Abstract:
An applicator for placing an insert within a vagina. The insert can be a catamenial tampon, incontinence device, medicament, dressing, and the like. The applicator has orientation indicators to allow the user to properly orientate the insert within the vagina. The applicator also has an inwardly curved radius on the leading edge to reduce any resistance during insertion and withdrawal of the applicator. The applicator may also have at least one vent to facilitate expulsion of the insert or to deliver medicaments or lubricants inside the body cavity. The insert applicator has a rounded cross-section to maximize the available space for the insert, while also facilitating insertion of the applicator into the vagina.

Description:
FIELD OF THE INVENTION 
   The present invention relates generally to devices for delivering an insert into a body cavity, particularly a vagina and to methods for their use. The insert may be a catamenial tampon, incontinence device, medicament, dressing, or other similar inserts. The invention may find particular use for delivering inserts used to reduce the occurrence and/or severity of female urinary incontinence. More particularly, the present invention relates to an improved carriage for an applicator for delivering an incontinence device. 
   BACKGROUND OF THE INVENTION 
   Some women, especially women who have given birth to one or more children, and older women, can experience incidences of involuntary urine loss due to stress urinary incontinence or combined stress and urge incontinence. Accordingly, as the world&#39;s female population ages, there is an ever increasing need for a non-surgical procedure and/or device to reduce the involuntary urine loss commonly associated with “stress urinary incontinence.” One way to alleviate the problem of incontinence is to place an insert within the vagina to allow the urethra to compress and/or provide support for the bladder neck in order to prevent the involuntary loss of urine. Inserts developed for such purposes are disclosed in U.S. Pat. Nos. 6,090,038; 6,090,098; 6,142,928; U.S. application Ser. No. 09/675,459; and in U.S. application Ser. No. 09/675,460. 
   One challenge associated with the use of the inserts of the above mentioned patents and applications is that they are most effective when properly oriented within the vagina. Furthermore, because the inserts are relatively large compared to other vaginally inserted devices, such as catemenial tampons, there is a challenge making a device that can properly place the inserts within the vagina without causing discomfort. One solution is disclosed in commonly assigned, co-pending U.S. Ser. No. 09/675,458, which shows an elliptical applicator. While this applicator is suitable for its intended use, the applicator of the present invention improves upon that device. 
   In addition, another problem associated with the use of inserts is that they may be difficult to eject from the applicator, which may result in unnecessary discomfort experienced by the user. Therefore, it would be desirable to provide an applicator in which the insert may be easily ejected from the applicator. The applicator of the present invention solves this problem by providing vents that reduce the friction between the insert and the inner surface of the applicator. As a result, the insert is more easily ejected from the applicator. 
   SUMMARY OF THE INVENTION 
   In one aspect of the present invention, an insert applicator includes an outer member adapted to house an insert, and an inner member moveable within the outer member and operable to discharge the insert from the outer member. The leading, vaginal insertion end portion of the outer member has an inwardly curved radius. The insert applicator may also be provided with at least one vent on the outer member that will reduce the friction between the insert and the inner surface of the outer member and will also aid in the expulsion of the insert from the applicator. 
   In another aspect of the invention, a device is provided that includes an insert and an applicator. The applicator includes an outer member adapted to house the insert and an inner member moveable within the outer member and operable to discharge the insert out of an exit portion of the outer member. The outer member is substantially cone-shaped and has a wider cross-section at the insert exit portion that has an inwardly curved radius to present a smooth surface to reduce friction during insertion of the device. The applicator may also be provided with at least one vent on the outer member that will reduce the friction between the insert and the inner surface of the outer member. The vents will also aid in the expulsion of the insert from the outer member or carriage. 
   In another aspect of the invention, a device is provided for reducing the occurrence and/or severity of female urinary incontinence. The device includes an insert and an applicator. The applicator includes an outer member adapted to house the insert and an inner member moveable within the outer member and operable to discharge the insert from an exit portion of the outer member. The outer member has an inwardly curved radius at the leading or vaginal insertion end. 
   Other aspects of the invention will be apparent to those of skill in the art in view of the appended claims. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a perspective view of one embodiment of the applicator according to the present invention. 
       FIG. 2  is a side elevation of another embodiment of the applicator according to the present invention that shows vents located near one end of the applicator. 
       FIG. 3  is a side elevation of another embodiment of the applicator according to the present invention that shows vents along a substantial portion of the cone shaped portion of the applicator. 
       FIG. 4  is a view of one embodiment of an insert that can be used with the applicators of the present invention. 
       FIG. 5  is a view of another embodiment of an insert that can be used with the applicators of the present invention. 
       FIG. 6  is a perspective view of one embodiment of the applicator of the present invention that shows an insert in phantom and in a position to be delivered. 
       FIG. 7  is a perspective view of the applicator shown in  FIG. 6  that shows the insert discharged from the applicator. 
       FIG. 8  is a front view of one embodiment of the applicator of the present invention where the applicator has an elliptical shape. 
       FIGS. 9A-9D  are cross sectional views of alternate embodiments of the applicator according to the present invention. 
   

   DESCRIPTION OF THE INVENTION 
   Referring now to the drawings and initially to  FIG. 1 , an insert applicator according to the present invention is shown generally at  100  in a pre-assembled configuration. The applicator  100  has an outer member or insert housing (or carriage)  110  and an inner member or plunger  140 . The inner member  140  is slidably disposed within the outer member  110 . The outer member  110  has a curved shape such as a cylinder, particularly a circle or ellipse and has an inner surface  112  and an outer surface  114 . The outer member  110  extends along a longitudinal axis  102  from a leading, vaginal insertion end portion  116  to a trailing end portion  126 . The outer member  110  houses an insert (not shown) that is to be discharged into the vaginal cavity. 
   Desirably, the outer member  110  includes a substantially cone-shaped portion  122  and a substantially cylindrical-shaped portion  130  extending substantially parallel to the longitudinal axis  102 . In a direction substantially parallel to its longitudinal axis, the cone-shaped portion  122  and the cylindrical portion  130  may have the same shape or may have different shapes. For example, both may have a substantially circular, or oval or elliptical cross-section. Preferably, the cone-shaped portion is oval or elliptical. 
   The outer member  110  and, in particular, the vaginal insertion end portion  116  has a major axis  104  and a minor axis  106 . In one embodiment as shown in  FIG. 1 , the major axis  104  and the minor axis  106  are nearly equal. In other words, in this embodiment, the cross-section of the vaginal insertion end portion  116  of the outer member  110  is almost circular. In another embodiment, best illustrated in  FIG. 8 , the major axis  104  is defined by the longest diameter of the cross-section and the minor axis  106  is defined by the shortest diameter of the cross-section. In other words, in this embodiment, the cross section of the vaginal insertion end portion  116  of the outer member  110  is substantially elliptical. An elliptical shape is preferred because it more closely resembles the shape of the vagina and therefore, will be more easily inserted into and removed from the vagina. 
   The cone-shaped portion  122  has a wider cross-section at the vaginal insertion end  116 , and a smaller cross-section connected with the cylindrical portion  130 . The vaginal insertion end portion  116  of the outer member  110  has an inwardly curved radius  118  to provide a continuous surface and a smooth reduced friction surface. In other words, the leading edge  116  of the outer member  110  is inwardly curved such that the leading edge is the apex of the outer member. The inwardly curved radius  118  ranges from about 0.005 to about 0.05 inches, preferably from about 0.01 to about 0.03 inches. The inwardly curved radius  118  extends into the inner surface  112  of the outer member  110  where it stops to define a flange  120  on at least a portion of the circumference of the inner surface  112  of the outer member  110 . The flange  120  helps to maintain the insert  20 ,  30  within the outer member  110  until its discharge into the vagina. 
   The cylindrical shaped portion  130  defines a gripping portion for the outer member  110 . The cylindrical portion  130  terminates at the trailing end  126 , which is provided with an outer flange  134  that extends at least a portion of the circumference of the trailing end  126  to provide a gripping surface for the outer member  110 . Preferably, the outer flange  134  extends the entire circumference of the trailing end  126 . 
   The trailing end  126  may also be provided with an inner flange  136  that surrounds at least a portion of the inner surface  112  of the outer member  110 . The inner flange  136  is located in the cylindrical shaped portion  130  and may be located in the same plane as the outer flange  134  or may be located in a different plane. The inner flange  136  will act as a stop for the inner member  140 . 
   The applicator  100  may also include one or more orientation indicators  132 . In the embodiment shown in  FIG. 1 , the orientation indicator  132  is in the form of a raised rib that extends parallel to the longitudinal axis  102  of the applicator  100 . The orientation indicator  132  is located on the outer surface of the outer member  110  and is desirably located on the cylindrical shaped portion  130 . The orientation indicator  132  is positioned to indicate the relative rotational position of the applicator  100 , and therefore, allows the user to correctly orient the insert  20 ,  30  inside the vagina, as more fully described below. 
   In one embodiment where the applicator  100  is elliptical as shown in  FIG. 6 , the orientation indicator  132  is located on the major axis  104  of the elliptical cross-section of the outer member  100 . In this embodiment, an orientation indicator  132  is located on each major axis  104  opposite each other and on the cylindrically shaped portion  130 . Alternatively, the orientation indicator  132  may be located on the minor axis  106 . 
   The applicators of the present invention should be made of a biocompatible material, such as a paperboard stock, or a plastic. The outer member  110  is preferably about 50 to 75 mm in length, more preferably about 60 to 70 mm, and most preferably about 65 mm. The major axis of the elliptical cross-section is preferably about 20 to 40 mm in length, more preferably about 25 to 35 mm, and most preferably about 30 mm. The minor axis of the elliptical cross-section is about 10 to 30 mm in length, more preferably about 10 to 20 mm, and most preferably about 15 mm. The inner member  150  is preferably about 50 mm to about 100 mm in length, more preferably about 65 to 85 mm, and most preferably about 75 mm. 
   Various modifications may be made to the applicators shown without departing from the scope of the present invention. For example, while it is preferred that the orientation indicators  132  are located on the minor axis  106  of the elliptical cross-section of the outer member  110 , the orientation indicators  132  may alternately be placed on other areas of the outer member  110 , as well as on the inner member  140 . The orientation indicators  132  may also be significantly larger than those shown. In addition, while the orientation indicators  132  have been shown as tabs, the orientation indicators  132  may be formed of other structures or by indicia such as marks or the like. 
   Furthermore, although the applicators in some embodiments have a substantially elliptical cross-section for the entire longitudinal length of both the outer member  110  and the inner member  140 , some applicators within the scope of the invention may have a substantially elliptical cross-section for less than the entire longitudinal length of either the outer member and/or the inner member. In the preferred embodiments, the applicators will have a substantially elliptical cross-section at least at the leading, vaginal insertion end  116  portion of the outer member  110 , with the option of having a more conventional or circular cross-section the rest of the length. In more preferred embodiments, the applicators will have a substantially elliptical cross-section for a substantial portion of the longitudinal length of the outer member  110  and/or inner member  140 . In even more preferred embodiments, the applicators will have a substantially elliptical cross-section for at least half the longitudinal length, and in even more preferred embodiments, the substantially elliptical cross-section will extend at least three-quarters the longitudinal length of the outer member  110  and/or inner member  140 . In the most preferred embodiment, the applicators will have a substantially elliptical cross-section for substantially the entire length of the outer member  110  and/or inner member  140 . 
   As noted above, the inner member  140  is sized and shaped to be slidably disposed within the outer member  110  and to share the common longitudinal axis  102  as the outer member  110 . The inner member  140  is operable to discharge the insert  20 ,  30  into the vagina when the applicator  100  is inserted into the vagina. The inner member  140  has a shaft  142  that connects a head portion  144  and a trailing end  146 , which is provided with a flange  148  located about a substantial portion of the circumference of the trailing end  146  to provide a gripping surface. 
   The head portion  144  is in contact with the insert  20 ,  30  while the insert  20 ,  30  is disposed within the outer member  110 . The head portion  144  operates to discharge the insert  20 ,  30  from the outer member  110 . The inner member flange  148  will contact the outer member flange  134  provided on the cylindrically shaped portion  130  of the outer member  110  when the inner member  140  is pushed forward (i.e., in a direction from the trailing end  126  toward the vaginal insertion end  116 ) to discharge the insert  20 ,  30 . In addition, the head portion  144  is provided with a head flange  145  that will contact the inner flange  136  provided on the inner surface  112  of the outer member  110  to act as a stop for the inner member  140  so that the inner member  140  cannot be removed from the outer member  110 . 
   Turning now to  FIGS. 2 and 3 , an alternate embodiment of the insert applicator  100  according to the present invention is shown in a pre-assembled configuration. In this embodiment, the applicator  100  is the same as that described above with respect to  FIG. 1 , but it includes at least one vent  124  provided on the outer member  110 . 
   The at least one vent  124  is preferably placed on the cone shaped portion  122  adjacent the substantially cylindrical-shaped portion  130 . Preferably, a plurality of vents  124  are spaced about the circumference of the outer member  110 . The vents  124  may take any shape but are generally shaped to provide a major axis parallel to the longitudinal axis  102 . The vents  124  reduce the friction experienced by the insert  20 ,  30  against the inner surface  112  of the outer member  110 . In addition, the vents  124  will aid in the expulsion of the insert  20 ,  30  during discharge of the insert  20 ,  30  into the vagina. Moreover, the vents  124  will likely be useful in delivering drugs, medicaments, lubricants and the like as the inner member  140  pushes the insert  20 ,  30  out the vaginal insertion end  116  of the outer member. 
   Referring more particularly to  FIG. 3 , the vents  124  are shown as extending from the cylindrically shaped portion  130  a substantial distance toward the vaginal insertion end  116 . Accordingly, one skilled in the art will understand that the vents can have any suitable length as illustrated in  FIGS. 2 and 3 . 
     FIGS. 4 and 5  illustrate inserts in the form of an incontinence insert that can be delivered using the applicator of the present invention. An “incontinence insert” as used herein refers to devices specifically designed, configured, and/or adapted for placement into a vagina in order to reduce the occurrence and/or severity of female urinary incontinence. While incontinence inserts are typically made of non-absorbent materials, at least partially absorbent materials may also be used. There is, however, no advantage to using absorbent materials because there is no intent to absorb any bodily fluids. Therefore, incontinence inserts are readily distinguishable from catamenial tampons. Nevertheless, one skilled in the art will understand that the applicator of the present invention may be useful in delivering catamenial tampons, medicaments, and the like. 
   In  FIG. 5 , an insert having an “M-shape” profile in a plane parallel to the directions indicated by arrows  29  is shown generally at  20 . Such inserts are more fully disclosed in U.S. Pat. No. 6,142,928; U.S. application Ser. Nos. 09/675,459 and 09/675,460, all of which are incorporated herein by reference in their entireties. Briefly, the insert  20  is formed from an elongated member having a first end portion  22  and a second end portion  24 , and has three folds,  21 ,  23 , and  26 . The first end portion  22  and the second end portion  24  are aligned generally adjacent each other and, together with the folds  21 ,  23 ,  26 , form a generally planar M-shaped profile. An inward crease  28  is formed in a direction generally perpendicular to the plane of the M-shaped profile. One of the end portions is attached to a withdrawal member, such as a string  27 . The insert  20  preferably includes, or is predominately made from, a resilient material that functions to expand the insert  20  in at least a direction indicated by arrows  29  once the insert  20  is placed within the vagina. 
   In order for the insert  20  to be most effective in reducing the occurrence and/or severity of incontinence, the insert  20  should be properly placed and correctly oriented within the vagina. Specifically, the insert  20  should expand in the direction  29  so as to press against and/or compress the urethra and support the urinary sphincter muscle, thereby reducing the occurrence and/or severity of incontinence, as more fully described in U.S. Pat. No. 6,142,928. The applicators of the present invention help provide this correct orientation of the insert, as described above with reference to  FIGS. 1-3  and  6 - 7 . 
   To correctly orient the insert  20 , the user simply discharges the insert in a position so that it expands in a direction indicated by arrow  29  ( FIG. 5 ) towards the urethra and provides support to the urinary sphincter muscle. This can be accomplished simply by discharging the insert  20  only when the applicator  100 , having been inserted into the vagina, is oriented such that an imaginary line connecting the two orientation indicators  132  are substantially perpendicular with the major axis of the opening of the vagina. As used herein, the major axis of the opening of the vagina is defined as the axis across the opening of the vagina generally extending in direction from the prepuce of the clitoris to the fourchet and/or the anal opening. The correct orientation is accomplished by rotating the applicator  100  ninety degrees in either direction after insertion of the applicator  100  into the vagina but before expulsion of the insert. 
   Those skilled in the art will recognize that the applicator  100  is also useful with the insert  30  shown in  FIG. 4 , as well other inserts. Those skilled in the art will also appreciate that various modifications may be made to the incontinence inserts shown. For example, the manners of attachment of the withdrawing member shown in  FIGS. 4 and 5  are only exemplary, and other manners known in the art can be used equally as well. While various modifications may be made to the inserts shown, the advantages of the applicator  100  are most apparent and fully realized where the effective functioning of the insert is at least in part dependent upon its correct orientation within the vagina, as is the case for the inserts of FIG.  4  and FIG.  5 . 
     FIGS. 9A-9D  illustrate cross-sections of alternate embodiments of the applicators of the present invention. As previously mentioned, the most preferred applicators have substantially elliptical cross-sections in at least in their leading, vaginal insertion end portions, in order to accurately approximate the shape of the opening of the vagina, thereby facilitating the insertion of the applicator, while also maximizing the space available for housing an insert. Other cross-sections, while perhaps not facilitating the insertion process as well as a substantially elliptical cross-section, are advantageous nevertheless to maximize the space for housing a particular insert, such as an insert having an asymmetrical shape. 
     FIG. 9A  illustrates an alternate embodiment of the applicators having non-circular cross-section according to the present invention. The cross-section is substantially “egg-shaped,” that is, one portion  410  of the cross-section is substantially circular in contour, and another portion  420 , continuous with the substantially circular portion  410 , is substantially elliptical in contour. 
     FIG. 9B  illustrates another alternate cross-section for the applicators of the present invention. The cross-section includes one portion  430  that is substantially circular in contour, and another portion  440 , continuous with the substantially circular portion  430 , is substantially flat or straight. 
     FIG. 9C  illustrates a third alternate cross-section for the applicators of the present invention. The cross-section includes one portion  450  that is substantially elliptical in contour, and another portion  460 , continuous with the substantially elliptical portion  450 , is substantially flat or straight. 
     FIG. 9D  illustrates a fourth alternate cross-section for the applicators of the present invention. The cross-section is defined herein as a “soft-square,” that is, the cross-section is substantially a square. Its corners  470  and/or the sides  480 , however, are slightly or softly curved. Other slightly curved quadrilaterals may also be used may for the cross-sections, such as soft-rectangles and soft-trapezoids. 
   Like the substantially elliptical cross-sections, the alternate cross-sections of  FIGS. 9A-9D  are shown in a direction substantially perpendicular to the longitudinal axis of the applicator. Furthermore, the alternate non-circular cross-sections of  FIGS. 9A-9D  need not extend the entire length of the applicator, but rather may be combined with other cross-sections. The preferred alternate embodiments of the applicators will have the cross-sections of any of  FIGS. 9A-9D  at least at the leading, vaginal insertion end portion of the outer member. In more preferred embodiments, the applicators will have one of the alternate cross-sections for a substantial portion of the longitudinal length of the outer member and/or inner member. In even more preferred embodiments, the applicators will have an alternate cross-section for at least half the longitudinal length, and in even more preferred embodiments, the alternate cross-section will extend at least three-quarters the longitudinal length of the outer member and/or inner member. In the most preferred embodiment, the applicators will have an alternate cross-section for substantially the entire length of the outer member and/or inner member. 
   According to another aspect of the present invention, a method is provided for properly positioning an insert within a vagina so that the insert is effective in reducing the occurrence and/or severity of involuntary urine loss. The method uses an insert applicator according to the present invention. Specifically, the preferred applicators useful in the method have a curved cross section, such as an elliptical cross-section, or one of the cross-sections shown in  FIGS. 9A-9D . 
   In one embodiment of the method, the applicator is inserted into the vagina such that the major axis of the substantially elliptical cross-section of the applicator is substantially parallel with the major axis of the opening of the vagina. The applicator is inserted and advanced into the vagina until either the fingers of the user that are holding the gripping portion of the applicator are resting against the body, or until the gripping portion is flush with the vaginal opening. Typically, the applicator is advanced approximately 2 to 3 inches. After inserting the applicator, the applicator is rotated about 90 degrees such that the minor axis of the elliptical cross-section is substantially perpendicular with the major axis of the opening of the vagina. The insert is then discharged into the vagina in its proper orientation. 
   In an alternate embodiment, where the applicators have orientation indicators, the applicator is oriented based upon the orientation indicators. Preferably, the applicator is first inserted into the vagina, and then oriented by rotation based upon the orientation indicators. Alternatively, the applicator may be oriented before insertion based upon the orientation indicators, so that the applicator is correctly oriented when inserted. The insert is then discharged into the vagina in its correct orientation. 
   While the invention has been described in conjunction with specific embodiments, it is to be understood that many alternatives, modifications, and variations will be apparent to those skilled in the art in light of the foregoing description. Accordingly, this invention is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and scope of the appended claims.