Abstract:
A device for delivering a medicated product or the like to a bodily cavity is provided. The device includes a barrel member having a distal end. The barrel member is sized to contain the medicated product. The device includes a plunger sized to extend into the barrel member. A cap is adapted to move between a sealing position, in which the cap is positioned adjacent to the barrel member and seals the distal end of the barrel member, and a dispensing position, in which the cap is moved in a direction away from the barrel member. The cap includes at least one opening sized to allow the medicated product to flow through the cap when the cap is in the dispensing position. A retainer mechanism is provided for retaining the cap on the barrel when the cap is in the dispensing position.

Description:
FIELD OF THE INVENTION 
     The present invention relates to pre-filled applicator devices and, more particularly, to a pre-filled applicator device for delivering medicated materials to a bodily cavity or passage. 
     BACKGROUND OF THE INVENTION 
     Applicators for delivering medicated materials to an internal bodily cavity, such as the vaginal canal, are known. A conventional applicator includes a barrel member for receiving medicated materials, a plunger member for expelling the medicated materials from the barrel member into a bodily cavity, and a cap sized to cover the barrel member. 
     Some applicators are provided with the medicated materials pre-installed in the barrel member. Some of these applicators require a foil pouch to effectively seal the barrel member. In cases where the medicated materials are not pre-filled, a separate tube containing the medicated materials is provided and the user is directed to load the medicated materials from the separate tube into the applicator. However, it is often difficult to load an accurate dose of the medicated materials from the separate tube into the applicator. 
     With both types of applicators, the user is typically required to remove the cap from the barrel member to dispense the medicated materials out of a single opening formed at the distal end of the barrel member. 
     SUMMARY OF THE INVENTION 
     The present invention relates to a device for delivering a medicated product or the like to a bodily cavity. The device includes a barrel member having a distal end which has an opening and a proximal end. The barrel member is sized to contain the medicated product. The device includes a plunger sized to extend into the barrel member. A cap is adapted to move between a sealing position, in which the cap is positioned adjacent to the barrel member and seals the distal end of the barrel member, and a dispensing position, in which the cap is moved in a direction away from the barrel member. The cap includes at least one opening sized to allow the medicated product to flow through the cap when the cap is in the dispensing position. In this manner, complete removal of the cap is not required to dispense the medicated product from the applicator. 
     A retainer mechanism is provided for retaining the cap on the barrel when the cap is in the dispensing position. The retainer mechanism prevents the cap from being completely disjointed from the barrel member. A sealing mechanism, such as a piston, is provided for sealing the proximal end of the barrel member. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a more complete understanding of the present invention, reference is made to the following Detailed Description of the Invention considered in conjunction with the accompanying drawings, in which: 
         FIG. 1  is an exploded perspective view of an applicator according to the present invention; 
         FIG. 2  is a perspective view of the applicator shown in  FIG. 1  in an assembled configuration ready for use; 
         FIG. 3  is a partial perspective view showing the screw cap in a closed, sealing position; 
         FIG. 4  is a partial perspective view showing the screw cap in an open, dispensing position; 
         FIG. 5  is a partial cross-sectional view of the screw cap and the barrel member; 
         FIG. 6  is a cross-sectional view, taken along section lines  6 - 6  and looking in the direction of the arrows, of the applicator shown in  FIG. 2 ; 
         FIG. 7  is a cross-sectional view of the applicator in a dispensing position; 
         FIG. 8  is a partial cross-sectional view showing the applicator of  FIG. 7  in greater detail; 
         FIG. 9  is a partial cross-sectional view showing the applicator of  FIG. 8  in greater detail; 
         FIG. 10  is a partial cross-sectional view showing another embodiment of the applicator of the present invention, which includes a barrel member having external threads and a screw cap with internal threads; 
         FIG. 11  is a partial cross-sectional view of an applicator showing another embodiment of the applicator of the present invention, which includes a barrel member having external threads and retention rings, and a screw cap with internal threads and a retention bead; 
         FIGS. 12 and 13  are partial cross-sectional views of an applicator showing another embodiment of the applicator of the present invention, which includes a screw cap with prongs having external threads; and 
         FIG. 14  is a partial cross-sectional view of an applicator showing another embodiment of the applicator of the present invention, which includes a screw cap that is sized to be snap-fitted onto the barrel member. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1  illustrates an applicator  10  that is adapted for use in delivering pharmaceutical products or medicated materials (e.g., creams, ointments, lubricants, contraceptive gels, etc.) to a bodily cavity, such as a vaginal cavity. The applicator  10  includes a barrel member  12 , a screw cap  14 , a plunger  16 , and a piston  18 , each of which can be made from a suitable material (e.g., thermoplastics such as high density polyethylene, low density polyethylene, and linear low density polyethylene, polypropylene, etc.). Other plastic materials can also be used to manufacture the components of the applicator  10 . 
     The barrel member  12  is provided with an interior passageway  20  extending therethrough, and an annular wall  22  defining the passageway  20 . The barrel member  12  is sized to contain approximately 5 cc of medicated materials pre-filled in the passageway  20 . It will be understood that the applicator  10  can contain other quantities of medicated materials. 
     The barrel member  12  is provided with a proximal section  24 , a distal section  26 , and an intermediate section  28  located between the proximal and distal sections  24 ,  26 . The proximal section  24  includes an open end  30 , as well as a ribbed surface  32  so as to provide a gripping surface during the use of the applicator  10 . The distal section  26  of the barrel member has a proximal end  34 , which is adjacent to the intermediate section  28 , and an open distal end  36  opposite to the proximal end  34 . The distal section  26  has a reduced diameter relative to the proximal and intermediate sections  24 ,  28  (i.e., the diameter of the distal section  26  is less than that of the proximal and intermediate sections  24 ,  28 ). The distal section  26  includes a first annular retention ring  38  and a second annular retention ring  40  for purposes to be discussed hereinafter. More particularly, the first annular retention ring  38  and the second annular retention ring  40  project radially outwardly from the distal section  26 . 
     The distal section  26  of the barrel member  12  includes a series of internal threads  42  (FIGS.  1  and  5 - 8 ) proximate to the open distal end  36 . The internal threads  42  are sized to threadedly engage and mate with the screw cap  14  for purposes to be discussed hereinafter. 
     The barrel member  12  is sized to allow for the appropriate amount of medicated materials and to allow for comfortable insertion into the vagina. The barrel member  12  has a length to allow for at least three inches of penetration into the vagina and to allow sufficient space for gripping the proximal section  24  of the barrel member  12  with a user&#39;s fingers. More particularly, the barrel member  12  has a length of 4.5 inches and a diameter of approximately 0.5 inches. It will be understood that these dimensions are merely exemplary and that the barrel member  12  can have other dimensions. 
     Referring to  FIGS. 3 and 4 , the screw cap  14  is sized to be moveable relative to the barrel member  12 . The screw cap  14  includes a closed insertion end  44  and an opposite open end  46 . The screw cap includes an outer wall  48  with a plurality of radially dispersed openings  50  formed along the circumference of the screw cap  14  for allowing the flow of medicated materials therethrough. A plurality of grooves  52  extends from a respective opening  50  along a longitudinal direction toward the open end  46 . The grooves  52  are designed for allowing a user to attain a firm grip on the screw cap  14  and to make it easier to rotate the screw cap  14 . The grooves  52  also function as flow channels to facilitate in distributing the medicated materials as the medicated materials flow out from the openings  50 . 
     An annular retention bead  54  (see  FIGS. 5-9 ) is formed in the screw cap  14 . The annular retention bead  54  projects radially inwardly from an inner surface  56  of the outer wall  48 . The annular retention bead  54  cooperates with the first and second retention rings  38 ,  40  (see FIGS.  1  and  5 - 9 ) for purposes to be discussed hereinafter. 
     The screw cap  14  includes a hollow inner post  58  (see  FIGS. 4-8 ) having a wall  60  positioned within the outer wall  48  of the screw cap  14 . As a result of their generally coaxial arrangement, the wall  60  of the hollow inner post  58  and the outer wall  48  of the screw cap  14  cooperate to form an annular space  62  (see  FIGS. 6-8 ) therebetween. The hollow inner post  58  protrudes from the insertion end  44  toward the open end  46  of the screw cap  14 , and includes a chamfered end  64  adjacent to the insertion end  44 . The hollow inner post  58  includes a plurality of external threads  66  (see  FIGS. 4-8 ) sized to threadedly engage and mate with the internal threads  42  (see FIGS.  1  and  5 - 8 ) of the barrel member  12 . The external threads  66  and the internal threads  42  cooperate with each other so as to allow the screw cap  14  to be securely connected to the barrel member  12  and to allow relative movement between the screw cap  14  and the barrel member  12 , as the screw cap  14  is rotated relative to the barrel member  12 . 
     The screw cap  14  is movable between a closed position (see  FIGS. 3 and 5 ), in which position the screw cap  14  is threaded onto the barrel member  12  and the chamfered end  64  of the hollow inner post  58  serves to seal the open distal end  36  of the barrel member  12 , and an open position (see  FIGS. 2 ,  4 , and  6 - 8 ), in which position the screw cap  14  is unthreaded but retained on the barrel member  12 . 
     Referring to  FIG. 1 , the plunger  16  is moveably received in the passageway  20  of the barrel member  12  through the proximal section  24  of the barrel member  12 . The plunger  16  includes a ribbed shaft  68  having a thumb platform  70  formed at the proximal end  72 . The thumb platform  70  has an outer diameter larger than that of the proximal section  24  of the barrel member  12  so as to prevent the thumb platform  72  from being received in the passageway  20 , thereby inhibiting the further movement of the plunger  16  toward the distal end  36  of the barrel member  12 . The plunger  16  includes a contact platform  74  formed at the distal end  76  with a tapered tip  78  sized to cooperate with the piston  18  for purposes to be described hereinafter. The contact platform  74  has an outer diameter smaller than that of the proximal section  24  of the barrel member  12  so that the contact platform  74  can be inserted into the passageway  20 . 
     With reference to  FIGS. 1 and 6 , a closure, such as the piston  18 , is pre-installed in the passageway  20  of the barrel member  12  and serves to seal the open proximal end  30  of the barrel member  12  to thereby prevent the medicated materials from flowing therethrough. The piston  18  includes an annular portion  80  and a closed tapered portion  82  extending from the annular portion  80 , and an opening  84  (see  FIG. 6 ) formed in the annular portion  80  that is sized to accommodate the tip  78  of the plunger  16 . The annular portion  80  is friction-fitted against the wall  22  of the barrel member  12 . 
     With reference to  FIG. 5 , the applicator  10  is assembled by attaching the screw cap  14  to the barrel member  12  such that the external threads  66  of the hollow inner post  58  of the screw cap  14  mate with the internal threads  42  of the barrel member  12 . The applicator  10  is assembled and delivered to the user in this closed position, as shown in  FIGS. 3 and 5 . The applicator  10  can be provided with the medicated product pre-filled in the passageway  20 . 
     In order to use the pre-filled applicator  10 , the screw cap  14  is gripped by the user&#39;s fingers and then the screw cap  14  is rotated about 90 to 180 degrees relative to the barrel member  12  in a counterclockwise manner until it overrides the first retention ring  38  formed on the barrel member  12 , as shown in  FIG. 6 . In this open position, the screw cap  14  is captured between the first and second retention rings  38 ,  40  as best shown in  FIG. 9 , and the distal end  36  of the barrel member  12  and the openings  50  in the screw cap  14  are exposed as shown in  FIGS. 6-8 . The retention bead  54  formed on the screw cap  14  and the second retention ring  40  formed on the barrel member  12  cooperate to prevent the screw cap  14  from overriding the second retention ring  40 , thereby retaining the screw cap  14  on the barrel member  12 . The retention bead  54  and the first retention ring  38  cooperate to prevent the screw cap  12  from overriding the first retention ring  38  to move back toward the barrel member  12 , thereby preventing the barrel member  12  from resealing prior to delivery of the medicated materials. Thus, the retention bead  54  and the first and second retention rings  38 ,  40  serve as stops by limiting the axial movement of the screw cap  12 . Needless to say, the present invention could also be configured such that the screw cap  14  moves in a clockwise manner. Thus, the present invention is not limited by the term “counterclockwise.” 
     The screw cap  14  and the distal section  26  of the barrel member  12  are then inserted into a vaginal canal (not shown) in a conventional manner. In doing so, the barrel member  12  is gripped by the user&#39;s fingers at the ribbed surface  32  of the proximal section  24 . After properly placing the distal section  26  of the barrel member  12  in the vaginal canal, the thumb platform  70  of the plunger  16  is pushed toward the piston  18  so as to move the piston  18  and the plunger  16  toward the distal end  36  of the barrel member  12 , as shown in  FIGS. 7 and 8 . In this regard, the applicator  10  can be held and operated by the user in any conventional manner. For instance, with the proximal section  24  of the barrel member  12  held by the user&#39;s index and middle fingers, the thumb platform  70  of the plunger  16  can be pushed by the user&#39;s thumb. As the piston  18  and the plunger  16  move toward the distal end  36  of the barrel member  12 , the piston  18  pushes the medicated product toward the screw cap  14  where the medicated product is radially released through the openings  50  formed in the screw cap  14 . The grooves  52  facilitate to distribute the medicated product forward and backward along the vaginal canal. In order to ensure the full release of the medicated product from the applicator  10 , the plunger  16  is pushed until the thumb platform  70  is positioned adjacent to the proximal open end  30  of the barrel member  12 . After the release of the medicated product from the applicator  10  into the vaginal canal, the applicator  10  is removed from the vaginal cavity. The applicator  10  is then discarded or cleaned and disinfected for subsequent use. 
     It should be appreciated that the applicator  10  of the present invention provides numerous advantages over conventional applicators. For instance, the screw cap  14  serves to seal the distal end  36  of the barrel member  12 , which maintains the long term stability of the medicated materials by providing a moisture and gas barrier. The screw cap  14  also functions as a nozzle to distribute the medicated materials in a radial manner. The applicator  10  is adaptable to current pre-filled applicator technology. Because the applicator  10  is pre-filled with medicated materials, it is not necessary to fill the applicator  10  with medicated materials from a separate tube. 
     It should be noted that the applicator  10  of the present invention can have numerous modifications and variations. For instance, the applicator  10  can be provided with a barrel member  12  having external threads (not shown) and an inner post  58  having inner threads (not shown) that are sized to threadedly engage and mate with the external threads. The applicator  10  can be provided with any suitable mechanism for preventing the screw cap  14  from inadvertently falling off from the barrel member  12  while in use. The applicator  10  can be modified to include a single opening (not shown) in the screw cap  14 . Although the present invention is especially suitable for use in delivering medicated materials to vaginal canals or cavities, it can be used to dispense medicated materials or other pharmacological products in other body cavities such as a rectum. The screw cap  14  can be rounded, bullet shaped, or conical at the insertion end  44  to facilitate insertion of the applicator  10 . The distal section  26  of the barrel member  12  could include a distal subsection, a proximal subsection, a slightly tapered intermediate subsection positioned between the distal and proximal subsections, and a single retention ring positioned at the intersection of the distal and intermediate subsections. The plunger  16  could serve as a closure to seal off the proximal end  30  of the barrel member  12 . 
       FIG. 10  shows another embodiment of an applicator, indicated generally as  110 , that operates and is constructed in manners consistent with the applicator  10  shown in  FIGS. 1-9 , unless stated otherwise. The applicator  110  includes a barrel member  112  having external threads  111  with an initial channel  115 , an intermediate channel  117 , and a terminal channel  119 . 
     The screw cap  114  includes an insertion end  144  and a plurality of openings  150  formed along the circumference of the screw cap  114 . A hollow inner post  158  protrudes from the insertion end  144  and serves to seal the open distal end  136  of the barrel member  112 . The screw cap  114  includes an outer wall  148  with a first internal thread  121  and a second internal thread  123 , which are sized to threadedly engage and mate with the external threads  111  of the barrel member  112 . The external threads  111  and the first and second internal threads  121 ,  123  cooperate with each other so as to allow the screw cap  114  to be securely connected to the barrel member  112  and to allow relative movement between the screw cap  114  and the barrel member  112 , as the screw cap  114  is rotated relative to the barrel member  112 . 
     The screw cap  114  is movable between a closed position (see  FIG. 10 ), in which position the first internal thread  121  is engaged with the initial channel  115  and the second internal thread  123  is engaged with the intermediate channel  117 , and an open position (not shown), in which position the first internal thread  121  is engaged with the intermediate channel  117  and the second internal thread  123  is engaged with the terminal channel  119 . 
     The applicator  110  is assembled by attaching the screw cap  114  to the barrel member  112  such that the first and second threads  121 ,  123  formed on the screw cap  114  mate with the external threads  111  formed on the barrel member  112 . The applicator  110  is assembled and delivered to the user in this closed position, as shown in  FIG. 10 . 
     In order to use the pre-filled applicator  110 , the screw cap  114  is gripped by the user&#39;s fingers and then the screw cap  114  is rotated relative to the barrel member  112  in a counterclockwise manner until the screw cap  114  assumes its open position. Because the external threads  111  do not extend beyond the terminal channel  119 , the screw cap  114  remains threaded on the barrel member  112  as the screw cap  112  is rotated. As a result, further rotation of the screw cap  114  in a counterclockwise manner is impeded, thereby retaining the screw cap  114  on the barrel member  112 . 
       FIG. 11  shows another embodiment of an applicator, indicated generally as  210 , that operates and is constructed in manners consistent with the applicator  10  shown in  FIGS. 1-9 , unless stated otherwise. The applicator  210  includes a barrel member  212  having external threads  211 , a first retention ring  238 , and a second retention ring  240 . 
     Like the screw cap  114  of the applicator  110 , the screw cap  214  includes an insertion end  244 , a plurality of openings  250 , and an inner post  258 . The screw cap  214  includes an outer wall  248  with a plurality of internal threads  213  which are sized to threadedly engage and mate with the external threads  211  of the barrel member  214 . A retention bead  254  is formed in the screw cap  214 . 
     The applicator  210  is assembled by attaching the screw cap  214  to the barrel member  212  such that the internal threads  213  formed on the screw cap  214  mate with the external threads  211  formed on the barrel member  212 . The applicator  210  is assembled and delivered to the user in this closed position, as shown in  FIG. 11 . 
     In order to use the pre-filled applicator  210 , the screw cap  214  is gripped by the user&#39;s fingers and then the screw cap  214  is rotated relative to the barrel member  212  in a counterclockwise manner until it overrides the first retention ring  238  formed on the barrel member  214 . In this open position (not shown), the screw cap  214  is captured between the first and second retention rings  238 ,  240 . The retention bead  254  formed on the screw cap  214  and the second retention ring  240  formed on the barrel member  212  cooperate to prevent the screw cap  214  from overriding the second retention ring  240 , thereby retaining the screw cap  214  on the barrel member  212 . The retention bead  254  and the first retention ring  238  cooperate to prevent the screw cap  214  from overriding the first retention ring  238  to move back toward the barrel member  212 , thereby preventing the barrel member  212  from resealing prior to delivery of the medicated materials. 
       FIGS. 12 and 13  show another embodiment of an applicator, indicated generally as  310 , that operates and is constructed in manners consistent with the applicator  10  shown in  FIGS. 1-9 , unless stated otherwise. The applicator  310  includes a barrel member  312  having a plurality of internal threads  311  and a shoulder  313  formed at the intersection of the distal section  326  and the intermediate section  328 . The shoulder  313  serves as a stop, as will be described in further detail below. 
     The screw cap  314  includes an insertion end  344  and a plurality of openings  350 . A plurality of prongs  315  extends from the insertion end  344 . The prongs  315  include external threads  317  which are sized to threadedly engage and mate with the internal threads  311  of the barrel member  312 . Retention lugs  319  are formed on the free end  321  of each of the prongs  315 . The retention lugs  319  project radially outwardly from the free ends  321  of the prongs  315 . The number of prongs  315  can vary. For example, the applicator  310  shown in  FIG. 13  employs fewer prongs  315  than that of the applicator  310  shown in  FIG. 12 . 
     The applicator  310  is assembled by attaching the screw cap  314  to the barrel member  312  such that the internal threads  311  formed on the barrel member  312  mate with the external threads  317  formed on the screw cap  314 . The applicator  310  is assembled and delivered to the user in this closed position, as shown in  FIGS. 12 and 13 . 
     In order to use the pre-filled applicator  310 , the screw cap  314  is gripped by the user&#39;s fingers and then the screw cap  314  is rotated relative to the barrel member  312  in a counterclockwise manner until the retention lugs  319  contact the shoulder  313  of the barrel member  312 . The retention lugs  319  cooperate with the shoulder  313  to impede further rotation of the screw cap  314  in a counterclockwise manner, which retains the screw cap  314  on the barrel member  312 . 
       FIG. 14  shows another embodiment of an applicator, indicated generally as  410 , that operates and is constructed in manners consistent with the applicator  10  shown in  FIGS. 1-9 , unless stated otherwise. The applicator  410  includes a barrel member  412  with a flange portion  411  at the distal end  436  and a shoulder  413  formed proximate to the distal end  436 . The barrel member  414  includes first and second grooves  415 ,  417 . 
     The screw cap  414  includes an insertion end  444 , a plurality of openings  450 , and an inner post  458 . The screw cap  414  includes an outer wall  448  with a first retention bead  438  and a second retention bead  440 . 
     The applicator  410  is assembled by attaching the screw cap  414  to the barrel member  412  such that the first retention bead  438  is positioned between the flange portion  411  and the shoulder  413  while the second retention bead  440  is snap fitted in the first groove  415 . The applicator  410  is assembled and delivered to the user in this closed position, as shown in  FIG. 14 . 
     In order to use the pre-filled applicator  410 , the outer wall  448  of the screw cap  414  is pulled radially outwardly to remove the second retention bead  440  from the first groove  415 . The screw cap  414  is pushed in an axial direction until the first retention bead  438  contacts the flange portion  411  of the barrel member  412 . The second retention bead  440  is then snap-fitted in the second groove  417 , which retains the screw cap  414  on the barrel member  412 . 
     It will be understood that the embodiments described herein are merely exemplary and that a person skilled in the art may make many variations and modifications without departing from the spirit and scope of the invention. All such variations and modifications, including those discussed above, are intended to be included within the scope of the invention as defined by the appended claims.