw member and a second jaw member, wherein at least one of the first and second jaw members is movable relative to the other jaw member, and wherein the at least one sensor is positioned on at least one of the first and second jaw members.

### Claim 3 (depends on 2)

The powered surgical cutting and stapling instrument of claim 2, further comprising:
a magnet positioned on the first jaw member;
a magnetic field sensor, wherein the magnetic field sensor is coupled to the processor and the processor is configured to determine a gap distance between the first and second jaw members based on a signal received form the magnetic field sensor, where in the signal from the magnetic field sensor is proportional to the gap distance between the magnet and the magnetic field sensor, wherein the processor is configured to monitor the gap distance over the predetermined time period to determined the rate of change of the gap over the predetermined time period.

### Claim 4 (depends on 2)

The powered surgical cutting and stapling instrument of claim 2, further comprising:
a knife channel defined in at least one of the first or second jaw members, wherein the channel is configured to translate a knife therealong;
a knife configured to translate along the knife channel;
a motor operatively coupled to the knife to advance and retract the knife along the knife channel ; and
a current sensor configured to measure current draw of the motor while the motor advances the knife to cut tissue grasped between the first and second jaw members;
wherein the processor is configured to receive a signal from the current sensor over the predetermined time period, wherein the signal is representative of the current draw of the motor while advances the knife through the tissue; and
wherein the processor is configured to determine a rate of change of the current draw of the motor while the motor advances the knife through the tissue over the predetermined period.

### Claim 5 (depends on 2)

The powered surgical instrument of claim 2, further comprising a force sensor positioned in at least one of the first or second jaw members to measure compression of tissue grasped between the first and second jaw members, wherein the processor is configured to receive a signal from the force sensor over the predetermined time period, wherein the signal is representative of the tissue compression, and wherein the processor is configured to determine a rate of change of tissue compression over the predetermined period.

### Claim 6 (depends on 2)

The powered surgical instrument of claim 2, further comprising at least one electrode coupled to a sub-therapeutic radio frequency (RF) energy source configured to drive a low energy level RF signal through tissue grasped between the first and second jaw members to measure electrical impedance of the tissue; wherein the processor is configured to receive a signal from the at least one electrode over the predetermined time period, wherein the signal is representative of the tissue impedance, and wherein the processor is configured to determine a rate of change of the tissue impedance over the predetermined period.

### Claim 7 (depends on 2)

The powered surgical instrument of claim 2, further comprising a strain gauge positioned in a movable jaw member of the first or second jaw members to measure strain of the jaw member when tissue is grasped between the first and second jaw members, wherein the processor is configured to receive a signal from the strain gauge over the predetermined time period, wherein the signal is representative of the strain of the movable jaw member, and wherein the processor is configured to determine a rate of change of the strain over the predetermined period.

### Claim 8 (depends on 1)

The powered surgical cutting and stapling instrument of claim 1, comprising:
a handle;
a trigger movable relative to the handle; and
a pressure sensor or strain gauge positioned on the movable trigger;
wherein the processor is configured to receive a signal from the strain gauge over the predetermined time period, wherein the signal is representative of the force applied to the movable trigger, and wherein the processor is configured to determine a rate of change of the force over the predetermined period.

### Claim 9

A powered surgical cutting and stapling instrument comprising:
an end effector comprising a first jaw member and a second jaw member, wherein at least one of the first and second jaw members is movable relative to the other jaw member, and wherein the at least one sensor is positioned on at least one of the first and second jaw members.
a pressure sensor or strain gauge positioned in at least one of the first or second jaw members;
at least one processor;
a memory operatively associated with the processor, the memory including machine executable instructions that when executed by the processor cause the processor to:
monitor the pressure applied to tissue grasped between the first and second jaw members; and
determine a type of tissue grasped between the first and second jaw members based on the tissue pressure measurement.

### Claim 10 (depends on 9)

The powered surgical instrument of claim 9, wherein the processor is configured to determine tissue displacement by measuring tissue pressure along a first axis and along a second axis, wherein the first and second axes are transverse relative to each other.

### Claim 11 (depends on 10)

The powered surgical instrument of claim 10, wherein when tissue pressure reaches a predetermined threshold, the amount of tissue displacement as well as the rate of the tissue displacement before reaching the threshold to differentiate tissue types.

### Claim 12 (depends on 9)

The powered surgical instrument of claim 9, wherein the processor is configured to determine tissue displacement based on multiple thresholds or progressive thresholds to provide higher resolution of tissue types with similar viscoelastic properties.

### Claim 13

A powered surgical cutting and stapling instrument comprising:
an end effector comprising a first jaw member and a second jaw member, wherein at least one of the first and second jaw members is movable relative to the other jaw member, and wherein the at least one sensor is positioned on at least one of the first and second jaw members.
a pressure sensor or strain gauge positioned in at least one of the first or second jaw members;
a gap sensor to measure a gap distance between the first and second jaw members;
at least one processor;
a memory operatively associated with the processor, the memory including machine executable instructions that when executed by the processor cause the processor to:
monitor the pressure applied to tissue grasped between the first and second jaw members;
monitor the gap distance between the first and second jaw members; and
determine a type of tissue grasped between the first and second jaw members based on the tissue pressure and the gap distance measurement.

### Claim 14 (depends on 13)

The powered surgical cutting and stapling instrument of claim 13, wherein the pressure and gap distance measurements are used by the processor to determine an amount tissue grasped between the first and second jaw members.

### Claim 15 (depends on 14)

The powered surgical cutting and stapling instrument of claim 14, wherein when a small portion of the first and second jaw members are covered in tissue, the processor is configured to compensate tissue compression measurements.

### Claim 16 (depends on 14)

The powered surgical cutting and stapling instrument of claim 14, wherein the processor is configured to determine elapsed time in conjunction with pressure and gap distance measurements to determine a derivative parameter

### Claim 17 (depends on 16)

The powered surgical cutting and stapling instrument of claim 16, wherein the processor is configured to determine that a measured parameter has reached an asymptotic value when a rate of change remains constant after a set period of time.

### Claim 18 (depends on 16)

The powered surgical cutting and stapling instrument of claim 16, wherein the processor employs rate of change information to determine when a steady state has been achieved and thereby signaling a next step in a process.

### Claim 19 (depends on 18)

The powered surgical cutting and stapling instrument of claim 18, wherein the processor is configured to send a signal to a display alerting a user of the instrument to start a next step in the process or the processor is configured to automatically start the next step of the process once a steady state is reached.

### Claim 20 (depends on 16)

The powered surgical cutting and stapling instrument of claim 16, wherein the processor is configured to combine impedance rate of change with strain in at least one of the first ands second jaw members to relate force and compression.
