IMPLANTABLE PROSTHETIC DEVICE FOR PRODUCING A PENILE ERECTION IN MEN WITH ERECTILE DYSFUNCTION AND PRODUCTION METHOD THEREOF

Abstract

A prosthetic device can be implanted in the corpora cavernosa of a penis with erectile dysfunction. The device being formed by two cylinders that can be inflated with a fluid. The device comprises a variable-length erectable portion formed by a chamber that can be pressurized with a low volume of fluid and is formed between an expandable membrane and an axially extendable and foldable longitudinal rib. The membrane and rib extend between a distal tip element and an intermediate connector from which a shortenable anchoring rod emerges, the rib being a single piece formed by a variable-length distal section, an intermediate section that is foldable and extendable in an axial direction, and a proximal section comprising optimized means for the continuous lateral supply of the fluid to the pressurisable chamber. The device also has an integrated unit for storing and pressurizing the fluid, which can be implanted in the scrotum.

Claims

1. A prosthetic device implantable within the cavernous body of a penis with erectile dysfunction and its production procedure where the device is of the type formed by two cylinders that are inflatable with a fluid allowing it to be implanted in a wide range of patients depending on the length of the penis and optimizes the use of a low volume of fluid to achieve a functional erection; wherein it comprises an erectable portion of variable length composed of a pressurizable chamber with a low volume of fluid formed between an expandable membrane and an axially extensible and foldable longitudinal nerve which extend between a distal tip element and an intermediate connector from which emerges a cuttable anchor rod, where said nerve is in one piece that is formed by a distal section of variable length, an intermediate section that is foldable and extensible in the axial direction, and a proximal section that includes optimized means for continuous lateral supply of the fluid towards the pressurizable chamber; said device also having an integrated fluid storage and pressurization unit implantable in the scrotal sacs.

2. The prosthetic device according to claim 1, wherein said optimized means of continuous lateral supply of the fluid comprise an internal axial channel in the proximal portion of the nerve, which has an open end and a pointed opposite inner end which branches laterally in a horizontal axis of the nerve forming lateral channels that flow into corresponding lateral openings, having said lateral channels an inclined path with respect to an axial axis of the nerve.

3. The prosthetic device according to claim 1, wherein the nerve is formed by a longitudinal robust body with a continuous outer surface a distal end and a proximal end between which the proximal, intermediate and distal sections extend, where the proximal section is partially hollow, the intermediate section has a reduction in its mass and the distal section has a mantle of variable length.

4. The prosthetic device according to claim 3, wherein said distal section has a cuttable distal end, to adjust the length of the nerve.

5. The prosthetic device according to claim 3, wherein said distal section has different preset lengths and includes a distal perimeter recess.

6. The prosthetic device according to claim 3, wherein said intermediate section has an axial core of smaller diameter than the rest of the nerve, which in turn, comprises a plurality spaced annular nerves forming a corrugation that folds and extends axially.

7. The prosthetic device according to claim 3, wherein said intermediate section has a microperforated structure that weakens the portion and allows its folding and axial extension.

8. The prosthetic device according to claim 3, wherein said intermediate section has a surface with successive radial depressions forming an accordion shaped portion that allows its folding and axial extension.

9. The prosthetic device according to claim 1, wherein the intermediate section has a single length.

10. The prosthetic device according claim 1, wherein the intermediate section has different preset lengths.

11. The prosthetic device according to claim 1, wherein the expandable membrane is a textile membrane formed by a continuous tubular fabric without longitudinal seam, embedded in medical grade silicone that allows high pressure and rigidity ensuring its expandable characteristic under sealing and impermeability conditions, which comprises an open distal end, an open proximal end, an inner surface and an outer surface.

12. The prosthetic device according to claim 11, wherein the tubular tissue of said membrane is formed by an orthogonal mesh where both the longitudinal and the concentric fibres present a normally corrugated state that allows the expansion of the membrane in both directions.

13. The prosthetic device according to claim 11, wherein the tubular fabric of said membrane is formed by a diagonal mesh that allows the expansion of the membrane in both directions.

14. The prosthetic device according claim 1, wherein the membrane is attached to the intermediate connector through its proximal end and is attached to the tip element through its distal end.

15. The prosthetic device according to claim 1, wherein the pressurizable chamber is formed by a cylindrical space radially comprised between the outer surface of the nerve and the inner surface of the membrane, and axially it has a distal zone that limits with the tip element and a proximal zone that limits with the intermediate connector.

16. The prosthetic device according to claim 1, wherein the pressurizable chamber begins to fill or empty from its proximal area with the fluid that emerges or enters through the lateral openings of the nerve.

17. The prosthetic device according to claim 1, wherein the tip element is solid of elastomeric material, it has a rounded distal end (and a proximal portion with a straight edge comprising a central axial opening.

18. The prosthetic device according to claim 1, wherein the tip element is solid of elastomeric material, it has a rounded distal end and a proximal portion with a straight edge comprising a central axial opening and an outer annular groove coaxial to the central opening.

19. The prosthetic device according to claim 1, wherein the intermediate connector is a solid piece with a distal end, an annular groove coaxial to the central cavity, a proximal end with a central recess.

20. The prosthetic device according to claim 19, wherein said inner channel is curved, it has an open front end that connects with the central cavity and a lower curved end that flows out in a lower opening.

21. The prosthetic device according to claim 1, wherein the anchor rod is a preferably cylindrical body, with a cuttable rear end and a front end through which it joins to the intermediate connector; it comprises a series of annular grooves regularly spaced from each other that determine cutting points to cut its length.

22. The prosthetic device according to claim 1, wherein the integrated fluid storage and pressurization unit comprises a single reservoir which has a flexible structure in the form of a bellows and lateral compression which allows to contain and pump sufficient fluid to pressurize each one of the pressurizable chambers of each one of the erectable portions of the device.

23. The prosthetic device according to claim 22, wherein the integrated storage and pressurization unit also includes a pressurization control means which comprises a pressure relief valve that establishes a controlled fluid communication between the erectable portions of the device and said reservoir in the form of a bellows; where said integrated unit has a size that allows it to be placed in the scrotal sac.

24. The prosthetic device according to claim 23, wherein the valve is connected on one side to the reservoir in the form of a bellows and on the other it is connected to a pair of flexible conduits that transfer the fluid between the reservoir and each of the erectable portions of the device.

25. The prosthetic device according to claim 1, wherein each of the flexible conduits comprises a lower end for connection to the valve and an upper end connection opposite with the lower opening of each of the intermediate connectors.

26. The prosthetic device according to claim 1, wherein the nerve the tip element the intermediate connector and the anchor rod are made of biocompatible elastomeric material, such as a medical grade silicone polymer, applied in different thicknesses and hardness for each element.

27. A production procedure of the prosthetic device of claim 1, which allows to obtain a device of variable length that can be implanted in a wide range of patients according to the size of their penis, wherein it comprises the steps of: a) moulding the nerve of a single predefined length with the distal section of excess length; b) moulding the tip element with a single axial opening at its proximal end; c) moulding the intermediate connector; d) manufacturing the membrane with a constant diameter and thickness, and an undetermined length as a tubular sleeve; e) moulding the anchor rod of a determined diameter and undetermined length; f) defining the final length of the nerve cutting its distal end sizing and cutting a piece of membrane in a length according to the final length of the cut nerve, defining a distal end and a proximal end of said piece of membrane already cut; h) mounting, joining and sealing the joints of all the pieces together; i) provide the integrated storage and pressurization unit with a predefined amount of internal fluid according to the final size of the prosthesis and join its flexible ducts with each of the intermediate connectors.

28. The production procedure of the prosthetic device according to claim 27, wherein when moulding the intermediate connector, its central cavity of the distal end has a diameter that coincides with the outer diameter of the proximal end of the nerve; its coaxial slot has a size matching the cross section of the tubular membrane its central recess on the proximal face has a diameter that coincides with the diameter of the anchor rod; and the lower opening of its inner channel has a diameter that coincides with the upper end of the flexible conduit of the integrated storage and pressurization unit.

29. The production procedure of the prosthetic device according to claim 27, wherein the membrane preferably has a thickness of approximately 1 mm.

30. The production procedure of the prosthetic device according to claim 27, wherein the nerve, the intermediate connector, the tip element the anchor rod and the flexible reservoir of the integrated storage and pressurization unit are moulded in biocompatible elastomeric material preferably a medical grade silicone polymer, in suitable matrices for each piece.

31. The production procedure of the prosthetic device according to claim 27, wherein when mounting, joining and sealing all the pieces together the distal end of the nerve and the distal end of the tubular membrane are coupled together and sealed within the central axial opening of the tip element; the proximal end of the nerve is coupled and sealed in the central cavity of the connector while the proximal end of the membrane is coupled and sealed to the coaxial annular groove of the connector; the distal end of the anchor rod is coupled and sealed within the central recess of the connector; and the upper end of the flexible conduit of the integrated unit is coupled and sealed to the lower opening of the connector.

32. The production procedure of the prosthetic device of claim 1, which allows to obtain a device of variable length that can be implanted in a wide range of patients according to the size of their penis, wherein it comprises the steps of: a) moulding the nerve according to at least three different predefined lengths, each with the intermediate section of a length proportional to the total length and with its distal section comprising a perimeter recess at its tip; b) moulding the tip element having a central axial opening and an outer annular groove; c) moulding the intermediate connector; d) manufacturing the membrane with a constant diameter and thickness, and an undetermined length as a tubular sleeve; e) moulding the anchor rod of a determined diameter and undetermined length; f) sizing and cutting a piece of membrane in length according to the length of the moulded nerve defining a distal end and a proximal end of said piece of membrane; g) mounting, joining and sealing the joints of all the pieces together. h) providing the integrated storage and pressurization unit with a predefined amount of internal fluid according to the final size of each prosthesis and joining its flexible ducts with each of the intermediate connectors.

33. The production procedure of the prosthetic device according to claim 32, wherein the at least three different predefined lengths of the nerve correspond to a shorter length, a longer length and an intermediate length.

34. The production procedure of the prosthetic device according to claim 33, wherein preferably the shortest length is 8 centimeters, the intermediate length is 12 centimeters and the longest length is 16 centimeters.

35. The production procedure of the prosthetic device according to claim 32, wherein when moulding the tip element its central axial opening has a diameter equivalent to the diameter of the lowered end of the nerve and its outer annular groove has a cross section matching the cross section of the membrane.

36. The production procedure of the prosthetic device according to claim 32, wherein when moulding the intermediate connector its central cavity of the distal end has a diameter that coincides with the outer diameter of the proximal end of the nerve; its coaxial slot has a size matching the cross section of the membrane; its central recess on the proximal face has a diameter that coincides with the diameter of the anchor rod; and the lower opening of its inner channel has a diameter that coincides with the upper end of the flexible conduit of the integrated storage and pressurization unit.

37. The production procedure of the prosthetic device according to claim 32, wherein the membrane is preferably manufactured with a thickness of approximately 1 mm.

38. The production procedure of the prosthetic device according to claim 32, wherein the nerve, the intermediate connector, the tip element the anchor rod and the flexible reservoir of the integrated storage and pressurization unit are moulded in biocompatible elastomeric material preferably a medical grade silicone polymer in suitable matrices for each piece.

39. The production procedure of the prosthetic device according to claim 32, wherein when mounting, joining and sealing all the pieces together, the distal end with the perimeter recess of the nerve is coupled and sealed within the central axial opening of the tip element; the distal end of the membrane is coupled and sealed within the outer annular groove of the tip element the proximal end of the nerve is coupled and sealed in the central cavity of the intermediate connector while the proximal end of the membrane is coupled and sealed in the coaxial annular groove of the connector; the distal end of the anchor rod is coupled and sealed within the central recess of the connector; and the upper end of the flexible conduit of the integrated unit is coupled and sealed to the lower opening of the connector.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0131] For the achievement of the objectives, the disclosure can be performed in the form illustrated in the accompanying drawings; however, the drawings are only illustrative and do not limit the scope of the disclosure and may acquire multiple implementations as long as they are under a common inventive concept. Thus, a detailed description of the disclosure will be carried out together with the Figures that are an integral part of this presentation, where:

[0132] FIG. 1 shows a side view of the prosthetic device, in an erect state.

[0133] FIG. 2 shows a front isometric view of the prosthetic device.

[0134] FIG. 3 shows a side elevation view of the nerve of the prosthetic device.

[0135] FIG. 4a shows an enlarged sectional front view of the proximal nerve portion of the prosthetic device.

[0136] FIG. 4b shows a bottom plan view of the proximal portion of the prosthetic device nerve.

[0137] FIG. 5 shows a lateral elevation view of the prosthetic device nerve where its intermediate portion stands out.

[0138] FIG. 6 shows a side elevation view of the prosthetic device nerve, where a first embodiment of its distal portion stands out.

[0139] FIG. 7 shows a side elevation view of the prosthetic device nerve where a second embodiment of its distal portion stands out.

[0140] FIG. 8 shows a sectional front elevation view of the extensible membrane of the prosthetic device.

[0141] FIG. 9 shows a sectional side elevation view of a complete cylinder of the prosthetic device.

[0142] FIG. 10 shows a top plan view of a complete cylinder of the prosthetic device in a flaccid state.

[0143] FIG. 11 shows an enlarged sectional side view of a first embodiment of the point element of the prosthetic device.

[0144] FIG. 12 shows a sectional side view of a connection detail between the point element of FIG. 11 with the nerve and the membrane.

[0145] FIG. 13 shows an enlarged sectional side view of a second embodiment of the point element of the prosthetic device.

[0146] FIG. 14 shows a sectional side view of a connection detail between the point element of FIG. 13 with the nerve and the membrane.

[0147] FIG. 15 shows a sectional side view of the intermediate connector.

[0148] FIG. 16 shows a sectional side view of the junction of the intermediate connector with the nerve, the membrane and the anchoring stem.

[0149] FIG. 17 shows a side view of a cylinder of the prosthetic device in the intermediate erection state.

[0150] FIG. 18 shows a top front isometric view of the prosthetic device in an erect state.

[0151] FIG. 19 shows the set of cylinder parts that are made of silicone.

[0152] FIG. 20 shows a side view of the complete prosthetic device in a completely flaccid state.

[0153] FIG. 21 shows a side view of the complete prosthetic device in an intermediate state of erection.

[0154] FIG. 22 shows a side view of the complete prosthetic device in an erect state.

[0155] FIG. 23 shows a sectional side view of a first embodiment of the prosthetic device nerve.

[0156] FIG. 24 shows a side view of the extensible membrane of indeterminate length in the stage of dimensioning and cutting its final length.

[0157] FIG. 25 shows a partial sectional side view of the nerve, the membrane, the intermediate connector and the anchoring stem facing each other for assembly.

[0158] FIG. 26 shows a sectional side view of a connection detail of the first embodiment of the point element with the first embodiment of the prosthetic device nerve.

[0159] FIG. 27 shows a partial sectional side view of the nerve, the membrane, the intermediate connector and the anchoring stem already assembled together.

[0160] FIG. 28a shows a partial sectional side view of a second embodiment of the nerve according to a smaller size production.

[0161] FIG. 28b shows a partial sectional side view of a second embodiment of the nerve according to an intermediate size production.

[0162] FIG. 28c shows a partial sectional side view of a second embodiment of the nerve according to a larger size production.

[0163] FIG. 29 shows a side view of the extensible membrane of indeterminate length in the stage of dimensioning and cutting its final length.

[0164] FIG. 30 shows a sectional side view of a connection detail of the second embodiment of the point element with the second embodiment of the prosthetic device nerve.

DETAILED DESCRIPTION

[0165] The disclosure refers to a prosthetic device (1) that can be implanted inside the cavernous body of a penis with erectile dysfunction and to its production method where the device is of the type formed by two cylinders that are inflatable with a fluid, allowing it to be implanted in a wide range of patients according to the length of their penis and optimizes the use of a low volume of fluid in order to achieve a functional erection.

[0166] As it can be seen in FIG. 1, the device (1) comprises an erectable portion (10) of variable length, composed of a pressurizable chamber (100) with a low volume of fluid formed between an expandable membrane (300) and an axially extensible and foldable longitudinal internal nerve (200) where said nerve (200) is in one piece formed by a distal section (206) of variable length, an intermediate section (205) that is foldable and extensible in the axial direction, and a proximal section (204) comprising optimized means for the continuous lateral supply of the fluid towards the pressurizable chamber (100).

[0167] Looking now at FIG. 2, it is possible to see that the erectable portion (10) of the device (1) extends between a distal point element (400) and an intermediate connector (500) which also connects to a cuttable anchoring stem (600) and an integrated unit (700) for storage and pressurization of the implantable fluid in the scrotal sacs.

[0168] As best seen in FIG. 3, the nerve (200) is formed by a robust longitudinal body with a continuous outer surface (203), a distal end (201) and a proximal end (202) between which the proximal (204), intermediate (205) and distal (206) sections extend, where the proximal section (204) is partially hollow, the intermediate section (205) has a reduction (213) in its mass and the distal section (206) has a mantle (216) of variable length.

[0169] In relation to the aforementioned optimized means of continuous lateral delivery of the fluid, these are illustrated more clearly in FIG. 4a where an increased detail of the proximal portion (204) of the nerve (200) can be appreciated, the means are composed of an internal axial channel (208) in said proximal portion (204) where said channel has an open end (209) through which the fluid enters and which coincides with the proximal end (202) of the nerve, the axial channel (208) it extends to an opposite internal end (210) which is pointed; from this area, the axial channel branches laterally according to a horizontal axis (x) of the nerve, as shown in FIG. 4b forming two lateral channels (211) that flow into corresponding lateral openings (212) with an elliptical contour through which the fluid exits out of the nerve, said lateral channels (211) having an inclined path with respect to an axial axis (z) of the nerve (200).

[0170] As for the intermediate section (205) of the nerve (200) which is foldable and extensible in the axial direction, according to a first embodiment shown in FIG. 5, it has a decrease (213) in its mass that allows that zone acts as a collapsible and axially extensible portion; it has an axial core (214) of smaller diameter than the rest of the nerve (200) and comprises a spaced plurality of annular ribs (215) forming a corrugation that allows the folding of that area and in turn, allows its axial extension.

[0171] In an alternative embodiment (not illustrated), said intermediate section (205) has a micro perforated structure that weakens the portion and allows it to be folded and axially extended. Similarly, in another alternative embodiment (not illustrated) said intermediate section (205) has a surface with successive radial depressions forming an accordion-shaped portion that allows its folding and axial extension.

[0172] Regarding the length of said intermediate section (205), in one embodiment of the nerve this section has a single length; while in another embodiment of the nerve the intermediate section (205) has different preset lengths.

[0173] In relation to the distal section (206) of the nerve (200), in a preferred embodiment shown in FIG. 6 it has a straight mantle (216) of distal end (201) that can be freely cut to define different shorter lengths of the nerve and thus assembling different prostheses of different lengths. And in an alternative embodiment of said distal section (206), as seen in FIG. 7, it has a straight mantle (216) with a distal perimeter recess (217) that generates a smaller diameter with respect to the mantle (216) where in this alternative embodiment the distal section (206) is not cuttable, but is produced in different preset lengths.

[0174] The expandable membrane (300) is a textile membrane formed by a continuous tubular fabric without longitudinal seam embedded in medical silicone that allows high pressure and rigidity, ensuring its expandable characteristic under sealing and impermeability conditions; referring to the illustration of FIG. 8 the membrane (300) comprises an open distal end (301), an open proximal end (302), an inner surface (303), and an outer surface (304). Where said membrane (300), being of a textile structure, comprises an orthogonal woof where both the longitudinal and the concentric fibres present a normally corrugated state that allows the expansion of the membrane in both directions; in an alternative embodiment it comprises a diagonal woof that also allows the membrane to expand in both directions.

[0175] As best shown in FIG. 9, the membrane (300) is attached to the intermediate connector (500) through its proximal end (302) and is attached to the point element (400) through its distal end (301), as well as the nerve (200) is attached to the intermediate connector (500) through its proximal end (202) and is attached to the point element (400) through its distal end (201). Between the membrane (300) and the nerve (200) the pressurizable chamber (100) is formed, describing a cylindrical space comprised radially between the outer surface (203) of the nerve (200) and the inner surface (303) of the membrane (300), and axially it has a distal zone (101) that limits with the distal point element (400) and a proximal zone (102) that limits with the intermediate connector (500).

[0176] As illustrated in FIG. 10, the pressurizable chamber (100) begins to fill or to empty from its proximal area (102) with the fluid that emerges or enters through the lateral openings (212) of the nerve (200).

[0177] Referring to FIG. 11, in a preferred embodiment of the point element (400) said element is solid of elastomeric material, it has a rounded distal end (401) and a proximal portion (402) with a straight edge (403) comprising a central axial opening (404) where it jointly and sealedly receives the distal end (201) of the nerve (200) and the distal end (301) of the membrane (300), as seen in FIG. 12.

[0178] In an alternative embodiment of the point element (400) shown in FIG. 13, it is made of solid elastomeric material, has a rounded distal end (401) and a proximal portion (402) with a straight edge (403) comprising a central axial opening (404) where it receives the recess (207) of the nerve (200) and further comprises an outer annular groove (405) coaxial to the central opening (404) where it receives the distal end (301) of the membrane (300), as seen in FIG. 14.

[0179] Taking into consideration the content of FIG. 15, the intermediate connector (500) is a solid piece with a distal end (501) that has a central cavity (502), an annular groove (503) coaxial to the central cavity (502), a proximal end (504) with a central recess (505) and an inner channel (506). Said inner channel (506) is curved, it has an open front end (507) that connects with the central cavity (502) and a lower curved end (508) that flows into a lower opening (509).

[0180] And as best exemplified in FIG. 16, the central cavity (502) of the connector (500) is coupled with the proximal end (202) of the nerve (200); the annular groove (503) is coupled with the proximal end (302) of the membrane (300); while its central recess (505) is coupled with the anchoring stem (600).

[0181] Said anchoring stem (600), as seen in FIG. 17, is a preferably cylindrical body with a rear end (601) that can be cut and a front end (602) through which it is attached to the intermediate connector (500); it comprises a series of annular grooves (603) regularly spaced from each other that determine cut points where the stem can be cut to reduce its length.

[0182] As for the integrated fluid storage and pressurization unit (700), which forms part of the device (1) and is best shown in FIG. 18, it comprises a single reservoir (701) which has a flexible structure in the form of bellows and lateral compression, it allows to contain and pump enough fluid to pressurize each one of the chambers (100) (not illustrated) of each one of the erectable portions (10) of the device (1). The integrated storage and pressurization unit (700) also includes a pressurization control means which comprises a pressure relief valve (702) that establishes controlled fluid communication between the erectable portions (10) of the device (1) and said reservoir (701) in the form of a bellows; where said integrated unit (700) has a size that allows it to be placed in the scrotal sac.

[0183] The valve (702) is connected on one side to the reservoir (701) in the form of a bellows and on the other it is connected to a pair of flexible conduits (703) that transfer the fluid between the reservoir (701) and each of the erectable portions (10) of the device (1). Where each of the flexible conduits (703) comprises a lower end (704) for connection to the valve (702) and an opposite upper end (705) for connection to the lower opening (509) of each of the intermediate connectors (500).

[0184] Taking as reference the set of components that appear in FIG. 19, the nerve (200), the point element (400), the intermediate connector (500) and the anchoring stem (600) are made of biocompatible elastomeric material, such as medical grade silicone applied in different thicknesses and hardness for each element.

[0185] In operation, when the device (1) is in a state of total flaccidity, as exemplified in FIG. 20, the erectable portion (10) of the device remains folded downwards due to the effect of the foldable intermediate section (205) of the nerve (200) and due to the lack of pressurization inside the chamber (100), however, the penis shows a natural flaccid appearance where a certain length and thickness are preserved.

[0186] In the erection process, as shown in FIG. 21, the user activates the integrated unit (700) performing lateral compressive actions of the reservoir (701) so that its bellows-shaped structure collapses and pushes the fluid out of itself, this allows the fluid to be transferred to the chamber (100) with a single pump and is pressurized by the action of the valve (702) that prevents the return of the fluid to the reservoir (701). The fluid leaves the integrated unit (700) through the flexible conduits (703), enters the intermediate connector (500) where it is transferred to the proximal portion (204) of the nerve (200) where it passes through the inner axial channel (not illustrated) to then exit in an equal and constant manner through each of the lateral openings (212) arranged in the nerve (200); the chamber (100) begins to fill and as its pressurization increases, it stiffens the entire erectable portion (10), the penis begins to rise from the point element (400) changing the axial axis of the nerve (200) from a folded downwards curved state towards a slightly curved inclined arrangement, so that later at higher pressurization, it ends at an upward angle, as it can be seen in FIG. 22; further pressurization of the chamber (100) also causes the axial extension of the collapsible portion (205) of the nerve (200), in conjunction with the axial and radial expansion of the membrane (300); thus, the erectable portion (10) of the device (1) increases its rigidity, increases its length, thickness and changes its position to one of erection, replicating the same changes in the body of the penis which gives a desired effect of obtaining a functional erection in a short time with little manipulation of the integrated unit (700) and with an increase in size and turgidity of the organ.

[0187] The deactivation of the erection process is carried out with the opening of the pressure relief valve (702), compressing it laterally in the area of the scrotum; this opening of the valve causes the pressurized fluid in the chamber (100) to begin to return to the reservoir (701) following the same route that it made on its way out, but in the opposite direction.

[0188] The disclosure also includes the production procedure for the prosthetic device (1), which makes it possible to obtain a device of variable length that can be implanted in a wide range of patients depending on the size of their penis, without the production of the device meaning to have special tooling for each measure of each piece;

[0189] In a first embodiment, the production procedure of the prosthetic device (1) comprises the steps of: [0190] a) moulding the nerve (200) of a single predefined length with the distal section (206) of exceeded length; [0191] b) moulding the point element (400) with a single axial opening (404) at its proximal end (402); [0192] c) moulding the intermediate connector (500); [0193] d) manufacturing the expandable membrane (300) with a constant diameter and thickness and an indeterminate length as a tubular sleeve; [0194] e) moulding the anchoring stem (600) of a determined diameter and indeterminate length; [0195] f) defining the final length of the nerve (200) cutting its distal end (201); [0196] g) cutting a length of membrane (300) in accordance with the final length of the cut nerve (200), defining a distal end (301) and a proximal end (302) of said cut membrane piece (300); [0197] h) mounting, joining and sealing the joints of all the pieces together; [0198] i) arranging the integrated storage and pressurization unit (700) with a predefined amount of internal fluid according to the final size of the prosthesis and joining its flexible conduits (703) with each of the intermediate connectors (500).

[0199] In this embodiment, as illustrated in FIG. 23 and mentioned in step a) of the procedure, the nerve (200) is moulded with a single predefined length with the distal section (206) having an exceeded length, so that subsequently, as mentioned in step f), the final length of the nerve (200) is defined by freely cutting its distal end (201).

[0200] Similarly, as indicated in step d), the expandable membrane (300) is manufactured with a constant diameter and thickness and an indeterminate length as a tubular sleeve where this thickness is preferably 1 mm. Then, as indicated in step g), a piece of membrane (300) is cut in length according to the final length of the cut nerve (200) defining a distal end (301) and a proximal end (302) in said piece of membrane (300), as illustrated in FIG. 24.

[0201] As seen in FIG. 25, when moulding the intermediate connector (500), its central cavity (502) has a diameter that coincides with the outer diameter of the proximal end (202) of the nerve (200); its coaxial slot (503) has a size matching the cross section of the membrane (300); its central recess (505) has a diameter that coincides with the diameter of the anchoring stem (600); and the lower opening (509) of its inner channel (506) has a diameter matching the upper end (705) of the flexible conduit (703) of the integrated storage and pressurization unit (700) (not shown).

[0202] The nerve (200), the intermediate connector (500), the point element (400), the anchoring stem (600) and the flexible reservoir (701) of the integrated storage and pressurization unit (700) are moulded in biocompatible elastomeric material preferably a medical grade silicone polymer, in suitable matrices for each part.

[0203] By mounting, joining and sealing all the pieces together, as seen in FIG. 26, the distal end (201) of the nerve (200) and the distal end (301) of the membrane (300) are coupled together and sealed within the central axial opening (404) of the point element (400); while, as seen in FIG. 27, the proximal end (202) of the nerve (200) is coupled and sealed in the central cavity (502) of the connector (500) while the proximal end (302) of the membrane (300) is coupled and sealed to its coaxial annular groove (503); the distal end (602) of the anchoring stem (600) is coupled and sealed within the central recess (505) of the connector (500); and the upper end (705) of the flexible conduit (703) of the integrated unit (700) is coupled and sealed to the lower opening (509) of the connector 500 (not shown).

[0204] A second embodiment of the production procedure of the prosthetic device (1) comprises the steps of: [0205] a) moulding the nerve (200) according to at least three different predefined lengths, each with the intermediate section (205) of a length proportional to the total length and with its distal section (206) comprising a perimeter recess (207) at its point; [0206] b) moulding the point element (400) having a central axial opening (404) and an outer annular groove (405); [0207] c) moulding the intermediate connector (500); [0208] d) manufacturing the membrane (300) with a constant diameter and thickness and an indeterminate length as a tubular sleeve; [0209] e) moulding the anchoring stem (600) of a determined diameter and indeterminate length; [0210] f) sizing and cutting a piece of membrane (300) in length according to the length of the moulded nerve (200) defining a distal end (301) and a proximal end (302) of said piece of membrane (300); [0211] g) mounting, joining and sealing the joints of all the pieces together. [0212] h) arranging the integrated storage and pressurization unit (700) with a predefined amount of internal fluid according to the final size of each prosthesis and joining its flexible conduits (703) with each of the intermediate connectors (500).

[0213] In this second embodiment, as illustrated in FIG. 28a, FIG. 28b and FIG. 28c as well as mentioned in step a) of the procedure, the nerve (200) is moulded according to at least three different predefined lengths, a shorter length, a longer length and an intermediate length; each one with the intermediate section (205) of a length proportional to the total length and with its distal section (206) comprising a perimeter recess (207) at its point. Preferably, the shortest length is 8 centimetres, the intermediate length is 12 centimetres, and the longest length is 16 centimetres.

[0214] Similarly, as indicated in step d), the expandable membrane (300) is manufactured with a constant diameter and thickness and an indeterminate length as a tubular sleeve, where this thickness is preferably 1 mm. Then, as indicated in step g), a piece of membrane (300) is cut in length according to the length of the moulded nerve (200) defining a distal end (301) and a proximal end (302) in said piece of membrane (300), as illustrated in FIG. 29.

[0215] In the same way that it is illustrated in the aforementioned FIG. 25, when moulding the intermediate connector (500), its central cavity (502) has a diameter that coincides with the outer diameter of the proximal end (202) of the nerve (200); its coaxial slot (503) has a size matching the cross section of the membrane (300); its central recess (505) has a diameter that coincides with the diameter of the anchoring stem (600); and the lower opening (509) of its inner channel (506) has a diameter matching the upper end (705) of the flexible conduit (703) of the integrated storage and pressurization unit (700) (not shown).

[0216] In this second embodiment of the production procedure, it is also the case that the nerve (200), the intermediate connector (500), the point element (400), the anchoring stem (600) and the flexible reservoir (701) of the integrated (700) storage and pressurization unit are moulded in biocompatible elastomeric material preferably a medical grade silicone polymer, in suitable matrices for each piece.

[0217] By mounting, joining and sealing all the pieces together, as seen in FIG. 30, the distal end (201) of the nerve (200) with the perimeter recess (207) is coupled and sealed within the central axial opening (404) of the point element (400); while the distal end (301) of the membrane (300) is coupled and sealed within the outer annular groove (405) of the point element (400). In the same way as illustrated in FIG. 27 above, the proximal end (202) of the nerve (200) is coupled and sealed in the central cavity (502) of the connector (500) while the proximal end (302) of the membrane (300) is coupled and sealed to its coaxial annular groove (503); the distal end (602) of the anchoring stem (600) is coupled and sealed within the central recess (505) of the connector (500); and the upper end 705 of the flexible conduit (703) of the integrated unit (700) is coupled and sealed to the lower opening (509) of the connector (500) (not shown).