IP Library › Granted Patent US 12,746,110
Granted Patent B2
US 12,746,110 · App. 18/180,068 · Granted Sep 29, 2026

Systems and methods for making encapsulated hourglass shaped stents

Inventors: Nir Nae (Binyamina, IL); Lior Rosen (Zikhron Ya'akov, IL); Neal Eigler (Agoura Hills, CA); Erez Rozenfeld (Shoham, IL); Werner Hafelfinger (Thousand Oaks, CA); Yeela Scop (Tel Aviv, IL)
Assignee: V-Wave Ltd.
A61F2/07A61B2017/00252A61B2017/00575A61F2002/072A61F2/2415A61F2/844A61F2/91A61F2/915A61F2/958A61F2210/0014A61F2210/0076A61F2220/0041A61F2220/0058A61F2230/001A61F2230/0067A61F2230/0078A61F2240/00A61F2240/001A61F2240/004A61F2250/0039A61F2250/0082A61M27/002
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Quick Facts
Patent No.
US 12,746,110
App. No.
18/180,068
Granted
Sep 29, 2026
Kind
B2
Abstract

Systems and methods for the manufacture of an hourglass shaped stent-graft assembly having an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium. The encapsulated stents may also be used to treat pulmonary hypertension.

Claims (29)

1 . An apparatus for making an encapsulated stent-graft assembly, the apparatus comprising:

a stent frame having a first end region, a second end region, and a middle region positioned between the first end region and the second end region, the stent frame configured to expand to an expanded state wherein the first end region and the second end region flare outwardly;

a biocompatible graft tube configured to extend along the stent frame such that there are two layers of the biocompatible graft tube disposed on the first end region and on the second end region and three layers of the biocompatible graft tube disposed on the middle region;

a mandrel configured to be positioned within the stent frame in the expanded state, wherein the mandrel is sized and shaped to conform to the flared first and second end regions; and

a compressor configured to compress the biocompatible graft tube onto the stent frame while the stent frame is in the expanded state and the mandrel is positioned therein for making the encapsulated stent-graft assembly.

2 . The apparatus of claim 1 , wherein the mandrel comprises a first portion having a first mandrel end that is removably coupled to a second portion comprising a second mandrel end.

3 . The apparatus of claim 1 , wherein the compressor comprises a first half that is removably coupled to a second half.

4 . The apparatus of claim 1 , further comprising a sleeve configured to receive the stent frame and to be positioned within the compressor.

5 . The apparatus of claim 4 , wherein the sleeve is flexible and comprises a first sleeve end and a second sleeve end.

6 . The apparatus of claim 4 , wherein the sleeve comprises a clamshell configured to apply a compressive force to optimize conformance of the biocompatible graft tube to the stent frame.

7 . The apparatus of claim 1 , wherein the biocompatible graft tube comprises a first graft portion, a second graft portion, and a third graft portion, and

wherein the first graft portion is deposited on an exterior surface of the middle region and an exterior surface of the first end region, the second graft portion is deposited on an interior surface of the first and second end regions and the middle region, and the third graft portion is deposited on an exterior surface of the second end region and the exterior surface of the middle region, thereby forming the two layers of the biocompatible graft tube disposed on the first end region and on the second end region and the three layers of the biocompatible graft tube disposed on the middle region.

8 . The apparatus of claim 1 , wherein the two layers of the biocompatible graft tube disposed on the first end region and on the second end region and the three layers of the biocompatible graft tube disposed on the middle region are configured to be sintered together to form a monolithic layer of graft material upon application of heat, thereby forming the encapsulated stent-graft assembly.

9 . The apparatus of claim 1 , wherein the stent frame comprises through-wall openings such that application of heat is configured to cause the two layers of the biocompatible graft tube disposed on the first end region to bond to one another, the two layers of the biocompatible graft tube disposed on the second end region to bond to one another, and the three layers of the biocompatible graft tube disposed on the middle region to bond to one another.

10 . The apparatus of claim 4 , further comprising a barrier layer configured to be disposed between the stent frame and the sleeve to prevent contaminants from transferring to the stent frame.

11 . The apparatus of claim 1 , wherein the mandrel comprises at least one ventilation hole configured to reduce a suction effect created when the biocompatible graft tube is compressed onto the stent frame while the mandrel is positioned therein.

12 . The apparatus of claim 1 , wherein the encapsulated stent-graft assembly, in the expanded state, forms an hourglass shape.

13 . The apparatus of claim 1 , wherein the biocompatible graft tube is configured to extend along the stent frame such that there is an additional layer of the biocompatible graft tube disposed on the first end region and/or on the second end region of the stent frame.

14 . The apparatus of claim 1 , wherein the biocompatible graft tube comprises expanded polytetrafluoroethylene (ePTFE).

15 . An apparatus for making an encapsulated stent-graft assembly, the apparatus comprising:

a stent frame having a first region, a second region, and a third region, the stent frame configured to expand to an expanded state wherein the first region and the second region flare outwardly;

a biocompatible graft tube configured to extend along the stent frame such that there are two layers of the biocompatible graft tube disposed on the first region and on the second region and three layers of the biocompatible graft tube disposed on the third region;

a mandrel configured to be positioned within the stent frame in the expanded state, wherein the mandrel is sized and shaped to conform to the flared first and second end regions; and

a compressor configured to compress the biocompatible graft tube onto the stent frame while the stent frame is in the expanded state and the mandrel is positioned therein for making the encapsulated stent-graft assembly.

16 . The apparatus of claim 15 , wherein the mandrel comprises a first portion having a first mandrel end that is removably coupled to a second portion comprising a second mandrel end.

17 . The apparatus of claim 15 , wherein the compressor comprises a first half that is removably coupled to a second half.

18 . The apparatus of claim 15 , further comprising a flexible sleeve configured to receive the stent frame and to be positioned within the compressor.

19 . The apparatus of claim 18 , wherein the flexible sleeve comprises a clamshell configured to apply a compressive force to optimize conformance of the biocompatible graft tube to the stent frame.

20 . The apparatus of claim 15 , wherein the encapsulated stent-graft assembly, in the expanded state, forms an hourglass shape.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 8, 2023
From: NAE, NIR; ROSEN, LIOR; EIGLER, NEAL; ROZENFELD, EREZ; HAFELFINGER, WERNER; SCOP, YEELA
To: V-WAVE LTD.
Reel/Frame 063570/0938 →
Continuity (9)
Division 17659312 · Apr 14, 2022
Continuation 17095615 · Nov 11, 2020
Continuation PCTIB2019060257 · Nov 27, 2019
Division 16205213 · Nov 29, 2018
Continuation In Part 16205213 · Nov 29, 2018
Continuation In Part 15798250 · Oct 30, 2017
Continuation 15608948 · May 30, 2017
Provisional Application 62343658 · May 31, 2016
Related Publication 20230277343A1 · Sep 7, 2023
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