Medical electrode glove with partially insulating layer
A medical device treats diseases of the hand, wrist, and arm, including osteoarthritis and osteoarthrosis of the joints of the human hand. The medical device includes a multi-layer glove system, an arm wrap, a signal generator, lead wires, and a garment. The multi-layer glove system serves as the treatment electrode. One of the layers electrically insulates a portion of the hand, allowing a different portion to make electrical contact with a conductive layer. The arm wrap serves as the return electrode. The signal generator produces a specific, spike shaped electrical signal, together with the multi-layer glove system, at the treatment site. The device can reduce pain and increase joint function of the treated joints.
The present invention generally relates to treating joints, such as a human hand and wrist.
The hand and wrist are affected by a number of diseases including several forms of arthritis, such as rheumatoid arthritis and osteoarthritis. Rheumatoid arthritis is a chronic, systemic inflammatory disease of unknown etiology characterized by the manner in which it involves the joints. The onset of the disease may be acute or insidious. Articular involvement is manifested clinically by pain, stiffness, loss of motion, deformity of joints, and the signs of inflammation. Rheumatoid arthritis affects many joints, most commonly the hands and wrists.
Osteoarthritis or osteoarthrosis is a degenerative joint disease, which commonly affects both axial and peripheral diarthrodial joints in humans. The effects of this increase steadily with age, so it is more common in the elderly. Osteoarthritis causes progressive deterioration and loss of articular cartilage from the surfaces of joints, and reactive changes at joint margins and in the underlying bone. Symptoms that are treatable include joint pain, stiffness, limitation of motion, and synovitis or joint inflammation. The treatments for rheumatoid arthritis and osteoarthritis of the hand and wrist are distinctly different, often individualized, and may include application of an electrical signal to the joints.
In U.S. Pat. No. 5,273,033 to Hoffman, which is specifically incorporated by reference herein, a device is shown that is said to decrease pain and improve joint function in patients with osteoarthritis of the knee.
SUMMARYEmbodiments are disclosed for a medical device that treats diseases of bones and joints, including the hand, wrist, and arm, such as rheumatoid arthritis and osteoarthritis. In one embodiment, the medical device includes a multi-layer glove system, an arm wrap, a signal generator, lead wires, and a garment. The multi-layer glove system serves as a treatment electrode. One of the layers electrically insulates a portion of the hand, allowing a different portion of the hand to make electrical contact with a conductive layer. The arm wrap serves as a return electrode. The signal generator produces a desired waveform, such as a spike shaped electrical signal, through the multi-layer glove system, at the treatment site. The garment has lead wires for connecting the multi-layer glove system and arm wrap to the signal generator. The garment keeps the lead wires in place and helps prevent the user from becoming tangled in the wires.
When a patient operates the medical device, a desired electrical signal is delivered to the joints of the hand and elbow. The system can reduce pain and increase the function of the treated joints. Other features and advantages will become apparent from the following detailed description, drawings, and claims.
BRIEF DESCRIPTION OF THE DRAWINGSFor a more complete understanding of various embodiments of the present invention, reference is now made to the following descriptions taken in connection with the accompanying drawings in which:
In one embodiment, garment 103 is a jacket worn over a patient's clothing. Garment 103 may be made of a variety of materials, including traditional clothing fabric or a woven polymer fabric and can be designed for comfort. Garment 103 has at least one lead wire 104 sewn into the material of garment 103, but could have two lead wires, one for treating the left side of the patient's body and one for treating the right side.
Lead wire 104 has a signal generator connection 106, an arm wrap connection 107, and a glove connection 108. Signal generator connection 106 may be a keyed shape to ensure proper connection to the signal generator, also described below. Arm wrap connection 107 and glove connection 108 may be metal snaps, although other releasable connection mechanisms may be used. The connections may be color-coded to ensure connection to the proper component.
Lead wire 104 is attached to, or held within, garment 103 so that when garment 103 is worn, each connection is held for easy attachment to the desired components of medical device 10. In addition, garment 103 helps to prevent the patient from becoming entangled in the lead wires. Signal generator connection 106 is held near pocket 105 for attachment to signal generator 50 in the pocket. Arm wrap connection 107 is held near a point about half way between the elbow and shoulder of the patient for attachment to arm band 101. Garment 103 has a flap 109 to allow the patient easy access to arm wrap 101. Glove connection 108 is held near the wrist for attachment to the multi-layer glove system. A like design would apply to a second lead wire (not shown) for use on the other side of the body.
Garment 103 may have snaps or other releasable connection mechanisms at the locations recited above. The snaps may be used to hold the various connections when not in use. For example, a snap 110 is located near the wrist of the patient and may hold glove connection 108 when the multi-layer glove system is not connected.
Referring to
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Protective outer glove 400 has a lead wire connection 401 positioned on the back of the glove, in the area covering the patient's wrist. Lead connection 401 releasably connects to the glove connection 108 of lead wire 104 (shown in
Protective outer glove 400 may be made from any fabric traditionally used to manufacture gloves. It may also have a coating on its inner surface to prevent the conductive gel used with conductive glove 300 from saturating the fabric of protective outer glove 400. Protective outer glove 400 can be made, for example, from spandex fiber with an inner rubberized coating.
This embodiment of the multi-layer glove system has a number of useful features. Protective outer glove 400 prevents conductive glove 300 from making accidental electrical contact with areas of the patient's skin other than the finger portions as described above. The patient may handle objects or use his or her hands during treatment without interfering with the electrical signal. In addition, the inner surface coating contains the conductive gel to inhibit the gel from being deposited on other areas of the patient's skin, the patient's clothing, and objects that the patient may handle during treatment. Similarly, the inner surface coating also helps prevent the conductive gel from drying-out during treatment, thereby prolonging the effectiveness of the gel.
The complementary conductive hook-and-loop fasteners also perform a safety function. When the patient removes the protective outer glove, the electrical connection between the complementary conductive hook-and-loop fasteners is broken automatically and without additional action being required. Thus, the conductive glove is de-energized when the protective outer glove is removed. Should the patient accidentally leave the signal generator on before removing the glove system, this feature prevents the patient from accidentally completing the electrical circuit with an area of the skin other than the desired treatment area.
The glove system can isolate the finger portions as a treatment area. It is believed that isolating the finger portions as a treatment area is effective in treating symptoms associated with diseases of the joints, such as rheumatoid arthritis of the hand. It is theorized that isolation of the finger portions as a treatment area allow for superior ion conduction through the cartilage of the treated joints, thereby increasing the current through the joints. The increased current produces an increased electrical field in the cartilage, which is believed to mimic the electrical potentials found in healthy cartilage that cause the body to produce new cartilage.
Although the beneficial effects are thought to decrease as the distance from the treatment area increases, the glove system may be effective in treating aliments of the elbow. Use of the medical device disclosed herein is believed to reduce the patient's evaluation of pain and symptoms in the treated joints and increase the patient's evaluation of function in the treated joints. The ability of the glove system to isolate the fingertips may also have applications in traditional transcutaneous electrical nerve simulation therapy.
Turning to the electrical components and waveforms,
Signal generator 50 has an LCD display 501, which allows the patient to read information concerning the level of treatment, duration of treatment, battery status, signal generator status, and other information. Signal generator 50 has an On/Off button 502 which allows the patient to turn the unit on and off, a stimulation increase button 503 that may be pressed to increase the level of electrical stimulation produced by a treatment channel of signal generator 50, and a stimulation decrease button 504 that may be pressed to change the level of electrical stimulation produced with suitable thresholds. Signal generator 50 may have multiple treatment channels, each having a set of stimulation increase and decrease buttons. The generator could have selectable alternative waveforms.
A function button 505 may be pressed to display the treatment time on LCD 501. A battery button 506 may be pressed to display the battery charge level on LCD 501.
As will be realized, the inventions are capable of other and different embodiments and its several details may be capable of modifications in various respects, all without departing from the invention as set out in the appended claims. For example, the treatment signal produced by signal generator 50 may vary from the waveform described above, or the multi-layer glove system may be used with a current-sourced electrical signal generator, such as a traditional transcutaneous electrical nerve stimulator. Accordingly, the drawings and description are to be regarded as illustrative in nature and not in a restrictive or limiting sense with the scope of the application being indicated in the claims.
Claims
1. A medical device comprising:
- a lead wire for providing an electrical signal to at least one portion of a patient's body, the lead wire having at least two electrically conductive paths for the creation of an electrical circuit, the electrical circuit including at least a portion of the patient's body;
- a non-invasive conductive electrode for contacting the patient's skin;
- a multi-layered glove system, the glove system having an electrically insulating layer and a non-invasive conductive layer, the electrically insulating layer insulating a portion of a hand and not the entirety of the hand of the patient from contact with the non-invasive conductive layer, the non-invasive conductive layer having an inner surface and an outer surface, the inner surface making electrical contact with at least a portion of the hand of the patient;
- a signal generator for producing a desired electrical signal in at least a portion of the patient's body, the signal generator being releasably electrically coupled to the non-invasive conductive electrode via one of the electrically conductive paths of the lead wire, and the signal generator being releasably electrically coupled to the non-invasive conductive layer via another of the electrically conductive paths of the lead wire.
2. The medical device of claim 1, wherein the electrically insulating layer is designed such that when worn on a hand, the skin of the fingers and thumb distal to the metacarpophalangeal joints are not covered by the electrically insulating layer, and the metacarpophalangeal joints, the back of the hand, and the palm of the hand are covered by the electrically insulating layer.
3. The medical device of claim 1, wherein the non-invasive conductive electrode contacts the surface of the skin about halfway between the elbow and the shoulder.
4. The medical device of claim 1, wherein the desired electrical signal is a periodic signal selected to rebuild cartilage of a joint when applied to a joint of the human body.
5. The medical device of claim 1, wherein the desired electrical signal is a voltage-sourced, spike-shaped, monophasic, repeating, and asymmetrical DC signal characterized by an exponential decay and having a frequency of about 95 to 105 hertz, a voltage of about 0 to 12 volts at the peak, a voltage and current pulse width of about 1.8 ms at the 10% point of peak and about 0.64 ms at the 50% point of peak, and a current of about 0 to 24 mA at 500 ohms resistive load with an average of about 0.2 mA at 500 ohms resistive load.
6. The medical device of claim 1, wherein the desired electrical signal is subsensory.
7. The medical device of claim 1, wherein at least a portion of the electrically insulating layer includes one of vinyl, neoprene, or polyurethane.
8. The medical device of claim 1, wherein at least a portion of the non-invasive conductive layer includes silver plated nylon.
9. A medical device comprising:
- a multi-layered glove system having an electrically insulating layer and a non-invasive conductive layer for use over the electrically insulating layer, the insulating layer formed to cover and insulate a portion of a wearer's hand and not the entirety of the hand from contact with the non-invasive conductive layer to leave an exposed portion, the non-invasive conductive layer having an inner surface and an outer surface, the inner surface making electrical contact with at least part of the exposed portion; and
- a conductive lead for allowing a lead wire to be manually connected and disconnected from the non-invasive conductive layer.
10. The medical device of claim 9, wherein the electrically insulating layer is designed such that when worn on a hand, the skin of the fingers and thumb distal to the metacarpophalangeal joints are not covered by the electrically insulating layer, and the metacarpophalangeal joints, the back of the hand, and the palm of the hand are covered by the electrically insulating layer.
11. The medical device of claim 9, further comprising a conductive electrode for contacting the surface of the skin below the shoulder.
12. The medical device of claim 9, where the non-invasive conductive layer receives a desired electrical signal selected to rebuild cartilage of a joint when applied to a joint of the human body.
13. The medical device of claim 9, wherein at least a portion of the electrically insulating layer includes one of vinyl, neoprene, or polyurethane.
14. The medical device of claim 9, wherein at least a portion of the non-invasive conductive layer includes silver plated nylon.
15. A method comprising:
- covering a portion of a hand and not the entirety of the hand of a patient with an electrically insulating layer;
- covering the hand of the patient and electrically insulating layer with a non-invasive conductive layer such that the non-invasive conductive layer makes electrical contact with at least a portion of the hand not covered by the electrically insulating layer;
- contacting the patient's skin with a non-invasive conductive electrode; and
- providing a desired electrical signal in at least a portion of the patient's body by electrically connecting the non-invasive conductive layer and non-invasive conductive electrode to a signal generator.
16. The method of claim 15, wherein the electrically insulating layer is designed such that when worn on a hand, the skin of the fingers and thumb distal to the metacarpophalangeal joints are not covered by the electrically insulating layer, and the metacarpophalangeal joints, the back of the hand, and the palm of the hand are covered by the electrically insulating layer.
17. The method of claim 15, wherein the non-invasive conductive electrode contacts the surface of the skin about halfway between the elbow and the shoulder.
18. The method of claim 15, wherein the desired electrical signal is a periodic signal selected to rebuild cartilage of a joint when applied to a joint of the human body.
19. The method of claim 15, wherein the desired electrical signal is a voltage-sourced, spike-shaped, monophasic, repeating, and asymmetrical DC signal characterized by an exponential decay and having a frequency of about 95 to 105 hertz, a voltage of about 0 to 12 volts at the peak, a voltage and current pulse width of about 1.8 ms at the 10% point of peak and about 0.64 ms at the 50% point of peak, and a current of about 0 to 24 mA at 500 ohms resistive load with an average of about 0.2 mA at 500 ohms resistive load.
20. The method of claim 15, wherein the desired electrical signal is subsensory.
21. The method of claim 15, wherein at least a portion of the electrically insulating layer includes one of vinyl, neoprene, or polyurethane.
22. The method of claim 15, wherein at least a portion of the non-invasive conductive layer includes silver plated nylon.
Type: Application
Filed: Nov 9, 2005
Publication Date: May 31, 2007
Inventor: Kent Hoffman (Parkton, MD)
Application Number: 11/270,381
International Classification: A41D 19/00 (20060101);