Functional penis prosthesis

Abstract

The present invention discloses an external functional penis prosthesis that simulates real genitals at both the sensorial and functional level, in any of its states. For this purpose, the prosthesis of the invention is based on a limited pneumatic erectile system comprising different steps that simulate a total or partial erection in a gradual and controlled manner, thereby obtaining a hardness and behaviour that are similar to those of an actual physiological penis. The pneumatic erectile system comprises an inflatable hollow elastic body surrounded by a non-elastic fascia, at least one reservoir in the form of a testicle as an inflation bulb, tubes and a switch valve. The system is attached in an ergonomic support and the entire assembly is covered by an elastic membrane in the form of skin that provides a realistic appearance and functionality.

Description

[0001] DESCRIPTION

[0002] Functional penile prosthesis.

[0003] OBJECT OF THE INVENTION

[0004] The present invention relates to a functional external penile prosthesis that enables the emulation of real male genitals, both at a sensory and functional level, in any of their states.

[0005] To this end, the prosthesis of the invention is configured based on a novel pneumatic erectile system that enables total or partial erection in a gradual and controlled manner, obtaining a hardness analogous to that of a real physiological penis in each state of erection, thereby allowing the performance with complete fidelity of actions analogous to the natural behavior of a penis.

[0006] BACKGROUND OF THE INVENTION

[0007] Penile prostheses designed for male transgenders or FTM (Female to Male) are known in the state of the art. They have the capacity to enable the wearer to perform specific actions and functions associated with the behavior of male genitals, with a more or less realistic appearance.

[0008] These prostheses fit externally onto a person's genital area, adapting to their anatomy, so their use does not require surgery. Designed for people who lack male genitalia, these prostheses are intended to emulate them both in appearance and functionality.

[0009] Known external prostheses can be classified by the functions they perform. Thus, the following types of prostheses are known:

[0010] Pack: These are prostheses that emulate the male genitalia in a resting or flaccid state, and do not perform any of its functions. Stand-to-Pee (STP): These allow for the resting position and also allow urination while standing through a funnel system.

[0011] Erectile (Pack & Play): These are designed for the resting position, but are designed for sexual intercourse, so they must be able to assume an erect position. They also usually allow for stimulation of the wearer.

[0012] - Complete (All in one): they combine all the functions of the previous ones.

[0013] The earliest known prostheses were merely bulges or erect dildos with no special functionality and a very unrealistic appearance. Today, while most penile prostheses remain 3D stills or realistic "sculptures," their appearance has been greatly improved by the introduction of pinchable skin, movable testicles, etc., and some already offer different solutions to the aforementioned functions, although these solutions have significant shortcomings, as detailed below.

[0014] To carry out the erection function (Play function), from a mechanical point of view, the solutions involve pumping a fluid (pneumatic or hydraulic system) or introducing a rigid or flexible rod into the main body that simulates the penis (mechanical system).

[0015] However, known solutions are based on a "fixed shape" cast from a single mold. This part, extracted from the mold and made of elastomers, is "erected" by inflating like a balloon or by forming it, and the results obtained are far from emulating a real erection.

[0016] Known prostheses that employ a mechanical system employ a rigid or flexible rod that is inserted into a cavity within the prosthesis along the shaft of the penis, which, by slightly increasing in thickness and length, assumes an erect position. These prostheses in which the mechanical system is applied, when obtained by casting or injecting an elastomer (such as silicone) into a mold, are more or less ductile or malleable prostheses, but with a "fixed shape." Their elastic memory means that their shape and position do not vary naturally, resulting in a behavior that is very far from that of real genitals since they are unable to achieve a realistic flaccidity-erection transition, in which the erection process occurs gradually and with a hardness that is selectable at the will of the wearer. Thus, prostheses with a mechanical erection system based on a rod, such as those disclosed in They present the following disadvantages when it comes to reproducing an erection:

[0017] - An external element (stem) is required to be inserted to achieve the erect position.

[0018] - The insertion of the shaft eliminates the transition to erection; it simply forces the main body into a specific position in a single step, resulting in a non-adjustable erection. In other words, an erection does not occur; erection is understood as a gradual process of the penis changing from a flaccid state to an erect state.

[0019] - The transition from resting to erect and vice versa cannot be performed with the prosthesis in place, which undoubtedly reduces its practicality and reduces the naturalness of actions performed with it.

[0020] - The final hardness and rigidity of the penis are not adjustable or realistic, since it is a soft layer surrounding a hard piece.

[0021] - The interaction of the erectile body with the wearer is null.

[0022] On the other hand, some penile prostheses are known, such as those disclosed in documents US2021052464A1, W02010079795A1, and FR3123800A1, which use pneumatic and / or hydraulic systems similar to those described above. However, these examples present deficiencies inherent to a theoretical concept. For example, when inflating a balloon with air or water, to achieve hardness, the balloon must approach its elastic limit, with the risk of rupture. To try to solve this problem, one can resort to thickening the walls or using a silicone with greater resistance to deformation, thus losing malleability and realism, or even resorting to a rigid, highly hard material (such as metal) to give the body a false sensation of "hardness."

[0023] Thus, document US2021052464A1 discloses a penile prosthesis featuring a pneumatic erectile system based on an unreliable shaft or body with means to allow expansion along the length and restrict expansion across the width of the unreliable body (paragraph 75 of said document). These means are embodied in a containment sleeve arranged around the unreliable body. That is, the function of this element is not to provide hardness or rigidity, but rather to direct inflation so that it occurs along the shaft instead of laterally. Thus, the containment sleeve is only capable of stopping non-longitudinal expansion (expansion in width), but not longitudinal expansion (neither forward nor backward), thus being incapable of preventing the increase in volume of the unreliable body.In other words, if the prosthesis disclosed in document US2021052464A1 were pressed, it would deform, expanding forward at the end of the glans, since it is not limited by the aforementioned containment sleeve in that direction, and therefore would be unable to provide sufficient hardness or rigidity to emulate a real erect penis.

[0024] Document W0201007975A1 discloses a device for replacing the male sexual organ, provided with a body that includes a longitudinal penis with an inflated balloon and an area with a portion of scrotum and a deformable testicle as a manual pump for the propulsion of simulated urine, ejaculate fluid, or air. More specifically, the device disclosed in document W0201007975A1 consists of a thick-walled, almost solid body, which has an inflated cavity and another conduit (which would undoubtedly affect the sensory response of the inflated penis) to allow the passage of ejaculatory fluid, urine, or air. In practice, the inflation of the inflated cavity would result in a body of a presumably elastic material with very thick walls that increases its dimensions to a certain extent, but which, however, does not acquire a level of hardness or pressure remotely similar to that of a real erect penis.Thus, in terms of sensoriality and functionality, the device in document W0201007975A1 is more analogous to an inflated silicone phallic body, whose consistency is mainly given by the thickness of the solid elastic walls, and it still largely maintains the same lack of rigidity and tension characteristic of the material used.

[0025] Therefore, the device in document W0201007975A1 does not offer a similarity to a human penis with the sensoriality, behavior, and functionalities that allow it to emulate a real physiological penis, since it would not achieve the rigidity or hardness of a real erection nor a sensory experience faithful to the real anatomical texture and thickness.

[0026] On the other hand, document PR 3123800A1 discloses a penile prosthesis comprising a deformable, phallic-shaped body comprising an erectile module and rigid means for receiving a liquid and simulating an erection. The prosthesis additionally features a deformable metallic exoskeleton arranged along the entire length of the rigid means, configured to stiffen the erectile module in the erect position. However, what this element achieves is to provide an artificial metallic hardness, which is neither gradual nor progressive, and is present in all states of erection, including flaccidity, greatly deviating from the sensations of a real erect penis, which is soft to a certain extent, but exhibits a force opposing the deformation it undergoes.Additionally, since said exoskeleton is arranged only around the unreliable means, it does not improve the sensory response of the glans, contrary to the proposed invention, as detailed below.

[0027] In summary, the deficiencies of these existing pneumatic-hydraulic proposals are:

[0028] - The actual hardness of the penis during erection and the "pressure" or rigidity it presents is what an inflated balloon can achieve or what can be achieved by increasing the thickness by adding material around the balloon, moving away from the reality of the erectile process in both cases.

[0029] - Rapid and complete emptying of the penis is not guaranteed, regardless of the degree of erection.

[0030] - When an elastic band is inflated with sufficient pressure, it deforms, tending toward a spherical shape, unless it is entirely contained by a non-elastic surface. Therefore, none of the prostheses disclosed in the aforementioned documents can achieve a limiting shape of the penis in erection, unlike the present invention. Thanks to the configuration described below, based on a limited system, not only is it possible to achieve a suitable final shape of the penis in erection, but this shape can also be varied by controlling its inflation or deflation, creating different erection patterns.

[0031] On the other hand, there are known prostheses with a mixed pneumatic-mechanical system that combine a pneumatic system with a rod to reproduce an erection. However, they have the disadvantage of requiring two actions: first, the pneumatic inflation of the prosthesis and then the insertion of the rod. This requires force: first it must be inflated and then the rod must be inserted, which requires manipulating the prosthesis, forcing it to be removed and replaced each time an erection is attempted. Thus, the disadvantages of this type of prosthesis can be summarized as follows:

[0032] - A full erection cannot be achieved with the prosthesis in place, which undoubtedly reduces its functionality.

[0033] - Two actions are required to complete the erection completely.

[0034] - The rigidity and hardness achieved in the erection of the penis are not adjustable.

[0035] - The interaction of the erectile body with the wearer is null.

[0036] In conclusion, it is clear that the two systems currently used in external penile prostheses to emulate a real erection have clear deficiencies and fail to reproduce a functional erectile process.

[0037] For all the above reasons, the applicant for this protection application detects the need to develop a novel and advantageous configuration of a functional external penile prosthesis, which allows simulating the appearance and functions of a real penis, in such a way that a real erection is possible, carried out in a gradual and controlled manner at will, obtaining a degree of hardness and pressure or rigidity equal over the entire surface of the penis body which, analogously to reality, increases progressively with the erection, changing in size, shape, volume, hardness and even color, all in a comfortable and agile way with simple manipulation that does not reduce the functionality or reality of the aforementioned functions.

[0038] DESCRIPTION OF THE INVENTION

[0039] The present invention solves the aforementioned problem by offering a functional penile prosthesis that realistically simulates the male reproductive system, both in appearance and functionality. Specifically, the proposed prosthesis resembles the human penis in terms of sensory perception, behavior, and functionality during erection, with skin that stretches, slides, retracts, and resists like the real thing. This is a limited system that allows the penis body to erect, taking on a specific shape as it gradually hardens and exhibits pressure against deformation and an organic consistency. It also guarantees complete and rapid deflation of the penis body, allowing it to comfortably return to a resting state.

[0040] To this end, the prosthesis of the invention comprises a limited pneumatic erectile system based on different layers that completely enclose a balloon or elastic body that creates an erectile body, which allows the system to be presumed, thus reaching a level of hardness and pressure equal across the entire surface of the penis body (including the glans) directly proportional to the inflation of the elastic body, and therefore, to the degree of erection (eliminating the 'balloon effect' detailed above), and which allows the penis to be returned to its resting state at will. Advantageously, the erectile process achieved in the present invention is gradual, with the size, rigidity and hardness of the erectile body being under the control and will of the user, being able to maintain for the desired time in any of the intermediate states of erection that occur in a real physiological erection.

[0041] Another advantageous aspect of the invention is that the pneumatic erectile system transmits to the user, through the skin or elastic membrane that contains it, bio-organic sensations that further enhance its realistic behavior.

[0042] According to the essence of the invention, the pneumatic erectile system is provided with the following elements:

[0043] - a hollow elastic body with an inlet for a fluid, preferably air, which may have one or two distinct sinuses, and which provides consistency to the prosthesis in a resting state;

[0044] - a non-elastic fascia or limit fascia, which is an anatomically shaped sheath that surrounds the elastic body, limiting its expansion and allowing it to achieve rigidity and hardness at will. Furthermore, its anatomical shape defines an erectile and a non-erectile section within the elastic body, where the erectile section corresponds to the part that simulates and erects the penis. Therefore, by varying the geometry of the non-elastic fascia, the final shape and size of the erect prosthesis can be defined;

[0045] - at least one reservoir, in the form of a testicle, which is deformable under pressure to act as an inflation bulb, which is provided with at least one conduit for the entry and / or exit of a fluid, preferably air, where the conduit preferably has a non-return valve that determines the direction of entry of the air and prevents it from escaping;

[0046] - at least one connecting pipe connecting the tank and the elastic body; and

[0047] - an air shut-off valve located in the connecting line, which allows for tightness and the evacuation of air at will throughout the entire pressure range. The prosthesis is complemented by an ergonomic support to which the pneumatic erectile system is attached, preferably by means of an adhesive, and which adapts to the wearer on one side and receives the pneumatic erectile system on the other. Specifically, the elastic body is coupled to the ergonomic support via its non-erectile section. The ergonomic support preferably has an appendage for stimulating the wearer in the area coinciding with the non-erectile section of the elastic body. This appendage may have different lengths, depending on the desired stimulation, and optionally has protrusions for stimulating the wearer.In this way, as any pressure variation in the erectile region is transferred to the entire body and therefore to the ergonomic support, interactive stimulation is achieved between the wearer and the recipient.

[0048] Finally, the prosthesis includes a skin-like elastic membrane of variable thickness (the thickness depends on the desired dynamic properties of the different parts of the prosthesis). This membrane covers the pneumatic erectile system and the ergonomic support, giving the prosthesis its realistic external appearance. Advantageously, all the prosthesis's internal elements transmit bio-organic sensations through the elastic membrane, enhancing its realistic behavior.

[0049] Thus, the pneumatic erectile system passes from a resting state to an erect state in a gradual and controlled manner, by means of the introduction of air from the outside by actuating the reservoir as an inflation bulb, air that passes to the elastic body through the reservoir conduit and the connecting line, producing the inflation of the elastic body, limited to the limit of shape and size determined by the geometry of the non-elastic fascia, while the actuation of the air switch valve allows passing from the erect state to the resting state by releasing the air contained in the elastic body.In this way, it is possible to control the erection process at will, by activating the pump-like reservoir to a greater or lesser extent, and to return to the resting state by activating the air switch valve to a greater or lesser extent. Thanks to the layered structure described above, the system is pressurized until the desired rigidity and final size are achieved, eliminating the "balloon effect," and then returning to the resting state. Thus, the erectile process is gradual and controllable at will, and can be maintained in any of the intermediate states of erection.

[0050] The non-elastic fascia solves the problem described above, in which other known devices have containment sleeves that do not provide hardness, such as the one disclosed in document US2021052464A1, where the inflation is directed to allow the expansion of the inflexible body lengthwise, but not to the sides, so it is not able to pressurize the air over its entire surface, and therefore, the hardness or rigidity necessary to simulate a real erection is not achieved.

[0051] Non-elastic fascia can consist of one or two breasts. The difference lies in the final shape adopted by the penis; in the borderline fascia of one breast (whether with one balloon - or elastic body - or two), the section of the erect body is necessarily circular. In the fascia with two breasts, the erect section can be controlled and varied toward a more ovoid and anatomical shape, but in both cases the erectile process develops with equal effectiveness.

[0052] Optionally, the prosthesis features an elastic fascia covering the non-elastic fascia, so that the elastic fascia is positioned between the elastic membrane and the non-elastic fascia, compressing the assembly at all times and ensuring complete deflation when moving from a state of "greater erection" to one of "lesser erection."

[0053] Preferably, the elastic fascia has a cavity integrated into the elastic fascia itself, open at its free end and closed at its other end; that is, the cavity is open at the end that corresponds to the glans penis. This cavity is arranged or located coincident with the lower part of the elastic body, beneath it. Its function is to provide greater anatomical fidelity to the prosthesis, as it allows it to simulate the corpus spongiosum through which the urethra passes. Additionally, the cavity can act as a reservoir for lubricant, which is gradually released due to the pressures exerted on the penis during sexual activity. Specifically, due to the viscosity of the lubricant, and because the walls of the cavity are very close at the open end, at the level of the glans, the lubricant would not flow out unless a certain amount of pressure is applied.

[0054] Another key aspect of the invention is the design of the elastic membrane that collects and envelops the set of elements of the prosthesis, sealing it to the ergonomic support and simulating real skin in appearance and behavior.

[0055] Known prostheses that use commercial elastomers and silicones do not offer realistic behavior on the skin, since, if their thickness is reduced to achieve a more realistic skin, breakage problems arise, and if their thickness is increased to a value that is safe against breakage, the appearance and texture of the prosthesis is far from that of real skin.

[0056] During normal use, the prosthesis of the invention is subjected to pressure, stretching and friction, so the mechanical, elastic and stress-resistant properties of the skin-like elastic membrane are of particular importance.

[0057] To meet these requirements without losing the resemblance (in aesthetics and performance) to real skin, the elastic membrane is composed of a non-porous, reinforced, elastic composite fabric made of a platinum-cured silicone woven with an elastic fabric (nylon, Lycra, elastin, etc.). This gives the elastic membrane mechanical characteristics and stress tolerance superior to those of a skin made solely of silicone. These properties, provided by the weaving, are crucial for achieving a durable, resilient, and lifelike skin.

[0058] Preferably, the silicone of the elastic composite fabric comprising the elastic membrane is a Shore 0010 to 0030 silicone encapsulated by a Shore 2 silicone, while the elastic fabric is preferably a Lycra with an elongation to break of between 300% and 620%. In the context of the present invention, Lycra is understood to mean the elastic material formed by a percentage of elastane, which normally ranges between 5% and 20%, in addition to other components, which are usually polyamide and / or polyester.

[0059] Also preferably, the lycra has a thread concentration between 30x15 threads / cm 2 and 90x45 threads / cm 2 , so that the elastic membrane offers a breaking limit of at least 2.65 kg / cm.

[0060] Thus, the elastic membrane is a thin skin, with a thickness that varies depending on the area of ​​the prosthesis, preferably between 0.75 mm and 3 mm, which maintains its elasticity and resistance to stretching and folding, and with a texture that changes color as the prosthesis changes state, due to the characteristics of the material it is made of, which contributes to the realism of the prosthesis.

[0061] As for the rest of the materials used, the elastic fascia has a preferred thickness between 0.5 mm and 2.5 mm.

[0062] In one embodiment of the invention, the elastic fascia is comprised of silicone with a shore of 2, 0030, 0020, and / or 0010. In an alternative embodiment, the elastic fascia is comprised of a non-porous, reinforced, elastic composite fabric formed by a platinum catalyst curing silicone woven with an elastic fabric, wherein the silicone has a shore of 0020 or 0030.

[0063] On the other hand, the non-elastic fascia is preferably made up of a woven, non-porous composite fabric composed of a shore 2 platinum-catalyzed curing silicone woven with a non-elastic fabric, where the non-elastic fabric has a thickness of 0.2 mm and a regular weave of 32x32 threads / cm. 2 , so that the non-elastic fascia has a thickness between 0.5 mm and 2.5 mm with a breaking limit of 98 N / cm.

[0064] Finally, it should be noted that the elastic body preferably has an elongation to break between 845% and 900%.

[0065] Once the essential aspects of the proposed functional penile prosthesis have been defined, it remains to be seen how the prosthesis is secured to the wearer, ensuring it remains secure and easy to insert and remove, comfortable, lightweight, discreet, and effective during sexual activity. Conventional harness-based attachment systems rely on a ring that "pinches" the prosthesis against the pubic bone, potentially obstructing the prosthesis's ducts.

[0066] In one embodiment, the ergonomic support is attached to the wearer's body using a suitable adhesive. However, in an alternative embodiment, a band is secured to the ergonomic support, preferably with a central connection and means for connecting to a harness at the ends of said band. This harness incorporates elasticity in its tensioners, allowing the prosthesis to slide slightly (thus complementing stimulation for the wearer) without losing its solidity. If the elastic body has two distinct sinuses, the central connection of the band is arranged between the two sinuses of the elastic body.

[0067] Thus, the band is a piece with a three-dimensional 'X' shaped design in which the stretching planes occur at two heights. This 'X' translates the stretching tensions into a perpendicular force (maximum at the central joint) and cancels out deformations in the prosthesis, leaving it fully exposed to touch and sight. This fastening system secures the prosthesis to the wearer and, combined with the sliding and pressure resulting from sexual play, increases the stimulating effect of the ergonomic support, which can be complemented by the placement of a vibrator, preferably inside the appendage to stimulate the wearer. Alternatively, the vibrating device can be placed on the non-erectile section of the elastic body.

[0068] In short, the prosthesis of the invention offers the following advantages:

[0069] - It allows the “erection process”, which is achieved without having to remove the prosthesis.

[0070] - A regular and uniform erection is achieved, without assistance from external elements.

[0071] - Inflation can be stopped and held in any state, allowing for size increase without leaving the “resting state.”

[0072] - The erection is adjustable and controlled by the user (size, hardness and rigidity).

[0073] - The hardness and pressure of the penis are analogous to reality, progressing with erection to a maximum that ultimately depends on how much the user wants to inflate the prosthesis, and occur across its entire surface (including the glans).

[0074] - It enables interactive stimulation between the wearer and the receiver.

[0075] - An “organic” response to touch and handling is achieved thanks to the skin-like elastic membrane.

[0076] - Manual device, does not require batteries or electronic charging media

[0077] DESCRIPTION OF THE DRAWINGS

[0078] To complement the description that follows and in order to help better understand the characteristics of the invention, in accordance with some preferred examples of practical implementation thereof, some figures are attached as an integral part of said description, in which the following has been represented for illustrative and non-limiting purposes:

[0079] Figure 1 shows a partial perspective and sectional view of three embodiments of the invention that include the elastic fascia, where Figure 1.A corresponds to an embodiment in which the elastic body of the erectile system and the non-elastic fascia have a single sinus, Figure 1.B corresponds to an embodiment in which the non-elastic fascia has one sinus and the elastic body has two sinuses, and Figure 1.C corresponds to an embodiment in which the non-elastic fascia and the elastic body have two sinuses.

[0080] Figure 2.- Shows an embodiment of the prosthesis without elastic fascia, where Figure 2.A shows a perspective view of the assembly covered with the elastic membrane as skin with a sectional cut that allows observing the detail of the non-elastic fascia and the sinuses of the elastic body, while Figure 2.B shows a sectional cut of the body of the penis.

[0081] Figure 3.- Shows an embodiment of the prosthesis with elastic fascia, where Figure 3.A shows a perspective view of the assembly covered with the elastic membrane as skin with a sectional cut that allows observing the detail of the elastic fascia, the non-elastic fascia and the sinuses of the elastic body, while Figure 3.B shows a sectional cut of the body of the penis.

[0082] Figure 4.- Shows an embodiment of the prosthesis with elastic fascia, two sinuses for the elastic body and the non-elastic fascia, and two reservoirs as testicles, in which Figure 4.A shows the detail of the conduits and valves of the pneumatic erectile system, while Figure 4.B shows the same elements together with the elastic body.

[0083] Figure 5.- Shows the flow diagram of the operation of the pneumatic erectile system, in which Figure 5.A shows the deflation process of the elastic body and Figure 5.B shows the inflation process.

[0084] Figure 6.- Shows a perspective view of the ergonomic support and the elastic body fixed thereto, such that Figure 6.A illustrates a variant embodiment in which the ergonomic support does not have an appendix, Figure 6.B shows a variant embodiment in which the appendix covers the clitoris area of ​​the wearer leaving access to the vagina free, and Figure 6.C illustrates a variant embodiment in which the appendix has an unreliable extension connected to the pneumatic erectile system, such that the extension is introduced into the vagina of the wearer.

[0085] Figure 7.- Shows a schematic perspective view from different angles of the band arranged on the ergonomic support, such that Figure 7.A shows a rear elevation view, Figure 7.B shows a rear perspective view and Figure 7.C shows a side view.

[0086] Figure 8.- Shows a schematic view of the prosthesis of the invention of Figure 7 attached with a harness to the wearer's body.

[0087] Figure 9.- Shows an example of an embodiment of the non-return valve that is arranged in the air inlet and / or outlet ducts of the pneumatic erectile system, in which the non-return valve is made up of a cylindrical casing that contains a tube with a flat, open and expandable termination at one of its ends, such that Figure 9.A shows the inoperative valve, Figure 9.B shows the valve in the closed position, and Figure 9.C shows the valve in the open position.

[0088] Figure 10.- Shows an example of an embodiment of the air switch valve of the pneumatic erectile system that allows the release of air from the elastic body, in which the switch valve is integrated by a flexible casing that contains a tube with a cross section and a blind termination at one of its ends, so that in figure 10.A the closed valve is shown and in figure 10.B the open valve is shown when actuated.

[0089] Figure 11.- Shows an example of an embodiment of the air switch valve of the pneumatic erectile system that allows the release of air from the elastic body, in which the switch valve has a recess to facilitate its manipulation.

[0090] Figure 12.- Shows a sectional view of an embodiment of the prosthesis in which the elastic fascia has an open cavity at its free end, and where not all the components of the prosthesis have been represented to facilitate understanding of the figure. PREFERRED EMBODIMENT

[0091] The figures shown show several embodiments in which the functional penile prosthesis comprises the following elements:

[0092] - a pneumatic erectile system provided with:

[0093] - a hollow elastic body (3), provided with an air inlet,

[0094] - a non-elastic fascia (2) with an anatomical shape that surrounds the elastic body (3),

[0095] - two tanks [(4), (4')] acting as testicles, where at least one of them acts as an inflation bulb, and where one of the tanks (4) has two air inlet and / or outlet ducts (7) provided with a non-return valve (5) while the second tank (4') is provided with at least one duct (7) for air inlet and / or outlet,

[0096] - a connecting line (8) connecting the tanks [(4), (4')] and the elastic body (3),

[0097] - an air shut-off valve (6) arranged in the connecting line (8),

[0098] - an ergonomic support (10) where the pneumatic erectile system is fixed, and

[0099] - an elastic membrane (19) of variable thickness, like skin, that covers the entire pneumatic erectile system and the ergonomic support (10). As shown in figures 2.A and 3.A, the elastic membrane (19) has an integrated piece (20) therein which is arranged at the free end of the elastic body (3) like a glans. Advantageously, during the erection process the integrated piece (20) like a glans experiences an increase in volume and hardness, modifying its shape and surface appearance (color and surface tension) thanks to the portion of the limited system that is located beneath it.

[0100] Additionally, in the embodiments illustrated in Figures 1 , 3, 4 and 5, the prosthesis additionally has an elastic fascia (1 ) that covers the non-elastic fascia (2). Thus, in said embodiments, the elastic body (3) is limited by two concentric layers. As shown in Figure 1 , the non-elastic fascia (2) can have two distinct sinuses (2'). The difference lies in the final shape achieved: in the non-elastic fascia (2) of one sinus (whether the elastic body (3) has one sinus or two) the section of the erect body is necessarily circular. In the non-elastic fascia (2) of two sinuses (2'), the erect section can be controlled and varied towards a more ovoid and anatomical shape, but in both cases the erectile process develops with equal effectiveness.

[0101] As detailed above, the pneumatic erectile system allows for an adjustable erection process, which occurs gradually until the desired final rigidity, shape and hardness are reached. To this end, as can be seen in the diagram in Figure 5 in which the erectile system has two tanks [(4), (4')] as inflation bulbs, when said tanks are actuated, air is introduced from the outside through the ducts (7) and the connecting line (8) to the sinuses (3') of the elastic body (3), causing the elastic body (3) to inflate. Thus, the non-elastic fascia (2), which is folded in its resting state, stretches to its elastic limit, adopting its final shape. From that point on, if the tanks [(4), (4')] continue to be pumped, the pressure inside the elastic body (3) increases until the desired rigidity and hardness are achieved.

[0102] On the other hand, the activation of the air switch valve (6) allows the emptying to be controlled. When activated, the elastic body (3) deflates and the non-elastic fascia (2) folds, further compressed by the elastic fascia (1), which helps to collect the assembly to the initial size of the penis at rest or flaccid.

[0103] Since the erectile system acts as a pneumatic machine, tensions and frictions are produced that can preferably be minimized by using a permanent internal lubricant. For this reason, the inclusion of a lubricant between the elastic membrane (19) and the non-elastic fascia (2) and / or between the elastic body (3) and the non-elastic fascia (2) is contemplated in the embodiment examples that do not include the elastic fascia (1 ), while in the examples that do contemplate this element, the inclusion of a lubricant between the elastic membrane (19) and the elastic fascia (1 ), and between the elastic fascia (1 ) and the non-elastic fascia (2) is also foreseen.

[0104] On the other hand, in the embodiment examples illustrated in Figures 1 to 3 and 12 it can be seen that the elastic fascia (1) has a cavity (17) open at one of its ends, which contributes to the realism of the prosthesis, since it allows simulating the spongy body through which the urethra passes in the human body. Having described embodiment examples for the pneumatic erectile system, it should be noted that the ergonomic support (10) is a fundamental component, since on the one hand it adapts to the wearer and on the other it receives the elastic body (3), and with it, the remaining elements. It is preferably obtained in a low shore silicone (around 00-30) so that it is comfortable in contact with the skin. Thus, the elastic body (3) is coupled to the ergonomic support (10) by its non-erectile section, leaving the erectile section free. Preferably, the ergonomic support (10) includes an appendix (11) that may include protuberances (21) for stimulation of the wearer.As can be seen in Figure 6, the appendix (1 1 ) can have different lengths. Figure 6.B shows an embodiment in which the appendix (11 ) covers the clitoris area of ​​the wearer, leaving access to the vagina free, while in Figure 6.C the appendix (1 1 ) covers the clitoris area and extends to the entrance of the vagina, and has an unreliable extension (11 ') connected to the pneumatic erectile system, such that the extension (11 ') is introduced into the vagina of the wearer for stimulation. Although it has not been represented in the embodiment examples illustrated in the figures accompanying this specification, as detailed above, the device of the invention may have a vibrating device to stimulate the wearer, preferably located in the appendix (11 ) of the ergonomic support (10).

[0105] As detailed above, the prosthesis of the invention preferably has an integrated fastening system, which optimizes the prosthesis and does not interfere with the correct functioning of the erectile and ejaculatory systems. The fastening system is based on a band (12) that is fixed to the ergonomic support (10) and that has a central connection (13) and connection means (15) to a harness (16) at the ends (14) thereof.

[0106] Thus, the band (12) is configured as an 'X' shaped piece in which the stretching planes occur at two heights. This X translates the stretching tensions into a perpendicular force (maximum at the central joint (13)) and cancels out deformations in the prosthesis, leaving it fully exposed to touch and sight. Figure 8 shows an example of placement of the prosthesis using a harness (16) that contemplates elasticity in its tensioners, allowing a certain sliding of the prosthesis and thus complementing the stimulation to the wearer, without losing solidarity with him.

[0107] Finally, it should be noted that each valve present in the system has been designed to optimize the functioning of the prosthesis.

[0108] Figure 9 shows an exemplary embodiment in which the non-return valves (5) arranged in the inlet and / or outlet conduits (7) of the pneumatic erectile system are made up of a cylindrical casing (5') containing a tube with a flat end (5") that is open and expandable at one of its ends. Thus, when the fluid (air or liquid) enters through the tube, it expands the flat end (5"), opening it and passing to the cylindrical casing (5') and from there to the valve outlet without any obstacle. When the fluid enters through the opposite end, it reaches the cylindrical casing (5') that retains the fluid. The fluid then presses on the flat end (5"), closing it and preventing the fluid from continuing towards the valve inlet. The higher the pressure, the more tightly the flat end (5") will close, thus guaranteeing a perfect seal.

[0109] As for the air shut-off valve (6) of the pneumatic erectile system that allows the release of air from it for deflation of the prosthesis, according to the preferred embodiment illustrated in figure 10, it is integrated by a flexible casing (6') that contains a tube with a cross section (6") and a blind termination (6"') at one of its ends. In the resting state, the cross section (6"') remains closed, preventing the escape of air. As the pressure increases inside the casing (6'), the geometry of the tube is further stabilized, keeping the cross section (6"') closed.

[0110] To open the air passage, simply press or bend the flexible casing (6'); this causes the inner tube to deform and the cross section (6") to open, releasing air to the outside at will. To close it again, simply release pressure on the flexible casing (6').

[0111] As shown in Figure 1 1 , preferably, the body of the air switch valve (6) has a recess (18) to facilitate its manipulation. Thus, during use of the prosthesis this recess (18) facilitates the location and manipulation of the valve (6), making the prosthesis very easy to use.

[0112] Optionally, the pneumatic erectile system has a safety valve. The function of the safety valve is to release the air outlet at a certain pressure in order to avoid breakages or leaks due to pressure peaks. It is preferably located at a point in the pressurized pneumatic circuit of the erectile system where it is not in the way and where it does not impair the external appearance. A probable location would be in the connection line (8), before the air switch valve (6) and with the exhaust outlet in the ergonomic support (10), thus being invisible from the outside.

[0113] Among other alternatives, the safety valve is based on the design of a small integrated plug that is expelled from its coupling at a certain pressure, which is below the burst pressure of the weakest element. This plug is not independent, it is not loose, it is concealed in the elastic membrane (19) and can be accessed with the prosthesis in place.

[0114] For all the above reasons, the non-limiting embodiments described fully and effectively resolve the deficiencies of Pack & Play type functional prostheses, achieving a satisfactory functional erectile process and simulated ejaculation, as well as a behavior and response to manipulation analogous to reality.

Claims

MODIFIED CLAIMS received by the International Bureau on 29 July 2025 (29.07.2025) 1. Functional penile prosthesis, characterized in that it comprises: - a pneumatic erectile system provided with: - a hollow elastic body (3), provided with an air inlet, - a non-elastic fascia (2) with an anatomical shape that surrounds the elastic body (3), - at least one tank (4), in the form of a testicle, which is deformable under pressure to act as an inflation bulb, which is provided with at least one duct for the entry and / or exit of air, - at least one connecting line (8) connecting the tank (4) and the elastic body (3), - an air shut-off valve (6) arranged in the connecting line (8), - an ergonomic support (10) where the pneumatic erectile system is fixed, and - an elastic membrane (19) of variable thickness like skin that covers the entire pneumatic erectile system and the ergonomic support (10), where the pneumatic erectile system goes from a resting state to an erect state in a gradual and controlled manner, by means of the introduction of air from the outside by actuating the tank as an inflation bulb, air that passes to the elastic body (3) through the tank conduit and the connection line (8) producing the inflation of the elastic body (3), while the actuation of the air switch valve (6) allows going from the erection state to the resting state by releasing the air contained in the elastic body (3).

2. Functional penile prosthesis, according to claim 1, characterized in that the air inlet and / or outlet duct of the testicle-shaped reservoir has a non-return valve (5).

3. Functional penile prosthesis, according to claim 2, characterized in that the valve MODIFIED SHEET (ARTICLE 19) non-return valve (5) is made up of a cylindrical casing (5') containing a tube with a flat end (5") open and expandable at one of its ends.

4. Functional penile prosthesis, according to claim 1, characterized in that it has an elastic fascia (1) that covers the non-elastic fascia (2), such that the elastic fascia (1) is arranged between the elastic membrane (19) and the non-elastic fascia (2).

5. Functional penile prosthesis, according to any of the preceding claims, characterized in that the pneumatic erectile system has two tanks [(4), (4')], where one of the tanks (4) has two air inlet and / or outlet ducts (7) while the second tank (4') is provided with at least one duct (7) for air inlet and / or outlet.

6. Functional penile prosthesis, according to claim 1, characterized in that the elastic body (3) has two differentiated sinuses (3').

7. Functional penile prosthesis, according to claim 1, characterized in that it has a vibrating device for stimulating the wearer.

8. Functional penile prosthesis, according to claim 1, characterized in that the ergonomic support (10) has an appendix (11) for stimulating the wearer.

9. Functional penile prosthesis, according to claim 8, characterized in that the appendix (11) has protuberances (21) for the stimulation of the wearer.

10. Functional penile prosthesis, according to claim 8, characterized in that the appendix (11) covers the clitoris area of ​​the wearer, leaving access to the vagina free.

11. Functional penile prosthesis, according to claim 8, characterized in that the appendix (11) covers the clitoris area and extends to the entrance of the vagina.

12. Functional penile prosthesis, according to claim 1 1 , characterized in that the appendix (11 ) has an unreliable extension (1 1 ') connected to the pneumatic erectile system, such that the extension (1 1 ') is introduced into the vagina of the wearer.

13. Functional penile prosthesis according to claim 1 and any of the claims of claim 8. a a 12-, characterized in that the vibrating device is arranged in the appendix (1 1).

14. Functional penile prosthesis, according to claim 1, characterized in that a band (12) is fixed on the ergonomic support (10) with connecting means (15) to a harness (16) at the ends (14) of the band (12).

15. Functional penile prosthesis, according to claims 6 and 14, characterized in that the band (12) has a central union (13) arranged between the two sinuses (3') of the elastic body (3).

16. Functional penile prosthesis, according to claim 1, characterized in that the elastic membrane (19) is made up of an elastic, reinforced, non-porous composite fabric formed by a platinum-catalyzed curing silicone woven with an elastic fabric.

17. Functional penile prosthesis, according to claim 16, characterized in that the curing silicone is a shore silicone between 0010 and 0030 encapsulated by a shore 2 silicone.

18. Functional penile prosthesis, according to claim 16, characterized in that the elastic fabric is a lycra with an elongation to break between 300% and 620%.

19. Functional penile prosthesis, according to claim 16, characterized in that the elastic membrane (19) has a thickness between 0.75 and 3 mm.

20. Functional penile prosthesis, according to claim 4, characterized in that the elastic fascia (1) is integrated by silicone with a shore of 2, 0030, 0020 and / or 0010.

21. Functional penile prosthesis, according to claim 4, characterized in that the elastic fascia (1) is made up of an elastic, reinforced, non-porous composite fabric formed by a platinum-catalyst curing silicone woven with an elastic fabric, where the silicone has a shore of 0020 or 0030.

22. Functional penile prosthesis, according to claim 4, characterized in that the elastic fascia (1) has a thickness between 0.5 and 2.5 mm.

23. Functional penile prosthesis, according to claim 4, characterized in that the elastic fascia (1) has a cavity (17) open at its free end, such that the cavity (17) is arranged in a manner coinciding with the lower part of the elastic body (3).

24. Functional penile prosthesis, according to claim 1, characterized in that the elastic body (3) has an elongation until breaking between 845% and 900%.

25. Functional penile prosthesis, according to claim 1, characterized in that the non-elastic fascia (2) is made up of a woven, non-porous composite fabric composed of a shore 2 platinum catalyst curing silicone woven with a non-elastic fabric, where the non-elastic fabric has a thickness of 0.2 mm and a regular weave of 32x32 threads / cm. 2 , so that the non-elastic fascia (2) has a thickness between 0.5 mm and 2.5 mm with a breaking limit of 98 N / cm.

26. Functional penile prosthesis, according to claim 1, characterized in that it has a lubricant between the elastic membrane (19) and the non-elastic fascia (2) and / or between the elastic body (3) and the non-elastic fascia (2).

27. Functional penile prosthesis, according to claim 4, characterized in that it has a lubricant between the elastic membrane (19) and the elastic fascia (1), between the elastic fascia (1) and the non-elastic fascia (2) and / or between the non-elastic fascia (2) and the elastic body (3).

28. Functional penile prosthesis, according to claim 1, characterized in that the air switch valve (6) that allows the release of air from the elastic body (3) is made up of a flexible casing (6') that contains a tube with a cross section (6") and a blind end (6"') at one of its ends.

29. Functional penile prosthesis, according to claim 1, characterized in that the body of the air switch valve (6) has a recess (18) to facilitate its manipulation.

30. Functional penile prosthesis, according to claim 1, characterized in that it has an integrated part (20) in the elastic membrane (19) that is arranged coinciding with the free end of the elastic body (3) in the form of a glans.

31. Functional penile prosthesis, according to claim 1, characterized in that the pneumatic erectile system has a safety valve.

32. Functional penile prosthesis, according to claim 1, characterized in that the non-elastic fascia (2) has two differentiated sinuses (2').

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