Surgery – Body protecting or restraining devices for patients or infants – Restrainers and immobilizers
Utility Patent
1999-08-27
2001-01-02
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Restrainers and immobilizers
C128SDIG008, C600S029000
Utility Patent
active
06167886
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to a device for the treatment of male and female urinary incontinence according to the preamble of claim
1
.
Urinary incontinence is understood as meaning the involuntary loss of urine from the urinary bladder and urethra. The causes are either direct damage to the occlusive mechanism (sphincter muscle) of the urinary bladder, generally as a result of an operation on the prostate gland or by infiltration of a prostate gland carcinoma in men or a sphincter muscle injury as a result of childbirth in the case of women. Further causes of urinary incontinence are nerve damage resulting form metabolic diseases such as e.g. diabetes mellitus or as a result of traumas to the nerves to the urinary bladder and its occlusive mechanism such as stroke, tumor operations in the pelvic region or injuries to the spinal cord.
In the case of incontinence due to nerve damage, the occlusive mechanism of the bladder can normally no longer be sufficiently opened so that the loss of urine (incontinence) occurs only after maximum filling of the urinary bladder, and even after elimination, the bladder is not completely empty. Therefore, the excretion of urine occurs uncontrollably and without completely emptying the volume of the bladder. The consequences are not only the urination but also an over-expansion of the urinary bladder and in many cases the reflux of urine up to both kidneys with subsequent kidney damage. The various forms of incontinence generally affect people of advanced age.
2. Description of the Prior Art
A wide range of different methods are already known for treating and overcoming the urinary incontinence, depending on the cause of the incontinence and the sex of the patient; in serious cases, however, these are generally not sufficiently effective or require an operation with or without implantation and is not free from disadvantages in all cases.
In the case of incontinence due to a partial or complete loss of function of the occlusive mechanism of the urinary bladder, particularly in the case of the man, use of a surgically implantable “Scott” artificial bladder sphincter muscle is known (AMS 800 from Messrs American Medical Systems) and can be used. The implant is very expensive and should only be implanted by experienced surgeons. Serious infections or necroses of the tissue surrounding the implant caused by pressure necessitating the removal of the implant again have been repeatedly observed. In women, this form of incontinence can frequently be successfully treated by physical therapy or by a less serious operation without implant.
A further known device for overcoming male incontinence consists of a penis clamp or penoring by which pressure from outside exerts a more or less traumatizing pressure on the penis or urethra. Furthermore there is a risk of slipping in the underwear with subsequent urination.
Furthermore, urine collecting systems worn outside the body with urine bag (urinal) or absorbent media (disposable napkins) are known for both sexes which serve to collect the urine; these result in skin irritation due to the urine, unpleasant odor and thus social isolation.
Furthermore, a device for female incontinence is known by which the urinary bladder is emptied via a short catheter protruding out of the urethra by manual actuation of a valve located in the vestibule of the vagina (EP 0407 218 A1). The valve located in the vestibule of the vagina can lead to a colonization of the device with bacteria from the vestibule of the vagina.
More recently, a device for female incontinence has come onto the market under the name “Reliance TM” (U.S. Pat. No. 5,090,424) which consists of an inflatable urethra insert which has to be completely removed several times a day before each emptying of the bladder rather like a tampon and subsequently has to be replaced by a new device, thus making it very costly.
Finally, devices for male incontinence are known with which many of the disadvantages outlined above can basically be avoided (U.S. Pat. No. 4,946,449, DE-OS 4,014,369=U.S. Pat. No. 4,932,938, EP-A 0,265,207, EP 0,543,309 B1). These known devices consist essentially of a catheter which is inserted into the male urethra and carries a balloon at its proximal end which can be filled with a fluid (e.g. water) and thus expanded. This balloon closes off the urinary bladder at the entry to the urethra and prevents the catheter from unintentionally slipping out. There is a second balloon which is positioned at a distance from the first balloon. The second balloon is closer to the distal end than the first balloon. The second balloon can be filled with fluid which, when the catheter is in the fitted condition, the second balloon lies outside the bladder sphincter muscle in the urethra and thus prevents the catheter from unintentionally slipping further into the bladder. The length of the catheter is such that when inserted its distal end is completely contained in the penis; a valve is located in the distal end section which can be felt through the wall of the urethra in the penis area. The valve is for example a crocodile valve, lip valve, ball valve or slit valve whose normally closed condition can be changed to the open position by the pressure of the two fingers so that urination is possible. These known valves located in the distal end section of the catheter have several serious disadvantages. The maximum lumen cross-section of a catheter is 5-6 mm which makes the production of lip or crocodile valves miniaturized to these dimensions difficult or even impossible at reasonable cost. A liquid pressure of up to 100 cm water column is exerted on the closed valve in opening direction by the pressure inside the bladder so that the danger of the valve tipping outward with subsequent loss of function is practically unavoidable. The silicone material used almost exclusively for long term catheters has only a relatively low rubbery-elastic resilience so that lip valves and crocodile valves made of this material require a metal-elastic spring device to return the open valve into a sealing closed position. The production of this spring device in the small dimensions in question here is also technically very complicated. Metallic devices in the catheter wall also result in a hardening of the wall and increase the danger of pressure-related damage to the delicate urethra mucosae. All the above-mentioned valves fitted to the distal end of the catheter result in a significant loss of catheter lumen. This applies in particular to ball valves and slit valves so that no adequate flow of urine is assured in open condition with these valve types. Non-deformable valve elements such as e.g. balls tend to become considerably encrusted due to the substances dissolved in the urine.
SUMMARY OF THE PRESENT INVENTION
The task of the invention is therefore to design a device for treatment and remedying in particular of the male incontinence of the type described at the beginning in such a way that the catheter valve is easy to manufacture, closes reliably with adequate elastic resilience, does not open accidentally even under high pressure inside the bladder, leaves the catheter lumen effectively free in its complete cross-section for free drainage of the urine from the bladder and the insertion of the device into the urethra and its removal from the urethra is simple. In addition, the device should be suitable in its basic principle, but after adaptation to the different anatomical situation of the woman, also for treatment and remedying of the female urinary incontinence.
According to the invention, this task is solved with a device of the type described at the beginning by designing the device in accordance with the characterizing part of claim
1
.
The device to which the invention relates is an incontinence catheter which can be completely inserted into the urethra with two sealing balloons, whereby the valve closing off the catheter is located at the proximal end of the catheter extending into the urinary bladder. The valv
Engel Kilian
Engel Konrad
Brown Michael A.
Chen Tony D.
Fong Jerry
Medi-Globe Vertriebs GmbH
Rozsa Thomas I.
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