# US 11,308,075 B2 · Surgical network, instrument, and cloud responses based on validation of received dataset and authentication of its source and integrity

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- Number: US 11,308,075 B2
- Document ID: US11308075B2
- Status: Granted
- Kind: B2
- Application number: 16/182,224
- Filed: 2018-11-06
- Published: 2019-07-04
- Granted: 2022-04-19
- Earliest claimed: 2017-12-28
- Assignees: Cilag GmbH International
- Applicants: Ethicon LLC
- Inventors: Frederick E. Shelton, IV; Jason L. Harris
- Web page: https://patentgrep.com/patent/US11308075B2

## CPC

- G06F 11/00: Error detection; Error correction; Monitoring (error detection, correction or monitoring in information storage based on relative movement between record carrier and transducer G11B20/18; monitoring, i.e. supervising the progress of recording or reproducing G11B27/36; in static stores G11C29/00)
- G06F 16/2365: {Ensuring data consistency and integrity}
- A61B 18/00: Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body (eye surgery A61F9/007; ear surgery A61F11/00)
- A61B 34/25: {User interfaces for surgical systems}
- A61B 34/30: Surgical robots
- A61B 34/37: Leader-follower robots (A61B34/35 takes precedence)
- A61B 90/361: {Image-producing devices, e.g. surgical cameras}
- G06F 16/24568: {Data stream processing; Continuous queries}
- G06F 16/2477: {Temporal data queries}
- G06F 16/26: Visual data mining; Browsing structured data
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 20/00: ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 40/63: for local operation
- G16H 40/67: for remote operation
- H04L 9/0894: {Escrow, recovery or storing of secret information, e.g. secret key escrow or cryptographic key storage}
- H04L 9/32: including means for verifying the identity or authority of a user of the system {or for message authentication, e.g. authorization, entity authentication, data integrity or data verification, non-repudiation, key authentication or verification of credentials}
- A61B 17/07207: {the staples being applied sequentially}
- A61B 17/07292: {Reinforcements for staple line, e.g. pledgets}
- A61B 17/1155: {Circular staplers comprising a plurality of staples}
- A61B 17/128: for applying or removing clamps or clips
- A61B 18/1206: {Generators therefor}
- A61B 18/14: Probes or electrodes therefor
- A61B 90/30: Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
- A61B 2017/00017: {Electrical control of surgical instruments}
- A61B 2017/00199: {with a console, e.g. a control panel with a display}
- A61B 2017/00221: {with wireless transmission of data, e.g. by infrared radiation or radiowaves}
- A61B 2017/00225: {Systems for controlling multiple different instruments, e.g. microsurgical systems}
- A61B 2017/07257: {characterised by its anvil}
- A61B 2017/07271: {characterised by its cartridge}
- A61B 2017/07285: {characterised by its cutter}
- A61B 2018/00601: {Cutting}
- A61B 2018/0063: {Sealing}
- A61B 2018/00994: {combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound}
- A61B 2018/1253: {monopolar}
- A61B 2018/126: {bipolar}
- A61B 2034/2065: {Tracking using image or pattern recognition}
- A61B 2034/252: {indicating steps of a surgical procedure}
- A61B 2034/301: {for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes}
- A61B 2034/302: {specifically adapted for manipulations within body cavities, e.g. within abdominal or thoracic cavities}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/364: {Correlation of different images or relation of image positions in respect to the body}
- A61B 2090/373: {using light, e.g. by using optical scanners}
- A61B 2218/002: Irrigation
- A61B 2218/006: for smoke evacuation
- A61B 2218/007: Aspiration
- A61B 2218/008: for smoke evacuation
- G05B 2219/36542: Cryptography, encrypt, access, authorize with key, code, password
- G06N 20/00: Machine learning
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- H04L: TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION (arrangements common to telegraphic and telephonic communication H04M)
- G05B: CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS (systems for controlling or regulating non-electric variables G05D; systems for regulating electric or magnetic variables G05F; control devices or systems insofar as characterised by mechanical features only G05G)
- G06N: COMPUTING ARRANGEMENTS BASED ON SPECIFIC COMPUTATIONAL MODELS

## Abstract

A system for validating data purportedly generated in a medical procedure is disclosed. The system includes a medical hub, at least one remote server communicatively coupled to the medical hub, and a medical instrument communicatively coupled to the medical hub. The system is configured to access the data, validate the data to determine if the data is validly generated by the medical procedure, determine that the data contains at least one flaw or error, and improve data integrity by preventing the at least one flaw or error from being integrated into a larger dataset associated with the at least one remote server.

## Claims

### Claim 1

A system for validating data generated in performance of a medical procedure, the system comprising:
a medical hub;
at least one remote server communicatively coupled to the medical hub; and
a medical instrument communicatively coupled to the medical hub;
wherein the system is configured to:
access data associated with a medical procedure;
analyze the accessed data to determine validity of the accessed data, wherein valid data comprises unaltered data generated in the performance of the medical procedure and invalid data comprises altered data modified or created outside of the medical procedure;
determine that the accessed data is generated from a validated medical instrument;
determine that the accessed data contains at least one error; and
prevent the integration of the at least one error into a larger dataset associated with the at least one remote server, wherein the larger dataset provides real time contextual information for intraoperative or perioperative changes, wherein preventing the at least one error from being integrated into the larger dataset comprises:
flagging the at least one error in the accessed data; and
identifying the validated medical instrument as containing a systematic error, wherein identifying the validated medical instrument as containing the systematic error comprises;
configuring the validated medical instrument into a controlled situation;
running a predefined routine on the validated medical instrument during the controlled situation; and
comparing a response by the validated medical instrument during the predefined routine to a result.

### Claim 2 (depends on 1)

The system of claim 1, wherein the system is further configured to:
analyze the accessed data to determine that there is a presence or an absence of a sequential trend or pattern in the accessed data, and wherein the sequential trend or pattern is common to surgical procedures;
wherein determining that the accessed data contains the at least one error comprises determining that the accessed data does not contain the sequential trend or pattern.

### Claim 3 (depends on 1)

The system of claim 1, wherein the system is further configured to:
identify an encrypted validation checksum key associated with the medical instrument;
wherein determining that the accessed data contains the at least one error comprises determining that at least part of the accessed data does not match with the encrypted validation checksum key.

### Claim 4 (depends on 1)

The system of claim 1, wherein the system is further configured to:
analyze the accessed data to determine that there is a presence or an absence of a sequential trend or pattern in the accessed data, and wherein the sequential trend or pattern is unique to a type of surgical procedure that occurred when the accessed data was generated;
wherein determining that the accessed data contains the at least one error comprises determining that the accessed data does not contain the unique sequential trend or pattern.

### Claim 5 (depends on 1)

The system of claim 1, wherein the system is further configured to:
receive a report of a malicious actor from another medical hub;
wherein determining that the accessed data contains the at least one error comprises determining that the accessed data contains a characteristic consistent with the report of the malicious actor.

### Claim 6 (depends on 1)

The system of claim 1, wherein preventing the at least one error from being integrated into the larger dataset comprises isolating the at least one error from the larger dataset and integrating the remainder of the accessed data into the larger dataset.

### Claim 7 (depends on 1)

The system of claim 1, wherein preventing the at least one error from being integrated into the larger dataset comprises determining that the at least one error is a result of the accessed data being altered and removing the accessed data from being integrated into the larger dataset.

### Claim 8

A method for validating data generated in a medical procedure, the method comprising:
accessing, by a processor of at least one remote server, data generated in the performance of a medical procedure;
analyzing, by the processor, the accessed data to determine validity of the accessed data, wherein valid data comprises unaltered data generated in the performance of the medical procedure and invalid data comprises altered data modified or created outside of the medical procedure;
determining, by the processor, that the accessed data is generated from a validated medical instrument;
determining, by the processor, that the accessed data contains at least one error; and
preventing, by the processor, the integration of the at least one error into a larger dataset associated with the at least one remote server, wherein the larger dataset provides real time contextual information for intraoperative or perioperative changes, wherein preventing the at least one error from being integrated into the larger dataset comprises:
flagging the at least one error in the accessed data; and
identifying the validated medical instrument as containing a systematic error, wherein identifying the validated medical instrument as containing the systematic error comprises:
configuring the validated medical instrument into a controlled situation;
running a predefined routine on the validated medical instrument during the controlled situation; and
comparing a response by the validated medical instrument during the predefined routine to a result.

### Claim 9 (depends on 8)

The method of claim 8, further comprising:
analyzing, by the processor, the accessed data to determine that there is a presence or an absence of a sequential trend or pattern in the accessed data, and wherein the sequential trend or pattern is common to surgical procedures;
wherein determining that the accessed data contains the at least one error comprises determining that the accessed data does not contain the sequential trend or pattern.

### Claim 10 (depends on 8)

The method of claim 8, further comprising:
identifying, by the processor, an encrypted validation checksum key associated with a medical instrument;
wherein determining that the accessed data contains the at least one error comprises determining that at least part of the accessed data does not match with the encrypted validation checksum key.

### Claim 11 (depends on 8)

The method of claim 8, further comprising:
analyzing, by the processor, the accessed data to determine that there is a presence or an absence of a sequential trend or pattern in the accessed data, and wherein the sequential trend or pattern is unique to a type of surgical procedure that occurred when the accessed data was generated;
wherein determining that the accessed data contains the at least one error comprises determining that the accessed data does not contain the unique sequential trend or pattern.

### Claim 12 (depends on 8)

The method of claim 8, further comprising:
receiving, by the processor, a report of a malicious actor from a medical hub;
wherein determining that the accessed data contains the at least one error comprises determining that the accessed data contains a characteristic consistent with the report of the malicious actor.

### Claim 13 (depends on 8)

The method of claim 8, wherein preventing the at least one error from being integrated into the larger dataset comprises isolating the at least one error from the larger dataset and integrating the remainder of the accessed data into the larger dataset.

### Claim 14 (depends on 8)

The method of claim 8, wherein preventing the at least one error from being integrated into the larger dataset comprises determining that the at least one error is a result of the accessed data being altered and removing the accessed data from being integrated into the larger dataset.

### Claim 15

A non-transitory computer readable medium comprising instructions stored thereon that, when executed by a processor, cause the processor to perform operations comprising:
accessing data associated with a medical procedure, through a processor of at least one remote medical server;
analyzing the accessed data to determine validity of the accessed data, wherein valid data comprises unaltered data generated in the performance of the medical procedure and invalid data comprises altered data modified or created outside of the medical procedure;
determining that the accessed data is generated from a validated medical instrument;
determining that the accessed data contains at least one error; and
preventing the integration of the at least one error into a larger dataset associated with the at least one remote medical server, wherein the larger dataset provides real time contextual information for intraoperative or perioperative changes, wherein preventing the at least one error from being integrated into the larger dataset comprises:
flagging the at least one error in the accessed data; and
identifying the validated medical instrument as containing a systematic error, wherein identifying the validated medical instrument as containing the systematic error comprises:
configuring the validated medical instrument into a controlled situation;
running a predefined routine on the validated medical instrument during the controlled situation; and
comparing a response by the validated medical instrument during the predefined routine to a result.

### Claim 16 (depends on 15)

The non-transitory computer readable medium of claim 15, wherein the operations further comprise:
analyzing the accessed data to determine that there is a presence or an absence of a sequential trend or pattern in the accessed data, and wherein the sequential trend or pattern is common to surgical procedures;
wherein determining that the accessed data contains the at least one error comprises determining that the accessed data does not contain the sequential trend or pattern.