IP Library Granted Patent US 11,857,785
Granted Patent B2
US 11,857,785 · App. 17/887,661 · Granted Jan 2, 2024

Systems, methods and devices for electrical stimulation therapy

Inventors: Richard H. Pearce (Cary, NC); Jon Christopher McAuliffe (Jacksonville, FL)
Assignee: Theragen, Inc.
A61N1/36031A61B5/4833A61N1/0464A61N1/0468A61N1/0492A61N1/326A61N1/36034
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Quick Facts
Patent No.
US 11,857,785
App. No.
17/887,661
Granted
Jan 2, 2024
Kind
B2
Abstract

Systems, devices and methods are provided for transcutaneously delivering energy impulses to bodily tissues for therapeutic purposes, such as for enhancing the body's bone healing process in spinal fusion patients. A therapeutic stimulator system comprises a housing for an energy source and a signal generator. The system further includes one or more electrodes coupled to the signal generator. A processor is coupled to the housing and configured to determine usage levels of the signal generator and/or motion data of the housing. The system may include a mobile device that allows the patient to input user status data, such as pain levels, and compare the user status data with the usage levels and/or the motion data, thereby improving patient compliance with a prescribed therapy regimen.

Claims (27)

1. A therapeutic stimulation system for use after a surgical intervention on a patient, the system comprising:

an energy source;

a housing comprising a signal generator coupled to the energy source, wherein the signal generator is configured to generate a therapeutic signal and apply the therapeutic signal through a skin of the patient to a target site;

a sensor coupled to the housing and configured to sense a physiological parameter of the patient; and

a computer-readable program configured for downloading onto a device, the computer-readable program being configured to instruct the device to prompt a user, when the user is the patient, to enter patient status information and further being configured to compare the patient status information with the physiological parameter, wherein the patient status information comprises one or more patient reported outcome measures obtained after the surgical intervention has been completed.

2. The system of claim 1 , wherein the one or more patient reported outcome measures comprises one or more of: level of post-interventional pain, mood, medication use, activity level, and amount of sleep.

3. The system of claim 1 , wherein the physiological parameter includes one or more of: heart rate, heart rate variability, heart rhythm, blood pressure, blood oxygen, blood flow, body temperature, gaze, and gait.

4. The system of claim 1 , wherein the sensor is a motion sensor configured to detect motion of the housing, and the physiological parameter comprises motion data.

5. The system of claim 1 , further comprising a processor within the housing.

6. The system of claim 5 , wherein the processor is configured to determine usage levels of the signal generator, and further wherein the usage levels are based on a period of time that the therapeutic signal is applied to the skin of the patient.

7. The system of claim 6 , wherein the computer-readable program is configured to compare the patient status information with the usage levels.

8. The system of claim 5 , wherein the processor is configured to determine a plurality of motion data obtained from the sensor over a time frame and to group the plurality of motion data into at least one parameter.

9. The system of claim 1 , further comprising one or more electrodes coupled to the signal generator, wherein the energy source is configured to transmit one or more electrical impulses from the electrodes transcutaneously through the outer skin surface to a target location within a spine of the patient.

10. The system of claim 9 , wherein the one or more electrical impulses are sufficient to enhance bone healing in the patient.

11. The system of claim 9 , wherein the one or more electrical impulses have a frequency of about 50 kHz to about 70 kHz.

12. The system of claim 9 , wherein the one or more electrical impulses have an amplitude of about 5 mA to about 10 mA.

13. The system of claim 1 , wherein the computer-readable program is configured to compile the patient status information into an aggregate set of data.

14. The system of claim 1 , wherein the computer-readable program is configured to compare the patient status information with the physiological parameter over a period of time, wherein the period of time is longer than 24 hours.

15. The system of claim 1 , wherein the computer-readable program controls the device to prompt the patient to enter the patient status information a period of time after the signal generator has applied the therapeutic signal.

16. The system of claim 15 , wherein the period of time is at least one hour.

17. The system of claim 1 , wherein the device is wearable on the patient.

18. A therapeutic stimulation system for use after a surgical intervention on a patient, the system comprising:

an energy source;

a housing comprising a signal generator coupled to the energy source, wherein the signal generator is configured to generate a therapeutic signal and apply the therapeutic signal through a skin of the patient to a target site;

a sensor coupled to the housing and configured to sense a physiological parameter of the patient; and

a computer-readable program configured for downloading onto a device, the computer-readable program being configured to instruct the device to prompt the patient to enter a level of post-intervention pain of the patient after the surgical intervention has been completed, and further being configured to compare the level of post-intervention pain with the physiological parameter.

19. The system of claim 18 , wherein the device is wearable on the patient.

Assignments (4)
RELEASE OF SECURITY INTEREST Recorded Feb 24, 2025
From: FORTRESS CREDIT CORP., AS AGENT
To: THERAGEN, INC.
Reel/Frame 070303/0364 →
SECURITY INTEREST Recorded Feb 21, 2025
From: THERAGEN, INC.; NEUROTECH NA, INC.
To: ANKURA TRUST COMPANY, LLC, AS COLLATERAL TRUSTEE
Reel/Frame 070289/0154 →
SECURITY INTEREST Recorded Jan 31, 2023
From: THERAGEN, INC.
To: FORTRESS CREDIT CORP., AS AGENT
Reel/Frame 062546/0644 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 15, 2022
From: PEARCE, RICHARD H.; MCAULIFFE, JON CHRISTOPHER
To: THERAGEN, INC.
Reel/Frame 060805/0425 →
Continuity (3)
Continuation 17506851 · Oct 21, 2021
Provisional Application 63146196 · Feb 5, 2021
Related Publication 20220387783A1 · Dec 8, 2022