Application Serial No. 09/396,891, filed on September 15, 1999, and of U. S. Application Serial No. 09/232,476, filed on January 15,1999.

BACKGROUND OF THE INVENTION Field of Invention This invention relates to contraceptive and prophylactic devices for preventing pregnancies and the transmission of sexually transmitted diseases during sexual intercourse, and more particularly to condoms, micro-condoms and penile caps.

Prophylactic devices which adhere only to the glans of the male's penis have difficulty adhering to the glans with the current adhesive tape technology commercially available. Adhesive tapes with enough tack to remain securely adhered to the glans are difficult to remove without causing user discomfort and duress. This invention adheres to the penis in a manner to maximize user frictional stimulation by utilizing a technique to adhere a glans cap to the male glans which affords reliability during coitus and ease of separation post coitus.

The instant method involves pre-applying a fast-curing liquid adhesive to the surface of the glans before applying a high tack tape adhesive to the glans for the purpose of securing a glans cap to the glans. The coating cured over the surface of the glans serves as a stable bonding surface for adhesion of a glans cap. A hypo-allergenic solvent is used post coitus to dissolve the coating thereby removing the glans cap from the glans

penis.

Description of the Related Art Numerous prophylactics have been developed which cover the length of the tumescent male organ or adhere to the glans of the penis about the urethral opening to seal the urethral opening against foreign bodily fluids and microorganisms. Those prophylactics which cover the length of the tumescent penis interfere with frictional stimulation. Additionally, the device may slip off completely when the penis assumes a flaccid condition after ejaculation.

This slippage may result in seminal fluid leaking out of the prophylactic. Another objection to the use of conventional condoms is that their thinness tends to allow them to tear or leak during use, thereby permitting the exchange of bodily fluid between partners. The leakage problem can be diminished by manufacturing the condom of thicker material, but such a method will further lower the level of stimulation afforded the user.

Those prophylactics, known as penile caps or microcondoms, which adhere near the tip of the glans penis, such as described in U. S. Pat. No. 5,421,350, U. S. Pat. No.

4,869,269, U. S. Pat. No. 4,821,742, U. S. Pat. No.

3,677,225, and U. S. Pat. No. 5,458,114, significantly reduce the penile glans and shaft surface area deprived of frictional stimulation. Penile caps which adhere only to the glans area immediately surrounding the urethral orifice risk being pulled off completely or partially, either way compromising the biological barrier formed by the adhesive seal encircling the urethral opening. While minimizing bonding surface area is preferable to maximize frictional stimulation, maximizing bonding surface area is preferable from a failure prevention perspective.

U. S. Patents 4,869,269,4,821,742,3,677,225 and 5,458,114 all disclose a micro-condom or penile cap which is formed closely to the shape of the glans and seals directly to the area immediately surrounding the urethral opening, thereby reducing the chance for fluid exchange. However, all four of these devices could suffer localized failure of the adhesive seal or be pulled off of the glans during coitus by cyclic tensile forces because of the minimized bonding area.

U. S. Pat. No. 4,869,269 provides a seminal reservoir that is much too large, rigid and projecting for the comfort of the user's partner. Additionally, the design of this structure has poor stiffness against radially applied compressive forces, such as those developed by squeezing together the thumb and forefinger during typical application of the device, presenting the likelihood of collapsing its structure during application and enabling two points diametrically opposed on the adhesive coated surface to contact each other, bond, and render the condom unuseable.

In a similar design, U. S. Pat. No 5,458,114 offers an adhesive condom which also minimizes the area of the glans deprived of sensation but once again it is designed as a structure which could easily collapse during handling, thus enabling two points diametrically opposed on the adhesive coated surface to contact each other and render the condom unuseable. Additionally, the proposed bladder and bowl pieces of the design are suggested to be bonded together unless they are able to be manufactured as a single unit. Having multiple parts joined together by assembly procedures reduces the reliability of the device and presents the possibility of failure if a bond joint is poorly formed during manufacture or comes apart during use because the geometrically unstable bladder has become wedged between nearby surfaces within the receptive body

cavity or instead between the penis and the body cavity after bladder deployment. Furthermore, this design exposes the deployed bladder to a pattern of cuts in the outer envelope which can develop localized areas of high stress in the thin bladder material, again presenting the opportunity to tear the bladder material if it were to become wedged and pulled. Such a tear would completely defeat the purpose of the contraceptive prophylactic.

U. S. Patent Nos. 4,821,742 and 3,677,225 are similar in design and are designed to adhere only to the area immediately surrounding the urethral orifice, or meatus, and are prone to failure due to the very small surface area adhered to the glans of the penis, which must oppose cyclic tensile and shear forces encountered during coitus.

Additionally, no mounting tool is described as being used with the invention of U. S. Patent No. 4,821,742, and the flimsy nature of the base portion of the invention invites the opportunity for the user to collapse and bond the adhesive surfaces of the base portion together, rendering the device unapplicable or unintentionally leave a crease in the base material during application which subsequently becomes a leakage path for ejaculate. While U. S. Patent No. 3,677,225 does describe a tool for applying the prophylactic, the tool is in two separate halves which offers the unsteady user the unintentional opportunity to apply the device with leakage paths in the form of creases or wrinkles in the prophylactic material as it is bonded down.

U. S. Pat. No. 5,421,350 discloses a micro-condom or penile cap which covers the glans rather than the greater part of the penis. Although the device is designed toward increased user stimulation, its coverage of the entire glans limits frictional stimulation around the most sensitive part of the penis. Additionally, the design of this structure has poor stiffness against radially

applied compressive forces, such as those developed by squeezing together the thumb and forefinger during typical application of the device, presenting the likelihood of collapsing its structure during application and enabling two points diametrically opposed on the adhesive coated surface to contact each other, bond, and render the condom unuseable.

The proposed invention resembles a penile cap in the fact that it adheres to the tip of the glans of the penis to form a leakproof seal around the urethral orifice.

However, unlike other penile caps, the proposed invention has integrally attached, adhesive-coated strips for handling and force distribution which lie adhered along the surface of the glans. These strips serve to oppose tensile forces acting on the perimeter of the adhered area and in doing so prevent the possible failure of the adhesive seal, which is a probable scenario in other designs because of cyclical tensile loading. The strips only cover small landings on the glans surface leaving the rest of the glans surface area, especially the highly sensitive coronal ridge, exposed to unimpeded frictional stimulation offering improvement over rolldown, full length prophylactics.

The force distribution strips disperse the tensile load acting on the penile cap without overly depriving the user of frictional stimulation to the major surface area of the glans. In addition to the force distribution strips, the proposed invention also has a fluid absorbing means in the bladder portion of the invention to absorb and contain male urethral discharge which significantly increases the probability of maintaining a functional adhesive seal.

A significant hurdle which must be overcome is the difficulty of keeping the glans cap securely fastened to the glans during coitus. The skin of the glans is similar

to skin over the remainder of the human body in that it is not a continuous, smooth surface, but is instead covered with miniature crevasses. The outermost layer of skin consists of dead skin cells. When an adhesive tape is pressed to the skin of the glans, the combination of dead skin cells which can be shed and crevasses over the surface both contribute to poor adhesion of the tape adhesive material. In the case of an adhesive tape securing the flange of a glans cap to the surface of the glans penis, the crevasses of the glans skin permit pre-ejaculate seminal fluid to seep between the pre-applied adhesive of the glans cap and the skin surface of the glans penis. Once seminal fluid begins to seep into the bondline area, hydro-dynamic wedging acts as a mechanism for failure of the bondline in those areas where shed skin cells have not already caused adhesive failure.

In the instant device and method, a curable coating is applied over the dry, clean skin of the glans penis. A cleaned skin removes skin cells about to shed. Once this coating cures, it smooths over the surface of the glans by filling in the miniature crevasses of the glans epidermis and serves as a base layer to adhere the adhesive surface of a glans cap to the glans penis. The coating eliminates the risk of hydro-dynamic wedging of seminal fluid between the material of the glans cap and the skin of the glans penis.

The bonding of the prophylactic to the user is achieved in a two-part process. In the first phase the user applies a liquid adhesive to the skin of the glans and penile shaft in areas to which the prophylactic will be bonded. In the second phase adhesive preapplied to selected surfaces on the prophylactic is exposed and mated to the cured adhesive coating on the skin, forming the bondline between the glans skin and the prophylactic. After usage the bondline is broken by applying a hypo-allergenic solvent

means of removal known in the art which dissolves the liquid adhesive means of attachment dried on the skin.

The proposed invention is also contoured to the shape of the tumescent glans during application by using a membrane tensioning means which holds the substantially annular surface of the device in a taut condition so that it can be stretched out over the contour of the glans penis during bonding.

BRIEF SUMMARY OF THE INVENTION The primary objective of the invention is to serve as a seal over the urethral opening of the male sex organ, with the capability to withstand tensile and shearing forces significantly larger than those which could be expected under normal coital activity, so as to effectively prevent the exchange of bodily fluids between partners. A second objective of the invention is to provide a contraceptive penile cap prophylactic which is easy to handle, install and remove. A third objective of the invention is to place near the urethral orifice a very flexible, collapsible bladder with absorbent means which does not discomfort the user or partner during coitus, but is capable of expanding as necessary to contain ejaculate.

To achieve the first objective, the proposed invention resembles a penile cap which seals over the urethral opening similar to the prior art with the exception that a plurality of extensions of the prophylactic material extend radially outwardly from and beyond the substantially annular flange of the device to provide more adhesion surface to bond to the surface of the glans and distribute any tensile or shearing loading over a greater surface area.

The geometry of the penile cap is that which is suitable to form a seal, such as an annular seal, encircling the

urethral opening and serving as an enclosure over the urethral opening, preventing biological microorganisms from entering the urethral opening, and to also connect two or more radial force distribution extensions to the penile cap geometry. The prophylactic itself is made of any pliable material known in the art to be suitable for the application such as synthetic latex. Like the prior art, a medical grade adhesive material know in the art, such as Monsanto Gelva Acrylic Water-based Medical Grade Adhesive 2222, or Fitchburg 545 free film coated onto a thermoformable polyester liner, or 3M Medical Transfer Film, is used to coat selected surfaces of the device.

The adhesive coated surfaces are the proximal surface of the radial extensions of the device and the proximal surface of the substantially annular flange of the device.

Unlike the prior art, a second medical grade liquid adhesive known in the art, such as Mastisol, is used to coat selected portions of the penile shaft and glans. A fast curing liquid adhesive, such as tincture of benzoine, gum mastic such as Mastisol by Ferndale Laboratories, purified pine tar or any other medically approved mildly non-polar cellulose-based gum, is applied to the surface of the glans penis and along the top and bottom of the penile shaft. After the liquid adhesive has cured, a glans cap with its own pre-applied high-tack adhesive is bonded to the glans penis and penile shaft over the surface coated by the cured liquid adhesive. This cured liquid adhesive forms a first biological barrier over the skin of the glans and penile shaft and establishes a continuous surface smoother than the skin of the penis as a base layer for the successful adhesion of a medical tape adhesive. A second biological barrier is formed between the cured liquid adhesive and the pre-applied adhesive tape bonding agent of the glans cap device when the bonding surface of the glans cap is positioned and firmly pressed against the coated glans surface. Post coitus,

the glans cap can be separated from the penis by dissolving the cured liquid adhesive with a medically approved alcohol-based solvent such as isopropyl alcohol, medically approved petroleum distillates such as the product Detachol by Ferndale Laboratories, or soapy water, or a combination thereof.

The adhesive coating on the proximal surface of the prophylactic annular flange bonds to the dried adhesive coating on the glans skin to adhere the flange in a manner to completely enclose the urethral opening and prevent biological microorganisms from entering the urethra.

Additionally, the adhesive coating along the proximal surface of each of the radial extensions adheres the extensions to the glans and shaft of the penis to distribute tensile and shearing forces acting on the prophylactic, thereby ensuring continuous, proper adhesion during coitus. The adjustment for the length of different male sex organs is made possible by applying the radial extension strips in two parts.

To bond the radial extension strips in two parts first the fast curing liquid adhesive is applied to the penile shaft. After the liquid adhesive has cured, small lengths of the extension strips are bonded to the penile shaft near the base of the penis. The substantially annular portion of the device and the extension strips attached to that portion are then bonded to the tumescent male member such that the extension strips of the device overlap the small lengths of extension strips near the base of the penis. The device is removed from the glans after coitus by peeling it off, as an adhesive coated bandage is removed, or by using an approved, non-injurious, hypoallergenic adhesive solvent, such as Detachol or other noninjurious means known in the art, and then the prophylactic is disposed of still containing the captured ejaculate.

To achieve the second objective of the invention, a support, if removable, is in contact with the distal surface of the prophylactic along the radial extensions and also about the distal surface of the annular region encircling the urethral area of the glans to lend support to these areas while the prophylactic is being handled.

The support of the distal surface of the annular region is able to be a hoop such that the annular region remains stretched out during application but can be shaped to conform to the glans contour by simply pressing the tumescent glans against the proximal surface of the stretched annular portion of the prophylactic.

Alternatively, if the supporting structure is integrally manufactured as part of the prophylactic, the same annular region and radial extension areas are still supported during handling, but the integral supporting structure is not removed until the prophylactic itself is removed.

Having the supporting structure integral to the device does not cause additional duress for either partner as an integral supporting structure could be manufactured to be a thin yet semi-rigid support from techniques known in the art such as latex coating of either wire or plastic semi-rigid hoops. Semi-rigid in this application implies not being easily deformed under the ordinary handling practices of such an installation procedure, but deformable by greater manual dexterity forces.

To achieve the third objective of the invention, a very-thin-walled bladder is integrally formed to the main body annular surface for the purpose of collecting ejaculate. The thin-wall bladder is able to expand as necessary to contain ejaculated semen. The thin-wall construction of the bladder allows it to deform as necessary to prevent discomfort or injury caused by compressive forces generated from contacting body cavity walls. A collapsible absorbent material known in the art, such as cotton fabric or synthetic sponge, is placed

inside of the bladder to absorb any seminal fluid discharged from the male urethra during coital activity.

The absorbent material helps to contain the discharge which is important for preventing hydrodynamic wedging of urethral discharge into the bondline of the adhesive if the prophylactic were to be compressed between the glans and a wall of the receptive body cavity.

Hydrodynamic wedging will encourage premature failure of the bondline.

This device affords the user more frictional stimulation than roll-down condoms or glans-covering penile caps but without the clumsy handling issue or the questionable reliability of those penile caps which adhere only to a small annular region around the urethral opening of the glans.

A glans cap without integral extensions could still be bonded to the glans penis with a reduced level of reliability if that glans cap were part of a kit consisting of a fast-curing liquid adhesive, a glans cap with an adhesive coating on the proximal surface of the mounting flange, and a liquid solvent to later dissolve the cured liquid adhesive coating on the glans penis. The method of applying a liquid adhesive to the surface of the glans would still be the same and would still establish a first biological barrier over the skin of the glans and establish a continuous surface smoother than the skin of the glans as a base layer for the successful adhesion of a medical tape adhesive and would also establish a second biological barrier formed between the cured liquid adhesive and the pre-applied adhesive tape bonding agent of the glans cap when the bonding surface of the glans cap is positioned and firmly pressed against the coated glans surface.

BRIEF DESCRIPTION OF THE DRAWINGS Figure la shows a rear isometric view of the prophylactic having integral extensions, a fluid absorbing means and a removable support structure according to the invention.

Figure lb shows a front isometric view of the prophylactic having integral extensions, a fluid absorbing means and a removable support structure according to the invention.

Material has been cut away from some areas for clarity of illustration. Some items in Figures la and lb are exploded away or peeled back from the main body of the invention for purposes of illustration clarity.

Figure 2 shows an exploded front isometric view of the prophylactic having integral extensions, a fluid absorbing means and a removable means of support.

Figure 3 shows the application process for bonding of the prophylactic having integral extensions, a fluid absorbing means and removable supports to the glans and shaft of a penis.

Figure 4 shows a front isometric view of the prophylactic having integral extensions, a fluid absorbing means, and an integral support structure.

Figure 5 shows the prophylactic having integral extensions and a fluid absorbing means successfully bonded to the glans and shaft of a penis.

Figure 6 shows a kit of an embodiment of the invention consisting of a container of liquid adhesive with an applicator, a glans cap having a reservoir containment means and mounting flange coated with pre-applied adhesive, and a container of liquid solvent with an applicator.

In Figure 7, the initial step of the method of applying a fast-curing liquid adhesive to the clean, dry surface of the glans is demonstrated.

In Figure 8, a glans cap is being bonded to the cured liquid adhesive coating the glans surface according to the method of the invention.

Figure 9 shows a glans cap successfully bonded to the glans penis by the instant method.

Figure 10 shows a glans cap being removed from a glans penis post coitus by using the liquid solvent to dissolve the cured liquid adhesive.

Figures lla-llc show isometric views of the mounting flange and reservoir of a glans sheath and also illustrate a perimeter clamping technique to tautly restrain the mounting flange. Sections of the mounting flange, reservoir and clamp have been cut away for illustrative clarity.

Figures 12a and 12b show an isometric view of a perimeter crimping technique to tautly restrain the mounting flange of a glans sheath. Sections of the mounting flange, reservoir and crimp have been cut away for illustrative clarity.

Figures 13a and 13b show an isometric view of a perimeter stake-down technique to tautly restrain the mounting flange of a glans sheath. Sections of the mounting flange, reservoir and crimp have been cut away for illustrative clarity.

Figure 14 shows an isometric view of a perimeter hooking technique to tautly restrain the mounting flange of a glans sheath. A section of the mounting flange, reservoir

and crimp has been cut away for illustrative clarity.

DETAILED DESCRIPTION OF THE INVENTION Referring to the drawings, Figures la and lb show the prophylactic having integral extensions, a fluid absorbing means and a removable support structure as it would be prepared for the user. Similar reference numbers denote similar elements throughout the several views.

The overall structure which is the prophylactic is generally designated by the reference number 15. The prophylactic device 15 consists of a reservoir or containment means 3 and several finger-shaped radial extensions 2 attached to a single substantially annular connection flange 1 having an orifice or through-passage 16 leading to the opening of the reservoir 3. The extensions 2 are provided to facilitate handling of the prophylactic and to improve force distribution during use.

Along the distal outer surface of each of the radial extensions 2 are removably attached, semi-rigid means of radial support 10 to assist handling. The membrane tensioning hoop means of contouring 8 prevents the flange 1 from collapsing while it is being adhered to the glans 12. The hoop 8 and the semi-rigid radial supports 10 are removably attached to the distal surfaces of the flange 1 and radial extensions 2 using cohesive forces of like materials or using a bonding agent known in the art, such as 3M double stick tape 9416, which remains with the hoop 8 and radial supports 10 when they are removed from the flange 1 and radial extensions 2.

Two different adhesives are used to secure the prophylactic having integral extensions to a user. A pre-applied means of adhesion 5 medical grade adhesive known in the art, such as 3M 1509 Medical Transfer Tape, covers the proximal inner surfaces of the annular flange 1

and the integral extensions 2 and is protected by a first removable protecting means 18 and a second removable protecting means 7. A liquid coating means of adhesion 6 known in the art, such as Mastisol or Tincture of Benzoine, coats selected topological areas of the glans 12 and penile shaft 13. The bondline between the prophylactic and the glans 12 and shaft 13 is formed by bringing the exposed pre-applied transfer tape 5 into intimate contact with the cured adhesive coating 6 on the glans 12 and shaft 13. The bondline establishes a leakproof seal around the urethral orifice 14.

As shown in Figure 2, the liquid coating 6 is applied to selected areas of the glans 12 and shaft 13. The first protective means 18 and the second protective means 7 covering the pre-applied transfer film 5 are removed to expose the transfer film 5 for the bonding process.

Figure 3 shows the bonding process. After exposing the pre-applied film 5 by removing the first protective means 18, the user brings the stretched annular flange 1 still on the membrane tensioning means of contouring 8 into contact with the coated area of the glans 12 immediately surrounding the urethra 14 such that the reservoir orifice 16 centers about the urethral opening 14. By pulling the means of contouring 8 far enough towards the base of the shaft 13, the stretched membrane of the flange 1 will be forced to assume the shape of the glans 12 and will securely adhere to the glans. After the flange 1 is bonded to the glans 12, the membrane tensioning means 8 is removed from the distal surface of the flange 1. The next process is to adhere the integral extensions 2 of the device to the glans 12 and shaft 13. The second removable protective means 7 is removed to expose the pre-applied film 5 along the integral extensions. To account for the variability in length of the male organ an extension strip section for force distribution 17 is attached near the

base of the shaft 13 and the semi-rigid means of support 10 is removed from each section 17 bonded near the base.

The integral extension 2 attached to the flange 1 overlaps this additional section by an amount to necessarily permit coverage of the shaft 13 from the glans 12 to the base of the shaft 13. After successfully overlapping the sections 17 and the integral extensions of the force distribution strips 2, the removable semi-rigid supports 10 are pressed against the skin to bring the pre-applied film 5 of the integral extensions 2 and the cured liquid adhesive 6 into intimate contact and then the supports 10 are separated from the integral extensions 2. This bonding operation forms a leakproof seal about the male urethral orifice 14 and places near the orifice 14 a collapsible, expandable reservoir or means of containment 3 and a non-rigid means of absorption 4.

Figure 4 shows a variation in the design of the device 15 wherein the support structure 11 is not removable but is instead integral to the invention. The integral supports are embedded into the prophylactic material at the time of manufacture and are made out of semi-rigid material such as plastic or thin continuous wire. The integral support structure prevents the annular portion 1 and radial extensions 2 from buckling while being handled during application. The bonding process is similar to the removable support design in that the removable protective means 7 and 18 are removed to expose the pre-applied adhesive 5 and then the proximal surface of the annular portion 1 and the radial extensions 2 are pressed into intimate contact with the cured liquid coating means of adhesion 6 on the glans 12 and shaft 13.

In Figure 5, a prophylactic 15 has been successfully bonded to the glans 12 and shaft 13 of a penis in a manner which forms a leakproof seal about the male urethral orifice 14 and places near the orifice 14 a collapsible,

expandable reservoir means of containment 3 and a non-rigid means of absorption 4.

Referring back to Figure 1, the preferred embodiment of the device is made of a pliable material such as synthetic latex and has a substantially annular flange 1 which connects a reservoir or containment means 3 to two radial extensions 2 shaped as rectangular strips. The flange 1, being substantially annular, has an outer diameter between 2.0 and 0.5 inches, preferably 1.375 inches; an inner diameter between 1.0 and 0.2 inches, preferably 0.438 inches; and a thickness between 0.1 and 0.0002 inches, preferably 0.004 inches. The reservoir 3 has an orifice diameter 16 between 0.2 and 1.0 inches, preferably 0.438 inches in diameter; a wall thickness between 0.1 and 0.0002 inches, preferably 0.004 inches; and a volume capacity between 0.01 and 1.0 fluid ounces, preferably 0.06 fluid ounces. The radial extensions 2 have a length between 0.25 and 10.0 inches, preferably 4.0 inches; a width between 0.06 and 0.75 inches, preferably 0.188 inches; and a thickness between 0.0002 and 0.1 inches but preferably 0.004 inches. The removable semi-rigid braces 10 have length between 0.25 and 6.0 inches, preferably 4.0 inches; a width between 0.06 and 0.75 inches, preferably 0.188 inches; and a thickness between 0.002 and 0.1 inches, preferably 0.010 inches. The membrane tensioning means of contouring has an inner diameter between 0.5 and 2.0 inches but preferably 1.375 inches and an outer diameter between 0.55 and 2.5 inches but preferably 1.625 inches and is between 0.1 and 0.002 inches thick but preferably 0.010 inches thick. The first removable protective member has a tab 9 integrally attached to it.

Referring back to Figure 4, the preferred embodiment of the alternative integral semi-rigid supporting frame design has radial extensions 2 with widths of at least 0.06 inches, preferably 0.188 inches, and thicknesses of

at least 0.0002 inches, preferably 0.004 inches in those areas not covering framework and preferably 0.020 inches thick in those areas covering framework. All other dimensions for the flange 1 and reservoir 3 are the same as those in the preferred embodiment of the removable support design of Figure 1.

A kit 19 for the application method of the invention is shown in Figure 6 and consists of a container 20 of liquid adhesive with an applicator 21, a glans cap 15 having a minimum of a reservoir containment means 3, an orifice-through passage 16 and flexible mounting flange 1 coated with pre-applied adhesive 5, and a container 22 of liquid solvent with an applicator 23. The glans cap assembly is manufactured such that a biological barrier exists between the pre-applied adhesive 5 and the surface of the mounting flange 1 of the glans cap 15.

The initial step of the application method is shown in Figure 7. A fast-curing liquid adhesive coating 6, such as tincture of benzoine, gum mastic such as Mastisol by Ferndale Laboratories, purified pine tar or any other medically approved mildly non-polar cellulose based gum or a combination thereof, is applied to the skin of the glans penis 12 by means of an applicator 21 and is allowed to cure. Once cured, the coating 6 forms a first biological barrier over the skin of the glans 12.

As shown in Figure 8, after the liquid adhesive coating 6 has cured on the glans 12, the pre-applied adhesive 5, such as medical double-sided transfer tape similar to 3M Medical Transfer Tape #1509, covering the flange 1 of a glans cap 15, is brought into intimate contact with the coating 6 on the glans 12 and is pressed to conform against the glans. This pressing action bonds together the cured liquid adhesive 6 and the pre-applied adhesive 5 to establish a second biological barrier between the

coating and the adhesive of the glans cap.

Figure 9 shows a glans cap 15 successfully bonded to the glans penis 12. A small portion of the flange 1 has been removed to show the pre-applied adhesive 5 of the glans cap 15 conformed to the surface of the glans 12 and bonded to the coating 6. The first biological barrier between the coating 6 and the glans penis surface 12 and the second biological barrier between the coating 6 and the glans cap adhesive 5 prevent the exchange between sexual partners of micro-organisms which can transmit venereal diseases.

Figure 10 shows the glans cap 15 being removed from the glans penis 12 post coitus. To remove the cap 15 a solvent 22 such as isopropyl alcohol, medically approved petroleum distillates such as the product Detachol by Ferndale Laboratories, SD alcohol 40 found in hairspray, or soapy water or a combination thereof is applied by means of an applicator 23 about the surface of the flange 1 of the glans cap 15 to dissolve the liquid adhesive coating 6 from the glans surface 12. The glans cap containing captured ejaculate is discarded after removal.

The first advantage of the prophylactic is the adhesive-coated flange which is small enough in area to cover only the topology of the glans of the penis immediately surrounding the urethral opening thereby reducing the glans area deprived of friction stimulus in comparison to roll-down prophylactics. The adhesive-coated annular flange still has enough area to create an effective sealing surface around the urethral opening for the purpose of forming an enclosure to protect the urethral opening against biological microorganisms.

The second advantage of the prophylactic is that it

provides a means to place near the urethral orifice a very flexible, collapsible reservoir and a fluid absorption means which is able to capture and contain ejaculate and which can deform as necessary when subject to compressive forces caused by the device contacting cavity walls, thereby protecting the cavity wall tissue from injury.

The third advantage of the prophylactic of the instant invention is the system of radial extensions which disperse the tensile and shear force loads acting on the prophylactic sealing surface, thereby maintaining the integrity of the seal and greatly improving the reliability of the device over other adhesively attached penile caps bonding only to the area immediately surrounding the urethral opening.

The fourth advantage of the prophylactic of the instant invention is that the flange, the reservoir and the system of radial extensions can be manufactured as a single device of unitary construction, thereby eliminating the introduction of features of assembly, necessary in multiple piece designs, which could compromise the reliability of a prophylactic. Further, integrally-formed semi-rigid spines are also able to be manufactured into the unitary construction design to simplify handling or eliminate handling complications during application.

The fifth advantage of the prophylactic is that because of the ease of application and minimal surface area deprived of frictional stimulation, user apprehension towards the prophylactic device will be appreciably less than that of roll-down prophylactics covering the entire penile shaft, thereby increasing usage of a device which prevents unwanted pregnancies and protects the public against the transmission of venereal diseases.

Thus, the disclosed prophylactics and methods of

application are reliable for tautly stretching a glans- sheath mounting flange prior to glans/penis adhesion and for later releasing the tautly stretched glans-sheath flange in order to leave the flange, and thus the glans sheath, conformally adhered to the glans penis for coitus.

If a rigid tool is used for application of the prophylactic, a potential problem is the risk of debonding the mounting flange from the glans penis as the tool is pried away from the distal surface of the mounting flange after glans-to-flange bonding. The tool cannot be a continuous piece without imposing a separation, or debonding, effort beginning at the edge of the mounting flange, which is a prime opportunity to pull the edge of the adhered mounting flange away from the glans penis.

Instead, multiple rigid tool sections adhered to the mounting flange distal surface allow multiple opportunities to crevass the mounting flange material.

Thus, a more reliable method of restraining the flange material is to either removably clamp or removably crimp the edge against a hoop or to removably stake down the flange around the perimeter, or removably hook the perimeter of the flange over a series of small protrusions in a manner which later permits separation of the flange material from a rigid stretching tool.

Therefore, according to another aspect of the invention, Figure lla shows an isometric view of a glans sheath 15 made of a material known in the art, such as natural or synthetic latex, having a mounting flange 1 coated with adhesive 5 and having a reservoir 4. Figure llb shows an isometric view of a glans sheath having the same components but with the mounting flange 1 draped over the perimeter of a rigid tool 24 made of a suitable material, such as plastic, and a perimeter clamping means 26, such as a steel retaining clip, tautly restraining the mounting flange material. The clamping means 26 is removed after

bonding the mounting flange to the appropriate glans penis skin via the adhesive coating 5 on the flange surface.

Figure lie shows a magnified view of the mounting flange material 1 being captured between the rigid tool 24 and the perimeter clamping means 26.

Figure 12a shows an isometric view of a glans sheath 15 having the same mounting flange 1, adhesive coating 5 and reservoir 4 components but with the mounting flange 1 and the lip 27 of a rigid tool 24 crimped together by a perimeter crimping means 28, such as a steel or aluminum crimp, to tautly restrain the mounting flange material 1.

The mounting flange material is restrained until the crimping means 28 is removed after bonding the mounting flange to the appropriate glans penis skin via the adhesive coating 5 on the flange surface. Figure 12b shows a magnified view of the mounting flange material 1 being crimped against the lip 27 of the rigid tool 24 via the removable crimping means 28.

Figure 13a shows an isometric view of a glans sheath 15 having the same mounting flange 1, adhesive coating 5 and reservoir 4 components but with the mounting flange 1 staked down by a series of staking means 29, such as steel or plastic staking needles, about the perimeter of the mounting flange to tautly restrain the flange. The staking means 29 are pierced through the flange material, thereby creating a series of small holes at the perimeter of the flange, and are held fast in a rigid tool material 24. The stakes are set with enough height that the mounting flange cannot recoil and slip over the stakes.

The mounting flange is held tautly by the frictional interference between each impaling staking means 29 and each hole 30 pierced through the flange material 1. After successfully bonding the mounting flange to the appropriate penis-glans skin via the adhesive coating 5, the rigid tool 24 and staking means 29 are slowly pulled

away from the bonded flange in a manner which overcomes the frictional interference between the series of staking means 29 and the created holes 30, such that the staking means slip through the series of created holes. Figure 13b shows a magnified view of the mounting flange material 1 tautly restrained by an impaling staking means 29 held fast in a rigid tool 24 and frictionally interfering with a hole 30 created by the impaling stake.

Figure 14 shows an isometric view of a glans sheath 15 having the same mounting flange 1, adhesive coating 5 and reservoir 4 components but with the mounting flange 1 tautly restrained by a series of hooking means 31, such as plastic hooks, which are held fast in a rigid tool material 24. The individual hooking means 31 are set with enough height that the mounting flange cannot recoil and slip over the hooking means 31. A series of clearance openings 32 are located about the perimeter of the mounting flange. The mounting flange 1 is hooked over each hooking means 31 via the series of clearance openings 32 and is stretched taut by this method thereby eliminating the need to impale a stake through the mounting flange to tautly restrain the flange as discussed previously. After successfully bonding the mounting flange to the appropriate penis-glans skin via the adhesive coating 5, the rigid tool 24 and hooking means 31 are separated from the glans sheath 15. Preferably the hooking means 31 are coated with a material known in the art, such as a waxy material like candle wax, to prevent the hooking means from adhering to the adhesive coating 5 as the hooking means 31 and rigid tool 24 are slowly pulled away from the flange in a manner which does not pull the bonded flange away from the appropriate glans penis skin. The hooking means 31 can be manufactured such that the portion of the hooking means which is near the rigid tool is rigid but the portion of the hooking means further away from the rigid tool is flexible to bend as

needed to draw the hooking means through the clearance openings 32 as the hooking means and rigid tool are separated from the flange bonded to the glans penis skin.

While the embodiments described herein are at present considered to be preferred, it is understood that various modifications and improvements may be made therein without departing from the invention. The scope of the invention is indicated in the appended claims and all changes that come within the meaning and range of equivalency of the claims intended to be embraced therein.