Bioadhesive delivery catheter manifold with mixing fixture and methods

Patent metadata

Field	Value
Publication number	US-9370345-B2
Application number	US-201313744018-A
Country	US
Kind code	B2
Filing date	Jan 17, 2013
Priority date	Jan 24, 2012
Publication date	Jun 21, 2016
Grant date	Jun 21, 2016

Abstract

A bioadhesive delivery catheter includes a manifold, a dual lumen tube, and a mixing member. The manifold includes a delivery device passage and an injection port. The tube is insertable into the delivery device passage and includes first and second lumens positioned side-by-side. The first lumen extends proximal of the second lumen within the delivery device passage, and the second lumen is in flow communication with the injection port. The mixing member is positioned between a proximal inlet of the injection port and the second lumen and is configured to help mix a bioadhesive material that is delivered through the injection port into the second lumen.

First claim

What is claimed is:

1. A bioadhesive delivery catheter, comprising:
a manifold comprising:
a delivery device passage;
an injection port;

a tube insertable into the delivery device passage and comprising:
first and second lumens positioned side-by-side, the first and second lumens being separated from each other by a separation plane, the separation plane being positioned between the first and second lumens without intersecting the first lumen or the second lumen, the first lumen having a first lumen proximal end, the second lumen having a second lumen proximal end, the proximal end of the first lumen positioned proximal of the proximal end of the second lumen within the delivery device passage, the second lumen arranged in flow communication with the injection port;

a mixing member positioned between a proximal inlet of the injection port and the second lumen.

2. The bioadhesive delivery catheter of claim 1 , wherein a proximal end of the tube includes a taper.

3. The bioadhesive delivery catheter of claim 1 , wherein the tube has a reduced profile at a proximal end at a location proximal of the second lumen.

4. The bioadhesive delivery catheter of claim 1 , wherein the mixing member comprises a mixing chamber defined within the delivery device passage adjacent to the tube.

5. The bioadhesive delivery catheter of claim 1 , wherein the mixing member comprises a mixing insert positioned within the injection port.

6. The bioadhesive delivery catheter of claim 1 , wherein the mixing member comprises at least first and second mixing inserts positioned in a passage defined in the manifold between the injection port and the delivery device passage.

7. The bioadhesive delivery catheter of claim 1 , wherein the manifold includes a bioadhesive passage that extends from the injection port to the delivery device passage, the mixing member being positioned in the bioadhesive passage.

8. The bioadhesive delivery catheter of claim 1 , wherein the delivery device passage includes proximal and distal passage portions, the proximal passage portion having a smaller cross-sectional shape than the distal passage portion.

9. The bioadhesive delivery catheter of claim 8 , wherein the injection port defines a bioadhesive passage that intersects with the distal passage portion.

10. A method of delivering a bioadhesive material, comprising:
providing a delivery device, a manifold and a tube, the manifold including a delivery device passage and an injection port, the tube comprising first and second lumens positioned side-by-side, the first and second lumens being separated from each other by a separation plane, the separation plane being positioned between the first and second lumens without intersecting the first lumen or the second lumen, the first lumen having a proximal end positioned proximal of a second lumen proximal end, the tube being inserted into the delivery device passage with the second lumen in flow communication with the injection port;
extending the delivery device through the first lumen and into a vessel puncture to locate the vessel puncture;
delivering the bioadhesive material through the injection port and the second lumen to the vessel puncture to seal closed the vessel puncture.

11. The method of claim 10 , further comprising mixing the bioadhesive material while delivering the bioadhesive material through the manifold.

12. The method of claim 10 , wherein the tube comprises a reduced profile at a proximal end of the tube.

13. The method of claim 10 , wherein the manifold includes a mixing chamber positioned proximal of a proximal opening into the second lumen, the method including mixing the bioadhesive material in the mixing chamber during delivery of the bioadhesive material into the second lumen.

14. The method of claim 10 , further comprising a mixing member positioned in the injection port, the method including mixing the bioadhesive material with the mixing member during delivery of the bioadhesive material into the second lumen.

15. A method of forming a bioadhesive delivery catheter, comprising:
forming a manifold having a delivery device passage and an injection port;
forming a tube having first and second lumens, the first lumen having a first lumen proximal end positioned further proximally than a second lumen proximal end, the first and second lumens being separated from each other by a separation plane, the separation plane being positioned between the first and second lumens without intersecting the first lumen or the second lumen;
inserting the proximal ends of the first and second lumens of the tube into the delivery device passage to provide flow communication between the second lumen and the injection port;
positioning a sealant mixing member between an inlet to the injection port and an opening into the second lumen.

16. The method of claim 15 , wherein the sealant mixing member comprises a protrusion that creates turbulence in a flow of bioadhesive material delivered into the injection port.

17. The method of claim 15 , wherein the sealant mixing member comprises a mixing chamber that is in fluid communication with the delivery device passage.

18. The method of claim 15 , wherein the delivery device passage includes proximal and distal passage portions having different cross-sectional sizes, the tube having a reduced cross-section proximal end portion sized for insertion into the proximal passage portion.

19. The method of claim 15 , further comprising forming a taper in a proximal end portion of the tube, the taper overlapping with a proximal opening into the second lumen of the tube.

20. The method of claim 15 , further comprising bonding the tube to the manifold within the delivery device passage.

Assignees

• St Jude Medical Puerto Rico

Inventors

• Tegels Zachary J
• Vidlund Robert M
• Borgmann Doreen
• Parsonage Edward E
• Escobar Martha

Classifications

• A61B17/0057

  Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009) · CPC title

• Y10T29/49826

  Assembling or joining · CPC title

• A61B17/00491 Primary

  Surgical glue applicators · CPC title

• A61B2017/0065

  the implement being an adhesive · CPC title