Systems and methods for therapeutic electrical stimulation

• US 8,386,032 B2
• Filed: 11/21/2008
• Issued: 02/26/2013
• Est. Priority Date: 01/07/2008
• Status: Active Grant

• Current Assignee: DJO LLC (Enovis Corp.)
• Original Assignee: EMPI Incorporated (Enovis Corp.)
• Inventors: Bachinski, Thomas Jerome, Shindley, Richard Paul, Lutz, Dennis
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US12/276,068
• Publication Number:
  US 20090182393A1
• Time in Patent Office: 1,558 Days
• Field of Search: 607/2, 607/46, 607/115, 607/117
• US Class Current: 607/2
• 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 patch configured to mate with a therapeutic electrical stimulation device, comprising:

a shoe connected to a first side of the patch, the shoe including a first end and a second end, and a body extending in a longitudinal direction from the first end to the second end, and having first and second surfaces, the first end of the shoe defining at least one port, and the first surface of the shoe defining a connection member; and

at least one conductor positioned in the at least one port of the first end of the shoe, the at least one conductor being electrically connected to at least one electrode;

wherein the shoe is configured for sliding insertion into a receptacle defined by a controller of the therapeutic electrical stimulation device so that the at least one conductor is connected to the controller to deliver electrical current from the controller, through the at least one conductor, and to the at least one electrode, and

wherein the connection member is configured to displace a non-conductive detent defined by the controller and to be at least partially captured by the detent to retain the shoe within the receptacle.

2. The patch of claim 1, wherein the at least one electrode extends through the second surface of the shoe into the insulating layer.

3. The patch of claim 2, wherein the at least one electrode includes a first portion that extends in the longitudinal direction and is connected to the at least one conductor of the shoe, and the at least one electrode includes a second portion that extends generally perpendicular with respect to the longitudinal direction through the second surface of the shoe.

4. The patch of claim 1, wherein the shoe defines a channel sized to receive a railway of the controller as the shoe is slid into the receptacle.

5. The patch of claim 4, wherein the channel is defined in multiple surfaces of the shoe.

6. The patch of claim 1, wherein the patch is carried in a garment configured to be worn by a user.

7. 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,

a patch including a first portion and a second portion; and

a receptacle including at least one conductor, the at least one conductor being electrically coupled to the electrical signal generator to receive the electrical signal, the receptacle arranged and configured to receive the first portion of the patch to electrically couple the first portion of the patch with the at least one conductor, the receptacle defining a non-conductive detent positioned to be displaced by the second portion of the patch and to capture the second portion of the patch to retain the first portion within the receptacle.

8. The system of claim 7, 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 of the shoe is electrically coupled to one of the electrodes; and

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

9. The system of claim 8, 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.

10. The system of claim 7, 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.