Abstract:
The present invention provides holding devices and methods for using the same. One aspect of the invention provides a holding device configured to hold a container having a dose or multiple doses of a liquid medicine with a needle-piercable cap. The holding device includes a holder for the container, a base, and an angular adjustment linkage between the base and the holder. Another aspect of the invention provides a method of loading a syringe with a liquid medicament held in a container. The method includes: providing a holding device including a holder for the container, a base, and an angular adjustment linkage between the base and the holder; placing the holding device on a surface; placing the container into the holder; and using two hands to draw the liquid medicament from the container into the syringe.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation-in-part of U.S. patent application Ser. No. 12/829,510, filed Jul. 2, 2010. The entire contents of this application is hereby incorporated by reference herein. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to a device for holding medicament containers in a position to aid withdrawal of a liquid medicament into a syringe. In particular, the devices of the present invention include a stable base that can rest on a surface or be attached to a surface to free both hands for operating the syringe. 
       BACKGROUND OF THE INVENTION 
       [0003]    A significant number of individuals administer subcutaneous injections for therapeutic purposes. For example, a significant portion of the estimated 23 million Americans with diabetes mellitus will self-administer subcutaneous insulin injections at some point. 
         [0004]    Referring to  FIG. 1 , medicaments are often provided in a vial  102 . It is often difficult for individuals to safely and accurately fill a syringe  104  with the medicament provided in the vial  102 . In order to fill the syringe  104 , the individual must hold both the vial  102  and the syringe tube  106  while pulling back on the syringe plunger  108 . Care must be taken to avoid aspirating air from the vial  102  into the syringe  104  so as to avoid an air embolism. 
         [0005]    U.S. Pat. No. 6,006,798 describes a syringe loading jig that includes a molded jig structure having cavities for the vial and the syringe and securing clips for both, as well as fastening mechanisms for securing the jig to a vertical surface. U.S. Pat. No. 5,351,866 describes a vial holder having a handle portion adapted to be carried by a human hand and a friction mount for releasably retaining a vial. 
         [0006]    U.S. Patent Application Publication No. 2004/004171 describes a safety device for holding a vial or ampule, while a syringe is used to extract liquid medication. The device is held by hand with the vial inserted, thereby permitting the vial to be distanced from the hand holding the vial or ampule. 
         [0007]    U.S. Pat. No. 5,240,047 describes a unitary one-piece needle-guide and bottle-holder device. 
         [0008]    U.S. Pat. No. 5,247,972 describes an alignment guide for hypodermic syringes. 
         [0009]    U.S. Pat. No. 6,497,697 describes a syringe guide and vial holder. 
         [0010]    The challenges of holding a vial  102  while loading a syringe  104  are particularly exacerbated in the elderly, many of whom suffer from arthritis, peripheral neuropathies, and/or other conditions that diminish strength, dexterity, and/or fine motor skills. 
         [0011]    None of the prior art appear to have solved these challenges. Simple devices and methods to aid individuals in connection with these challenges are still desirable. 
       SUMMARY OF THE INVENTION 
       [0012]    The present invention provides holding devices and methods for using the same. One aspect of the invention provides a holding device configured to hold a container having a dose or multiple doses of a liquid medicine with a needle-piercable cap. The holding device includes a holder comprising a split barrel and a base. 
         [0013]    This aspect of the invention can have a variety of embodiments. The holding device can include an angular adjustment linkage between the base and the holder. The linkage can include a ball-and-socket joint. 
         [0014]    The base can have a bottom surface that comprises a non-skid material. The non-skid material can be selected from the group consisting of: rubber, polychloroprene, silicone, and polyurethane. 
         [0015]    The holding device can include one or more suction cups on the base. The holding device can include a clamp for attaching to a mounting surface. 
         [0016]    Another aspect of the invention provides a method of loading a syringe with a liquid medicament held in a container. The method includes: providing a holding device including a holder including a split barrel and a base; mounting the holding device on a surface; placing the container into the holder; and using two hands to draw the liquid medicament from the container into the syringe. 
         [0017]    This aspect of the invention can have a variety of embodiments. The holding device can include an angular adjustment linkage and the method can include adjusting the angle of the container relative to the mounting surface to facilitate drawing the medicament into the syringe without air. The surface can be selected from the group consisting of: a refrigerator, a cabinet, a countertop, and a table. 
         [0018]    Another aspect of the invention provides a holding device configured to hold a container having a dose or multiple doses of a liquid medicine with a needle-piercable cap. The holding device includes a holder comprising a split barrel and a suction cup. The holding device is fabricated from a single piece of material. 
         [0019]    This aspect of the invention can have a variety of embodiments. The material is plastic. The material can be rubber. 
         [0020]    Another aspect of the invention provides a holding device configured to hold a container having a dose or multiple doses of a liquid medicine with a needle-piercable cap. The holding device includes a holder for the container, a base, and an angular adjustment linkage between the base and the holder. 
         [0021]    This aspect of the invention can have a variety of embodiments. The linkage can include a ball-and-socket joint. The base can have a bottom surface that comprises a non-skid material. The non-skid material can be selected from the group consisting of: rubber, polychloroprene, silicone, and polyurethane. 
         [0022]    The base can be a tripod. The holding device can include one or more suction cups on the base. The base can include a clamp for attaching to a mounting surface. The holder can include one or more resiliently flexible walls adapted to press against the container. 
         [0023]    The holder can include one or more levers configured to flex the one or more resiliently flexible walls, thereby allowing insertion or removal of the container. The holder can be a split barrel. The holder can be a clip. The clip can be a binder clip. 
         [0024]    Another aspect of the invention provides a method of loading a syringe with a liquid medicament held in a container. The method includes: providing a holding device including a holder for the container, a base, and an angular adjustment linkage between the base and the holder; placing the holding device on a surface; placing the container into the holder; and using two hands to draw the liquid medicament from the container into the syringe. 
         [0025]    This aspect of the invention can have a variety of embodiments. The method can further include adjusting the angle of the container relative to the surface to facilitate drawing the medicament into the syringe without air. The surface can be selected from the group consisting of: a refrigerator, a cabinet, a countertop, and a table. 
         [0026]    Another aspect of the invention provides a holding device configured to hold a container having a dose or multiple doses of a liquid medicine with a needle-piercable cap. The holding device includes a holder for the container, the holder comprising a binder clip, and a base. 
         [0027]    This aspect of the invention can have a variety of embodiments. The base can be a tripod. The tripod can include an angular adjustment linkage. 
     
    
     
       FIGURES 
         [0028]    For a fuller understanding of the nature and desired objects of the present invention, reference is made to the following detailed description taken in conjunction with the accompanying drawing figures wherein like reference characters denote corresponding parts throughout the several views and wherein: 
           [0029]      FIG. 1  depicts an insulin vial and a syringe according to the prior art. 
           [0030]      FIG. 2A  is a multiview orthographic projection of a vial-holding device including a ball-and-socket joint according to one embodiment of the invention, with vial. 
           [0031]      FIG. 2B  depicts a vial-holding device including a clamp according to one embodiment of the invention. 
           [0032]      FIG. 2C  depicts a front elevational view of a device according to another embodiment of the invention having a suction cup. 
           [0033]      FIG. 2D  provides cross-sectional side view of the vial-holding device of  FIG. 2C . 
           [0034]      FIGS. 2E and 2F  depict the vial-holding device of  FIG. 2A  with tilted vial and inserted syringe. 
           [0035]      FIG. 3  depicts a method for loading a syringe with a substance held in a vial. 
           [0036]      FIG. 4  depicts a one-piece vial-holding device. 
           [0037]      FIGS. 5A-5C  depicts a vial-holding device having a binder clip and a tripod according to one embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0038]      FIG. 2A  provides a multiview orthographic projection of a vial-holding device  200  with vial according to an embodiment of the invention. Vial-holding device  200  includes a base  202  and a vial holder  204 . 
       Base 
       [0039]    Base  202  can be any device capable of securing the vial-holding device  200  in a manner sufficient allow for piercing of the septum  206  of the vial  102 . In some embodiments, the base  202  is configured for mounting on a mounting surface such a table, countertop, and the like. In such an embodiment, base  202  can include a substantially flat bottom surface  208 . The base is sized and weighted (if necessary or desirable) to provide stability to the vial while manipulating a syringe to withdraw fluid from the vial. Those skilled in the mechanical arts can provide a suitable base. 
         [0040]    The base  202  can be made of, or can have attached to the bottom surface  208 , a material with a high coefficient of static and/or dynamic friction vis-à-vis surfaces on which the device  200  may be placed (e.g., wood, stone, and the like). Suitable materials with high friction include non-skid polymers such as rubber, polychloroprene (also known as neoprene), silicone, polyurethanes (available, for example, under the SORBOTHANE® trademark from Sorbo, Inc. of Twinsburg, Ohio), and the like. In some embodiments, one or more weights (e.g., lead, rocks, plates, and the like) can be used to apply additional force to surface  208  to limit movement. Such weight can be molded into the base or added to the base in any convenient manner well known to those skilled in the mechanical arts. 
         [0041]    In another embodiment depicted in  FIG. 2B , one or more clamps  213  can be used to secure base  202  to the mounting surface. 
         [0042]    In still another embodiment depicted in  FIGS. 2C and 2D , base  202  can be or can be coupled to one or more suction devices  214 . Exemplary suction devices  214  include suction cups that are actuated by pressing the suction cup against a mounting surface to displace air between the suction cup and the mounting surface. One embodiment of a suction cup that has been tested successfully has an inner radius of 0.875 inch when looking at a cross-section through the center of the cup. 
         [0043]    In yet another embodiment, base  202  can include one or more magnets (not depicted) for mounting on ferrous surfaces. 
       Vial Holder 
       [0044]    Vial holder  204  is a device capable of holding a vial  102  tightly while a syringe is inserted into the vial  102 . 
         [0045]    The vial holder can include one or more resiliently-flexible walls adapted to press against and thereby hold the vial  102 . For example, in some preferred embodiments, vial holder  204  includes a split barrel structure  210  that can flex to receive and securely hold vial  102 . Although split barrel structure  210  in  FIG. 2  typically has an opening of about 120°, one of ordinary skill in the art will appreciate that opening can range from about 0° to a maximum opening that still is capable of frictionally holding the container. The opening of course will depend on the flexibility of the material as well as the friction between the material and the container. For example, opening can be about 0°, about 5°, about 10°, about 15°, about 20°, about 25°, about 30°, about 35°, about 40°, about 45°, about 50°, about 55°, about 60°, about 65°, about 70°, about 75°, about 80°, about 85°, about 90°, about 95°, about 100°, about 105°, about 110°, about 115°, about 120°, about 125°, about 130°, about 135°, about 140°, about 145°, about 150°, about 155°, about 160°, about 165°, about 170°, and about 175° depending on the material used. 
         [0046]    A number of other techniques can be used to couple vial  102  with vial holder  204 . For example, vial holder  204  can include a strap to hold vial against a surface (e.g., a curved surface). In another example, the vial  102  can include a ferrous material and vial holder can include one or more magnets. In still another example, vial holder  204  and a vial  102  can include corresponding hook-and-loop fasteners (available, for example, under the VELCRO® trademark from Velcro USA Inc. of Manchester, New Hampshire). Further, other containers for liquid medicaments, such as, e.g., ampules, can also be held by similar holding devices modified to accommodate the container geometry by techniques well known to those skilled in the art. 
       Linkages 
       [0047]    In some embodiments, vial-holding device  200  includes a linkage  212  for coupling base  202  and vial holder  204 . In other embodiments, base  202  and vial holder  204  are formed from single piece of material. 
         [0048]    Preferred linkages permit angular rotation of the vial or other container. In one example, linkage  212  is a ball-and-socket joint. Such an embodiment can be a particularly helpful feature for preventing aspiration of air in the vial  102  into syringe  104 . 
         [0049]    As illustrated in  FIG. 2E , if the vial  102  is held horizontally and, if the user angles the syringe  104  even slightly upward, air can be aspirated into the syringe  104 , particularly as the substance in the vial  102  is withdrawn. 
         [0050]    However, as depicted in  FIG. 2F , users of preferred embodiments of the invention can manipulate linkage  212  to angle vial holder  204  and vial  102  so that the liquid in the vial  102  covers the syringe needle during loading. Moreover, if the user angles the syringe  104 , the syringe  104  will be less likely to aspirate air. 
         [0051]    Although the vial holder  204  is depicted as angled approximately 15° from horizontal, one of ordinary skill in the art will appreciate that vial holder  204  can be adjusted to any desired angle from horizontal depending on the particular adjustable linkage that is used. For example, vial holder  204  can be adjusted to about 0° from horizontal, about 5° from horizontal, about 10° from horizontal, about 15° from horizontal, about 20° from horizontal, about 25° from horizontal, about 30° from horizontal, about 35° from horizontal, about 40° from horizontal, about 45° from horizontal, and the like. Also, the vial-holding device  200  can be mounted on a vertical surface and the vial holder  204  can be positioned at about 50° from horizontal, about 55° from horizontal, about 60° from horizontal, and the like. Also, the holding device can be mounted on a vertical surface and the angular adjustment made from the vertical to aid filling a syringe. 
         [0052]    In order to facilitate a desired angle vial  102 , vial holder  204  can, in some embodiments, be elevated further from the bottom of base  202 . For example, vial-holding device  200  can be configured such the bottom of vial  102  is held any desired distance d from the bottom of base  202 . In preferred embodiments, the distance d is approximately the same dimension as the height of the container to be held. Typically, the distance d can be between about 1″ and about 4″. For example, distance d can be about 1″, about 2″, about 3″, and about 4″. However, for particular circumstances, d can be greater; in such cases the base of the device may also need to be larger for stability. 
       Materials 
       [0053]    One of ordinary skill in the art will appreciate that base  202 , vial holder  204 , and linkage  212  can be fabricated from a variety of materials including metals, plastics, wood, and the like by use of various manufacturing techniques such as molding, casting, machining, and the like. However, as noted above, when the vial holder provides a friction fit to hold the vial during withdrawing liquid into a syringe, the material must have sufficient flexibility to accommodate the vial and must provide the friction fit either by the material of the holder or a lining material added to the holder. 
       Methods of Loading Syringes 
       [0054]    Referring now to  FIG. 3 , a method  300  is provided for loading a syringe with a liquid substance held in vial or other suitable medicament container. 
         [0055]    In step S 302 , a vial-holding device is provided. The vial-holding device can be one of the embodiments provided herein. For example, the vial-holding device can include a vial holder with a split barrel and a base. In another example, the vial-holding device can include a vial holder that can be adjusted angularly such that when the vial is inserted into the vial holder, the vial can be angled as desired with respect to a horizontal line or a vertical line, depending on the orientation of the surface on which it is mounted. In still another example, the vial-holding device can include a binder clip and/or a tripod as discussed below. 
         [0056]    In step S 304 , the vial-holding device is optionally placed on a surface such as a table, a countertop, a refrigerator door, a cabinet door, and the like. 
         [0057]    In step S 306 , the vial is placed in the vial holder and the angle adjusted with appropriate device holders permitting an angular adjustment. 
         [0058]    In step S 308 , the substance in the vial is drawn from the vial into the syringe using both hands to manipulate the syringe. For example, the vial septum can be pierced with the syringe needle (step S 308   a ). The syringe plunger can then be withdrawn to draw the liquid in the vial into the syringe (step S 308   b ). 
         [0059]    In some embodiments, two hands are used to hold operated the syringe. In other embodiments, one hand can be used, at least in part, to prevent the vial holding device from sliding during syringe insertion 
       One-Piece Vial-Holding Device 
       [0060]    Referring now to  FIG. 4 , a one-piece vial-holding device  400  is provided. Vial-holding device  400  includes a split barrel structure  410  coupled to a suction cup  408 . 
         [0061]    Vial-holding device  400  can be fabricated from single piece of material such as plastics, rubbers, metals, and the like by techniques such as molding, casting, machining, and the like. 
       Working Example 
       [0062]    Referring now to  FIG. 5 , a holding device  500  is provided according to an embodiment of the invention. The holding device  500  includes a tripod base  502  and a clip holder  504  for holding a vial  102 . 
         [0063]    The tripod  502  can be any device having three legs. For example, the tripod can be a commercially-available table-top tripod such as the ALPEN® Micro-Adjustable Table Top Tripod  705  available from Alpen Outdoor Corporation of Cucamonga, Calif.; the BURRIS™ 300156 Camera/Spotting Scope Pack Pod available from Greeley, Colo.; the BUSHNELL® Ultra Compact Table Top Tripod 784406C available from Bushnell Corporation of Overland Park, Kan.; the CARSON® HANDIPOD Pocket Fold-Flat Tripod TA-2 available from Carson Optical, Inc.; and the like. 
         [0064]    The tripod  502  can, in some embodiments, include one or more feet having a non-skid material as discussed herein. The tripod  502  can also include an angular adjustment linkage  508  configured to alter the orientation of the clip holder  504 . Tripod  502  can include a male-threaded member (not depicted) for coupling with clip holder  504 . The clip holder  504  can include a female-threaded bore (not depicted) adapted to couple with the male-threaded member of the tripod  502 . Alternatively, a nut (e.g., a nut made from a metal, a polyamide, nylon, or the like) can be bonded to clip holder (e.g., by adhesive, welding, brazing, and the like) for coupling with the tripod  502 . Clip holder  504  can, in some embodiments, be a binder clip (e.g., a 2″ binder clip) as described in U.S. Pat. No. 1,139,627. Wires  510   a,    510   b  act as levers that can be compressed to cause the binder clip  504  to expand and allow for insertion and removal of vial  102 . In some embodiments, wires  510  are bent (e.g., about 90°) as depicted in  FIG. 5A   
       Advantages 
       [0065]    The vial-holding devices  200 ,  400  described herein advantageously allow for the use of both hands to pierce the septum  206  of vial  102 . Additionally, because the vial-holding devices  200 ,  400  can be mounted on virtually any surface, a vial  102  can be removed from a refrigerator and immediately placed within a vial-holding device  200 ,  400  placed on an a refrigerator door or adjacent countertop or cabinet. Thus, the invention reduces the risk of dropping and potentially breaking a vial  102 . 
       Equivalents 
       [0066]    The foregoing specification and the drawings forming part hereof are illustrative in nature and demonstrate certain preferred embodiments of the invention. It should be recognized and understood, however, that the description is not to be construed as limiting of the invention because many changes, modifications and variations may be made therein by those of skill in the art without departing from the essential scope, spirit or intention of the invention. Also, various combinations of elements, steps, features, and/or aspects of the described embodiments are possible and contemplated even if such combinations are not expressly identified herein. 
       Incorporation by Reference 
       [0067]    The entire contents of all patents, published patent applications, and other references cited herein are hereby expressly incorporated herein in their entireties by reference.