Abstract:
The present invention relates to applicators for delivering objects into a body cavity, having a pivotal finger grip tab to improve the ability of a user to maintain a secure grip on the applicator during use. Prior to use the tab can reside in a first position that is proximal the applicator outer surface. When a user is ready to insert the applicator into a body cavity, the tab is pivoted outwardly to a second position distal the applicator outer surface. The tab in its outwardly pivoted second position provides a surface for a user&#39;s finger and/or thumb to apply a force that is parallel to the length of the applicator instead of perpendicular (normal force) to the applicator. Thus minimizing the opportunity for applicator failure and resistance to material expulsion as a result of increased friction on the material itself or an optional expulsion member.

Description:
FIELD OF THE INVENTION 
     The present invention relates to applicators for delivering materials into a body cavity, having a pivotal finger grip tab to improve the ability of a user to maintain a secure grip on the applicator during use. 
     The applicator is particularly useful for delivering catemenial devices into the vaginal canal. 
     BACKGROUND OF THE INVENTION 
     Applicators for delivering materials into a body cavity typically comprise an insertion member having an  15  insertion end and a gripper end opposite thereof, and an expulsion member slideably fitted within the insertion member. The gripper end will generally incorporate features to allow a user to more or less securely hold the applicator during use, which includes the following steps: inserting the applicator into a body cavity, expelling a substantially enclosed material contained by the applicator, and withdrawing the applicator from the body. 
     Attempts have been made to improve the user&#39;s ability to manipulate the applicator during use. One approach is to significantly reduce the diameter of the applicator in the gripper end, as can be seen in Whitehead, U.S. Pat. No. 4,508,531. A disadvantage to this approach is while a reduced diameter grip may help in preventing fingers from slipping during insertion, there is little or no resistance offered in the opposite direction during the expulsion step. This is a step with which many users have difficulty. 
     Another approach to improve the grip of the applicator during use is to incorporate projections, such as in the form of a ring, at the base of the applicator member being inserted into the body. Examples of this approach are disclosed in Voss, U.S. Pat. No. 4,361,150, and in Sartinoranont, U.S. Pat. No. 4,447,222. In order for the projections to function as intended, they must be of significant dimension. However, a number of disadvantages are realized as the projection dimensions increase. One disadvantage is the handling of the applicators during high-speed manufacturing. Applicators are transferred from one position to another many times throughout their manufacture, and the projections can become snagged, severely affecting the output efficiency and quality of the products. Many high-speed manufacturing processes include at least one buffering system that accumulates materials and products between major steps of manipulation and assembly. Applicators with projections generally do not stack neatly (parallel) in the buffering systems. This negatively affects the efficiency of space and transfer, and it potentially creates jams in the process due to applicators being “hung up” in the accumulators or interconnected with adjacent applicators. 
     A second disadvantage of applicators having projections is related to the packaging of the fully assembled applicators. Just as the applicators will not stack neatly in the buffering systems of high-speed manufacturing equipment, the applicators will not stack neatly in a package of two or more. Either extra packaging material is needed to compensate for non-parallel stacking, or additional equipment and processing steps is required to orient adjacent applicators such that the projections are opposite one another. 
     Yet another approach to improve the handling of applicators is to increase the friction in the gripper end. This is especially true, as tampon manufacturers are moving toward the use of higher gloss surfaces, which are purported to aid in ease of applicator insertion into a body cavity. An example of this approach is disclosed in Voss, U.S. Pat. No. 3,575,169, wherein an applicator is coated with pulverized stone or sand. 
     Hagerty, U.S. Pat. No. 5,709,652, discloses an applicator having a plurality of finger-accepting apertures to provide relatively abrupt, finger-accepting edges to frictionally resist movement of a user&#39;s finger in response to longitudinal forces on the device. Although a useful contribution to the art, the finger-accepting edges of Hagerty, are limited to the wall thickness of the tubular element. 
     With many of gripping features described heretofore, the natural tendency of a user is to maximize the friction by applying an increasingly greater normal force, which may result in applicator failure. This failure can be two-fold: one, the applicator can collapse under the normal force and two, the applicator insertion member can increase the amount of friction on an expulsion member slideably fitted within the insertion member, resulting in the inability to expel the material contained by the applicator. 
     In view of the shortcomings of the prior art, what is needed is an applicator which has substantial resistance to finger slip during use, minimizes applicator collapse and failure, is conducive to high-speed manufacturing, and is conducive to efficient packaging. 
     SUMMARY OF THE INVENTION 
     The present invention relates to an applicator for delivering an object into a mammalian body cavity having at least one pivotal finger grip tab located on an elongate insertion member, to provide a user with a secure hold during the insertion, expulsion, and withdrawal steps of applicator use. Prior to use the tab can reside in a first position that is proximal the applicator outer surface, resulting in improvements over the stated disadvantages of the prior art; in particular, during the manufacture and packaging of the applicators. When a user is ready to insert the applicator into a body cavity, the tab is pivoted outwardly to a second position distal the applicator outer surface. The tab in its outwardly pivoted second position provides a bearing surface for one or more of a user&#39;s manual digits (fingers and thumb) to apply a force that is parallel to the length of the applicator instead of perpendicular (normal force) to the applicator. This minimizes increased friction caused by collapsing the finger grip portion of the tubular insertion member against the insertable object and/or an optional expulsion member. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of an applicator according to the present invention. 
     FIGS. 2A-2G are front views of finger grip tabs having various geometric patterns as provided by the present invention. 
     FIG. 3 is perspective view of a tubular insertion member having a ring-shaped tab pivotally connected thereon. 
     FIG. 4 is a perspective view of a tubular insertion member having two finger grip tabs in an outwardly pivoted position. 
     FIG. 5 is perspective view of a tubular insertion member having a finger grip tab pivotally attached thereto. 
     FIG. 6 is a cross section taken through line  6 — 6  of FIG. 5, depicting a pivotally attached tab in a first position substantially radially symmetric with the tubular insertion member. 
     FIG. 7 is a perspective view of a tubular insertion member having a formed tab in the gripper end of a tubular insertion member, as well as an optional weakened region adjacent the formed tab. 
     FIG. 7A is an enlarged view of the finger grip portion of the applicator of FIG.  7 . 
     FIG. 7B is a partial cross-section taken through line  7 B— 7 B of FIG.  7 A. 
     FIG. 7C illustrates a user&#39;s manipulation of the finger grip depicted in FIG.  7 B. 
     FIG. 8 is a cross section taken through line  8 — 8  of FIG. 7, depicting the formed tab in a first position radially symmetric with the tubular insertion member. 
     FIG. 9 is a side view of an applicator according to the present invention while in use. 
     FIG. 10 is a side view of a tubular insertion member having a formed tab in the gripper end and having an optional gap between the edges of the tab and the surrounding area of the tubular insertion member. 
     FIG. 11 is a side view of a tubular insertion member having an optional protuberance positioned adjacent a tab fixed end for restricting the angle of tab rotation. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The following is a detailed description of the present invention, wherein like elements are labeled with like numerals in FIGS. 1-11. Referring to FIG. 1, one embodiment of the present invention relates to an applicator  10  comprising a tubular insertion member  11  and an expulsion member  12  as prepared for use in expelling its contained material. The tubular insertion member  11  comprises an insertion end  20 , a gripper end  21 , a length  22  that runs from the insertion end  20  to the gripper end  21 , and a tab  30  pivotally connected to the tubular insertion member  11  in the gripper end  21 . The tab  30  has a fixed end  31  where it is connected to the tubular insertion member  11 , and a free end  32  that can pivot about the fixed end  31 . The insertion end  20  may have a plurality of inwardly curved petals  40  forming a substantially closed dome  41 . 
     The tab  30  is illustrated perpendicular to the length  22  of the applicator  10 . The tab  30  can take this orientation by pivoting it in an arc from an original orientation parallel to the length  22  of the applicator  10 . 
     The tab may take essentially any desired shape including triangles, ovals, rectangles, bulbs, tear-drops, having flared free ends, or having flared fixed ends, and other various geometric patterns. Representative, non-limiting examples of useful geometric patterns for the tab  30  are illustrated in FIGS. 2A-2G. 
     FIG. 3 depicts an embodiment of the present invention having a ring-shaped tab  30 ′. The ring-shaped tab  30 ′ is configured and dimensioned to accept a least a portion of a user&#39;s manual digit(s). As an added convenience, a tab  30 ′ in the form of a ring would allow a user to essentially have both hands free during the many steps involved in removing and disposing of a soiled tampon and insertion of a subsequent tampon. In contrast to the tab  30  of FIG. 1, the tab  30 ′ of FIG. 3 is pivotable from an original orientation substantially perpendicular to the length of the applicator. 
     The tubular insertion member has at least one tab. 
     Preferably, it contains a plurality of tabs disposed about the circumference of the gripper end. A preferred embodiment is illustrated in FIG. 4, in a side view depicting a first and second tab  30  positioned approximately 180° from one another. FIG. 4 shows the tab free ends  32  in an outwardly pivoted position distal the outer surface of the tubular insertion member  11 . 
     FIGS. 5 through 8 are useful in illustrating the differences in connecting tab  30  to insertion member  11  according to the present invention. As can be seen in FIGS. 5 and 6, tab  30  is an additional and separate element to that of the tubular insertion member  11 . Tab  30  can be formed during the formation of the tubular insertion member  11 , such as by an injection molding process, or formed separately and then joined to the tubular insertion member  11  in a separate processing step, such as by the use of adhesives, ultrasonic welding, or heat sealing. 
     FIGS. 7-7C and  8  depict a tubular insertion member  11  having a tab  30  formed directly in the gripper end  21 . The tab  30  is integrally connected to the insertion member  11  by completely cutting through the wall of the tubular insertion member  11  along at least portions of the periphery of the tab  30 , leaving a fixed end  31 . A representative, non-limiting list of methods useful for defining the tab  30  by a line of separation in the tubular insertion member wall is the following: die-cutting, laser cutting, water jet cutting, thermoforming, grinding, and the like. 
     FIGS. 7,  7 A,  7 B and  8  depict the formed tab  30  in a first position that has substantially the same elevation as portions of the insertion member  11  surrounding the tab prior to use. As used herein, the phrase “substantially the same elevation” and modifications thereof include co-planar, having the same radius (as in FIG.  8 ), and having a thin member attached to or extending from the surface (as in FIG.  6 ). In a preferred embodiment, wherein the insertion member  11  is tubular (as in FIG.  8 ), the tab  30  is radially symmetric to the surrounding area of the tubular insertion member  11 . In other words, the radial distance R 1  from a center point is substantially equal to the radial distance R 2 . This is the position of the tab  30  during manufacturing, assembly, and packaging, thereby providing several benefits. In the radially symmetric position, the applicator can be processed on high-speed equipment, capable of enduring a plurality of transfer points in any direction without snagging and creating jams. Additionally, the applicators will stack in a substantially parallel fashion in accumulating reservoirs that typically accompany state of the art processing equipment (see U.S. Pat. No. 4,755,164). If the tab free ends were pivoted outwardly to a second position during manufacture and assembly, then the applicators would “fan” in two directions in the reservoirs as a result of non-parallel stacking, potentially resulting in transfer failures due to applicator jams and/or interconnected adjacent applicators. 
     FIG. 7 depicts the tab fixed end  31  as a perforated line. Preferably, the perforated line has a radius corresponding to the radius of the tubular insertion member  11  to account for the tube curvature when tab  30  is pivoted outwardly. Fixed end  31  may optionally be a scored or perforated line, thereby reducing the amount of force required to outwardly pivot tab free end  32  from its initial radially symmetric position to a second position that is distal the outer surface of the tubular insertion member  11 . 
     As shown in FIG. 7C, when a consumer is ready to use the applicator, she simply pivots the tab free end  32  from its initial radially symmetric position to an outward second position that is distal the outer surface of the tubular insertion member. The user grasps the applicator in the gripper end with one or two hands, utilizing the tab to provide resistance to finger slip during applicator insertion, material expulsion, and applicator withdrawal. FIG. 9 illustrates an applicator  10  of the present invention in use, with a user&#39;s thumb  60  residing on a first tab  30 , and a finger  61  residing on a second tab  30 , which is approximately oppositely disposed about the circumference of the tubular insertion member  11 . 
     Referring to FIGS. 7A and 7B, a region of weakness  50  adjacent the tab free end  32  can optionally be employed to further enable a user to position a finger and/or thumb underneath the tab free end  32  for pivoting the tab  30  outwardly to its useable position as shown in FIG.  7 C. The region of weakness  50  will allow the tubular insertion member  11  in that region to be inwardly displaced. Preferably the region of weakness  50  comprises scored or perforated lines adjacent the tab free end  32 . As used herein, scored is defined as a partial cut (less than 100 percent) through the thickness of the tubular insertion member. Perforated is defined as a line of holes with uncut or scored material residing between the holes. The dimension and geometry of the holes can vary, as well as the dimension of the uncut material therebetween. FIGS. 7A and 7B illustrate a preferred arrangement of the region of the weakness  50  including a series of perforated lines  51  having perforated components  52  and land components  53 , with terminal perforated components  52   a  most proximal the tab free end  32  adjoining the tab free end  32 . This helps to increase the inward displacement of weakened region  50 , thereby providing sufficient space to fit a portion of a user&#39;s finger/thumb underneath the tab free end  32 . 
     FIG. 10 illustrates an optional gap  70  between the is edges of the tab  30  and the tubular insertion member  11  surrounding the tab  30 . This gap  70  can also aid a user in positioning a thumb or finger underneath the tab free end  32  for pivoting the tab  30  outwardly to its useable position. The gap  70  may be positioned along the entire tab periphery (excluding the fixed end  31 ) or alternatively in select areas. The dimensions of the gap width is from about 0.5 to about 3.0 millimeters, preferably between 0.75 and 1.25 millimeters. This gap width may serve to relieve material stress during pivoting of the tab to avoid tearing the material. The edges may also be substantially abutted, in an effort to maintain the hygienic state of the material contained by the applicator. 
     Referring to FIG. 11, it is preferred that the tab free end  32  is pivoted outwardly approximately 90° from its initial position, radially symmetric to the outer surface of the tubular insertion member. This preferred position provides the maximum amount of resistance to finger slip during use of the applicator  10 . To restrict the angle of pivot, one or more protuberances  80  can optionally be employed adjacent the fixed end  31  of the tab  30 . The protuberances  80  may take the form of bumps, pyramids, rings, and the like. 
     The applicators of the present invention can be made of any useful materials. Generally, materials known to those of ordinary skill in the art include plastics (polymers) and cardboard. The plastic is applicators may be of conventional polymers, such as polyolefins, or be of more sophisticated polymers and polymer blends formulated to provide features such as biodegradability and/or water dispersibility. Examples of applicators that are designed to be dispersible or biodegradable are disclosed in U.S. Pat. Nos. 5,002,526 and 5,782,794 (relating to applicators made from polyvinyl alcohol based compositions), U.S. Pat. No. 5,350,354 (relating to applicators made from starch based compositions), and U.S. Pat. No. 4,900,299 (relating to applicators made from poly(3-hydroxybutyric acid) based compositions). Plastic applicators are often made by the following non-limiting processes: injection-molding, blow-molding, and extrusion. 
     Cardboard applicators can be constructed from a single layer of cardboard material, or from a plurality of laminated layers to provide benefits relating to the various layers. Useful cardboard stock for the formation of the tubular insertion members and expulsion members include, without limitation, paperboard, cardboard, cup stock, paper, and the like. The applicators can be made by the following non-limiting processes: 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. No. 4,755,164. 
     The cardboard applicators may include a surface layer, which may be useful to increase the comfort and ease of insertion and withdrawal of the applicator. The surface layer may be in the form of laminated films, cured coatings, and the like. An example of such a surface layer is disclosed in co-pending application Ser. No. 09/105,787 filed on Jun. 26, 1998. A representative, non-limiting list of useful materials to be used as the surface layer includes, waxes, cellophane, polyolefins, polyesters, epoxies, and the like. The surface layers may also include thermal stabilizers, pigments, fragrances, surfactants, antimicrobial agents, medicaments, and the like. There are many techniques known for applying the surface layers. A representative, non-limiting list of such techniques includes spraying, extruding, slot-coating, brushing, transfer coating, and the like. Additional processing steps may be required to cure the surface treatments to a useable form, such as applying irradiation or other forms of energy. 
     Typical dimensions for each of the tubular insertion and expulsion members include a length of from about 50 to about 100 millimeters, a diameter of from about 8 to about  16  millimeters, and a thickness of from about 0.4 to about 0.6 millimeters. Preferably, the diameter of the expulsion member is less than the diameter of the tubular insertion member to allow for a telescopic arrangement of the two, as shown in FIG.  1 . 
     The tubular insertion member of the applicator provided by the present invention is preferably substantially closed prior to expulsion of the materials contained therein. Alternatively, the insertion end of the applicator can be more or less open, that is the diameter in along the length of the tubular insertion member is substantially equivalent to the diameter of the insertion end. Proctor &amp; Gamble, of Cincinnati, Ohio, currently offers for sale an open-ended tampon applicator under the trade name TAMPAX brand flushable applicator tampons. As can be seen in FIG. 1, one technique for substantially closing the insertion end of the applicator, is by employing a plurality of inwardly curved petals. The petals will flex and/or hinge to an open position upon expelling materials contained by the applicator. The number of petals generally ranges from about 4 to about 6. An alternative technique for substantially closing the insertion end of an applicator is by pleating the insertion end. This technique is disclosed in U.S. Pat. No. 5,782,793. When an applicator is constructed with more than one layer of material, a single layer may extend into the insertion end in an effort to reduce the force required to expel the contained materials. An example of this is disclosed in U.S. Pat. No. 5,827,214. These collective closures may be of spherical shape, or alternatively tapered shape. 
     Preferably the applicators provided by the present invention are cylindrical tubes that are substantially straight along their lengths, not including their gripper end. The applicators may however, be curvilinear to improve comfort and manipulation of the applicator during insertion and withdrawal from a body cavity. An example of a curved applicator can be seen in U.S. Pat. No. 5,158,535. 
     The applicator of the present invention can be used for the delivery of catemenial devices, such as tampons, intravaginal collection devices, and interlabial pads. The applicator may also be useful for delivery of oral, rectal, and vaginal suppositories, as well as nasal devices, such as nasal tampons. Further, the applicator can be used for delivery of various other materials including, medicaments, moisturizers, vitamins and minerals, spermicides, and odor controlling agents. These materials may be in the form of solids, creams, foams, gels, and the like. 
     The user may grasp the applicator and pivot the free end of the tab or tabs outwardly from the insertion member. The applicator is then inserted into the body cavity, and the contained material is expelled through the insertion end of the insertion member by forcing the expulsion member through its gripper end while bearing against the tab. To facilitate this expulsion, the user grasps the insertion member adjacent the outwardly pivoted tab or tabs with her manual digits that are disposed toward the insertion end, and she forces the expulsion member into the insertion member by the use of one or more additional manual digits. If the tab is in the form of a ring, she may insert a manual digit into the ring to bear against it during the expulsion of the contained material. 
     The disclosures of all patents, as well as any corresponding published foreign patent applications, mentioned throughout this patent application are hereby incorporated by reference herein. 
     The specification and embodiments 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.