Wound sealant preparation and application device and method

• US 5,887,755 A
• Filed: 07/21/1997
• Issued: 03/30/1999
• Est. Priority Date: 06/06/1995
• Status: Expired due to Fees

• Current Assignee: Biomet Biologics LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Quantic Biomedical Partners
• Inventors: Hood, Andrew G. III
• Primary Examiner(s): Kaufman, Joseph A.
• Application Number:
  US08/898,374
• Time in Patent Office: 617 Days
• Field of Search: 222/135, 222/137, 222/145.2, 222/145.5, 222/148, 222/195, 222/386, 222/394, 239/427.5
• US Class Current: 222/135
• 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: B01F 23/454 by injecting a mixture of liquid and gas
• CPC Class Codes: B01F 25/25 Mixing by jets impinging against collision plates
• CPC Class Codes: B01F 33/50112 of the syringe or cartridge type
• CPC Class Codes: B01F 35/13 using one or more of the components of the mixture to wash-out the mixer
• CPC Class Codes: B01F 35/1453 by means of jets of fluid, e.g. air
• CPC Class Codes: B01F 35/522 comprising compartments keeping the materials to be mixed separated until the mixing is initiated containers or packages for packaging two or more different materials which must be maintained separate prior to use in admixture B65D81/32
• CPC Class Codes: B05C 17/00553 with means allowing the stock of material to consist of at least two different components
• CPC Class Codes: B05C 17/01 with manually mechanically or electrically actuated piston or the like B05C17/00533 takes precedence

Abstract

The present invention provides a preparation and application device useful for mixing and dispensing a plurality of fluids, wherein the fluids must be mixed immediately prior to use. In one embodiment, the device includes two fluid delivery systems connected to a manifold having two separate fluid channels. Each fluid channel conducts fluid to a mixing chamber, from which, following mixing, the mixture of fluids is dispensed. The manifold additionally includes a gas channel having an outlet connected to one of the fluid channels, which can be used to supply a pressurized gas to the mixing chamber to expel the mixture from the chamber, reducing the likelihood that the mixture can clog the device. The invention also provides a method for preparing and dispensing a mixture of two fluids.

Claims

1. A device for mixing a plurality of fluids and applying the resultant mixture, said device including a manifold comprising:

an inlet end having first and second inlets and an outlet end opposite said inlet end having first and second outlets;

first and second fluid channels extending from said first and second inlets to said first and second outlets, respectively; and

a gas channel extending from a third inlet and terminating at an outlet wherein said outlet is continuous with a wall of said first fluid channel wherein said gas channel does not extend to the outlet end of said manifold.

2. The device of claim 1 wherein said manifold has a center axis that extends from said inlet end to said outlet end and said first and second fluid channels each cross said center axis in different planes.

3. The device of claim 1 wherein said gas channel outlet is located at a position in said first fluid channel closer to said first outlet than to said first inlet.

4. The device of claim 3 wherein said gas channel outlet is located at a position in said first fluid channel at about one-tenth of the length of said first fluid channel from said first outlet.

5. The device of claim 1 additionally comprising first and second fluid inlet fittings on the inlet end of said manifold positioned at the first and second inlets, respectively, said first and second fluid inlet fittings adapted to couple first and second fluid delivery systems, respectively, to said first and second fluid channels, respectively.

6. The device of claim 5 additionally comprising first and second fluid delivery systems coupled to said first and second inlet fittings, respectively, wherein said first and second fluid delivery system are adapted to controllably provide a first and second fluid, respectively, to said first and second fluid channels, respectively.

7. The device of claim 6 wherein said first and second fluid delivery systems comprise syringes.

8. The device of claim 6 wherein said first syringe has a length identical to said second syringe and a cross-sectional area at least ten times larger than the cross-sectional area of said second syringe.

9. The device of claim 1 additionally comprising a gas inlet fitting on said manifold at said gas channel, said gas inlet fitting adapted to couple a pressurized gas source to said gas channel.

10. The device of claim 1 additionally comprising a delivery spout attached to said outlet end of said manifold, said outlets of said first and second fluid channels positioned so that fluid streams exiting said first and second fluid channels are deflected by substantially opposing regions of the inner surface of said delivery spout.

11. The device of claim 10 wherein said delivery spout is removably attached to said manifold.

12. The device of claim 11 wherein a fluid application system attached to the outlet end of the manifold forms the delivery spout.

13. The device of claim 12 wherein the fluid application system is selected from the group consisting of a catheter and a spray jet nozzle.

14. A device for mixing a plurality of fluids and applying the resultant mixture, said device comprising:

a manifold comprising;

an inlet end and an outlet end opposite said inlet end;

first and second inlets located in said inlet end and first and second outlets located in said outlet end;

first and second fluid channels extending from said first and second inlets to said first and second outlets, respectively; and

a gas channel extending from a third inlet in said inlet end and terminating at an outlet wherein said outlet is continuous with a wall of said first fluid channel wherein said gas channel does not extend to the outlet end of said manifold;

a one way valve positioned in said gas channel;

first and second fluid inlet fittings on the inlet end of the manifold positioned at the first and second fluid channel inlets, respectively, said first and second fluid inlet fittings adapted to removably connect to first and second syringes, respectively;

first and second syringes removably connected to said first and second inlet fittings, respectively so that said first syringe is capable of providing a first fluid to said first fluid channel, and said second syringe is capable of providing a second fluid to said second fluid channel;

a mixing chamber positioned on the outlet end of said manifold so that fluid streams exiting said first and second fluid channels are deflected by opposing regions of the mixing chamber; and

a delivery spout for delivering fluids from the mixing chamber to a target.

15. A method for preparing and dispensing a mixture of a plurality of biological fluids comprising:

(a) admixing a first biological fluid with a pressurized gas to form a first biological fluid-gas mixture;

(b) vigorously mixing said first biological fluid-gas mixture with a second biological fluid in a mixing chamber to form a second biological fluid-gas mixture, wherein the second biological fluid-gas mixture develops a viscosity greater than the first biological fluid-gas mixture; and

(c) ejecting a stream of said second biological fluid-gas mixture through an opening of said mixing chamber before said second biological fluid-gas mixture can plug the opening.

16. The method of claim 15 additionally comprising, after dispensing a desired amount of said second biological fluid-gas mixture, purging said mixing chamber of said second biological fluid-gas mixture by flowing pressurized gas through said mixing chamber.

17. The method of claim 16 additionally comprising, after purging said mixing chamber, repeating operations (a)-(c) of claim 15.

18. The method of claim 15 wherein said pressurized gas is a sterile medical gas.

19. The method of claim 18 wherein said first biological fluid includes fibrinogen and said second biological fluid includes a fibrinogen activator.

20. The method of claim 19 wherein said fibrinogen activator is thrombin.