Balloon actuated apparatus having multiple embolic filters, and method of use

• US 20020161390A1
• Filed: 04/30/2001
• Published: 10/31/2002
• Est. Priority Date: 04/30/2001
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Mouw, Steven L.
• Granted Patent: US 6,746,469 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/012 Multiple filtering units
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2230/0067 conical

Abstract

An apparatus having multiple filters for capturing embolic material released from a lesion in an occluded body vessel being treated with an interventional procedure. The filters are placed downstream from the lesion, and the porosity of the filters decreases for each succeeding filter downstream from the lesion. Before encountering the filters, the embolic material passes a unidirectional barrier acting as a one-way valve to prevent backflow. The unidirectional barrier and filters are positioned along a plurality of arms. The arms may be fabricated from a memory metal, and the memory position of the plurality of arms is a collapsed position surrounding a common longitudinal axis. The apparatus includes an expansion member, such as a balloon, which inflates to move the plurality of arms radially outward to deploy the filters. Embolic material passes through the unidirectional barrier and is trapped between the layers of filters. When the balloon is deflated, the plurality of arms return to the memory position, collapse the unidirectional barrier and the filters, and embolic material remains trapped between the layers of filters.

Claims

1. An apparatus for filtering embolic material, comprising:

a plurality of arms, each arm having a proximal end and a distal end;

a expandable member located near the distal end of each of the arms, wherein the expandable member causes the plurality of arms to move radially outward;

a first filter located at a first segment point near the proximal end and the distal end of each of the arms; and

a unidirectional barrier located adjacent to the first filter at the proximal end of each of the arms such that the unidirectional barrier allows embolic material to pass in a flow direction toward the first filter, and not in an opposite flow direction.

2. The apparatus of claim 1, further comprising:

a second filter located at a second segment point of each of the arms;

wherein the first filter has a porosity higher than the porosity of the second filter such that the second filter is capable of capturing embolic material which may pass through the first filter.

3. The apparatus of claim 2, wherein:

the first filter and the second filter limit the radial movement of the plurality of arms such that the diameter defined by the first segment point of each of the arms is substantially the same as the diameter defined by the second segment point of each of the arms.

4. The apparatus of claim 1, wherein:

an anti-coagulant is bound to the first filter.

5. The apparatus of claim 1, wherein:

the plurality of arms is composed of a memory metal and has a memory position, and the memory position represents the plurality of arms collapsed toward one another along a longitudinal axis.

6. The apparatus of claim 1, wherein:

each arm has a greater thickness at the distal end than at the proximal end.

7. An apparatus for filtering embolic material, comprising:

a first filter having a first porosity;

a unidirectional barrier arranged to allow embolic material to pass in the direction toward the first filter, and not in the opposite direction; and

means for deploying the first filter and the unidirectional barrier from a collapsed position to an expanded position.

8. The apparatus of claim 7, wherein:

the means for deploying includes a plurality of arms having a proximal end, a distal end, and a first segment point between the proximal end and the distal end, wherein the unidirectional barrier is located at the proximal end of the plurality of arms, and the first filter is located at the first segment point of the plurality of arms; and

an expandable member located near the distal end of the plurality of arms, wherein inflating the expandable member causes the plurality of arms to move radially outward.

9. The apparatus of claim 8, further comprising:

a second filter, the second filter having a smaller porosity than the first filter such that the second filter is capable of screening smaller embolic material than the first filter; and

the plurality of arms includes a second segment point between the first segment point and the distal end, wherein the second filter is located at the second segment point of the plurality of arms, and embolic material is captured between the first filter and the second filter.

10. The apparatus of claim 9, wherein:

the first filter and the second filter limit the radial movement of the plurality of arms such that the diameter defined by the first segment point of each of the arms is substantially the same as the diameter defined by the second segment point of each of the arms.

11. The apparatus of claim 8, wherein:

the plurality of arms is composed of a memory metal and has a memory position, and the memory position represents the plurality of arms collapsed toward one another along a longitudinal axis.

12. The apparatus of claim 8, wherein:

the plurality of arms have a greater thickness at the distal end than at the proximal end.

13. The apparatus of claim 7, wherein:

an anti-coagulant is bound to the first filter.

15. The method of claim 14, wherein:

the embolic filter device further includes a second filter capable of screening smaller embolic material than the first filter; and

the capturing of embolic material further includes capturing embolic material between the first filter and the second filter.

16. The method of claim 14, wherein:

the expanding of the expandable member includes inflating the expandable member with a fluid.

17. The method of claim 16, further comprising:

deflating the expandable member, wherein the plurality of arms collapse toward one another.

18. The method of claim 17, wherein:

the plurality of arms is composed of a memory metal and has a memory position, and the memory position represents the plurality of arms collapsed toward one another along a longitudinal axis when the expandable member is deflated.

19. The method of claim 14, wherein:

the capturing of embolic material further includes inhibiting coagulation with an anti-coagulant bound to the first filter.

14. A method of filtering embolic material, comprising:

inserting an embolic filter device into a body vessel, wherein the embolic filter device includes a plurality of arms having a proximal end, a distal end, and a first segment point between the proximal end and the distal end, a expandable member located at the distal end of the plurality of arms, a first filter located at the first segment point of the plurality of arms, and a unidirectional barrier located at the proximal end of the plurality of arms;

advancing the embolic filter device to a position downstream of the lesion to be treated in the blood vessel;

expanding the expandable member to move the plurality of arms radially outward and deploy the first filter; and

capturing, in the embolic filter device, embolic material produced during treatment of the lesion, wherein embolic material passes the unidirectional barrier in the direction toward the first filter, and not in the opposite direction, and the first filter screens embolic material of a certain size.