# US 9,039,735 B2 · Apparatus and methods for sealing a vascular puncture

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- Number: US 9,039,735 B2
- Document ID: US9039735B2
- Status: Granted
- Kind: B2
- Application number: 14/181,490
- Filed: 2014-02-14
- Published: 2014-06-26
- Granted: 2015-05-26
- Earliest claimed: 2004-11-05
- Assignees: Access Closure, Inc.
- Applicants: AccessClosure, Inc.
- Inventors: Farhad Khosravi; Suresh S. Pai; Celso J. Bagaoisan
- Web page: https://patentgrep.com/patent/US9039735B2

## CPC

- 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)}
- A61B 17/00491: {Surgical glue applicators}
- 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)}
- A61L 26/0052: {Mixtures of macromolecular compounds}
- A61L 26/008: {Hydrogels or hydrocolloids}
- A61L 27/58: Materials at least partially resorbable by the body
- A61L 31/042: {Polysaccharides}
- A61L 31/044: {Collagen}
- A61L 31/046: {Fibrin; Fibrinogen}
- A61L 31/048: {obtained by reactions only involving carbon-to-carbon unsaturated bonds (A61L31/041 takes precedence)}
- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- A61L 31/145: {Hydrogels or hydrocolloids}
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00495: {for two-component glue}
- A61B 2017/00637: {for sealing trocar wounds through abdominal wall}
- A61B 2017/0065: {the implement being an adhesive}
- A61B 2017/00654: {entirely comprised between the two sides of the opening}
- A61L 2300/232: Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
- A61L 2300/252: Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
- A61L 2300/418: Agents promoting blood coagulation, blood-clotting agents, embolising agents
- A61L 2300/606: Coatings
- A61L 2400/04: Materials for stopping bleeding
- A61L 2420/06: Coatings containing a mixture of two or more compounds
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## 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

### Claim 1

An apparatus for sealing a blood vessel wall penetration disposed at an end of a tissue tract, said apparatus comprising:
a shaft having a proximal end and a distal end;
an occlusion element near the distal end of the shaft, said occlusion element being transformable between a radially contracted configuration for passage through the tissue tract and a radially expanded configuration for deployment within the blood vessel to occlude the penetration;
a hemostatic implant disposed on an exterior surface of the shaft proximal to the occlusion element such that the occlusion element can be removed through the hemostatic implant, the hemostatic implant configured to be carried by the shaft adjacent the occlusion element prior to advancement of said apparatus into the tissue tract; and
a protective sleeve retractably disposed over the hemostatic implant.

### Claim 2 (depends on 1)

An apparatus as in claim 1, wherein the occlusion element comprises an expandable wire mesh.

### Claim 3 (depends on 2)

An apparatus as in claim 2, further comprising an actuator for moving the expandable wire mesh between the radially contracted and radially expanded configurations.

### Claim 4 (depends on 3)

An apparatus as in claim 3, wherein the hemostatic implant comprises collagen.

### Claim 5 (depends on 1)

An apparatus as in claim 1, wherein the occlusion element comprises an expandable frame.

### Claim 6 (depends on 1)

An apparatus as in claim 1, wherein the occlusion element comprises an inflatable balloon.

### Claim 7 (depends on 1)

An apparatus as in claim 1, wherein the hemostatic implant comprises a cylindrical plug carried by the shaft.

### Claim 8 (depends on 1)

An apparatus as in claim 1, wherein the hemostatic implant comprises collagen.

### Claim 9 (depends on 1)

An apparatus as in claim 1, wherein the hemostatic implant comprises polyethylene glycol.

### Claim 10 (depends on 1)

An apparatus as in claim 1, wherein the shaft comprises a tubular body.