Abstract:
A catheter support comprising a pliant tubular structure of rigidity greater than the penis including a region surrounding the penis shaft, a region surrounding the penis head, and a substantially closed end having an aperture aligned with the penis terminal opening through which the catheter is received. The catheter support limits or eliminates catheter movement substantially radial to the axis of the catheter and thus radially against the inner opening if the penis head, substantially reducing or eliminating abrasion or other insult to the penis surfaces and tissue that interface with the catheter. One embodiment comprises 2 substantially identical elongated halves having longitudinal recesses and hinged together to close around the penis end and catheter providing the catheter support in a structure having improved comfort and wearability.

Description:
FIELD OF THE INVENTION 
     The present invention relates to supports for catheters introduced into the body, in particular, to supports for catheters introduced into the penis. 
     BACKGROUND OF THE INVENTION 
     The penis, having its unique structure, functions and tissue is in general unwelcoming to catheters and the rigid mechanical catheter supports. While having some minor degree of rigidity, relative to catheters inserted therein, the penis is relatively flaccid and further includes soft, sensitive and delicate tissues at its terminal end. Moreover, at this terminal end with the entering catheter, most discomfort is experienced by the wearer. 
     Attempts to alleviate discomfort by inserting a sleeve within the initial penis opening much like a catheter introducer ultimately becomes more uncomfortable than the catheter itself, and often cannot be worn for the needed duration. Other external rigid structures are generally unwearable or cannot be reliably supported by the penis, while flexible and very pliant structures may not provided the needed catheter support. 
     SUMMARY OF THE INVENTION 
     The catheter support according to the present invention comprises a pliant tubular structure of rigidity greater than the penis including a region surrounding the penis shaft, a region surrounding the penis head, and a substantially closed end having an aperture aligned with the penis terminal opening through which the catheter is received. The catheter support limits or eliminates catheter movement substantially radial to the axis of the catheter and thus radially against the inner opening if the penis head, substantially reducing or eliminating abrasion or other insult to the penis surfaces and tissue that interface with the catheter. 
     One embodiment comprises 2 substantially identical elongated halves having longitudinal recesses and hinged together to close around the penis end and catheter providing the catheter support in a structure having improved comfort and wearability. 
     Further design embodiments accommodate variations in application. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
       These and further features of the present invention will be better understood by reading the following Detailed Description together with the Drawing, wherein 
         FIG. 1  is an end view and a cross-sectional view of one embodiment according to the present invention; 
         FIG. 2  is an end view and a cross-sectional view of an alternate embodiment according to the present invention; 
         FIG. 3  is an end view and a cross-sectional view of an further alternate embodiment according to the present invention; 
         FIG. 4  is an end view and a cross-sectional view of a further alternate embodiment according to the present invention; 
         FIG. 5  is an exploded perspective view of a further alternate embodiment according to the present invention; 
         FIG. 6  is side, end and plan view of a further alternate embodiment according to the present invention; 
         FIG. 7  is a side perspective and end view of a further alternate embodiment according to the present invention; 
         FIG. 8  is a side perspective and end view of a further alternate embodiment according to the present invention; and 
         FIG. 9  is a partial side view and an end view of a further alternate embodiment according to the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     An end view  52  and a cross section view  54  of a first embodiment of the present invention is shown in  FIG. 1  and is a substantially tubular outer structure  56  having a first section  62  with an opening  64  into the outer structure  56 . The first section  62  opening  64  is typically symmetrical about a longitudinal axis extending the length of the outer structure  56 , and has a substantially uniform opening throughout the length of the opening  64  and is sized to lightly grip the shaft portion of a penis. The embodiment of the present invention shown provides some movement of the penis relative to the outer structure  56  and is shown in a rearward position  50 A as well as a maximally forward position  50 B and typically assumes a position between the forward and rearward positions. In one embodiment, the first section is approximately 1″ in length having an opening diameter of 0.75″, and a wall  76  thickness of about 0.187″. 
     A second section  70  of the outer structure also has an opening  71  that aligns with the opening  64 , gradually expands from the opening  64  diameter to a larger diameter  74 , and is substantially symmetrical about the axis  60 . In one embodiment, the larger diameter  74  is about one-eight larger than opening  62 , which is approximately 0.85″ and the second section axially extends approximately 1.25″ from the first section  62 . The second section  70  has a wall  76  of thickness typically diminishing from the wall  76  thickness, and has an opening  71  typically has a rounded interior end distal from the first section  62  which is seen as a rapidly diminished diameter, at which point a third section  80  begins. The second section is typically dimensioned to retain and enclose the penis head. 
     In the embodiment of  FIG. 1 , the third section  80  has a substantially reduced diameter opening  82  typically sized to receive a catheter therethrough, and providing a slight additional margin around the catheter to permit catheter insertion and/or retention without binding or pulling on the catheter  90  inserted into the opening  82 . In this embodiment, the opening  82  is substantially uniform in diameter along the axis  60 , and is typically centered about the axis  60 . An opening  82  in one embodiment is 0.185″ through a third section length of 0.75″ 
     A second embodiment of the present invention shown in  FIG. 2  by an end view  86  and a cross section view  88  and is has a substantially tubular outer structure  84  having a first section  62  and second section  70  substantially the same as provided by the prior embodiment of  FIG. 1 . The second embodiment includes a third section  91  substantially the same as the third section  80  of the prior embodiment of  FIG. 1 , except that the longitudinal or axial opening  92  is non-uniform, and as shown in  FIG. 2 , tapers from a minimum opening end  93  to a maximum opening end  94  (proximal the penis head). In one embodiment, the minimum opening end  93  is slightly larger than the catheter  90 , e.g. approximately 3/16″ for a 14 French catheter, and the maximum opening  94  expands amounts up to at least 100 percent of the minimum opening. 
     A third embodiment of the present invention shown in  FIG. 3  by an end view  102  and a cross section view  104  and is has a substantially tubular outer structure  106  having a first section  62  and second section  70  substantially the same as provided by the prior embodiment of  FIG. 1 . The third embodiment includes a third section  110  substantially the same as the third section  80  of the prior embodiment of  FIG. 1 , except that the longitudinal or axial opening  112  is enlarged and receives a sleeve  100  into the enlarged opening  112 . The sleeve  100  can be a single element having a cylindrical opening to receive the catheter  90 , or a multisectioned element as shown, with 2 (or more) mating pieces  114 ,  116 , which in the embodiment shown in  FIG. 3 , includes members  118  which extend radially outward from the mating pieces  114 ,  116  and each engage a corresponding recess  120  extending radially from the opening  112  in the third section  110 . 
     A fourth embodiment of the present invention shown in  FIG. 4  by an end view  132  and a cross section view  134  and is has a substantially tubular outer structure  84  having a first section  62  and second section  70  substantially the same as provided by the prior embodiment of  FIG. 1 . 
     In the embodiment of  FIG. 4 , the third section  130  has a substantially reduced diameter opening  138  typically sized to receive a catheter therethrough, and providing a slight additional margin around the catheter to permit catheter insertion and/or retention without binding or pulling on the catheter  90  inserted into the opening  138 , and to accommodate a lubricant, e.g. a dry, PTFE, etc. lubricant  142  between the catheter  90  and the opening  138  surface. In this embodiment, the opening  138  is substantially uniform in diameter along the axis  60 , and is typically centered about the axis  60 . An opening in one embodiment is 0.185″ through a third section length of 0.75″ A further embodiment includes a washer  140  having an inner opening sized to permit the catheter to pass through yet small enough to urge the lubricant  142  to be retained in the opening  138  without restricting movement of the catheter  90 . 
     A typical use of the embodiments  FIGS. 1-4  is to insert the catheter  90  into the head of the penis a desired amount and then to apply the embodiments of  FIGS. 1-4  around the penis either by guiding the formed outer structure over the penis, or if comprising multiple section, carefully closing the outer structure over the penis. 
     A further alternate embodiment  150  is shown in  FIG. 5 , comprising two longitudinal halves, each having a relatively rigid outer shell  152  which substantially surrounds and retains a resilient insert  154 . Typically, the insert  154  comprises a softer material  154  such as foam, and are shaped to proved a sequence of longitudinal openings within sections  162 ,  164  and  166  of the insert to accommodate the penis shaft, the penis head and the catheter with a corresponding sequence of inner axially aligned openings of appropriate diameters, which in one embodiment corresponds to the openings sections  62 ,  70  and  80  of the embodiment of  FIG. 1 , and have wall  170  thickness defined by the section openings and the shell  152  inner dimensions. In one embodiment, the insert  154  comprises a flexible foam to allow for body changes and a compression grip about the penis shaft and/or head. Moreover, the insert implementation of the present invention provide low-cost accommodation of various penis sizes by correspondingly dimensioned inner openings with different pairs of inserts  154  while maintaining the same outer shell  152 . Alternate embodiments of this and other embodiments include a polypropylene or other water absorbing or water-wicking layer  157  disposed to be in contact with the penis, or porous foam  156  and/or shell  152 , or equivalent in the other embodiments of the present invention. An optional shell inner extension  158  extends into the insert recess  168  and into which the catheter is initially inserted. Typically the shells  152  mate and include a means to secure the shells  152  together such as clips  160  which engage corresponding portions or recesses in the typically identical mating shell (not shown). Alternately, the shells (and inserts therein) can be secured together with encircling elements (not shown) and a recess  172  may be included within the periphery of the shell  152 . 
     A further embodiment  180  is shown in  FIG. 6 , wherein the catheter support comprises two mating pieces  182 A,  182 B mating on a plane substantially including the axis, and connected by a hinge  184 . In the embodiment shown, the catheter support includes 3 axially contiguous regions  192 ,  194  and  196  having inner openings substantially axially aligned, and may comprise the dimensions of the corresponding openings  64 ,  72  and  82  as may be proportioned to the anticipated penis dimensions. To guide the closing together of the mating catheter support pieces  182 A,  182 B about the hinge  184 , ridge guides  186  and complementary mating ridge guide recesses  188  are formed and positioned to receive the corresponding guide elements from the other of the mating pieces. In the instant embodiment, they are longitudinally disposed on the divided wall edge of the catheter holder  180  parallel to the axis  60 . In addition to the closure devices previously discussed regarding other embodiments and applied hereto, still further closure devices  190 A,  190 B or as may be known in the art may be applied to the embodiments of the present invention. Closure devices applicable to this and other embodiments include tape, snaps, VELCRO (a trademark of Velcro Corp.), buttons and/or clasps. 
     A typical use of the embodiments  FIGS. 5 and 6  is to insert the catheter  90  into the head of the penis a desired amount and then to apply the embodiments of  FIGS. 5 and 6  around the penis either by guiding the formed outer structure over the penis, or if comprising multiple section, carefully closing the outer structure over the penis. Alternate embodiments of the catheter support  180  of  FIG. 6  (or  150  of  FIG. 5 ) may further include a substantially rigid single outer shell having an central top opening through which the catheter is received, such as formed according to two mating shells  152  of  FIG. 6  applied over mating pieces  182 A,  182 B (or two of  170 ,  FIG. 5 ). This substantially rigid outer shell is applied over the inserts  154  or mating pieces  182 A,  182 B after being closed over the penis, and may further extend the entire length of the insert or mating pieces or partially therealong. 
     The further alternate embodiment  200  of  FIG. 7  comprises a tubular member  210  having an opening  202  at one end sized to receive the penis head and shaft and a smaller opening  204  at the opposite end of the tubular member  210  through which a catheter (not shown) is received and supported as described in the above embodiments. The tubular member  210  includes a slot  206  extending along the wall of the tubular member  210  (including slot in each of a penis shaft support, a penis head support and a catheter support as describe in the above embodiments aligned or otherwise in communication) from the opening into which the penis is received, to the smaller opening  204  and through which the catheter may be moved and ultimately be place through the smaller opening  204  and into the center of the tubular member  210 . The slot  206  and other slots (not shown) extending along a smaller portion of the length of the tubular member may provide ventilation or air movement and mitigate the build-up of moisture, and such slots are applicable to other embodiments shown herewith. The embodiment may also include a slot  206  with walls  208  and raised portions  212  (or other mechanism) which urges the catheter to remain in the smaller opening  204 . Alternate embodiment provide a resilient tubular member having adhesive disposed on the slot walls  208  permitting all or portions of the slot to be closed around the penis. 
     A further alternate embodiment  220  according to the present invention comprising a tubular member  230  having a opening  222  disposed at one end of the tubular member into the penis shaft and penis head is received and a smaller opening at the opposite end of the tubular member through which a catheter  224  passes (and is supported as provided with the above embodiments) and forms an assembly together with the tubular member  230 . This embodiment (and other above embodiments) may further include apertures  232  disposed along the length of the tubular member extending inward to provide a ventilation passageway providing a flow of air proximal or in contact with the penis (or internal moisture controlling layers, e.g.  157  of  FIG. 5 ) to reduce moisture or heat (or both) within the embodiments of the present invention. 
     A further alternate embodiment  240  is shown in  FIG. 9 , wherein the catheter support end of tubular member, also receiving the penis shaft and penis head in an opposite end opening, comprises several sections  244  extending radially outward from the catheter support end opening  242 . The section  244  tips  246  converge but stop short and form the opening  242  through which the catheter passes, and may comprise the thickness necessary for catheter support as described for the above embodiments or may merely provide a sufficiently rigid outer structure to protect and support the catheter from moving radially against the head of the penis as radial or other forces are applied to the catheter outside the catheter support, having a thickened insert material therebehind to provide the above described catheter support. 
     The embodiments provided herein are understood to be exemplary and the scope of the present invention is not limited thereto. Modifications and substitutions as may be known to one of ordinary skill in the art are included herewith. The scope of the claims is not limited except by the claims which follow.