Fibrin sealant applicator system

• US 6,471,670 B1
• Filed: 10/04/1999
• Issued: 10/29/2002
• Est. Priority Date: 10/05/1998
• Status: Expired due to Fees

• Current Assignee: United States Surgical Corporation (Medtronic Plc)
• Original Assignee: United States Surgical Corporation (Medtronic Plc)
• Inventors: Emmons, Clifford L., Cimini, Chad, Leeuwen, Tim Van, Enrenfels, Karl, Reth, Csaba L.
• Primary Examiner(s): Hayes, Michael J.
• Application Number:
  US09/411,090
• Time in Patent Office: 1,121 Days
• Field of Search: 604/82, 604/86-88, 604/92, 604/181, 604/184, 604/187, 604/191, 604/199, 604/200, 604/201, 604/218, 222/135, 222/137, 222/145.1, 222/145--14, 222/325-327, 239/398
• US Class Current: 604/88
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61M 35/003 Portable hand-held applicators having means for dispensing or spreading integral media hand-held massage devices with liquid delivery A61H7/003

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 fibril sealant applicator system according to the present disclosure includes two piston-type sub-assemblies coupled to two vials storing a fibrinogen and a 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 a fibrinogen and a thrombin solution. 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.

Claims

1. An applicator system for dispensing a first solution and a second solution of a multicomponent biological adhesive, the applicator system comprising;

a piston-reservoir assembly having a reservoir sub-assembly coupled to a piston sub-assembly, said reservoir sub-assembly having two reservoirs and said piston sub-assembly having two pistons, each of said two reservoirs matingly engaging a corresponding one of said two pistons, said two pistons having fluid communication means for communicating fluid from said two reservoirs to a distal end of each of said two pistons; and

a loading unit assembly configured for being coupled with said piston-reservoir assembly and at least two vials each storing at least one component of said multicomponent biological adhesive, said loading unit assembly having movable piercing means for moving towards said at least two vials and piercing a seal on each of said at least two vials, said loading unit assembly further having fluid communication means for communicating fluid from said distal end of each of said two pistons to an interior of each of said at least two vials by distally moving each of said two reservoirs toward each of said two pistons to decrease a volumetric capacity of each of said two reservoirs;

wherein each of said at least one component of said multicomponent biological adhesive is mixed with said fluid communicated from said distal end of each of said two pistons to said interior of each of said at least two vials to form said first and second solutions, said first and second solutions being communicated to a corresponding one of said two reservoirs via said fluid communication means of said loading unit assembly and said fluid communication means of said piston-reservoir assembly by proximally moving each of said two reservoirs away from each of said two pistons to increase said volumetric capacity of each of said two reservoirs, wherein said loading unit assembly being uncoupled from said piston-reservoir assembly for dispensing said first and second solutions of said multicomponent biological adhesive by compressing each of said two reservoirs toward each of said two pistons to decrease said volumetric capacity of each of said two reservoirs.

2. The applicator system according to claim 1, further comprising a dispensing unit assembly having at least two conduits and being configured for being coupled to said piston-reservoir assembly to align said at least two conduits with said fluid communication means of said two pistons.

3. The applicator system according to claim 2, wherein said dispensing unit assembly includes piercing means for piercing a seal fitted on each of said distal ends of said two pistons.

4. The applicator system according to claim 2, wherein said dispensing unit assembly is configured for performing laparoscopic surgical procedures.

5. The applicator system according to claim 3, wherein said piercing means includes two needles having a bore therethrough, said bore of each of said two needles being in fluid communication with said at least two conduits.

6. The applicator system according to claim 1, further comprising locking means for locking said reservoir sub-assembly to said piston sub-assembly to prevent distal movement of said two reservoirs towards said two pistons.

7. The applicator system according to claim 6, wherein said locking means includes a tab protruding from a rest bar of said piston sub-assembly, said tab being dimensioned to matingly engage a hole of said reservoir sub-assembly upon movement of said rest bar from a unlocked position to a locked position.

8. The applicator system of claim 1, further comprising a check-valve assembly having at least two check-valves configured for fitting at each of said distal ends of said two pistons, each of said at least two check-valves having a bore therethrough for providing fluid communication between said fluid communication means of said two pistons and said fluid communication means of said loading unit assembly.

9. The applicator system of claim 8, wherein each of said at least two check-valves includes a valve for preventing fluid communication between said fluid communication means of said two pistons and said fluid communication means of said loading unit assembly via each of said bores of said at least two check-valves.

10. The applicator system of claim 8, further comprising a dispensing unit assembly having at least two conduits and being configured for being coupled to said at least two check-valves to align said at least two conduits with a corresponding one of said two bores of said at least two check-valves.

11. The applicator system according to claim 1, wherein one of said at least two components is thrombin and another of said at least two components is fibrinogen.

12. The applicator system according to claim 11, wherein sterile water is communicated from said two reservoirs to said interior of each of said at least two vials to mix said sterile water with said thrombin and fibrinogen components to form said first and said second solutions, respectively, wherein said first solution is a thrombin solution and said second solution is a fibrinogen solution and said multicomponent biological adhesive is a fibrin sealant.

13. The applicator system according to claim 12, wherein said sterile water is hermetically sealed within said piston-reservoir assembly by providing distal and proximal seals to said distal ends of said two pistons and to proximal ends of said two pistons, respectively.

14. The applicator system according to claim 13, wherein said distal and proximal seals are manufactured from silicone.

15. The applicator system according to claim 1, wherein said piston-reservoir assembly is manufactured from polypropylene.

16. The applicator system according to claim 1, wherein said loading unit assembly is manufactured from ABS plastics.

17. A kit for dispensing a first solution and a second solution of a multicomponent biological adhesive, the kit comprising:

at least two piston assemblies each having a piston matingly engaging a reservoir storing a fluid therein, each of said pistons having fluid communication means for providing fluid communication between a corresponding one of said reservoirs and a distal end of said pistons for communicating said fluid stored within said reservoirs to said distal end of said pistons;

a loading unit assembly having a movable piercing shuttle, said movable piercing shuttle having a first end configured for coupling to said at least two piston assemblies and a second end configured for coupling to at least two vials each storing a component of said multicomponent biological adhesive, said loading unit assembly further having fluid communication means for communicating said fluid from said distal end of said pistons to an interior of each of said at least two vials by distally moving said reservoirs towards said pistons to mix said fluid with said components stored within said at least two vials to form said first and second solutions, said fluid communication means of said loading unit assembly further communicating said first and second solutions from said interior of each of said at least two vials to said reservoirs by proximally moving said reservoirs away from said pistons; and

a dispensing unit assembly having at least two conduits each configured to align with a corresponding one of said fluid communication means of each of said pistons when coupling said dispensing unit assembly to said distal ends of said at least two piston assemblies, wherein said first and second solutions are dispensed by said dispensing unit assembly by distally moving said reservoirs towards said pistons.

18. The kit according to claim 17, wherein said dispensing unit assembly includes piercing means for piercing a seal fitted on each of said distal ends of said two pistons.

19. The kit according to claim 17, wherein said dispensing unit assembly is configured for performing laparoscopic surgical procedures.

20. The kit according to claim 19, wherein said piercing means includes two needles having a bore therethrough, said bore of each of said two needles being in fluid communication with said at least two conduits.

21. The kit according to claim 17, further comprising a check-valve assembly having at least two check-valves configured for fitting at each of said distal ends of said two pistons.

22. The kit according to claim 21, wherein each of said at least two check-valves includes a bore therethrough for providing fluid communication between said fluid communication means of said two pistons and said fluid communication means of said loading unit assembly.

23. The kit according to claim 21, wherein each of said at least two check-valves includes a valve for preventing fluid communication through each of said bores.

24. The kit according to claim 21, wherein said dispensing unit assembly is configured for being coupled to said at least two check-valves to align said at least two conduits of said dispensing unit assembly with a corresponding one of said two bores of said at least two check-valves for providing fluid communication between said bores of said at least two check-valves and said at least two conduits of said dispensing unit assembly.

25. The kit according to claim 17, wherein said component stored by one of said at least two vials is thrombin and said component stored by another of said at least two vials is fibrinogen.

26. The kit according to claim 25, wherein said fluid stored within each of said reservoirs is sterile water capable of being communicated from said reservoirs to said interior of each of said at least two vials to mix said sterile water with said thrombin and fibrinogen to form said first and said second solutions, respectively, wherein said multicomponent biological adhesive is a fibrin sealant.

27. The kit according to claim 26, wherein said sterile water is hermetically sealed within said at least two piston assemblies by providing distal and proximal seals to said distal ends of said two pistons and to proximal ends of said two pistons, respectively.

28. The kit according to claim 27, wherein said distal and proximal seals are manufactured from silicone.

29. The kit according to claim 17 wherein said at least two piston assemblies are manufactured from polypropylene.

30. The kit according to claim 17, wherein said loading unit assembly is manufactured from ABS plastics.

31. The kit according to claim 17, wherein said dispensing unit assembly includes a plurality of ultrasonically welded components.