Devices, systems and methods for treating pain with electrical stimulation

• US 9,737,709 B2
• Filed: 06/19/2015
• Issued: 08/22/2017
• 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:
  US14/744,335
• Publication Number:
  US 20150360027A1
• Time in Patent Office: 795 Days
• 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 controller disposed within the housing, the controller including a programmable processor and a signal generator, the processor configured to receive waveform information and output stimulation control signals, the signal generator configured to receive the stimulation control signals and generate corresponding electrical stimulation waveforms, wherein the signal generator has a first signal line and a second signal line;

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

an electrode that is repositionable with respect to the housing, the electrode having a surface for contacting a patient'"'"'s skin and configured to transmit the electrical stimulation waveforms through the patient'"'"'s skin to a nerve beneath the skin, the electrode electrically discontinuous from the second signal line when in a first position and in electrical communication with the second signal line when in a second position.

2. The electrical stimulation device of claim 1, further comprising a port in the exterior surface of the housing, the port coupled to the programmable processor, wherein the processor is configured to receive the waveform information from an external source through the port.

3. The electrical stimulation device of claim 2, wherein the waveform information received in the programmable processor through the port programs the processor to adjust at least one characteristic of the electrical stimulation waveforms.

4. The electrical stimulation device of claim 1, wherein the electrical stimulation waveforms have predetermined amplitudes and frequencies that are fixed.

5. The electrical stimulation device of claim 1, wherein the electrical stimulation waveforms vary in response to waveform information received in the programmable processor.

6. The electrical stimulation device of claim 5, wherein the waveform information is received in the programmable processor via a port in the exterior surface of the housing.

7. The electrical stimulation device of claim 2, wherein the waveform information includes frequency of the electrical stimulation waveforms.

8. The electrical stimulation device of claim 2, wherein the waveform information includes amplitude of the electrical stimulation waveforms.

9. The electrical stimulation device of claim 2, wherein the waveform information includes pulse width or pulse shape of the electrical stimulation waveforms.

10. The electrical stimulation device of claim 2, wherein the waveform information received in the programmable processor through the port programs the processor to adjust the electrical stimulation waveforms over a specific time according to a programmed schedule.

11. The electrical stimulation device of claim 1, wherein the waveform information received in the programmable processor includes stimulation protocols in a prescribed treatment regimen, wherein the waveform information programs the processor to adjust the electrical stimulation waveforms according to the prescribed treatment regimen.

12. The electrical stimulation device of claim 2, wherein the waveform information received in the programmable processor through the port programs the processor to output stimulation control signals that generate a first, low frequency electrical stimulation waveform followed by a second, high amplitude electrical stimulation waveform.

13. The electrical stimulation device of claim 2, wherein the processor receives the waveform information from a USB connection through the port.

14. The electrical stimulation device of claim 1, wherein the processor receives the waveform information wirelessly from an external source, and wherein the waveform information programs the processor to adjust at least one characteristic of the electrical stimulation waveforms.

15. A system for transmitting electrical stimulation through a patient'"'"'s skin to a nerve beneath the skin, the system comprising:

a hand-held electrical stimulation device comprising

a housing enclosing a programmable processor and a signal generator, the processor configured to receive stimulation protocols through a port in an exterior surface of the housing, the processor further configured to output stimulation control signals, the signal generator configured to receive the stimulation control signals and generate corresponding electrical stimulation waveforms, wherein the signal generator has a first signal line and a second signal line,

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

an electrode that is repositionable with respect to the housing, the electrode having a surface for contacting a patient'"'"'s skin and configured to transmit electrical stimulation through the patient'"'"'s skin to a nerve beneath the skin, the electrode electrically discontinuous from the second signal line when in a first position and in electrical communication with the second signal line when in a second position, the electrical stimulation transmitted to the nerve based on the stimulation protocols received in the programmable processor; and

a docking station in data communication with a communication network, the docking station configured to receive the hand-held electrical stimulation device and download the stimulation protocols to the programmable processor through the port when the hand-held electrical stimulation device is received in the docking station.

16. The system of claim 15, wherein the stimulation protocols include a prescribed treatment regimen downloaded to the docking station via the communication network.

17. The system of claim 15, wherein the stimulation protocol received in the programmable processor through the port programs the processor to adjust at least one characteristic of the electrical stimulation waveforms.

18. The system of claim 17, wherein the at least one characteristic includes at least one of frequency, amplitude, pulse width, pulse shape, and duration of the electrical stimulation waveforms.

19. The system of claim 15, wherein the hand-held electrical stimulation device is configured to upload electrical stimulation waveform data to the docking station via the port when the hand-held electrical stimulation device is received in the docking station.

20. The system of claim 15, wherein the hand-held electrical stimulation device further comprises a rechargeable battery, and wherein the port receives an electrical connector configured to recharge the battery.