Sealing device and delivery system

• US 10,792,025 B2
• Filed: 08/25/2016
• Issued: 10/06/2020
• Est. Priority Date: 06/22/2009
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Masters, Steven J.
• Primary Examiner(s): Ou, Jing Rui
• Application Number:
  US15/247,055
• Publication Number:
  US 20170105711A1
• Time in Patent Office: 1,503 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 2017/00526 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
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

The invention relates to a sealing device for repair of cardiac and vascular defects or tissue opening such as a patent foramen ovale (PFO) or shunt in the heart, the vascular system, etc. and particularly provides an occluder device and trans-catheter occluder delivery system. The sealing device would have improved conformity to heart anatomy and be easily deployed, repositioned, and retrieved at the opening site.

Claims

1. (A medical device comprising:

a wire frame that includes a plurality of wires that each extends from a proximal end of the wire frame to a distal end of the wire frame and a sealing member attached to the wire frame, the plurality of wires and the sealing member forming;

a proximal eyelet at the proximal end of the wire frame, the proximal eyelet defined by proximal end portions of each of the plurality of wires converging from different locations about a longitudinal axis of the medical device;

a distal eyelet at the distal end of the wire frame, the distal eyelet defined by distal end portions of each of the plurality of wires converging from different locations about the longitudinal axis of the device;

a proximal disk adjacent the proximal eyelet and comprising a plurality of proximal petals;

wherein when viewed in a direction along the longitudinal axis in a deployed configuration of the medical device, each of the proximal petals includes two portions of the sealing member overlapping adjacent petals within the proximal disk and a portion of the sealing member non-overlapping the adjacent petals within the proximal disk to include a portion of each petal arranged toward the distal disk;

wherein the adjacent petals of the proximal disk are not interwoven with one another;

a distal disk adjacent the distal eyelet and comprising a plurality of distal petals;

wherein when viewed in a direction along the longitudinal axis in a deployed configuration of the medical device, each of the distal petals includes two portions of the sealing member overlapping adjacent petals within the distal disk and a portion of the sealing member portion non-overlapping the adjacent petals within the distal disk to include a portion of each petal arranged toward the proximal disk, and each of the plurality of wires form one of the proximal petals and one of the distal petals; and

a waist portion disposed between the proximal disk and the distal disk.

2. The medical device of claim 1, wherein each of the plurality of wires comprises an inner peripheral edge and an outer peripheral edge.

3. The medical device of claim 2, wherein the outer peripheral edge of each of the plurality of wires are arranged at an outermost edge of the wire frame.

4. The medical device of claim 3, wherein the outer peripheral edge of each of the plurality of wires are arranged within one of the distal disk and the proximal disk.

5. The medical device of claim 2, wherein the inner peripheral edge of each of the plurality of wires are arranged within the waist portion.

6. The medical device of claim 2, wherein the inner peripheral edge of each of the plurality of wires are arranged at an open internal area in the deployed configuration.

7. The medical device of claim 1, wherein the plurality of proximal petals are formed by overlapping proximal portions of the plurality of wires, and the plurality of distal petals are formed by overlapping distal portions of the plurality of wires.

8. The medical device of claim 1, wherein the plurality of wires are overlapping and equally spaced about one of the proximal eyelet and the distal eyelet.

9. The medical device of claim 1, wherein the wire frame comprises an hourglass shape.

10. A medical device comprising:

a wire frame that includes a plurality of wires that each extends from a proximal end of the wire frame to a distal end of the wire frame and a sealing member attached to the wire frame, the plurality of wires forming;

a proximal eyelet at the proximal end of the wire frame, the proximal eyelet defined by proximal end portions of each of the plurality of wires wound together from different locations about a longitudinal axis of the device;

a distal eyelet at the distal end of the wire frame, the distal eyelet defined by distal end portions of each of the plurality of wires wound together from different locations about the longitudinal axis of the device;

a proximal disk adjacent the proximal eyelet and comprising a plurality of proximal petals;

wherein when viewed in a direction along the longitudinal axis in a deployed configuration of the medical device, each of the proximal petals includes portions of the sealing member overlapping adjacent petals and a portion of the sealing member non-overlapping the adjacent petals within the proximal disk to include a portion of each petal arranged toward the distal disk;

wherein the adjacent petals of the proximal disk are not interwoven with one another;

a distal disk adjacent the distal eyelet and comprising a plurality of distal petals;

wherein when viewed in a direction along the longitudinal axis in a deployed configuration of the medical device, each of the distal petals includes portions of the sealing member overlapping adjacent petals and a portion of the sealing member non-overlapping the adjacent petals within the distal disk to include a portion of each petal arranged toward the proximal disk, and each of the plurality of wires form one of the proximal petals and one of the distal petals; and

a waist portion disposed between the proximal disk and the distal disk.

11. The medical device of claim 10, wherein each of the plurality of wires comprises an inner peripheral edge and a proximal outer peripheral edge and a distal outer peripheral edge.

12. The medical device of claim 11, wherein the proximal outer peripheral edge is arranged within the proximal disk and the distal outer peripheral edge is arranged within the distal disk.

13. The medical device of claim 12, wherein the proximal outer peripheral edge of each of the plurality of wires form a perimeter of the proximal disk and the distal outer peripheral edge of each of the plurality of wires form a perimeter of the distal disk.

14. The medical device of claim 13, wherein the perimeter of the proximal disk is substantially circular and the perimeter of the distal disk is substantially circular.

15. The medical device of claim 13, wherein the proximal outer peripheral edge and the distal outer peripheral edge of each of the plurality of wires includes a curvature.

16. The medical device of claim 15, wherein the curvature of the proximal outer peripheral edge of each of the plurality of wires transitions the plurality of wires toward the waist portion and the curvature of the distal outer peripheral edge of each of the plurality of wires transitions the plurality of wires toward the waist portion.

17. The medical device of claim 11, wherein the inner peripheral edge of each of the plurality of wires are arranged within the waist portion.

18. A medical device comprising:

a proximal eyelet formed by proximal end portions of a plurality of wires wound together from different locations about a longitudinal axis of the device;

a distal eyelet formed by distal end portions of the plurality of wires wound together from different locations about the longitudinal axis of the device;

a sealing member coupled to the plurality of wires;

a waist portion formed by an inner peripheral edge of each of the plurality of wires between the proximal eyelet and the distal eyelet and the sealing member;

a proximal disk adjacent the proximal eyelet and comprising a plurality of proximal petals formed by the sealing member and the plurality of wires;

wherein when viewed in a direction along the longitudinal axis in a deployed configuration of the medical device, each of the proximal petals includes portions of the sealing member overlapping adjacent petals within the proximal disk and a portion of the sealing member non-overlapping the adjacent petals within the proximal disk to include a portion of each petal arranged toward the distal disk;

wherein the adjacent petals of the proximal disk are not interwoven with one another;

a distal disk adjacent the distal eyelet and comprising a plurality of distal petals formed by the sealing member and the plurality of wires;

wherein when viewed in a direction along the longitudinal axis in a deployed configuration of the medical device, each of the distal petals includes portions of the sealing member overlapping adjacent petals within the distal disk and a portion of the sealing member non-overlapping the adjacent petals within the proximal disk to include a portion of each petal arranged toward the proximal disk, and each of the plurality of wires form one of the proximal petals and one of the distal petals; and

a waist portion disposed between the proximal disk and the distal disk.

19. The medical device of claim 18, wherein the proximal outer peripheral edge of each of the plurality of wires forms a proximal disk and the distal outer peripheral edge of each of the plurality of wires forms a distal disk.