Apparatus and methods for sealing vascular punctures

• US 8,075,587 B2
• Filed: 08/08/2005
• Issued: 12/13/2011
• Est. Priority Date: 12/14/2000
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Ensure Medical, Inc. (Cardinal Health, Inc.)
• Inventors: Ginn, Richard S.
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US11/200,459
• Publication Number:
  US 20050273137A1
• Time in Patent Office: 2,318 Days
• Field of Search: 606/213, 606/232, 604/6.1, 604/5.01, 604/9, 604/41, 604/43, 604/256, 604/29
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 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 Class Codes: A61B 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid

Abstract

An apparatus for sealing a passage through tissue communicating with a blood vessel includes a bioabsorbable plug member coupled to the distal end of a carrier member. The plug member includes a lumen extending therethrough that communicates with a lumen extending through the carrier member. A sealing member is disposed in the plug member lumen for sealing the lumen. A guide member is slidable into the lumen such that edges of a groove extending between proximal and distal portions of the guide member engage a wall of the lumen to define a bleed back lumen. The guide member is inserted into the passage until the distal portion enters the vessel. The plug member is advanced over the guide member until the plug member enters the vessel, whereupon blood enters the bleed back lumen to identify the location of the vessel relative to the plug member.

Claims

1. A device for sealing a passage through tissue, comprising:

a body comprising a proximal end, a distal end, the body comprising a lumen extending between the proximal end and a distal inlet port;

a sealing member disposed within the lumen that is expandable across the lumen for substantially sealing the lumen from fluid flow therethrough, and an elongated guide member having at least one longitudinal groove with opposing edges, wherein the opposing edges define a longitudinal opening, such that insertion of the guide member into the body lumen forms a bleed back lumen.

2. A device for sealing a passage through tissue, comprising:

a bioabsorbable body comprising a proximal end, a distal end, the body comprising a lumen extending between the proximal end and a distal inlet port;

a sealing member disposed within the lumen that is expandable across the lumen for substantially sealing the lumen from fluid flow therethrough, and an elongated guide member having at least one longitudinal groove with opposing edges, wherein the opposing edges define a longitudinal opening, such that insertion of the guide member into the body lumen forms a bleed back lumen.

3. The device of claim 2, wherein the sealing member comprises a material that is expandable when exposed to fluid to substantially seal the lumen.

4. The device of claim 3, wherein the material comprises an expandable gel foam.

5. The device of claim 2, wherein the sealing member comprises an annular-shaped member.

6. The device of claim 2, wherein the sealing member comprises a bioabsorbable material.

7. The device of claim 2, wherein the sealing member is biased towards a first configuration for substantially sealing the lumen from fluid flow therethrough, and is movable to a second configuration for accommodating introduction of one or more devices through the lumen.

8. The device of claim 2, further comprising a connector on the proximal end of the body for detachably securing the body to a delivery device.

9. The device of claim 2, further comprising an elongate shaft extending from the proximal end of the body.

10. The device of claim 2, wherein the body has a length of not more than about ten millimeters.

11. The device of claim 2, wherein the body has a diameter and a length, the diameter being not more than about twice the length.

12. A device for sealing a passage through tissue, comprising:

a bioabsorbable body comprising a proximal end, a distal end, the body comprising a lumen extending between a proximal port and a distal port, the lumen comprising a tapered portion that tapers in cross-section;

a sealing member comprising a generally annular-shaped member disposed adjacent a wide end of the tapered portion of the lumen, the sealing member being movable into the tapered portion for substantially sealing the lumen from fluid flow therethrough, and an elongated guide member having at least one longitudinal groove with opposing edges, wherein the opposing edges define a longitudinal opening, such that insertion of the guide member into the body lumen forms a bleed back lumen.

13. The device of claim 12, wherein the sealing member comprises a material that is expandable when exposed to fluid to substantially seal the lumen.

14. The device of claim 12, wherein the sealing member comprises a coil of material.

15. The device of claim 12, wherein the sealing member comprises a flexible material that may be wedged into the tapered portion.

16. The device of claim 12, wherein the sealing member comprises a bioabsorbable material.

17. The device of claim 12, further comprising a connector on the proximal end of the body for detachably securing the body to a delivery device.

18. The device of claim 12, further comprising an elongate shaft extending from the proximal end of the body.

19. The device of claim 12, wherein the body has a length of not more than about ten millimeters.