Surgery – Instruments
Reexamination Certificate
1999-12-23
2002-11-12
Peffley, Michael (Department: 3739)
Surgery
Instruments
C606S139000
Reexamination Certificate
active
06478791
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention generally relates to medical devices, methods and systems, particularly for the treatment of urinary incontinence.
Urinary incontinence arises in both men and women with varying degrees of severity, and from different causes. In men, the condition frequently occurs as a result of prostatectomies which result in mechanical damage to the 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.
An alternative procedure which is often performed to enhance support of the bladder is the Kelly plication. This technique involves midline plication of the fascia, particularly for repair of central defects. In this transvaginal procedure, the endopelvic fascia from either side of the urethra is approximated and attached together using silk or linen suture. A similar procedure, anterior colporrhaphy, involves exposing the pubocervical fascia and reapproximating or plicating portions of this tissue from either side of the midline with absorbable sutures. While the Kelly plication and its variations are now often used for repair of cystocele, this procedure was originally described for the treatment of incontinence.
Each of these known procedures has associated shortcomings. Surgical operations which involve midline plications or direct suturing of the tissue structures supporting the urethra or bladder neck region require great skill and care to achieve the proper level of artificial support. In other words, it is necessary to occlude or support the tissue sufficiently to inhibit urinary leakage, but not so much that intentional voiding is made difficult or impossible. Balloons and other bulking agents which have been inserted can migrate or be absorbed by the body. The presence of such inserts can also be a source of urinary tract infections.
For these reasons, it would be desirable to provide improved devices, systems and methods for treating urinary incontinence in men and women. In particular, it would be desirable to provide techniques for treating urinary incontinence which did not artificially compress or obstruct the urethra, but which enhanced the support and functioning of the patient's natural pelvic tissue structures. It would further be desirable if these improved techniques could be performed rapidly in a minimally invasive manner and with good efficacy, despite normal variations in individual surgeon's surgical skills and experience.
2. Description of the Background Art
The impact of surgical treatments of the urethra were described in
Female Urology,
2nd Ed., by Shlomo Raz (1996). This reference also describes techniques of surgical repair for treatment of cystocele (including the Kelly plication and the Burch procedure) on pages 340-342, while various alternative known surgical interventions for treatment of incontinence are schematically illustrated on page 356. At least some of these procedures are also described in
Female Pelvic Disorders, Investigation And Management
by J. Thomas Benson (1992) on pages 239-240.
The following patents and published applications relate to the treatment of urinary incontinence. U.S. Pat. Nos. 5,437,603; 5,411,475; 5,376,064; 5,314,465; 5,304,123; 5,256,133; 5,234,409; 5,140,999; 5,012,822; 4,994,019; 4,832,680; 4,802,479; 4,773,393; 4,686,962; 4,453,536; 3,939,821; 3,926,175; 3,924,631; 3,575,158; 3,749,098; and WO 93/07815.
An electrosurgical probe for the controlled contraction of tissue of joints and for dermatological indicators is described in U.S. Pat. No. 5,458,596. A bipolar electrosurgical probe having electrodes formed over a restricted arc of its distal end for treatment of, e.g., the esophagus, as described in U.S. Pat. No. 4,765,331. An electrosurgical probe for retrograde sphincterotomy is described in U.S. Pat. No. 5,035,696.
SUMMARY OF THE INVENTION
The present invention provides improved devices, methods, and systems for the surgical treatment of urinary incontinence. The techniques of the present invention generally enhance the support provided by the natural tissues of the pelvic floor without directly applying compressive pressure against the urethra. The invention provides methods and probes that are particularly well suited for forming plications in the endopelvic fascia which are displaced laterally on either side of the midline. In the preferred embodiments, the plication probes impose a predetermined level of trauma to the approximated tissues so as to promote the formation of adhesions. These tough fibrous scar tissues can maintain the enhanced support provided by the reduction in effective support tissue length after reabsorption of a temporary fastener (such as a reabsorbable suture, staple, or the like). The use of a plicating probe which draws the tissue laterally inward toward the probe and affixes the plication not only speeds up the procedure, but also provides a fold having a fold depth within a predetermined size range so as to effectively inhibit incontinence.
In a first aspect, the present invention provides a therapy for incontinence. The therapy comprises engaging an endopelvic support tissue with a probe, and manipulating the engaged tissue with the probe to form a fold having a first portion of the tissue adjacent to a second portion of the tissue along a fold depth, the fold depth being within a predetermined range. The first and second tissue portions are then affixed together with the probe to decrease a dimension of the tissue such that incontinence is inhibited.
Generally, the tissue portions will comprise the endopelvic fascia. This tissue will ideally be drawn laterally inward to fold either towards or away from the probe, the tissue often being affixed into two separate folds disposed on opposite sides of (and separated from) the urethra. The approximated portions of the endopelvic fascia may be affixed together by advancing a fastener from the probe at least partially through each tissue portion. Suitable fasteners include suture, staples, barbed tacks, helical coils, and the like, and will preferably be at least partially bio-absorbable. Where bio-absorbable fasteners are used, the probe will preferably also promote adhesion formation between the first and second tissue portions by abrading the adjacent tissue surfaces, by transmitting an electrical current through the tissues, or the like. The probe will often draw the tissue portions towards each other so as to define a tissue fold having a tissue depth of between about 2.0 mm and 2.0 cm from the tis
Carter Garry L.
Claude John P.
Densow David C.
Do Paul L.
Morrison George A.
Peffley Michael
SURX, Inc.
Townsend and Townsend / and Crew LLP
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