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Title:
APPARATUS FOR STIMULATING PENILE, SCROTAL, ANAL, VAGINAL AND CLITORAL TISSUE
Document Type and Number:
WIPO Patent Application WO/1996/020753
Kind Code:
A1
Abstract:
Male and female electrodes (50, 160, 170, 180, 190) for stimulating penile, scrotal, anal, vaginal, and clitoral tissue are shown. The electrodes are formed from elastomeric material and preferably include memory bend wires (54, 169, 179, 189, 194) that maintain a formed shape of the electrodes. Electrical stimulation to such areas is intended to control incontinence, to induce penile erection where impotence occurs, or to induce excitation and orgasm. A male penile ring electrode (100, 110, 700, 710) formed from elastomeric or flexible material and intended for use in pairs, has an outer nonconductive surface (101, 111, 701, 711), and an inner conductive layer (106, 116, 706, 716). A contact (108, 708) for connecting the electrode to a source of electricity is mounted on the outer surface and connects to the inner layer. A like electrode (120, 720) that can be used alone has two nonconductive portions separating two inner conductive portions. Female electrodes such as an elongated ball (50) having a nonconductive ring (53) about its centerline and two conductive portions (51, 52) about the nonconductive ring, and a plug having a conductive tip (166) and sides (167, 168) with nonconductive material (162, 164) therebetween are also disclosed. Additionally, anal and male urethral electrodes (190) formed from the same elastomeric material are provided.

Inventors:
BOUTOS DAVID (US)
Application Number:
PCT/US1995/016629
Publication Date:
July 11, 1996
Filing Date:
December 19, 1995
Export Citation:
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Assignee:
BOUTOS DAVID (US)
International Classes:
A61F5/37; A61F5/41; A61N1/04; A61N1/05; A61N1/36; (IPC1-7): A61N1/04
Foreign References:
US5456709A1995-10-10
US5385577A1995-01-31
Other References:
See also references of EP 0801583A4
Download PDF:
Claims:
CLAIMS
1. What is claimed is: An electrode apparatus comprising: a nonconductive base (161, 171, 181, 191); electrode means formed from elastomeric material and having a conductive member (167, 174, 187, 193) coupled to said base; and at least one electrical connector (165a, 172, 182, 192) mounted to said base and in direct contact with said conductive member.
2. The electrode apparatus of claim 1, further comprising a memory bend wire (169, 179, 189, 194) located within said electrode means, said memory bend wire serving to substantially maintain a formed shape of said electrode means.
3. The electrode apparatus of claim 2, wherein said electrode means is elongated in an elongation direction, and said memory bend wire extends within said electrode means substantially along said elongation direction.
4. The electrode apparatus of claim 3, wherein said electrode means is a plug having a first conductive side portion (186), a second conductive side portion (187), a point, and a nonconductive volume (184) formed between said first and second conductive side portions, said nonconductive volume extending to and including said point.
5. The electrode apparatus of claim 3, wherein said electrode means is a plug having a nonconductive stripe (176) running around its circumference and conductive areas (174, 175) on both sides of said nonconductive stripe.
6. The electrode apparatus of claim 3, wherein said electrode means is a plug having a conductive tip (166), a first conductive side portion (167), a second conductive side portion (168), and a nonconductive volume (162, 164) formed between said first and second conductive side portions and said conductive tip.
7. The electrode apparatus of claim 1, wherein said electrode means is a plug having a first conductive side portion (186), a second conductive side portion (187), a point, and a nonconductive volume (184) formed between said first and second conductive side portions, said nonconductive volume extending to and including said point.
8. The electrode apparatus of claim 1, wherein said electrode means is a plug having a nonconductive stripe (176) running around its circumference and conductive areas (174, 175) on both sides of said nonconductive stripe.
9. The electrode apparatus of claim 1, wherein said electrode means is a plug having a conductive tip (166), a first conductive side portion (167), a second conductive side portion (168), and a nonconductive volume (162, 164) formed between said first and second side portions and said conductive tip.
10. The electrode apparatus of claim 9, wherein said conductive tip and said first and second conductive side portions are insulated from one another, and said conductive tip is electrically connected to one of said connectors (163).
11. An electrode apparatus comprising a ballshaped electrode (50) formed from elastomeric material and having at least one conductive portion (51, 52).
12. The electrode apparatus of claim 11, wherein said ball shaped electrode has two conductive portions (51, 52) separated by a nonconductive portion (53), and wherein said nonconductive portion is a ring located about the centeriine of said ballshaped electrode and said conductive portions are about said ring.
13. The electrode apparatus of claim 12, wherein said ring is configured as a cylinder and each of said conductive portions is configured as a hemisphere.
14. An electrode apparatus comprising: a body (50, 160, 170, 180, 190) formed from elastomeric material and having at least one conductive portion (51, 167, 174, 187, 193); and a memory bend wire (54, 169, 179, 189, 194) located within said body, said memory bend wire serving to substantially maintain a formed shape of said body.
15. The electrode apparatus of claim 14, wherein said body is an elongated ball (50) having an elongation direction, and said body further comprises a nonconductive ring (53) located substantially centrally relative to said elongation direction.
16. The electrode apparatus of claim 14, wherein said body is an elongated ball (50) having an elongation direction, and said memory bend wire extends within said body substantially along said elongation direction.
17. A ringshaped electrode apparatus formed from elastomeric material having: a contiguous outer nonconductive insulating surface (701, 711); a contiguous inner conductive surface (706, 716); a volume of conductive material between said outer and inner surfaces; and an electrical connector (708) mounted on said outer surface and in communication with said inner conductive surface.
18. The electrode apparatus of claim 17, further comprising a nonconductive handle (709) formed on said outer surface.
19. The electrode apparatus of claim 17, wherein said volume of conductive material terminates at two conductive side edges (702, 704, 712, 714).
20. A ringshaped electrode apparatus formed from elastomeric material, said electrode comprising: a first portion having a first outer nonconductive insulating surface (722), a first inner conductive surface (726), a first volume of conductive material between said first outer and first inner surfaces, and a first electrical connector (728) mounted on said first outer surface and in communication with said first inner conductive surface; a second portion having a second outer nonconductive insulating surface (732), a second inner conductive surface (736), a second volume of conductive material between said second outer and second inner surfaces, and a second electrical connector (738) mounted on said second outer surface and in communication with said second inner conductive surface; a first nonconductive portion joining a first end of said first portion to a first end of said second portion; and a second nonconductive portion joining a second end of said first portion to a second end of said second portion.
21. The electrode apparatus of claim 20, further comprising a nonconductive handle (744) formed on one of said first and second nonconductive portions.
22. A ringshaped electrode apparatus comprising: a flexible body (102, 112) having an inner surface and a contiguous outer nonconductive surface (101, 111); an inner conductive layer (106, 116) coupled to said inner surface and substantially insulated from said outer nonconductive surface; and an electrical connector (108) mounted on said outer nonconductive surface and in communication with said inner conductive layer.
23. The electrode of claim 22, further comprising a nonconductive handle (109) located on said outer surface.
24. The electrode of claim 22, wherein said inner conductive layer comprises a first conductive portion (126) having a first end (132) and a second end (134), and a second conductive portion (130) having a first end (136) and a second end (140), wherein said electrical connector (128) is in communication with said first conductive portion, and wherein said electrode further comprises: a first nonconductive portion (142) joining said first end of said first conductive portion to said first end of said second conductive portion; and a second nonconductive portion (146) joining said second end of said first conductive portion to said second end of said second conductive portion.
25. The electrode of claim 24, further comprising a second electrical connector (138) mounted on said outer nonconductive surface and in communication with said second conductive portion.
26. An electrode apparatus comprising: a flexible strap (402) having a first surface (404), a nonconductive surface (406), a first end (408) and a second end (410); a conductive layer (414) coupled to said first surface and substantially insulated from said nonconductive surface; an electrical connector (416) mounted on said nonconductive surface and in communication with said conductive layer; and means for attaching (412) said first end to said second end.
27. The electrode apparatus of claim 26, wherein said conductive layer comprises a first conductive portion (514) having a first end (522) and a second end (524) and a 5 second conductive portion (516) having a first end (526) and a second end (528); said electrical connector (518) is in communication with said first conductive portion; and said electrode apparatus further comprises: a first nonconductive portion (530) joining said first 10 end of said first conductive portion to said first end of said second conductive portion; and a second nonconductive portion (532) situated on said first surface and located at one of said first and second ends of said flexible strap.*& 15.
28. The electrode apparatus of claim 27, further comprising a second electrical connector (520) mounted on said nonconductive surface and in communication with said second conductive portion.*& 20.
29. The electrode apparatus of claim 27, wherein said first and second conductive portions are configured such that said first conductive portion does not contact said second conductive portion when said first end of said 25 flexible strap is attached to said second end of said flexible strap.
30. An electrode apparatus comprising: a base plate (41) which has two contacts (30) for 30 connecting to a source of electricity (10); a first electrode means (50) formed from elastomeric material and having a conductive portion (51, 52), said first electrode means being in the shape of a ball; a second electrode means formed from elastomeric 35 material and having a conductive portion; a wire (45) connected at one end to one of said contacts and connected at the other end to said conductive portion of said first electrode means; and a second wire connected at one end to the other of said contacts and connected at the other end to said conductive portion of said second electrode means.
31. The electrode apparatus of claim 30, wherein said first electrode means comprises an elongated ball (50) having an elongation direction, and a memory bend wire (54) extending within said elongated ball substantially along said elongation direction and serving to substantially maintain a formed shape of said elongated ball.
32. The electrode apparatus of claim 30, wherein said second electrode means is in the shape of a ball like said first electrode means.
33. The electrode apparatus of claim 30, wherein said second electrode means is a ring (100, 110, 120, 700, 710, 720) having a conductive inner surface and a nonconductive outer surface.
34. The electrode apparatus of claim 30, wherein said second electrode comprises: a flexible strap (402, 502) having a first surface (404, 504), a nonconductive surface (406, 506), a first end (408, 508) and a second end (410, 510); a conductive layer (414, 514) coupled to said first surface and substantially insulated from said nonconductive surface; an electrical connector (416, 518) mounted on said nonconductive surface and in communication with said conductive layer; and means for attaching (412, 512) said first end to said second end.
Description:
APPARATUS FOR STIMULATING PENILE, SCROTAL, ANAL, VAGINAL

AND CLITORAL TISSUE

TECHNICAL FIELD This invention relates to apparatus for applying electrical energy to living tissue. More particularly, the present invention relates to apparatus for electrically stimulating penile, scrotal, anal, vaginal, and clitoral tissue. In a further and more specific aspect, the invention relates to electrically stimulating penile, scrotal, vaginal, and clitoral tissue for the purposes of treating incontinence in men and women, inducing penile erection, and inducing male and female orgasm.

BACKGROUND ART

It is widely known that the application of electrical stimulation to certain neuromuscular areas in or near the genitalia can be used to treat incontinence in both men and women. Also known is that the application of electrical stimulation to penile tissue can cause erection where impotence may exist due to physiological or psychological conditions. Additionally, it is known that the application of electrical stimulation to penile, vaginal, clitoral, anal, or prostate tissue can induce orgasm, even where the subject has suffered vascular degenerative neural neuropathy. Finally, it is known that diabetes and many other medical disorders can cause penile impotence.

The art is replete with various apparatus used to apply electrical stimulation to the subject areas. Rigid rings capable of transmitting low levels of electricity to the skin and muscles are typically applied about the penis and/or the scrotum. Insertable rolled or plug-type electrodes, made to be rolled to size or sized in a variety of sizes to fit the user's anatomy, are known for the purpose of applying low levels of electricity to the skin and muscles inside and surrounding the vagina and the anus.

Urinary incontinence is a common problem that may require long term retraining of self-control, particularly

after a . stroke, or permanent use of an external control device. The prior art does not teach an apparatus that is designed to be worn while the user, fully dressed, moves about his or her everyday course of events. Rigid rings are useable for males where the application of electrical current to only a portion of penile tissue is sufficient to induce urethral control or erection. This is because sufficient expansion room is required within the ring to accommodate penile engorgement. Rigid rings are particularly problematic where penile atrophy has occurred, and the desired goal is erection or orgasm. The tremendously varying size of the penile tissue from rest to engorgement may cause a need to use a large diameter ring on a small diameter penis, or to change rings during a treatment.

For the female, a discrete unit, usable in a variety of ways, is desirable to control incontinence or to stimulate and to induce orgasm. Such a unit should be particularly designed to be worn under a user's clothing, and operative while the female is engaged in normal everyday activity.

It would be highly advantageous, therefore, to remedy the foregoing and other deficiencies inherent in the prior art. Accordingly, it is an object of the present invention to provide improvements in electrical stimulation apparatus for both men and women.

Another object of the invention is the provision of improvements especially adapted for use in connection with apparatus for controlling and treating incontinence in men and women.

And another object of the invention is to provide improved means for the application of electrical stimulation to the vagina. Still another object of the immediate invention is the provision of an improved means for the application of electrical stimulation to the vagina that can be easily

adapted for the application of electrical stimulation to the clitoral tissue.

Yet another object of the invention is to provide means for the application of electrical stimulation to the penile and scrotal tissue.

Yet still another object of the invention is the provision of improved means for the application of electrical stimulation to the penile and scrotal tissue that can expand with penile erection. A further object of the instant invention is to provide improvements in the connectivity of electrical stimulation apparatus.

And a further object of the invention is the provision of a male and female electrical stimulation apparatus that can be worn comfortably and discretely under a user's clothing.

Yet a further object of this invention is to provide male electrical stimulation apparatus that can induce erection and orgasm, and female electrical stimulation apparatus that can induce orgasm.

And yet another object of the invention is the provision of means and improvements according to the foregoing which will materially reduce the cost of male and female electrical stimulation apparatus.

DISCLOSURE OF INVENTION

Briefly, to achieve the desired objects of the instant invention in accordance with a preferred embodiment thereof, first provided is a female electrical stimulation apparatus having a base plate to which an electrode is attached by wire, and to which a controller may be attached. The base plate has tethers so that it may be tethered to the body of the female user.

The female electrode apparatus and its electrode are fabricated from elastomeric material. The female electrode may be inserted into the vagina and positioned therein so that the application of electricity may contract the muscles surrounding the ureter, thereby controlling

incontinence, or positioned therein so the application of electricity may induce excitation and orgasm. The female electrode may also be mounted in a hole in the base plate so that it may worn against the clitoral tissue, thereby also inducing excitation and orgasm.

A male electrode in the form of a ring to. be wrapped around penile and/or scrotal tissue comprises an alternate embodiment of the invention. The ring is also formed from elastomeric material, and has a metal button snap contact mounted on its outside but connected electrically to the conductive material forming the side edges of the ring and its interior side. In an embodiment having one electrical contact, the entire outer surface of the ring is nonĀ¬ conductive. This ring is used in pairs, where one ring is connected to the negative side of the controller and the second ring is connected to the positive side of the controller.

The male electrode may alternatively be configured in the form of a strap that may be formed into a ring to be wrapped around penile and/or scrotal tissue. The strap is formed from a flexible material, and has a metal button snap contact mounted on its outside but connected electrically to conductive material coupled to its interior side. An alternate male electrode ring that may be used alone has two contacts, where one contact is connected to the negative side of the controller, and the second contact is connected to the positive side of the controller. Two small non-conductive sections of the ring are located between the contacts. Using the two contact ring or two of the single contact rings, electricity may be applied to the base of the penis and/or the scrotum, to thereby contract the bladder muscles to control incontinence, or positioned thereon so the application of electricity may induce excitation and orgasm.

An electrode having two conductive surfaces may alternatively be configured in the form of a flexible strap having a non-conductive section that separates two

conductive sections. The strap may be formed into a ring to be used in a manner similar to the double contact electrode ring.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and further and more specific objects and advantages of the instant invention will become readily apparent to those skilled in the art from the following detailed description of preferred embodiments thereof taken in conjunction with the drawings, in which:

FIG. 1 is a perspective view of a female electrode apparatus and controller in accordance with the present invention;

FIG. 2 is a cross sectional view of the female electrode shown in FIG. 1;

FIG. 3 is a perspective view of a male electrode apparatus;

FIGS. 4-5 are bottom and top views, respectively, of an alternate embodiment of the male electrode apparatus; FIG. 6 is a perspective view of a further embodiment of the male electrode apparatus;

FIG. 7 is cross-sectional view of the female electrode apparatus operatively disposed within and about the vagina of the user; FIG. 8 is a perspective view of a male electrode apparatus operatively disposed about the penile and scrotal tissue of the user;

FIG. 9 is a frontal view of the female electrode apparatus; FIG. 10 is a side- view showing an alternate positioning of the female electrode apparatus;

FIG. 11 is a side view showing another positioning of the female electrode apparatus;

FIGS. 12-13 are perspective views of an alternate embodiment of the male electrode apparatus;

FIGS. 14-15 are bottom and top views, respectively, of an alternate embodiment of the male electrode apparatus;

FIGS. 16-17 are perspective views of an alternate embodiment of the male electrode apparatus;

FIG. 18 is a cross-sectional view of a vaginal electrode; FIG. 19 is a cross-sectional view showing an alternate embodiment of the vaginal electrode shown in FIG. 18;

FIG. 20 is a cross-sectional view of an anal electrode; and

FIG. 21 is a cross-sectional view of an alternate embodiment of the anal electrode that may also be utilized as a male urethral electrode.

BEST MODE FOR CARRYING OUT THE INVENTION

Turning now to the drawings in which like reference characters indicate corresponding elements throughout the several views, attention is first directed to FIG. 1 where controller 10 is shown. As shown herein, controller 10 has positive and negative female jacks, i.e., 1/8 inch phone plugs (not shown) where wire connector plugs 12 and 14 connect to controller 10.

Controller 10 has switch 15 which selectively turns controller 10 on and off, and knobs 16, 16a, 17, 18 and 19 that modulate frequency coarse, frequency fine, pulse, power fine, and power coarse, respectively. Pushbuttons 22 and 24 can be used to kill power to either female jack on controller 10, respectively. Also included on controller 10 are lights 22a and 24a, which are lit when their respective jacks have current.

Controller 10 is generally battery powered, and generates a 9 or 12 volt DC current. This current may be modified and regulated as noted above. Controller 10 may alternatively be configured as an electrical source that provides a pulsed electrical signal rather than a DC signal. Extending from plugs 12 and 14 are shielded wires 26 and 27, which terminate with button snap female contact heads 28 and 29, respectively. Inside button snap female

contact heads 28 and 29, are button snap female contacts (not shown).

As shown in FIG. 1, contact heads 28 and 29 terminate at female electrode apparatus 40. Apparatus 40 has base plate 41, tethers 43 and 44, wire 45 which is connected to electrode 50, aperture 46, and wire groove 47. As will be readily apparent to one skilled in the art, the button snap female contacts in contact heads 28 and 29 are each connected to a button snap male contact. Each button snap male contact resembles contact 108 shown in FIG. 3, but in this case the two button snap male contacts are embedded in base plate 41.

Base plate 41 is fabricated from elastomeric material such as silicon, viton, and neoprene, and such material is non-conductive. The button snap male contacts embedded in it, as described above, are conductive, and are generally made from metal. Wire 45 is an insulated two strand wire, having at a first end one strand connected to one button snap male contact, and the other strand connected to the other button snap male contact. Such male connectors are embedded within base plate 41.

FIG. 2 represents a cross sectional view of the exemplary electrode 50 shown in FIG. 1. Electrode 50 is generally ball-shaped, e.g., spherical, oblong, or elliptical. Electrode 50 is fabricated from elastomeric nonconductive material such as low modulus silicon, viton, and neoprene and has conductive portions 51 and 52. To make conductive portions 51 and 52 conductive, carbon particles are embedded in the silicon, viton, and neoprene. At the second end of wire 45, one strand is embedded into conductive portion 51, and the other strand is embedded into conductive portion 52. Nonconductive portion 53 insulates the circuit to conductive portion 51 from the circuit to conductive portion 52. In the preferred embodiment, nonconductive portion 53 is a cylindrical ring and conductive portions 51 and 52 are each shaped as a hemisphere.

According to a preferred aspect of the present invention, electrode 50 is in the shape of an elongated ball and includes a memory bend wire 54 located within it. During fabrication, electrode 50 may be molded around memory bend wire 54. Preferably, memory bend wire 54 is insulated such that conductive portions 51 and 52 are not electrically connected. Memory bend wire 54 allows electrode 50 to be formed and reformed into a variety of different shapes. For example, FIG. 2 illustrates electrode 50 formed into a slightly curved shape. Memory bend wire 54 is pliable yet rigid enough to substantially maintain the formed shape of electrode 50. As such, electrode 50 may be bent or curved according to individual preferences. In general use of female electrode apparatus 40, base plate 41 is positioned over the vaginal area, generally with aperture 46 about the clitoral area. Tethers 43 and 44 are threaded through base plate 41 and may be draped around the user's body and tied in back to hold base plate 41 in position. More on the use of female electrode apparatus 40 will be discussed in connection with FIGS. 7 and 9-11 below.

Turning to FIG. 3, shown are electrode rings 100 and 110. Ring 100 includes a body 102 fabricated from a flexible material such as leather or Nylon webbing. Body 102 has an inner surface (hidden from view) and a contiguous outer nonconductive surface 101. An inner conductive layer 106 is preferably coupled to the inner surface of body 102. Inner conductive layer 106 is substantially insulated from outer nonconductive surface 101. Ring 100 also includes male button snap contact 108 and handle 109. Handle 109 is preferably nonconductive, which allows a user to physically manipulate the position of ring 100 without electrical contact. Contact 108 is embedded through outer nonconductive surface 101 such that it communicates with inner conductive layer 106.

Inner layer 106 may be formed from any electrically conductive material. For example, inner layer 106 may be a

metallic sheet or a silicon or neoprene substrate impregnated with carbon particles (see above description of electrode 50) .

Ring 110 is structurally identical to ring 100 except ring 110 has no handle equivalent to handle 109. Ring 110 includes a body 112 having an outer nonconductive surface 111 and an inner surface (hidden from view). Inner conductive layer. 116 is coupled to the inner surface of body 112. Handle 109 allows the user to rotate and move ring 100 forward and aft when ring 100 is in place around penile tissue, and electrical current is traveling to ring 100 from controller 10, without accidentally touching any conductive surfaces. The same manipulation is not required for ring 110, since it is intended to be placed around the top of the scrotal area.

Since each of rings 100 and 110 have one contact, they must be used in pair, in pair with each other, or one of rings 100 or 110 may be utilized in conjunction with one of the various electrodes described below. These rings must be used in such pairings for the completion of an electrical circuit.

FIGS. 4-5 illustrate bottom and top views, respectively, of an electrode 400. Electrode 400 is formed from a flexible strap 402 having a first surface 404, a nonconductive surface 406, a first end 408, and a second end 410. Flexible strap 402 may be formed from leather. Nylon webbing, or any other suitable material. Electrode 400 includes a closure 412 configured to attach first and second ends 408 and 410 together. For example, closure 412 may be a hook and loop fastener (as shown) or a snap assembly. Electrode 400 is preferably configured such that strap 402 forms a ring when first and second ends 408 and 410 are attached together. Of course, closure 412 may be adapted such that the amount of overlap between first and second ends 408 and 410 is adjustable to facilitate the formation of a variety of ring diameters.

A conductive layer 414 is coupled to first surface 404. Conductive layer 414 is substantially insulated from

nonconductive surface 406. To provide voltage to conductive layer 414, an electrical connector 416 is preferably mounted on nonconductive surface 406 such that it communicates with conductive layer 414. Connector 416 may be configured similar to snap contact 108 (see FIG. 3). To establish a current path, two electrodes 400 may be cooperatively used. To prevent a user from inadvertently contacting a conductive surface, electrode 400 may include a nonconductive handle (not shown) similar to nonconductive handle 109 shown in FIG. 3 and described above.

Turning to FIG. 6, shown are electrode rings 700 and 710 according to alternate embodiments of the present invention. Rings 700 and 710 are similar to rings 100 and 110, respectively. However, rings 700 and 710 are fabricated from elastomeric material such as low modulus silicon, viton, and neoprene generally having a hardness of 30 shore A plus or minus 10, and elongation of 700%, and a tear strength of 50. Ring 700 has outer surface 701, side edges 702 and 704, inner surface 706, male button snap contact 708, and handle 709. Contact 708 is embedded through outer surface 701 into inner surface 706, which is contiguous with edges 702 and 704 and unshielded therebetween.

Outer surface 701 including handle 709 is nonconductive. Inner surface 706 and side edges 702 and 704 are conductive by virtue of carbon particles embedded in the silicon, viton, or neoprene. Thus, a volume of conductive material is located between outer surface 701 and inner surface 706. The carbon particles have a hardness of 65 shore A plus or minus 10, and elongation of 200%, and a tear strength of 35.

Ring 710 is structurally identical to ring 700 except ring 710 has no handle equivalent to handle 709. Ring 710 has outer surface 711, side edges 712 and 714, and inner surface 716. As described above in connection with ring 110, ring 710 is not intended to be manipulated after electricity is applied thereto.

In FIG. 7, female electrode apparatus 40 is shown in place in a cross-sectional view of a female body at the lower abdomen. Shown is pelvic region 200, with clitoral area 201, vagina 202, bladder 203, and urethra 204. Wires 26 (not shown in FIG. 7) and 27 are connected to controller 10.

Female electrode 50 in two of three modes is placed within the vagina. To control incontinence, electrode 50 is placed shallowly within vagina 202, and a minimal amount of electricity is applied. In this way electrical current is applied to the muscles (not shown) surrounding urethra 204 which will constrict urethra 204 thereby preventing the leakage of urine. The tethers shown in FIG. 1 may be used to hold apparatus 40 in place about the user's body, and controller 10 may be carried in a pocket.

Electrode 50 may also be placed shallowly or more deeply within vagina 202, and with adjustment of the electrical current, may be used to induce excitation and orgasm. Aperture 46 allows access to the clitoral area, if additional manual stimulation is desired.

In FIG. 8, ring 100 is shown about the base of penis 300, and ring 110 is shown about the top of the scrotal sac 310. Ring 100 in particular has the ability to stretch in diameter considerably, allowing a regular size ring to accommodate a normally sized penis from rest to erection, and for a small diameter to stretch considerably, as needed when used where penile atrophy or impotence has occurred.

The electrical current can be adjusted considerably with controller 10. When adjusted one way, this arrangement of rings 100 and 110 can control incontinence, and in another way can be used to induce erection, excitation and orgasm. It should be appreciated that one or more of rings 100 and 110 may be replaced with a like number of electrodes 400 (described above in connection with FIGS. 4-5). Furthermore, rings 100 or 110 may be replaced with rings 700 or 710 (described above in connection with FIG. 6), respectively.

FIG. 9 shows a frontal view of apparatus 40. Shown here is one of the male button snap contacts, contact 30. A corresponding contact rests under connector 28, while connector 28 has in it a female button snap contact. FIG. 10 shows a side view of apparatus 40, in its third and nonvaginal mode for use. In this mode, electrode 50 is placed into aperture 46, while wire 45 is tucked into groove 47. When configured in this mode, tethering apparatus 40 in position like in FIG. 7, positions electrode 50 on clitoral area 201. This mode is intended to induce orgasm with the application of electricity to the clitoris.

FIG. 11 also shows a side view of apparatus 40 ready for the first two modes of use described herein. Note that to convert apparatus 40 from the mode seen in FIG. 10 to that in FIG. 11, all one has to do is to push electrode 50 from left to right (as shown in FIGS. 10 and 11) to remove it from aperture 46. Electrode 50 may also be placed within the anal cavity of a male or female for the inducement of excitation and orgasm. Electrode 50 is depicted in FIGS. 10-11 without the curved shape shown in FIG. 2.

The invention also encompasses an apparatus like apparatus 40 with two electrodes wired thereto (not shown). In this apparatus, each electrode is similar to electrode 50. Yet both conductive segments of each electrode are wired from one side of the two-stranded wire (analogous to wire 45), so that both electrodes must touch the body for electrical current to pass from them, and between them. Such apparatus is highly useful for stimulating bladder and ureter control muscles since the electrical current will travel through the body between the electrodes. To accomplish this, one must place one electrode at the front of the body, e.g., within the vaginal cavity, and the other at the rear of the body, e.g., within the anal cavity. A male version of this apparatus could substitute one of rings 100, 110, 700, or 710, or electrode 400 (see FIGS. 3- 6) for one of the ball-shaped electrodes.

FIGS. 12-13 detail alternate penile electrode ring

120. Unlike rings 100 and 110 which each have one contact and must be used in pairs, ring 120 has two contacts and may be used about the penile shaft without the use of another ring.

Ring 120 includes a body 122 fabricated from a flexible material such as leather or Nylon webbing. Body 122 has an inner surface (hidden from view) and a contiguous outer nonconductive surface 124. An inner conductive layer includes a first conductive portion 126 and a second conductive portion 130. First conductive portion 126 has a first end 132 and a second end 134. Second conductive portion 130 also has a first end 136 and a second end 140. Conductive portions 126 and 130 are each coupled to the inner surface of body 122, and are substantially insulated from outer nonconductive surface 124.

Conductive portions 126 and 130 are insulated from each other via first and second nonconductive portions 142 and 146. First nonconductive portion joins first end 132 of first conductive portion 126 to first end 136 of second conductive portion 130. In like manner, second nonconductive portion 146 joins second end 134 of first conductive portion 126 to second end 140 of second conductive portion 130. Conductive portions 126 and 130 may be formed from any electrically conductive material such as metallic sheets or silicon or neoprene substrates impregnated with carbon particles (see above description of electrode 50) . Male button snap connectors 128 and 138 are mounted through outer nonconductive surface 124 and communicate with second and first conductive portions 130 and 126, respectively. Additionally, handle 144 extends from outer surface 124 and is also nonconductive, allowing ring 120 to be manually moved and rotated while electricity is applied. Such nonconductive surfaces may be fabricated from low modulus silicon, viton, or neoprene.

In use, controller 10 is connected in like fashion to electrode ring 120, as it is shown connected to female electrode apparatus 40 (see FIG. 1). Snap connectors with heads 28 and 29 are connected to connectors 128 and 138. Rather than employing ring 120, the present invention may employ an electrode 500, as shown in FIGS. 14-15. FIG. 14 shows a bottom view of electrode 500 and FIG. 15 shows a top view of electrode 500. Electrode 500 is similar to electrode 400 (see FIGS. 4-5), therefore the description of electrode 400 should be referred to.

Electrode 500 is formed from a flexible strap 502 having a first surface 504, a nonconductive surface 506, a first end 508, and a second end 510. Electrode 500 includes a closure 512 configured to attach first and second ends 508 and 510 together. Although closure 512 is depicted as a hook and loop fastener, other securing devices may be equivalently implemented. Electrode 500 is configured such that strap 502 forms a ring when first and second ends 508 and 510 are attached together. A conductive layer includes a first conductive portion 514 and a second conductive portion 516, each of which is coupled to first surface 504. A first electrical connector 518 is preferably mounted on nonconductive surface 506 such that it communicates with first conductive portion 514. A second electrical connector 520 is similarly mounted such that it communicates with second conductive portion 516. Electrode 500 may also include a nonconductive handle (not shown) similar to nonconductive handle 109 shown in FIG. 3 and described above. First conductive portion 514 has a first end 522 and a second end 524, and second conductive portion 516 has a first end 526 and a second end 528. Electrode 500 includes a first nonconductive portion 530 joining first end 522 of first conductive portion 514 to first end 526 of second conductive portion 516. In addition, electrode 500 preferably includes a second nonconductive portion 532 situated on first surface 504 and located at first end 508 of strap 502. Nothing prevents second nonconductive

portion 532 from being located at second end 510 rather than at first end 508. Alternatively, electrode 500 may incorporate nonconductive portions at both ends 508 and 510. As with electrode 400, electrode 500 preferably forms a ring when first and second ends 508 and 510 are attached together. Accordingly, first and second conductive portions 514 and 516 are configured such that they do not contact one another when first and second ends 508 and 510 are attached via closure 512. Second nonconductive portion 532 is also adapted to reduce the likelihood of electrical contact between first and second conductive portions 514 and 516 when electrode 500 is formed into a ring.

FIGS. 16-17 detail alternate penile electrode ring 720. Ring 720 is formed from an elastomeric material similar to rings 700 and 710. Unlike rings 700 and 710 which each have one contact and must be used in pairs, ring 720 has two contacts and may be used about the penile shaft without the use of another ring. Ring 720 has nonconductive outer surfaces 722 and 732, and also has nonconductive portions comprising outer surfaces 740 and 750, top rims 742 and 752, bottom rims adjacent outer surfaces 740 and 750 (not shown but analogous to top rims 742 and 752), and inner surfaces 743 and 753. The inner thickness of the electrode walls between outer surfaces 740 and 750, and inner surfaces 743 and 753, respectively, are also nonconductive.

Additionally, handle 744 extends from outer surface 740 and is also nonconductive, allowing ring 720 to be manually moved and rotated while electricity is applied. Such nonconductive surfaces and portions are comprised of low modullus silicon, viton, and neoprene.

Like the above electrodes, the conductive surfaces 724, 726, 734, and 736, and the bottom rims adjacent outer surfaces 722 and 732, and the inner thickness of the electrode walls between outer surfaces 722 and 732, and inner surfaces 726 and 736, respectively, are comprised of low modullus silicon, viton and neoprene that is embedded

with carbon particles. Thus, two volumes of conductive material are defined between the inner and outer surfaces of the conductive portions of ring 720. Male button snap connectors 728 and 738 are embedded through surfaces 722 and 732 into the conductive material between rims 724 and 734, and their respective bottom rims.

Turning to FIG. 18 vaginal electrode 160 is shown. Electrode 160 is desirably fabricated from the same materials as electrode 50 (see FIG. 2), and is nonconductive at a base 161, at vertical portion 162, and at portion 164. Vertical portion 162 and portion 164 form a nonconductive volume between conductive side portion 167, conductive side portion 168, and tip 166. Tip 166 and side portions 167 and 168 are conductive and preferably insulated from one another. The tip 166 is electrically connected to a first connector 163, and side portions 167 and 168 are electrically connected to second and third connectors 165a and 165b, respectively. Electrode 160 is intended for connection like electrode 40. Base 161 is a relatively planar ellipsoid member that is also nonconductive.

Connectors 165a and 165b are preferably in direct contact with conductive side portions 167 and 168, respectively. In other words, electrode 160 requires no electrical wires, jumpers, or other electrical interface between connectors 165a and 165b and conductive side portions 167 and 168, respectively. This feature enables electrode 160 to be easily manufactured by, for example, known molding techniques. It should be apparent to one skilled in the art that two or more of the conductive surfaces and portions of vaginal electrode 160 can be wired together utilizing, for example, jumper wires at connectors 163, 165a, and 165b. In this way, electrode 160 can be used with another single connector electrode.

According to a preferred aspect of the present invention, electrode 160 includes a memory bend wire 169 located within it. Memory bend wire 169 is similar to

memory bend wire 54 described above in connection with FIG. 2. In this embodiment, memory bend wire 169 can also serve as the electrical connection between tip 166 and first connector 163. Alternatively, a separate wire (not shown) may be utilized along with an insulated memory bend wire 169. As described above, memory bend wire 169 enables electrode 160 to maintain its shape after being manipulated by a user.

FIG. 19 illustrates a cross-sectional view of an alternate embodiment of a vaginal electrode 170 formed from the same elastomeric materials and in the same manner as taught herein. Electrode 170 has a nonconductive base 171, through which connectors 172 and 173 are mounted.

Connector 172 is mounted to be in direct contact with conductive portion 174, whereas connector 173 is shielded from conductive portion 174. Nonconductive portion 176 is configured as a stripe that runs around the circumference of electrode 170. Conductive portion 174 is located on one side of nonconductive portion 176, and conductive portion 175 is located on the other side of nonconductive portion 176.

Shielded wire 177, which is run through conductive portion 174 as electrode 170 is formed, has a first nonshielded end connected to connector 173. Wire 177 has unshielded end 178 which feeds current to conductive portion 175. Again, it should be apparent to one skilled in the art that the two conductive portions of vaginal electrode 170 can be wired to one connector instead of two, by simply running the first unshielded portion of wire 177 connected to connector 173 into conductive portion 174. In this way, electrode 170 can be used with another single connector electrode.

Rather than utilizing shielded wire 177, electrode 170 may include an elastomeric conductive rod enclosed within a nonconductive channel or surrounded by nonconductive material. Forming a conductive portion within electrode 170 may be desirable to lower manufacturing costs.

As with electrode 160, a memory bend wire 179 is preferably located within electrode 170 to enable a user to adjust the shape of electrode 170. As described above, memory bend wire 179 is preferably shielded such that conductive portions 174 and 175 remain insulated from one another. Nothing prevents wire 177 from being incorporated with memory bend wire 179 into a single assembly.

Anal electrode 180 is formed from the same elastomeric materials as taught herein and is shown in FIG. 20. It has base 181, connectors 182 and 183 mounted through base 181, nonconductive portion 184, and conductive portions 186 and 187. Nonconductive portion 184 defines a nonconductive volume that extends from base 181 to and including the point of eiectrode 180. As described above, connectors 182 and 183 are preferably in direct physical and electrical contact with conductive portions 187 and 186, respectively. Anal electrode 180 has a wider portion 185, and a narrower portion 188. This allows electrode 180 to be held easily within the anal cavity when in use to control incontinence or for sexual purposes.

Anal electrode 180 preferably includes a memory bend wire 189 located therein. Memory bend wire 189 functions as described above in connection with electrodes 50, 160, and 170 (see respective FIGS. 2 , 18, and 19). If memory bend wire 189 is located wholly within nonconductive portion 184, then it need not be electrically insulated. '

FIG. 21 shows an electrode 190 which can be used within the anal cavity or can be sized to fit inside the male urethral cavity. Electrode 190, which is preferably formed from the same elastomeric materials as taught herein, has nonconductive base 191 and connector 192 mounted through base 191 and in direct contact with conductive portion 193. Electrode 190 is intended for use with another single connector electrode like ring 100. Using electrode 190 for urethral stimulation, while also using a single connector embodiment of electrode 180 in the anal cavity provides for an extremely efficient method of controlling male incontinence. Electrical

stimulation is applied directly to the areas, as well as through the body where urethral control muscles are located. This causes them to contract thereby closing off the path to the bladder. Electrode 190 also includes a memory bend wire 194 located therein. Memory bend wires are described above for various embodiments of the present invention. Memory bend wire 194 allows electrode 190 to maintain its shape after manipulation by a user. Various changes and modifications to the embodiments herein chosen for purposes of illustration will readily occur to those skilled in the art. To the extent that such modifications and variations do not depart from the spirit of the invention, they are intended to be included within the scope thereof which is assessed only by a fair interpretation of the following claims.

Having fully described the invention in such clear and concise terms as to enable those skilled in the art to understand and practice the same, the invention claimed is: