Abstract:
An applicator includes a barrel having an outer surface, an insertion end, and an opposed gripper end; a fluid lubricant disposed in fluid communication with a portion of the outer surface of the barrel; and optionally a plunger arranged and configured to be moveable within the barrel to expel an insertable device from the barrel and into a body cavity. Methods of delivering an insertable device into a body cavity may include the steps of moving a plunger into an insertion member to dispense fluid lubricant to the outer surface of the insertion member; the step of inserting an insertion member portion having encapsulated lubricant on an outer surface thereof into a body cavity thereby rupturing the capsule; and/or the steps of moving a plunger into an insertion member, rupturing a reservoir containing fluid lubricant, moving the fluid lubricant toward the outer surface of the insertion member, and inserting the insertion member into the body cavity.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This invention is related to the following copending application: U.S. Ser. No. 11/______, filed on even date herewith, entitled “Novel Tampon Applicator” (Att&#39;y Docket, J&amp;J-5168). 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to applicators for delivering materials into mammalian body cavities. The applicator is particularly useful for delivering intravaginal devices, such as catamenial devices, into a vaginal canal.  
       BACKGROUND OF THE INVENTION  
       [0003]     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.  
       SUMMARY OF THE INVENTION  
       [0004]     The present invention relates to an applicator for delivering an insertable device into a body cavity. The applicator includes a barrel, a fluid lubricant, and optionally a plunger arranged and configured to be moveable within the barrel to expel an insertable device from the barrel and into a body cavity. The barrel has an outer surface, an insertion end, and an opposed gripper end. The fluid lubricant is disposed in fluid communication with at least a portion of the outer surface of the barrel. The fluid lubricant may be disposed within the barrel, and/or contained within a reservoir. Preferably, the barrel has at least one fluid conduit disposed between the outer surface of the barrel and an inner surface of the barrel disposed toward the insertable device useful to deliver the fluid lubricant to the outer surface of the barrel. Additionally, the outer surface of the barrel defines apertures in fluid communication with the at least one fluid conduit.  
         [0005]     Additionally, the present invention relates to methods of delivering an insertable device into a body cavity. For example, a method comprising the steps of moving a plunger into an insertion member dispenses fluid lubricant to the outer surface of the insertion member. Alternatively, a lubricant may be encapsulated on the outer surface of the insertion member; upon insertion into the body cavity, the capsules rupture to dispense lubricant. Yet another embodiment, the steps of moving a plunger into an insertion member ruptures a reservoir to move fluid lubricant toward the outer surface of the insertion member insertion. 
     
    
     BRIEF DESCRIPTION OF THE DRAWING  
       [0006]      FIG. 1A  is a perspective view of an applicator according to the present invention comprising a tubular insertion member and a lubricant carrier disposed thereon.  
         [0007]      FIG. 1B  is a cross-section along line B-B of  FIG. 1A .  
         [0008]      FIG. 2  is a longitudinal cross-section of an applicator, such as depicted in  FIG. 1A , having a reservoir connected to the insertion member and an exploded view of a portion of the insertion member.  
         [0009]      FIG. 3  is a longitudinal cross-section of an applicator, such as depicted in  FIG. 1A , having a reservoir disposed between and defined by the insertion member and plunger and an exploded view of a portion of the insertion member.  
         [0010]     FIGS.  4 A-C, are longitudinal cross-sections of an applicator, such as depicted in  FIG. 1A , having a reservoir disposed between the plunger and an insertable device, and  FIG. 4B  includes an exploded view of a portion of the insertion member.  
         [0011]     FIGS.  5 A-B are transverse cross-sections of an applicator wherein the reservoir is formed of a plurality of discrete sections disposed between the insertion member and plunger. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0012]     The term “diameter” as used in herein the specification and the claims means a chord passing through the center of a figure or body; the length of a straight line through the center of an object  
         [0013]     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).  
         [0014]     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 including, without limitation, applicators for other catamenial devices, such as collection cups, inflatable plugs or cups, and the like; incontinence devices; suppositories; nasal packing; and the like.  
         [0015]     The present invention relates to applicators for delivering materials into body cavities, comprising an elongate insertion member for at least partial insertion into a body cavity. The elongate insertion member has an insertion end and gripper end opposite thereof.  
         [0016]     Referring now to the drawings, wherein like-reference numerals designate like elements,  FIG. 1  depicts an applicator  10 , comprising a tubular insertion member  12 , having an insertion end  14  and a gripper end  16  that is suitable to contain an insertable device  18  for the body cavity. The insertion end  14  may have a plurality of inwardly curved petals  20  that form a substantially closed feature  22 , and the gripper end  16  may have a structure  17  to enhance the user&#39;s grip on the applicator. The applicator  10  also includes an expulsion member  24  having a first end  26  that is insertable into the tubular insertion member  12  and is capable of bearing against the device  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 for slideable introduction into the tubular insertion member  12  through its gripper end  16 .  
         [0017]     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 insertable device  18  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.  
         [0018]     The applicator devices of the present invention can be made of materials known to those of ordinary skill in the art. Generally, the applicators may be plastic or paper. Plastic materials include, without limitation, polyolefins such as polyethylene and polypropylene, polyesters such as polyethylene terephthalate, polycaprolactone, polyvinyl alcohol, ethylene-vinyl acetate 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. The expulsion member can be formed as a solid or a tubular element.  
         [0019]     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.  
         [0020]     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.  
         [0021]     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.  
         [0022]     The tubular insertion member of the applicator provided by the present invention is preferably substantially closed prior to expulsion of the materials contained therein. Alternatively, the insertion end of the applicator can be more or less open, that is the diameter 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.  
         [0023]     In order to facilitate insertion and removal of the applicator from the body, a fluid lubricant can be delivered to the applicator surface that may have a lubricant carrier (generically “ 30 ”) operatively linked thereto. The fluid lubricant may also provide cleansing and/or freshness to the user. As used herein the Specification and Claims, the term “operatively linked” relates to elements that are connected directly or indirectly to each other. For example, a lubricant carrier affixed to the applicator would be operatively linked. Alternatively, a lubricant carrier that is not physically attached to the applicator, but which is attached to an insertable device contained within the applicator would also be operatively linked to the applicator.  
         [0024]     Referring to  FIGS. 1A and 1B , the lubricant carrier  30   a  can be a textured pile fabric, such as terry cloth, or other textured fibrous structure. In this embodiment, the lubricant carrier  30   a  is affixed to the tubular insertion member  12  about its outer surface  32 . As shown in  FIG. 1A , the lubricant carrier  30   a  extends from the insertion end to the gripper end (as shown, both the extreme insertion and gripper ends are left uncovered by the lubricant carrier  30   a ).  
         [0025]     According to the present invention, a fluid lubricant  34  is not disposed on or within a lubricant carrier  30   b . Instead, the fluid lubricant  46  is preferably contained within a reservoir  48   b . Referring to  FIG. 2 , a reservoir  48   b , e.g., a squeeze bulb, is connected to the insertion member  12  through a tube  38   b . The insertion member  12   b  has formed in the walls thereof a conduit  40   b  and manifold  42   b  that distributes the fluid lubricant  34  through a plurality of apertures  44   b  formed in the outer surface  32   b  of the insertion member  12   b . The fluid lubricant  34  then may permeate the fluid carrier  30   b.    
         [0026]     The lubricant carrier  30  may also “swab” the surfaces of the body cavity into which it is inserted, during both insertion and withdrawal motions. This wiping or cleansing action is helpful to provide a clean and fresh feel to the user. Therefore, lubricant may also incorporate additives. A representative, non-limiting list of such additives includes cleansers, emollients, anti-inflamatories, probiotics, antibiotics, and the like. Specific compositions may include health-promoting compositions such as glyceryl monolaurate as disclosed in Brown-Skrobot, U.S. Pat. No. 5,641,503, the disclosure of which is herein incorporated by reference.  
         [0027]     Referring to  FIG. 3 , a reservoir  36   c  is defined by the insertion member  12   c  and plunger  24   c . The insertion member  12   c  is tapered from a relatively large diameter proximate the gripper end  16   c  toward a smaller diameter proximate the insertion end  14   c . As the plunger  24   c  is moved into the insertion member  12   c , a resilient ring  46   c  moves the fluid lubricant  34  along the inner surface  48  of the insertion member  12   c . As the annular space between the inner surface  48  and the plunger cylinder  50   c  diminishes, the fluid lubricant  34  is forced through the apertures  44   c  and to the outer surface  32   c  of the insertion member  12   c . The fluid lubricant  34  thus coats the outer surface  32   c  or saturates a lubricant carrier  30   c , depending upon the structure of the applicator  10 .  
         [0028]     Referring to FIGS.  4 A-C, a reservoir  36   d  is disposed between the plunger  24  and insertable device  18 . The reservoir  36   d  is in fluid communication with the outer surface  32   d  of the insertion member  12   d , e.g., through a conduit  40   d . As the plunger  24  advances within the insertion member  12   d , the plunger forces the fluid lubricant  34  from the reservoir  36   d , into the conduit  40   d , through apertures  44   d , and into lubricant carrier  30   d  to form at least one saturated region  52   d . As the plunger  24  continues into the insertion member  12   d , substantially all of the lubricant carrier  30   d  may become saturated, and the plunger can destroy or otherwise bypass or pass through the reservoir  36   d  and eject the insertable device  18 .  
         [0029]     Referring to FIGS.  5 A-B, a reservoir  36   e  may be formed of a plurality of discrete sections  54   e , each of which may be associated with one or more apertures  44   e .  FIG. 5A  shows the applicator system prior to use. Apertures  44   e  are closed by plunger projections  56   e  that extend radially outwardly from the plunger cylinder  50   e . The discrete sections  54   e  may be arranged between the plunger cylinder  50   e  and the inner surface of the insertion member  48   e . Thus, when the plunger  24   e  is rotated, e.g., clockwise (in the direction of the arrow), an inclined face of the projections  56   e  can direct the fluid lubricant  34  through the now-opened apertures  44   e  to coat the outer surface  32   e  of the insertion member  12   e . The outer surface  32   e  of the insertion member  12   e , may optionally have a separate lubricant carrier (not shown) disposed thereon.  
         [0030]     The applicator of the present invention can be constructed of paperboard or plastic. The paperboard applicators 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.  
         [0031]     If the applicator includes a surface layer, the layer 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.  
         [0032]     The 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 4 to about 6. An alternative technique for substantially closing the insertion end of an applicator is by pleating the insertion end. This technique is disclosed in 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.  
         [0033]     Plastic applicators may be manufactured using any useful technique. 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, at least the tubular insertion members can be formed through an injection molding process. This process is often used, because it allows the manufacture to balance some key characteristics of the tubular insertion member. Molding inserts and cores can be machined to form a slightly tapered product. For example, the wall thickness around the gripping end is relatively thick to maintain structural stability during the insertion and expulsion steps of use, while the thickness in the insertion end can be minimized to provide flexibility and low expulsion force. Injection molding also enables the manufacture to make uniquely shaped tubular insertion members. As mentioned above, the less sophisticated and/or less expensive techniques, such as extrusion and blow molding can also be employed.  
         [0034]     The intrawall conduits described above relating to  FIGS. 8-11  can be more easily formed in plastic applicators. The appropriate number and form of channels can be formed through procedures known to those of ordinary skill in the art. In addition to forming the channels during molding, an open channel in the outer surface of an insertion member can be covered with a film or other outer member to enclose the channel.  
         [0035]     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, and rectum. These materials may be in the form of solids, creams, foams, gels, and the like.  
         [0036]     Preferably, the applicator is used to deliver intravaginal devices, including catamenial devices, such as tampons, intravaginal collection devices, and 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.  
         [0037]     In use, a woman may place the insertion end into the body cavity orifice, delivering the insertable device into the body cavity by pushing on expulsion member until the insertable device is expelled from the tubular insertion member and withdrawing applicator from the body, leaving insertable device within the body cavity.  
         [0038]     Alternately, a user could pull tubular insertion member onto expulsion member while maintaining expulsion member steady relative the user&#39;s body. This substantially eliminates friction between the insertable device and the user&#39;s body.