EP0656768A4

EP0656768A4 - Penile implant with triglyceride fill.

Info

Publication number: EP0656768A4
Application number: EP93920240A
Authority: EP
Inventors: Terry Russell Knapp; V Leroy Young
Original assignee: Lipomatrix Inc
Current assignee: Lipomatrix Inc
Priority date: 1992-08-20
Filing date: 1993-08-20
Publication date: 1996-03-06
Also published as: WO1994004095A1; CA2142900A1; EP0656768A1; BR9306919A; JPH08500504A; AU5083593A

Abstract

A penile prosthesis (12) or implant utilizes expandable cylinders or bladders (14) implanted in the penis along with a fluid transfer system including a pump (18), hydraulic reservoir (24), and interconnecting fuid lines, connectors, etc. The prosthesis includes a biocompatible triglyceride with radiopaque dye as the hydraulic fluid (20) utilizes radiolucent materials to form the bladder (14) to enhance leak detection, and textures the exterior surface of the reservoir and bladders in order to decrease the likelihood of failure through fold flaw or capsular contracture.

Description

PENILE IMPLANT WITH TRIGLYCERIDE FILL Cross-Reference to Related Applications

This application is a continuation-in-part of U.S. Application Serial No. 07/932,603 filed August 20, 1992; and is related to U.S. Application Serial No. 07/952,687 filed September 29, 1992

Background and Summary of the Invention

Implantable penile prostheses are well known in the art and generally include a pair of bladder-like penile implants for implantation into the two corpora cavernosa, a fluid transfer system including a reservoir for containing 50 c.c. of a hydraulic liquid fill, and a pump with a set of valves in fluid lines interconnecting the implants with the reservoir. The fluid transfer system is generally constructed of elastomeric compo- nents, including tubing and connectors, and silicone is a typical material used for their construction. Because of its size, the reservoir is generally implanted in the abdomen while the pump is generally bulb-shaped and is typically implanted within the male scrotum. Erection is typically achieved by pumping the bulb-like pump to transfer fluid from the reservoir into the bladder-like penile implants. Examples of these devices are shown in the following U.S. Patents: Patent No. 3,954,102; Patent No. 4,360,010; Patent No. 4,424,807; Patent No. 4,558,693; Patent No. 4,881,530; and Patent No. 5,101,813.

The hydraulic fluid generally used in the prior art includes silicone oil, saline, water, and other kinds of non-specific "biocompatible filler". These materials are generally chosen because of their presumed biocompat- ability and/or lubricity. In U.S. Patent No. 3,954,102, a biocompatible fill is suggested which may be doctored with a biocompatible radiopaque dye in order to facili¬ tate the tracing of any leaks from the system to thereby localize and minimize the required surgical intrusion to correct the leak. The tracing of leaks is an important consideration for prior art penile implants because of their regular use and resulting significant incidence of failure. In performance of the intended use of penile implants, there is a regular cycling of the hydraulic fill from the reservoir to the bladders and then back again. Because of this cycling of fluid, there is a focus on the abrasive effect that the fluid has on the bladders, as well as the pump and its valves, and the tubes and connectors, over time. This is because of the risk of deterioration, leakage, and even rupture of one or more of the system components. With the fill material suggested and used in the prior art, problems arising from this abrasive action, including most often pump failure, fluid line and connector leakage, and fold flaw failure have occurred with some degree of regularity. Still another type of failure involves the formation of a scar capsule around the reservoir, and contraction of this capsule to restrict the reservoir and interfere with the deflation of the bladders. This leaves the patient with an erection which cannot be relieved. This "capsu- lar contracture" is similar to that which is experienced with breast implants in women where a breast implant is surrounded with a scar capsule which contracts into a painfully hard, circular mass which renders the breast hard and unnaturally shaped.

In the prior art, reservoirs are generally left filled for up to six weeks so that if a scar capsule forms, it will form to a size permitting the reservoir to be fully refilled after the implant has been operated. Unfortunately, the scar capsule can still contract and tighten over time such that this prior art protocol is not entirely successful.

With prior art devices, leaks are detected and localized by using a frontal x-ray wherein the x-ray intensity and exposure time used is similar to that for a chest x-ray as the x-rays are required to traverse a substantial amount of body tissue. This x-ray intensity explained the need, mentioned above, for a biocompatible radiopaque dye to be utilized as other structure, even silicone, used in the implant becomes transparent in these radiographs. However, for those implants utilizing a saline filler material, even a radiopaque dye is not successful in all cases in finding a leak as the human body can metabolize saline relatively quickly, perhaps overnight. Thus, in the prior art, detection and loca¬ tion of leaks utilizing x-ray was not completely success¬ ful. This was unfortunate as the ability to locate a leak is very important in correcting it with surgery. Upon detection of the leak, the failed component could be identified as well as the site necessary for surgical invasion. Thus, saline filler with radiopaque dye did not completely solve the problem of locating leaks.

Still another problem in the prior art with the use of saline as a hydraulic filler is the tendency for the penis to feel abnormal and perhaps like an inflated balloon, even when flaccid. Obviously, the cosmetic and aesthetic value of the penile implant would be impaired to the extent that it does not achieve a normal and natu¬ ral "feel". This "water balloon effect" is more pro- nounced in a partially deflated penis which is the pre¬ dominant condition for the patient's everyday life. This effect is exacerbated by the fact that penile implants are generally not totally deflatable.

The inventors herein are aware of the various texturing and profiling of breast implants which have been developed in the prior art in order to render them more biocompatible and diminish the likelihood of the formation of capsular contracture. Some examples of these are to be found in the following U.S. patents: 4,531,244; 4,648,880; 4,899,744; 4,955,907; 4,955,909; 4,960,425; 4,963,150; 5,007,929; 5,011,494; 5,022,942; and 5,092,348, the disclosures of which are incorporated herein by reference. Generally, to the inventors' knowl¬ edge, these techniques have been used with success in breast implants but their teachings have not been uti¬ lized with respect to other implants, including penile implants. Of course, as known in the art, mammographies are performed at significantly reduced x-ray intensities and exposures, levels heretofore not useful with respect to penile implants.

The inventors herein are also aware of U.S. Patent No. 4,995,882, incorporated herein by reference, and rights to which are owned by the assignee of the present invention, which discloses and claims a breast implant which utilizes a biocompatible radiolucent fill. Radio- lucency is achieved even at the low intensities of x-rays used for mammography. This radiolucent fill may be com¬ prised of any biocompatible triglyceride such as peanut oil, soybean oil, or any other material having an effec- tive atomic number of 6.0 within a range of ±0.5, the effective atomic number of body fat. This invention is a good and valuable invention which enhances the chances for early detection of cancer in performing mammographies on female breasts which are augmented with this breast implant. The inventors herein are also aware of pending U.S. Application Serial No. 07/952,687 filed September 29, 1992 entitled Breast Implant With Radiolucent Shell , the rights to which are owned by the assignee of the present invention and the disclosure of which is incorpo- rated herein by reference, which discloses and claims a breast implant having a shell made with radiolucent mate¬ rials instead of the silicone shell predominantly found in the prior art. The use of radiolucent materials in the shell eliminates the last vestiges of artifacts which might otherwise appear on a radiograph when a mammograph is taken of a breast with an implant having radiolucent fill only. This is an important and valuable invention which improves on the '882 patent and demonstrates its usefulness in those implants for which mammography is customarily used for the early detection of cancer.

In order to solve the various problems in the prior art relating to penile implants, the inventors herein have developed a penile implant using triglyceride as the hydraulic fill, partial radiolucency of the im- plant structure to enhance leak detection, a radiopaque dye for the fill which does not metabolize too rapidly to hinder leak detection, and texturing to eliminate failure of otherwise failure prone implant parts. Significant advantages have been obtained on several grounds. First- ly, the radiolucency of the fill and bladder permits the utilization of an x-ray technique having greatly reduced intensities and exposure times to view at least the blad¬ der portion in the patient's penile shaft for leak detec¬ tion. Perhaps more important, however, is the dramati- cally increased lubrication effect on the hydraulic sys¬ tem which is experienced with the triglyceride-based material used. The typical biocompatible fill material suggested for use in the prior art, which is generally silicone oil or saline, will typically achieve approxi¬ mately 350,000 cycles before fold flaw failure occurs through rupture or the like of the penile implant blad¬ der. The inventors herein have performed tests with the hydraulic fill of the present invention where over 10 million cycles have been completed with no failure expe¬ rienced. While 350,000 cycles might ordinarily be con- sidered to be adequate for more than the useful life of a penile implant, it must be remembered that prior to fold flaw failure, the abrasive action of the hydraulic fill will more likely cause a deterioration of the other sys¬ tem components leading to leakages, or other problems within the system which must be then corrected through surgery. Obviously, surgery is sought to be avoided at all costs especially in view of the sensitive part of the human anatomy involved, both physically as well as psychologically. In order to enhance leak detection, the implant bladders may be made of radiolucent material, and a radi¬ opaque dye added to the triglyceride fill. This enables, for the first time, at least a partial x-ray procedure to be used to detect leaks in the bladder area of the im- plant by using x-ray intensities and exposure times much reduced over the intensities and exposure times experi¬ enced with full body x-rays. The harmful effects of x- ray in the testicular area are well known and have been appreciated for many years. This improved implant con- struction enables at least a portion of the implant to be viewed at much less risk to the patient. Use of the radiolucent material for the bladder prevents the bladder itself from obscuring the fill as an appropriate x-ray is taken. Furthermore, as explained above, a phenomenon known as fold flaw failure readily occurs in the bladder of penile implants. This is generally experienced at the point in the bladder where the penis bends to become less obtrusive upon deflation of the implant. This repeated bending and unbending as the implant is inflated and deflated can cause a fold to occur in the bladder at that point which, after repeated use, can fail by tearing or the like. Thus, this important cause of failure may be readily detected using x-rays which do not expose the entire testicular area to the x-ray techniques customari¬ ly used in the prior art. Still another feature of the present invention is the utilization of texturing in several parts of the implant in order to increase its biocompatibility. As explained above, a "capsular contracture" effect can be experienced at the site of implantation of the reservoir. This source of failure can be reduced through the use of texturing, as with breast implants, by texturing the exterior surface of the reservoir. Texturing may also be used in the implant bladders to decrease the tendency for fold flaw failure as the texturing will enhance the inte- gration of the bladder surface with the surrounding tis¬ sue thereby preventing kinking or accute folding upon deflation.

While the principal advantages and features of the present invention have been described above, a more com- plete and thorough understanding of the invention may be attained by referring to the drawings and description of the preferred embodiment which follow. Brief Description of the Drawings

The figure is a cross-sectional view of a penile implant with hydraulic system implanted in a patient. Detailed Description of the Preferred Embodiment

As shown in the figure, a penile implant 12 is implanted in the penis 10 of a male patient that includes a bladder 14 having surface texturing on the exterior surface thereof. The bladder 14 may be made from any of the radiolucent materials previously disclosed in the related application cross-referenced above. A tubing 16 interconnects the bladder 14 with a pump 18 filled with a hydraulic fill 20 which may be any suitable triglyceride, such as peanut oil or soybean oil. Any suitable bio- compatible material demonstrating the same approximate degree of lubricity and metabolic rate to enhance leak detection may be used. Generally, these materials com¬ prise triglycerides. Another tubing 22 connects the pump 18 with a reservoir 24 implanted in the abdomen 28 area of a patient's body, with the exterior surface of reser¬ voir 24 having texturing 26.

The surface texturing of the bladder and reservoir helps resolve different problems previously experienced in prior art penile implants. With respect to the blad- der 14, the surface texturing helps to prevent the kink¬ ing in the bladder as tissue grows into the fold general¬ ly created as the bladder 14 deflates and the penis 10 fold over or bends downwardly to become less obtrusive. On the other hand, with respect to the reservoir 24, as mentioned above a scar capsule can form around the reser¬ voir 24 and contract which would impede its being re¬ filled with hydraulic filler as required to deflate the implant.

There are various changes and modifications which may be made to the invention as would be apparent to those skilled in the art. However, these changes or modifications are included in the teaching of the dis¬ closure, and it is intended that the invention be limited only by the scope of the claims appended hereto.

Claims

What Is Claimed Is:

1. In a penile implant, said implant including a pressurized hydraulic system for achieving an erection, the improvement comprising a triglyceride hydraulic fill material for said hydraulic system.

2. The penile implant of Claim 1 wherein said hydraulic fill includes a radiopaque marker.

3. The penile implant of Claim 2 wherein at least some parts of said penile implant are made of materials which are radiolucent at reduced x-ray intensities.

4. The penile implant of Claim 3 wherein said penile implant includes a bladder for inflation to there¬ by produce an erection, said bladder being constructed of radiolucent material.

5. The penile implant of Claim 2 wherein at least some parts of said penile implant have textured exterior surfaces.

6. The penile implant of Claim 5 wherein said penile implant includes a reservoir for holding a quanti¬ ty of said hydraulic fill, said reservoir having its exterior surface textured.

7. The penile implant of Claim 5 wherein said penile implant includes a bladder for inflation to there¬ by produce an erection, said bladder having its exterior surface textured.

8. In a penile implant, said penile implant in¬ cluding a pressurized hydraulic system for achieving an erection, the improvement comprising a textured exterior surface on at least some parts of said penile implant.

9. The penile implant of Claim 8 wherein said penile implant includes a reservoir for holding a quanti¬ ty of said hydraulic fill, said reservoir having its exterior surface textured.

10. The penile implant of Claim 9 wherein said penile implant includes a bladder for inflation to there- by produce an erection, said bladder having its exterior surface textured.

11. The penile implant of Claim 10 wherein said hydraulic system includes a triglyceride hydraulic fill material.

12. The penile implant of Claim 11 wherein said hydraulic fill includes a radiopaque marker.

13. A penile implant having a bladder, a reservoir connected to said bladder, hydraulic fluid contained within said reservoir, and means for selectively forcing said hydraulic fluid from said reservoir into said blad¬ der to thereby produce an erection, said hydraulic fluid being comprised of a triglyceride fluid.

14. The penile implant of Claim 13 wherein said reservoir has an exterior surface and further comprising texturing on said exterior surface.

15. The penile implant of Claim 14 wherein said penile implant includes a bladder for inflation to there¬ by produce an erection, said bladder having its exterior surface textured.

16. The penile implant of Claim 15 wherein said hydraulic fill includes a radiopaque marker and wherein at least said bladder is made of a material which is radiolucent at reduced x-ray intensities.