Devices for reducing the size of an internal tissue opening

• US 8,529,597 B2
• Filed: 05/19/2010
• Issued: 09/10/2013
• 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): McDermott, Corrine M
• Assistant Examiner(s): MASHACK, MARK F
• Application Number:
  US12/783,498
• Publication Number:
  US 20100324595A1
• Time in Patent Office: 1,210 Days
• Field of Search: 606/139, 606/200, 606/213, 606/151, 606/153, 623/1.1, 623/1.11, 623/1.23, 623/23.72, 623/1.15, 623/1.3
• 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 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, non-slip on handles A61B2017/00429
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014

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 tissue structure and adjacent a atrium of a heart, the expandable medical device comprising:

a multi-cellular central frame portion configured to self expand from a first, non-tubular orientation to a second, non-tubular orientation, the first orientation being configured to fit within a catheter, the second orientation being configured to be deployed and operable within the tissue structure and adjacent the left atrium, said central frame portion comprising a plurality of interconnecting central frame support segments defining four cells, at least one of said central frame support segments having a length and a width, the width varying along at least a portion of the length; and

at least one anchor linked to said multi-cellular central frame portion;

wherein said plurality of interconnecting central frame support segments each include an arcuate portion extending along the length thereof, and each cell of said multi-cellular central frame portion is defined beat least four of said plurality of interconnecting central frame support segments such that each cell includes a common central frame support segment of an adjacent cell; and

wherein said multi-cellular central frame portion, including said plurality of interconnecting central frame support segments and said at least one anchor, is a seamless, monolithic structure; and

wherein said seamless, monolithic structure is substantially planar in the second non-tubular orientation.

2. A medical device as recited in claim 1, 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.

3. A medical device as recited in claim 1, wherein said central frame support segments defining said multi-cellular central frame portion including at least two central frame support segments extending alongside each other.

4. A medical device as recited in claim 1. wherein said at least one anchor comprises engaging members having a wave-crest configuration.

5. A medical device as recited in claim 1, wherein said at least one anchor comprises engaging members having a blunt peak portion and an edge configured to aggressively engage tissue, said edge defined lower than said peak portion.

6. A medical device as recited in claim 1, further comprising a tissue growth member configured to be attached to said central frame portion and configured to induce tissue growth.

7. A medical device as recited in claim 6, wherein the tissue growth member comprises an elongated member positioned along at least one of the central frame support segments of the central frame portion and configured to be positioned within the tissue structure.

8. A medical device as recited in claim 6, wherein the tissue growth member extends along opposing sides of at least one of the central frame support segments of the central frame portion and is configured to be positioned within the tissue structure.

9. A medical device as recited in claim 6, wherein the tissue growth member comprises a polymeric material.

10. A medical device as recited in claim 6, wherein at least one of the central frame portion and the at least one anchor comprise one or more clips, the one or more clips being configured to attach the tissue growth member to at least one of the central frame portion and the at least one anchor.

11. 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 frame adapted to move between a first orientation and a second orientation, 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 each include an arcuate portion extending along a length thereof, and each cell of said multi-cellular structure is defined by at least four of said plurality of frame segments such that each cell includes a common frame segment of an adjacent cell; and

wherein said frame, including said central portion, said plurality of frame segments, said at least one proximal anchor, and said at least one distal anchor, is a seamless, monolithic structure.

12. A medical device as recited in claim 11, 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.

13. A medical device as recited in claim 11, wherein said at least one proximal anchor comprises engaging members having a wave-crest configuration.

14. A medical device as recited in claim 11, wherein said at least one proximal anchor comprises engaging members extending from a segment of the at least one proximal anchor to a blunt peak portion and having an edge configured to aggressively engage tissue, said edge being positioned between the segment of the at least one proximal anchor and said peak portion.

15. A medical device as recited in claim 11, further comprising a tissue growth member configured to be attached to said frame and configured to induce tissue growth.

16. A medical device as recited in claim 15, wherein the tissue growth member comprises an elongated member 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.

17. A medical device as recited in claim 15, 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.

18. A medical device as recited in claim 15, wherein the tissue growth member comprises a polymeric material.

19. 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 each include an arcuate portion extending along the length thereof, and said central frame segments define a multi-cellular structure such that each cell is defined by at least four of said central frame segments and such that each cell includes a common central frame segment of an adjacent cell; and

wherein said framework, including said central portion, said central frame segments, and said at least one anchor, is a seamless, monolithic structure.

20. A medical device as recited in claim 19, 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.

21. A medical device as recited in claim 19, wherein said at least one anchor comprises engaging members having a wave-crest configuration.

22. A medical device as recited in claim 19, wherein said at least one anchor comprises engaging members extending from a segment of the at least one anchor to a blunt peak portion and having an edge configured to aggressively engage tissue, said edge being positioned between the segment of the at least one anchor and said peak portion.

23. A medical device as recited in claim 19, further comprising a tissue growth member configured to be attached to said framework and configured to induce tissue growth.

24. A medical device as recited in claim 23, wherein the tissue growth member comprises an elongated member 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.

25. A medical device as recited in claim 23, wherein the tissue growth member comprises:

a first elongate tissue growth portion 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; 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.

26. A medical device as recited in claim 23, wherein the tissue growth member comprises a polymeric material.

27. 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 each include an arcuate portion extending along the length thereof, and each cell of said multi-cellular structure is defined by at least four of said central frame segments such that each cell includes a common central frame segment of an adjacent cell; and

wherein said framework, including said central portion, said central frame segments, and said at least one anchor, is a seamless, monolithic structure.

28. A medical device as recited in claim 27, 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.

29. A medical device as recited in claim 27, wherein said at least one anchor comprises engaging members having a wave-crest configuration.

30. A medical device as recited in claim 27, wherein said at least one anchor comprises engaging members extending from a segment of the at least one anchor to a blunt peak portion and having an edge configured to aggressively engage tissue, said edge being positioned between the segment of the at least one anchor and said peak portion.

31. A medical device as recited in claim 27, further comprising a tissue growth member configured to be attached to said framework and configured to induce tissue growth.

32. A medical device as recited in claim 31, wherein the tissue growth member comprises an elongated member 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.

33. A medical device as recited in claim 31, wherein the tissue growth member comprises:

a first elongate tissue growth portion 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; 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.

34. A medical device as recited in claim 31, wherein the tissue growth member comprises a polymeric material.

35. 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 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 including central frame segments defining a multi-cellular structure, a first proximal anchor, a second proximal anchor and at least one distal anchor extending from said central portion, wherein said first and second proximal anchors are configured to extend in the first atrium and said at least one distal anchor configured to extend in the second atrium;

wherein said first proximal anchor and said second proximal anchor each include a plurality of anchor frame segments, wherein at least two of the plurality of 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;

wherein said central frame segments each include an arcuate portion extending along a length thereof, and each cell of said multi-cellular structure is defined by at least four of said central frame segments such that each cell includes a common central frame segment of an adjacent cell; and

wherein said framework, including said central portion, said central frame segments, said first proximal anchor, said second proximal anchor, said at least one distal anchor, and said plurality of anchor frame segments, is a seamless, monolithic structure.

36. A medical device as recited in claim 35, wherein said at least one proximal anchor and said at least one distal anchor are each configured to extend substantially coplanar with said central portion.

37. A medical device as recited in claim 35, wherein said central frame segments having the 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.

38. A medical device as recited in claim 35, wherein 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 frame.

39. A medical device as recited in claim 35, wherein said first proximal anchor and said second proximal anchor comprise engaging members, at least one of the engaging members having a wave-crest configuration.

40. A medical device as recited in claim 35, wherein said first proximal anchor and said second proximal anchor comprise engaging members, at least one of said engaging members extending from a segment of its respective anchor to a blunt peak portion and having an edge configured to aggressively engage tissue, said edge being positioned between the segment of the respective anchor and said peak portion.

41. A medical device as recited in claim 35, wherein at least two of said central frame segments extend alongside each other.

42. A medical device as recited in claim 35, further comprising a tissue growth member attached to said framework.

43. A medical device as recited in claim 42, wherein the tissue growth member comprises an elongated member 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.

44. A medical device as recited in claim 42, wherein the tissue growth member comprises:

a first elongate tissue growth portion 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; 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.

45. A medical device as recited in claim 42, wherein the tissue growth member comprises a polyurethane foam.

46. A medical device as recited in claim 42, wherein the tissue growth member comprises a porous member configured to induce tissue in-growth.

47. A medical device as recited in claim 42, wherein the tissue growth member comprises a polymeric material.

48. A medical device as recited in claim 42, wherein the tissue growth member is configured to extend away from a plane defined by the substantially flat configuration of the framework.

49. A medical device as recited in claim 42, wherein the tissue growth member comprises a longitudinal length, a width and a depth, the depth configured to extend away from a plane defined by the substantially flat configuration of the framework, the depth being a greater dimension than the width.

50. A medical device as recited in claim 42, wherein the framework comprises a frame depth thickness defining a thickness of the substantially flat configuration, the depth of the tissue growth member having a dimension that is about three to about twenty-five times greater than the frame depth thickness.

51. A medical device as recited in claim 42, wherein the framework comprises a frame depth thickness defining a thickness of the substantially flat configuration, the depth of the tissue growth member having a dimension that is about eight to about seventeen times greater than the frame depth thickness.

52. A medical device as recited in claim 42, wherein the framework comprises one or more clips, the one or more clips being configured to attach the tissue growth member to the framework.

53. 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 medical device comprising:

a frame 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 frame comprising a central portion having central frame segments defining a multi-cellular structure, and at least one proximal anchor and at least one distal anchor extending from said central portion, and 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; and

a tissue growth member attached to the frame, the, tissue growth member comprising;

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 he oriented transverse to the axis of the hole;

wherein said central frame segments each include an arcuate portion extending along a length thereof, and each cell of said multi-cellular structure is defined by at least four of said central frame segments such that each cell includes a common central frame segment of an adjacent cell; and

wherein said frame, including said central portion, said central frame segments, said at least one proximal anchor, and said at least one distal anchor, is a seamless, monolithic structure.

54. The medical device of claim 53, wherein the first elongate tissue growth portion and the second elongate tissue growth portion are configured to provide multiple layers of tissue growth to occlude the hole in the tissue structure.

55. The medical device of claim 53 wherein the tissue growth member comprises a third elongate tissue growth portion positioned proximal to the first elongate tissue growth portion, the third elongate tissue growth portion configured to be oriented transverse to the axis of the hole.

56. The medical device of claim 55, wherein the third elongate tissue growth portion is positioned along the at least one proximal anchor and along the central portion of the frame.

57. The medical device of claim 53, wherein the second elongate tissue growth portion is oriented on the central portion of the frame to substantially mirror an orientation of the first elongate tissue growth portion.

58. The medical device of claim 53, wherein the tissue growth member is configured to extend away from a plane defined by the substantially fiat configuration of the frame.

59. The medical device of claim 58, wherein the first elongate tissue growth portion comprises a longitudinal length, a width and a depth, the depth configured to extend away from a plane defined by the substantially flat configuration of the frame, the depth being a greater dimension than the width.

60. The medical device of claim 58, wherein the frame comprises a frame depth thickness defining a thickness of the substantially flat configuration, the depth of the first elongate tissue growth portion having a dimension that is about three to about twenty-five times greater than the frame depth thickness.

61. The medical device of claim 58, wherein the frame comprises a frame depth thickness defining a thickness of the substantially flat configuration, the depth of the first elongate tissue growth portion having a dimension that is about eight to about seventeen times greater than the frame depth thickness.

62. The medical device of claim 53, wherein the tissue growth member comprises a foam material.

63. The medical device of claim 53, wherein the tissue growth member comprises a polyurethane foam material.

64. The medical device of claim 53, wherein the tissue growth member comprises a polymeric material.

65. The medical device of claim 53, wherein the tissue growth member comprises a biocompatible material configured to induce tissue growth.

66. The medical device of claim 53 wherein the frame comprises one or more clips, the one or more clips being configured to attach the tissue growth member to the frame.