Devices for reducing the size of an internal tissue opening

• US 8,979,941 B2
• Filed: 08/08/2007
• Issued: 03/17/2015
• Est. Priority Date: 08/09/2006
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Davis, Clark C., Miles, Scott D., Fox, DeWayne C., Edmiston, Daryl R., Linder, Richard J.
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): PAEZ, LUCAS M
• Application Number:
  US11/836,037
• Publication Number:
  US 20080039929A1
• Time in Patent Office: 2,778 Days
• Field of Search: 606/151, 606/153, 606/213, 623/1.15, 623/1.3
• US Class Current: 623/23.72
• 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• 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 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• 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 2017/00654 entirely comprised between the two sides of the opening
• 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
• CPC Class Codes: A61B 2017/00884 : enhancing wound closure
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/12054 : Details concerning the detachment of the occluding device from the introduction device

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 can include a member adapted to induce tissue growth. The anchors can extend from the body portion and return back to the body portion to define a closed periphery. The anchors can include undulations and can include multiple segments. A method of forming a closure device can include positioning a material on a working surface and cutting a closure device from the material.

Claims

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

a catheter configured to be positioned adjacent the hole defined in the tissue structure; and

a frame configured to maintain a substantially flat configuration as said frame transitions and self-expands from a non-deployed state within the catheter to an intended, as-deployed state from the catheter and within the tissue structure, said frame oriented substantially parallel to, or extending substantially along, the axis of the hole while in said intended, as-deployed state within the tissue structure, said frame comprising a central portion with at least one distal anchor and at least one proximal anchor, said at least one distal anchor and said at least one proximal anchor configured to extend substantially coplanar with said central portion, said at least one distal anchor configured to extend in the left atrium and said at least one proximal anchor configured to extend in the right atrium, said at least one distal anchor including a first distal anchor and a second distal anchor each directly extending from said central portion at distinct first locations and connecting back directly to said central portion at distinct second locations to define a portion of a first closed periphery of said first distal anchor and a portion of a second closed periphery of said second distal anchor, said first closed periphery being separate and distinct from said second closed periphery, wherein said first closed periphery and said second closed periphery respectively exhibit a first undulation and a second undulation each configured to facilitate movement of said frame between said non-deployed state and said intended, as-deployed state of said frame.

2. A medical device as recited in claim 1, wherein said frame comprises a superelastic material.

3. A medical device as recited in claim 1, wherein said central portion comprises a multi-cellular structure.

4. A medical device as recited in claim 1, wherein at least a portion of said central portion defines at least a portion of said closed periphery of at least one of said first distal anchor and said second distal anchor.

5. A medical device as recited in claim 1, wherein said at least one distal anchor comprises a plurality of anchor frame segments extending from said central portion, wherein at least two of the anchor frame segments are extendable at least partially substantially parallel to each other.

6. A medical device as recited in claim 1, wherein at least one of said at least one distal anchor and said at least one proximal anchor is moveable between a collapsed orientation and an expanded orientation.

7. A medical device as recited in claim 1, wherein said at least one distal anchor comprises a plurality of anchor frame segments extending from said central portion to define a multi-cellular structure.

27. The medical device of claim 1, further comprising a tissue growth promoting member associated with said frame.

28. The medical device of claim 27, wherein said tissue growth promoting member is attached to said frame such that said tissue growth promoting member extends substantially out of plane from said substantially flat configuration.

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

a catheter configured to be positioned adjacent the hole defined in the tissue structure; and

a frame, formed of a super-elastic material, including a central portion, at least one distal anchor and at least one proximal anchor, the frame being configured to maintain a substantially flat configuration as said frame transitions and self-expands from a non-deployed state within the catheter to an intended, as deployed state from the catheter and within the tissue structure, said frame oriented substantially parallel to, or extending substantially along, the axis of the hole while in said intended, as-deployed state within the tissue structure, at least one of the at least one distal anchor and the at least one proximal anchor being configured to adapt to different sizes of tissue structures, said at least one distal anchor and said at least one proximal anchor configured to extend substantially coplanar with said central portion, said at least one distal anchor configured to extend in the left atrium and said at least one proximal anchor configured to extend in the right atrium, each of said at least one distal anchor and said at least one proximal anchor exhibiting an undulation formed of the super-elastic material, said undulation biased toward moving said frame to said intended, as-deployed state and said undulation configured to facilitate movement of said frame between said non-deployed state and said intended, as-deployed state, wherein the undulation of each of said at least one distal anchor and said at least one proximal anchor are configured to generally face each other in the intended, as-deployed state.

9. A medical device as recited in claim 8, wherein said central portion comprises a multi-cellular body portion.

10. A medical device as recited in claim 9, wherein at least one of said at least one distal anchor and said at least one proximal anchor is operatively associated with said multi-cellular body portion.

11. A medical device as recited in claim 8, wherein said at least one distal anchor comprises a plurality of anchor frame segments extending from said central portion, wherein at least two of the anchor frame segments are extendable at least partially substantially parallel to each other.

12. A medical device as recited in claim 8, wherein said at least one distal anchor comprises a plurality of anchor frame segments extending from said central portion to define a multi-cellular structure.

13. A medical device as recited in claim 8, further comprising a tissue growth inducing member associated with said frame.

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

a catheter configured to be positioned adjacent the hole defined in the tissue structure;

a frame configured to maintain a substantially flat configuration as said frame transitions and self-expands from a non-deployed state within the catheter to an intended, as-deployed state from the catheter and within the tissue structure, said frame oriented substantially parallel to, or extending substantially along, the axis of the hole while in said intended, as-deployed state within the tissue structure, said frame comprising a central portion and at least one distal anchor and at least one proximal anchor, said at least one distal anchor and said at least one proximal anchor configured to extend substantially coplanar with said central portion, said at least one distal anchor configured to extend in the left atrium and said at least one proximal anchor configured to extend in the right atrium, said at least one distal anchor including a first distal anchor and a second distal anchor, said first distal anchor including multiple anchor portions configured to extend in the left atrium, said second distal anchor including multiple anchor portions configured to extend in the left atrium, said multiple anchor portions of said first distal anchor and said second distal anchor directly coupled to and extending from distinct locations of said central portion, said multiple anchor portions being configured to position and stabilize said frame; and

a tissue growth member attached to said frame and configured to be positioned inside the hole defined in the tissue structure, said tissue growth member extending out-of-plane from said substantially flat configuration of said frame in said intended, as-deployed state such that said tissue growth member is independently bendable relative to said frame upon contacting tissue in the hole of the tissue structure.

15. A medical device as recited in claim 14, wherein said frame comprises a flat stent.

16. A medical device as recited in claim 14, wherein said central portion comprises a plurality of segments defining one or more cells.

17. A medical device as recited in claim 14, wherein said multiple anchor portions comprise reinforced segments.

18. A medical device as recited in claim 17, wherein said reinforced segments extend from a joining portion of said central portion.

19. A medical device as recited in claim 14, wherein at least one of said at least one distal anchor and said at least one proximal anchor is at least partially defined by at least a portion of said central portion.

20. A medical device deployable at least partially within a hole defined in a tissue structure between a left atrium and a right atrium of a heart, the hole defining an axis oriented axially through the hole, the medical device comprising:

a catheter configured to be positioned adjacent the hole defined in the tissue structure; and

a unitary seamless frame configured to maintain a substantially flat configuration as said frame transitions and self-expands from a non-deployed state within the catheter to an intended, as-deployed state from the catheter and within the tissue structure, said frame oriented substantially parallel to, or extending substantially along, the axis of the hole while in said intended, as-deployed state within the tissue structure, said unitary seamless frame including a central portion and at least one distal anchor and at least one proximal anchor each extending from said central portion, the central portion extending substantially coplanar with both the at least one distal anchor and the at least one proximal anchor, said at least one distal anchor configured to extend in the left atrium and said at least one proximal anchor configured to extend in the right atrium, the at least one distal anchor including a first distal anchor and a second distal anchor, each of the first distal anchor and the second distal anchor including a distinct anchor frame segment, the anchor frame segment including a tapered portion, wherein an end of the tapered portion directly interconnects to another portion of its respective distal anchor that extends to and interconnects with the central portion of the frame.

21. A medical device as recited in claim 20, wherein the first distal anchor and the second distal anchor comprises a plurality of anchor frame segments extending from said central portion, wherein at least two of the anchor frame segments are extendable substantially parallel to each other along at least a portion of their respective lengths.

22. A medical device as recited in claim 20, wherein said frame comprises a multi-cellular structure.

23. A medical device as recited in claim 20, wherein at least one of said at least one distal anchor and said at least one proximal anchor is operatively associated with said central portion.

24. A medical device as recited in claim 20, wherein said frame is configured to preferentially expand from a constricted configuration to a less constricted configuration.

25. A medical device as recited in claim 20, wherein the first distal anchor and the second distal anchor comprises a plurality of anchor frame segments extending from said central portion to define a multi-cellular structure.

26. A medical device as recited in claim 20, wherein said central portion comprises a plurality of central frame struts to define a multi-cellular structure.

29. The medical device of claim 20, further comprising a tissue growth promoting member associated with said frame.

30. The medical device of claim 29, wherein said tissue growth promoting member is attached to said frame such that said tissue growth promoting member extends substantially out of plane from said substantially flat configuration.