# US 10,455,052 B2 · Surgical instrument usage data management

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- Number: US 10,455,052 B2
- Document ID: US10455052B2
- Status: Granted
- Kind: B2
- Application number: 14/832,497
- Filed: 2015-08-21
- Published: 2015-12-10
- Granted: 2019-10-22
- Earliest claimed: 2012-03-22
- Assignees: Ethicon, Inc.
- Applicants: Ethicon Endo-Surgery, Inc.
- Inventors: Cory G. Kimball; Daniel W. Price; William E. Clem; Amy L. Marcotte; Danius P. Silkaitis; John B. Schulte; Michael R. Lamping; Stephen L. Balek
- Web page: https://patentgrep.com/patent/US10455052B2

## CPC

- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- A61B 17/28: Surgical forceps (biopsy forceps A61B10/06; {for holding suture needles or materials A61B17/0483; for removing or smashing calculi A61B17/221; surgical scissors A61B17/3201;} obstetrical forceps A61B17/44)
- A61B 17/320092: {with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw}
- A61B 18/1445: {at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod}
- A61B 90/90: Identification means for patients or instruments, e.g. tags
- A61B 90/98: using electromagnetic means, e.g. transponders
- G06Q 20/085: {involving remote charge determination or related payment systems}
- G16H 40/40: for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
- G16H 40/63: for local operation
- H04L 67/60: Scheduling or organising the servicing of application requests, e.g. requests for application data transmissions using the analysis and optimisation of the required network resources (admission control or resource allocation H04L47/70)
- A61B 2017/00017: {Electrical control of surgical instruments}
- A61B 2017/00026: {Conductivity or impedance, e.g. of tissue}
- A61B 2017/00221: {with wireless transmission of data, e.g. by infrared radiation or radiowaves}
- A61B 2017/0046: {with a releasable handle; with handle and operating part separable}
- A61B 2017/00464: {for use with different instruments}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00725: {Calibration or performance testing}
- A61B 2017/2931: {with releasable head}
- A61B 2017/320093: {additional movable means performing cutting operation}
- A61B 2017/320094: {additional movable means performing clamping operation}
- A61B 2017/320095: {with sealing or cauterizing means}
- A61B 2017/320097: {with stapling means}
- A61B 2018/0063: {Sealing}
- A61B 2018/00988: {Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter}
- A61B 2090/0803: {Counting the number of times an instrument is used}
- A61B 2090/0804: {Counting number of instruments used; Instrument detectors}
- A61B 2090/0807: {Indication means}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G06Q: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- H04L: TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION (arrangements common to telegraphic and telephonic communication H04M)

## Abstract

A surgical instrument operable to sever tissue includes a body assembly and a selectively coupleable end effector assembly. The end effector assembly may include a transmission assembly and an end effector. The body assembly includes a trigger and a casing configured to couple with the transmission assembly. An information transmission system transmits instrument information received from a sensor, for example, to a secure server via a secure gateway connected to the instrument. The instrument may be previously tested on a calibration kit to pre-determine and load surgeon-specific settings onto the instrument prior to use.

## Claims

### Claim 1

A method for uploading information from a generator in communication with a surgical instrument, the surgical instrument including a detachable transmission assembly extending distally from a body, wherein an end effector is disposed at a distal end of the transmission assembly, wherein the method comprises the steps of:
(a) capturing a set of performance data via a sensor disposed in at least one of the detachable transmission assembly, the end effector, or the body of the surgical instrument, wherein the act of capturing the set of performance data via the sensor is performed while the surgical instrument is used in a medical procedure on a first patient;
(b) storing one or more unique identifiers associated with at least one of the detachable transmission assembly, the end effector, or the body of the surgical instrument;
(c) capturing a set of generator data while the set of performance data is captured;
(d) creating a set of component use data based upon the set of performance data, the one or more unique identifiers, and the set of generator data;
(e) uploading the set of component use data, via a processor, to a server; and
(f) associating the set of component use data with a patient file of the first patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein the set of component use data comprises at least one of the end effector oscillation data or the end effector time usage data, the method further comprising:
(a) calculating a cost based on at least one of the end effector oscillation data or the end effector time usage data;
(b) displaying the cost, via the processor, on the display screen; and
(c) transmitting the cost to one or more manufacturers or vendors of at least one of the body, the detachable transmission assembly, or the end effector.

### Claim 3 (depends on 1)

The method of claim 1, further comprising analyzing one or more patient files to generate a report on a surgeon-specific usage of at least one of the body, one or more detachable transmission assemblies, or one or more end effectors.

### Claim 4 (depends on 1)

The method of claim 1, further comprising:
(a) creating a use cost based upon the set of component use data, wherein the use cost describes an overall cost of use associated with the surgical instrument during the medical procedure on the first patient;
(b) displaying the use cost, and displaying a second use cost created during a second medical procedure for a second patient; and
(c) identifying a desirable surgical instrument component based upon the use cost and the second use cost, wherein use of the desirable surgical instrument component is associated with a lowest cost of use.

### Claim 5 (depends on 1)

The method of claim 1, wherein:
(a) the one or more unique identifiers comprise identifiers associated with each of the detachable transmission assembly, the end effector, and the body of the surgical instrument;
(b) the set of performance data comprises data separately describing the use of each of the detachable transmission assembly, the end effector, and the body of the surgical instrument during the medical procedure; and
(c) the set of component use data comprises individual use data for each of the detachable transmission assembly, the end effector, and the body of the surgical instrument.

### Claim 6

A method comprising:
(a) associating one or more unique identifiers with one or more components of a surgical instrument, the surgical instrument comprising one or more sensors, a memory, and a generator, wherein the memory is configured to store the one or more unique identifiers, wherein the generator is communicatively coupled to a server through a secure gateway;
(b) capturing a set of operation data via the one or more sensors, the set of operation data describing one or more aspects of a use of the surgical instrument during a medical procedure;
(c) storing a secure key on the secure gateway;
(d) transmitting the one or more unique identifiers and the set of operation data to the secure gateway;
(e) requesting a remote secure key from the server and, where the secure key is validated by the remote secure key, transmitting the one or more unique identifiers and the set of operation data to the server; and
at a database communicatively coupled with the server, storing the one or more unique identifiers and the set of operation data.

### Claim 7 (depends on 6)

The method of claim 6, further comprising:
(a) configuring the database to store different types of operation data comprising two or more of the following:
(i) duration of use,
(ii) voltage conditions during use,
(iii) total current used, or
(iv) number of activations;
(b) associating the one or more unique identifiers and the set of operation data with a patient data, the patient data identifying a patient on which the medical procedure was performed; and
(c) calculating an overall cost of use for the surgical instrument for the medical procedure based upon the set of operation data.

### Claim 8 (depends on 7)

The method of claim 7, further comprising comparing the overall cost of use for the surgical instrument with a second overall cost of use for a second surgical instrument and displaying the results via a computer communicatively connected with the server.

### Claim 9 (depends on 7)

The method of claim 7, further comprising transmitting the overall cost of use to a third party server as part of a commercial transaction.

### Claim 10 (depends on 7)

The method of claim 7, further comprising configuring the server to:
(a) display a first graph view in response to a request for the first graph view, wherein the first graph view shows steadiness of the surgical instrument and units of force applied to the surgical instrument during a period of time;
(b) display a second graph view in response to a request for the second graph view, wherein the second graph view depicts power measured in watts generated by the surgical instrument and voltage measured in volts associated with the surgical instrument during a period of time;
(c) display a third graph view in response to a request for the third graph view, wherein the third graph view depicts frequency slope measured in hertz per second and current measured in amps during a period of time; and
(d) display a fourth graph view in response to a request for the fourth graph view, wherein the fourth graph view depicts frequency measured in hertz per second during a period of time.

### Claim 11 (depends on 6)

The method of claim 6, further comprising:
(a) determining, from the set of operation data, that a surgeon has used the surgical instrument in a potentially dangerous manner; and
(b) adjusting the power provided by the generator to prevent unnecessary injury.

### Claim 12 (depends on 11)

The method of claim 11, wherein the potentially dangerous manner is applying an unnecessary amount of force while using the surgical instrument.

### Claim 13 (depends on 6)

The method of claim 6, further comprising:
(a) associating the one or more unique identifiers and the set of operation data with a patient data, the patient data identifying a patient on which the medical procedure was performed; and
(b) displaying, via a computer communicatively connected with the server, the surgical instruments associated with the patient through the one or more unique identifiers and at least a subset of the set of operation data associated with the patient.

### Claim 14 (depends on 6)

The method of claim 6, further comprising configuring the database to store different types of operation data comprising two or more of the following:
(a) steadiness of the surgical instrument over a period of time;
(b) speed of a cutting portion of the surgical instrument over a period of time;
(c) pressure on a cutting portion of the surgical instrument over a period of time;
(d) power generated by the surgical instrument over a period of time;
(e) voltage conditions for the surgical instrument over a period of time;
tissue impedance for a tissue the surgical instrument is being applied to over a period of time;
(g) current supplied to the surgical instrument over a period of time; or
(h) frequency of a moving part of the surgical instrument over a period of time.

### Claim 15 (depends on 6)

The method of claim 6, wherein the database is configured to store sensor data originating from two or more of the following:
(a) a piezoelectric accelerometer;
(b) a gyroscope;
(c) a pressure sensor;
(d) a force transducer;
(e) acoustic impedance sensor;
(f) thermal sensor; or
(g) electrical impedance sensor.

### Claim 16 (depends on 6)

The method of claim 6, wherein the memory is configured to store unique identifiers corresponding to:
(a) a removable end effector;
(b) a transmission assembly; and
(c) a handle assembly.

### Claim 17 (depends on 6)

The method of claim 6, further comprising configuring the database to store a custom note, wherein the custom note is associated with the set of operation data, and wherein the custom note describes a condition influencing the generation of the set of operation data.

### Claim 18

A method comprising:
(a) associating a set of unique identifiers with components of a surgical instrument, the surgical instrument comprising a set of sensors, a memory, a generator, a removable end effector, and a transmission assembly, wherein the memory is configured to store the set of unique identifiers, wherein the generator is communicatively coupled to a server;
(b) generating a set of operation data via the set of sensors, the set of sensors comprising one or more of a piezoelectric accelerometer, a gyroscope, a pressure sensor, a force transducer, or a thermal sensor, the set of operation data describing one or more aspects of a use of the surgical instrument during a procedure being performed, the set of operation data comprising:
(i) data captured by the set of sensors,
(ii) a duration of use for the surgical instrument, and
(iii) a number of activations for the surgical instrument;
(c) transmitting a procedure type, the set of unique identifiers and the set of operation data to the server, wherein the procedure type describes the procedure;
(d) at a database communicatively coupled with the server, storing the set of unique identifiers and the set of operation data;
(e) determining a cost associated with the use of the surgical instrument based on the set of operation data;
(f) tracking costs associated with a plurality of types of medical devices in the database; and
(g) determining a device type that is associated with a low cost of use based on the tracked costs in the database.

### Claim 19 (depends on 18)

The method of claim 18, further comprising:
(a) receiving a set of calibration data from the surgical instrument during a calibration procedure performed by a surgeon on a sample of tissue, wherein the set of calibration data describes one or more surgeon tendencies displayed by the surgeon during the calibration procedure;
(b) using the set of calibration data to configure a set of performance characteristics of the surgical instrument, the set of performance characteristics comprising a power output of the generator, wherein the set of performance characteristics are configured to compensate for the one or more surgeon tendencies;
(c) transmitting the set of performance characteristics to the surgical instrument; and
(d) configuring the surgical instrument based upon the set of performance characteristics.

### Claim 20 (depends on 19)

The method of claim 19, wherein a surgeon tendency of the one or more surgeon tendencies indicates a tendency to apply an abnormally high force to tissue, and wherein a compensatory characteristic of the set of performance characteristics is configured to cause the generator to reduce power to account for the abnormally high force.