WO1980000302A1

WO1980000302A1 - Improvements in surgical implants

Info

Publication number: WO1980000302A1
Application number: PCT/GB1979/000130
Authority: WO
Inventors: S Hakky
Original assignee: S Hakky
Priority date: 1978-08-02
Filing date: 1979-08-02
Publication date: 1980-03-06
Also published as: EP0016140A1; US4718410A

Abstract

A penile implant for assisting disabled men to achieve satisfactory sexual intercourse comprises a flexible rod-like body (1) having an inflatable chamber (3) surrounded by a non-stretchable mesh (4), and a flexible tail portion (2) projecting from the proximal end of the body. A flexible tube (8) connects the chamber to a flexible bulb (7) for pressurising the chamber, this tube and bulb also being implantable in the patient's body. A non-return valve (10) at the outlet of the bulb prevents return of pressure fluid to the bulb when the chamber is pressurised to stiffen the implant. The valve housing (12) is integral with the bulb wall (11) and can be manually distorted to release the pressure when the implant is to be relaxed. The chamber (3), tube (8) and bulb (7) are filled with fluid at atmospheric pressure. In a modification, the inflatable chamber is constructed so as to be axially expandible upon inflation thereof so as to produce a more natural physiological action.

Description

IMPROVEMENTS IN SURGICAL IMPLANTS

The present invention relates to surgical implants and, more particularly, to penile implants for assisting disabled men to have satisfactory sexual intercourse and achieve fertilisation of the women's ova. In order successfully to achieve fertilisation, it is necessary for the man's penis to be erect so as to penetrate as deeply as possible into the woman's vagina. Many disabled men, such as spastics, paraplegics and those suffering from chronic leukemia, whilst capable of producing semen for the reproductive process are not capable of having an erection and, therefore, cannot satisfactorily penetrate the woman's genital canal to fertilise the ova and initiate such reproduction. This disability can be rectified by means of surgical im- plants. For example, in one implant procedure two in¬ flatable members are implanted respectively in the corpora cavernosa of the penis and a reservoir containing liquid for inflating the two members is implanted in the abdomen. The members are inflated, when desired, in order to erect the penis, by means of two flexible bulbs which are im¬ planted in the scrotum and are arranged to pump liquid from the reservoir into the members. Each of. these bulbs is connected to the reservoir and its associated inflat¬ able member by two tubes and four valves in order to pump liquid from the reservoir into the member, when required, and subsequently to return it to the reservoir after intercourse. Such an implant is complex and expensive and involves a difficult surgical operation.

It is an object of the present invention to provide an inflatable penile implant which is much simpler than the hitherto known device and is also simpler to implant in a patient.

To this end, the invention consists in penile implant comprising "a flexible rod-like body made from synthetic material and having an inflatable chamber therein, a flexible tail-like portion projecting from the proximal end of the body, a flexible bulb for con- taining fluid for pressurising the chamber connected t the chamber by a flexible tube, and a non-return valve arranged to prevent fluid discharged from the bulb int the chamber from returning to the bulb, said valve hav a deformable housing whereby the valve can be manually distorted so as to permit the fluid to return from the chamber to the bulb.

Two implants according to the invention are use for each patient. One of the rod-like bodies is insert ed into each corpora cavernosa of the penis with the tail-like portion projecting towards the base or root o the penis. This tail-like portion improves the support for the body and its affect, upon inflation of the flui chamber. The body "is inserted into the penis through small incision made in the underside. The associated bulb is implanted in the dartos pouch of the scrotum an the tube connecting the bulb to the fluid chamber in th rod-like body is also suitably implanted in the patient body so that there is no visible evidence of the implan When the patient requires to use his implants, it is a simple matter for him to squeeze the bulbs so' as to in¬ flate and pressurise or stiffen the chambers in the rod like bodies and erect the penis. When sexual activity is finished, it is also a simple matter for the patient to locate and deform the valve housings so as to allow the chambers to be depressurised and permit the penis t return to normal.

The fluid for inflating and pressurising the chamber in the rod-like body is charged into the chambe tube and bulb at atmospheric pressure and may be a gas or liquid. If a liquid is utilised, this should'prefer ably be decanted to render it gas free before it is charged into the implant.

In one embodiment, the inflatable chamber is an elongated, generally cylindrical chamber and is disposed adjacent the proximal end of the rod-like body. Rein- forcing..means, such as a net or mesh is embedded in the body about the chamber so as substantially to prevent the body from expanding when the chamber is pressurised in order to stiffen the implant. A reinforcing member may be embedded in the rod-like body adjacent its distal end in order to stiffen this end.

In a second embodiment, which has a physiological action more nearly resembling that occurring naturally, the inflatable chamber is constructed so as to be axially extensible or expandible upon inflation of the chamber by squeezing of the flexible bulb. Such an inflatable chamber may be defined by an elongated generally cylin¬ drical balloon which is attached at opposite ends to distal and proximal end portions of the body and which is enclosed within a tubular bellows member similarly attached and formed from non-stretchable material. This bellows member constrains the balloon to expand or con¬ tract axially when inflated or deflated. It may, itself, be enclosed within a second tubular bellows member made from resilient synthetic material and also attached at opposite ends to the distal and proximal end portions of the body. This bellows and balloon assembly may be encas¬ ed within an external membrane of resilient synthetic material which is attached at opposite ends to the end portions of the body substantially flush with the adja- cent peripheries thereof.

Hence, when a patient fitted with two penile implants according to this second embodiment squeezes the associated bulbs so as to inflate and pressurise the chambers, the rod-like bodies extend or expand axially of the implant so as to erect the penis. When the patient deforms the valve housingsof the non-return valves so as to allow the inflatable chambers to depressurise, the bodies contract axially to permit the penis to return to normal. It will be appreciated, therefore, that these implants produce an artificial erection which, physiologically, is very similar to that occurring naturally. Moreover, this embodiment has the advantage that the size of bulb required for inflating the chambe is significantly smaller.

Preferably, the tail-like portion of the implant is solid and formed from resilient synthetic material and is inclined to the axis of the rod-like body. To improve the physiological action, the distal end of the body may be formed with means, such as grooves, which enable the tissue of the penis to key with this end of the body so that the distal end of the penis is positiv ly moved together with the implant.

Conveniently, the non-return valve is located at the bulb outlet, with the valve housing being formed integrally with the bulb. The valve may comprise a flexible valve disc integral with the valve housing and have one or more orifices via which fluid is discharged from the bulb. The disc is resiliently urged into con¬ tact with a valve seat which closes the orifices in order to prevent return flow to the bulb. However, whe it is desired to release the pressure in the inflatable chamber, the valve housing may be manually deformed so as to distort the disc out of contact with the seat and permit fluid to return to the bulb via the orifices. I an alternative construction, the valve may comprise a ball or similar floating valve member which engages a seat at the bulb outlet so as to prevent return fluid flow to the bulb. As with the first mentioned construc tion, the valve housing may be readily deformed to un¬ seat the valve member and permit return flow. In order that the invention may be more readily understood, reference will now be made to the accom- panying drawings in which Figures 1 and 2 illustrate sectional views through two different embodiments of the invention, respectively.

Referring to Figure 1 of the drawings, the im— plant comprises a flexible rod-like body 1 moulded from a resilient synthetic material, such as silicone rubber. Moulded coaxially with the body and projecting from its proximal end is a solid, flexible, tail-like portion 2. An elongated cylindrical chamber 3 is formed within the body, coaxially therewith, adjacent its proximal end.

A reinforcing net or mesh k of non-stretchable material, such as a Dacron mesh, is embedded in the material of the body about the chamber so as substantially to pre¬ vent the chamber from expanding when it is inflated. Embedded in the body forwardly of the chamber and extend¬ ing towards the distal end of the body is a stiffening member 5. This may be moulded from polypropylene. Al¬ ternatively, the distal end portion of the body may be stiffened by injecting hard silicone rubber into this end of the body. The distal end 6 of the body is tapered to a rounded point.

The chamber 3 is connected adjacent its proximal end to a flexible bulb 7 by means of a flexible tube 8. This tube is reinforced by a spiral filament of rigid plastics material which is embedded in the tube along the full length thereof. The bulb may be moulded from sili¬ cone rubber and incorporates a non-return valve 10 at its outlet. The bulb wall 11 is integral with the valve housing 12 and the valve element comprises a resilient disc 13 moulded integrally with the housing. The disc 13 has four orifices Λ h (only two of which are shown in Figure 1) equally spaced about its centre. It cooperates with a rigid valve seat member 15 which has a central passageway 16 and which is secured within a cavity 17 in the bulb on the inside of the valve disc so that the valve seat 18 at its upper end closes the orifices in the valve disc when this is in its normal position. A its other end the valve housing has a port 19 connecte to the tube 8.

The chamber 3, tube 8, and bulb 7 are filled wi a gas on liquid at atmospheric pressure.

Two of the foregoing implants are utilised in a patient. When they have been implanted in the manner described above, it is a simple matter for the patient to produce an erection by squeezing the bulbs which have been implanted in his dartos pouch. When each bu is squeezed, the pressure produced in the bulb lifts t valve disc 13 off its seat 18 and allows the pressuris fluid to flow through the orifices I k into the tube an thence, into the chamber 3_» whereupon the latter is in flated and pressurised. When the bulb is released, th fluid pressure within the chamber and tube holds the valve disc against its seat and, hence, the valve shut When it is desired to depressurise the chamber and to terminate the erection, it is also an easy matter for the patient to squeeze the valve housing 12 so as to d tort this and the valve disc and, hence, disengage the orifices I k from the valve seat 18, whereupon the pres ised fluid can return to the bulb via the orifices and the passageway 16. In one particular example of the implant descri above, the rod-like body is 150 mm long and has a diam ter of 1 mm; the tail-like portion is 60 mm long; a the diameter of the maximum circular cross section of bulb is approximately 30 mm. Figure 2 illustrates a penile implant which has a more natural physiological action. It comprises a rod-like body 21 having a rounded distal end or head portion 22, a central portion 23 and a tapered tail-li portion Zh at its proximal end. The head portion 22 h annular grooves 25 which serve to key the head to the tissue of the penis. The tail portion is inclined t

the axis of the body 21 at an angle of approximately 30°. The head and tail portions may be formed of solid resil¬ ient synthetic material, such as silicone rubber.

The central body portion 23 includes an inflatable chamber 2.6 and is constructed so as to be axially exten¬ sible or expandible upon inflation of this chamber. The chamber is defined by an elongated generally cylindrical balloon 27 made from rubber or another elastic material, and similar to a Fogartty catheter balloon. The balloon is enclosed within a first tubular bellows member 28 made from non-stretchable material which constrains the balloon to expand or contract axially when inflated or deflated. This bellows member is formed from woven arterial Dacron, such as "De Bakey" arterial Dacron. The first bellows member 28 is enclosed within a second tu¬ bular bellows member 29 and the assembly of the two bellows members and the balloon is enclosed within an external covering membrane 30 which is substantially flush with the adjacent peripheries of the head and tail portions 22,24. The membrane 30 and second bellows member 29 are formed from resilient synthetic material, such as, silicone rubber. The four members 27-30 con¬ stituting the central portion 23 are arranged coaxially and are fixed at opposite ends to end walls 31_>32 bonded respectively to the head and tail portions. Intermediate their opposite ends, the central body parts 27-3° are not interconnected and are free to move independently of one another.

The cylindrical balloon 27 is connected adjacent its proximal end to a flexible bulb 33 by means of a flexible tube 3h . This tube is reinforced by a spiral filament 35 of rigid plastics material, such as nylon, or stainless steel, which is embedded in the tube along the full length thereof. The bulb is of ovoid shape and may be moulded from resilient synthetic material, such as silicone rubber. It has a non-return valve, schemati-

IfUREA __.0MPI cally indicated at^"36, integral with its outlet 37. The bulb 33 and the valve 37 are of similar constructi to the previous embodiment and will not there ore be further described in detail. However, this particular construgtion of implant enables the bulb 33 to be made smaller than that required for the implant shown in Figure 1.

The chamber 26, tube 3 and bulb 33 are filled with gas or liquid at atmospheric pressure. As with the previous embodiment, tw.o implants 21 are utilised for each patient. They are implanted and operated in a similar manner to that described above. When each bulb is squeezed, the pressure produced by t bulb forces liquid through the non-return valve 3 into the associated chamber 26, whereupon the latter is in¬ flated and, owing to the constraining action of the first tubular bellows member 8, expands axially to erec the penis. When each bulb is released, its valve 6 prevents the pressurised fluid from returning from the chamber 26 to the bulb. When it is desired to depressu ise each chamber and terminate the erection, it is also an easy matter for the patient to squeeze the housing of each valve so as to distort this and permit pressure fluid to return to the valve. I^{11 one} particular example of the implaht shown in Figure 2, the chamber 26 may be expanded to 10 cm in length, when inflated, whilst it contracts to 5 or 6 cm when deflated.

The annular grooves 25 about the head 22 of the body key with the penis tissue so as to cause the dista end of the penis to move with the implant when the cen¬ tral body portion 23 contracts upon deflation of the chamber 26. On the other hand, the outer surface of th covering membrane 30 is smooth so that this can move relatively to the penis tissue. The result is that the physiological action of the implant is substantially equivalent to that occurring naturally.

Whilst a particular embodiment has been describ¬ ed, it will be understood that modifications can be made without departing from the scope of the invention as defined by the appended claims.

Claims

C AIMS

1. A surgical implant comprising an inflatable penile member for implanting within a penis, and in¬ flating means for inflating the penile member also adapted., to be implanted in the patient's body, charact- erised in that the penile member comprises a flexible rod-like body (1 ,21 ) made from synthetic material and having an inflatable chamber (3_»26) therein, and a flexible tail-like portion (2,24) projecting from the proximal end of said body, and in that the inflating means comprises a flexible bulb (7_»33) for containing fluid for pressurising the chamber connected to the chamber by a flexible tube (8,34), and a non-return val (10,36) arranged to prevent fluid discharged from the bulb (7_»33) into the chamber (3,26) from returning to the bulb, said valve having a deformable housing (12) whereby the valve can be manually distorted so as to permit the fluid to return from the chamber to the bulb

2. An implant as claimed in claim 1 , characterised in that the inflatable chamber (3) is an elongated, generally cylindrical chamber disposed adjacent the proximal end of the rod-like body (1 ) and reinforcing means (4) is embedded in the body about the chamber so as substantially to prevent said body from expanding radially when the chamber is inflated to stiffen the body.

3. An implant as claimed in claim 1 or 2, character ised in that reinforcing means (5) is embedded in the rod-like body (1 ) adjacent its distal end in order to stiffen this end.

4. An implant as claimed in claim 1 , characterised in that the inflatable chamber (26) is constructed so as to be axially extensible or expandible.upon inflatio of the chamber.

5. An implant as claimed in claim 4, characterised in that the inflatable chamber (26) is defined by an elongated generally cylindrical balloon (27) attached at opposite ends to the rod-like body and enclosed within tubular bellows means (28 or 28,29) similarly attached to the body and formed from non-stretchable material, said bellows means being adapted to constrain the balloon to expand and contract axially, and an external membrane (3θ) of resilient synthetic material enclosing the bellows and balloon assembly and attached at opposite ends to the rod-like body substantially flush with the periphery thereof.

6. An implant as claimed in any one of the preceding claims, characterised in that the tail-like portion (24) is inclined to the axis of the rod-like body (21 ) .

7. An implant as claimed in any one of the preceding claims, characterised in that the distal end (22) of the body is formed with means (25) for enabling the tissue of the penis to key with said end so that the distal end of the penis is positively movable together with the implant.

8. An implant as claimed in any one of the preceding claims, characterised in that the non-return valve (10,36) is located at the bulb outlet, the valve housing (1 ) be¬ ing formed integrally with the bulb (7_»33).

9. An implant as claimed in any one of the preceding claims, characterised in that the inflatable chamber (3,26), flexible bulb (7,33) and interconnecting tube (8,34) are charged with a gas or liquid at substantially atmospheric pressure.