External penile prosthesis for augmenting male potency

An elastomeric device for improving the erection of the human penis may include a frustoconical collar sized to receive and snugly jacket the user's penis and apply effective pressure on the dorsal penile veins, and a radially extending pubic shield adapted to overlay the pubic area of the user. An elastic strap attached to the pubic shield may encircle the underside of the scrotum to apply effective pressure on the deep veins behind the scrotum and to retain the device on the user's penis during sexual activity. When used in combination with a conventional vacuum erection device, substantially airtight seals are established around the open end of the vacuum device, the base of the penis, and the anterior sealing surface of the pubic shield during evacuation pumping. Related methods are also described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a non-provisional utility patent application Ser. No. 62/975,112, filed on Feb. 11, 2020, which is incorporated herein by reference.

FIELD

This disclosure relates to devices used in the noninvasive treatment of erectile dysfunction, and more particularly, to a constriction penile prosthesis, methods of making such prosthesis, and methods of using such prosthesis in combination with a vacuum erection device.

BACKGROUND

Erectile dysfunction (impotence) is the inability to get and keep an erection suitable for sexual intercourse. Erectile dysfunction, or ED, is the most common sex problem that men report to their doctor. Causes include medications, chronic illnesses, poor blood flow to the penis, or fatigue. Causes are usually medical but can also be psychological.

Most men have occasionally expressed some difficulty with their penis becoming hard or staying firm. However, ED is only considered a concern if satisfactory sexual performance has been impossible on a number of occasions for some time.

Men who have a problem with their sexual performance may be reluctant to talk with their doctor or friends, seeing it can be an embarrassing issue. Since the discovery that the drug Sildenafil, or Viagra™, effected penile erections, most people have become aware that ED is a treatable medical condition.

About one third of all grown-up men in the civilized world are more or less affected by this infirmity, especially those of middle or older age, but also more and more young men who are exposed to or susceptible to stress.

It is well known that ED may be the cause of various side effects such as alcoholism, heavy smoking, drug addiction, divorce, job problems, depression, brutality, racism, terrorism, and suicide. On the other hand, sexually content couples are more likely to keep themselves physically and mentally fit and have a positive outlook on life.

More than half of all physically induced cases of ED are associated with venous insufficiency of erectile tissues due to malfunction of venous swell pads and flaps which act as backflow valves. Most of these valves are in the dorsal penile veins and in the plexus of veins at the root of the penis behind the scrotum. About 30% of ED cases are caused by insufficient arterial blood supply due to arteriosclerotic obstruction or anti-hypertension medications.

External constriction devices have been provided which contract around the base of the flaccid penis and prevent the outflow of blood once the penis has risen into an erect state. Conventional constriction devices include several different styles. Examples of such devices include those disclosed in U.S. Pat. No. 1,608,806 issued Nov. 30, 1926 to Peter W. Nelson, and U.S. Pat. No. 4,872,462 issued Oct. 10, 1989 to Gilbert Salz. Such devices have not been successfully adopted for use with external erection devices.

The second category includes smaller, less cumbersome devices, known as constriction bands or rings which can be used alone or in combination with a vacuum erection device. Once an erection is achieved, the constriction device impedes the flow of blood from the penis, keeping it in an erect state. Such devices include U.S. Pat. No. 3,759,253 issued on Sep. 18, 1973 to Charles A. Cray and U.S. Pat. No. 4,539,980 issued on Sep. 10, 1985 to John L. Chaney. Such rings, usually consisting of elastic rubber, are strapped around the already erect penis. The pinch-off encompasses veins, arteries, and nerves, thus not only stopping the venous backflow which is desired, but also preventing the supply of fresh arterial blood. Shortly after the pinch-off, therefore, the penis becomes engorged and turns blue and numb, and the circumference where the ring is pinching the base of the penis starts to cause pain. The parts of the penis behind the pinch, around the scrotum, and in the perineum and at the penis root which are not pinched-off, turn limp so that the stiff front of the penis in front of the pinch-off is dangling down instead of erect. Accordingly, a normal coitus activity is not possible. Further, the ejaculate cannot escape through the choked off urethra but is emptied retrograde into the bladder.

Other constriction devices are available designed specifically for use with vacuum erection devices. Such constriction devices include a compression ring as disclosed in U.S. Pat. No. 1,225,341 issued on May 8, 1917 to Otto Lederer, a device with a short elastic sleeve as disclosed in Swiss Pat. No. 347,300 granted on Jun. 30, 1960 to Guiseppi Meldi, or an elastic sleeve with an expansible diaphragm as disclosed in U.S. Pat. No. 4,641,638 issued on Feb. 10, 1987 to Robert D. Perry.

Use of bands or rings with a vacuum erection device requires that either one ring or several bands, doubled or redoubled, be slipped over the open end of the plastic cylinder. Once the band or ring is in place around the end of the cylinder, the cylinder is slipped over the flaccid penis and pressed over the groin. In some devices, the closed end of the cylinder is flat or textured to permit it to be braced against a stationary structure to assist the user in holding the cylinder firmly against the pubic bone, thereby promoting a better seal around the open end of the cylinder and simultaneously freeing the hands of the user to connect and operate the vacuum pump. Once erection is achieved, the constriction ring or band is slipped off the open end of the cylinder, whereupon it contracts around the base of the erect penis.

Several drawbacks have been encountered through the use of conventional bands and rings, either alone or in combination with commercially available vacuum erection devices. Often, pubic skin or the scrotum can be sucked into the vacuum chamber causing pain or injury. Removal of the band can be painful and difficult.

Establishing an airtight seal around the open end of the vacuum cylinder during evacuation is also suboptimal, and the effectiveness of the existing vacuum cylinders for creating a satisfactory penile erection is significantly reduced primarily due to the lack of a seating surface adaptable to conform to the user's groin and the open end of the vacuum cylinder to provide an airtight seal.

A combination seal and constricting device has been described by Walsdorf et.al. in U.S. Pat. No. 5,344,389 issued Sep. 6, 1994. The subject device is made of a pliable elastomeric material and is characterized by a centrally disposed cylindrical collar connected at one end thereof to a radially extending skirt having a sealing surface.

The above described devices and prior art devices, in general, have insufficient means to adequately restrain venous backflow of all three main penile draining veins, the vena dorsalis superficialis, the vena dorsalis profunda penis at the top side of the penis, and the venae profundi penis at the underside of the penis behind the scrotum.

Albert G. Fischer in U.S. Pat. No. 5,439,007 issued Aug. 8, 1995 describes a suspensory for improving the erection of the human male penis including a rigid, generally rectangular ring composed of two crossbars and two sidebars, which, in use surrounds the penis as well as the scrotum.

There remains a need for an elastomeric, soft, and conformable external penile prosthesis and associated assembly that is easy to wear, remove, and provide a convenient, air-tight, and reliable seal, coordinated with a vacuum erection device. Further, the device should be effective in substantially compressing all three penile veins without inadvertently compressing the urethra, nerves, arteries, or skin.

SUMMARY

The present disclosure relates to the improved design and function over elastic rings, constriction bands, suspensories, external inflatable cuffs, and other constriction devices available for the external treatment of impotence. The disclosed device may be used alone or in combination with a vacuum erection device. The device may be used by men of normal potency to enhance their sexual pleasure, satisfy their partners, and to promote physiologic health of the user's genitourinary system and harmony between couples. Compared to existing therapies such as surgical implantation of a penile prosthesis or self-injection of vasoactive chemicals into the erectile tissues of the penis, the use of the present external penile prosthesis is harmless and inexpensive.

The design as provided focuses on the provision of a device that is user friendly, easy to handle, convenient to place and take off, reuse, and keep clean. In order to accomplish these objectives and others, the prosthesis may be provided in different sizes and may be configured to fit in an airtight fashion over the front opening of a vacuum erection tube.

In some embodiments, there is provided a penile prosthesis device having an elastic frustoconical collar designed to fit snugly around the base of the penis, and a radially extending pubic shield having a forwardly facing compressible sealing surface and a rearward facing seating surface that conforms to the user's pubis. According to some embodiments, a penile prosthesis as described herein is provided with a radially inwardly extending dorsal ridge that projects from the roof of the prosthesis collar and bears on the top of the penis, effectively compressing the superficial and deep penile veins and preventing backflow of the venous blood, without inadvertently compressing the penile arteries and nerves.

In contrast to constriction rings which cut off the venous return and engorgement of the penile veins and portion of the corpora cavernosa at the root of the penis behind the constriction zone so that the penile shaft dangles loosely between the thighs, a penile prosthesis as described herein may include a collar-flange structure which supports the erect penile shaft in a substantially 90-degree angle or other desired angle from the abdomen. Furthermore, the corpora cavernosa are protected from constriction by provision of a wide area of surface contact along the inner wall of the collar as described in more detail herein.

According to some embodiments of the invention, the bottom circumference of the collar may include a ventral recess sized and configured to accommodate the user's urethra at the underside of the penile shaft and thus allow normal antigrade ejaculation.

According to some embodiments of the invention, the lateral walls of the collar may include a plurality of longitudinal ribs and grooves sized and configured to increase the surface area of the central channel of the collar upon stretching of the collar. Further, the ribs and grooves may provide a conformal grip on the erect penis and prevent unwanted movement or slippage of the device during sexual activity.

In some embodiments, the invention further presents a penile prosthesis collar portion that provides elastomeric wall regions that are relatively more flexible and more distensible, and stretch more than the sidewall ribs, thus forming a dual modulus collar.

In further embodiments, any of the regions of variable thickness or variable hardness in the collar wall may produce a bending, twisting, or straightening movement of the collar upon active stretching.

In some embodiments of the present invention, an elongate resilient retention strap member is provided to secure the device during coitus. Both ends of the elastic strap are connected at connection points to the periphery of the pubic shield. Once the device is in place, the strap is stretched and placed behind the scrotum so that during coitus the device is retained on the penis. The deep penile veins at the underside surface at the root of the penis in the perineum behind the scrotum are simultaneously compressed by the strap to ensure that all the draining veins of the penis are adequately compressed.

Some embodiments describe fabrication and operation of a soft external penile prosthesis that includes a flexible body having a relatively firm pubic shield and a collar, each having a width, a diameter, a length, and a thickness. The flexible body may have a channel disposed within the collar, the channel defined by an upper wall and two sidewalls, wherein the upper wall includes a dorsal ridge that is strain limiting; and wherein the upper wall is positioned and arranged such that the sidewalls elastically stretch and expand to widen the channel to accommodate penile entry and/or expansion of the surrounding collar within a vacuum device. The two sidewalls converge inferiorly at a ventral recess configured to accommodate a user's urethra. The collar may be formed of elastic portions having different modulus of elasticity, so that during expansion of the collar, the modulus of elasticity of each portion at least partially controls the amount of expansion of each portion, thereby allowing the upper wall ridge to compress the penile dorsal veins, and allowing the lower wall to prevent compression of the urethra at the bottom of the channel. The penile prosthesis may be used in combination with a conventional vacuum erection device.

Still further, some exemplary embodiments provide a simplified method of penile erection actuation with a penile prosthesis/vacuum tube combination, which allows for convenient placement and taking off of the device, and establishing a substantially airtight seal around the open end of the vacuum tube and the base of the penis during evacuation pumping.

According to some embodiments, an external penile prosthesis of the present invention provides an improved airtight seal between the forwardly facing surface of the annular flange and the front edge of a conventional vacuum tube, avoiding the use of an adapter diaphragm and adapter insert, or other such mechanisms. Further, the cumbersome step of transferring a constriction band from the vacuum tube to the penis may be avoided.

In some embodiments, an external penile prosthesis may be adapted for use in the treatment of erectile dysfunction of a user, the user having a pubis, a scrotum, and a penis including a shaft, a base of the shaft, a top side, an underside, a glans, a urethra, a superficial dorsal vein, a deep dorsal vein, arteries, nerves, corpora cavernosa, and corpus spongiosum, the prosthesis including: a collar having a central channel that is contractible to accommodate the user's penis in a flaccid state and expandable to accommodate the user's penis in an erect state, the central channel including a dorsal ridge and a ventral recess; and a pubic shield extending radially from the collar at a proximal end of the collar, the shield having a rearward facing surface conformable to the user's pubis; wherein the dorsal ridge is configured to reversibly compress the superficial dorsal vein and the deep dorsal vein of the penis and substantially avoid compression of the arteries and nerves; and wherein the ventral recess is configured to substantially avoid compression of the urethra.

In some embodiments, a method of fabricating an elastomeric penile prosthesis may include molding a penile prosthesis assembly including a shield and a collar in a single, integral, unitary piece from different pieces of thermoset compatible silicone rubber, the prosthesis including rearward and inner portions formed from a less elastic silicone rubber than forward and outer portions of the prosthesis, the shield and the collar being molded to form a smooth, shoulderless external surface and a textured internal surface.

In some embodiments, a method of fabricating an external penile prosthesis having a collar and a shield may include providing a mold core having a configuration corresponding to a shape of a central passageway of the collar; providing a polymeric insert in the form of a prefabricated dorsal ridge receivable within a corresponding concavity of the mold core; providing a polymeric insert in the form of a prefabricated ventral sulcus wall receivable overlying a corresponding convexity of the mold core; dip molding an inner layer of the collar and a rearward layer of the shield; allowing the layers to cure; dip molding a front layer of the shield; allowing the layers to cure at room temperature or inside an oven into a single, fused, integral piece of elastomeric rubber; and removing the mold core from the integral piece of elastomeric rubber.

In some embodiments, a method of fabricating a penile prosthesis may include providing an outer mold having a mold cavity of generally an outer configuration of the prosthesis and having a surface texture desired for the prosthesis; providing a mold core receivable within the mold cavity, the mold core and the mold cavity being sized and configured to define inner and outer configurations and surface features of the prosthesis; inserting dorsal ridge and ventral sulcus wall members about the mold core; enclosing the mold core and parisons within the outer mold; and filling remaining portions of the mold cavity with another parison of liquid silicone rubber by injection molding, which, when molded and cured, will display a selected degree of elasticity and hardness.

In some embodiments, a method of using a penile prosthesis as described herein with a vacuum erection device which comprises a vacuum cylinder with an open end, the shield of the prosthesis having a forward-facing sealing surface, the collar of the prosthesis having a funnel-like front aperture, may include placing the penile prosthesis over the open end of the vacuum cylinder so that the sealing surface of the shield rests flush against the open end of the vacuum cylinder thereby forming an airtight seal between the shield and the vacuum cylinder; placing the user's flaccid penis into the funnel-like front aperture of the penile prosthesis thereby creating a seal between the user's penis and the penile prosthesis; operating the vacuum erection device to draw the penis into the cylinder; further activating the vacuum within the cylinder gradually while the user performs Kegel or pelvic contraction exercises until the penis is in the desired erect state; pressing the vacuum cylinder against the pubic shield, driving the shield towards the user's groin, stabilizing the root of the penis and driving the user's penis forward and deeper into the cylinder, thus maximizing erection of the penis; releasing the vacuum within the cylinder; and removing the erect penis from the cylinder with the prosthesis disposed about the penis.

Other objects, advantages, and novel features of the invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawings.

DETAILED DESCRIPTION

As shown inFIGS.1-5, for example, an external penile prosthesis10may include a frustoconical collar12defining a central channel14therethrough having a relatively wider proximal opening16and a relatively narrower distal opening18. The proximal opening16may be positioned nearer to the user's pubic region when using the prosthesis10, and the distal opening18may be positioned further from the user's pubic region. A radially extending flange or pubic shield20may be substantially concentrically disposed around collar12and may be molded to have a substantially uniform thickness from the edge22of pubic shield20to the proximal opening16of channel14thereof. The pubic shield20may transition to the collar12via a smooth shoulder24. The collar12may feather inwardly toward the distal opening18to a fairly thin dimension. Pubic shield20has an outer surface27and is preferably flexible and provides a smooth seating inner surface26that retains the penile prosthesis10despite movements of the user during coitus. Edge22of pubic shield20may be easily grasped by the user during application to or removal from the penis50. In some embodiments, shield20may have a uniform thickness of about 7-8 mm, for example, but any suitable thickness may be used, and such thickness may or may not be uniform. In some embodiments, shield20may be substantially circular and may have a diameter of about 60-80 mm, for example, but other suitable sizes and shapes may be used. In some embodiments, in an unexpanded state, shield20may extend radially about 20 mm from collar12to edge22.

The collar12may have a smooth, tapered, leading end30to guard against irritation or erosion of a sexual partner's tissues. A trailing portion of collar12may merge into a central portion of shield20forming the proximal opening16such that collar12may be shaped like a funnel and may be substantially trefoil or ovoid in cross-section. The wall thickness of collar12at the proximal opening16may be around 3 mm, for example, and may gradually become thinner towards distal opening18. Of course, any suitable thickness may be used, and the thickness may or may not be tapered. In some embodiments, when collar12is in its relaxed, unexpanded state, it may have an outside diameter at its proximal end of about 3.5 cm and an outside diameter at its distal end of about 2.5 cm, an inside proximal diameter of about 3.0 cm, and an inside distal diameter of about 2 cm, for example. The collar12may extend substantially perpendicularly outward from pubic shield20to a distance about 2.5 cm, for example. In some embodiments, collar12may have a length ranging from about 25 mm to about 50 mm and an unexpanded outer diameter ranging from about 20 mm to about 35 mm. In some embodiments, channel14may have an unexpanded proximal diameter of about 30-40 mm and an unexpanded distal diameter of about 17-22 mm, for example. In some embodiments, collar12may have an unexpanded length and an unexpanded outer diameter wherein the unexpanded length ranges from about 1.2 to about 1.7 times the unexpanded outer diameter. In some embodiments, collar12may have an unexpanded length and an unexpanded outer diameter wherein the unexpanded length and the unexpanded outer diameter are about equal. Of course, any suitable dimensions and proportions may be used.

In some embodiments, as shown inFIGS.1-4, for example, collar12and the openings16,18may be centrally disposed relative to the edge22, which may have a diameter of about 8 cm, for example. The thickness of pubic shield20may be about 0.8 cm, for example. The thickness of the sidewall of the collar12may proximally be about 5 mm and may distally be about 3.5 mm. It should be understood that such dimensions and proportions may vary as penile prosthesis10is provided in different sizes. Further, the measurements may be varied according to factors such as, for example, the hardness or modulus of elasticity of the material used in making penile prosthesis10. The opening18of collar12should be expandable to accommodate a maximum diameter of the shaft of an erect penis of a particular patient.

Referring again toFIGS.1-5, opening18of collar12may have a minimum diameter when in its relaxed, unexpanded state that is slightly smaller than the diameter of a flaccid penis50with which it is used, but stretchable enough to accommodate the erect penis50to avoid undue constriction. It is believed that most adult erect penises can be accommodated with a limited number of properly sized prostheses having a range of collars12and openings16,18of differing diameters, that may, for example, be labeled as small, medium, and large to best accommodate the penis size of a particular user.

Referring now toFIGS.3and4, as shown projecting inwardly from the inner roof of channel14, the collar12may include a dorsal ridge32which, when the device is in use, bears on the top of the penis tissue to minimize or prevent outflow of venous blood from the penis50. Desirably, in some embodiments dorsal ridge32may be substantially wedge-shaped and may compress a surface area of the penis50which is wide enough to accommodate anatomical variations in the positions of the superficial and deep dorsal penile veins, and dorsal ridge32may be smoothly rounded to be comfortable to the wearer. In some embodiments, dorsal ridge32may be ribbed or otherwise shaped to prevent slippage. In some embodiments, dorsal ridge32may be provided in a contrasting color to the rest of the collar12to facilitate visual identification of the ridge during use and to insure proper placement of the dorsal ridge32at the dorsum of the user's penis. By positioning dorsal ridge32substantially in the midline extending from the upper margin of proximal opening16close to the user's pubis and anteriorly to the level of leading end30, steady and firm compression to the deep dorsal veins may be maintained, regardless of sexual activity. Since dorsal ridge32is essentially wedge-shaped, it exerts maximal pressure in the midline, where the dorsal penile veins are located, and displaces the dorsal arteries and nerves, which extend parallel to the veins sideways into the relatively wider dorsolateral recesses17of channel14.

In some embodiments, the collar12may be integrally formed with the pubic shield20and the dorsal ridge32, and together they may provide a versatile penile erection augmentation prosthesis that can accommodate the size of a particular penis at different stages of erection. As the penis sizes may vary significantly, it may be advisable to maintain an inventory of different sized devices to address all users and conditions. While functional, the need to maintain and manufacture an inventory of devices with different sizes, moduli of elasticity, and hardness may be reduced to a practical minimum. In practice, a particular patient may be provided with at least two different devices to try at the outset. Smaller or larger devices as well as other devices of lesser or greater elasticity may be provided to the user as desired. For example, such personalized attention may be provided by a professional who is familiar with the issues of erectile dysfunction as well as the different options available for its treatment.

FIGS.6-9provide various perspective views of the penile prosthesis10to better illustrate some advantageous features of some embodiments of the prosthesis. Although the exemplary penile prosthesis10ofFIGS.6-9depicts the shield20and the collar12in certain shapes prior to deployment, one of ordinary skill in the art will recognize that the present invention is not so limited. By changing the shape of the body of penile prosthesis10, or the size, position, or configuration of the collar12and shield20, different sizes, shapes, and configurations may be achieved. For example, as shown inFIG.10, an embodiment of penile prosthesis10′ is shown having a collar12that is off-center with respect to shield20and disposed at a non-perpendicular angle with respect to shield20, such that prosthesis10′ would direct a user's penis slightly upward, for example. Thus, an individual penile prosthesis10can be scalable in size and shape by replacing one component with another. For example, although the exemplary collar12shown inFIGS.8and9is depicted as frustoconical in the longitudinal direction and trefoil in cross-section when unexpanded, one of ordinary skill in the art will recognize that other configurations are possible. By changing the shape of collar12, various functional properties may be enhanced or modified.

Turning now toFIGS.11,12, and13, penile prosthesis10may be turned inside out by the user to enable thorough washing of the device after use. As shown inFIG.11, features at the top surface of channel14and visible when the prosthesis10is turned inside out may include dorsal ridge32with partial visualization of a pair of superior lateral wall ribs38(further shown inFIG.16andFIG.17) on each side of dorsal ridge32.

FIG.12demonstrates features of penile prosthesis10oriented so as to view the ventral portion of channel14, mainly a ventral recess34, with partial visualization of inferior lateral wall grooves40(refer also toFIG.16andFIG.17) on each side of ventral recess34.

The viewed inner surface26of shield20is shown to better advantage inFIGS.11,12, and13, and is optionally smoothly textured to provide comfort to the user and improved wettability of the inner wall of collar12as it slides against the user's skin.

Referring now toFIGS.14A-17, there are shown embodiments of cross-sections of collar12of penile prosthesis10. In some embodiments, collar12may comprise at least two materials possessing different hardness and elastic moduli. In some embodiments, the collar12may have a substantially trefoil or triangular cross-sectional configuration, with the dorsal ridge32forming a top sidewall, and two sidewalls converging towards the ventral recess34. As shown inFIG.16andFIG.17, the sidewalls may be formed of a plurality of lateral wall ribs38and lateral wall grooves40that enclose channel14of collar12. Alternatively, as shown inFIG.15, the sidewalls may be substantially smooth. The outer surface of collar12may be smooth, such as may define a shoulderless construction. The dorsal ridge32may be thicker than other regions of the collar12and therefore substantially less elastic than the rest of the collar. The plurality of lateral wall ribs38may press against the lateral walls of the base of the penile shaft while the plurality of lateral wall grooves40therebetween become flattened and elongated in response to circumferential stretching of the collar12by the expanding penile shaft as shown inFIGS.19and21, for example. As the collar sidewalls are stretched and displaced radially outward, the dorsal ridge32may be depressed inwardly thus applying downward pressure upon the penis that is sufficient to restrict the flow of blood through the dorsal veins. Blood being supplied to the penis by the arteries may thus be maintained and retained in the erectile tissue of the organ “corpora cavernosa” to cause and maintain penile erection.

Referring now toFIGS.18-21, the circumference of channel14prior to penis entry and enlargement of channel14(shown inFIGS.18and20) may be substantially less than the circumference of the penis during arousal as shown inFIGS.19and21, so that the aroused penis, especially when erection is induced sufficiently as within a vacuum device, will exert a biasing force on the inner walls of collar12when the prosthesis10is mounted upon the penis. In practice, if used with a vacuum tube200(see, e.g.,FIGS.36,37,41), a flaccid penis may be drawn into channel14by vacuum pressure within vacuum tube200, and the corpora cavernosa60may become engorged with blood, stretching the tunica albuginea80, thus increasing the stiffness of the penis50, including the root56of the penis50within collar12, and the collar sidewalls are stretched and the channel14is expanded. Collar12, being disposed around the base of the penis50, is expanded and becomes more rigid. The top region of collar12may flatten slightly and may be drawn downward into increased pressure contact against a dorsal region of the penis50as illustrated inFIGS.19and21.

In some embodiments, the dorsal ridge32may be integrally formed with the pubic shield20and should be sufficiently firm to effectively press onto the penile dorsum to restrict the flow of venous blood in the dorsal veins. Advantageously, the substantial wedge-shape of the dorsal ridge32serves to distract the dorsal penile arteries74and penile nerves66laterally outward thus avoiding inadvertent interference with arterial blood flow or injury to the penile nerves66.

With reference toFIG.1, for example, in some embodiments, the various parts of prosthesis10may be made from the same elastomeric material. Various functional properties may be engineered by controlling the relative thicknesses of the component walls, so as to obtain regions of higher and lower stiffness. In homogenous elastomers, regions of lower stiffness are those defined by the thinnest walls (e.g., by the portions with the lowest resistance to stretching). Expansion and stretching in these regions may further thin the walls and may increase the volume of channel14in these regions. To accommodate the asymmetric elongation of two opposite walls of channel14, the penile tissues within the expanding volume may bend to some degree. Upon expansion of the user's penis by evacuation pumping in a vacuum chamber, for example, an asymmetrical or differential biasing counterforce may be configured to cause the prosthesis10to bend the user's penis with respect to the axis of channel14to correct deformity and/or annoying angulation if needed.

In some embodiments, more than one elastomeric material may be used in making the prosthesis10. For example, materials having a high elastic modulus may be used for portions of the prosthesis10where expansion or stretching is undesirable, while materials having a low elastic modulus may be used for portions of the prosthesis10where extensibility is desired. Upon active stretching of the collar12by the penis50undergoing erection and enlargement, either spontaneously or by creating a vacuum in a vacuum device, the stretching of the collar12is accommodated by bending of the collar12around the stiffer limiting layer at the top side of the collar12or selectively along the sidewalls, for example.

With further reference toFIG.18, in some embodiments, the cross-sectional configuration of collar12may be trefoil or triangular in shape. Upon expansion of channel14by penis50, as shown inFIG.19, channel14may assume a substantially circular or ovoid cross-sectional configuration generally conforming to a cross-sectional configuration of an erect penis50. This transformation of the cross-sectional configuration of collar12, together with the variations in the functional design variables selected for different portions of the collar12, may be designed and configured to, by way of nonlimiting example, a) selectively compress the dorsal penile veins, b) grab and support the base of the erect penis in a desired erect state, c) prevent undue compression of the penile nerves, arteries, corpora cavernosa, corpus spongiosus, and urethra, d) controllably bias the erect penis differentially and directionally in the cephalad-caudad plane and/or right-left orientation as desired or needed, e) avoid slippage of the device during sexual activity, f) maintain engorgement and stiffness of the corpora cavernosa posterior to the pubic shield, and any combination of the forgoing.

As used herein, stiffness refers to the resistance of an elastic body to deformation (e.g., extension or elongation) by an applied force. In general, elastic modulus is related to, but not the same as, stiffness. Elastic modulus is a property of the constituent material, whereas stiffness may refer to a property of a structure. That is, the elastic modulus is an intrinsic property of the material; stiffness, on the other hand, may generally refer to a property of the network or architecture of the structure, and may be dependent on the material modulus and the shape and boundary conditions. Because stiffness is a function of the Young's elastic modulus, the material modulus can be used as a comparative measure of the relative stiffness of the collar wall, and a predictor of the deflection upon stretching or expansion of the channel wall.

Strain is a description of deformation in terms of relative displacement of a body. A deformation results from a stress induced by applied forces, in the case here, for example, by the expansion of the penile shaft within the channel14upon vacuum activation or other arousal. Because materials of lower stiffness or smaller elastic modulus will deform to a greater degree than the higher elastic modulus materials, the low stiffness materials experience strain or deformation first. As a result, the strain in the material of the higher stiffness or greater elastic modulus is smaller or “limited.” As used herein, a wall of the channel14that is stiffer, e.g., has a higher elastic modulus, is referred herein as a “strain limiting” wall, e.g., the wall including dorsal ridge32.

In some embodiments, the prosthesis10may be made up of the same material and its elasticity may be engineered by controlling the relative thicknesses of the various regions, so as to obtain regions of higher and lower stiffness. In homogenous elastomers, elasticity may be significantly controlled by tailoring those regions defined by the thinnest walls (e.g., by the structure or region with the lowest resistance to stretching).

Referring again toFIGS.18and19, in some embodiments, the inferior wall of ventral recess34may be relatively thin and more compliant in order to prevent compression of the urethra82and corpus spongiosum62upon expansion of the shaft of the penis50within collar12. Being the most compliant and thinnest, the wall of the ventral recess34may be the least resistant to stretching, and the lower perimeter25of the collar12may become significantly wider than upper perimeter15to conform to the underside of the erect penis50.

With reference toFIGS.19and21, stretching of the collar12around the penile shaft reconfigures the walls of the collar12to urge dorsal ridge32down on the penile veins in the dorsum of the penile shaft thereby inhibiting venous backflow and maintaining the penile erection.

FIGS.19and21(refer also toFIG.42) show anatomical cross-sectional views of the shaft of the human penis50following expansion of a user's erect penis. The penile shaft is composed of three erectile columns, namely, the two corpora cavernosa60and the corpus spongiosum62, as well as the columns enveloping fascial layers64, nerves66, cavernosal arteries68, superficial dorsal vein (SDV)70, deep dorsal vein (DDV)72, dorsal penal arteries74, and lymphatics (not shown), all covered by areolar tissue76, and skin78.

The tunica albuginea80becomes thicker ventrally, where it forms a groove to accommodate corpus spongiosum62. Tunica albuginea80of corpus spongiosum62is considerably thinner (less than 0.5 mm) than that of corpus cavernosa60(approximately 2 mm). The cut surface of corpus cavernosa60looks like a sponge. Blood flows to the corpora cavernosa60via the paired deep cavernosal arteries68of the penis, which run near the center of each corpus cavernosum60. Corpus spongiosum62lies in the ventral groove between the two corpora cavernosum60. The urethra82passes through the corpus spongiosum62. Corpus spongiosum62possesses a much thinner and elastic tunica albuginea to allow for distention of the corpus spongiosum62for passage of ejaculate through the urethra82. The distal extension of the corpus spongiosum62, the glans penis84, covers the distal tips of the corpora cavernosa60to provide a cushioning effect.

On the dorsal aspect of the corpora cavernosa60, the superficial and deep dorsal veins70and72, and paired dorsal penal arteries74, and branches of the dorsal nerves66are contained within the deep penile fascia (Buck fascia)64. This fascia splits to surround the corpus spongiosum62, and it extends into the perineum into the deep fascia of the ischiocavernosus and bulbospongiosus muscles. The deep penile (Buck) fascia64encloses these muscles and each crus of the corpora cavernosa60and the bulb of the corpus spongiosum62, adhering these structures to the pubic and ischial bones and to the urogenital diaphragm.

In some embodiments, collar12may be comprised of at least two materials of different hardness and/or elastic modulus, which may provide a resilient but relatively inelastic dorsal ridge32as well as relatively elastic and stretchable sidewalls. With particular reference toFIG.18, in some embodiments ventral wall42of ventral recess34may be relatively thin and stretchable, forming a protective truss for the user's urethra82.

In some embodiments, as shown inFIGS.20and21, for example, ventral wall42may be relatively thick, measuring around 2-4 mm, for example. In some embodiments, the ventral wall42may be formed of a relatively higher material hardness. The stiffness of ventral wall42may be controlled using a relatively thick ventral wall42, using a material of relatively higher material hardness, or both. The relatively increased stiffness of ventral wall42may provide protection against undue deformation of ventral recess34upon expansion of channel14by the erect penis50and consequent stretching of the sidewalls44of collar12.

In some embodiments, as shown inFIG.22, a segment of relatively greater hardness may be embedded in ventral wall42around the ventral recess34to form a strain-limiting layer that further protects the urethra82and corpus spongiosum62from compression by ventral wall42upon expansion of channel14by an erect penis50. The molded section42can be secured to the softer and more elastic sidewalls using conventional molding methods, such as insert molding, for example.

In some embodiments, sections of the same or similar materials can be adhered using a small molecular silicone precursor e.g., an adhesive. First, a small molecular silicone precursor can be layered onto a first layer of material. Then, a second layer of material can be placed on top of the first layer of material with the silicone precursor. The composite material is then placed into an oven to cure and bond the layers. Of course, any suitable method of manufacture may be used.

With reference to the particular embodiment illustrated inFIG.22, it may be advantageous to form sidewall44segments of a silicone elastomer with a hardness as measured on a durometer scale of, for example, Shore A10; dorsal ridge32with a hardness of Shore A20; the ventral wall segment42with a hardness of Shore A15. Of course, other hardness values may be used. Expansion of channel14, in this particular example, would further thin the sidewall grooves40and flatten the sidewall ribs38, as the sidewalls44elongate differentially, whereas dorsal ridge32and ventral wall42would elongate to a lesser degree. At the same time, the volume of channel14would increase. To accommodate the differential elongation of two adjacent or opposing walls of channel14, the structure surrounding the expanding volume bends outward as demonstrated inFIGS.19and21. Circumferential expansion may be symmetrical or asymmetrical depending on the relative thickness and/or material modulus of the various wall segments. Upon pressurized expansion, channel14spanning the length of collar12may be configured to controllably bend and assume various configurations along the longitudinal axis of channel14.

In some embodiments, a sidewall of collar12may be configured to stretch upon expansion of the user's penile shaft within channel14. A sidewall that is configured to stretch upon expansion, also called an actuating wall, may, for example, have an average thickness less than about 2 mm. In contrast, a wall that is configured not to expand upon pressurization, also called a strain limiting wall, may have a thickness greater than about 2 mm. The size of the strain limiting wall may also depend on the relative stiffness compared to the actuating wall. For example, if the elastic modulus of the strain limiting wall is substantially greater than that of the actuating wall, then the strain limiting wall can be substantially smaller.

In some embodiments, penile prosthesis10may be formed of two or more contiguous layers. For example, as shown inFIGS.23and24, penile prosthesis10may include an outer layer28and an inner layer29. In some embodiments, outer layer28may include a material of a lower modulus of elasticity and/or lower hardness than that of a material forming inner layer29, so that during expansion of channel14, the elasticity of prosthesis10is primarily controlled by the elasticity of inner layer29. Outer layer28may be more elastic and softer, thereby presenting a relatively more agreeable interface to the sexual partner's tissues. Dorsal ridge32may be integrally formed with the inner layer29and may be relatively firm.

FIG.24is a cross-sectional view taken along the line D-D ofFIG.23depicting features of some embodiments of the midportion of collar12. For example, dorsal ridge32may be molded separately, such as by injection molding. The molded part may be inserted into a corresponding cavity of an inner mold or mandrel that is designed and configured to assume the shape and dimension of pubic shield20and channel14of collar12, seeFIG.32, followed by sequential dip molding or layering of liquid polymer that forms inner layer29, followed by layering of outer layer28. The composite layers are then cured and removed from the mandrel. In some embodiments, a silicone elastomer may be used in compositions for making one or more of dorsal ridge32, outer layer28, and inner layer29. If such compositions are used, the portions28,29,32may generally bond together well upon curing.

Variations on this technique are possible and can be readily altered based on the teachings herein to suit many applications. For example, as shown inFIG.22, one could use three or more polymer compositions (e.g., one for ventral wall42, one for dorsal ridge32, and one for sidewalls44), each with different moduli of elasticity, so long as at least the outer layer28is of lower modulus and the dorsal ridge32is of a higher modulus.

Although some of the figures illustrate the combination of only two portions of different moduli of elasticity and/or hardness, some embodiments of the invention may include more than two portions, where the material forming the portions could each have a different modulus.

In some embodiments, a wall of collar12may be configured to elongate or bend upon expansion of channel14, also called an actuating wall, which can have a thickness less than 3 mm, for example. In contrast, a wall that is configured not to elongate or bend upon expansion can have a thickness greater than 3 mm, for example. The size or configuration of dorsal ridge32(strain limiting) contributes to its relative stiffness compared to the sidewalls44(actuating wall). Of course, any suitable materials, elastic modulus, and thickness combinations may be used, depending on the desired properties and characteristics of the prosthesis10.

In some embodiments, a choice of materials (e.g., silicone of different hardness) coupled with the design of the wall segments of collar12may help determine the response of the device to expansion. Generally, the expansion force necessary to achieve a particular amplitude of actuation scales with the stiffness of the wall segments. Different combinations may provide a different behavior with stretching or bending, upon expansion of collar12. For the same channel geometry, the bending may increase with increasing difference in elastic modulus between the actuating wall and the strain limiting wall.

FIG.18illustrates sidewalls44having multiple lateral wall ribs38and lateral wall grooves40protruding into channel14. The inner folds facilitate the stretching and recoil of the sidewalls44upon expansion and contraction of channel14. Corrugations or pleating prescribe the circumferential expanded configuration of the device around the erect penile shaft as demonstrated inFIGS.19and21. As channel14expands circumferentially, dorsal lateral recesses17widen substantially, and dorsal ridge32, acting as a strain limiting wall, becomes biased inwardly into channel14. As shown inFIGS.19and21, dorsal ridge32may bear down on the dorsal region of penis50to restrict blood flow through dorsal veins70and72.

With reference toFIG.23andFIG.24, in some embodiments, the pubic shield20and the collar12of penile prosthesis10may comprise at least two polymeric materials of different elastic modulus, which allows for a flexible but relatively non-distensible shield20and an appropriately stretchable and relatively softer collar12. The forwardly facing outer surface27of the pubic shield20may be formed of a compressible and relatively softer elastic material (e.g., a hardness on the durometer scale of about 10) than the rearward facing inner surface26, which may be formed of a harder material (e.g., a hardness on the durometer scale of about 20) that gives the flange20structural integrity and cross-sectional stability, and prevents buckling of the flange20into the vacuum cylinder. The collar12is preferably integrally formed with the shield20, and may be formed in a two-piece construction that includes a dorsal ridge32which has essentially the same hardness as the inner layer29which forms the inner wall of collar12.

In some embodiments, with reference toFIG.24, segments forming a penile prosthesis10may be prepared by casting them individually in a suitable injection mold, dip casting, or other suitable molding technique.FIG.24is a cross-sectional view taken along the line D-D of collar12of the penile prosthesis10shown inFIG.23. One feature of external penile prosthesis10is the configuration of channel14in the relaxed unstretched configuration, shown inFIG.24, for example, and its deformation by an expanding penile shaft therein, shown for example inFIGS.19and21. Collar12surrounds channel14, which is illustrated as being generally triangular but it could be trefoil or some other near-triangular configuration. A prominent dorsal ridge32projects from the upper wall of collar12into channel14, forming one side of the triangle.

In some embodiments, channel14may be approximately triangular in shape. For example, as shown inFIG.22andFIG.24, diametrically opposite of dorsal ridge32is a ventral recess34. The ventral recess34may form the inner angle of an approximately triangular channel14. A pair of dorsolateral recesses17diametrically opposite the sidewalls44may help define the other two angles of the triangle.

By way of example, and not limitation, the maximum thickness of the dorsal ridge32may be about 12 mm (0.47 inch), its side-to-side width may be about 16 mm (0.63 inch), and its longitudinal dimension or length may be about 23 mm (0.9 inch). The distance between dorsal ridge32and ventral wall42across channel14may be about 18 mm (0.71 inch). The distance between inferolateral ribs39across ventral recess34may be about 11.6 mm (0.45 inch) when channel14is not stretched. The dimensions prescribed may be approximate and depend on the penis size of the individual.

As shown inFIG.24, a pair of inferolateral ribs39project from the inside of the lateral walls44into ventral recess34of channel14. InFIG.24, the channel14is shown presently unstretched so the ventral recess34is at a narrower width than it may be when stretched.

In some embodiments, penile prosthesis10may be designed to be installed around the base of the penile shaft with the male organ still in a flaccid state and utilizing a vacuum erection device. However, males who are able to have an erection may choose to put on the device using only a lubricant, avoiding the use of a vacuum device.

FIG.25illustrates a prior art constricting band or ring applied at the base of a user's penis. Devices of this kind have been used alone (if the patient is able to achieve erection) or in combination with conventional commercially available vacuum erection devices that allow the user to transfer the constricting ring from around the constricting device to the base of his penis. Use of bands or rings with a vacuum erection device requires that either one ring or several bands, doubled or redoubled, be slipped over the open end of the plastic cylinder. Once erection is achieved, the constriction ring or band is slipped off the open end of the cylinder, whereupon it contracts around the base of the erect penis. Placement of the ring or band around the erect penis significantly restricts the flow of blood back out of the penis. However, the pinch-off encompasses veins, arteries, nerves, the corpora cavernosa, the corpus spongiosus, and the urethra. Shortly after the pinch-off, therefore, the penis turns blue and numb, and the circumference where the ring is pinching starts to hurt. The part of the penis behind the pinch-off at the penis root remains limp, so that the stiff portion of the penis before the pinch-off dangles down instead of being erect. Sexual activity with a partner is often cumbersome. If orgasm is reached, the ejaculate cannot escape through the choked off urethra, but is emptied backwards into the bladder.

FIG.26shows an exemplary embodiment of a penile prosthesis10of the present invention surrounding the base of a user's penis50in the usual erect posture. The penile prosthesis10may be placed in position with the aid of a lubricant with or without the use of a conventional vacuum device as described herein.

Referring now toFIGS.27and28, in some embodiments, the central axis A-A of collar12, as viewed in the sagittal plane of penile prosthesis10, may be oriented in a caudal-cranial direction. As shown inFIGS.27and28, when penile prosthesis10is placed over the user's erect penis50so that collar12encircles the shaft of penis50, and a rearward facing inner surface26of pubic shield20rests flush against the user's groin90, collar12biases the shaft of the penis50upward into a preferred functional angulation. Further, this improved penile angulation holds prosthesis10firmly in a posteriorly retracted position and prevents the prosthesis10from sliding forward over penis50. Another advantage of this improved angulation is enhanced compression of the dorsal penile veins by dorsal ridge32, while diminishing the degree of further urethral compression.

Referring toFIG.29, in some embodiments, a centrally disposed frustoconical collar12may enclose a channel14having a central axis X-X that forms a 90-degree angle with the axis Y-Y of pubic shield20. When the device shown inFIG.29is positioned over the user's penis, the penis will point substantially in a straight orientation with respect to the longitudinal axis X-X.

In other embodiments shown inFIG.30, central axis X1-X1of channel14may be biased to the user's left, forming an angle of, for example, 115 degrees to the user's left and 65 degrees to his right. Accordingly, this particular configuration of collar12will deviate the user's penis towards his left.

In yet another embodiment, shown inFIG.31, this particular orientation of collar12along axis X2-X2would deviate the user's penis to his right. Of course, such angulation may be variable, and formation of penile prostheses having a range of angulations are feasible.

In certain embodiments of the present invention, a penile prosthesis having a collar12that is configured to form a predetermined angle with respect to the plane of the annular flange20may be used for the treatment of selected patients suffering from Peyronie's disease. Peyronie's disease is manifested by an abnormal bend that occurs in the erect penis of the sufferer and can be associated with painful erection and/or painful intercourse. Peyronie's disease is related to the development of scar tissue or plaque that forms on tissues (e.g. tunica albuginea) inside the penile shaft. One non-surgical approach for the treatment of Peyronie's disease includes injecting drugs into the plaques that lessens the compression applied by the plaque to the erect penis, however the efficacy of this approach is limited. Surgical treatment for Peyronie's disease includes excising portions of the tunica albuginea and corporal plication.

In some embodiments, the angle formed between the collar12and the pubic shield20may be configured to change upon expansion of the penile shaft within the device upon pneumatic actuation of the vacuum device in such a manner that a force is exerted on the penis to bend it in a certain predetermined direction. For example, the penile prosthesis device may be configured to deflect the penile shaft to correct deformity in a stent-like fashion after repeated use over time.

Certain types of penile deformity may be correctable or improved during sexual intercourse. Further, such deformity may be corrected over a period of time following repeated use of the device by the user alone or with a partner. Unlike traditional hard splints or stents used in other parts of the body such as in dentistry or orthopedics, a specially designed penile prosthesis intended to correct a particular penile deformity may act as a soft actuator which maintains its adaptive properties when it is provided with a particular form or collar-flange angle, or when it is pressurized or vacuum actuated such that it can partially conform to the shape of the erect penile shaft. Furthermore, the amount of deflective force applied on the erect penis can be spread out over a large surface area in a controlled manner because the elastomeric material used can easily deform. In this way, a corrective penile prosthesis design for treatment of a specific deformity can effectively provide momentary or permanent benefit without injuring the body organ.

In some embodiments, an external penile prosthesis may be in the form of an actuator that may be created, for example, by molding one or more pieces of elastomeric material into a desired shape. Such an actuator may include a collar portion having a hollow interior or channel that can be extended or expanded with the user's penis in the state of erection to pressurize, inflate, and/or actuate the actuator as further described in U.S. patent application Ser. No. 15/895,299, filed Feb. 13, 2018, titled “External Penile Erection System,” which is incorporated herein by reference. Upon actuation, the shape or profile of the actuator changes. In certain cases, actuation may cause the actuator to curve or straighten into a predetermined target shape. One or more intermediate target shapes between a fully unactuated shape and a fully actuated shape may be achieved by partially expanding the actuator. The actuator may be actuated using a conventional or modified erection vacuum device thereby changing the degree to which the collar portion of the actuator bends, twists, and/or extends.

In some embodiments, all of the elements of the prosthesis may be fabricated from a moldable, pliable, elastomeric material such as silicone rubber because of its inert, non-wetting surface, durability, and other desirable characteristics. Other materials that are commercially available or yet to be developed may also be used.

The collar12and shield20portions may be formed in a mold having a mold cavity of corresponding shape. The collar12portion of the mold cavity may be loaded with a silicone rubber material which, when cured, may be relatively soft and elastic while the shield20portion of the mold cavity may be loaded with a silicone rubber material which, when cured, may be of greater stiffness. The silicone rubber materials for the collar12and shield20may be compatible with each other and may display the same or similar desirable properties except that the collar12portion may be substantially more elastic than the shield20portion. For example, the collar12material described may have a modulus of elasticity whereby it may be stretched up to three or five times its original dimensions while maintaining adequate tear strength. Additionally, collar12may provide a softer feel to both partners, which is a very desirable feature. In contrast, shield20may be made from a silicone rubber compound which may be approximately half as elastic, and may be capable of being stretched approximately two or three times its original dimensions. Desirably, shield20presents a relatively firm wall against the entry portion of a vacuum tube.

In some embodiments, the prosthesis10may be comprised of at least two polymeric materials of different elastic modulus, which allows for a flexible but relatively non-distensible shield portion as well as a collar with elastic and stretchable collar portions. The regions of differing durometer/elasticity in the device can be fabricated and achieved in a variety of ways. In exemplary embodiments, the regions may be formed in an edge-to-edge manner or along an overlapping border region using conventional overmolding, insert molding, and/or dip molding techniques, for example. It will be appreciated that the prosthesis could also be formed by layering materials of differing elasticities, providing layers having different thicknesses, providing reinforcement fibers or materials which create regions of different durometer within a matrix of the same material; in other exemplary embodiments, inflatable members may be interposed between the layers or regions of the structure which may be controlled by the user in the manner of a soft robotic.

In general, some embodiments of the present invention may provide an external penile prosthesis10having elements with different thicknesses and different material moduli, which upon stretching around a penile shaft, support the shaft in an erect state and/or control its deflection. In some embodiments, such penile erection augmentation may depend at least partly, however, on having an expandable collar12wall chosen to accommodate the size and rigidity of a particular penis being treated, as penile states of erection and rigidity even in the same individual may vary from time to time, and the same user may prefer a device that provides a different degree of constriction. Multiple components of differing hardness may be combined into the same device collar such that one part of the wall is less distensible and another part of the wall is more compliant or elastomeric, such that when the device is applied to a user's penis, both the non-distensible and compliant components are activated simultaneously.

With reference toFIGS.32-35, in some embodiments of a method of manufacture of a penile prosthesis, a two-piece mold150may be used to form the lateral wall ribs and lateral wall grooves of the sidewalls. An outer mold may define the outer contours of the two-piece mold, and the mold cavity can be filled with one or more liquid polymer parisons to form the sidewalls. Once set, the two-piece mold can be separated and the parts removed. The other segments may be molded in a similar fashion. For example, a mold core152may include a dorsal ridge mold core154and a central channel mold core156. Central channel mold core156may be placed within mold150, and polymeric materials may be injected therein to form prosthesis10. The penile prosthesis10may then be assembled from the preformed segments by placing the segments into a master mold. For example, the segments may be bonded together using a heat fusing process.

FIG.36illustrates an embodiment for how a penile prosthesis10may serve as an erection obtaining and maintaining device in conjunction with a conventional vacuum tube200for receiving the user's penis50. In some embodiments, it is not necessary to use a separate diaphragm (not shown) for sealing the open end202of the vacuum tube200around the penis. Instead, penile prosthesis10may be placed directly over the open end202of vacuum tube200whereby an airtight seal is obtained between the soft and smooth front outer surface27of pubic shield20and open end202of vacuum tube200.

Referring toFIG.36, penile prosthesis10may be positioned upon the front opening of conventional vacuum tube200, and the user's flaccid penis50is shown approaching the funnel-like proximal opening16of pubic shield20. The forwardly facing outer surface27of shield20rests flush against the front edge202of vacuum tube200creating an air-tight seal. As the glans penis84rests snugly within the funnel-like opening of prosthesis10and the vacuum apparatus is activated, the vacuum within the chamber206automatically draws penis50(dotted line) into the chamber. Pubic shield20is sufficiently firm and extends radially a sufficient distance beyond the circumference of the open end of vacuum tube200so that it is not pulled into the chamber206during the evacuation cycle.

FIG.37illustrates the penile prosthesis10after it has been deposited on the flaccid penis50(dotted line). At this time, the dorsal ridge32of collar12is bearing down on the top of the penis50at its base snugly and not loosely if the appropriate channel14size has been selected. The user may now perform pelvic muscle contraction exercises to force blood under pressure into his penis to augment the action of the vacuum tube to produce a firmer erection. The root56of the penis behind the prosthesis10also becomes rigidized with the rest of the penis when an erection has been obtained. The sidewalls of collar12bear inward on the now rigidized corpora cavernosa, thus supporting the penile shaft together with surrounding collar12against shield20, which rests against the user's groin90.

Referring toFIGS.37and41, vacuum tube200is pressed toward the user's groin90so that pubic shield20is squeezed tightly between the circumference of open end202and the user's groin90. The outer surface27and the seating inner surface26of pubic shield20create an air-tight seal between vacuum tube200and penile prosthesis10drawing penis50further into chamber206and augmenting the user's erection. Note that the root56of the penis50is drawn further forward within penile prosthesis10without risk of drawing the patients' skin or scrotum inadvertently into the device. Physiologically, there is blood in the root56of the penis50posterior to the shield20of the prosthesis10even after the corpora cavernosa are filled by the pelvic exercises. The erection can be improved and maximized by the user using his fingers to press the shield20back against the pubic tissues and scrotum in a circular fashion to massage this blood through the prosthesis10and into the penis50. This action also insures and reinforces the pressure of the dorsal ridge32against the dorsal penile veins70and72, and this action pulls the root56of the penis50further into the vacuum chamber206and helps to elongate the penile shaft52. Desirably, the entire length of the penis50from its glans84to its root56posterior to the prosthesis10may become rigid. In prior art constriction rings, refer toFIG.25, which only fit over the base54of the penis and do not support the portion of the penis posterior to the device, this portion of the penis remains relatively flaccid. By contrast, in embodiments of prosthesis10as described herein, when the penis50is brought to the desired erect state, the vacuum within the chamber206is emptied, and erect penis50is removed while prosthesis10remains snugly positioned around the base54of penis50as shown inFIG.38, while the user engages in the desired intimate activities.

In some embodiments, a penile prosthesis10may include a retention strap300, as also described herein in reference toFIG.39AandFIG.39B, for example. Retention strap300may be made of a flexible or elastic material. Upon completion of the desired activities, prosthesis10may be removed by first sliding retention strap300from behind the scrotum102, then collar12may be slid forward toward the glans penis84. Contralateral edges22of shield20may be grasped and pulled apart by the user, thus widening channel14of collar12, relieving pressure upon the dorsum of the penis in the region of the dorsal penile veins. This may be accompanied by rotation of the prosthesis10in order to ensure relief of compression of the veins and facilitate return of the erect penis to a flaccid state. Simultaneously, compression of dorsal penile veins70and72is relieved by removal of compressive action of dorsal ridge32. As the penis50becomes flaccid, removal of the prosthesis10becomes easier. Water may be poured along the seating inner surface26and into the funnel-like opening16(see, e.g.,FIG.2) thus creating a slippery interface that aids in removal of the prosthesis10.

FIG.39Ashows a penile prosthesis10according to some embodiments which includes a retention strap300connected to the periphery of pubic shield20of the prosthesis10. The retention strap300may be integrally molded with the rest of the penile prosthesis10. As shown in the exemplary embodiment ofFIG.39A, the retention strap300may have an essentially semicircular shape. Between the lower periphery of pubic shield20and retention strap300is an aperture321which is provided to encircle the user's scrotum102when the prosthesis10is used. The retention strap300may be formed of an elastic material that may be stretched substantially beyond its original length and when relaxed it may return to its original length.

The length of retention strap300may be around 7 cm, for example, and may be greater than the distance between connection points302aand302b. The unstretched length of retention strap300may be varied to accommodate different user's anatomy. Dotted line300sand stretched aperture321sdepict a wide latitude of stretchability of strap300in order to accommodate a wide variety of anatomies for different users. Any suitable dimensions may be used.

In order to simplify the construction of penile prosthesis10, the components may be integrally molded to include retention strap300. In other embodiments, retention strap300may be made separately. Of course, the hardness and modulus of elasticity of strap300may be chosen to be different from the rest of pubic shield20in order for the strap300to provide appropriate elastic recoil and strength.

In some embodiments, the ends of retention strap300may be connected to connection points302aand302balong the periphery of pubic shield20. Connection points302aand302bmay be positioned opposite to each other relative to the aperture321such as below the level of channel14of collar12in order to bias the prosthesis10posteriorly and inferiorly upon stretching of strap300(see arrows350).

Due to the arrangement of the elastic strap300with respect to channel14, the channel's cross-sectional configuration may be deformed upon depression of connection points302aand302bas retention strap300is tensioned downward. As a result of tensioning of the retention strap300, dorsal ridge32may be urged inwards into channel14as shown by arrow352compressing the dorsum of the penis within channel14thus augmenting compression of dorsal penile veins70and72, pubic shield20may be forced downwards and backwards against the user's pubis causing a tighter fit of the device, or both. Additionally, in some embodiments, the deep penile veins at the underside surface at the root of the penis in the perineum behind the scrotum are simultaneously compressed by the strap300to ensure that all the draining veins of the penis are adequately compressed. These actions may help stabilize penile prosthesis10against forward slippage during sexual activity without the user's aid. Advantageously, in some embodiments, the fitting latitude of retention strap300may be widened thus promoting functionality and user's satisfaction. Downward bias of pubic shield20may depress ventral recess34, thus relieving pressure upon the user's urethra by the ventral recess wall42. In some embodiments, connection points302aand302bmay be positioned at a horizontal line spaced at or below the level of ventral recess34.

With reference toFIG.39B, according to some embodiments, retention strap300may include a strap buckle340connected to a first strap portion300aattached to the penile prosthesis10at a first connection point (e.g., connection point302aas shown inFIG.39A) and a second strap portion300battached to the penile prosthesis10at a second connection point (e.g., connection point302bas shown inFIG.39A). The strap buckle340may, for example, be adjustable and configured for quick and easy cinching and release. For example, buckle340may include a button342that may be pressed in order to allow the buckle340to slide forward with respect to the strap portions300aand300band thereby cinch them up about the user's scrotum (e.g., while the user holds the ends308aand308b), and when the button342is released the buckle340may be held snugly in place with respect to the strap portions300aand300b. Similarly, button342may be pressed in order to slide buckle340backward with respect to the strap portions300aand300band thereby loosen strap300for removal from the scrotum. In some embodiments, ends308aand308bof strap portions300aand300bmay be loose ends, or ends308aand308bmay be tied or otherwise fastened together, or strap portions300aand300bmay be part of a continuous strap300.

In one aspect, an external penile prosthesis retention strap may include two attachment portions connected by an adjustable length strap. The strap may be of a sufficient length to wrap around the user's scrotum, to secure an external penile prosthesis around the base of a user's penis. The strap may, in some cases, be sufficiently wide to reduce or prevent movement and/or rotation of the prosthesis. The strap may, in some cases, be sufficiently tightened by the user to generate enough tension to compress the deep veins behind the scrotum to eliminate venous insufficiency and maintain a strong erection. In some embodiments, the strap buckle340may be disposed between a second end of the first strap and a proximal end of a second strap for removably surrounding a user's scrotum.

With reference now toFIGS.40A and40B, according to some embodiments, the elastic strap300may be formed and provided separately from pubic shield20in different lengths, diameters, cross-sectional configurations, and elastic strengths and moduli. The cross-sectional configuration of elastic strap300may be circular, oval, ovoid, or other suitable configuration, and may be about 5 mm in diameter and about 7-15 cm in unstretched length, for example. The ends of the strap may be reversibly connected and disconnected from pubic shield20at connection points302aand302b(seeFIG.39A). The pubic shield-collar structure may be molded of a polymer and may have a pair of anchoring sockets304aand304barranged at connection points302aand302b. Anchoring sockets304aand304bmay define annular spaces with relatively narrow central apertures305aand305b, and peripheral flanges306aand306bextending annularly in surrounding relation to the central apertures.

As shown inFIGS.40A and40B, a female component312(which may be one of a pair of female components, only one is shown for simplicity) of a snap button assembly310may be shaped and configured to complement the shape of one of anchoring sockets304aand304b, and may be of the same size or slightly larger than the sockets304aor304b. When a female component312is squeezed through central aperture305aor305b, and positioned within the annular space of one of the anchoring sockets304aor304b, it becomes entrapped therein by one of the peripheral flanges306aor306b, thus preventing its expulsion by pulling action of elastic strap300. A bonding agent or glue, for example, may be used to hold the component312securely within the socket304aor304b. The female component312may include a deformable button body314and a fastener receiving aperture318. The female component312may be adapted to retainingly receive the shank324of an associated male component320in an axial recess316through the fastener receiving aperture318. When assembled, the fastener receiving aperture318of button body314may be easily identifiable along the edge of pubic shield20. Button body314may be made of metal or synthetic polymer, for example, and may include a circular domed head having a central axial recess316accessible through the fastener receiving aperture318.

As shown inFIG.40B, male component320of snap button assembly310may be made of metal or preferably synthetic polymer and may include a circular base322and a central shank324projecting therefrom. The shank324may have a maximum diameter substantially equal to or slightly larger than the diameter of the fastener receiving aperture318. The shank324may have a waist portion326adisposed substantially centrally thereof and extending there around in tandem relation to a waist receiving portion326bin the central axial recess316of button body314. Male component320may terminate distally at a spear tip328. The overall configuration of male component320may be designed and configured to fit snugly and firmly within central axial recess316in order to act as a clutch or locking mechanism to hold elastic strap300securely and detachably to pubic shield20. Those with ordinary skill in the art will appreciate that other forms of snap button assemblies may be utilized, and other methods of reversible fastening of male fasteners within apertures of female button bodies may be utilized. Of course, any suitable means of fastening strap300to shield20may be used.

With further attention toFIG.40B, a stem portion330may project perpendicularly centrally from the back face of circular base322contralateral to central shank324. Stem330may be adapted for tight insertion and secure bonding within a corresponding recess332at one end of elastic strap300. In some embodiments for assembly of penile prosthesis10, shank324of male component320may be inserted through fastener receiving aperture318of button body314to which one end of elastic strap300is to be attached, and then shank324may be fitted forcibly into axial recess316in button body314until the components are tightly aligned so that a click is perceived, ensuring accurate alignment of waist portions326aand326bthus preventing male component320from being separated from button body314upon stretching of elastic strap300.

FIG.41shows a conventional vacuum type penile erection device for a male penis50having a shaft portion52, a base portion54, a root portion56, and a glans84. The penile erection device includes a vacuum tube200into which the male penis50is inserted. A source of vacuum such as a hand or electric pump (not shown) for evacuating or removing air from tube200via flexible hose204is provided.

Vacuum tube200may be a conventional, generally cylindrical shaped transparent plastic tube having a distal end connected to a flexible hose204or to a mechanized battery-operated air pump, for example. Conventionally, the diameter of the tube200is about 2 inches. The tube200is rigid and maintains its shape when at least 24 inches of mercury or other suitable level of vacuum pressure is achieved inside the tube. An outwardly projecting lip208is formed around the circumference of the open proximal end of tube200. The lip208may have a thickness of about 0.24 inch and its edges may be rounded for comfort and for forming an air-tight seal against the front surface of pubic shield20of penile prosthesis10. The tube200may be sized to accommodate the genitalia of most male individuals.

Most commercially available vacuum erection devices utilize a diaphragm seal made of an integral piece of soft, flexible rubber to facilitate comfort and to create an air-tight fit against the user's pubis and around the user's penis. However, one shortcoming of such diaphragms is that they may not form a sufficiently air-tight seal to produce a desired amount of vacuum pressure inside the tube.

Conventional constriction rings used with such vacuum tubes and diaphragms are not designed to allow the root of the penis to be drawn into the constrictor ring (refer toFIG.25). When the vacuum tube is removed, only that portion of the shaft of the penis anterior to the ring becomes erect, and the part of the penis behind the ring including the portion of the penis at the level of the scrotum does not become filled with pressurized blood and therefore does not become rigid. The base and root of the penis remain or return to a flaccid state, and the penis does not achieve and maintain a natural erect state.

FIG.42illustrates certain basic anatomical landmarks of the human male pelvis in relation to an embodiment of a penile prosthesis10as described herein: pubic bone100, scrotum102, anus104, rectum106, prostate gland108, glans penis84, bulbous spongiosum116, corpus cavernosus60, urinary bladder112, urethra82, corpus spongiosum62, and pubococcygeous (PC) muscle and/or the levator ani muscle118.

When an external penile prosthesis10as described herein is used with a simple vacuum tube (as shown inFIG.41for example), without the aid of a diaphragm, a complete air-tight state is achieved due to compression of the front face27of pubic shield20against lip208of vacuum tube200.

Referring again toFIG.42, the prosthesis10is designed for facilitating unhindered flow of blood into the entire penis50while selectively obstructing venous return from the dorsal penile veins and the deep veins behind the scrotum102. When the prosthesis10is positioned properly as shown inFIG.42, including placement of elastic strap300behind the scrotum102, the user is encouraged to perform repeated voluntary contractions of his pelvic muscles including the pubococcygeous (PC muscle), and/or the levator ani muscle118. This action potentiates venous engorgement of the entire penis50including the portions in front of and behind the prosthesis10. Contraction of the muscle also compresses the urethra82(when one desires to interrupt urination temporarily). As advised by erectile dysfunction specialists, contracting this muscle repeatedly several times per day or on a daily basis strengthens the muscle and improves its physiologic health. This exercise may have the added benefit of controlling the condition of overactive bladder. The PC muscle in both the male and female runs between the pubic bone100in front and the coccyx (tail bone) in the back. Voluntary tensioning of this muscle by the user, especially when using the prosthesis10during evacuation pumping by a vacuum erection device, can increase blood flow in the deep part of the penis50behind the prosthesis10as well as in front of the prosthesis10into the visible erect shaft52of the penis50. Exercises for toning these muscles are known as Kegel exercises. Cyclically tensing and relaxing of these muscles by the user while wearing the device of the invention and while the user's penis50is in full erection, on a daily basis, can improve blood flow into the penis50, especially when this routine is performed with or without coitus.

All patents and published patent applications referenced in this disclosure are incorporated herein by reference.

While the apparatus of the invention is described herein in relation to exemplary embodiments, it is understood that other alterations and modifications of the invention will become apparent to those of ordinary skill in the art upon reading this disclosure, and it is intended that the scope of the invention be limited only to the broadest interpretation of the appended claims to which the inventor is legally entitled.

The embodiments described herein are some examples of the current invention. It will be appreciated by those skilled in the art that changes could be made to the embodiments and features described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention. Among other things, any feature described for one embodiment may be used in any other embodiment. Also, unless the context indicates otherwise, it should be understood that when a component is described herein as being mounted or connected to another component, such mounting or connection may be direct with no intermediate components or indirect with one or more intermediate components. The scope of the invention is defined by the attached claims and other claims that may be drawn to this invention, considering the doctrine of equivalents, and is not limited to the specific examples described herein.