BACKGROUND OF THE INVENTION:

This invention relates to stiffening devices for a penis, and more particularly to a condom which may be easily affixed even to a flaccid penis, and al so to implant- type stiffening devices.

At present, two types of condoms are known: the rol l on type which ^• rolls over the penis; and the pul l over type which is pulled over the penis. Both of these known condoms are suitable for use only when the penis is erect. If the penis is flaccid, for example as would be the case - ^' wi th an impotent male, it is extremely difficul t, if not impossible to place the condom on the penis. •

More particularly, when condoms using rheopexic fluid as a stiffening agent, as disclosed and claimed 1n my U.S. Patent No. 4,432,357 , which condoms are particularly suitable for use with impotent males, 1t is difficult to place the condom over the flaccid penis. Therefore, an object of the present invention is to provide a condom which may be easily placed over the penis of the user, even a flaccid penis of an impotent male.

Penile implants are presently well known. Typical penile implants are discussed in an article entitled, "Complications of Penile Prosthesis Surgery for Impotence" ^" by Joseph J. Kaufman, Arie Lindner and Shlomo Raz, The Journal of Urology, Volume 128, December, 1982, pages 1192 and 1193, the entire contents of which are Incorporated herein by reference. Penile prosthetic devices are also discussed in the article entitled, "Penile Prosthetic Surgery Under ¹ Local Anesthesia" by Joseph ^' J..Kaufman; The Journal of Urology, Volume 128, December, 1982, pages 1190 and 1191, the entire contents of which are also incorporated herein by reference. The known penile prosthesis is generally a semi-rigid rod or an inflatable device. The semi¬ rigid rod has the disadvantage of always ^* being semi-rigid. The inflatable

device has the disadvantage of requiring additional structures to Inflate and deflatethe prosthesis. These prior art devices are thus unsatisfactory.

Therefore, a further object of the present invention is to provide a penile prosthesis which may be easily implanted in the penis and which is simpler in design and .operation than the prior art devices.

Yet another object of the invention is to provide a condom which may be easily placed over the penis of the user, even a flaccid penis of an impotent male, which condom need not include the stiffening rheopexic material dis¬ closed herein and disclosed in my copending application Serial No. 388,107. Such a condom is particularly useful with impotent males using other penis stiffening means, and who require the use of a condom for birth and/or disease control.

SUMMARY OF THE INVENTION

According to the present invention, a condom comprises an elongated generally tubular member of thin, flexible material ;an elongated opening provided along at least a substantial portion of the length of the elongated tubular member so as to facilitate placing the elongated tubular member over a flaccid penis; and means for closing the elongated opening after placing of the condom on a flaccid penis. Preferably, the tubular member has chambers thereon for receiving rheopexic material to serve as a stiffening agent. A penile prosthesis according to the present invention comprises an.elongated generally tubular member having closed ends and defining at least one chamber therein; and a rheopexic material 1n the at least one chamber and retained sealingly within the at least one chamber; the elongated tubular member being adapted to be implanted in a penis.

BRIEF DESCRIPTION OF THE DRAWINGS:

Fig. 1 is a perspective view of a condom, 1n its erected state, according to the present invention;

Fig. 2 is a cross-sectional view of the condom of Fig. 1, drawn to an enlarged scale;

Fig. 3 is a partial perspective, partial cross-sectional view of a modified condom of Fig. 1, but provided with a protective flap, drawn to an enlarged scale;

Fig. 4 is a further example of the invention wherein the protective flap of Fig. 3 is replaced with a protective sleeve; .

Fig. 5 illustrates a modification of the embodiment of Fig. 4 wherein the sleeve comprises a roll-down sleeve integrally formed with the front portion of the condom; Fig. 6 illustrates the embodiment of Fig. 5 with the roll-down sleeve partially rolled down;

Fig. 7 illustrates a condom with a zip-type closure having a slide fastener device thereon;

Fig. 8 Is a detail perspective cross-section of one type of conventional slide fastener device as used in Figs. 7, 9 and 10;

Fig. 9 illustrates a modified embodiment of Fig. 1 wherein the slide fastener device extends at a right angle to the longitudinal direction of the condom at the base or bottom portion thereof;

Fig. 10 illustrates a modification of the embodiment of Fig. 9;

Fig. 11 illustrates the invention as applied to a penile prosthesis;

Fig. 12 illustrates a penile prosthesis of Fig. 11 in greater detail; and

Fig. 13 illustrates a modified embodiment of the prosthesis of Figs. 11 and 12.

DETAILED DESCRIPTION

The condoms of the present invention preferably are generally of the type illustrated in my U.S. Patent No. 4,432,357. The condom is provided with a plurality of chambers or compartments 10 illustrated in Fig. 2, which compartments are filled with rheopexic fluid of the type disclosed in said U.S. Patent No. 4,432,357. The rheopexic fluid is not discussed in detail herein. Also, the various compartments containing the rheopexic fluids may be of the type shown in said U.S. patent No. 4,432,357, a detailed description not being given herein since the entire contents of U.S. patent No. 4,432,357 is incorporated herein by reference. The compartments are shown schematically in Figs. 2 and 3, but are not shown in the other-drawings of the present applicati

While the present invention is particularly useful with condoms using rheopexic fluid therein as a stiffening agent, the concepts of the present invention can be used with other types of condoms having other stiffening devices and wherein the penis may be provided with an internal implant-type stiffening device. The concepts of the present invention are also applicable to condoms having no stiffening means per se or to condoms having stiffening means other than those specifically disclosed herein. The main object of the present invention is to provide a condom which can be placed on a flaccid penis, for example by impotent males.

Referring to Fig. 1, the condom 20 comprises, ^' for.example, as shown in U.S. Patent No. 4,432,357 with Inner and outer layers, having rheopexic fluid therein. The condom is further provided with an elongated opening member 21 which may be generally of the type desig- nated as a ''zip-lock" closure. The closure is shown in more detail in

Fig. 2. The closure 21 comprises interengaging members 22, 23, the member 23 having a projection 24 thereon which engages in a recess 25 of member 22. Preferably, the projection 24 has a protrusion 25 which engages in a concave portion 27 of the recess 25 to provide a firm interlocking engagement of the • projection 24 in the recess 25. The closure in Figs. 1 and 2 is closed by pressing the members 22, 23 together along the direction of the arrows A shown in Fig. 2. This will provide a firm, liquid-tight seal along the length of the condom, and since the condom is supplied with the locking members 22, 23 opened, the condom may be easily placed over the penis, the closure members .22, ^' 23 then being pressed together in the direction of the arrows A in Fig. 2, to firmly close the condom over the penis, ready for use. Preferably, the locking members 22, 23 are fabricated of a material which is firmer than that of the material forming the circular part of the condom. Also, the condom preferably has about one inch at the top thereof

which is solid or closed (not provided with the zip-type opening) for accumulatio of ejaculated spermatozoa. By providing the solid or closed upper or head portion of the condom, the safety aspect of preventing possible leakage of spermatozoa after ejaculation is improved. As shown in Fig. 3, a flap, of latex or having compartments containing rheopexic fluid, can be provided to go over the zip-type closure of Figs. 1 and 2 to prevent irritation from occurring to the sex partner. Preferably, the flap 30 illustrated in Fig. 3 extends upwardly above the upper portion of closure members 22, 23 and is adhered or sealed to the condom at 31. This insures that the flap will remain covering the closure members 22, 23 during use, and provides a smoother outer surface of the condom to further prevent irrita¬ tion from occurring to the sex partner.

As shown in Fig. 3 an inner flap 35 may be.provided to protect the male organ from irritation due to the closure 22, 23. The inner flap 35 is prefer- ably generally coextensive with outer flap 30.

Fig. 4 illustrates a modified protective arrangement wherein a sleeve 40 is slid over the condom after the condom is placed over the penis. For example, after the condom is placed over the penis and the zip-closure members 22, 23 are pressed together to close same, the sleeve 40 is then slipped over the closed condom to serve as a protective layer to prevent irritation to the sex partner.

Fig. 5 illustrates an improved arrangement of providing a circular sleeve over the condom for protective purposes. In Fig. 5, the sleeve 50 is integrally formed at the upper portion 51 of the condom with the outer surface of the condom so as to provide a smooth junction which will not irritate the sex partner. The sleeve 50 is rolled up, as shown in Fig. 5. After closure of the zip closure members 22, 23, the sleeve 50 1s then rolled downwardly to completely cover the zip closure member in a secure and positive fashion. Fig. 6 illustrates the roll-down sleeve 50 at an Intermediate position, 1t being clear that sufficient material is provided in the roll-down sleeve 50 to permit it to be rolled all the way down to the base of the condom.

In the above embodiments, it should be clear that the zip-closure members 22, 23 are tapered at the upper ends or at the head portion of the condom, as shown in Fig. 1, to further prevent irritation to the sex partner. This is shown by means of Inclined surfaces 28 In F1g. 1. Fig. 7 illustrates a modified embodiment wherein the closure comprises a plastic zipper (a slide fastener device^ 60 utilizing a conventional zipper slide 61 for closing the plastic zipper. The plastic slide fastener or zipper members 62, 63 are integrally formed with edges 64, 65 of the condom, as are the closure members 22, 23 with the edges of the condom 20 shown in Fig. 1. The zipper 60 is of conventional construction and is shown in detail in Fig. 8. To use the condom of Fig. 7, the condom, in its open state, is placed over the flaccid penis, and the slide 61 is pulled downwardly toward the base of the penis to firmly close the plastic zipper 60. The slide 61 can be removed completely from the condom at the base portion of the condom, or a stop member 66 can be formed at the bottom of the condom to prevent the slide 61 from coming off the base of the condom. This arrangement will permit the zipper 60 to be re-used, thereby permitting the condom to be re-used, as desired. If the stop members 66 are provided to prevent the slide 61 from coming off the end of the zipper members 62, 63, it is desirable that some type of protective device

be provided at the base of the condom to prevent the retained slide 61 from irritating the sex partner. A suitable device is a sleeve such as shown in Fig. 4, but the sleeve not being as long as the sleeve of Fig. 4 since it is only necessary to cover the lower end portion of the zipper 60. Also, in this embodiment, it is preferable, to.use a flap such as flap 30 to protect the sex partner from irritation by the zipper 60. Sleeve 40 of Fig. 4 could also be used for protective purposes. The roll-down sleeve 50 of Figs. 5 and 6 could also be used, this arrangement being very advantageous since it will also "roll" relatively easily over the slide 61 at the base portion of the condom to serve as a protector shield therefor.

As seen in Fig. 7, a flap 80 can be integrally formed with the lower portion of the condom 67, the flap 80 having an adhesive portion 81 covered by a release material (such-as a release paper) 82. In use, when the slide 61 is moved down to the bottom of the condom, the release paper 82 is removed and the flap 80 is paIced across the bottom portion of the condom, over the slide 61, and adhered to the opposite side of the condom, thereby covering the slide 61 and also securely locking the condom in its closed position to prevent inadvertent opening thereof.

Such a flap 80 can also be provided in the embodiment of Figs. 1 and 6 to insure that the bottom portion of the condom will remain closed. The flap 80 in the embodiment of Figs. 1 and 6 is not illustrated 1n the drawings, but it can be implemented in substantially the same way as shown in Fig. 7. The inner and outer flaps 35, 30, respectively, shown in Fig. 3 may have adhesive portions along their longitudinal vertically extending free edges, the adhesive material being covered by a release paper or the like. During use, the free ends of the flaps 30 and/or 35 can be adhered to the remaining portion of the condom, if desired. It is generally not necessary to provide an adhesive for the inner flap 35 since it will be retained in place by the pressure of the condom on the penis. If adhesive securing of the free edge of a flap is desired, it is generally preferable to use it in connection with outer flap 30.

Fig. 9 illustrates a further modified embodiment wherein theupper or slide fastener 60 is turned at right angles at the base portion of the condom so that after the slide 61 is pulled down, the slide is retained in a horizontal, rather than vertical position relative to the penis. A protective sleeve - 70 is provided at the base portion of the condom to serve as protection from irritation of the partner by the slide 61. The sleeve 70 is shown outwardly spaced from condom 68 in Fig. 9 for ease of illustration, but preferably it is of elastic material and is tightly formed against the main body of the condom 68. In the embodiment of Fig. 9, the roll-down sleeve 50 of Figs. 5 and 6, is used. Alternatively, the slip-on sleeve 40 of Fig. 4 or the flap 30 of Fig. 3 can be provided either with or without the upwardly directed lower sleeve 70, for protective purposes. Still further, as seen in Fig. 10, the sleeve 70 can be provided in a roll-up manner, such as the roll-down sleeve 50 of Figs. 5 and 6. In Fig. 9, after the ^' slide 61 is slid down to the base of the condom 68, the roll-up sleeve 71 is rolled upwardly, as shown in chain lines, to cover the slide 61. The sleeve 71 is of elastic material and preferably tightly encircles the base of the condom so as to securely cover the slide 61.

15

In the •embodiments of Figs. 9 and 10, ^' since a fixed member is located at the base of the condom, it is more difficult to insert the condom onto a flaccid penis than the -embodiments discussed previously. However, if the zipper or slide fastener device for the elongated opening of the condom is in the o state during insertion of the penis, it is still possible to relatively easily insert the condom over the penis since the user can extend his fingers through the elongated open closure and pull the flaccid penis through the lower members 70 or 71 (Figs. 9 and 10, respectively). After the penis is pulled through the lower portion 70, 71, then the condom can be closed in the longitudinal direction, as discussed hereinabove.

Once the condom of the present invention is placed on the penis, a "pseudo erection" can take place by means of the rheopexic material such as disclosed in U..S. Patent No. 4.432,357. or by other, means which may be provided either with-n the condom or within, the penis of the user.

Any of the cnndoms of Figs. 1-10 may have rheopexic fluid receiving chambers (as seen in Fig. 2),or such chambers may be eliminated. When the chambers are eliminated, the condom may be a single layer condom having the same opening and closing constructions as shown in Figs. 1 and 3-10 to aid in placing the condom over a flaccid or semi-flaccid penis. Such a condom may have stiffening means other than rheopexic fluid or may have no stiffening means at all. Penile implants, such as those already known or those shown in Figs. 11-13 may be used with the condoms which have rheopexic fluid receiving chambers as shown in Fig. 2 o ^r with those openable condoms not using rheopexic fluid.

While a particular slide fastener 60 is shown, other equivalent elongated fasteners can be used.

Fig. 11 shows a penile prosthesis which is implanted in a penis. Fig. 11 shows two penile prostheses 100, 101, which prostheses are generally elongated tubular members having rheopexic material therein. Fig. 12 shows a broken view of a typical prosthesis 100 with rheopexic fluid 102 therein. The advantage of the penile prosthesis of Figs. 11 and 12 is that in the normal state, the tubular prosthesis 100 is generally flaccid. In an agitated state, the rheopexic material within the prosthesis 100, 101 will stiffen the prosthesis 100, 101 due to the characteristics of rheopexic materials, thereby providing a "psuedo' erection". Upon cessation of stimulation, the rheopexic material will revert back to its normal, non-agitated state and the penis will then again become flaccid. These are precisely the characteristics required of a penile prosthesis.

The details of implanting a penile prosthesis of the present invention into a penis is not given herein since such details are known, as is evident from the two articles entitled, "Complications of Penile Prosthesis Surgery for Impotence" and "Penile Prosthetic Surgery Under Local Anesthesia", which were mentioned herεinabove. The tubular members 100, 101 can be made

17

of inert, flexible biologically safe materials, such as polypropylene or similar materials so as to contain the rheopexic material in a leak-proof or liquid-tight state. Similar materials asare used for inflatable penile prostheses can be used for the elongated tubular members 100, 101 of the

5 present invention.

The elongated prosthesis shown in Figs. 11 and 12 can be provided with compartments or chambers therein, such as shown in Fig. 13. For example, a longitudinally extending divider 103 can be provided internally of the prosthesis 100 to divide same into upper and lower compartments 104, 105, 0- each of which is sealed off from each other and each of which is filled with rheopexic material 102. The prosthesis of Fig. 13 can also be divided into adjacent longitudinally extending compartments by providing internal dividers 106 which extend vertically in Fig. 13. The longitudinal divider 103 and/or the vertically extending dividers 106 can be provided,

15 as desired, depending upon the characteristics required and the type of rheopexic material used.

The rheopexic fluid used in the invention is preferably an aqueous solution of a dial yl sulfosuccinate salt of the formula

wherein R is an alkyl group containing 6 to 12 carbon atoms and preferably 8 to 12 carbon atoms with the octyl (e.g., 2-ethylhexyl) group being particularly preferred. M is a Group IA ion and preferably sodium, potassium or lithium, with sodium being particu larly preferred. The 1,4-bis(2-ethylhexyl) sodium sulfosuccinate is the most preferred compound. The aqueous solution is preferably a Normal saline solution

(0.9 gram- of- sodium chloride in 100 milliliters of water) or a Ringer's solution (0.86 gram sodium chloride, 0.03 gram potassium chloride and 0.33 gram calcium chloride in 100 milliliters of water) . These solutions are referred to as physiological electro- lyte solutions or coπimonly physiological solution.

The solutions can contain from about 0.7 to 1.3 grams of the salt per 100 milliliters of water and preferably between about 0.8 and 0.10 grams. The range of between about 0.85 and 0.95 grams per 100 milliliters is particularly preferred.

- The dialkyl (e.g., the 1,4-bis(2-ethylhexyl) sulfosuccinate salt is dissolved in the physiological solution in an amount betwe about 15 and 200 gramε per 100 milliliters of solution and prefera

in an amount between about 19 and 100 grams. The range of betwee about 19 and 65 grams is particularly preferred.

The rheopexic solution should have a pH of at least about 4 to exhibit the desired rheopexic characteristics. It preferabl has a pH of at least about 5, with the range between about 5 and 7 being preferred-. The effect of pH on rheopexic dispersions of dioctyl sodium sulfosuccinate in Normal saline are disclosed in an article by Levinson, Allen and Diagle in the Journal of Colloi and Interface Science, Vol. 72, No. 1, October 15, 1979, pages 159-160.

Other characteristics of rheopexic dispersions of dioctyl sodium sulfosuccinate are disclosed in the Levinson, Allen and Diagle article in the Journal of Colloid and Interface Science, Vol. 56, No. 2, August 1976, pages 38-8-390, and in the Levinson, Allen, Vishnupad and Ecanow article in the Journal of Pharmaceu¬ tical Sciences, Vol. 65-, No. 8, August 1976, pages 1265-1266.

The rheopexic solutions can be prepared by dissolving the dialkyl sulfosuccinate salt in the physiological solution. The salt may be in the form of a solid or in the form of a dispersion or solution in water or a water mixture, such as a water alcohol oaf water glycol mixture.

The preferred source of sodium dioctyl sulfosuccinate are the AEROSOL OT surfactants marketed by American Cyanamid. The preferred product is AEROSOL OT 100 which is a waxy solid sodium dioctyl sulfosuccinate. The OT 75 which contains about 75% of the solid salt and 25% of a mixture of water and alcohol and the OT 70 PG v/hich contains about 70% of the solid salt with the

remainder a mixture of water and propylene glycol also have provided useful rheopexic fluids when dissolved in the physio¬ logical solution.

The rheopexic effect is obtained over a wide temperature range between freezing and boiling with the range of 1.5 ^β C to

100 ^β C being preferred and the range of 1.5°C-29 ^β C being particu¬ larly preferred.

The gel viscosity attained and the time during which the gel will remain in gel form after the applied stress is removed varies with the particular sulfosuccinate salt form used to prepare the rheopexic solution. A rheopexic solution prepared from OT-100 (100% solid salt) (1) attains a higher viscosity than a rheopexic solution prepared from OT-75, and (2) retains its gel viscosity for a longer time after the applied stress is removed.

The rheopexic fluid used in the embodiments exemplified herein was prepared by dissolving 19 parts by weight of solid powdery sodium 1,4-bis(2-ethylhexyl) sulfosuccinate (AEROSOL OT-100 in 100 ml. of Normal saline solution.

21

The rheopexic fluid described above 1s used in accordance with the present invention in condoms wherein the thickening effect of the rheopexic fluid under application of shear stress causes stiffening of the condom during use, thereby aiding the user in maintaining an erection.