Devices, systems and methods for treating pain with electrical stimulation

• US 9,061,148 B2
• Filed: 08/08/2012
• Issued: 06/23/2015
• Est. Priority Date: 09/22/2011
• Status: Active Grant

• Current Assignee: DJO LLC (Enovis Corp.)
• Original Assignee: DJO LLC (Enovis Corp.)
• Inventors: Bachinski, Thomas Jerome, Silvola, Dain, Moore, Michael, Dave, Jay, Winn, Joseph
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US13/570,004
• Publication Number:
  US 20130085551A1
• Time in Patent Office: 1,049 Days
• Field of Search: 607/46, 607/59, 607/145, 607/146
• US Class Current: 1/1
• CPC Class Codes: A61H 2201/0153 hand-held
• CPC Class Codes: A61H 2201/0157 portable
• CPC Class Codes: A61H 2201/0184 by raising an alarm
• CPC Class Codes: A61H 2201/0188 Illumination related features
• CPC Class Codes: A61H 2201/10 with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
• CPC Class Codes: A61H 2201/1604 Head
• CPC Class Codes: A61H 2201/1609 Neck
• CPC Class Codes: A61H 2201/1635 Hand or arm, e.g. handle hand-held, A61H2201/0153; fore-arm support, A61H2003/006
• CPC Class Codes: A61H 2201/1685 interchangeable modular devices, A61H2201/0107
• CPC Class Codes: A61H 2201/5007 computer controlled
• CPC Class Codes: A61H 2201/501 connected to external computer devices or networks
• CPC Class Codes: A61H 2201/5012 using the internet
• CPC Class Codes: A61H 2201/5028 Contact activation, i.e. activated at contact with a surface of the user to be treated
• CPC Class Codes: A61H 2201/5035 Several programs selectable
• CPC Class Codes: A61H 2201/5043 Displays
• CPC Class Codes: A61H 2201/5048 Audio interfaces, e.g. voice or music controlled
• CPC Class Codes: A61H 2201/5082 Temperature sensors
• CPC Class Codes: A61H 2205/02 Head
• CPC Class Codes: A61H 2205/022 Face
• CPC Class Codes: A61H 2205/04 neck
• CPC Class Codes: A61H 2205/062 : Shoulders
• CPC Class Codes: A61H 2205/065 : Hands
• CPC Class Codes: A61H 2205/081 : Back
• CPC Class Codes: A61H 2205/10 : Leg
• CPC Class Codes: A61H 2205/12 : Feet
• CPC Class Codes: A61H 2230/065 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/605 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/655 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 23/02 : with electric or magnetic drive
• CPC Class Codes: A61H 39/002 : Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61H 39/04 : Devices for pressing such points, e.g. Shiatsu or AcupressureMassage or pressure on general areas A61H9/00 - A61H23/00
• CPC Class Codes: A61H 39/08 : Devices for applying needles to such points, i.e. for acupuncture ; Acupuncture needles or accessories therefor
• CPC Class Codes: A61N 1/0456 : Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36021 : for treatment of pain
• CPC Class Codes: A61N 1/36034 : specified by the stimulation parameters
• CPC Class Codes: A61N 1/37264 : Changing the program; Upgrading firmware

Abstract

Devices, systems and methods are provided for treating migraine headaches and other conditions by non-invasive electrical stimulation of nerves and other tissue. A hand-held device includes a housing with a controller having a signal generator, an electrode for delivering electrical signals, and a conductive surface configured as a return path for the electrical signals. In certain implementations, the electrode is repositionable with respect to the housing. The patient can self-apply the hand-held device by pressing it against areas in need of pain relief. The device may include a pressure-sensitive gating switch to control delivery of the stimulation therapy. In certain embodiments, the electrode is a rollerball electrode. The device may include a chamber for retaining and dispensing conductive gel to the therapy site. In certain approaches, the device includes an electrode support for coupling an electrical stimulation system to the head for hands-free electrical stimulation therapy.

Claims

1. A non-invasive electrical stimulation device, comprising:

a housing having an exterior surface;

a chamber within the housing configured for holding a gel;

a controller having a signal generator disposed within the housing, wherein the signal generator has a first signal line and a second signal line;

a port in the exterior surface of the housing and coupled to the controller, the port configured to receive an input from an external source, the controller further configured to implement stimulation protocols based on information downloaded to the controller through the port;

a conductive surface coupled to the exterior surface of the housing and being in electrical communication with the first signal line of the signal generator; and

a rollerball electrode in fluid communication with the chamber, the rollerball electrode configured to transmit electrical stimulation through a patient'"'"'s skin to a nerve beneath the skin and configured to rotate and apply a conductive gel that enhances electro-stimulation therapy delivered through the rollerball electrode to a patient, the electrical stimulation based on the stimulation protocols implemented by the controller.

2. The device of claim 1, wherein the chamber is removable from the housing.

3. The device of claim 1, wherein the chamber is fixedly coupled to the housing.

4. The device of claim 1, wherein the housing has a socket with a lip and a collar, and wherein the electrode is positioned within the socket between the lip and the collar.

5. The device of claim 4, wherein the chamber includes an electrically conductive element.

6. The device of claim 1, wherein the conductive surface is coupled to a distal portion of the housing.

7. The device of claim 6, wherein the conductive surface includes an inner portion and an outer portion, wherein the inner portion and outer portion are electrically and physically coupled, and the outer portion is formed from a conductive gel.

8. The device of claim 7, wherein the inner portion is formed from a conductive metal.

9. The device of claim 1, wherein the chamber comprises an aperture configured to promote airflow into the chamber as the gel is delivered.

10. The device of claim 1, wherein the housing comprises a display configured to indicate a status of the stimulation protocol.

11. The device of claim 1, the controller further configured to implement firmware updates based on the input received through the port.

12. The device of claim 1, wherein the input received through the port comprises at least one of an electrical connector configured to recharge a battery of the device, an external power supply, and data uploaded to the device through a USB connection.