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

• US 20120158048A1
• Filed: 01/03/2012
• Published: 06/21/2012
• 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 9,125,633 B2
• Time in Patent Office: Days
• US Class Current: 606/214
• 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 2017/00951 adhesive
• 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. 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 or feeder channels leading thereto, the fluid components remaining isolated from one another in two of the feeders or feeder channels, and initiating mixing with one another in a third of the feeders or feeder channels.

Claims

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

a luer hub sub-assembly configured to engage the at least two reservoirs and forming a first hub fluid channel and a second hub fluid channel to provide passage to a first fluid component and a second fluid component;

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

a spray tip sub-assembly disposed at an end of the cannula including at least a portion of a tip insert received in a tip cap, the tip cap having an end wall with a delivery opening therethrough, the tip insert and the tip cap forming at least three feeder channels, and the tip insert and tip cap formed to define at least three flow paths in correspondence to the at least three feeder channels, each of the feeder channels being in fluid communication with a flow path, the tip insert forming fluid communication between the first fluid carrying lumen and a first flow path of the at least three flow paths to provide for passage of the first component and fluid communication between a second flow path of the at least three flow paths to provide passage for the second component, the tip insert and the tip cap forming a third flow path of the at least three flow paths, the tip cap and the tip insert forming a first transfer channel between the first flow path and the third flow path and a second transfer channel between the second flow path and the third flow path, wherein a portion of one of the fluid components flows through the first flow path into the first feeder channel and a portion of the second component flows through the second flow path into the second feeder channel and the remaining portions of the first and second components flow through the first and second transfer channels into the third flow path and then into the third feeder channel.

2. The apparatus of claim 1, wherein the tip insert includes a plurality of angled indentations in a proximal side thereof.

3. The apparatus of claim 1, wherein a proximal side of the end wall of the tip cap includes a recessed spinner region therein and a plurality of feeder channels that direct fluid from the sides of the tip insert and into the recessed spinner region.

4. The apparatus of claim 2, wherein a proximal side of the end wall of the tip cap includes a recessed spinner region therein and a plurality of feeder channels that direct fluid from the sides of the tip insert and into the recessed spinner region.

5. The apparatus of claim 3, wherein each of the plurality of feeder channels 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.

6. The apparatus of claim 3, 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 feeder channels, 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.

7. The apparatus of claim 3, wherein:

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

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

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

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

9. 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.

10. 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.

11. 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.

12. The apparatus of claim 11, 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.

13. The apparatus of claim 12, 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.

14. The apparatus of claim 1, wherein the cannula has a proximal end region engaging the luer hub sub-assembly, and each of the first and second fluid-carrying lumens being in fluid communication with a respective fluid path hole, a third lumen and a fourth lumen;

and

the spray tip sub-assembly further including 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 feeder channels 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.

15. The apparatus of claim 1, 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.