Electrical stimulation device and method for therapeutic treatment and pain management

• US 9,669,212 B2
• Filed: 02/05/2015
• Issued: 06/06/2017
• Est. Priority Date: 04/19/2005
• Status: Active Grant

• Current Assignee: DJO LLC (Enovis Corp.)
• Original Assignee: DJO LLC (Enovis Corp.)
• Inventors: Mueller, Pierre-Yves, Lampo, Pierre-Yves, Schonenberger, Klaus, Buhlmann, Felix, Masko, Marshall, Guex, Steve, Moore, Gary L., Lavalley, Patrick
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US14/615,387
• Publication Number:
  US 20150151124A1
• Time in Patent Office: 852 Days
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/322 Electromedical brushes, combs, massage devices
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A disposable electrical stimulation device and method for providing therapeutic treatment and pain management in a convenient, compact configuration. Electrode size and shape and relative configuration can be varied according to an intended application and use, or a universal configuration can be provided for use on almost any area of the body. The common structure of communicatively coupled dual electrodes including control circuitry and a power source accommodates a range of different sizes, configurations, stimulation treatment intensities, and other physical and electrical characteristics that can be pre-customized and packaged for specific, limited time use. The device can therefore be used in methods of providing therapy, managing pain, and achieving other treatment goals by electrical stimulation.

Claims

1. A compact electrical stimulation device comprising:

a first disposable and self-adhesive electrode portion including a first connector;

a second disposable and self-adhesive electrode portion, separate from the first electrode portion, the second electrode portion including a second connector;

a control module including a third connector selectively attached to the first connector of the first electrode portion and comprising;

at least one preprogrammed treatment program comprising at least one customizable treatment characteristic;

a status indicator adapted to indicate at least one of a characteristic of the device and a characteristic of the preprogrammed treatment program; and

a first and a second control input adapted to customize the at least one treatment characteristic within a predetermined range, the first control input tactilely differentiated from the second control input;

a flexible cable coupled at a first end to the control module and including a fourth connector at a second end selectively attached to the second connector of the second electrode portion; and

a power source housed in a structure also having the control module and electrically coupled to the control module to power the electrical stimulation device.

2. The compact electrical stimulation device of claim 1, wherein the power source is replaceable.

3. The compact electrical stimulation device of claim 1, wherein the control module is disposable when the power source is depleted.

4. The compact electrical stimulation device of claim 1, wherein the at least one preprogrammed treatment program is selected from a group consisting of a transcutaneous electrical nerve stimulation (TENS) program, a muscle stimulation program, a massage program, a bone growth stimulation program, and a cartilage growth stimulation program.

5. The compact electrical stimulation device of claim 1, wherein the status indicator comprises a light emitting diode (LED).

6. The compact electrical stimulation device of claim 5, wherein the control module comprises a transparent or semi-transparent housing, and wherein the status indicator is embedded within the control module housing.

7. The compact electrical stimulation device of claim 1, further comprising a strain relief connector proximate the second end.

8. The compact electrical stimulation device of claim 1, wherein each of the first, second, third, and fourth connectors are snap connectors.

9. The compact electrical stimulation device of claim 1, wherein the at least one customizable treatment characteristic comprises a stimulation intensity, and wherein the predetermined range varies from a preset minimum stimulation intensity to a preset maximum stimulation intensity.

10. The compact electrical stimulation device of claim 1, wherein the first and second control inputs are integrated in a flexible dual-function keypad, and wherein a first zone of the keypad comprises the first control input and a second zone of the keypad comprises the second control input.

11. The compact electrical stimulation device of claim 10, wherein the first zone comprises a depressible outer ring portion of the keypad and the second zone comprises a depressible inner button portion of the keypad.

12. A compact and disposable electrical stimulation device comprising:

a first disposable and self-adhesive electrode portion and a separate second disposable and self-adhesive electrode portion, the second electrode portion including a first connector;

a control module integrated with the first electrode portion and comprising;

at least one preprogrammed treatment program comprising at least one customizable treatment characteristic; and

a first and a second control input adapted to customize the at least one treatment characteristic within a predetermined range, the first control input tactilely differentiated from the second control input;

a flexible cable coupled at a first end to the control module and including a second connector at a second end selectively attached to the first connector of the second electrode portion; and

a power source electrically coupled with the control module and integrated with one of the first or second electrode portions.

13. The compact electrical stimulation device of claim 12, wherein the at least one preprogrammed treatment program is selected from a group consisting of a transcutaneous electrical nerve stimulation (TENS) program, a muscle stimulation program, a massage program, a bone growth stimulation program, and a cartilage growth stimulation program.

14. The compact electrical stimulation device of claim 12, wherein the control module further comprises a status indicator adapted to indicate at least one of a characteristic of the device and a characteristic of the preprogrammed treatment program.

15. The compact electrical stimulation device of claim 14, wherein the status indicator comprises a light emitting diode (LED).

16. A compact electrical stimulation device comprising:

a first disposable and self-adhesive electrode portion including a first connector;

a second disposable and self-adhesive electrode portion, separate from the first electrode portion, the second electrode portion including a second connector;

a control module including a third connector selectively attached to the first connector of the first electrode portion and comprising;

at least one preprogrammed treatment program comprising at least one customizable treatment characteristic;

a status indicator adapted to indicate at least one of a characteristic of the device and a characteristic of the preprogrammed treatment program; and

a first and a second control input adapted to customize the at least one treatment characteristic within a predetermined range, the first control input tactilely differentiated from the second control input;

a flexible cable coupled at a first end to the control module and including a fourth connector at a second end for selectively attached to the second connector of the second electrode portion; and

a power source electrically coupled to the control module by the flexible cable.

17. The compact electrical stimulation device of claim 16, wherein the power source is integrated in the second electrode portion.