Closure device

• US 9,241,696 B2
• Filed: 10/29/2009
• Issued: 01/26/2016
• Est. Priority Date: 10/30/2008
• Status: Expired due to Fees

• Current Assignee: Abbott Vascular Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Vascular Incorporated (Abbott Laboratories)
• Inventors: Mehl, Douglas H.
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): David, Shaun L
• Application Number:
  US12/608,773
• Publication Number:
  US 20100114156A1
• Time in Patent Office: 2,280 Days
• Field of Search: 606/213, 606215-218
• US Class Current: 1/1
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument

Abstract

A closure device for closing an opening in tissue is provided. The closure device according the present invention includes a delivery system for deploying a closure element, wherein the closure element is movable between a delivery configuration and a deployed configuration to close an opening in tissue. The closure device of the present invention may further include a charge of hemostatic material.

Claims

1. A method of closing an opening in a blood vessel, the method comprising:

inserting a closure device at least partially through the opening and into the blood vessel, the closure device including a delivery tube, an actuator, and a closure element, the closure element comprising a body having a proximal portion, a distal portion, and a waist portion, a distal end of the delivery tube being configured with a bias and applies a radial compressive force to the closure element;

reconfiguring the distal portion of the closure element from a pre-deployed configuration to a deployed configuration, by pulling a distal end of the closure element in a proximal direction, while maintaining the proximal portion of the closure device in a pre-deployed configuration, wherein in the deployed configuration, one or more extensions of the distal portion protrude outward from the body beyond an outer edge of the opening in the blood vessel;

engaging an inside portion of the blood vessel distally from the opening in the blood vessel with the distal portion of the closure device by moving the closure device in a proximal direction;

following engaging the inside portion of the opening in the blood vessel, deploying the proximal portion of the closure element from the delivery tube;

reconfiguring the proximal portion of the closure element from the pre-deployed configuration to a deployed configuration by collapsing a collapsible portion of the body in an outward direction, wherein in the deployed configuration, one or more extensions of the proximal portion protrude outward from the body to engage an outside portion of the blood vessel proximally from the opening in the blood vessel; and

locking the proximal portion and the distal portion of the closure element in the deployed configuration by advancing a locking element formed on the actuator through a lumen of the proximal portion.

2. The method recited in claim 1, wherein the locking element is tapered from a proximal end to a distal end.

3. The method according to claim 1, further comprising deploying a hemostatic material on or adjacent to the opening in the blood vessel.

4. The method recited in claim 1, further comprising disengaging the delivery tube and actuator from the closure element and removing the delivery tube and actuator.

5. The method recited in claim 1, further comprising holding the proximal end of the closure device between the locking element and a coupler element, the coupler element being coupled to or incorporated with the actuator.

6. The method recited in claim 1, further comprising severing the actuator proximally to the locking element.

7. The method recited in claim 1, wherein reconfiguring the proximal portion of the closure element from the pre-deployed configuration to the deployed configuration further comprises:

compressively restraining the proximal portion of the closure device within the delivery tube, thereby preventing the collapsible portion of the body from collapsing in the outward direction after the locking element is pulled out of the proximal portion of the closure device; and

releasing the proximal portion of the closure device from the delivery tube, thereby collapsing the collapsible portion of the body and reconfiguring the proximal portion of the closure device to the deployed configuration.

8. The method of claim 1, further comprising positioning the closure device at a predetermined depth within the delivery tube with at least a portion of the closure device extending beyond the distal end of the delivery tube.

9. The method of claim 8, wherein the predetermined depth is set by a protrusion that limits the insertion of the closure device within the delivery tube.

10. A method of closing an opening in a blood vessel, the method comprising:

inserting a closure device at least partially through the opening, the closure device including a delivery tube, an actuator, and a closure element, the closure element comprising a body having a proximal portion, a distal portion, and a waist portion, a portion of the distal portion of the closure element extending distally from a delivery tube distalmost end prior to inserting the closure device at least partially through the opening, and the proximal portion of the closure element being disposed, within the delivery tube prior to inserting the closure device at least partially through the opening, adjacent a blocking protrusion disposed within a lumen of the delivery tube that prevents proximal movement of the closure device within the lumen of the delivery tube;

reconfiguring the distal portion of the closure element from a pre-deployed configuration to a deployed configuration, by pulling the distal end of the closure element in a proximal direction, while maintaining the proximal portion of the closure device in a pre-deployed configuration, wherein in the deployed configuration, one or more extensions of the distal portion protrude outward from the body;

engaging the inside portion of the opening in the blood vessel with the distal portion of the closure device by moving the closure device in a proximal direction; and

reconfiguring the proximal portion of the closure element from the pre-deployed configuration to a deployed configuration by collapsing a collapsible portion of the body in an outward direction, wherein in the deployed configuration, one or more extensions of the proximal portion protrude outward from the body.

11. The method recited in claim 10, further comprising locking the distal portion and the proximal portion of the closure element in their respective deployed configurations.

12. The method according to claim 10, further comprising deploying a hemostatic material on or adjacent to the opening in the blood vessel.

13. The method recited in claim 10, further comprising disengaging the delivery tube and actuator from the closure element and removing the delivery tube and actuator.

14. The method recited in claim 10, wherein collapsing a portion of the body comprises pulling a locking element through and out of the proximal portion of the closure device, the locking element being coupled to or incorporated with the actuator and being configured to collapse the collapsible portion of the body in the outward direction.

15. The method recited in claim 14, further comprising holding the proximal end of the closure device between the locking element and a coupler element, the coupler element being coupled to or incorporated with the actuator.

16. The method recited in claim 14, further comprising severing the actuator proximally to the locking element.

17. The method recited in claim 14, wherein reconfiguring the proximal portion of the closure element from the pre-deployed configuration to the deployed configuration further comprises:

compressively restraining the proximal portion of the closure device within the delivery tube, thereby preventing the collapsible portion of the body from collapsing in the outward direction after the locking element is pulled out of the proximal portion of the closure device; and

releasing the proximal portion of the closure device from the delivery tube, thereby collapsing the collapsible portion of the body and reconfiguring the proximal portion of the closure device to the deployed configuration.

18. The method of claim 10, further comprising positioning the closure device at a predetermined depth within the delivery tube.

19. The method of claim 18, wherein the predetermined depth is set by a protrusion that limits the insertion of the closure device within the delivery tube.