WO2016011267A1

WO2016011267A1 - Embolic protection device

Info

Publication number: WO2016011267A1
Application number: PCT/US2015/040773
Authority: WO
Inventors: John P. PIGOTT
Original assignee: Pigott John P
Priority date: 2014-07-18
Filing date: 2015-07-16
Publication date: 2016-01-21

Abstract

An embolic protection device (20) has a cage-like frame (22) made of interconnected members. A mesh (26) sized to filter emboli covers a portion of the frame. A plurality of linkage members extends from one end of the frame to a tube (50), and may additionally extend from a second end of the frame to the tube. Preferably, the device is sized to be temporarily secured within the aortic arch (15) and prevent emboli from traveling through the arteries (12, 13, and 14) branching from the aortic arch.

Description

EMBOLIC PROTECTION DEVICE

Inventor: Dr. John P. Pigott

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62/026,179, filed July 18, 2014, which is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

[0002] Exemplary embodiments of the present invention relate generally to embolic protection devices, such as can be used to prevent or reduce the risks associated with emboli in the bloodstream. In particular, this invention relates to an embolic protection device that can be inserted into a blood vessel to prevent emboli from entering multiple vessels that branch outwardly therefrom, while still allowing blood flow to those vessels.

BACKGROUND AND SUMMARY OF THE INVENTION

[0003] Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure used to treat subjects with severe aortic valve stenosis or an abnormally narrowing of the aortic valve opening. During the procedure, a prosthetic aortic valve is delivered through a catheter tube and inserted into the existing aortic valve. The prosthetic aortic valve is then expanded therein and implanted to replace the existing aortic valve. However, a risk associated with the TAVI procedure is the embolization of debris, such as plaque and calcified particles, which can be released from the existing aortic valve. In severe cases, a piece of embolus can travel through the aortic arch and into a carotid artery causing stroke or even death.

[0004] To reduce or eliminate these risks, it is known to provide an embolus protection device in the aortic arch to prevent emboli from entering arterial vessels that branch outwardly therefrom. One known device is an embolic deflector. The embolic deflector is percutaneously inserted into the aortic arch and then deployed to cover the openings that lead into the various arterial vessels. The embolic deflector may also include a screen portion to allow blood flow through the deflector and into the arterial vessels. However, it may be difficult to completely seal around all of the openings that lead into the various arterial vessels using the embolic deflector due to the irregular (i.e., arcuate) shape of the aortic arch. Thus, it would be desirable to provide an embolic protection device that can be positioned in a blood vessel to effectively prevent emboli from entering multiple vessels that branch outwardly therefrom while still allowing blood flow to those vessels.

[0005] This invention relates to an embolic protection device that can be inserted into a blood vessel to prevent emboli from entering multiple vessels that branch outwardly therefrom, while still allowing blood flow to those vessels. Specifically, a collapsible catheter device is disclosed that can be navigated through the arcuate arch of the aorta. The catheter device may then be deployed such that it opens to an expanded position that substantially seals against the walls of the aorta. The device may comprise a larger mesh over the majority of the surface configured to maintain the structure of the device but otherwise allow blood flow to pass therethrough. A distal portion of said device may expand to a larger radius than a proximal portion to reflect the anatomy of the aortal arch. Select portions of the device may be covered with a much finer mesh adapted to stop emboli from traveling therethrough while still allowing blood flow. In particular those portions of the device facing the branching arteries of the aorta, including, without limitation, the brachioephalic artery, the left common arotid artery, and the left subclavian artery may be covered with said mesh. The mesh may be of any shape or size, and may be comprised of several smaller, individual sections of mesh.

[0006] Various aspects of this invention will become apparent to those skilled in the art from the following detailed description of the preferred embodiments, when read in light of the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] In addition to the features mentioned above, other aspects of the present invention will be readily apparent from the following descriptions of the drawings and exemplary embodiments, wherein like reference numerals across the several views refer to identical or equivalent features, and wherein:

[0008] Figure 1 is a sectional elevation view of an aortic arch having an embolic protection device in accordance with this invention disposed therein, which is illustrated in a contracted position.

[0009] Figure 2 is an enlarged sectional elevation view of the embolic protection device shown in Figure 1. [0010] Figure 3 is a sectional elevation view of the aortic arch shown in Figure 1 wherein the embolic protection device is illustrated in an expanded position.

[0011] Figure 4 is a side elevation view of the embolic protection device shown in Figure 3.

[0012] Figure 5 is a sectional elevation view of the aortic arch shown in Figure 1 wherein the embolic protection device is disposed therein in an alternative manner.

[0013] Figure 6 is a sectional elevation view of the embolic protection device shown in Figure 5 illustrated with a portion of the outer mesh removed or otherwise rendered transparent to highlight additional features of the present invention.

[0014] Figure 7 is a top plan view of the embolic protection device shown in Figure 4.

[0015] Figure 8 is a top plan view of an embolic protection device in accordance with another exemplary embodiment of the present invention.

[0016] Figure 9 is a top plan view of an embolic protection device in accordance with another exemplary embodiment of the present invention.

[0017] Figure 10 is a top plan view of an embolic protection device in accordance with another exemplary embodiment of the present invention.

[0018] Figure 11 is a top plan view of an embolic protection device in accordance with another exemplary embodiment of the present invention.

[0019] Figure 12 is a top plan view of an embolic protection device in accordance with another exemplary embodiment of the present invention. DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENT(S)

[0020] Various embodiments of the present invention will now be described in detail with reference to the accompanying drawings. In the following description, specific details such as detailed configuration and components are merely provided to assist the overall understanding of these embodiments of the present invention. Therefore, it should be apparent to those skilled in the art that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the present invention. In addition, descriptions of well-known functions and constructions are omitted for clarity and conciseness.

[0021] Referring now to the drawings, there is illustrated in figure 1 an aortic arch 10 having an embolic protection device 20 disposed therein in accordance with the present invention. The embolic protection device 20 in shown in the contracted position. As will be explained below, the embolic protection device 20 can be placed in the contracted position and percutaneously inserted into a blood vessel and positioned at a location where multiple vessels branch outwardly therefrom. Once in position, the embolic protection device 20 can be deployed and expanded within the blood vessel. In the expanded position, the embolic protection device 20 diverts emboli through the blood vessel and prevents the emboli from entering the branching vessels while still allowing blood flow to those vessels.

[0022] In one example, the embolic protection device 20 can be disposed within the aortic arch 10 of a subject prior to performing a transcatheter aortic valve

implantation (TAVI) procedure. The embolic protection device 20 is useful to prevent or reduce the risks typically associated with emboli that are released during the TAVI procedure, such as a stroke for example. Although the embolic protection device 20 will be described and illustrated in the context of a TAVI procedure, it should be appreciated that the embolic protection device 20 can be used in any desired environment and for any desired purpose.

[0023] As shown in figure 1 , an ascending aorta 11 leads from the heart (not shown) to the aortic arch 10. An aortic valve (not shown) is located between the heart and the ascending aorta 11. Multiple arterial vessels branch outwardly from the aortic arch 10, such as the brachiocephalic artery 12, the left common carotid artery 13, and the left subclavian artery 14. A descending aorta 15 continues from the aortic arch 10 to lower extremities of the subject's body. As blood is pumped from the heart, it flows through the aortic valve and into the aortic arch 10. Blood flow is then diverted to the numerous arterial vessels or continues down the descending aorta 15, as indicated by the broken arrows.

[0024] Referring now to figure 1 and figure 2, the illustrated embolic protection device 20 is a cylindrical, flexible member that is capable of expanding from a first or contracted position (shown in figure 1 and figure 2) to a second or expanded position (shown in figure 3 and figure 4) wherein the diameter of the embolic protection device 20 is larger when in the expanded position. The illustrated embolic protection device 20 may be placed in the contracted position and percutaneously inserted into a blood vessel, such as a femoral artery (not shown) for example, and fed over a previously positioned guide wire 16 until it is positioned in the aortic arch 10. Alternatively, the embolic protection device 20 can be delivered into the aortic arch 10 using an aortic valve replacement catheter 18 as will be explained below or fed through a delivery catheter (not shown).

[0025] The illustrated embolic protection device 20 is initially disposed within an outer sheath 30, although such is not required. The outer sheath 30 may extend from an operating handle (not shown), which will be further explained below. The outer sheath 30 is an elongated, cylindrical tube that can be made from any biocompatible material, such as polyvinyl or polyethylene and may include a braided wall reinforcement if so desired. It should also be appreciated that the outer sheath 30 can have any outer diameter, wall thickness, or length for a desired application.

[0026] A plurality of linkages 40 are configured to attach the embolic protection device 20 to an inner tube 50. The illustrated linkages 40 are connected at their first ends to an end portion of the embolic protection device 20. For example, the linkages 40 can be connected to the embolic protection device 20 by fused connections, pivotal hinge connections, fasteners, or in any other manner. The linkages 40 may radially extend beyond an outer surface of the embolic protection device 20 to facilitate retrieval of the embolic protection device 20 within the outer sheath 30 if so desired. Although not shown, the linkages 40 may continue to axially extend along any length of the inner or outer surface of the embolic protection device 20. The linkages 40 can be wire, tubing, or any other elongated members and can be made from any generally resilient material such as a metal wire or the like.

[0027] The linkages 40 can be secured to the inner tube 50 using any process, such as a soldering, brazing, or welding process. Alternatively, the linkages 40 can be secured to the inner tube 50 using a fastener arrangement, such as an annular collar, pivotal hinges, or any other components.

[0028] The illustrated inner tube 50 is a cylindrical member that extends within the outer sheath 30. The inner tube 50 can be formed from a generally resilient material such as nitinol, for example, which provides rigidity yet maintains adequate flexibility to enable the embolic protection device 20 to be passed through the blood vessel and into the aortic arch 10. It should be appreciated, however, that the inner tube 50 can be formed from any suitable material for a desired application. Further, the inner tube 50 need not be a cylindrical structure, but may alternatively be a solid wire or the like.

[0029] As briefly described above, the embolic protection device 20 may be provided with an operating handle (not shown), although such is not required. The operation handle can be any device that is configured to selectively operate the embolic protection device 20 between the contracted position and the expanded position. For example, the operating handle may include a first handle portion and a second handle portion that is moveable relative to the first handle portion. An opposite end of the inner tube 50 can be attached to the first handle portion and an opposite end of the outer sheath 30 can be attached to the second handle portion. Thus, the outer sheath 30 can be selectively moved relative to the embolic protection device 20 and the inner tube 50 by operation of the second handle portion. Alternatively, the operating handle can be a powered device or any other movable mechanism if so desired.

[0030] Referring now to figure 3 and figure 4, the embolic protection device 20 is illustrated in the expanded position. The embolic protection device 20 can be operable between the contracted position and the expanded position in any manner. As shown by the direction arrow in figure 4, the outer sheath 30 can be moved relative to the embolic protection device 20 by the operating handle (not shown) until the embolic protection device 20 becomes fully exposed from the outer sheath 30. The illustrated embolic protection device 20 is then configured to automatically expand once removed from the outer sheath 30, although such is not required.

[0031] For example, the embolic protection device 20 may include a frame 22 that is biased for expansion. The illustrated frame 22 is a cage-like structure made from a plurality of resilient members that are interconnected together, such as wire members or the like. The frame 22 may be shaped as pair of abutting hollow cylinders having different outer diameters and a sloping transition section between the sections. The resilient members can be interconnected in any manner for contraction and expansion of the embolic protection device 20. In one example, the resilient members may be connected to form diamond shaped sections or any other deformable shape structure. Alternatively, the resilient members may be intermeshed with one another to form a plurality of linked components if so desired. In this embodiment, the frame 22 need not be biased for expansion but can be expanded in any other manner, such as with expansion members (see figure 6) or a balloon catheter (not shown). The frame 22 can be made from stainless steel, nitinol, plastic, or any other biocompatible material. Thus, it should be appreciated that the frame 22 can be any flexible structure that is capable of expanding and contracting. Further, it should be appreciated that the frame 22 is not required.

[0032] The illustrated embolic protection device 20 includes a first diameter D1 and a second diameter D2 that is larger than the first diameter D1 , although such is not required. As shown in figure 3, the second diameter D2 is sized to fully traverse the inner lumen of the ascending aorta 11 such that the embolic protection device 20 engages the inner walls of the ascending aorta 11 forming a seal therebetween. The first diameter D1 can be any diameter sufficient to allow adequate blood flow through the aortic arch 10, but need not engage the inner walls thereof. It should be

appreciated, however, that the first diameter D1 may be sized such that the embolic protection device 20 engages the inner walls of the descending aorta 15 forming a seal therebetween if so desired.

[0033] The illustrated embolic protection device 20 also includes a sleeve 24, although such is not required. The sleeve 24 can be a layer of generally impermeable material that fully or partially extends around the circumference of the frame 22. As shown, the sleeve 24 extends around an inner circumference or surface of the frame 22 but may alternatively extend around an outer surface of the frame 22 if so desired. The sleeve 24 can be made from polytetrafluoroethylene (PTFE) or any other biocompatible material. It should be appreciated that the sleeve 24 may be any thickness or can be partially impermeable if so desired, as will be explained below in another embodiment.

[0034] The illustrated embolic protection device 20 further includes a screen portion 26. The screen portion 26 is configured to provide fluid communication through a surface of the embolic protection device 20. The screen portion 26 can be any fluid permeable barrier that is configured to filter or otherwise remove emboli from the blood stream that enters the various arterial vessels 12, 13, and 14 through the embolic protection device 20. For example, the screen portion 26 can be embodied as a semipermeable membrane that allows blood, but not embolic debris, to pass therethrough. The illustrated screen portion 26 is a flexible netting that is formed from interlaced or woven fibers. The screen portion 26 can be made from any biocompatible material that is flexible, including but not limited to PTFE fibers, one or more thin-gauge wires, or other types of filtering elements commonly employed within the body, in hemodynamic circuits, or in heart lung machines and dialysis machines. Further, the screen portion 26 can be made using any suitable process. The screen portion 26 can be secured to the frame 22 or the sleeve 24 in any manner, including but not limited to a fusion process, a woven process, an adhesive, or threading.

[0035] As shown in figure 5 and figure 6, the embolic protection device 20 may be inserted and positioned in the blood vessel using an aortic valve replacement (AVR) catheter 18. For example, the AVR catheter 18 can be used to implant the prosthetic heart valve during a TAVI procedure. As such, the step of initially inserting the embolic protection device 20 into the aortic arch 10 using a separate catheter can be eliminated by using the AVR catheter 18 to position the embolic protection device 20 in the aortic arch 10. The outer sheath 30 may initially extend over the AVR catheter 18 and the embolic protection device 20 to retain the embolic protection device 20 in the contracted position. Once the AVR catheter 18 has been properly positioned to perform the TAVI procedure, the embolic protection device 20 can be deployed and expanded by pulling the outer sheath 30 away from the embolic protection device 20.

[0036] As shown, the embolic protection device 20 may be attached to the AVR catheter 18 using any number of linkages 40 extending from a first end portion and/or a second end portion of the embolic protection device 20, although such is not required. It should be appreciated that the embolic protection device 20 may include any additional components to accomplish the functions described herein and below.

[0037] In one example, the illustrated embolic protection device 20 and any of the other embodiments described herein may include a plurality of extension members 28, although such is not required. The illustrated extension members 28 are attached at their first ends to an outer surface of the AVR catheter 18 and at their second ends to the frame 22 of the embolic protection device 20. When the embolic protection device 20 is in the contracted position (see figure 1 and figure 2), the extension members 28 lie in a generally flat position parallel with the AVR catheter 18. However, when the embolic protection device 30 is deployed from the outer sheath 30, the extension members 28 pivot outwardly in a radial direction from the AVR catheter 18 so as to expand the embolic protection device 20. It should be appreciated that the extension members 28 may be biased to extend outwardly from the AVR catheter 18, such as with resilient connections or spring elements for example. The extension members 28 may also be made from a generally resilient material, such as nitinol, or from any other suitable material, such as stainless steel or plastic.

[0038] As shown in figure 7, the illustrated screen portion 26 has an elliptical shape that axially extends along the first diameter D1 of the embolic protection device 20. The screen portion 26 has a sufficient length so that it can traverse each of the openings leading to the arterial vessels 12, 13, and 14. In other embodiments, the embolic protection device may be utilized in other areas of the body. In such

embodiments, the screen portion 26 may have a sufficient length so that it can traverse the opening of whatever area is intended to be blocked. Returning to the illustrated exemplary embodiment of the present invention, the screen portion 26 also circumferentially extends along an upper surface of the embolic protection device 20 and is oriented towards the openings leading to the arterial vessels 12, 13, and 14. Numerous embodiments of the screen portion 26 will be further described and illustrated below.

[0039] Referring now to figure 8, there is illustrated an embolic protection device 120 in accordance with another exemplary embodiment of this invention. The embolic protection device 120 may include any structural features as described and illustrated above in the first embodiment, although such is not required. Similar features have been numbered with common reference numerals but have been increased to 100 (i.e. 120, 122, 124, etc.). It should be appreciated that similar features are structured similarly, operate similarly, and/or have the same function unless otherwise indicated by the drawings or this specification.

[0040] For example, the embolic protection device 120 may be fed over a guide wire 116 and include a frame 122 and a sleeve 124. A plurality of linkages 140 are configured to attach the embolic protection device 120 to an inner tube 150, and the illustrated embolic protection device 120 may be initially disposed within an outer sheath 130, although such is not required. However, the illustrated embolic protection device 120 further includes a plurality of screen portions 126. The illustrated screen portions 126 are elliptical in shape and each extends along a substantial length of the first diameter D1. As such, the screen portions 126 may be positioned laterally adjacent to one another in a parallel manner. It should be appreciated that the screen portions 126 can have any length or width for a desired application. Further, the embolic protection device 120 may include any number or configuration of screen portions described herein. For example, the embolic protection device 120 may include screen portions 126 that are located about the circumference thereof if so desired. Thus, the embolic protection device 120 may be positioned within the aortic arch 10 in any orientation.

[0041] Referring now to figure 9, there is illustrated an embolic protection device 220 in accordance with another exemplary embodiment of this invention. The embolic protection device 220 may include any structural features as described and illustrated above in the previous embodiments, although such is not required. Similar features have been numbered with common reference numerals but have been increased to 200 (i.e. 220, 222, 224, etc.). It should be appreciated that similar features are structured similarly, operate similarly, and/or have the same function unless otherwise indicated by the drawings or this specification.

[0042] For example, the embolic protection device 220 may be fed over a guide wire 216 and include a frame 222 and a sleeve 224. A plurality of linkages 240 are configured to attach the embolic protection device 220 to an inner tube 250, and the illustrated embolic protection device 220 may be initially disposed within an outer sheath 230, although such is not required. However, the illustrated embolic protection device 220 further includes a plurality of screen portions 226. The illustrated screen portions 226 are oval in shape and each circumferentially extends about a portion of the first diameter D1. As such, the screen portions 226 may be positioned along any axial length of the first diameter D1. It should be appreciated that the screen portions 226 can have any length or width for a desired application. Further, the embolic protection device 220 may include any number or configuration of screen portions described herein. For example, the embolic protection device 220 may include screen portions 226 that extend along a top surface and a bottom surface thereof if so desired.

[0043] Referring now to figure 10, there is illustrated an embolic protection device 320 in accordance with another exemplary embodiment of this invention. The embolic protection device 320 may include any structural features as described and illustrated above in the previous embodiments, although such is not required. Similar features have been numbered with common reference numerals but have been increased to 300 (i.e. 320, 322, 324, etc.). It should be appreciated that similar features are structured similarly, operate similarly, and/or have the same function unless otherwise indicated by the drawings or this specification.

[0044] For example, the embolic protection device 320 may be fed over a guide wire 316 and include a frame 322 and a sleeve 324. A plurality of linkages 340 are configured to attach the embolic protection device 320 to an inner tube 350, and the illustrated embolic protection device 320 may be initially disposed within an outer sheath 330, although such is not required. However, the illustrated embolic protection device 320 further includes a plurality of screen portions 326A and screen portion 326B. The illustrated screen portions 326A are generally oval in shape and are positioned laterally adjacent to one another. The screen portion 326B is a square and may be positioned in any location relative to the screen portions 326A as desired. It should be appreciated that the screen portions 326A can have any length or width, and the screen portion 326B can have any length sides for a desired application. Further, the embolic protection device 320 may include any number or configuration of screen portions 326A and 326B described herein. [0045] Referring now to figure 11 , there is illustrated an embolic protection device 420 in accordance with another exemplary embodiment of this invention. The embolic protection device 420 may include any structural features as described and illustrated above in the previous embodiments, although such is not required. Similar features have been numbered with common reference numerals but have been increased to 400 (i.e. 420, 422,424, etc.). It should be appreciated that similar features are structured similarly, operate similarly, and/or have the same function unless otherwise indicated by the drawings or this specification.

[0046] For example, the embolic protection device 420 may be fed over a guide wire 416 and include a frame 422, a sleeve 424, and a screen portion 426. A plurality of linkages 440 are configured to attach the embolic protection device 420 to an inner tube 450, and the illustrated embolic protection device 420 may be initially disposed within an outer sheath 430, although such is not required. However, the illustrated screen portion 426 is spiral in shape, thereby extending around the circumference of the embolic protection device 420. The screen portion 426 can axially extend along any length of the first diameter D1 or the second diameter D2 if so desired. It should be appreciated that the screen portion 426 can have any width for a desired application. Thus, the embolic protection device 420 may be positioned within the aortic arch 10 in any desired orientation.

[0047] Referring now to figure 12, there is illustrated an embolic protection device 520 in accordance with a sixth embodiment of this invention. The embolic protection device 520 may include any structural features as described and illustrated above in the previous embodiments, although such is not required. Similar features have been numbered with common reference numerals but have been increased to 500 (i.e. 520, 522, 524, etc.). It should be appreciated that similar features are structured similarly, operate similarly, and/or have the same function unless otherwise indicated by the drawings or this specification.

[0048] A plurality of linkages 540 are configured to attach the embolic protection device 520 to an inner tube 550. The illustrated embolic protection device 520 may be fed over a guide wire 516 and include a first frame portion 522A and a second frame portion 522B that are located at opposite ends of an intermediate frame portion 522C, although such a configuration is not required. The first frame portion 522A is located near an end portion of the first diameter D1 and the second frame portion 522B is located near an end portion of the second diameter D2. As such, the first and second frame portions 522A, 522B can provide rigidity to the ends of the embolic protection device 520. If desired, the first and second frame portions 522A, 522B may also be configured to automatically expand once deployed from an outer sheath 530, as the frame described above in the previous embodiments. The first and second frame portions 522A, 522B may also engage the inner walls of the aortic arch (not shown) to provide a seal therewith, although such is not required. The illustrated intermediate frame portion 522C includes a plurality of axially extending wire members that are laterally spaced apart from one another. Although not shown, the wire members may be intermeshed with one another if so desired. The illustrated intermediate frame portion 522C allows the embolic protection device 520 to contract and expand with relative ease and provides increased flexibility for bending around the aortic arch (not shown) for example. The embolic protection device 520 may also include any number of extension members (not shown) if so desired, as described above with reference to figure 5 and figure 6. It should be appreciated, however, that the frame of the embolic protection device 520 may be configured in any manner.

[0049] The illustrated embolic protection device 520 also includes a screen portion 526 that circumferentially extends along an entire length of the embolic protection device 520. However, the screen portion 526 may circumferentially extend about any portion of the embolic protection device 520 or along any length thereof. The screen portion 526 can allow for increased blood flow through the embolic protection device 520 to the arterial vessels (not shown). The screen portion 526 may also allow the embolic protection device 520 to be positioned within the aortic arch (not shown) in any orientation. The screen portion 526 can be any permeable structure, such as described above for example.

[0050] Any embodiment of the present invention may include any of the optional or preferred features of the other embodiments of the present invention. The exemplary embodiments herein disclosed are not intended to be exhaustive or to unnecessarily limit the scope of the invention. The exemplary embodiments were chosen and described in order to explain the principles of the present invention so that others skilled in the art may practice the invention. Having shown and described exemplary embodiments of the present invention, those skilled in the art will realize that many variations and modifications may be made to the described invention. Many of those variations and modifications will provide the same result and fall within the spirit of the claimed invention. It is the intention, therefore, to limit the invention only as indicated by the scope of the claims.

Claims

CLAIMS WHAT IS CLAIMED IS:

Claim 1 . A device for placement in a human blood vessel to capture emboli comprising: a plurality of interconnected members arranged in the shape of a pair of abutting hollow cylinders defining a cage, said cage operable between a contracted position and an expanded position wherein the cage has a larger diameter when in the expanded position;

a screen sized to filter the emboli, said screen located on a surface of the cage; a tube having a smaller diameter than the cage when the cage is in the contracted position; and

a plurality of linkages secured to the cage at a first end and secured to the tube at a second end.

Claim 2. The device of claim 1 wherein:

the second hollow cylinder of the cage has a larger diameter than the first hollow cylinder; and

the first hollow cylinder of the cage is secured to the plurality of linkages.

Claim 3. The device of claim 2 wherein:

the first hollow cylinder of the cage is sized to create a seal with and be temporarily secured to a wall of the blood vessel when the cage is in the expanded position.

Claim 4. The device of claim 3 wherein:

the first hollow cylinder of the cage is sized to create a seal with and be temporarily secured to the aortic arch when the cage is in the expanded position; and the screen is of sufficient size and location on the cage to entirely cover the entrances to the three arteries extending from the aortic arch when the cage is secured to the aortic arch.

Claim 5. The device of claim 1 further comprising:

a sheath operable between a deployed position wherein the sheath extends over the cage when the cage is in the contracted position, and a retracted position wherein the sheath is retracted from the cage.

Claim 6. The device of claim 5 wherein:

the cage is biased in the expanded position.

Claim 7. The device of claim 1 wherein:

the screen is oval shaped.

Claim 8. The device of claim 1 wherein:

the screen comprises at least two portions, each portion having the same size and shape.

Claim 9. The device of claim 1 wherein:

the screen comprises at least two portions, each portion having a different shape.

Claim 10. The device of claim 1 wherein:

the screen is spiral shaped.

Claim 1 1 . The device of claim 1 wherein:

the tube extends concentrically through the cage.

Claim 12. The device of claim 1 1 wherein:

the plurality of linkages comprises a first and second set of linkages, the first set of linkages extends from the tube to a first end of the cage, and the second set of linkages extends from the tube to a second end of the cage.

Claim 13. The device of claim 12 further comprising:

a plurality of extension members in communication with the tube at a first end and the frame at a second end, the extension members located substantially perpendicular to the outer surface of the tube when the frame is in the expanded position and substantially parallel to the outer surface of the tube when the frame is in the contracted position.

Claim 14. The device of claim 13 wherein:

the plurality of extension members are secured to the portion of the tube located within the cage.

Claim 15. A method of preventing embolic material from entering side branch vessels connected to the aortic arch of a human, said method comprising the steps of:

intravascularly introducing an embolic protection device in a collapsed position along a catheter, said embolic protection device comprising a plurality of interconnected members arranged in the shape of a pair of abutting hollow cylinders defining a frame, a tube having a smaller diameter than the frame when the frame is in the contracted position, a plurality of linkages connected to the frame on a first end and to the tube on a second end, and a mesh located on a surface of the frame sized to cover the side branch vessels of the aortic arch when the embolic protection device is in an expanded position and having pores sized to filter the embolic material and allow communication of blood fluid;

transvascularly delivering the embolic protection device into the aortic arch; and expanding the embolic protection device in the aortic arch to the expanded position wherein the first hollow cylinder of the frame is secured to the aortic arch and the mesh is located to cover the side branch vessels connected to the aortic arch.

Claim 16. The method of claim 1 1 further comprising the steps of:

returning the embolic protection device to the collapsed position; and removing the embolic protection device from the patient's body by retracting the catheter.

Claim 17. A device for placement in a human blood vessel to capture emboli comprising:

a first plurality of interconnected members shaped as a hollow cylinder defining a first cage portion;

a second plurality of interconnected members shaped as a hollow cylinder defining a second cage portion;

a frame extending between the first and second cage portions;

a screen located on a surface of the frame and sized to filter the emboli and allow communication of the blood fluid;

a tube having a smaller diameter than the first and second cage portions;

a linkage wherein a first end of said linkage is secured to the tube and a second end of said linkage is secured to the second cage portion;

wherein the first and second cage portions are operable between a contracted position wherein the first and second cage portions have an initial diameter, and an expanded position, wherein the first and second cage portions have a subsequent diameter that is larger than the initial diameter; and

wherein said second cage portion has a smaller outer diameter than the first cage portion when the first and second cage portions are in the expanded position.

Claim 18. The device of claim 17 wherein: the first cage portion is sized to provide a seal with and be temporarily secured to the aortic arch when the first cage portion is in the expanded position; and

the screen is of sufficient size and location on the frame to cover the entrances to the three arteries extending from the aortic arch when the first cage portion is secured to the aortic arch.

Claim 19. The device of claim 17 further comprising:

a sheath operable between a deployed position wherein the sheath extends over the first and second cage portions when the first and second cage portions are in the contracted position, and a retracted position wherein the sheath is retracted from the first and second cage portions.

Claim 20. The device of claim 18 wherein:

the first and second cage portions are biased in the expanded position.