Closure device

• US 8,657,852 B2
• Filed: 03/08/2013
• Issued: 02/25/2014
• Est. Priority Date: 10/30/2008
• Status: Active Grant

• Current Assignee: Abbott Vascular Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Vascular Incorporated (Abbott Laboratories Incorporated)
• Inventors: Roorda, Wouter E., McCrystle, Kelly J., Voss, Laveille K., Ding, Ni, Clark, Ian J.
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US13/791,829
• Publication Number:
  US 20130190810A1
• Time in Patent Office: 354 Days
• Field of Search: None
• 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, resorptive for implantable prostheses A61F2210/0004
• 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 device for closing an opening in a wall of a body lumen includes a closure element with a first flange and a second flange. Both the first flange and the second flange may have a delivery cross-sectional dimension and a deployed cross-sectional dimension. The device for closing an opening further includes a first coupler element disposed on the first flange and a second coupler element disposed on the second flange, the first and second coupler elements cooperating to couple the first flange to the second flange.

Claims

1. A method of closing an opening in tissue, comprising:

inserting a closure device at least partially through an opening formed in tissue, the closure device including a delivery tube, an actuator, and a closure element, the closure element having a delivery configuration and a deployed configuration, the closure element comprising;

a first flange configured to move between the delivery configuration and the deployed configuration, the first flange having a delivery cross-sectional dimension in the delivery configuration and a deployed cross-sectional dimension in the deployed configuration;

a second flange configured to move between the delivery configuration and the deployed configuration, the second flange having a delivery cross-sectional dimension in the delivery configuration and a deployed cross-sectional dimension in the deployed configuration;

a first coupler element disposed on the first flange extending in a first direction; and

a second coupler element disposed on the second flange extending in a second direction, the first direction and the second directions being parallel but opposite, the first flange extending in the second direction in its delivery configuration and the second flange extending in the first direction in its delivery configuration, the first coupler element and the second coupler element configured to couple the first flange to the second flange, the first coupler element and the second coupler element being uncoupled in the delivery configuration, wherein the first coupler element further includes friction elements that resist relative movement between the first coupler element and the second coupler element,

wherein the first and second flanges are positioned simultaneously in the delivery tube in the delivery configuration, and

wherein the delivery cross-sectional dimension of the first flange is smaller than the deployed cross-sectional dimension of the first flange, the delivery cross-sectional dimension of the second flange is smaller than the deployed cross-sectional dimension of the second flange, and the delivery cross-sectional dimension of the second flange is smaller than the deployed cross-sectional dimension of the second flange,

applying a force to the actuator to move the first flange of the closure element from the delivery configuration toward the deployed configuration;

applying a second force to the actuator to move the second flange of the closure element from the delivery configuration toward the deployed configuration; and

applying a third force to the actuator to couple the first flange to the second flange.

2. The method recited in claim 1, further comprising engaging the first flange of the closure element with a distal surface of tissue adjacent the opening when the first flange of the closure element is in the deployed configuration and prior to moving the second flange from the delivery a configuration toward the deployed configuration.

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

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 from the opening in the tissue.

5. The method of claim 1, wherein applying the third force to the actuator to couple the distal portion to the proximal portion includes pressing the second coupler element of the second flange over the first coupler element of the distal element.

6. A method of closing an opening in tissue, comprising:

inserting a closure device at least partially through an opening formed in tissue, the closure device including a delivery tube, an actuator, and a closure element, the closure element defined by a body having a proximal portion having a first flange, a distal portion having a second flange, and a waist, the closure element further comprising a first coupler element disposed on the first flange extending in a first direction and a second coupler element disposed on the second flange extending in a second direction, the first direction and the second directions being parallel but opposite, the first flange extending in the second direction in its delivery configuration and the second flange extending in the first direction in its delivery configuration, the first coupler element and the second coupler element configured to couple the first flange to the second flange, the first coupler element and the second coupler element being uncoupled in the delivery configuration, wherein the first coupler element further includes friction elements that resist relative movement between the first coupler element and the second coupler element, wherein the first and second flanges are positioned simultaneously in the delivery tube in the delivery configuration, and

wherein the delivery cross-sectional dimension of the first flange is smaller than the deployed cross-sectional dimension of the first flange, the delivery cross-sectional dimension of the second flange is smaller than the deployed cross-sectional dimension of the second flange, and the delivery cross-sectional dimension of the second flange is smaller than the deployed cross-sectional dimension of the second flange;

applying a force to the actuator to move the first flange of the closure element from the delivery configuration toward a deployed configuration by pushing the first flange out of the delivery tube and into the opening formed in the tissue, while maintaining the second flange of the closure device in the delivery configuration;

applying a second force to the actuator to move the second flange of the closure element from the delivery configuration toward the deployed configuration; and

applying a third force to the actuator to couple the first flange to the second flange.

7. The method of claim 6, wherein applying the third force to the actuator to couple the first flange to the second flange includes pressing a waist portion of one of the first flange or the second flange into a waist portion of the opposite portion.

8. The method recited in claim 6, further comprising engaging the first flange of the closure element with a distal surface of tissue adjacent the opening when the first flange of the closure element is in the deployed configuration and prior to moving the second flange from the delivery configuration toward the deployed configuration.

9. The method according to claim 6, further comprising deploying a hemostatic material on or adjacent to the opening in the tissue.

10. The method recited in claim 6, further comprising disengaging the delivery tube and actuator from the closure element and removing the delivery tube and actuator from the opening in the tissue.

11. A method of closing an opening in tissue, comprising:

inserting a closure device at least partially through an opening formed in tissue, the closure device including a delivery tube, an actuator, and a closure element, the closure element defined by a body having a distal portion, a proximal portion, and a waist, the closure element comprising;

the distal portion being configured to move between a delivery configuration and a deployed configuration, the distal portion having a delivery cross-sectional dimension in the delivery configuration and a deployed cross-sectional dimension in the deployed configuration;

the proximal portion being configured to move between a delivery configuration and a deployed configuration, the proximal portion having a delivery cross-sectional dimension in the delivery configuration and a deployed cross-sectional dimension in the deployed configuration;

a first coupler element disposed on the distal portion extending in a first direction; and

a second coupler element disposed on the proximal portion extending in a second direction, the first direction and the second directions being parallel but opposite, the distal portion extending in the second direction in its delivery configuration and the proximal portion extending in the first direction in its delivery configuration, the first coupler element and the second coupler element configured to couple the distal portion to the proximal portion, the first coupler element and the second coupler element being uncoupled in the delivery configuration, wherein the first coupler element further includes friction elements that resist relative movement between the first coupler element and the second coupler element,

wherein the delivery cross-sectional dimension of the distal portion is smaller than the deployed cross-sectional dimension of the distal portion, and the delivery cross-sectional dimension of the proximal portion is smaller than the deployed cross-sectional dimension of the proximal portion,

applying a force to the actuator to move the distal portion of the closure element from a pre-deployed configuration to a deployed configuration by pushing the distal portion out of the delivery tube and into the opening formed in the tissue, while maintaining the proximal portion of the closure device in a pre-deployed configuration, wherein in the deployed configuration, a flange of the distal portion protrudes outward from the body;

applying a second force to the actuator to move the proximal portion of the closure element from the pre-deployed configuration to a deployed configuration by pushing the proximal portion out of the delivery tube and into the opening formed in the tissue, wherein in the deployed configuration, a flange of the proximal portion protrudes outward from the body.

12. The method recited in claim 11, further comprising engaging the distal portion of closure element with a distal surface of tissue adjacent the opening when the distal portion of the closure element is in the second configuration and prior to moving the proximal portion from a first configuration toward a second configuration.

13. The method according to claim 11, further comprising deploying a hemostatic material on or adjacent to the opening in the tissue.

14. The method recited in claim 11, further comprising disengaging the delivery tube and actuator from the closure element and removing the delivery tube and actuator from the opening in the tissue.