Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Hollow or tubular part or organ
Reexamination Certificate
1998-11-10
2001-02-06
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Hollow or tubular part or organ
C600S029000, C606S108000
Reexamination Certificate
active
06183520
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of prosthetic urethral valves or seals for controlling urinary continence. More particularly, the present invention relates to a prosthetic urethral device having an opening pressure that varies in response to changes in physiologic parameters. The present invention also relates to an introducer for transurethrally introducing the prosthetic device in a nonsurgical or minimally invasive procedure.
BACKGROUND OF THE INVENTION
Urinary incontinence is a widespread problem in the United States and throughout the world. Urinary incontinence affects people of all ages and can severally impact a patient both physiologically and psychologically. Urinary incontinence has a number of causes, including birth defects, disease, injury, aging, and urinary tract infection.
In light of the foregoing, a number of attempts have been made to combat urinary incontinence. One such attempt involves the use of a catheter connected to a collection bag with a clamping device on the catheter. Indwelling catheters, however, have a number of drawbacks. For instance, there is an infection risk associated with indwelling catheters, which provide a direct passage for bacteria or other microorganisms into the bladder. Thus, indwelling catheters can only be used for relatively short-term situations. In addition, indwelling catheters and associated collection bags are not cosmetically appealing to most patients.
Prosthetic urethral valves of the prior art for controlling incontinence also have numerous disadvantages. For instance, many prior art urethral valves utilize an inflatable cuff around the outside of the urethra. One disadvantage of such a valve is that it requires surgery for installation. In addition, such a valve must be operated externally and thus is dependent on manual intervention.
Intraurethral valves of the prior art also generally require manual intervention. Another problem associated with intraurethral valves is that they may be displaced into the bladder or expelled from the urethra. There is also an infection risk associated with many such valves since they extend into the meatus and/or have portions of the device external to the urethra providing a passage for micro-organisms into the bladder.
Thus, there remains a need for a nonsurgically installed prosthetic urethral valve or seal that responds to physiological conditions and thus can be controlled voluntarily by the patient without manual intervention.
SUMMARY OF THE INVENTION
In one aspect of the present invention, there is provided a prosthetic urethral valve assembly. The valve assembly includes a tubular body having a proximal end, a distal end, and a central lumen extending therethrough. Attached to the proximal end of the tubular body is a first anchor. The first anchor conforms to a portion of the base of the bladder so that the prosthetic urethral valve assembly remains properly located relative to the bladder and the urethra. The valve assembly also includes a second anchor, which is attached to the tubular body at a point between the proximal end and the distal end of the tubular body. The second anchor lies within the urethra and helps to anchor the valve assembly therein. The valve assembly also includes a valve, which can be located within the lumen of the tubular body between the proximal end and the distal end of the tubular body. When positioned in the patient, the distal end of the tubular body is disposed in the midurethra, such as between the internal urethral sphincter and the external urethral sphincter or introitus so that the opening pressure of the valve varies in response to changes in physiologic parameters.
Another aspect of the present invention relates to a method of maintaining urinary continence in a patient. The method includes positioning the prosthetic urethral valve assembly of the present invention in a patient so that the distal end of the tubular body and preferably the valve lie in the midurethra, such as between the internal urethral sphincter and the external urethral sphincter so that the opening pressure of the valve varies in response to changes in physiologic parameters. For example, the opening pressure of the valve can vary in response to pressure exerted on the urethra caused by a rise in abdominal pressure.
Another aspect of the present invention relates to a method of varying the opening pressure of a prosthetic urethral valve in response to changes in abdominal pressure. The method includes providing a prosthetic urethral valve having a proximal end, a distal end, and a valved flow path therebetween. The valve is positioned in a patient within the flow path between the bladder and the outside of the patient. Preferably, the valve is positioned in the patient within the urethra between the internal sphincter and the external sphincter. The method also includes exposing the distal side of the valve to elevations in intraabdominal pressure and increasing the opening pressure of the valve in response to elevations in intraabdominal pressure.
In accordance with another aspect of the present invention, there is provided an intraurethral device for maintaining urinary continence. The device in accordance with this aspect of the present invention is preferably valveless. The device includes a tubular body having a proximal end, a distal end, and a central lumen extending therethrough. Attached to the proximal end of the tubular body is a first anchor, which conforms to a portion of the base of the bladder so that the device remains properly located relative to the bladder and the urethra. The device is made of a substantially compliant material so that the tubular body of the device reversibly seals in response to internal forces affecting the urethra and bladder neck. For instance, when micturition is undesired, the tubular body of the device reversibly seals in response to inwardly directed urethral forces, thereby maintaining urinary continence. The tubular body of the device can also reversibly seal by kinking in response to rotational descent of the bladder neck and urethra, thereby maintaining continence, such as in patients suffering from incontinence caused by hypermobility and/or weak pelvic floor muscles.
Another aspect of the present invention relates to an alternate embodiment of the intraurethral device for maintaining urinary continence. The device includes a tubular body having a proximal end, a distal end, and a central lumen extending therethrough. The tubular body has a shape which conforms to the urethra. The device also includes a first anchor which is attached to the tubular body. The first anchor is preferably attached to the proximal end of the tubular body. The first anchor conforms to a portion of the urethra, preferably the proximal urethra, to resist migration of the intraurethral device relative to the urethra. The device may also include a second anchor attached to the tubular body. The device is made of a substantially compliant material so that portions of the device, such as the tubular body and/or first anchor, reversibly seal in response to anatomical forces affecting the urethra and bladder neck.
In accordance with another aspect of the present invention there is provided a combination of a device for treating urinary incontinence and an introducer for transurethrally introducing the device. The introducer is an elongate generally tubular structure having a first end, a second end, and a central lumen extending therethrough. The tubular structure preferably has a variable diameter. The variable diameter feature of the tubular structure may be accomplished by providing the wall of the tubular structure with a longitudinally extending split. The split may extend partially or fully along the length of the wall of the tubular structure. The variable diameter of the tubular structure allows expansion of the tubular structure to facilitate loading and deployment of the device. The variable diameter of the tubular structure also allows contraction of the tubular structure during transurethral intro
Brenneman Rodney A.
Maciel Mario
Pintauro William L.
Wallin Sheila K.
Galt Laboratories, Inc.
Jackson Suzette J.
Knobbe Martens Olson & Bear LLP
Willse David H.
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