# US 2026/0083545 A1 · Apparatus for treatment of aorta disease with a balloon expandable section

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- Number: US 2026/0083545 A1
- Document ID: US20260083545A1
- Status: Published application
- Kind: A1
- Application number: 19/304,192
- Filed: 2025-08-19
- Published: 2026-03-26
- Earliest claimed: 2024-08-28
- Assignees: Braile Biomédica Indústria Comércio e Representações Ltda.
- Applicants: Braile Biomédica Indústria Comércio e Representações Ltda.
- Inventors: Rafael Braile Cunha; Vinicius Ladeia Semenzim; Marco Orlandi; Antonio Rizza; Lucas Roberto Dos Santos
- Web page: https://patentgrep.com/patent/US20260083545A1

## CPC

- A61F 2/07: Stent-grafts
- A61F 2210/0004: bioabsorbable
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2230/0006: circular
- A61F 2250/0098: radio-opaque, e.g. radio-opaque 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)

## Abstract

A stent graft apparatus for endovascular treatment of aortic diseases includes a balloon-expandable section and a self-expanding section connected by radial sutures to form a unitary device. The balloon-expandable section comprises a metallic framework configured for deployment via balloon inflation and includes a plurality of radially equidistant radiopaque markers for fluoroscopic visualization. The self-expanding section comprises a shape-memory material configured to exert continuous radial force upon release. The connected sections are sequentially deployed through a catheter-based delivery system, allowing the balloon-expandable section to anchor the graft precisely at the treatment site before the self-expanding section is released to conform to the vessel anatomy. This configuration facilitates both accurate positioning and anatomical adaptability, reducing the risk of migration and improving fixation in complex aortic regions. The apparatus may be used to treat aneurysms, dissections, or injuries in various segments of the aorta.

## Claims

### Claim 1

An apparatus for endovascular treatment of aortic disease, comprising:
a stent graft including a proximal balloon-expandable section and a distal self-expandable section,
wherein the balloon-expandable section comprises a metallic structure configured to expand in response to an inflatable balloon;
wherein the self-expandable section comprises a self-expanding framework configured to exert a radial outward force upon deployment;
wherein the balloon-expandable section and the self-expandable section are integrally connected via radial or longitudinal sutures to form a continuous unitary device; and
wherein the apparatus comprises a plurality of radiopaque markers fixedly attached to the balloon-expandable section and distributed radially equidistantly.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein the metallic structure of the balloon-expandable section comprises stainless steel or cobalt-chromium alloy.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein the self-expanding framework comprises a nitinol structure.

### Claim 4 (depends on 1)

The apparatus of claim 1, wherein the radiopaque markers are composed of at least one of gold, platinum, or tantalum.

### Claim 5 (depends on 1)

The apparatus of claim 1, wherein the sutures are arranged in a circumferential pattern to evenly distribute mechanical stress during deployment.

### Claim 6 (depends on 1)

The apparatus of claim 1, wherein the balloon-expandable section is adapted to remain fixed in position during deployment of the self-expandable section.

### Claim 7

An endoprosthesis apparatus for treating aortic artery disease, comprising:
a delivery catheter;
a stent graft navigable through the catheter, the stent graft including:
a proximal balloon-expandable metallic segment configured for precise positioning via balloon inflation;
a distal self-expandable segment configured to automatically expand upon deployment;
a set of radial or longitudinal sutures joining the balloon-expandable segment to the self-expandable segment; and
a plurality of radiopaque markers affixed to the balloon-expandable segment and visible under fluoroscopy to facilitate precise placement, wherein the balloon-expandable segment is deployed prior to the self-expandable segment.

### Claim 8 (depends on 7)

The apparatus of claim 7, wherein the catheter comprises a sheath configured to retract sequentially to release the balloon-expandable segment, followed by the self-expandable segment.

### Claim 9 (depends on 7)

The apparatus of claim 7, wherein the stent graft is pre-loaded in a compressed state within the catheter prior to navigation through the vasculature.

### Claim 10 (depends on 7)

The apparatus of claim 7, wherein the balloon is positioned coaxially within the balloon-expandable segment and is adapted for selective inflation.

### Claim 11 (depends on 7)

The apparatus of claim 7, wherein the radiopaque markers are placed at the ends and midpoint of the balloon-expandable segment for enhanced visualization.

### Claim 12 (depends on 7)

The apparatus of claim 7, wherein the delivery catheter comprises a handle mechanism operable to control sequential deployment of the two sections.

### Claim 13

A hybrid stent graft apparatus for endovascular treatment of aneurysms, dissections, or injuries in the aorta, comprising:
a proximal balloon-expandable section configured to be positioned at a target region and anchored through balloon expansion;
a distal self-expandable section configured to conform to the patient's anatomy and maintain fixation through radial force;
a plurality of radially distributed and equidistant radiopaque markers affixed to the balloon-expandable section; and
a radial or longitudinal suturing interface joining the balloon-expandable and self-expandable sections enabling structural continuity and synchronized deployment, wherein the apparatus is adapted for sequential deployment such that the balloon-expandable section is deployed and anchored before release of the self-expandable section.

### Claim 14 (depends on 13)

The apparatus of claim 13, wherein the self-expandable section is configured to expand to a preset diameter upon release from the catheter.

### Claim 15 (depends on 13)

The apparatus of claim 13, wherein the balloon-expandable section is configured to withstand high-pressure balloon inflation without permanent deformation.

### Claim 16 (depends on 13)

The apparatus of claim 13, wherein the apparatus is sized to conform to a curvature radius characteristic of the aortic arch.

### Claim 17 (depends on 13)

The apparatus of claim 13, wherein the balloon-expandable section comprises at least three fixation posts to prevent migration.

### Claim 18 (depends on 13)

The apparatus of claim 13, wherein the self-expandable section comprises multiple interconnected stent rings for enhanced flexibility.

### Claim 19 (depends on 13)

The apparatus of claim 13, wherein the radial or longitudinal sutures are bioresorbable.

### Claim 20 (depends on 13)

The apparatus of claim 13, wherein the apparatus further comprises a heparin coating to reduce thrombogenicity.
