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United States Patent m
Maurer et al.
[ii] Patent Number:  Date of Patent:
 ELECTRODE FOR ACTIVATING PELVIC REFLEXES
 Inventors: Donald D. Maurer, Marine on the St.
Croix; Mary M. Lien, Arden Hills, both of Minn.
 Assignee: Empi, Inc., St. Paul, Minn.
 Appl. No.: 975,518
 Filed: Not. 12,1992
 Int. Cl.« A61N 1/05; A61N 1/36
 UJS. CI 607/41; 607/138
 Field of Search 128/788, 801, 802, 419 S,
128/401; 607/39-41, 66, 138
 References Cited
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3,800,800 4/1974 Garbe et al 128/408
3,933,147 1/1976 Du Vail et al 128/2 S
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4,124,028 11/1978 Gallo 128/419 S X
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4,564,024 1/1986 Wohler, Jr 128/419 S X
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4,785,828 11/1988 Maurer 128/788
4,873,996 10/1989 Maurer 128/844
4,881,526 11/1989 Johnson et al 128/24.5
4,909,263 3/1990 Norris 128/788
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5,199,443 4/1993 Maurer et al 128/788
5,213,097 5/1993 2^indler 128/401
5,233,987 8/1993 Fabian et al 607/41
FOREIGN PATENT DOCUMENTS
• 2387049 4/1978 France .
2547203 6/1983 France .
2622458 5/1989 France .
2822616 11/1979 Germany .
8807819.1 9/1988 Germany .
8807820.5 9/1988 Germany .
WO84/01515 4/1984 WIPO .
Empi, Inc., Innova Feminite Incontinence Treatment
System Design Rationale, 1992.
Empi, Inc., Innova, 1991, 1992.
Intravaginal Stimulation for Urinary Incontinence Selected Abstracts.
Ivan A. Brezovich, Ph. D.; Michael B. Lilly, M.D.; John R. Durant, M.D.; and Diane B. Richards, R.N.; A Practical System for Clinical Radwfrequency Hyperthermia, Mar. 1981, vol. 7, pp. 423-430. Electrical Treatment of Anal Incontinence by B. R. Hopkinson, R. Lightwood, "The Lancet", pp. 297-298, Feb. 5, 1966.
Guard for Intra-Anal Plug Electrode, by E. S. Glen,
"The Lancet", pp. 325-326, Aug. 9, 1969.
Primary Examiner—Lee S. Cohen
Attorney, Agent, or Firm—Kinney & Lange
An electrode for activating pelvic reflexes in a patient is made of a molded elongated tubular member and a patient conforming handle member. The tubular member has a plurality of conductive polymer bands separated by at least one nonconductive polymer band. The patient conforming handle member connects to the distal end of the tubular member for properly positioning the electrode and for preventing movement of the electrode in either a proximal or a distal direction.
35 Claims, 2 Drawing Sheets
ELECTRODE FOR ACTIVATING PELVIC
BACKGROUND OF THE INVENTION 5
The present invention relates generally to the field of electrical neuromuscular stimulation for treatment of incontinence. In particular, the present invention is a molded electrode device with handle having increased efficacy, safety, and comfort.
Incontinence affects an estimated 12-15 million adults nationwide. Defined as the inability to retain urine or feces through loss of sphincter control, incontinence costs society an estimated $10.3 billion annually. 15
Electrical neuromuscular stimulation is widely used to assist persons afflicted with motor or nerve dysfunctions in performing muscle contraction maneuvers. This technique is also used to re-educate patients in the proper use of the dysfunctional muscles. For the treat- 2Q merit of incontinence, pulses of electrical current stimulate sensory nerve fibers located within the vagina or rectum. This in turn causes reflex contractions of the pelvic floor muscles and reflex inhibition of a spastic bladder muscle. 25
"Stress incontinence" can result from the patient's inability to properly contract or close the external sphincter of the urethra when there is increased pressure on the bladder, such as during coughing or lifting. It has been shown that neuromuscular stimulation can 30 cause contractions of the pelvic floor by means of a vaginal or anal electrode which effectively prevents the unwanted leakage of urine. Furthermore, through the use of such an electrode, patients can educate themselves to voluntarily or automatically impede the flow 35 of urine. Another important application of the pelvic floor contractions is the exercise and toning of the muscles of the pelvic floor which support the bladder, urethra, and other organs. Pelvic floor muscles which have become lax or stretched due to either the process of 40 child birth, obesity, multiple sclerosis, or degenerative changes associated with aging can be strengthened and tightened to properly support the particular organs, thus positively affecting the patient's ability to maintain continence. 45
Another common form of incontinence is called "urge incontinence". This condition results from a hyperactive or spastic bladder muscle. Electrical stimulation to sensory nerve fibers can activate certain reflex contractions of the pelvic floor muscles which inhibit 50 the inappropriate bladder contractions associated with urge incontinence.
Anal incontinence is a similar problem. It is the inability to prevent the involuntary expulsion of gas, liquid, or solids from the lower bowel. The ani sphincter mus- 55 cles of continent persons prevent involuntary expulsions from the lower bowel. The ani sphincter is made up of two distinct muscles; the external anal sphincter and the internal anal sphincter. The external sphincter, made up of striated muscles, is capable of voluntary 60 control. Conversely, the internal sphincter, made up of smooth muscle, is incapable of voluntary control. Once again, neuromuscular stimulation via an anal electrode can cause contractions of pelvic floor muscles, including the dysfunctional external sphincter muscle to effec- 65 tively prevent incontinence. Furthermore, patients can educate themselves to voluntarily or automatically prevent these involuntary expulsions.
Electrical neuromuscular stimulation has become a recognized and accepted form for the treatment of incontinence. Several prior art references disclose vaginal or anal electrodes for the prevention of incontinence. However, these prior art references have short-comings which limit their effectiveness. First, prior art electrodes have a tendency to be pulled inward into the rectum during stimulation periods due to muscle contractions of pelvic floor muscles. They also have a tendency to fall out of the vagina or rectum during nonstimulation periods. Second, the diameter and rigid composition of prior art electrodes often cause discomfort and pain to the patient.
Therefore, there is a continuing need for an improved flexible electrode for use in the vagina or rectum which can effectively restore continence, is securely held in place during either stimulation or non-stimulation periods, and will be comfortable to the patient.
SUMMARY OF THE INVENTION
The present invention provides an electrode device having increased efficacy, safety, and comfort. The electrode has a handle at its distal end to prevent the electrode from being pulled inward into the rectum during stimulation periods and from falling out of the rectum during non-stimulation periods. Also, both the length and diameter of the electrode have been reduced for the comfort and safety of the patient.
The electrode, which controls incontinence in a patient by activating pelvic floor muscles, incorporates a molded elongated tubular member having a plurality of conductive polymer bands separated by at least one nonconductive polymer band. A flexible and anatomically correct handle member connected to the distal end of the tubular member properly positions the electrode within the rectum and prevents movement of the electrode in either a proximal or a distal direction. The handle member fits comfortably between the gluteal muscles of the patient.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. lis a perspective view of the present invention.
FIG. 2 is an end view of the present invention as viewed from a line 2—2 of FIG. 1.
FIG. 3 is a longitudinal sectional view of the present invention.
FIG. 4 is sectional end view of the present invention as viewed from a line 4—4 of FIG. 3.
DETAILED DESCRIPTION OF THE
A portable patient treatment device 10 and treatment electrode 12 are shown in FIG. 1. Portable patient treatment device 10 includes port 14, first channel control 16, second channel control 18, operation lights 20 and 22, and timed treatment control 24. Treatment electrode 12 includes first conductive polymer electrode 26, second conductive polymer electrode 28, third conductive polymer electrode 30, tip 31, non-conductive polymer bands 32, neck 33, handle 34, cable 36, and plug 38.
During operation, treatment electrode 12 is connected to portable patient treatment device 10 by cable 36. For patient stimulation, treatment electrode 12 is inserted into a patient's rectum while plug 38 is connected into portable patient treatment device 10 via port 14.
Treatment electrode 12 is a two channel device. First conductive polymer electrode 26 and second conduc