Patent Publication Number: US-2007100289-A1

Title: Methods of applying a substance

Description:
This application is a continuation-in-part of co-pending application Ser. No. 10/160,166, filed Jun. 4, 2002, which is incorporated herein by reference thereto. 
    
    
     BACKGROUND OF THE INVENTION  
      This invention relates to an applicator and to methods of applying a substance, and particularly relates to an applicator for use with a focused dosimetry device for dispensing single and multiple doses of a medicinal cream, compound, or the like, for, and methods of, dispensing the cream from the applicator onto areas of the human anatomy to be treated.  
      Various medical conditions, which are located within the vaginal and/or anal cavities of the human anatomy, can be treated with medicinal creams and other substances of similar consistency. Frequently, such creams are prescribed by physicians. In some instances, it is beneficial and economical for the patient to self-administer, or have a caretaker administer, the measured dosage applications.  
      Applicators developed in the past facilitate the. dispensing of the cream generally within the vaginal and/or anal body cavities, but tend not provide structure which focuses the cream directly onto the critical areas for a most effective treatment.  
      Also, it is important to provide the self-administering patient, or caretaker, with notification when the applicator has been inserted an appropriate depth into the body cavity to a location which is adjacent the area to be treated.  
      Thus, there is a need for a multiple-dose delivery device, and an applicator thereof, which focuses the cream directly onto the critical areas to be treated, and which notifies the patient or the caretaker the applicator has been properly located.  
     SUMMARY OF THE INVENTION  
      This invention contemplates an applicator for dispensing a substance therethrough, which includes a body formed about an axis and with an axial passage. The axial passage is formed with an entry opening at a first axial end thereof and a closed end at a second axial end of the axial passage opposite the first axial end. At least one slot has a prescribed slot length formed through the body and extends in an axial direction in communication with at least a portion of the axial passage. The at least one slot is spaced from the entry opening by a prescribed proximal distance. The body is formed with an outer surface which is contiguous with the at least one slot.  
      This invention further contemplates an applicator including a flange which extends from an outer surface of a body of the applicator laterally of the axial passage and has a surface facing toward a closed distal end of the body. The surface of the flange conforms to an area of the human anatomy surrounding an external opening of a body cavity intended for receipt of the body of the applicator.  
      This invention also contemplates an applicator which includes a flange for providing a tactile notification to the user of the applicator that a prescribed length of the applicator has been inserted into the body cavity.  
      Further, this invention contemplates a method of applying a substance to an area to be treated within a body cavity of a patient, including the steps of establishing a defined space adjacent the area to be treated within the body cavity at a location spaced from an external opening of the body cavity at least by a predetermined proximal distance, forming a mass of the substance externally of the body cavity, moving the mass of the substance into the defined space adjacent the area to be treated, and moving at least a portion of the mass of the substance from the defined space onto the area to be treated within the body cavity.  
      Also, this invention contemplates a method of applying a substance to an area to be treated within a body cavity of a patient by further including the step of tactilely notifying a user when the defined space has been established adjacent the area to be treated.  
      Other objects, features and advantages of the present invention will become more fully apparent from the following detailed description of the preferred embodiment, the appended claims and the accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      In the accompanying drawings:  
       FIG. 1  is a partially-sectioned side view showing a focused dosimetry device, having attached thereto a first embodiment of an applicator embodying certain principles of the invention;  
       FIG. 2  is an exploded side view showing components of the focused dosimetry device of  FIG. 1 , including the first embodiment of the applicator of  FIG. 1  in accordance with certain principles of the invention;  
       FIG. 3  is a sectional side view showing a second embodiment of an applicator, in accordance with certain principles of the invention;  
       FIG. 4  is a sectional view taken along lines  4 - 4  of  FIG. 3  showing internal details of the second embodiment of the applicator of  FIG. 3 , in accordance with certain principles of the invention;  
       FIG. 5  is a sectional view showing a third embodiment of an applicator, in accordance with certain principles of the invention;  
       FIG. 6  is a sectional view taken along line  6 - 6  of  FIG. 5  showing the third embodiment of the applicator of  FIG. 5 , in accordance with certain principles of the invention; and  
       FIG. 7  is a perspective view showing a cap which can be attached to the focused dosimetry device of  FIG. 1  in lieu of the applicators of  FIGS. 1 through 6 . 
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
      In the focused dosimetry device of  FIG. 1 , as described below, a substance, such as medicinal cream, compound, or the like, is deposited into a barrel of a cartridge of the device. The volume of the cream deposited in the cartridges of the respective embodiments represents a single dose or multiple doses.  
      The consistency of the cream is such that the cream does not flow easily within or out of the cartridge without a force being applied to the barrel-confined mass thereof. Typically then, a plunger head within the barrel is urged by pushing a stem, which is in contact with the head, to force the cream to exit the barrel.  
      The focused dosimetry device described below is particularly useful for applying and focusing each administered dose of cream to affected areas of vaginal and anal cavities of the human anatomy.  
      The below-described focused dosimetry device includes a dispensing end at which the cream is dispensed from the cartridge to the affected area of the patient. Such dispensing end of the focused dosimetry device will hereinafter be referred to as the distal end. The opposite end of each such device, which includes a stem, will be referred to as the proximal end of the device. The end of any component of each focused dosimetry device, which is closest to the distal end of the device, will be referred to as the proximal end of the component, and the other end of such component, which is opposite the proximal end, will be referred to as the distal end.  
      Referring to  FIGS. 1 and 2 , a focused dosimetry device is identified as device  60 , and is typically used in multiple dose applications. The device  60  includes a cartridge  62 , having a barrel  64 , for containing a substance such as the medicinal cream, or any other substance having a cream-like consistency. The device  60  is a multiple dose device. However, the device  60  could be used as a single dose device.  
      In the device  60 , the barrel  64  is formed with a hollow interior barrel passage  66 , having a distal opening  68  at a distal end thereof and a proximal opening  70  at proximal end thereof. A finger-rest flange  72  is formed radially outward on the barrel  64  at the proximal end thereof.  
      A small-diameter sleeve  74  forms an integral part of the cartridge  62 , and is in axial alignment with the barrel  64  at the distal end thereof, and forms a sleeve passage  76 , which is in communication with the barrel passage  66 . The exterior of the small-diameter sleeve  74  is tapered in the form of a frustum, with the smaller diameter of the frustum located at the distal end of the sleeve, and the axis of the frustum being coincidental with the axis of the barrel  64 .  
      A large-diameter sleeve  78  also forms an integral part of the cartridge  62 , at the distal end thereof, and is in axial alignment with the barrel  64 , and coaxial alignment with the small- diameter sleeve  74 . An internal cylindrical wall of the large- diameter sleeve  78  is threaded, and the proximal end of the sleeve is closed and not in communication with the barrel passage  66 .  
      An applicator  80 , or tip, which is formed with a smooth body  81  having an axial passage  82  therein, is assembled with the cartridge  62  at the distal end of the barrel  64 , for example, by use of a known coupling facility such as the coupling facility identified with U.S. registered trademark LUER-LOC.  
      In particular, as shown in  FIG. 2 , the axial passage  82  of the applicator  80  is formed with a tapered proximal opening  84  which mates with the exterior taper of the sleeve  74  of the cartridge  62  to facilitate one aspect of the attachment of the applicator with the cartridge. The body  81  of the applicator  80  is formed with a first ear  86  and a second ear  88 , which extend in radially opposite directions from the proximal end of the applicator. Upon assembly of the applicator  80  with the cartridge  62 , the outboard ends of the ears  86  and  88  are threadedly applied to, and within, the large-diameter sleeve  78  by rotation of the applicator. The rotation of the applicator  80  also enhances the tapered assembly of the tapered small-diameter sleeve  74  with the tapered proximal opening  84  of the axial passage  82 .  
      It is noted that facilities, other than as described above, can be used to attach the applicator  80  to the cartridge  62  without departing from the spirit and scope of the invention. Such attachment facilities could be threaded, unthreaded, tapered, press fit, or the like.  
      As shown in  FIGS. 2 and 4 , the applicator  80  is further formed with an inner passage  90 , four axially-aligned, equally angularly spaced sets of three axially-spaced radially-oriented holes  92  in each set, and four axially-elongated slots  94 . The tapered proximal opening  84 , the inner passage  90 , the holes  92  and the slots  94  of the applicator  80  are all in communication with each other to facilitate the smooth flow of the cream from the barrel  64  and through the applicator.  
      The applicator  80  is formed with a rounded distal end  96  and a tactile-indicator flange  98  near the proximal end thereof. The rounded distal end  96 , and the smooth applicator body  81 , provide a user-friendly applicator. The flange  98  provides a tactile indication to the self-administering patient, or the administering caretaker/user (hereinafter referred to as “the patient” or the “user,” respectively) that the applicator  80  has been inserted into the vaginal or anal cavity at the appropriate distance for placement of the slots  94  adjacent the areas to be treated with the cream.  
      Referring again to  FIGS. 1 and 2 , a plunger head  100  includes a compliant section, also referred to as a compliant plunger  102 , which is locatable and movable within the passage  66  of the barrel  64 . The plunger head  100  also includes a receptor section  104  which is coupled to the plunger  102 . The plunger head  100  is assembled for sliding movement within the passage  66  of the barrel  64 , between the proximal opening  70  and the distal opening  68  of the barrel.  
      A hollow rigid stem  106 , which, for example, could be composed of a thermoplastic material such as polycarbonate, is formed by a secured assembly of a stem member  108  and a thumb piece  110 , which is formed at the proximal end thereof with a flange-like thumb rest  112 . The stem member  108  is formed with a stem structure  114  at a closed distal end thereof, with the stem structure being in the shape of a frustum. The distal end of the stem  106  is initially inserted into the proximal opening  70  of the barrel  64  such that the stem structure  114  engages a proximal end of the receptor section  104  of the plunger head  100 . This provides facility for urging the plunger head  100  within the passage  66  of the barrel  64 , toward the distal end thereof.  
      The diameter of the proximal end of the stem structure  114  of the stem  106  is smaller than the diameter of the stem member  108 , thereby forming a shoulder  116  at the junction of the stem structure and the stem member. Also, a shoulder  118  is formed radially on an intermediate portion of the thumb piece  110 , which abuts a proximal end  120  of the stem member  108  upon assembly of the stem member and the thumb piece, whereafter the thumb piece and the stem member are bonded together.  
      When the patient, or the user, is preparing to administer a dose contained in the cartridge  62 , the cap  122  is removed and the applicator  80  is attached to the distal end of the cartridge. The distal end of the stem  106  is then inserted into the passage  66  of the barrel  64  at the proximal end thereof, and the stem structure  114  is moved into the receptor opening  148  to seat the stem structure in the opening.  
      The patient, or the user, then places the applicator  80  through an external opening of, and into, the body cavity to be treated. The patient, or the user, senses the initial engagement of the flange  98 , with an area of the human anatomy adjacent the external opening, as tactile notification that the applicator  80  is in the appropriate location for administering the cream. The patient, or the user, pushes the stem  106  toward the distal end of the cartridge  62 , whereby the first dose of cream is urged into the applicator  80 , and is then dispensed from the applicator onto the area to be treated. By moving the device  60  away from the external opening of the body cavity, the applicator  80  is extracted from the body cavity.  
      Referring to  FIGS. 3 and 4 , a second embodiment of an applicator, identified as applicator  80   a , is formed with four equally, angularly and axially-elongated through slots  202  in place of the holes  62  and slots  94  of the applicator  80 . Otherwise, the applicator  80   a  is identical to the applicator  80 , and is assembled with the cartridge  62  in the same manner described above with respect to the applicator  80 . The axially-elongated through slots  202  of the applicator  80   a  provide a faster and more widespread application of the cream to the affected area to be treated in comparison to the delivery through the holes  92  of the applicator  80 .  
      Referring to  FIGS. 5 and 6 , a third embodiment of an applicator, identified as applicator  80   b , and which is the preferred embodiment, is similar to the applicators  80  and  80   a . For example, each of the applicators  80 ,  80   a  and  80   b  is formed with the smooth body  81  having the axial passage  82  therein, and is to be assembled with the cartridge  62  at the distal end of the barrel  64 . Also, each of the applicators  80 ,  80   a  and  80   b  is formed with the axial passage  82 , with a tapered proximal opening  84 , which mates with the exterior taper of the sleeve  74  of the cartridge  62  to facilitate one aspect of the attachment of the applicators with the cartridge. The body  81  of each of the applicators  80 ,  80   a  and  80   b  is formed with the first ear  86  and the second ear  88 , which extend in radially opposite directions from the proximal end of the applicators, to facilitate assembly of the applicators with the cartridge  62  in the manner described above with respect to the applicator  80 .  
      In addition, the body  81  of the applicator  80   b  is formed with the two diametrically-opposed axially-elongated through slots  204 , which, individually, are identical to the through slots  202  of the applicator  80   a . The applicator  80   b  is also formed with two wipers  206  and  208  which extend radially outward from diametrically opposite sides of the body  81  of the applicator  80   b , and which extend axially and parallel to the through slots  204 . The through slots  204  and the two wipers  206  and  208  are equally angularly spaced about the axis of the body  81 , as shown in  FIG. 4 . Each of the two wipers  206  and  208  extend radially outward from the body  81  in the shape of a convex mound.  
      A first pair of ramps  210  and  212  are formed with, and extend axially in opposite directions from, opposite ends of the wiper  206 , and extend from a radially outwardmost surface  214  of the wiper to respective adjacent surface portions  216  of the body  81 . A second pair of ramps  218  and  220  are formed with, and extend axially in opposite directions from, opposite ends of the wiper  208 , and extend from a radially outwardmost surface  222  of the wiper to respective adjacent surface portions  224  of the body  81 . It is noted that the applicator  80   b  can function in accordance with certain principles of the invention without the wipers  206  and  208 , for example, in a manner similar to the applicator  80   a.    
      The applicator  80   b  is also formed with a tactile-indicator flange  226  which functions in similar fashion as the flange  98  of the applicators  80  and  80   a , as described above. A distal side of the flange  226  of the applicator  80   b  is formed with a straight portion  228 , which extends toward the axis of the applicator and toward the distal end thereof. A shallow concave portion  230  of the flange  226  extends between the straight portion  228  and the outer surface of the body  81 .  
      When a patient, or user, uses the applicator  80   b , the body  81  is inserted into the body cavity of the patient until the patient, or user, tactilely senses engagement with the flange  226 , in the manner noted above with respect to the use of the a applicators  80  and  80   a . With the combined straight portion  228  and the concave portion  230  on the distal side of the flange  226 , a gentile and gradual engagement of the flange with the patient is accomplished to avoid discomfort to the patient during the process.  
      In the same manner noted above with respect to the applicator  80   a , the axially-elongated through slots  202  of the applicator  80   b  provide a faster and more widespread application of the cream to the affected area to be treated. After the cream has been applied within the body cavity, the focused dosimetry device  60 , including the applicator  80   b , may be rotated and/or oscillated about the applicator axis. With such action, the outer surface of the applicator  80   b  engages the deposited cream, and spreads the cream about the area to be treated.  
      While the applicator  80   b  is the preferred embodiment, any of the three applicators  80 ,  80   a  and  80   b  can be used with the cartridge  62 , without departing from the spirit and scope of the invention.  
      As illustrated in  FIG. 5 , the body  81  of the applicator  80   b  is formed about a longitudinal axis, and with the axial passage  82 . The axial passage  82  includes an entry port  201  at a proximal or first end of the axial passage. A dispensable substance, such as the above-noted cream, can be moved from the cartridge  62 , through the entry port  201  and into the axial passage  82 . The axial passage  82  extends axially longitudinally from the entry port  201  toward the closed distal end  96  of the body  81 , and to a closed distal, or second, end  203  of the axial passage, by a predetermined passage distance. As noted above, each of the slots  204  is formed laterally or radially through the body  81 , and is coincidental with an intermediate section  205  of the axial passage  82 . Also, each of the slots  204  is in communication with the intermediate section  205  of the axial passage  82  and is contiguous with the outer surface of the body  81 . This structural arrangement facilitates the dispensing of the cream from the intermediate section  205  of the axial passage  82  to an exterior area adjacent the outer surface of the body  81 , and particularly onto the area to be treated within the body cavity of the patient.  
      Each of the slots  204  is elongated and extends axially longitudinally by a prescribed slot distance, or slot length, from a proximal end  207  of the slot to a distal or second end  209  of the slot. The pair of slots  204  represent a plurality of elongated circumferentially-spaced slots formed radially through the body  81  and extending in an axial direction in communication with the intermediate section  205  of the axial passage  82  and the exterior of the body.  
      A proximal section  211  of the axial passage  82  extends axially longitudinally by a prescribed proximal distance, or proximal length, from the entry port  201  to a location immediately adjacent the proximal ends  207  of the slots  204 , but does not overlap the proximal ends  207 . A distal section  211  of the axial passage  82  extends axially longitudinally by a prescribed distal distance, or distal length, from the closed distal, or second, end  203  of the axial passage  82  to a location immediately adjacent the distal ends  209  of the slots  204 , but does not overlap the distal ends  209 .  
      As further illustrated in  FIG. 5 , the proximal length of the axial passage  82  is less that the slot length of the slots  204 , and is greater than the distal length of the axial passage.  
      The intermediate portion  205  of the axial passage  82 , which is immediately adjacent and in communication with the slots  204 , represents a defined space. In addition, the defined space can be provided by a container having an internal defined volume, with an entry opening for depositing the mass of the substance therein, and an exit opening for facilitating dispensing of at least portions of the mass of the substance therefrom. The defined space of the intermediate portion  205  of the axial passage  82 , as well as the container, can also be considered an elongated defined space.  
      As also illustrated in  FIG. 5 , a proximal or first side of the tactile-indicator flange  226  is radially aligned with the entry opening  201  of the axial passage  82 . Further, the angled straight portion  228  and the concave curved portion  230  of the distal or second side of the flange  226  blend to form a contoured surface. The contoured surface on the distal side of the flange  226  conforms anatomically to an area of the patient adjacent the external, or entry, opening of the body cavity, into which the applicator  80   b  is to be ultimately inserted.  
      In this manner, the contoured surface of the flange  226  forms a partially occlusive interface, or effectively a seal, with the anatomy of the patient to limit outflow leakage of the substance from the body cavity, at least during the period when the substance is being moved onto the area to be treated. Therefore, the contoured surface of the distal side of the flange  226  provides a means for limiting any outflow of the substance from the body cavity through the external opening thereof when at least portions of the substance are being moved through the opening of the container and onto the area to be treated.  
      The concave curved portion  230  of the flange  226  forms a curvature in the body  81  at a juncture of the outer surface of the body and the distal side of the flange, which is facing toward the closed distal end  96  of the body. As noted above, the body  81  is closed at the distal end  96  thereof, which prevents antegrade inflow leakage of the cream from the axial passage  82 , or container, farther into the body cavity beyond the defined space, in a direction away from the external opening. It is noted that the body cavity could be an anal cavity, a vaginal cavity, or any cavity of the body in which the cream is to be administered.  
      The outer surface, or exterior, of the body  81  of the applicator  80   b , as illustrated in  FIGS. 5 and 6 , is cylindrical in shape from the junction of the curved portion  230  of the flange  226  and the outer surface, and extends in the cylindrical shape to the distal end  96  of the body. In addition, the axial passage  82  is cylindrical in shape from the first end  201  to the second end  203  of the axial passage. It is noted that the outside surface and the axial passage of each of the applicators  80  and  80   a , as illustrated in  FIGS. 1 through 4 , are also cylindrical in shape.  
      As noted above, the distal side of the flange  226 , including the straight portion  228  and the curved portion  230 , will tactilely engage the anatomical area of the patient, or the user, to notify the patient, or the user, that the slots  204  of the applicator  8   b , or the exit opening of the container, have been located adjacent the area to be treated. Thus, the flange  226 , and the distal side thereof, provide a means, responsive to locating the slots  204 , or the exit opening of the container, adjacent the area to be treated by the patient, or the user, for notifying the patient, or the user, that each of the slots, or the exit opening of the container, is located adjacent the area to be treated.  
      When the patient is to self-administer, or a user is to apply, the cream from the applicator  8   b  onto the area of the body cavity to be treated, the proximal end of the applicator is assembled with the distal end of the cream-containing cartridge  62  by using any of the attachment techniques described above. Thereafter, the patient, or the user, inserts the closed, rounded, distal end  96  of the applicator  80   b , or the container, through the external opening of the body cavity of the patient. The patient, or the user, continues to move trailing portions of the applicator, or the container, into the body cavity, whereby the applicator, or container, can move apart any interfacing portions of the body cavity which may be in the path of movement of the applicator, or container, into the body cavity.  
      Eventually, the defined space, as described above, is established at a location within the body cavity, which is spaced from the external opening of the body cavity at least by the prescribed proximal distance. The cream is formed in a mass externally of the body cavity such as, for example, in the cartridge  62 . The mass of cream is then moved from the cartridge  62  and into the defined space of the axial passage  82  of the prepositioned applicator  80   b , or the prepositioned container. Thereafter, at least portions of the mass of cream, adjacent the slots  204 , or exit opening of the container, are moved, or urged, from the defined space onto the area to be treated within the body cavity.  
      The mass of the cream, which is moved into the defined space from the cartridge  62 , is shaped in an elongated form of the elongated defined space, and is moved in a direction of elongation of the elongated form of the mass. Prior to moving the at least portions of the mass of the cream through the slots  204 , or the exit opening of the container, the mass is maintained within the elongated defined space in the elongated form by the confinement of the applicator  80   b , or the container.  
      The patient, or the user, continues to move the applicator  80   b , or the container, into the body cavity until being tactilely notified by the flange  226 , or similar structure of the container, that the slots  204 , or exit opening of the container, have been placed adjacent the area to be treated.  
      As the patient, or the user, is tactiley notified, as described above, the distal or second side of the flange  226 , or similar structure of the container, engages and compresses against the area surrounding the external opening of the body cavity. With this action, the partially occlusive interface is formed, effectively sealing the external opening of the body cavity during a period when the at least portions of the mass of the substance are being moved or urged onto the area to be treated. In this manner, the structure of the distal or second side of the flange  226 , or similar structure of the container, limits the outflow of the substance from the body cavity during the moving or urging of the at least portions of the mass of the substance onto the area to be treated. After the cream, or substance, has been deposited onto the area to be treated, the patient, or the user, may rotate the applicator  80   b , by rotating the cartridge  62  as described above, for providing a more uniform dispersal of the cream onto the area to be treated, prior to withdrawal of the applicator from the body cavity.  
      While the foregoing description has been directed toward the self-administration of the cream into the body cavity by the patient, as the user, it is to be understood that administering of the cream into the body cavity of the patient could be accomplished by the caregiver, or a user other than the patient. Therefore, the “user ” could be the patient or someone other than the patient. In the event that the user is someone other than the patient, the non- patient user would be tactilely notified when the contoured surface of the flange  226  engages the area around the external opening of the body cavity.  
      Further, as noted above, the applicators  80  and  80   a  include structure which functions in the manner of the applicator  80   b . For example, as shown in  FIGS. 1 through 4 , applicators  80  and  80   a  are formed with the body  81  having the axial passage  82 , and with slots which communicate with the axial passage. The slots of the applicators  80  and  80   a  are contiguous with the outer surface of the body  81 , and each of the applicators is formed with a tactile flange which is radially aligned with the entry end of the axial passage  82 .  
      The foregoing description has been directed to the use of the applicator  80   b  for the application of the medicinal cream onto areas to be treated within the body cavity of the patient. It is to be understood that the applicator  80   b , as well as the applicators  80  and  80   a , can be used for the application of a substance into a body cavity of the human anatomy for purposes other than medicinal. Further, the applicators  80 ,  80   a  and  80   b  can be used for applying a substance to surfaces other than those of the human anatomy. For example, the applicators could be used for applying a substance onto interior walls of a non-human enclosure having an entry opening. Further, apart from internal applications, the applicators  80 ,  80   a  and  80   b  may be used to apply the contents thereof to external surfaces of the human anatomy (e.g., skin) or to non-human external surfaces (e.g., industrial uses).  
      In general, the above-identified embodiments are not to be construed as limiting the breadth of the present invention. Modifications, and other alternative constructions, will be apparent which are within the spirit and scope of the invention as defined in the appended claims.