Male urinary incontinence control device

Details Male urinary incontinence control device Male urinary incontinence control device

2001-10-09

2004-12-07

Brown, Michael A. (Department: 3764)

Surgery

Body protecting or restraining devices for patients or infants

Restrainers and immobilizers

C128SDIG008, C600S029000

Reexamination Certificate

active

06827085

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Technical Field
This invention generally relates to medical appliances and, more particularly, to a device used to control urinary incontinence of a male patient.
2. Discussion
Male urinary incontinence is a long-recognized medical condition which can pose an embarrassment to men whose natural urethral valve or sphincter is no longer capable of controlling the flow of urine from the bladder. Urinary incontinence can arise from a variety of causes, including disease, surgery, neurological dysfunction, malformation of urethral valve, physical deterioration accompanying advancing age, and other causes. Externally applied absorbent pads and internal catheters connected to collection bags are currently used as solutions to the problem of incontinence. Each of these solutions ultimately entails the external collection of the urine which escapes the bladder. Unfortunately, collection devices such as these can often be uncomfortable, inconvenient, unsanitary, offensive, unreliable and even inadequate during use.
A variety of other devices are known for more actively regulating or controlling male urinary incontinence, rather than merely externally capturing or collecting urine. Some of these other devices include clamps or valves which are surgically implanted, positioned around and compressing the urethra. The clamp or valve is actuated in one way or another to permit the flow of urine through the urethra. These invasive devices have several drawbacks. The most significant of these drawbacks is the risk and cost associated with performing the implant surgery.
Other commonly employed devices for the control of incontinence are non-invasive devices or appliances which include a strap, band, cuff, clamp, cradle, or other member which encircles the penis shaft. A device of this type is positioned about and tightened around the penis shaft until sufficient pressure is applied to the urethra and the corpus spongiosum to substantially or completely close the urethra. The device is loosened or removed to permit the flow of urine through the urethra when appropriate.
A wide variety of non-invasive type devices are know in the art. Such devices can include single or plural members which are flexible or rigid. Some devices include a projection intended to lie beneath the urethra and corpus spongiosum to apply a sealing pressure to the urethra and corpus spongiosum. This projection can be rigid or resilient, or can even be an inflatable sac. This last construction is shown in U.S. Pat. No. 4,800,900 (issued to G. J. French on Jan. 31, 1989, and herein after referred to as ‘the '900 patent’), and is particularly advantageous in that deflation of the sac reduces the pressure applied to the urethra sufficiently to allow urination without requiring removal of the device from the penis shaft.
Devices of the encirclement type usually permits sufficient tightening of the device around the penis shaft to prevent or substantially reduce the leakage of urine through the urethra. Unfortunately, sufficient tightening of the encirclement type device almost universally results in the application of an unacceptable and sometimes painful amount of pressure to tissues other than the urethra and corpus spongiosum. In particular, virtually all devices of this type apply undue pressure to the superficial dorsal vein, the deep dorsal veins, and the dorsal arteries and nerves. This grouping of veins, arteries, and nerves will be referred to as the central dorsal vascular group throughout the present disclosure. Some encirclement type devices even increase this problem by including one or more projections which lie transversely across these portions of the penis shaft. Even when the device includes a projection intended to engage the urethra, the projection may be oriented so that it applies across too much on the lower or ventral side of the penis shaft.
Devices of this general type are often subject to other drawbacks as well. Some are difficult to properly position on the penis shaft. Others are relatively complex in construction, and therefore relatively expensive to manufacture. Some provide poor adjustability to the particular patient using them. Further, wearing many of these devices can be quite uncomfortable, and virtually impossible to withstand for more than a few hours at a time.
In light of the above, a need appears within the industry for a device for controlling male urinary incontinence which avoids applying undue pressure to the superficial dorsal vein, the deep dorsal vein, the lateral superficial veins and the dorsal arteries and nerves of the penis shaft, while ensuring that sufficient pressure is applied to the urethra and the corpus spongiosum to prevent or substantially reduce leakage from the urethra. A need also exists for a device which provides for a relatively precise selection of the dorsally and ventrally applied pressures. The needed device would avoid inflicting pain, trauma and/or damage to the skin and underlying tissues of the penis shaft when used. It would be desirable for such a device to be comfortably worn by the patient for an entire day without removal, except for removal to permit urination. It would further be desirable for such a device to be relatively inexpensive in construction, and relatively easy both to properly position on the penis shaft, and to remove for urination.
SUMMARY OF THE INVENTION
The foregoing problems are solved and a technical advance is achieved in an illustrative male urinary incontinence control device which is particularly useful in that it is more comfortable to wear and use than prior devices, yet provides adequate closure of the urethra so as to prevent or substantially reduce leakage of urine through the urethra. The present invention can most simply be considered as an improvement in a strap, band, cuff, clamp or cradle type incontinence control device, the improvement comprising the inclusion of a means (such as a pair of projections or bolsters) which applies pressure preferentially at the specific areas between the lateral superficial veins and the superficial dorsal vein, the deep dorsal vein and the dorsal arteries and nerves. The superficial dorsal vein, the deep dorsal vein and the dorsal arteries and veins can, for practical purposes, be considered comprised within a single group located very near the top center of the dorsal surface of the penis shaft. As previously mentioned, this grouping will be referred to as “the central dorsal vascular group”. Thus, the control device of the present invention includes a means which applies pressure preferentially at the specific areas between the lateral superficial veins and the central dorsal vascular group.
“Preferentially” (or “preferential”) should be understood as meaning that the pressure applied to the penis shaft by the pressure applying means is greater at these specific areas than the pressure applied elsewhere to the penis shaft, save perhaps for the pressure applied ventrally to the urethra and the corpus spongiosum. The device of the present invention also applies pressure ventrally to the urethra and the corpus spongiosum, however, with the result that the urethra can be closed or substantially closed, while undue pressure on the superficial dorsal vein, the lateral superficial veins, the deep dorsal vein and the dorsal arteries and nerves is avoided. “Substantially” means that leakage through the urethra when the device is in place is reduced to as low as about three to five percent of the patient's daily urine output, typically only about 36 to 75 ml of a daily outflow of about 1200 to 1500 ml.
This improvement is preferably embodied in a male urinary incontinence control device in which three projections or bolsters are carried on and are selectively adjustable and movable along the arms of the generally C-shaped resilient member. The words “projections” and “bolsters” are equivalent for the purposes of the invention, and “bolsters” should be understood to be a generic term, encompassing not only “projections,” but also all equivalents

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