Title:
INCONTINENCE DEVICE
United States Patent 3866611


Abstract:
A penile clamp for control of male incontinence including a pair of clamping surfaces hingedly connected together at one end by a flexible hinge member and releasably attachable together at their opposite end by a self-adhering type of fastening, with a pair of pressure applying members in spaced-apart relation on one clamping surface and a single pressure applying member on the opposite clamping surface disposed in relation to the pair of opposing pressure members to exert a three-point clamping action on an organ clamped between the surface.



Inventors:
BAUMRUCKER GEORGE O
Application Number:
05/425249
Publication Date:
02/18/1975
Filing Date:
12/17/1973
Assignee:
BAUMRUCKER; GEORGE O.
Primary Class:
Other Classes:
128/DIG.15, 128/DIG.25
International Classes:
A61B17/122; A61F2/00; (IPC1-7): A61B17/08
Field of Search:
128/346,325,DIG.25,326,327 251
View Patent Images:
US Patent References:
3705586UMBILICAL CORD CLAMP1972-12-12Sarracino
3612475FLEXIBLE TUBE CLOSURE1971-10-12Dinger
3503398ATRAUMATIC CLAMP FOR VASCULAR SURGERY1970-03-31Fogarty et al.
3203421Incontinence clamp device1965-08-31Bialick
3171184Clamp1965-03-02Posse
3155096Male incontinence clamp1964-11-03Outwin
3147754Device for controlling incontinence1964-09-08Koessler
1728322Device for elastically clamping off the male urethra1929-09-17Badrian



Primary Examiner:
Gaudet, Richard A.
Assistant Examiner:
Opitz R.
Attorney, Agent or Firm:
Mann, Brown, McWilliams & Bradway
Claims:
1. A penile clamp for controlling male incontinence including a pair of clamping pieces, flexible hinge means hingedly connecting the clamping pieces together adjacent one end thereof, releasable fastening means securing the clamping pieces together at the opposite end thereof from the hinge means, pressure members on the respectively opposing faces of the clamping pieces, one of said clamping pieces having a pressure member extending continuously lengthwise substantially full length thereof and disposed substantially centrally between the two sides thereof, the opposite clamping piece having a pair of laterally spaced pressure members extending continuously lengthwise substantially full length thereof adjacent respectively opposite side edges of the clamping piece, said last-named pressure members being disposed in offset opposing relation to the first-named pressure member whereby to define an S-shaped clamping path between the clamping pieces and provide a plurality of sealing points, said clamping pieces comprising upper and lower hingedly connected members respectively, said firstnamed pressure member being disposed on the upper clamping piece, said last-named pressure members being disposed on the lower clamping piece, said releasable fastening means comprising a self-adhering device including a positive material piece fixed on the upper clamping piece, and a flexible negative material piece fixed to the lower clamping piece extending over the positive material piece and

2. A penile clamp for controlling male incontinence including a pair of clamping pieces, flexible hinge means hingedly connecting the clamping pieces together adjacent one end thereof, releasable fastening means securing the clamping pieces together at the opposite end thereof from the hinge means, pressure members on the respectively opposing faces of the clamping pieces, one of said clamping pieces having a pressure member extending continuously lengthwise substantially full length thereof and disposed substantially centrally between the two sides thereof, the opposite clamping piece having a pair of laterally spaced pressure members extending continuously lengthwise substantially full length thereof adjacent respectively opposite side edges of the clamping piece, said last-named pressure members being disposed in offset opposing relation to the first-named pressure member whereby to define an S-shaped clamping path between the clamping pieces and provide a plurality of sealing points, said clamping pieces comprising upper and lower hingedly connected members respectively, said first-named pressure member being disposed on the upper clamping piece, said last-named pressure members being disposed on the lower clamping piece, said pressure members comprising soft block-like pad devices and said pair of pressure members on the opposite clamping piece each partially overlap said pressure member on said one

3. A penile clamp for controlling male incontinence including a pair of clamping pieces, flexible hinge means hingedly connecting the clamping pieces together adjacent one end thereof, releasable fastening means securing the clamping pieces together at the opposite end thereof from the hinge means, pressure members on the respectively opposing facing of the clamping pieces, one of said clamping pieces having a pressure member extending continuously lengthwise substantially full length thereof and disposed substantially centrally between the two sides thereof, the opposite clamping piece having a pair of laterally spaced pressure members extending continuously lengthwise substantially full length thereof adjacent respectively opposite side edges of the clamping piece, said last-named pressure members being disposed in offset opposing relation to the first-pressure member whereby to define an S-shaped clamping path between the clamping pieces and provide a plurality of sealing points, said clamping pieces comprising upper and lower hingedly connected members respectively, said first-named pressure member being disposed on the upper clamping piece, said last-named pressure members being disposed on the lower clamping piece, and said pressure members being comprised of hollow tubular soft material.

Description:
BACKGROUND OF THE INVENTION

Heretofore, penile clamping devices have been provided which have a direct clamping action on the organ and which, while having a cushioning pad on each of the opposing clamping surfaces, were of generally rigid construction that exerted a positive clamping action that was harsh and uncomfortable to wear and utilized a mechanical type of releasable locking device for securely retaining the clamping surfaces in tightly engaged relationship across the organ to prevent leakage by the application of sheer clamping pressure at but a single point. These prior devices not only were uncomfortable but, especially on long periods of wear, cut off the blood supply to the organ beyond the clamp and frequently resulted in complications which many times necessitated medical attention. Infection and ulcerated conditions were not uncommon with the use of such clamping device.

The mechanical locking mechanisms were particularly objectionable, especially with disabled persons such as the blind, crippled, or military veterans, paraplegics, or elderly men. The complicated functioning of such mechanical locking devices made it very difficult for a handicapped person to actuate the mechanism, either to lock the device, or to release it. When a man had to operate these mechanisms by touch or "by feel," because he couldn't see the mechanism, either as a result of blindness or because he was fat or corpulent, it became extremely difficult or impossible to manipulate the parts of the mechanism for interengagement for locking or releasing the device.

SUMMARY OF THE INVENTION

The present invention overcomes all of the shortcomings of prior art penile clamping devices and affords a degree of comfort in its use not available with the prior devices. This greatly improved clamping device has been devised primarily for the purpose of compressing and obstructing the male urethra to prevent leakage and dribbling where voluntary control of the passage of urine is no longer possible for any reason. The prior clamps frequently were applied by the patient at a comfortable pressure which he found tolerable but which in reality was not sufficient to compress the urethra to the point where leakage would be prevented. If the clamp was applied with a sufficient compression to close the urethra, it was too tight to be comfortable to the patient and had the effect also of shutting off the blood supply to the organ beyond the clamp. This caused a cyanosed condition of that portion of the organ, as well as swelling thereof, and which at times progressed to the development of an ulcerated condition and eventual necrosis of the skin.

The invention provides a penile clamp which is applied in a generally similar manner across the shaft of the penis, but with a moderate degree of pressure, and this moderately applied pressure is disposed such that the urethra is compressed in a plurality of locations, as distinguished from the one spot of the prior clamps. The present clamping action bends or clamps the urethra into the shape of a reverse curve, or an S shape, so that a plurality of sealing points are provided instead of the simple one spot sealing arrangement previously. The single spot sealing clamps have been the only type available on the market, but the three-point pressure applying action of this improved clamp not only completely stops the urinary flow, but does so with a minimum of pressure and is completely comfortable. This three-point moderate pressure clamp, therefore, can be worn more comfortably for greater periods of time while definitely stopping the dribbling or leaking condition, and with less likelihood of developing any of the complications caused by prior devices.

OBJECTS OF THE INVENTION

The primary purpose of this invention is to provide a penile clamp designed to compress the male urethra and prevent urinary dribbling or leakage by the application of a moderate amount of pressure.

The principal object of the invention is the provision of a penile clamp having a three-point pressure applying action to compress the male urethra at a plurality of points and obtain an effective sealing action with minimum applied pressure.

An important object of the invention is to provide a penile clamp having spaced-apart clamping surfaces hingedly connected together at one end and releasable secured together at the opposite end by self-adhering attaching means.

A further important object of the invention is the provision of a penile clamp having hingedly connected clamping surfaces in opposite relationship, with spaced-apart pressure applying members on one of the surfaces and a single pressure applying member on the other of the surfaces disposed intermediate the spaced pressure members on the opposite surface, and means for releasably securing said surfaces and pressure members in opposite relationship.

Another object of the invention is to provide a penile clamp having upper and lower hingedly connected clamping surfaces, with a pair of spaced-apart pressure pads on the lower surface disposed in opposite relationship to the upper clamping surface and a single pressure pad on the upper clamping surface in opposite relationship to the lower surface and disposed intermediate the pair of spaced pressure pads on the lower surface.

DESCRIPTION OF THE DRAWINGS

The foregoing and other and more specific objects of the invention are attained by the incontinence clamp arrangement and construction illustrated in the accompanying drawings wherein:

FIG. 1 is a general perspective view of the penile clamp of this invention showing the application thereof by a patient, with the securing means ready to be attached;

FIG. 2 is a perspective view of a clamp, with the securing means shown in released position;

FIG. 3 is a side elevational view of the clamp showing it as applied in use, with the securing means illustrated in position to be attached to hold the hinged parts in operative clamping relationship;

FIG. 4 also is an elevational view of the clamp shown applied in fully clamped position closing off the urethra, with the releasable securing means in attached position locking the clamp parts in operative relationship; and

FIG. 5 is a transverse sectional view through a clamp showing it applied and illustrating the three-point pressure application in its simplest form, whereby the urethra is compressed at a plurality of points and caused to assume the shape of a reverse curve or S shape, and thereby effectively seal off the urethra at multiple stop points.

DESCRIPTION OF PREFERRED EMBODIMENT

In the drawings, the clamp device 10 is comprised of an upper clamping surface member 11 and a lower clamping surface member 12 which are hingedly connected together in operative relationship by a flexible hinge member 13. The clamping surface members 11 and 12 are adapted to be releasably secured together at their ends opposite the hinge 13. A self-adhering releasable type of fastening is utilized for this purpose in the form illustrated. For purposes of this disclosure, this fastening is shown as comprised of Velcro materials which provide a dry fastening held together by friction. The term "Velcro" is a tradename for a hook and loop type of closure material. As used here, the positive hook piece of material 14 is fixed to the upper surface member 11 and the negative pile piece 15 is fixed to the lower surface member 12. By this means, the two clamping surfaces 11 and 12 can be pressed toward each other to secure any clamping pressure desired, and the flap of negative material 15 then pulled around the end of the upper clamping surface member 11 and pressed against the surface of the positive material 14 on the top face of the upper member where it is securely held by the interaction of these two materials in a well-known manner. This provides an effective attachment or lock for the hinged parts 11 and 12, and which is very simple to actuate, so that an elderly person, or one who may be handicapped in any way, will find the arrangement very easy to operate in either the locking or releasing movements. Either operation may be had without the necessity for any great skill or manipulation.

In the actual practice of this invention, the upper and lower clamping surface members 11 ans 12 may be approximately 3 inches in length and about 1 and 5/16 inches in width by about three thirty-seconds to an eighth of an inch in thickness, thus providing two oblong, generally plate-like surface members which may be fabricated of a suitable plastic material such as one selected from the group including polyethylene, polypropylene, polyvinyl chloride, polystyrene, or the like, and which may be made by extrusion or by molding, as preferred. The clamp structure may be made of other materials, if desired, but a suitable plastic structure enables the provision of a very light-weight device which may readily be cleaned or sterilized by simple procedures. The clamping surface members 11 ans 12 and the flexible hinge member 13 are illustrated in FIG. 2 as separate elements suitably secured together, but it is contemplated that this assembly may be fabricated in a single piece where the flexible hinge portion 13 may be integral with the clamping plates 11 and 12 as shown in FIG. 1. In this event, the plates 11 and 12 would be maintained at their normal thickness for effective clamping action, but the integral hinge portion 13 might be molded of thinner section to obtain the desired relative flexability.

The clamping plate surface members 11 and 12 are normally disposed in opposite relationship for applying the desired clamping action, and the opposing faces of these clamping plates are provided with pressure pads to make the clamping action more comfortable and to ease continued use of the device. The arrangement of these pressure pads is of great importance in achieving the advantages afforded by this invention. As best shown in FIG. 2, particular note must be taken of the dispostion of a spaced-apart pair of pressure pads 18 and 19 on the upwardly disposed face of the lower clamping surface plate 12 in opposite relationship to the upper clamping surface plate 11. However, a single pressure pad 20 is disposed on the underside of the upper clamping surface plate 11 in opposite relationship to the lower clamping surface plate 12. This single pressure pad 20, in opposing relationship to the lower clamping plate 12 containing the pressure pads 18 and 19, is disposed in substantially intermediate relation to those pressure pads for a purpose hereinafter to appear.

it is by the relative disposition of the three pressure pads 18, 19 and 20 that the three-point clamping action of this clamp device 10 is obtained. The pressure pads all run lengthwise on the respective plates 11 and 12. The pads 18 and 19 are spaced apart on the lower clamping plate so that the pads are disposed adjacent to the respective side edges of this plate, while the pressure pad 20 extends lengthwise substantially along the center of the upper clamping plate 11. The proportions of the several pressure pads is such that the upper pad 20 partially overlies the lower pads 18 and 19. By this arrangement, as best indicated in FIg. 5, when the clamp is applied, the urethra is compressed at a plurality of points and is caused to assume the shape of a reverse curve or an S-shaped curve, and thereby effect a multi-point seal against the dribbling or leakage of any urine. further, the multi-point application of these clamping forces enables the attainment of complete stoppage of any urinary flow with the application of minimum pressure at the several stop points. By effecting the S curve in the urethra, the need for increased sealing pressure is reduced and the flow stopped with lower pressure than is necessary in the single point application of clamping pressure in prior clamping devices.

The pressure members 18, 19 and 20, because of the application of compression at substantially reduced pressures at multiple locations on the urethra, in the manner described, effectively close off the urethra with less pressure as compared to the greater pressure utilized by prior devices applied at a single point to effect the stoppage. The pressure members 22, 23 and 24, if desired, might be molded of the same material and integrally with the respective clamping plates 11 and 12 as indicated in FIG. 1. By providing smooth rounded surfaces on such pressure members the reduced operating pressures necessary of this clamp device and by applying such pressure in the S form obtained with the arrangement, enables such integral structures to be utilized and which can be worn with complete comfort because of the minimal pressure brought to bear to obtain complete stoppage of urine flow.

The pressure pads 18, 19 and 20 as shown in FIG. 2, can be made from a suitable grade of soft rubber, or a synthetic foam material having the necessary degree of firmness to obtain the desired clamping action and closing off of the urethra without undue force, so that compression of the urethra can be had to the extent required without excessive pressure being applied. The pressure pads may take the form of tubular rubber sections having the same general proportions, spacing and relationship as the elements 18, 19 and 20, and having generally the same cushioning properties as those elements. This arrangement also effects the three-point clamping action and the multi-point seal or stop action to uncontrolled urine flow. It is important to note that the multiple pressure pads 18 and 19 are disposed on the lower plate 12 to exert an upwardly directed clamping force, and the single pressure pad 20 is disposed on the upper plate 11 to exert a downwardly directed clamping force. The clamp 10 is thus made more effective to compress the urethra and thereby close off the flow of urine because the urethra is normally located adjacent the bottom of the penis, and when the clamping force of the pressure pads 18, 19 and 20 is brought to bear across the shaft of the penis, the urethra is immediately deflected into a reversely curved of S shape by the pressure pads 18, 19, as it is compressed against the pressure pad 20, and thereby develop the multiple point sealing action of the clamp 10 against dribbling or leakage.

The clamp in the form disclosed herein, may be fabricated from materials which afford a most economical and readily manufactured design, whether made in one piece as indicated in FIG. 1, or in a plurality of pieces, as shown in FIg. 2. The hinge piece 13 in this latter form is readily attachable to the clamping surface plates 11 and 12, and the Velcro fastenings pieces 14 and 15 may easily be secured to the respective plates 11 and 12, all by cementing in place, if desired, for a permanent and lasting relationship to provide a clamping device that will endure and last through many applications without adversely affecting the bond between the related parts. The clamp can be manufactured cheaply enough that it can be made disposable, if that is the intent, or it can be cleaned with solutions such as alcohol for repeated use over long periods.

This clamp, by comparative tests, has demonstrated its capacity to clamp off the urethra more effectively, with considerably less pressure, and with greatly lessened likelihood of complications requiring medical attention. This is obtained primarily by the three-point application of clamping pressure, whereby the required pressure is reduced by effecting the S curve in the urethra to obtain the multi-point sealing or stoppage of urine flow, and the simplified fastening device enables use of the clamp by the handicapped. The clamp not only is less expensive to manufacture, but is of lighter construction and more simple to manipulate by persons having less than normal dexterity of their hands and fingers, such as elderly men, requires less clamping pressure to effect full sealing compression of the urethra, and, because of the fact that it is less expensive to produce, may be marketed at a price such that it can be economically disposable.

From the foregoing, it can readily be seen that a penile clamp has been provided having a simply operated, releasable fastening device, and which operates effectively at a lower clamping pressure by utilizing relatively soft pressure pieces in opposed relatively staggered relationship on respectively opposite clamping pieces to compress the uretha at multiple points by deflecting the urethra into an S curve and thereby prevent dribbling or leakage of urine.