Systems and methods for therapeutic electrical stimulation

• US 9,737,705 B2
• Filed: 06/09/2016
• Issued: 08/22/2017
• Est. Priority Date: 01/07/2008
• Status: Active Grant

• Current Assignee: DJO LLC (Enovis Corp.)
• Original Assignee: DJO LLC (Enovis Corp.)
• Inventors: Bachinski, Thomas Jerome, Shindley, Richard Paul, Lutz, Dennis
• Primary Examiner(s): Johnson, Nicole F
• Application Number:
  US15/178,468
• Publication Number:
  US 20160287866A1
• Time in Patent Office: 439 Days
• Field of Search: 607 2, 607 46
• CPC Class Codes: A61B 2560/0456 Apparatus provided with a docking unit
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0468 Specially adapted for promoting wound healing
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/048 Electrodes characterised by a specific connection between lead and electrode
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/323 Interference currents, i.e. treatment by several currents summed in the body
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/3603 Control systems
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 2001/083 : Monitoring integrity of contacts, e.g. by impedance measurement
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

A patch for a therapeutic electrical stimulation device includes a shoe connected to the first side of the patch, the shoe including a body extending in a longitudinal direction from a first end to a second end, and having first and second surfaces, the first end of the shoe defining at least two ports, and the first surface of the shoe defining a connection member. The patch also includes at least one conductor positioned in the ports of the first end of the shoe. The shoe is configured for sliding insertion into a receptacle defined by a controller so that the conductor is connected to the controller to deliver electrical current from the controller, through the conductor, and to the electrodes, and the connection member is at least partially captured by a detent defined by the controller in the receptacle to retain the shoe within the receptacle.

Claims

1. A system for delivering therapeutic electrical stimulation, the system including a controller comprising:

a power source including a rechargeable battery;

an electrical signal generator powered by the power source and generating an electrical signal, and a receptacle including at least one conductor, the conductor being electrically coupled to the electrical signal generator to receive the electrical signal, the receptacle arranged and configured to receive a portion of a patch to electrically couple a portion of the patch with the conductor, the receptacle defining a detent positioned to capture the portion of the patch to retain the portion within the receptacle.

2. The system of claim 1, further comprising the patch for a therapeutic electrical stimulation device, the patch comprising:

an insulating layer having a first side and a second side;

a shoe connected to the first side of the patch and including at least two conductors, wherein the shoe is configured for insertion into the receptacle of the controller;

at least two electrodes adjacent the second side of the patch, wherein each conductor is electrically coupled to one of the electrodes; and

an adhesive layer connected to the second side of the insulating layer.

3. The system of claim 2, wherein the shoe comprises a first portion that is normal to the first side of the insulating layer and a second portion that is angled from the first portion.

4. The system of claim 3, wherein the second portion is angled about ninety degrees from the first portion.

5. The system of claim 2, wherein the shoe includes a member that is partially captured by the detent defined by the controller in the receptacle to retain the shoe within the receptacle.

6. The system of claim 1, wherein the controller operates to generate electrical signals for transcutaneous electrical nerve stimulation, drug delivery, iontophoresis therapy, edema reduction, wound healing, or interferential current therapy.

7. The system of claim 1, further comprising the patch for a therapeutic electrical stimulation device.

8. The system of claim 7, wherein the patch comprises:

an insulating layer having a first side and a second side.

9. The system of claim 8, further comprising:

at least two conductors;

at least two electrodes adjacent the second side of the patch, wherein each conductor is electrically coupled to one of the electrodes; and

an adhesive layer connected to the second side of the insulating layer.

10. The system of claim 1, wherein the controller comprises an outer protective shell formed of an upper housing and a lower housing, wherein a lower edge of the upper housing is configured to be connected with an upper edge of the lower housing.

11. The system of claim 9, wherein the upper housing and the lower housing comprise a material selected from the group consisting of plastic and metal.

12. The system of claim 9, wherein a fastener connects the upper housing to the lower housing, wherein the fastener is selected from the group consisting of an adhesive, a screw, and a latching mechanism.

13. The system of claim 9, wherein the upper housing and lower housing cooperate to enclose the rechargeable battery and electrical circuitry.

14. The system of claim 1, wherein the receptacle is a keyed receptacle configured to allow connection of the controller with various types of patches.

15. The system of claim 1, wherein the controller includes a user interface having a power button.

16. The system of claim 14, wherein the power button is configured to turn the controller ON when first depressed and to turn the controller OFF when depressed again.

17. The system of claim 9, wherein the controller is configured to generates a voltage potential between the electrodes, such that in operation current enters a user'"'"'s skin through one electrode, passes through the skin, and then returns through the other electrode.

18. The system of claim 1, wherein the controller comprises an auxiliary charging port selected from the group consisting of a USB port and a micro-USB port.

19. The system of claim 1, wherein the device includes electrical circuitry configured to program the controller, and wherein the controller includes a computer readable media or a flash memory configured to be rewritten with new therapy programs to enhance the functionality of the controller.

20. The system of claim 1, wherein the device is configured to provide transcutaneous electrical nerve stimulation, wherein the controller is configured to generate electrical impulses and supply the electrical impulses to the patch, and wherein the patch is configured to receive the electrical impulses from the controller to supply the electrical impulses to a therapeutic location, wherein the therapeutic location is a patient'"'"'s skin.

21. The system of claim 1, wherein the patch comprises an electrically conductive adhesive layer configured to connect with the patient'"'"'s skin.

22. The system of claim 1, further comprising a wireless personal area networking device.

23. The system of claim 21, wherein the wireless personal area networking device is a communication device selected from the group consisting of a Bluetooth™

communication device and a WiFi communication device.

24. The system of claim 22, wherein the communication device is configured to download different firmware to alter the operation of the controller.

25. The system of claim 1, further comprising at least one additional device, wherein the two or more devices are in data communication with each other to synchronize therapies provided by each respective device.

26. The system of claim 24, wherein a wireless communication device is used to communicate between the two or more devices via a data communication network selected from the group consisting of an internet, a local area network, and an intranet.

27. The system of claim 1, wherein the controller comprises firmware configured to provide a therapy to a particular part of the body.

28. The system of claim 1, wherein the controller is programmed to adjust a therapy over a specific time.

29. The system of claim 1, further comprising at least one additional controller, wherein the controllers are programmed to communicate with each other to synchronize a therapy that is delivered to a user, thereby forming a body area network.

30. The system of claim 28, wherein the body area network is formed through wireless communication.