Patent Document

FIELD OF THE INVENTION 
   The following invention relates generally to instrumentalities and methodologies in preparing and administering biological adhesives. More specifically, the instant invention is directed to a method and apparatus for simultaneously loading dispensing assemblies with multiple components of biological glue and preparing the biological glue in a manner specific to the required need. 
   BACKGROUND OF THE INVENTION 
   This application represents applicant&#39;s ongoing efforts in the field of collecting, preparing, and dispensing components of biological adhesives. 
   U.S. Pat. No. 5,759,171 discloses a sprayer for fibrin glue configured with a pistol grip, barrel, and trigger, and adapted to hold two syringes containing the fibrin glue components. Activation of the trigger moves a plunger support, emptying the two syringes. Each syringe communicates with an outlet having an atomizer, and the atomizers are oriented to form the fibrin glue away from the tip of the sprayer, to prevent clogging. 
   U.S. Pat. No. 5,975,367 is directed to a hand-held dispenser for fibrin glue. The dispenser includes a spring-based rack that communicates with two syringes containing fibrin glue components such that the dispensed components may mix away from the tip of the dispenser. Drops or elongate lines of fibrin glue may be dispensed. 
   U.S. Pat. No. 6,077,447 reveals an apparatus, system and method for fractionating from whole blood, plasma, or other blood products the clotting factor known as fibrinogen, one component of a biological adhesive. A container is loaded with blood product containing fibrinogen, and the container is then put in registry with a heat transfer platen. The platen and container combination is rocked contemporaneously with temperature changes that induce a phase change in the blood product. The fibrinogen is then extracted from the container for subsequent use. 
   U.S. Pat. No. 6,274,090 B1 divulges an apparatus and method for preparing thrombin, another component of a biological adhesive. The thrombin component is extracted from donor plasma and converted to thrombin, while also removing contaminating proteins. Additionally, a system is described in which thrombin and adhesive and clotting proteins are simultaneously harvested from the same donor plasma, providing a more stable product than previously available. Both procedures occur in about one hour in a sterile environment, and are thereby optimized for use in a surgical setting. 
   WIPO application 00/74713A1 describes an improved thrombin processing unit that may be used with the methods revealed in U.S. Pat. No. 6,274,090 B1. 
   SUMMARY OF THE INVENTION 
   The present invention streamlines processing of thrombin and adhesive and clotting proteins to produce biological adhesives. Processing time is shorted, and the loading of syringes with the biological adhesives may be accomplished with improved sterility, less waste and more expeditious and particularly safer handling (e.g., from needle sticks) than heretofore experienced. 
   The present invention especially enhances the economics and practicalities of processing blood into biological adhesives. Customarily, a donor provides 500 mL (one “unit”) of whole blood. This unit, when processed, yields 250–300 mL of plasma, which results in two components: 4.5–8.5 mL clotting proteins and about 8.5 mL of thrombin. Since the minimum quantum of biological adhesive needed comprises 1–2 mL, and because each component comprises approximately 50 percent of the two-part adhesive, one unit of whole blood can generate approximately 4 to 8 doses of biological adhesive. The instant invention loads and packages biological adhesive in convenient doses. 
   Syringe pair assemblies are attached to a dispensing manifold on a loading station. Processing units for each component of the biological adhesive are mounted near the dispensing manifold, with dispensing lines running therebetween. Blood product is introduced into the separate processing units for the components for the adhesive. The desired component is extracted from the blood product. The components run through separate dispensing lines into syringes such that each syringe pair contains one syringe loaded with each component. The syringe pairs are removed from the dispensing manifold and may be utilized in a variety of ways when in actual use. The syringes are compatible with an adhesive spraying apparatus, such as the spraying means as recited in claims  3 ,  4 ,  7 , and  8 , and may also be used with a heating station to maintain the adhesive components at an optimal temperature for use in a surgical setting. 
   OBJECTS OF THE INVENTION 
   Accordingly, it is a primary object of the present invention to provide a new and novel device and method for loading multiple syringes with biological glue components. 
   It is a further object of the present invention to provide a device and method as characterized above in which the loading procedure is independent of the application for which the biological glue is utilized. 
   It is a further object of the present invention to provide a device and method as characterized above which minimizes waste in loading the biological glue dispenser, improves efficiency and maintains sterility. 
   It is a further object of the present invention to provide a device and method as characterized above that minimizes clogging of the dispenser in delivering the biological glue to the intended site. 
   It is a further object of the present invention to provide a device and method as characterized above that may be utilized in a surgical setting. 
   Viewed from a first vantage point, it is an object of the present invention to provide an apparatus for collecting thrombin and clotting proteins, comprising, in combination: a first conduit operatively connected to a source of thrombin; and a second conduit operatively connected to a source of clotting proteins, each said conduit operatively connected to a plurality of dispensing means. 
   Viewed from a second vantage point, it is an object of the present invention to provide a method for loading dispensing means with thrombin and clotting proteins, the steps including: attaching a plurality of said dispensing means to separate dispensing lines containing thrombin and clotting proteins; manipulating said plurality of dispensing means to purge air in each of said dispensing lines; and sequentially filling said plurality of dispensing means through each of said dispensing lines. 
   These and other objects will be made manifest when considering the following detailed specification when taken in conjunction with the appended drawing figures. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a perspective view of the loading station. 
       FIG. 2  is a side view of the dispensing manifold with attached syringes within their associated membranes. 
       FIG. 3  is a view of the dispensing manifold. 
       FIG. 4  is a view of the syringe pair assembly in its membrane in the contracted position. 
       FIG. 5  is a view of the syringe pair assembly in its membrane in the extended position. 
       FIG. 6  depicts the first step in a loading process, extending the syringe pair assembly in the endmost position. 
       FIG. 7  depicts the second step in a loading process, contracting the syringe pair assembly in the endmost position. 
       FIG. 8  depicts the third step in a loading process, filling the syringe pair assembly closest to the support. 
       FIG. 9  depicts the fourth step in a loading process, filling the syringe pair assembly second from the support. 
       FIG. 10  depicts the fifth step in a loading process, filling the syringe pair assembly third from the support. 
       FIG. 11  depicts the sixth step in a loading process, filling the syringe pair assembly fourth from the support. 
       FIG. 12  is a view of the syringe pair assembly in its contracted position within its associated membrane. 
       FIG. 13A  is a top view of a syringe pair assembly that may be used with the loading station of the present invention. 
       FIG. 13B  is a bottom view of a syringe pair assembly that may be used with the loading station of the present invention. 
       FIG. 14  is a view of the syringe pair assembly in its extended position within its associated membrane. 
       FIG. 15  depicts a spraying apparatus for use with the syringe pair assembly of the present invention. 
       FIG. 16  depicts the spraying apparatus and a syringe pair assembly having a first attachment. 
       FIG. 17  depicts the spraying apparatus and a syringe pair assembly having a second attachment. 
       FIG. 18  depicts the spraying apparatus and a syringe pair assembly having a third attachment. 
       FIG. 19  depicts the spraying apparatus and a syringe pair assembly having a fourth attachment. 
       FIG. 20  is a top view of a syringe pair assembly having an output coupling and spray nozzle. 
       FIG. 21  is a bottom view of the syringe pair assembly having an output coupling and spray nozzle. 
       FIG. 22A  is a perspective view of the output coupling. 
       FIG. 22B  is a view along the section  22 B— 22 B, depicting the outlet path of the contents of one syringe of the syringe pair assembly. 
       FIG. 22C  is a view along the section  22 C— 22 C, depicting the outlet path of the contents of the other syringe of the syringe pair assembly. 
       FIG. 23  is an exploded view of a nozzle attachment that may be associated with the output coupling of the present invention. 
       FIG. 24  is a cutaway view of a nozzle attachment that may be associated with the output coupling of the present invention. 
       FIG. 25  is an exploded view of attachments that may be associated with the output coupling of the present invention, one having a spray nozzle and the other having a helical mixing path. 
       FIGS. 26 and 27  are cutaway views of lengthening attachments having helical mixing paths and spray nozzle ends that may be associated with the present invention. 
       FIG. 28  depicts a heating apparatus that receives the syringe pair assembly of the present invention, here used with the spraying apparatus of  FIG. 15 . 
       FIG. 29  depicts a heating apparatus that receives the syringe pair assembly of the present invention, here used with the assembly shown in  FIGS. 20 and 21 . 
   

   DESCRIPTION OF PREFERRED EMBODIMENTS 
   Considering the drawings, wherein like reference numerals denote like parts throughout the various drawing figures, reference numeral  10  as shown in  FIG. 1  is directed to the loading station according to the present invention. 
   In its essence, the loading station  10  includes a support  2 , to which the following are mounted: a thrombin processing unit  4 , a clotting and adhesive proteins processing unit  6 , and a dispensing manifold  8 . Each unit  4 ,  6  has a separate dispensing line  16   a ,  16   b  to the dispensing manifold  8  as shown in  FIG. 1 , to maintain sequestration of each component of the biological glue. The outlet  12  connected to the thrombin processing unit  4  leads into a reserve vessel  14 , whereby pressure from a thrombin syringe  7  causes thrombin to enter the reserve vessel  14 . Rods  1  suspend support  2 . Hooks  3  support the thrombin processing unit  4 , the clotting and adhesive proteins processing unit  6 , and reserve vessel  14 . Clips  5  support the dispensing manifold  8 . The dispensing manifold  8  is preferably oriented to load a plurality of syringe pair assemblies  20  ( FIG. 13B ) with components of the biological glue.  FIG. 2  depicts four such syringe pair assemblies  20 , but it is also observed from  FIG. 2  that additional assemblies  20  may be present. 
   The syringe pair assembly  20  is pictured in  FIGS. 13A ,  13 B. The assembly  20  includes two syringes (dispensing means)  22   a ,  22   b ; a barrel-holding frame  24 ; and a plunger connector  26 . A fitting  18  is also present, the fitting  18  adapted to frictionally hold the syringe pair assembly  20  together and link to the dispensing manifold  8  via tubing  9 . The barrel-holding frame  24  includes a spring-based plastic retaining member  28 ; in  FIG. 13B , the retaining member  28  secures the barrel-holding frame  24  to the fitting  18 . The spring  27  is shown as a resilient leaf ( FIG. 13B ) integral with frame  24  and leading to the retainer  28 . The assembly  20  is housed inside a membrane  30 , particularly during loading. The membrane  30  is preferably flexible plastic, formed with a gathered (doubled-over) portion  32  about the assembly  20 . The gathered portion  32  is formed by creating pleats  36  using “accordion”-type folds in the membrane  30 , with a first layer  30   a  ( FIG. 11 ) of the membrane  30  proximate the syringe pair assembly  20  ( FIGS. 4 ,  12 ) and an outer layer  30   b  which moves from an overlying position (relative to the first layer  30   a ) to a coextensive position after loading a syringe pair assembly  20 , one with clotting proteins and the other with thrombin. One end of the membrane  30  is sealed over the tubing  9  that connects to the dispensing line  16   a ,  16   b  via dispensing manifold  8 . The other end of the membrane  30  is also closed and is deployed about the syringe plungers  38   a ,  38   b , to allow an operator to grasp and extend the plunger end during filling of the syringe pair assembly  20  without exposure to ambient conditions. Downward force, shown by the arrow A in  FIG. 6 , while grasping the plunger end and the membrane  30  allows the pleats  36  of the gathered portion  32  to expand while always encasing the now-fully extended assembly  20  ( FIGS. 5 ,  14 ). The plunger end of the membrane  30  will be opened ( FIG. 14 ) in an operatory to allow access to the filled syringe pair assembly  20  during a surgical procedure. As shown in  FIG. 14 , a free end  37  of the membrane  30  shows the membrane as formed from the parts  37   a ,  37   b , sealed together but separable (by peeling apart) to expose plunger connector  26  of the loaded syringe pair. Thus, the loaded syringe pair is maintained sterile until actual use in surgery. 
   The procedure for loading the assemblies  20  with thrombin and adhesive and clotting proteins is shown in  FIGS. 6–11 . Before loading, all assemblies  20  are encased in membranes  30  and attached to the dispensing manifold  8  using the fittings  18 . The assembly  20  located furthest from the end of the dispensing manifold  8  is preferably drawing on the dispensing lines  16   a ,  16   b  by extending the syringe plungers ( FIG. 6 ) to fill the dispensing lines  16   a ,  16   b  and dispensing manifold  8 . It is then preferably returned to its original contracted position ( FIG. 7 ) after having expelled excess air. Beginning from the opposite end, each assembly  20  is successively extended to fill the syringe barrels  34   a ,  34   b  with the appropriate amounts of thrombin and clotting and adhesive proteins ( FIGS. 8–11 ). After all assemblies  20  are loaded, each assembly  20  and its associated membrane  30  may then be removed from the dispensing manifold  8  by heat sealing or crimping tubing  9  and severing at the crimp or heat seal, or upstream at the juncture  11  of the tubing  9  with the manifold  8 . 
   To remove assembly  20  from membrane  30 , spring  27  is depressed toward syringes  22   a ,  22   b  to release retaining member  28  from mating catch on fitting  18 . Syringes  22   a ,  22   b  are twisted and pulled away from fitting  18 , allowing assembly  20  to reside loose within membrane  30 . Membrane  30  is then peeled apart, as described earlier, to remove assembly  20 . 
   Once filled and removed, the assembly  20  may be fitted with an outlet coupling  40 , shown in  FIG. 22A . The retaining member  28  latches to a catch  42  on coupling  40  ( FIG. 21 ). As shown in  FIGS. 22B and 22C , the outlet coupling  40  equips each syringe  22   a ,  22   b  with a separate exit path  44   a ,  44   b , such that the thrombin and the adhesive and clotting proteins may exit separately as lines or dots from ports  46   a ,  46   b  in the outlet coupling  40 , thereby preventing clogging of the outlet coupling  40 . A recessed threaded area  48  is located proximate the ports  46   a ,  46   b  of the outlet coupling  40  to support a dispensing attachment. 
   The recessed female threaded area  48  of the outlet coupling  40  may receive any of a variety of dispensing attachments having a threaded end  49 ; examples of attachments are shown in  FIGS. 16–21 ,  23 – 27 . The spray nozzle  50  shown in  FIGS. 23 ,  24  may be combined with lengthening attachments, shown in  FIGS. 25–27 . These lengthening attachments are preferably constructed with an external cylindrical shroud  63  which overlies intermediate sleeves  65  that support a central internal helical path  54  to enhance admixture of the thrombin and the adhesive clotting proteins. Mixing of the thrombin with the adhesive and clotting proteins occurs within the chosen attachment and is dispensed out the spray end  52  of the spray nozzle  50  for precise placement. The spray nozzle  50  is comprised of a barrel  51  having tactile enhancing, longitudinally extending peripheral ribs  53 . The end  52  includes a flow diverter  55  and a restrictor orifice body  57  having an orifice  59 . The body  57  is press-fit into bore  61  of nozzle  50  or attached by other means. 
     FIG. 15  depicts a dispensing apparatus  60  adapted to receive the syringe pair assembly  20 . In this embodiment, the outlet coupling  40  connects to the dispensing apparatus  60  by registering a clasp  42  present on the underside of the outlet coupling  40  with a pivot  62  ( FIG. 15 ). The syringe pair assembly  20  is inserted into the outlet coupling  40  and the frame  24  is removed. 
     FIGS. 28 ,  29  depict a heating apparatus  70 , which includes a plurality of elongated arctuate indentations  72 , each shaped with projecting saddles  73  to receive a syringe pair assembly  20  and to ensconce a large portion of each syringe&#39;s barrel. The heating apparatus  70  contains resistive heating elements  74  to maintain the assemblies  20  at a constant temperature for heat transfer through indentations  72  and saddles  73 . The power cord  76  is connected to a power supply  78 , which in turn plugs into an electrical supply outlet. A sensor and microcontroller  76  optimize temperature. Compatible dispensing assemblies include, but are not limited to, the spraying apparatus  60  of  FIG. 15  and the basic syringe setup depicted in  FIGS. 20 ,  21 . Thus, the prepared biological glue is readily available for use during the medical procedure. 
   Moreover, having thus described the invention, it should be apparent that numerous structural modifications and adaptations may be resorted to without departing from the scope and fair meaning of the instant invention as set forth hereinabove and as described hereinbelow by the claims.

Technology Category: 1