Abstract:
A urinary incontinence device applicator has an insertion barrel; a plunger slidable within the insertion barrel; means to indicate appropriate insertion depth of the insertion barrel associated therewith into a user&#39;s vagina; and means to indicate appropriate orientation of the insertion barrel associated therewith.

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates to an applicator for urinary incontinence devices. The applicator is useful for placing the device in the vagina in the correct position to enable the device to function. 
     Tampons are absorbent articles that are inserted into a woman&#39;s vagina to absorb blood while she is menstruating. Urinary incontinence devices are inserted into a woman&#39;s vagina to reduce or inhibit urinary incontinence. Applicators may be used to ease the insertion of urinary incontinence devices and tampons. Applicators typically include a generally cylindrical barrel for holding the tampon or device and placing in the vagina, and a plunger for expelling the device or tampon into the vagina. Cardboard and plastic applicators are known in the art. 
     The placement and orientation of a urinary incontinence device is important in enabling the device to function properly. For some devices, it is important that the device is deployed in a position where pressure is applied to the urethra at the neck of the bladder. As some urinary incontinence devices expand to generate force, it is important that the device is oriented so that the force is directed toward the urethra. Therefore, the urinary incontinence device needs to be deployed in the right location and in the correct orientation. 
     Tampon applicators are known to contain finger grip portions. World Patent Application number WO2006/005009A1 discloses an applicator with indicia for low placement in the vagina on the barrel. There is a continuing need for a urinary incontinence applicator that deploys the device in the right location and in the correct orientation. 
     SUMMARY OF THE INVENTION 
     The present invention provides a urinary incontinence device applicator. The applicator has an insertion barrel; a plunger slidable within the insertion barrel; means to indicate appropriate insertion depth of the insertion barrel associated therewith into a user&#39;s vagina; and means to indicate appropriate orientation of the insertion barrel associated therewith. 
     In another embodiment, the invention provides a system to provide a urinary incontinence device. The system includes an applicator and an intravaginal urinary incontinence device substantially contained within the applicator. The applicator includes a substantially tubular insertion barrel having an insertion end, an opposite gripper end, and a longitudinal axis; a plunger extending from the gripper end of and slidable within the insertion barrel; an insertion depth indicator arranged and configured to bear against a user&#39;s labia majora extending from the insertion barrel proximate the gripper end; and means to indicate appropriate orientation of the insertion barrel associated with the applicator. The means to indicate appropriate orientation of the insertion barrel is arranged and configured to deliver the intravaginal urinary incontinence device in an appropriate orientation into the user&#39;s vagina. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention will be more fully understood and further advantages will become apparent when reference is made to the following detailed description of the invention and the accompanying drawings in which: 
         FIG. 1  is a perspective view of an applicator of the present invention. 
         FIG. 2  is a front view of the applicator of  FIG. 1 . 
         FIG. 3  is a perspective view of a second applicator of the present invention. 
         FIG. 4  is a side elevation of the applicator of  FIG. 3 . 
         FIG. 5  is a front view of the applicator of  FIG. 3 . 
         FIGS. 6A-C  is a series of partial side elevations of an alternative embodiment of the applicator of the present invention illustrating different angular positions of the insertion depth indicator. 
         FIGS. 7A-B  are side elevations of another alternative embodiment of the applicator of the present invention illustrating different longitudinal positions of the insertion depth indicator. 
         FIG. 8  is a side elevation of the applicator of  FIG. 7B  as the urinary incontinence device is deployed. 
         FIG. 9  is a sagittal cross-section of the female pelvis illustrating relationship between the vagina, bladder, urethra, pubic bone, urethro-vesical junction, and labia. 
     
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     With reference to  FIGS. 1-2 , applicators  10  according to the present invention include an insertion barrel  12 . The insertion barrel is sized and shaped to contain the urinary incontinence device  14  within it, and it has an external insertion depth indicator  16 . The length of the barrel (to the base of petals, if present, at the insertion end) may range from about 20 mm to about 100 mm, preferably about 40 mm to about 60 mm, most preferably about 50 mm. The diameter or the barrel may range from about 5 mm to about 20 mm, preferably about 18 mm to about 20 mm. The thickness of the barrel is sufficient to withstand the pressure exerted by the device, and may range, for example, from about 1 mm to about 3 mm. The barrel has an insertion end  18  to east the insertion of the applicator into the vagina, and an opposite, gripper end  20  into which the urinary incontinence device can be loaded. The insertion end  18  may be open, or as is known in the tampon art, may have petals  22  (not required) for easing insertion of the applicator and for retaining the device until deployment. 
     The insertion barrel may be made from any suitable material, such as polyethylene, polypropylene, acetal resins, styrene copolymers (including rubber-modified glassy plastics such as ABS [a two-phase system of styrene-acrylonitrile copolymer and styrene-budatidene copolymer]). The insertion depth indicator may be molded into the barrel or may be formed separately and attached to the applicator through conventional methods, such as adhesives, friction fits and the like. 
     The insertion depth indicator  16  is a raised element on the insertion barrel surface, oriented generally perpendicular to the longitudinal axis of the insertion barrel (and thus, the direction of insertion). This provides a tactile feedback when the insertion is completed, e.g., bearing against the user&#39;s labia majora  17 . While a small height of discontinuity is sufficient to give a tactile feedback, the height of the discontinuity also defines a bearing surface that can be held against the body to maintain the correct insertion depth during deployment of the device. The height of the discontinuity may range from 2 mm to 20 mm. 
     The insertion depth indicator may be made from any suitable material, such as polyethylene, polypropylene, a variety of copolymers, silicone, and elastomeric materials, such as ethylene propylene diene monomer and the like. The insertion depth indicator may be molded into the barrel or may be formed separately and attached to the applicator through conventional methods, such as adhesive, friction fit, and the like. The insertion depth indicator may also function as and/or incorporate a finger grip  24 . The insertion depth indicator is positioned such that the device is deployed in the proper position within the vagina. The distance between the insertion end of the barrel  12  and the insertion depth indicator  16  may range from about 40 mm to about 80 mm, for example about 60 mm. The amount that the insertion depth indicator extends about the circumference of the insertion barrel, the “angle of wrap,” α, may vary. An angle of wrap, α, of 360° shown in  FIGS. 1-2 , provides the largest and most stable bearing surface  26 ; however, smaller angles, e.g., about 90° as shown in  FIGS. 3-5 , require less material and are more convenient to stack and store. The bearing surface  26  can also consist of multiple segments spaced around the circumference of the insertion barrel. These multiple segments can also have different heights of the indicator. 
     The external depth indicator may be integral with the barrel (including permanently and immovably attached), or it may be adjustable, if desired. This may be helpful to improve comfort for the user. As exemplified in  FIGS. 6A-C , it may be desirable to permit the indicator  16  to pivot about a hinge  28 .  FIG. 6B  shows the indicator  16  pivoted into a forward position, and  FIG. 6C  shows it pivoted back toward the gripper end  20 . The choice may depend upon the position of the woman during insertion of the device. The angle may depend on the woman&#39;s particular anatomy—the curves of her labia. In addition, the woman may desire to rotate the indicator  16  around the barrel  12  to bear differently on her body. Finally as shown in  FIGS. 7A-B , the woman may desire to change the location of the indicator  16  along the length of the barrel  12  if she desires to fine-tune the insertion depth based upon her knowledge of her own anatomy. To aid in this adjustment, indicia  29  may be provided on the insertion barrel  12   
     Applicators according to the present invention also include a deployment plunger  30 , an elongate device, designed to slidingly fit within the barrel  12 . The plunger  30  has a leading end  32  to bear against and to deploy the incontinence device and an opposite end  34  having a stop  36  to prevent the plunger from being pushed too far and to ensure proper placement of the device in the vagina. The plunger  30  is moved axially into the insertion barrel  12  to deploy the device from the insertion end  18  into the vagina. The barrel  12  and plunger  30  may be made from any suitable material. For example, the barrel and plunger may be molded from conventional thermoplastic materials such as, but not limited to, polyethylene, polypropylene and a variety of copolymers. 
     Referring to  FIG. 8 , the insertion depth of the base  37  of the incontinence device will be determined by two dimensions when the applicator is fully inserted and deployed. Dimension “A” is the axial length of the plunger from the plunger stop  36  to the leading end  32  of the plunger  30  where it contacts the device  14 . Dimension “B” is the axial length from the plunger stop  36  to the bearing surface  26  of the insertion depth indicator  16 . The insertion depth of the base  37  of the device from the body exterior is A-B. The applicator is designed so that the portion of the device  14  in the vagina  100  that applies pressure to the urethra  102  is placed at the urethro-vesical junction  104 , and/or the base  37  of the device  14  is at least 10 mm to 20 mm, for example 15 mm above the hymenal opening  106 , as shown in  FIG. 9  (dimension D 1 ). To this dimension is added the distance D 2  between the outer surface of the labia majora  17  and the hymenal opening. 
     Applicators according to the present invention may also include an orientation indicator  38 . The orientation indicator  38  is utilized to place the incontinence device in the vagina such that when it is deployed, the portion of the device that applies pressure exerts pressure on the urethra-vesical junction, and any anchoring members lie on the lateral sides of the vagina. The orientation indicator  38  clearly marks the orientation of the device within the applicator. The indicator may be a raised line, a colored line, dots, embossments, or any suitable mark or shape that indicates orientation. The orientation indicator may be on any or all of a conventional finger grip, the insertion depth indicator, and the barrel itself. If the device is aligned with the orientation indicator when it is within the applicator, then it will be aligned to the body after insertion. When the orientation indicator  38  is part of the insertion depth indicator  16 , the orientation indicator  38  may be part of the shape of the insertion depth indicator  16 . For example, the insertion depth indicator  16  may have an apex, which is the indicator. 
     Suitable urinary incontinence devices for use with the applicators of the present invention include, but are not limited to, devices taught in co-pending US Patent Applications Attorney Docket, PPC5238, U.S. application Ser. No. 11/456,376, filed, Jul. 10, 2006; U.S. application Ser. No. 11/776,178, filed, Jul. 11, 2007; U.S. application Ser. No. 11/456,390, filed, Jul. 10, 2006; U.S. application Ser. No. 11/456,402, filed, Jul. 10, 2006; U.S. application Ser. No. 11/456,424, filed, Jul. 10, 2006; U.S. application Ser. No. 11/776,185, filed, Jul. 11, 2007; U.S. application Ser. No. 11/456,433, filed, Jul. 10, 2006; and U.S. application Ser. No. 11/456,442, filed, Jul. 10, 2006. 
     Examples are set forth below to further illustrate the nature of the invention and the manner of carrying it out. However, the invention should not be considered as being limited to the details thereof. 
     EXAMPLE 1 
     Barrel and plunger components according to  FIGS. 7A-B  were molded out of linear low-density polyethylene (LLDPE) with a 1% modified polyethylene slip additive. Samples of these components were also molded out of high-density polyethylene (HDPE) and low-density polyethylene (LDPE). The LLDPE however was the material of choice for actual use testing. The collar and finger grip components also utilized single cavity injection molds. A finger-grip sleeve and the insertion depth indicator collar were both designed to be friction fit attached to the applicator, and the distance from the collar to the base of the petals was about 50 mm. The material utilized was a 65-durometer thermoplastic elastomer under the trade name of C-flex. 
     EXAMPLE 2 
     A use test was performed with 20 women to mainly determine the ability of the applicators of the present invention to correctly place the device in the body. An intra-vaginal incontinence device prototype was inserted into the vagina utilizing the applicator of Example 1. The first test was for the subject to insert the device via the provided applicator and instructions. For this test, a physician checked the placement of the device post insertion and assessed whether the device was too high, at the correct location, or too low. 
     Referring again to  FIG. 9 , the device  14  was considered to be too high if the base  37  of the device  14  in the vagina  100  was located above the urethro-vesical junction  104 . This was assessed by palpation and/or visualization. If the doctor could feel the pubic bone  108  before the base  37  of the device  14 , the device was considered to be too high. The device  14  was considered to be at the correct location if a working portion of the device  14  was at the urethro-vesical junction  104 . If the doctor could see that the device  14  was at least 10 mm (D 1 ) into the vagina  100  past the hymenal ring  106 , or if the doctor could feel the base  37  of the device before feeling the pubic bone  108 , the device  14  was considered to be at the correct location. The device was considered to be too low if it was placed outside the hymenal ring  106  or less than 10 mm into the vagina  100  past the hymenal ring  106 . 
     If the device was placed incorrectly (too high or too low), the subject was asked to re-insert the device with feedback on the initial placement. The results of this study of placement via applicator are shown in Table 1 below. 
     
       
         
               
               
               
             
           
               
                   
                 TABLE 1 
               
               
                   
                   
               
               
                   
                 Insertion 
                 % With Correct Placement 
               
               
                   
                   
               
             
             
               
                   
                 Initial 
                 75 (15/20) 
               
               
                   
                 Second 
                 40 (2/5)  
               
               
                   
                 Total 
                 85 (17/20) 
               
               
                   
                   
               
             
          
         
       
     
     Based on the data above, it was determined that the devices of the present invention are effective at placing urinary incontinence devices in the proper position within the vagina, either initially or with guidance and practice.