Daisy occluder and method for septal defect repair

• US 5,741,297 A
• Filed: 08/28/1996
• Issued: 04/21/1998
• Est. Priority Date: 08/28/1996
• Status: Expired due to Term

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: Nitinol Medical Technologies Incorporated
• Inventors: Simon, Morris
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): PHAM, THUY D
• Application Number:
  US08/697,832
• Time in Patent Office: 601 Days
• Field of Search: 606/213, 606/215, 606/151, 600/32, 623/11, 604/285, 604/286
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• 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

The star occluder includes a frame formed from a first plurality of arms extending radially in a first plane and a second plurality of arms extending radially in a second plane which is spaced from and substantially parallel to the first plane. Loop joinder legs extend between the base ends of the first and second arms, and a first membrane sheet is supported by and extends over the first plurality of arms while a second membrane sheet is supported by and extends over the second group of arms. The frame is somewhat flexible when expanded so that the loop joinder legs expand into contact with the periphery of a septal defect and determine the size to which the frame will expand.

Claims

1. A septal defect occluder comprising:

a frame adapted to be inwardly radially collapsed from an expanded configuration to a collapsed configuration,

said frame in the expanded configuration including a first plurality of spaced, loop shaped arms extending radially in a first plane, said first arms each having a base end formed by two spaced end portions,

a second plurality of spaced, loop shaped arms extending radially in a second plane substantially parallel to and spaced from said first plane, said second arms each having a base end formed by two spaced end portions,

and a plurality of spaced loop joinder links extending between the base ends of said first and second arms, an end portion of each of said first arms being connected by one of said plurality of loop joinder links to an end portion of a second arm,

a first sheet of material supported by and extending over said first arms, and

a second sheet of material supported by and extending over said second arms.

2. The septal defect occluder of claim 1 wherein said frame is formed from a single elongated strand of material.

3. The septal defect occluder of claim 2 wherein said elongated strand of material is a shape memory material having a first low temperature condition in which said material is relatively pliable and a second high temperature condition wherein said material is resiliently deformable but relatively rigid and wherein said material assumes a predetermined functional form.

4. The septal defect occluder of claim 1 wherein with said frame in the expanded configuration, said base ends of said first and second plurality of arms are configured to define a single central open area, said first and second plurality of arms extending radially outward from the periphery of said central open area and being connected by said loop joinder links at the periphery of said central open area.

5. The septal defect occluder of claim 4 wherein said first and second sheets of material are joined together within said central open area.

6. The septal defect occluder of claim 1 wherein said first plurality arms each have an outermost end section spaced from said base section thereof and said second arms each have an outermost end section spaced from said base section thereof, the outermost end sections of said first arms being curved toward said second arms and the outermost end sections of said second arms being curved toward said first arms when said frame is in the expanded configuration.

7. The septal defect occluder of claim 1 wherein each of said second plurality of spaced arms extends outwardly and centrally between two adjacent arms of said first plurality of spaced arms when said frame is in the expanded configuration.

8. The septal defect occluder of claim 7 wherein said first and second plurality of spaced arms each include at least three arms.

9. The septal defect occluder of claim 7 wherein with said frame in the expanded configuration, each of said first and second plurality of spaced arms is petal shaped in configuration to form petal loops, the base end of each such petal loop being formed by the two spaced end portions, each of which is connected to a loop joinder link extending to an end portion of a petal loop shaped arm in a different plane, each such petal loop being defined by an elongate strand extending radially outward from one of said two spaced end portions and curving to form an arcuate outermost end of petal loop and then extending inwardly to said remaining end portion.

10. The septal defect occluder of claim 9 wherein all but one of said petal shaped arms of both said first and second plurality of arms are of substantially equal length, said one arm being of greater length.

11. The septal defect occluder of claim 9 wherein said frame is formed from a single elongate strand of wire.

12. The septal defect occluder of claim 11 wherein said elongated strand of wire has a first end section and a second end section joined by a weld to form said frame.

13. The septal defect occluder of claim 12 wherein said first plurality of arms each has an outermost end section adjacent to the arcuate outermost end thereof and said second plurality of arms each has an outermost end section adjacent to the arcuate outermost end thereof, the outermost end sections of said first arms being curved toward said second arms and the outermost end sections of said second arms being curved toward said first arms when said frame is in the expanded configuration.

14. The septal defect occluder of claim 13 wherein said first sheet of material is provided with pockets to receive the outermost end sections of said first arms and said second sheet of material is provided with pockets to receive the outermost end sections of said second arms.

15. The septal defect occluder of claim 14 wherein with said frame in the expanded configuration, said base ends of said first and second plurality of arms are configured to define a single central circular area, said first and second plurality arms extending radially outward from said central circular area.

16. The septal defect occluder of claim 15 wherein said first and second sheets of material are joined together within said central circular area.

17. The septal defect occluder of claim 16 wherein said first and second plurality of spaced arms each include three arms.

18. The septal defect occluder of claim 17 wherein said first and second sheets of material are triangular in shape with an apex area at each of the three points of the triangle, said pockets being formed in said apex areas.

19. The septal defect occluder of claim 18 wherein said single elongated strand of wire forming said frame is a shape memory material having a first low temperature condition in which said material is relatively pliable and a second high temperature condition wherein said material is resiliently deformable but relatively rigid and wherein said material assumes a predetermined functional form.

20. The septal defect occluder of claim 19 wherein said first and second sheets of material are formed from elastic dacron.

21. The septal defect occluder of claim 1 which includes an elongate flexible tether having a first end section and a second end section, said first sheet of material having first and second spaced openings positioned centrally thereof, said elongate tether extending from said first end section through said first opening in said first sheet of material and between said first and second sheets of material around said loop joinder links and out through said second opening in said first sheet of material to said second end section.

22. A septal defect occluder comprising:

a frame adapted to be inwardly radially collapsed from an expanded configuration to a collapsed configuration,

said frame in the expanded configuration including a first plurality of spaced arms extending radially in a first plane, each of said first arms having a base end and an outermost end section spaced from said base end,

a second plurality of spaced arms extending radially in a second plane substantially parallel to and spaced from said first plane, each of said second arms having a base end and an outermost end section spaced from said base end, the outermost end sections of said first arms being curved toward said second arms and the outermost end sections of said second arms being curved toward said arms when said frame is in the expanded configuration,

and loop joinder links extending between the base ends of said first and second arms,

a first sheet of material supported by and extending over said first arms, and

a second sheet of material supported by and extending over said second arms, said first sheet of material being provided with pockets to receive the outermost end sections of said first arms and said second sheet of material being provided with pockets to receive the outermost end sections of said second arms.

23. The septal defect occluder of claim 22 wherein said first and second sheets of material are polygonal in shape with an apex area at each of the points of the polygon, said first sheet of material being supported by one of said first plurality of arms extending into each apex area thereof and said second sheet of material being supported by one of said second plurality of arms extending into each apex area thereof.

24. The septal defect occluder of claim 23 wherein with said frame in the expanded configuration, said base ends of said first and second plurality of arms are configured to define a single central circular area, said first and second plurality arms extending radially outward from said central circular area.

25. The septal defect occluder of claim 24 wherein said first and second sheets of material are joined together within said central circular area.

26. The septal defect occluder of claim 25 wherein said frame is formed from a single elongated strand of material.

27. The septal defect occluder of claim 26 wherein said elongated strand of material is a shape memory material having a first low temperature condition in which said material is relatively pliable and a second high temperature condition wherein said material is resiliently deformable but relatively rigid and wherein said material assumes a predetermined functional form.

28. The septal defect occluder of claim 24 which includes an elongate flexible tether having a first end section and a second end section, said elongate tether extending from said first end section around said loop joinder links between said first and second plurality of arms to said second end section.

29. A septal defect occluder comprising:

a frame adapted to be inwardly radially collapsed from an expanded configuration to a collapsed configuration,

said frame in the expanded configuration including a first plurality of spaced arms extending radially in a first plane, said first arms each having a base end,

a second plurality of spaced arms extending radially in a second plane substantially parallel to and spaced from said first plane, said second arms each having a base end,

and a plurality of spaced loop joinder links extending between the base ends of said first and second arms, the base end of each of said first arms being connected by said plurality of loop joinder links to base ends of two arms in said second plurality of arms,

a first sheet of material supported by and extending over said first arms, and

a second sheet of material supported by and extending over said second arms.