Abstract:
The present invention features a device to prevent the unwanted flow of urine in incontinent human males. This penile clamp is designed to provide an external pressure applied to the underside of the penis at the base thereof to close the urethral canal. The apparatus comprises a rigid projection on the lower member of the device that applies a concentrated force on the canal. The upper bar of the device provides the means of attaching a pad as an integral part of an easily disinfected clamp that is hinged at one end and provided with an adjustable tensioning closure device at its other end. The closure device is easily removable to allow one hand release of the penis restriction. A screw-type adjustment is easily set and is easily disassembled by a quick-release apparatus. While the clamp can be closed over the penis of an incontinent male to prevent urination, it does not appreciably restrict blood flow therein.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention pertains to a device for restricting the flow of urine through the penis of a male and providing for the voluntary release of urine, and, more particularly, to an easily adjustable, penis-clamping apparatus for incontinent males.  
         BACKGROUND OF THE INVENTION  
         [0002]    While male incontinence is a common and often neglected problem, the distress, embarrassment and inconvenience imposed on individuals suffering from involuntary urination warrants the development of non-invasive solutions to this condition.  
           [0003]    To date, one of the common means of preventing the involuntary flow of urine in incontinent males has been to clamp the penis via a device that becomes painful, socially restrictive and difficult to keep clean. Such devices cause pressure to be applied upon the urethra, which consequently restricts the flow of urine through the penis. Another means of incontinence control is to place the penis in a pouch with a water-tight seal at the base of the penis and collect urine in a discharge bag.  
           [0004]    U.S. Pat. No. 4,942,886 (entitled “External Incontinency Device” and issued to Timmons on Jul. 24, 1990) discloses a device having rigid members hinged together at one end and a ratchet portion with a plurality of recesses. When a strap is placed in one of the recesses, the two halves of the device are caused to maintain a predetermined position of clamping the penis. Unfortunately, due to the nature of the ratchet recess portion, inadvertent pressure against one or both of the sides of the device can cause a tightening of the device and a subsequent, excessive or pathological constriction of the penis.  
           [0005]    One of the more popular devices for treating male incontinence is sold under the trademark Bard Cunningham Clamp.RTM. This device, too, has a ratchet-type closure mechanism that is subject to the same types of difficulties regarding any inadvertent bumping or touching thereof.  
           [0006]    While not specifically addressing incontinence, U.S. Pat. No. 4,139,007 (entitled “Method and Apparatus for Conception” and issued to Diamond on Feb. 13, 1979) also discloses a male contraceptive device that prevents the leakage of semen into the female vagina. This device also has a ratchet recess portion, which is also subject to the same problems as experienced with Timmons.  
           [0007]    To substitute for the rachet mechanism, Velcro® has been used in various devices. For example, U.S. Pat. Nos. 3,155,096 and 3,866,611 both feature the use of Velcro® fasteners as the closure mechanism. (The former, entitled “Male Incontinence Clamp” issued to Outwin on Nov. 3, 1964; the latter, entitled “Incontinence Device”, issued to Baumrucker on Feb. 18, 1975.) Unfortunately, as lint and other foreign materials become embedded in the operating mechanism (i.e., hooks and eyes) of the material, Velcro® has a tendency to become less efficient. Over a period of time, therefore, such devices become less useful.  
           [0008]    U.S. Pat. No. 3,203,421 (entitled “Incontinence Clamp Device” and issued to Bialick on Aug. 31, 1965) discloses a device in which a knurled knob is used to tighten together the two portions of the hinged device. The tension appears to be predetermined, and the release of the penis is accomplished by completely removing the device, thus making use thereof at a urinal impossible. Two hands are required to reposition the device. While trying to operate the device, there is also a certain risk involved in dropping any of the parts thereof.  
           [0009]    U.S. Pat. No. 5,415,179 (entitled “Male Urinary Incontinence Device” and issued to Mendoza on May 16, 1995) discloses a device comprising a “U-shaped “lower unit with a hinged upper bar which closes across the open section of the lower unit. The upper bar has a screw mechanism with a pad that causes compression of the penis when the pad is screwed down on the penis. While this will create sufficient pressure to stop the flow of involuntary urine, there is the risk of reducing or stopping the blood flow to the penis. As there is no direct pressure on the urethra, the pressure must be applied to the entire cross-section of the penis and the pressure sufficient to close the urethra. In addition, the mechanism is not convenient for voluntary urination as the complete device must be removed and reapplied using both hands.  
           [0010]    U.S. Pat. No. 5,571,125 (entitled “Penis—Clamping Device for the Incontinent” and issued to Chadwick on Nov. 5, 1996) discloses a hinged clamshell device that can easily open and close. The device employs a hinged section with padded rigid straight jaws that are held shut with a screw/spring closure device. The closure device allows the user to adjust the pressure applied to the penis. The closure device also employs a quick release apparatus. However the disadvantage of this device is the hinge-jaw design and the establishment of an uneven pressure distribution on the penis. Since the jaws of the device are straight and unyielding, the pressure will be greatest on the hinged side where the jaws pinch down on the penis and there is no direct pressure on the urethra.  
           [0011]    U.S. Pat. No. 5,184,629 (entitled “Male Urinary Anti-incontinence Device and Method” and issued to Erickson and Timm on Feb. 9, 1993) discloses a hinged cradle member with an elastic strap closure mechanism. The cradle member includes integral hinges situated about an axis perpendicular to the penile shaft and interconnecting the dorsal and ventral sections of the device through which the shaft of the penis is placed. The unique aspect of this device is an integral urethral occlusion pad on the ventral member such that upon closure and securing with the elastic (velcro) strap, the urethra is occluded. The disadvantage of this device is that it folds along the length of the penis and requires a substantial length of shaft for placement. In addition, there is no means of adjusting the amount of pressure applied to the penis to occlude the urethra.  
           [0012]    The foregoing approaches to alleviating the problem of urinary incontinence in men leave much to be desired, since these designs offer little in the way of comfort or convenience for the user. In addition, none of these clamps is easy to clean, or are any capable of adjusting pressure directly upon the urethra. It should be obvious to the casual observer that such devices are neither comfortable nor efficient in resolving the problems imposed by an incontinent condition. In fact, such clamps are sometimes not only unworkable, but are actually dangerous when residual urine bums the skin or when inadvertent tightening causes penile constriction.  
           [0013]    There is a need for an improved penile clamp that is safe, comfortable, easily cleanable and more socially practical (i.e., utilizing one-handed operation) than that heretofore devised. The ease of attachment and usage, as well as an emergency quick release, should also be combined with infinitely variable adjustment to enable the application of different pressures to accommodate the individual needs of users. For sanitary reasons, it is preferable that the clamping device does not absorb urine through the use of absorptive materials (pads). 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0014]    [0014]FIG. 1 is a perspective view of the clamping device of the present invention locked together in a closed position by means of the post assembly;  
         [0015]    [0015]FIG. 2 illustrates the clamping action of the device with a cross sectional view of a penis;  
         [0016]    [0016]FIG. 3 is a perspective view of the clamping device in the open and unlocked position with the post assembly swung to the front;  
         [0017]    [0017]FIG. 4 is a perspective view of the clamping device in the open and unlocked position with the post assembly swung to the front and the upper clamping bar swung open;  
         [0018]    [0018]FIG. 5 is a perspective view of the clamping device in the closed position but opened slightly such that the urethra is not occluded and urine would be allowed to flow;  
         [0019]    [0019]FIG. 6 is a front view of FIG. 5 showing the increased space between the lower body member and the upper bar;  
         [0020]    [0020]FIG. 7 is an exploded view of the components of the hinge assembly;  
         [0021]    [0021]FIG. 8 is a top and side view of the upper clamping bar;  
         [0022]    [0022]FIG. 9 is a top, side and end view of the lower body member;  
         [0023]    [0023]FIG. 10 is an exploded view of the components of the closure assembly;  
         [0024]    [0024]FIG. 11 is a top and side view of the spring holder;  
         [0025]    [0025]FIG. 12 is a perspective view of a the disclosed device using an alternate hinge;  
         [0026]    [0026]FIG. 13 is a perspective view of the top clamp of FIG. 12; and  
         [0027]    [0027]FIG. 14 is a perspective view of the bottom clamp of FIG. 12. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0028]    The present invention comprises a hinged penile clamp that is designed so that it easily opens and closes. For user comfort, the device is padded with a closed-cell non-liquid visco elastic polymer or similar padding material. The inventive clamp is designed to allow for precise pressure application by employing a screw-type, tightening adjustment for the upper and lower members. The screw-type adjustment is easily set, and is easily disassembled by means of a quick-release apparatus. Despite its being easily disassembled, the adjustment apparatus will not permanently change as a result of accidental manipulation or external forces. In addition, the device will allow for the temporary release of pressure on the urethra utilizing one-hand operation.  
         [0029]    Although the disclosed device provides an improved method of addressing male incontinence, it also provides a method of blocking the flow of isotopes used in prostrate x-rays. The device can also be used to prevent the accidental release of urine during urological procedures when used in place of a catheter.  
         [0030]    In male incontinence device, as illustrated in FIGS.  1 - 11 , comprises an upper clamping bar  100  hinged about a lower body member  200  and held in place by a movable and releasable post assembly  50 . The lower body member  200  has a raised portion or protrusion  215  in the approximate center of the member such that when the device is clamped about the central body of the penis  250 , the protrusion  215  applies increased pressure on the urethra  255 , by squeezing it between the hump and the internal structures of the penis, to prevent the flow of urine.  
         [0031]    [0031]FIG. 1 is a perspective view of the device  10  of the present invention illustrating an upper bar  100  with an adjacent pressure pad  150  and a lower body member  200  locked together in a closed position by means of the post assembly  50 . The post assembly  50  contains a post  300 , a screw cap  350 , a spring  400 , and spring holder  500  and is described in more detail in conjunction with FIG. 10.  
         [0032]    In FIG. 2, the clamping action of the device with a cross sectional view of a penis  250  is illustrated. The clamping device  10  is positioned such that the protrusion  215  located on the lower body member  200  compresses the urethra  255  against the corpora canernosa  260 ′,  260 ″ within the body of the penis  250 .  
         [0033]    As illustrated in the exploded view of FIGS. 7 and 8, the upper clamping bar  100  is preferably a “U” shaped piece having a hinge end  110 , a central section  105  and a handle end  120 . The hinge end  110  extends upwards and inwards forming a concentric shape about an axis  115 . The hinge end  110  is comprised of two fingers  112 ′ and  112 ″ with a slot  135  formed between them to facilitate the connection with the lower body member  200  as illustrated in FIG. 9. The fingers  112 ′,  112 ″ form the hinge about the cylinder  225  of the lower body member  200 . The central section  105  is generally “U” or semi-circular shaped to engage a penis. The central section  105  contains one or more holes  130 , or other means, for attaching a disposable pad  150 . In cross section, the central section is rectangular to provide a larger surface area for contact with the penis and decrease the risk of pressure skin necrosis. The handle end  120  extends out from the central section  105  to provide a platform for connection with the post assembly  50  and a place for the person to grasp. The slot  145  provides a receiving area for the spring loaded post assembly  50  with the upper clamping bar  100 .  
         [0034]    The disposable pad  150  is comprised of a closed cell visco-elastic polymer or similar material with a means of attachment to at least the under surface central section  105  of the upper clamping bar  100  as well as the lower bar  200  if desired. As illustrated the shape of the pad  150  is such that it will be “U” shaped or such as to be complimentary to the shape of the central section  105  of the upper clamping bar  100 . The thickness of the pad will vary to accommodate different size penises and to provide the necessary counter pressure to the lower bar  200  without impeding the circulation within the penis. As illustrated, the pad  150  has molded on to the surface that contacts the upper clamping bar  100  a means of attachment with the clamping bar  100 . In the illustrated embodiments, and shown in detail in FIG. 7, one or more attachment post(s)  155  and securing cap(s)  160  are positioned on the pad  150  to coincide with the attachment hole(s)  130  of the clamping bar  100 . The securing cap  160  is a flexible and resilient material that will deform significantly to allow passage through the attachment hole  130  and then revert back to its original shape after passing through the bar  100  to prevent the inadvertent release of the pad  150  from the bar  100 . The resilience of the material must be such, however, that it can be removed by pulling the attachment post  155  and cap  160  back through the attachment hole  130 .  
         [0035]    The lower body member  200 , shown in FIG. 9, is comprised of the central section  210 , the hinge post  220  and hinge cylinder  225 , and the closure, or handle, end  230 . The hinge post  220  and hinge cylinder  225  are positioned to provide an axis  75  about which the upper clamping bar  100  rotates. The hinge post  220  and slot  135  are dimensioned to interact with one another to enable easy rotation of the upper clamping bar  100 . The central section  210  has a raised protrusion or protrusion  215  in the center of the lower body member  200  that, as stated heretofore, is dimensioned to place pressure on the urethra  255 .  
         [0036]    As illustrated more clearly in FIGS. 9 and 10, the connection end  230  has a post attachment section  235  on the surface opposite to the mating surface with the upper clamping bar  100 . The post attachment section  235  is designed to provide a “snap fit” of the post hinge cylinder  320  within the curved section  237  of the attachment  235 . The curved section  237  has a cut out  245 , as seen clearly in FIG. 9, to allow the post  310  to rotate to a plane parallel to the axis  75 , as seen in FIG. 3.  
         [0037]    The post assembly  50  as illustrated in FIG. 10 is comprised of post  300 , an internally threaded screw cap  350 , a spring  400  and a spring holder  500 . The post  300  has a central body  310 , preferably cylindrical, with a short post hinge cylinder  320 , or other rotatable connection member, attached perpendicular to the central body  310 . The post hinge has an axis  85  which, when the post hinge cylinder  320  is snapped into post attachment  235 , coincides with the axis of the post attachment  235 . The other end of the post  300  is a threaded section  305  for attachment of the screw cap  350 . The spring  400  is a stainless steel spring with sufficient stiffness to maintain pressure against the spring holder  500 , which in turn provides sufficient pressure between the upper clamping bar  100  and the lower body member  200  to prevent separation. The holder  500 , as seen more clearly in FIG. 11, is of sufficient internal diameter to hold the spring  400  and has an outer spherical or partially spherical shape  510  to rest on the upper clamping bar  100 . The holder  500  has two “wings”  515 ′,  515 ″ which provide the user with a means of grasping the holder  500  and pulling up on the holder wings  515 ′,  515 ″ to relieve the force exerted by the spring  400  on the upper clamping bar  100 . The holder has an opening  520  dimensioned for concentric placement over the post  300 . As seen in FIG. 11, the wings  515 ′ and  515 ″ are preferably slightly curved to provide a better, and more comfortable grip.  
         [0038]    The preferred method of using the above-described device  10  will now be described in conjunction with FIGS.  3 - 5 ,  7  and  10 . First, before the device  10  is inserted onto the penis shaft or member of a user, the closure assembly  50  is disengaged, FIG. 3 such that the upper clamping bar  100  can be rotated away from the lower body  200 , FIG. 4. At this time, an area of substantial access is provided for insertion of the penis into the device  10 , preferably such that the penis lies on the lower body member  200  with the protrusion  215  directly beneath the urethra  255 , as illustrated in FIG. 2. The bar  100  is then rotated towards the lower bar  200  until the handle end  120  of the bar  100  is proximate the lower member  200 . The closure assembly  50  is then swung upwards such that the post  310  is situated in slot  245  and slot  145  of the lower body  200  and upper bar  100 , respectively, FIG. 5. In order to facilitate swinging the closure assembly  50  upwards, the spring can be compressed by grasping the spring holder  500  under the wings  515 ′,  515 ″ and rotating the closure assembly  50  with the holder  500  elevated above the upper bar  100 . Care is taken to have in place a pad  150  that provides sufficient pressure on the penis so that the urethra  255  is occluded by the protrusion  215 . The pads  150  can be supplied in various thicknesses to provide the desired compression. Additional compression adjustment can be made by compressing the spring  400  by means of the knob  350  that is threaded on to the upper portion  305  of the post  300 . The knob  350  retains the spring  400  against the spring holder  500 , which in turn holds the upper clamp  100  against the lower member  200 . Turning the knob  350  clockwise relative to the post  300  compresses the spring  400  and applies increased pressure to the penis. In addition, increasing the compression of the spring  400  will increase the resistance of the closure assembly  50  from accidental release.  
         [0039]    Advantageously, when the penis is located in the device  10 , the clamping bar  100  confines the movement of the penis. The central section  105  of the “U-shaped” body  100  limits any side-to-side movement of the penis, thus preventing movement out from under the applied pressure. Further, because of the raised protrusion  215 , increased pressure is applied directly to the urethra  255  thus decreasing the pressure required to preventing urine flow to the remainder of the penis. Further, the pad  150  provides a more comfortable engaging surface with the outer skin of the penis. This feature, along with the fact that the present arrangement does not result in any pinching or other force that constricts the blood flow through the penis, means that even when strong pressure is being applied by the protrusion  215 , the device  10  can be worn for long periods of time without discomfort.  
         [0040]    The device  10  of the present invention also has the advantage that it provides a lower uniform pressure on the outer surface of the penis at all times. Thus, opposing force, such as when the user coughs or laughs, will not result in movement of the protrusion  215  such that a reduced pressure situation occurs to allow fluid flow through the urethra  255 .  
         [0041]    When the user desires to urinate, he presses places his thumb on top of the knob  350  and a finger under each of the spring holder wings  515 ′,  515 ” and compresses the spring  400 . Compressing the spring  400  allows the upper clamping bar  100  to open and the pressure applied by the protrusion  215  to the urethra  255  is reduced thus allowing the urine to flow. When urination is terminated, the spring holder is released thus lowering the clamping bar and applying pressure again to the urethra  255 . Thus, it can be seen that, due to the spring-loaded nature of closure  50 , the device  10  can be successfully operated with one hand, without removal of the device and at no risk of losing parts of the device.  
         [0042]    In the event of an emergency or extreme discomfort whereby the device  10  needs to be removed instantaneously, the user can simply rotate the post assembly  500  to the open position by pushing the knob  350  to the side with his thumb while grasping the lower body  200  with one or two fingers.  
         [0043]    A further embodiment of the clamp device  700  is shown in FIGS. 12, 13 and  14  in which the hinge between the upper clamp body  705  and lower clamp body  710  has been modified. The two fingers  112  forming the hinge  110  in the embodiment of FIGS.  1 - 11  have been replaced with a curved extension  727  extending from the upper clamp body  705 . The curved extension is dimension to fit within the slot  726  in the lower clamp body  710 . The dimensioning of the slot  726 , in relationship to the curved extension  727  must be such that the extension  727  can rotate freely within the slot  726  without side-to-side movement. The curvature and length of the extension  727 , however, must be sufficient to prevent any separation between the upper clamp body  705  and the lower clamp body  710 , thereby reducing the intended pressure and therefore effectiveness of the device  700 . The remaining structure of the clamp  700  remains as described in conjunction with the foregoing embodiments. This hinge embodiment reduces the bulk and size of the device as compared to that shown in other embodiments.  
         [0044]    Since other modifications and changes varied to fit particular operating requirements and environments will be apparent to those skilled in the art, the invention is not considered limited to the example chosen for purposes of disclosure, and covers all changes and modifications which do not constitute departures from the true spirit and scope of this invention.  
         [0045]    Almost all of the components, especially  100 ,  200 ,  300 ,  350 ,  500 ,  705  and  710  can be made from a hard plastic to facilitate longevity, cleaning and ease of manufacturing. The pad  150  is preferably a closed cell, visco-elastic, resilient biocompatible polymer. The spring is preferably a non-corroding steel such as stainless steel