Abstract:
Fibrin sealant applicator systems are provided for dispensing a first and a second protein solution to form a biological adhesive which overcome the disadvantages of the prior art. The first and second protein solutions are preferably fibrinogen and thrombin solutions which may intermix on an application site or within the applicator to form a fibrin sealant. The fibrin sealant applicator systems according to the present disclosure include two piston-type sub-assemblies coupled to two vials storing the fibrinogen and thrombin via a coupling unit. The piston-type sub-assemblies store sterilized water within reservoirs which are in fluid communication with the vials via the coupling unit. The water is forced into the vials to form the fibrinogen and thrombin solutions. The solutions are then drawn into the reservoirs and a Y-coupler is attached to the distal end of the piston-type sub-assemblies The Y-coupler provides fluid communication between the reservoirs and a nozzle body for dispensing the solutions when distal pressure is created within the reservoirs to force the solutions towards the nozzle body.

Description:
PRIORITY  
       [0001]    This application claims priority to a U.S. provisional application filed on Oct. 5, 1998 and having U.S. Provisional Application Serial No. 60/103,073; the contents of which are incorporated herein by reference. 
     
    
     
       BACKGROUND  
         [0002]    1. Technical Field  
           [0003]    The disclosure relates generally to an applicator system for applying a tissue sealant based on human or animal proteins and more particularly to an apparatus for applying an adhesive formed by combining solutions of the proteins to tissues or organs for sealing wounds or leaks, stopping bleeding and the like.  
           [0004]    2. Description of Related Art  
           [0005]    A fibrin sealant is a biological adhesive sealant formed by mixing two protein components, including fibrinogen and thrombin. Each protein component is derived from human plasma and is subjected to virus elimination and/or inactivation procedures. The components are typically individually dehydrated and stored in separate vials as sterile freeze-dried powders.  
           [0006]    It is known that purified fibrinogen and thrombin, together with a variety of known adjuvants, can be combined in vitro to produce a hemostatic agent and/or a tissue sealant. Because of the rapid interaction of fibrinogen and thrombin, it is important to maintain these two blood proteins separate until applied at the application site. These protein solutions are generally delivered by devices such as a dual syringe apparatus.  
           [0007]    One dual syringe apparatus for applying a fibrinogen-based tissue adhesive is disclosed in U.S. Pat. No. 4,359,049 to Redl et al. Redl et al. disclose a mechanism in which two standardized one-way syringes are held in a support having a common actuating means. The dispensing end of each syringe is inserted into a collection manifold where the two components are mixed. The components are then dispensed through a common needle onto the application site.  
           [0008]    A dual syringe apparatus for the application of fibrinogen and thrombin solutions to an application site generally contain several parts, such as a syringe plunger, a “Y” manifold connector, a dispensing needle, a syringe holder, syringe needles, and conduits for transporting the solutions to the dispensing needle. Therefore, known fibrin sealant applicators, such as disclosed in U.S. Pat. No. 4,359,049 to Redl et al. discussed above, and in U.S. Pat. No. 4,874,368 to Miller et al. and U.S. Pat. No. 4,979,942 to Wolf et al. are difficult to reuse. The replenishment of the protein components typically require a combination of steps including, inter alia, removing a clip which couples the syringe plunger, removing the syringe plunger, detaching the syringes from the “Y” connector, removing the syringes from the holder, inserting new syringes, affixing the syringes to the “Y” connector, adding fibrinogen to one syringe and thrombin to another syringe, replacing the syringe plunger, replacing the plunger clip, and dispensing the solutions. In an application where time is of the essence, such a lengthy replenishing process is impractical and cumbersome.  
           [0009]    Therefore, it would be advantageous to provide a fibrin sealant applicator system which obviates the need to replenish the solutions after the solutions have been depleted; provides for a quick and error-proof method of usage; keeps the solutions within air-sealed compartments prior to usage to prevent air from mixing with the solutions; and is economical.  
         SUMMARY  
         [0010]    Fibrin sealant applicator systems are provided for dispensing a first and a second protein solution to form a biological adhesive which overcome the disadvantages of the prior art. The first and second protein solutions are preferably fibrinogen and thrombin solutions which may intermix on an application site or within the applicator to form a fibrin sealant. The fibrin sealant applicator systems according to the present disclosure include two piston-type sub-assemblies coupled to two vials storing the fibrinogen and thrombin via a coupling unit. The piston-type sub-assemblies store sterilized water within reservoirs which are in fluid communication with the vials via the coupling unit. The water is forced into the vials to form the fibrinogen and thrombin solutions. The solutions are then drawn into the reservoirs and a Y-coupler is attached to the distal end of the piston-type sub-assemblies. The Y-coupler provides fluid communication between the reservoirs and a nozzle body for dispensing the solutions when distal pressure is created within the reservoirs to force the solutions towards the nozzle body. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]    Various embodiments are described herein with reference to the drawings, wherein:  
         [0012]    FIGS.  1 - 18  illustrate the components and method of operation of a fibrin sealant applicator in accordance with a first embodiment of the present disclosure wherein:  
         [0013]    [0013]FIG. 1A is an exploded view of two piston-type sub-assemblies;  
         [0014]    [0014]FIG. 1B is a top plan view of the two piston-type sub-assemblies shown by FIG. 1A in an open configuration;  
         [0015]    [0015]FIG. 1C is a cross-sectional view of the two piston-type sub-assemblies taken along line A-A in FIG. 1B;  
         [0016]    [0016]FIG. 1D is a top plan view of the two piston-type sub-assemblies shown by FIG. 1A in a closed configuration;  
         [0017]    [0017]FIG. 1E is a cross-sectional view of the two piston-type sub-assemblies taken along line A-A in FIG. 1D;  
         [0018]    [0018]FIG. 2A is a perspective view of two cylindrical reservoirs of the subassemblies shown by FIGS.  1 A- 1 E;  
         [0019]    [0019]FIG. 2B is a bottom plan view of the two cylindrical reservoirs shown by FIG. 2A;  
         [0020]    [0020]FIG. 2C is a cross-sectional view of the two cylindrical reservoirs taken along line A-A in FIG. 2B;  
         [0021]    [0021]FIG. 3A is a perspective view of two pistons of the sub-assemblies shown by FIGS.  1 A- 1 E;  
         [0022]    [0022]FIG. 3B is a bottom plan view of the two pistons shown by FIG. 3A;  
         [0023]    [0023]FIG. 3C is a cross-sectional view of the two pistons taken along line A-A in FIG. 3B;  
         [0024]    [0024]FIG. 4A is a perspective view of a septum for sealing a distal end of each piston shown by FIGS.  3 A- 3 C;  
         [0025]    [0025]FIG. 4B is a top view of the septum shown by FIG. 4A;  
         [0026]    [0026]FIG. 5A is a perspective view of a seal for connection to a proximal end of each piston shown by FIGS.  3 A- 3 C;  
         [0027]    [0027]FIG. 5B is a bottom plan view of the seal shown by FIG. 5A;  
         [0028]    [0028]FIG. 5C is a cross-sectional view of the seal shown by FIG. 5A taken along line A-A in FIG. 5B;  
         [0029]    [0029]FIGS. 6A and 6B are perspective views of the bottom portion of a loading unit;  
         [0030]    [0030]FIG. 6C is a top plan view of one side of the bottom portion shown by FIGS. 6A and 6B;  
         [0031]    [0031]FIG. 6D is a top plan view of an opposite side of the bottom portion shown by FIGS. 6A and 6B;  
         [0032]    [0032]FIG. 7A is a perspective view of the top portion of the loading unit;  
         [0033]    [0033]FIG. 7B is a top plan view of one side of the top portion shown by FIG. 7A;  
         [0034]    [0034]FIG. 7C is a top plan view of an opposite side of the top portion shown by FIG. 7A;  
         [0035]    [0035]FIG. 8A is a perspective view of a hollow needle;  
         [0036]    [0036]FIG. 8B is a side view of the hollow needle shown by FIG. 8A;  
         [0037]    [0037]FIG. 8C is a cross-sectional view of the hollow needle shown by FIG. 8A taken along line A-A in FIG. 8B;  
         [0038]    [0038]FIG. 9A is a perspective view of the hollow needle placed within a shuttle of the loading unit for piercing a seal on a vial inserted within the loading unit;  
         [0039]    [0039]FIG. 9B is an assembly view of the hollow needle shown by FIG. 9A being placed within the shuttle;  
         [0040]    [0040]FIG. 9C is a side view of the hollow needle-shuttle assembly;  
         [0041]    [0041]FIG. 9D is a cross-sectional view of the hollow needle-shuttle assembly shown by FIG. 9C taken along line A-A in FIG. 9C;  
         [0042]    [0042]FIG. 9E is an enlarged view of the area of detail indicated by arrow “B” in FIG. 9D;  
         [0043]    [0043]FIG. 10A is an assembly view showing coupling of the two piston-type sub-assemblies, the loading unit, and the vials;  
         [0044]    [0044]FIG. 10B is top plan view of the components shown by FIG. 10A;  
         [0045]    [0045]FIG. 10C is a cross-sectional view of the components shown by FIG. 10A taken along line A-A in FIG. 10B;  
         [0046]    [0046]FIG. 10D is a top plan view of the assembled components shown by FIG. 10A with the shuttle in a non-piercing position and the piston-type sub-assemblies in the open configuration;  
         [0047]    [0047]FIG. 10E is a cross-sectional view of the assembled components shown by FIG. 10D taken along line A-A in FIG. 10D;  
         [0048]    [0048]FIG. 10F is a top plan view of the assembled components shown by FIG. 10A with the shuttle in a piercing position and the piston-type sub-assemblies in the open configuration;  
         [0049]    [0049]FIG. 10G is a cross-sectional view of the assembled components shown by FIG. 10F taken along line A-A in FIG. 10F;  
         [0050]    [0050]FIG. 10H is a top plan view of the assembled components shown by FIG. 10A with the shuttle in the piercing position and the piston-type sub-assemblies in the closed configuration;  
         [0051]    [0051]FIG. 10I is a cross-sectional view of the assembled components shown by FIG. 10H taken along line A-A in FIG. 10H;  
         [0052]    [0052]FIG. 11A is an exploded of a Y-coupler;  
         [0053]    [0053]FIG. 11B is a top plan view of the Y-couple shown by FIG. 11A;  
         [0054]    [0054]FIG. 11 C is a cross-sectional view of the Y-coupler shown by FIG. 11A taken along line A-A in FIG. 11B;  
         [0055]    [0055]FIG. 11D is a cross-sectional view of the Y-coupler shown by FIG. 11A taken along line C-C in FIG. 11C;  
         [0056]    [0056]FIG. 12A is a perspective view of an adaptor of the Y-coupler shown by FIG. 11A;  
         [0057]    [0057]FIG. 12B is a side view of the adaptor shown by FIG. 12A;  
         [0058]    [0058]FIG. 12C is a cross-sectional view of the adaptor shown by FIG. 12A taken along line A-A in FIG. 12B;  
         [0059]    [0059]FIG. 13A is a perspective view of a body tip of the Y-coupler shown by FIG. 11A;  
         [0060]    [0060]FIG. 13B is a side view of the body tip shown by FIG. 13A;  
         [0061]    [0061]FIG. 13C is a cross-sectional view of the body tip shown by FIG. 13A taken along line A-A in FIG. 13B;  
         [0062]    [0062]FIG. 14A is a perspective view of a collar of the Y-coupler shown by FIG. 11;  
         [0063]    [0063]FIG. 14B is a side view of the collar shown by FIG. 14A;  
         [0064]    [0064]FIG. 14C is a cross-sectional view of the collar shown by FIG. 14A taken along line A-A in FIG. 14B;  
         [0065]    [0065]FIG. 15A is a perspective view of a nozzle body of the Y-coupler shown by FIG. 11A;  
         [0066]    [0066]FIG. 15B is a top plan view of the nozzle body shown by FIG. 15A;  
         [0067]    [0067]FIG. 16A is an assembly view of coupling the two piston-type sub-assemblies and the Y-coupler;  
         [0068]    [0068]FIG. 16B is a top plan view of the assembled components shown by FIG. 16A with the piston-type sub-assemblies in the open configuration;  
         [0069]    [0069]FIG. 16C is a cross-sectional view of the assembled components shown by FIG. 16B taken along line A-A in FIG. 16B;  
         [0070]    [0070]FIG. 16D is a top plan view of the assembled components shown by FIG. 16A with the piston-type sub-assemblies in the closed configuration;  
         [0071]    [0071]FIG. 16E is a cross-sectional view of the assembled components shown by FIG. 16D taken along line A-A in FIG. 16D;  
         [0072]    [0072]FIG. 17A is a perspective view of the components of a laparoscopic tip assembly configured for coupling to the two piston-type sub-assemblies shown by FIG. 11A;  
         [0073]    [0073]FIG. 17B is a side view of the assembled components of the laparoscopic tip assembly shown by FIG. 17A;  
         [0074]    [0074]FIG. 17C is a cross-sectional view of the assembled components shown by FIG. 17B taken along line A-A in FIG. 17B;  
         [0075]    [0075]FIG. 18A is a perspective view of the laparoscopic tip shown by FIG. 17A;  
         [0076]    [0076]FIG. 18B is a top plan view of the laparoscopic tip shown by FIG. 18A;  
         [0077]    [0077]FIG. 18C is a cross-sectional view of the laparoscopic tip shown by FIG. 18A taken along line A-A in FIG. 18B;  
         [0078]    FIGS.  19 - 30  illustrate the components and method of operation of a fibrin sealant applicator in accordance with a second embodiment of the present disclosure wherein:  
         [0079]    [0079]FIG. 19A is an exploded is an exploded view of two piston-type sub-assemblies;  
         [0080]    [0080]FIG. 19B is a top plan view of the two piston-type sub-assemblies shown by FIG. 19A in an open configuration;  
         [0081]    [0081]FIG. 19C is a cross-sectional view of the two piston-type sub-assemblies taken along line A-A in FIG. 19B;  
         [0082]    [0082]FIG. 19D is a top plan view of the two piston-type sub-assemblies shown by FIG. 19A in a closed configuration;  
         [0083]    [0083]FIG. 19E is a cross-sectional view of the two piston-type sub-assemblies taken along line A-A in FIG. 19D;  
         [0084]    [0084]FIG. 20A is a perspective view of two cylindrical reservoirs of the sub-assemblies shown by FIGS.  19 A- 19 E;  
         [0085]    [0085]FIG. 20B is a bottom plan view of the two cylindrical reservoirs shown by FIG. 20A;  
         [0086]    [0086]FIG. 20C is a cross-sectional view of the two cylindrical reservoirs taken along line A-A in FIG. 20B;  
         [0087]    [0087]FIG. 21A is a perspective view of two pistons of the sub-assemblies shown by FIGS.  19 A- 19 E;  
         [0088]    [0088]FIG. 21B is a bottom plan view of the two pistons shown by FIG. 21A;  
         [0089]    [0089]FIG. 21C is a cross-sectional view of the two pistons taken along line AA in FIG. 21B;  
         [0090]    [0090]FIGS. 22A and 22B are perspective views of the bottom portion of a loading unit;  
         [0091]    [0091]FIG. 22C is a top plan view of one side of the bottom portion shown by FIGS. 22A and 22B;  
         [0092]    [0092]FIG. 22D is a top plan view of an opposite side of the bottom portion shown by FIGS. 22A and 22B;  
         [0093]    [0093]FIG. 23A is a perspective view of the top portion of the loading unit;  
         [0094]    [0094]FIG. 23B is a top plan view of one side of the top portion shown by FIG. 23A;  
         [0095]    [0095]FIG. 23C is a top plan view of an opposite side of the top portion shown by FIG. 23A;  
         [0096]    [0096]FIG. 24A is a perspective view of an adaptor for connecting check-valves to vials;  
         [0097]    [0097]FIG. 24B is a side view of the adaptor shown by FIG. 24A;  
         [0098]    [0098]FIG. 24C is a cross-sectional view of the adaptor shown by FIG. 24A taken along line A-A in FIG. 24B;  
         [0099]    [0099]FIG. 250A is an assembly view showing coupling of the two piston-type sub-assemblies, the check-valves, the adaptor, and the vials;  
         [0100]    [0100]FIG. 25B is top plan view of the assembled components shown by FIG. 25A;  
         [0101]    [0101]FIG. 25C is a cross-sectional view of the assembled components shown by FIG. 25B taken along line A-A in FIG. 25B;  
         [0102]    [0102]FIG. 26A is an exploded of a Y-coupler;  
         [0103]    [0103]FIG. 26B is a top plan view of the Y-couple shown by FIG. 26A;  
         [0104]    [0104]FIG. 26C is a cross-sectional view of the Y-coupler shown by FIG. 26A taken along line A-A in FIG. 26B;  
         [0105]    [0105]FIG. 27A is a perspective view of an adaptor of the Y-coupler shown by FIG. 26A;  
         [0106]    [0106]FIG. 27B is a side view of the adaptor shown by FIG. 27A;  
         [0107]    [0107]FIG. 27C is a cross-sectional view of the adaptor shown by FIG. 27A taken along line A-A in FIG. 27B;  
         [0108]    [0108]FIG. 28A is a perspective view of a body tip of the Y-coupler shown by FIG. 27A;  
         [0109]    [0109]FIG. 28B is a side view of the body tip shown by FIG. 28A;  
         [0110]    [0110]FIG. 28C is a cross-sectional view of the body tip shown by FIG. 28A taken along line A-A in FIG. 28B;  
         [0111]    [0111]FIG. 29A is a perspective view of a collar of the Y-coupler shown by FIG. 27A;  
         [0112]    [0112]FIG. 29B is a side view of the collar shown by FIG. 29A;  
         [0113]    [0113]FIG. 29C is a cross-sectional view of the collar shown by FIG. 29A taken along line A-A in FIG. 29B;  
         [0114]    [0114]FIG. 30A is a top plan view of the piston-type sub-assemblies in the open configuration coupled to the Y-coupler;  
         [0115]    [0115]FIG. 30B is a cross-sectional view of the assembled components shown by FIG. 30A taken along line A-A in FIG. 30A;  
         [0116]    [0116]FIG. 30C is a top plan view of the piston-type sub-assemblies in the closed configuration coupled to the Y-coupler; and  
         [0117]    [0117]FIG. 30D is a cross-sectional view of the assembled components shown by FIG. 30C taken along line A-A in FIG. 30C. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0118]    Two embodiments of a fibrin sealant applicator system are described herein below in conjunction with FIGS.  1 A- 30 D. With reference to FIGS.  1 A- 18 C, the components and method of operation of the first embodiment of the fibrin sealant applicator system are described. With reference to FIGS.  19 A- 30 D, the components and method of operation of the second embodiment of the fibrin sealant applicator system are described. The fibrin sealant applicator system embodiments described herein below are preferably manufactured from biodegradable plastics and other materials. In their preferred embodiments, both are packaged as a kit and used only once to apply a solution of fibrinogen and a solution of thrombin to an application site.  
         [0119]    Referring to FIGS.  1 - 10 , the components used during the formation and loading of the fibrinogen and thrombin solutions to the first embodiment of the fibrin sealant applicator system will now be described. For this purpose, the fibrin sealant applicator system includes two piston-type sub-assemblies  10  (FIGS.  1 A- 1 E) coupled together and each having a reservoir assembly  12  (FIGS.  2 A- 2 C), a piston assembly  14  (FIGS.  3 A- 3 C), a septum  16  (FIGS.  4 A- 4 B); and a coupling unit  18  (FIGS.  6 A- 6 D and  7 A- 7 C) having two hollow needles  20  (FIGS.  8 A- 8 C and  9 A- 9 E) therein.  
         [0120]    Each reservoir assembly  12  includes a cylindrical reservoir  22  having a compartment  24  for storing sterilized water therein. The sterilized water is preferably stored within compartment  24  of each reservoir  22  during manufacturing and hermetically sealed therein to prevent contamination thereof. Each reservoir assembly  12  is preferably made from polypropylene.  
         [0121]    Each piston assembly  14  includes a piston  26  having a bore  28  therethrough (FIGS.  3 A- 3 C), an elongated cylindrical tube  30  extending through bore  28 , a distal seal  32 , and a proximal seal  34 . Each piston assembly  14  is preferably made from polypropylene and distal and proximal seals  32  and  34  are preferably made from silicone. Distal seal  32 , as shown by FIGS.  4 A- 4 B, is semi-spherical in shape and configured to matingly engage seal  16 . Distal seal  32 .and seal  16  are then attached to the distal end of piston assembly  14  as shown by FIG. 1A to prevent contaminants from entering the two piston-type sub-assemblies  10 .  
         [0122]    Proximal seal  34 , as. shown by FIGS.  5 A- 5 C, is cylindrical in shape having a bore  36  therethrough and threads  38  on an inner and outer surface. Proximal seal  34  is configured for placement on a proximal end of piston assembly  14  to wedge the proximal end of piston  26  within compartments  24  as shown by FIG. 1A. Distal and proximal seals  32  and  34  prevent contaminants from entering the piston-type subassemblies and compromising the sterility of the sterile water within compartment  24  of each reservoir  22 .  
         [0123]    A connecting mechanism  40  connects each piston assembly  14 . Connecting mechanism  42  includes a hatch-bar  44  having a finger-controlled locking assembly  46 . Locking assembly  46  includes a rest bar  48  having tab  50  protruding therefrom. Rest bar  48  moves from an unlocked position to a locked position to move tab  50  to matingly engage a hole  52  (FIGS. 1A and 2A) on reservoir assembly  12  to lock reservoir assembly  12  to piston assembly  14 . This prevents reservoirs  22  from being inadvertently moved distally or pushed against pistons  26 . When the solutions are ready to be dispensed, the operator can use a finger to lift rest bar  48  to disengage tab  50  from within hole  52 . Accordingly, locking assembly  46  is unlocked, thereby allowing free movement of reservoir assembly  12  along the longitudinal axis of piston assembly  14 . It is contemplated to design locking assembly  46  to also provide a locking function when reservoir assembly  12  has been moved distally towards piston assembly  14  to prevent proximal movement of reservoir assembly  12 .  
         [0124]    With reference to FIGS. 1C, 1E and  10 A- 10 I, each reservoir  22  is in fluid communication with the distal end of corresponding piston  26  via bore  54  extending within tube  30 . It is contemplated to size bore  54  to allow for little or no water to remain therein when dispensing the sterilized water to vials containing powdered fibrinogen and thrombin, as further described below.  
         [0125]    A coupling unit  56  (FIGS.  6 A- 6 D and  7 A- 7 C) having body half portions  58  and  60  acts as an interface between piston-type sub-assemblies  10  and vials  62  (See FIGS.  10 A- 10 I). Coupling unit  56  includes molded compartments therein for fitting vials  62  and a shuttle  64 . Coupling unit  56  includes a proximal interface  66  for receiving and coupling to the two piston-type sub-assemblies  10  and a distal interface  68  for receiving and coupling to vials  62  storing fibrinogen and thrombin. Vials  62  are inserted within distal interface  68  and are coupled to the coupling unit by a coupling mechanism  67 . Coupling mechanism  67  includes flexible tabs  69  which flex outwardly as vials  62  are inserted within distal interface  68  and then flex back to grip the neck of vials  62  and hold them in place. Body half portions  58  and  60  of the coupling unit  56  are preferably made from ABS plastics.  
         [0126]    With reference to FIGS.  9 A- 9 E, shuttle  64  includes two proximal hollow needles  70  within recess  72  for piercing septum  16  and distal seal  32  when the two piston-type sub-assemblies  10  are inserted within proximal interface  66 . Recess  72  is configured to matingly engage the distal end of pistons  26  and to securely connect coupling unit  56  with the two piston-type sub-assemblies  10 . The distal hollow needles  74  (FIGS.  8 A- 8 C and  9 A- 9 E) having a base  76  are matingly engaged to distal recesses  78  on shuttle  64  (FIGS.  10 A- 10 I) for piercing a seal overlaying vials  62 . Proximal hollow needles  70 , distal hollow needles  74 , and bores  80  within shuttle  64  form passageways  82  for providing fluid communication between the distal end of piston assembly  14  and vials  62  as shown by FIGS. 9D, 9E,  10 C,  10 E,  10 G and  10 I.  
         [0127]    Shuttle  64  is capable of moving between tabs  84  within coupling unit  56  and hatch-bar  44  of the piston assembly  14 . Therefore, in order to prevent inadvertent piercing of the seal overlaying vials  62 , shuttle  64  is kept positioned near proximal interface  66  of coupling unit  56  until the operator is ready to form the solutions.  
         [0128]    With reference to FIGS.  10 D- 10 I, the solutions are formed by moving shuttle  64  distally from a non-piercing position to a piercing position in order for needles  74  to pierce the seal overlaying vials  62  (FIG. 10G). Distal holding needles  74  are preferably made from nylon. Reservoir assembly  12  is then moved distally to decrease the volumetric capacity within compartments  24  to force the sterilized water therein to flow distally through bores  54  of tubes  30  (FIG. 10I). The water flows through bores  54  and passageways  82  into vials  62 . The entire assembly is then shaken to thoroughly mix the water with the powdered fibrinogen and thrombin to form the solutions. Reservoir assembly  12  is then moved proximally away from piston assembly  14  creating proximal pressure within the reservoirs  22  to draw the solutions from vials  62  to reservoirs  22 .  
         [0129]    When the solutions have been drawn into reservoirs  22 , shuttle  64  is moved proximally to remove needles  74  from within vials  62 . Vials  62  are then removed from distal interface  68  of coupling unit  56 . Coupling unit  56  is subsequently removed from the two piston-type sub-assemblies  10  and a Y-coupler unit  86  (FIGS.  11 A- 11 D) is then coupled to the two piston-type sub-assemblies  10  as shown by FIGS.  16 A- 16 E.  
         [0130]    Y-coupler unit  86  includes an adaptor  88 , a body tip  90 , a collar  92 , a nozzle body  94 , and a seal  96 . The components are assembled together as shown by FIGS.  11 A- 11 D to form Y-coupler  86 . Adaptor  88  includes two hollow needles  98  recessed within cavities  100  to prevent accidental piercing or pricking of an operator&#39;s finger (FIGS.  12 A- 12 C). Hollow needles  98  matingly engage seal  16  and distal seal  32  at the distal end of piston assembly  14  to provide fluid communication between reservoirs  22  and distal face  102  of adaptor  88 . Adaptor  88  and body tip  90  are preferably made from polypropylene. Alternatively, adaptor  88  and body tip  90  are made from ABS plastics. Collar  92  and nozzle body  94  are preferably made from ABS plastics.  
         [0131]    Distal face  102  connects to proximal face  104  by snap-fitting distal face  102  into proximal face  104  of body tip  90  such that fluid communication is provided between hollow needles  98  and passageways  106  extending within body tip  90  (FIGS.  13 A- 13 C). Passageways  106  lead to cavities  108  within collar  92  (FIGS.  14 A- 14 C). Cavities  108  lead to openings  110  within nozzle body  94  (FIGS.  15 A- 15 B) to dispense any solutions flowing through cavities  108  when seal  96  is absent. Specifically, the solutions are dispensed by moving reservoirs  22  distally to decrease the volumetric capacity therein and force the solutions distally towards openings  110 .  
         [0132]    With reference to FIGS.  17 A- 17 C and  18 A- 18 C, a laparoscopic tip  112  having an adaptor  114  for matingly engaging body tip  90  may be provided to the fibrin sealant applicator to provide fluid communication between passageways  106  and bores  116 . It is contemplated that adaptor  88 , body tip  90 , and laparoscopic tip  112  are ultrasonically welded.  
         [0133]    Reference will now be made to a second embodiment of the fibrin sealant applicator system in conjunction with FIGS.  19 A- 30 D. The second embodiment works substantially the same as the first embodiment described above and identical reference numerals identify the same or similar components.  
         [0134]    The second embodiment includes two piston-type sub-assemblies  10  each having a reservoir assembly  12  (FIGS.  20 A- 20 C) and a piston assembly  14  (FIGS.  21 A- 21 C). Piston assembly  14  includes two check-valve retainers  130  each having a compartment  132  therein. Each compartment  132  includes passageway  134  in fluid communication with bore  28 . A check-valve  136  is placed within each check-valve retainer  130  having a bore  138  therethrough and a nozzle  140  covered by a seal  141  as shown by FIGS.  19 A- 19 E. Each bore  138  is in fluid communication with a corresponding passageway  134  and each nozzle  140  is in fluid communication with a bore  142  within adaptor  144  (FIGS.  24 A- 24 C) as shown by FIGS.  25 A- 25 C. It is contemplated to provide each check-valve  136  with a valve for opening and closing bore  138  traversing therethrough to prevent and allow fluid communication between reservoir assembly  12  and the distal ends of check-valves  136 .  
         [0135]    With continued reference to FIGS.  25 A- 25 C, each bore  142  is in fluid communication with a hollow distal needle  146  fitted within a recess  148  of adaptor  144 . Hollow distal needles  146  provide fluid communication between reservoirs  22  and vials  62  when adaptor  144  is moved distally within coupling unit  148  and needles  146  contact and pierce a seal overlaying vials  62 . Coupling unit  148  is similar in design and operation as coupling unit  56  with slight design modifications in top portion  150  (FIGS.  22 A- 22 D) and bottom portion  152  (FIGS.  23 A- 23 C) for housing check-valve retainers  130  and adaptor  144  therein.  
         [0136]    Y-coupler  86  (FIGS.  26 A- 26 C) having adaptor  154  (FIGS.  27 A- 27 C), body tip  90  (FIGS.  28 A- 28 C), collar  92  (FIGS.  29 A- 29 C) and nozzle body  94  (see FIGS.  15 A- 15 B of the first embodiment) is fitted to check-valves  136  when vials  62 , adaptor  144  and coupling unit  148  are removed from the two piston-type subassemblies  10  when the solutions have been formed and drawn into reservoirs  22  as shown by FIGS.  30 A- 30 D.  
         [0137]    Specifically, with reference to FIGS.  27 A- 27 C, adaptor  154  of Y-coupler  86  includes two male connectors  156  having a bore  158  therein for matingly engaging nozzles  140  of check-valves  136  for providing fluid communication between reservoirs  22  and openings  110  within nozzle body  94 . With reference to FIGS.  30 A- 30 D, the solutions can then be dispensed by distally moving reservoirs  22  to decrease the volumetric capacity therein as discussed above with respect to the first embodiment.  
         [0138]    It is contemplated that a laparoscopic tip can also be provided for the second embodiment. It is further contemplated to coat the passageways and bores wherein the solutions flow with a non-stick polymer to prevent the solutions from attaching to the components of the fibrin sealant applicator and to allow the components to be readily cleaned. It is further contemplated that similar components of the two embodiments are manufactured from the same materials. Additionally, it is further contemplated to provide the components of the two embodiments as a kit. Therefore, it is understood that various modifications may be made to the embodiments disclosed herein.  
         [0139]    Also, besides applying a fibrin sealant, the fibrin sealant applicator systems can be used to perform human or veterinary surgical procedures, such as applying antiseptics and medication. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the above disclosure and appended claims.