Patent Publication Number: US-2013253470-A1

Title: Medicament Dispensing Devices and Methods

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 13/428,262 filed Mar. 23, 2012, entitled “Medicament Dispensing Devices and Methods” which is a continuation of U.S. patent application Ser. No. 12/377,899 filed Feb. 18, 2009, entitled “Medicament Dispensing Devices and Methods,” which claims priority under 35 USC §371 of PCT Application Serial No. PCT/US08/63112, filed May 8, 2008, entitled “Medicament Dispensing Devices and Methods,” which claims priority to and is a continuation-in-part of U.S. patent application Ser. No. 11/800,812, filed May 8, 2007, entitled “Unit Dose Dry Powder Ejection Carpule,” which are each incorporated herein in their entirety by reference. 
    
    
     TECHNICAL FIELD 
     A medicament dispensing device and method, in particular, a medicament dispensing device suitable for manual use or for use with a medicament dispensing gun. 
     BACKGROUND 
     Unit dose medical and dental medicament delivery systems have been used for many years. In particular, unit dose delivery systems have been used in dentistry to dispense topical and subdermal antibiotic medicaments for the treatment of dental wounds. Known devices typically must be used with a medicament dispensing gun. In addition, typical prior art devices provide no functionality for the dispensing of a partial dose of the selected medicament. 
     The treatment of certain types of wounds or conditions requires the insertion of a medicament delivery device to a specific subdermal depth to achieve best results. Prior art dispensing devices in many cases provide little or no control over the depth of medicament insertion. The present invention is directed toward overcoming one or more of the problems discussed above. 
     SUMMARY OF THE EMBODIMENTS 
     One embodiment disclosed herein is a medicament dispensing device including a substantially rigid carpule body which has a dispensing end and an actuation end opposite the dispensing end. The carpule body is substantially tubular and thus defines a carpule bore. The device further includes a plunger operatively disposed within the carpule bore having a plunger actuator near the actuation end of the carpule body and a plunger tip opposite the plunger actuator. The plunger tip and an orifice at the dispensing end of the carpule bore define a medicament volume which may be loaded with a medicament selected to achieve specific therapeutic goals. 
     The actuation end of the medicament dispensing device may include an enlarged head adapted to be received in a medicament dispensing gun. Alternatively, the actuation end may include or be associated with a plunger extension which provides for or facilitates the manual actuation of the plunger actuator. The plunger actuator may be recessed or otherwise configured to avoid accidental actuation. Thus, the medicament dispensing device embodiments as described herein are well-suited for the emergency treatment of wounds and other traumatic injuries with manually actuated embodiments and the treatment of non-emergency conditions with dispensing gun actuated embodiments. 
     In an embodiment which features a plunger extension, the medicament dispensing device may further include an attachment ring or other structure connecting the plunger extension in sliding engagement with the carpule body. The carpule body may also include a wound depth scale. The depth scale is typically associated with the dispensing end of the carpule body. 
     Similarly, the medicament dispensing device may include a dosage scale. The dosage scale may be associated with the actuation end of the carpule body. Other locations for the dosage scale are within the scope of the present disclosure. In one representative but non-limiting embodiment the dosage scale will include indicia associated with a notch at or near the actuation end of the carpule body. The notch may further be operatively associated with the plunger actuator. The indicia facilitate the selective delivery of a partial dosage of the medicament. In this representative embodiment, the bottom of the notch may define a stop which limits the travel of the plunger actuator and thus limits the quantity of medicament which may properly be delivered at full dosage. 
     The medicament dispensing device may include a plunger tip which has substantially the same diameter as the orifice. In addition, the plunger tip may define a concave or concave-shovel surface facing the orifice. This configuration is particularly well-suited for the dispensing of powdered medicaments, such as powdered topical antibiotics. The carpule body near the dispensing end may be tapered, rounded, or otherwise shaped to facilitate insertion of the medicament dispensing device into a wound, or other treatment site. The dispensing end may be rigid and non-deformable. 
     It may be desirable for specific embodiments or to achieve specific treatment goals that the carpule body be angled along its length. An angle along the length of the carpule body such that the central axis of the actuation and dispensing ends of the carpule body define an angle of between 100 and 120 degrees may be advantageous. An angle of 115 degrees may be particularly advantageous. 
     The medicament dispensing device may include a protective cover. The protective cover may cover the entire carpule body, plunger extension, or any other apparatus associated with the dispensing device. Alternatively, the protective cover may cover and protect only a portion of the medicament dispensing device, for example the dispensing end, and any medicament contained therein. The protective cover may further include apparatus which facilitates the removal of same, for example a tab and scored seam. 
     Another embodiment disclosed herein is a method of dispensing medicament. The method includes providing a device as described above to a user. The user may then insert the medicament dispensing device into a site to a selected depth of insertion. The depth of insertion may be verified with a depth scale associated with the medicament dispensing device as described above. The method may then include depressing the plunger to dispense pre-loaded medicament into the site. 
     As used herein, a site may be a wound or other trauma site where it is desired to dispense topical antibiotic or other emergency care type medicaments. Alternatively, a site may be any place on a human or animal body where it is desired to dispense a specific quantity of medicament. For example, a site may be a periodontal pocket. 
     The plunger may be depressed to dispense medicament by the actuation of a medicament dispensing gun. Alternatively, the plunger may be depressed by manual actuation, for example, with a plunger extension or similar apparatus. The manual actuation of a plunger extension may be facilitated by attaching the plunger extension to the medicament dispensing device with a sliding engagement. 
     The method may further include dispensing a partial dose of the medicament. Verification of the dispensing of a partial dosage may be made with a dosage scale associated with the medicament dispensing device. Alternatively, full dosage of the medicament may be administered by depressing the plunger into engagement with a plunger stop. The method may further include removing a protective cover from the device prior to use. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of a medicament dispensing device. 
         FIG. 2  is a longitudinal section view of the medicament dispensing device of  FIG. 1  along the axis of the carpule bore. 
         FIG. 3  is a perspective view of a medicament dispensing device suitable for self-actuation and the treatment of wounds. 
         FIG. 4  is a longitudinal section view of the medicament dispensing device of  FIG. 3  along the axis of the carpule bore. 
         FIG. 5  is a perspective view of a protective cover configured to protect the entire medicament dispensing device of  FIG. 3 . 
         FIG. 6  is a perspective view of a protective cover configured to protect the dispensing end of the medicament dispensing device of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION 
     One embodiment disclosed herein is a medicament dispensing device  10  having a substantially rigid carpule body  12 . As shown in  FIG. 1 , the carpule body  12  includes a dispensing end  14  and an actuation end  16 . The carpule body  12  is substantially tubular, accordingly the carpule body  12  defines a carpule bore  18 . 
     The medicament dispensing device  10  also includes a plunger  20  operatively positioned within the carpule bore  18 . As shown in  FIG. 2 , the plunger  20  includes a plunger actuator  22  which is operatively positioned near the actuation end  16  of the carpule body  12 . The plunger also includes a flexible plunger shaft  24  extending from the plunger actuator  22  to a plunger tip  26  at the opposite end of the plunger from the plunger actuator  22 . The plunger actuator  22  may be recessed or otherwise configured to prevent accidental actuation. 
     As is described in further detail herein the plunger is positioned in sliding engagement with the carpule bore  18 . Typically, the plunger  20  will be positioned toward the actuation end of the carpule body prior to use of the medicament dispensing device  10  for the dispensing of a selected medicament. In use the plunger  20  will be moved lengthwise through the carpule bore  18  toward the dispensing end  14  of the carpule body  12 . Accordingly, when the medicament dispensing device  10  is configured to dispense a medicament, the plunger tip  26  and a portion of the carpule bore  18  at the dispensing end  14  will define a medicament volume  27  into which selected medicaments may be placed and stored. An orifice  28  is defined by the carpule body at the dispensing end for the dispensing of a selected medicament. 
     As is described in detail herein, the medicament dispensing device  10  may be configured for use with a conventional medicament dispensing gun. Alternatively, the medicament dispensing device  10  may be configured for the manual dispensing of a medicament without the assistance of an external apparatus such as a dispensing gun. Referring to  FIG. 1 , the actuation end  16  of the carpule body  12  may include an enlarged head  30  configured and shaped to be received in an appropriate socket associated with a medicament dispensing gun (not shown on  FIG. 1 ). In this embodiment, the carpule bore  18  will typically extend through the enlarged head  30  allowing the appropriate plunger or other apparatus associated with the medicament dispensing gun ready access to the plunger actuator  22 . 
     Alternatively, as is best shown on  FIGS. 3 and 4 , the medicament dispensing device  10  may be configured for manual actuation. Manual actuation is particularly advantageous in an embodiment of the medicament dispensing device  10  which is designed for emergency use, for example in the treatment of battlefield wounds. A medicament dispensing device  10  configured for manual actuation may include a plunger extension  32  which may optionally have a thumb pad  34 . The plunger extension  32  can be configured to have a diameter of less than the diameter of the carpule bore  18  at the actuation end of the carpule body  12 . Accordingly, the plunger extension, as is shown in  FIGS. 3 and 4 , can be made to interface with and transfer applied force to the plunger actuator  22 . Thus, in an emergency setting the user of this embodiment of the medicament dispensing device  10  may self-dispense medicament by engaging the plunger extension  32  with the plunger actuator  22  and manually applying force on the thumb pad  34 . 
     In embodiments of the medicament dispensing device  10  which include a plunger extension  32 , the plunger extension  32  may be loosely attached to the carpule body  12  with an attachment ring  36  and connector  37 . The attachment ring  36  may be slidably engaged with the outside surface of the carpule body  18  such that the plunger extension may be readily slid axially into the carpule bore  18  when the medicament dispensing device  10  is actuated. Although the attachment ring  36  and plunger extension  32  are illustrated in  FIGS. 3 and 4  as a cylindrical plunger extension  32  and a ring-shaped attachment ring  36 , other configurations of this apparatus are within the scope of the present disclosure. For example, the plunger extension  32  may be fabricated with a cross-sectional shape which is not cylindrical. Furthermore, any structure suitable to attach the plunger extension  32  to the carpule body  12  will be suitable for the implementation of any embodiment of the medicament dispensing device  10 , which includes an optional attachment between the plunger extension and body  12 . 
     Returning to  FIG. 1 , it may be noted that the medicament dispensing device  10  may include a wound depth scale  38  associated with the carpule body  12  near the dispensing end  14 . The wound depth scale  38  may be a relatively simple series of bands, lines or other indicia placed around the carpule body  12 . Alternatively, the wound depth scale  38  may be configured to provide more sophisticated information, and could for example include selected depth measurement information. The wound depth scale  38  may optionally be color-coded, or have other features designed to enhance the visibility and readability of the wound depth scale  38  in use. 
     Similarly, the medicament dispensing device  10  may include a dosage scale  40  which will typically be associated with the actuation end  16  of the carpule body  12 . It is within the scope of the present disclosure, however, to have the dosage scale placed elsewhere on the carpule body  12 . One example of a dosage scale which is particularly well suited for the implementation of the medicament dispensing device  10  is illustrated in  FIGS. 1-4 . The illustrated embodiment of a dosage scale is not intended to be limiting upon the scope of the present disclosure. The representative dosage scale  40  of  FIGS. 1-4  includes selected indicia  42  associated with a notch  44 . The notch  44  may be defined by suitable openings in the carpule body  12  at the actuation end  16 . As is best shown on  FIG. 2 , in this embodiment the plunger actuator  22  may include one or more tabs  46  configured to be received in and slide within the notch  44 . 
     One or more selected portions of the tab  46  may be used in conjunction with the indicia  42  to determine dosage. For example, as is shown in  FIG. 2  the edge of the tab  46  which is toward the dispensing end  14  corresponds with the upper indicia  42 , indicating that the medicament dispensing device  10  as configured in  FIG. 2  has not been used to dispense medicament. As described in detail below, the process of dispensing medicament involves moving the plunger actuator  22  toward the dispensing end  14 . Accordingly, as a specific amount of medicament is dispensed, the bottom edge of tab  46  will correspond with specific indicia  42 . As will be readily apparent from the examination of  FIG. 2 , when the plunger actuator  22  is fully depressed, the bottom edge of the notch  44  will correspond with the bottom indicia  42 , indicating that a full dosage of the selected medicament has been administered. 
     The carpule body at the bottom of the notch  44  may define a stop  48  which can engage with the tab  46  to define the full possible range  50  of plunger  20  motion. Alternatively, a separate stop structure may be used to implement this feature. It is important to note that the range  50  of plunger motion is directly related to the quantity of medicament dispensed. Accordingly, a maximum quantity of medicament to be dispensed may be selected and determined by using the stop  48  or similar structure to define a selected plunger travel range  50  which corresponds to the desired full dosage. 
     As is best shown on  FIG. 2  the plunger tip  26  may have substantially the same diameter as the orifice  28 . The complete and effective dispensing of medicament, and the avoidance of apparatus jams may be enhanced if the plunger tip  26  has a concave surface facing the orifice. A concave-shovel head at the plunger tip  26  may be provided which is advantageous for dispensing powdered medicaments. It may also be noted on  FIG. 1  that the carpule body  12  at the dispensing end  14  may include a selected taper  52  which may be a rounded or flattened taper  52  selected to achieve specific therapeutic goals. In certain embodiments the dispensing end  14  may be a very rigid and non-deformable end which can facilitate insertion. 
     Optionally, the central axis of the carpule body  12  at the dispensing end may be angled from the central axis of the carpule body  12  at the actuation end  16 . It should be noted that any angle or curvature of the body  12  is entirely optional, and may be selected to achieve specific therapeutic goals. However, it has been determined that the angle between the axis of the body at the actuation end  16  and dispensing end  14  of between 100 and 120 degrees is advantageous for certain of the treatments described below. More particularly, a body angle of 115 degrees has been determined to be advantageous. A representative angular displacement  54  along the carpule body  12  is shown in  FIG. 1 . As shown in  FIG. 1 , the angular displacement  54  may be accomplished with a curved carpule body  12 , alternatively two or more linear segments along the carpule body  12  may be used to implement this feature. 
     The medicament dispensing device  10  may include a protective cover  56  associated with some or all of the medicament dispensing device  10 . For example, as is shown in  FIG. 5  the protective cover  56  may be implemented with a sheath  58  which in use covers and seals all structures associated with any embodiment of the medicament dispensing device  10 , for example, the embodiment shown in  FIGS. 3 and 4 . In particular, the sheath  58  may protectively cover both the carpule body  12  and the associated apparatus, any medicament contained therein, and the plunger extension  32  and associated apparatus. The sheath  58  may include apparatus or structures which facilitate the easy opening of the protective cover  56 . The protective cover  56  may be implemented with any known method of sealing and protecting a medical device. For example, as is shown on  FIG. 5 , the sheath  58  may include a tab  60  and a scored seam  62  which facilitates the opening of the protective cover  56 . In use a simple pull on the tab  60  will cause sheath  58  to separate along the scored seam  62 . 
     Alternatively, the protective cover  56  may cover only a portion of the medicament dispensing device  10  and preferably, any medicament stored therein. For example as is shown on  FIG. 6 , the protective cover may be implemented with a partial sheath  64  associated with the dispensing end  14  of the carpule body  12 . 
     Another embodiment disclosed herein includes a method of dispensing a medicament. In the most generalized sense the method includes providing a medicament dispensing device  10  such as is described above. A medicament dispensing device  10  includes a plunger  20  operatively associated with a carpule bore  18  such that the plunger tip  26  and an orifice  28  associated with a dispensing end  14  of the carpule bore  18  together define a medicament volume  29  at the dispensing end  14 . The medicament dispensing device  10  will typically be provided pre-loaded with a select type and quantity of medicament. The medicament may be a powdered antibiotic, gel, liquid, or other substance in any dispensable form which has desired therapeutic properties. 
     In use the medicament dispensing device  10  may be inserted into a site to a selected depth. The depth may be verified using a wound depth scale  38  associated with the medicament dispensing device  10 . When the medicament dispensing device is inserted into the site to an appropriate depth, the plunger may be depressed to dispense the medicament into the site. 
     As used herein, site means any location on a human or animal subject where it is desired to dispense a medicament. For example, the site may be a wound. Alternatively, the site may be a non-traumatized location on a human or animal subject, such as a periodontal pocket. Thus, the method may include the treatment of traumatic injuries such as bullet wounds or non-emergency conditions such a periodontal disease. 
     The size and configuration of the medicament dispensing device  10  may be adapted for specific treatment goals. For example, in one embodiment for the treatment of periodontal disease the orifice  28  is approximately 1.3 mm in diameter and the plunger travel range is set to approximately 2-10 mm. Thus, this embodiment is configured to dispense approximately 2-10 mg. of medicament at a site. 
     The medicament dispensing device  10  may be manufactured from any suitably rigid material, however various plastic polymers including, but not limited to, polyethylene, polypropylene, nylon or other plastics which are relatively easy and inexpensive to manufacture, and are easily sterilized. These and similar plastics are particularly well-suited for the fabrication of a medicament dispensing device  10  and associated apparatus. 
     As described above, the plunger  20  of the medicament dispensing device  10  may be actuated with a medicament dispensing gun, or manually. If a medicament dispensing gun is the desired means of actuation, (for example when treating a non-emergency condition such as periodontal disease) the method will include loading the medicament dispensing device  10  into a suitable medicament dispensing gun. The medicament dispensing device  10  may be engaged with a socket associated with the gun at an enlarged head  30  associated with the medicament dispensing device  10 . The dispensing end  14  of the medicament dispensing device  10  may then be inserted into the site to a selected depth as observed on the wound depth scale  38 . Thereupon, the plunger  20  may be actuated thus dispensing the medicament by depressing a trigger associated with the medicament dispensing gun. 
     Alternatively, an embodiment of the medicament dispensing device  10  configured for self treatment or use in emergency settings may be used to implement the described methods. For example, the medicament dispensing device  10  may include a plunger extension  32  as shown in  FIGS. 3 and 4  plus associated apparatus which facilitate the selective actuation of the plunger with a user&#39;s thumb. This embodiment is particularly well-suited for the self treatment, or the treatment by untrained personnel of battlefield-type wounds such as are suffered by soldiers and police officers. In this embodiment, the medicament dispensing device  10  may be utilized to dispense a topical antibiotic (which may be a powdered antibiotic) into a bullet or other wound thus preventing infection, gangrene, and the potential loss of life or limb. 
     In an emergency situation as described above, the medicament may be dispensed by placing the medicament dispensing device  10  into a wound to a desired depth as viewed on a wound depth scale  38 . The medicament may then be readily dispensed by depressing the plunger extension  32  with the user&#39;s thumb. If the medicament dispensing device  10  is equipped with a dosage scale  40  as described above a full or partial dosage of medicament may be readily administered. The dispensing of a full dosage may be facilitated by including a stop  48  in association with the actuation apparatus. 
     Any embodiment of the medicament dispensing device  10  may include a protective cover  56 . Assuming that a protective cover  56  is provided, the method will also include removing the protective cover prior to utilizing the device. The protective cover  56  may be easily removed by pulling on a tab  60 , breaking open a sheath  58  along a scored seam  62 . Alternatively, other methods of opening a protective cover may be utilized to access the medicament dispensing device  10 . 
     While the invention has been particularly shown and described with reference to a number of embodiments, it would be understood by those skilled in the art that changes in the form and details may be made to the various embodiments disclosed herein without departing from the spirit and scope of the invention and that the various embodiments disclosed herein are not intended to act as limitations on the scope of the claims. All references cited herein are incorporated in their entirety by reference. The disclosure also encompasses all possible permutations of the claim set, as if they were multiple dependent claims.