Surgery – Endoscope – Urological
Reexamination Certificate
2000-05-18
2002-11-05
Dvorak, Linda C. M. (Department: 3739)
Surgery
Endoscope
Urological
C600S029000, C600S037000
Reexamination Certificate
active
06475139
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to a surgical instrument and a method for treating female urinary incontinence and in particular to a needle adapted to provide visualization of the tissue during the procedure.
Women account for more than 11 million of incontinence cases. Moreover, a majority of women with incontinence suffer from stress urinary incontinence (SUI). Women with SUI involuntarily lose urine during normal daily activities and movements, such as laughing, coughing, sneezing and regular exercise.
SUI may be caused by a functional defect of the tissue or ligaments connecting the vaginal wall with the pelvic muscles and pubic bone. Common causes include repetitive straining of the pelvic muscles, childbirth, loss of pelvic muscle tone, and estrogen loss. Such a defect results in an improperly functioning urethra. Unlike other types of incontinence, SUI is not a problem of the bladder.
Normally, the urethra, when properly supported by strong pelvic floor muscles and healthy connective tissue, maintains a tight seal to prevent involuntary loss of urine. When a woman suffers from the most common form of SUI, however, weakened muscle and pelvic tissues are unable to adequately support the urethra in its correct position. As a result, during normal movements when pressure is exerted on the bladder from the diaphragm, the urethra cannot retain its seal, permitting urine to escape. Because SUI is both embarrassing and unpredictable, many women with SUI avoid an active lifestyle, shying away from social situations.
U.S. Pat. No. 5,112,344 describes a method and apparatus for treating female incontinence. The surgical instrument for the application of a filamentary element into the body comprises a tubular shaft having a handle at one end and a flexible needle slidably receivable in the shaft and adapted at one end to receive a filamentary element. The method of treating female incontinence comprises looping a filamentary element between the wall of the vagina and the rectus abdominis sheath in the anterior wall of the abdomen whereby it passes to each side of the urethra, adjusting the loop to bring the vaginal wall and the urethra into the correct spatial relationship to the pubis allowing the development of scar tissue between the vaginal wall and the anterior wall of the abdomen pubic symphysis and removing the filamentary element.
U.S. Pat. No. 5,899,909 discloses a surgical instrument comprising a shank having a handle at one end and connecting means at the other end to receive, one at a time, two curved needle-like elements which are connected at one end to one end of a tape intended to be implanted into the body. In practice, the tape is passed into the body via the vagina first at one end and then at the other end at one side and the other, respectively, of the urethra to form a loop around the urethra, located between the urethra and vaginal wall. The tape is extended over the pubis and through the abdominal wall and is tightened. The tape ends are cut at the abdominal wall, and the tape is left implanted in the body. U.S. Pat. No. 5,899,909 is incorporated herein by reference.
One particular disadvantage of the prior art, especially for surgeons unfamiliar with the surgical method is not completely knowing the location of the needle tip relative to adjacent pelvic anatomy. If the needle tip is allowed to accidentally pass across the surface of any blood vessel, lymphatic duct, nerve, nerve bundle or organ possible complications may arise.
It would be beneficial to provide a needle for use in implanting a mesh tape within a female body to prevent incontinence that has a design that provides for visualization of the tissue as the needle passes through the woman's lower abdomen.
SUMMARY OF THE INVENTION
The invention overcomes the deficiencies of the prior art and provides for an improved needle for use with an apparatus and a method for the treatment of female stress urinary incontinence. The invention provides a surgical instrument comprising a handle at one end and connecting means at the other end to receive, one at a time, two curved needle-like elements, each of which has a modified tip. The needle may have a constant or varying diameter. Each needle connects at one end to separate ends of a tape intended to be implanted within the body. In practice, a first end of the tape is passed, via one of the curved needles, into the body via the vagina at one side of the urethra. The needle and first end of the tape pass over the pubis and through the abdominal wall. The second needle element connects to the second end of the tape and passes into the body via the vagina at the opposite site of the urethra from the first end of the tape thereby forming a loop or sling around the urethra with the tape. The second end of the tape is extended over the pubis and through the abdominal wall. The tape ends are cut at the abdominal wall, and the tape is left in the body.
The invention further provides for a single curved needle element having a modified tip. The needle may have a constant or varying diameter and further provides for a easy attachment means enabling the surgeon to connect both the first and second tape ends to the single needle to perform the above-stated procedure.
In both embodiments, the needle is modified to contain an inner lumen for passage of optical devices and/or fluids. A surgical optical system may interface directly with the needle, or altematively, the hand piece or handle may be modified to accept the optical system. The tip of the needle is also modified to contain a window or viewing port that allows for the transmission of light from the ambient target tissue into the imaging lens of the optical system. The optical system allows the surgeon to maintain continuous anatomic visualization during introduction and navigation of the needle within the lower abdomen.
The object of the invention is to provide a surgical instrument for implanting a mesh to treat incontinence that provides for an optical viewing system that allows the surgeon to view tissue and vital organs as the needle penetrates the lower abdomen of a female patient.
An advantage of the invention is that it reduces the risk of perforating unintended body structures when carrying out the procedure.
These and other features and advantages of the present invention will become apparent from the following more detailed description, when taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention.
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Dvorak Linda C. M.
Ethicon Inc.
Ram Jocelyn
LandOfFree
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