Abstract:
Embolic devices and methods for mixing and delivering embolic material in a sterile environment facilitate delivery of the embolic material directly into a patient thereby preventing the embolic material from becoming contaminated. Such devices include a sealable container couplable to a syringe, a dissolvable caplet or gel-cap including a solid or liquid embolic material, a sealed vial with a breakable neck containing an embolic material, and a flexible container including internal compartments separated by breakable membranes.

Description:
Cross Reference to Related Case  
       [0001]    This application claims priority to and the benefit of Provisional U.S. Patent Application Serial No. 60/311,602, filed Aug. 10, 2001, the entirety of which is hereby incorporated by reference. 
     
    
     
       FIELD OF THE TECHNOLOGY  
         [0002]    The invention relates generally to embolic devices and more specifically to devices for mixing and delivering embolic material.  
         BACKGROUND OF THE TECHNOLOGY  
         [0003]    Embolization is the therapeutic introduction of various substances (embolic material) into a patient&#39;s circulatory system for the purpose of occluding vessels, either to arrest or to prevent hemorrhaging or to defunctionalize a structure or an organ.  
           [0004]    Typical methods of introducing embolic material, such as spherical polyvinyl alcohol for example, require a user to peel or unscrew a cap off of a container and pour the embolic material out of the container into a mixing vessel. The embolic material, after being mixed with a carrier material, such as ethanol, and a hydrating material, such as saline, may then be introduced into a syringe and subsequently injected into a catheter. This procedure is inconvenient and potentially wasteful.  
         SUMMARY  
         [0005]    The present invention relates to embolic devices for mixing and delivering embolic material. Specifically, the embolic devices facilitate mixing of the embolic material in a sterile environment and delivery of the embolic material directly into a patient, thereby preventing the embolic material from becoming contaminated.  
           [0006]    Accordingly, in one aspect, the invention involves a method of mixing and dispensing an embolic material. The method includes providing a container having a luer fitting and containing an embolic material; transferring at least one fluid from a syringe into the container via the luer fitting, and agitating the container to mix the embolic material and the fluid(s). The method further includes transferring at least a portion of the mixed material into a syringe; and administering the mixed material from the syringe.  
           [0007]    In another aspect, the invention utilizes a flexible container including a plurality of internal compartments separated by breakable membranes; the container also includes a sealed fluid connection. One of the compartments contains an embolic material and each other compartment contains a material to be mixed therewith. Pressure is applied so as to break at least one of the seals, and the flexible container is kneaded to mix contents from the compartments separated by the at least one broken seal. The method still further includes unsealing the fluid connection and dispensing the mixed contents therethrough for administration.  
           [0008]    In one embodiment, the container includes a plurality of breakable membranes and the pressure-applying and kneading steps are repeated in a sequential manner so as to mix the contents of two adjacent compartments before another breakable membrane is broken. Indeed, the contents of all compartments may be combined prior to the kneading step.  
           [0009]    In still another aspect, the invention involves providing a caplet including an embolic material surrounded by an inert dissolvable material, dissolving the caplet in a fluid to form a mixture, and administering the mixture. In one embodiment, the caplet is dissolved in a liquid including saline.  
           [0010]    In yet another aspect, the invention involves a method of mixing and dispensing an embolic material. The method includes providing a caplet including an embolic material in solid form, dissolving the caplet in a fluid to form a mixture, and administering the mixture. In one embodiment, the caplet is dissolved in a liquid including saline.  
           [0011]    In another aspect, the invention involves providing a sealed, blow-molded vial which contains an embolic material. The vial includes a luer connector and, thereover, a breakable fitting providing a fluid seal over the luer connector. The method further includes transferring the embolic material to a syringe via the luer fitting and administering the mixed material from the syringe.  
           [0012]    In still another aspect, the invention involves a medical device including a container for holding an embolic material and a cap including a luer fitting. The cap facilitates removable coupling of a syringe barrel to the container to selectively seal and unseal the container.  
           [0013]    In yet another aspect, the invention involves a medical device including a flexible outer package. The medical device further includes plurality of membranes disposed within the flexible outer package and positioned to define therein a plurality of compartments. At least one of the plurality of membranes is breakable when pressure is applied to a compartment bounded by the at least one membrane, thereby allowing contents from the compartment to mix with contents of an adjacent compartment. The medical device further includes a sealable outlet for dispensing the mixed contents.  
           [0014]    In another aspect, the invention involves a medical device including a dissolvable solid material defining an enclosed cavity, and a solid or liquid embolic material disposed within the enclosed cavity.  
           [0015]    In still another aspect, the invention involves a medical device including a sealed vial including an interior, a connector, and a flexible and breakable seal over the connector. When the neck is broken, access is afforded to the interior of the vial via the connector. The medical device further includes an embolic material disposed in the interior of the vial. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]    In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the technology.  
         [0017]    [0017]FIG. 1A is a perspective view of an embolic material mixing and/or delivery device including a cap with a luer fitting and a container coupled to a syringe according to one embodiment of the invention.  
         [0018]    [0018]FIG. 1B is a perspective view of an embolic material mixing and/or delivery device including a cap with a luer fitting and a container according to another embodiment of the invention.  
         [0019]    [0019]FIG. 1C is a perspective view of the syringe shown in FIG. 1A directly connected to a catheter disposed in a patient.  
         [0020]    FIGS.  2 A- 2 C are plan views of embolic material mixing and delivery devices including a flexible outer package with a plurality of internal compartments and a luer connector according to another embodiment of the invention.  
         [0021]    [0021]FIG. 2D is a plan view of the embolic material mixing and delivery device shown in FIGS.  2 A- 2 C connected to a catheter disposed in a patient.  
         [0022]    [0022]FIG. 3 is a perspective view of a capsule package for embolic material according to yet another embodiment of the invention.  
         [0023]    [0023]FIG. 4A is a perspective view of a squirt vial package for delivering embolic material according to still another embodiment of the invention.  
         [0024]    [0024]FIG. 4B is a perspective view of a squirt vial package including a luer connector according to yet another embodiment of the invention.  
         [0025]    [0025]FIG. 4C is a perspective view of the squirt vial package shown in FIG. 4B directly connected to a catheter disposed in a patient. 
     
    
     DETAILED DESCRIPTION  
       [0026]    Referring to FIGS. 1A and 1B, in one embodiment, a device  100  in accordance with the invention includes a cap  102  having a luer fitting  104 , and a container  106  used for mixing and/or delivering embolic material such as spherical polyvinyl alcohol (S-PVA), for example. In other embodiments, the container  106  can be large or small depending on the amount of embolic material to be mixed. The cap  102  is removably coupled to the container  106  via a threaded connection or a friction connection and seals the container  106 . The cap  102  can also include a protective cover  108  which is used to protect the luer fitting  104  when the luer fitting  104  is not in use. The luer fitting  104  is removably coupled to the barrel  110  of a syringe  112  and allows a user to transfer fluid (such as embolic material) from the container  106  to the syringe  112  or vice versa. In various embodiments, the container  106  can be made of glass or a nonleaching and/or nonextracting plastic composition.  
         [0027]    In typical operation, the container  106  is partially filled with an embolic material  114 . The user attaches the barrel  110  of the syringe  112  to the luer fitting  104  and injects a hydrating liquid and/or other liquid, such as a contrast agent, into the container  106  holding the embolic material. The user may repeat this procedure to add other fluids (e.g. saline) to the container  106 . The user then detaches the barrel  110  of the injection syringe  112  from the luer fitting  104  and shakes or agitates the container  106  (e.g., with the cap  108  in place), thereby mixing the embolic material with the newly added liquid(s). The user next attaches to the luer fitting  104  a new syringe  116 , turns the container  106  upside down and aspirates the mixture out of the container  106  into the syringe  116 .  
         [0028]    Referring to FIG. 1C, the user can then attach the syringe  116  to a catheter  120  introduced within a patient P and administer the mixture.  
         [0029]    This embodiment of the invention does not require the cumbersome procedures of the prior art, or the use of complex valves (such as a three-way stopcock) to mix the embolic material with other liquids, and provides a convenient and sterile mixing container (i.e., container  106 ). This embodiment also facilitates easy injection and removal of liquids from the container  106  and provides a closed system for handling the embolic material  114 .  
         [0030]    Referring to FIG. 2A, in another embodiment, a device  200  includes a flexible outer container (e.g., plastic, for example) or package  202  with a plurality of internal compartments  206 ,  208  and a sealable connector  204  in fluid communication with one of the compartments (e.g. a main compartment  206 ). Each of the internal compartments  206 ,  208  is separated by a breakable seal  210 . In one embodiment, the breakable seal  210  is created by heat sealing the package  202  where the breakable seal  210  is desired. The contents that are to be stored in the compartment  208  are put into the package  202 . The breakable seal  210  is then created by heat sealing the package  202  to isolate the contents in the compartment  208  from the compartment  206 . The contents that are to be stored in compartment  206  are then put into the package  202 . This process may be repeated to create additional compartments. In other embodiments, the breakable seal  210  can be a thin plastic membrane. In some embodiments, the package  202  is made of single or multilayer extrusions of inert polymeric materials.  
         [0031]    Referring to FIG. 2B, in another embodiment, a series of internal compartments  208 ,  212 ,  216  is positioned around the perimeter of the package  202  and around the central compartment  206 . The central compartment  206  is separated from the perimeter compartments  208 ,  212 ,  216  by breakable seals  210 ,  214 ,  218 .  
         [0032]    Referring to FIG. 2C, in still another embodiment, the internal compartments  206 ,  208 ,  220 ,  224  is positioned one after the other. This configuration is useful when the contents of the compartments are intended to be mixed in a particular sequence. For example, the contents of compartment  206  and compartment  224  can be mixed together by breaking the seal  226 . Likewise, the contents of compartment  208  and compartment  220  can be mixed by breaking the seal  201 . The two new mixtures are still separated by seal  222  and can be mixed when desired by breaking the seal  222 .  
         [0033]    Referring again to FIG. 2B, typically, each of the plurality of internal compartments  206 ,  208 ,  212 ,  216  contains one or more solid or liquid component(s) and all the components are intended to be mixed together. For example, one of the plurality of internal compartments  206 ,  208 ,  212 ,  216  can contain an embolic material such as S-PVA in liquid or solid form. Another of the plurality of internal compartments  206 ,  208 ,  212 ,  216  can contain saline, and still another of the plurality of internal compartments  206 ,  208 ,  212 ,  216  can contain a contrast agent.  
         [0034]    In operation, the user, in order to mix the contents of the separate compartments  206 ,  208 ,  212 ,  216 , squeezes a particular compartment (e.g.  208 , for example), and thereby breaks the seal  210  between the squeezed compartment and an adjacent compartment  206 . The user then kneads the flexible outer package  202  until the components from the adjacent compartments  206 ,  208  are mixed. For example, the user can squeeze the compartment  208  containing the embolic material so as to break the seal  210  between the compartment  208  containing the embolic material and the compartment  206  containing the saline. After kneading the flexible outer package  202  until the embolic material and the saline are properly mixed, the user can squeeze the compartment  212  containing the contrast agent so as to break the seal  214 . The user again kneads the flexible outer package  202  until the contrast agent, the embolic material, and the saline are properly mixed. Thereafter, the user can unseal the connector  204  (i.e. remove or unscrew a cap) and dispense the mixture into a desired container for delivery into a patient.  
         [0035]    Referring to FIG. 2D, the sealable connector  204  can be a luer fitting that is capable of being attached directly to a catheter  230  (or syringe, or other medical device with a luer fitting) that is introduced in a patient P.  
         [0036]    Advantages of the flexible package  202  with the plurality of compartments  206 ,  208 ,  212  include having all the separate components of an embolic mixture conveniently contained within one package, which itself facilitates mixing of the components without exposing any of them to an external environment or requiring the use of additional mixing containers.  
         [0037]    Referring to FIG. 3, in still another embodiment of the invention, a device  300  includes either liquid or solid embolic material  304  (such as S-PVA) encapsulated in a dissolvable solid material (e.g., a gel-cap)  302  or a solid embolic material formed into a caplet  306 . The gel-cap  302  or caplet  306  can be dissolved in a saline solution. After the gel-cap  302  or caplet  306  has been dissolved, the resulting embolic mixture can be drawn into a syringe or poured into some other delivery device and then introduced into a patient through a catheter. Additionally, the gel-cap  302  material is made of an inert substance that does not affect the embolic mixture upon dissolving. The gel-caps  302  or caplets  306  are stored in protective package  308  until needed.  5  In one embodiment, the protective package  308  is a plastic bubble package  310  with a paper or foil backing  312 . A gel-cap  302  or caplet  306  is removed from the plastic bubble package  310  by pressing or crushing a particular bubble, thereby forcing the gel-cap  302  or caplet  306  through the paper or foil backing  312 . Advantages of the dissolvable gel-cap  302  or caplet  306  include easy and efficient storage of the embolic material.  
         [0038]    Referring to FIGS. 4A and 4B, in yet another embodiment, a device  400  includes a unit dose bottle  402 . The unit dose bottle  402  is a sealed, blow-molded vial that is filed with an embolic material, such as S-PVA, and saline. In operation, the user twists off the flexible neck  404  (or cap) and dispenses the contents of the unit dose bottle into a desired container for delivery into a patient. In various embodiments, the unit dose bottle  402  can be made of polypropylene, polyethylene, or other coextruded materials.  
         [0039]    Referring to FIGS. 4B and 4C, in another embodiment, the unit dose bottle  402  includes a breakable neck  407 . In operation, the user twists off (or breaks) the neck  408  thereby exposing a luer connector  406  which can be attached directly to a catheter  408  (or syringe, or other medical device with a luer fitting) that is introduced in a patient  410 .  
         [0040]    Variations, modifications, and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the technology. Accordingly, the technology is not to be defined solely by the preceding illustrative description