TAMPON APPLICATOR HAVING IMPROVED FINGER GRIP

Abstract: Applicators of the present invention are useful for inserting objects into body cavities, particularly catamenial and prophylactic devices into a vaginal canal. The applicators comprise a tubular insertion member and a retrofitted gripping member. The gripping member has an outer diameter greater than that of the insertion member. An interface is created due to this size differential, which provides a visual or tactile cue of applicator insertion depth, and thereafter object positioning within the body cavity. The gripping member comprises at least one raised area on its outwardly disposed surface, providing resistance to movement of the user's manual digit in response to longitudinal forces on the insertion member. Methods of assembling the applicators are also disclosed.

Description: TAMPON APPLICATOR HAVING IMPROVED FINGER GRIP Field of the Invention. The present invention provides an applicator comprising a tubular insertion member and a retrofitted gripping member. The applicator is particularly useful for delivering a catamenial device into the vaginal canal, such as a tampon or menstrual collection cup. Background of the Invention Applicators for inserting and expelling objects into a body cavity typically comprise a tubular insertion member having an insertion end and a trailing end opposite thereof, and an expulsion member slideable within the tubular insertion member. The trailing end generally incorporates features to allow a user to more or less securely hold the applicator during use - inserting the applicator into a body cavity, expelling a substantially enclosed object contained by the applicator, and withdrawing the applicator from the body. Unfortunately, many applicators known in the art comprise a gripping section that exhibits a weakness during at least one of the three above-identified steps of using the applicator. Voss, US Pat. No. 4,361,150, and Sarti oranont, US Pat. No. 4,447,222, incorporates projections, such as a ring, at the trailing end of the applicator member. These projections provide resistance to rearward finger slippage during the expulsion step of using an applicator, and they may help the user to remove the applicator from her body. hitehead, US Pat. No. 4,508,531, reduces the diameter of the applicator in the vicinity of the tubular insertion member trailing end. The reduced diameter creates a shoulder near the insertion end to resist finger slippage toward the insertion end during the insertion step. Both of these approaches suffer from providing resistance to finger slippage in only one direction. Efforts to provide resistance in two directions, as disclosed in the art, suffer from shortcomings as well. First, Voss, US Pat. No. 3,575,169, increases the friction on the trailing end of the tubular insertion member by coating it with pulverized stone or sand. This may be especially helpful as applicator manufacturers are moving toward the use of higher gloss surfaces, which are purported to aid in ease of applicator insertion into a body cavity. Second, Hagerty, US Pat. No. 5,709,652, employs a plurality of finger-accepting apertures in the applicator to provide relatively abrupt, finger- accepting edges. These edges frictionally resist movement of a user's finger in response to longitudinal forces on the device. Although a useful contribution to the art, the finger-accepting edges disclosed by Hagerty, are generally limited to the wall thickness of the applicator. Finally, Suzuki et al . , US 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 a annular rib at its rear open end. This device has two or more physical restraints as a means for the user to hold the applicator securely during all of the steps of use. It is noteworthy that the Suzuki applicator is limited to a "plastic" outer sleeve. One skilled in the art would recognize that it would be difficult to form similar physical restraints (shoulder and rib) on a paperboard applicator. Plastic applicators incorporating such design features traditionally employ sophisticated molds and processes in injection molding operations, e.g., comprising split cores and/or side slides. The resulting mold designs and processing steps can add significant costs to the final product. Accordingly, what is needed, is an applicator that can be manufactured by low-cost, high-speed equipment and retrofitted with a superior gripping member that has features to help during insertion of the applicator into a body cavity, expulsion of a contained object, and withdrawal of the applicator from the body. Summary of the Invention 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 affixed to the tubular insertion member. The tubular insertion member has an insertion end, an oppositely disposed trailing end, and a trailing end outer diameter. The gripping member has an outer diameter greater than a coincident trailing end outer diameter and a raised area. In one preferred embodiment, the gripping member has a length to inner diameter ratio of at least about 0.5. In another preferred embodiment, the gripping member has a length of at least about 5 mm. The gripping member comprises at least one raised area on its outwardly disposed surface. This raised area resists movement of the user's manual digit in response to longitudinal forces on the insertion member. Longitudinal forces are created during both the insertion step of use, as well as the expulsion step delivering the contained object from the insertion member into the body cavity. In another embodiment, the present invention relates to an applicator for inserting an object having a gripping member with at least one flexible arm extending from an inner surface thereof . The tubular insertion member trailing end is fitted between the gripping member inner surface and the at least one flexible arm. A tubular expulsion member may be slideably fitted within the trailing end, and this position of the expulsion member urges the flexible arm against the tubular insertion member to provide a more secure device. The flexible arm may also help to prevent the expulsion member from being separated from the insertion member prior to use. In yet another embodiment, the present invention relates to an applicator having a tubular insertion member as described above with an aperture proximate its trailing end. The applicator also has a gripping member with an annular ring having a flexible arm substantially perpendicular to and extending from an inner peripheral edge of the ring. The flexible arm has a distally located protuberance, and this protuberance extends outwardly from the interior of the tubular insertion member and through the aperture when the gripping member is affixed to the insertion member. The annular ring and the extending protuberance form raised areas that resist movement of a user's manual digit in response to longitudinal forces on the insertion member. The present invention also provides methods for making applicators having retrofitted gripping members, including affixing gripping members as disclosed above, to the trailing end of a tubular insertion member. In a preferred embodiment of the present invention, a tubular insertion member is provided having an insertion end and a trailing end and a tubular expulsion member slideable within the trailing end. A gripping member is coaxially aligned with the insertion and expulsion members. The tubular insertion member is clamped with a first clamping mechanism, and the gripping member is clamped with a second clamping mechanism. An optional internal stabilizing tool may be passed through the gripping member and into a portion of the expulsion member. A displacement tool, in a telescopic position over the internal stabilizing tool, then engages the gripping member, after which the second clamping mechanism is retracted. Through linear displacement of the displacement tool, the gripping member is advanced over the expulsion member and onto at least a portion of the tubular insertion member trailing end. Lastly, displacement tool, the internal stabilizing tool, and the first clamping member are all retracted, thereby freeing the assembled applicator for any further processing steps . Brief Description of the Drawings FIG. 1 is a perspective view of an applicator having a tubular insertion end, a trailing end opposite thereof, and a tubular expulsion member slideably fitted within the trailing end. FIG. 2 is a perspective view of the applicator in FIG. 1 having a gripping member retrofitted onto the trailing end of the tubular insertion member. FIG. 3 is a perspective view of a preferred gripping member. FIG. 4 is a cross-sectional view of the applicator in FIG. 2. FIG. 5 is an end view of the gripping member shown in FIG. 3, depicting a plurality of the protuberances and stops . FIG. 6 is a cross-sectional view taken from FIG. 5. FIG. 7 is a side view of a gripping member having two distally located flanges. FIG. 8 is a perspective view of a second preferred gripping member employing optional internal flexible arms . FIG. 9 is a cross-sectional view of the gripping member in FIG. 8 retrofitted onto a tubular insertion member . FIG. 10 is a perspective view of a third preferred gripping member comprising an annular ring having flexible arms extending therefrom. FIG. 11 is a side view of the gripping member in FIG. 10 retrofitted onto a tubular insertion member. FIG. 12 is a diagram of steps included in a method of manufacturing applicators provided by the present invention. FIG. 13 is a diagram of steps included in a second method of manufacturing applicators provided by the present invention. FIG. 14 is a side elevation of an alternative embodiment of the present invention, prior to and after assembly. FIG. 15 is a cross-sectional view of an alternative embodiment of a gripping member retrofitted onto a tubular insertion member. Detailed Description of the Invention and the Preferred Embodiments As used herein the specification and the claims, the term "diameter" (and variants thereof) relates to a chord passing through the center of a figure or body, i.e., the length of a straight line through the center of an object. As used herein the specification and the claims, the phrase "coplanar diameter" (and variants thereof) relates to diameters of two or more elements having the same longitudinal axis, the diameters extending along parallel lines perpendicular to and in the plane of the longitudinal axis. As used herein the specification and the claims, the phrase "coincident diameter" (and variants thereof) relates to diameters of two or more elements extending through the same point and along the same line or plane. Thus, a pair of coplanar diameters that extend through the same point are coincident . The present invention provides an applicator comprising a tubular insertion member and a retrofitted, superior gripping member, employing design features that aid in inserting the applicator into a body cavity, expelling a contained object, and withdrawing the applicator from the body. Manufacturing the gripping member separately provides numerous advantages, some of which will be discussed below. One significant advantage is the versatility of materials and processes available for manufacturing the tubular insertion and expulsion members. 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. However, their features intended to aid the consumer in handling the product during use have been limited. Embossed rings and finger-accepting apertures are typically confined to the gauge of the paperboard (or combined layers) used. A superior gripping member, manufactured separately, can be retrofitted onto a paperboard tubular insertion member, without significantly eliminating any of the noted appeal. Insertion and expulsion members are also manufactured from plastic. Generally, commercially available products are made from polyolefins, such as polyethylene, and at least the tubular insertion members of these products are formed through an injection molding process. This process is used to enable the manufacturer to balance key characteristics of the tubular insertion member. Molding inserts and cores are machined to form a tapered product in which 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 manufacturer to make uniquely shaped (e.g., curved) tubular insertion members as well as to make gripping features that would be difficult or impossible to achieve using alternative processes. However, there are less sophisticated and less expensive polymer forming techniques, such as extrusion and blow molding, that could be employed if it is not necessary to incorporate complex features into the tubular insertion member, itself. Instead, the more complex features could be separately formed and retrofitted onto such an inexpensively manufactured tubular insertion member. In this manner, the gripping member itself can provide a substantial portion of the structural stability necessary for inserting and expelling objects into body cavities. Therefore, a minimum amount of paperboard or an extremely thin-walled polymeric tube may be used in conjunction with the gripping member as a complete and useful system. This approach can reduce the cost of manufacture and eliminate the likelihood that the applicator may collapse during use. A second advantage offered by separate component manufacturing is realized through the option of using state of the art high-speed equipment, such as disclosed in Hinzmann, U.S. Pat. No. 4,755,164, the disclosure of which is herein incorporated by reference, and commercially available from Hauni Richmond, Inc. of Richmond, Virginia. Hinzmann employs reservoir systems that accumulate applicator components between major steps of manipulation and assembly. Applicators with any significant projections extending from their outer surfaces will not stack neatly (parallel) in the reservoir systems, thereby reducing the efficiency of space and transfer. Such products may also create process downtime due to applicators being "hung up" in the accumulators . The reservoir systems provide efficiency in multi-component manufacturing by maintaining continuous overall production even during downtime of an upstream piece of equipment. Manufacture of the tubular insertion member, expulsion member, and e.g., tampons, as well as component assembly, can take place with the gripping member retrofitted as a final step prior to packaging. One technique that can be employed for affixing a separately manufactured gripping member to a tubular insertion member is to press the gripping member onto the outer surface of one end. This technique necessitates that the gripping member's smallest outer diameter will be greater than the coincident outer diameter of the tubular insertion member it is combined with. This size differential creates an interference fit between the element and may also provide a visual or a tactile cue of applicator insertion depth, and thereafter object positioning within the body cavity. Greater control and handling is also provided with a gripping member having a greater diameter than that of the tubular insertion member. Applicators known in the art having reduced diameter gripping regions, do so by "necking down" a portion of the tubular insertion member (see for example Huffman, US Pat. No. 4,573,964). As the gripping area is reduced, so is the amount of control by the user. Moreover, an expulsion member used with such an applicator will necessarily become small and more difficult to use. Consumers have voiced dislikes associated with small expulsion members. Another, related technique is to press a fitting extending from the gripping member into the end of the tubular insertion member. This technique necessitates that the fitting extending from an inner portion of the gripping member has an outer diameter that creates an interference with the inner diameter of the tubular insertion member it is combined with. Preferred embodiments of the present invention are illustrated in the figures and corresponding description, wherein like elements are labeled with like numerals. As shown in FIG.l, applicator 1 comprises a tubular insertion member 10 having an insertion end 11, an opposing trailing end 12, and a tubular expulsion member 20 slideably fitted within the trailing end 12. The insertion end 11 is preferably substantially closed prior to expulsion of an object contained therein. As can be seen in FIG. 1, one technique for substantially closing the insertion end 11 is by employing a plurality of inwardly curved petals 13. The petals will flex and/or hinge to an open position upon expelling objects contained by the tubular insertion member 10. The number of petals generally ranges from about 4 to about 6. An alternative technique is a pleating process is disclosed in Neilsen et al . , US Pat. No. 5,782,793. Alternatively, the insertion end may be more or less open, that is the diameter along the length of the tubular insertion member is substantially equivalent to the diameter of the insertion end. Proctor & Gamble, of Cincinnati, Ohio, currently offers for sale an open-ended tampon applicator under the trade name TAMPAX brand flushable applicator tampons. The tubular insertion and expulsion members of the present invention can be made from numerous materials generally known to those of ordinary skill in the art, such as plastic (polymers) and paperboard. Plastic applicator members may comprise 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. A representative, non-limiting list of polymers, includes polyolefins, such as polyethylene, and polypropylene; polystyrene, polyvinyl alcohol, polylactic acid, poly (3-hydroxybutyric acid), and combinations thereof. Examples of applicators that are designed to be dispersible or biodegradable are disclosed in Herring, US Pat. No. 5,002,526 and Assenheimer-Downs, US Patent No. 5,782,794 relating to applicators made from polyvinyl alcohol based compositions, Billmers, US Pat. No. 5,350,354 relating to applicators made from starch based compositions, and Webb, US Pat. No. 4,900,299 relating to applicators made from poly (3-hydroxybutyric acid) based compositions. Plastic members may be made by injection molding, blow molding, extrusion and the like. Paperboard tubular and expulsion members may be constructed from a single layer of paperboard material, or from a plurality of laminated layers. Useful paperboard stock for the formation of the members includes, without limitation, paperboard, cardboard, cup stock, paper, and the like. The following non-limiting processes may be used for making paperboard applicator components: spiral winding as disclosed in Campion et al . , US Pat. No. 5,346,468, convolute winding as disclosed in Whitehead, US Pat. No. 4,508,531, and forming a sheet around a mandrel and then sealing an overlapped seam as disclosed in Hinzmann, US Pat. No. 4,755,164. Paperboard members may include one or more surface layers, which may be useful to increase the comfort and ease of insertion and withdraw of the applicator. The surface layers may be in the form of laminated films, cured coatings, and the like. An example of such a surface layer is disclosed in Blanchard, US Pat. No. 6,171,426 (BI) . A representative, non-limiting list of useful materials to be used as the surface layers 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 other than simple air curing, 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 20 millimeters, and a thickness of from about 0.1 to about 0.6 millimeters. Preferably the insertion and expulsion members are cylindrical tubes that are substantially straight along their lengths. They may however, be of alternative geometry, such as square, elliptical, or triangular in cross-section. Additionally, the tubular members may be curvilinear along their length to improve comfort and manipulation of the applicator during insertion and withdraw from a body cavity. An example of curved applicator components can be seen in Paul et al . , US Pat. No. 5,158,535. Referring to FIG. 2 which illustrates a preferred embodiment, applicator 1 further comprises a gripping member 30, which is manufactured separately from the insertion and expulsion members and thereafter affixed, preferably immovably, to at least a portion of the trailing end of the tubular insertion member. FIGS. 2-6 depict this preferred embodiment of the gripping member 30, having a minimum outer diameter 31, a length "L" , and an intermediate area 40 disposed between two longitudinally separated raised areas 41a and 41b. The gripping member has a leading end 45 directed toward the insertion end of the tubular insertion member 10 and a trailing edge 32 disposed distal the insertion end of the tubular insertion member, as assembled. The curvilinear transition between the intermediate area and the two raised areas preferably forms a "saddle-shaped" profile. This profile provides comfort and control by corresponding to the natural curvature of a user's manual digits (thumb and fingers) . A distally located optional flange 42 is also depicted in the figures. The flange 42 provides a structure for the user to grasp to withdraw the insertion member from a body cavity. The gripping member length "L" is at least about 5 millimeters, and preferably at least about 10 millimeters. Such a length of the gripping member allows the user to grasp the gripping member, rather than placing her manual digits (e.g., fingers) on either side of it . The gripping member should be of sufficient length, such that the utility of design features employed to provide resistance to movement of the user's fingers, is not compromised. For example, if the length of the gripping member is capable of accepting the user's manual digits, especially between longitudinally separated raised areas, it becomes less likely that the user's fingers, etc., would span the distance between these raised areas and lose the benefits of the present invention. Such a distance "D" is preferably at least about 0.35 inches (about 9 mm), more preferably about 0.4 to about 0.6 inches (about 10 mm to about 15 mm) . We have learned that consumers would like to have small diameter applicators while not compromising absorbency. This improves comfort while inserting the device. However, as the diameter of the applicator decreases, user control correspondingly decreases. In an effort to ensure that the gripping member has sufficient area to grasp during use, especially with relatively small diameter insertion members, the gripping member preferably has a length to diameter ratio of at least about 0.5. The inner surface of the gripping member may have features that improve its fixation to the tubular insertion member. For example, a series of optional protuberances 44 are also shown in the figures. The tubular insertion member may employ a cavity proximal its trailing end, such as an aperture 14 shown in FIG. 1, which is capable of receiving one or more of the protuberances 44. The cavity may be any generally concave feature that is capable of receiving the protuberances, examples including embossed regions and apertures. The cross-sectional view in FIG. 4 illustrates the protuberances 44 residing in a portion of two apertures 14 as taught in Hagerty, US Patent No. 5,709,652, the disclosure of which is herein incorporated by reference . The protuberances may be designed such that they provide additional resistance to separation of the gripping member from the tubular insertion member. For example, the protuberances may be triangulated, or comprise a barb, wherein an apex or barb is capable of pressing into a surface of the tubular insertion member. "Pressing into" may include creating indentations, ruptures, gouges and the like. Referring now to FIGS. 5 and 6, preferably the gripping member has from about 2 to about 12 protuberances, and more preferably from 3 to 9. The protuberances have a height "H" . It may be helpful in some constructions to relate the height of the projection to the thickness of the material forming the tubular insertion member, the manner of attachment of the gripping member, and the relative outside diameter "Φ τ " of the tubular member trailing end and the inside diameter 31 of the gripping member. In a press fit attachment, the height "H" is preferably at least about 0.0005 inches (about 0.01 mm), more preferably at least about 0.001 inches (about 0.03 mm) . In a mechanical latch attachment, the height "H" may be at least about 0.003 inches (about 0.08 mm), more preferably, at least about 0.005 inches (about 0.1 mm), and most preferably about 0.01 to about 0.02 inches (about 0.3 to about 0.5 mm) . The protuberances may have an arc "S" of at least about 0.5 degrees, preferably, in a mechanical latch attachment manner as disclosed in e.g., FIGS. 3-7, an arc of about 3 to about 10 degrees, and most preferably about 5 to about 7 degrees . The gripping member 30 may optionally have at least one stop 50 extending inwardly from a trailing edge 32, the edge of the gripping member 30 that is the furthest from the insertion end 11 of the tubular insertion member, as assembled. The stop is capable of maintaining the gripping member 30 at the trailing end 12 of the tubular insertion member. A preferred embodiment has nine protuberances and three stops . Additionally, FIGS. 5 and 6 illustrate the preferred out of phase positional relationship of the protuberances 44 and the stops 50. This positioning provides the attractive option of using simpler injection molding processes and equipment. The inner surface of the leading end 45 of the gripping member 30 is preferably tapered from a relatively larger inner diameter at the leading end 45 to a relatively smaller inner diameter further into the gripping member 30. This increases the tolerances during assembly of the gripping member 30 and tubular insertion member 10, such as imperfectly formed parts, misalignment, and the like. While the FIGS. 2-6 show a gripping member 30 being affixed to the tubular insertion member 10 overlying a portion of the insertion member trailing end 12, the present invention may also employ a gripping member 30' that extends beyond the trailing end 12 in a direction away from the insertion end 11. This may be achieved by a gripping member 30' that abuts the tubular insertion member trailing end 12, or that has a fitting 43 that extends from an inner portion of the gripping member 30' toward the insertion end 11 of the tubular insertion member, as assembled, the leading end 45 of the gripping member 30' and is insertable into the trailing end 12 of the tubular insertion member. While a rearwardly extending gripping member 30' may not require the protuberances and stops in the manner described above, the embodiments illustrated in FIGS. 14A and 15 incorporate protuberances. In this aspect of the present invention, the maximum outer diameter "Φ G max" is greater than the maximum coplanar trailing end outer diameter Φ τ . Preferably, the minimum outer diameter Xλ Φ G min" of the gripping member 30' is at least equal to, and more preferably greater than, the maximum coplanar outer "Φ τ max" diameter of the tubular insertion member trailing end 12. The external physical features of a rearwardly extending gripping member 30' can be substantially the same as those described below for FIGS. 2-6. The tubular insertion member 10 acts as an outer sleeve over the fitting 43 of the gripping member 30' shown in FIG. 14A. Thus, in a manner similar to that shown above in FIGS. 2-6, the insertable gripping member 30' may incorporate a series of optional external protuberances on the fitting 43 to improve the interference between the fitting 43 and the tubular insertion member. The external protuberances may also be designed such that they provide additional resistance to separation of the fitting 43 from the tubular insertion member. These protuberances are illustrated as a screw thread in FIG. 14A. As additional examples, the protuberances may be triangulated, or comprise a barb, wherein an apex or barb is capable of pressing into a surface of the tubular insertion member. "Pressing into" may include creating indentations, ruptures, gouges and the like. In the embodiment of FIGS. 14A & B, the fitting 43 extends from the leading end 45 of the gripping member. This permits the use of a shorter tubular insertion member. In this embodiment, the fitting 43 is the first portion to engage the tubular insertion member 10 during assembly. Thus, it can be appropriately dimensioned to provide accurate and reliable fixation, including an appropriately tapered leading portion. In contrast, the fitting 43 of the embodiment of FIG. 15 extends from an inner portion of the gripping member 30' proximal the trailing edge 32. In this embodiment, the leading end 45 of the gripping member 30' may be the portion to engage the tubular insertion member 10 during assembly. Again, this element can be appropriately dimensioned to provide accurate and reliable fixation, including an appropriately tapered leading portion. In alternative embodiments of an inner fitting 43 of FIG. 15, the leading portion of the fitting 43 could extend beyond the leading end 45 of the rest of the gripping member 30'. The interior dimensions of the extending gripping member 30' can also be tailored to the desired expulsion member. For example, a reduced diameter expulsion member can save material costs of the applicator device. It may also be easier to mold in a non-circular cross- section to allow orientation of an expulsion device than is currently possible in a standard paperboard tubular insertion member 10 or to otherwise improve the interlocking of the expulsion member and tubular insertion member 10 to prevent separation of the elements prior to use. The gripping member 30 illustrated in FIGS. 2-6 has a curvilinear outer profile, generally "saddle" shaped, wherein the two raised areas 41a and 41b are created by increasing the outer diameters towards the respective edges of the gripping member. An alternative gripping member outer profile is depicted in FIG. 7, wherein the intermediate area 40 has a flat profile yielding a constant outer diameter along the length, with the two raised areas 41a and 41b being formed by longitudinally separated flanges . Additional outer profiles are possible, wherein the outer surface has at least one raised area that is capable of providing resistance to movement of a user's manual digit in response to longitudinal forces on the tubular insertion member. All of the figures depict the gripping member having two raised areas separated by an intermediate area; however, a single raised area in conjunction with the other specified design features may be sufficient for the utility of the present invention. To improve the fixation of the gripping member to the tubular insertion member, the gripping member may employ optional design features that reside within the tubular insertion member trailing end 12. Referring now to FIGS. 8 and 9, the gripping member 30 may optionally comprise one or more flexible arms 60 connected to its inner surface. The tubular insertion member 10 is fitted between the gripping member inner surface and the flexible arms. In this embodiment, protuberances 44 reside on the flexible arms 60. The protuberances 44 may be positioned within tubular insertion member apertures 14 as shown in FIG. 9. Alternatively, retrofitting to tubular insertion members not employing apertures, the protuberances may incorporate design features capable of pressing into the tubular insertion member inner wall to offer a more secure fit. Another embodiment contemplated by the present invention is shown in FIG. 10. This embodiment minimizes both the cost and the environmental impact, due to a reduction in material required. The gripping member 30 comprises an annular ring 70 and one or more flexible arms 60 extending from an inner peripheral edge 71. The annular ring provides resistance to rearward finger movement during the expulsion step of using the applicator. Referring now to FIG. 11, to provide resistance in the opposite direction, a tubular insertion member 10 with apertures 14 proximal its trailing end is used, and protuberances 44, distally located on the flexible arms, are capable of extending therethrough. Materials useful for the manufacture of the gripping member include the following, non-limiting, representative materials: paperboard, paper, polymeric material, foam, and combinations thereof. Particularly useful polymeric materials include polyethylene, polypropylene, polystyrene, polyvinyl alcohol, polylactic acid, poly (3-hydroxybutyric acid), rubber and other elastomers, and combinations thereof. The gripping member may optionally comprise an additive, either through incorporation into the manufacturing materials, or added to the component through a subsequent processing step. A representative, non- limiting list of additives includes fragrance, odor- neutralizing agents, bacteriostats, bacteriocides, and moisturizers. The gripping member can be made from any known techniques in the art. Injection molding and blow molding are two such methods useful for making the gripping member from a polymer. Alternatively it can be constructed with paperboard, wherein paper mache techniques are useful . Similar methods of manufacture to that of the tubular insertion member can be used for making the gripping member from paperboard, wherein additional steps are employed to form the along length diameter differential, such as rolling or folding the distal part of the first and second section. The gripping member outer surface may optionally comprise friction-enhancing means, such as tacky coatings, etched patterns, and the like. Such coatings and/or treatments may be evenly distributed about the outer surface, or they may be restricted to or concentrated in certain, desired portions. The gripping member may be transparent or opaque, and it may be pigmented, as desired. Where a range of differing products is offered to the consumer, the gripping member can be color-coded to indicate a particular product. The present invention also provides methods for making applicators having retrofitted gripping members, such as those described in relation to FIGS. 1-11. Generally the gripping member may be pressed onto a portion of the tubular insertion member and maintained in its position through the dimensions of each component. Preferably, design features as described above such as protuberances, flexible arms, and stops are employed to help secure the gripping member to the tubular insertion member. Beyond these features and for use with gripping members that do not overly the tubular insertion member, other mechanical features such as suction cups, chemical adhesives, and thermoplastic welding techniques may be used to affix the gripping member or to enhance the fit between the gripping member and the tubular insertion member. In particular, adhesives, such as chemical adhesives and thermoplastic welding adhesives may be used to attach the abutting- type gripping members . Typical applicators comprise both a tubular insertion member and an expulsion member slideably fitted therein into an opening at the trailing end thereof. The process of assembling the two components, as well as filling the tubular insertion member with an object can vary significantly. Accordingly, the gripping member may be fitted onto a portion of the tubular insertion member prior or after assembly, prior or after filling, and fitted from either end of the tubular insertion member. A detailed description of the preferred methods of making the applicators of the present invention, including the steps and sequencing follows . FIG. 12 illustrates a method for making an applicator comprising the step of pressing preferred gripping member 30 onto a portion of the tubular insertion member trailing end 12 through the use of both linear displacement LI, and optional rotational displacement Rl . The rotational displacement can occur simultaneously with and/or after the linear displacement. The optional rotational displacement is at least about 0.5 degrees, preferably at least about 5 degrees, and more preferably from about 10 to about 45 degrees . Referring to FIG. 13, another method for making an intravaginal applicator comprises the steps outlined below. A typical tubular insertion member 10 is provided, having an insertion end 11 and a trailing end 12. Slideably fitted within an opening at the trailing end 12 is a tubular expulsion member 20. An object such as a tampon (not shown) for insertion into a body cavity may be loaded in the tubular insertion member from the trailing end prior to assembling the expulsion member with the tubular insertion member, or alternatively be loaded from the insertion end. If the latter method is used, then any closing of the insertion end will take place thereafter, such as through a post-doming process. A gripping member 30 is provided and coaxially aligned with the insertion and expulsion members. The tubular insertion member is clamped with a first clamping mechanism 80, and the gripping member is clamped with a second clamping mechanism 81. Useful clamping or holding mechanisms will be recognized by one ordinarily skilled in the art. For example, a two-sided clamp comprising a surface capable of conforming to the outer geometry of the insertion and gripping members can be used. An optional internal stabilizing tool 90 is passed through the gripping member and into a portion of the expulsion member. A displacement tool 91 may engage the gripping member, and the second clamping mechanism may be retracted. In a preferred embodiment illustrated in FIG. 13, the internal stabilizing tool 90 may be held within the displacement tool 91 in a telescopic arrangement. Through linear motion L2 of the displacement tool, the gripping member is advanced over the expulsion member and onto (or into) at least a portion of the tubular insertion member trailing end 12. Lastly, the displacement tool, the optional internal stabilizing tool, and the first clamping member are all retracted, thereby freeing the assembled applicator 1 for any further processing steps . The sequencing of the steps may be altered to some degree without departing from the spirit and scope of the present invention. Beyond those steps described above, additional procedures may be included in an assembly process. First, the step of advancing the gripping member onto the tubular insertion member trailing end 12 may comprise both linear L2 and rotational displacement R2. To accomplish this optional step, the displacement tool comprises at least one prong 92 capable of juxtaposition with an at least one stop (shown as element 50 in FIGS. 5 and 6) extending inwardly from a bottom edge of the gripping member. Rotation of the displacement tool will then correspond to rotation of the gripping member. Second, because the gripping member may employ protuberances extending from its surface, the gripping member may be further manipulated to take advantage of these protuberances. For example, the protuberances preferably press into the outer surface of the insertion member to create indentations or "tracks" as the gripping member is pressed on. In an effort to maximize the utility of the protuberances, the gripping member may be rotated, labeled as rotational displacement R2 , once it has completed its linear transition onto the tubular insertion member is completed. The minimum rotational displacement required, preferably, is an amount slightly greater than the arc length of the protuberances. An upper range of rotational displacement will be apparent as multiple protuberances are used, that is, the displacement should not be to the extent of removing a protuberance from one track and placing it into another. When tubular insertion members comprise apertures proximate their trailing end, the rotational displacement will also help to align the protuberances with those apertures . Finally, another method contemplated by the present invention includes connecting multiple components together in a manner to collectively form a gripping member circumscribing the trailing end of the tubular insertion member. This may be desirable, because to injection mold this part as a single component, a mold having side action (side slides) would usually be used. This side action increases the cycle times and decreases the amount of parts per mold area, both of which increase the costs per part. An example of a multicomponent gripping member could be dividing the gripping member illustrated in FIGS. 2-6 into two separate rings separable, e.g., at the diameter line indicated as 31 in FIG. 6. The rings may employ coupling design features, such as mating male and female elements that are capable of fitting together to affix the gripping member to the tubular insertion member. An alternative design may separate the gripping member into two or more elements that could "clamp" the tubular insertion member. Such a gripping member could be separated into two halves defined by a plane extending from line "L" in FIG. 3. An advantage, when using injection molding processes for manufacture, provided by the concept of manufacturing multicomponent gripping members allows sophisticated design features to be included without the necessity of sophisticated molds. The multicomponent gripping members can be molded in more economical single action molds. The applicator of the present invention can be used for the delivery of intravaginal objects, such as tampons, menstrual collection devices, and contraceptives. 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 applicators can be packaged with other non-like or like products, and used as a system of products to satisfy individual consumer needs. In particular, the applicators can be packaged with externally worn or used absorbent products, such as a sanitary napkins, pantiliners, and interlabial pads. 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.

Claims: What is claimed is ; 1. An applicator for inserting an object into a body cavity, comprising: a) a tubular insertion member having an insertion end, an oppositely disposed trailing end and a trailing end outer diameter; and b) a gripping member affixed to the tubular insertion member trailing end having an outer diameter greater than the coincident trailing end outer diameter, a length to inner diameter ratio of at least about 0.5, a raised area, and a trailing edge disposed distal the insertion end of the tubular insertion member, as assembled. 2. The applicator of claim 1 wherein the gripping member has a minimum outer diameter that is greater than the coincident trailing end outer diameter. 3. The applicator of claim 1 wherein the gripping member has two raised areas separated longitudinally by an intermediate area having a diameter less than that of each of the raised areas. 4. The applicator of claim 3 wherein the gripping member comprises curvilinear transitions between the intermediate area and the two raised areas. 5. The applicator of claim 1 wherein the gripping member comprises at least one feature capable of encircling a user's finger during use. 6. The applicator of claim 1 wherein the gripping member comprises a protuberance extending from an inner surface arranged and configured to press into an outer surface of the tubular insertion member. 7. The applicator of claim 6 wherein the tubular insertion member comprises a cavity proximate the trailing end that is arranged and configured to receive the protuberance . 8. The applicator of claim 6 wherein the trailing edge of the gripping member has a stop extending inwardly therefrom. 9. The applicator of claim 1 wherein the tubular insertion member comprises paperboard. 10. The applicator of claim 1 wherein the gripping member comprises polymeric material . 11. The applicator of claim 10 wherein the gripping member comprises foam. 12. The applicator of claim 10 wherein the polymeric material is selected from the group consisting of polyethylene, polypropylene, polystyrene, polyvinyl alcohol, polylactic acid, poly (3-hydroxybutyric acid), and combinations thereof. 13. The applicator of claim 1 further comprising a tubular expulsion member slideable within the trailing end of the tubular insertion member. 14. An applicator for inserting an object into a body cavity, comprising: a) a tubular insertion member having a trailing end and a trailing end outer diameter; and b) gripping member affixed to the tubular insertion member trailing end having an outer diameter greater than the coincident trailing end outer diameter, a length of at least about 5 millimeters, a raised area, and a trailing edge disposed distal the insertion end of the tubular insertion member, as assembled. 15. The applicator of claim 14 wherein the gripping member has a minimum outer diameter that is greater than the coincident trailing end outer diameter. 16. The applicator of claim 14 wherein the gripping member has two raised areas separated longitudinally by an intermediate area having a diameter less than that of each of the raised areas. 17. The applicator of claim 16 wherein the gripping member comprises curvilinear transitions between the intermediate area and the two raised areas. 18. The applicator of claim 14 wherein the gripping member comprises at least one feature capable of encircling a user's finger during use. 19. The applicator of claim 14 wherein the gripping member comprises a protuberance extending from an inner surface arranged and configured to press into an outer surface of the tubular insertion member. 20. An applicator for inserting an object into a body cavity, comprising: a) a tubular insertion member having a trailing end; and b) a gripping member having at least one flexible arm extending from an inner surface thereof ; wherein the tubular insertion member trailing end is fitted between the gripping member inner surface and the at least one flexible arm. 21. The applicator of claim 20 further comprising a tubular expulsion member slideably fitted within the tubular insertion member trailing end, wherein the expulsion member is arranged and configured to urge the at least one flexible arm against the tubular insertion member. 22. The applicator of claim 20 wherein the gripping member has an outwardly disposed raised area. 23. The applicator of claim 22 wherein the gripping member has two raised areas separated longitudinally by an intermediate area having a diameter less than that of each of the raised areas. 24. An applicator for inserting an object into a body cavity, comprising: a) a tubular insertion member having a trailing end and an aperture proximate the trailing end extending from an outer surface to an inner surface thereof; and b) a gripping member comprising an annular ring, a flexible arm substantially perpendicular to and extending from an inner peripheral edge of the annular ring, the flexible arm having a distally located protuberance; wherein the flexible arm is fitted within the tubular insertion member trailing end, and the protuberance is extends through the aperture . 25. A method for making an applicator, comprising the steps of: a) providing a tubular insertion member having a trailing end and a trailing end outer diameter; b) affixing a gripping member to the trailing end, the gripping member having an outer diameter greater than the coincident tubular insertion member outer diameter, a length to diameter ratio of at least 0.5, and a raised area. 26. The method of claim 25 wherein the tubular insertion member comprises paperboard. 27. The method of claim 25 wherein the step of affixing the gripping member comprises advancing the gripping member toward and rotating the gripping member with respect to the tubular insertion member. 28. The method of claim 27 wherein the step of rotating the gripping member results in a rotational displacement of about 10 to about 45 degrees. 29. The method of claim 27 wherein the gripping member has at least one protuberance having an arc length and extending from an inner surface, and the step of affixing the gripping member comprises rotating the gripping member an amount greater than the arc length of the at least one protuberance . 30. A method for making an applicator, comprising the steps of: a) providing a tubular insertion member having a trailing end, and a tubular expulsion member slideable within the trailing end; b) providing a gripping member capable of fitting over a portion of the tubular insertion member trailing end; c) coaxially aligning the tubular insertion member and the gripping member; d) clamping the insertion end with a first clamping mechanism and the gripping member with a second clamping mechanism; e) engaging the gripping member with a displacement tool telescopically positioned over the internal stabilizing tool; f) retracting the second clamping mechanism, while advancing the displacement tool toward the tubular insertion member to move the gripping member onto the trailing end; g) retracting the displacement tool; and h) retracting the first clamping mechanism. 31. The method of claim 30 further comprising the step of passing an internal stabilizing tool through the gripping member and into the tubular expulsion member prior to engaging the gripping member with the displacement tool . 32. The method of claim 30 further comprising a step of rotating the displacement tool to rotate the gripping member with respect to the trailing end of the tubular insertion member, after the gripping member is moved onto the trailing end. 33. The method of claim 32 wherein the gripping member has a trailing edge having at least one stop extending inwardly therefrom, and the displacement tool has at least one prong capable engaging with the at least one stop, wherein rotating the displacement tool rotates the gripping member. 34. The method of claim 32 wherein the step of rotating the gripping member results in a rotational displacement of about 10 to about 45 degrees. 35. An applicator for inserting an object into a body cavity, comprising: a) a tubular insertion member having an insertion end, an oppositely disposed trailing end and a trailing end outer diameter; and b) a gripping member affixed to the tubular insertion member trailing end and extending beyond the trailing end in a direction away from the insertion end, having a maximum outer diameter greater than the maximum coplanar trailing end outer diameter, a minimum outer diameter that is at least equal to the maximum coplanar trailing end outer diameter, and a leading end directed toward the insertion end of the tubular insertion member and a trailing edge disposed distal the insertion end of the tubular insertion member, as assembled 36. The applicator of claim 35 wherein the gripping member has two raised areas separated longitudinally by an intermediate area having an outer diameter less than that of each of the raised areas. 37. The applicator of claim 36 wherein the gripping member comprises curvilinear transitions between the intermediate area and the two raised areas. 38. The applicator of claim 35 wherein the gripping member abuts the trailing end of the tubular insertion member. 39. The applicator of claim 35 wherein the gripping member comprises a fitting arranged and configured to extend from an inner portion of the gripping member toward the insertion end of the tubular insertion member, as assembled. 40. The applicator of claim 39 wherein the fitting extends from the leading end of the gripping member. 41. The applicator of claim 35 wherein the gripping member comprises at least one feature capable of encircling a user's finger during use. 42. A method for making an applicator, comprising the steps of : a) providing a tubular insertion member having a trailing end and a trailing end outer diameter; b) affixing a gripping member to the trailing end, the gripping member having a maximum outer diameter greater than the maximum coplanar trailing end outer diameter, a minimum outer diameter that is at least equal to the maximum coplanar trailing end outer diameter and a length to diameter ratio of at least 0.5. 43. The method of claim 42 wherein the tubular insertion member comprises paperboard. 44. The method of claim 42 wherein the step of affixing the gripping member comprises advancing the gripping member toward and rotating the gripping member with respect to the tubular insertion member. 45. The applicator of claim 35 wherein the gripping member has a minimum outer diameter that is at least equal to the maximum coplanar trailing end outer diameter.

Inventors: BINNER CURT, HULL RAYMOND J, PIERSON LINDA M, VOGT GARY, BINNER, CURT, HULL, RAYMOND, J., PIERSON, LINDA, M., VOGT, GARY
Applicants: MCNEIL PPC INC, MCNEIL-PPC, INC.
Application year: 2001
Main classification: A61F13
IPC codes: A61F13