Patent Publication Number: US-7717873-B2

Title: Applicator device for suppositories and the like

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
   This is a divisional of U.S. patent application Ser. No. 10/366,710, filed Feb. 12, 2003 now U.S. Pat. No. 7,198,612 which is a continuation-in-part of U.S. patent application Ser. No. 10/172,729, filed Jun. 14, 2002, now U.S. Pat. No. 7,104,968. The disclosures of U.S. patent application Ser. Nos. 10/172,729 and 10/366,710 are incorporated herein by reference in their entirety. 

   FIELD OF THE INVENTION 
   The present invention relates to applicator devices for suppositories and the like and, more particularly, to an applicator device adapted for depositing suppositories and the like in a bodily cavity or passage. 
   BACKGROUND OF THE INVENTION 
   Suppository applicators have been in use for delivering suppositories to bodily cavities, such as vaginal canals and recta. Conventional applicators are equipped with barrel members for receiving suppositories and plunger members for expelling same from the barrel members. The barrel members have loading ends which are typically equipped with finger-like members or segments projecting therefrom for releasably attaching suppositories to the loading ends (see, for instance, U.S. Pat. Nos. 2,754,822; 3,667,465; 3,934,584; 4,361,150; 5,201,779; 5,404,870; and 5,860,946). The finger-like members are sized such that, when suppositories are loaded onto the loading ends, they are enclosed substantially entirely by the finger like-members. 
   The applicators discussed above have various disadvantages. For instance, suppositories, when exposed to moisture, tend to stick to surfaces that are in contact therewith. In such circumstances, when the applicators are exposed to relatively high humidity, suppositories loaded therein tend to stick to the loading ends of the applicators. Because the suppositories are enclosed substantially entirely by the finger-like members, they have a relatively large area of contact with the loading ends of the applicators. As a result, when the suppositories stick to the applicators during storage or use, it becomes difficult to expel same from the applicators. 
   SUMMARY OF THE INVENTION 
   The present invention overcomes the disadvantages and shortcomings discussed above by providing an improved applicator device for delivering pharmaceutical products or the like to a bodily cavity. More particularly, the device includes a barrel member having a distal end which is equipped with an opening. The applicator also includes a plurality of petals extending outwardly from the distal end in a generally axial direction. The petals cooperate with the opening so as to form a receptacle for releasably receiving a pharmaceutical product in the distal end of the barrel member. Each of the petals has a truncated flexible tip sized and shaped so as to engage a substantially central portion of the pharmaceutical product such that a large section of the pharmaceutical product extends outwardly beyond the petals so as to facilitate the release of the pharmaceutical product from the receptacle. The device also includes a plunger member for releasing the pharmaceutical product from the receptacle. In accordance with the present invention, the device can be packaged in a package together with the pharmaceutical product received in the receptacle. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     For a more complete understanding of the present invention, reference is made to the following detailed description of the present invention considered in conjunction with the accompanying drawings, 
       FIG. 1  is an exploded perspective view of a suppository applicator constructed in accordance with a first exemplary embodiment of the present invention; 
       FIG. 2  is a perspective view of the applicator of  FIG. 1  in an assembled configuration ready for use; 
       FIG. 3  is a perspective view of the applicator of  FIG. 2  packaged in a blister packaging assembly; 
       FIG. 4  is an exploded perspective view of the blister packaging assembly of  FIG. 3 ; 
       FIG. 5  is a perspective view of the applicator of  FIG. 2  illustrating the dispensing of a suppository product; 
       FIGS. 6 and 7  are side elevational views of the applicator shown in  FIGS. 1 ,  2  and  5 , illustrating its operation; 
       FIG. 8  is an exploded perspective view of a suppository applicator constructed in accordance with a second exemplary embodiment of the present invention; 
       FIG. 9  is a perspective view of the applicator of  FIG. 8  in an assembled configuration ready for use; 
       FIG. 10  is a perspective view of the applicator of  FIG. 9  packaged in a blister packaging assembly; 
       FIG. 11  is an exploded perspective view of the blister packaging assembly of  FIG. 10 ; and 
       FIGS. 12 and 13  are side elevational views of the applicator shown in  FIGS. 8 and 9 , illustrating its operation. 
   

   DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS 
   Referring to  FIGS. 1 ,  2  and  5 , there is shown a suppository applicator  10  constructed in accordance with a first embodiment of the present invention. More particularly, the applicator  10  is adapted for use in depositing an oval-shaped suppository product  12  in a bodily cavity, such as a vaginal cavity, a rectum, etc. The applicator  10  includes a barrel member  14  and a plunger member  16  extending through the barrel member  14 . The barrel member  14  and the plunger member  16  are made from a suitable material (e.g., thermoplastics, polyolefins, polyolefin copolymers, modified polyvinyl chloride, thermoplastic rubber compounds, polyurethanes, etc.) preferably by a conventional injection molding process. Alternatively, one or both of the barrel member  14  and the plunger member  16  can be made by using other conventional processes. 
   Now referring to  FIGS. 1 ,  2  and  5 - 7 , the barrel member  14  is provided with an interior passageway  18  extending therethrough. The barrel member  14 , which has a unitary construction and an annular wall  20  defining the passageway  18 , is provided with a proximal section  22 , a distal section  24  and an intermediate section  26 . The intermediate section  26  is located between the proximal and distal sections  22 ,  24 . The proximal section  22  includes an open end  28 , as well as a ribbed surface  30  so as to provide a gripping surface during the use of the applicator  10 . The distal section  24  has a proximal end  32 , which is connected to the intermediate section  26 , and a distal end  34  opposite to the proximal end  32 . The distal section  24  has a flaring construction (i.e., the diameter of the proximal end  32  is smaller than the diameter of the distal end  34 ) and has an opening  36  formed therein and communicating with the passageway  18 . 
   An engaging member, such as an annular ring or projection  35  (see  FIGS. 1 ,  6  and  7 ), is formed on the intermediate section  26  adjacent to the proximal end  32  of the distal section  24  for purposes to be discussed hereinafter. More particularly, the annular ring  35  projects radially inwardly from an inner surface  37  (see  FIG. 1 ) of the wall  20  into the passageway  18  of the barrel member  14 . The annular ring  35  can be formed integrally with the wall  20  or can be formed as a member discrete and separate from the wall  20 . 
   The distal section  24  of the applicator  10  is provided with three flexible, truncated petals  38  (see  FIGS. 1 ,  2  and  5 - 7 ) encircling the opening  36  and extending outwardly therefrom in a direction generally parallel to the longitudinal axis of the barrel member  14  (referred to hereinafter as “the axial direction”). The petals  38  cooperate with the opening  36  and the distal section  24  so as to form a receptacle  40  for releasably receiving the suppository product  12  therein. Each of the petals  38  is provided with a generally semi-circular shape and has a base  42 , which is integrally connected to the distal end  34  of the distal section  24 , and a tip  44 , which is located opposite the base  42 . Due to its truncated construction, each of the petals  38  has an axial length sufficient to securely retain the suppository product  12  within the receptacle  40 , but short enough to create a minimal frictional resistance to the suppository product  12  during its dispensing from the receptacle  40 . With reference to  FIG. 6 , the petals  38  are sized and shaped such that, when the suppository product  12  is received in the receptacle  40 , the tips  44  of the petals  38  engage a substantially central portion  46  of the suppository product  12  (e.g., the tips  44  are adapted to engage a portion of the suppository product  12  located slightly outwardly in the axial direction from the central portion  46  of the suppository product  12 ). By way of example, each of the petals  38  can have an axial length which is substantially equal to one half of the width of the suppository product  12  measured along its major axis. As a result, a substantial part of the suppository product  12  (e.g., an approximately half of the suppository product  12 ) extends axially beyond the receptacle  40  to facilitate easy unloading of the suppository product  12  from the receptacle  40 . 
   Now referring to  FIGS. 1 ,  6  and  7 , each of the petals  38  is provided with a concave interior surface  48  which corresponds generally to the contour of the central portion  46  of the suppository product  12 . More particularly, each of the petals  38  curves slightly inwardly in a generally radial direction as it extends from its base  42  to its tip  44  so as to engage and retain the suppository product  12  in the receptacle  40  (see  FIG. 6 ). In this manner, even if a large part of the suppository product  12  extends beyond the tips  44  of the petals  38 , the petals  38  cooperate with one another so as to retain the suppository product  12  in the receptacle  40 . Additionally, the tips  44  of the petals  38  form a second opening that maintains a larger diameter than a smallest inner diameter along the length of the barrel member  14  or the diameter at the intermediate section  26  at the interface of the proximal section  22  and the distal section  24  both before and after release of the suppository product  12 , as shown in  FIGS. 6 and 7 . 
   With reference to  FIG. 6 , the barrel member  14  is also constructed such that the thickness of the wall  20  at the distal section  24 , and more specifically at the tips  44  of the petals  38 , is significantly smaller than the thickness of the wall  20  at the proximal section  22 . In this manner, the petals  38  are provided with a sufficient flexibility and resiliency such that the petal tips  44  are expandable radially outwardly and contractible radially inwardly so as to permit easy loading and unloading of the suppository product  12 . 
   Referring back to  FIGS. 1 ,  2  and  5 - 7 , the plunger member  16  includes a ribbed shaft  50  having a proximal end  52  and a distal end  54  and movably received in the passageway  18  of the barrel member  14 . The proximal end  52  of the shaft  50  has beads  56  (see  FIG. 1 ). A thumb platform  58  is also formed on the proximal end  52  of the shaft  50  and has a centrally positioned mounting tab  60 . The mounting tab  60  has a female receptacle opening  62  (see  FIG. 1 ) having beads  64  adapted to engage the beads  56  of the shaft  50  such that the proximal end  52  of the shaft  50  can be snap-fitted into the receptacle opening  62  of the thumb platform  58 . In this manner, the thumb platform  58  is securely attached to the shaft  50  by an interference fit. A contact platform  66  is integrally formed with the distal end  54  of the shaft  50 . The contact platform  66  is sized and shaped so to be received movably in the receptacle  40  of the distal section  24  of the barrel member  14  for use in discharging the suppository product  12  from the applicator  10 . In this regard, the contact platform  66  has an oversized shape (i.e., has a diameter similar or substantially identical to the width of the suppository product  12  measured along its minor axis) for purposes to be discussed hereinafter. 
   With reference to FIGS.  2  and  5 - 7 , the plunger member  16  is movable relative to the barrel member  14  in the axial direction between a retracted position (see  FIGS. 2 and 6 ), in which the contact platform  66  is positioned adjacent the proximal end  32  of the distal section  24  of the barrel member  14 , and an extended position (see  FIGS. 5 and 7 ), in which the contact platform  66  is located axially outwardly from the tips  44  of the petals  38  and hence the receptacle  40 . In this regard, the outer diameter of the thumb platform  58  is greater than that of the proximal section  22  of the barrel member  14  so as to prevent the plunger member  16  from moving beyond its extended position (see  FIG. 7 ). Similarly, the outer diameter of the contact platform  66  is larger than the inner diameter of the proximal end  32  of the distal section  24  such that the contact platform  66  engages an interior portion  68  (see  FIG. 6 ) of the distal section  24  located adjacent to the proximal end  32 , thereby inhibiting the plunger member  16  from moving beyond its retracted position. When the plunger member  16  is positioned in its retracted position, the contact platform  66  abuts an end of the suppository product  12  (see  FIG. 6 ) so as to prevent it from being positioned too far into the receptacle  40 . More particularly, the contact platform  66  ensures that the suppository product  12  is cradled in the receptacle  40  in a preferred holding position, in which it is engaged by the distal section  24  of the barrel member  14  only at the tips  44  of the petals  38 , thereby minimizing the area of contact between the suppository product  12  and the barrel member  14 . In this regard, the receptacle  40  preferably has a size which is greater than that of the suppository product  12  such that the entire interior surface of the receptacle  40 , with the exception of the tips  44  of the petals  38 , is out of contact with the suppository product  12 , whereby the suppository product  12  can be released easily from the receptacle  40 . 
   With reference to  FIGS. 1 ,  6  and  7 , the annular ring  35 , which is formed in the passageway  18  of the barrel member  14 , is sized and shaped such that the shaft  50  movably extends through the annular ring  35 . The annular ring  35  is adapted to slidably grip the shaft  50  so as to create a frictional fit between the barrel member  14  and the plunger member  16 . That is, the shaft  50  is constantly engaged by the annular ring  35  throughout its movement between the extended and retracted positions and is thereby held in position by the annular ring  35 . In this manner, the shaft  50  and therefore the plunger member  16  are inhibited from moving freely and causing interference during the use of the applicator  10 . In an alternate embodiment, the annular ring  35  can be eliminated, thereby permitting free movement of the plunger member  16 . 
   Referring back to  FIG. 1 , the applicator  10  is assembled by inserting the shaft  50  into the passageway  18  through the opening  36  of the distal section  24  such that its proximal end  52  is extended outwardly from the open end  28  of the barrel member  14 . The thumb platform  58  is then attached to the proximal end  52  of the shaft  50 . The suppository product  12  is then inserted into the receptacle  40  of the applicator  10  for delivery into a bodily cavity. 
   The applicator  10  can be provided to a user without the suppository product  12  pre-installed in the receptacle  40 . Alternatively, the applicator  10  can be provided to a user with the suppository product  12  pre-filled in the receptacle  40 . When provided in its pre-filled form, the applicator  10  can be packaged in packaging means, such as a blister packaging assembly  70  (see  FIGS. 3 and 4 ). More particularly, the blister packaging assembly  70  includes a thermoformed, blister-type PVC (polyvinyl chloride) plastic tray  72  for receiving the pre-filled applicator  10 . Alternatively, the tray  72  can be made from any other suitable materials. The tray  72  includes an outer perimeter rim  74  and a compartment  76  projecting from the rim  74 . The compartment  76  includes an outer cavity section  78  for receiving the distal section  24  of the barrel member  14 , including the suppository product  12  pre-installed in the receptacle  40 . The compartment  76  is also equipped with an intermediate cavity section  80  for receiving the intermediate section  26  of the barrel member  14 . The intermediate cavity section  80  includes a pair of side extensions  82  for receiving user&#39;s fingers during the removal of the applicator  10  from the tray  72 . An intermediate cavity section  84  is also connected to the intermediate cavity section  80  for receiving the proximal section  22  of the barrel member  14 , while an outer cavity section  86  is connected to the intermediate cavity section  84  for receiving the thumb platform  58  of the plunger member  16 . A peelable lid  88  laminated with an aluminum foil is attached to the packaging tray  72  in a conventional manner for sealing the applicator  10  in the compartment  76 . 
   In order to use the pre-filled applicator  10  packaged in the packaging assembly  70 , the applicator  10  is removed from the packaging assembly  70 . The distal section  24  of the applicator  10 , together with the suppository product  12  attached thereto, is then inserted into a vaginal canal (not shown) in a conventional manner. In doing so, the barrel member  14  is gripped by the user&#39;s fingers at The ribbed surface  30  of the proximal section  22 . After properly placing the distal section  24  and the suppository product  12  in the vaginal canal, the thumb platform  58  of the plunger member  16  is pushed toward the distal section  24  of the barrel member  14  so as to move the barrel member  14  from its retracted position (see  FIGS. 2 and 6 ) to its extended position (see  FIGS. 5 and 7 ). In this regard, the applicator  10  can be held and operated by the user in any conventional manner. For instance, with the proximal section  22  of the barrel member  14  held by the user&#39;s index and middle fingers, the thumb platform  58  of the plunger member  16  can be pushed by the user&#39;s thumb. As the plunger member  16  moves from its retracted position to its extended position (as indicated by the arrow in  FIG. 6 ), the contact platform  66  of the plunger member  16  pushes the suppository product  12  out of the receptacle  40 . During the release of the suppository product  12  from the receptacle  40 , the tips  44  of the petals  38  expand in a radially outward direction so as to facilitate the release of the suppository product  12 . In order to ensure the release of the suppository product  12  from the applicator  10 , the thumb platform  58  is pushed until the plunger member  16  is positioned in its extended position, in which the contact platform  66  is located axially outwardly from the receptacle  40  (see  FIGS. 5 and 7 ). 
   After the release of the suppository product  12  from the applicator  10  into the vaginal canal, the plunger member  16  is pulled back into its retracted position so as to place the contact platform  66  within the receptacle  40 . In this manner, during the removal of the applicator  10  from the vaginal cavity, the contact platform  66  is prevented from coming in contact with tissue walls of the vaginal cavity and causing injury to same. The applicator  10  is then cleaned and disinfected for subsequent use or is discarded. 
   It should be appreciated that the applicator  10  of the present invention provides numerous advantages over conventional applicators. For instance, because the petals  38  of the applicator  10  have a truncated construction, they are adapted to retain the suppository product  12  in the receptacle  40 , while permitting easy release of same from the receptacle  40 . As a result, the suppository product  12  can be released from the applicator  10  in response to the application of an axial force that is significantly less than the force required for conventional applicators. In this manner, even if the suppository product  12  sticks to the interior surface of the receptacle  40  during its storage or insertion into a bodily cavity, it can be released from the receptacle  40  without significant difficulty. Because of its ability to release the suppository product  12  stuck to the receptacle  40 , the applicator  10  can be provided to users in pre-filled and packaged form. 
   The oversized contact platform  66  of the plunger member  16  further ensures the proper dispensing of the suppository product  12  from the receptacle  40 . For instance, because of its large size, the contact platform  66  tends to apply an axial force evenly to the suppository product  12 , thereby minimizing distortion of the suppository product  12  during its release from the receptacle  40 . Moreover, the contact platform  66  functions to strip the suppository product  12  off the interior surface of the receptacle  40  if there is excess friction or sticking between the suppository product  12  and the barrel member  14 . In addition, because the suppository product  12  is mounted to the flaring distal section  24 , the remaining sections of the barrel member  14  (i.e., the intermediate and proximal sections  26 ,  22 ) can be made relatively slender. 
   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 different number of petals  38 . Moreover, although the present invention is especially suitable for use in delivering suppository products to vaginal canals or cavities, it can be used to dispense suppository products or other pharmacological products in other body cavities such as a rectum. Further, the applicator  10  can be modified to accommodate suppository products having different geometrical shapes. In addition, the petals  38  can be provided with different shapes and lengths. The applicator  10  can also be packaged in different types of packages. 
   A second exemplary embodiment of the present invention is illustrated in  FIGS. 8-13 . Elements illustrated in  FIGS. 8-13  which correspond to the elements described above with reference to  FIGS. 1-7  have been designated by corresponding reference numbers increased by one hundred. Unless stated otherwise, the second exemplary embodiment of  FIGS. 8-13  is constructed, used and operated in the same basic manner as the exemplary embodiment shown in  FIGS. 1-7 . 
   With reference to  FIGS. 8 ,  9 ,  12  and  13 , there is shown a suppository applicator  110  constructed in accordance with the second embodiment of the present invention. The applicator  110 , which is adapted for use in delivering an oval-shaped suppository product  112  to a bodily cavity (e.g., a vaginal orifice), includes a barrel member  114  having an open proximal end  128  and an open distal end  134 . Unlike the barrel member  14  of the embodiment of  FIGS. 1-7 , the entire barrel member  114  is substantially cylindrical in shape and is slightly tapered as it extends from the proximal end  128  to the distal end  134  (i.e., the diameter of the proximal end  128  is slightly greater than that of the distal end  134 ). As a result, the distal end  134  of the barrel member  114  is not flared. The barrel member  114  includes an interior passageway  118  extending between the proximal and distal ends  128 ,  134 . A perimeter rim wall  190  is formed at the proximal end  128 , while first restricting means, such as an annular retaining rib  192  is formed in the passageway  118  adjacent the proximal end  128 . Flexible, truncated petals  138  are also formed at the distal end  134  of the barrel member  114 . The petals  138  cooperate with one another so as to define a receptacle  140  for receiving the Suppository product  112 . 
   Still referring to  FIGS. 8 ,  9 ,  12  and  13 , the applicator  110  also includes a plunger member  116  having a single-piece construction. More particularly, the plunger member  116  includes a ribbed shaft  150 , a proximal end  152  and a distal end  154 . Second restricting means, such as a thumb platform  158 , is formed at the proximal end  152  for engagement with the rim wall  190  of the barrel member  114 , while a contact platform  166  is formed at the distal end  154 . The contact platform  166  has a diameter smaller than the inner diameter of the retaining rib  192  of the barrel member  114  such that it can be inserted into the passageway  118 . The diameter of the contact platform  166  is also larger than an inner diameter D (see  FIG. 8 ) of the receptacle  140  defined by the petals  138  such that, when the contact platform  166  is positioned in the receptacle  140 , it comes in contact with the petals  138  and causes same to flex radially outwardly (see  FIG. 13 ), thereby facilitating the release of the suppository product  112  from the receptacle  140 . A stopping platform  194  is formed on the shaft  150  adjacent to the proximal end  152  of the shaft  150 . The stopping platform  194  has a diameter slightly larger than the inner diameter of the retaining rib  192  of the barrel member  114  for purposes to be discussed hereinafter. In this regard, the stopping platform  194  is slightly flexible such that it can be inserted into the passageway  118  from the proximal end  128  of the barrel member  114  and positioned between the retaining rib  192  and the distal end  134 . 
   The plunger member  116  is movably mounted in the passageway  118  of the barrel member  114 . As a result, the plunger member  116  is movable relative to the barrel member  114  between a retracted position (see  FIG. 12 ), in which the contact platform  166  is located remote from the petals  138 , and an extended position, in which the contact platform  166  is in contact with the petals  138  (see  FIG. 13 ). In this regard, the retaining rib  192  of the barrel member  114  is engageable with the stopping platform  194  of the plunger member  116  so as to inhibit the plunger member  116  from moving beyond its retracted position. Similarly, the rim wall  190  of the barrel member  114  is adapted to engage the thumb platform  158  of the plunger member  116  for the purpose of inhibiting it from moving beyond its extended position. 
   With reference to  FIGS. 10 and 11 , a blister packaging assembly  170  is provided for packaging the applicator  110  pre-filled with the suppository product  112 . More particularly, the packaging assembly  170  has a construction basically identical to that of the blister packaging assembly  70  of the embodiment shown in  FIGS. 1-7 . For instance, the packaging assembly  170  has a tray  172  for receiving the pre-filled applicator  110  and a peelable lid  188  attached to the tray  172 . 
   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.