Abstract:
An applicator and method for delivering an object into a body cavity. In particular, the applicator includes a tubular insertion member having an outer surface, an inner surface, an insertion end, a first stop affixed to the inner surface proximate the insertion end, and a trailing end opposite the insertion end. The tubular insertion member containing a cage having an inner surface, an outer surface, a plurality of arms extending from an inner end portion toward the insertion end of the tubular insertion member, and a second stop affixed the outer surface proximate the inner end of the cage. The object is held within the cage until placement into the user&#39;s body and the first and second stops are capable of engaging to allow the object to be delivered into the body cavity while the cage remains constrained within the insertion member.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention provides an applicator for inserting an object such as a bulky device into a human or other mammalian body cavity. In particular, the invention provides an applicator having a cage for holding a bulky device. Upon insertion, the bulky device is able to expand to its full size. Expulsion of the bulky device from the applicator requires substantially reduced force.  
         BACKGROUND OF THE INVENTION  
         [0002]    Applicators for inserting and delivering objects into a body cavity typically include an insertion member having an insertion end and a trailing end opposite thereof, and an expulsion member slideably fitted within the insertion member. The trailing end will generally incorporate some sort of a gripping feature to allow a user to more or less securely hold the applicator during use, which may include the following steps: inserting the applicator into a body cavity, delivering a substantially enclosed object contained by the applicator, and withdrawing the applicator from the body.  
           [0003]    Some catamenial devices such as tampons and collection cups may be bulky in size and may need to be compressed to fit within the applicator. These particular devices may be difficult to expel from the applicator. Expulsion often requires higher forces due to friction of the device against the inner surface of the insertion member.  
           [0004]    Additionally, users of the push type applicators typically experience discomfort when inserting a tampon. Even though the outer surface of the insertion member may be smooth and somewhat lubricious for easy and smooth insertion, the tampon usually has a rough and irregular surface as a consequence of its absorptive and material properties. These properties tend to cause frictional discomfort when the tampon is expelled out of the insertion member and against the delicate walls and folds of the vagina.  
           [0005]    Some applicators utilize a hollow tube having an open insertion end through which the tampon is always exposed while other applicators utilize a completely closed or partially closed design. The partially or completely closed insertion tip can help prevent premature contamination or wetting and subsequent expansion of the absorbent tampon. A tampon that has a portion expanded due to premature wetting will be difficult to remove from the applicator.  
           [0006]    Examples of applicators having a protected insertion end are shown in U.S. Pat. Nos. 5,087,239; 5,279,541; 5,348,534 and 5,569,177. Additionally, these applicators are shown having segmented insertion portions with a hinge region or a reduced thickness in the insertion portion.  
           [0007]    Attempts have been made to reduce the amount of force to expel tampon. In particular, WO 9607383 discloses an applicator having an insertion tip that has at least some of the paper fibers stretched and/or broken so as to allow it to be opened with a minimum amount of expulsion force. U.S. Pat. Nos. 4,923,440, 4,318,404 and 4,286,594 use a sheath or a portion of the insertion member that convolutes back onto itself to deliver the catamenial device to the vaginal cavity.  
           [0008]    An attempt to provide an applicator for a bulky device is disclosed in EP 0 616 797. This publication discloses an insertion tube for a vaginal cup that has an outer tube slideable on an inner tube. At the insertion end of the inner tube, there are two jaws into which the vaginal cup is folded and placed. The outer tube is then moved up over the jaws to secure the cup within the applicator. After insertion of the applicator into the vaginal cavity, the outer tube is slid away from the jaws, which causes the jaws to open and release the vaginal cup.  
           [0009]    Additionally, U.S. Pat. No. 6,095,998 discloses an expandable bag catamenial tampon and an applicator, which spreads the tampon open within the vaginal cavity. The bag-like tampon is placed over the leading end of the applicator in its initial flaccid configuration, which defines an initial width. The applicator is used to spread the tampon to a greater deployed width.  
           [0010]    The present invention reduces the amount of friction between a bulky device such as a catamenial device and the applicator barrel as well as reducing the friction between the bulky device and vaginal wall. This is accomplished by having a cage for containing the catamenial device that slides out the applicator barrel (insertion member) and then glides the bulky device inside the vagina up to the predetermined point at which it opens up and to release the bulky device. The bulky device is then free to expand.  
         SUMMARY OF THE INVENTION  
         [0011]    This invention relates to an applicator for delivering an object into a body cavity, the applicator including a tubular insertion member having an outer surface, an inner surface, an insertion end, a first stop affixed to the inner surface proximate the insertion end, and a trailing end opposite the insertion end. The tubular insertion member contains a cage having an inner surface, an outer surface, a plurality of arms extending from an inner end portion toward the insertion end of the tubular insertion member, and a second stop affixed the outer surface proximate the inner end of the cage. The object is held within the cage until placement into the user&#39;s body, and the first and second stops are capable of engaging to allow the object to be delivered into the body cavity while the cage remains constrained within the insertion member.  
           [0012]    Additionally, this invention relates to a method of delivering an object into a body cavity from an applicator. The method includes the steps of inserting the insertion end of an insertable member into the user&#39;s body; displacing the cage contained therein toward the insertion end; and expelling an object from the cage into the body cavity. 
       
    
    
     DESCRIPTION OF THE DRAWINGS  
       [0013]    [0013]FIG. 1 is a cross-sectional view of an applicator containing a bulky device showing an optional plunger in phantom.  
         [0014]    [0014]FIG. 2 is a plan view of the applicator of FIG. 1 with the bulky device partially expelled.  
         [0015]    [0015]FIG. 3 is a plan view of the applicator of FIG. 1 with the bulky device expelled and the cage fully deployed.  
         [0016]    [0016]FIG. 4 is an alternate embodiment of an applicator containing a bulky device. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0017]    This invention relates to applicators for bulky devices. As used herein, the term “bulky device” generally refers to any type of device especially an intravaginal device such as an absorbent article, a support device, or an obstructing device useful to block the flow of and/or collect bodily liquids. The term includes, without limitation, all absorbent of tampons such as foam tampons, bag-type tampons, or compressed tampons; birth control devices such as diaphragms or intrauterine devices (IUDs); and incontinence devices and vaginal supports such as pessaries; and obstructing devices. Obstructing devices include menstrual collection cups and inflatable or expandable blocking devices.  
         [0018]    In a first embodiment shown in FIG. 1, applicator  10  has at least one tubular element, insertion member  20 , and cage  30 . Additionally, applicator  10  may include an optional plunger  40  as shown in dotted lines. Insertion member  20  has insertion end  22 , trailing end  24 , inner surface  21 , outer surface  23 , and first stop  26  on inner surface  21 . Insertion end  22  may be substantially closed, protecting bulky device  5  from wetness or contamination. Such closure may include a domed surface having cuts or perforations, pleats, segments pivotally attached to insertion end  22  (shown as closed petals  28  in FIG. 2), or other means. Cage  30  has inner surface  31 , outer surface  33 , at least one arm  32  (shown FIG. 2), resilient hinge  34 , second stop  36 , and end  38 . In a preferred embodiment, cage  30  is a unitary unit but may be formed from multiple pieces integrally connected together. As used herein, a “unitary” device is one that has the characteristic of being a unit or a whole. This includes both devices that are created from a single element and those formed by fixing together individual elements to form the whole.  
         [0019]    In the preferred embodiment, first stop  26  is disposed about the interior surface  21  of insertion member  20  and second stop  36  is disposed about the outer surface  33  of cage  30 . It is preferred that at least one stop is a continuous ring.  
         [0020]    Bulky device  5  is contained within cage  30  in a compressed form. Cage  30  may be any type of structure such as a closed or opened wall tube into which the bulky device is confined. In a preferred embodiment, the bulky device in contained within a plurality of extending arms. There are preferably at least two arms and more preferably, at least four arms. Arm  32  preferably includes a flexible, elongated structure such as a wide or narrow rod or tube. Arm  32  may have a flat, cylindrical or curved shape with preferably a smooth, convexly rounded outer surface to provide a comfortable structure for contacting the user&#39;s body. Arm  32  has first end  35  and second end  37 . First end  35  is adjacent the insertion end  22  of the insertion member  20  and second end  37  is adjacent hinge  34 . First end  35  may include a straight, blunt end or may include a hook-like end that encases the outer end of bulky device  5 .  
         [0021]    As shown in FIG. 1, plunger  40  has pushing end  42  and trailing end  44 . Plunger  40  is slideably fitted within the trailing end  24  of insertion member  20 . Pushing end  42  has means such that cage end  38  is pushed toward insertion end  22  of insertion member  20 . For instance, pushing end  42  may have a smaller inner circumference than cage end  38 . While plunger  40  has been illustrated as a tubular member, alternate embodiments may be use. For example, a stick-type of pusher or a solid implement may be used to push cage end  38  toward insertion end  22 . Alternately, the user may digitally push cage end  38  toward insertion end  22 . In this embodiment, the user&#39;s finger would replace the use of a tubular plunger  40 . Plunger  40  can be a separate element from cage  40 , or it may be removably attached thereto. Additionally, plunger  40  may be unitary with the cage  30 .  
         [0022]    First stop  26  engages second stop  36  to prevent complete expulsion of cage  30  from insertion member  20 . First stop  26  and second stop  36  are configured so as when cage  30  is fully delivered from insertion member  20 , hinge  34  is aligned with petals  28 . Additionally, first stop  26  can also serve to reduce the inner diameter of insertion member  20  to better maintain cage  30  in a closed arrangement until fully deployed.  
         [0023]    Although it is not required, applicator  10  may have fingergrip-enhancing features disposed on trailing end  24  of insertion member  20 .  
         [0024]    [0024]FIG. 2 shows cage  30  partially expelled from insertion member  20 . To achieve this state, plunger  40  has been pushed toward insertion end  22 , causing cage  30  to open petals  28 . In a preferred embodiment, arm  32  slides on inner surface  21  of insertion member  20  and on first stop  26 . At the point of expulsion as illustrated in FIG. 2, resilient hinge  34  has not been deployed and bulky device  5  is still compressed, maintaining its form within arms  32  of cage  30 .  
         [0025]    [0025]FIG. 3 shows arms  32  completely expelled and bulky device  5  in a fully expanded state. First stop  26  contacts second stop  36  and resilient hinge  34  is deployed. As resilient hinge  34  is deployed, arms  32  open and release bulky device  5  from cage  30 .  
         [0026]    In use, a woman may place insertion end  22  into the vaginal opening, delivering bulky device  5  into the vagina by pushing on plunger  40  until bulky device  5  is expelled from cage  30  and withdrawing applicator  10  from the body, leaving bulky device  5  within the vagina.  
         [0027]    Alternately, a user could pull insertion member  20  onto plunger  40  while maintaining plunger  40  steady relative the user&#39;s body. This substantially eliminates friction between the bulky device  5  and the user&#39;s body.  
         [0028]    [0028]FIG. 4 shows an alternate embodiment of the invention. Applicator  10  has insertion member  20  and a unitary cage/plunger combination  50 . Bulky device  5  is contained within cage/plunger combination  50 . Cage/plunger combination  50  is pushed toward the insertion end  22  of insertion member  20  until trailing end  44  contacts trailing end  24  of insertion member  20 . Resilient hinge  34  deploys and bulky device  5  is delivered into the vaginal cavity. Alternately, a third stopper may be included on cage/plunger  50  to contact first stop  26 .  
         [0029]    Applicators are generally constructed of one of two basic materials: plastic and paperboard. Paperboard products appeal to both the manufacturer and the consumer, derived from factors such as ease of manufacture, cost of manufacture, purchase cost, environmental benefits, and flushability. A gripping member, manufactured separately, can be retrofitted onto a paperboard tubular insertion member, without significantly eliminating any of the noted appeal.  
         [0030]    The cardboard used in tampon applicators can be a single layer of cardboard material, or it can be a plurality of laminated layers to provide multiple benefits relating to the various layers. Useful cardboard stock for the formation of the tubular elements includes, without limitation, paperboard, cardboard, cup stock, paper, and the like. The laminated cardboard material may include a surface layer or coating of plastic, wax, silicone, and the like, which may be useful to increase the comfort to the user during insertion and withdrawal. The plastic coating may include, without limitation, polyolefins such as polyethylene and polypropylene, polyesters such as polyethylene terephthalate, polycaprolactone, polyvinyl alcohol, ethylene-vinyl acetate copolymers, cellophane, and the like.  
         [0031]    Preferred tubular element materials include laminated cardboard. Preferred laminated cardboard includes plastic laminated or plastic coated cardboard materials. These plastic laminated cardboard materials may include additional layers such as adhesive layers, tie layers, and the like.  
         [0032]    Examples of processes used for making paperboard applicator components are as follows: spiral winding as disclosed in U.S. Pat. No. 5,346,468; convolute winding as disclosed in U.S. Pat. No. 4,508,531; and forming a sheet around a mandrel and then sealing an overlapped seam as disclosed in U.S. Pat. Nos. 4,755,164 and 5,599,293.  
         [0033]    The applicator and cage may also be manufactured from conventional plastic, such as injection-moldable or blow-moldable plastic, biodegradable plastic, such as those disclosed in the commonly assigned application U.S. Ser. No. 08/006,013 (Dabi et al. filed Jan. 15, 1993, the entire contents herewith incorporated by reference). All commercially available products are made from an olefin-based polymer, such as polyethylene. It is preferred that the insertion members be formed through an injection molding process. This process is used because the manufacture must balance some key characteristics of the tubular insertion member. Molding inserts and cores are machined to form a tapered product, such that the wall thickness in the gripping region is relatively thick to maintain structural stability during the insertion and expulsion steps of use, while the thickness in the insertion end is minimized to provide flexibility and low expulsion force. Injection molding also enables the manufacture to make uniquely shaped tubular insertion members. There are less sophisticated/expensive polymer forming techniques, such as extrusion and blow molding that can be employed. Manufacturing a gripping member separately, and then retrofitting it to the insertion member, allows these alternatives to be used. Preferably the cage is made from a material that has a low friction coefficient against the applicator and allows for easy movement with little resistance. Additionally, the arms of the cage must be flexible thereby allowing the arms to pivotally open and release the bulky device.  
       EXAMPLES  
       [0034]    The present invention will be further understood by reference to the following specific Examples that are illustrative of the composition, form and method of producing the device of the present invention. It is to be understood that many variations of composition, form and method of producing the device would be apparent to those skilled in the art. The following Examples, wherein parts and percentages are by weight unless otherwise indicated, are only illustrative.  
       Example 1  
       [0035]    A commercially available plastic applicator was manually loaded with a Beppy foam tampon (available from Asha International, Rotterdam). The Beppy tampon is approximately 47 mm in diameter, measured in an uncompressed state. A similar tampon was loaded into a plastic prototype of the present invention. The two applicators were then hand tested for expulsion force by gripping the barrel finger grip with a stand that would not force on the section of the barrel but provide strength in the longitudinal direction. The applicator, gripped in this way, was forced by hand against a digital/top loading balance and the peak of resisting force for the expulsion of the tampon was visualized and recorded. Each sample was tested ten times and the results averaged. The averages are reported in Table 1.  
                                                   Sample   Force Required                           Commercial product   1845 g           Present Invention   1075 g                      
 
         [0036]    It is clear from this data that the use of the cage in the applicator of the present invention significantly reduces the force necessary to expel a resilient, otherwise unrestrained, product in comparison to a conventional applicator.  
         [0037]    The specification and examples above are presented to aid in the complete and non-limiting understanding of the invention disclosed herein. Since many variations and embodiments of the invention can be made without departing from its spirit and scope, the invention resides in the claims hereinafter appended.