Abstract:
A method and apparatus for reconstituting a multiple component material is disclosed. More particularly, the present invention discloses an apparatus utilizing an operator controllable pressurization device to generate a pressure differential between two receptacles attached to the device. The receptacles may contain individual components of a multiple component material, and may include liquid-liquid or liquid-solid compounds. The apparatus includes a material transfer lumen attachable to a first and second component receptacle. A pressurization lumen is connected to one of the component receptacles to facilitate material transfer. One embodiment of the present invention utilizes a negative pressure differential created in the second receptacle to facilitate transfer. In another embodiment, a positive pressure is created in the first receptacle to force material transfer between the two receptacles.

Description:
BACKGROUND OF THE INVENTION THE DEVICE  
         [0001]    Many drugs administered to patients comprise a compound of medicament components mixed shortly before use. Oftentimes it is necessary to store these substances in separate receptacles until use. Reconstitution of the compound may require the mixing of a liquid-phase component and a solid-phase component, or the mixing of two liquid-phase components. Commonly, the solid-phase component is in powder form to permit stable storing of a component. The receptacles used to store these components may be constructed of glass, plastic, or other suitable material.  
           [0002]    One way currently used to reconstitute material requires a first component to be injected with a syringe into a receptacle containing a second component. For example, a syringe having a needle attached thereto is inserted through the rubber membrane top of a receptacle containing a first liquid-phase component, and the liquid-phase component is withdrawn into the syringe barrel. The needle is then removed from the liquid-phase component receptacle. Subsequently, the needle of the syringe is inserted through the rubber membrane top of the second liquid-phase or solid-phase component receptacle, and the liquid-phase component is injected from the syringe barrel into the second receptacle. The second receptacle is shaken to mix the components. Thereafter, a needle, attached to a syringe, is inserted through the rubber membrane top, the component mixture is drawn into the syringe barrel, and the needle is removed from the receptacle. The component mixture may then be administered.  
           [0003]    An improvement to this process is the subject of U.S. Pat. No. 5,445,631, entitled “Fluid Delivery System”, to Tadatoshi et al. The device of that invention includes a double-ended spike containing a lumen. The problem created by the device disclosed therein failed to address pressurize equalization between the individual component containers. As a result, the rate of material transfer is in constant fluctuation due to thermodynamic issues.  
           [0004]    These problems were addressed in WO 96/29112, entitled “Fluid Control Device”, to Handelman et al. The Handelman device utilizes pressurized component vials storing their contents under a high vacuum to create a pressure differential.  
           [0005]    With respect to these devices, it is desirable to have a system capable of reconstituting a multiple component material using commercially available component storage receptacles. Additionally, it is desirable to have a reconstitution system wherein the operator may control the rate of reconstitution. Yet another problem associated with drug reconstitution is that some drugs, e.g. drugs used for chemotherapy, may be hazardous to hospital personnel. It is, thus, also desirable to have a reconstitution device and method that reduces or eliminates the possibility of inadvertent needle sticks.  
         BRIEF SUMMARY OF THE INVENTION  
         [0006]    The present invention discloses a method and apparatus for reconstituting a multiple component material. More particularly, the present invention discloses a method and apparatus utilizing an operator-controlled pressurization differential to transfer and reconstitute solutions. The individual components may comprise liquid-liquid, or liquid-solid mixtures. For example, the present invention is especially useful for reconstituting a fibrinogen-based tissue sealant. Another use of the present invention involves the reconstitution of multiple component chemotherapy drugs. In sum, the present invention in its broadest sense should not be construed to be limited to any particular multiple component materials, although particular examples may be shown and disclosed.  
           [0007]    In one embodiment, a first receptacle receiver having at least a material flow lumen and a pressure lumen in communication therewith is in fluid communication with a second receptacle receiver through said material flow lumen. A user-controllable source of positive pressure is used to create a pressurization differential between the first and second receptacles, thereby resulting in transfer of the materials.  
           [0008]    In yet another embodiment, a first receptacle receiver having at least a material flow lumen in communication therewith is in fluid communication through said material flow lumen with a second receptacle receiver having a pressure lumen in communication therewith. A user-controllable source of negative pressure is used to create a pressurization differential between the first and second receptacles, thereby resulting in a material transfer.  
           [0009]    Also disclosed in the present invention is a method of reconstituting a solution, comprising the steps of creating fluid communication between a first receptacle and a second receptacle, and creating a pressure differential between said first receptacle and said second receptacle, thereby causing the contents of the first receptacle to flow into said second receptacle.  
           [0010]    Other objects, features, and advantages of the present invention will become apparent from a consideration of the following detailed description. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]    The apparatus of the present invention will be explained in more detail by way of the accompanying drawings, wherein:  
         [0012]    [0012]FIG. 1 is a side elevation view of an embodiment of the reconstitution device of the present invention;  
         [0013]    [0013]FIG. 2 is a side view of the reconstitution device illustrated in FIG. 1;  
         [0014]    [0014]FIG. 3 is a side cross-sectional view of the reconstitution device illustrated in FIG. 1;  
         [0015]    [0015]FIG. 4 is a side cross-sectional view of the reconstitution device of the present invention utilizing a syringe to provide a pressure differential;  
         [0016]    [0016]FIG. 5 is a side view of another embodiment of the reconstitution device of the present invention having an enclosed first receptacle receiver;  
         [0017]    [0017]FIG. 6 is a side cross-sectional view of the reconstitution device illustrated in FIG. 5;  
         [0018]    [0018]FIG. 7 is a side elevation view of another embodiment of the reconstitution device of the present invention;  
         [0019]    [0019]FIG. 8 is a side view of the reconstitution device illustrated in FIG. 7 having a first receptacle and second receptacle connected to the device;  
         [0020]    [0020]FIG. 9 is a side cross-sectional view of the reconstitution device illustrated in FIG. 7 showing the device prior to use; and  
         [0021]    [0021]FIG. 10 is a side cross-sectional view of the reconstitution device illustrated in FIG. 7 showing the device in use. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0022]    Disclosed herein is a detailed description of various illustrated embodiments of the present invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention. The section titles and overall organization of the present detailed description are for the purpose of convenience only and are not intended to limit the present invention.  
         [0023]    The reconstitution device of the present invention is used to facilitate the transfer of components between separate component receptacles. More particularly, the present invention permits the user to create a pressure differential between a first component receptacle and a second component receptacle, thereby enabling efficient material transfer between receptacles. The present invention enables the operator to transfer material from commercially available component receptacles with increased user safety. In addition to increasing safety, the present invention greatly reduces the likelihood of material contamination. As those skilled in the art will appreciate, the present invention is simple and inexpensive to manufacture and utilizes existing component receptacles. It is anticipated as being within the scope of the present invention to produce a reconstitution device capable of functionally coupling with a plurality of component receptacles in a plurality of sizes.  
         [0024]    [0024]FIG. 1 shows an apparatus  10  for reconstituting a multiple component material having a first receptacle receiver  12 , a second receptacle receiver  14 , a device body  16  positioned therebetween, and a vacuum device interface  18 . As those skilled in the art will appreciate the present invention may be manufactured in a plurality of sizes to accommodate a variety of receptacle sizes. The apparatus  10  may be constructed of a plurality of materials, including, without limitation, polyethylene, polypropylene, polystyrene, or a like material.  
         [0025]    As shown in FIG. 2, the apparatus  10  comprises a first receptacle receiver  12  having a first receptacle stop  20  and receptacle support members  22   a  and  22   b  terminating in receptacle locking members  24   a  and  24   b . A first receptacle orifice  26  is formed by the first receptacle stop  20  and may include receptacle support members  22   a  and  22   b . If desired, alternate embodiments of the present invention may be manufactured without the receptacle support members  22   a  and  22   b . Positioned within the first receptacle orifice  26  is a first component cannula  28  having a first pointed tip  30  and a first component withdrawal port  32 . The second receptacle receiver  14  comprises a second receptacle stop  34  and a second component cannula  36  having a second pointed tip  38  and disposing a vacuum port  40  and a transfer port  42 . Interposed between the first receptacle receiver  12  and the second receptacle receiver  14  is a device body  16  having a pressurization interface  18  positioned thereon.  
         [0026]    [0026]FIG. 3 shows a sectional view of the present invention. As shown in FIG. 3, the pressurization interface  18  forms a pressurization orifice  44 , which is in communication with the pressurization port  40  through pressurization lumen  46  located within the second cannula  36 . The transfer lumen  50 , located adjacent to the pressurization lumen  46  within the second cannula  36 , terminates at the transfer port  42  and is in communication with the withdrawal port  32  located on the first cannula  28 .  
         [0027]    [0027]FIG. 4 shows the present invention using a syringe  56  as a pressurization device. The syringe  56  comprises a syringe body  62 , a syringe distal tip  64 , a syringe plunger  66 , and a syringe pusher  68 . The syringe distal tip  64  is positioned within the pressurization orifice  44  formed by the pressurization interface  18 . A first receptacle  58  is positioned within the first receptacle receiver  12  such that receptacle locking members  24   a  and  24   b  securely position the first receptacle  58  within the receptacle orifice  26 . A second receptacle  60  is positioned within the second receptacle receiver  14 . As shown in FIG. 4, locating the first receptacle  58  within the first receptacle receiver  12  results in the first pointed tip  30  of the first cannula  28  piercing the sealing material (not shown) of the first receptacle  58 , thereby positioning the first cannula  28  within the first receptacle  58 . Likewise, locating the second receptacle  60  within the second receptacle receiver  14  results in the second pointed tip  38  of the second cannula  36  piercing the sealing material (not shown) of the second receptacle  60 , thereby positioning the second cannula  36  within the second receptacle  60 . The first cannula  28  and the second cannula  36  may be manufactured from a plurality of materials, including, without limitation, polyethylene, polypropylene, polystyrene, stainless steel, or a like material.  
         [0028]    A second embodiment of the present invention is illustrated in FIGS. 5 and 6. The reconstitution device  110  includes a first receptacle receiver  112 , a second receptacle receiver  114 , a device body  116  positioned therebewteen, and a vacuum device interface  118 . Like the previous embodiment, the present embodiment may be manufactured in a plurality of sizes and shapes to accommodate various component receptacles. The present embodiment includes an encapsulated first receptacle receiver  112 , formed by first receptacle stop  120  and a continuous receptacle support member  122  defining a first receptacle orifice  126 . At least one receptacle locking member  124  is positioned on the receptacle support member  122  and located within the first receptacle orifice  126 .  
         [0029]    As shown in FIGS. 5 and 6, the multiple internal lumen configuration of the present embodiment is similar to the previous embodiment. The pressurization interface  118  forms a pressurization orifice  144 , which is in communication with the pressurization port  144  through the pressurization lumen  146  located within the second cannula  136 . The transfer lumen  150 , located adjacent to the pressurization lumen  146  within the second cannula  136 , terminates at the transfer port  142  and is in communication with the withdrawal port  132  located on the first cannula  128  located within the first receptacle orifice  126 .  
         [0030]    [0030]FIGS. 7 and 8 shows a third embodiment of the present invention. The apparatus  210  comprises a first receptacle receiver  212 , a second receptacle receiver  214 , and a device body  216  positioned therebewteen. Like the previous embodiment, the present embodiment may be manufactured in a plurality of sizes and shapes to accommodate various component receptacles.  
         [0031]    [0031]FIGS. 9 and 10 show the present embodiment during various stages of use The first receptacle receiver  212  comprises a first receptacle stop  220  and a first receptacle support member  222  terminating with at least one receptacle locking member  224 . A first receptacle orifice  226  is formed by the first receptacle stop  220  and the first receptacle support member  222 . The first receptacle orifice  226  comprises a first multi-lumen component cannula  228  having a first pointed tip  230 , a first component withdrawal port  232  and a pressurization port  234 . The second receptacle receiver  214  comprises a second receptacle stop  236  and a second receptacle support member  238 . A second receptacle orifice  240  is formed by the second receptacle stop  236  and the second receptacle support member  238 . A pressurization piston  242 , which sealably interacts with the second receptacle support member  238 , is slidably positioned within the second receptacle orifice  240 , thereby forming a compression chamber  244 . A cannula port  246  is positioned on the pressurization piston  242 . At least one pressure transfer port  248  is located on the second receptacle stop  236 . The second multi-lumen cannula  250  is connected to the second receptacle stop  236  and comprises a pointed tip  252 , a material transfer port  254  and a venting port  256 . The device body  216 , positioned between the first receptacle receiver  212  and the second receptacle receiver  214 , comprises a pressurization lumen  258 , a material transfer lumen  260 , a venting lumen  262 , and a venting orifice  264 . The pressurization lumen  258  is in fluid communication with the pressurization port  234  located on the first cannula  228  and the pressure transfer port  248  located within the compression chamber  244 . The material transfer lumen  260  is in fluid communication with the first component withdrawal port  236  and the material transfer port  254 . The venting lumen  262  is in fluid communication with the venting port  256  and a venting orifice  264  located on the device body  216 .  
         [0032]    The present invention comprises various methods for reconstituting a multiple component material. More specifically, the method permits the reconstitution of a material from multiple component receptacles which are in fluid communication. An operator controlled pressure differential is created to effect a transfer of materials between the receptacles.  
         [0033]    A first method of reconstitution, which can be practiced with the apparatus shown in FIGS.  1 - 6 , utilizes a negative pressure formed in the second receptacle  60 . Alternatively, the method may be practiced by the introduction of a positive pressure introduced to the first receptacle  58 , followed by the introduction of a negative pressure into the second receptacle  60 . For example, a first receptacle  58  is positioned within the first receptacle receiver  12 , wherein the first cannula  28  is in fluid communication with the material stored therein. A second receptacle  60  is positioned within the second receptacle receiver  14 , such that the second cannula  36  is located within the second receptacle  60 . A syringe  56 , for example, may be coupled to the pressurization interface  18 , wherein the syringe distal tip  64  is positioned within the pressurization orifice  44 . It should be understood that alternative instruments may be used to create a pressure differential, including, for example, a mechanical vacuum device. A pressure differential is created within the second receptacle  60  as the syringe plunger  66  is retracted from the syringe barrel  62 . The negative pressure differential created within the second receptacle results in the first component traversing the transfer lumen  50  and entering the second receptacle  60 . Alternatively, the user may first inject air into the second receptacle  60  with the syringe  56 . The injected gas causes a positive pressure differential, which equalizes within the first receptacle  58  and second receptacle  60 . The subsequent retraction of the syringe plunger  66  results in the creation of a negative pressure differential within the second receptacle  60 . Those skilled in the art will appreciate the present embodiment provides for the reconstitution of a multiple component material without introducing an ambient gas or material, thereby reducing the likelihood of contamination.  
         [0034]    Yet another embodiment of the method of reconstituting a material is disclosed herein. This embodiment may be practiced by utilizing the apparatus disclosed in FIGS.  7 - 10  which comprises positioning a first receptacle  266  within the first receptacle orifice  226  formed on the first receptacle receiver  212 , wherein the first multi-lumen cannula  228  is located within the first receptacle  266  and in communication with material stored therein. A second receptacle  268  is positioned within the second receptacle orifice  240  and contacts the pressurization piston  242 . The user forcibly advances the second receptacle receiver  214  over the second receptacle  268 , resulting in the insertion of the second multi-lumen cannula  250  into the second receptacle  266 . Simultaneously, advancement of the second receptacle receiver  214  over the second receptacle  268  advances the pressurization piston  242  towards the second receptacle stop  236 , thereby decreasing the effective volume of the compression chamber  244 . The ambient gas being displaced by the compression chamber&#39;s decreasing volume is directed into the first receptacle  266  through the pressurization lumen  258 . A pressurization differential is created between the first and second receptacles, wherein the first receptacle  266  incurs a positive pressure. The pressure differential results in the first component contained within the first receptacle  266  traversing the withdrawal port  232  and the transfer lumen  260 , thereby entering the second receptacle  268  through the material transfer port  254 . During the reconstitution procedure the second receptacle  268  utilizes the venting port  256  connected to the venting orifice  264  to equalize pressure within the second receptacle  268 .  
         [0035]    In closing, it is noted that specific illustrative embodiments of the invention have been disclosed hereinabove. However, it is to be understood that the invention is not limited to these specific embodiments. Accordingly, the invention is not limited to the precise embodiments described in detail hereinabove. Those skilled in the art will appreciate the benefits advanced by the present invention. For example, no material transfer between the receptacles will occur until a pressure differential is established. Also, with respect to the first disclosed embodiment, the material transfer occurs within a sealed environment, therefor the likelihood of contamination is greatly reduced. With respect to the claims, it is applicant&#39;s intention that the claims not be interpreted in accordance with the sixth paragraph of 35 U.S.C. § 112 unless the term “means” is used followed by a functional statement. Further, with respect to the claims, it should be understood that any of the claims described below can be combined for the purposes of the invention.