Abstract:
A method and apparatus for placing a bladder output control device is disclosed in which a tool has a surface which receives the bladder output control device and holds it for accurate placement of the device on the body of a user. The tool includes an illumination device mounted internal to the tool and provides illumination used in placement of the bladder output control device. The tool further includes a mirrored surface to enable better visualization of where the bladder output control device is located relative to its target location during placement of the device on the body of the user.

Description:
FIELD OF THE INVENTION 
     The present invention relates to an applicator or placement device for use in placing a bladder output control device on the body of a user. The present invention particularly relates to an applicator used for placing a bladder output control device, such as in external incontinence device, on the urinary meatus of a female user. Further, the present invention also relates to a placement device used for placing a bladder output device, such as a urinary catheter, through the urinary meatus and into the bladder. 
     BACKGROUND OF THE INVENTION 
     In the course of normal bodily activity, the bladder functions to cyclically store and evacuate urine and thereby effectuate the removal of liquid waste from the body. Although it is not uncommon for the human bladder to operate properly throughout the entire life of an individual, with increasing frequency, individuals are encountering a condition whereby the storage and release of urine is difficult to control with the desired success. Such a condition has been named urinary incontinence and is believed to be one of the most widespread and costly medical conditions prevailing in modem society. 
     The cause of urinary incontinence is found in the underlying conditions of the bladder or urinary sphincter muscles, which conditions may have varying degrees of complexity. For example, in women, urinary incontinence may be caused by multiple pregnancies, childbirth, and aging that causes a relaxation in the pelvic muscles, which in turn causes incontinence. On the other hand, other causes may include multiple sclerosis, stroke, and spinal cord injuries, all of which disrupt the nerves that control the muscles which control urine retention and evacuation. 
     Urinary incontinence may be temporary or chronic and there are several options for managing and treating the problem ranging from simply wearing an absorbent pad all the way to submitting to an invasive surgical procedure. Nearly every case of urinary incontinence, however, can be treated with substantial success. As such, it is somewhat surprising that of the approximately 13 million individuals in the United States alone that are suffering from urinary incontinence, less than half seek any medical attention, and fewer than one in ten afflicted individuals are actually treated. 
     One of the reasons that many instances of urinary incontinence go untreated is that the treatment may be obtrusive, embarrassing or simply inconvenient to the effected patient given the manageability of the condition. Another reason is likely due to costs and the ease with which a particular treatment may be obtained. Accordingly, there have been several previous attempts to arrive at a cost effective, unobtrusive treatment that is readily available to the user, particularly as such treatment relates to female incontinence. 
     Examples of such treatments may be found in U.S. Pat. No. 5,074,855 and U.S. Pat. No. 5,336,208 which each disclose a device for controlling urinary incontinence in a human female by way of a resilient pad configured to seal against and occlude the urinary meatus of the user. In both patents an adhesive is provided to seal the body of the device against the urinary meatus to hold urine in the bladder. The device is removed and discarded when the user must urinate. Then, after urination, a new device is applied. 
     Further examples may be found in International Application Nos. 96/39,989, 96/39,990 and 96/39,991, each of which disclose a female urinary incontinence device in the form of a urethral cap with a partially deformable body portion, a hand gripping portion and a body contacting surface. The body portion defines a chamber which allows for a vacuum seal when applied to the patient&#39;s body. This device too is removed when the user urinates, at the completion of which the device is then reapplied. 
     Yet still further examples are found in U.S. Pat. Nos. 6,056,687 and 6,200,261 which are hereby incorporated by reference in their entirety into the present application. These devices are also applied to the body of a female user over the urinary meatus, however, since these devices incorporate an integral valve mechanism, the user need not replace the device with each occurrence of urination but need only open the valve at the time of urination and then close the valve after urination is complete. 
     Another condition commonly diagnosed in individuals and opposite to urinary incontinence is urinary retention. Urinary retention (whether acute or chronic) may be caused by either an outflow obstruction or poor bladder contractibility. In each case, the oufflow resistance exceeds the pressure generated by contraction of the detrusor muscle that, under normal functioning, pushes the urine out. 
     Urinary catheterization is a procedure commonly employed to treat and relieve urinary retention. The procedure involves passing a catheter through the urinary meatus and into the bladder. Once the catheter is in the bladder, the balloon is inflated to position and secure the catheter in place. The catheter is then connected to a urine collection bag for closed urinary drainage. 
     The above-described devices for treatment of urinary incontinence and urinary retention (and other similar products not specifically described) offer many advantages to potential users, including cost effectiveness, availability and convenience. However, it has been discovered that one obstacle or disadvantage to such devices is the potential difficulty encountered in correctly placing and applying such devices to the female body. The location of the urinary meatus is oftentimes very difficult for a user of the device to visualize without assistance, which, in turn, leads to difficulty in placing the incontinence device at the precise location over the urinary meatus, necessary to ensure proper functioning of the device. Specifically for cases involving urinary incontinence, this difficulty is increased if the user is fully clothed and finds herself needing to place the device in the confines of a public restroom facility. 
     In view of the above, it is apparent that there is a need to provide assistance to the user of bladder output control devices such as those described above that ensures the proper operation of the device and thereby successfully treats the incontinence and retention. Such assistance includes providing better visualization to the user without increasing the effort already required to apply the device. It further includes ensuring that the placement task can be achieved within limited space constraints. 
     OBJECTS AND SUMMARY OF THE INVENTION 
     In view of the foregoing, it is an object of the present invention to provide a placement device that addresses the obstacles and disadvantages associated with the consistent and reliable placement of bladder output control device on the body. 
     A further object of the present invention is to provide a placement device that enables a user to easily visualize the site at which the bladder output device must be placed in order to ensure proper operation of the device. 
     A further object of the present invention is to provide a placement device that enables the user to place an external incontinence device on the body within the restricted confines of a bathroom facility such as a public toilet stall. 
     A further object of the present invention is to provide a placement device that is economical to produce and which is readily accessible to potential users. 
     A further object of the present invention is to provide a placement device that may be used without the assistance of medical care personnel. 
     A further object of the present invention is to provide a placement device that enables the user to place a catheter through the urinary meatus to the bladder for relief of acute or chronic urine retention. 
     These and other objects not specifically enumerated herein are believed to be addressed by the present invention which contemplates a device for placement of an external incontinence device which has at least a handle and a surface fixed to the handle which receives the external incontinence device. An illumination device is also included and is mounted on the handle providing illumination at the aforesaid surface. 
     The present invention further contemplates a tool for placement of an external incontinence device which includes a handle portion for gripping the tool and a flange extending from the handle portion. The flange has a surface for holding the external incontinence device. Further, a compartment is disposed in at least the handle portion for housing an illumination device and the illumination device is positioned in the compartment so as to provide illumination at the surface for holding the external continence device. 
     The present invention further contemplates a tool for placement of a catheter which includes a handle portion for gripping the tool and a flange extending from the handle portion. The flange has an opening for holding the catheter. Further, a compartment is disposed in at least the handle portion for housing an illumination device and the illumination device is positioned in the compartment so as to provide illumination at the surface adjacent to the distal end of the catheter. 
     The present invention also contemplates a method of placing an external incontinence device on the body of a user which may includes the steps of holding a handle of a placement tool wherein the handle has a surface for receiving the external incontinence device and then placing the external incontinence device on the surface. The next steps may include directing the external incontinence device toward a urinary meatus of a user and then activating an illumination device mounted on the placement tool either prior to or after the directing step whereby the activation provides illumination at the surface. The following step would likely include visualizing a location of the external incontinence device relative to the urinary meatus and then placing the external incontinence device over the urinary meatus. The final steps would likely include moving the external incontinence device into contact with the body, and then withdrawing the placement tool from the body. 
     The present invention also contemplates a method of placing a catheter in the body of a user which may includes the steps of holding a handle of a placement tool wherein the handle has a flange with an opening for receiving the catheter and then placing the catheter into the opening. The next steps may include directing the catheter toward a urinary meatus of a user and then activating an illumination device mounted on the placement tool either prior to or after the directing step whereby the activation provides illumination at the surface. The following step would likely include visualizing a location of the catheter relative to the urinary meatus and then directing the catheter through the urinary meatus. The final steps would likely include moving and securing the catheter into the bladder, and then withdrawing the placement tool from the body. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     Other features and advantages of the present invention will be seen as the following description of particular embodiments progresses in conjunction with the drawings, in which: 
     FIG. 1 is a top perspective view of an embodiment of an applicator/placement device in accordance with the present invention; 
     FIG. 2 is side perspective view of an embodiment of an applicator/placement device in accordance with the present invention; 
     FIG. 2 a  is a side perspective view of another embodiment of an applicator/placement device in accordance with the present invention; 
     FIG. 3 is a cross-sectional side view of an embodiment of an applicator/placement device in accordance with the present invention the invention; 
     FIG. 3 a  is a cross-sectional side view of another embodiment of an applicator/placement device in accordance with the present invention the invention; 
     FIG. 3 b  is a cross-sectional side view of another embodiment of an applicator/placement device in accordance with the present invention the invention; 
     FIG. 4 is a perspective view of another embodiment of an applicator/placement device in accordance with the present invention; 
     FIG. 4 a  is a perspective view of another embodiment of an applicator/placement device in accordance with the present invention; 
     FIG. 5 is cross-sectional side view of another embodiment of an applicator/placement device in accordance with the present invention; 
     FIG. 5 a  is a cross-sectional side view of another embodiment of an applicator/placement device in accordance with the present invention; 
     FIG. 5 b  is a cross-sectional side view of another embodiment of an applicator/placement device in accordance with the present invention; and 
     FIG. 6 is a cross-sectional view of another embodiment of an applicator/placement device in accordance with the present invention taken along the lines  6 — 6  of FIG.  5 ; 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring to FIGS. 1-3, a first embodiment of an applicator or placement device in accordance with the present invention includes a circular handle  102  perpendicularly connected to, and extending from, the center of a circular flange  104 . The circular flange  104  is substantially greater in diameter than the circular handle  102  and internal to the circular handle  102  and circular flange  104  is a compartment  106  which extends the length of the handle  102  and the thickness of the flange  104 . 
     The portion of the compartment  106  located in the circular handle  102  contains essentially three components, namely a SPST push-button switch  108  located at the proximal end of the handle  102 , a AA size electrical battery  110  located generally in the central portion of the handle  102  and an illumination source  112  located in the distal end of the handle  102 . The portion of the compartment  106  located in the circular flange  104  is sized to receive and hold an external continence device  114 . 
     In one embodiment of this disclosed applicator/placement device, the bladder output control device is an external incontinence device  114  which is the same device as that disclosed in U.S. Pat. No. 6,200,261, incorporated herein by reference. As disclosed in that patent, the external incontinence device  114  includes a valve mechanism  115  for selectively opening or closing th e external incontinence device  114  as desired by t he user. However, other types of external incontinence devices can be contemplated for use with this embodiment of the applicator/placement tool. 
     Referring to FIGS. 1 and 3, at the junction of the circular handle  102  and the circular flange  104  is an access port  116  which extends from the outer surface of the circular handle  102  to the compartment  106 . This port  116  is sized to receive the actuation line  118  from the external continence device  114  so that the user may pull the external continence device  114  snugly into the compartment  106 . In the operation of the incontinence device  114 , the actuation line  118  also serves as the structure for opening the valve  115  of the incontinence device  114 . 
     Referring to FIGS. 2 and 3, the outwardly facing surface  120  of the circular flange  104  serves as the receiving surface for a mounting flange  122  of the external continence device  114 . In this disclosed embodiment, the mounting flange  122  is triangular in shape, however, other shapes could also be used. 
     As mounted on the applicator, the external continence device  114  is positioned such that the valve portion  115  of the device  114  is situated within the compartment  106  of the handle and the underside of the mounting flange  122  is in touching engagement with the outwardly facing surface  120  of the circular flange. This placement is enabled through the tensioning of the actuation line  118  through the access port  116 . 
     In further respect to the circular flange  104 , the outwardly facing surface  120  is configured to be a mirrored surface over most if not all of its surface area. In a preferred embodiment, this surface is achieved by sizing a mirror piece to fit on the outwardly facing surface area  120  and then adhering the mirror piece to the outwardly facing surface area  120  by any suitable adhesive means. 
     In operation, a user will mount the incontinence device  114  onto the applicator/placement tool by inserting the actuation line  118  through the access port  116 . The user will then insert the top portion of the incontinence device (in this case the valve portion  115 ) into the compartment  106  until the underside of the mounting flange  122  is in touching engagement with the outwardly facing surface  120  of the circular flange  104 . The user may then apply tension to the actuation line  118  to ensure that the incontinence device is securely mounted onto the tool. 
     Once the incontinence device  114  is mounted the user may then actuate the push-button switch  108 , which closes the contacts between the battery  10  and the illumination source  112  and causes the illumination source  112  to generate light. Light from the illumination source  112  then travels down through the compartment  106  of the circular flange  104 . Since the incontinence device  114  is translucent, a quantity of light from the illumination source  112  will be diffused through the incontinence device  114  so as to provide illumination at the outwardly facing surface  120  of the circular flange  104 , as shown in FIG.  3 . Alternatively, as shown in FIGS. 2 a  and  3   a , the illumination source  112 , possibly in combination with a lens or lenses (not shown), may be configured to generate a focused beam of light through the incontinence device  114 . The focused beam of light provides improved illumination at the specific targeted area. 
     If not previously performed, the user will then remove any protective material from the exposed side of the external incontinence device  114  and expose the adhesive that is coated on the exposed side. The user will then orient the device in a manner such that the light emanating from the compartment  106  of the circular flange  104  is directed toward the urinary meatus. 
     Furthermore, by positioning the tool at an angle relative to the meatus, the user will be thereby enabled to visualize the meatus and surrounding area on the mirrored, outwardly facing surface  120  of the circular flange  104 . Moreover, the user can then position the external continence device  114  in a manner such that the opening for directing the urine can be placed precisely over the meatus. The user will then move the tool so that the adhesive contacts the body. Upon withdrawing the tool, the incontinence device  114  is then removed from the tool and remains secured to the user in a manner that ensures proper treatment of the incontinence. 
     FIG. 3 b  shows another embodiment of an applicator/placement tool in accordance with the present invention. In a manner analogous to that described with respect to the access port  116  of the embodiment disclosed in FIGS. 1-3, the access port  124  also extends from the outer surface of the circular handle  102  to the compartment  106 . This port  124  is sized to receive and hold a urinary catheter  126 . The distal end of the catheter  126  is positioned flush against the outwardly facing surface  120  of the tool. The position of the catheter  126  in the tool still allows a quantity of light from the illumination source  112  to provide illumination at the outwardly facing surface  120  of the circular flange  104 . The light emitted from the outwardly facing surface  120  of the circular flange  104  may be either focused or diffuse, depending on the type of illumination source  112 , including possible lenses, used with the tool. 
     In operation, a user will insert the catheter  126  into the applicator/placement tool until the distal end of the catheter  126  is flush against the outwardly facing surface  120  of the tool. Once the catheter  126  is correctly positioned in the tool, the user may then actuate the push button switch  108 , which closes the contacts between the battery  110  and the illumination source  112  and causes the illumination source  112  to generate light. Light from the illumination source  112  travels down through the compartment of the circular flange  104  and around the catheter  126 , providing either diffuse or focused illumination at the outwardly facing surface  120  of the circular flange  104 . The tool is then positioned at an angle relative to the meatus to allow the user to insert the catheter  126  through the meatus and into the bladder. After the distal end of the catheter  126  is secured to the bladder upon inflation of the balloon, the tool is removed and a urine collection bag is attached to the proximal end of the catheter  126 . 
     In a preferred embodiment, the applicator or placement tool as disclosed in FIGS. 1-3 b  is made from a molded plastic material. However, other materials can be used, including metal, composite or any other material having the necessary structural characteristics to accomplish the function. 
     Referring now to FIGS. 4-6, another embodiment of an applicator/placement tool in accordance with the present invention includes an elongated, rectangular handle  202  and a rectangular, articulating flange  204  which are hinged to one another through a hinge assembly  206 . 
     The hinge assembly  206  includes a tongue portion  210  which extends at an angle from one end of the handle  202  and is received in a groove region  212  of the articulating flange  204 . The tongue portion  210  and the groove region  212  are then secured to one another with a pair of hinge pins  214  about which the handle  202  and articulating flange  204  pivot. In one embodiment, the fit between the tongue portion  210  and the groove region  212  is an interference fit so that movement of the articulating flange  204  relative to handle  202  is somewhat stiff and requires intentional effort by the user to achieve such movement. In another embodiment, the desired stiffness can be obtained by using pins  214  that are somewhat larger than the openings into which they are inserted in the flange  204  and handle  202 . 
     In a manner analogous to that described with respect to the circular handle  102  of the embodiment disclosed in FIGS. 1-3, the handle  202  includes a compartment  216  which contains essentially three components, namely, a SPST push-button switch  218 , a size AA battery power supply  220  and an illumination source  222 . The compartment  216  extends substantially the entire length of the handle from the proximal end where the switch  218  is located to and through the distal end containing the tongue portion  210 . 
     The articulating flange  204  is configured to have a recessed circular housing  224  extending into the flange  204  from a receiving surface  226  of the articulating flange  204  for receiving, for example, the incontinence device  114  which was discussed previously. In communication with the recessed circular housing  224  is an access port  228  that extends from the bottom of the recessed circular housing  224  to the opposite external surface of the articulating flange  204 . This port is for the actuating line  118  of the incontinence device  114  and serves the same purpose as the access port  116  discussed in the previous embodiment. 
     Also in communication with the recessed circular housing  224  is an illumination access port  230  which extends from one side of the recessed circular housing  224  into the groove region  212  of the hinge assembly  206 . The illumination access port  230  is in alignment with the distal end of the compartment  216  of the handle  202 . 
     Positioned within the distal end of the compartment  216  of the handle  202  and the illumination access port  230  is a flexible optical fiber  232  which has one end placed in the compartment  216  a small distance from the illumination source  222  and the other end within the recessed circular housing  224  of the articulating flange  204 . As so positioned, the optical fiber  232  is capable of transmitting light from the illumination source  222  to the recessed circular housing  224  regardless of the relative angular position of the handle  202  to the articulating flange  204 . 
     The receiving surface  226  of the articulating flange  204  is configured to be a mirrored surface over substantially its entire surface area. Similarly, the top surface  234  of the handle  202  is also configured to have a mirrored surface, although not necessarily over substantially its entire surface area. 
     In operation the applicator/placement tool of this embodiment operates similarly to the embodiment disclosed in FIGS. 1-3. A user will mount the incontinence device  114  onto the applicator/placement tool by inserting the actuation line  118  through the access port  230 . The user will then insert the top portion of the incontinence device  114  (in this case the valve portion  115 ) into the recessed circular housing  224  until the underside of the mounting flange  122  is in touching engagement with the receiving surface  226  of the articulating flange  204 . The user may then apply tension to the actuation line  118  to ensure that the incontinence device  114  is securely mounted onto the tool. 
     Once the incontinence device  114  is mounted the user may then actuate the push-button switch  218 , which closes the contacts between the battery  220  and the illumination source  222  and causes the illumination source  222  to generate light. Light from the illumination source  222  then travels down through the distal end of the compartment  206  of the handle  202  and into the optical fiber  232 . The optical fiber  232  then transmits the light into the recessed circular housing  224 . Since the incontinence device  114  is translucent, a quantity of light from the light source  222  will be diffused through the incontinence device  114  so as to provide illumination at the receiving surface  226  of the articulating flange  204 , as shown in FIG.  5 . Alternatively, as shown in FIGS. 4 a  and  5   a , the illumination source  222 , possibly in combination with a lens or lenses (not shown), may be configured to generate a focused beam of light through the incontinence device  114 . As shown in FIG. 5 a , the optical fiber  232  is bent at a 90° angle  233  and its distal end is aligned with a hole in the external incontinence device  114 . The focused beam of light passes therethrough and provides improved illumination at the specific targeted area. 
     If not previously performed, the user will then remove any protective material from the exposed side of the external incontinence device  114  and expose the adhesive that is coated on the exposed side. The user will then orient the device  114  in a manner such that the light emanating from the recessed circular housing  224  of the articulating flange  204  is directed toward the urinary meatus. 
     In this embodiment, the tool offers versatility to the user during the step of orienting the device  114  towards the urinary meatus insofar as the user may pivot the articulating flange  204  into whatever angular relationship offers the best visualization of the meatus. The visualization is further enhanced by the presence of two mirrored surfaces, one on the articulating flange  204  and one on the top surface  234  of the handle  202 . In this manner, the user can then position the external continence device  114  such that the opening for directing the urine can be placed precisely over the meatus. The user will then move the tool so that the adhesive contacts the body. Upon withdrawing the tool, the incontinence device  114  is then removed from the tool and remains secured to the user in a manner that ensures proper treatment of the incontinence. 
     FIG. 5 b  shows another embodiment of an applicator/placement tool in accordance with the present invention. In a manner analogous to that described with respect to the access port  228  of the embodiment disclosed in FIGS. 4-6, the access port  236  also extends from the bottom of the recessed circular housing  224  to the opposite external surface of the articulating flange  204 . This port  236  is sized to receive and hold a urinary catheter  126 . The distal end of the catheter  126  is positioned flush against the receiving surface  226  of the articulating flange  204 . The position of the catheter  126  in the tool still allows the optical fiber  232  to transmit light from the illumination source  222  to the recessed circular housing  224 . The light emitted from the recessed circular housing  224  of the articulating flange  204  may be either focused or diffuse, depending on the type of illumination source  222 , including possible lenses, used with the tool. 
     In operation, a user will insert the catheter  126  into the applicator/placement tool until the distal end of the catheter  126  is flush against the recessed circular housing  224  of the tool. Once the catheter  126  is correctly positioned in the tool, the user may then actuate the push button switch  218 , which closes the contacts between the battery  220  and the illumination source  222  and causes the illumination source  222  to generate light. Light from the illumination source  222  travels down through the distal end of the compartment  206  of the handle  202  and into the optical fiber  232 . The optical fiber  232  then transmits the light into the recessed circular housing  224  and around the catheter  126 , providing either diffuse or focused illumination at the receiving surface  226  of the articulating flange  204 . The tool is then positioned at an angle relative to the meatus to allow the user to insert the catheter  126  through the meatus and into the bladder. After the distal end of the catheter  126  is secured to the bladder upon inflation of the balloon, the tool is removed and a urine collection bag is attached to the proximal end of the catheter  126 . 
     In a preferred embodiment, the applicator or placement tool as disclosed in FIGS. 4-6 is made from a molded plastic material. However, other materials can be used, including metal, composite or any other material having the necessary structural characteristics to accomplish the function. 
     Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.