Abstract:
Some medicaments, such as botulinum toxin, are sold in small glass vials with a cap that comprises a seal. The seal is punctured to allow liquid to be added to reconstitute the medicament, then allow the medicament to be withdrawn through a needle into a syringe. A substantially larger amount of a liquid medicament may be obtained by using an adaptor device. An adaptor device may have a puncture component that allows a flexible tube to be inserted through the seal at an angle that allows an end of a flexible tube to rest on the bottom on a vial around the edge of the vial. This may allow vial to be tipped so that the liquid pools around the end of the flexible tube, thus significantly increasing the amount of liquid that can be withdrawn.

Description:
[0001]    This application claims the benefit of U.S. Provisional Patent Application No. 61/526,649, filed on Aug. 23, 2011, the entire disclosure of which is incorporated herein by this reference. 
     
    
       [0002]    Many medicaments, for example, botulinum toxin, are sold in small glass vials with a cap that comprises a seal. The seal is puncturable to allow liquid to be added, for example, to reconstitute the medicament. The reconstituted medicament may then be withdrawn through a needle into a syringe. 
         [0003]    One disadvantage of this type of packaging may be that the needle and syringe configuration may not be able to draw a significant amount of the liquid in the vial, thus resulting in loss of a significant part of the product. This is especially undesirable when the medicament is expensive. 
         [0004]    Improved systems for facilitating efficient withdrawal of liquid medicaments from containers, such as glass vials, would be desirable. 
       SUMMARY 
       [0005]    Accordingly, an adaptor device for facilitating efficient recovery of fluid from a vial is provided. The device allows a substantially larger, or at least more significant, amount of a liquid medicament to be withdrawn from a vial. Generally, the device includes a puncture component that allows a flexible tube to be inserted through the seal at an angle that allows an end of a flexible tube to rest on the bottom on a vial around the edge of the vial. This may allow vial to be tipped so that the liquid pools around the end of the flexible tube, thus significantly increasing the amount of liquid that can be withdrawn for use. 
         [0006]    More specifically, an adaptor device in accordance with one embodiment comprises: a puncture component, a flexible tube, an inserter, and a coupling component. A puncture component may have a cylindrical portion, a proximal end, and a tapered distal end configured to puncture a seal. The puncture component may have a passage comprising: an entrance at or near the proximal end of the puncture component; a interior portion, connected to the entrance, and residing entirely within the puncture component; and an exit, connected to the interior portion so that the interior portion is between the first portion and the exit. In some embodiments, a puncture component may be configured to allow the entrance of the passage and the exit of the passage to be on opposite sides of the seal. An inserter may be coupled to the flexible tube and configured to direct the distal end of the tube through the passage and out of the exit of the passage. A coupling component may be configured to allow fluid communication between the proximal end of the flexible tube and a syringe. The device of any one of the preceding claims, wherein the seal is configured to be punctured by a needle for withdrawal of a medicament through the needle into a syringe. 
         [0007]    In some embodiments, the puncture component is configured to allow the entrance of the passage and the exit of the passage to be on opposite sides of the seal. 
         [0008]    In some embodiments, the device is configured to allow the flexible tube to be guided through the seal via the puncture component so that the distal end of the flexible tube extends from the exit of the puncture component at an angle that is not perpendicular to the seal. 
         [0009]    In another aspect of the invention, a method of recovering a medicament, such as a botulinum toxin, from a vial is provided, the method including the steps of drawing a medicament from the vial using an adaptor device as described herein. 
         [0010]    Each and every feature described herein, and each and every combination of two or more of such features, is included within the scope of the present invention provided that the features included in such a combination are not mutually inconsistent. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    The present invention may be more clearly understood and the advantages thereof better appreciated by considering the below Detailed Description and accompanying Drawings of which: 
           [0012]      FIG. 1A  is a perspective view of a high recovery adaptor device, in accordance with an embodiment of the invention, being used with a medicament vial having a puncturable seal; 
           [0013]      FIG. 1B  is another perspective view of the device shown in  FIG. 1 , with a recovery tube being inserted therein; 
           [0014]      FIG. 1C  is a cross-sectional view of an angled passageway feature of the device 
           [0015]      FIG. 2  is a perspective view of a device, in accordance with an embodiment of the invention, as coupled to a medicament vial; 
           [0016]      FIGS. 3 and 3A  are cross-sectional views of the device shown in  FIG. 2 ; 
           [0017]      FIG. 4  is another cross-sectional view of the device shown in  FIG. 2 , with a recovery tube inserted therein; 
           [0018]      FIG. 5  is a perspective view of another device in accordance with an embodiment of the invention; 
           [0019]      FIGS. 6 and 7  are cross-sectional views of the device shown in  FIG. 5 ; 
           [0020]      FIG. 8  is a perspective view of yet another device in accordance with an embodiment of the invention; 
           [0021]      FIGS. 9 and 10  are cross-sectional views of the device shown in  FIGS. 8 ; and 
           [0022]      FIGS. 11 and 12  are cross-sectional views of a coupling component feature of certain embodiments of the invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0023]    Turning now to the Figures, generally, an adaptor device in accordance with the invention, may comprise a puncture component, a flexible tube, an inserter, and a coupling component. While there are many ways the present adaptor may be configured, schematic drawing of some embodiments are shown. 
         [0024]      FIGS. 1A and 1B  show an adaptor device  8  comprising a puncture component  10 , the puncture component  10  being shown penetrating a medicament vial seal  50 . The adaptor device  8  may include a flexible conduit or tube  100 . The flexible tube  100  has a distal end  110  and a proximal end  102 . Tube  100  is shown in a retracted state in  FIG. 1A  and is shown in an extended state in  FIG. 1B . 
         [0025]    Puncture component  10  comprise a body  20 , for example, a cylindrical body  20 , having a proximal end  30 , and a tapered distal end  40 . Distal end  40  is configured to puncture a seal  50 , for example, an existing seal  50  on a medicament container. Such a seal is typically configured to be punctured by a needle or cannula for reconstituting medicament and/or for withdrawal of medicament through a needle into a syringe. Seal  50  may be a polymer such as a latex or rubber, polytetrafluoroethylene, a polyalkylene, an acrylic, a polyurethane, a polyalkylene, a substituted vinyl polymer, etc.; a foil such as an aluminum foil; paper; cork; etc. 
         [0026]    The puncture component  10  includes a passage  60  configured to receiving tube  100 . Passage  60  includes an inlet or entrance  70  at or near the proximal end  30  of the puncture component  10 . Passage  60  may be defined by interior wall portion  80 , connected to the entrance  70 , and residing within the puncture component  10 . Passage  60  also includes an exit  90  at the distal end of the interior portion  80 . When device  8  is in use with puncture component  10  inserted into seal  50  as shown, entrance  70  of the passage  60  and the exit  90  of the passage  60  are generally disposed on opposing sides of the seal  50 . 
         [0027]    Passage  60  may include an angle such as shown in  FIGS. 1A and 1B , such that proximal portion  62  of passage  60  is disposed substantially perpendicular to seal  50 , and distal portion  64  of passage  60  is disposed at an angle with respect to proximal portion  62 . Alternatively, passage  60  may be substantially entirely linear, without an angle between distal portion and proximal portion, such as depicted in  FIG. 1C . Thus, it can be appreciated that passage  60 , shown in  FIG. 1C  would be disposed at an angle other than perpendicular to seal  50 . 
         [0028]    Unless explicitly stated otherwise, when describing the structure and operation of the device herein, it will be assumed that the entrance  70  of the passage  60  and the exit  90  of the passage  60  are on opposite sides of the seal  50 . However, seal  50  itself may not be part of a device or a method described herein. 
         [0029]    Tube  100  and passage  60  are generally sized and structured to allow tube  100  to be easily inserted and passed through the full length of passage  60 . In certain embodiments, passage  60  has an inner diameter of about 0.1 mm to about 2 mm, and tube  100  has an outer diameter of about 0.05 mm to about 1.5 mm. 
         [0030]    More specifically, the puncture component  10  is configured so that when a flexible tube  100  is extended through the passage  60  of the puncture component  10 , the distal portion of the flexible tube  100 , e.g. the portion of flexible tube  100  between the exit  90  of the passage  60  and the distal end  110  of flexible tube  100 , may form an angle that is not perpendicular to the seal  50 . Angle of tube  100  guided by passage  60  is sized to direct distal end of tube  100  to a corner of the vial, for example, to enhance recovery of liquid medicament therefrom. When the device  8  is in use for recovering medicament, flexible tube  100  is extended distally through passage  60  such that the distal end  110  of tube  100  may rest on or near the bottom of a vial containing liquid medicament, for example, away from a center of the vial. When the liquid level is low, the vial can be tipped so that the liquid pools around the tube distal end  110 . Thus, a significantly greater amount of medicament can be withdrawn for use as compared to withdrawal by a needle in a conventional manner. 
         [0031]    As shown generally in  FIGS. 1B and 1C , device  210  is configured to direct a distal end of tube  100  in a direction not perpendicular with the a plane defined by seal  50 , when device is placed on or coupled to seal  50 . This may be accomplished in any number of ways, one of which is shown in  FIG. 1   b  and an alternative with is shown in  FIG. 1C . For example, passage  60  may be configured to direct tube at an angle not perpendicular to seal  50 . In  FIG. 1B , angle  135 , defined as the angle between longitudinal axis of proximal portion of passage  60  and longitudinal axis of distal portion of passage  60 , may be an angle of greater than 0° to less than 90°. More specifically, angle  135  may be about 10° to about 80°, about 20° to about 70°, for example, about 30° to about 60° degrees, for example, about 40° to about 50° degrees. In certain embodiments of the invention, when the adapter is in use and placed in or engaged with a seal of a vial, tube  100  generally is aligned at an angle about 40° to about 80°, about 60° to about 75°, or about 65° to about 70° from a plane defined by seal  50 . In these embodiments, tube  100  is sufficiently flexible to pass through bend  132  in passage  60 , for example, without kinking or collapsing. 
         [0032]    An inserter  200  may be coupled to the flexible tube  100 . An inserter  200  may be any feature configured to direct the distal end  110  of the tube  100  through the passage  60 , so that part of flexible tube  100  extends beyond the exit  90  of passage  60 . Some inserters may be similar to an inserter  200  depicted in  FIGS. 2-4 , discussed below. Inserter  200  may comprise a fixed component  510  which is affixed to puncture component  10 . The fixed component  510  may be an open cylinder having a platform  515  affixed toward the bottom  525  of the fixed component  510 . Puncture component  10  is affixed to the platform  515  so that it extends beyond the bottom  525  of the fixed component  510 . A cap  600  of a medicament bottle  650  may meet platform  515  so that puncture component  10  pierces seal  50  of cap  600 . 
         [0033]    A movable component  520  is moveably coupled to the fixed component  510 . Movable component  520  may be an open cylinder which slidably engages open cylinder of the fixed component  510 . Moveable component  510  may comprise a ceiling  560 . Ceiling  560  may be affixed to a descending guiding cylinder  540 . An ascending guiding cylinder  530  may extend upward from platform  515  to guide the moveable component  520  into the fixed component  510 , as shown in  FIGS. 3 and 4 . 
         [0034]    Moveable component  520  is slid into fixed component  510  to a collapsed configuration, shown in  FIG. 4 . In an extended configuration ( FIG. 3 ), flexible tube  100  is withdrawn from puncture component  10  such that distal end  110  of flexible tube  100  does not protrude past exit  90  of passage  60 . In a collapsed configuration ( FIG. 4 ), flexible tube  100  is extended past exit  90  of passage  60 , for example, such that distal end  110  of tube  100  contacts vial corner. 
         [0035]    Other inserters  200  of the invention may be configured as depicted in  FIGS. 5-7 . Turning specifically to  FIGS. 6 and 7 , in this exemplary embodiment, inserter  200  comprises fixed component  320  which is affixed to puncture component  10 . Fixed component  320  may be an open cylinder having a platform  330 . Puncture component  10  is affixed to platform  330  so that it extends beyond the bottom  340 . A cap  600  of a medicament bottle  650  may meet platform  330  so that puncture component  10  pierces seal  50  of cap  600 . 
         [0036]    Rotatable component  350  may be configured to fit inside fixed component  320  and rotate with respect to fixed component  320 . Rotatable component  350  may comprise a spool component  355  which is rotatably coupled to fixed component  320 . Spool component  355  may further comprise rotatable male fitting  360  that couples to fixed female fitting  390  that may be part of platform  330 . Flexible tube  100  may be wrapped around spool component  355  so that rotation of rotatable component  350  inserts tube  100  through passage  60 . 
         [0037]    Yet other inserters  200  of the invention may be configured as depicted in  FIGS. 8-10 . Inserter  200  may comprise fixed component  720  which is affixed to puncture component  10 . Fixed component  720  may be an open cylinder having platform  730 . Puncture component  10  is affixed to platform  730  so that it extends beyond the bottom  740  of fixed component  720 . A cap  600  of a medicament bottle  650  may meet platform  720  so that puncture component  10  pierces seal  50  of cap  600 . 
         [0038]    Turning specifically to  FIGS. 9 and 10 , rotatable component  800  may be configured to fit inside fixed component  720  and rotate with respect to fixed component  720 . Rotatable component  800  may comprise a spool component  810  which is rotatably coupled to fixed component  720 . Spool component  810  may further comprise rotatable spool fittings  830  and  840  that couple to fixed fittings  750  and  760  that may be part of platform  730 . Flexible tube  100  may be wrapped or wound around spool component  810  so that rotation of rotatable component  800  effects distal movement and insertion of tube  100  through passage  60 . 
         [0039]    In some embodiments, the inserter includes a suitable locking mechanism to prevent retraction of the tube during insertion. 
         [0040]    The coupling component  300  may be any structural feature configured to allow fluid communication between the proximal end  102  of the flexible tube and a means for withdrawing fluid therefrom, for example, a syringe. Exemplary coupling components  300  may be configured, for example, as depicted in  FIGS. 11-12 . The coupling component  300  may comprise a reservoir component  905  in fluid communication with the proximal end  102  of the flexible tube  100 . A valve  550  may be coupled to the reservoir component  905 . A syringe component  910  may be configured so that valve  550  is opened when the syringe component  910  is coupled to the reservoir component  905 . Syringe component  910  comprises stopper  960 . A gap  945  may allow flow of fluid medicament to a syringe. 
         [0041]    Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. 
         [0042]    The terms “a,” “an,” “the” and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of any claim. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention. 
         [0043]    Groupings of alternative elements or embodiments disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims. 
         [0044]    Certain embodiments are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, the claims include all modifications and equivalents of the subject matter recited in the claims as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is contemplated unless otherwise indicated herein or otherwise clearly contradicted by context. 
         [0045]    In closing, it is to be understood that the embodiments disclosed herein are illustrative of the principles of the claims. Other modifications that may be employed are within the scope of the claims. Thus, by way of example, but not of limitation, alternative embodiments may be utilized in accordance with the teachings herein. Accordingly, the claims are not limited to embodiments precisely as shown and described.