WO2012019429A1

WO2012019429A1 - Penile implant and a preparation method thereof

Info

Publication number: WO2012019429A1
Application number: PCT/CN2011/001265
Authority: WO
Inventors: 叶明�
Original assignee: 上海索康医用材料有限公司
Priority date: 2010-08-12
Filing date: 2011-08-02
Publication date: 2012-02-16
Also published as: CN101940506B; CN101940506A

Abstract

A penile implant comprises a laminar structure of several expanded polytetrafluoroethylene flakes, including an outmost layer (11) having several arc-shaped lobes and several smooth inner layers (12) disposed below the outmost layer through lamination or bonding; and the laminar structure having an arc-shaped cross section. The penile implant has a good biological compatibility, and permanent implantation can be achieved by controlling the size of micro-pores in the prosthesis to facilitate the in-growth of the tissue cells, so as to avoid sliding, displacement, and corresponding complications; and the laminar structure thereof brings convenience for a doctor to perform modification as required by a patient. A method for preparing the penile implant is further disclosed.

Description

Penis implant and preparation method thereof

TECHNICAL FIELD The present invention relates to a medical prosthesis, and belongs to the field of medical devices; in particular, to a penile implant and a method of preparing the same. BACKGROUND OF THE INVENTION Penile short refers to the adult male penis under normal physiological conditions, its length and circumference are smaller than the average of normal men, and sexual life is necessarily affected. And accompanied by male secondary sexual characteristics ('pubic hair, mane and beard, voice change, larynx, male genital morphology, etc.) dysplasia or gradual deterioration, mental dysfunction, general malaise, lack of male masculinity; cause psychological and physiological problems for patients A huge impact.

Penis thickening is an operation aimed at improving the shape of the penis, improving sexual life and alleviating sexual stress. This type of surgery has certain needs in the adult male population. Commonly used surgical methods for penile shaping include fat filling techniques, polymer injection (mostly polyester), and silicone prosthesis implantation. However, the problem caused by the fat injection method is the persistence of the effect, because the fat is gradually absorbed by the body, and the corresponding appearance of the repaired portion is irregular, requiring re-injection, which increases the patient's economic burden and pain. In the case of silicone implantation, there will be an exogenous reaction, and the glass ball implanted in the skin is easy to rupture; and some penile implants prepared by polysaccharide polymers are prone to postoperative edema, infection and other syndromes, and these organisms The long-term effects of degrading polymers are for further observation. ' ' disclosure of invention

It is an object of the present invention to provide a penis thickening implant having good biocompatibility, which can be permanently implanted without prosthesis slippage or displacement, and corresponding complications, And after use, it is more natural in appearance, and can meet the requirements of patients both physiologically and psychologically.

In order to achieve the above object, the present invention provides a penile implant which is a layered structure comprising a plurality of layers of expanded polytetrafluoroethylene sheets, the layered structure comprising a plurality of arcuate convexities The outermost layer, and a plurality of smooth inner layers disposed under the outermost layer by lamination or adhesive; the layered structure has an arcuate cross section.

The layered structure of the penile implant has a circular cross section.

The layered structure of the penile implant has a "C" shape in cross section; wherein each corner of the "C" shaped penile implant is ground into a smooth arc to prevent the top of the implant Broken skin.

The outermost layer of the layered structure comprises a plurality of zigzag protrusions; the outermost zigzag protrusion structure reduces the tension of the prosthesis under bending.

The outermost layer of the layered structure comprises a plurality of undulating protrusions.

The expanded polytetrafluoroethylene is soft, soft enough and tough. It has been pressed into a layered structure having a c-shaped cross section through a mold before use, which is closer to the natural characteristics of the human body.

The expanded polytetrafluoroethylene has a pore diameter of 20 to 50 micrometers, and the tissue cells can be grown by controlling the size of the micropores in the prosthesis, so that the penile implant can be permanently implanted without prosthesis. Slide or shift.

The invention also provides a preparation method of a penile implant, the method comprising the following specific steps: Step 1: preparing a semi-finished product: a ratio of a polytetrafluoroethylene raw material and a squeezing agent according to a weight ratio of 20:1 to 30:1 Mixing, at room temperature, after pressing preforming, forming rod-shaped polytetrafluoroethylene, heating to 40~100 °C rolling to form a sheet having a thickness of 4~5 mm;

Step 2, the polytetrafluoroethylene sheet obtained in the step 1 is heated to 300 to 400 ° C for stretching, and is puffed to produce a large amount of "knuckle and fiber structure", maintained at the temperature, and fixed for 3 hours to obtain swelling. Bulk polytetrafluoroethylene flakes;

Step 3, taking a plurality of expanded polytetrafluoroethylene sheets obtained in the step 2, laminating at 280-360 ° C or bonding with an adhesive, and then processing and shaping the mold to obtain a penile implant. Things.

In the step 1, the extrusion aid is mixed with the polytetrafluoroethylene to form a paste, so that after the shearing force, the spherical resin particles are stretched into a uniform fibrous structure, and The action of the lubricant; the propellant is generally selected from gasoline-based solvents such as petroleum ether, mineral spirits, and paraffin oil.

The penile implant of the invention can thicken the penis of the patient, the implant is made of expanded polytetrafluoroethylene, has good biocompatibility, and can control the structure of the expanded polytetrafluoroethylene The size of the hole allows the tissue cells to grow in, which can fix the prosthesis and prevent the prosthesis from being displaced. At the same time, the fibrous capsule is not formed after the implantation of the prosthesis, and can be completely removed when necessary. The material is soft, has a certain compressibility and is resistant to pulling. These characteristics can avoid thrombosis, sinusoids Fibrosis or occlusion.

Moreover, the layered structure of the penile implant of the present invention is clinically convenient for the doctor to select the thickness of the implant depending on the patient's condition. For mild patients, doctors can simply implant one or two layers of structure from the implant to achieve the purpose of thickening without the need for a scalpel for engraving. The operation is simple and convenient, greatly shortening the operation. Time has alleviated the suffering of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic illustration of one embodiment of a penile implant of the present invention having a C-shaped cross section.

2 is a top plan view of a penile implant of the present invention.

Figure 3 is a side elevational view of the penile implant of the present invention. The best way to implement the invention

The technical solution of the present invention will be further described below in conjunction with the embodiments.

As shown in Fig. 1, the penile implant of the present invention is a layered structure comprising a plurality of layers of expanded polytetrafluoroethylene sheets, the layered structure comprising an outermost layer 11 having a plurality of arcuate projections and by lamination or sticking The mixture is disposed in a plurality of smooth inner layers 12 below the outermost layer 11; the layered structure has an arcuate cross section, and in another embodiment of the invention, the layered structure has a C-shaped cross section.

The invention also provides a method for preparing a penile implant, which comprises the following specific steps - step 1, to produce a semi-finished product: a raw material of a polytetrafluoroethylene pellet and a lubricating spirits solvent (provided by Exxon Chemical) Mix in a ratio of 20: 1-30: 1 by weight, and mix them with a vibrator to achieve uniformity. Then, at room temperature, it is pre-formed by pressing (pressure: 10 to 30 tons) to form rod-shaped polytetrafluoroethylene, which is rolled at 40 to 100 ° C by a twin-shaft roller press, and the rotation speed of the master-slave roller is 1: 1-1 : 5, forming a sheet having a thickness of 4 to 5 mm;

Step 2, the polytetrafluoroethylene sheet obtained in the step 1 is heated to 300 to 400 ° C, and stretched by a biaxial stretching machine, and the stretching ratio is 3 to 6 times, which is puffed to produce a large number of "sections". And the fiber" structure, the pore size is about 20 ~ 50 microns, maintained at this temperature, stereotyped for 3 hours, obtained expanded polytetrafluoroethylene sheet l ~ 1.5mm, cut to the required length;

Step 3, taking a plurality of expanded polytetrafluoroethylene sheets obtained in the step 2. In the embodiment, the shaped penile implant has 4 layers of expanded polytetrafluoroethylene sheets, and is laminated at 280-360 ° C. Or bonding with an adhesive (the adhesive used in this embodiment is polyperfluoroethylene propylene), and then processed by a mold, Shaped, the resulting outermost jagged shaped penile implant with a layered structure, length 60-80 mm, diameter 15-40 mm, total thickness 4-6 mm, thickness of each layer 1 -1.5 mm, the spacing between the teeth of the outermost layer 11 is 2-4 mm, and the inclination angle of the circumference is 30-45 °C. 2 is a front plan view of the penile implant, and FIG. 3 is a side view of the penile implant of the present invention.

The shaped penis thickened implant does not need to be engraved, and its layered structure facilitates the doctor to "de-layer" the prosthesis according to the patient's specific conditions, greatly reducing the time for engraving the prosthesis and reducing the falsehood. The time the body is exposed to the air reduces the chance of infection and shortens the operation time. The expanded polytetrafluoroethylene material of the present invention has a microporous structure, allows tissue cells to grow in, and fixes the prosthesis without causing displacement and sliding of the prosthesis, which is of special significance for penile repair. The tooth structure and the inclination angle of the edge, the molding material is "C" type, which makes the return tension greatly reduced, and the material is made into an arc shape to prevent the skin from being broken and the chance of postoperative infection is reduced.

Although the present invention has been described in detail by the preferred embodiments thereof, it should be understood that the foregoing description should not be construed as limiting. Various modifications and alterations of the present invention will be apparent to those skilled in the art. Therefore, the scope of the invention should be limited by the appended claims.

Claims

6 Claims

A penile implant, characterized in that the penile implant is a layered structure comprising a plurality of layers of expanded polytetrafluoroethylene sheets, the implant of the layered structure comprising a plurality of arcuate projections Outer layer

(11), and a plurality of smooth inner layers (12) disposed under the outermost layer (11) by lamination or adhesive; the layered structure has an arcuate cross section.

2. A penile implant according to claim 1 wherein the layered structure of the penile implant has a circular cross section.

3. The penile implant of claim 1, wherein the layered structure of the penile implant has a "C" shape in cross section.

4. The penile implant of claim 3, wherein each corner of the edge of the "C" shaped penile implant is ground into a smooth arc.

The penile implant according to any one of claims 1 to 4, characterized in that the outermost layer (11) of the layered structure comprises a plurality of zigzag protrusions.

The penile implant according to any one of claims 1 to 4, characterized in that the outermost layer (11) of the layered structure comprises a plurality of undulating projections.

The penile implant according to any one of claims 1 to 4, wherein the expanded polytetrafluoroethylene is a soft type.

8. The penile implant of claim 7, wherein said expanded polytetrafluoroethylene has a pore size of from 20 to 50 microns.

9. A method of preparing a penile implant according to claim 1 or 2 or 3 or 4 or 7, characterized in that Therefore, the method includes the following specific steps:

In step 1, the polytetrafluoroethylene raw material and the extrusion aid are mixed in a ratio of 20:1 to 30:1 by weight, and at room temperature, after being preformed by pressing, a rod-shaped polytetrafluoroethylene is formed, and then at 40 to 100°. C rolling, forming a sheet having a thickness of 4 to 5 mm;

Step 2, the polytetrafluoroethylene sheet obtained in the step 1 is heated to 300 ° C to 400 ° C for stretching, and the stretching ratio is 3 to 6 times, which is puffed to produce a large number of "node and fiber" structures, which are maintained. At this temperature, shaping, obtaining expanded polytetrafluoroethylene flakes;

Step 3, taking a plurality of expanded polytetrafluoroethylene sheets obtained in the step 2, laminating at 280 to 360 ° C or bonding with an adhesive, and then forming a penile implant by molding.