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
06808489
ABSTRACT:
BACKGROUND
The present disclosure relates to medical devices used in implant surgery. More specifically, the present disclosure relates to a penile prosthesis, or penile implant, adapted to receive rear tip extenders.
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. In 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 prostheses.
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 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 two cylinders each 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 cylinders. Fluid is transferred from the pump assembly, through the tubing, and into the inflation chambers. The rear tip is not inflated.
The penile prosthesis is an invasive treatment and requires a delicate and painful surgery to implant. To reach the corpus cavernosae 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, is inserted back into the body toward the pubic bone. To ensure a proper fit, the surgeon may choose to attach one or more rear tip extenders to the rear tip. One example of a rear tip extender is a silicone rubber cap that fits onto the rear tip or another rear tip extender that will provide the proper length of the cylinder.
A concern during implant surgery is infection around the prosthesis. One straightforward method of reducing the chances of infection is to impregnate antibiotics into the tissue-contacting surfaces of the prosthesis. One such antibiotic formulation is minocycline hydrochloride and rifampin. A second method is to coat the tissue-contacting surfaces of the prosthesis with a hydrophilic material. Prior to implantation, the surgeon will soak the prosthesis in an antimicrobial solution such as a bath including a bacterio-static product like poly vinyl pyrollidone (PVP). The hydrophilic material will hold the solution on the surface of the prosthesis. This second method, however, suffers from some disadvantages. For example, the prosthesis becomes slippery when soaked in the antimicrobial solution. The prosthesis is more slippery than one with impregnated antibiotics from the first method, and is more slippery than one without a surface treatment.
A slippery prosthesis can cause problems when used with rear tip extenders. Prostheses applying the second method use slide-on friction-fit rear tip extenders. These extenders look like hollow versions of the tapered rear tip, or hollow cones. The hollow cones slide on the end of the rear tip and stay on because of the friction created with the rear tip against the inside of the cone. Surgeons have determined that in some cases, the rear tip extender will slide off the rear tip of a prosthesis prepared with the second method. The rear tip extender then can be lost in the body.
Another difficulty of these rear tip extenders is that the shape itself can cause trauma to the patient in what otherwise is a very sensitive area. Imagine stacking a hollow cone on another cone. The stack is efficient, but there is not a smooth profile at the wide end of the hollow cone, i.e., the wide end of the rear tip extender. The discontinuity or protuberance at the end of the rear tip extender can cause trauma to the patient. This trauma is compounded if more than one rear tip extender is applied.
Accordingly, there is a need in the art for a less invasive rear tip extender that does not include an irritating discontinuity when attached to a prosthesis, and one that can be reliably attached to a slippery prosthesis after it has been soaked in a antimicrobial solution.
SUMMARY
The present disclosure is directed to an improved rear tip and rear tip extender where the rear tip securely attaches to a rear tip extender, even when slippery, and can avoid creating an irritating discontinuity in the profile.
In a first aspect, the disclosure is directed to a penile implant having a cylinder with a rear tip. The rear tip includes a section having a generally smooth profile and a section having a connector end. A rear tip extender is adapted to fit over the section having the connector end. The rear tip extender includes a base, wherein the base fits over the rear tip at an interface. The rear tip is adapted to receive the rear tip extender with a ring in groove attachment. The base is aligned with the generally smooth profile of the rear tip without a protuberance at the interface.
In a second aspect, the disclosure is directed to a penile implant including a cylinder having a rear tip. The cylinder includes a hydrophilic coating adapted to receive an antimicrobial solution. A rear tip extender is adapted to fit over the rear tip, and the rear tip and rear tip extender are connected together with a ring in groove attachment.
REFERENCES:
patent: 4602621 (1986-07-01), Hakky
patent: 5050592 (1991-09-01), Olmedo
George Stephanie A.
Glaser Ginger Sackett
AMS Research Corporation
Gilbert Samuel G.
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