Surgery – Endoscope – Urological
Reexamination Certificate
2001-04-02
2002-08-13
Dvorak, Linda C. M. (Department: 3739)
Surgery
Endoscope
Urological
C600S210000, C600S220000, C600S200000, C604S517000
Reexamination Certificate
active
06432045
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to medical devices and, more particularly, to surgical tools and scopes for viewing and performing surgical operations within body passages.
2. Description of Related Art
A condition known as stress urinary incontinence refers to a functionally insufficient urinary tract of a patient. In a patient having this condition, tissue relaxation of the sphincter mechanism, located at the urinary outflow of the bladder into the urethra, can cause a loss of bladder control. A filler material, such as collagen, can be injected into and adjacent to the urinary sphincter muscle at the bladder neck to “bulk” up the muscle tissue and help ensure adequate closure of the urinary sphincter.
SUMMARY OF THE INVENTION
In accordance with the present invention, a hand-held device or “urethra scope” is provided that is used to expand and visualize tissue within a body lumen. When the body lumen comprises a female urethra, the urethra scope is inserted through the urethra to the bladder neck, and a long needle is used to inject a filler material into and adjacent to the urinary sphincter muscle for the treatment of stress urinary incontinence. The filler material may also be injected along the entire length of the urethra. The urethra scope of the present invention enables visualization of the bladder neck through the female urethra (“transurethral procedure”) in order to facilitate injection of the filler material.
The urethra scope of the present invention provides lighting and a clear path to all urethral tissues and the bladder sphincter. The filler material may comprise collagen and/or micro-spheres, such as disclosed in U.S. Pat. No. 5,344,452, or, for example, any other type of injectable bulking agent. In accordance with the present invention, the injection of a urinary bulking agent into the respective tissues serves to fortify the respective tissue structures and re-establish bladder control. The urethra scope and associated methods of operation disclosed herein may be configured for and used on other body passages as well in modified embodiments. The entire injection procedure is preferably performed on an outpatient basis requiring minimal or no sedation of the patient.
The female urethra is about 2.5 to 4 cm long and can be expanded to at least 7-8 mm in diameter. In implementing preferred methods of the present invention, an insertion probe of the urethra scope does not need to be opened or expanded within the urethra. Instead, the insertion probe of the urethra scope is moved distally to expand the urethra walls and is moved proximally to permit the urethra walls to relax inward. The urethra scope of the present invention can also be used in other parts of the body using similar methods of operation, wherever access to and visualization of an anatomical structure in tangential fashion is required.
The urethra scope is designed to be a tissue expansion and visualization device for insertion into tissues and tissue lumens, such as the female urethra. The urethra scope can be manufactured as a reusable or disposable medical instrument or a combination of both. In a preferred embodiment, the device is constructed with a disposable insertion probe (single-use, sterile item comprising or consisting of, for example, plastic, stainless steel, or wire coated with, for example, a polymer or vitreous material), which is attached to a reusable handle (limited use item). The wire construction may comprise, for example, a mesh-shaped conical configuration, for example, wherein the wire is coated with a biocompatible material. In addition to serving as a tissue expansion and visualization tool, the urethra scope can serve as a diagnostic tool to enable physicians to treat their patients with injection treatments, surgical ablation of tissue, tissue biopsies, etc. The advantages of the urethra scope include cost effectiveness, ease of use, decreased likelihood of cross contamination due to sterile disposable cones that are inserted into the urethra, and improved ergonomics and handling. The placement of tangential and distal windows in the insertion probe allows for visualization and treatment of the entire length and circumference of the urethral walls and bladder neck.
The present invention, together with additional features and advantages thereof, may best be understood by reference to the following description taken in connection with the accompanying illustrative drawings.
REFERENCES:
patent: 2292237 (1942-08-01), Parcher
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patent: 4785796 (1988-11-01), Mattson
patent: 5688224 (1997-11-01), Forkey et al.
patent: 5928138 (1999-07-01), Knight et al.
patent: 6165125 (2000-12-01), Elliott
Kelleher Brian
Lemperle Stefan M.
Lipsitz David
Stone Corbett
Artes Medical
Ram Jocelyn
Stout, Uxa Buyan & Mullins, LLP
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