Surgery – Body inserted urinary or colonic incontinent device or... – Implanted
Reexamination Certificate
2000-03-09
2001-08-14
Lacyk, John P. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Implanted
C128SDIG008, C600S037000
Reexamination Certificate
active
06273852
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 conical needle for facilitating the perforation of different layers of tissue, with each tissue layer having a different resistance against perforation.
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, tightening the loop to bring the vaginal wall 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.
Current needles for implanting tapes have a short conical tip and a curved body with a constant diameter. When the conical needle tip perforates a layer of human tissue having a high resistance against perforation (like fascia or muscle), the force required is high compared to the force required to perforate soft human tissue (like fat). To lower the maximum force required by the surgeon to penetrate fascia or muscle, the needle tip is pointed. After the conical tip passes through a tissue layer with a high perforation resistance, however, the force required to further pass the needle through the tissue suddenly drops close to zero. As an undesirable consequence then, the needle may penetrate through tissue faster than the surgeon intends, possibly causing the surgeon to lose control of the needle and risking the possibility of unintentionally perforating other body structures, such as, bone, organs or blood vessels, with the pointed needle tip.
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 a more even resistance for perforating differing types of tissue.
It would also be beneficial to simplify the design of the surgical instrument to facilitate the loading of the tape onto a needle during the operation. In this manner, the instrument would be more receptive to various types of tapes, such as synthetic, cadaver tissue and engineered tissue.
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 have a blunt tip and 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 handle and to the second end of the tape. The needle and second end of the tape pass 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 blunt tip and 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.
The invention still further provides for a tape comprising of a synthetic mesh in combination with a natural material whereby the natural material would reside below the urethra to eliminate potential erosion issues.
In one aspect the invention provides a needle element having a distal end and a proximal end. The diameter of the needle varies increasingly from the distal end to the proximal end. The distal end further defines a tip having a blunt end. The proximal end provides for a connecting means to the handle.
The object of the invention is to provide a surgical instrument that requires a reduced maximum force to pass the tape through body tissue.
A further object of the invention is to provide a needle that requires a more constant force to pass through body tissue.
An advantage of the invention is that it reduces the risk of perforating other body structures.
A further advantage of the invention is that it provides for a quick connecting means of the tape to the needle thus allowing for the use of non-synthetic tissue as the supporting element.
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.
REFERENCES:
patent: 5112344 (1992-05-01), Petros
patent: 5337736 (1994-08-01), Reddy
patent: 5362294 (1994-11-01), Seitzinger
patent: 5899909 (1999-05-01), Claren et al.
patent: 5934283 (1999-08-01), Willem et al.
patent: 6042534 (2000-03-01), Gellman et al.
Chen Chao-Chen
Lehe Jorn
Luscombe Brian H.
Ethicon Inc.
Kreger, Jr. Verne E.
Lacyk John P.
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