DEVICE FOR MIXING AND DISPENSING OF TWO-COMPONENT REACTIVE SURGICAL SEALANT

• US 20110319930A1
• Filed: 06/25/2010
• Published: 12/29/2011
• Est. Priority Date: 06/25/2010
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Roush, Daniel E., Yardimci, Atif M., Stevens, Justin
• Granted Patent: US 8,672,237 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• 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: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: B01F 25/10 Mixing by creating a vortex flow, e.g. by tangential introduction of flow components
• CPC Class Codes: B01F 33/50112 of the syringe or cartridge type
• 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: B01F 35/715 Feeding the components in several steps, e.g. successive steps
• CPC Class Codes: B05B 1/04 in flat form, e.g. fan-like, sheet-like
• CPC Class Codes: B05B 1/3436 the interface being a plane perpendicular to the outlet axis
• CPC Class Codes: B05B 11/0078 Arrangements for separately storing several components arrangements for pumping several liquids or other fluent materials from several containers B05B11/1081
• CPC Class Codes: B05B 11/02 Membranes or pistons acting on the contents inside the container, e.g. follower pistons
• CPC Class Codes: B05B 7/0408 with arrangements for mixing two or more liquids
• CPC Class Codes: B05B 9/0838 supply being effected by follower in container, e.g. membrane or floating piston, or by deformation of container

Abstract

An applicator for mixing and applying multi-component compositions to a work surface, such as two-component surgical sealants, while avoiding clogs, preventing cross-contamination of the components until a point of intended mixing at a location within the apparatus immediately upstream of an application opening in a tip cap, decreasing pressure drop along the applicator to facilitate fluid delivery, and increasing efficiency of mixing of the components. A luer hub sub-assembly having a proximal hub and a distal hub, an elongate, four-lumened cannula, and a spray tip sub-assembly are provided, with interconnections between the sub-assemblies preserving isolation of the fluid components from one another. The tip cap sub-assembly includes registration structure to assure proper alignment between tip cap and tip insert. The end wall of the tip cap includes a spinner region with three feeders leading thereto, the fluid components remaining isolated from one another in two of the feeders, and initiating mixing with one another in a third of the feeders.

Claims

1. An apparatus for delivering a mixture of at least two fluid components in a manner that prevents premature cross-contamination of the fluid components, comprising:

a luer hub sub-assembly, including

a proximal hub having a first fluid channel and a second fluid channel;

a distal hub having a proximal side with a first elongate groove and a second elongate groove therein, each of the first and second elongate recessed channels, together with a distal wall of the proximal hub, defining a respective first and second fluid channel of the distal hub, the first and second fluid channels of the distal hub being in fluid communication with the first fluid channel and second fluid channel, respectively, of the proximal hub, and further including a female cannula-mating port provided on a distal side of the distal hub, wherein the first and second fluid channels of the distal hub terminate at a respective fluid path hole opening to an interior of the cylindrical female cannula-mating port;

a malleable cannula having a proximal end region received in the cylindrical female cannula-mating port, the malleable cannula including first and second fluid-carrying lumens, each of the first and second fluid-carrying lumens being in fluid communication with a respective one of the fluid path holes, a third lumen having a wire disposed therein, and a fourth lumen; and

a spray tip sub-assembly including a tip insert received in a tip cap, the tip cap having an end wall with a delivery opening therethrough.

2. The apparatus of claim 1, wherein the tip insert includes a proximally-projecting webbing thereon received in the slot in the distal end of the malleable cannula.

3. The apparatus of claim 1, wherein the wire is an annealed wire.

4. The apparatus of claim 1, wherein the malleable cannula comprises soft thermoplastic polyurethane elastomer.

5. The apparatus of claim 1, wherein the tip insert is generally triangular and includes three side walls and a plurality of angled indentations in a proximal side thereof.

6. The apparatus of claim 5, wherein a proximal side of the end wall of the tip cap includes a recessed spinner region therein and a plurality of feeders that direct fluid from the sides of the tip insert and into the recessed spinner region.

7. The apparatus of claim 6, wherein each of the plurality of feeders is of a generally triangular shape, with two sidewalls that angle inward toward one another with increasing radial proximity to a center of the recessed spinner region.

8. The apparatus of claim 6, wherein an opening in the form of an arcuate segment is defined between each of the side walls of the tip insert and an interior surface of the tip cap, through which fluid components from the first and second fluid-carrying lumens pass prior to entering the feeders, wherein:

a first of the arcuate segments receives a fluid component from only the first fluid-carrying lumen of the malleable cannula;

a second of the arcuate segments receives a fluid component from only the second of the fluid-carrying lumen of the malleable cannula; and

a third of the arcuate segments receives fluid components from both the first and second fluid-carrying lumens of the malleable cannula.

9. The apparatus of claim 6, wherein:

a first of the plurality of feeders receives a fluid component from only the first fluid-carrying lumen of the malleable cannula;

a second of the plurality of feeders receives a fluid component from only the second fluid-carrying lumen of the malleable cannula; and

a third of the plurality of feeders receives fluid components from both the first and second fluid-carrying lumens of the malleable cannula.

10. The apparatus of claim 5, wherein the slots include one of a solvent and adhesive bonding therein.

11. The apparatus of claim 1, wherein the delivery opening of the tip cap is provided with oval-shaped slit at a distal end thereof.

12. The apparatus of claim 1, wherein the tip cap includes a nipple extending about the delivery opening on a distal surface of the end wall.

13. The apparatus of claim 1, wherein the end wall of the tip cap is provided with a plurality of proximally-extending guide pins, each of which is received in a respective pin-receiving aperture provided in a distal side of the tip insert.

14. The apparatus of claim 1, wherein the distal end region of the malleable cannula includes a pair of notches extending from a distal end wall of the malleable cannula to a pair of stop walls axially spaced proximally of the distal end wall, each of the notches exposing a respective semi-cylindrical channel extending from a respective one of the first and second fluid-carrying lumens, and alignment ledges extending laterally from each of the semi-cylindrical channels to an outer perimeter of the malleable cannula.

15. The apparatus of claim 14, wherein the tip insert includes a female mating port complementary to a male projection of the malleable cannula defined by the alignment ledges, the distal end wall, and a portion of the outer perimeter of the malleable cannula extending between the distal end wall and the stop walls.

16. The apparatus of claim 15, wherein the tip projection further includes a pair of flow path archways, each of the fluid path archways aligning with a respective one of the semi-cylindrical channels when the male projection of the malleable cannula is received in the female mating port, each of the flow path archways providing fluid communication from one of the semi-cylindrical channels to a space between an inner surface of a cylindrical wall of the tip cap and an exterior of the tip insert.

17. The apparatus of claim 1, wherein the tip cap is provided with a registration notch along an exterior surface and a corresponding inwardly-directed registration key, the registration key engaging a complementary alignment keyway notch provided in the distal end of the tip insert.

28. The tip cap sub-assembly of claim 1, wherein the tip cap includes an elongate nipple region on a distal side of the end wall of the tip cap, intersecting the delivery opening.

18. A tip cap sub-assembly for an apparatus for delivering a mixture of at least two fluid components, comprising:

a tip insert having a proximal side and a distal side; and

a tip cap including a cylindrical sidewall and an end wall having a delivery opening therethrough, the tip insert received in the tip cap such that the distal side of the tip insert faces a proximal side of the end wall of the tip cap;

wherein the tip insert includes one or more angled indentations in the proximal side thereof, each of the angled indentations directing fluid sprayed at the proximal side of the tip insert toward an inner surface of the cylindrical sidewall of the tip cap and around at least two sides of the tip insert, such that a first mixing component only is directed to an area between the sides of the tip insert and the sidewall of the tip cap and at least one of the distal side of the tip insert and the proximal side of the end wall of the tip cap includes a recessed spinner region therein that mixes fluid components prior to delivery through the delivery opening.

19. The tip cap sub-assembly of claim 18, wherein the tip insert includes a pair of alignment posts projecting proximally from the proximal side of the tip insert.

20. The tip cap sub-assembly of claim 19, wherein one of the alignment posts has an outer diameter greater than the other alignment post.

21. The tip cap sub-assembly of claim 19, further comprising a webbing extending between the alignment posts.

22. The tip cap sub-assembly of claim 18, further comprising a plurality of guide pins projecting proximally of the proximal side of the end wall of the tip cap, each of said guide pins received in a complementary pin-receiving hole provided in the distal side of the tip insert.

23. The tip cap sub-assembly of claim 18, wherein the delivery opening of the tip cap is provided with oval-shaped slit at a distal end thereof.

24. The tip cap sub-assembly of claim 18, wherein the recessed spinner region is provided in the proximal side of the end wall of the tip cap and a plurality of feeders are further provided in the proximal side of the end wall that direct fluid from the sides of the tip insert and into the recessed spinner region.

25. The tip cap sub-assembly of claim 24, wherein each of the plurality of feeders is of a generally triangular shape, with two sidewalls that angle inward toward one another with increasing radial proximity to a center of the recessed spinner region.

26. The tip cap sub-assembly of claim 24, wherein an opening in the form of an arcuate segment is defined between each of the side walls of the tip insert and the cylindrical sidewall of the tip cap, through which fluid components pass prior to entering the feeders, wherein:

a first of the arcuate segments receives only a first fluid component;

a second of the arcuate segments receives only a second fluid component; and

a third of the arcuate segments receives both the first and the second fluid components.

27. The tip cap sub-assembly of claim 18, wherein the tip cap includes a nipple extending about the delivery opening on a distal surface of the end wall.

29. An apparatus for delivering a mixture of at least two fluid components in a manner that prevents premature cross-contamination of the fluid components, comprising:

a luer hub sub-assembly;

a cannula having a proximal end region engaging the luer hub sub-assembly, the cannula including first and second fluid-carrying lumens, each of the first and second fluid-carrying lumens being in fluid communication with a respective one of the fluid path holes, a third lumen and a fourth lumen; and

a spray tip sub-assembly including a tip insert received in a tip cap, the tip cap having an end wall with a delivery opening therethrough and a plurality of feeders, and the tip insert having at least two indentations for deflecting a first mixing component from the first fluid-carrying lumen to a first area between the tip cap and the tip insert, a second mixing component from the second fluid-carrying lumen to an a second area between the tip cap and the tip insert, and a combination of the first and second mixing components from both the first and second fluid-carrying lumens to a third area between the tip cap and the tip insert, each of the first, second and third areas being separate from each other, such that there are three fluid paths, each of which enters one of the plurality of feeders before mixing, wherein one the three fluid paths is a combination of the first and second mixing components, another is the first mixing component only, and another is the second mixing component only.

30. The apparatus of claim 29, wherein the luer hub sub-assembly includes:

a proximal hub having a first fluid channel and a second fluid channel;

a distal hub having a proximal side with a first elongate groove and a second elongate groove therein, each of the first and second elongate recessed channels, together with a distal wall of the proximal hub, defining a respective first and second fluid channel of the distal hub, the first and second fluid channels of the distal hub being in fluid communication with the first fluid channel and second fluid channel, respectively, of the proximal hub, and further including a female cannula-mating port provided on a distal side of the distal hub, wherein the first and second fluid channels of the distal hub terminate at a respective fluid path hole opening to an interior of the cylindrical female cannula-mating port.