Patent Publication Number: US-8522842-B2

Title: Vial stabilizer

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of provisional patent application 61/187,087 filed Jun. 15, 2009 by the present inventors and the application is hereby incorporated by reference in its entirety. 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not Applicable 
     NAMES OF PARTIES TO JOINT RESEARCH AGREEMENT 
     Not Applicable 
     REFERENCE TO SEQUENCE LISTING 
     Not Applicable 
     DESCRIPTION OF ATTACHED APPENDIX 
     Not Applicable 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The disclosed invention relates to a holder for stabilizing vials during reconstitution, infusion or fluid transfer between vials. 
     2. Description of Related Art 
     Many products, especially in the healthcare industry, are stored in a freeze dried or powdered formulation rather than in a liquid form. This is done for a variety of reasons, including to increase the shelf life of the medication by preventing premature degradation of the drug. Another common reason is to reduce the weight and size of the product, thus decreasing shipping and packaging costs. Due to this common practice of packaging compositions in a freeze dried, powdered or lyophilized form, users, and especially health care workers, frequently encounter the need to reconstitute a vial of a dry formulation to a liquid form so that it may be used. In the medical field, reconstitution is often performed so the medication can then be administered to the patient via oral, injection or other methods. 
     A common practice employed by health care workers in order to accomplish reconstitution of dried medicine is to fill a syringe with diluent and then inject the diluent into the top stopper of the dried medication vial, using a needle on the end of the syringe. In some cases this practice is not practical as the volume of diluent required is greater than what can fit in a syringe. In that instance, the health care worker resorts to attaching a needle, spike or rigid cannula to a bottle of diluent and then turning the diluent bottle upside down over the top of the medication bottle to allow the fluid contents to transfer from the diluent bottle to the medication bottle. The latter is a common practice, particularly in the field of home infusion therapy and to some extent in healthcare fields in general. 
     The above described practice invites issues surrounding safety, stability and efficiency. When the diluent vial, is up-ended over the medication bottle, and held precariously only by the needle, spike or cannula, the top vial tips and moves. At best it leans wildly. To avoid a disastrous result incurred by the diluent vial falling off or becoming disengaged from the medication bottle, the healthcare worker must hold the diluent vial manually over the top of the medication vial for several minutes for the fluid to infuse. Often multiple vials must be reconstituted for one patient encounter. During this tedious process the healthcare worker&#39;s hands are engaged in holding the vials and the healthcare worker cannot perform other activities. 
     The above employed practices are slow, inefficient, unprofessional and dangerous. The vials of medication are frequently very expensive and must be held so they do not fall and break. They must also be held so the top vial does not inadvertently detach. Were the top vial to detach, the patient could be injured by the needle or the sterility of the vial and its contents could be compromised should the needle or cannula touch other surfaces. 
     There is a need for an efficient, safe, professional way to hold vials during the reconstitution of medications or the transfer of fluids from one vial to another. Such a method and apparatus must be relatively inexpensive, easy to break down and pack, small and light enough to transport, and easy and fast to use. 
     NOTATION AND NOMENCLATURE 
     Certain terms are used throughout the following description to refer to particular method components. As one skilled in the art will appreciate, design and manufacturing companies may refer to a component by different names. This document does not intend to distinguish between components that differ in name but not function. 
     In the following discussion, the terms “including” and “comprising” are used in an open-ended fashion, and thus should be interpreted to mean “including, but not limited to . . . ” Also, the term “couple” or “couples” is intended to mean either an indirect or direct connection. Thus, if a first device couples to a second device, that connection may be through a direct connection or through an indirect connection via other intermediate devices and connections. Moreover, the term “method” means “one or more components” combined together. Thus, a method can comprise an “entire method” or “sub methods” within the method. 
     The terms “bottle” and “vial” are used interchangeably and have the same or substantially similar meaning when used herein. 
     The terms “band” and “strap” are used interchangeably and have the same or substantially similar meaning when used herein. 
     SUMMARY OF THE INVENTION 
     The disadvantages in the prior art are solved by the disclosed method and apparatus for holding and stabilizing vials of medication and vials of diluents during the transfer of fluids. 
     The disclosed apparatus comprises a flat base of large enough area to accommodate a plurality of bottles or vials lined up sequentially. In the preferred embodiment, the apparatus has a vertical arm extending up from each end of the base and has a slider arm and knob for purposes of height adjustment to accommodate vials of varying height. Stretched across the top of the device, being looped over or otherwise attached to each vertical arm, is a stabilizer band that may be a closed loop band or may comprise two independent bands. The stabilizer band may have elastic properties for ease of application and removal. 
     The disclosed method and apparatus allows the healthcare worker to line up one or more bottles of dried formulation along the base, attach a needle, cannula or spike to the bottle of diluent, and then up-end the diluent bottle over the bottle of dried formulation to safely and efficiently reconstitute multiple bottles of medication or other product concurrently. The apparatus safely stabilizes the bottles, preventing the possibility of contamination, needle stick, breakage, spillage, or waste. Use of the apparatus enables the healthcare worker to do other necessary tasks, rather than holding each bottle of diluent individually while waiting for reconstitution to slowly occur. 
     As home care infusion time is often billed by the hour, minutes are valuable. The quicker the healthcare worker is able to deliver the vital and expensive medications to the patients, the greater the savings to the patient and the healthcare agency. 
     Home care infusion workers and home health nurses typically must travel to and from patient homes. Any equipment they transport with them must be very easily portable and storage efficient. 
     The disadvantages described herein are solved by a method and apparatus for safely stabilizing vials during fluid transfer or reconstitution of a dried formulation. 
     It is an objective of the disclosed invention to provide a small tool to enable more efficient and professional medication reconstitution or fluid transfer, and with an apparatus that is easily dismantled and compactly packed for storage or transport. 
     It is an objective of the disclosed invention to reduce the possibility of contamination during medication reconstitution or fluid transfer. 
     It is an objective of the disclosed invention to provide a method and apparatus whereby the health care worker does not have to physically hold the vials during medication reconstitution or fluid transfer. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The application makes no claim for the structure of certain objects depicted in the photos and drawings, such as drawings of vials or bottles, and they are considered prior art. 
       The drawings contained herein represent preferred embodiments of the invention and are not intended to limit the scope. For a detailed description of various embodiments, reference will now be made to the accompanying illustrative drawings in which: 
         FIG. 1  illustrates a front view of a preferred embodiment of the apparatus. 
         FIG. 2  illustrates a front view of a preferred embodiment of the apparatus. 
         FIG. 3  illustrates an exploded view of a preferred embodiment of the apparatus. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       FIG. 1  illustrates a front view of a disclosed preferred embodiment for the disclosed bottle stabilizer apparatus  10 . The base  12  of the apparatus  10  may be of varying sizes. The prototype developed by the inventor employed a base  12  that was four inches wide, fourteen inches long and six inches tall, although any deviation from the expressed measurements is acceptable in order to accommodate various types and sizes of vials including medication vials  14  and diluent vials  16 . The base  12  may be of any stable composition and may include wood, plastic, composite, metal, rubber, glass or other stable flat surface. In the preferred embodiment a lightweight plastic composite base  12  was used. 
     The base  12  may have flat felt, rubber or other soft small discs or feet to protect the surface on which the base  12  sits. 
     A vertical arm  18  rises from each end of the base  12 . The base  12  may have a groove  20  such that the vertical arm  18  can slide into the groove  20  and lock into place. 
     Each vertical arm  18  may be of varying heights but in the preferred embodiment each is between four inches and eight inches in height. In order to provide for adjustment of the apparatus  10  to support bottles of varying heights, the vertical arm  18  may comprise two parts, one part being an adjustment slider arm  22  and the other part being a slider arm housing  24 , into which the slider arm  22  may retract or protrude from. The adjustment slider arm  22  extends up from the slider arm housing  24  by at least one half inch or a length sufficient for grasping between two fingers and sufficient for secure placement of a stabilizer band  28  around the top. In the preferred embodiment, the top of the adjustment slider arm  22  has a notch  26  such that the band  28  rests in the notch  26  and thus does not unintentionally slide up or down on the slider arm  22 . 
     To accommodate vials of varying sizes, the adjustment slider arm  22  may be raised or lowered as needed. In the preferred embodiment, located on the exterior surface of the slider arm housing  26  is a twistable adjustment knob  30  having a central leg protruding through a slot in the slider arm housing  24  and capable of making contact with the slider arm  22 . The knob  30  may be loosened, withdrawing the central leg, so that the user can raise or lower the slider arm  22  as desired. Once the slider arm  22  is at the desired height, the user may tighten the knob  30 , protruding the central leg of the knob to make contact with the slider arm  22  to hold the slider arm  22  in place. 
     The slider arm  22  and the slider arm housing  26  may be made of a variety of materials but in a preferred embodiment are made of a lightweight metal. They may also be composite plastic or any other suitable rigid composition. The slider arm housing  26  may be of varying size but in a preferred embodiment is between five and seven inches tall, between one half inch and one inch wide and between one and two inches across. These measurements may vary depending on the specific contemplated use of the apparatus and size of the bottles or vials being used. 
     Although medicinal use is contemplated as a viable use of the described method and apparatus, the vial stabilizer described herein could be employed for a variety of non-medical uses as well, including any situation where a fluid transfer from one bottle to another was necessitated and support of the top bottle would be of assistance. 
     It is also pointed out that the disclosed apparatus should not require FDA approval as it is not a device that participates in any way with the medicinal contents or the actual fluid transfer, rather it is merely a rack or stabilizer for the vials, much in the way that an intravenous pole may hold an intravenous bag or a medicine cup holds a patient&#39;s medicine prior to the patient consuming it. Further, the device could be used to support any type of non-medical bottles or vials during fluid transfer as well. 
       FIG. 2  illustrates a front view of the apparatus without vials in place, illustrating the base and features more clearly and showing the apparatus itself as it could be used to support vials or bottles during any medical or non-medical fluid transfer. 
       FIG. 3  illustrates an exploded view of the apparatus revealing its parts in greater detail. This view better depicts the groove  20  where, in the preferred embodiment, the vertical arm  18  has a corresponding protruding edge  32  at its end surface, capable of sliding into the groove  20  and locking into place. This feature enables the device to be easily dismantled and compactly stored for travel or during periods of nonuse. In an alternative embodiment, the vertical arm  18  may simply be permanently attached to the base  12 , or temporarily attached in some other fashion. 
     In the preferred embodiment, the adjustment knob  30  has, as pictured, a twistable exterior portion which has a central leg protruding into the slider arm housing  24  as shown to where it can make contact with the slider arm  22 . When the adjustment knob  30  is turned to the left the central leg retracts from the slider arm  22  so that the slider arm  22  may be raised or lowered. When the knob  30  is turned to the right the central leg of it protrudes and makes contact with the slider arm  22  in order to hold the vertical arm  18  in place upon reaching the desired height. 
     In the disclosed apparatus, the stabilizer band  28  can comprise either a closed loop or two single bands, with or without elastic properties, provided the stabilizer band travels from the top of one vertical arm  18  to the other, along each side of the apparatus  10 . The stabilizer band may loop over the outside of the top of the vertical arms  18 , may clip into a notched area  26 , or by any reasonable means, affix to the top of each vertical arm  18 . The band  28  should be of a size that it is taut upon being looped over the top of each vertical arm  18 , or clipped into its place on the arm  18 . Although a rubberized band  28  is depicted in the preferred embodiment, any type of stretchy, taut stabilizer of varying width and thickness can be used. 
     In the preferred embodiment, as depicted in  FIG. 1 , the medication bottle  14  sits on the base  12 . A diluent bottle  16  is up-ended over the medication bottle  14 . The diluent bottle  16  is stabilized by resting between the inner sides of a closed loop band  28  or between the inner sides of two individual bands  28 . 
     If desired the base may incorporate a plurality of slightly sunken round spots for each bottom vial to sit on, providing even more bottle stability. 
     The method and apparatus disclosed herein effectively keep the bottles from tipping over, allow the transfer to be conducted on multiple bottles or containers at once, and represent a safer, more efficient way to effectuate the reconstitution of medicine or other contents, solving multiple problems inherent in the prior art. 
     The apparatus disclosed is designed to set up quickly, be disassembled quickly, and, once disassembled, take up very little space. 
     Although the figures disclosed herein represent a preferred embodiment of an apparatus for stabilizing bottles or vials during the transfer of fluids or medicines, the invention should not be limited to this specific apparatus. The method disclosed herein may be achieved by any similar device that provides for stabilization of one or more bottles during a contents transfer. 
     While the disclosed method and apparatus has been described in conjunction with the preferred embodiments thereof, many changes, modifications, alterations and variations will be apparent to those skilled in the art. The invention should therefore not be limited to the particular preferred embodiment disclosed but should include all embodiments that could fall within the scope of the claims. 
     Accordingly, the preferred embodiments of the invention shown in the drawings and described in detail above are intended to be illustrative, not limiting, and various changes may be made without departing from the spirit and scope of the invention as defined by the claims set forth below.