It is known to treat stress urinary incontinence by implanting an inflatable prosthesis within the periurethral tissues. When the prosthesis is properly positioned within the periurethral tissues and inflated, localized tissue volume is increased, enhancing the passive occlusive pressure of the urethral sphincter and thereby achieving continence. Examples of such inflatable prostheses and of instruments for implanting, dispensing, and inflating these prostheses in the periurethral tissues are shown, for example, in U.S. Pat. No. 4,686,962, U.S. Pat. No. 4,773,393, U.S. Pat. No. 4,802,479, and U.S. Pat. No. 4,832,680, which patents are incorporated herein by reference.
Prior art procedures for implanting the inflatable prosthesis in the periurethral tissues comprise forming a first trocar tract to the periurethral tissues on one side of the sphincter. A prosthesis is placed on the tip of a catheter and introduced through this tract to a target location within the periurethral tissues. An isotonic fluid medium is then infused through the catheter and into the prosthesis to inflate it. A second trocar tract is then formed to the periurethral tissues on the other side of the sphincter, and the procedure is repeated with a second prosthesis through the other trocar tract.
Certain difficulties are presented by these prior art implantation procedures. For example, it can be difficult to position the implants properly along the length of the urethra so as to be properly positioned with respect to the sphincter. If the prosthetic devices are not properly positioned with respect to the urethral sphincter, the occlusive pressure will be suboptimal, and continence may not be achieved. Also, the possibility exists that the physician could accidentally puncture the urethra or bladder while implanting the devices. Further, since the trocar tracts are formed independently, the inflation of the first implant can distend the periurethral tissues and push the urethra away from its normal alignment, thereby making the proper positioning of the second implant more difficult.
Finally, the prior art procedure can be somewhat difficult for the physician to perform and may require more than one attempt to properly position the implants, thereby resulting in increased trauma to the patient.
Thus there is a need for an improved apparatus and method for implanting prostheses within periurethral tissues.
There is also a need for an apparatus and method for implanting prostheses within periurethral tissues which will ensure proper positioning of the implants with respect to the urethral sphincter.
Further there is a need for an apparatus and method for implanting prostheses within periurethral tissues which will prevent the possibility of the physician accidentally puncturing the urethra or bladder.
There exists a still further need for an apparatus and method for implanting a pair of prostheses within periurethral tissues in which the implantation of the first prosthesis does not adversely impact the physician's ability to position the second prosthesis properly.
USPTO Backgrounds
USPTO Backgrounds