Embolic protection during percutaneous heart valve replacement and similar procedures

• US 9,943,396 B2
• Filed: 10/13/2015
• Issued: 04/17/2018
• Est. Priority Date: 06/23/2008
• Status: Active Grant

• Current Assignee: Lumen Biomedical, Inc.
• Original Assignee: Lumen Biomedical, Inc.
• Inventors: Galdonik, Jason A., Ogle, Matthew F., Anderson, Edward, Webster, Mark W. I.
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US14/881,711
• Publication Number:
  US 20160030153A1
• Time in Patent Office: 917 Days
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/012 Multiple filtering units
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

Various devices are described to provide filtering of flow from the aorta to the left carotid artery and the right carotid artery. The filters can be brought into a desired position through one or more peripheral arteries. A single filter device can provide the desired filtering or a plurality of devices can be used. In particular a single filter device can span between the brachiocephalic artery and the left carotid artery. These filter devices can be used effectively to capture emboli generated during procedures on the heart so that emboli do not travel to the patient'"'"'s brain where the emboli can cause a stroke or other adverse event. In particular, these filters can be used during percutaneous procedures on the heart, such as endovascular heart valve replacement.

Claims

1. A filtration system for capture emboli in a blood vessel comprising

a tubular element,

a first sealing member and a second sealing member spaced apart and attached to the exterior of a distal section of the tubular element, with the first sealing member distal to the second sealing member,

a central port in the tubular element between the first sealing member and the second sealing member providing opening into a lumen extending past respectively the first sealing member and the second sealing member, and

two or more filtration elements associated with the lumen at the distal section of the tubular element,

wherein the first sealing member and the second sealing member each having an extending outward deployed configuration and a delivery configuration, and

wherein the filtration elements are configured such that fluid flows through the central port into the lumen, by passes respectively the first sealing member and the second sealing member and exits the tubular element through the two or more filtration elements.

2. The filtration system of claim 1 wherein the first sealing member and the second sealing member each comprises a balloon having a diameter in the deployed configuration large enough to occlude a blood vessel.

3. The filtration system of claim 2 wherein the tubular element further comprises a balloon inflation lumen in fluid communication with the two balloons.

4. The filtration system of claim 2 wherein the tubular element further comprises a first balloon inflation lumen that is in fluid communication with the balloon associated with the first sealing member and a second balloon inflation lumen that is in fluid communication with the balloon associated with the second sealing member.

5. The filtration system of claim 1 wherein the sealing members comprise a membrane on a self expanding metal frame.

6. The filtration system of claim 1 further comprising a sheath slidably mounted on the tubular element and having a configuration covering the sealing members.

7. The filtration system of claim 1 wherein the two or more filtration elements comprise fibers.

8. The filtration system of claim 7 wherein at least some of the fibers are surface capillary fibers.

9. The filtration system of claim 7 wherein at least some of the fibers comprise polymer.

10. The filtration system of claim 1 wherein the two or more filtration elements comprise a porous membrane.

11. The filtration system of claim 1 wherein the distance between the first sealing member and the second sealing member on the distal section of the tubular member is sufficient to span the aortic arch between entrance of the brachiocephalic artery and the left carotid artery for a human patient.

12. The filtration system of claim 1 wherein the diameter of the tubular member is suitable for placement inside aortic arch percutaneously.

13. A method for providing embolic protection during an endovascular procedure on a patient'"'"'s heart using a filtration system comprising

a tubular element,

a first sealing member and a second sealing member spaced apart and attached to the exterior of a distal section of the tubular element, with the first sealing member distal to the second sealing member,

a central port in the tubular element between the first sealing member and the second sealing member providing opening into a lumen extending past respectively the first sealing member and the second sealing member, and

one or more filtration elements associated with the lumen at the distal section of the tubular element,

wherein the first sealing member and the second sealing member each having an extending outward deployed configuration and a delivery configuration, and

wherein the filtration elements are configured such that fluid flows through the central port into the lumen, by passes respectively the first sealing member and the second sealing member and exits the tubular element through the one or more filtration elements, the method comprising,

delivering the filtration system through the right subclavian artery along the aortic arch into the left carotid artery to position the central port in the aortic arch, the first sealing element in the left carotid artery, and the second sealing element in the brachiocephalic artery;

deploying the sealing elements to occlude the blood flow directly into the carotid arteries from the aorta while allowing blood flow to enter the lumen through the central port and exit the tubular element through the one or more filtration elements as filtered blood flow into the carotid arteries, by passing the first sealing member and the second sealing member.

14. The method of claim 13 further comprising performing an endovascular procedure on the heart while the filtration system is filtering flow into the carotid arteries.

15. The method of claim 14 wherein the procedure comprises replacement of the aortic valve.

16. The method of claim 13 further comprising performing a surgical procedure on the heart while the filtration system is filtering flow into the carotid arteries.

17. The method of claim 13 further comprising delivering a heart valve delivery catheter through the descending aorta or the subclavian artery to the heart to effect at least a step related to removal of a heart valve or the placement of a prosthetic heart valve.

18. The method of claim 13 further comprising removing the filtration system from the arteries following performance of an endovascular procedure on the heart.

19. The method of claim 18 wherein at least a part of the removal process is accompanied by aspiration.