Systems and methods for therapeutic electrical stimulation

• US 9,381,353 B2
• Filed: 11/20/2015
• Issued: 07/05/2016
• 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:
  US14/948,189
• Publication Number:
  US 20160074658A1
• Time in Patent Office: 228 Days
• Field of Search: 607/2, 607/115, 607/117
• US Class Current: 1/1
• 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 for a therapeutic electrical stimulation device, the patch including an insulating layer having a first side and a second side having at least two electrodes positioned adjacent thereto, the patch further comprising:

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; and

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

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

2. The patch of claim 1, wherein the electrodes extend through the second surface of the shoe into the insulating layer.

3. The patch of claim 2, wherein each of the electrodes includes a first portion that extends in the longitudinal direction and is connected to one of the two conductors of the shoe, and each of the electrodes 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. A method of delivering therapeutic electrical stimulation, the method comprising:

providing the patch of claim 4, positioning a channel formed by the shoe of the patch with the railway formed in a receptacle of the controller;

advancing the controller in a first direction along the railway toward the patch to insert the shoe of the patch into the receptacle of the controller; and

allowing a member of the shoe engage a detent formed by the controller to capture the shoe within the controller and to form an electrical connection between the controller and the patch.

7. The method of claim 6, further comprising:

moving the member in a first direction to uncouple the detent from the member of the shoe; and

moving the shoe in a second direction opposite to the first direction to remove the patch from the controller.

8. The method of claim 6, further comprising advancing the controller in a second direction to cause the controller to engage with the shoe.

9. The method of claim 7, wherein the second direction is substantially perpendicular to the first direction.

10. The method of claim 6, further comprising:

operating the therapeutic electrical stimulation device in a first mode by executing a first firmware algorithm;

downloading a second firmware algorithm;

installing the second firmware algorithm onto the therapeutic electrical stimulation device; and

executing the second firmware algorithm to operate the therapeutic electrical stimulation device in a second mode.

11. The method of claim 10, wherein the first mode provides a transcutaneous electrical nerve stimulation therapy, and wherein the second mode is different than the first mode.

12. The method of claim 10, wherein the second mode provides an iontophoresis therapy.

13. The method of claim 10, further comprising purchasing the second firmware algorithm before downloading the second firmware algorithm.

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