Aortic occlusion device

• US 10,130,371 B2
• Filed: 05/13/2014
• Issued: 11/20/2018
• Est. Priority Date: 05/13/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Dehdashtian, Mark, Jimenez, Teodoro S., Satter, Nathan, Schroeder, Fabian D., Mazzei, Raffaele, Kosmoski, Jeff, Zamani, Shaun, Yestrepsky, Adam
• Primary Examiner(s): Stigell, Theodore
• Application Number:
  US14/276,795
• Publication Number:
  US 20140350523A1
• Time in Patent Office: 1,652 Days
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 2205/3331 Pressure; Flow

Abstract

Embodiments of aortic occlusion devices are described herein that include radially expandable and collapsible proximal and distal end portions, such as annular self-expanding stents or frames, that are configured to radially expand within an aorta to secure the device within the aorta. The devices can also include a catheter extending axially between the distal end portion and the proximal end portion and a porous covering, or filter, positioned around the catheter and between the proximal end portion and the distal end portion and configured to filter emboli from blood flowing into upper-body arteries. The device can further include a one-way valve positioned at or adjacent to the distal end portion of the device and configured to restrict retrograde blood flow through the device toward the heart.

Claims

1. An aortic occlusion device, comprising:

a radially expandable and collapsible proximal end portion and a radially expandable and collapsible distal end portion, wherein the distal end portion comprises a substantially conical portion, and the proximal and distal end portions are configured to radially expand within an aorta to secure the device within the aorta;

a catheter extending axially between the distal end portion and the proximal end portion;

a porous covering positioned around the catheter and between the proximal end portion and the distal end portion; and

a one-way valve positioned between the substantially conical portion of the distal end portion and the proximal end portion of the device and configured to restrict retrograde blood flow through the device toward the heart.

2. The aortic occlusion device of claim 1, wherein the device is configured to be positioned in the aortic arch.

3. The aortic occlusion device of claim 2, wherein the distal end portion is configured to be positioned in the ascending aorta.

4. The aortic occlusion device of claim 2, wherein the proximal end portion is configured to be positioned in the descending aorta.

5. The aortic occlusion device of claim 1, wherein the device is radially self-expandable from a collapsed configuration to an expanded configuration within the aorta.

6. The aortic occlusion device of claim 1, wherein the proximal end portion and the distal end portion each comprise discrete radially expandable frames.

7. The aortic occlusion device of claim 6, wherein the radially expandable frames comprise self-expandable stents.

8. The aortic occlusion device of claim 6, wherein the radially expandable frames comprise balloon-expandable stents.

9. The aortic occlusion device of claim 1, wherein the device is configured to be inserted and removed from a patient'"'"'s body percutaneously using a delivery catheter.

10. A system including

the aortic occlusion device of claim 1,

a cardiopulmonary bypass system configured to provide a flow of oxygenated blood to the aortic occlusion device in a retrograde flow direction, and

a source of cardioplegia fluid in fluid communication with the catheter.

11. An aortic occlusion device, comprising:

a radially expandable and collapsible proximal end portion and a radially expandable and collapsible distal end portion, the proximal and distal end portions configured to radially expand within an aorta to secure the device within the aorta, wherein the distal end portion comprises a substantially conical portion;

a catheter extending axially between the distal end portion and the proximal end portion;

a porous covering positioned around the catheter and between the proximal end portion and the distal end portion; and

a valve between the conical portion of the distal end portion and the proximal end portion of the device, wherein the valve is configured to restrict retrograde blood flow through the device toward the heart, wherein the valve comprises a cylindrical valve housing with radial openings therein, and the valve further comprises a movable valve element configured to selectively cover and uncover the radial openings.

12. The aortic occlusion device of claim 11, wherein the movable valve element comprises a flexible sealing member movable between an open position wherein free portions of the flexible sealing member flare radially away from the cylindrical valve housing, and a closed position wherein the free portions of the flexible sealing member engages against the cylindrical valve housing.

13. The aortic occlusion device of claim 12, wherein the flexible sealing member comprises a plurality of leaflets having free ends configured to open radially away from the cylindrical valve housing and to close inwardly against the cylindrical valve housing.

14. The aortic occlusion device of claim 11, wherein the valve moves from an open configuration to a closed configuration responsive to fluid flow.

15. The aortic occlusion device of claim 11, wherein the distal end portion is configured to be positioned and expanded in the ascending aorta, and the proximal end portion is configured to be positioned and expanded in the descending aorta.