Patent Abstract:
An applicator system for delivering an object into a mammalian body cavity is disclosed. The applicator includes a tubular insertion member arranged and configured to contain the object and a linearly-biased expulsion member having a first end slideably fitted within the tubular insertion member. The tubular insertion member has an insertion end and a gripper end, opposite thereof. The expulsion member extends out of the gripper end of the tubular insertion member, and terminates in a second end. The applicator also includes an expulsion member restraint capable of restraining the second end of the expulsion member proximate an outer surface of the insertion end of the tubular insertion. The expulsion member is bent when so restrained.  
     The invention also relates to a method of delivering an object into a body cavity from an applicator. In this method, the applicator is substantially as described above, and the method includes the steps of: a) releasing the expulsion member restraint to permit the expulsion member to spontaneously attain a substantially linear configuration with the second end extending rearwardly away from the gripper end of the tubular insertion member; b) inserting the insertion end of the tubular insertion member into the body cavity; c) applying force on the second end of the expulsion member to move the first end thereof toward the insertion end of the tubular insertion member; d) expelling the object out of the insertion end of the tubular insertion member and into the body cavity; and e) removing the applicator from the body cavity.

Full Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates to applicator systems for delivering materials into mammalian body cavities having a compact format in which the expulsion member is manipulated to present a shorter than normal length during storage. The applicator is particularly useful for delivering intravaginal devices, such as catamenial devices, into a vaginal canal.  
         BACKGROUND OF THE INVENTION  
         [0002]    Applicators for delivering materials into a body cavity typically comprise a tubular insertion member having an insertion end and a gripper end opposite thereof, and an elongate expulsion member slideably fitted within the tubular insertion member for expelling the contained materials. A class of applicators is known as compact applicators, because they present a shorter packaged size, especially length, than required for use.  
           [0003]    One type of compact applicator has an insertion member adapted to contain the insertable device and an expulsion member that is stored between the insertable device and the insertion member, e.g., in an annular space between a cylindrical tampon and a cylindrical, tubular insertion member. An example of this type of compact applicator is shown in Ring, U.S. Pat. No. 4,291,696. This type requires the user to prepare the applicator for use by first partially withdrawing the expulsion member in a controlled manner prior to pushing against the insertable device to expel it from the insertion member. This step introduces significant complexity to the applicator, as the insertable device must be prevented from following the expulsion member as it is withdrawn. Additionally, the expulsion member should also be somehow prevented from being completely removed from the insertion member.  
           [0004]    A second type of compact applicator stores substantial portions, if not all, of the expulsion member outside of the insertion member. One example of this approach is disclosed in Buzot, U.S. Ser. No. 09/331907, filed Dec. 23, 1998, based upon WO 99/33429. This applicator includes an external pusher element that is bent and inserted through an opening in the applicator to bear on a rear surface of the tampon. While this is an interesting and promising advance in the art, it requires several manipulations by the user prior to expelling the tampon from the applicator.  
           [0005]    Another approach is described in Sakurai et al. U.S. Pat. No. 4,269,187. This approach incorporates a push-out top end contained within an outer cylinder and at least one inserting supporting piece connected to the push-out top end and folded outwardly from the outer cylinder. A preferred embodiment of this device incorporates a pair of such outwardly folded elements supporting pieces that are locked together prior to use. Again, this approach also appears to require the user to actively unfold and manipulate the push-out elements prior to use.  
           [0006]    Therefore, what is needed is a compact applicator that requires little manipulation by a user prior to use and that is robust to reliably and easily expels an insertable object contained therein.  
         SUMMARY OF THE INVENTION  
         [0007]    An applicator system for delivering an object into a mammalian body cavity is disclosed. The applicator includes a tubular insertion member arranged and configured to contain the object and a linearly-biased expulsion member having a first end slideably fitted within the tubular insertion member. The tubular insertion member has an insertion end and a gripper end, opposite thereof. The expulsion member extends out of the gripper end of the tubular insertion member, and terminates in a second end. The applicator also includes an expulsion member restraint capable of restraining the second end of the expulsion member proximate an outer surface of the insertion end of the tubular insertion. The expulsion member is bent when so restrained.  
           [0008]    The invention also relates to a method of delivering an object into a body cavity from an applicator. In this method, the applicator is substantially as described above, and the method includes the steps of: a) releasing the expulsion member restraint to permit the expulsion member to  5  spontaneously attain a substantially linear configuration with the second end extending rearwardly away from the gripper end of the tubular insertion member; b) inserting the insertion end of the tubular insertion member into the body cavity; c) applying force on the second end of the expulsion member to move the first end thereof toward the insertion end of the tubular insertion member; d) expelling the object out of the insertion end of the tubular insertion member and into the body cavity; and e) removing the applicator from the body cavity. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWING  
       [0009]    [0009]FIG. 1 is a side elevation of a compact tampon applicator according to the present invention in its stored or packaged configuration and, in phantom, locations of a portion of the expulsion member as it moves into a ready-for-use configuration.  
         [0010]    [0010]FIG. 2 is a cross-section of the side elevation of FIG. 1.  
         [0011]    [0011]FIG. 3 is a perspective view of an expulsion member useful in the present invention.  
         [0012]    [0012]FIGS. 4 and 5 are cross-sections taken along lines  4 - 4  and  5 - 5  of FIG. 3.  
         [0013]    [0013]FIGS. 6A and 6B are end elevations of two embodiments of applicators according to the present invention.  
         [0014]    [0014]FIG. 7 is a detail of the insertion end of a tubular insertion member and the second end of an expulsion member according to an alternative embodiment of the present invention.  
         [0015]    [0015]FIG. 8 is a side elevation of an alternative embodiment of the present invention in a ready-for-use configuration.  
         [0016]    [0016]FIG. 9 is a side elevation of the alternative embodiment of FIG. 8 in a stored or packaged configuration.  
         [0017]    [0017]FIG. 10 is a cross-section of the hinge portion of the beam in the alternative embodiment of FIG. 8, taken along line  10 - 10 .  
         [0018]    [0018]FIG. 11 is a detail of the-insertion end of a tubular insertion member and the second end of an expulsion member according to an alternative embodiment of the present invention.  
         [0019]    [0019]FIG. 12 is a side elevation of an alternative embodiment of the present invention in a packaged configuration.  
         [0020]    [0020]FIG. 13 is a side elevation of the alternative embodiment of FIG. 12 in an unpackaged, ready-for-use configuration.  
         [0021]    [0021]FIG. 14 is a side elevation of the embodiment of FIG. 1 in a ready-for-use configuration.  
         [0022]    [0022]FIG. 15 is a side elevation of the embodiment of FIG. 1, as a contained tampon is being expelled. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]    As used in herein the specification and the claims, an element is “linearly-biased” if it tends to exhibit a substantially linear configuration in the absence of significant outside forces. For example, an element that is capable of being bent under an outside influence, such as a restraint, and of spontaneously reverting to a substantially linear configuration when the outside influence is removed is a linearly-biased element.  
         [0024]    The term “diameter” as used in herein the specification and the claims relates to a chord passing through the center of a figure or body, and it can be measured as the length of this straight line (chord) through the center of the body in a given plane. Unless otherwise noted, this plane is perpendicular to the major longitudinal axis of the body. In a non-circular cross-section, the body may have a maximum diameter and a minimum diameter.  
         [0025]    As used herein, a “unitary” device is one that has the characteristic of being a unit or a whole. This includes both devices that are created from a single element and those formed by fixing together individual elements to form the whole.  
         [0026]    As used herein the specification and the claims, the term “intravaginal device” and related terms includes support devices, obstructing devices useful to block the flow of and/or collect bodily liquids, and the like. The term includes, without limitation, incontinence devices and vaginal supports, such as pessaries; and obstructing devices, such as menstrual collection cups and inflatable or expandable vaginal blocking devices (devices which do not, themselves, absorb the bodily liquids).  
         [0027]    While the present invention generally relates to applicator devices having a tubular insertion member, the following detailed description will refer, specifically, to a tampon applicator for ease of understanding. One of ordinary skill in the art will recognize other uses for this invention.  
         [0028]    Referring now to the drawings, wherein like reference numerals designate like elements, FIGS. 1 and 2 depict an applicator  10 , comprising a tubular insertion member  12 , having an insertion end  14  and a gripper end  16  that is suitable to contain a tampon  18  that can be delivered into the body cavity. The insertion end may have a plurality of inwardly curved petals  20  that form a substantially closed feature  22 . The applicator  10  also includes a linearly-biased expulsion member  24  having a first end  26  that is insertable into the tubular insertion member  12  and is capable of bearing against the tampon  18 . The expulsion member  24  terminates in a second end  28 , opposite the first end  26 , that may be manipulated to move the first end  26  within the tubular insertion member  12 . The first end  26  of the expulsion member  24  is arranged and configured to be slideably introduced into the tubular insertion member  12  through its gripper end  16 .  
         [0029]    The applicators  10  or other tubular devices of the present invention can have tube geometries or cross-sections that are useful to contain the object to be inserted. Often, the shape of the tampon  18  or other element contained suggests the shape of the tubular insertion member  12 , but departures from this general rule may be made. Therefore, the tubular insertion member  12  may take on numerous cross-sectional shapes including, without limitation, circular, oval, polygonal (e.g., trapezoidal, rectangular, triangular), and the like. For example, cylindrical tampons may be contained within rectangular insertion members and trapezoidal tampons (such as those disclosed in Van Iten et al., U.S. Pat. No. 5,350,371) and cup-shaped-tampons (such as those disclosed in Bailey, U.S. Pat. No. 2,330,257) can be contained in a generally cylindrical insertion member. In addition, the insertion member  12  can substantially elongated, curved, or flexible, or it can take on other shapes that are apparent to one of ordinary skill in the art. The specific geometry, itself, is not critical to the practice of the present invention. In addition, the edge of the tubular device (both finished and unfinished) may be a standard, planar edge coincident with a plane perpendicular to the longitudinal axis of the tubular device. However, the edge may also be coincident with a plane oblique to the longitudinal axis, or it may be otherwise contoured and/or recessed as described in the commonly assigned, copending application of Buzot, U.S. Ser. No. 09/454,989 (herein incorporated by reference).  
         [0030]    The first end  26  of the linearly-biased expulsion member  24  is provided to bear against the rear end  19  of the tampon  18 , especially as it is use to expel the tampon  18 . In order to expel the tampon  18  effectively, it is useful to provide a first portion  30  of the expulsion member  24  located adjacent the first end  26 . It is preferred that the first portion  30  has a length that is sufficient to provide some directional stability to the expulsion member  24  in the tubular insertion member  12 . In particular, it is preferred that the enlarged portion  30  corresponds to the size and shape of the interior of the gripper end  16  of the tubular insertion member  12  proximate the first portion  30 . This allows the expulsion member  24  to more easily slide within the tubular insertion member  12  without binding or becoming jammed.  
         [0031]    The expulsion member  24  (shown alone in FIG. 3) also has a second portion  32  extending from the first portion  30  to the second end  28 . Preferably, the second portion is formed of a beam  32  having a reduced cross-section in comparison to the first portion  30 . As this beam  32  is used to transmit force exerted on the second end  28  along the expulsion member  24  and through the first portion  30  to the tampon  18 , the second portion should have sufficient column strength and rigidity to transmit such linear forces without significant deformation. While the linear forces encountered in use of applicators may vary, it is preferred that the beam  32  be capable of withstanding a linear force sufficient to expel the tampon  18  into a user&#39;s vaginal canal without buckling. Generally, this force is at least about 5 N (Newtons), more preferably, at least about 10 N, and most preferably, at least about 15 N. This column strength can be determined by securing the first portion of the expulsion member into an appropriately sized receptacle placed on the fixed jaw of a Instron Universal Testing Machine, available from Instron Corporation, Canton, Mass., USA, to prevent the first portion from twisting or bending. The moveable jaw is brought to contact the second end of the expulsion member and is then set to compress the expulsion member at a rate of about 5 cm/minute. The force exerted on the expulsion member is measured continuously, and the point at which this force begins to fall instead of rise is the point at which the expulsion member buckles. The maximum force achieved is the column strength of the expulsion member. Notwithstanding the required column strength and rigidity necessary to transmit the expulsion forces, the beam must also be sufficiently flexible to be bent into a compact configuration, again without permanent damage to itself, such as a permanently set bent configuration.  
         [0032]    The proportion of the expulsion member  24  provided by the first portion  30  and by the second portion  32  can vary. However, the first portion  30  preferably has sufficient length and other external dimensions to help it to be predictably oriented in the tubular insertion member  12 . For example, it is helpful if the first portion has dimensions to allow it to slide within the tubular insertion member  12  while maintaining a substantially uniform orientation to the longitudinal axis of the insertion member  12 . These dimensions may include a length that is approximately equal to the maximum diameter of the first portion  30  or greater.  
         [0033]    The second portion  32  preferably has sufficient length to be wrapped back towards the insertion end of the tubular insertion member  12 . Thus, it preferably extends about ¾ of the length of the expulsion member or less. This provides a sufficient length to dispense an object from the tubular insertion member  12 . An additional relationship can be the relationship of the packaged length of the applicator  10  having a bent expulsion member  24 . Thus, it is preferred that the packaged length of the applicator (“L” as shown in FIG. 1) is less than about 70% of the length of the applicator  10  having an extended expulsion member  24  (“L′” as shown in FIG. 1), and more preferably, less than about 60%.  
         [0034]    The second portion  32  is preferably a beam, and it can have any cross-section that effectively transmits the linear forces described above and permits the required bending. A representative, non-limiting list of useful cross-sections include circular, oval, and the like; polygonal including triangular, trapezoidal, parallelograms such as rectangular, rhomboidal, and the like; “I”-section; angle sections; “T”-sections; “Z”-sections; “H”-sections; channel-section, including standard channel-sections with substantially straight base and walls, “U”-sections, and sections defined by circular segments; and other sections that provide the appropriate balance of column strength and rigidity under linear forces aligned with the longitudinal axis of the beam and flexibility under forces directed at an angle to the longitudinal axis of the beam. Preferred cross-sections of the beam include channel sections, and especially preferred cross-sections include channel-sections defined by circular segments. Such circular segments may be further described by their central angle, θ.  
         [0035]    In a preferred embodiment, the first portion is an enlarged portion, and the second portion comprises a beam having a reduced cross-sectional area in comparison to the enlarged portion. This provides a good bearing surface against the tampon, corresponds to the larger interior dimensions of the tubular insertion member, and allows a less bulky beam to extend outwardly from the tubular insertion member that can be bent around the insertion member for more discrete packaging.  
         [0036]    Preferably, expulsion member  24  has a hinge portion  34  intermediate the first end  26  and the second end  28 . In a particularly preferred embodiment, the hinge portion  34  is adjacent the enlarged portion  30  of the expulsion member  24 . The hinge portion  34  provides a defined bending location for the expulsion member  24 . However, unlike unbiased hinges, the hinge portion  34  doesn&#39;t affect the linear bias of the expulsion member  24 . Therefore, the hinge portion  34 , in addition to the usual characteristic of providing a bending location, must be able to transmit linear force from the second end  28  of the expulsion member  24  to the first end  26  and to provide a mechanism to return the expulsion member  24  to a substantially linear configuration once an outside, bending influence is removed.  
         [0037]    Useful hinge portions  34  can be provided by an unmodified portion of the beam  32 ; by a modified portion of the beam  32 ; by an added, biased hinge element such as a spring-biased hinge; and by any other useful element that provides the properties and characteristics described above.  
         [0038]    Preferably, the hinge portion  34  is provided by an unmodified portion of the beam  32 , if the beam  32  is sufficiently flexible to bending moments (or forces) by itself, or by a modified portion of the beam  32 , such as a localized reduction in wall height of a channel-section beam. As used herein the specification and the claims, the term “wall height” relates to a measure of  5  the distance from the uppermost edges of a channel wall or the ends of a circular segment down to the base of a substantially flat-bottomed channel or the midpoint of the circular segment. These measurements can be seen in FIGS. 4 and 5. Other modifications of beam sections can be used. For example, one or more flanges may be locally reduced or removed from a hinge portion of “I”-, “H”-, “Z”-, “T”-, or angle section beams. In the case of the hinge portion  34  formed of either a modified or unmodified portion of the beam  32 , it is preferred that the hinge portion  34  provides a gradual bend of the beam in contrast to a localized angle or crease. This gradual bend results in significantly less material damage of the beam  32  and provides more spring-back upon release.  
         [0039]    Preferably, the hinge portion  34  provides sufficient spring-back to provide an angle a upon release of less than 90°, more preferably, less than about  600 , and most preferably, about 0°. As can be seen in FIG. 1, this angle a is the amount by which the spring-back of the material fails to provide a straight beam  32 . This provides a more rigid structure to transmit the expulsion force applied to the second end  28  through the expulsion member  24  to the tampon. 18 .  
         [0040]    The applicator  10  also includes an expulsion member restraint capable of restraining the second end  28  of the expulsion member  24  proximate an outer surface of the insertion end  14  of the tubular insertion member  12  such that the expulsion member  24  is bent when so restrained. The restraint may be unitary with the applicator, or it may be external to the applicator. Unitary restraints can be unitary with the tubular insertion member  12  or, preferably, unitary with the expulsion member  24 . In several embodiments, illustrated in FIGS. 1-3 and  6 - 11 , the restraint is unitary with the second end  28  of the expulsion member  24 . The first of these embodiments, shown in FIGS. 1-3 and  6 A and  6 B, the expulsion member  24  has a tubular enlarged portion  30  and a beam  32  having a cross-section substantially corresponding to a circular segment having a first central angle providing a first wall height. The second end  28  has a unitary mechanical catch  36  in the form of a portion of the beam having a larger central angle, greater than about 180° providing a greater wall height. The increased central angle provides a mechanical catch  36  that is capable of engaging an outer surface of the tubular insertion member  12 , especially when the tubular insertion member  12  is cylindrical.  
         [0041]    Another embodiment in which the restraint is a mechanical catch that is unitary with the second end  28  of the expulsion member  24  is shown in FIG. 7. In this embodiment, the mechanical catch  36 ′ is a hook  38 . This hook  38  is oriented to engage with a gap disposed between adjacent petals  20  at the insertion end  14  of the tubular insertion member  12 . The hook  38  is sufficiently flexible to be released from this gap to allow the expulsion member  24  to reacquire its substantially linear orientation.  
         [0042]    Yet another restraint that is unitary with the expulsion member  24  is based upon an adhesive material  40  disposed on the second end  28  of the expulsion member  24 . An example of-this embodiment is shown in FIGS. 8-10, which also illustrate a “T” cross-section beam  32 . Preferably, the adhesive material  40  is a pressure sensitive adhesive that is substantially non-transferable to the outer surface of the tubular insertion member  12 .  
         [0043]    In addition, the restraint may be unitary with the tubular insertion member  12 . An example of such a restraint is shown in FIG. 11 in which the tubular insertion member  12  has an aperture  41  or a receptacle (not shown) provided therein to accept at least a portion of the second end  28  of the expulsion member  24 .  
         [0044]    Alternatively, the restraint may be external to the applicator as shown in FIGS. 12 and 13. Preferably, the external restraint substantially surrounds the expulsion member second end  28  and the tubular insertion member  12 . In a particularly preferred embodiment, the external restraint is formed of packaging material  42 . Of course alternatives may be employed, such as a band of elastic material, plastic, or even paper.  
         [0045]    Additional features may be incorporated into the tubular insertion member  12  and/or expulsion member  24 . For example, one or both members may incorporate features to help keep them together prior to and during use. The tubular insertion member  12  may incorporate an internally directed stop  44  to help to contain the tampon  18  and the first portion  30  of the expulsion member  24 . In addition, the expulsion member  24  may incorporate one or more raised features, such as a raised ring  46 . This raised feature  46  can interact with the internally directed stop  44  to improve the ability of the tubular insertion member  12  and the expulsion member  24  to remain interlocked. The expulsion member  24  may also incorporate a locking device to reinforce the hinge portion  34  to prevent premature collapse or otherwise increase the column strength of the extended expulsion member  24 .  
         [0046]    The applicator devices of the present invention can be made of materials known to those of ordinary skill in the art. Generally, the tubular insertion members are plastic or paper. Plastic materials include, without limitation, polyolefins such as polyethylene and polypropylene (including polyolefin copolymers); polyesters such as polyethylene terephthalate; polyamides such as nylon; polyurethanes; polystyrene; polycaprolactone; polyvinyl alcohol; ethylene-vinyl acetate copolymers; elastomers such as silicones, natural rubbers, and synthetic rubbers including block copolymers; cellophane; PHBV such as those disclosed in Dabi et al., U.S. Pat. No. 5,910,520 (herein incorporated by reference); starch-based polymers including those disclosed in Dabi et al., U.S. Pat. No. 5,910,520; and the like.  
         [0047]    Paper materials include, without limitation, paperboard, cardboard, cup stock, paper, and the like. The paper may be a single layer of material, or it can be a plurality of laminated layers to provide multiple benefits relating to the various layers. Laminated paper material may include a surface layer or coating of plastic, wax, silicone, lubricants, and the like, which may be useful to increase the comfort to the user during insertion and withdrawal. The plastic coating may include, without limitation, those plastic materials listed above. Laminated paper material may also include additional layers such as adhesive layers, tie layers, and the like.  
         [0048]    An example of such a surface layer is disclosed in Blanchard, U.S. Pat. No. 6,171,426. A representative, non-limiting list of useful materials to be used as the surface layer includes, waxes, cellophane, polyolefins, polyesters, epoxies, and the like. The surface layers may also include thermal stabilizers, pigments, fragrances, surfactants, antimicrobial agents, medicaments, and the like.  
         [0049]    The tubular insertion member  12  of the applicator  10  provided by the present invention is preferably substantially closed prior to expulsion of the materials contained therein. Alternatively, the insertion end of the applicator can be more or less open, that is the diameter along the length of the tubular insertion member is substantially equivalent to the diameter of the insertion end. Procter &amp; Gamble, of Cincinnati, Ohio, currently offers for sale an open-ended tampon applicator under the trade name TAMPAX flushable applicator tampons.  
         [0050]    The expulsion member  24  of the applicator  10  provided by the present invention can be made from the same materials as discussed above for the tubular insertion member  12 . However, although paper is not as useful unless modified substantially to provide the appropriate spring-back, and some metals such as superelastic metal alloys such as Nitinol (Ni—Ti alloy) may also be used. However, plastics are most preferred materials. The above, representative list of plastics useful for the tubular insertion member are also useful for the expulsion member. The expulsion member  24  having a modified hinge portion  34  may also be optimized by determining a minimum beam dimension for the hinge portion  34  to provide the appropriate column strength to resist buckling failure during expulsion. This minimum beam dimension-may also reduce the likelihood that the beam would become irrecoverably damaged during the bending of the hinge portion  34  to allow the desired spring-back. Additionally, reinforcements to the remainder of the beam  32  may provide benefits in use. This may be especially true in providing appropriate column strength.  
         [0051]    Typical dimensions for each of the tubular insertion and expulsion members include a length of from about 50 to about 100 millimeters, a diameter of from about 8 to about 16 millimeters, and a thickness of from about 0.4 to about 0.6 millimeters. Preferably, the diameter of the expulsion member is less than the diameter of the tubular insertion member to allow for a telescopic arrangement of the two.  
         [0052]    The applicator of the present invention can be made by appropriate processes that will be recognized by those of ordinary skill in the art. For example, paper tubular insertion members can be constructed from a single layer of paper material, or from a plurality of laminated layers to provide multiple benefits relating to the various layers. The applicators can be made from sheets of material using several processing including, without limitation: spiral winding as disclosed in Campion et al., U.S. Pat. No. 5,346,468, convolute winding as disclosed in Whitehead, U.S. Pat. No. 4,508,531, and forming a sheet around a mandrel and then sealing an overlapped seam as disclosed in Hinzmann, U.S. Pat. No. 4,755,164.  
         [0053]    If the applicator includes a surface layer, as described above, it may be applied using any useful technique. Many techniques are 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.  
         [0054]    Again, the tubular insertion member of the applicator provided by the present invention is preferably substantially closed prior to expulsion of the materials contained therein. One technique for substantially closing the insertion end of the applicator is by employing a plurality of inwardly curved petals. The petals will flex and/or hinge to an open position upon expelling materials contained by the applicator. The number of petals generally ranges from about four to about six. An alternative technique for substantially closing the insertion end of an applicator is by pleating the insertion end. This technique is disclosed in Neilsen et al., U.S. Pat. No. 5,782,793. When an applicator is constructed with more than one layer of material, a single layer may extend into the insertion end in an effort to reduce the force required to expel the contained materials. An example of this is disclosed in Fox et al., U.S. Pat. No. 5,827,214. These collective closures may be of spherical shape, or alternatively tapered shape.  
         [0055]    Plastic applicator members may be manufactured using any useful technique, and many techniques are known for manufacturing plastic applicators. A representative, non-limiting list of such techniques includes injection-molding, blow-molding, extrusion, formation from one or more sheets (as described above for paper), and the like. Generally, the applicator members (for example, the tubular insertion members) can be formed through an injection molding process. This process may be used, because it allows the manufacture to balance some key characteristics of the tubular insertion member. Mold inserts and cores can be machined to form a slightly tapered product. For example, the wall thickness around the gripper end  16  is relatively thick to maintain structural stability during the insertion and expulsion steps of use, while the thickness in the insertion end  14  can be minimized to provide flexibility and low expulsion force. Injection molding also enables the manufacture to make uniquely shaped tubular insertion members and expulsion members. As mentioned above, the less sophisticated and/or less expensive techniques, such as extrusion and blow molding can also be employed. For example, extruded tubes can be further manipulated to form additional features, such as raised or indented rings or other formations. They can also have portions removed to form the hinge portion of the expulsion member. Extruded plastic tubes provide further orientation of the polymer. This orientation may be useful to increase the spring-back and column strength of the expulsion member.  
         [0056]    The applicator of the present invention can be used for the delivery of an object into a mammalian body cavity. Such objects may include suppositories, absorbent devices, and the like, and they may be delivered into body cavities including the mouth, nose, vagina, urethra, and rectum. These materials may be in the form of solids, creams, foams, gels, and the like.  
         [0057]    Preferably, the applicator is used to deliver intravaginal devices, including catamenial devices, such as tampons, intravaginal collection devices, and is interlabial pads; birth control devices such as diaphragms or intrauterine devices (IUDs); compositions in the form of suppositories, such as medicaments, moisturizers, vitamins and minerals, spermicides, and odor controlling agents; medical devices and incontinence devices and vaginal supports such as pessaries; and obstructing devices. Obstructing devices include menstrual collection cups and inflatable or expandable blocking devices.  
         [0058]    In use, the applicator  10  can be removed from its packaging material, e.g.,  42 . If the packaging material  42  is used as an external restraint (as in FIG. 12), the expulsion member  24  would then automatically unfold to provide a substantially linear expulsion member  24 , as shown in FIG. 13. Alternatively, the user may need to initiate separation of the second end  28  of the expulsion member  24  from the tubular insertion member  12  by releasing the mechanical catch  36  or adhesive material  40  to allow the expulsion member  24  to unfold (as shown in FIGS. 1 and 14). Next, a user may place insertion end  14  into the body cavity orifice, delivering tampon  18  into the body cavity by pushing on expulsion member  24  until tampon  18  is expelled from tubular insertion member  12  (as shown in FIG. 15) and withdrawing applicator  10  from the body, leaving tampon  18  within the body cavity.  
         [0059]    Alternately, a user could pull tubular insertion member  12  onto expulsion member  24  while maintaining expulsion member  24  steady relative the user&#39;s body. This substantially eliminates friction between the tampon  18  and the user&#39;s body.  
         [0060]    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.

Technology Classification (CPC): 0