# US 12,005,258 B2 · Medical system for therapy adjustment

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 12,005,258 B2
- Document ID: US12005258B2
- Status: Granted
- Kind: B2
- Application number: 17/404,542
- Filed: 2021-08-17
- Published: 2022-02-03
- Granted: 2024-06-11
- Earliest claimed: 2018-04-26
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Vinod Sharma
- Web page: https://patentgrep.com/patent/US12005258B2

## CPC

- A61N 1/36514: {controlled by a physiological quantity other than heart potential, e.g. blood pressure (controlled by two or more physical parameters A61N1/36585)}
- A61B 5/0031: {Implanted circuitry}
- A61B 5/256: Wearable electrodes, e.g. having straps or bands
- A61B 5/29: for permanent or long-term implantation
- A61N 1/36564: {controlled by blood pressure}
- A61N 1/37252: {Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data}
- G16H 20/13: delivered from dispensers
- G16H 40/63: for local operation
- G16H 40/67: for remote operation
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61N 1/3706: {Pacemaker parameters (stimulation threshold A61N1/371)}
- A61N 1/3756: {Casings with electrodes thereon, e.g. leadless stimulators}
- G16H 40/60: for the operation of medical equipment or devices
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- 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

## Abstract

Methods and systems for seamless adjustment of treatment are disclosed. A determination can be made as to whether to intervene with a patient's treatment based on data obtained from implantable electrodes and/or non-implantable electrodes. The data from non-implantable electrodes have a correction factor applied to adjust for less accuracy compared to data acquired from implantable electrodes.

## Claims

### Claim 1

A system for managing patient therapy, the system comprising:
(a) an implantable medical device comprising one or more electrodes configured to be implanted within a patient's body, to acquire first signals corresponding to one or more physiological signals sensed from within the patient's body, and to generate first data transmissions in response to the acquired first signals;
(b) a wearable device comprising one or more electrodes configured to be positioned in contact with an external surface of the patient's body, to acquire second signals corresponding to at least one of the one or more physiological signals sensed from the external surface of the patient's body, and to generate second data transmissions in response to the acquired second signals;
(c) an input/output device to receive the first data transmissions and the second data transmissions; and
(d) one or more processors configured to:
(i) receive the first data transmissions and the second data transmissions,
(ii) calculate a heart failure risk score based on comparing the received first data transmissions and the received second data transmissions to one or more thresholds, and weighting the first data transmissions differently than the second data transmissions,
(iii) determine whether data of the received first data transmissions and the received second data transmissions is indicative of a heart failure worsening episode based on the heart failure risk score, and
(iv) display one of an indication of the heart failure worsening episode or the heart failure risk score on a graphical user interface of a computing device in response to the heart failure worsening episode being detected.

### Claim 2 (depends on 1)

The system of claim 1 wherein the heart failure risk score is weighted such that the second data transmissions is accorded up to 85% weight compared to the first data transmissions being weighted 100%.

### Claim 3 (depends on 1)

The system of claim 1 wherein the heart failure risk score is weighted such that the second data transmissions is accorded up to 90% weight compared to the first data transmissions.

### Claim 4 (depends on 1)

The system of claim 1 wherein the heart failure risk score is weighted such that the second data transmissions is accorded up to 95% weight compared to the first data transmissions.

### Claim 5 (depends on 1)

The system of claim 1 wherein the heart failure risk score is weighted such that the second data transmissions is accorded less weight compared to the first data transmissions.

### Claim 6

A method for managing patient therapy, the method comprising:
a. sensing one or more physiological signals from one or more electrodes associated with an implantable medical device disposed within a patient's body;
b. acquiring first signals corresponding to the one or more physiological signals sensed from within the patient's body and generating first data transmissions in response to the acquired first signals;
c. sensing at least one of the one or more physiological signals from electrodes capable of being positioned over an external surface of the patient's body, acquiring second signals from the external surface of the patient's body and generating second data transmissions in response to the acquired second signals;
d. receiving the first data transmissions and the second data transmissions by an input/output device;
e. receiving the first data transmissions and the second data transmissions via one or more processors,
f. calculating a heart failure risk score based on comparing, via the one or more processors, the received first data transmissions and the received second data transmissions to one or more thresholds and weighting the first data transmissions differently than the second data transmissions,
g. determining, via the one or more processors, whether data of the received first data transmissions and the received second data transmissions is indicative of a heart failure worsening episode based on the heart failure risk score, and
h. adjusting, via the one or more processors, a patient's therapy in response to the heart failure worsening episode being determined.

### Claim 7 (depends on 6)

The method of claim 6 wherein the heart failure risk score is weighted such that the second data transmissions is accorded up to 85% weight compared to the first data transmissions.

### Claim 8 (depends on 6)

The method of claim 6 wherein the heart failure risk score is weighted such that the second data transmissions is accorded up to 90% weight compared to the first data transmissions.

### Claim 9 (depends on 6)

The method of claim 6 wherein the heart failure risk score is weighted such that the second data transmissions is accorded up to 95% weight compared to the first data transmissions.

### Claim 10 (depends on 6)

The method of claim 6 wherein the heart failure risk score is weighted such that the second data transmissions is accorded less weight compared to the first data transmissions.
