Closure device

• US 8,323,312 B2
• Filed: 06/09/2009
• Issued: 12/04/2012
• Est. Priority Date: 12/22/2008
• Status: Active Grant

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Clark, Ian J.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): Papeika, Rachel S
• Application Number:
  US12/481,377
• Publication Number:
  US 20100160958A1
• Time in Patent Office: 1,274 Days
• Field of Search: 606/138, 606/139, 606/151, 606/153, 606/155, 606/157, 606/158, 606/213, 606/214, 606/215, 606/216, 606/217, 606/142, 606/221, 623/23.72
• US Class Current: 606/216
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• 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 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

Devices and methods are disclosed herein for a closure device. A closure device includes a body movable from a pre-deployed configuration towards a deployed configuration, a plurality of tissue-engaging portions extending from the body. At least two of the tissue-engaging portions are separated by a first distance in the deployed configuration and a second distance in the pre-deployed configuration in which the first distance is smaller than the second distance. The closure device also includes a plurality of device-capture features secured to the body. The device-capture features are configured to move the tissue-engaging portions to a separation greater than the first distance.

Claims

1. A method, comprising:

deploying a closure element from a pre-deployed configuration to a deployed configuration and into tissue adjacent a tissue opening to substantially close the opening following a first procedure, the deployed configuration defining a plane generally parallel to the tissue adjacent the tissue opening, the closure element comprising;

a body having a plurality of expandable elements, the expandable elements moving resiliently between the pre-deployed configuration where the body is disposed out of the plane and the deployed configuration where the body is disposed about a central axis extending substantially normal to the plane and lying in the plane of the body;

a plurality of tissue-engaging portions extending from the body, at least two of the tissue-engaging portions being separated by a first distance in the deployed configuration and a second distance in the pre-deployed configuration, wherein the first distance is smaller than the second distance, and wherein the tissue-engaging portions are oriented generally towards the central axis in the deployed configuration and generally parallel to the central axis in the pre-deployed configuration, and

a plurality of device capture features operatively associated with the expandable elements, the plurality of device capture features being substantially parallel to the tissue engaging portions in the pre-deployed and deployed configurations and lying in the plane with the body in the deployed configuration;

locating the deployed closure element;

engaging the device-capture features; and

moving the device-capture features generally within the plane and in a direction opposite from that of the tissue engaging portions and radially outwardly and away from each other to increase a diameter of the body to withdraw the tissue-engaging portions from engagement with the tissue adjacent the tissue opening.

2. The method as in claim 1, wherein the tissue adjacent the tissue opening is skin.

3. The method as in claim 1, wherein the expandable elements include alternating curved elements having inner and outer curved regions.

4. The method as in claim 3, wherein moving the device-capture features to withdraw the tissue-engaging portions includes applying a force to at least one of the inner curved regions.

5. The method as in claim 3, wherein moving the device-capture features to withdraw the tissue-engaging portions includes applying a force to at least one of the outer curved regions.

6. The method of claim 1, wherein the body is biased towards the deployed configuration for biasing at least one of the tissue-engaging portions towards another tissue-engaging portion and the device capture feature is configured to move at least one of the tissue-engaging portions away from another tissue-engaging portion.

7. The method of claim 1, wherein the body comprises an inner periphery and an outer periphery and wherein at least one of the device-capture features is disposed within the inner periphery.

8. The method of claim 1, wherein the body comprises an inner periphery and an outer periphery and wherein at least one of the device-capture features is disposed generally about the outer periphery.

9. The method of claim 1, wherein the body comprises an inner periphery and an outer periphery and wherein at least one of the device-capture features is disposed outside of the outer periphery.

10. The method of claim 1, wherein the closure element further comprises a radiopaque marker and wherein the method further comprises locating the deployed closure element using the radiopaque marker.

11. The method of claim 1, wherein moving the device-capture features to withdraw the tissue-engaging portions includes moving the device-capture features in a direction away from a central axis of the closure element.

12. The method of claim 1, wherein moving the device-capture features to withdraw the tissue-engaging portions includes moving the tissue-engaging portions toward a direction being generally parallel to a central axis of the closure element.

13. The method of claim 1, wherein a pair of the plurality of device capture features are laterally offset about the central axis.

14. A method, comprising:

deploying a closure element from a pre-deployed configuration to a deployed configuration and into tissue adjacent a tissue opening to substantially close the opening following a first procedure, the deployed configuration defining a plane generally parallel to the tissue adjacent the tissue opening, the closure element comprising;

a body having a plurality of expandable elements, the body further defining a plane in the deployed configuration, the expandable elements moving resiliently between the pre-deployed configuration where the body is disposed out of the plane and the deployed configuration where the body is disposed about a central axis extending substantially normal to the plane and lying in the plane of the body;

a plurality of tissue-engaging portions extending from the body, at least two of the tissue-engaging portions being separated by a first distance in the deployed configuration and a second distance in the pre-deployed configuration, wherein the first distance is smaller than the second distance, and wherein the tissue-engaging portions are oriented generally towards the central axis in the deployed configuration and generally parallel to the central axis in the pre-deployed configuration, and

a plurality of device capture features operatively associated with the expandable elements, the plurality of device capture features being laterally offset about the central axis, lying in the plane with the body, and each being disposed at an apex of an expandable element of the plurality of expandable elements;

locating the deployed closure element;

engaging the device-capture features; and

moving the device-capture generally within the plane and circumferentially outwardly and away from each other and the central axis of the body to increase a diameter of the body to withdraw the tissue-engaging portions from engagement with the tissue adjacent the tissue opening.

15. The method of claim 14, wherein the body comprises an inner periphery and an outer periphery and wherein at least one of the device-capture features is disposed within the inner periphery.

16. The method of claim 14, wherein the body comprises an inner periphery and an outer periphery and wherein at least one of the device-capture features is disposed generally about the outer periphery.

17. The method as in claim 16, wherein moving the device-capture features to withdraw the tissue-engaging portions includes applying a force to at least one of the outer curved regions.

18. The method of claim 14, wherein the body comprises an inner periphery and an outer periphery and wherein at least one of the device-capture features is disposed outside of the outer periphery.

19. The method of claim 14, wherein the closure element further comprises a radiopaque marker and wherein the method further comprises locating the deployed closure element using the radiopaque marker.

20. The method of claim 14, wherein moving the device-capture features to withdraw the tissue-engaging portions includes moving the device-capture features in a direction away from a central axis of the closure element.

21. The method of claim 14, wherein moving the device-capture features to with the tissue-engaging portions includes moving the tissue-engaging portions toward a direction being generally parallel to a central axis of the closure element.

22. A method, comprising:

deploying a closure element from a pre-deployed configuration to a deployed configuration and into tissue adjacent a tissue opening to substantially close the opening following a first procedure, the deployed configuration defining a plane generally parallel to the tissue adjacent the tissue opening, the closure element comprising;

a body having a plurality of expandable elements that include alternating curved elements having inner and outer curved regions, the body further defining a plane in the deployed configuration, the expandable elements moving resiliently between the pre-deployed configuration where the body is disposed out of the plane and the deployed configuration where the body is disposed about a central axis extending substantially normal to the plane and lying in the plane of the body;

a plurality of tissue-engaging portions extending from the body, at least two of the tissue-engaging portions being separated by a first distance in the deployed configuration and a second distance in the pre-deployed configuration, wherein the first distance is smaller than the second distance, where the tissue-engaging portions are oriented generally towards the central axis in the deployed configuration, and generally parallel to the central axis in the pre-deployed configuration, and

a plurality of device capture features operatively associated with the expandable elements, the plurality of device capture features being substantially parallel to the tissue engaging portions in the pre-deployed and deployed configurations, lying in the plane with the body, and laterally offset about the central axis, wherein the body is biased towards the deployed configuration for biasing at least one of the tissue-engaging portions towards another tissue-engaging portion, and the device capture feature is configured to move at least one of the tissue-engaging portions away from another tissue-engaging portion, the closure element including a radiopaque marker;

locating the deployed closure element using the radiopaque marker;

engaging the device-capture features; and

moving the device-capture features generally within the plane and radially outwardly in a direction away from both each other and from the tissue engaging portions to increase a diameter and a circumference of the body to withdraw the tissue-engaging portions from engagement with the tissue adjacent the tissue opening.

23. The method as in claim 22, wherein moving the device-capture features to withdraw the tissue-engaging portions includes applying a force to at least one of the inner curved regions.