Aortic implant method

• US 10,568,731 B2
• Filed: 02/11/2016
• Issued: 02/25/2020
• Est. Priority Date: 02/12/2015
• Status: Active Grant

• Current Assignee: Hemodynamx-Technologies, Ltd.
• Original Assignee: Hemodynamx-Technologies, Ltd.
• Inventors: Karavany, Sagy, Feld, Tanhum, Nishri, Boaz
• Primary Examiner(s): Prebilic, Paul B
• Application Number:
  US15/550,661
• Publication Number:
  US 20180036109A1
• Time in Patent Office: 1,475 Days
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Apparatus and methods are described for regulating blood flow in an ascending aorta of a subject including inserting a device (20) into the ascending aorta. When in a deployed state, the device defines an inner surface (24) that defines a conduit (26) through the device, at least a portion (25) of the inner surface diverging, such that a cross-sectional area of the conduit at the downstream end (34) of the diverging portion is greater than a cross-sectional area of the conduit at the upstream end (30) of the diverging portion. The device is deployed within a longitudinal portion of the ascending aorta, such that blood flow through the portion of the ascending aorta, via any flow path other than through the conduit, is less than 20 percent of total blood flow through the portion of the ascending aorta. Other applications are also described.

Claims

1. A method of using a device comprising:

identifying a subject as suffering from an aortic valve stenosis; and

in response thereto, reducing pressure loss downstream of an aortic valve of the subject, by;

inserting, into an aorta of the subject, a device that, when in a deployed state, defines an upstream end, a downstream end, and an inner surface that defines a conduit through the device that extends from the upstream end of the device to the downstream end of the device, at least a portion of the conduit diverging in a direction from an upstream end of the diverging portion to a downstream end of the diverging portion, such that a cross-sectional area of the conduit at the downstream end of the diverging portion is greater than a cross-sectional area of the conduit at the upstream end of the diverging portion; and

deploying the device within a longitudinal portion of the ascending aorta that is downstream of the aortic valve, such that the device maintains its deployed state, and such that the outer circumference of a region at the downstream end of the device apposes an inner wall of the ascending aorta, the region at the downstream end of the conduit being configured to impede backflow of blood, outside of the conduit, toward the aortic valve,

the conduit reducing pressure loss of blood flowing through the conduit, relative to a loss of pressure of blood flowing through the longitudinal portion of the ascending aorta in the absence of the device, by reducing an area of flow separation of the blood flow.

2. The method according to claim 1, wherein the device does not include a prosthetic valve, and wherein inserting the device into the aorta does not include inserting a prosthetic valve into the aorta.

3. The method according to claim 1, wherein deploying the device within the longitudinal portion of the ascending aorta comprises deploying the device within the longitudinal portion of the ascending aorta such that the region at the downstream end of the device excludes all backflow of blood through the longitudinal portion of the ascending aorta, via any flow path other than through the conduit.

4. The method according to claim 1, wherein deploying the device within a longitudinal portion of the ascending aorta comprises deploying the device within a longitudinal portion of the ascending aorta, such that a portion of the inner surface that is proximal to the diverging portion of the conduit, defines a converging portion of the conduit that converges in a direction from an upstream end of the converging portion to a downstream end of the converging portion.

5. The method according to claim 1, wherein the device includes a set of one or more balloons, and wherein deploying the device comprises inflating the one or more balloons.

6. The method according to claim 1, wherein the device has a length of more than 20 mm, when in the deployed state.

7. The method according to claim 1, wherein a ratio of a diameter of the conduit at the downstream end of the diverging portion to a diameter of the conduit at the upstream end of the diverging portion is greater than 4:

3, when the device is in the deployed state.

8. The method according to claim 1, a difference between a diameter of the conduit at the downstream end of the diverging portion to a diameter of the conduit at the upstream end of the diverging portion is greater than 3 mm, when the device is in the deployed state.

9. The method according to claim 1, wherein the device includes an outer support structure configured to anchor the device inside the aorta by contacting an inner wall of the aorta.

10. The method according to claim 9, wherein the inner surface and the outer support structure are made of stent graft material.

11. The method according to claim 10, wherein the inner surface and the outer support structure are made of a single continuous piece of stent graft material.

12. The method according to claim 1,

wherein deploying the device within the longitudinal portion of the ascending aorta such that the outer circumference of the region apposes the wall of the ascending aorta comprises deploying the device such that a surface of the device extends radially outward around a full circumference of the conduit, and contacts a location selected from the group consisting of:

(i) the inner wall of the ascending aorta, and (ii) an outer support structure of the device that is in contact with the inner wall of the ascending aorta,

the surface being configured to impede blood flow therethrough.

13. The method according to claim 12, wherein deploying the device such that the surface of the device extends radially outward around the full circumference of the conduit and contacts the selected location comprises deploying the device such that a downstream end of the inner surface that defines the conduit extends radially outward around the full circumference of the conduit and contacts the selected location.

14. The method according to claim 12, wherein deploying the device such that the surface of the device extends radially outward around the full circumference of the conduit and contacts the selected location comprises deploying the device such that a surface that is disposed around the full circumference of the conduit at the downstream end of the conduit and that extends radially outward contacts the selected location.

15. The method according to claim 12, wherein deploying the device such that the surface of the device extends radially outward around the full circumference of the conduit and contacts the selected location comprises deploying the device such that two surfaces of the device extend radially outward around the full circumference of the conduit and contact the selected location, both of the surfaces being configured to impede blood flow therethrough.

16. The method according to claim 15, wherein deploying the device such that two surfaces of the device extend radially outward around the full circumference of the conduit and contact the selected location comprises causing blood to coagulate in a region between the two surfaces.