Sealing device and delivery system

• US 10,368,853 B2
• Filed: 10/24/2017
• Issued: 08/06/2019
• 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 G
• Application Number:
  US15/791,678
• Publication Number:
  US 20180042592A1
• Time in Patent Office: 651 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 comprising:

a plurality of wound wires forming;

a first eyelet,

a second eyelet,

a first disc member,

a second disc member, and

a defect-occupying portion disposed between the first disc member and the second disc member; and

a sealing member in contact with the frame including one or more openings configured to at least partially prevent or relieve a fluid pressure differential between an interior and an exterior of the sealing member, the sealing member forming a first occluding member with the first disc member and a second occluding member with the second disc member configured to seal a range of defect sizes from a largest defect size to a smallest defect size that is approximately 60% of the largest defect size.

2. The medical device of claim 1, wherein the one or more openings define passages through the sealing member.

3. The medical device of claim 1, wherein the one or more openings being configured to at least partially prevent or relieve the fluid pressure differential facilitates maintaining the medical device in a desired position and configuration in relation to the patient'"'"'s anatomy.

4. The medical device of claim 1, wherein the one or more openings includes two, three, four, five, six, seven, eight, nine, ten, eleven, or twelve openings.

5. The medical device of claim 1, wherein the one or more openings are arranged on at least one of the first occluding member and the second occluding member.

6. The medical device of claim 1, wherein the range of defect sizes includes at least one of:

8-15 mm, 13-20 mm, 18-25 mm, 23-30 mm, and 28-35 mm.

7. The medical device of claim 6, wherein outer diameters of the first occluding member and the second occluding member are at least one of:

approximately 27 mm and configured to seal the range of defect sizes of 8-15 mm, approximately 32 mm and configured to seal the range of defect sizes of 13-20 mm, approximately 37 mm and configured to seal the range of defect sizes of 18-25 mm, approximately 44 mm and configured to seal the range of defect sizes of 23-30 mm, approximately 48 mm and configured to seal the range of defect sizes of 28-35 mm.

8. The medical device of claim 7, wherein an outer diameter of the defect-occupying portion is at least one of:

approximately 17 mm and configured to seal the range of defect sizes of 8-15 mm, approximately 22 mm and configured to seal the range of defect sizes of 13-20 mm, approximately 27 mm and configured to seal the range of defect sizes of 18-25 mm, approximately 32 mm and configured to seal the range of defect sizes of 23-30 mm, and approximately 36 mm and configured to seal the range of defect sizes of 28-35 mm.

9. A medical device comprising:

a plurality of wound wires forming;

a first eyelet,

a second eyelet,

a first disc member,

a second disc member; and

a sealing member in contact with the frame including one or more openings configured to at least partially prevent or relieve a fluid pressure differential between an interior and an exterior of the sealing member, the sealing member forming a first occluding member with the first disc member and a second occluding member with the second disc member.

10. The medical device of claim 9, 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 or two or more layers of the sealing member is present.

11. The medical device of claim 9, 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.

12. The medical device of claim 9, further comprising a defect-occupying portion disposed between the first disc member and the second disc member;

and medical device is configured to seal a range of defect sizes from a largest defect size to a smallest defect size that is approximately 60% of the largest defect size.

13. The medical device of claim 12, wherein the range of defect sizes includes at least one of:

8-15 mm, 13-20 mm, 18-25 mm, 23-30 mm, and 28-35 mm.

14. The medical device of claim 13, wherein outer diameters of the first occluding member and the second occluding member are at least one of:

approximately 27 mm and configured to seal the range of defect sizes of 8-15 mm, approximately 32 mm and configured to seal the range of defect sizes of 13-20 mm, approximately 37 mm and configured to seal the range of defect sizes of 18-25 mm, approximately 44 mm and configured to seal the range of defect sizes of 23-30 mm, approximately 48 mm and configured to seal the range of defect sizes of 28-35 mm.

15. The medical device of claim 14, wherein an outer diameter of the defect-occupying portion is at least one of:

approximately 17 mm and configured to seal the range of defect sizes of 8-15 mm, approximately 22 mm and configured to seal the range of defect sizes of 13-20 mm, approximately 27 mm and configured to seal the range of defect sizes of 18-25 mm, approximately 32 mm and configured to seal the range of defect sizes of 23-30 mm, and approximately 36 mm and configured to seal the range of defect sizes of 28-35 mm.

16. The sealing device of claim 15, wherein one or more of the one or more openings each have an open area within a range of about 0.4 mm² to about 4.0 mm².

17. A method of deploying a medical device within a defect of a patient, the method comprising:

arranging the medical device at the defect, the medical device including a plurality of wound wires forming;

a first eyelet, a second eyelet, a first disc member, a second disc member, and a defect-occupying portion disposed between the first disc member and the second disc member; and

a sealing member in contact with the frame including one or more openings configured to at least partially prevent or relieve a fluid pressure differential between an interior and an exterior of the sealing member, the sealing member forming a first occluding member with the first disc member and a second occluding member with the second disc member configured to seal 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

deploying the first occluding member on a first side of the defect, the second occluding member on a second side of the defect-occupying portion within the defect.

18. The method of claim 17, further comprising determining a size of the defect selecting the medical device based on the size of the defect falling within a range of one of 8-15 mm, 13-20 mm, 18-25 mm, 23-30 mm, and 28-35 mm.

19. The method of claim 18, wherein outer diameters of the first occluding member and the second occluding member are at least one of:

approximately 27 mm and configured to seal the range of defect sizes of 8-15 mm, approximately 32 mm and configured to seal the range of defect sizes of 13-20 mm, approximately 37 mm and configured to seal the range of defect sizes of 18-25 mm, approximately 44 mm and configured to seal the range of defect sizes of 23-30 mm, approximately 48 mm and configured to seal the range of defect sizes of 28-35 mm and an outer diameter of the defect-occupying portion is at least one of;

approximately 17 mm and configured to seal the range of defect sizes of 8-15 mm, approximately 22 mm and configured to seal the range of defect sizes of 13-20 mm, approximately 27 mm and configured to seal the range of defect sizes of 18-25 mm, approximately 32 mm and configured to seal the range of defect sizes of 23-30 mm, and approximately 36 mm and configured to seal the range of defect sizes of 28-35 mm.