Surgery – Body protecting or restraining devices for patients or infants – Restrainers and immobilizers
Reexamination Certificate
2001-09-17
2003-08-26
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Restrainers and immobilizers
C128SDIG008, C600S029000
Reexamination Certificate
active
06609522
ABSTRACT:
BACKGROUND OF THE INVENTION
Male urinary incontinence can result from a variety of physical or neurological conditions. The incidence of incontinence increases with advanced age. Surgical treatment of prostate cancer or benign prostatic hyperplasia (BPH), such as radical prostatectomies, open or transurethral prostatectomy, and trauma to the membranous urethra or bladder neck can all cause temporary or permanent incontinence in men.
Existing external compressive incontinence control devices are based on the principle that if the entire cross-section of the penile shaft is sufficiently compressed, the urethra will be correspondingly flattened to prevent any urine leakage. In order to prevent the urine leakage, the penis must be flattened to about 40% or more of the normal penile diameter. When a conventional penile clamp is used with this level of compression, the major side effect is constriction of blood vessels and prevention of blood circulation to the penis. While most users of the penile clamps of these types learn to periodically remove the clamps to temporarily restore blood circulation, it is nonetheless a major inconvenience. In addition, these conventional devices are heavy and bulky, uncomfortable and insufficiently discreet.
Others have recognized that it would be desirable to selectively compress the urethra, which is situated along the central underside of the penile shaft, without exerting undue compression of the entire penile shaft. While these devices compress the urethra more than the body of penis, the devices are either too bulky, which detracts from the user's comfort level and privacy, or are comprised of many components which increase the complexity and cost of the device and the probability of failure. Also, many of the devices require two hands for application or removal.
SUMMARY OF THE INVENTION
This invention relates to a urethral compression device. The urethral compression device has a compression element which extends longitudinally, so that when engaging the penis the compression element extends parallel to the urethra to compress the urethra. A latching mechanism retains the urethral compression device in the position to compress the urethra.
In an embodiment, the urethral compression device has an arced shaped element having a first and a second arm. A compression element that applies pressure is carried by the arced element for compressing the urethra. The compression device can be made of a molded plastic material that is positioned in an open state when in an unstressed condition. The user bends one arm to connect the ends of the arms together and places the device under stress in the closed position. The user can easily remove the device when the arc shaped element is in the open unstressed state.
In an embodiment of the invention, the pressure applying or compression device has a width of between 100 percent and 150 percent of the diameter of the urethra for optimally compressing the urethra and minimally compressing the rest of the penis. The device can be fabricated in a number of different sizes as needed.
In an embodiment, the device has a latching mechanism including a plurality of teeth carried by one arm and a pawl on the other arm to engage the teeth for retaining the arced shaped element in a closed position. The arced shaped element is biased towards an open position such that release of the arms opens the device.
The urethral compression device provides a male urinary incontinence control device that is effective, non-invasive, reliable, comfortable and easily adjustable without complicated construction, adjustment procedures, or accessories. In addition, the design of the device also ensures that the user is able to maintain a high degree of privacy without being noticed by others when the user is wearing and manipulating the device.
By applying pressure selectively to the area of urethra, the urethra can be sufficiently compressed or occluded to prevent urine flow without exerting undue pressure to other parts of the penis or reducing blood circulation.
In an embodiment, the urethral compression device is structured without an apparent localized hinge point. Because of the properties inherent in the construction materials, the device is provided with sufficient flexibility to allow the opening and closing of the pair of ends.
In several embodiments, the urethral compression device has a pair of distinct latching mechanisms to retain the device around the penis and to compress the urethra. The compression of the urethra in those embodiments is accomplished by a compression hinge which closes and forms a pressuring device as the compression hinge is moved towards the urethra. The second or compression latching mechanism holds the compression hinge in position.
In an embodiment, the urethral compression device has a strap, a closure latching mechanism, a compression latching mechanism, and a compression hinge. The device has a pair of substantially flat pressure-applying elements hinged together at the compression hinge. The compression latching mechanism which works in conjunction with the compression hinge to compress the urethra. The latching mechanism has a plurality of teeth which define receptacles and an engaging tab.
The second ends of the flat pressure-applying elements are moved towards each other, therein moving the compression hinge perpendicular towards the penis to compress the urethra. The moving of the second ends of the flat pressure-applying elements results in moving of the compression latching mechanism into a closed latched position retaining the compression hinge against the penis.
The closure latching mechanism, in an embodiment, has a locking tab which projects inwardly into a receptacle which receives the strap. To secure the urethral compression device around the user's penis, the strap is threaded through the receptacle and secured by engaging the locking tab against the strap.
In one embodiment, the urethral compression device has a control clamp carried by a flexible strap. The control clamp has a compression projection that extends transverse to the urethra. The compression projection is carried by a rotating arm that pivots about a base at an axis at the opposite end of the arm from the compression projection. The arm pivots about the axis moving the compression projection away or towards the base. The movement of the arm is controlled by an adjustment screw.
The urethral compression device can be opened for urination, closed after urination, and adjusted to the desired degree of compression by the user using only one hand, without the need for necessarily using the other hand.
The urethral compression device does not need to be removed from the penis in order to allow the user to urinate. When the device is in place and is opened for urination, the ends of the device springs open such that the opened device remains on the penis shaft. This functionality is provided to avoid the necessity of removing the device from the penis shaft, when it is supported by the user during urination.
The size, weight and operational simplicity afford a particular discreteness to this invention. The design of the invention allows the wearer to use the urethral compression device without detection since the invention does not inhibit normal body movements. The small size of the invention does not add obvious volume bulk beneath user's clothing.
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Beane Richard
Cheng Gordon
Kumar Sanjaya
Simmers Richard
Bowditch & Dewey LLP
Brown Michael A.
UroScientific Incorporated
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