Patent Publication Number: US-2006004332-A1

Title: Vacuum installed external male catheters and methods of using same

Description:
BACKGROUND  
      Urination incontinence devices with external catheters, also called urisheaths, are well known devices for gathering uncontrolled urine and flowing it into a collection device. Such devices also have well-known problems making them complicated, difficult, uncomfortable, and generally unreliable from the point of view of persons having to use them. One chronic problem is keeping the catheter in place on the penis, for which some such incontinence devices utilize an adhesive to removably bond the penis and the interior of the catheter. Some condom catheters are provided with an adhesive pre-applied to the interior of the catheter. Upon unrolling the condom catheter, the adhesive is positioned between the interior of the catheter and the penis and affixes the catheter to the penis. Catheters with pre-applied adhesive are difficult and expensive to manufacture. Other condom catheters are provided with separate adhesive strips. The patient first applies the adhesive strips to his penis, and then unrolls the catheter on his penis and over the adhesive strips, thus, affixing the catheter to the penis. Mounting a condom catheter tends to invoke a natural reaction of the penis to shrink and withdraw into the body. Furthermore, because catheters employ adhesives that are sticky by their nature, they tend to adhere where they first contact the penis, and are difficult to unroll and mount over a full length of a penis that is rapidly withdrawing into the body. This results in poorly mounted condom catheters that tend to spontaneously detach from the penis and/or leak. In addition, mounting a catheter to a penis with an adhesive causes discomfort to some patients over both a short term and a long term. Also, adhesives can irritate a penis.  
      Other existing devices first mount a condom catheter on a deployment tool or a housing assembly, and then use a vacuum to assist in positioning the catheter on a penis, or draw the penis into a housing. For example, applicant&#39;s prior U.S. Pat. No. 5,499,977 (incorporated herein by reference) utilizes a plastic housing as a deployment tool. The housing incorporates a rubber bulb as a vacuum source. The plastic housing includes a flared opening configured to match a penis tip. A rolled-up ring portion of a condom catheter is carried on the plastic housing, and deployed therefrom onto the penis. By way of further example, applicant&#39;s U.S. Pat. No. 5,662,631 (incorporated herein by reference) utilizes a vacuum to draw a penis having a previously mounted catheter into a tubular housing to which a urine drain tube is attached.  
     SUMMARY  
      An embodiment of the present invention provides a method for quickly and comfortably mounting a condom catheter. The method comprises coupling a vacuum source to an outlet of a male condom urinary catheter, the catheter having an interior surface and including a thin cylindrical sheath of elastic material, the outlet configured for connection with a urine collection device, and a neck coupled between the sheath and the outlet. The method also comprises placing a portion of the interior surface of the catheter proximate to a head of a penis, at least a portion of the catheter sheath having been rolled outward upon itself to form consecutively larger rolls, applying a vacuum from the vacuum source to the catheter outlet sufficient to draw the portion of the interior of the catheter against the head of the penis, unrolling the catheter sheath onto the penis, and releasing the vacuum. The method may further comprise limiting movement of the head of the penis toward the wearer&#39;s body using the catheter after the catheter has been drawn against the penis. The method may also further comprise moving the head of the penis away from the wearer&#39;s body using the catheter after the catheter has been drawn against the penis.  
      A further aspect of the invention provides a sleeper catheter. The device comprises a generally cylindrical and at least semi-rigid catheter sleeve that includes an open proximal end having an inside diameter and an exterior surface, an open distal end, and a closure element that forms a substantially airtight seal in cooperation with the sleeve distal end, wherein the closure element is located at or proximate to the distal end. The sleeper catheter further comprises a thin cylindrical sheath of elastic material having an inside diameter less than the sleeve inside diameter. The sheath may be an integral extension of the sleeve or may be a separately joined element. If the sheath is removable from the sleeve, the sheath includes an open distal end configured for airtight coupling with a circumferential portion of the sleeve exterior surface. In either form, the sheath has an open proximal end configured for substantially airtight coupling with a penis, which forms a continuous interior chamber between the sheath proximal end and the sleeve distal end. The sleeve and the sheath cooperatively provide a substantially airtight installation on the penis by placing the open proximal end of the sheath closely around a circumference of the penis proximal to a head of the penis. The substantially airtight installation is further provided by applying a vacuum to the interior chamber sufficient to draw at least a portion of the penis and at least a portion of the sheath into the sleeve, and preferably bring the head of the penis proximate to the open distal end of the sleeve. The head of the penis is retained proximate to the distal end of the sleeve when the vacuum is released and the closure is applied to the open distal end of the sleeve such that, upon unintentional retraction of the penis from the sleeve, a vacuum is created biasing the penis toward the distal end. In an embodiment, the vacuum may be applied through the open distal end of the sleeve; the closure element may include a cap, and the open distal end of the sleeve correspondingly includes an engagement means for receiving the cap. The cap, when engaged with the open distal end, preferably does not extend more than 2.5 cm beyond the open distal end, thereby limiting the overall physical structure of the catheter.  
      An additional aspect of the invention provides a kit that comprises the sleeper catheter described above and instructions for mounting the sleeper catheter on a penis. The instructions comprise placing a circumferential portion of an interior surface of the sheath over a head of a penis and closely around a circumference of the penis proximal to a head of the penis. The instructions also comprise applying a vacuum to the interior chamber sufficient to draw at least a portion of the penis and at least a portion of the sheath into the sleeve and bring the head of the penis proximate to the open distal end of the sleeve, releasing the vacuum, and establishing a substantially airtight environment within the interior chamber. The instruction to establish a substantially airtight environment may include applying the closure element to the distal end of the sleeve, and may further include wearing the sleeper catheter.  
      Another aspect of the invention provides a method for treatment of male urinary dysfunction. The method comprises wearing a sleeper catheter on a penis, and maintaining the airtight closure of the sleeper catheter with the penis inside at least a portion of the sleeve of the device for an effective time duration. The male urinary dysfunction may include at least one condition from a group consisting of difficulty initiating the flow of urine, slow urine stream once urination has started, need to pass urine more often than usual during a day (frequency) or overnight (nocturia), dribbling, returning to urinate within a short time after initial urination, feeling of urgency to urinate, and sensation that emptying is not complete. The effective time duration may include wearing the device at least three hours a day for at least three days.  
      These and various other features as well as advantages of the present invention will be apparent from a reading of the following detailed description and a review of the associated drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      Aspects of the invention, together with features and advantages thereof, may best be understood by making reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like referenced numerals identify like elements, and wherein:  
       FIG. 1  illustrates a side and partial cross-section view of a male condom urinary catheter  20  of a kit, according to an embodiment of the invention;  
       FIG. 2  illustrates the catheter of  FIG. 1  with the sheath in a rolled up configuration and a vacuum source, according to an embodiment of the invention;  
       FIG. 3  illustrates a head of a penis proximate to a circumferential portion of the interior surface of the catheter of  FIG. 1 , according to an embodiment of the invention;  
       FIG. 4  illustrates the sheath of the catheter of  FIG. 1  unrolled onto the penis while the syringe maintains a vacuum, according to an embodiment of the invention;  
       FIG. 5  illustrates a partial cross-section view of a sleeper catheter, according to an embodiment of the invention;  
       FIG. 6  illustrates the sleeper catheter of  FIG. 5  with a penis proximate to a circumferential portion of the interior surface of the sheath, according to an embodiment of the invention;  
       FIG. 7  illustrates the sleeper catheter of  FIG. 5  with a vacuum source coupled to the distal opening, according to an embodiment of the invention;  
       FIG. 8  illustrates the sleeper catheter of  FIG. 5  with the penis and a portion of the sheath having been drawn into a chamber formed by the interior surface of the sleeve, according to an embodiment of the invention; and  
       FIG. 9  illustrates the sleeper catheter of  FIG. 5  with a closure element sealing the interior chamber and establishing an airtight environment, according to an embodiment of the invention. 
    
    
     DETAILED DESCRIPTION  
      In the following detailed description of exemplary embodiments of the invention, reference is made to the accompanying drawings, which form a part hereof. The detailed description and the drawings illustrate specific exemplary embodiments by which the invention may be practiced. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the present invention.  
       FIG. 1  illustrates a side and partial cross-section view of a male condom urinary catheter  20 , according to an embodiment of the invention. The catheter  20  includes a cylindrical sheath  22  having a thin sidewall  23 . The catheter  20  also includes an outlet  26  that connects with a gravity or vacuum urine collection device (not shown), and a neck  28  coupled between the sheath  22  and the outlet  26 . The catheter  20  further includes a proximal end  32  of the sheath  22  that has an opening (shown in phantom) for insertion of a penis, and a distal end  34  having a urine discharge opening  35  that couples with the urine collection device. An interior surface  24  is defined between the proximal end  32  opening and the urine discharge opening  35 .  
      The catheter  20  may have any configuration suitable for deployment and mounting on a penis, with or without use of an adhesive. For example, in one embodiment, the cylindrical sheath  22  includes a longitudinal length of approximately 7.5 cm and an internal diameter D 1  of approximately 2.5 cm. The outlet  26  includes a tubular structure with a length of approximately 2.5 cm, an outside diameter D 2  of approximately 1 cm, and a smaller inside diameter terminating in the discharge opening  35 . The outlet  26  may have any configuration suitable for mounting with a urine collection device, such as the diameter D 2  being selected to sealingly fit with a tube leading into a urine collection bag. The neck  28  provides a dimensional, and optionally a structural, transition between the sheath  22  and the outlet  26 . A portion of the interior surface  24  (not shown) of the neck  28  optionally provides a flexible and comfortable surface for contact with a head of a penis.  
      The catheter  20  may be made from any elastomer material suitable for direct contact with a penis, and may be a natural or synthetic material. For example, the catheter  20  may be made from a latex rubber, a silicone rubber, a polyester polyurethane, or a combination of these or other materials. The thin sidewall  23  may have any thickness suitable for condom catheter use that provides sufficient elasticity to elastically retain the sheath  22  on a penis over time; such thickness may be function of the material selected for the sheath  22 . Optimally, the neck  28  and the outlet  26  have a thicker sidewall than the thin sidewall  23  of the sheath  22 , providing at least a degree of rigidity or stiffness to these portions.  
       FIG. 2  illustrates the catheter  20  of  FIG. 1  with the sheath  22  in a rolled up configuration and a vacuum source “S” in the form of a vinyl bulb, according to an embodiment of the invention. Before placement and/or mounting on a penis, at least a portion of the catheter sheath  22  is preferably rolled outward upon itself to form consecutively larger rolls  36 . The catheter  20  is typically sold with at least a portion of the catheter sheath  22  rolled outward upon itself to form the consecutively larger rolls  36 . If at least a portion of the catheter sheath  22  is not rolled into the rolls  36 , a initial step in mounting the catheter  20  includes rolling the catheter sheath  22  outward upon itself starting at the proximal end  32  to form the consecutively larger rolls  36 . The elasticity of the elastomer material retains the rolls  36  proximate to an unrolled portion of the sheath  22  or the neck  28 . The rolls  36  form a funnel directing a penis into the unrolled portion of the sheath  22 , and optionally proximate to the neck  28 .  
      The vacuum source may provide any form of vacuum or suction, for example, the suction may be provided by a handheld device, a user inhaling through a tube, or a mechanical system.  FIG. 2  illustrates the vacuum source as a handheld, soft vinyl bulb S, which is commonly available as an ear bulb. The vinyl bulb S includes a tapered inlet that sealingly fits inside the urine discharge opening  35 .  
       FIG. 3  illustrates a distal portion or head of a penis P proximate to a circumferential portion  38  of the interior surface  24  of the catheter  20  of  FIGS. 1 and 2 , according to an embodiment of the invention.  FIG. 3  also illustrates the tapered inlet of the vinyl bulb S of  FIG. 2  coupled into the discharge opening  35 . A step in mounting the catheter  20  on a penis includes placing a circumferential portion of the penis P proximate to the circumferential portion  38  of the interior surface  24  of the catheter. In this step, a wearer will typically insert the head of the penis P past the catheter sheath roll  36  and proximate to the junction between the sheath  22  and the neck  28 . The circumferential portion  38  may be at any location in either, or both of, the sheath  22  and the neck  28 . The head of the penis P either may or may not, also, be proximate to the neck portion  28  of the catheter as a matter of personal preference. Optimally, a circumferential portion of the penis P contacts the circumferential portion  38  of the sheath  22  before application of the vacuum described below.  
      Another step in mounting the catheter  20  includes coupling the vacuum source, illustrated as the vinyl bulb S, to the distal opening  35  of catheter outlet  26 . When the vacuum source is a handheld device such as the vinyl bulb S illustrated in  FIG. 3 , a compressive force F is applied to the vacuum source S to compress and ready it for application of a vacuum. The compressive force F may be applied at anytime prior to unrolling the rolls  36 . For example, the vinyl bulb S may be first compressed and then coupled with the distal end  34 . Alternatively, the vinyl bulb S may be loosely coupled with the distal end  34  and then compressed with the force F. Air forced from the vinyl bulb S is vented past the loose coupling. In another alternative, the vinyl bulb S is coupled with the distal end  34  and then compressed with the force F. Air forced from the vinyl bulb S is vented through a passage formed by the inner surface  24  and past the roll  36 . If the head of the penis P has been placed proximate to the circumferential portion  38 , the air is also vented past the head.  
      Another step in mounting the catheter  20  includes applying a vacuum from the vacuum source, illustrated as the vinyl bulb S, to the catheter outlet  26  sufficient to draw the circumferential portion  38  of the interior  24  of the catheter firmly against the head of the penis P and form a relatively airtight seal. In the embodiment illustrated in  FIG. 3 , the vacuum is applied by releasing the force F and allowing the body of the vinyl bulb S to expand toward its normal shape. The vacuum and airtight seal helps stabilize the catheter  20  relative to the head of the penis P and hold it in a relatively fixed position. Furthermore, the vacuum and resulting relatively airtight seal provide a grip on the head of the penis P by the catheter  20 . A person may then hold the neck  28  of the catheter  20  firmly with their thumb and forefinger, and limit the natural shrink and withdraw movements of the head of the penis P toward the wearer&#39;s body by holding the catheter stationary relative to the body. Additionally, the grip also allows the penis P to be extended by gently moving the head of the penis P away from the wearer&#39;s body for improved mounting of the sheath  22 . Both are expected to aid in mounting the condom catheter  20  on the penis P.  
       FIG. 4  illustrates the sheath  22  of the catheter  20  of  FIGS. 1-3  unrolled onto the penis P while the vinyl bulb S maintains a vacuum, according to an embodiment of the invention. An additional mounting step includes unrolling the catheter sheath rolls  36  onto the penis P progressively away from the head of the penis. The grip provided by the vacuum may be used to stabilize the penis P during the unrolling of the catheter sheath rolls  36 . As the sheath rolls  36  are unrolled, the thin sidewall  23  of sheath  22  is disposed proximate to the penis P. The elastic properties of the catheter sheath  22  reduce a circumference of the unrolled sheath against the penis P, drawing it elastically against the penis, retaining the sheath against the penis, and forming a further substantial airtight seal. The vacuum provided by the vinyl bulb S is maintained and/or renewed during the unrolling step, optimally until the entire roll  36  is unrolled.  
      A final step includes releasing the vacuum by uncoupling the vinyl bulb S from the catheter outlet. The sheath  22  remains against the penis P after the vacuum is released, and optimally the elasticity of the sheath maintains the airtight seal of the sheath  22  with penis P. The outlet  26  is ready for connection with a urine collection device. Such devices often apply a vacuum to the penis as an aid in collecting uncontrolled urine. Such vacuum is expected to reestablish a substantial airtight seal between the sheath  22  and the penis P if it was lost upon release of the vacuum. A substantially airtight seal over substantially an entire length of the penis P is expected to improve wearer comfort, protection against unexpected or premature need to change the catheter  20 , and prevention of urine migration and build-up. The absence of an adhesive is further expected to improve these same factors.  
       FIG. 5  illustrates a partial cross-section elevation view of a sleeper catheter  50 , according to an embodiment of the invention. The sleeper catheter  50  includes a generally cylindrical and at least semi-rigid catheter sleeve  60 , a closure element illustrated as a closure cap  76 , and a condom sheath  80 . The sleeve  60  includes a proximal portion  62  that has an opening  64 , an inside diameter D 4 , an interior surface  65 , and an exterior surface  66 . The sleeve  60  also includes a neck  68  coupling the proximal portion  62  and a distal end  72 . The distal end  72  has an opening  73 , inside diameter D 5 , and a mount for the closure element, illustrated as threads  74  for a screw-on closure such as the closure cap  76 . The closure cap  76  includes threads  78  that engage the threads  74  of the distal end  72 . The interior surface  65  is defined between the proximal opening  64  and the distal opening  73 .  
      The condom sheath  80  includes a thin cylindrical sheath  82  having an inside diameter D 6 , an interior surface  85 , a distal end portion  92  having an opening  94  configured for airtight coupling with a circumferential portion of the sleeve exterior surface  66 . The inside diameter D 6  is less than the sleeve inside diameter D 4 . The sheath  80  also includes a proximal end portion  86  having an opening  88  for insertion of a penis. The sheath  80  and the sleeve  60 , when distal portion  92  is coupled with exterior surface  66 , form a continuous interior chamber between the sheath proximal end opening  88  and the sleeve distal end opening  73 .  
      The catheter sleeve  60  includes a tubular structure that is at least semi-rigid, and optimally thin walled for light weight. The sleeve  60  may be made from any suitable material, including a metal such as aluminum, a polymeric such as plastic, and a composite. The at least semi-rigid structure has sufficient rigidity and strength to maintain its shape while being worn as described below, and for the distal portion of the sleeve  80  to be compressively coupled to the exterior surface  66  of its proximal end portion  62 . The neck  68  provides a dimensional and structural transition between the sleeve  60  and the distal end  72 .  
      The condom sheath  80  is similar in materials and construction to the catheter  20  of  FIG. 1 , except that it has a generally uniform diameter D 6  and a single wall thickness. Further, like the catheter  20 , the condom sheath may be made from any elastomer material suitable for direct contact with a penis, and may be either natural or synthetic material.  
      The closure element may be any device, or combination of devices, providing an airflow open position and sealed position. Since the sleeper catheter  50  may be worn during the day under normal clothing, an aspect of the invention provides an unobtrusive or low-profile closure element that minimizes visibility of the catheter under a man&#39;s clothes. Certain embodiments provide a low-profile closure cap  76  with threads  78  that engage threads  74  on the distal end  72 , which seals the opening  73  when the threads are engaged. Other embodiments provide a toggled cap that toggles between an open position that does not obstruct the opening  73  and a closed position that seals the opening.  
      An embodiment of the sleeve  60  includes a hollow plastic cylinder having an internal diameter D 4  of approximately 3.5 cm, and a proximal end  62  length of approximately 10 cm. The sleeve  60  further includes a neck  68  and a distal end  72  having a length of approximately 1.3 cm each, and a distal end internal diameter D 5  of approximately 0.75 cm. An embodiment of the low-profile closure cap  76  includes a length L 7  of approximately 1.3 cm and course threads  74  that engage corresponding course threads  74  of the distal end  72 .  
      An embodiment of the condom sheath  80  includes a thin-walled latex rubber sheath having a length of approximately 10 cm and an internal diameter D 6  of approximately 3.3 cm. The sleeve  60  and the sheath  80  are elastically coupled in an airtight configuration by stretching an approximately 1.3 cm length of the sheath  80  by hand over the proximal end opening  64  and further over approximately a 1.3 cm length of the exterior surface  66  of the proximal end portion  62  of the sleeve  60  as illustrated in  FIG. 5 . The coupling may be augmented in any manner, for example, by an adhesive, circular clamp, reinforced portion of the sheath  80 , or a retention grove in the sleeve  50 .  
       FIG. 6  illustrates the sleeper catheter  50  of  FIG. 5  with a penis P proximate to a circumferential portion  96  of the interior surface  85  of the sheath  80 , according to an embodiment of the invention. An initial step in mounting the sleeper catheter  50  on the penis P includes placing the open proximal end  88  of the sheath  82  around a circumferential portion of the penis proximate to the head of the penis. This may be accomplished by stretching the proximal opening  88  to enlarge its diameter, and moving it over the head of the penis and toward the body, and then releasing the stretched proximal opening, thus placing a circumferential portion  96  of the interior surface  85  of the sheath around a circumferential portion of the penis. The elasticity of the sheath  82  forms an airtight seal between the sheath and the penis.  
       FIG. 7  illustrates the sleeper catheter  50  of  FIG. 5  with a vacuum source coupled to the distal opening  73 , according to an embodiment of the invention. Another step in mounting the sleeper catheter  50  on the penis P includes coupling a vacuum source to the catheter. As described in conjunction with the condom catheter  20  of  FIGS. 1-4 , the vacuum source may be any type of device or combination of devices or sources that provide a vacuum or suction.  FIG. 7  illustrates the vacuum source as the vinyl bulb S of  FIG. 2 . Similarly, as described in conjunction with the condom catheter of  FIGS. 1-4 , a step in mounting the sleeper catheter  50  includes reading the vacuum source if required. When the vacuum source is the vinyl bulb S, it is readied for application of a vacuum by compressing it with the force F. Another step includes coupling the vacuum source, illustrated as vacuum source vinyl bulb S, to the sleeper catheter  50 .  FIG. 7  illustrates an embodiment where the vacuum source vinyl bulb S is coupled with the catheter  50  by inserting an outlet of the vinyl bulb into the distal end opening  73 . In another embodiment, a separate sealable port for application of a vacuum is provided.  
       FIG. 8  illustrates the sleeper catheter  50  of  FIG. 5  with the penis P and a portion of the sheath  80  having been drawn into a chamber formed by the interior surface  65  of the sleeve  60 , according to an embodiment of the invention. A step in mounting the sleeper catheter  50  includes applying a vacuum to the interior chamber sufficient to draw at least a portion of the penis P and at least a portion of the sheath  80  into the sleeve  60  and bring the head of the penis proximate to neck  68  and/or the open distal end  73  of the sleeve. Typically, the head of the penis P is brought up into the proximal end  62  and within 0.6 to 1.3 cm of the neck  68 .  
      Another step includes releasing the vacuum. The vacuum is released from the embodiment illustrated in  FIG. 8  by uncoupling the vinyl bulb S from the distal end  73 . The circumferential portion  96  of the condom sheath  80  remains coupled or around the circumferential portion of the penis P, and another portion of the sheath has been folded over the circumferential portion  96  with its elasticity reinforcing the airtight seal created with the penis by the circumferential portion  96 . The head of the penis P is generally retained proximate to neck  68  and/or the open distal end  73  of the sleeve after the vacuum is released.  
       FIG. 9  illustrates the sleeper catheter  50  of  FIG. 5  with a closure element sealing the interior chamber and establishing an airtight environment, according to an embodiment of the invention. The embodiment illustrated includes the closure cap  76  with threads that engage the distal threads  74  of the sleeve  60 . A final step includes applying the closure element after release of the vacuum, which as illustrated, includes screwing the cap  76  onto the threads  74  until an airtight seal is formed. Application of the closure element establishes a sealed environment in cooperation with the substantially airtight seal by the circumferential portion  96  of sheath  82  against the penis P. The substantially sealed environment resists retraction, withdrawal, and/or shrinkage of the penis P from the catheter sleeve  50 . Upon unintentional retraction of the penis P from the sleeve  50 , a vacuum is created biasing the penis toward the neck  68  and distal end  72 . Because the cap  76  has a low profile, such as a length L 7  of 2.5 cm or less, the sleeper catheter  50  has an overall small longitudinal profile and a reduced likelihood of being noticed while worn under clothes.  
      An aspect of the invention allows a wearer to urinate without removing the sleeper catheter  50 . With an appropriately sized distal end inside diameter D 5 , for example, a diameter of at least 0.6 cm, a wearer may unscrew the cap  76 , urinate, clean the catheter distal end  72 , and screw the cap  76  back on.  
      A kit according to an embodiment of the invention includes the sleeper catheter  50  and instructions for mounting the catheter on a penis. The instructions include steps that generally may be performed in any order except where specifically required. The instruction include: 
          placing a circumferential portion  96  of an interior surface  85  of the sheath  82  over a head of a penis and closely around a circumference of the penis proximal to the head of the penis;     applying a vacuum to the interior chamber formed by the interior surface  85  of the sheath  82  and the interior surface  65  of the sleeve sufficient to draw at least a portion of the penis and at least a portion of the sheath  82  into the sleeve and bring the head of the penis proximate to the open distal end  72  of the sleeve;     releasing the vacuum; and     establishing a substantially airtight environment within the interior chamber.        

      In another embodiment, a kit according to an embodiment includes the catheter sleeve  60  and instructions for mounting the condom sheath  80  on the sleeve to form the sleeper catheter and mounting the sleeper catheter on a penis. The instructions include: 
          coupling a circumferential portion of the sleeve exterior surface  66  to the open distal end  94  of the cylindrical sheath  80 , the sheath and the sleeve when coupled forming a continuous interior chamber between the sheath proximal end and the sleeve distal end;     placing a circumferential portion  96  of an interior surface  85  of the sheath  82  over a head of a penis and closely around a circumference of the penis proximal to the head of the penis;     applying a vacuum to the interior chamber formed by the interior surface  85  of the sheath  82  and the interior surface  65  of the sleeve sufficient to draw at least a portion of the penis and at least a portion of the sheath  82  into the sleeve and bring the head of the penis proximate to the open distal end  72  of the sleeve;     releasing the vacuum; and     establishing a substantially airtight environment within the interior chamber.        

      In a further embodiment, a kit according to an embodiment of the invention includes a condom sheath  80  and instructions for mounting the condom sheath on the catheter sleeve  60  to form the sleeper catheter and mounting the sleeper catheter on a penis. The instructions include: 
          coupling a circumferential portion of the sleeve exterior surface  66  to the open distal end  94  of the cylindrical sheath  80 , the sheath and the sleeve when coupled forming a continuous interior chamber between the sheath proximal end and the sleeve distal end;     placing a circumferential portion  96  of an interior surface  85  of the sheath  82  over a head of a penis and closely around a circumference of the penis proximal to the head of the penis;     applying a vacuum to the interior chamber formed by the interior surface  85  of the sheath  82  and the interior surface  65  of the sleeve sufficient to draw at least a portion of the penis and at least a portion of the sheath  82  into the sleeve and bring the head of the penis proximate to the open distal end  72  of the sleeve;     releasing the vacuum; and     establishing a substantially airtight environment within the interior chamber. 
 
 Therapeutic Method 
       

      Urinary dysfunction includes conditions such as difficulty initiating a flow of urine, slow urine stream once urination has started, need to pass urine more often than usual during a day (frequency) or overnight (nocturia), dribbling, returning to urinate within a short time after initial urination, feeling of urgency to urinate, and sensation that emptying is not complete. Current options for treating urinary dysfunction are generally limited to medication and surgery, which may have adverse consequences.  
      Anecdotal trials done by the inventor on himself and others suggest that wearing the sleeper catheter  50  during at least a portion of a day for at least several days has a desirable effect of diminishing symptoms of male urinary dysfunction without adverse consequences to their health. For example, after wearing the sleeper catheter  50  during the day for several days, several individuals reported that their symptoms of urinary dysfunction diminished an observable amount, such as waking less often during a night to urinate, and reduced urination frequency during a day. The therapeutic duration, i.e., the number of hours the sleeper catheter  50  is worn per day and total number of days worn may vary depending on the individual and his particular symptoms. A minimum effective or therapeutic time duration is presently estimated at approximately at least three hours a day for at least three days. The sealed environment may be opened occasionally while the sleeper catheter  50  is being worn for urination or other reasons without adverse impact on the treatment. Since wearing the sleeper catheter  50  is not known to have any adverse health consequences, an individual may wish to wear the sleeper catheter as often as comfortable and/or convenient until a desired improvement in urinary function is achieved.  
      An embodiment of the invention provides a method for treatment of male urinary dysfunction. The method includes mounting the sleeper catheter  50  on a penis according to the instructions described above for an effective time duration for reduction of urinary dysfunction symptoms, such as approximately least three hours a day for at least three days.  
      Although the present invention has been described in considerable detail with reference to certain preferred embodiments, other embodiments are possible. Therefore, the spirit and scope of the appended claims should not be limited to the embodiment described herein.