Devices for reducing the size of an internal tissue opening

• US 9,585,644 B2
• Filed: 09/10/2013
• Issued: 03/07/2017
• Est. Priority Date: 08/09/2006
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Linder, Richard J., Davis, Clark C., Miles, Scott D., Fox, DeWayne C., Edmiston, Daryl R., Ewell, David A.
• Primary Examiner(s): Templeton, Christopher L
• Application Number:
  US14/023,462
• Publication Number:
  US 20140172011A1
• Time in Patent Office: 1,274 Days
• 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 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• 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 2017/0061 Implements located only on one side 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 2017/00858 high friction or non-slip
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/00867 shape memory effect

Abstract

A medical system for treating an internal tissue opening can include a closure device and associated delivery device. The closure device can include a body portion operatively associated with a first anchor and a second anchor. The body portion can include a plurality of segments defining a multi-cellular structure. The closure device can be configured to apply lateral force to tissue of the internal tissue opening to bring tissue together. The closure device can have a substantially flat aspect, and have a depth thickness that is substantially greater than the thickness or width of a majority of the members forming the closure device to reduce out of plane bending. The closure device can also include a member adapted to induce tissue growth.

Claims

1. An expandable medical device deployable at least partially within a hole defined in a tissue structure between a first atrium and a second atrium of a heart, the hole defining an axis oriented axially through the hole, the expandable medical device comprising:

a frame configured to maintain a substantially flat configuration as said frame transitions and self-expands from a non-deployed state to an intended, as deployed state, said frame configured to be oriented parallel to, or extending along, the axis of the hole when in the intended, as-deployed state within the tissue structure, said frame comprising a central portion, at least one proximal anchor and at least one distal anchor, said central portion comprising a plurality of frame segments defining a multi-cellular structure, said at least one proximal anchor and said at least one distal anchor each configured to extend substantially coplanar with said central portion in the intended, as-deployed state with said at least one proximal anchor configured to extend in the first atrium and said at least one distal anchor configured to extend in the second atrium;

wherein said plurality of frame segments define four cells of the multi-cellular structure, each frame segment extending directly to and defining a length between nodes such that each cell is defined by four frame segments and only four nodes, each node connecting adjacently extending frame segments, and wherein said plurality of frame segments each include arcuate portions extending along the length of each frame segment such that a collective length of the arcuate portions extends along a majority of the length of each frame segment, and each cell of said multi-cellular structure is defined by said plurality of frame segments such that each cell includes a common frame segment of an adjacent cell.

2. The medical device as recited in claim 1, wherein said frame is configured to assume said substantially flat configuration lying in a first plane, said frame being configured to resist movement out of said first plane of the substantially flat configuration.

3. The medical device as recited in claim 1, wherein said at least one proximal anchor comprises engaging members configured to engage tissue.

4. The medical device as recited in claim 1, further comprising a tissue growth member configured to be attached to said frame and configured to induce tissue growth.

5. The medical device as recited in claim 4, wherein the tissue growth member comprises an elongated configuration positioned along the central portion of the frame and configured to be positioned in the hole and oriented transverse to the axis of the hole.

6. The medical device as recited in claim 4, wherein the tissue growth member comprises:

a first elongate tissue growth portion positioned along the central portion of the frame and configured to be positioned in the hole and oriented transverse to the axis of the hole; and

a second elongate tissue growth portion positioned proximal to the first elongate tissue growth portion, the second elongate tissue growth portion configured to be oriented transverse to the axis of the hole.

7. The medical device as recited in claim 4, wherein the tissue growth member comprises a polymeric material.

8. A medical device deployable at least partially within a hole defined in a tissue structure, the hole defining an axis oriented axially through the hole, the medical device comprising:

a framework configured to maintain a substantially flat configuration as said framework transitions and self-expands from being constricted within a catheter to being deployed from the catheter, said framework configured to be oriented parallel to, or extending along, the axis of the hole when in a state for intended deployment within the tissue structure, said framework comprising a central portion and at least one anchor extending from said central portion, said central portion including central frame segments having a length and a width, wherein the width of at least one of said central frame segments varies along at least a portion of the length of said at least one of said central frame segments in a tapered configuration;

wherein said central frame segments extend to define a multi-cellular structure having four cells, the length of each central frame segment extending directly to and between nodes such that each cell is defined by four central frame segments and only four nodes, each node connecting adjacently extending central frame segments, and wherein said central frame segments each include arcuate portions extending along the length of each central frame segment such that a collective length of the arcuate portions extends along a majority of the length of each central frame segment, and each cell includes a common central frame segment of an adjacent cell.

9. The medical device as recited in claim 8, wherein said at least one anchor comprises a first proximal anchor and a second proximal anchor each including a plurality of anchor frame segments, wherein at least two of the anchor frame segments extend substantially parallel to each other along at least a portion of their respective lengths for each of the first proximal anchor and the second proximal anchor.

10. The medical device as recited in claim 8, wherein said at least one anchor comprises engaging members configured to engage tissue.

11. The medical device as recited in claim 8, further comprising a tissue growth member configured to be attached to said framework and configured to induce tissue growth.

12. The medical device as recited in claim 11, wherein the tissue growth member comprises an elongated configuration positioned along the central portion of the framework and configured to be positioned in the hole and oriented transverse to the axis of the hole.

13. The medical device as recited in claim 11, wherein the tissue growth member comprises a polymeric material.

14. A medical device deployable at least partially within a hole defined in a tissue structure, the hole defining an axis oriented axially through the hole, the medical device comprising:

a framework configured to maintain a substantially flat configuration as said framework transitions and self-expands from being constricted within a catheter to being deployed from the catheter, said framework configured to be oriented parallel to, or extending along, the axis of the hole when in a state for intended deployment within the tissue structure, said framework comprising a central portion and at least one anchor extending from said central portion, said central portion including central frame segments defining a multi-cellular structure, at least one of said central frame segments including a longitudinal length dimension and having an aspect ratio of a depth dimension to a lateral width dimension of at least 2 to 1, wherein said depth dimension is defined to extend perpendicular relative to said substantially flat configuration of said framework;

wherein said central frame segments define four cells of said multi-cellular structure, a length of each central frame segment extending directly to and between nodes such that each cell is defined by four central frame segments and only four nodes, each node connecting adjacently extending central frame segments, and wherein said central frame segments each include arcuate portions extending along the length of each central frame segment such that a collective length of the arcuate portions extends along a majority of the length of each central frame segment, and each cell of said multi-cellular structure is defined by said central frame segments such that each cell includes a common central frame segment of an adjacent cell.

15. The medical device as recited in claim 14, wherein said at least one anchor comprises a first proximal anchor and a second proximal anchor each including a plurality of anchor frame segments, wherein at least two of the anchor frame segments extend substantially parallel to each other along at least a portion of their respective lengths for each of the first proximal anchor and the second proximal anchor.

16. The medical device as recited in claim 14, wherein said at least one anchor comprises engaging members configured to engage tissue.

17. The medical device as recited in claim 14, further comprising a tissue growth member configured to be associated with said framework and configured to induce tissue growth.

18. The medical device as recited in claim 17, wherein the tissue growth member comprises an elongated configuration positioned along the central portion of the framework and configured to be positioned in the hole and oriented transverse to the axis of the hole.

19. The medical device as recited in claim 17, wherein the tissue growth member comprises a polymeric material.