Topical analgesia using electrical and vibration stimuli

• US 8,121,696 B2
• Filed: 01/21/2008
• Issued: 02/21/2012
• Est. Priority Date: 02/02/2007
• Status: Active Grant

• Current Assignee: Innova Medical Design, Llc.
• Original Assignee: Rommel P. Vallero
• Inventors: Vallero, Rommel P.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US12/017,324
• Publication Number:
  US 20080188779A1
• Time in Patent Office: 1,492 Days
• Field of Search: 607/46
• US Class Current: 607/46
• CPC Class Codes: A61M 5/422 Desensitising skin
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

The present invention is an electrode with one or more conductive surfaces and one or more access windows allowing needles, lancets and other similar objects to pass through or near the electrode and into the underlying skin layer. The electrode adheres to skin and surrounding mild electrical and vibration stimulation acts to mask the pain signals caused when sharp objects penetrate the skin. The stimulation is delivered by an attachable electrical unit designed to generate both the TENS and vibration stimuli while connected to the electrode. In addition, a flap which is attached to the electrode may serve as a bandage type dressing by flipping down over the access window(s) once the procedure is done. The present invention is an electrode with one or more electrically isolated conductive surfaces coupled to a TENS and vibration generating unit. It is designed to allow access to underlying skin and is meant to be easily produced, with the electrode being disposable after each patient use.

Claims

1. A method for providing topical analgesia during a procedure, comprising:

attaching an electrode to a patient'"'"'s skin, the electrode having one or more conductive surfaces and at least one access point for allowing objects to pass through the at least one access point and into the patient'"'"'s skin;

attaching a module to the electrode;

generating, using the module, electrical energy in order to deliver an electrical stimuli through the electrode to the patient'"'"'s skin to provide an analgesic effect;

generating, using the module, vibration to create a vibration stimuli through the electrode to the patient'"'"'s skin to provide an additional analgesic effect; and

flipping down a flap hinged to the electrode over the at least one access point to act as a bandage dressing after the procedure is completed, wherein the electrode and flap remain on the patient to act as a bandage.

2. The method of claim 1, wherein the electrode comprises:

at least one electrically conductive layer for conducting the electrical stimuli from the module;

at least one electrically conductive adhesive layer, for adhering the electrically conductive layer to the patient'"'"'s skin; and

at least one electrically insulating layer, covering at least a portion of the electrically conductive layer.

3. The method of claim 1, wherein the step of attaching the module to the electrode further comprises the step of attaching the module to the electrode using one or more of ferromagnetic/electrically conductive discs, conductive buttons, conductive leads, conductive tabs, conductive hooks, conductive snaps, conductive adhesive, and hook and loop fastener to allow transmission of vibration and electrical energy.

4. The method of claim 1 further comprising the steps of:

inputting a control signal to the module to control the intensity and duration of the electrical stimuli and vibration; and

controlling intensity and duration of the electrical stimuli and vibration using a controller in the module.

5. The method of claim 4, further comprising the steps of:

initially ramping up one or more of electrical stimuli and vibration using the controller, to avoid surprising the patient;

generating randomly timed bursts of one or more of electrical stimuli and vibration to distract the patient from the procedure; and

automatically generating, using the module, electrical energy and vibration when connected to the electrode and automatically discontinuing generation of electrical energy and vibration when not in use.

6. The method of claim 4, further comprising the step of indicating, using an LED, at least one or more of the status of the controller, battery status, operation of the electrical and vibration stimuli and patient physiology.

7. The method of claim 4, further comprising the step of displaying on a display, at least one or more of the status of the controller, battery status, operation of the electrical and vibration stimuli and patient physiology.

8. The method of claim 4, further comprising the step of generating one or more of a light display and sounds, for distracting the patient during the procedure.

9. The method of claim 1, wherein the access point comprises an orifice, wherein the step of attaching the electrode further comprises the step of:

inserting an object through the orifice and puncturing the patient'"'"'s skin, such that the electrode surrounds the object and provides electrical and vibration stimuli to mask pain signals in the patient'"'"'s skin.

10. An apparatus for providing topical analgesia during a procedure, comprising:

an electrode for attaching to a patient'"'"'s skin, the electrode having one or more conductive surfaces and one or more access points for allowing objects to pass through the access point and into the patient'"'"'s skin;

a module, attachable to the electrode, for generating electrical energy in order to deliver an electrical stimuli through the electrode and to the patient'"'"'s skin to provide an analgesic effect; and

a flap, hinged to the electrode, acting as a bandage dressing by flipping down over the one or more access points after the procedure is completed, wherein the electrode and flap remain on the patient to act as a bandage,

wherein the electrode adheres to the patient'"'"'s skin and the electrical stimuli act to mask pain signals caused when the objects penetrate the patient'"'"'s skin.

11. The apparatus of claim 10, wherein the electrode comprises:

at least one electrically conductive layer for conducting the electrical stimuli from the module;

at least one electrically conductive adhesive layer, for adhering the electrically conductive layer to the patient'"'"'s skin; and

at least one electrically insulating layer, covering at least a portion of the electrically conductive layer.

12. The apparatus of claim 10, further comprising attachment means for attaching the module to the electrode, the attachment means comprising one or more of ferromagnetic/electrically conductive discs, conductive buttons, conductive leads, conductive tabs, conductive hooks, conductive snaps, conductive adhesive, and hook and loop fastener, to allow transmission of electrical energy.

13. The apparatus of claim 10 wherein the module includes:

a controller for controlling intensity, timing, and duration of the electrical stimuli; and

an input means for inputting a control signal to control the intensity and duration of the electrical stimuli.

14. The apparatus of claim 13, wherein the controller initially ramps up electrical stimuli, generates randomly timed bursts of electrical stimuli, and automatically actuates the module to generate electrical energy when connected to the electrode and automatically actuates the module to discontinue generation of electrical energy when not in use.

15. The apparatus of claim 13, wherein the module further comprises an LED for indicating at least one or more of the status of the controller, battery status, operation of the electrical stimuli, and patient physiology.

16. The apparatus of claim 13, wherein the module further comprises a display for displaying at least one or more of the status of the controller, battery status, operation of the electrical stimuli, and patient physiology.

17. The apparatus of claim 13, wherein the module further comprises one or more of a light display and a sound generator, for distracting the patient during the procedure.

18. The apparatus of claim 10, wherein the access point comprises a window formed in the electrode, for allowing insertion of an object for puncturing the patient'"'"'s skin, such that the electrode surrounds the object and provides electrical stimuli to mask pain signals in the patient'"'"'s skin.

19. An apparatus for providing topical analgesia during a procedure, comprising:

(a) an electrode comprising;

(i) a non-conductive backing layer;

(ii) an electrically conductive layer positioned against the non-conductive backing layer, the electrically conductive layer comprising a first conductive surface and a second conductive surface;

(iii) an insulation component disposed between the first conductive surface and the second conductive surface;

(iv) an electrically conductive adhesive layer positioned against the electrically conductive layer, the electrically conductive adhesive layer comprising a first conductive adhesive surface positioned against the first conductive surface and a second conductive adhesive surface positioned against the second conductive surface, wherein the electrically conductive adhesive layer is configured to be adherable to a patient'"'"'s skin;

(v) at least one access point defined in the electrode, the at least one access point configured to allow objects to pass through the access point and into the patient'"'"'s skin; and

(b) a stimulation module attachable to the electrode, the stimulation module configured to generate stimuli to mask the pain signals caused when objects penetrate the patient'"'"'s skin; and

(c) a flap hingedly coupled to the non-conductive backing layer, the flap configured to move between an open position and a closed position wherein the flap is disposed over the at least one access point.

20. The apparatus of claim 19, wherein the stimulation module comprises an electrical stimulation generating unit.

21. The apparatus of claim 19, wherein the stimulation module comprises a vibration stimulation generating unit.

22. The apparatus of claim 19, wherein the stimulation module comprises:

(a) a transcutaneous electrical nerve stimulation (“

TENS”

) generating unit configured to transmit electrical current to the electrode;

(b) a vibration stimulation generating unit configured to transmit vibration energy to the electrode;

(c) a controller operably coupled to the TENS generating unit and the vibration stimulation generating unit, the controller configured to control the TENS generating unit and the vibration stimulation generating unit; and

(d) an input component operably coupled to the controller, the input component configured to allow a user to input a control signal to control intensity and duration of the electrical current and vibration energy.

23. The apparatus of claim 22, wherein the controller is further configured to initially gradually increase at least one of the electrical current and the vibration energy, generate randomly timed bursts of at least one of the electrical current and the vibration energy, automatically turn the apparatus on when the electrode and the module are coupled, and automatically shut off the apparatus when not in use.

24. The apparatus of claim 19, further comprising an attachment structure attachedly disposed between the stimulation module and the electrode, the attachment structure comprising one or more of ferromagnetic/electrically conductive discs, conductive buttons, conductive leads, conductive tabs, conductive hooks, conductive snaps, conductive adhesive, and hook and loop fastener, wherein the attachment structure is configured to allow transmission of vibration and electrical energy from the module to the electrode.

25. The apparatus of claim 19, wherein the stimulation module further comprises a display configured to display at least one of a status of the controller, battery status, operation of the electrical and vibration stimuli, and patient physiology.

26. The apparatus of claim 19, wherein the stimulation module further comprises at least one of a light display and a sound generator, wherein the light display and the sound generator are configured to distract the patient during the procedure.

27. The apparatus of claim 19, wherein the access point comprises an orifice, wherein the orifice has a circular, rectangular, or oval shape.

28. The apparatus of claim 19, wherein the access point comprises a notch.