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WO2001024869A1 - Systeme d'application d'un materiau de scellement a base de fibrine - Google Patents

Systeme d'application d'un materiau de scellement a base de fibrine Download PDF

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Publication number
WO2001024869A1
WO2001024869A1 PCT/US1999/023135 US9923135W WO0124869A1 WO 2001024869 A1 WO2001024869 A1 WO 2001024869A1 US 9923135 W US9923135 W US 9923135W WO 0124869 A1 WO0124869 A1 WO 0124869A1
Authority
WO
WIPO (PCT)
Prior art keywords
pistons
assembly
reservoirs
fluid communication
piston
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US1999/023135
Other languages
English (en)
Inventor
Karl Ehrenfels
Chad Cimini
Csaba L. Rethy
Tim Van Leeuwen
Clifford L. Emmons
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
United States Surgical Corp
Original Assignee
United States Surgical Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by United States Surgical Corp filed Critical United States Surgical Corp
Priority to AU62885/99A priority Critical patent/AU6288599A/en
Priority to PCT/US1999/023135 priority patent/WO2001024869A1/fr
Publication of WO2001024869A1 publication Critical patent/WO2001024869A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00491—Surgical glue applicators
    • A61B2017/00495—Surgical glue applicators for two-component glue

Definitions

  • 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.
  • 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.
  • Tbese protein solutions are generally delivered by devices such as a dual syringe apparatus.
  • Qa ⁇ jttoaKgytiftge apparatus for applying a fibrinogen-based tissue _ ft «i ⁇ .t&cl ⁇ sMl_3Er ⁇ s21?atent No. 4,359,049 to Redl et al.
  • Redl et al. disclose ; 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.
  • 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. Patent No. 4,359,049 to Redl et al. discussed above, and in U.S. Patent No. 4,874,368 to Miller et al. and 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.
  • 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
  • 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.
  • 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:
  • FIG. 1A is an exploded view of two piston-type sub-assemblies
  • FIG. IB is a top plan view of the two piston-type sub-assemblies shown by FIG. 1A in an open configuration
  • FIG. IC is a cross-sectional view of the two piston-type sub-assemblies taken along line A-A in FIG. IB;
  • FIG. ID is a top plan view of the two piston-type sub-assemblies shown by FIG. 1A in a closed configuration
  • FIG. IE is a cross-sectional view of the two piston-type sub-assemblies taken along line A-A in FIG. ID;
  • FIG. 2A is a perspective view of two cylindrical reservoirs of the sub- assemblies shown by FIGS. 1A-1E;
  • FIG. 2B is a bottom plan view of the two cylindrical reservoirs shown by FIG. 2A;
  • FIG. 2C is a cross-sectional view of the two cylindrical reservoirs taken along line A-A in FIG. 2B;
  • FIG. 3 A is a perspective view of two pistons of the sub-assemblies shown by FIGS. 1A-1E;
  • FIG. 3B is a bottom plan view of the two pistons shown by FIG. 3A;
  • FIG. 3C is a cross-sectional view of the two pistons taken along line A-A in FIG. 3B;
  • FIG. 4A is a perspective view of a septum for sealing a distal end of each piston shown by FIGS. 3A-3C;
  • FIG. 4B is a top view of the septum shown by FIG. 4A;
  • FIG. 5A is a perspective view of a seal for connection to a proximal end of each piston shown by FIGS. 3A-3C;
  • FIG. 5B is a bottom plan view of the seal shown by FIG. 5A;
  • FIG. 5C is a cross-sectional view of the seal shown by FIG. 5A taken along line A-A in FIG. 5B;
  • FIGS. 6A and 6B are perspective views of the bottom portion of a loading unit
  • FIG. 6C is a top plan view of one side of the bottom portion shown by FIGS. 6A and 6B;
  • FIG. 6D is a top plan view of an opposite side of the bottom portion shown by FIGS. 6A and 6B;
  • FIG. 7A is a perspective view of the top portion of the loading unit;
  • FIG. 7B is a top plan view of one side of the top portion shown by FIG.
  • FIG. 7C is a top plan view of an opposite side of the top.portion shown by FIG. 7A;
  • FIG. 8A is a perspective view of a hollow needle
  • FIG. 8B is a side view of the hollow needle shown by FIG. 8A;
  • FIG. 8C is a cross-sectional view of the hollow needle shown by FIG. 8A taken along line A-A in FIG. 8B;
  • 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;
  • FIG. 9B is an assembly view of the hollow needle shown by FIG. 9A being placed within the shuttle;
  • FIG. 9C is a side view of the hollow needle-shuttle assembly
  • FIG. 9D is a cross-sectional view of the hollow needle-shutde assembly shown by FIG. 9C taken along line A-A in FIG. 9C;
  • FIG. 9E is an enlarged view of the area of detail indicated by arrow "B" in FIG. 9D;
  • FIG. 10A is an assembly view showing coupling of the two piston-type sub-assemblies, the loading unit, and the vials;
  • FIG. 10B is top plan view of the components shown by FIG. 10A;
  • FIG. IOC is a cross-sectional view of the components shown by FIG. 10A taken along line A-A in FIG. 10B;
  • 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;
  • FIG. 10E is a cross-sectional view of the assembled components shown by FIG. 10D taken along line A-A in FIG. 10D;
  • FIG. 10F is a top plan view of the assembled components shown by FIG. 10A with the shuttie in a piercing position and the piston-type sub-assemblies in the open configuration;
  • FIG. 10G is a cross-sectional view of the assembled components shown by FIG. 10F taken along line A-A in FIG. 10F;
  • 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;
  • FIG. 101 is a cross-sectional view of the assembled components shown by FIG. 10H taken along line A-A in FIG. 10H;
  • FIG. 11A is an exploded of a Y-coupler
  • FIG. 1 IB is a top plan view of the Y-couple shown by FIG. 11 A;
  • FIG. 1 IC is a cross-sectional view of the Y-coupler shown by FIG. 11 A taken along line A-A in FIG. 11B;
  • FIG. 1 ID is a cross-sectional view of the Y-coupler shown by FIG. 11A taken along line C-C in FIG. HC;
  • FIG. 12A is a perspective view of an adaptor of the Y-coupler shown by FIG. 11A;
  • FIG. 12B is a side view of the adaptor shown by FIG. 12A;
  • FIG. 12C is a cross-sectional view of the adaptor shown by FIG. 12A taken along line A-A in FIG. 12B;
  • FIG. 13 A is a perspective view of a body tip of the Y-coupler shown by FIG. 11 A;
  • FIG. 13B is a side view of the body tip shown by FIG. 13A;
  • FIG. 13C is a cross-sectional view of the body tip shown by FIG. 13A taken along line A-A in FIG. 13B;
  • FIG. 14A is a perspective view of a collar of the Y-coupler shown by FIG. 11 A;
  • FIG. 14B is a side view of the collar shown by FIG. 14A;
  • FIG. 14C is a cross-sectional view of the collar shown by FIG. 14A taken along line A-A in FIG. 14B;
  • FIG. 15A is a perspective view of a nozzle body of the Y-coupler shown by FIG. 11A;
  • FIG. 15B is a top plan view of the nozzle body shown by FIG. 15A;
  • FIG. 16A is an assembly view of coupling the two piston-type sub- assemblies and the Y-coupler
  • 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;
  • FIG. 16C is a cross-sectional view of the assembled components shown by FIG. 16B taken along line A-A in FIG. 16B;
  • 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;
  • FIG. 16E is a cross-sectional view of the assembled components shown by FIG. 16D taken along line A-A in FIG. 16D;
  • 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. 1A;
  • FIG. 17B is a side view of the assembled components of the laparoscopic tip assembly shown by FIG. 17A;
  • FIG. 17C is a cross-sectional view of the assembled components shown by FIG. 17B taken along line A-A in FIG. 17B;
  • FIG. 18A is a perspective view of the laparoscopic tip shown by FIG. 17A;
  • FIG. 18B is a top plan view of the laparoscopic tip shown by FIG. 18A;
  • FIG. 18C is a cross-sectional view of the laparoscopic tip shown by FIG. 18A taken along line A-A in FIG. 18B;
  • 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:
  • FIG. 19A is an exploded is an exploded view of two piston-type sub- assemblies
  • FIG. 19B is a top plan view of the two piston-type sub-assemblies shown by FIG. 19A in an open configuration
  • FIG. 19C is a cross-sectional view of the two piston-type sub-assemblies taken along line A-A in FIG. 19B;
  • FIG. 19D is a top plan view of the two piston-type sub-assemblies shown by FIG. 19A in a closed configuration
  • FIG. 19E is a cross-sectional view of the two piston-type sub-assemblies taken along line A-A in FIG. 19D;
  • FIG. 20A is a perspective view of two cylindrical reservoirs of the sub- assemblies shown by FIGS. 19A-19E;
  • FIG. 20B is a bottom plan view of the two cylindrical reservoirs shown by FIG. 20A;
  • FIG. 20C is a cross-sectional view of the two cylindrical reservoirs taken along line A-A in FIG. 20B;
  • FIG. 21 A is a perspective view of two pistons of the sub-assemblies shown by FIGS. 19A-19E;
  • FIG. 21B is a bottom plan view of the two pistons shown by FIG. 21A;
  • FIG. 21C is a cross-sectional view of the two pistons taken along line A- A in FIG. 21B;
  • FIGS. 22A and 22B are perspective views of the bottom portion of a loading unit
  • FIG. 22C is a top plan view of one side of the bottom portion shown by FIGS. 22A and 22B;
  • FIG. 22D is a top plan view of an opposite side of the bottom portion shown by FIGS. 22A and 22B;
  • FIG. 23A is a perspective view of the top portion of the loading unit
  • FIG. 23B is a top plan view of one side of the top portion shown by FIG. 23A;
  • FIG. 23C is a top plan view of an opposite side of the top portion shown by FIG. 23A;
  • FIG. 24A is a perspective view of an adaptor for connecting check- valves to vials
  • FIG. 24B is a side view of the adaptor shown by FIG. 24A
  • FIG. 24C is a cross-sectional view of the adaptor shown by FIG. 24A taken along line A-A in FIG. 24B;
  • FIG. 250A is an assembly view showing coupling of the two piston-type sub-assemblies, the check-valves, the adaptor, and the vials;
  • FIG. 25B is top plan view of the assembled components shown by FIG. 25A;
  • FIG. 25C is a cross-sectional view of the assembled components shown by FIG. 25B taken along line A-A in FIG. 25B;
  • FIG. 26A is an exploded of a Y-coupler
  • FIG. 26B is a top plan view of the Y-couple shown by FIG. 26A;
  • FIG. 26C is a cross-sectional view of the Y-coupler shown by FIG. 26A taken along line A-A in FIG. 26B;
  • FIG. 27A is a perspective view of an adaptor of the Y-coupler shown by FIG. 26A;
  • FIG. 27B is a side view of the adaptor shown by FIG. 27A;
  • FIG. 27C is a cross-sectional view of the adaptor shown by FIG. 27A taken along line A-A in FIG. 27B;
  • FIG. 28A is a perspective view of a body tip of the Y-coupler shown by FIG. 27A;
  • FIG. 28B is a side view of the body tip shown by FIG. 28A;
  • FIG. 28C is a cross-sectional view of the body tip shown by FIG. 28A taken along line A-A in FIG. 28B;
  • FIG. 29A is a perspective view of a collar of the Y-coupler shown by FIG. 27A;
  • FIG. 29B is a side view of the collar shown by FIG. 29A;
  • FIG. 29C is a cross-sectional view of the collar shown by FIG. 29A taken along line A-A in FIG. 29B;
  • FIG. 30A is a top plan view of the piston-type sub-assemblies in the open configuration coupled to the Y-coupler;
  • FIG. 30B is a cross-sectional view of the assembled components shown by FIG. 30A taken along line A-A in FIG. 30A;
  • FIG. 300 is a top plan view of the piston-type sub-assemblies in the closed configuration coupled to the Y-coupler;
  • FIG. 30D is a cross-sectional view of the assembled components shown by FIG. 30C taken along line A-A in FIG. 30C.
  • FIGS. 1A-30D Two embodiments of a fibrin sealant applicator system are described herein below in conjunction with FIGS. 1A-30D.
  • FIGS. 1A-18C the components and method of operation of the first embodiment of the fibrin sealant applicator system are described.
  • FIGS. 19A-30D 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.
  • the fibrin sealant applicator system includes two piston-type sub-assemblies 10 (FIGS. 1A-1E) coupled together and each having a reservoir assembly 12 (FIGS. 2A-2C), a piston assembly 14 (FIGS. 3A-3C), a septum 16 (FIGS. 4A-4B); and a coupling unit 18 (FIGS. 6A-6D and 7A-7C) having two hollow needles 20 (FIGS. 8A-8C and 9A-9E) therein.
  • 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.
  • Each piston assembly 14 includes a piston 26 having a bore 28 therethrough (FIGS 3A-30), 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. 4A-4B, 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.
  • Proximal seal 34 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 sub- assemblies and compromising the sterility of the sterile water within compartment 24 of each reservoir 22.
  • 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.
  • 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.
  • 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.
  • a coupling unit 56 (FIGS. 6A-6D and 7A-7C) having body half portions 58 and 60 acts as an interface between piston-type sub-assemblies 10 and vials 62 (See FIGS. 10A-10I).
  • 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
  • Body half portions 58 and 60 of the coupling unit 56 are preferably made from ABS plastics.
  • 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. 8A-8C and 9A-9E) having a base 76 are matingly engaged to distal recesses 78 on shuttie 64 (FIGS. 10A-10I) 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, 10C, 10E, 10G and 101.
  • 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.
  • 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. 101). 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.
  • shuttle 64 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-couplerunit 86 (FIGS. 11A-11D) is then coupled to the two piston-type sub-assemblies 10 as shown by FIGS. 16A-16E.
  • 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. 11A-11D 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's finger (FIGS. 12A-12C). 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.
  • 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. 13A-13C). Passageways 106 lead to cavities 108 within collar 92 (FIGS. 14A-14C). Cavities 108 lead to openings 110 within nozzle body 94 (FIGS. 15A-15B) 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.
  • 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.
  • FIGS. 19A-30D Reference will now be made to a second embodiment of the fibrin sealant applicator system in conjunction with FIGS. 19A-30D.
  • the second embodiment works substantially the same as the first embodiment described above and identical reference numerals identify the same or similar components.
  • the second embodiment includes two piston-type sub-assemblies 10 each having a reservoir assembly 12 (FIGS. 20A-20C) and a piston assembly 14 (FIGS. 21A-21C).
  • 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. 19A-19E.
  • 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. 2 A-24C) as shown by FIGS. 25A-25C. 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.
  • 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. 22A-22D) and bottom portion 152 (FIGS. 23A-23C) for housing check-valve retainers 130 and adaptor 144 therein.
  • Y-coupler 86 (FIGS. 26A-26Q having adaptor 154 (FIGS. 27A-27Q, body tip 90 (FIGS. 28A-28C), collar 92 (FIGS. 29A-29C) and nozzle body 94 (see FIGS. 15A-15B 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 sub- assemblies 10 when the solutions have been formed and drawn into reservoirs 22 as shown by FIGS. 30A-30D.
  • 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.
  • 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.
  • 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.
  • 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.

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  • Engineering & Computer Science (AREA)
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  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne des systèmes d'application de matériau de scellement à base de fibrine, destinés à distribuer une première et une seconde solution protéinique, aux fins de formation d'un adhésif biologique. Les systèmes d'application (10) de l'invention comprennent deux sous-ensembles du type piston (14) couplés, par l'intermédiaire d'une unité de couplage (56), à deux ampoules (62) conservant respectivement le fibrinogène et la thrombine. Ces sous-ensembles du type piston (14) conservent de l'eau stérilisée dans des réservoirs (12), lesquels sont en communication fluidique avec les ampoules (62) par l'intermédiaire de l'unité de couplage (56). L'eau est injectée dans les ampoules (62), afin de former les solutions de fibrinogène et de thrombine. Ces solutions sont ensuite soutirées pour être introduites dans les réservoirs (12), un dispositif de couplage en Y (86) étant fixé sur l'extrémité distale des sous-ensembles du type piston (14), qui permet une communication fluidique entre les réservoirs (12) et un corps de buse (94), aux fins de distribution des solutions lorsque la pression distale est créée à l'intérieur des réservoirs (12), de manière que la solution soit refoulée vers le corps de la buse (94).
PCT/US1999/023135 1999-10-06 1999-10-06 Systeme d'application d'un materiau de scellement a base de fibrine Ceased WO2001024869A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU62885/99A AU6288599A (en) 1999-10-06 1999-10-06 Fibrin sealant applicator system
PCT/US1999/023135 WO2001024869A1 (fr) 1999-10-06 1999-10-06 Systeme d'application d'un materiau de scellement a base de fibrine

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1999/023135 WO2001024869A1 (fr) 1999-10-06 1999-10-06 Systeme d'application d'un materiau de scellement a base de fibrine

Publications (1)

Publication Number Publication Date
WO2001024869A1 true WO2001024869A1 (fr) 2001-04-12

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PCT/US1999/023135 Ceased WO2001024869A1 (fr) 1999-10-06 1999-10-06 Systeme d'application d'un materiau de scellement a base de fibrine

Country Status (2)

Country Link
AU (1) AU6288599A (fr)
WO (1) WO2001024869A1 (fr)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004100798A1 (fr) * 2003-05-19 2004-11-25 Mixpac Systems Ag Dispositif de decharge pour deux composants avec cartouche de decharge et melangeur
US6884232B1 (en) 2003-10-31 2005-04-26 Baxter International Inc. Laparoscopic spray device and method of use
US6921381B2 (en) 2001-10-05 2005-07-26 Baxter International Inc. Laparoscopic spray device and method of use
US7441973B2 (en) 2006-10-20 2008-10-28 Ethicon Endo-Surgery, Inc. Adhesive applicator
US7658305B2 (en) 2006-10-25 2010-02-09 Ethicon Endo-Surgery, Inc. Adhesive applier with articulating tip
US7749235B2 (en) 2006-10-20 2010-07-06 Ethicon Endo-Surgery, Inc. Stomach invagination method and apparatus
US7833216B2 (en) 2006-11-08 2010-11-16 Ethicon Endo-Surgery, Inc. Fluid plunger adhesive dispenser
US7892250B2 (en) 2006-11-01 2011-02-22 Ethicon Endo-Surgery, Inc. Use of biosurgical adhesive on inflatable device for gastric restriction
US7914511B2 (en) 2006-10-18 2011-03-29 Ethicon Endo-Surgery, Inc. Use of biosurgical adhesive as bulking agent
US8608642B2 (en) 2010-02-25 2013-12-17 Ethicon Endo-Surgery, Inc. Methods and devices for treating morbid obesity using hydrogel
US8876844B2 (en) 2006-11-01 2014-11-04 Ethicon Endo-Surgery, Inc. Anastomosis reinforcement using biosurgical adhesive and device

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3767085A (en) * 1971-08-02 1973-10-23 J Cannon Mixing syringe
US3944261A (en) * 1975-03-05 1976-03-16 Texas Medical Products, Inc. Bifurcated tubing connector
US4874368A (en) * 1988-07-25 1989-10-17 Micromedics, Inc. Fibrin glue delivery system
US5116315A (en) * 1989-10-03 1992-05-26 Hemaedics, Inc. Biological syringe system
US5505704A (en) * 1993-04-02 1996-04-09 Eli Lilly And Company Manifold medication injection apparatus and method
US5582596A (en) * 1992-09-26 1996-12-10 Juridical Foundation The Chemo-Sero-Therapeutic Research Institute Applicator for applying a biocompatible adhesive
US5740965A (en) * 1995-04-18 1998-04-21 Machida Endoscope Co., Ltd. Adhesive sprayer for living body

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3767085A (en) * 1971-08-02 1973-10-23 J Cannon Mixing syringe
US3944261A (en) * 1975-03-05 1976-03-16 Texas Medical Products, Inc. Bifurcated tubing connector
US4874368A (en) * 1988-07-25 1989-10-17 Micromedics, Inc. Fibrin glue delivery system
US5116315A (en) * 1989-10-03 1992-05-26 Hemaedics, Inc. Biological syringe system
US5582596A (en) * 1992-09-26 1996-12-10 Juridical Foundation The Chemo-Sero-Therapeutic Research Institute Applicator for applying a biocompatible adhesive
US5505704A (en) * 1993-04-02 1996-04-09 Eli Lilly And Company Manifold medication injection apparatus and method
US5740965A (en) * 1995-04-18 1998-04-21 Machida Endoscope Co., Ltd. Adhesive sprayer for living body

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6921381B2 (en) 2001-10-05 2005-07-26 Baxter International Inc. Laparoscopic spray device and method of use
WO2004100798A1 (fr) * 2003-05-19 2004-11-25 Mixpac Systems Ag Dispositif de decharge pour deux composants avec cartouche de decharge et melangeur
US6884232B1 (en) 2003-10-31 2005-04-26 Baxter International Inc. Laparoscopic spray device and method of use
US7914511B2 (en) 2006-10-18 2011-03-29 Ethicon Endo-Surgery, Inc. Use of biosurgical adhesive as bulking agent
US7441973B2 (en) 2006-10-20 2008-10-28 Ethicon Endo-Surgery, Inc. Adhesive applicator
US7749235B2 (en) 2006-10-20 2010-07-06 Ethicon Endo-Surgery, Inc. Stomach invagination method and apparatus
US7658305B2 (en) 2006-10-25 2010-02-09 Ethicon Endo-Surgery, Inc. Adhesive applier with articulating tip
US7892250B2 (en) 2006-11-01 2011-02-22 Ethicon Endo-Surgery, Inc. Use of biosurgical adhesive on inflatable device for gastric restriction
US8876844B2 (en) 2006-11-01 2014-11-04 Ethicon Endo-Surgery, Inc. Anastomosis reinforcement using biosurgical adhesive and device
US7833216B2 (en) 2006-11-08 2010-11-16 Ethicon Endo-Surgery, Inc. Fluid plunger adhesive dispenser
US8608642B2 (en) 2010-02-25 2013-12-17 Ethicon Endo-Surgery, Inc. Methods and devices for treating morbid obesity using hydrogel

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