IP Library Granted Patent US 12,616,834
Granted Patent B2
US 12,616,834 · App. 17/772,571 · Granted May 5, 2026

Apparatuses, systems, and methods for therapy mode control in therapy devices

Inventor: Christopher Brian Locke (Bournemouth, GB)
Assignee: KCI Manufacturing Unlimited Company
A61N1/36031A61H9/005A61B5/0015A61B5/445A61B5/742A61H2201/5071
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Quick Facts
Patent No.
US 12,616,834
App. No.
17/772,571
Granted
May 5, 2026
Kind
B2
Abstract

This disclosure describes devices, systems, and methods related to therapy devices that are operable in multiple operating modes. An exemplary therapy device is configured to be coupled to a patient and includes a stimulation generator and a controller coupled to the stimulation generator. The controller is configured to transition the stimulation generator from operating in a first operating mode to operating in a second operating mode responsive to determining activity of the patient.

Claims (74)

1 . A control device comprising:

a processor configured to control a therapy device, the therapy device comprising:

a stimulation generator configured to provide stimulation to a tissue site;

a first electrode;

a second electrode;

a first section of electrically conductive adhesive electrically coupled with the first electrode; and

a second section of electrically conductive adhesive electrically coupled with the second electrode, the second section of electrically conductive adhesive separate from the first section of electrically conductive adhesive;

wherein the first section of electrically conductive adhesive and the second section of electrically conductive adhesive are configured to couple the therapy device to a patient; and

a memory coupled to the processor and configured to store instructions, wherein the processor is configured to execute the instructions stored at the memory to:

determine that the patient associated with the therapy device is in an active state;

transition the therapy device from a first operating mode to a second operating mode, wherein the second operating mode is an activity operating mode, wherein the activity operating mode comprises a reduced intensity stimulation operating mode as compared to the first operating mode;

receive a user input indicating a request to enter a break operating mode, wherein the break operating mode is a second reduced intensity stimulation operating mode or a paused therapy mode;

determine a count value of break operating modes in response to receiving the user input indicating the request to enter the break operating mode;

compare the determined count value of break operating modes to a break operating mode threshold; and

determine whether to enter the break operating mode based on the comparison of the determined count value of break operating modes to the break operating mode threshold.

2 . The control device of claim 1 , wherein the activity operating mode comprises an inactive or standby operating mode.

3 . The control device of claim 1 , wherein the stimulation generator is configured to provide electric stimulation therapy.

4 . The control device of claim 1 , wherein the stimulation generator includes a pump configured to provide compression therapy.

5 . The control device of claim 1 , wherein the processor is further configured to transition the therapy device to a third operating mode, wherein the third operating mode is a second activity operating mode or a night time mode.

6 . The control device of claim 1 , further comprising one or more sensors coupled to the processor, wherein the one or more sensors comprise an inertial sensor, a heart rate sensor, a temperature sensor, a moisture sensor, an electrical sensor, or a combination thereof, and wherein the one or more sensors are configured to generate sensor data indicating an activity level of the patient.

7 . A therapy device, comprising:

a stimulation generator configured to provide stimulation therapy to a tissue site of a patient;

a first electrode;

a second electrode;

a first section of electrically conductive adhesive electrically coupled with the first electrode;

a second section of electrically conductive adhesive electrically coupled with the second electrode;

wherein the first section of electrically conductive adhesive and the second section of electrically conductive adhesive have an open circuit configuration when the first section of electrically conductive adhesive and the second section of electrically conductive adhesive are not coupled to the patient;

wherein the first section of electrically conductive adhesive and the second section of electrically conductive adhesive are configured to couple the therapy device to the patient; and

a controller coupled to the stimulation generator and configured to:

transition the stimulation generator from operating in a first operating mode to operating in a second operating mode responsive to determining that the patient is in an active state, wherein the second operating mode includes a second therapy parameter less than a first therapy parameter of the first operating mode, wherein the therapy parameters include voltage, drive voltage, current, duty cycle, compression pressure, or a combination thereof; and

transition the stimulation generator from operating in the first operating mode or the second operating mode responsive to:

receiving a user input indicating a request to enter a break operating mode;

determining a count value of break operating modes in response to receiving the user input indicating the request to enter the break operating mode;

comparing the determined count value of break operating modes to a break operating mode threshold; and

entering the break operating mode in response to the determined count value of break operating modes being less than the break operating mode threshold.

8 . The therapy device of claim 7 , wherein the stimulation generator comprises a pump, and further comprising a pressure sensor coupled to the pump and configured to measure a pressure output by the pump and to send pressure data to the controller, the pressure data indicative of the pressure output.

9 . The therapy device of claim 7 , further comprising a temperature sensor, the temperature sensor configured to measure a temperature of the tissue site of the patient and generate temperature data, wherein the controller is further configured to determine an infection, a perfusion level, or both based on the temperature data.

10 . The therapy device of claim 7 , further comprising a heart rate sensor, the heart rate sensor configured to measure a heart rate of the patient and generate heart rate data, and wherein the controller is further configured to determine an infection, a perfusion level, or both based on the heart rate data.

11 . The therapy device of claim 7 , further comprising an inertial sensor coupled to the therapy device, the inertial sensor configured to measure an inertia of the therapy device and generate inertia data, wherein the controller is further configured to determine an inertia of the patient based on the inertia data.

12 . The therapy device of claim 11 , wherein the controller is further configured to select a reduced power mode or an inactive mode based on comparing the inertia of the patient to one or more inertial thresholds.

13 . The therapy device of claim 11 , wherein the controller further includes a gait analyzer configured to determine a gait based on the inertia data.

14 . The therapy device of claim 7 , further comprising a moisture sensor coupled to the therapy device, the moisture sensor configured to measure a hydration of tissue of the tissue site, humidity of the tissue site, or both, and generate moisture data, wherein the controller is further configured to determine an infection based on the moisture data.

15 . The therapy device of claim 7 , further comprising an electrical sensor coupled to the therapy device, the electrical sensor configured to measure an electrical parameter of the stimulation generator and generate electrical data, wherein the electrical parameter includes voltage, current, or both, and wherein the controller is further configured to determine if the therapy device is misplaced, if the therapy device has been removed, or both, based on the electrical data.

16 . The therapy device of claim 7 , wherein the controller further includes an artificial intelligence (AI) application configured to determine activity, select an operating mode, adjust a threshold, or a combination thereof, based on AI models and sensor data.

17 . The therapy device of claim 7 , wherein the controller is further configured to output a notification via the therapy device, a notification to a remote device of the patient, a notification to a remote device associated with a care provider, or a combination thereof, responsive to determining that a therapy condition has not been satisfied.

18 . A method for providing therapy, the method comprising:

coupling a therapy device to a user, the therapy device comprising:

a stimulation generator configured to provide stimulation to a tissue site;

a sensor;

a first electrode;

a second electrode;

a first section of electrically conductive adhesive electrically coupled with the first electrode;

a second section of electrically conductive adhesive electrically coupled with the second electrode, the second section of electrically conductive adhesive separate from the first section of electrically conductive adhesive;

wherein coupling the therapy device to the user is accomplished by coupling the first section of electrically conductive adhesive and the second section of electrically conductive adhesive to the user; and

identifying a power-on event of the therapy device;

responsive to the power-on event, operating the stimulation generator of the therapy device in a first operating mode, the first operating mode associated with a first therapy parameter;

receiving, from the sensor of the therapy device, sensor data indicating activity by the user;

determining whether the activity satisfies a first activity threshold;

responsive to determining that the activity satisfies the first activity threshold, operating the stimulation generator in a second operating mode, the second operating mode associated with a second therapy parameter, wherein the first therapy parameter is greater than the second therapy parameter, and wherein the second therapy parameter comprises a voltage, a drive voltage, a current, a duty cycle, a compression pressure, or a combination thereof; and

operating the stimulation generator in a break operating mode responsive to:

receiving a user input indicating a request to enter the break operating mode, wherein the break operating mode is a reduced intensity stimulation operating mode or a paused therapy mode;

determining a count value of break operating modes in response to receiving the user input indicating the request to enter the break operating mode;

comparing the determined count value of break operating modes to a break operating mode threshold; and

determining that the determined count value of break operating modes is less than the break operating mode threshold.

19 . The method of claim 18 , wherein the stimulation generator comprises a pump, and further comprising:

receiving, from a pressure sensor, pressure data indicating a pressure applied by the pump;

comparing the pressure to a pressure threshold; and

responsive to determining that the pressure is greater than the pressure threshold, reducing a duty cycle of the pump.

20 . The method of claim 18 , further comprising:

receiving first temperature data from a first temperature sensor coupled to the tissue site;

receiving second temperature data from a second temperature sensor coupled to a second tissue site;

determining a temperature difference based on the first temperature data and the second temperature data;

comparing the temperature difference to a temperature threshold; and

determining whether the tissue site has an infection based on comparing the temperature difference to the temperature threshold.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 9, 2024
From: KCI LICENSING, INC.
To: KCI MANUFACTURING UNLIMITED COMPANY
Reel/Frame 066064/0923 →
CORRECTIVE ASSIGNMENT TO CORRECT THE APPLICATION LISTED ON SCHEDULE OF IP RIGHTS ATTACHED TO ASSIGNMENT AT LINES 55: 71; 89; 116-129; AND 131 NEED TO BE DELETED PREVIOUSLY RECORDED AT REEL: 064788 FRAME: 0823. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Sep 13, 2023
From: KCI LICENSING, INC.
To: 3M INNOVATIVE PROPERTIES COMPANY
Reel/Frame 064886/0479 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 31, 2023
From: KCI LICENSING, INC.
To: 3M INNOVATIVE PROPERTIES COMPANY
Reel/Frame 064788/0823 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 1, 2023
From: LOCKE, CHRISTOPHER BRIAN
To: KCI LICENSING, INC.
Reel/Frame 064448/0529 →
Continuity (2)
Provisional Application 62931384 · Nov 6, 2019
Related Publication 20220395232A1 · Dec 15, 2022
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V.A. Kuznetsov & N.a. Bagautdinov, “Vacuum and Vacuum-Sorption Treatment of Open Septic Wounds,” in II All-Union Conference on Wounds and Wound Infections: Presentation Abstracts, edited by B.M. Kostyuchenok et al. (Mos… [cited by applicant]
V.A. Solovev, Dissertation Abstract, Treatment and Prevention of Suture Failures after Gastric Resection (S.M. Kirov Gorky State Medical Institute, Gorky, U.S.S.R. 1988) (“Solovev Abstract”). [cited by applicant]
V.A.C.® Therapy Clinical Guidelines: A Reference Source for Clinicians; Jul. 2007. [cited by applicant]