Patent Document

BACKGROUND OF THE INVENTION  
         [0001]    I. Field of the Invention  
           [0002]    This invention relates generally to a system for treating female stress incontinence, and more particularly to a kit containing components for facilitating placement of an incontinence prevention device in the female urethra.  
           [0003]    II. Discussion of the Prior Art  
           [0004]    In my U.S. Pat. No. 6,311,689B1, I describe an incontinence prevention device that comprises a soft, flexible, elastomeric shaft member, preferably silicone, that is sized to fit in the female urethra and which has a retention structure in the form of a closed loop at a distal end of the shaft member that is adapted to cooperate with the bladder neck to prevent the device from being expelled during voluntary urination. The device further includes a proximal wing-like retention structure adapted to cooperate with the vestibule proximate the urethral meatus to prevent upward migration.  
           [0005]    In order to insert the incontinence prevention device, a lumen is provided for receiving a straightening stylet therein. With the stylet fully inserted, the distal retention loop is rendered generally rectilinear so as to exhibit a low profile. The tip portion may then be lubricated and the device is inserted by advancing the distal retention structure in its straightened condition on the stylet through the urethral meatus and up the urethra until the distal retention device is resident in the patient&#39;s bladder. At this point, the stylet is removed, allowing the loop to reform on the distal end of the shaft.  
           [0006]    While the device and method of insertion described in the &#39;689 patent is safe and effective, concern has been expressed by some patients about the use of a stiffening stylet. Some have expressed fear that the stiffening stylet might be made to pierce through the wall defining the stylet lumen, and that it could result in injury to the urethral wall as the incontinence prevention device is being inserted.  
           [0007]    It is accordingly a principal object of the present invention to provide a method and apparatus for inserting an incontinence prevention device in the female urethra that does not require the use of a stiffening stylet wire to render the device initially rectilinear for placement within the urethra.  
           [0008]    It is a further object of the invention to provide an incontinence prevention device and an insertion mechanism as a kit for use by a patient at home and without the aid of a medical professional.  
         SUMMARY OF THE INVENTION  
         [0009]    The present invention provides a kit for use in treating female stress incontinence. The kit contains an incontinence prevention device having a relatively soft, elastomeric shaft with a closed loop bladder retention structure at a distal end thereof and a vestibule engaging retention structure at its proximal end. The insertion assembly includes a deployment base member having a finger grip at a proximal end thereof and at least one rigid shaft projecting longitudinally from the finger grip. The rigid shaft includes a device engagement element at its distal end. The kit further includes a tubular handle, referred to herein as a deployment tube, for receiving the incontinence prevention device in a lumen thereof at a time immediately prior to deployment of the incontinence prevention device into the urethra. The deployment tube is slidable over the rigid shaft for facilitating loading of the incontinence device into the lumen of the deployment tube. Its diameter is such that the retention loop is collapsed and rectilinear. The kit further contains a plunger that is adapted to fit within the lumen of the deployment tube and which can be used to eject the incontinence device from the deployment tube into the urethra.  
           [0010]    The incontinence device can be loaded into the deployment tube a short time prior to self-placement into the urethra so that the retention loop does not take a set, that could preclude the loop retention structure from opening up upon reaching its location in the bladder neck. Moreover, there is no need for the patient to touch the incontinence device itself, thereby maintaining a sterile condition and minimizing the occurrence of infection.  
           [0011]    There are, of course, additional features of the invention that will be described hereinafter which will form the subject matter of the appended claims. Those skilled in the art will appreciate that the preferred embodiments may readily be used as a basis for designing other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions since they do not depart from the spirit and scope of the present invention. The foregoing and other features and other advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings. 
       
    
    
     DESCRIPTION OF THE DRAWINGS  
       [0012]    [0012]FIG. 1 is a perspective view of a kit comprising the incontinence device and a preferred embodiment of an associated insertion assembly, all contained within a sterile package;  
         [0013]    [0013]FIG. 2 is a side elevation view of the deployment base member in the embodiment of FIG. 1;  
         [0014]    [0014]FIG. 3 is a cross-sectional view taken along the line  3 - 3  in FIG. 2;  
         [0015]    [0015]FIG. 4 is a perspective view of the deployment tube contained in the kit of FIG. 1;  
         [0016]    [0016]FIG. 5 is a partial cross-sectional view of the deployment tube mounted on the deployment base member prior to use;  
         [0017]    [0017]FIG. 6 is a perspective view of the deployment pusher;  
         [0018]    [0018]FIG. 7 is a cross-sectioned side view of the deployment tube with the pusher member inserted fully therein; and  
         [0019]    [0019]FIG. 8 is a perspective view of an alternative embodiment of the present invention. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0020]    Referring first to FIG. 1, there is shown a component kit  10  comprising a sterile package  12  containing an incontinence prevention device  14 , a deployment base member  16 , a deployment tube  18  and a pusher plunger  20 . The kit may also conveniently contain a supply of a gel lubricant (not shown). Following the sealing of the kit components in the package  12 , the package is subjected to a sterilization operation such as by subjecting the package to gamma radiation in a manner well known in the art or by introducing a sterilant such as ethylene oxide into the package.  
         [0021]    The incontinence prevention device  14  may be made in accordance with the teachings of my patent 6,311,689B1, which is hereby incorporated by reference. It need not, however, have a stylet lumen therein. The device comprises an elongated, soft, elastomeric shaft  24  having an enlarged closed loop  26 , also formed from a soft elastomeric material preferably silicone rubber, affixed to the distal end of the shaft  24 . A proximal retention member  28  in the form of a wing-like projections, also of a soft material that is configured to conform to the vestibule proximate the urethral opening is disposed on a proximal end of the shaft  24 .  
         [0022]    Those desiring more detailed information on the size and shape configuration of the incontinence prevention device  14  may derive same from a reading of the aforereferenced &#39;689 patent.  
         [0023]    As will be explained in greater-detail hereinbelow, the device  14  may be self-inserted into the urethra by a female subject by first loading the device  14  into the deployment tube  18  in a manner yet to be described and then positioning the distal end of the delivery tube proximate the urethral meatus and expelling the device  14  from the deployment tube  18  using the deployment plunger  20  as a pusher device.  
         [0024]    Because the retention loop  26  of the device  14  can, with time, take on a permanent set if packaged with the device  14  already contained within the lumen of the deployment tube  18 , it is a feature that the placement of the incontinence prevention device  14  within the deployment tube can be achieved only a relatively short time prior to use of the deployment device to insure that the retention loop  26  will fully expand to its open-loop shape once the loop enters the urinary bladder where it is unconstrained either by the delivery tube  18  or the urethra. It is also important to insure that the device  14  remains sterile and that it does not come in contact with the subject&#39;s fingers during the insertion process. The delivery kit  10  of the present invention assures these results.  
         [0025]    Referring next to FIG. 2, there is shown a side elevation view of the deployment base member  16  of FIG. 1. In the preferred embodiment, it comprises a finger grip element  30  which may be somewhat semi-circular in shape and having a recessed central portion  32  defined by a peripheral wall  34 . Having this shape allows the device  16  to be readily gripped between the thumb and forefinger of a user&#39;s hand.  
         [0026]    Projecting longitudinally from a base  36  of the finger grip element  30  is a longitudinally extending rod  38  having an integrally molded, L-shaped hook as a device engagement element  40  formed at the distal end thereof. In accordance with the embodiment of FIG. 2, the deployment base member  16  further includes a second rigid, longitudinally-extending, rail  42  that has an integrally molded stop member  44  at its distal end. The rail  42  preferably has a somewhat I-shaped cross-section, as best seen in the cross-sectional view of FIG. 3.  
         [0027]    The length of the rail  42  is greater than that of the first rigid rod  38  by a predetermined amount. Without limitation, the length of the first rod  38  may be approximately 92.75 mm and the length of the rod  42  may be 107.25 mm.  
         [0028]    Referring now to FIG. 4, it shows a perspective view of the deployment tube  18  of the kit  10 . Tube  18  has a distal end  44  and a proximal end  46  with a lumen  48  extending therebetween. Integrally formed with and projecting perpendicularly to the longitudinal axis of the tube  18  at its distal end  44  is an insertion limit  50 . The lower end of the insertion limit member  50  includes a T-shaped notch  52 . It is dimensioned to engage the guide rail  42  comprising the second rod of the deployment base member  16  when the first rod  38  of the deployment base member  16  is disposed within the lumen  48  of the deployment tube  18 . The lumen  48  has a shape to accept the rigid rod  38  therein with sufficient clearance to permit the tube to slide relative to the road  38 . Opposed sidewall surfaces of the tube  18  may be slightly indented as at  54  and these surfaces are preferably knurled to facilitate gripping thereof by the user.  
         [0029]    To facilitate entry of the retention loop  26  of the incontinence device  14  into the deployment tube  18 , it has been found expedient to provide a flared or oval opening on the proximal end of the deployment tube where the opening has a chamfered edge  49 . This shape on the distal end of the deployment tube causes the retention loop  26  to compress into two contiguous parallel, rectilinear segments as it is being drawn by the hook-shaped device engagement element  40  into the lumen  48  of the deployment tube. Further, the lumen of the deployment tube may also be of an oval cross-section throughout its length or may transition to a circular cross-section at a predetermined point along the length thereof as reflected in FIG. 4.  
         [0030]    The cross-sectional view of FIG. 5 shows the deployment tube  18  in surrounding relationship to the first rod  38  of the deployment base member  16 . Here it can be seen how the T-shaped notch  52  on the retention limit member  50  engages the guide rail  42 . Also visible in the view of FIG. 5 is the fact that the length of the deployment tube  18  is slightly less than the length of the first rod  38  such that the hook-shaped engagement element  40  extends outward from the distal end  46  of the deployment tube.  
         [0031]    In loading the incontinence device  14  into the deployment tube  18 , the device comes packaged with the loop  25 , fitted over the hook-shaped element  40  in the space between the element  40  and the proximal end  46  of the deployment tube. That is to say, the kit comes with the loop  26  encircling the L-shaped hook element  40 , thus obviating the need for the users to touch the sterilized device  14 . Now, when the finger grip  30  is grasped between the thumb and foregoing of the user&#39;s one hand and the thumb and forefinger of the other hand are placed on the surfaces  54  of the deployment tube, the deployment tube may be slid in the distal direction causing the retention loop to be drawn into the lumen  48  of the deployment tube as the retention limit  50  slides along the I-shaped guide rail  42  of the base member  16 . The deployment tube is slid in the distal direction until the retention limit member  50  comes into abutment with the stop member  44  on the rail  42 , at which point only a predetermined portion of the retention loop  26  will extend out beyond the distal end of the deployment tube  18 , given the difference in length of the cylindrical rod  38  and the guide rail  42 . The extending portion is still maintained rectilinear in that the remainder of the loop is still constrained by the wall of the deployment tube. The described incontinence device loading system also assures proper orientation of the loop as it expands upon entry into the bladder. With the aid of the L-shaped hook, the loop exits the lumen of the deployment tube in the same orientation as it had upon entry into the proximal end of the tube.  
         [0032]    Because the guide rail  42  has its upper flange notched, as at  56 , when the retention limit member  50  reaches the stop  44 , the guide tube with the incontinence prevention device contained therein can be lifted free of rail  42  of the deployment base member  16 .  
         [0033]    Next, the portion of the retention loop projecting outward from the distal end of the deployment tube can be dipped into a sterile lubricating gel which may come with the kit and the user will next insert the distal end  58  of the plunger  20  (FIG. 6) into the lumen  48  at the proximal end  46  thereof and will then insert the protruding portion of the retention loop into the urethral meatus until the insertion limit member  50  is brought into contact with the subject&#39;s vestibule. The insertion limit member  50  is sufficiently large to prevent the deployment tube from passing through the meatus. Now, by depressing the finger rest  60  of the plunger  20 , the incontinence prevention device is forced out from the deployment tube  18  and through the urethra until the finger rest  60  of the plunger abuts the end  46  of the deployment tube as shown in FIG. 7. The length of the plunger is judiciously chosen such that when fully inserted, the retention loop will be disposed within the subject urinary bladder where it can expand to its open loop shape for nesting in the bladder neck.  
         [0034]    The deployment base member, deployment tube and pusher may be molded from a suitable medical grade plastic, such as ABS, but limitation to this material is not to be inferred.  
         [0035]    [0035]FIG. 8 illustrates an alternative embodiment of the deployment device of the present invention. Here, the deployment base member includes only a single longitudinally extending rod  70  that is affixed to and projects from the finger grip member  72 . Fitted over the rod  70  is a deployment tube  74  that has a stop member  76  at a distal end thereof. The rod  70  terminates in a hook  78  that extends outwardly beyond the distal end  80  of the deployment tube  74  when the stop  76  is in abutment with the base of the finger grip member  72 . An incontinence prevention device of the type already described is shown with its retention loop  26  looped over the hook  78 . The configuration shown in FIG. 8 would be packaged in a sterile container with the hook  78  engaging the loop  26 .  
         [0036]    When removed by the user from the sterile package, she would grasp the finger grip  72  between the thumb and forefinger of one hand and the deployment tube  74  between the thumb and forefinger of the other hand and then slide the deployment tube  74  to the right as shown in FIG. 8, drawing the retention loop  26  and the stem  14  into the deployment tube  74 . Instructions with the device would advise the user to uncouple the hook from the loop once a portion of the loop, approximately 15 mm in length, is projecting from the distal end of the deployment tube. As before, the projecting portion of the loop remains collapsed and rectilinear. It would be dipped in a lubricant and the deployment tube positioned such that the lubricated tip of the retention loop is inserted into the urethral meatus and the stop  76  abuts the user&#39;s vestibule. A pusher, like that shown in FIG. 6, is again used to move the incontinence prevention device out of the deployment tube and through the urethra until the retention loop  26  enters the urinary bladder and expands to its open loop configuration.  
         [0037]    This invention has been described herein in considerable detail in order to comply with the patent statutes and to provide those skilled in the art with the information needed to apply the novel principles and to construct and use such specialized components as are required. However, it is to be understood that the invention can be carried out by specifically different equipment and devices, and that various modifications, both as to the equipment and operating procedures, can be accomplished without departing from the scope of the invention itself. For example, a piece of string could be substituted for the deployment base member hook where the string loops through the retention loop of the incontinence prevention device and through the lumen of the deployment tube. Immediately prior to deployment, by pulling on the string, the incontinence prevention device will be drawn into and through the deployment tube with a portion of the retention loop extending beyond the end of the deployment tube as earlier described.

Technology Category: 4