# US 11,998,183 B2 · Occluder with access passage and closure thereof

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,998,183 B2
- Document ID: US11998183B2
- Status: Granted
- Kind: B2
- Application number: 18/493,558
- Filed: 2023-10-24
- Published: 2024-02-15
- Granted: 2024-06-04
- Earliest claimed: 2019-08-26
- Assignees: St. Jude Medical, Cardiology Division, Inc.
- Applicants: St. Jude Medical, Cardiology Division, Inc.
- Inventors: Tracee Eidenschink; Andrea Stafford; Brian Perszyk; Theodore P. Dale; Luann Raposo; Alex Bloomquist; Michael P. Meyer
- Web page: https://patentgrep.com/patent/US11998183B2

## 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)}
- A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/00575: {for closure at remote site, e.g. closing atrial septum defects}
- 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 2017/00867: {shape memory effect}
- A61B 2017/00884: {enhancing wound closure}
- A61B 2017/3425: {for internal organs, e.g. heart ports}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The present disclosure is directed to embodiments of an occlusive medical device including a frame and at least one closure coupled to the frame. The frame includes a distal annular flange having a radially outer surface and a radially inner surface, a proximal annular flange having a radially outer surface and a radially inner surface, and a waist portion extending between and connecting the distal annular flange to the proximal annular flange. The radially inner surface of the distal annular flange, the waist member, and the radially inner surface of the proximal annular flange define an unobstructed passageway through the frame. The at least one closure is configured to close the passageway to: (i) provide an occlusive effect, and (ii) enable subsequent access through the passageway.

## Claims

### Claim 1

An occluder for occluding an atrial septal defect (“ASD”) within an atrial septal wall, the occluder comprising:
a self-expanding mesh frame formed of braided wires of nitinol, the frame including (i) a distal annular flange having a radially outer surface and a radially inner surface, the distal annular flange configured to be positioned with a left atrium and to engage a distal surface of the atrial septal wall, (ii) a proximal annular flange having a radially outer surface and a radially inner surface, the proximal annular flange configured to be positioned within a right atrium and to engage a proximal surface of the atrial septal wall, and (iii) a waist member extending between and connecting the distal annular flange to the proximal annular flange, the waist member configured to engage a surface of the ASD; and
a fabric closure formed of polyethylene terephthalate,
wherein the radially inner surface of the distal annular flange, the waist member, and the radially inner surface of the proximal annular flange define an access passage through the mesh frame, and the fabric closure is connected to the waist member and positioned radially inward of the waist member to (i) restrict bodily fluids from passing through the access passage and to (ii) enable subsequent access through the access passage when the occluder is deployed within the ASD,
wherein the mesh frame includes a plurality of spokes extending radially inwardly from the radially inner surface of the proximal annular flange, the plurality of spokes coupled to an attachment member, the attachment member configured to couple the occluder to a delivery device,
wherein the plurality of spokes define a plurality of access ports leading to the access passage, the plurality of access ports being sized to accommodate medical devices having a diameter of 4 Fr to 36 Fr.

### Claim 2 (depends on 1)

The occluder of claim 1, wherein the occluder includes only one fabric closure.

### Claim 3 (depends on 2)

The occluder of claim 2, wherein the fabric closure is circular.

### Claim 4 (depends on 1)

The occluder of claim 1, wherein the mesh frame is formed with two layers of braided wires of nitinol.

### Claim 5 (depends on 1)

The occluder of claim 1, wherein the proximal annular flange, the distal annular flange, and the waist member are integral with each other.

### Claim 6 (depends on 5)

The occluder of claim 5, wherein the plurality of spokes are formed non-integrally with the mesh frame.

### Claim 7 (depends on 5)

The occluder of claim 5, wherein the plurality of spokes are formed integrally with the mesh frame.

### Claim 8 (depends on 7)

The occluder of claim 7, wherein the plurality of spokes are formed of the braided wires of nitinol that form the mesh frame.

### Claim 9 (depends on 8)

The occluder of claim 8, wherein the plurality of spokes are formed by extending portions of the braided wires of nitinol radially inwardly from the proximal annular flange.

### Claim 10 (depends on 1)

The occluder of claim 1, wherein the attachment member is positioned at a radial center of the occluder.

### Claim 11 (depends on 10)

The occluder of claim 10, wherein the attachment member is a screw member with threads.

### Claim 12 (depends on 1)

The occluder of claim 1, wherein a diameter of the radially outer surface of the distal annular flange is at least 5 mm larger than a diameter of the access passage.

### Claim 13 (depends on 1)

The occluder of claim 1, wherein the radially inner surface of the distal annular flange, the waist member, and the radially inner surface of the proximal annular flange define the access passage to accommodate the medical devices.

### Claim 14 (depends on 1)

The occluder of claim 1, wherein an unobstructed area of the distal annular flange delimiting the access passage and defined by the radially inner surface of the distal annular flange represents between 50% and 70% of a total surface area defined by the radially outer surface of the distal annular flange.

### Claim 15 (depends on 14)

The occluder of claim 14, wherein an unobstructed area of the proximal annular flange delimiting the access passage and defined by the radially inner surface of the proximal annular flange represents between 50% and 70% of a total surface area defined by the radially outer surface of the proximal annular flange.

### Claim 16 (depends on 1)

The occluder of claim 1, wherein the fabric closure is connected to the waist member via sutures.

### Claim 17 (depends on 1)

The occluder of claim 1, wherein the fabric closure is trapped within the mesh frame.

### Claim 18 (depends on 1)

The occluder of claim 1, wherein the plurality of spokes includes three spokes.

### Claim 19 (depends on 1)

The occluder of claim 1, wherein the plurality of spokes includes more than five spokes.