Abstract:
Disclosed is a catheter guide for female self-catheterization to assist in guiding a catheter into the user&#39;s urethra. The catheter guide includes a hand-held guide with a vaginal insert portion joined to a handle at a fixed or an adjustable angle. There is an enclosed or open canal in the vaginal insert portion which can be aligned with the urethra, when the insert portion is in the vagina, and through which a catheter can be guided into the urinary tract.

Description:
FIELD OF THE INVENTION 
       [0001]    Disclosed invention relates to medical devices for use in cases of urinary abnormalities and, more specifically, to a portable catheter for assisting in the process of intermittent female self-catheterization. 
       BACKGROUND 
       [0002]    The bladder serves two functions: for storage of urine and evacuation of urine. If a bladder cannot function as a reservoir to retain urine, the problem is known as incontinence. Conversely, if a bladder is unable to evacuate urine, the problem is called urinary retention. 
         [0003]    One solution is to use somewhat ineffective and expensive drugs and medications. Another solution is an indwelling Foley catheter which is uncomfortable and can lead to urinary tract infections. The Foley catheter has an expansible ring-like balloon at the distal end. The catheter would be inserted into the bladder through the urethra, and then the balloon would be expanded sufficiently to prevent withdrawal without first deflating the balloon. With this catheter, urine could continuously drain from the bladder through openings in the distal end of the catheter and subsequently through a drain tube. 
         [0004]    While such catheters are successful in draining urine, they present a number of problems. Great care must be taken when moving the person using these catheters to prevent accidental pulling and partial withdrawal of the catheter or over-inserting it, which severely limits the mobility of the user. Care and skill are also required in inserting and removing the catheter to assure that the proper length is inserted, the balloon is expanded to the proper extent, and the balloon is fully deflated prior to removal. 
         [0005]    Yet another solution to some urinary problems is self intermittent catheterization (SIC), where the female patient catheterizes herself several times a day. It is safe, simple, and has the lowest risk of infection. Unfortunately, because of the anatomical location of the opening of the female urethra it is difficult to perform SIC. This is especially true in the obese patients or the physically handicapped. On the whole, intermittent self-catheterization is difficult if not impossible, because the process generally requires the patient to have fine motor skills and good vision to locate the urethra. 
         [0006]    The U.S. Pat. No. 5,045,078, granted to Linda R. Asta, discloses an apparatus to assist in guiding a catheter into the urinary meatus. Asta&#39;s apparatus is comprised of a vaginal insert and a handle and has at least one guide or alignment hole on its handle. The guide hole of the handle is alignable with the urinary meatus when the insert portion is in the vagina. To effectively use Asta&#39;s apparatus, the user needs to completely insert the vaginal insert in her vagina and hope for the guide hole to be aligned with her urethra. However, if its guide hole does not align with her urinary meatus, there is no provision for maneuvering the catheter into the urinary meatus. Asta suggests having multiple alignment holes or a single movable alignment hole on her apparatus&#39; handle, but these embodiments have the same shortcomings as Asta&#39;s embodiment with a single hole. 
         [0007]    Additionally, while Asta suggests the possibility of using a Foley-type catheter with her device, it is not possible to pass the tip of any Foley catheter through her guide holes as they are disclosed and illustrated in her patent. And, if her guide holes are so large that a Foley catheter can pass through them, then such holes cannot be used for guiding a catheter into the user&#39;s urethra. 
         [0008]    In general, for the reasons mentioned and more, the existing solutions to urinary abnormalities are not very satisfactory. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIGS. 1A and 1B  illustrate a catheter guide that comprises a handle and a vaginal insert according to an embodiment of the invention, wherein the vaginal insert has a guide channel/canal through it. 
           [0010]      FIG. 2  illustrates the embodiment of  FIG. 1 , where the catheter guide is in an inserted position. 
           [0011]      FIGS. 3A ,  3 B, and  3 C illustrate another embodiment of the invention in which the guide channel is an open canal, into which a catheter can enter from its side opening. 
           [0012]      FIG. 4  illustrates yet another embodiment of the catheter guide where the angle between the handle and the vaginal insert portion is adjustable. 
       
    
    
     DETAILED DESCRIPTION 
       [0013]    The described embodiments herein increase the potential and possibility for intermittent self-catheterization by those women with, for example, neuromuscular dysfunctions or complications resulting from other urinary disorders which require the process of intermittent self-catheterization to aid in the function of micturition. The proposed embodiments describe a catheter guide for use during female intermittent self-catheterization for the purpose of assisting in guiding a catheter into the urinary meatus. 
         [0014]    While several details have been discussed in this section, one skilled in the art will understand that the invention may be practiced without such details. In other instances, well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments. 
         [0015]    Unless the context clearly requires otherwise, throughout the description and the claims, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” Words using the singular or plural number also include the plural or singular number respectively. Additionally, the words “herein,” “above,” “below” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. When the claims use the word “or” in reference to a list of two or more items, that word covers all of the following interpretations of the word: any of the items in the list, all of the items in the list and any combination of the items in the list. 
         [0016]      FIGS. 1A and 1B  are illustrations of an embodiment of the catheter guide  100 . It is a self contained, single or multi piece, disposable or reusable apparatus which has a handle  110  and uses a vaginal orifice/insert  120  with a guide canal  130  which acts as a template to guide the catheter  140  into the urethra and the bladder. The catheter guide  100  may be made of any surgically acceptable material, such as plastic, and its structure may be rigid or flexible. The catheter guide  100 , in its entirety or partially, may be constructed as a hollow or solid structure, or a combination thereof, to reduce weight and/or cost. 
         [0017]    In the embodiment of  FIGS. 1A and 1B , the guide channel  130  is an enclosed conduit and the catheter  140  enters it from one end and exits from the other end. The vaginal insert portion  120  may have any suitable shape that can comfortably enter the vagina. In one embodiment the vaginal insert portion  120  may have oval or circular cross-sections which decrease in dimensions as the cross-sections approach the tip of the vaginal insert portion  120 . 
         [0018]    Typically, the anatomical location of the urethral opening with respect to the top of the vaginal orifice is about 0.5 to 0.75 centimeters and the length of the female urethra is also 2.5 to 3.0 centimeters. The disclosed apparatus utilizes this anatomical relationship to aid the patient in catheterizing herself. The catheter  140  is placed within the guiding channel  130  and as the vaginal insert  120  enters into the vagina and advances into the vaginal canal, the catheter  140  is directed into the urethral opening, the urethra, and subsequently into the bladder. It is simple, painless, and it does not require direct observation or manual dexterity. 
         [0019]    In some embodiments the handle  110 , the vaginal insert  120 , or both may include, for example, a mirror, a light, a scope, a camera, a sensor, a measurement apparatus, etc., or a combination thereof. Such additional components on the handle  110  and/or the vaginal insert  120  will help the user to better locate her urinary meatus and to easily insert the catheter into her urethra and/or help her with her other needs.  FIG. 1A  shows a mirror attached to one end of the handle  110 . 
         [0020]    The detailed description of the embodiments of the invention is not intended to be exhaustive or to limit the invention to the precise form disclosed above or to the particular field of usage mentioned in this disclosure. While specific embodiments of, and examples for, the invention are described above for illustrative purposes, various equivalent modifications are possible within the scope of the invention, as those skilled in the relevant art will recognize. Also, the teachings of the invention provided herein can be applied to other systems, not necessarily the system described above. The elements and acts of the various embodiments described above can be combined to provide further embodiments. 
         [0021]      FIG. 2  shows an embodiment of the catheter guide  100  in an inserted position  200 , with the vaginal insert  120  in the vagina  220 . This is shown in a position relative to the rectum  210 , the uterus  230  and the bladder  240 . In  FIG. 2 , the catheter  140 , the end of which passes through the guide canal  130  of the vaginal insert  120 , enters into the urinary meatus, and through the urethra into the bladder. Catheter  140  may be a Foley-type catheter or a plastic type urethral catheter. 
         [0022]    In one embodiment the guide channel  130  is wider than the catheter  140  and the user of the apparatus can wiggle the catheter  140  to enter it into the urethral opening. In another embodiment the inside diameter of the guide channel  130  is substantially the same as the outside diameter of the catheter  140  and the user of the apparatus can align the catheter  140  with the urethral opening  230  by small movements of the apparatus, for example, in and out of vagina. 
         [0023]    In general, a method of using these apparatus may be described as follows: 1) the patient gently spreads her legs; 2) cleans her vaginal introitus; 3) lubricates the tip of the vaginal insert portion  120  and the tip of the catheter  140 ; 4) places the tip of the vaginal insert portion  120  into her vaginal opening with the handle  110  pointed upward; 5) advances the catheter guide  100  into the vaginal canal. This device, using the vaginal canal as a template, directs the catheter into the urethra. If the catheter  140  does not enter the urethra at once, patient can wiggle the catheter  140  or the catheter guide  100  to insert the catheter  140  into her urethra. The bladder then empties under gravity; and 6) the patient withdraws the device and completes the catheterization process. 
         [0024]      FIGS. 3A ,  3 B, and  3 C illustrate another embodiment  300 , in which the guide channel  330  is an open canal, as opposed to the enclosed channel  130  of  FIGS. 1A and 1B , and the catheter  140  can enter its entire length from the side. In some embodiments the guide channel may be a combination of these configurations. The catheter guide  300  can be used to guide a conventional Foley catheter or any Foley-type catheter into the patient&#39;s urethra and the bladder since such catheters, because of the size of their tips, cannot enter from an end-opening of an enclosed channel such as channel  130  of  FIG. 1A  or enter the guide hole(s) of U.S. Pat. No. 5,045,078. As a catheterizing device, this embodiment can utilize any catheter on the market such as the Foley catheter. 
         [0025]    To use catheter guide  300 , the Foley catheter is simply clipped to or inserted into the guide channel  330  from its open side, after which the patient can use the vaginal canal as a template to direct the catheter into the bladder. The procedure is identical to the SIC mentioned above. After the catheter is inserted into the bladder and urine flows through the catheter, the user can inflate the Foley balloon to secure the catheter&#39;s position in the bladder. She then unclips or pulls out the catheter from the open side of the device  300  and completes the catheterization. 
         [0026]      FIG. 4  illustrates yet another embodiment of the catheter guide  400  where the angle between the handle  410  and the vaginal insert portion  420  is adjustable. In this embodiment the handle  410  may be hinged to the vaginal insert portion  420  and be kept in any desired position, with respect to the vaginal insert  420 , by friction or by any other means known in mechanical arts. Such arrangement makes the apparatus adaptable to different users&#39; physical makeup and flexibility. 
         [0027]    All of the above patents and applications and other references, including any that may be listed in accompanying filing papers, are incorporated herein by reference. Aspects of the invention can be modified, if necessary, to employ the systems, functions, and concepts of the various references described above to provide yet further embodiments of the invention. 
         [0028]    The above detailed description of the embodiments of the invention is not intended to be exhaustive or to limit the invention to the precise form disclosed above. While specific embodiments of, and examples for, the invention are described above for illustrative purposes, various equivalent modifications are possible within the scope of the invention, as those skilled in the relevant art will recognize. 
         [0029]    The teachings provided herein can be applied to other apparatus and systems, not necessarily the system described herein. The elements and acts of the various embodiments described above can be combined to provide further embodiments. 
         [0030]    Particular terminology used when describing certain features or aspects of the invention should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features, or aspects of the invention with which that terminology is associated. In general, the terms used in the following claims should not be construed to limit the invention to the specific embodiments disclosed in the specification, unless the above Detailed Description section explicitly defines such terms. Accordingly, the actual scope of the invention encompasses not only the disclosed embodiments, but also all equivalent ways of practicing or implementing the invention. 
         [0031]    While certain aspects of the invention are presented below in certain claim forms, the inventors contemplate the various aspects of the invention in any number of claim forms. Accordingly, the inventors reserve the right to add additional claims after filing the application to pursue such additional claim forms for other aspects of the invention.