Surgery – Body inserted urinary or colonic incontinent device or... – Implanted
Reexamination Certificate
2000-03-08
2002-08-27
Lacyk, John P. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Implanted
C128SDIG008
Reexamination Certificate
active
06440060
ABSTRACT:
FIELD OF THE INVENTION
The present invention is generally directed to an intra-urethral device and method for making and using the same. More particularly, the present invention is directed to an intra-urethral device that can be used to inhibit leakage of urine due to incontinence. A device of the present invention can have a shape corresponding to the urethral orifice and also include an insertion element to facilitate self-insertion.
BACKGROUND OF THE INVENTION
Urinary incontinence is the inability of a person to control urine flow. Incontinence may result for a variety of reasons, such as anatomical abnormalities and neurological disorders. Nerve injury, childbirth, and a congenitally short urethra are all common causes of incontinence in woman. Bladder control problems are also a common cause of incontinence and affect twice as many women as men. Loss of bladder control is not a natural part of aging, although its frequency increases with aging, thus limiting the activity of many older persons.
The female urinary system is composed of two kidneys, two ureters, one bladder and one urethra. The urinary tract begins at the kidneys, continues through the ureters to the bladder, and from the bladder to the urethra, through which urine exits the body. The kidney filters the blood to remove waste and produces urine. The ureters, approximately 30 cm in length, extend from the base of the kidneys and pass through the bladder wall into the bladder itself. The bladder is a hollow muscular organ with a volume capacity of approximately 350-450 ml in a normal adult. Continence is maintained during the filling phase because urethral pressure remains greater than intravesical (bladder) pressure. When the bladder's capacity is reached, the musculature of the bladder contracts, pushing the urine through an opening in the base of the bladder to the urethra (Chisholm and Fair, Scientific Foundations of Urology, Oxford: Heinemann Medical Books, pp. 272-285, 1990).
The urethra in females is approximately 3-4 cm long and has an average inner diameter of 8 mm, varying in diameter from 4-10 mm throughout its length. A cross section of the average urethra would show that the innermost layer of the urethra hangs in folds during rest. When urine flow occurs, the urethra widens and shortens, pulling the folds back into a circular cross section. The urethra constitutes an inner, mucous-producing epithelial lining (urothelium) surrounded by a longitudinal layer of smooth muscle, which in turn is surrounded by a heavy layer of circular smooth muscle fibers. These circular smooth muscles constitute the true involuntary urethral sphincter. External to this are circular striated (voluntary) C-shaped muscles, which surround the middle third of the urethra and comprise the voluntary sphincter known as the rhabdosphincter. The pelvic floor musculature acts as a sling to keep pelvic organs in place and functioning properly.
The urinary system works to ensure that a person can control micturition. As the bladder fills, muscles stretch and nerves signal the brain that the bladder is full, leading to the urge to urinate. In continent persons, a voluntary decision is then made whether or not to urinate. When it is desirable to not urinate, the spinal cord transmits the message from the brain telling the external sphincter to contract. As the external sphincter contracts, it signals the bladder to relax and the bladder neck to stay closed, and the urge to urinate subsides. Additionally, the contraction of the sphincter increases the intraurethral pressure, such that it is greater than the intravesical pressure, thereby preventing urine passage through the urethra. This difference between the intravesical pressure and the intra-urethral pressure is termed the urethral closure pressure. When a person desires to void, the brain signals the external sphincter to relax, decreasing pressure in the urethra until urethral pressure is less than the intravesical (bladder) pressure and flow ensues.
Incontinence, or the inability to retain urine, can be broadly divided into five types. Stress incontinence results from an increase in intra-abdominal pressure, which is translated to the bladder, and for which the rhabdosphincter and pelvic floor muscles cannot compensate. Urge incontinence is a sudden need to urinate that is so urgent it cannot be controlled. This may be associated with spasm of the bladder muscle. Mixed incontinence patients experience both stress and urge incontinence. Overflow incontinence occurs when the bladder fails to empty completely due to obstruction. Small amounts of urine are lost because the bladder neck cannot remain closed against the full bladder. The last type of incontinence, functional incontinence, results when mobility limitations prevent the patient from getting to the bathroom; this is often compounded by spinal and/or nerve injury.
The present invention is designed to prevent the leakage of urine caused by incontinence, which may result from an increase in intra-abdominal pressure due to activities such as coughing, laughing, sneezing and exercising or, alternatively, can be caused by weakened pelvic floor muscles, a weakened external sphincter, a urethra which has lost muscle tone, or an abnormally short urethra.
There are currently many prosthetic devices available to compensate for incontinence. Many of the devices, however, cause urinary tract infections. Some tend to slip or migrate during use and end up in the bladder, where they may cause a great deal of harm and require invasive surgical procedures for removal. Other devices are permanent devices, which require surgery for implementation and have long term biocompatibility problems.
For instance, U.S. Pat. No. 5,131,906 to Chen discloses a device including a centrally disposed rod or tube member, a truncated spherical shell depending from one end of the member, and a plurality of elastic bands uniformly spaced around the shell periphery. Moreover, U.S. Pat. No. 5,090,424 to Simon et al. discloses a flexible urethral plug including a soft inflatable plastic catheter and a transportable fluid which is moved from an external bellows to inflate the catheter within the urethra to block urine flow. Another example of such a device is disclosed in U.S. Pat. No. 5,306,226 to Salama. Salama relates to a urine tube extending through a balloon which is inflated in the neck of the bladder to seal the urethra.
However, in contrast to the present invention, all of the above devices suffer from common disadvantages, including a susceptibility to urine encrustation and provision for direct entry of bacteria into the bladder. Additionally, the spherical design of the aforementioned devices may not totally prevent urine leakage. Because of the fluid mechanics inherent with the spherical design, back pressure caused by urine in the bladder may compress a spherical device, while simultaneously causing the urethral walls to expand, allowing urine to leak.
Other prior art incontinence control devices include devices permanently installed within the urethra, such as those disclosed in U.S. Pat. No. 5,114,398 to Trick et al.; U.S. Pat. No. 5,004,454 to Bevar et al.; and U.S. Pat. No. 5,140,999 to Ardito. However, these devices also suffer from some significant disadvantages including the requirement for surgical implantation, inclusion of metal parts subject to corrosion by urine, and need for patient manipulation to permit urination, which may introduce bacteria into the urethra.
Furthermore, temporary incontinence plugs have been previously described by U.S. Pat. No. 5,082,006 to Jonasson and by Nielson et al., “The Urethral Plug: A New Treatment Modality for Genuine Urinary Stress Incontinence in Women,”
Journal of Urology
144: 1199-1202 (1990). The Jonasson device comprises an oblong shaft having at least one knob arranged at a distance from the proximal end of the shaft. This device permits undesirable leakage, however, of approximately 15 ml of fluid. Additionally, the device also allows bacteria to enter the urethra. The device disclosed b
Clemson University
J.M. Robertson Intellectual Property, L.L.C.
Lacyk John P.
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