MXPA99002017A - Flexible applicator for inserting an article into a mammalian body cavity - Google Patents

Abstract

The present invention relates to a flexible applicator for inserting an article into a mammalian body cavity. The applicator has an elongate, hollow, structural member suitable for containing the insertable article, and an elongate expulsion member which is slidable within the structural member. The structural member has opposed inside and outside surfaces, and its length dimension is substantially greater than its width and height dimension. In addition, the structural member has a plurality of flex-enhancing elements which are arranged and configured to increase the lateral flexibility of the structural member.

Description

AP CAPOR FLEXIBL &TO INSERT AN ARTICLE IN A CAVITY OF THE BODY OF A MAMMERIAN FIELD-OF-THE INVENTION The present invention relates to flexible devices for inserting an article into a body cavity of a mammal. In particular, the insertion device has an elongated hollow structural member having a plurality of flexibility enhancing elements that increase its lateral flexibility.

BACKGROUND OF THE INVENTION Hollow insertion devices, such as tampon applicators, are generally constructed of one or two basic materials: plastic and cardboard. Although cardboard applicators are generally stiffer than plastic applicators, no material fits easily into the body cavity into which the applicator is inserted. Attempts to allow an applicator to fit more tightly into a body cavity, such as a vagina, have included tampon applicators, such as those described in Paul et al., U.S. Pat. Nos. 5,158,535 and 5,267,953; and Fox et al., patent of E.U.A. No. 5,437,628. Unfortunately, this approach fails in two main areas: first, not all users have the same body shape, and secondly, the use of these curved devices requires the user to carefully orient the applicator during use. Frequently, this should be done in crowded bathrooms with poor visual control. In view of the poor ability of the prior art to adjust to many different body shapes, what is required is an applicator device that is rigid enough to allow the insertion of an article into the cavity of a body and that also retains sufficient flexibility to conform to the unique individual form of a user's body.

BRIEF DESCRIPTION OF THE INVENTION The present invention relates to a flexible applicator for inserting an article into a body cavity of a mammal. The applicator has an elongated hollow structural member, suitable for containing the insertable article, and an elongated ejection member that is slidable within the structural member. The structural member has opposite inner and outer surfaces, and its dimension in length is substantially greater than its dimension in width and height. In addition, the structural member has a plurality of flexibility enhancing elements that are arranged and configured to increase the lateral flexibility of the structural member. The flexible applicator of the present invention can be used as a tampon applicator for feminine hygiene, or for vaginal or rectal delivery of prophylactic compositions and / or medicaments. The invention also relates to a method of forming a flexible applicator. In this method, flexibility enhancing elements are formed in a structural member having an outer surface, a layer of a flexible material is superimposed on the outer surface of the structural member, and the structural member is formed into an elongated hollow member, suitable for contain the insertable article. The hollow member has opposite insertion and fastener ends. The flexible material can be laminated to the outer surface of the structural member, (i) by applying a rolling material to the outer surface of the structural member,. { ii) -Applying the flexible material to the rolling stock.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a plan view of a double preform, useful in the formation of a tampon applicator in accordance with the present invention, employing relatively narrow grooves as the flexibility enhancing elements, Figure 2 is a partially plan view Cropped from a preform useful in the formation of a tampon applicator in accordance with the present invention. Figure 3 is a side elevation of a tampon applicator in accordance with the present invention. Fig. 4 is a cross section taken along line 4-4 of Fig. 3. Fig. 5 is a perspective view of a tampon applicator of compliance CQ? the present invention, which has been curved. Figure 6 is a partially cut-away schematic view of a portion of the tampon applicator of Figure 5. Figures 7-9 are plan views of preforms of an alternative embodiment, useful in forming a tampon applicator in accordance with present invention, which employs wide grooves, grooves and cuts, respectively, as the flexibility enhancing elements. Fig. 10 is a partially cutaway side elevational view of an alternative embodiment of a tampon applicator in accordance with the present invention, employing folds as the flexibility enhancing elements.

DETAILED DESCRIPTION OF THE PREFERRED MODALITY In Figure 3, a preferred embodiment of the present invention is illustrated, that is, a tampon applicator 10 for vaginal insertion of a menstrual tampon 12. The tampon applicator 10 comprises an external barrel 14 and a plunger 16 which is slidable within of the barrel 14 to eject the buffer 12 therefrom. The barrel 14 is a hollow elongated structural member. It has opposite inner and outer surfaces, a dimension in length that is substantially greater than its dimensions in width and height, and opposite ends of insertion 18 and fastener 20. Barrel 14 also has a plurality of flexibility enhancing elements (illustrated as slots 22). ) formed in it, which are arranged and configured to increase its lateral flexibility. The plunger 16 may also incorporate flexibility enhancing elements (not shown), in its structure, to increase its lateral flexibility in a manner similar to the barrel 14. The barrel 14 may also have a plurality of petals 24 formed at the insertion end 18 to allow the end to be closed substantially. The closure of the insertion end 18 can take any configuration, including without limitation, dome, conical, elliptical, etc. The fastening end 20 may have features to assist the user in holding the barrel more securely during use. These features are shown as large openings 26, but may also include raised structures, indentations or grooves, incremental friction linings, etc. In a preferred embodiment, the barrel 14 also has a flexible material 28 disposed on its outer surface. This flexible material 28 may be attached to the barrel by means of an intermediate layer, such as an adhesive 30, to form a laminar unit, or it may be applied as a coating directly on the exterior surface of the barrel 14_ The person skilled in the art will readily recognize it. Other methods of joining the flexible material 28 to the barrel 14. In certain embodiments of the invention, such as those of Figures 1-7 and 9, it may be appropriate to apply the laminating adhesive 30 on the outer surface of the barrel 14 or the material barrel former, before applying the flexible material 28 thereto. In other embodiments, more conventional coating and / or rolling methods may be used. Optionally, a second flexible material 29 can be disposed on the inner surface of the barrel 14 by means of a second intermediate layer such as the adhesive 31. This second flexible material 29 can help reduce or eliminate the chances of the tampon 12 being trapped at the edges 21, 23, of perforated elements that increase flexibility. The flexibility enhancing elements useful in the operation of the present invention include, without limitation, perforations such as slits, grooves, cuts, and the like (including perforations extending through almost the entire thickness of the structural member or of a more layers in a laminar unit that this member forms); folds, canaiitsis and the like. Preferably, the flexibility enhancing elements are disposed along the length of the barrel 14. They may be aligned along this length, or they may be arranged in a substantially misaligned alternating pattern. When the flexibility enhancing elements are aligned along the length, the applicator 10 will generally have flexibility mainly in a plane through its central axis. When they are misaligned (as shown in Figures 8 and 9), the aplícador in general will have flexibility in more than one plane. When the structural member forming the barrel 14 has the preferred flexible material 28 disposed on its outer surface, the flexibility enhancing elements can result in the segmentation of the structural member into discrete units such as short tube lengths that are substantially shorter than its diameter. These segments will then be held and held together as a flexible barrel 14 by the external flexible material 28, and optionally by the internal flexible material 29. The flexibility enhancing elements may also be the result of a continuous spiral groove which results in a plurality of grooves when viewed in longitudinal cross-section. Again, this type of flexibility enhancing elements would benefit from the use of at least the outer flexible material 28 to hold the bonded structural material like a barrel 14. The flexibility enhancing elements are preferably arranged and configured to substantially maintain the longitudinal compressive strength of the structural member. In this way, the user is able (ie to maintain control of the insertion device, especially the barrel 14, during its insertion into the body cavity, In a particularly preferred embodiment, the incrementing elements of flexibility in the barrel 14, they are perforations having edges 21, 23. These perforations may have a major axis and a minor axis Preferably, the major axis of the flexibility enhancing elements is oriented substantially perpendicular to the length of the applicator. of the perforations may abut (for example, the slits 22A shown in Figure 8) or may be separate (for example, the slots 22 shown in Figure 3 and the cuts 22B shown in Figure 9) when the barrel 14 is located. in a relaxed state, not subjected to stress When the barrel 14 is subjected to forces having a component perpendicular to the longitudinal axis, the elements will increase s of flexibility allow the barrel 14 to bend in a curved orientation, as shown in Figure 5. In the curved orientation, the edges 21 A, 23 A of the slits 22 A will be separated, while the edges 21, 23 of the slots 22 will generally be closed as shown in Figure 6. Although this discussion focuses on the flexibility enhancing elements in the barrel 14, it is also applicable to flexibility enhancing elements (not shown) in the plunger 16. In the alternative embodiment illustrated in Figure 10, the flexibility enhancing elements in the barrel 14 comprise a fold 22C. In this embodiment, the fold 22C is directed substantially inwardly from the outer surface of the barrel 14. This inward direction of the fold 22C allows the outer surface to remain substantially smooth. In this mode, it is likely that the buffer 12 has a smaller diameter, or the barrel 14 has a larger diameter to leave the annular space occupied by the folds 22C. The barrel 14 can be made of structural materials generally known to the person skilled in the art. These materials include, without limitation, plastic sheeting; moldable plastic such as injection mouldable or blow moldable plastic; biodegradable plastic such as that described in the commonly assigned application of Dabi et al., US Series. No. 08 / 006,013, filed January 15, 1993 (incorporated herein by reference); and cardboard. The cardboard used as the structural material can be a single layer of cardboard material, or it can be a plurality of laminated layers to provide multiple benefits relative to the various layers. The useful provision of cardboard for the formation of the tubular elements includes, without limitation, paperboard, cardboard, paper and the like. The structural material preferably has disposed thereon the flexible material 28 generally discussed above, to provide an aesthetic similar to conventional plastic coated or plastic laminated cardboard applicators. This flexible material 28 is preferably a substantially continuous layer extending from one side to the other of the structural material in the flexibility enhancing elements, and is not supported by itself. The flexible material 28 can be a plastic film, an elastomeric film, coated paper and the like. Useful plastics include, without limitation, polyolefins such as polyethylene and polypropylene, polyesters such as polyethylene terephthalate, polycaprolactone, polyvinyl alcohol, vinyl acetate-ethylene copolymers, cellophane, and the like. Useful elastomers include, but are not limited to, Cylindrical Cylindrical & -tertiary-butadiene, copolymer-isobutylene-isoprene, polychloroprene (DuPont Neoprene ™) systems, polyurethanes, polysulfide rubbers, polyacrylate elastomers, they comprise the copolymerization of ethyl acrylate and esters of acrylic acid-lower alkanol, nitrile rubber, butyl rubber, polysulfide rubber, polyisoprene, ethylene-propylene terpolymers such as EDPM rubber, silicone rubber, and the like. Useful coated papers include waxed paper, plastic coated paper, silicone coated paper, and the like. Preferred structural materials include laminated cartons and cartons. These plastics laminated paperboard materials may include additional layers such as adhesive layers, tie layers and the like. . The typical dimensions for the barrel 14 useful in tampon applicators, include a length of approximately 5 to 8 cm, a diameter of approximately 8 to 16 mm, and thicknesses of approximately 0.4 to 0.6 mm. Preferably, the diameter of the plunger 16 is smaller than the diameter of the barrel 14 to allow a telescopic arrangement of the plunger 16 inside the barrel 14 as shown in Figure 3: The insertion device may be formed in various ways currently known to the skilled artisan. in the matter. Tubular structural members can be formed as a continuous spiral wound tube and subsequently cut to form the tubular elements. On the other hand, individual tubular elements or shorter tubes can be formed from rectangular sheets (or preforms) of cardboard. These preforms can be wound around a central axis X in the manner indicated in Figure 2, and can be secured with longitudinal seams 32 as shown in Figure 4. This is shown in greater detail in the U.S. patent. No. 4,755,164 to Hinzmann, incorporated herein by reference. Alternatively, they can be convolutively rolled as described in the US patent. No. 4,508,531 of Whitehead The shorter tubes can be cut to form a small number of tubular elements, similar to the coiled tubes, in a continuous spiral. During use, the user simply removes the tampon applicator 10 from any protective wrapping in which it may be packed, holds the holding end 20 and inserts the insertion end 18 of the applicator into the vagina. After the insertion of the applicator 10, the ejection member 16 is pushed towards the barrel 14 to expel the tampon 12 from the barrel 14 towards the vagina. The applicator 10 is then removed from the vagina and can be discarded. Although the above detailed description refers to a preferred embodiment of insertion devices, that is, a tampon applicator, one skilled in the art will readily recognize that the same device can be used for vaginal or rectal delivery of prophylactic compositions such as spermicides. and / or drugs such as fungicides. The compositions and / or medicaments can be in the form of solids, creams, foams, gels and the like. The specification and the previous modalities are presented to help the. complete and non-limiting understanding of the invention described herein. Since many variations and embodiments of the invention can be made without departing from its spirit and scope, the invention resides in the appended claims below.

Claims (1)

1. NOVELTY OF THE INVENTION CLAIMS 1. - A flexible applicator for inserting an article into a body cavity of a mammal, comprising: a) an elongated hollow structural member suitable for containing the insertable article, the structural member having opposite inner and outer surfaces, one dimension in length that is substantially greater than one dimension in width and height, opposite insertion and fastener ends, and a plurality of flexibility enhancing elements that are arranged and configured to increase the lateral flexibility of the structural member; and b) an elongate expulsion member that is slidable within the structural member. . XI.- The flexible applicator according to claim 1, characterized in that the flexibility-increasing elements are arranged and configured to substantially maintain the longitudinal compressive strength of the structural member. 3. The flexible applicator according to claim 1, further characterized in that it comprises a layer of a flexible material disposed on the outer surface of the structural member. 4. The flexible applicator according to claim 3, characterized in that the layer of flexible material is not supported by the structural member in the region of the flexibility-increasing elements. 5. The flexible applicator according to claim 3, characterized in that the layer of flexible material is a polymeric layer. 6. The flexible applicator according to claim 5, characterized in that the polymeric layer is a film. !2 7. - The flexible applicator according to claim 3, characterized in that the layer of flexible material comprises an elastomer. 8. The flexible applicator according to claim 1, characterized in that the flexibility-increasing elements are disputed along the length of the structural member. 9.j- The flexible applicator according to claim 1, characterized in that the flexibility-enhancing elements comprise perforations having edges. 10. The flexible applicator according to claim 9, characterized in that the edges adjoin substantially. 11. The flexible applicator according to claim 9, characterized in that the edges are separated. 12. The flexible applicator according to claim 1, characterized in that the flexibility-increasing elements comprise a fold. 13. The flexible applicator according to claim 12, characterized in that the fold is directed substantially inward, whereby the outer surface of the structural member is substantially smooth. . 14. The flexible applicator according to claim 1, characterized in that the insertion end is substantially closed. 15. The flexible applicator according to claim 1, characterized in that the fastening end has at least one clamping increase characteristic. 16. The flexible applicator according to claim 1, characterized in that the flexibility-increasing elements have a major axis and a minor axis, and the major axis is oriented substantially perpendicular to the length of the apiicador. 17. - The flexible applicator according to claim 1, characterized in that the flexibility enhancing elements are substantially aligned along the length of the apiícador. 8. The flexible applicator according to claim 1, characterized in that the flexibility-increasing elements are aligned in an alternating pattern, substantially misaligned, along the length of the applicator. 19. The flexible applicator according to claim 1, characterized in that the elongated ejection member comprises flexibility increasing elements. 20. The flexible applicator according to claim 1, characterized in that the elongated hollow structural member comprises a substantially cylindrical tube. 21. The flexible applicator according to claim 1, further characterized in that it comprises a layer of a flexible material disposed on the inner surface of the structural member. 22. A flexible applicator for inserting an article into a body cavity of a mammal, comprising: a) an elongated hollow structural member, suitable for containing the insertable article, the structural member having opposite inner and outer surfaces, one dimension in length which is substantially greater than a dimension in both width and height, opposite insertion and fastener ends, and means for increasing the lateral flexibility of the structural member; and b) an elongate ejection member that is slidable within the structural member. 23. The flexible applicator according to claim 22, further characterized in that it comprises a layer of a flexible material disposed on the outside of the structural member. 24. - The flexible applicator according to claim 23, characterized in that the layer of flexible material is not supported by the structural member in the region of the flexibility-increasing means. 25. The flexible applicator according to claim 22, characterized in that the flexibility-increasing means are arranged along the length of the structural member. 26. The flexible applicator according to claim 22, characterized in that the insertion end is substantially closed. 27. The flexible applicator according to claim 22, characterized in that the fastening end has at least one clamping increase characteristic. 28. The flexible applicator according to claim 22, characterized in that the elongated ejection member comprises means for increasing the lateral flexibility of the elongated ejection member. 29. A method of forming a flexible applicator, useful for inserting an article into a mammalian body cavity, comprising the steps of: a) forming flexibility enhancing elements in a structural member, the structural member having a surface Exterior; b) overlaying a layer of a flexible material on the outer surface1 of the structural member; and c) forming the structural member into an elongated hollow member, suitable for containing the insertable article, the hollow member having a length dimension substantially greater than a dimension in width and height, and opposite insert and fastener ends. The method according to claim 29, characterized in that the step of overlaying the layer of flexible material comprises (i) applying a lamination material to the outer surface of the structural member and (ii) applying the layer of flexible material to the material. rolling material. 31. - The method according to claim 29, characterized in that the step of forming the flexibility enhancing elements comprises piercing the structural member. _ 32. The method according to claim 31, characterized in that the step of drilling the structural member comprises making grooves in the structural member. 33. The method according to claim 29, characterized in that the step of forming an elongated hollow member comprises forming a cylindrical tube. 34.- The method according to claim 33, characterized in that »the tube is a convolutely convoluted tube. 35. The method according to claim 33, characterized in that the tube is a spirally wound tube. 36.- The method according to claim 33, characterized in that the tube is a longitudinally stitched tube. 37. The method according to claim 29, further characterized by comprising. He passes the dinner- ^ ubstantially the insertion end of the hollow member. 38. The method according to claim 29, further characterized in that it comprises the step of forming at least one feature of increased clamping at the clamping end of the hollow member. 39.- A method of forming a flexible applicator, useful for inserting an article in a body cavity of a mammal, comprising the steps ele: a) forming flexibility enhancing elements in a structural member, the structural member having a surface Exterior; and b) forming the structural member into an elongated hollow member suitable for containing the insertable article, the hollow member having a dimension in length -46. substantially greater than one dimension in width and height, and opposite insert and fastener ends.