# US 10,945,826 B2 · Endoluminal prosthetic assemblies, and associated systems and methods for percutaneous repair of a vascular tissue defect

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- Number: US 10,945,826 B2
- Document ID: US10945826B2
- Status: Granted
- Kind: B2
- Application number: 16/058,248
- Filed: 2018-08-08
- Published: 2018-12-06
- Granted: 2021-03-16
- Earliest claimed: 2016-02-09
- Assignees: Medtronic Vascular, Inc.
- Applicants: Medtronic Vascular, Inc.
- Inventors: Francesco Piccagli; Jeffery Argentine; Kieran Coghlan; Carlo Guala; Massimo Morero; Darren Galligan
- Web page: https://patentgrep.com/patent/US10945826B2

## CPC

- A61F 2/07: Stent-grafts
- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61F 2/852: Two or more distinct overlapping stents
- A61F 2/95: Instruments specially adapted for placement or removal of stents or stent-grafts
- 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 2002/067: {modular}
- A61F 2002/077: {having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve}
- A61F 2002/826: {more than one stent being applied sequentially}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2210/0061: swellable
- A61F 2230/0006: circular
- A61F 2230/0008: elliptical or oval
- A61F 2230/0069: cylindrical
- A61F 2250/0003: having an inflatable pocket filled with fluid, e.g. liquid or gas
- A61F 2250/0004: adjustable
- A61F 2250/0018: differing in elasticity, stiffness or compressibility
- A61F 2250/0039: differing in diameter
- A61F 2250/006: modular
- A61F 2250/0063: Nested prosthetic parts
- 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)

## Abstract

A prosthetic assembly for repairing a target tissue defect within a target vessel region configured includes an exclusion structure sized to substantially bypass target tissue defect, and includes a branch assembly. The branch assembly can include a self-expanding outer branch prosthesis having an inflow region configured to deform to a non-circular cross-sectional-shape when deployed, and a support structure at least partially disposed within the inflow region. The support structure preserves blood flow to the branch vessel while the deformed inflow region inhibits blood leakage between and/or around the prosthetic assembly.

## Claims

### Claim 1

A method for repairing a target tissue defect in a blood vessel of a patient, the method comprising:
positioning a branch assembly in a radially-contracted configuration within a region of the blood vessel having the target tissue defect, the branch assembly including an outer branch stent-graft and an inner support structure, the outer branch stent-graft including a sealing material and a stent, wherein an outflow region of the outer branch stent-graft is positioned within a branch vessel branching from the blood vessel and an inflow region of the outer branch stent-graft is positioned within the blood vessel;
positioning an exclusion structure in the blood vessel, wherein at least a proximal portion of the exclusion structure is adjacent to the inflow region of the outer branch stent-graft in the blood vessel, and wherein a central portion of the exclusion structure is aligned with the target tissue defect in the blood vessel;
expanding the exclusion structure in the blood vessel such that the central portion bypasses the target tissue defect in the blood vessel; and
expanding the branch assembly to a deployed configuration such that the outer branch stent-graft is disposed partially in the vessel and partially in the branch vessel, and the inner support structure is at least partially disposed within the inflow region of the outer branch stent-graft, wherein the proximal portion of the exclusion structure at least partially deforms the inflow region of the outer branch stent-graft without substantially deforming the inner support structure.

### Claim 2 (depends on 1)

The method of claim 1, wherein expanding the branch assembly comprises:
retracting a delivery sheath from the branch assembly to release the outer branch stent-graft to self-expand into a space between the exclusion structure and a wall of the blood vessel, wherein the sealing material of the outer branch stent-graft provides a barrier to blood flow between the wall and the exclusion structure.

### Claim 3 (depends on 2)

The method of claim 2, wherein
after retracting the delivery sheath to release the outer branch stent-graft to self-expand, expanding the branch assembly further comprises expanding the inner support structure with a balloon assembly.

### Claim 4 (depends on 2)

The method of claim 2, wherein after retracting the delivery sheath to release the outer branch stent-graft to self-expand, expanding the branch assembly further comprises further retracting the delivery sheath from the inner support structure and allowing the inner support structure to self-expand to a preformed position and shape.

### Claim 5 (depends on 1)

The method of claim 1, wherein the step of positioning the branch assembly comprises
delivering the branch assembly by a first catheter to the region prior to positioning the exclusion structure in the blood vessel, and wherein the branch assembly is positioned at the region in the first catheter.

### Claim 6 (depends on 1)

The method of claim 1, wherein expanding the branch assembly is after expanding the exclusion structure.

### Claim 7

A method for repairing a target tissue defect in a blood vessel of a patient, the method comprising:
positioning a branch assembly in a radially-contracted configuration within a region of the blood vessel having the target tissue defect, wherein a distal segment of the branch assembly is disposed within a branch vessel and a proximal segment of the branch assembly is disposed within the blood vessel, and wherein the branch assembly includes,
an outer branch stent-graft having an inflow region at the proximal segment; and
an inner support structure configured to be at least partially disposed within the inflow region at the proximal segment of the branch assembly;
positioning an exclusion structure in the blood vessel, wherein at least a proximal portion of the exclusion structure is adjacent to the proximal segment of the branch assembly in the blood vessel, and wherein a central portion of the exclusion structure is aligned with the target tissue defect in the blood vessel;
expanding the exclusion structure in the blood vessel such that the central portion bypasses the target tissue defect in the blood vessel;
expanding the branch assembly to a deployed configuration, wherein the proximal portion of the exclusion structure at least partially deforms the inflow region of the outer branch stent-graft without substantially deforming the inner support structure
wherein the outer branch stent-graft and the support structure are both disposed in a first delivery catheter prior to deployment, wherein expanding the branch assembly to a deployed configuration further includes:
deploying the outer branch stent-graft from the first delivery catheter,
after deploying the outer branch stent-graft, advancing the first delivery catheter such that the support structure is at least partially disposed within the outer branch stent-graft, and
after advancing the first delivery catheter, deploying the support structure at least partially within the outer branch stent-graft.

### Claim 8 (depends on 7)

The method of claim 7, wherein the first delivery catheter includes an inner member coupled to a distal tip, further comprising after deploying the outer branch stent-graft and before advancing the first delivery catheter, retracting the inner member and the distal tip towards a sheath of the first delivery catheter.

### Claim 9 (depends on 7)

The method of claim 7, wherein deploying the support structure comprises inflating a balloon to radially expand the support structure.

### Claim 10 (depends on 7)

The method of claim 7, wherein deploying the support structure comprises retracting a sheath of the first delivery catheter from around the support structure, thereby enabling the support structure to self-expand.

### Claim 11 (depends on 7)

The method of claim 7, wherein deploying the outer branch stent-graft comprises retracting a sheath from around the outer branch stent-graft, thereby enabling the outer branch stent-graft to self-expand.