Reinforced penile prosthesis with a system for comfortable wearing and a system for intraoperative length adjustment

Abstract

This utility model relates to medicine, specifically sexology, and concerns prostheses used in the treatment of patients suffering from erectile dysfunction. The technical result of the claimed utility model is increased rigidity of penile prostheses in the distal portion, even across a range of small diameters. At the same time, the flexibility of the penile flexion zone is maintained for comfortable wear during everyday life.

Description

[0001] The utility model relates to medicine, in particular to urology and sexopathology, and concerns prostheses for the treatment of erectile dysfunction.

[0002] Inserting penile prostheses into the corpora cavernosa is a safe, complete cure for erectile dysfunction and is used when other treatments have failed or become ineffective. Penile prostheses come in one-piece (RU 216162, etc.), two-piece (RU 205290, etc.), and three-piece (AMC 700, etc.) designs. Single-piece, non-steerable penile prostheses typically cause discomfort to the patient in everyday life, unlike three-piece, steerable ones, as they lack a wearer comfort system.

[0003] The penile implants we've previously developed are comfortable, but they're made entirely of silicone, which doesn't always provide the required firmness for small diameters. To improve resistance to bending, the penile implant's elasticity needs to be increased, while maintaining flexibility in the middle portion for comfortable wear.

[0004] Structurally, the closest analogue to our patent is the phalloendoprosthesis according to the patent for utility model RU 216162, since it has a similar system for intraoperative length adjustment on the proximal side.

[0005] This device is selected as a prototype.

[0006] Prototype Description:

[0007] A phalloendoprosthesis made of an elastic bioinert material, consisting of a distal, a concave intermediate and proximal parts, wherein the distal part has a cylindrical shape and ends distally in a semi-ellipse, in which one or more pairs of notches are made that form secondary semi-ellipses, and the proximal part is made in the form of a truncated cone, tapering in the proximal direction, and ends in a semi-ellipse, wherein the proximal part has transversely located annular recesses, characterized in that the narrowing in the lower part of the concave intermediate part is greater than the narrowing in the upper or lateral parts of the concave intermediate part, wherein the cross-section of the intermediate part is smaller than the cross-sections of the distal or proximal parts.

[0008] The phalloendoprosthesis also differs in that the distal part has longitudinal grooves along the distal part to pairs of notches that form secondary semi-ellipses.

[0009] The phalloendoprosthesis is also distinguished by the fact that stiffening ribs are located along the secondary semi-ellipses of the distal part.

[0010] The prototype has a significant drawback, namely the high flexibility of small diameter sizes in the distal part, which leads to the impossibility of introjections and frictions, which in turn excludes the use of small diameter penile prostheses in clinical practice, since the penis with an installed penile prosthesis is too flexible for introjections and frictions.

[0011] The indicated drawback is solved in the utility model we claim.

[0012] The objective of the utility model is to create a one-component phalloendoprosthesis for the cavernous bodies with reinforced proximal and distal parts while maintaining flexibility in the central part, as well as maintaining the intraoperative length adjustment system.

[0013] The technical result of the claimed utility model is a fragmentary increase in rigidity from the distal side and partially from the bending zone to the proximal side, sufficient for introjections and frictions, while maintaining the flexibility of the bending zone of the phalloendoprosthesis, sufficient for comfortable wearing of the phalloendoprosthesis in everyday life.

[0014] The stated problems are solved in the claimed utility model: A reinforced penile endoprosthesis with a system for comfortable wearing and a system for intraoperative length adjustment.

[0015] As will be clear from the description of the utility model, it is capable of various embodiments, and some details may be modified in various respects without departing from the scope of the utility model. Accordingly, the drawings and description should be considered illustrative and non-limiting, given that the scope of the claims is defined in the claims.

[0016] The stated claimed result is achieved due to the fact that in the claimed utility model the phalloendoprosthesis is made of an elastic bioinert material, characterized in that it is made in the form of a cylinder, which on the distal side ends in a rounded cone, and on the proximal side - in a hemisphere and has on the proximal side a system for intraoperative length adjustment in the form of more than one mark in the form of recesses in the form of transversely located rings at equal intervals.

[0017] In addition, the penile prosthesis is characterized by having silicone reinforcement that starts from the system for intraoperative length adjustment in the form of more than one mark in the form of recesses in the shape of transversely located rings at equal intervals, and can reach the distal end of the penile prosthesis, while the reinforcement is completely or partially interrupted in the middle part of the penile prosthesis, forming an area for maintaining flexibility for comfortable wearing.

[0018] The claimed penile endoprosthesis is made of an elastic bioinert material, such as silicone, and has a cylindrical body on the proximal side, which ends in a semi-ellipse, and on the distal side - a rounded cone.

[0019] The proximal end features a system for intraoperative length adjustment, consisting of multiple markings in the form of transversely arranged rings at regular intervals. For example, from the proximal end distally, there are 10 markings in the form of transversely arranged rings every 5 mm.

[0020] The silicone implant, used for intraoperative length adjustment, is reinforced with one or more layers of surgical mesh, such as surgical mesh, in the distal direction. The surgical mesh can be arranged circularly, that is, in a ring-shaped arrangement.

[0021] Silicone reinforcement provides localized increase in the rigidity of the phalloendoprosthesis, that is, a decrease in flexibility at the reinforcement level.

[0022] Approximately in the middle of the penile prosthesis, there is a section where reinforcement is either reduced (meaning the number of reinforcing layers of the surgical mesh is reduced) or absent altogether. Essentially, this section maintains flexibility for comfortable wear.

[0023] The penile prosthesis is inserted into the cavernous bodies of the penis.

[0024] Before inserting the penile prosthesis into the patient, the length of the protruded canal is measured proximally and distally. In other words, the length of the protruded canal is measured from the base of the penis to the tip, proximally and distally. This gives the total length of the protruded canal. Subtracting the total length of the prosthesis from the penile prosthesis length yields the amount by which the penile prosthesis needs to be shortened.

[0025] Shortening is possible in multiples of the pitch of the marks in the form of recesses in the shape of transversely located rings of the system for intraoperative length adjustment.

[0026] The penile prosthesis is inserted into the protruded canal, with the proximal end of the penile prosthesis pointing proximally and the distal end of the penile prosthesis pointing distally toward the glans penis. The penile prosthesis is inserted similarly on the opposite side.

[0027] The utility model is accompanied by drawings, where Fig. 1 shows a side view of the phalloendoprosthesis, and Fig. 2 shows a cross-section of the reinforced part of the phalloendoprosthesis.

[0028] The phalloendoprosthesis has a body in the form of a cylinder 1 on the proximal side, which ends in a semi-ellipse 2, and in a rounded cone 3 on the distal side.

[0029] On the proximal side there is a system for intraoperative length adjustment 4, in the form of more than one mark in the form of recesses in the shape of transversely located rings 5 ​​at equal intervals.

[0030] From the system for intraoperative length adjustment to the distal side, the silicone is reinforced with a 6 surgical mesh.

[0031] Approximately in the middle part of the phalloendoprosthesis there is an area where flexibility is maintained for comfortable wearing 7, the reinforcement of which is either reduced, that is, the number of reinforcing layers of the surgical mesh is reduced, or there is no reinforcement at all in this area.

[0032] The penile prosthesis is inserted into the corpora cavernosa of the penis. A man has two corpora cavernosa, left and right. During surgery, two penile prostheses are inserted into the left and right corpora cavernosa. Each corpora cavernosa is probed proximally and distally.

[0033] Before inserting the penile prosthesis into the patient, the length of the protruded canal is measured proximally and distally. In other words, the length of the protruded canal is measured from the base of the penis to the tip, proximally and distally. This gives the total length of the protruded canal. Subtracting the total length of the prosthesis from the penile prosthesis length yields the amount by which the penile prosthesis needs to be shortened.

[0034] Shortening is possible in multiples of the pitch of the marks in the form of recesses in the shape of transversely located rings 5 ​​of the system for intraoperative length adjustment 4.

[0035] The penile prosthesis is inserted into the protruded canal, with the proximal end of the penile prosthesis, which ends in a semi-ellipse (2), pointing proximally, and the distal end of the penile prosthesis, which ends in a rounded cone (3), pointing distally toward the glans penis. The penile prosthesis is inserted similarly on the opposite side.

[0036] A fragmentary increase in rigidity from the distal side and partially from the bending zone to the proximal side, sufficient for introjections and frictions, while maintaining the flexibility of the bending zone of the penile prosthesis, sufficient for comfortable wearing of the penile prosthesis in everyday life is ensured by reinforcing the penile prosthesis with a surgical mesh from the distal side and partially from the proximal side, from the system for intraoperative length adjustment 4, while the area maintaining flexibility for comfortable wearing 7 remains flexible and allows bending the penis and positioning it as comfortably as possible for wearing in everyday life.

[0037] The proposed penile prosthesis is relatively simple and inexpensive to manufacture. The procedure is minimally invasive and can be performed by any experienced urologist.

Claims

1. A phalloendoprosthesis made of an elastic bioinert material, characterized in that it is made in the form of a silicone cylinder, which ends in a rounded cone on the distal side and a semi-ellipse on the proximal side, while on the proximal side of the cylinder there are marks in the form of recesses for intraoperative length adjustment in the form of transverse rings placed at equal intervals, and in the distal direction the silicone has reinforcement with a surgical mesh, which is interrupted in the middle part, forming an area for maintaining flexibility for comfortable wearing.

2. A phalloendoprosthesis according to claim 1, characterized in that the silicone reinforcement extends to the distal end.

3. A phalloendoprosthesis according to paragraph 1, characterized in that the silicone reinforcement is made with one layer of surgical mesh.

4. A phalloendoprosthesis according to paragraph 1, characterized in that the silicone reinforcement is made with layers of surgical mesh.

5. A phalloendoprosthesis according to claim 1, characterized in that in the middle part the silicone reinforcement is completely interrupted.

6. A phalloendoprosthesis according to claim 1, characterized in that in the middle part the silicone reinforcement is partially interrupted.

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