Apparatus and methods for sealing a vascular puncture

Patent metadata

Field	Value
Publication number	US-8945178-B2
Application number	US-201213610849-A
Country	US
Kind code	B2
Filing date	Sep 11, 2012
Priority date	Nov 5, 2004
Publication date	Feb 3, 2015
Grant date	Feb 3, 2015

Abstract

Apparatus for sealing a puncture through tissue to a blood vessel includes a cartridge including a proximal end, a distal end sized for insertion into a puncture, and a lumen extending therebetween. A bioabsorbable plug is disposed within the lumen adjacent the distal end, and an anchoring element is disposed within the lumen proximal to the plug. A pusher member is disposed within the lumen for deploying the plug and anchoring element out the distal end of the cartridge. The plug may be formed from lyophilized hydrogel and the anchoring element may be formed from air-dried hydrogel, the anchoring element hydrating slower than the plug when exposed to an aqueous environment. During use, the plug and anchoring element are delivered into the puncture, the plug is cinched against the vessel wall. Protrusions on the anchoring element engage tissue surrounding the puncture to prevent proximal movement of the plug.

First claim

We claim:

1. A method for sealing a puncture extending through tissue to a body lumen, comprising:
introducing a positioning member comprising a hollow body into the puncture until a positioning element thereon is disposed within the body lumen;
retracting the positioning member until the positioning element contacts a wall of the body lumen; and
delivering a bioabsorbable plug into the puncture over the positioning member until the plug is disposed proximate the positioning element; and
delivering an anchoring element into the puncture above the plug to prevent the plug from moving proximally within the puncture, wherein the anchoring element is generally cylindrical.

2. The method of claim 1 , wherein the positioning element comprises an expandable member that is introduced into the puncture in a contracted condition, the method further comprising expanding the expandable member within the body lumen before retracting the positioning member.

3. The method of claim 2 , further comprising: collapsing the expandable member; and withdrawing the positioning member from the puncture after the plug is delivered into the puncture.

4. The method of claim 1 , wherein the plug and anchoring element are carried within a tubular member, and wherein the plug and the anchoring element are delivered into the puncture simultaneously by advancing the tubular member into the puncture.

5. The method of claim 4 , further comprising retracting the tubular member while maintaining the plug and the anchoring element within the puncture to expose the plug and the anchoring element within the puncture.

6. The method of claim 5 , further comprising cinching the plug against a wall of the body lumen.

7. The method of claim 5 , wherein the anchoring element comprises one or more protrusions that engage tissue surrounding the puncture when the anchoring element is exposed within the puncture to prevent the anchoring element from moving proximally within the puncture.

8. The method of claim 5 , wherein a pusher member is disposed within the tubular member proximal to the anchoring element, and wherein the plug and anchoring element are maintained within the puncture by retracting the tubular member while maintaining the pusher member substantially stationary.

9. The method of claim 8 , wherein the tubular member and pusher member are movable from a proximal end of the positioning member towards the positioning element, the pusher member and positioning element comprising cooperating elements that engage when the pusher member reaches a predetermined distal location to prevent subsequent proximal retraction of the pusher member beyond the predetermined distal location.

10. The method of claim 9 , wherein the predetermined distal location corresponds to a location where the plug is disposed adjacent the positioning element.

11. The method of claim 10 , further comprising advancing the pusher member to compress the plug against the positioning element.

12. The method of claim 5 , wherein the plug is exposed to bodily fluid when the tubular member is retracted whereupon the plug hydrates to enhance sealing the puncture.

13. The method of claim 12 , wherein the plug and the anchoring element comprise hydrogel material, the anchoring element hydrating more slowly than the plug when exposed within the puncture.

14. The method of claim 1 , further comprising delivering a sealing compound into the puncture after delivering the plug into the puncture.

15. The method of claim 1 , wherein the plug comprises lyophilized hydrogel that expands when delivered within the puncture and exposed to bodily fluid therein.

16. The method of claim 1 , wherein the plug comprises prothrombotic material.

17. The method of claim 1 , the plug comprising a laminate structure including one or more layers of lyophilized hydrogel and an adherent material that is activated when delivered within the puncture and exposed to bodily fluid therein.

18. The method of claim 1 , wherein the plug comprises a proximal end and a distal end, and wherein a composition of the plug varies between the proximal and distal ends such that the distal end expands more rapidly than the proximal end when exposed to bodily fluid within the puncture.

19. The method of claim 1 , wherein the plug comprises a proximal end and a distal end, and wherein a composition of the plug varies between the proximal and distal ends such that the distal end expands to a larger size than the proximal end when exposed to bodily fluid within the puncture.

20. A method for sealing a puncture extending through tissue to a body lumen, comprising:
introducing a positioning member into the puncture until a positioning element thereon is disposed within the body lumen;
retracting the positioning member until the positioning element contacts a wall of the body lumen; and
delivering a bioabsorbable plug into the puncture over the positioning member until the plug is disposed proximate the positioning element;
delivering an anchoring element that is generally cylindrical into the puncture above the plug to prevent the plug from moving proximally within the puncture,
wherein the plug and anchoring element are carried within a tubular member, and wherein the plug and the anchoring element are delivered into the puncture simultaneously by introducing the tubular member into the puncture; and
withdrawing the positioning member from the puncture after the plug and anchoring element are delivered into the puncture.

21. A method for sealing a puncture extending through tissue to a body lumen, comprising:
manipulating a positioning member comprising a hollow body into the puncture until a positioning element thereon is placed in contact with a wall of the body lumen;
manipulating a bioabsorbable plug into the puncture until the plug is disposed proximate the positioning element and wherein the step of manipulating the bioabsorbable plug into the puncture is carried out without dilating the puncture; and
anchoring the plug in the puncture with a generally cylindrical anchoring element to prevent the plug from moving proximally within the puncture.

22. The method of claim 21 , wherein the step of anchoring the plug comprises delivering an anchoring element into the puncture above the plug to prevent the plug from moving proximally within the puncture.

23. The method of claim 21 , wherein the step of manipulating the plug comprises advancing the plug along the positioning member towards the positioning element.

24. The method of claim 21 , wherein the step of manipulating the plug is performed subsequent to the step of manipulating the positioning member.

25. The method of claim 21 , further comprising withdrawing the positioning member from the puncture after the plug is anchored in the puncture.

Assignees

• Pai Suresh S
• Bagaoisan Celso J
• Khosravi Farhad
• Access Closure Inc

Inventors

• Pai Suresh S
• Bagaoisan Celso J
• Khosravi Farhad

Classifications

• A61B2017/00495

  for two-component glue · CPC title

• A61B2017/0065

  the implement being an adhesive · CPC title

• A61B17/00491

  Surgical glue applicators · CPC title

• A61B17/0057 Primary

  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

• A61B2017/00672

  Locating means therefor, e.g. bleed back lumen · CPC title