# US 10,245,137 B2 · Graft with expandable region and methods of making and using the same

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- Number: US 10,245,137 B2
- Document ID: US10245137B2
- Status: Granted
- Kind: B2
- Application number: 14/906,853
- Filed: 2014-07-22
- Published: 2016-06-30
- Granted: 2019-04-02
- Earliest claimed: 2013-07-22
- Assignees: Atrium Medical Corporation
- Applicants: Atrium Medical Corporation
- Inventors: James J. Scutti; David G. Culp; Ibrahim E. Dagher; Kevin W. Penn
- Web page: https://patentgrep.com/patent/US10245137B2

## CPC

- A61B 17/11: for performing anastomosis; Buttons for anastomosis
- A61F 2/07: Stent-grafts
- A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other
- A61B 2017/1107: {for blood vessels}
- A61B 2017/1135: {End-to-side connections, e.g. T- or Y-connections}
- A61B 2017/1139: {Side-to-side connections, e.g. shunt or X-connections}
- A61F 2/954: for placing stents or stent-grafts in a bifurcation
- A61F 2002/061: {provided with means for allowing access to secondary lumens}
- A61F 2002/065: {Y-shaped blood vessels}
- A61F 2002/072: {Encapsulated stents, e.g. wire or whole stent embedded in lining}
- A61F 2002/826: {more than one stent being applied sequentially}
- A61F 2002/91575: {connected peak to trough}
- A61F 2002/91583: {by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band}
- A61F 2250/0018: differing in elasticity, stiffness or compressibility
- A61F 2250/0039: differing in diameter
- A61F 2250/0048: differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
- A61F 2250/0071: breakable or frangible
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)

## Abstract

A vascular graft suitable for implantation, and more particular to a vascular graft having an expandable outflow region for restoring patency of the graft after implantation into a body lumen.

## Claims

### Claim 1

A graft, comprising:
a conduit having a wall, the conduit comprising:
a body region;
an outflow region located adjacent to the body region;
at least one inflow aperture at an inflow end of the body region; and
an outflow aperture at an outflow end of the outflow region opposite from the at least one inflow aperture;
wherein the wall comprises a support structure and a biocompatible layer; and wherein the support structure along the outflow region configurable from a first shape to a second shape, the second shape being a flared shape having an expanded diameter along at least a portion of its length, and the first shape having a constrained diameter, smaller than the expanded diameter, along the outflow region due to the support structure along the outflow region being under continuous compressive stress resulting from a continuous applied load caused by the biocompatible layer against the support structure, wherein the compressive stress resulting from the continuous applied load in the outflow region is greater than a compressive stress resulting from a continuous applied load in the body region; and
wherein the support structure assumes the flared shape prior to combination with the biocompatible layer to form the wall, and the flared shape has multiple effective outer diameter measurements, and the support structure assumes the first shape after combination with the biocompatible layer to form the wall, and the first shape has a generally uniform effective outer diameter measurement.

### Claim 2 (depends on 1)

The graft of claim 1, wherein the compressive stress experienced by the support structure resulting from the continuous applied load in the outflow region when the support structure at the outflow region is in the first shape causes an elastic deformation of the support structure in the outflow region.

### Claim 3 (depends on 2)

The graft according to claim 2, wherein the at least one inflow aperture comprises a first inflow aperture and a second inflow aperture.

### Claim 4 (depends on 3)

The graft according to claim 3, wherein a longitudinal axis of the second inflow aperture intersects a longitudinal axis of the first inflow aperture at a non-parallel angle.

### Claim 5 (depends on 2)

The graft according to claim 2, wherein the support structure is constructed of a shape memory alloy.

### Claim 6 (depends on 2)

The graft according to claim 2, wherein the support structure comprises a zigzag wire shape.

### Claim 7 (depends on 2)

The graft according to claim 2, wherein the biocompatible layer encapsulates the support structure.

### Claim 8 (depends on 1)

The graft according to claim 1, wherein the at least one inflow aperture comprises a first inflow aperture and a second inflow aperture.

### Claim 9 (depends on 8)

The graft according to claim 8, wherein a longitudinal axis of the second inflow aperture intersects a longitudinal axis of the first inflow aperture at a non-parallel angle.

### Claim 10 (depends on 1)

The graft according to claim 1, wherein the support structure is constructed of a shape memory alloy.

### Claim 11 (depends on 1)

The graft according to claim 1, wherein the support structure comprises a zigzag wire shape.

### Claim 12 (depends on 1)

The graft according to claim 1, wherein the biocompatible layer encapsulates the support structure.

### Claim 13

A vascular graft, comprising:
a conduit having a wall, the conduit comprising:
a body region;
an outflow region located adjacent to the body region;
at least one inflow aperture at an inflow end of the body region; and
an outflow aperture at an outflow end of the outflow region opposite from the at least one inflow aperture;
wherein the wall comprises a support structure and a biocompatible layer; wherein prior to combination with the biocompatible layer to form the wall, the support structure comprises multiple effective outer diameter measurements along its length comprising a constant effective outer diameter measurement along the body region, and a flared shape along the outflow region defined by an effective outer diameter measurement along the outflow region that is incrementally greater at each segment along the support structure that is incrementally more distal from the at least one inflow aperture;
wherein after combination with the biocompatible layer to form the wall, the support structure in the outflow region is under continuous compressive stress resulting from a continuous applied load caused by the biocompatible layer which maintains the support structure along the outflow region at a constrained effective outer diameter measurement that is not incrementally greater at each segment along the support structure that is incrementally more distal from the at least one inflow aperture, wherein the compressive stress resulting from the continuous applied load in the outflow region is greater than a compressive stress resulting from a continuous applied load in the body region; and
wherein after application of a counter force to the support structure in the outflow region the support structure in the outflow region is reconfigured from the constrained effective outer diameter measurement to an expanded effective outer diameter measurement, at least a portion of which is at least one millimeter greater than the constrained effective outer diameter measurement.

### Claim 14

A graft, comprising:
a conduit having a wall, the conduit comprising:
a body region;
an outflow region located adjacent to the body region;
at least one inflow aperture at an inflow end of the body region; and
an outflow aperture at an outflow end of the outflow region opposite from the at least one inflow aperture;
wherein the wall comprises a support structure and a biocompatible layer; and wherein the support structure along the outflow region configurable from a first shape to a second shape, the second shape being a flared shape having an expanded diameter along at least a portion of its length, and the first shape having a constrained diameter, smaller than the expanded diameter, along the outflow region due to the support structure along the outflow region being under continuous compressive stress resulting from a continuous applied load caused by the biocompatible layer against the support structure, wherein the compressive stress resulting from the continuous applied load in the outflow region is greater than a compressive stress resulting from a continuous applied load in the body region;
wherein the support structure assumes the flared shape prior to combination with the biocompatible layer to form the wall, and the flared shape has multiple effective outer diameter measurements, and the support structure assumes the first shape after combination with the biocompatible layer to form the wall, and the first shape has a generally uniform effective outer diameter measurement; and
wherein the multiple effective outer diameter measurements along the outflow region comprise an effective outer diameter measurement that is incrementally greater at each segment along the support structure that is incrementally more distal from the at least one inflow aperture.

### Claim 15 (depends on 14)

The graft of claim 14, wherein the generally uniform effective outer diameter measurement approximately equals a constant effective outer diameter measurement along the body region and the constrained diameter of the support structure along the outflow region when in the first shape.

### Claim 16 (depends on 15)

The graft of claim 15, wherein following application of a counter force comprising a radial expansion force applied to the support structure in the outflow region, the graft reconfigures in such a way as to result in a plastically deformed biocompatible layer.

### Claim 17 (depends on 15)

The graft of claim 15, wherein a counter force comprising a radial expansion force applied to the support structure in the outflow region reconfigures the support structure along the outflow region from the constrained diameter to the expanded diameter along at least a portion of the support structure in the outflow region.
