Sealing device and delivery system

• US 9,808,230 B2
• Filed: 06/04/2015
• Issued: 11/07/2017
• Est. Priority Date: 06/06/2014
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Brown, Tyler J., Hua, Khoa, Nelson, Devin M., Rust, Keith O.
• Primary Examiner(s): WEHRHEIM, LINDSEY GAIL
• Application Number:
  US14/731,205
• Publication Number:
  US 20150351731A1
• Time in Patent Office: 887 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• 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 2017/00623 Introducing or retrieving devices therefor

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. In some embodiments, a sealing member is in contact with the wire frame. In some embodiments, the sealing member is configured to define one or more openings in the sealing member.

Claims

1. 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 that each extend from a proximal end of the wire frame to a distal end of the wire frame, the wires forming;

a first wire aggregation element defining a proximal eyelet near the proximal end of the wire frame and a second wire aggregation element defining a distal eyelet near the distal end of the wire frame, the first wire aggregation element formed from first end portions of each wire of the plurality of wires, and the second wire aggregation element formed from second end portions of each wire of the plurality of wires;

a first occluding member disposed adjacent the first wire aggregation element, each wire of the plurality of wires forming a respective petal of the first occluding member, wherein adjacent petals of the first occluding member overlap one another and are not interwoven with one another;

a second occluding member disposed adjacent the second wire aggregation element, each wire of the plurality of wires forming a respective petal of the second occluding member, wherein adjacent petals of the second occluding member overlap one another and are not interwoven with one another; and

a defect-occupying portion disposed between the first occluding member and the second occluding member, wherein each wire of the plurality of wires includes, in the defect-occupying portion, a first generally linear segment, a second generally linear segment, and a curved segment disposed between the first generally linear segment and the second generally linear segment; and

a sealing member configured with one or more openings defining passages through the sealing member, the sealing member disposed on the frame such that the one or more openings are located on one or both of the first occluding member and the second occluding member and the one or more openings are configured to relieve a fluid pressure differential between an interior and an exterior of the sealing member.

2. The medical device of claim 1, wherein the one or more openings are all located on the first occluding member.

3. The medical device of claim 1, wherein at least a first opening of the one or more openings is disposed at a location where, when the medical device assumes a deployed configuration, a single layer of sealing member is present.

4. The medical device of claim 1, wherein at least a first opening of the one or more openings is disposed at a location where, when the medical device assumes a deployed configuration, two or more layers of overlapping sealing member are present.

5. The medical device of claim 1, wherein at least a first opening of the one or more openings is disposed within an interior space defined by a petal of the first occluding member or the second occluding member, and wherein a perimeter of the first opening is spaced apart from a wire that forms the petal.

6. The medical device of claim 1, wherein at least a first opening of the one or more openings is disposed between two adjacent petals and wherein a perimeter of the first opening is spaced apart from wires that form the two adjacent petals.

7. A sealing device comprising:

an expandable frame comprising a plurality of wires, each of the wires extending from a proximal end to a distal end of the frame;

first and second end portions of each of the plurality of wires being wound to define a proximal eyelet and a distal eyelet, respectively, and the plurality of wires forming a proximal disk and a distal disk when the sealing device assumes a deployed configuration, the proximal disk and the distal disk each disposed between the proximal eyelet and the distal eyelet, each wire of the plurality of wires forming a respective petal of the proximal disk and forming a respective petal of the distal disk, wherein adjacent petals of the proximal disk overlap one another and are not interwoven with one another, adjacent petals of the distal disk overlap one another and are not interwoven with one another, and each of the petals is configured to conform to tissue; and

a sealing member that at least partially encapsulates the expandable wire frame, the sealing member configured with one or more openings defining passages through the sealing member located on at least one of the proximal disk or the distal disk and the one or more openings are configured to relieve a fluid pressure differential between an interior and an exterior of the sealing device.

8. The sealing device of claim 7, wherein the one or more openings are all located on the proximal disk.

9. The sealing device of claim 7, wherein at least a first opening of the one or more openings is disposed at a location where, when the sealing device assumes the deployed configuration, a single layer of sealing member is present.

10. The sealing device of claim 7, wherein at least a first opening of the one or more openings is disposed at a location where, when the sealing device assumes the deployed configuration, two or more layers of overlapping sealing member are present.

11. The sealing device of claim 7, wherein at least a first opening of the one or more openings is disposed within an interior space defined by a first petal of the proximal disk or the distal disk, and wherein a perimeter of the first opening is spaced apart from a wire that forms the first petal.

12. The sealing device of claim 7, wherein at least a first opening of the one or more openings is disposed between two adjacent petals and wherein a perimeter of the first opening is spaced apart from wires that form the two adjacent petals.

13. A sealing device comprising:

an expandable frame comprising a plurality of wires, each of the wires extending from a proximal end to a distal end of the frame;

first and second portions of each of the plurality of wires being wound to define a proximal eyelet and a distal eyelet, respectively, and the plurality of wires forming a proximal disk and a distal disk when the sealing device assumes a deployed configuration, the proximal disk and the distal disk each disposed between the proximal eyelet and the distal eyelet, each wire of the plurality of wires forming a respective petal of the proximal disk and forming a respective petal of the distal disk, wherein adjacent petals of the proximal disk overlap one another and are not interwoven with one another and adjacent petals of the distal disk overlap one another and are not interwoven with one another; and

a sealing member in contact with the frame, the sealing member configured with one or more discontinuities where a fluid passage through the sealing member is defined, and the one or more discontinuities are configured to relieve a fluid pressure differential between an interior and an exterior of the sealing device.

14. The sealing device of claim 13, wherein the one or more discontinuities are all located on the proximal disk.

15. The sealing device of claim 13, wherein at least a first discontinuity of the one or more discontinuities is disposed at a location where, when the sealing device assumes the deployed configuration, a single layer of sealing member is present.

16. The sealing device of claim 13, wherein at least a first discontinuity of the one or more discontinuities is disposed at a location where, when the sealing device assumes the deployed configuration, two or more layers of overlapping sealing member are present.

17. The sealing device of claim 16, wherein the first discontinuity is occluded by the sealing member unless the sealing device has an expanded portion that is expanded as a result of a differential pressure between the interior and the exterior of the sealing device.

18. The sealing device of claim 13, wherein at least a first discontinuity of the one or more discontinuities is disposed within an interior space defined by a first petal of the proximal disk or the distal disk, and wherein a perimeter of the first discontinuity is spaced apart from a wire that forms the first petal.

19. The sealing device of claim 13, wherein at least a first discontinuity of the one or more discontinuities is disposed between two adjacent petals and wherein a perimeter of the first discontinuity is spaced apart from wires that form the two adjacent petals.

20. The sealing device of claim 13, wherein one or more of the one or more discontinuities each have an open area within a range of about 0.4 mm² to about 4.0 mm².