Surgery – Sexual appliance – Male splint
Reexamination Certificate
2003-04-25
2004-10-26
Gilbert, Samuel G. (Department: 3736)
Surgery
Sexual appliance
Male splint
Reexamination Certificate
active
06808490
ABSTRACT:
BACKGROUND
The present disclosure relates to medical devices used in implant surgery. More specifically, the present disclosure relates to an inflatable penile prosthesis, or penile implant.
The study of impotence has recently become center stage in the field of medicine. In the early 1970's, the conventional view was that ninety percent of impotence cases were psychologically based, whereas only ten percent of the cases were caused by a physical condition. Today, doctors and scientists understand that the overwhelming majority of cases are caused by a physical condition. Accordingly, more and more resources are poured into the study of and treatment for impotence. According to a recent study, fifty-two percent of men between the ages of forty and seventy self-reported that they suffer from some type of erectile dysfunction. Another study estimated that over thirty million American men and their partners suffer from erectile dysfunction.
Advertisements for pharmaceutical treatments for impotence have become ubiquitous, and include endorsements from celebrities that suffer from erectile dysfunction. More and more men and their partners now are seeking treatment for impotence. In the recent past, it was estimated that only one in twenty sufferers of erectile dysfunction sought treatment from their doctors. Pharmaceutical treatments are successful for only a subset of impotence sufferers. More invasive treatments are necessary for many men. These treatments include injection therapy, vacuum devices and penile prosthesis.
For many impotence sufferers, the penile implant is the only solution to restore a happy and healthy sex life. The penile implant has been used for decades and provides a selected and reliable erection. The penile implant often includes a pair of cylinders. In some instances, these cylinders are inflatable, and are connected to a fluid-filled reservoir with a pump and valve assembly. The two cylinders are normally implanted into the corpus cavernosae of the patient's penis and the reservoir is typically implanted into the patient's abdomen. The pump assembly is implanted in the scrotum. During use, the patient actuates the pump and fluid is transferred from the reservoir through the pump and into the cylinders. This results in the inflation of the cylinders and produces rigidity for a normal erection. Then, when the patient desires to deflate the cylinders, a valve assembly within the pump is actuated in a manner such that the fluid in the cylinders is released back into the reservoir. This deflation returns the penis to a flaccid state.
A type of inflatable penile implant includes a cylinder having an inflation chamber side that is disposed within the penis (distal corpus cavernosae) and rear tip side that is disposed within the body (proximal corpus cavernosae). The penile implant includes a remote pump assembly that is connected via tubing to the cylinder. The tubing is connected to the cylinder at a tubing junction. Typically, this tubing junction is located near the interface between the inflation chamber and the rear tip. The tubing junction includes a strain relief that extends from the cylinder like a branch from a tree trunk. The tubing is inserted into the strain relief. In prior art examples, such as those in U.S. Pat. Nos. 4,651,721 and 5,167,611, among others, show a straight bore extending through the strain relief and into the inflation chamber. Fluid is transferred from the pump assembly, through the tubing, and into the inflation chamber.
The penile implant is an invasive treatment and requires a delicate and painful implant surgery to install. To reach the corpus cavernosum and implant the cylinders, the surgeon will first make an incision at the base of the penis, such as where it meets the scrotum. The patient is prepared for the cylinder after the surgeon has dilated each corpus cavernosum to create space for the cylinders. The distal end of the cylinder, i.e., the inflation chamber, is inserted into the corpus cavernosum. The proximal end of the cylinder, i.e., the rear tip and tubing junction, is inserted back into the body toward the pubic bone.
The tubing junction, and particularly the strain relief, increases the effective width, or effective diameter, of the cylinder. This increased width can create problems for both the surgeon and the patient during surgery. Some physicians have difficulty dilating the proximal corporal body sufficiently to accept the proximal end of the cylinder. And the added effective diameter of the tubing junction sometimes requires that the surgeon force the device through pelvic tissue, such as severe fibrotic tissue in some patients. This can make proper insertion and placement more difficult than if the cylinder were easily inserted, and can require further cutting and trauma. Further, the added effective width causes an increase in trauma to what is otherwise a sensitive area for the patient, which can require longer healing times.
SUMMARY
The present disclosure relates to penile implants that are easier to implant and reduce trauma because they provide for a smaller effective width during implantation, after implantation, or both. The present disclosure also provides for a shorter tubing junction while reducing effective width, further reducing trauma to the body.
In the first aspect, the present disclosure relates to a penile implant that includes a tubing junction that is smaller in effective diameter while implanted in the body. A penile implant includes an axially extending cylinder having an inflation chamber and a rear tip. The cylinder also includes a tubing junction disposed between the inflation chamber and rear tip and extending from the cylinder. The tubing junction includes a bore in fluid communication with the inflation chamber. In one example, this bore is in the strain relief of the tubing junction. The bore is configured to include a compound curve. The compound curve in the bore permits the strain relief to lay flatter against the cylinder than a straight bore or even a bore with a “hairpin” curve.
In another aspect, the present disclosure relates to a penile implant that includes a tubing junction that can assume a smaller effective diameter while being implanted into the body. Specifically, the surgeon is able to press the tubing against the cylinder than the related art to reduce the effective area of the penile implant. This penile implant includes a cylinder having an inflation chamber and a rear tip. A tubing junction is disposed between the inflation chamber and the rear tip. The tubing junction includes a strain relief that extends from the cylinder and forms an acute area proximate the intersection of the cylinder and the strain relief. The acute area includes a keyhole. The keyhole permits the strain relief to lie closer to the cylinder without causing damage to the tubing, strain relief, or other parts of the prosthesis.
The present disclosure provides many advantages, among which two are listed here. These two aspects have been demonstrated to provide a cylinder having an advantageously smaller effective diameter during or after implantation than the related art. The tubing junction with a bore configured to include a curve having a compound angle provides noticeable advantages both during and after implantation. One example has been demonstrated to be at least approximately fifteen percent smaller in effective diameter over popular products of the related art. Additionally, the aspect with the keyhole has been demonstrated to permit the strain relief to lie flat, i.e., zero degrees, against the cylinder, during implantation of the device. Other advantages will become apparent to those skilled in the art.
REFERENCES:
patent: 4718410 (1988-01-01), Hakky
patent: 5062417 (1991-11-01), Cowen
patent: 5250020 (1993-10-01), Bley
George Stephanie A.
Ling Jeremy J.
Morningstar Randy L.
AMS Research Corporation
Gilbert Samuel G.
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