Patent Abstract:
A filling device and method, particularly for two-component sealants such as fibrin sealants, which enables two fluids to be separately and directly filled to the reservoirs of a dual syringe fluid applicator from two storage containers, which can be standardized, sealed, sterilized bottles. The device has a connector which engages with the fluid applicator, is keyed to orient the applicator&#39;s fluid reservoirs in a predetermined manner and holds the containers in side-by-side alignment with the applicator. Two fluid conduits whose downward ends may be pointed to pierce seals on the bottles, extend between the applicator and the bottles and can each have a transverse reach to accommodate the girth of the bottles. The bottles may be tilted by the device to enable the conduits to draw maximal fluid from a lowermost point of the bottle. Tilting can be effected by a downward movement of the device supporting the applicator which movement can introduce the fluid conduits into the bottles. A shroud can enclose and seal the bottles and permit the apparatus complete with fluid applicator to be introduced into a sterile environment. Additionally embodiments for use with a single vial are also disclosed.

Full Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
   This application is a continuation-in-part of copending U.S. patent application Ser. No. 09/307,056, filed on May 7, 1999, to Epstein et al, now issued U.S. Pat. No. 6,475,183, the subject matter of which is hereby incorporated by reference. This application discloses subject matter related to our U.S. patent application Ser. No. 08/838,078, now issued U.S. Pat. No., 6,331,172, and Ser. No. 08/839,614, now issued U.S. Pat. No. 5,971,956, both filed Apr. 14, 1997, to patent application Ser. No. 08/946,364 filed Oct. 7, 1997, now issued U.S. Pat. No. 6,007,515, and to patent application Ser. No. 09/037,160 filed Mar. 9, 1998, now issued U.S. Pat. No. 6,063,055, all naming Gordon H. Epstein as first inventor. The disclosures of the aforementioned United States patent applications, “the above applications” are hereby incorporated herein by reference thereto. 

   BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   The present invention relates to a filling device for an applicator which applies multiple fluid sealant components to a work surface and is particularly, although not exclusively, useful for applying tissue sealant components to biological tissue to effect hemostasis or achieve other therapeutic results. More particularly, it relates to a dual compartment enclosed direct filling device for a hand-held applicator. 
   2. Description of Related Art Including Information Disclosed under 37 CFR 1.97 and 37 CFR 1.98 
   Use of tissue sealants and other biological materials is an important emerging surgical technique, well adapted for the operating room or field environments such as the doctor&#39;s office or mobile medical units. Preferred sealants include fibrin sealants which are formed from blood plasma components and comprise, on the one hand, a first component containing fibrinogen and Factor XIII and on the other hand a second component which usually includes thrombin, and calcium ions. The fibrinogen is capable of a polymerizing and being cross-linked to form a solid fibrin clot when the components are mixed. The necessary additional factors to simulate relevant portions of the natural blood coagulation cascade are suitably distributed between the fibrinogen and thrombin components. 
   Antanavich et al. U.S. Pat. No. 5,585,007, whose disclosure and references are hereby incorporated herein by reference thereto, provides an extensive discussion of the literature relating to fibrinogen sealant preparation (column 1, line 20 to column 4, line 62) and applicators column 4 line 62 to column 5, line 14), as well as a bibliography, (columns 6–10) and is a helpful guide to the teachings of prior workers in the field. 
   Depending upon the potency of the particular formulations employed, coagulation of the sealant may take place very rapidly, yielding a gel within perhaps 10 or 20 seconds. Though often very desirable for surgical reasons, such fast-acting properties present potential problems of fouling or clogging. These problems must be overcome in devising suitable applicators, methods of application and devices suitable for filling said applicators. 
   A popular manually operable applicator for such two-component sealants employs a dual syringe construction wherein two syringes, connected by a yoke, each provide a reservoir for one of the components. In most prior devices, the sealant components are discharged in separate streams and mixed externally of the applicator. Such applicators are similar in principle to household epoxy glue applicators commonly available in hardware stores. 
   Until May of 1998, when the FDA first approved such products, fibrin sealant was not commercially available in the US, therefore use of fibrin sealant was limited to supplies produced within the clinic, which are not subject to FDA control. 
   Current methods of filling biological glue applicators can be complicated and time consuming. As taught in Epstein U.S. Pat. No. 5,266,877 and in our assignee&#39;s international application PCT/US98/07846, components of the sealant can be placed in separate compartments in a flat filler tray for transfer to an applicator. Though useful as a device to permit rapid and reliable filling of a dual syringe applicator at the point of use, such filler trays are not suitable for external storage of the sealant components. This process can be time consuming and it requires a significant degree of care to efficiently transfer the sealant to the applicator. Also, a small amount of sealant will be left in the tray, and it is thus wasted. Furthermore the transfer of sealant components to multiple storage containers raises the likelihood in which the sealants will gather bio-burden, and bacteria, which can threaten the sterility of the sealant. 
   After FDA approval, however, fibrin sealant is now commercially available in the US. This availability has created a need for an effective and efficient device useful for transferring the components of the sealant, from commercially available or standardized, bottle-like storage containers, into an applicator. 
   There is accordingly a need for a device which can effectively deliver, in a sterile environment, multiple sealant components directly from their storage containers to an applicator. 
   SUMMARY OF THE INVENTION 
   The present invention solves the problem of effectively delivering multiple sealant components directly from commercially available or standardized storage containers, for example, bottles, to an applicator while allowing the use of the entire fill device within a sterile field. 
   In one aspect, the invention provides a direct dual filling device for the multiple sealant components of a liquid sealant, at least two of said components being complementary one to the other and polymerize when mixed, the direct filling device comprising a body having a plurality of inlet ports connected to drawing tubes which pierce the protective covering of commercially available bottles, the bottles containing the sealant components. The device also having a hood which snaps onto a base thereby enclosing the bottles. within the structure, allowing the device to be brought into a sterile field. The base having slanted bottle supports which hold the bottles in a tilted position. This feature allows the drawing tubes to extract virtually all of the fluid contained within the bottles. The device can be attached to an applicator with keying such that when the plunger of the applicator is retracted, fluid is drawn from each respective bottle to the proper reservoir contained within the applicator. Applications are disclosed for use with single vials. 
   The invention enables multiple sealant components to be directly delivered from their commercially available containers into an applicator without significant risk of contamination of the sealant components, and with minimal wasting of the sealant components. The different sealant components are delivered directly from their containers into separate individual reservoirs, thereby preventing coagulation of the sealant components. Once the hood of the device is guided onto the bottles and snapped onto the base, the entire device can be brought into the sterile environment. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     One way of carrying out the invention is described in detail below with reference to the drawings which illustrate one or more specific embodiments of the invention and in which: 
       FIG. 1  is a side elevational view of a direct dual filling device connected to an applicator according to the present invention; 
       FIG. 2  is an enlarged side elevational view of the present invention; 
       FIG. 3  is a view of the present invention along section lines  3 — 3  of  FIG. 2 ; 
       FIG. 3A  is a view similar to  FIG. 3  showing an alternate embodiment wherein the hood includes a locking member which comprises an o-ring. 
       FIG. 4  is a top view of the present invention; 
       FIG. 5  is a perspective view of the present invention; 
       FIG. 6  is a perspective view of a direct dual filling device connected to an applicator according to an alternative embodiment of the present invention; 
       FIG. 7  is an exploded view of an alternative embodiment of the present invention; 
       FIG. 8  is an elevational section view of an alternative embodiment of the present invention; 
       FIG. 9  is an elevational view of an alternative embodiment of the present invention; 
       FIG. 10  is an elevational view of an alternative embodiment of the present invention; 
       FIG. 10   a  is a partial elevational view depicting the vial support; 
       FIG. 11  is an elevational view of an alternative embodiment of the present invention; 
       FIG. 12  is a cut away view showing the hood being lowered onto the base during assembly; 
       FIG. 13  is a cut away view showing the drawing tube held in place by the guide 
       FIG. 14  is an exploded view showing an alternative embodiment of the hood; 
       FIG. 15  is an elevational section view of the embodiment shown in  FIG. 14 ; 
       FIG. 16  is a cut away view showing the hood of the embodiment shown in  FIG. 14  being lowered onto the base during assembly; 
       FIG. 17  is a partial cross-sectional view of the embodiment shown in  FIG. 14 ; 
       FIG. 18  is a frontal view showing a cover of an alternative embodiment of the invention for use with a single vial; 
       FIG. 19  is a frontal view showing the vial of the embodiment shown in  FIG. 18 ; 
       FIG. 20  is a frontal view showing the base of the embodiment shown in  FIG. 18 ; 
       FIG. 21  is a frontal view showing the assembled system of the embodiment shown in  FIG. 18  before engagement; 
       FIG. 22  is a frontal view showing the assembled system of the embodiment shown in  FIG. 18  after engagement; 
       FIG. 22A  is an enlarged side elevational view of the embodiment shown in  FIG. 22 , with portions of the device cut away. 
       FIG. 23  is a frontal view showing the assembled system without the cover of an alternative embodiment of a single vial system of the invention; 
       FIG. 24  is a frontal view showing the system with the cover of the embodiment shown in  FIG. 23 ; 
       FIG. 25  is a frontal view showing the assembled system of an alternative embodiment of a single vial system of the invention; 
       FIG. 26  is a frontal view showing a detailed view of the cover and needle assembly of the embodiment shown in  FIG. 25 ; and 
       FIG. 27  is a frontal view showing the assembled system of an alternative embodiment of a single vial system of the invention; 
   

   DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   Referring to  FIGS. 1 and 2  of the drawings, the direct dual filling device  10  comprises a body  12 , a hood  14  and a collar  16  which is adapted to fit an applicator  18 . The inventive device is preferably constructed out of a clear thermoplastic material such as polycarbonate, polystyrene, polypropylene, polytetrafluoroethylene, acrylonitrile butadiene-styrene or acrylic, however any suitable material may be used. 
   Applicator  18  preferably has at least two fluid reservoirs for separately holding and controllably dispensing reactable fluids, each of the fluid reservoirs being connected to a syringe by a fluid conduit. The applicator is of the type primarily used for applying multiple fluid sealant components to biological tissue to effect hemostasis or achieve other therapeutic results. 
   However the inventive filling device can be adapted to fit applicators having a wide variety of uses which require the direct filling of fluids into separate reservoirs located within an applicator. 
   Located within body  12  are inlet ports  20  and  21  which are adapted to receive syringes  22  and  23  of applicator  18 . Rubber O-rings  34  and  35  are positioned within inlet ports  20  and  21  respectively, such that an air tight seal is formed. Inlet ports  20  and  21  are connected to drawing tubes  24  and  25  by transverse channels  26  and  27  respectively, which drawing tubes  24  and  25  extend into bottles  28  and  29 . 
   Drawing tubes  24  and  25  should have sufficient length to extract substantially all the liquid contained within the bottle, or conversely they should have a length such that when the system is inverted substantially all of the liquid can be extracted. Drawing tubes  24  and  25  are preferably configured with pointed ends  30  and  31  which have the ability to pierce the protective packaging found on standard medical fluid bottles  28  and  29  and form a seal. Drawing tubes  24  and  25  are preferably formed out of a metallic material, however any suitable material such as thermoplastic may be used. The tubes can also have the ability to be removed from support sleeves  32  and  33  for replacement. 
   Channel  26  allows the fluid contained within right bottle  28  to be drawn through tube  24  and into syringe  22  for deposit within the proper receptacle located within applicator  18  without coming into contact with the fluid contained within bottle  29 . Similarly, channel  27  allows the fluid contained within left bottle  29  to be drawn through tube  25  and into syringe  23  for deposit within the proper receptacle located within applicator  18  without coming into contact with the fluid contained within bottle  28 . This allows the simultaneous filling of both sides of the applicator directly from the commercially available containers. Channels  26  and  27  can be formed out of thermoplastic tubing or molded directly into body  12  of the direct filling device  10 . 
   In order to fill applicator  18  directly from bottles  28  and  29 , hood  14  is placed over said bottles such that pointed tips  30  and  31  are approximately centered on the protective seal covering the bottles. The contoured shape of hood  14  guides the inventive device as the bottles are seated and snap into place within hood  14  by locking members  40 . As clearly shown in  FIG. 3 , locking members  40  are located within hood  14  such that they move apart when cap  42  of its respective bottle passes by during the insertion of the bottle, then once the bottle has reached the proper location locking members  40  retract under bottle cap  42  to lock or “seat” the bottles in place. Once the bottles have been seated the system may be inverted to ensure that all of the fluid is draw out of the bottles. In  FIG. 3A , an alternate locking member  40 A is illustrated showing the locking members comprising an o-ring which extends radially inward from the hood. 
   The plunger  19  of applicator  18  is then retracted thereby drawing the fluid contained within bottles  28  and  29  through their respective drawing tubes and channels into the syringes of applicator  18  for deposit within a reservoir. 
   The direct filling device  10 , as shown in  FIG. 4 , is connected to applicator  18  by a pair of snap fit members  36 . Applicator  18  is placed over the filling device such that the syringes are approximately centered over inlet ports  22  and  23 , then pressed down until locked in place by snap fit members  36 . The novel shaping of the collar  16  allows filling device  10  to mate with applicator  18  in only one orientation, thereby “keying” the fill device to the applicator. The general pentagon shape precisely fits to the applicator body in the same manner as interchangeable applicator tips or heads, which are used for droplet or spray dispensing of sealant. This feature of keying the filling device collar to the applicator ensures the proper fibrin components are delivered to their respective reservoirs without significant risk of cross-contamination, particularly when refilling. The agent bottles can only fit into the fill device hood  14  one way and the applicator can 
   As depicted in  FIG. 5 , bottle  29  is inserted into hood  14  until seated by locking members  40 . As can be clearly seen, hood  14  has a recess  44  which aides the user in removal of the bottles. Recess  44  is also useful, if hood  14  is opaque, to view any labels present on the bottle so it can be verified that the proper components are delivered into the proper reservoirs. Also shown is the contoured shape of hood  14 . The shape can be varied to allow use of different types and shapes of bottles. The hood can also be modified so that each side allows insertion of a different shaped bottle, thereby keying the bottles to the fill device. This in conjunction with the novel shape of the collar is important in ensuring that the proper components are delivered to the proper reservoirs within the applicator. 
   The direct dual filling device embodiment shown in  FIGS. 6–11  is a more detailed embodiment of the invention which includes most of the features shown in the embodiment of  FIGS. 1–5  and is suitable for manufacturing from injected molded plastics components. As will be described, several of the parts of the direct dual filling device shown in  FIGS. 6–11  embody similar construction and functionality to the components of the embodiment shown in  FIGS. 1–5 . 
   Many individual structural features of the components of the direct dual filling device can be seen from the exploded view of  FIG. 7 , while  FIGS. 8–13  show additional structural features and relationships of the internal components and  FIG. 6  shows the overall external appearance of the direct tool filling device while in use. 
   Referring to  FIG. 7 , the direct dual filling device  100 , shown in exploded view, comprises a hood  102 , having a first half  104  and a second half  106 , a pair of drawing tubes  108  and  110 , a pair of fluid conduits  112  and  114 , and a base  116 . First-half  104  and second half  102 , of hood  102  have a pair of drawing tube guides  118  and  120 , and a pair of recesses  122  and  124 . Base  116  has a pair of vial supports  126  and  128  which are configured to support vials  130  and  132 . Additionally, each of the vial supports  126  and  128  have a vial support surface  134 . 
   Hood  102  can be contoured to resemble the shape of the filling device when assembled with agent vials. The shape can also vary to allow use of different types and shapes of bottles. The hood can be modified so that each side allows insertion of a different shaped bottle, thereby keying the bottles to the fill device. This in conjunction with the novel shape of the collar is important in ensuring that the proper components are delivered to the proper reservoirs within the applicator. 
   In preferred embodiments, hood  102  and base  116  are essentially rigid, injected molded components having limited resilience in their thinner sections. Hood  102  is also preferably formed from a clear plastic such as polycarbonate or SAN. In contrast, fluid conduits  112  and  114  are preferably fabricated from a distinctly elastomeric, resilient molding material such as silicone rubber. 
   Once assembled hood  102  is configured to snap into the base by use of snap fit members  111 . Hood  102  and base  116  are configured such that they may only be assembled in one direction, so in use, the operator cannot assemble the device incorrectly. Base  116  and hood  102  are also color-coded to indicate which side is for the thrombin vial in which side is for the fibrinogen vial. Furthermore, base  116  is labeled with a “T” indicating the side for thrombin, and an “F” indicating the side for fibrinogen once hood  102  is snapped onto base  116 , bottles  108  and  110  can be brought into the sterile field. 
   When assembled, the upper portions of first-half  104  and second half  106  combine to form a collar  136 , embodying features of collar  16 . A pair of channels  137  having inlet ports  140  and  142  are also defined within hood  102 . Channels  137  are configured to retain fluid conduits  112  and  114 . 
   Fluid conduits  112  and  114  comprise a cylindrical cup  144  and a tubular arm  146 , which fits suitably within channel  137 . Cups  144  are internally configured to be pressed into tight sealing engagement, when so mounted to syringes  22  and  23  of applicator  18 , with the ends of sealant components syringes mounted in a mating applicator body, to receive liquid components therefrom. Tubular arms  146  of fluid conduits  112  and  114  are flexible and can readily be manipulated during assembling of filling device  102 . The ends of tubular arms  146  are configured to be fitted with the ends of drawing tubes  108  and  110  respectively. This configuration allows liquid components to be drawn through tube  108  into fluid conduit  112  and stored within the respective reservoir located within applicator  18 . Similarly, liquid component may be drawn through tube  110  into fluid conduit  114  and stored within the other reservoir located within applicator  18  without significant risk of contamination. When assembled, the filling device provides an airtight interface from the drawing tubes to the applicator reservoir. 
   Drawing tubes  108  and  110  should have sufficient length to extract substantially all the liquid contained within the corresponding vial. Drawing tubes  108  and  110  are preferably configured with a pointed end which has the ability to pierce the protective seal found on standard medical fluid bottles thereby forming a seal. Drawing tubes  108  and  110  generally resemble a needle, and are preferably formed out of a metallic material, however any suitable material such as thermoplastic may be used. Both of the tubes may be of similar diameter, however the tube diameter may differ to accommodate liquids having differing viscosities. 
   Drawing tube guides  118  and  120  are hinged within recesses  122  and  124  so that they may be housed within the recesses when the filling device used in use.  FIG. 13  illustrates the manner in which drawing to  108  is held in place by drawing tube guides  118 . Each of the guides has a forked end  119  which when used in conjunction with one another will hold drawing tube  118  in a vertical position. Recesses  122  and  124  should be of suitable size to allow for variations in the position of the guide, when it is being stored. 
   Collar  136  is connected to an applicator  18  by a pair of snap fit members  138 . Applicator  18  is placed over direct dual filling device  100  such that the syringes of applicator  18  are approximately centered over inlet ports  140  and  142 , then pressed down until in place by snap fit members  138 . Alternatively, collar  136  may be configured without snap fit members  138 . Due to the stability of the device when assembled, applicator  18  can be held in place by a combination of gravity and the friction generated by the tight nature of the seal formed between the syringes and the fluid conduits. The novel shaping of collar  136  allows direct dual filling device  100  to mate with applicator  18  in only one orientation, thereby “keying” the fill device to the applicator. The general pentagon shape precisely fits the applicator body in the same manner as interchangeable applicator tips or heads, which are used for droplet or spray dispensing of sealant. This feature of keying the filling device collar to the applicator insures the proper fibrin components are delivered to their respective reservoirs without significant risk of cross-contamination, and the resulting loss of materials caused by the cross-contamination. 
   As shown in  FIG. 8 , first-half  104  of hood  102  has a central divider  148  which divides the hood into two compartments  150  and  152 , which when hood  102  is assembled, house vials  130  and  132  respectively. Compartment  150  has an upper surface  154  which is slanted from its lowest point at divider  148  to its highest point at outer wall  156 . Similarly, compartment  152  has an upper surface and  158  which is slanted from its lowest point at divider  148  to its highest point at outer wall  160 . 
   Vial supports  126  and  128  are separated by divider slot  162  which is configured to receive central divider  148  of hood  102 . Vial support surface  134  has a slanted outer portion  164 , a level central portion  166 , and an inner slanted U-shaped surface  168 . The angle at which the inner and outer portions of vial support surface  134  is constructed, is substantially parallel to slanted upper surface  154  and  158  of hood  102 . Vial support surface  134  has a width which allows vials  130  and  132  to be suspended by their necks as shown in  FIG. 8 . 
   The assembly of the components of filling device  100  can take place at a factory or other such manufacturing facility prior to use of the inventive device. Drawing tubes  108  and  110  are mated with tubular arms  146  of fluid conduits  112  and  114 . The assembly is then snugly fitted within channel  137  such that drawing tubes  108  and  110  all are held by guides  118  and  120  respectively. Preferably, one half of channel  137  is of sufficient proportion to accommodate a greater portion of fluid conduits  112  and  114 . This allows the fluid conduits to be placed within the larger channel prior to be two halves being assembled, thereby allowing for greater restraint of the conduits prior to assembling the two halves of hood  102 . 
   Once the drawing tubes and fluid conduits are in place, first-half  104  and second-half  106 , of hood  102  are configured to be assembled together by snap fit members  105 . Alternatively, ultrasonic welding, glue, press fitting or any other method of assembly may be used. All of the components of the inventive device are then sterilized. When it is desired to use the inventive filling device the operator need only insert the vials and mate the hood onto the base. 
   Generally, the agent vials are not sterilized and are unable to be brought into a sterile environment without risk of contamination. However, when the agent vials are shrouded within the inventive filling device the assembly may be brought into a sterile environment for use. 
   The operator assembles the device by sliding the agent vials onto vial supports  126  and  128  such that the necks of the two agent vials are resting on vial support surface  134 . The angle at which the outer portion  164  of vial support surface  134  is configured, will cause the two agent vials to slide down into place resting on level central portion  166  of vial support surface  134 . The angle is such that friction will not stop the bottle from fully seating on level central portion  166 . As shown and  FIG. 10  a vial  130  is properly seated within vial support  126  when the center line  180  of vial  130  is positioned at a point on level central portion  166  further out than pivot fulcrum  182 . Pivot fulcrum  182  occurs at the point where level portion  166  transforms into inner support surface  168 . This positioning allows vial  130  to be firmly held in place by support  126 , while still allowing vile  130  to pivot in the direction of arrow  184 . By allowing vial  130  to fully seat within vial support surface  134 , vial  130  will maintain a level position during the first part of the insertion of the drawing tube. This allows the needle to properly align with the target area of the vials septum. Since the vials septum has a thin portion in be center which allows needles to puncture, it is desirable to align the drawing tube with this target area, thereby assuring a good seal. 
   Once the vials are properly seated, the hood assembly is placed over the base assembly such that divider  148  is positioned to engage within divider slot  162  as shown in  FIG. 9 . As the hood assembly is lowered onto the base in the direction of arrow  170 , divider  148  and divider slot  162  act to align drawing tubes  108  and  110  with the target area of agent vials  130  and  132 . 
   As the hood assembly is further lowered onto the base in the direction of arrow  170 , drawing tubes  108  and  110  puncture the septa of the agent vials creating an airtight interface. As indicated earlier the drawing tubes should be held vertical by their guides and the agent vials positioned correctly by the vial support face so that the drawing tubes puncture the target area of the septa. 
   As illustrated in  FIG. 12 , when guides  118  and  120  come into contact with the top portion of agent vials  130  and  132  they all are folded up and out of the way into recesses  122  and  124 . 
     FIG. 10  depicts the point at which the top portion of vials  130  and  132  comes into contact with upper surfaces  154  and  158 . As the housing moves onto the base in the direction of arrow  170 , the slanted configuration of upper surface  154  causes agent vial  130  to tilt in the direction of arrow  172 . Similarly, the slanted configuration of upper surface  158  causes agent vial  132  to tilt in the direction of arrow  174 . The vials are tilted because the top slanted inner surface of the housing vial cavities are forced down onto the lid of each vial, causing them to tilt to the same angle as the top of the inner cavity. 
   Simultaneously with the tilting of agent viles  130  and  132 , drawing tubes  108  and  110  are driven into the bottom corner of their respective viles. Ideally, the sharpened tips of the drawing tubes are shaped such that they conform to the shape of the bottom corner of the agent vials so that as much fluid as possible is drawn up. 
   Once the hood assembly has been completely lowered onto the base into the fully engaged position of  FIG. 11 , it may be locked into place by snap fittings  111 . Agent vials  130  and  132  are tilted in such a manner that drawing tubes  108  and  110  are forced into the bottom corner of each respective vial, which has now become the low point for the agent to pool into. This configuration along with the shaping of the drawing tubes allows for minimal waste of the agent contained within the vials. 
   Once the inventive filling device is assembled, it may be brought into a sterile field. Although, the agent vials are generally not sterile and therefore would not be allowed within a sterile environment for risk of contamination, the hood and base assembly has effectively shrouded the vials within a sterile environment so that they may be brought into a sterile field. 
     FIGS. 14–17  show an alternative embodiment of the inventive device. Referring to  FIGS. 14 and 15 , hood  102  comprises compliant upper arms  103  and  107  which act as compliant tipping arms. Arms  103  and  107  are vertically positioned and have a resilient flexibility to engage and tip vials  130  and  132  as hood  102  is lowered before the needles bottom out on the vials&#39; convexity and hold vials  130  and  132  in tilted position so as to optimize evacuation of the contents of vials  130  and  132 . Base  116  comprises modified vial supports  126 ′ and  128 ′ which are open on either side of vials  130  and  132 . Thus, a nurse or other user may load a device without touching the base thus avoiding contaminating the sterile field. 
   Referring to  FIG. 16  which shows a view similar to that shown in  FIG. 12 , hood  102  is provided internally with rounded jaws  131  and  133  (not shown) which firmly clasp the tops of vials  130  and  132 . Jaws  131  and  133  suspend vials  130  and  132  in carved rounded recesses  135  and  139  (not shown). The inside of the jaw has a part circular horizontal ledge where the bottle can sit vertically. Jaws  130  and  132  and recesses  135  and  139  maintain vials  130  and  132  in a vertical position prior to tilting as recesses  135  and  139  prevent tilting until the bottom of each vial is above the recesses. Arms  103  and  107  are vertically positioned and have a resilient flexibility to engage and tip vials  130  and  132  and the vials tilt after the hood clasps the bottoms of the vials. Base  116  is shaped to provide visual guides  117  and  121  to assist the user in visually matching the round and square portion of hood  102  and base  116  for alignment and proper orientation. Once assembled hood  102  is configured to snap into the base by use of snap fit members  111 . 
   When using the inline body, fibrinogen and thrombin typically take up only a small portion of the volume of the vial. With most of the vial being empty, depressurization is not a problem. Therefore, venting is not usually necessary. However, most medical personnel are used drawing out a desired volume of liquid from a vial by first injecting the same volume of sterile air into the vial. Then the syringe automatically withdraws the same amount of liquid volume to equalize the pressure in the vial. However such pressurization may cause problems in that fluids may back up into the needles prematurely. Additionally, this method also causes air bubbles and inaccurate dosages. Accordingly, venting is desirable to prevent such undesired pressurization and release unwanted air while maintaining the sterile field. To address this issue, an oversized piece of hypo tube can be used to provide a collar over the needle which has an inner diameter of 0.002 in greater than the outer diameter of the needle. When the needle pushes against the collar, it makes a gap allowing air to escape between the needle and collar. Alternatively as shown in  FIG. 17 , a pair of dagger-like molded inserts  113  and  115  alongside each needle which is against drawing tubes  108  and  110  which allow air to escape within the sterile field. If desired inserts  113  and  115  may be provided with sharply pointed tips or cutting edges to create a hole alongside the needles which stays open after piercing. The hole allows air but not liquid to escape. 
   Although only two bottles are depicted for use with the inventive filling device, adaptation can be easily made to allow the use of three or more, which can directly fill three or more reservoirs contained within the applicator. This adaptation can be accomplished by expanding the hood and adding another inlet port, transverse channel and drawing tube. 
   During surgery, it is desirable to have access to variable doses of intravenous drugs. However, due to the limitations of the operating theater, syringes are often pre-filled in a separate room under a hood which maintains the sterile field. Current practice for dispensing local anesthetic or saline during surgery is to reach in and out of the sterile field to get more fluids or to dump the fluid into a sterile bowl inside the sterile field. This practice raises the risk of needle sticks, contamination or misuse of a non-labeled fluid in the sterile field. 
   Referring to  FIGS. 18 to 22 , an alternative embodiment of the inventive device is shown in the form of a single vial, direct filling device  200  having a cover  210  which snaps onto a base  216  thereby enclosing the vial  214  within the structure, allowing device  200  to be brought into a sterile field. This device provides needleless filling of fluids from non-sterile vials inside the sterile field with reduced waste, while maintaining label visibility for application safety. The device consists of a base or bag, cover and a needle. With this device the vial is completely shrouded and can be moved into the sterile field. The device is for single use, but multiple fillings. It is understood that the system may come with a needle, tube, and/or other structures for mating with the syringe such as in accordance with one of the embodiments described above, with one example being shown in  FIG. 22A  which, where indicated, identifies similar structures with identical numbers as used with previous embodiments, or, alternatively, the syringe may be attached to a needle retracted within a protective cover so that the needle is only exposed within the sterile environment of the system. 
   Cover  210  has a hole  211  which receives needle  212  and has a tilted side portion  213  which accommodates vial  214  tilting. Base  216  has a curved notch  217  where the neck of vial  214  rests. Vial  214  may be any standard size vial which is used for intravenous medication. Vial  214  is loaded into the device and is suspended by its neck. This arrangement accommodates multiple vial sizes and tilting of vial  214 .  FIG. 21  shows the assembled system  200  with vial  214  sitting in base  216  in vertical position. Rib  218  is tilted before engagement.  FIG. 22  shows the device after it is fully assembled and with rib  218  fully engaged. Cover  210  has a feature that tilts the vial  214  for maximum fluid removal. This can be achieved while device  200  is sitting on a table in an upright position. When fully assembled the non-sterile vial  214  is shrouded and can be brought inside the sterile field providing a revisitable supply of medical fluid to the user. Both cover  210  and base  216  are preferably clear to allow for visual inspection of the vial label and fluid level. 
     FIGS. 23 &amp; 24  show an alternative embodiment of filler device  200  where the syringe can be filled in an upright position while sitting on a table. Filler device  200  does not tilt vial  214 , but instead has needle  212  extending completely to the bottom of vial  214 . More specifically,  FIG. 23  shows the inventive device before cover  210  is assembled to it. As shown in  FIG. 24 , in preferred embodiments, the inventive device  200  further comprises locking rings  219  and mating receptacles  220  to accommodate different vial sizes. 
     FIGS. 25 &amp; 26  show an alternative embodiment of the device shown in  FIGS. 23 and 24 . Needle  212  is a short needle which extends just past the septum into vial  214 . The device is then inverted for filling the syringe. This embodiment would be useful for withdrawing small volumes of fluid as a longer needle extending to the bottom of the vial may withdraw air instead of liquid. Inversion of the vial is often desirable for withdrawing suspensions. 
     FIG. 27  shows an alternative embodiment of the device shown in  FIGS. 25 and 26 . However, in this embodiment, a plastic bag is used as base  216 . More specifically the base  216  comprises a plastic bag that is attached to the cover  210 . When vial  214  is assembled the bag is unrolled and sealed with an adhesive strip. Cover  210  locks vial  214  into place. 
   While illustrative embodiments of the invention have been described above, it is, of course, understood that various modifications will be apparent to those of ordinary skill in the art. Many such modifications are contemplated as being within the spirit and scope of the invention.

Technology Classification (CPC): 0