WO1991014409A1

WO1991014409A1 - Penile prosthesis

Info

Publication number: WO1991014409A1
Application number: PCT/SE1991/000217
Authority: WO
Inventors: Arne M. Olsson; Jan-Ove Persson
Original assignee: Atos Medical Ab
Priority date: 1990-03-20
Filing date: 1991-03-20
Publication date: 1991-10-03
Also published as: SE9001012D0

Abstract

The invention relates to a closed liquid system penile prosthesis comprising at least one hollow tubular member (13) made of flexible material for implantation in the penis, a container (10) for implantation, means (12) connecting said tubular member (13) or members and said container (10), and valve means (11) for a releasable blocking of liquid flow from said tube or said tubes to said container. Said liquid system is provided with a diaphragm (28) which can be penetrated for removing and adding of liquid.

Description

PENILE PROSTHESIS

The invention relates to a penile prosthesis. After different forms of medical procedures and at some physiological states the ability of producing a penile erection is lost. Different types of more or less mechani¬ cal devices have been suggested to accomplish an improved erection. Prior art devices comprise different forms of coupling means that are mounted during implantation in the patient. Said devices are provided also with equally thick cylindrical tubular members which are arranged in the penis, a container for liquid and a one-way valve for pre¬ venting a return flow of liquid from said tubular members to said container. Said one-way valve involves a certain risk of unintended erection which cannot released without problems. As a result of the mounting being made in connec¬ tion to the implantation the time period for medical opera¬ tion increases and the risk of leaking at a later stage also increases.

Even though said tubular members in prior art prosthesises are made of a soft material they cannot be adapted to a changing of size of penis in the non-erected state, for instance when the penis is exposed to cold conditions. Said tubular members are bent in an uncontrol¬ led manner thereby increasing the risk of sharp folds and undue strain in the material in turn leading to an increased risk of a shortened length of life of the prosthesis.

To make possible an adjustment of the amount of liquid after the implantation of the prosthesis some type of injection port should be included in said closed fluid system. Fluid can then be added or removed through said port. A prosthesis constructed in this way is disclosed in US-A-4,724,830. The fluid provided within an implanted container is maintained under compression and may pass a valve provided between said container and said prosthesis when said valve is opened from outside by a pressure on a push button. Said valve comprises also a diaphragm through which a needle can be put so as to adjust the amount of liquid. To press liquid back to said container against the existing pressure said valve is again opened and the prosthesis is returned to a flaccid state by squeezing the penis.

An object of the present invention is to provide a device for improving the penile erection, said device eliminating the risk of unintentional erection. The strength of erection should be manually adjustable.

Furthermore, said device is readily implanted and readily adjusted with regard to the stiffening effect.

These objects are achieved by the present invention having the characteristic features of claim 1. Other advantages of the invention will become apparent from the sub claims.

The invention will be described in more detail by means of an embodiment, reference being made to the accom¬ panying drawings, in which FIG.l is a side view partly in cross section of the device according to the invention,

FIG. 2 is a sectional view of a part of the device of FIG. 1,

FIG. 3 is a side view of a tubular member according to the invention in a non-inflated state,

FIG. 4 is a side view of a tubular member according to the invention in an inflated state, and

FIG. 5 is an enlarged cross-sectional view of a section of the tubular member of FIG. 3. According to FIG. 1 the penile prosthesis comprises a container 10 formed as a bladder made of soft and flexible material. A material very suitable is silicone rubber, but also other similar materials can be used. Said container 10 is connected to two tubular members 13, having outer walls 34, through tubes 12 and through a control unit 11 described in more detail below. Only one tube 12 and one tubular member 13 are shown in FIG. 1. Said tubular members 13 are provided with a solid rear section 14 which is connected to said tube 12, and a hollow front section 15, the inside thereof being connected to said tube and also to said container 10 through passage-ways 16 in said rear section. Said walls 34 of said tubular members 13 are made of soft and pliable material allowing a compression of said tubular members and also an increase of volume of said members. Silicone rubber is a suitable material just as in case of said bladder. It is possible to mount detachable extenders 30 on the solid rear section 14 to make the total length of the prosthesis correspond to the anatomy of the patient. The function of the device is described in more detail below.

FIG. 2 shows in more detail the construction of said control unit 11, said unit comprising a valve housing 17. Passage-ways are arranged through said valve housing 17, and one of said passage ways, a rear passage way 17 opens into said container 10 enclosed by a thin wall 20. Said passage ways include also two front passage-ways, one of which is shown, which are connected to said tubes 12. A larger, in cross-section cylindrical cavity 21, is made between said passage ways in said valve housing. In said cavity 21 there is arranged a valve body 22 made of a material that is hard compared to other elements of the device. In a preferred embodiment said valve body is made of titan but also stainless steel and a hard polymer material can be used. One end of said valve body is provided with a radially extending flange 23 which is arranged in a section of said cavity 21 having the larger diameter. In front of said flange 23 said valve housing 17 is provided with a bulge 24 extending towards said flange 23. Said bulge 24 is formed to exert a pressure on said flange 23 and presses said flange towards a valve seat 25 formed in said valve housing. Said valve body 22 is in the other end provided with an extended hollow cylindrical section 26 which ends with a flange 27 extending radially inwardly. Said flange 27 contributes in preventing a body 28 made of soft and flexible material inserted in said extended cylindrical section 26 from being pressed out of said section. The complete extended cylindrical section is also surrounded by a cap 29 made of the same material as the rest of said valve housing and said container. The container is mounted on said control unit and attached thereto by engagement of a flange extending inwardly from a tapered section of said container in a groove formed in said control unit.

FIG. 3 shows a further developed tubular member 13, one section 33 thereof being corrugated or formed as a bellows. Hereby a considerably larger flexibility and adaptability to normal variations of the length of penis, for instance when having a cold bath, is achieved. In FIG. 3 the tubular member contains only a small amount of liquid. In FIG. 4 more liquid has been pressed into said tubular member and it is apparent that in this embodiment also the coefficient of length expansion is considerably improved.

The embodiment shown in FIG. 5 and which can be applied in any of the embodiments shown in FIG. 1 and FIG. 2 and in the embodiment shown in FIG. 3 and FIG. 4, the wall of said tubular member 13 is reinforced by a tubular shaped fabric insert 31. As a result of said fabric insert a considerably higher stiffness of said tubular member 13 is achieved, because the expansion of said tubular members taking place when liquid is pressed into said tubular members is limited by the fabric. A further increase of fluid does not result in a further expansion but in an increase of pressure and to an increase of stiffness. In a first embodiment according to FIG. 5 the rein¬ forcement is provided when an injection moulded tubular member 13 is turned inside out and is coated by a rein¬ forcement 31 formed as a sock. On the outside of said reinforcement a layer 32 made of the same material as the tubular member 13, is applied, the material being in a floating state. The material soaks through said reinforcement and engages the tubular member. When the material has hardened the tubular member 13 is turned inside out and is then glued to said rear section 14.

In a second embodiment according to FIG. 5 a polymer tubular member is mounted on a core in a moulding tool, and then the reinforcement 31 is drawn onto said tubular member. The core and the tubular member 13 and the rein- forcement 31 are then put in the moulding tool and a polymer is injection moulded thereon to form said layer 32.

Also other methods comprising gluing and injection moulding using other materials can be used to accomplish a composite tubular member according to FIG. 5. The penile prosthesis according to the invention is implanted in the following manner. The existing corpus cavernosum is removed from the penis and the hollow sections are inserted in the space generated thereby. The tubular members are then somewhat compressed. An appropriate number of extenders is then mounted on said rear solid sections of said tubular members so as to ensure that the prosthesis is essentially fixed and cannot be moved in the axial direction. During the entire implanta¬ tion said tubes and said container are connected to said tubular members and form together therewith a closed system. A suitable amount of a body natural floating material is from start provided in said container and said tubular members. Said container 10 is finally inserted in the scrotum of the patient. Said control unit 11 is available through the skin and when the penile prosthesis is to be used actively to augment the erection said valve body 22 is pressed down¬ wardly in FIG. 2 by a pressure being exerted on said cap 29 against the bulge 24, and thereby said flange is removed from said valve seat 25. Thereby an open connection is accomplished between said container 10 and said tubes 12. By maintaining the pressure on said cap to keep the valve opened and simultaneously compressing said container 10 it is then possible to press liquid from said container through said tubes to said hollow sections 15 of said tubular members. The volume of liquid is adjusted in such a way that the expansion and stiffening effect on said tubular members provides a desired improvement of erection. While it is necessary to proceed with both steps simul¬ taneously the risk of an unintentional erection is avoided. The pressure on the cap is then released and the erection is maintained until said valve body again is pressed downwardly and fluid again is pressed back to said container again being filled up to the starting level as a result of the positive pressure being exerted by the tissue being forced away by the expanded tubular members and as a result of the tubular members having a tendency to return to a starting volume. If an appropriate amount of liquid was not included from the start in the container it is possible during the implantation and also thereafter during the lifetime of the prosthesis to penetrate, during transillumination, the skin with a needle and also the body 28 functioning as a diaphragm to inject or suck a desired amount of liquid. While said body 28 is forced into said cylindrical space and being surrounded completely by said valve body made of rigid material a very good sealing is provided also at repeated penetration.

Claims

CLAIMS 1. A closed liquid system penile prosthesis comprising at least one hollow tubular member (13) made of flexible material for implantation in the penis, a container (10) for implantation, means (12) connecting said tubular member (13) or members and said container (10), a diaphragm (28) which can be penetrated for removing and adding of liquid, and valve means (11) formed to be closed in a normal state to prevent a flow of liquid in both directions between said tubular member or members and said container (10), c h a r a c t e r i s e d in that said container (10) is made compressible by manual pressure to force a desired amount of liquid into said tubular member (13) or members.

2. A penile prosthesis according to claim 1, c h a r a c t e r i s e d in that the walls of said tubular members (13) are reinforced by a reinforcement layer (31) so as to restrict the expansion of said tubular members when liquid is forced into said tubular members.

3. A penile prosthesis according to claim 1 or 2, c h a r a c t e r i s e d in that said tubular members (13) are provided with at least one section (33) which is folded or corrugated in the transverse direction of said tubular members and extendable in the longitudinal direction of said tubular members.

4. A penile prosthesis according to any of claim 1-3, c h a r a c t e r i s e d in that said valve member (11) comprises a valve housing (17) and a valve body (22) moving within said valve housing (17), that said diaphragm (28) is received in said valve means (11), and that a section of said valve means (11) receiving said diaphragm (28) is made of a material that is hard as compared to said diaphragm (28).

5. A penile prosthesis according to claim 4, c h a r a c - t e r i s e d in that one end of said valve body (22) is formed with a hollow cylindrical section (26), and that said diaphragm (28) is received in said cylindrical section (26).

6. A penile prosthesis according to claim 5, c h a r a c ¬ t e r i s e d in that said cylindrical section (26) is provided with a radially inwardly extending flange (27) assisting in preventing said diaphragm (28) from slipping out of said valve body (22).

7. A penile prosthesis according to claim 2, c h a r a c ¬ t e r i s e d in that said reinforcing layer (31) is provided between an outer wall (34) of said tubular members and a layer (32) made of a material having a length extension corresponding to the length extension of the material of said tubular members.

8. A penile prosthesis according to claim 3, c h a r a c - t e r i s e d in that said corrugated section (33) is formed in a central position of said tubular members (13).