Surgery – Body inserted urinary or colonic incontinent device or... – Implanted
Reexamination Certificate
2002-04-19
2004-06-01
Lacyk, John P. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Implanted
C604S174000, C600S561000
Reexamination Certificate
active
06743165
ABSTRACT:
COPYRIGHT NOTICE
A portion of the disclosure of this patent document may contain material which is subject to copyright protection. The copyright owner has no objection to the xerographic reproduction by anyone of the patent document or the patent disclosure in exactly the form it appears in the Patent & Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.
TECHNICAL FIELD
The present invention generally relates to devices, system, and methods for diagnosing and/or treating urinary incontinence. In an exemplary embodiment, the invention provides catheter-based pressure sensing systems for diagnosing female urinary incontinence, and in particular, provides systems for determining the relationship between urethral pressure and vesicle pressure in response to changes in abdominal pressure. Preferred aspects of the present invention relate to urethral catheter holder mechanisms.
BACKGROUND OF THE INVENTION
Urinary incontinence arises in both men and women with varying degrees of severity, and from different causes. In men, the condition most frequently occurs as a result of prostatectomies which result in mechanical damage to the urethral sphincter. In women, the condition typically arises after pregnancy when musculoskeletal damage has occurred as a result of inelastic stretching of the structures which support the genitourinary tract. Specifically, pregnancy can result in inelastic stretching of the pelvic floor, the external sphincter, and the tissue structures which support the bladder and bladder neck region. In each of these cases, urinary leakage typically occurs when a patient's abdominal pressure increases as a result of stress, e.g., coughing, sneezing, laughing, exercise, or the like.
Treatment of urinary incontinence can take a variety of forms. Most simply, the patient can wear absorptive devices or clothing, which is often sufficient for minor leakage events. Alternatively or additionally, patients may undertake exercises intended to strengthen the muscles in the pelvic region, or may attempt a behavior modification intended to reduce the incidence of urinary leakage.
In cases where such non-interventional approaches are inadequate or unacceptable, the patient may undergo surgery to correct the problem. A wide variety of procedures have been developed to correct urinary incontinence in women. Several of these procedures are specifically intended to support the bladder neck region. For example, sutures, straps or other artificial structures are often looped around the bladder neck and affixed to the pelvis, the endopelvic fascia, the ligaments which support the bladder, or the like. Other procedures involve surgical injections of bulking agents, inflatable balloons, or other elements to mechanically support the bladder neck.
In work related to the present invention, it has recently been proposed to treat incontinence by directing energy to a tissue structure comprising or supporting the patient's urethra, bladder neck, or bladder. The energy can contract collagenous structures such as fascia, tendons, or the like, increasing the structural support of these natural support tissues. As described in PCT Application Serial Nos. 98/16754 and 97/20191, the full disclosures of which are incorporated herein by reference, the energy may be transmitted through an intermediate tissue, or by accessing the collagenous tissue surface in a minimally invasive manner.
Researchers have studied female urinary incontinence by evaluating the relationship between a patient's urethral pressure and her vesicle (i.e.:, bladder) pressure. In an article by Kim et al.,
The Vesico-Urethral Pressuregram Analysis of Urethral Function Under Stress, Journal of Biomechanics,
Vol. 30, page 19 (1997), proposed a method for analyzing the interaction between the vesicle pressure and urethral pressure to assess urinary stress incontinence. Both urethral pressure and vesicle pressure will change in response to changes in abdominal pressure. However, the urethral and vesicle pressures may change at different rates as the abdominal pressure changes. Incontinence may occur when the vesicle pressure exceeds the urethral pressure. Hence, incontinence can be studied by producing a pressuregram showing the relationship between the urethral pressure and the vesicle pressure of the patient during abdominal pressure pulses.
A patient's vesicle and urethral pressures can be measured by introducing a catheter into the urethra and positioning pressure sensors of the catheter at the desired measurement sites in the urethra and/or bladder. The measurements of the patient's vesicle and urethral pressures are preferably taken simultaneously during changes in abdominal pressures.
Unfortunately, simultaneous pressure measurements can be difficult to obtain using presently available pressure-sensing catheters. Hence, existing systems are not well suited for diagnosing urinary incontinence of a particular patient. Similarly, while the recently proposed tissue contraction therapies offer great promise for treatment of urinary stress incontinence, proper treatment to enhance elongated or weak support structures of a particular patient could benefit significantly from improved techniques for diagnosing urinary incontinence.
In light of the above, it would be desirable to provide improved devices, systems, and methods for diagnosing and/or treating urinary incontinence.
SUMMARY OF THE INVENTION
The present invention generally provides improved devices, systems, and methods for diagnosing and/or treating urinary incontinence. The invention provides pressure-sensing catheter systems which can accurately and reliably monitor both a vesicle pressure and a maximum urethral pressure of a patient during an abdominal pressure pulse so as to determine relationships between these pressures. Work in connection with the invention has shown that diagnostic urethral pressure measurements during a pressure pulse are sensitive to loss of alignment between the pressure sensor and the target pressure location. Advantageously, alignment between, for example, the location of maximum urethral pressure and a pressure sensor of a catheter can be maintained using an anchoring structure having a surface which engages a tissue surface along the bladder neck, urethra, or external meatus (the tissue structure adjacent the urethral opening). These tissues generally moves with the urethra during abdominal pressure pulses, so that the anchoring structure will often move the pressure sensor when an abdominal pressure pulse is induced. The invention allows a reliable, accurate pressuregram to be generated, the pressuregram graphically showing an increase in urethral pressure relative to an increase in vesicle pressure. This pressuregram will ideally be displayed in real time to a system operator adjacent the patient, and may provide a quantitative and/or qualitative diagnostic output allowing selective remodeling of the patient's support structure so that the incontinence is inhibited.
In a first aspect, the invention provides an apparatus for evaluating urinary incontinence of a patient. The patient has a urethra extending from a bladder to a urethral opening, with a maximum urethral pressure disposed between the bladder and opening. The system comprises a pressure-sensing system including an elongate body having a proximal end and a distal end. A vesicle pressure sensor is disposed adjacent the distal end for measuring fluid pressure within the bladder. At least one urethral pressure sensor is disposed proximally of the vesicle pressure sensor for measuring urethral pressure. An anchoring structure is disposed along the elongate body. The anchoring structure is adapted to engage a tissue surface adjacent the urethra so as to maintain alignment between the urethral pressure sensor and the maximum urethral pressure when a pressure pulse moves the urethra. A processor is coupled to the pressure-sensing system. The processor calculates a relationship between the urethral pressure and the ves
Ingle Frank W.
Levy Stanley
Mosel Brian J.
Roy Loren L.
Barrish, Esq. Mark D.
Lacyk John P.
Solarant Medical, Inc.
Townsend and Townsend / and Crew LLP
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