Apparatus and methods for sealing a vascular puncture

• US 7,335,220 B2
• Filed: 11/05/2004
• Issued: 02/26/2008
• Est. Priority Date: 11/05/2004
• Status: Active Grant

• Current Assignee: Access Closure Incorporated (Cardinal Health, Inc.)
• Original Assignee: Access Closure Incorporated (Cardinal Health, Inc.)
• Inventors: Khosravi, Farhad, Pai, Suresh S., Bagaoisan, Celso J.
• Primary Examiner(s): Thanh; Loan H.
• Assistant Examiner(s): Neal; Timothy J
• Application Number:
  US10/982,384
• Publication Number:
  US 20060099238A1
• Time in Patent Office: 1,208 Days
• Field of Search: 606/213
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/232 Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/418 Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 26/0052 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 26/008 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/042 Polysaccharides
• CPC Class Codes: A61L 31/044 Collagen
• CPC Class Codes: A61L 31/046 Fibrin; Fibrinogen
• CPC Class Codes: A61L 31/048 : obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/06 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/145 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/148 : Materials at least partially resorbable by the body
• CPC Class Codes: C08L 71/02 : Polyalkylene oxides

Abstract

Apparatus for sealing a puncture communicating with a blood vessel includes a porous carrier formed from lyophilized hydrogel or other material. The plug may include at least 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.

Claims

1. An apparatus for sealing a puncture extending through tissue, comprising:

a cartridge comprising a proximal end, a distal end sized for insertion into a puncture through tissue, and a lumen extending between the proximal and distal ends;

a plug disposed within the cartridge lumen, the plug comprising a lumen extending between proximal and distal ends thereof;

a pusher member disposed within the cartridge lumen for deploying the plug from the cartridge when the cartridge is retracted relative to the pusher member;

a positioning member comprising an elongate member and an expandable positioning element carried on a distal end of the elongate member, the elongate member received though the lumens of the plug and the cartridge such that the cartridge, plug, and pusher member are advanceable from a proximal position on the positioning member to a distal position wherein the plug is disposed adjacent the positioning element; and

cooperating elements on the pusher member and the positioning member that limit subsequent movement of the pusher member relative to the positioning member when the pusher member is advanced to the distal position,

wherein the positioning member is removable through the pusher member with the positioning element collapsed, thereby allowing the positioning member to be withdrawn from a puncture before the pusher member is withdrawn such that pusher member prevents the plug from moving proximally while the positioning member is withdrawn.

2. The apparatus of claim 1, wherein the cooperating elements prevent the pusher member from being retracted proximally from the distal position.

3. The apparatus of claim 1, wherein the cooperating elements comprise first and second elements on the pusher member and the positioning member, the first element passing freely over the second element when the cartridge, plug, and pusher member are advanced to the distal position, the second element subsequently preventing the first element from passing proximally back over the second element, thereby preventing the pusher member from being retracted proximally from the distal position.

4. The apparatus of claim 3, wherein the first element comprises a latch element.

5. The apparatus of claim 4, wherein the second element comprises a raised element.

6. The apparatus of claim 1, wherein the plug is disposed immediately adjacent the positioning element in the distal position.

7. The apparatus of claim 1, wherein the cartridge is retractable relative to the pusher member, the pusher member comprising a distal end that prevents the plug from moving proximally while the cartridge is retracted.

8. The apparatus of claim 1, wherein the cooperating elements allow the pusher member to be directed distally from the distal position such that the plug may be compressed between the pusher member and the positioning element when the positioning element is expanded.

9. The apparatus of claim 1, wherein the plug is formed from a lyophilized hydrogel comprising hydrolytically degradable bonds, the hydrogel expanding when exposed to an aqueous physiological environment.

10. An apparatus for sealing a puncture extending through tissue, comprising:

a cartridge comprising a proximal end, a distal end sized for insertion into a puncture through tissue, and a lumen extending between the proximal and distal ends;

a plug disposed within the cartridge lumen, the plug comprising a lumen extending between proximal and distal ends thereof;

a pusher member disposed within the cartridge lumen for preventing the plug from moving proximally when the cartridge is retracted proximally relative to the pusher member for deploying the plug from the cartridge;

a positioning member comprising an elongate member and an expandable positioning element carried on a distal end of the elongate member, the elongate member received through the lumens of the plug and the cartridge such that the plug is disposed immediately adjacent the positioning element; and

cooperating elements on the pusher member and the positioning member that prevent the pusher member from being retracted proximally relative to the positioning element,

wherein the positioning member is removable through the pusher member with the positioning element collapsed, thereby allowing the positioning member to be withdrawn from a puncture before the pusher member is withdrawn such that pusher member prevents the plug from moving proximally while the positioning member is withdrawn.

11. The apparatus of claim 10, wherein the cooperating elements comprise first and second elements on the pusher member and the positioning member.

12. The apparatus of claim 11, wherein the first element comprises a latch element.

13. The apparatus of claim 12, wherein the second element comprises a raised element.

14. The apparatus of claim 10, wherein the cooperating elements allow the pusher member to be directed distally relative to the positioning element such that the plug may be compressed between the pusher member and the positioning element when the positioning element is expanded.

15. The apparatus of claim 10, wherein the plug is formed from a lyophilized hydrogel comprising hydrolytically degradable bonds, the hydrogel expanding when exposed to an aqueous physiological environment.

16. The apparatus of claim 10, wherein the plug comprises a folded sheet cylindrical shape.

17. The apparatus of claim 10, wherein the plug comprises an adherent layer on at least a portion of an exposed surface thereof, the adherent layer comprising a mixture of first and second hydrogel polymers that remain in an unreactive state until exposed to an aqueous physiological environment.

18. The device of claim 17, wherein the adherent layer further comprises a pH activating agent.

19. The apparatus of claim 10, wherein the hydrogel comprises PEG polymer.