Embolic protection during percutaneous heart valve replacement and similar procedures

• US 20090326575A1
• Filed: 06/22/2009
• Published: 12/31/2009
• Est. Priority Date: 06/23/2008
• Status: Active Grant

• Current Assignee: Lumen Biomedical, Inc.
• Original Assignee: Lumen Biomedical, Inc.
• Inventors: Galdonik, Jason A., Webster, Mark W.I., Ogle, Matthew F., Anderson, Edward
• Granted Patent: US 8,206,412 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 method for providing embolic protection during an endovascular procedure on a patient'"'"'s heart, the method comprising:

positioning one or more vascular filter elements to filter flow into the right carotid artery and the left carotid artery, wherein each of the one or more vascular filter elements are delivered through the right subclavian artery, the left subclavian artery, or a combination thereof.

2. The method of claim 1 wherein the one or more filter elements are delivered through the right subclavian artery.

3. The method of claim 2 wherein the one or more filter elements comprises two filter elements with a first filter element positioned to filter flow into the left carotid artery and a second filter element positioned to filter flow into the right carotid artery with placement of the second filter element in the right carotid artery or in the brachiocephalic artery.

4. The method of claim 2 wherein the one or more filter elements comprises a one or more filter elements associated with a single guide structure in which the guide structure spans between the brachiocephalic artery and the left carotid artery.

5. The method of claim 1 wherein the one or more vascular filter elements comprises a first filter element and a second filter element with the first element delivered through the right subclavian artery and the second filter element delivered through the left subclavian artery.

6. The method of claim 1 wherein the one or more filter elements are left unteathered inside an artery during the performance of an endovascular procedure on the heart.

7. The method of claim 1 wherein the one or more filter elements are removed from the arteries following performance of an endovascular procedure on the heart.

8. The method of claim 7 wherein at least a portion of the retrieval process is accompanied by aspiration.

9. The method of claim 1 further comprising performing an endovascular procedure on the heart while the one or more filters are filtering flow into the right common carotid artery and the left common carotid artery.

10. A filtration system comprising:

a catheter comprising a tubular element having a proximal end and a distal end, a lumen extending through the tubular element, and an expandable structure mounted toward the distal end on the exterior of the catheter; and

a filter device comprising;

a guide structure; and

a filter element mounted on the guide structure,

wherein the lumen of the catheter is suitable for the delivery of filter element mounted of the guide structure.

11. The filtration system of claim 10 wherein the filter element comprises surface capillary fibers having a first configuration in a bundle with a low profile and an extended configuration with the centers of the fibers flaring outward from the guide structure, wherein the guide structure comprises a corewire and an overtube with the corewire extending through a lumen of the overtube, and wherein the relative movement of the corewire and the overtube transitions the fibers from the low profile configuration to the extended configuration.

12. The filtration system of claim 10 wherein the expandable structure comprises a filter element mounted on the exterior of the catheter.

13. The filtration system of claim 10 wherein the expandable structure comprises an occlusive element and wherein the catheter further comprises an internal filter element and a bypass port proximal to the occlusion element to allow fluid to pass through the internal filter element to the bypass port to provide for filtered flow past the occlusion element.

14. The filtration system of claim 13 wherein the internal filter element comprises surface capillary fibers.

15. The filtration system of claim 13 wherein the occlusive element comprises a balloon.

16. The filtration system of claim 13 wherein the catheter is connected to an aspiration device at or near the proximal end of the catheter.

17. A filtration system comprising:

a catheter comprising;

a tubular element with a proximal end and a distal end, and a lumen extending through the tubular element,

a first filter device comprising a first guide structure and a first filtration element attached to the first guide structure, and

a second filter device comprising a second guide structure and a second filtration element attached to the second guide structure,

wherein the catheter has one or more lumens suitable for the delivery of the first filter device and the second filter device, and

wherein the catheter comprises a first port configured such that the first filter device can exit the catheter through the first port and a second port configured such that the second filter device can exit through the second port at an angled direction relative to the first filter device exiting the first port.

18. The filtration system of claim 17 wherein the filter elements each comprise surface capillary fibers having a first configuration in a bundle with a low profile and an extended configuration with the centers of the fibers flaring outward from the guide structure, wherein the guide structures independently comprise a corewire and an overtube with the corewire extending through a lumen of the overtube, and wherein the relative movement of the corewire and the overtube transitions the fibers from the low profile configuration to the extended configuration.

19. The filtration system of claim 17 wherein the filter elements are mounted detachably on the guide structures.

20. The filtration system of claim 17 wherein the catheter is connected to an aspiration device at or near the proximal end of the catheter.

21. A filter device comprising

an overtube,

a first corewire,

a second corewire,

a first filter element having a delivery configuration and a deployed configuration, and

a second filter element having a delivery configuration and a deployed configuration, the first filter element being positioned distal to the second filter element,

wherein at least a portion of the first corewire and at least a portion of the second corewire are within the overtube,

wherein the configuration of the first filter element is controlled through the relative position of the first corewire and the overtube, and

wherein the configuration of the second filter element is controlled through the relative position of the second corewire and the overtube.

22. The filtration system of claim 21 wherein the first filter element and the second filter element comprise surface capillary fibers wherein fibers are constrained in a bundle with a low profile in the delivery configuration and the centers of the fibers flaring outward in the deployed configuration.

23. The filtration system of claim 21 wherein the first filter element and the second filter element each comprise fibers mounted on a fiber support structure.

24. The filtration system of claim 23 wherein the fiber support structure of the first filter element is operably connected to the first corewire and the fiber support structure of the second filter element is operably connected to the second corewire.

25. A filtration system comprising

a first sealing member,

a second sealing member,

a lumen extending through the interior of each sealing member, and

one or more filtration elements associated with the lumen,

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

wherein the filtration elements are configured such that flow through the lumen extending past the first sealing member and the second sealing member passes through the one or more filtration elements.

26. The filtration system of claim 25 wherein the one or more filtration elements span between the first sealing member and the second sealing member.

27. The filtration system of claim 25 wherein one or more filter elements comprises a first filter element and a second filter element with the first filter element associated with the lumen extending within the interior of the first sealing element and the second filter element associated with the lumen extending within the interior of the second sealing element.

28. The filtration system of claim 25 wherein the one or more filter elements comprise surface capillary fibers.

29. A method for the endovascular replacement of a heart valve, the method comprising:

positioning one or more filter elements to filter flow from the heart flowing into the right carotid artery and the left carotid artery; and

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.

30. The method of claim 29 wherein the one or more filter elements are delivered through the right subclavian artery, the left subclavian artery, descending aorta, or a combination thereof.

31. The method of claim 29 wherein the one or more filter elements are left unteathered inside an artery during the performance of the endovascular replacement of a heart valve.

32. The method of claim 29 wherein the one or more filter elements are removed from the arteries following performance of the endovascular replacement of a heart valve.

33. The method of claim 32 wherein at least a port of the removal process is accompanied by aspiration.