Surgery – Instruments – Light application
Reexamination Certificate
2001-04-13
2003-09-09
Jeffery, John A. (Department: 3742)
Surgery
Instruments
Light application
C606S015000, C607S088000, C607S089000, C607S092000
Reexamination Certificate
active
06616653
ABSTRACT:
BACKGROUND OF THE INVENTION
Urinary incontinence, a condition involving involuntary loss of urine, affects millions of people throughout the world. Incontinence is often associated with medical disorders such as decubitus ulcers, urinary tract infections, detrusor hyperactivity and renal failure. In addition to the medical aspects of this condition, the social implications for an incontinent patient include loss of self-esteem, embarrassment, restriction of social and sexual activities, isolation, depression, and, in some instances, dependence on caregivers. As such, many affected patients do not report the problem to their physicians even though incontinence is highly treatable and even curable.
In general, normal continence results when the lower urinary tract, kidneys and nervous system function properly in combination with the patient's ability to recognize and appropriately respond to the urge to urinate. Ordinarily, the process of urination involves two phases. The first phase is the filling and storage phase whereby the bladder begins to fill with urine from the kidneys and stretches to accommodate the increased amount of urine. The ability to fill and store urine requires proper functioning of the sphincter muscle, to control urine output, and detrusor (bladder wall) muscle, to control and stabilize bladder distention. The second phase of urination is the emptying phase. The emptying phase requires simultaneous contraction of the detrusor muscle, to force urine out of the bladder, and relaxation of the sphincter muscle, to allow the urine to pass out of the body.
Continence problems may occur, for example, as a result of weakened pelvic muscles, malfunction of the urethral sphincter, trauma to the urethral area, neurological injury, hormonal imbalance or medication side-effects. In general, there are three types of urinary incontinence: stress incontinence, overflow incontinence and urge incontinence. Stress incontinence is the involuntary loss of urine that occurs due to sudden increases in intra-abdominal pressure resulting from activities such as coughing, sneezing, lifting, straining, exercise and, in severe cases, even simply changing body position. This condition usually occurs when the sphincter or pelvic muscles are weakened, for example by childbirth or surgery.
Overflow incontinence is a constant dripping or leakage of urine caused by an overfilled bladder. This condition often occurs in men due to the prevalence of obstructive prostate gland enlargement or tumor.
Urge incontinence, also termed “hyperactive bladder,” “frequency/urgency syndrome” or “irritable bladder,” occurs when an individual experiences the immediate need to urinate and loses bladder control before reaching the toilet. Urge incontinence is a common problem that increases with advancing age or results from a kidney or bladder infection.
Detrusor hyperactivity, or urge incontinence, is the second most common cause for urine incontinence and may be found in 10 to 15% of asymptomatic men and women between the ages of 10 to 50. The goal in controlling or eliminating detrusor hyperactivity is to reduce irritation of nerve endings at the bladder wall due to inflammation and decrease detrusor (bladder wall muscle) activity. Current treatment methods include bladder drilling, pharmacotherapy and surgical management.
Various methods of ablating the nerves that innervate the bladder have been used to treat incontinence. However, the most common surgical method for treatment of urge incontinence is bladder augmentation by enterocystoplasty. Augmentation cystoplasty is basically a reconstructive surgery in which a segment of the bowel is removed and used to replace a portion of the diseased bladder. Complications associated with this procedure include the usual complications resulting from major abdominal surgery, such as bowel obstruction, blood clots, infection and pneumonia. Because of the morbidity level, this procedure is generally considered a last resort in an incontinence treatment plan.
As a result, practitioners have continually sought a less invasive method of treating urinary incontinence. In particular, there is a desire to obtain minimally invasive yet highly effective device that can be used with minimal to no side effects. Such a device must be biocompatible, non-toxic and simple to use. In addition, the related treatment methods using the device should reduce pain, infections and post operative hospital stays. Further, the method of treatment should also improve the quality of life for patients.
BRIEF SUMMARY OF THE INVENTION
In view of the foregoing, it is apparent that there is a need for a minimally invasive device for treating urinary incontinence, for example, by reducing detrusor hyperactivity, so as to restore normal continence in a patient. There is also a need to provide a method of using such a device to create the desired continence effect.
With respect to the device of the present invention, in the incoherent light source embodiments, the therapeutic treatment device utilized is similar to the embodiments disclosed in U.S. Pat. No. 5,405,368 to Eckhouse, issued Apr. 11, 1995, prior copending U.S. application Ser. No. 08/508,129, filed Jul. 27, 1995, U.S. application Ser. No. 08/477,479, filed Jun. 7, 1995, U.S. application Ser. No. 08/473,532, filed Jun. 7, 1995, and U.S. application Ser. No. 08/383,509, filed Feb. 3, 1995 (collectively “the Eckhouse applications”), the disclosures of which are hereby fully incorporated herein by reference. In the laser light source embodiment, the treatment device is similar to that of Talmore, as described in U.S. Pat. Nos. 5,344,433 and 5,344,434, the disclosures of which are also hereby fully incorporated herein by reference.
The present invention differs from the Eckhouse and Talmore devices in that the exit area, through which the light emerges from the apparatus, is of a size and configuration such that it can be inserted through the urethra, proximal urethra and even into the bladder. An additional distinction is that the device of the present invention delivers light that can be used to treat bladder blood vessels, as opposed to external skin disorders. The present invention may also utilize any type of selective thermolysis of the superficial bladder vessels for the treatment of the above mentioned pathologies.
In general, the present invention contemplates a non-implantable device for treating urological disorders. The device includes a light source and a light source segment, wherein the light source provides the required therapeutic light to treat urological disorders. In addition, the light source segment houses the light source and is of a sufficiently small size and configuration so that it can be inserted through the urethra of the patient. The non-implantable device may also include a viewing assembly, comprising an eyepiece, steering control knob and a light port, and an elongate portion having one or more lumen extending along the length of the elongate portion. The lumens of the elongate portion, which are in communication with the viewing assembly and light source segment, enable direct visualization and illumination of the target site in the patient.
The present invention also contemplates a method of treating urological disorders which may include the steps of inserting a non-implantable device through the urethra and into the bladder of a patient and positioning a tip of the device adjacent a target site within the bladder. The next steps may include activating the device to selectively deliver light to the target site and, finally, removing the device from the bladder and urethra of the patient.
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Beyar Mordechai
Klugman Nathan
American Medical Systems Inc.
Jeffery John A.
Oppenheimer Wolff & Donnelly LLP
Wrigley Barbara A.
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