One-piece intracavitary penile prosthesis with intraoperative length adjustment system and wearing comfort system

Abstract

The utility model relates to medicine, in particular to sexology, and to a prosthesis for treating erectile dysfunction. The technical result of the utility model claimed for protection is to increase the comfort of wearing and the stability of the distal part at the level of the recess during penetration, as well as the rigidity of the middle part during sexual intercourse. The penis prosthesis is made of an elastic bioinert material, comprising a distal part, a recessed middle part and a proximal part. The distal part has a cylindrical shape, a semi-elliptical end, and has one or more pairs of recesses forming a secondary semi-ellipse; and the proximal part is configured as a truncated cone narrowed in the proximal direction and ends with a semi-ellipse, wherein the proximal part has a transverse annular recess. The narrowing in the lower part of the recessed middle part is greater than the narrowing in the upper part or the side part of the recessed middle part, and the cross-sectional area of ​​the middle part is smaller than the cross-sectional area of ​​the distal or proximal part.

Description

Technical Field

[0001] The utility model relates to medicine, in particular to urology and sexology, and specifically to a prosthesis for treating erectile dysfunction. Background Art

[0002] Penile prosthesis implanted in the corpora cavernosa is a radical treatment option for erectile dysfunction. One-piece, two-piece and three-piece penile prostheses exist in the prior art. Three-piece penile prostheses are generally considered the most comfortable for daily use. The main disadvantage of single-piece penile implants is that they are less comfortable for daily use than multi-piece prostheses.

[0003] Another important problem is that it is difficult to select the optimal length of the penile prosthesis individually, because the surgeon does not always know the specific length of the prosthesis to be inserted into the corpora cavernosa before the operation. The length of most modern penile prostheses can be changed by connecting some components.

[0004] This is a characteristic of the SPECTRA penile prosthesis (AMC), the Genesis penile prosthesis (Coloplast), and some other prostheses. In this case, some hidden cavities are formed. The presence of hidden cavities in the implanted device is undesirable because it increases the risk of infectious complications.

[0005] There are alternative penile prosthesis length adjustment systems as described in patents RU 2622379 and RU 2673915 C1.

[0006] The closest analogue in design to the device according to our patent is the prosthesis according to patent RU 202561.

[0007] This device was selected as a prototype.

[0008] Description of the prototype:

[0009] A penile prosthesis made of an elastic bioinert material, comprising a distal portion, a middle portion and a proximal portion, wherein the middle portion is concave and has a cross-sectional area smaller than the cross-sectional areas of the proximal portion and the distal portion; wherein the distal portion has a cylindrical shape, its end is a semi-ellipse (the distal end ends in a semi-ellipse), wherein the distal portion has one or more pairs of concave portions forming a secondary semi-ellipse, and the proximal portion is configured as a truncated cone narrowing in the proximal direction, the end of the truncated cone is a semi-ellipse (ending in a semi-ellipse).

[0010] Another feature of the penile prosthesis is that its proximal portion has one or more transverse annular depressions located at equal distances from the proximal end.

[0011] This prototype has proven to be very convenient for length adjustment during clinical use. However, there are some disadvantages, namely the increased flexibility of the distal part at the level of the concavity forming the secondary semi-oval. It is also necessary to improve the comfortable wearing system, namely to increase its stiffness during penetration (i.e. increase the area of ​​the narrowest part) while maintaining the flexibility required for wearing comfort. This disadvantage is inherited from an earlier prototype. Summary of the invention

[0012] The utility model claimed in the present invention solves the above-mentioned disadvantages.

[0013] The utility model aims to manufacture a single-piece penile (intracavitary) prosthesis with an improved comfortable wearing system and an improved distal portion length adjustment system.

[0014] The technical effect of the claimed utility model is to increase the rigidity of the middle part while retaining its flexibility.

[0015] The stated problem is solved in the claimed utility model: a one-piece (endoluminal) penile prosthesis with an intraoperative length adjustment system and a comfortable wearing system.

[0016] It can be seen from the description of the utility model that the utility model can have different embodiments, and certain components can exist in the utility model in different proportions. Therefore, in view of the fact that the claims have been defined in the utility model claims, the drawings and the description should be regarded as non-restrictive illustrative materials.

[0017] The effects claimed in the present application are achieved by the fact that according to the claimed utility model the penile prosthesis is made of an elastic bio-inert material and comprises a distal portion, a concave middle portion and a proximal portion.

[0018] The distal portion has a cylindrical shape, the distal end terminating in a semi-elliptical shape, and has one or more pairs of concave portions forming a secondary semi-elliptical shape;

[0019] The proximal portion is configured as a truncated cone that narrows in the proximal direction and ends in a semi-ellipse, wherein the proximal portion has a lateral annular depression, the narrowing of the lower concave middle portion is greater than the narrowing of the upper and lateral sides of the concave middle portion, wherein the cross-sectional area of ​​the middle portion is smaller than the cross-sectional areas of the distal portion and the proximal portion, and the reinforcing member is positioned along the secondary semi-ellipse of the distal portion.

[0020] The distal part has a longitudinal groove which runs along the distal part until a pair of recesses forming a secondary semi-ellipse. The claimed penile prosthesis is characterized in that the possibility of intraoperative length adjustment is possible from the distal side and the proximal side by cutting out some elements. No hidden cavity is formed. The cutting line in the distal part of the penile prosthesis extends along the secondary semi-ellipse, and therefore, the reinforcing member is also cut out, which makes that after the cutting, the distal part of the penile prosthesis also ends with a semi-ellipse and the distal end of the prosthesis becomes shorter. The cutting from the proximal side of the penile prosthesis is performed similarly to the prototype: in a paper cutter manner along the proximal side of the annular recess. Therefore, after the cutting, the proximal part of the prosthesis becomes shorter.

[0021] The claimed penile prosthesis has a distal portion, a proximal portion and a middle portion made of an elastic bioinert material (e.g. implantable silicone). All portions are integrally related and constitute a whole. The middle portion of the penile prosthesis is a narrowed prosthesis, wherein the narrowing along the sides and from the top is less than the narrowing at the bottom. In its cross section, the narrowest part of the middle portion can be configured as an ellipse or have a more complex shape; however, at the level of the border of the middle portion, the cross-sectional area of ​​the shape is less than the cross-sectional area of ​​the distal or proximal portion. The distal portion is configured as a cylinder, and the distal end ends in a semi-ellipse. There are paired recesses at equal distances forming secondary semi-ellipses, for example with steps of 1 cm. The recesses are not passed through. There are longitudinal reinforcing members intended to increase stiffness. There may be several secondary semi-ellipses (e.g. two).

[0022] The proximal portion is configured as a truncated cone that narrows in the proximal direction and ends in a semi-ellipse. In order to reduce the possibility of the penile prosthesis rotating within the dilation tube, it has a longitudinal groove along the distal portion until a pair of recesses forming a secondary semi-ellipse.

[0023] In order to reduce the length of the proximal end of the penile prosthesis, it has transverse annular recesses, for example 10 transverse annular recesses at a distance of 5 mm from each other.

[0024] The recess is configured such that a diameter of a proximal portion of the recess is smaller than a diameter of a distal portion of the recess.

[0025] Before implanting the penile prosthesis, the length of the dilator tube in the proximal and distal directions is measured. In other words, the length of the dilator tube is measured from the base to the tip of the penis in the proximal direction; it should match the length of the proximal part of the penile prosthesis plus half of the middle part, and the length of the dilator tube from the base to the tip in the distal direction should match the length of the distal part of the penile prosthesis plus half of the middle part. If necessary, the penile prosthesis can be shortened. The proximal part of the penile prosthesis can be shortened in a shearing manner along the proximal side of the annular depression using a scalpel. It can be shortened stepwise along the lateral annular depression. The distal part of the penile prosthesis can be shortened stepwise along the position of the secondary semi-oval. Using a scalpel or circular scissors, the excess length of the distal border of the secondary semi-oval can be cut off. The reinforcing member can also be cut off from the removed segment. Thus, the distal end of the penile prosthesis returns to a semi-oval shape after shortening. The penile prosthesis is inserted into the dilator tube, and the proximal end of the prosthesis is oriented in the proximal direction, respectively, while the distal end of the prosthesis is oriented in the distal direction toward the glans penis (penis head). The penile prosthesis is rotated within the dilation tube so that the narrowest part of its middle section is oriented downwards. Similarly, the penile prosthesis is placed on the opposite side. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The utility model is accompanied by drawings;

[0027] Figure 1 This is a side view of the penile prosthesis;

[0028] Figure 2 An enlarged view of the lateral annular depression is shown;

[0029] Figure 3 A top view of the penile prosthesis is shown;

[0030] Figure 4 A cross-sectional view of the mid-portion of the prosthesis is shown;

[0031] Figure 5 An overall view of the penile prosthesis is shown. DETAILED DESCRIPTION

[0032] The penile prosthesis comprises a proximal portion 1, a middle portion 2, and a distal portion 3, wherein the distal portion has a secondary semi-elliptical structure 4 with a reinforcing member 5. The proximal portion 1 has a transverse annular recess 6 with a proximal edge 7 and a distal edge 8. The distal length of the penile prosthesis 9 is the sum of the length of the distal portion 3 and half the length of the middle portion 2. The proximal length of the penile prosthesis 10 is the sum of the length of the proximal portion 1 and half the length of the middle portion 2. In order to prevent the penile prosthesis from rotating in the dilation tube, there may be a longitudinal groove 12 along the distal portion 3.

[0033] The penile prosthesis is made of elastic biologically inert material.

[0034] The procedure for implanting a penile prosthesis is as follows.

[0035] Under general or conducted anesthesia, a 3 cm longitudinal midline skin incision is made along the back near the base of the penis. Using a non-sharp instrument, the skin and underlying membrane are separated along the lateral surface of the right corpus cavernosum. While the testicular tunica albuginea is fixed with two retractors, a 1.5-2 cm longitudinal incision is made. Dilation is performed using a progressive Hegar dilator, first in the distal direction toward the top of the corpus cavernosum and then in the proximal direction. The length of the dilator tube is measured in the proximal and distal directions. The initial distal length 9 and the initial proximal length 10 of the penile prosthesis are specified by the manufacturer and are known before surgery. Among them, the initial proximal length 10 of the penile prosthesis is usually 110 mm; the initial distal length 9 of the penile prosthesis is selected based on the patient's anatomy. The length of the dilator tube can be equal to these numbers (if the corpus cavernosum can be fully dilated) or smaller (if the corpus cavernosum cannot be fully dilated). Therefore, the selected penile prosthesis sometimes needs to be shortened.

[0036] The shortened length of the penile prosthesis was calculated by subtracting the length of the dilator in the proximal direction from the proximal length 10 and rounding the result to the nearest 5 mm.

[0037] On the proximal part 1 (proximal side) of the penile prosthesis, there are transverse annular recesses 6 which are 5 mm apart from each other. Thus, a cut in the first and second transverse annular recesses 6 respectively results in a shortening of the penile prosthesis by 5 mm or 10 mm, etc. The cut should be made along the proximal edge 7 of the transverse annular recesses using a scalpel.

[0038] After shortening the proximal part 1 of the penile prosthesis, shortening of the distal part 3 can be performed if necessary. The length of the dilation tube in the distal direction should be subtracted from the distal length 9 of the penile prosthesis and rounded to 1 cm. Shortening of the penile prosthesis from the distal side is performed along the distal border of the secondary semi-elliptical structures 4, wherein the reinforcing members 5 of the removed segments are also cut away. The secondary semi-elliptical structures 4 are 1 cm apart from each other.

[0039] Thus, the resection along the first distal border of the secondary semi-elliptical structure 4 provides a 1 cm shortening of the distal portion 3 of the penile prosthesis.

[0040] The prosthesis is inserted into the dilation tube with the distal portion 3 facing the distal direction and the proximal portion 1 facing the proximal direction. Inside the dilation tube, the penile prosthesis is rotated in the dilation tube so that the narrowest part of the middle portion 2 is oriented downwards. The longitudinal groove 12 is used to prevent the penile prosthesis from self-rotating.

[0041] The surgical wound was then closed in layers.

[0042] Repeat the same procedure for the left corpus cavernosum.

[0043] The stiffness of the middle part (necessary for sexual intercourse) is provided by the fact that the cross-sectional area of ​​the narrowest part of the middle part is greater than that of the prototype, while at the same time the wearing comfort is not affected due to the upward displacement of the middle part relative to the longitudinal axis, while retaining the possibility of bending downwards, i.e. due to the fact that the middle part narrows more from the bottom than from the top or from the sides.

[0044] The penile prosthesis claimed in the present application is very simple and inexpensive to manufacture. Implantation of the penile prosthesis is minimally invasive and can be performed by any urologist.

Claims

1. A one-piece intracavitary penile prosthesis made of an elastic bioinert material, characterized in that: It includes a distal part, a concave middle part and a proximal part, wherein the distal part is cylindrical, the distal end ends in a semi-ellipse, and has one or more pairs of recesses forming a secondary semi-ellipse; and the proximal part is constructed as a truncated cone narrowing in the proximal direction, which ends in a semi-ellipse, wherein the proximal part has a transverse annular recess, characterized in that the narrowing in the lower part of the concave middle part is greater than the narrowing of the upper and side parts of the concave middle part, and the cross-sectional area of ​​the middle part is smaller than the cross-sectional areas of the distal part and the proximal part.

2. The one-piece intracavitary penile prosthesis according to claim 1, characterized in that: The distal portion has a longitudinal groove along the distal portion until the pair of recesses forming a secondary semi-elliptical shape.

3. The one-piece intracavitary penile prosthesis according to claim 1, characterized in that: A reinforcement member is positioned along the secondary semi-elliptical shape of the distal portion.

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