Methods for sealing a vascular puncture

Patent metadata

Field	Value
Publication number	US-9386969-B2
Application number	US-201514629429-A
Country	US
Kind code	B2
Filing date	Feb 23, 2015
Priority date	Nov 5, 2004
Publication date	Jul 12, 2016
Grant date	Jul 12, 2016

Abstract

Apparatus and methods for sealing a puncture communicating with a blood vessel are provided that include introducing a porous carrier formed from lyophilized hydrogel or other material into the puncture. The plug may include at least one of first and second hydrogel precursors and a pH adjusting agent carried by the porous carrier in an unreactive state prior to exposure to an aqueous physiological environment. Once exposed to bodily fluids, the carrier expands as the lyophilized material hydrates to enhance and facilitate rapid hemostasis of the puncture. When the plug is placed into the puncture, the natural wetting of the plug by bodily fluids (e.g., blood) causes the first and second precursors to react and cross-link into an adhesive or “sticky” hydrogel that aids in retaining the plug in place within the puncture.

First claim

We claim:

1. An apparatus for sealing a puncture extending through tissue, comprising:
a tubular member comprising a proximal end, a distal end sized for insertion through the puncture, a lumen extending between the proximal and distal ends, and a distal opening in communication with the lumen; a plug disposed within the lumen, the plug comprising a first precursor disposed on at least a portion of an exterior of a core of the plug, the first precursor remaining in an unreactive state prior to exposure to an aqueous physiological environment in the tissue whereupon the first precursor reacts to form a sticky hydrogel to retain the plug in place within the puncture; and a pusher member slidable within the lumen of the tubular member for deploying the plug through the lumen and out the distal opening of the tubular member, wherein the plug and/or hydrogel are swellable in the physiological environment.

2. The apparatus of claim 1 , wherein the plug comprises a lumen extending between proximal and distal ends thereof, the apparatus further comprising an elongate positioning member, the positioning member having an expandable element on a distal end thereof, the positioning member sized for passing through the lumen of the tubular member and the lumen of the plug.

3. The apparatus of claim 1 , further comprising a second precursor disposed on at least a portion of an exterior of the core, the second precursor remaining in an unreactive state prior to exposure to an aqueous physiological environment in the tissue whereupon the second precursor reacts with the first precursor to form a sticky hydrogel to retain the plug in place within the puncture.

4. The apparatus of claim 1 , further comprising an activating agent disposed on at least a portion of the exterior of the core, the activating agent facilitating or initiating reaction of the first precursor when exposed to an aqueous physiological environment.

5. The apparatus of claim 4 , wherein the first precursor comprises a hydrogel precursor, and wherein the activating agent comprises a pH activating agent that modifies a pH of the aqueous physiological environment to initiate the reaction of the first hydrogel precursor.

6. The apparatus of claim 1 , wherein the core comprises an elongate body having a disk shape, a solid cylindrical shape, a rolled sheet cylindrical shape, or a folded sheet cylindrical shape.

7. An apparatus for sealing a puncture extending through tissue and communicating with a body lumen, comprising: a tubular member comprising a proximal end, a distal end sized for insertion through the puncture and into the body lumen, a lumen extending between the proximal and distal ends, and a distal opening communicating with the tubular member lumen, the tubular member defming a longitudinal axis; a plug positioned within the lumen and comprising a first precursor disposed thereon, the first precursor remaining in an unreactive state prior to exposure to an aqueous physiological environment, the first precursor reacting when exposed to an aqueous physiological environment to form an adhesive on the plug, the plug further comprising a lumen extending between proximal and distal ends thereof; a pusher member movable within the tubular member lumen for deploying the plug out of the distal opening; and an elongate positioning member comprising a proximal end slidable through the plug lumen, and a distal end having a positioning element thereon, the positioning element movable radially away from the longitudinal axis of tubular member within the body lumen for preventing the positioning element from being removed from the body lumen into the puncture, wherein the plug and/or adhesive are swellable in the physiological environment.

8. The apparatus of claim 7 , wherein the positioning element is disposed within the tubular member lumen in a low profile condition as the tubular member is inserted into the body lumen, the positioning member being movable axially relative to the tubular member for deploying the positioning element within the body lumen, whereupon the positioning element assumes a large profile condition, preventing the positioning element from being removed from the body lumen into the puncture.

9. The apparatus of claim 7 , wherein the positioning element comprises a bioabsorbable element that is absorbed after being exposed to fluid within the body lumen.

10. The apparatus of claim 7 , wherein the positioning element comprises an expandable structure.

11. The apparatus of claim 7 , further comprising a second precursor disposed on the plug, the second precursor remaining in an unreactive state prior to exposure to an aqueous physiological environment whereupon the second precursor reacts with the first precursor to form an adhesive on the plug.

12. The apparatus of claim 7 , wherein the plug comprises an elongate body having a disk shape, a solid cylindrical shape, or a rolled sheet cylindrical shape.

13. An apparatus for sealing a puncture extending through tissue, comprising: a tubular member comprising a proximal end, a distal end sized for insertion through the puncture, a lumen extending between the proximal and distal ends, and a distal opening in communication with the lumen; a plug disposed within the lumen; a first hydrogel precursor disposed at least partially on an exterior surface of the plug, the first precursor remaining in an unreactive state on the plug prior to exposure to an aqueous physiological environment, whereupon the first precursor reacts to form a hydrogel; and a pusher member slidable within the lumen of the tubular member for deploying the plug through the lumen and out the distal opening of the tubular member, wherein the plug and/or hydrogel are swellable in the physiological environment.

14. The apparatus of claim 13 , wherein the plug comprises a lumen extending between proximal and distal ends thereof, the apparatus further comprising an elongate positioning member, the positioning member having an expandable element on a distal end thereof, the positioning member sized for passing through the lumen of the tubular member and the lumen of the plug.

15. The apparatus of claim 13 , further comprising a second precursor disposed at least partially on an exterior surface of the plug, the second precursor remaining in an unreactive state prior to exposure to an aqueous physiological environment in the tissue whereupon the second precursor reacts with the first precursor to form a hydrogel.

16. The apparatus of claim 15 , whereupon the second precursor is configured to react with the first precursor to form an adhesive on the plug.

17. The apparatus of claim 13 , further comprising an activating agent disposed on at least a portion of the plug, the activating agent facilitating or initiating reaction of the first precursor when exposed to an aqueous physiological environment.

18. The apparatus of claim 17 , wherein the first precursor comprises a hydrogel precursor, and wherein the activating agent comprises a pH activating agent that modifies a pH of the aqueous physiological environment to initiate the reaction of the first hydrogel precursor.

19. The apparatus of claim 13 , wherein the plug comprises an elongate body having a disk shape, a solid cylindrical shape, a rolled sheet cylindrical shape, or a folded sheet cylindrical shape.

20. An apparatus for sealing a puncture extending through tissue, comprising:
a tubular member comprising a proximal end, a distal end sized for insertion through the puncture, a lumen extending between the proximal

Assignees

• Incept Llc

Inventors

• Sawhney Amarpreet S
• Khosravi Farhad
• Pai Suresh S

Classifications

• A61L26/0052

  Mixtures of macromolecular compounds · CPC title

• A61L31/145

  Hydrogels or hydrocolloids · CPC title

• A61L2300/252

  Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines · CPC title

• A61L2300/418

  Agents promoting blood coagulation, blood-clotting agents, embolising agents · CPC title

• A61B2017/00004

  (bio)absorbable, (bio)resorbable or resorptive · CPC title