Sealing device and delivery system

• US 10,828,019 B2
• Filed: 03/15/2013
• Issued: 11/10/2020
• Est. Priority Date: 01/18/2013
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Goble, Jacob A., Lurie, Brandon A., Masters, Steven J., Mathena, Scot K., McClure, Richard L.
• Primary Examiner(s): Weisberg, Amy R
• Application Number:
  US13/838,166
• Publication Number:
  US 20140207185A1
• Time in Patent Office: 2,797 Days
• 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 2017/00575 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 2017/00597 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

Abstract

A medical device for sealing a defect in a body includes a wire frame that includes a plurality of wires that form a first occluding member and a second occluding member, the wire frame including a defect-occupying portion disposed between the first occluding member and the second occluding member. The defect-occupying portion is adapted to fill a wide range of potential defect sizes, such that no more than five devices of a range of sizes are required to effectively seal a range of nominal defect sizes of approximately 8 to 35 mm.

Claims

1. A medical device for sealing a defect or structure in tissue, the medical device comprising:

a wire frame that includes a plurality of wound wires that each extend from a proximal end of the wire frame to a distal end of the wire frame, the plurality of wound wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming;

a first eyelet arranged near the proximal end of the wire frame;

a second eyelet arranged near the distal end of the wire frame;

a first occluding member having a nominal diameter from 27 mm to 48 mm;

a second occluding member having a nominal diameter from 27 mm to 48 mm;

a defect-occupying portion disposed between the first occluding member and the second occluding member, wherein the defect-occupying portion comprises a nominal diameter from 17 mm to 36 mm, and

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion;

a sealing member in contact with the frame;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

2. The device of claim 1, wherein third generally curved segment comprises a radius of curvature from approximately 0.094 inches to approximately 0.305 inches.

3. The device of claim 1, wherein the plurality of wound wires comprises eight wound wires.

4. The device of claim 2, wherein the first eyelet is formed from first end portions of each wire of the six wound wires, and the second eyelet is formed from second end portions of each wire of the six wound wires, and the plurality of wound wires extend from the first eyelet at an angle from 150 to 152 degrees and the plurality of wound wires extend from the second eyelet at an angle of from 150 degrees to 152 degrees, and wherein movement of one wire of the plurality of wound wires is substantially independently to a movement of one or more other wires of the plurality of wound wires.

5. The device of claim 1, wherein the first occluding member is adapted to conform to a geometry of a first tissue surface and the second occluding member is adapted to conform to a geometry of a second tissue surface.

6. The device of claim 5, wherein the first occluding member and the second occluding member maintain a generally flat profile when the defect-occupying portion deflects to an outer diameter that is less than about 60% of the nominal outer diameter of the defect-occupying portion.

7. A medical device for sealing a defect or structure in a heart, the medical device comprising:

a wire frame that includes a plurality of wound wires that each extend from a proximal end of the wire frame to a distal end of the wire frame, the plurality of wound wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming;

a first eyelet arranged near the proximal end of the wire frame;

a second eyelet arranged near the distal end of the wire frame;

a first occluding member having a nominal diameter from 27 mm to 48 mm;

a second occluding member having a nominal diameter from 27 mm to 48 mm;

a defect-occupying portion disposed between the first occluding member and the second occluding member, wherein the defect-occupying portion comprises a nominal diameter from 17 mm to 36 mm, and

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion, and a first outer peripheral edge section extending between the first generally curved segment and the third generally linear segment and a second outer peripheral edge section extending between the second generally curved segment and the fourth generally linear segment;

a sealing member in contact with the frame;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

8. The device of claim 7, wherein the third generally curved segment comprises a radius of curvature from approximately 0.094 inches to approximately 0.305 inches.

9. The device of claim 8, wherein the first eyelet is formed from first end portions of each wire of the six wound wires, and the second eyelet is formed from second end portions of each wire of the six wound wires, and the plurality of wound wires extend from the first eyelet at an angle from 150 to 152 degrees and the plurality of wound wires extend from the second eyelet at an angle of from 150 degrees to 152 degrees, and wherein movement of one wire of the plurality of wound wires is substantially independently to a movement of one or more other wires of the plurality of wound wires.

10. The device of claim 7, wherein the plurality of wound wires comprises eight wound wires.

11. The device of claim 7, wherein the first occluding member is adapted to conform to a geometry of a first tissue surface and the second occluding member is adapted to conform to a geometry of a second tissue surface.

12. The device of claim 11, wherein the first occluding member and the second occluding member maintain a generally flat profile when the defect-occupying portion deflects to an outer diameter that is less than about 60% of the nominal outer diameter of the defect occupying portion.

13. A medical device for sealing a defect or structure in tissue, comprising:

a frame that includes a plurality of wound wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming;

a first eyelet arranged near the proximal end of the frame;

a second eyelet arranged near the distal end of the frame;

a first occluding member that is adapted to conform to a geometry of a first tissue surface and to provide an apposition force against the first tissue surface and having a nominal diameter from 27 mm to 48 mm,

a second occluding member that is adapted to conform to a geometry of a second tissue surface and to provide an apposition force against the second tissue surface and having a nominal diameter from 27 mm to 48 mm,

a defect-occupying member disposed between the first occluding member and the second occluding member, the defect-occupying member comprising a nominal diameter from 17 mm to 36 mm, and

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion, and

a sealing member in contact with the frame, wherein the plurality of wound wires include;

a first portion that defines a petal of the first occluding member;

a second portion that defines a petal of the second occluding member; and

a third portion, disposed between the first portion and the second portion, defining an inflection region of the defect occupying member;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

14. The device of claim 13, wherein the third generally curved segment comprises a radius from approximately 0.094 inches to approximately 0.305 inches.

15. The device of claim 13, wherein the plurality of wound elongate members comprise eight elongate members.

16. The device of claim 13, wherein the first occluding member and the second occluding member maintain a generally flat profile when the defect-occupying portion deflects to an outer diameter that is less than about 60% of the nominal outer diameter of the defect-occupying portion.

17. The device of claim 16, wherein the petal of the first occluding member is adapted to bear a load associated with the first tissue surface without imparting a substantial force to the other elongate members of the plurality of elongate members, and wherein the petal of the second occluding member is adapted to bear a load associated with the second tissue surface without imparting a substantial force to the other elongate members of the plurality of elongate members.

18. The device of claim 17, wherein the plurality of elongate members are lasercut from a Nitinol tube.

19. The device of claim 18, wherein the elongate members are wires.

20. The device of claim 19, wherein the third generally curved segment comprises a radius from approximately 0.094 inches to approximately 0.305 inches.

21. The device of claim 20, wherein the defect-occupying portion is adapted to substantially fill a range of defect sizes from a largest defect size to a smallest defect size that is approximately 60% of the largest defect size.

22. The device of claim 20, wherein the defect-occupying portion deflects to an outer diameter that is less than about 60% of its nominal outer diameter when a radial pressure of about 0.04 N/mm2 is applied to the defect-occupying portion.

23. A medical device for sealing defects or structures in a heart, the medical device comprising:

a wire frame that includes a plurality of wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming a first occluding member and a second occluding member, the wire frame including a defect occupying portion disposed between the first occluding member and the second occluding member, the defect occupying portion comprises a nominal diameter from 17 mm to 36 mm;

a first eyelet arranged near the proximal end of the wire frame;

a second eyelet arranged near the distal end of the wire frame;

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion, and wherein the medical device can be manufactured in a plurality of distinct sizes, and wherein a range of defect sizes from about 8 mm to about 35 mm can all be sealed using five or fewer distinct sizes of the medical device;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

24. A medical device for sealing a defect or structure in a heart, the medical device comprising:

a wire frame that includes a plurality of wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming a first occluding member and a second occluding member, the wire frame including a defect occupying portion disposed between the first occluding member and the second occluding member;

wherein the defect occupying portion comprises a nominal diameter of 17 mm and is adapted to not significantly deform the defect, and wherein the defect occupying portion is adapted to fill a range of defect sizes from 8 to 15 mm;

a first eyelet arranged near the proximal end of the wire frame;

a second eyelet arranged near the distal end of the wire frame;

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

25. The device of claim 24, wherein the first occluding member and the second occluding member maintain a generally flat profile when the defect-occupying portion deflects to an outer diameter that is less than about 60% of the nominal outer diameter of the defect-occupying portion.

26. The device of claim 24, wherein the first occluding member is adapted to conform to a geometry of a first tissue surface and provide an apposition force against the first tissue surface, and wherein the second occluding member is adapted to conform to a geometry of a second tissue surface and to provide an apposition force against the second tissue surface.

27. A medical device for sealing a defect or structure in a heart, the medical device comprising:

a wire frame that includes a plurality of wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming a first occluding member and a second occluding member, the wire frame including a defect-occupying portion disposed between the first occluding member and the second occluding member;

wherein the defect occupying portion comprises a nominal diameter of 22 mm and is adapted to not significantly deform the defect, and wherein the defect occupying portion is adapted to fill a range of defect sizes from 13 mm to 20 mm;

a first eyelet arranged near the proximal end of the wire frame;

a second eyelet arranged near the distal end of the wire frame;

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

28. The device of claim 27, wherein the first occluding member and the second occluding member maintain a generally flat profile when the defect-occupying portion deflects to an outer diameter that is less than about 60% of the nominal outer diameter of the defect-occupying portion.

29. The device of claim 27, wherein the first occluding member is adapted to conform to a geometry of a first tissue surface and provide an apposition force against the first tissue surface, and wherein the second occluding member is adapted to conform to a geometry of a second tissue surface and to provide an apposition force against the second tissue surface.

30. A medical device for sealing a defect or structure in a heart, the medical device comprising:

a wire frame that includes a plurality of wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming a first occluding member and a second occluding member, the wire frame including a defect-occupying portion disposed between the first occluding member and the second occluding member;

wherein the defect-occupying portion comprises a nominal diameter of 27 mm and is adapted to not significantly deform the defect, and wherein the defect-occupying portion is adapted to fill a range of defect sizes from 18 mm to 25 mm;

a first eyelet arranged near the proximal end of the wire frame;

a second eyelet arranged near the distal end of the wire frame;

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

31. The device of claim 30, wherein the first occluding member and the second occluding member maintain a generally flat profile when the defect-occupying portion deflects to an outer diameter that is less than about 60% of the nominal outer diameter of the defect-occupying portion.

32. The device of claim 30, wherein the first occluding member is adapted to conform to a geometry of a first tissue surface and provide an apposition force against the first tissue surface, and wherein the second occluding member is adapted to conform to a geometry of a second tissue surface and to provide an apposition force against the second tissue surface.

33. A medical device for sealing a defect or structure in a heart, the medical device comprising:

a wire frame that includes a plurality of wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming a first occluding member and a second occluding member, the wire frame including a defect-occupying portion disposed between the first occluding member and the second occluding member;

wherein the defect-occupying portion comprises a nominal diameter of 32 mm and is adapted to not significantly deform the defect, and wherein the defect-occupying portion is adapted to fill a range of defect sizes from 23 mm to 30 mm;

a first eyelet arranged near the proximal end of the wire frame;

a second eyelet arranged near the distal end of the wire frame;

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

34. The device of claim 33, wherein the first and second occluding members maintain a generally flat profile when the defect-occupying portion deflects to an outer diameter that is less than about 60% of the nominal outer diameter of the defect-occupying portion.

35. The device of claim 33, wherein the first occluding member is adapted to conform to a geometry of a first tissue surface and provide an apposition force against the first tissue surface, and wherein the second occluding member is adapted to conform to a geometry of a second tissue surface and to provide an apposition force against the second tissue surface.

36. A medical device for sealing a defect or structure in a heart, the medical device comprising:

a wire frame that includes a plurality of wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming a first occluding member and a second occluding member, the wire frame including a defect-occupying portion disposed between the first occluding member and the second occluding member;

wherein the defect occupying portion comprises a nominal diameter of 36 mm and is adapted to not significantly deform the defect, and wherein the defect occupying portion is adapted to fill a range of defect sizes from 28 mm to 35 mm;

a first eyelet arranged near the proximal end of the wire frame;

a second eyelet arranged near the distal end of the wire frame;

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

37. The device of claim 36, wherein the first occluding member and the second occluding member maintain a generally flat profile when the defect-occupying portion deflects to an outer diameter that is less than about 60% of the nominal outer diameter of the defect-occupying portion.

38. The device of claim 36, wherein the first occluding member is adapted to conform to a geometry of a first tissue surface and provide an apposition force against the first tissue surface, and wherein the second occluding member is adapted to conform to a geometry of a second tissue surface and to provide an apposition force against the second tissue surface.

39. A medical device for sealing a defect or structure in a heart, the medical device comprising:

a wire frame that includes a plurality of wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming a first occluding member and a second occluding member, the wire frame including a defect-occupying portion disposed between the first occluding member and the second occluding member;

wherein the defect-occupying portion is adapted to not significantly deform the defect, and wherein the defect occupying portion comprises a nominal diameter from 17 mm to 36 mm and is adapted to fill a 8 mm range of defect sizes up to about 35 mm;

a first eyelet arranged near the proximal end of the wire frame;

a second eyelet arranged near the distal end of the wire frame;

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

40. The device of claim 39, wherein the first occluding member and the second occluding member maintain a generally flat profile when the defect-occupying portion deflects to an outer diameter that is less than about 60% of the nominal outer diameter of the defect-occupying portion.

41. The device of claim 39, wherein the first occluding member is adapted to conform to a geometry of a first tissue surface and provide an apposition force against the first tissue surface, and wherein the second occluding member is adapted to conform to a geometry of a second tissue surface and to provide an apposition force against the second tissue surface.

42. A medical device for sealing a defect or structure in a heart, the medical device comprising:

a wire frame that includes a plurality of wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming a first occluding member and a second occluding member, the wire frame including a defect-occupying portion disposed between the first occluding member and the second occluding member;

wherein the defect occupying portion is adapted to not significantly deform the defect, and wherein the defect occupying portion comprises a nominal diameter from 17 mm to 32 mm and is adapted to fill a 8 mm range of defect sizes up to about 30 mm;

a first eyelet arranged near the proximal end of the wire frame;

a second eyelet arranged near the distal end of the wire frame;

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

43. The device of claim 42, wherein the first occluding member and the second occluding member maintain a generally flat profile when the defect-occupying portion deflects to an outer diameter that is less than about 60% of the nominal outer diameter of the defect-occupying portion.

44. The device of claim 42, wherein the first occluding member is adapted to conform to a geometry of a first tissue surface and provide an apposition force against the first tissue surface, and wherein the second occluding member is adapted to conform to a geometry of a second tissue surface and to provide an apposition force against the second tissue surface.

45. A medical device for sealing a defect or structure in a heart, the medical device comprising:

a wire frame that includes a plurality of wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming a first occluding member and a second occluding member, the wire frame including a defect-occupying portion disposed between the first occluding member and the second occluding member;

wherein the defect occupying portion is adapted to not significantly deform the defect, and wherein the defect occupying portion comprises a nominal diameter from 17 mm to 27 mm and is adapted to fill a 8 mm range of defect sizes up to about 25 mm;

a first eyelet arranged near the proximal end of the wire frame;

a second eyelet arranged near the distal end of the wire frame;

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion, and a first outer peripheral edge section extending between the first generally curved segment and the third generally linear segment and a second outer peripheral edge section extending between the second generally curved segment and the fourth generally linear segment;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

46. The device of claim 45, wherein the first occluding member and the second occluding member maintain a generally flat profile when the defect-occupying portion deflects to an outer diameter that is less than about 60% of the nominal outer diameter of the defect-occupying portion.

47. The device of claim 45, wherein the first occluding member is adapted to conform to a geometry of a first tissue surface and provide an apposition force against the first tissue surface, and wherein the second occluding member is adapted to conform to a geometry of a second tissue surface and to provide an apposition force against the second tissue surface.

48. A medical device for sealing a defect or structure in a heart, the medical device comprising:

a wire frame that includes a plurality of wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming a first occluding member and a second occluding member, the wire frame including a defect-occupying portion disposed between the first occluding member and the second occluding member;

wherein the defect occupying portion is adapted to not significantly deform the defect, and wherein the defect occupying portion comprises a nominal diameter from 17 mm to 22 mm and is adapted to fill a 8 mm range of defect sizes up to about 20 mm;

a first eyelet arranged near the proximal end of the wire frame;

a second eyelet arranged near the distal end of the wire frame;

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion, and a first outer peripheral edge section extending between the first generally curved segment and the third generally linear segment and a second outer peripheral edge section extending between the second generally curved segment and the fourth generally linear segment;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

49. The device of claim 48, wherein the first occluding member and the second occluding member maintain a generally flat profile when the defect-occupying portion deflects to an outer diameter that is less than about 60% of the nominal outer diameter of the defect-occupying portion.

50. The device of claim 48, wherein the first occluding member is adapted to conform to a geometry of a first tissue surface and provide an apposition force against the first tissue surface, and wherein the second occluding member is adapted to conform to a geometry of a second tissue surface and to provide an apposition force against the second tissue surface.

51. A medical device for sealing a defect or structure in a heart, the medical device comprising:

a wire frame that includes a plurality of wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming a first occluding member and a second occluding member, the wire frame including a defect-occupying portion disposed between the first occluding member and the second occluding member;

wherein the defect occupying portion is adapted to not significantly deform the defect, and wherein the defect occupying portion comprises a nominal diameter of 17 mm and is adapted to fill a 8 mm range of defect sizes up to about 15 mm;

a first eyelet arranged near the proximal end of the wire frame;

a second eyelet arranged near the distal end of the wire frame;

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion, and a first outer peripheral edge section extending between the first generally curved segment and the third generally linear segment and a second outer peripheral edge section extending between the second generally curved segment and the fourth generally linear segment;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

52. The device of claim 51, wherein the first occluding member and the second occluding member maintain a generally flat profile when the defect-occupying portion deflects to an outer diameter that is less than about 60% of the nominal outer diameter of the defect-occupying portion.

53. The device of claim 51, wherein the first occluding member is adapted to conform to a geometry of a first tissue surface and provide and apposition force against the first tissue surface, and wherein the second occluding member is adapted to conform to a geometry of a second tissue surface and to provide an apposition force against the second tissue surface.

54. An implantable medical device for sealing an aperture in tissue, comprising:

a wire frame that includes a plurality of wound wires that each extend from a proximal end of the wire frame to a distal end of the wire frame, the plurality of wound wires being configured to move substantially independently of adjacent wires to adapt to a shape of a defect, the plurality of wound wires forming;

a first eyelet arranged near the proximal end of the wire frame;

a second eyelet arranged near the distal end of the wire frame;

a first occluding member having a nominal diameter from 27 mm to 48 mm;

a second occluding member having a nominal diameter from 27 mm to 48 mm; and

a defect-occupying portion disposed between the first occluding member and the second occluding member, the defect-occupying portion having a nominal outer diameter from 17 mm to 36 mm, wherein the first and second occluding member maintain a generally flat profile when the defect-occupying portion deflects to an outer diameter that is less than about 60% of the nominal outer diameter of the defect-occupying portion, and

each of the plurality of wound wires includes a first generally linear segment and a first generally curved segment that define a petal of the first occluding member, a second generally linear segment and a second generally curved segment that define a petal of the second occluding member, a third generally linear segment, a fourth generally linear segment, a third generally curved segment disposed between the third generally linear segment and the fourth generally linear segment that define the defect-occupying portion;

a lock loop configured to lock the frame in a deployed configuration; and

a non-metal attachment loop attached to the first eyelet, the non-metal attachment loop including an area through which a retrieval cord may be arranged to interface with a delivery apparatus.

55. The device of claim 54, wherein the third generally curved segment comprises a radius from approximately 0.094 inches to approximately 0.305 inches.

56. The device of claim 55, wherein the first eyelet is formed from first end portions of each wire of the six wound wires, and the second eyelet is formed from second end portions of each wire of the six wound wires, and the plurality of wound wires extend from the first eyelet at an angle from 150 to 152 degrees and the plurality of wound wires extend from the second eyelet at an angle of from 150 degrees to 152 degrees, wherein movement of one wire of the plurality of wound wires is substantially independently to a movement of one or more other wires of the plurality of wound wires.

57. The device of claim 54, wherein the plurality of wound wires comprises eight wires.

58. The device of claim 54, wherein the first occluding member is adapted to conform to a geometry of a first tissue surface and the second occluding member is adapted to conform to a geometry of a second tissue surface.

59. The device of claim 58, wherein the defect-occupying portion is adapted to substantially fill a range of defect sizes from a largest defect size to a smallest defect size that is approximately 60% of the largest defect size.

60. The device of claim 59, wherein the defect-occupying portion deflects to an outer diameter that is less than about 60% of its nominal outer diameter when a radial pressure of about 0.04 N/mm2 is applied to the defect-occupying portion.

61. A method of sealing a defect or structure in a heart, comprising:

providing a medical device having;

a wire frame that includes a plurality of wound wires that each extend from a proximal end of the wire frame to a distal end of the wire frame, the wires forming;

a first occluding member;

a second occluding member;

a defect-occupying portion disposed between the first occluding member and the second occluding member, wherein the defect-occupying portion is adapted to substantially fill a range of defect sizes from a largest defect size to a smallest defect size that is approximately 60% of the largest defect size, and wherein the defect-occupying portion deflects to an outer diameter that is less than about 60% of its nominal outer diameter when a radial pressure of about 0.04 N/mm2 is applied to the defect occupying portion;

a sealing member in contact with the frame;

a non-metal attachment member coupled to the sealing member;

a retrieval cord coupled to the non-metal attachment member; and

a delivery apparatus coupled to the device and the retrieval cord;

advancing a delivery apparatus to a location of the defect or structure in the heart;

deploying the medical device at the location of the defect or structure to seal the defect whereby the medical device is de-coupled from the delivery apparatus to allow an assessment of the deployment under lower tension while maintaining coupling of the retrieval cord to the delivery apparatus.

62. The method of claim 61, further comprising the step of de-coupling the retrieval cord from the device.

63. The method of claim 61, further comprising the step of recapturing the medical device by using the retrieval cord.

64. The method of claim 61, wherein the defect or structure is an atrial septal defect.

65. The method of claim 61, wherein the defect or structure is an ostium secundum defect.

66. The method of claim 61, wherein the defect or structure is a patent foramen ovale defect.