Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Thermal applicators
Reexamination Certificate
2001-07-09
2004-06-15
Gibson, Roy D. (Department: 3739)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Thermal applicators
C607S098000, C606S041000
Reexamination Certificate
active
06751507
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 urinary sphincter. In women, the condition typically arises after pregnancy when musculoskeletal damage has occurred as a result of inelastic stretching of the structures supporting 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, urethra, 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 done related to the present invention, it has been proposed to treat urinary incontinence by selectively contracting or shrinking a portion of the pelvic support tissue so as to reposition the bladder and/or urogenital tract. U.S. patent application Ser. No. 08/910,370 generally describes laparoscopic and other minimally invasive devices, methods, and systems for shrinking tissues, particularly for treatment of incontinence. U.S. patent application Ser. No. 09/133,496 describes noninvasive devices, methods, and systems for shrinking of tissues, often by cooling a surface of an intermediate tissue and directing energy through the cooled intermediate tissue to the target tissue so as to effect shrinkage. U.S. patent application Ser. No. 09/170,767 is directed to static devices and methods to shrink tissues for incontinence. Finally, U.S. patent application Ser. No. 09/103,352 describes tuck and fold fascia shortening for incontinence. Each of these applications is assigned to the present assignee, and their full disclosures are incorporated herein by reference.
While these recent proposals for treatment of incontinence represent significant advancements in the art, treatment of incontinence and other conditions related to insufficient tissue support could benefit from still further advances. In particular, it is generally beneficial to minimize collateral damage imposed on the treated and adjacent tissues during any therapy. It would further be beneficial to provide alternative treatment mechanisms for reducing or eliminating the severity and occurrence of incontinence events.
A variety of other problems can arise when tissues of the body fail to provide adequate support. Weakened pelvic support tissues (particularly the ligaments and fascia of the pelvic area) can lead to a variety of ailments including, for example, cystocele, prolapse, and the like. Cosmetic surgeries are also often performed to enhance the support provided by fascial tissues. For example, abdominoplasty (often called a “tummy tuck”) is often performed to enhance support provide by the abdominal wall. The distortion of these support tissues may be due to strain, advanced age, congenital predisposition, or the like.
For these reasons, it would be desirable to provide improved devices, methods, and systems for treating the support tissues of the body. It would be particularly desirable to provide techniques for treatment of incontinence and other conditions by enhancing the support of the body's own tissue systems. It would further be advantageous if these improved techniques could take advantage of the recent advancements in minimally invasive and noninvasive therapies described hereinabove, and could effect treatment with decreased collateral damage. Some or all of these advantages are provided by the invention described hereinbelow.
2. Description of the Background Art
U.S. patent application Ser. Nos. 08/910,370; 09/133,496; 09/170,767; and 09/103,352 are described hereinabove. PCT Application No. 97/43,971 describes a method and apparatus for ablating turbinates. PCT Application No. 98/38,936 describes a method and apparatus for treating venous insufficiency. The impact of surgical treatments of the urethra were described by Shlomo Raz in FEMALE UROLOGY, 2
nd
Ed. (1996). This reference also describes techniques of surgical repair for treatment of cystocele 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.
An electrosurgical probe for the controlled contraction of tissues of joints and for dermatological indications 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, for example, the esophagus, is described in U.S. Pat. No. 4,765,331. Systems and methods for electrosurgical cutting and ablation are described in U.S. Pat. No. 5,697,882. Methods and apparatus for controlled contraction of soft tissues is described in U.S. Pat. No. 5,569,242. U.S. Pat. No. 5,423,811 describes a method for RF ablation using cooled electrodes.
SUMMARY OF THE INVENTION
The present invention provides improved methods, devices, and systems for treating the support structures of the body, as a treatment for incontinence and other conditions. In general, the invention takes advantage of two mechanisms to enhance the support provided by the fascia, ligaments and tendons: first, the invention increases a modulus of elasticity of these tissues, and particularly of the fascial tissues. The increase in modulus can be effected by directing sufficient energy to the fascial tissue so as to promote the formation of scar tissue. The resulting scarred tissue is generally significantly less elastic than the original fascia, and may also have an increased thickness (either as the result of fascial shrinkage or from the proliferation of scar tissue and/or smooth muscle cells). This local increase in modulus of the scarred support tissue can transfer stress and strain from the area of treatment to adjoining areas, and may also shorten the response time of the tissue plane to stress pulses (such as those which might result in incontinence events).
The second mechanism encompassed by the invention for enhancing the support is to promote attachment of adjacent support tissues to each other. Adjacent fascial tissue surfaces in the pelvic support system are often able to slide freely against each other. This free lateral movement allows the visceral organs to expand and contract over time. However, if there is inadequate support, the motion may become extreme and result in incontinence, prolapse, and other conditions. By directing energy (for example) at the interface between sliding fascial tissue surfaces, the relative motion at the interface can be restricted so
Carter Garry L.
Dietz Timothy G.
Morrison George A.
Gibson Roy D.
Solarant Medical, Inc.
Townsend & Townsend & Crew LLP
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