Abstract:
The present invention relates to applicators for inserting objects into body cavities, and to methods for making the same. The applicators are particularly useful for inserting catamenial and prophylactic devices into a vaginal canal. The applicators comprise a tubular insertion member and a retrofitted gripping member. The gripping member comprises a gripping sheet which superposes upon itself about the insertion member multiple times and provides resistance to movement of a user&#39;s manual digit in response to longitudinal forces on the tubular insertion member.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is related to the following copending application: U.S. Ser. No. 09/602,950, filed on Jun. 23, 2000, entitled “Applicator for Catamenial Device Having Improved Gripper End” 
    
    
     FIELD OF THE INVENTION 
     The present invention provides an applicator and a method of making the applicator for inserting catamenial devices into the body. In particular, the invention provides an applicator having a fingergrip that enables the user to securely grasp the applicator during use. 
     BACKGROUND OF THE INVENTION 
     Applicators for inserting and expelling objects into a body cavity typically comprise 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 gripping features to provide a surface that allows the user to securely hold the applicator during use. 
     One approach to improve handling of an applicator during use is to incorporate a gripping element into or onto the surface of the insertion member at the trailing end. This allows the diameter of the insertion member to remain uniform throughout its length (i.e., diameter of the trailing end is basically be the same diameter as the insertion end). Resistance to finger slippage may be provided by incorporating apertures, projections, ribs or ridges into the trailing end of the insertion member; by scoring the trailing end; or by incorporating a roughening agent into the finish of the gripping area of the trailing end. Voss (U.S. Pat. No. 3,347,234) and Sartinoranont (U.S. Pat. No. 4,447,222) disclose the use of a ring on the trailing end, Brecht (U.S. Pat. No. 3,015,332) discloses the use of a roughened surface. Voss (U.S. Pat. No. 3,575,169) discloses elements attached to the trailing surface. Jackson (WO 98/44885) discloses an applicator barrel provided with texture by a plurality of outwardly extending deformations. 
     Roberts et al. (U.S. Pat. No. 3,148,680) discloses roughening the surface with a plurality of ribs. Wiegner et al. (U.S. Pat. No. 4,412,833), Orenga et al. (U.S. Pat. No. 5,599,293) and Beastall et al. (GB 2132484) disclose the scoring of the gripping portion of the outer sleeve. Weyenberg et al. (U.S. Pat. No. 5,614,230) and Iskra (U.S. Pat. No. 5,702,553) both disclose an outwardly extending curl on the trailing end of the insertion member. 
     Hagerty (U.S. Pat. No. 5,709,652) discloses an applicator having a plurality of finger-accepting apertures in the trailing end. The apertures provide relatively abrupt, finger accepting edges to frictionally resist movement of a user&#39;s finger. 
     A second approach is to significantly reduce the diameter of the applicator in the vicinity of the tubular insertion member trailing end, as can be seen in Whitehead (U.S. Pat. No. 4,508,531) and Huffman (U.S. Pat. No. 4,573,964). Schoelling (U.S. Pat. No. 5,453,085) inserts a hollow grip piece having a reduced diameter into the trailing end of the insertion member. 
     Lichstein et al. (U.S. Pat. No. 4,536,178) discloses a tampon applicator having a tubular barrel to house the tampon and to accommodate a slideable plunger. The rear portion of the barrel has opposing, flattened gripping surfaces with ribs. Dohzono et al. (GB 2166656A) discloses a grip portion disposed to the rear of the insertion member. The grip portion has recessed or flat, plane-like portions. 
     Lastly, attempts have been made to incorporate two or more physical restraints as a means for the user to hold the applicator securely during all of the steps of use. U.S. Pat. No. 4,921,474 discloses a sanitary tampon applicator comprising a plastic outer sleeve having a diameter-reduced section along a length adjacent its rear end so as to form an annular shoulder, and an annular rib at its rear open end. 
     While the prior art is replete with examples of fingergrips, there still remains a need for an effective fingergrip which can be retrofitted or applied to the trailing end of an applicator of any shape, comprising features that aid in insertion of catamenial devices into the body cavity. 
     SUMMARY OF THE INVENTION 
     The present invention relates to a gripping member for providing a raised area of resistance to movement of a user&#39;s manual digit. The fingergrip member member has a leading end, a trailing end, and an intermediate portion therebetween. It includes a gripping sheet having an attachment end, an outer end opposite thereof. The gripping sheet is wound up to be superposed with the outer end exposed on the outer surface of the gripping member, and the gripping member has a raised area. 
     The invention also relates to an applicator for delivering an object into a body cavity. The applicator has an insertion end, and a trailing end opposite the insertion end. The trailing end has an edge. The applicator has a finger gripping member as described above attached to the outer surface of the trailing end of the applicator. 
     An applicator according to this invention can be formed by a method including the step of encircling a gripping sheet about the trailing end of a tubular insertion member in a manner that the gripping sheet superposes onto itself about the tubular insertion member to form a gripping member having a leading end, a trailing end, and an intermediate portion. The trailing end of the gripping member is disposed toward the trailing end edge of the tubular insertion member. 
    
    
     BRIEF DESCRIPTION OF THE DRAWING 
     FIG. 1 is a perspective view of tampon applicator; 
     FIG. 2 is a plan view of a gripping sheet according to a second, preferred embodiment; 
     FIG. 3 is a side elevation of a tampon applicator having a finger grip according to a second, preferred embodiment (plunger shown broken away); 
     FIG. 4 is a plan view of a gripping sheet according to a third embodiment; 
     FIG. 5 is a side elevation of a tampon applicator having a finger grip according to a third embodiment (plunger shown broken away); 
     FIGS. 6 and 7 show an alternate example of the third embodiment; 
     FIG. 8 is a plan view of a gripping sheet according to a first, preferred embodiment; 
     FIG. 9 is a side elevation of the sheet from FIG. 1 attached to a tampon insertion member (plunger shown broken away); and 
     FIG. 10 is a side elevation of a tampon applicator having a finger grip according to a first, preferred embodiment (plunger shown broken away). 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring now to the drawings, there are in the various figures multiple embodiments of fingergrips that are particularly useful for aiding in the insertion of catamenial and prophylactic devices into a vaginal canal. 
     FIG. 1 illustrates a generic applicator  10  comprising two tubular elements: insertion member  20  and plunger  40 . Insertion member  20  has insertion end  22  and trailing end  24 . Trailing end  24  has edge  26 . Plunger  40  is slideably fitted within the trailing end  24 . 
     Referring to FIGS. 2-10, the applicator  10  of the present invention further comprises a gripping member that can be manufactured separately from the insertion and plunger members and thereafter immovably affixed to at least a portion of trailing end  24  of insertion member  20 , or it can be formed about the trailing end  24  of insertion member  20 . 
     Another preferred embodiment of the present invention is shown in FIGS. 2 and 3. As seen in FIG. 2, sheet  102  has two longitudinal sides  104 ,  104 ′, attachment end  106  and outer end  108 . Although not necessary, longitudinal sides  104 ,  104 ′ may be symmetrical. Attachment end  106  may be affixed perpendicularly to trailing end  24  of insertion member  20  (not shown). While outer end  108  is shown as blunt, the end may be of any configuration. Especially preferred are ends that are blunt or angled or have sharp or rounded points. The gripping member  100  is formed by superposing sheet  102  completely around insertion member  20  with the outer end  108  exposed as shown in FIG.  3 . The central portion  110  of gripping member  100  has an increased height compared to leading and trailing gripper ends  112 ,  112 ′. 
     FIGS. 4-7 show gripping sheet  122  comprising attachment end  126 , two longitudinal sides  124 ,  124 ′ and outer end  128 . One of the longitudinal sides, either  124  or  124 ′, forms a right angle with attachment end  126 . For instance, as illustrated in FIG. 4, longitudinal side  124  forms a right angle with attachment end  126 . When gripping sheet  122  is attached to trailing end  24  and wrapped around insertion member  20 , gripping member  120  is formed. As shown in FIG. 5, leading gripper end  130  comprises a thicker or more built up gripping area than trailing gripper end  132 . Similarly, as seen in FIG. 6, longitudinal side  144 ′ forms a right angle with attachment end  146 . After wrapping sheet  142  about trailing end  24  to form gripping member  140 , trailing gripper end  150  comprises a thicker gripping area than leading gripper end  152 . In FIGS. 4 and 6, the longitudinal sides (sides  124 ,  124 ′ in FIG. 4 and 144,  144 ′ in FIG. 6) are unequal in length. 
     The gripping member may be formed from multiple gripping sheets. For example, two trapezoidal or triangular shaped gripping sheets (such as those seen in FIGS. 2,  4  and  6 ) can be positioned adjacent each other, either touching or slightly separated, on the trailing end of the insertion member. The resultant gripping member will have two thicker gripping areas and a portion of decreased diameter therebetween. Any number or placement of gripping sheets may be used. 
     FIGS. 8-10 shows, in general, another preferred shape for gripping member  260 . Gripping member  260  comprises sheet  262  which has two longitudinal sides  264 ,  264 ′, attachment end  266 , intermediate portion  270  having sides  272 ,  272 ′, and outer ends  274 ,  274 ′ (outer surface  276  of sheet  262  shown FIG.  9 ). While FIG. 8 shows the preferred embodiment for the gripping sheet having in general, an “M” shape, other shapes including “U”, “↑”, “V”, “W”, etc., (including the boxed form of the letters), are possible. Although not necessary, sides  272 ,  272 ′ may be symmetrical. As with the first embodiment, outer ends  274 ,  274 ′ may be of any configuration. 
     FIG. 9 shows attachment of sheet  262  to trailing end  224  of insertion member  220 . As shown, attachment end  266  of sheet  262  attaches perpendicular to edge  226  and encircles trailing end  224 . In the preferred embodiment, longitudinal side  264 ′ is perpendicular to the longitudinal axis and is adjacent edge  226  of the tubular insertion member. It is not necessary that longitudinal side  264 ′ is flush with edge  226 . Sheet  262  is continuously wrapped around trailing end until outer ends  274 ,  274 ′ are affixed to outer side  276 . Outer ends  274 ,  274 ′ may form a smooth junction with outer side  276 , but this is not necessary. 
     FIG. 10 shows a wrapped fingergrip made from sheet  262  which has been wrapped around trailing end  224  multiple times. As shown, fingergrip has leading and trailing portions  280 ,  280 ′, respectively having an increased height or thickness compared to intermediate portion  282 . This difference in thickness allows the user&#39;s finger to grip intermediate portion  282  and manipulate the tampon without slipping. Sides  272 ,  272 ′ also form an area of resistance which aids in the user securely handling the tampon applicator during use. The multiple steps formed by sides  272 ,  272 ′ provide increased surface area and resistance for the user&#39;s fingers. The thicker the material used to form gripping sheet  262 , the more pronounced the steps formed by sides  272 ,  272 ′ and generally, the greater frictional resistance the gripping member will exhibit to the user&#39;s fingers. A gripping sheet made from a thicker material will also cause outer ends  274 ,  274 ′ to form abrupt junctions with the layers upon which outer ends  274 ,  274 ′ have been overlaid. 
     As can be seen from the embodiments described above, the gripping member profile results from the orientation of one or both longitudinal sides to the direction of winding. For example, with a tubular insertion member having a substantially uniform cross-section in the region of the gripping member, a longitudinal side edge oriented perpendicular to the longitudinal axis of the tubular insertion member will provide a thicker gripping area adjacent that longitudinal axis as shown in FIGS. 5 and 7. In other words, if the gripping sheet is wound about the tubular insertion member with a longitudinal edge aligned with itself in lower layers, that edge of the gripping member will be thicker than edges at which the longitudinal edge of overlapping layers is offset from its position in lower layers. With the same limitations, if no longitudinal side edge is oriented perpendicular to the longitudinal axis (or aligned with its position in lower layers), the thicker gripping area will be away from the side edges as shown in FIG.  3 . 
     The longitudinal sides of the gripping sheet or of an individual gripping sheet portion are preferably not parallel to each other. This provides for the change in thickness as the sheet is superposed as it is wound onto itself, and it provides a maximum width of the gripping sheet or gripping sheet portion along the length of the gripping sheet or portion. The gripping sheets and gripping sheet portions disclosed above, generally have a maximum width at a distance from the outer end. Preferably, the maximum width is proximate the attachment end, but it could also be located intermediate the attachment and outer ends. ordinarily skilled practitioners will also recognize that the maximum width could be proximate the outer end to provide a smoother outer surface of the gripping member. However, this arrangement of relatively non-elastic materials, such as paper, could easily result in a wrinkled and unsightly outer surface of the gripping member. Of course, an elastic material would likely provide a substantially smooth outer surface. 
     Preferably, the longitudinal sides have a relatively smooth, straight edge. However, the finger engaging properties of the gripping member may be enhanced by providing a longitudinal side edge with a different edge treatment. A representative, non-limiting list of possible edge treatments including scallops, zigzag, notched or saw-toothed, and the like. This form edge treatment can provide a rougher leading and trailing end or other finger engaging surface of the gripping member. 
     Applicators are generally constructed of one of two basic materials: plastic and paperboard. Similarly, the gripping sheet can be constructed of identical materials. 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 convenience. A gripping member, manufactured separately, can be retrofitted onto a paperboard tubular insertion member, without significantly eliminating any of the noted appeal. 
     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 that 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. Preferred tubular element materials include laminated cardboards. Preferred laminated cardboards include 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. 
     Examples of processes used for making paperboard applicator components include, without limitation: 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. 
     Applicators may also be manufactured from conventional plastic, such as injection-moldable or blow-moldable plastic, biodegradable plastic, such as those disclosed Dabi et al. US Pat. No. 5,910,520, the entire contents herewith incorporated by reference. Generally, commercially available products are made from an olefinic-based polymer, such as polyethylene, and at least the insertion members are 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 slightly 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. 
     The gripping member of the present invention can be made from any process that allows the gripping sheet to be formed in the desired shape and wrapped around the formed applicator. Especially preferred are gripping sheets made from woven or nonwoven materials, paper, paper products, thermoplastic, laminated plastic and polymeric sheets. Materials that are treatable in order to become pliable and manipulated can also be used. An example of such a material is a plastic sheet that becomes soft and pliable upon heating. The surface of the gripping sheets may include roughening agents including pulverized stone or sand, edge deformations, apertures, scoring, plurality of ribs or raised portions. The attachment portion of the gripping sheet is attached to the trailing end of the insertion member of the applicator. 
     Preferably, the gripping sheet is wrapped around the insertion member multiple times. Gripping sheets made from thin material may result in a thinner gripping member while gripping sheets made from thicker materials will likely produce relatively thick gripping members. In a particular instance, a thicker gripping member may be required if the outer surface of the gripping sheet is smooth; the edges formed by the longitudinal edges may offer a rougher gripping area for the user&#39;s finger. Dimensions for the gripping sheet may vary according to the diameter of the tubular element. Additionally, the material used for the gripping sheet may dictate the number of times the gripping sheet over-wraps the tubular element and therefore, the length of the gripping sheet may vary. Materials having a thickness ranging from about 0.05 mm to about 3 mm are preferred. Especially preferred are gripping sheets having a thickness of 0.1 mm to about 2 mm. 
     Typical dimensions for the tubular elements useful in tampon applicators include a length of about 50 to 80 mm, a diameter of about 8 to 20 mm, and a thickness of about 0.1 to 0.6 mm. Preferably, the diameter of the inner tubular element (i.e., the plunger) is less than the diameter of the outer tubular element (i.e., insertion member) to allow for a telescopic arrangement of the inner tubular element within the outer tubular element as shown in FIG.  1 . 
     Any adhesives or methods of attachment may be used to secure the gripping sheet to the insertion member. Examples of suitable adhesives can be found in U.S. Pat. Nos. 4,718,898 and 4,857,393, the entire contents of which are hereby incorporated by reference. 
     Various embodiments of the present invention will be evident to one skilled in the art. Accordingly, the scope of the invention should not be limited to the specifics described above but instead be measured with respect to the appended claims.