US-12616834-B2 - Apparatuses, systems, and methods for therapy mode control in therapy devices

US12616834B2US 12616834 B2US12616834 B2US 12616834B2US-12616834-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.

Inventors

Christopher Brian Locke

Assignees

KCI MANUFACTURING UNLIMITED COMPANY

Dates

Publication Date: 20260505
Application Date: 20201106

Claims (20)

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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a National Stage entry of PCT/IB2020/060478, filed Nov. 6, 2020, which claims the benefit of priority to U.S. Provisional Application No. 62/931,384, filed on Nov. 6, 2019, which is incorporated herein by reference in its entirety. TECHNICAL FIELD Aspects of the present disclosure relate generally to therapy devices, and more specifically, but not by way of limitation, to therapy devices that provide electric stimulation therapy or compression therapy. BACKGROUND Some types of therapy systems provide compression therapy to stimulate blood flow in veins and arteries to promote healing and recovery and/or alleviate particular conditions. Such compression therapy may be provided by electric or mechanical stimulation to a tissue site to stimulate blood flow and muscle activity. With electric type stimulation therapy systems, an electrically conductive adhesive is generally used to adhere the therapy system (e.g., therapy device) to a patient. Such electrically conductive adhesives have relatively low bond/peel strengths as compared to other non-electrically conductive adhesives, and thus may be prone to shifting. Mechanical type stimulation therapy systems apply physical pressure, such as by direct contact (e.g., a massage head) or by a fluid (e.g., pressurized oxygen). With both types of stimulation therapy systems, placement is important to facilitate proper and intended functioning of the therapy system. To illustrate, if the electrodes of an electric type stimulation therapy system are not in an intended or designed position relative to tissue intended to receive treatment, the treatment may be less effective and/or cause discomfort (e.g., pain) to the patient. As another illustration, similarly, if the physical force/pressure of the compression therapy is not in an intended or designed position relative to tissue intended to receive treatment, the treatment may be less effective and/or cause discomfort (e.g., pain) to the patient. Conventional electrically conductive adhesives have a bond/peel strength that is designed to not cause damage to tissue during application or removal. Additionally, such conventional devices may be designed to be easily removed so that a patient can walk or workout without the device interfering or providing therapy or so that the patient can remove the therapy device when the patient desires a break or to sleep. However, because of such bond strength limitations and operational limitations, such electrically conductive adhesives may allow removal of the therapy device and repositioning or movement of the therapy device after application of the therapy device to a tissue site. Additionally, compression devices, such as compression sleeves, may be removed or repositioned by a user, such as when the patient is active. Thus, conventional stimulation therapy systems may not be repositioned properly or may become misaligned during use or from impact. Accordingly, the therapy devices may be reapplied incorrectly and may have reduced effectiveness and/or cause discomfort. SUMMARY This disclosure describes apparatus, systems, methods, and computer-readable storage devices for controlling therapy devices (e.g., a stimulation therapy device) in multiple operating modes, i.e., two or more operating modes. For example, a controller (e.g., a processor or other hardware) of a therapy device may be configured to operate a stimulation generator of the therapy device in one of multiple operating modes, such as a first operating mode (e.g., a “normal power operating mode”), a second operating mode (e.g., an “inactive or standby mode”), or a third operating mode (e.g., an activity or “reduced power operating mode”). Each of the different operating modes may provide respective benefits, and being able to operate the therapy device (e.g., stimulation generator thereof) in the different operating modes improves the flexibility of the therapy device, as compared conventional therapy devices or systems that are only configured to operate in a single operating mode. Such improved flexibility may enable the device to be designed to be non-removable throughout the day or in between servicing by a care provider. Therefore, such devices may alleviate the problems of misalignment that conventional patient removable therapy device have and may provide effective therapy in a wider range of conditions, such as when the user is active or when the user would like a break or reduced intensity therapy. As an illustrative, non-limiting example, an activity or reduced power operating mode may provide reduced intensity therapy or temporarily cease therapy when a user is active, such as walking, working out, etc. To illustrate, the muscles of the tissue site may be in use for the activity, and thus stimulation or compression induced by the therapy device to the muscles may not be as effective and/or may cause discomfort or the activity to be impaired. By enteri