Vascular closure device

• US 8,821,532 B2
• Filed: 01/30/2009
• Issued: 09/02/2014
• Est. Priority Date: 01/30/2009
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Schaeffer, Darin G.
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US12/363,271
• Publication Number:
  US 20100198254A1
• Time in Patent Office: 2,041 Days
• Field of Search: 606/139, 606/151, 606/200, 606/213, 623/23.72, 128/831, 128/842, 128/843
• 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 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence

Abstract

A device for closure of an opening formed through a wall of a body vessel of a patient is provided, as well as an introducer system for delivery of the closure device. Various embodiments include the closure device having hook members configured to engage the tissue interior of the body vessel wall, hook members configured to engage interstitial tissue adjacent to the body vessel, a plug member to contact sealably the opening from inside the body vessel, and combinations thereof. A retraction member is removably attached to the each of the embodiments to permit manipulation of the device. Remodelable material may be included with each of the embodiments to promote quicker healing. The introducer includes a sheath that is insertable through the opening and a pusher disposed within the lumen of the sheath and movable within the sheath lumen to deploy the device.

Claims

1. A device for closure of an opening formed through a wall of a body vessel of a patient, the device comprising:

an anchor body having a first end and a second end, the first end including a plurality of hook members each including a tissue engagement structure configured to engage tissue of said body vessel, the second end configured as an eyelet,

wherein the anchor body is formed of a single continuous wire and is movable between a contracted configuration and an extended configuration, where the anchor body is contractible to fit within said opening, and in the extended configuration the hook members of the anchor body are configured to be displaced outward to a cross-sectional area greater than the cross-sectional area of said opening and the tissue engagement structures of the hook members extend away from a central axis of the anchor body;

an implantable tubular member having a first end and a second end and a lumen extending therethrough, the second end configured to remain in abutting contact with the body vessel, the lumen sized to receive the anchor body in the contracted configuration, wherein the tubular member is slidably engageable with a portion of the anchor body to urge the anchor body to move from the extended configuration to the contracted configuration;

a retraction member disposed longitudinally within the lumen of the tubular member and attached to the eyelet of the anchor body, wherein the retraction member is retractable within the lumen of the tubular member to bring the second end of the tubular member closer to the first end of the anchor body;

a sheath having a proximal end and a distal end, a distal portion of the sheath insertable through said opening, the sheath having a lumen extending therethrough; and

a pusher disposed within the lumen of the sheath and movable within the sheath lumen;

the pusher having a proximal end and a distal end and a lumen extending therethrough;

wherein the anchor body is contractible to be disposed within the lumen of the sheath, the tubular member is interposed between the distal end of the pusher and the anchor body, and the retraction member has a first portion attached to the anchor body and a second portion extending past the first end of the tubular member.

2. The device of claim 1, wherein the hook members of the anchor body in the extended configuration are disposed about the central axis at an acute angle.

3. The device of claim 1, wherein the hook members of the anchor body in the extended configuration includes a first portion disposed about the central axis at an angle about substantially perpendicular thereto, a second portion disposed parallel to the central axis, and a bend interconnecting the first and second portions.

4. The device of claim 1, wherein the tissue engagement structures of the anchor body are configured to be disposed inside said body vessel and extend toward the second end of the anchor body to penetrate the tissue of said body vessel from inside said body vessel, wherein the hooks are configured to move radially inward such that a portion of an edge of said opening is brought to abut another portion of said opening edge.

5. The device of claim 1, wherein the tubular member includes remodelable material attached to the second end thereof, the remodelable material contactable with said opening.

6. The device of claim 5, wherein the remodelable material includes a lumen configured to have a smaller cross-sectional area than said opening and sized to receive the second end of the anchor body.

7. The device of claim 1, wherein the tubular member has a length sized to receive a portion of the anchor body that is external to said body vessel wall.

8. The device of claim 1, wherein the tubular member is adapted to be positioned external to said body vessel wall.

9. The device of claim 1, wherein the retraction member is lockable to permit manipulation of the anchor body.

10. A device for closure of an opening formed through a wall of a body vessel of a patient, comprising:

an anchor body defined about a central axis, the anchor body having a first end, a second end, and a bent member therebetween, the first end including a plurality of tissue engagement structures configured to engage tissue of said body vessel, wherein the anchor body is movable between a contracted configuration and an extended configuration, where the anchor body is contractible to fit within said opening, and in the extended configuration the bent member has a first portion angled away from the central axis and a second portion that is substantially parallel with the central axis, and the tissue engagement structures face away from the central axis and are configured to be displaced outward away from the central axis to a cross-sectional area greater than the cross-sectional area of said opening;

an implantable tubular member disposed about the central axis and having a first end, a second end, and a lumen extending therethrough, the lumen sized to receive the anchor body in the contracted configuration, wherein the tubular member is movable between a first position disposed away from the anchor body and a second position slidably engaging the anchor body, and, in the second position, the tissue engagement structures are positioned outside the lumen of the tubular member to capture the wall of the body vessel between the second end of the tubular member and the tissue engagement structures;

a retraction member disposed longitudinally within the lumen of the tubular member and removably attached to the anchor body, the retraction member being movable between a locked position and a free position, in the locked position the retraction member is fixed relative to the second end of the anchor body, and in the free position the retraction member is movable relative to the second end of the anchor body in order for the retraction member to be removed;

a sheath having a proximal end and a distal end, a distal portion of the sheath insertable through said opening, the sheath having a lumen extending therethrough; and

a pusher disposed within the lumen of the sheath and movable within the sheath lumen;

the pusher having a proximal end and a distal end and a lumen extending therethrough;

wherein the anchor body is contractible to be disposed within the lumen of the sheath, the tubular member is interposed between the distal end of the pusher and the anchor body, and the retraction member has a first portion removably attached to the anchor body and a second portion extending past the proximal end of the pusher;

wherein the tubular member is movable along the central axis over the retraction member in the locked position from the first position to the second position for the lumen of the tubular member to slidably engage the first portion of the bent member, whereby the tissue engagement structures are urged to converge inward toward the central axis and cross one another.

11. The device of claim 10, wherein the tubular member and the anchor body comprise a biodegradable material.

12. The device of claim 10, wherein the retraction member is removable from the second end of the anchor body when the tubular member is in the second position.

13. The device of claim 12, wherein the retraction member is a single strand that is looped through the anchor body and removable from the anchor body.

14. The device of claim 10, wherein the retraction member is retractable to bring the first end of the tubular member closer to the first end of the anchor body.

15. A device for closure of an opening formed through a wall of a body vessel of a patient, the device comprising:

an anchor body having a first end and a second end, the first end including a plurality of hook members each including a tissue engagement structure configured to engage tissue of said body vessel, the second end configured as an eyelet,

wherein the anchor body is moveable between a contracted configuration and an extended configuration and contractible to fit within said opening of the wall of the body vessel, and, in the extended configuration, the hook members of the anchor body are configured to be displaced outward to a cross-sectional area greater than the cross-sectional area of said opening and the tissue engagement structures of the hook members extend away from a central axis of the anchor body and toward the second end of the anchor body to penetrate an inner surface of the wall of the body vessel;

an implantable tubular member having a first end and a second end and a lumen extending therethrough, the lumen having a diameter sized to receive the anchor body in the contracted configuration and a length sized to extend from the wall of the body vessel to at least the second end of the anchor body to receive a portion of the anchor body that is external to the body vessel when the anchor body is deployed therein, wherein the tubular member is slidably engageable with a portion of the anchor body to urge the anchor body to move from the extended configuration to the contracted configuration;

a retraction member disposed longitudinally within the lumen of the tubular member and removably attached to the eyelet of the anchor body, wherein the retraction member is retractable within the lumen of the tubular member to bring the second end of the tubular member closer to the first end of the anchor body;

a sheath having a proximal end and a distal end, a distal portion of the sheath insertable through said opening, the sheath having a lumen extending therethrough; and

a pusher disposed within the lumen of the sheath and movable within the sheath lumen;

the pusher having a proximal end and a distal end and a lumen extending therethrough;

wherein the anchor body is contractible to be disposed within the lumen of the sheath, the tubular member is interposed between the distal end of the pusher and the anchor body, and the retraction member has a first portion attached to the anchor body and a second portion extending proximally past the distal end of the pusher.

16. A device for closure of an opening formed through a wall of a body vessel of a patient, comprising:

an anchor body defined about a central axis and formed of a single continuous wire, the anchor body having a first end, a second end, and a bent member therebetween, the first end including a plurality of tissue engagement structures facing away from the central axis and configured to engage tissue of said body vessel, wherein the anchor body is movable between a contracted configuration and an extended configuration, where the anchor body is contractible to fit within said opening, and in the extended configuration the bent member has a first portion extending away from the second end of the anchor body at an angle substantially perpendicular to the central axis and a second portion extending away from the first portion of the bent member and the second end of the anchor body and substantially parallel with the central axis, and the tissue engagement structures are spaced from the second end of the anchor body by a distance along the central axis and are configured to be displaced outward away from the central axis to a cross-sectional area greater than the cross-sectional area of said opening;

an implantable tubular member disposed about the central axis and having a first end, a second end, and a lumen extending therethrough, the lumen sized to receive the anchor body in the contracted configuration, wherein the tubular member is movable along the central axis between a first position disposed away from the anchor body and a second position slidably engaging the anchor body to capture the wall of the body vessel between the second end of the tubular member and the first end of the anchor body, where the tissue engagement structures extend toward the second end of the anchor body to penetrate an inner surface of the captured wall of the body vessel and the second end of the tubular member is configured to engage an outer surface of the captured wall of the body vessel opposite the inner surface;

a retraction member disposed longitudinally within the lumen of the tubular member and removably attached to the anchor body, wherein the retraction member is retractable within the lumen of the tubular member to bring the second end of the tubular member closer to the first end of the anchor body;

a sheath having a proximal end and a distal end, a distal portion of the sheath insertable through said opening, the sheath having a lumen extending therethrough; and

a pusher disposed within the lumen of the sheath and movable within the sheath lumen;

the pusher having a proximal end and a distal end and a lumen extending therethrough;

wherein the anchor body is contractible to be disposed within the lumen of the sheath, the tubular member is interposed between the distal end of the pusher and the anchor body, and the retraction member has a first portion attached to the anchor body and a second portion extending past the first end of the tubular member.