# US 11,298,116 B2 · Sealing device and delivery system

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- Number: US 11,298,116 B2
- Document ID: US11298116B2
- Status: Granted
- Kind: B2
- Application number: 16/522,234
- Filed: 2019-07-25
- Published: 2020-04-23
- Granted: 2022-04-12
- Earliest claimed: 2014-06-06
- Assignees: W. L. Gore & Associates, Inc.
- Applicants: W. L. Gore & Associates, Inc.
- Inventors: Tyler J. Brown; Khoa Hua; Devin M. Nelson; Keith O. Rust
- Web page: https://patentgrep.com/patent/US11298116B2

## CPC

- 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)}
- A61B 2017/00243: {cardiac}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/00579: {Barbed implements}
- A61B 2017/00592: {Elastic or resilient implements}
- A61B 2017/00597: {Implements comprising a membrane}
- A61B 2017/00606: {Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening}
- A61B 2017/00623: {Introducing or retrieving devices therefor}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## 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

### Claim 1

A medical device comprising:
a plurality of wound wires forming a frame, the frame including:
a first eyelet,
a second eyelet,
a first disc member,
a second disc member; and
a sealing member in contact with the frame configured to at least partially prevent or relieve a fluid pressure differential between an interior and an exterior of the sealing member, wherein each wire of the plurality of wires and a portion of the sealing member form a respective petal of the first disc member and each wire of the plurality of wires and a portion of the sealing member form a respective petal of the second disc member.

### Claim 2 (depends on 1)

The medical device of claim 1, wherein the first disc member is configured to conform to a geometry of a first tissue surface and to provide an apposition force against the first tissue surface and the second disc member is configured to conform to a geometry of a second tissue surface and to provide an apposition force against the second tissue surface.

### Claim 3 (depends on 2)

The medical device of claim 2, wherein the sealing member is configured to at least partially prevent or relieve fluid pressure to facilitate a position of the first disc member relative to the first tissue surface and a position of the second disc member relative to the second tissue surface.

### Claim 4 (depends on 1)

The medical device of claim 1, wherein open areas of the first eyelet and the second eyelet are configured to at least partially prevent or relieve fluid pressure between the interior and exterior of the sealing member to reduce expansion of the sealing member due to a differential pressure between the interior and exterior of the sealing member.

### Claim 5 (depends on 1)

The medical device of claim 1, wherein the plurality of wound wires and the sealing member form a first plurality of petals of the first disc member and a second plurality of petals of the second disc member, and the sealing member includes at least one opening configured to at least partially prevent or relieve the fluid pressure differential between the interior and the exterior of the sealing member, and the at least one opening is arranged with one of the first plurality of petals or one of the second plurality of petals.

### Claim 6 (depends on 5)

The medical device of claim 5, wherein adjacent petals of the first plurality of petals overlap one another and adjacent petals of the second plurality of petals overlap one another, and the at least one opening is arranged at an overlapping zone between at least one of the adjacent petals of the first plurality of petals or the adjacent petals of the second plurality of petals.

### Claim 7 (depends on 5)

The medical device of claim 5, wherein the at least one opening is one of a hole, a slit, a perforation, a passageway, a discontinuity, a separation, a vent, a valve, a one-way valve, a tube, an orifice, a channel, or a local area of greater permeability of the sealing member.

### Claim 8 (depends on 5)

The medical device of claim 5, wherein the at least one opening includes a diameter of approximately 1.0 mm with an open area of about 0.8 mm2.

### Claim 9 (depends on 5)

The medical device of claim 5, wherein the at least one opening includes an open area within a range of about 0.1 mm2 to about 0.7 mm2, 0.4 mm2 to about 1.0 mm2, about 0.8 mm2 to about 1.4 mm2, about 1.2 mm2 to about 1.8 mm2, about 1.6 mm2 to about 2.0 mm2, about 1.8 mm2 to about 2.4 mm2, about 2.2 mm2 to about 2.8 mm2, about 2.6 mm2 to about 3.2 mm2, about 3.0 mm2 to about 3.6 mm2, about 3.4 mm2 to about 4.0 mm2, about 3.8 mm2 to about 4.4 mm2, or greater than about 4.4 mm2.

### Claim 10 (depends on 5)

The medical device of claim 5, wherein the at least one opening 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.

### Claim 11 (depends on 1)

The medical device of claim 1, further comprising a defect-occupying portion disposed between the first disc member and the second disc member; and the 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.

### Claim 12 (depends on 11)

The medical device of claim 11, 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.

### Claim 13 (depends on 12)

The medical device of claim 12, 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.

### Claim 14 (depends on 13)

The medical device of claim 13, 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.

### Claim 15

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 frame, the frame including: a first eyelet, a second eyelet, a first disc member, a second disc member; and a sealing member in contact with the frame configured to at least partially prevent or relieve a fluid pressure differential between an interior and an exterior of the sealing member, wherein each wire of the plurality of wires and a portion of the sealing member form a respective petal of the first disc member and each wire of the plurality of wires and a portion of the sealing member form a respective petal of the second disc member; 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.

### Claim 16 (depends on 15)

The method of claim 15, 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.

### Claim 17 (depends on 16)

The method of claim 16, 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.

### Claim 18

A method of manufacturing a medical device, the method comprising:
arranging a plurality of wound wires to form a frame, the frame including a first eyelet, a second eyelet, a first disc member, a second disc member;
arranging a sealing member in contact with the frame such that each wire of the plurality of wires and a portion of the sealing member form a respective petal of the first disc member and each wire of the plurality of wires and a portion of the sealing member form a respective petal of the second disc member;
altering the sealing member to include at least one discontinuity configured to at least partially prevent or relieve a fluid pressure differential between an interior and an exterior of the sealing member.

### Claim 19 (depends on 18)

The method of claim 18, wherein altering the sealing member includes at least one of puncturing the sealing member, die cutting the sealing member, laser cutting the sealing member, perforating the sealing member, hot-knife cutting the sealing member, punching the sealing member, knife blade cutting the sealing member, removing a portion of the sealing member, and chemically treating the sealing member to form the at least one discontinuity.

### Claim 20 (depends on 18)

The method of claim 18, wherein altering the sealing member includes forming the at least one discontinuity without removing a substantial amount of the sealing member.