IP Library Granted Patent US 11,224,503
Granted Patent B2
US 11,224,503 · App. 16/322,047 · Granted Jan 18, 2022

Aortic implant

Inventors: Sagy Karavany (Kibbutz Dvir, IL); Tanhum Feld (Moshav Merhavya, IL); Boaz Nishri (D.N. Menashe, IL); Menashe Yacoby (Shoham, IL)
Assignee: Hemodynamx-Techologies Ltd.
A61F2/06A61F2/966A61F2002/068A61F2002/91525A61F2230/0093A61F2250/0039
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Quick Facts
Patent No.
US 11,224,503
App. No.
16/322,047
Granted
Jan 18, 2022
Kind
B2
Abstract

Apparatus and methods are described including inserting an implantable device ( 20 ) into a blood vessel of a subject while the implantable device is disposed inside a delivery device and is constrained in a constrained configuration by the delivery device. The implantable device is released from the delivery device into the blood vessel, thereby causing the implantable device to assume a non-constrained configuration by an upstream end of the implantable device radially expanding ( 120 ), a central portion ( 122 ) of the implantable device radially expanding such that along the central portion of the implantable device the inner surface ( 24 ) of the implantable device defines a diverging portion ( 25 ) of a conduit ( 26 ), and the implantable device forming a folded portion ( 128 ) between the upstream end of the implantable device and the central portion of the implantable device. Other applications are also described.

Claims (37)

1. Apparatus for use with a delivery device, comprising:

an implantable device having a proximal end and a distal end, the implantable device being configured:

to be inserted into an ascending aorta of a subject while the implantable device is disposed inside the delivery device and is constrained in a constrained configuration by the delivery device,

to assume a non-constrained configuration inside a longitudinal portion of the ascending aorta by being released from the delivery device, the implantable device being configured such that when disposed in the non-constrained configuration inside the longitudinal portion of the ascending aorta:

a proximal portion of the implantable device contacts an inner wall of the ascending aorta, such as to anchor the proximal end of the implantable device with respect to the ascending aorta,

along a central portion of the implantable device, an inner surface of the implantable device defines a conduit extending through the implantable device, the conduit comprising a diverging portion that diverges in a direction from a proximal end of the conduit to a distal end of the conduit, such that a cross-sectional area of the diverging portion of the conduit at its distal end is greater than the cross-sectional area of the diverging portion of conduit at its proximal end, the diverging portion being configured to reduce pressure loss of blood flowing through the conduit, relative to pressure loss of blood flowing through the longitudinal portion of the ascending aorta in an absence of the device, by reducing an area of flow separation,

the proximal end of the conduit being configured to be placed within the ascending aorta such that when an aortic valve of the subject is in an open state, the proximal end of the conduit is disposed within 25 mm of a tip of the aortic valve,

a distal portion of the implantable device contacts the inner wall of the ascending aorta, such as to anchor the distal end of the implantable device with respect to the ascending aorta, and

the implantable device defines a folded portion radially between the proximal portion of the implantable device and the central portion of the implantable device, such that along a longitudinal direction of the implantable device, there is partial overlap between the proximal portion of the implantable device and the central portion of the implantable device.

2. The apparatus according to claim 1 , wherein the implantable device is configured to define the folded portion by defining a folded portion that has a sinusoidal cross-sectional shape.

3. The apparatus according to claim 1 , wherein the implantable device does not include a prosthetic valve.

4. The apparatus according to claim 1 , wherein, when in the non-constrained configuration inside the ascending aorta, the implantable device is configured to define, at a region at its distal end, a surface extending radially outward, around a full circumference of the conduit, from the conduit to the inner wall of the ascending aorta.

5. The apparatus according to claim 1 , wherein the implantable device is made of a single continuous piece of stent graft material.

6. The apparatus according to claim 1 , wherein the implantable device is configured such that, when the implantable device is in the non-constrained configuration within the ascending aorta, the diverging portion of the conduit has a length of more than 20 mm.

7. The apparatus according to claim 6 , wherein the implantable device is configured such that, when the implantable device is in the non-constrained within the ascending aorta, the length of the diverging portion of the conduit is less than 70 mm.

8. The apparatus according to claim 1 , wherein the implantable device is configured such that, when the implantable device is in the non-constrained configuration inside the ascending aorta, a ratio between a diameter of the conduit at the distal end of the diverging portion of the conduit and a diameter of the conduit at the proximal end of the diverging portion of the conduit is less than 4:3.

9. The apparatus according to claim 1 , wherein the implantable device is configured such that, when the implantable device is in the non-constrained configuration inside the ascending aorta, the ratio between the diameter of the conduit at the distal end of the diverging portion of the conduit and the diameter of the conduit at the proximal end of the diverging portion of the conduit is more than 7:6.

10. The apparatus according to claim 1 , wherein, when in the non-constrained configuration inside the ascending aorta, the implantable device is configured to impede blood flow through the longitudinal portion of the ascending aorta in which the implantable device is placed, via any flow path other than through the conduit, to less than 20 percent of total blood flow through the longitudinal portion of the ascending aorta.

11. The apparatus according to claim 10 , wherein, when in the non-constrained configuration inside the ascending aorta, the implantable device is configured to impede blood flow through the longitudinal portion of the ascending aorta in which the implantable device is placed such that there is no blood flow through the longitudinal portion of the ascending aorta, via any flow path other than through the conduit.

12. A method comprising:

inserting an implantable device into an ascending aorta of a subject while the implantable device is disposed inside a delivery device and is constrained in a constrained configuration by the delivery device; and

releasing the implantable device from the delivery device into the ascending aorta, thereby causing the implantable device to assume a non-constrained configuration within a longitudinal portion of the ascending aorta, by:

an upstream end of the implantable device radially expanding such that an upstream portion of the implantable device contacts an inner wall of the ascending aorta,

a central portion of the implantable device radially expanding such that the central portion of the implantable device defines a conduit extending through the implantable device, the conduit comprising a diverging portion that diverges in a direction from an upstream end of the conduit to a downstream end of the conduit, such that a cross-sectional area of the diverging portion of the conduit at its downstream end is greater than the cross-sectional area of the diverging portion of the conduit at its upstream end, the diverging portion being configured to reduce pressure loss of blood flowing through the conduit, relative to pressure loss of blood flowing through the longitudinal portion of the ascending aorta in an absence of the device, by reducing an area of flow separation,

the proximal end of the conduit being placed within the longitudinal portion of the ascending aorta such that when an aortic valve of the subject is in an open state, the proximal end of the conduit is disposed within 25 mm of a tip of the aortic valve,

a downstream end of the implantable device radially expanding such that a downstream portion of the implantable device contacts an inner wall of the ascending aorta, such as to anchor the downstream end of the implantable device with respect to the ascending aorta, and

the implantable device forming a folded portion radially between the upstream portion of the implantable device and the central portion of the implantable device, such that along a longitudinal direction of the implantable device, there is partial overlap between the upstream portion of the implantable device and the central portion of the implantable device.

13. The method according to claim 12 , wherein causing the implantable device to assume the non-constrained configuration comprises causing the implantable device to form the folded portion by forming a folded portion that has a sinusoidal cross-sectional shape.

14. The method according to claim 12 , wherein the implantable device does not include a prosthetic valve, and wherein inserting the implantable device into the ascending aorta does not include inserting a prosthetic valve into the ascending aorta.

15. The method according to claim 12 , wherein releasing the implantable device from the delivery device into the ascending aorta, comprises causing the implantable device to assume a non-constrained configuration in which the implantable device defines, at a region at its downstream end, a surface extending radially outward, around a full circumference of the conduit, from the conduit to the inner wall of the ascending aorta.

16. The method according to claim 12 , wherein the implantable device includes an implantable device made of a single continuous piece of stent graft material.

17. The method according to claim 12 , wherein releasing the implantable device from the delivery device into the ascending aorta, comprises causing the implantable device to assume a non-constrained configuration in which the diverging portion of the conduit has a length of more than 20 mm.

18. The method according to claim 17 , wherein releasing the implantable device from the delivery device into the ascending aorta, comprises causing the implantable device to assume a non-constrained configuration in which the length of the diverging portion of the conduit is less than 70 mm.

19. The method according to claim 12 , wherein releasing the implantable device from the delivery device into the ascending aorta, comprises causing the implantable device to assume a non-constrained configuration in which a ratio between a diameter of the conduit at the downstream end of the diverging portion of the conduit and a diameter of the conduit at the upstream end of the diverging portion of the conduit is less than 4:3.

20. The method according to claim 12 , wherein releasing the implantable device from the delivery device into the ascending aorta, comprises causing the implantable device to assume a non-constrained configuration in which the ratio between the diameter of the conduit at the downstream end of the diverging portion of the conduit and the diameter of the conduit at the upstream end of the diverging portion of the conduit is more than 7:6.

21. The method according to claim 12 , wherein releasing the implantable device from the delivery device into the ascending aorta, comprises causing the implantable device to assume a non-constrained configuration in which the implantable device impedes blood flow through the longitudinal portion of the ascending aorta, via any flow path other than through the conduit, to less than 20 percent of total blood flow through the longitudinal portion of the ascending aorta.

22. The method according to claim 21 , wherein releasing the implantable device from the delivery device into the ascending aorta, comprises causing the implantable device to assume a non-constrained configuration in which the implantable device impedes blood flow through the longitudinal portion of the ascending aorta such that there is no blood flow through the longitudinal portion of the ascending aorta, via any flow path other than through the conduit.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 17, 2025
From: HEMODYNAMX TECHNOLOGIES LTD.
To: HEMODYNAMX LTD.
Reel/Frame 069909/0283 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 21, 2019
From: KARAVANY, SAGY; FELD, TANHUM; NISHRI, BOAZ; YACOBY, MENASHE
To: HEMODYNAMX-TECHOLOGIES LTD.
Reel/Frame 048665/0317 →
Continuity (2)
Provisional Application 62373993 · Aug 12, 2016
Related Publication 20190183629A1 · Jun 20, 2019
Cited By (3)
US 12,472,063 US 12,544,212 US 12,564,505