Penile prosthesis

Abstract

A penile prosthesis (1) comprising a main body (10) made of biocompatible material and comprising a first seat (4) for housing the urethra (U) of a user and a second seat (5) for housing the neurovascular bundle of the penis of said user, said first seat (4) being made from a part of said main body (10) opposite to the part in which said second seat (5) is made.

Description

[0001] DESCRIPTION

[0002] PENILE PROSTHESIS

[0003] Technical Field

[0004] The present invention relates to a penile prosthesis . Specifically, the present invention relates to a penile prosthesis , i . e . , an implantable device for penile lengthening .

[0005] More generally, the invention falls within the technical field of implantable medical devices , and more specifically, in the field of urological prostheses intended for reconstructive or aesthetic surgery of the male genital tract .

[0006] State of the Art

[0007] Currently, there are various types of penile prostheses used for the treatment of erectile dysfunction .

[0008] The main types known to date can be divided into : semirigid prostheses and two- or three-piece inflatable prostheses .

[0009] Semi-rigid, or malleable, prostheses consist of two flexible rods that are implanted inside the penis , specifically inside or near the corpora cavernosa . These rods can be manually bent to position the penis in an erect or flaccid position . While this type of prosthesis offers ease of use and a lower risk of mechanical failure due to the lack of moving components , it does have significant drawbacks .

[0010] A first major drawback is that the penis , remaining partially rigid at all times , can be uncomfortable in everyday life and can exert constant pressure on the penile tissues , potentially causing long-term injury . As for inflatable prostheses, either the two-piece or three-piece type (also known as two-component or three- component prostheses ) , they include two inflatable cylinders inserted into the penis and a pump generally located in the scrotum .

[0011] In the so-called three- component type, a reservoir containing a specific fluid is placed between the pump and the two cylinders ; this reservoir is generally implanted in the user' s abdomen .

[0012] To achieve an erection, the user presses the pump, which transfers fluid into the cylinders , thus generating an erection of the penis .

[0013] While these types of inflatable prostheses overcome some of the limitations of the aforementioned semirigid prostheses , they have significant disadvantages and drawbacks .

[0014] A major drawback is that they require considerable manual dexterity on the part of the user to ensure optimal inflation and deflation .

[0015] Another major drawback is the complexity of the surgical procedure required to properly position the two (or three ) pieces of the inflatable prosthesis .

[0016] It is understood that since the surgical procedure is more complex and invasive, it also increases the possibility of post-operative complications .

[0017] Finally, a common drawback to all types of penile prostheses known to date is the fact that they are all aimed at improving the erectile function of the user ' s penis but are not adequately optimal in lengthening it . Penile prostheses are, in fact , primarily designed to restore erectile function, not to increase penis length .

[0018] The inflatable and semi-rigid prostheses described above aim to ensure an erection sufficient for sexual activity, but do not offer penile lengthening .

[0019] From the above, an unsolved technical problem emerges : the lack of an implantable device specifically designed to lengthen the penis in a safe, effective, and minimally invasive manner, without interfering with the patient ' s intrinsic erectile physiology and preserving the neurovascular anatomical structures .

[0020] Object of the Invention

[0021] It is therefore an object of this invention to provide a penile prosthesis capable of overcoming the drawbacks of the prior art .

[0022] The object of this invention is also to provide a penile prosthesis that aims to achieve substantial penis lengthening through a procedure that does not impair normal erectile function .

[0023] A further object of the present invention is to provide a penile prosthesis made from materials already widely used in other types of prostheses and, therefore, already extensively tested and certified .

[0024] A further object of the present invention is to provide a penile prosthesis that can be implanted through a surgical procedure with less impact and therefore less risk .

[0025] According to the invention, these and other objects are achieved by a penile prosthesis having the technical characteristics described in the appended claims . The intended objects are achieved by a penile prosthesis whose inventive concept is based on the creation of an anatomical spacer .

[0026] This spacer is configured to be inserted between the plane of the corpora cavernosa and the glans , thus creating a physical increase in the length of the penis at rest and during erection .

[0027] The specific shape of the prosthesis , provided with seats and cavities to accommodate adjacent anatomical structures , allows for stable and safe positioning, respecting local physiology .

[0028] Brief Description of the Drawings

[0029] The technical characteristics of the invention, in accordance with the aforementioned objects , are clearly described in the attached claims , and its advantages are evident from the detailed description that follows , with reference to the attached drawings that illustrate an exemplary and non-limiting embodiment thereof , wherein :

[0030] - Figure 1 shows a schematic side view in partial section of a penile prosthesis according to the present invention in an in-use configuration,

[0031] - Figure 2 shows a side view in section of a penile prosthesis according to the present invention,

[0032] - Figure 3 shows a side view of the embodiment of the penile prosthesis shown in Figure 2 , and

[0033] - Figure 4 shows a top view of the embodiment of the penile prosthesis shown in Figures 2 and 3 .

[0034] Detailed Description

[0035] With reference to the illustration in Figure 1 , the reference numeral 1 designates a penile prosthesis , hereinafter also referred to simply as "prosthesis , " in accordance with the present invention .

[0036] The penile prosthesis 1 according to the present invention comprises a main body 10 made of biocompatible material .

[0037] This biocompatible material may advantageously comprise medical-grade silicone .

[0038] The biocompatible material may, however, be chosen from those known to date, for example, already tested and used in breast implant applications .

[0039] By way of example only, such biocompatible materials include one or more of medical-grade silicone, polyurethane, cohesive silicone gel, or polyethylene . The main body 10 comprises an upper portion 3 and a lower portion 6 joined together by a lateral surface . The main body 10 comprises a first seat 4 for housing the urethra U of a user and a second seat 5 for housing the neurovascular bundle of the penis P of the user . The neurovascular bundle refers to the bundle consisting of the dorsal veins of the penis , the dorsal arteries of the penis , and the dorsal nerves of the penis .

[0040] The first seat 4 and the second seat 5 are made one in one part and the other in the opposite part of the main body 10 .

[0041] Essentially, the first 4 and second 5 seats are designed as recesses that run the entire length of the main body 10 between the upper portion 3 and the lower portion 6 .

[0042] These seats 4 , 5 are designed to accommodate, once the penile prosthesis 1 of the present invention is applied to the user ' s penis P, the overall size and volume of the urethra (U) and the neurovascular bundle, respectively .

[0043] Advantageously, the penile prosthesis 1 according to the present invention also comprises at least one cavity 2 formed at the lower portion 6 of the main body 10 .

[0044] The at least one cavity 2 is designed to receive the terminal portion of the tunica albuginea that envelops the corpora cavernosa C of the user ' s penis P when the prosthesis 1 is applied to the user .

[0045] In the embodiment shown in Figures 1 and 2 , there are two cavities 2 , each designed to receive the respective terminal portion of the tunica albuginea that envelops the corpora cavernosa C of the penis P of the user .

[0046] It is understood that , depending on the shape and size of the corpora cavernosa C of the specific user, the shape of the cavity will be optimally determined to achieve a perfect counter-shaping of the terminal portion of the corpora cavernosa C in the respective cavities 2 .

[0047] The invention also provides the possibility of creating the prosthesis 1 customized for the individual patient . Starting from medical imaging data ( such as magnetic resonance imaging or computed tomography) , it is possible to map the patient ' s specific anatomy and produce, for example by 3D printing a mold, a prosthesis with the dimensions and shapes of the cavities 2 and the sites 4 and 5 that perfectly complement their anatomy . As shown in the attached figures , and in particular in Figures 1 to 3 , the main body 10 comprises a domed upper portion 3 ( i . e . , having a dome shape ) .

[0048] The dome shape of the upper portion 3 is suitable for insertion into the internal and lower portion of the penis P of said user, and in particular into the hollow internal portion of the glans .

[0049] In order to optimize the application of the penile prosthesis 1 according to the present invention to the user ' s penis , and in particular to the corpora cavernosa C, the cavities 2 comprise a respective surgical mesh 7 arranged in contact with their internal surface, as shown in Figure 2 .

[0050] Advantageously, this surgical mesh, in an embodiment not shown in the figures , can also be arranged in contact with the upper portion 3 of the main body 10 or on the entire external surface of the main body 10 itself .

[0051] As an alternative or addition to the use of a surgical mesh 7 , the external surface of the main body 10 , or portions thereof , may feature a micro- or macrotexturization .

[0052] This texturization, obtained during the molding of the prosthetic body, is intended to increase the contact area with the tissues and promote better adhesion and integration, reducing the risk of dislocation, rotation, or post-operative seroma .

[0053] One embodiment of the penile prosthesis 1 according to the present invention comprises a main body 10 made from an external casing of medical-grade silicone filled with silicone gel, water, saline solution, hydrogel, or any other biocompatible material suitable for application inside the user ' s human body .

[0054] In this embodiment , the physical properties of the material are important .

[0055] Advantageously, the main body 10 is made of medicalgrade silicone with a specifically calibrated hardness (durometer) .

[0056] The hardness must be sufficient to ensure the spacer function without collapsing under normal physiological pressures , yet soft enough not to cause erosion of the soft tissues of the glans penis or the tunica albuginea of the corpora cavernosa with which it comes into contact .

[0057] A Shore A durometer between 30 and 70 represents an optimal compromise .

[0058] Advantageously, the main body 10 has a length between 1 and 5 centimeters , defined as the maximum distance between the lower portion 6 and the upper portion 3 of the main body itself .

[0059] The length of the main body corresponds to the desired lengthening of the user ' s penis P .

[0060] Advantageously, the application of the penile prosthesis 1 according to the present invention is applied to the user ' s penis P using a known type of absorbable thread made of biocompatible material .

[0061] More specifically, the surgical procedure for implanting the prosthesis 1 can be considered minimally invasive .

[0062] It involves an incision, typically suprapubic or penoscrotal, the delicate separation of the plane between the corpora cavernosa and the glans , the insertion of the prosthesis 1 with the correct positioning of the urethra U and the neurovascular bundle P in their respective locations 4 and 5 , and the securing of the prosthesis with absorbable sutures .

[0063] To facilitate this procedure, the prosthesis 1 may be supplied as part of a surgical kit .

[0064] This kit may include, in addition to the prosthesis itself , a series of trial prostheses ( sizers ) of different lengths and / or diameters , to allow the surgeon to determine the optimal fit during the procedure .

[0065] The kit may also include a dedicated surgical instrument , such as a dissector-spacer, designed to atraumatically create the pocket between the corpora cavernosa and the glans to accommodate the prosthesis . The penile prosthesis 1 according to the present invention achieves the intended objects and provides significant advantages .

[0066] A first advantage of the penile prosthesis 1 according to the present invention lies in providing a prosthesis aimed at increasing the length of the user' s penis P , which is easy and safe to implant and does not require cutting the user' s neurovascular bundle or urethra U . It should be emphasized that this advantage derives from the purely mechanical and static operating principle of the prosthesis 1 .

[0067] Unlike prostheses for erectile dysfunction, it does not alter the rigidity of the penis , but rather alters its basic geometry by increasing its axial length .

[0068] The natural erectile function, dependent on the blood flow to the corpora cavernosa C, is entirely preserved . A further advantage of the penile prosthesis , object of this invention, is that , being made entirely of materials already known and used for some time in the prosthetic sector ( for example, in breast implants and breast augmentation) , it poses no risk in terms of biocompatibility with humans .

[0069] An additional advantage of the penile prosthesis presented herein is that it allows for a substantial increase in the length of the user ' s penis , thanks to its positioning as a spacer between the corpora cavernosa and the glans .

[0070] This optimized implantation, together with the specific technical construction of the penile prosthesis according to the present invention, achieves a further important advantage : in the event the user changes their mind, the removal procedure can also be carried out without any risk of sensory damage .

Claims

CLAIMS1. Penile prosthesis (1) for lengthening the penis (P) of a user, comprising a main body (10) made of biocompatible material, said main body (10) being configured to be interposed as a spacer between the corpora cavernosa (C) and the glans penis (G) of a patient, said main body (10) comprising a first seat (4) for housing the urethra (U) of a user and a second seat (5) for housing the neurovascular bundle of the penis of said user, said first seat (4) being made from a part of said main body (10) opposite the part in which said second seat (5) is made.

2. P enile prosthesis (1) according to the preceding claim, further comprising at least one cavity (2) formed at a lower portion (6) of said main body (10) , said at least one cavity (2) being adapted to receive the terminal portion of the corpora cavernosa of the penis of said user.

3. P enile prosthesis (1) according to the preceding claim, comprising two cavities (2) , each adapted to receive the respective terminal portion of a corpora cavernosa of the penis of said user.

4. Penile prosthesis (1) according to any of the preceding claims, wherein said main body (10) comprises a dome-shaped upper portion (3) , said upper portion (3) being adapted to be insertedinto the internal and lower portion of the penis of said user.

5. Penile prosthesis (1) according to any of the preceding claims 2 or 3, wherein said at least one cavity (2) comprises a respective surgical mesh (7) arranged in contact with its internal surface .

6. Penile prosthesis (1) according to any of the preceding claims, wherein said biocompatible material is medical-grade silicone.

7. Penile prosthesis (1) according to any of the preceding claims, wherein said main body (10) comprises an outer casing made of medical silicone filled with silicone gel, water, or hydrogel .

8. Penile prosthesis (1) according to any of the preceding claims, wherein said main body (10) has a length between 1 and 5 centimeters.

9. Penile prosthesis (1) wherein said main body (10) is attachable to said penis of said user by the use of absorbable thread made of biocompatible material .

10. P enile prosthesis (1) according to any of the preceding claims, characterized in that the external surface of said main body (10) has atexture designed to promote tissue integration and limit migration of the prosthesis.

11. Penile lengthening kit, characterized in that it comprises :- a penile prosthesis (1) according to any one of claims 1 to 10;- a set of trial prostheses of various sizes for intraoperative selection of the correct size.

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