# US 12,213,898 B2 · Self-sealing tubular grafts, patches, and methods for making and using them

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- Number: US 12,213,898 B2
- Document ID: US12213898B2
- Status: Granted
- Kind: B2
- Application number: 18/116,197
- Filed: 2023-03-01
- Published: 2023-06-29
- Granted: 2025-02-04
- Earliest claimed: 2016-04-25
- Assignees: Solinas Medical Inc.
- Applicants: Solinas Medical Inc.
- Inventors: James Hong; Erik van der Burg; Amy Lee
- Web page: https://patentgrep.com/patent/US12213898B2

## CPC

- A61F 2/89: the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
- A61F 2/06: Blood vessels
- A61F 2/07: Stent-grafts
- A61F 2/82: Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07)
- A61F 2/88: the wire-like elements formed as helical or spiral coils
- A61M 1/3655: {Arterio-venous shunts or fistulae}
- A61F 2/885: {comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis}
- A61F 2002/072: {Encapsulated stents, e.g. wire or whole stent embedded in lining}
- A61F 2230/0013: Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
- A61F 2230/0069: cylindrical
- A61F 2250/0069: Sealing means
- A61F 2250/0096: Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- 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

A self-sealing tubular graft is provided for implantation within a patient's body that includes an elongate tubular body including first and second self-sealing cannulation regions and a loop region extending between the first and second cannulation regions. The loop region includes one or more reinforcement members attached to a first length of the loop region and extending at least partially around a circumference of the tubular body. For example, the reinforcement members may include one or more sinusoidal or zigzag members extending along the first length with alternating peaks and valleys extending at least partially around a circumference of the tubular body. Self-sealing patches are also provided that include one or more reinforcement members embedded within base material.

## Claims

### Claim 1

A self-sealing cuff, comprising:
base material defining a first end, a second end, and having a “C” shaped cross-section defining opposing edges extending between the first and second ends; and
first and second reinforcement members embedded within the base material, the first reinforcement member extending axially along a first length and including elements that extend at least partially around a circumference of the base material, the second reinforcement member extending axially along the first length and including elements that extend at least partially around the circumference of the base material, the second reinforcement member spaced apart radially from the first reinforcement member,
wherein the first and second reinforcement members comprise first and second zigzag members that extends axially along the first length and include alternating loops defining peaks and valleys connected by arc elements that extend at least partially around the circumference of the “C” shaped cross-section, the second zigzag member is positioned concentrically around the first zigzag member, and
wherein the first and second zigzag members are out of phase with one another such that peaks of the first zigzag member are disposed opposite valleys of the second zigzag member along the opposite side edges and the arc elements of the second zigzag member overlap the arc elements of the first zigzag member at overlap points.

### Claim 2 (depends on 1)

The cuff of claim 1, wherein the first and second reinforcement members do not contact one another at the overlap points.

### Claim 3 (depends on 1)

The cuff of claim 1, wherein base material is located between the first and second reinforcement members at the overlap points.

### Claim 4 (depends on 1)

The cuff of claim 1, wherein the second reinforcement member contacts the first reinforcement member at the overlap points.

### Claim 5 (depends on 1)

The cuff of claim 1, wherein the second zigzag member contacts the first zigzag member at the overlap points at a top of the cuff between the opposite edges.

### Claim 6 (depends on 1)

The cuff of claim 1, wherein the first and second reinforcement members are configured to apply axially compressive forces to the base material along the first length.

### Claim 7

A self-sealing cuff, comprising:
base material defining a first end, a second end, a longitudinal axis extending between the first and second ends, and having a “C” shaped cross-section defining opposing edges extending between the first and second ends; and
first and second reinforcement members embedded within the base material, the first reinforcement member extending axially along a first length between the first and second ends and including are elements that extend at least partially around a circumference of the base material, the second reinforcement member extending axially along the first length and including elements that extend at least partially around the circumference of the base material, the second reinforcement member spaced apart radially from the first reinforcement member such that the arc elements of the second reinforcement member overlap the arc elements of the first reinforcement member at overlap points.

### Claim 8 (depends on 7)

The cuff of claim 7, wherein the first and second reinforcement members do not contact one another at the overlap points.

### Claim 9 (depends on 7)

The cuff of claim 7, wherein the base material is located between the first and second reinforcement members at the overlap points.

### Claim 10 (depends on 7)

The cuff of claim 7, wherein the second reinforcement member contacts the first reinforcement member at the overlap points where the second reinforcement member overlaps the first reinforcement member.

### Claim 11 (depends on 7)

The cuff of claim 7, wherein the first and second reinforcement members comprise first and second zigzag members that extends axially along the first length and include alternating loops defining peaks and valleys connected by the arc elements that extend at least partially around the circumference of the “C” shaped cross-section.

### Claim 12 (depends on 11)

The cuff of claim 11, wherein the first and second zigzag members are out of phase with one another such that peaks of the first zigzag member are disposed opposite valleys of the second zigzag member along the opposite side edges.

### Claim 13 (depends on 7)

The cuff of claim 7, wherein the first and second reinforcement members comprise first and second zigzag members that extends axially along the first length and include alternating loops defining peaks and valleys connected by the arc elements that extend at least partially around the circumference of the “C” shaped cross-section, and wherein the first and second zigzag members are out of phase with one another such that the second zigzag member contacts the first zigzag member at the overlap points where the second zigzag member overlap the arc elements of the first zigzag member.

### Claim 14 (depends on 7)

The cuff of claim 7, wherein the first and second reinforcement members are configured to apply axially compressive forces to the base material.

### Claim 15 (depends on 7)

The cuff of claim 7, further comprising:
fabric applied over exposed surfaces of the base material;
wherein the first and second reinforcement members comprise first and second zigzag members embedded within the base material,
wherein the first zigzag member extends axially along the first length and includes elements that extend at least partially around a circumference of the base material, the second zigzag member extends axially along the first length and includes elements that extend at least partially around the circumference of the base material, and
wherein the first and second zigzag members are out of phase with one another such that peaks of the first zigzag member are disposed opposite valleys of the second zigzag member along the opposite side edges, the second zigzag member spaced apart radially from the first zigzag member such that the base material is located between the first and second zigzag members.

### Claim 16 (depends on 7)

The cuff of claim 7,
wherein the first and second reinforcement members comprise inner and outer zigzag members embedded within the base material;
wherein the inner zigzag member extends axially along the first length and includes the arc elements that extend at least partially around a circumference of the base material, the outer zigzag member extends axially along the first length and includes the arc elements that extend at least partially around the circumference of the base material,
wherein the inner and outer zigzag members are out of phase with one another such that peaks of the inner zigzag member are disposed opposite valleys of the outer zigzag member along the opposite side edges, the outer zigzag member disposed around and spaced apart radially from the inner zigzag member along the first length, and wherein base material is located between the inner and outer zigzag members.

### Claim 17 (depends on 7)

The cuff of claim 7, wherein the “C” shaped cross-section defines an arc greater than one hundred eighty degrees (180°).

### Claim 18 (depends on 7)

The cuff of claim 7, further comprising fabric applied over exposed surfaces of the base material.

### Claim 19

A self-sealing cuff, comprising:
base material defining a first end, a second end, a longitudinal axis extending between the first and second ends, and having a “C” shaped cross-section defining opposing edges extending between the first and second ends; and
first and second zigzag members embedded within the base material, the first zigzag member extending axially along a first length between the first and second ends and including include alternating loops defining peaks and valleys connected by arc elements that extend at least partially around the circumference of the “C” shaped cross-section, the second zigzag member extending axially along the first length and including include alternating loops defining peaks and valleys connected by arc elements that extend at least partially around the circumference of the “C” shaped cross-section,
wherein the second zigzag member is spaced apart radially from the first zigzag member, and wherein the first and second zigzag members are out of phase with one another such that peaks of the first zigzag member are disposed opposite valleys of the zigzag member along the opposite side edges and the arc elements of the second zigzag member overlap the arc elements of the first zigzag member at overlap points.

### Claim 20 (depends on 19)

The cuff of claim 19, further comprising fabric applied over exposed surfaces of the base material.
