US20070233179A1

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Publication number: US20070233179A1
Application number: US11/762,193
Authority: US
Inventors: Eamon Brady; David Vale; Ronald Kelly; John Neilan; Steven Horan; Gerard Rabitte; Gerry McCaffrey
Original assignee: Salviac Ltd; Abbott Laboratories
Current assignee: Salviac Ltd; Abbott Laboratories
Priority date: 2001-12-21
Filing date: 2007-06-13
Publication date: 2007-10-04
Also published as: US20060241681A1; US20070233180A1; EP1455681A2; AU2002351156A1; AU2002353442A1; WO2003055413A2; US20070233183A1; WO2003055412A2; US20030130684A1; US8114115B2; AU2002353442A8; US7927349B2; US7037320B2; EP1455686A2; AU2002351156A8; WO2003055412A8; EP1455681B1; WO2003055413A3

Abstract

A support103for an embolic protection device comprises round wires116which may form one or more support hoops for a filter body. The circumferential hoop formed by the wires116ensures that in the expanded position, the filter body102will be supported by the support frame103in circumferential apposition with the interior wall of the vasculature. The wires116may have a strain distributing linkage element in the form of a loop120. The loop120acts as a diameter or circumference adjuster allowing an embolic protection device to adapt to different Bessel contours and sizes whilst maintaining apposition with the vessel wall. The strain relieving geometry of the loops enhances the compliance of the bend points without creating a weakened hinge point, thus ensuring that there is no discontinuity in the circumferential seal against the vessel wall.

Description

This application is a continuation of U.S. application Ser. No. 11/332,485 filed Jan. 17, 2006, which is a continuation of U.S. application Ser. No. 10/325,954, filed Dec. 23, 2002, now U.S. Pat. No. 7,037,320, and claims benefit under 35 U.S.C. § 119 to U.S. Provisional Application 60/341,836 filed Dec. 21, 2001, U.S. Provisional Application No. 60/341,805 filed Dec. 21, 2001, U.S. Provisional Application No. 60/373,640 filed Apr. 19, 2002, U.S. Provisional Application No. 60/373,641 filed Apr. 19, 2002 and U.S. Provisional Application No. 60/377,248 filed May 3, 2002, all of the disclosures of which are hereby incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to an embolic protection device.

In particular, it relates to an embolic protection device of the type comprising a collapsible filter body to capture embolic material, and a support to maintain the filter body in an expanded position when the embolic protection device is deployed in a vasculature.

2. Description of the Related Art

Embolic protection devices of this general type are known.

However, there exist a number of problems with some of the known devices. In particular, upon collapse of the filter support, prior to delivery of the embolic protection device into and/or retrieval from a vasculature, large, localized stresses may be induced in the support. Solutions to this problem heretofore may result in features which inhibit the optimum performance of the device. In some systems flow paths for the blood can develop between the filter body and the interior wall of the vasculature. In general conventional devices are not highly trackable because of their length in the wrapped delivery configuration.

There is therefore a need for an embolic protection device which overcomes at least some of the disadvantages that exist with some of the known devices.

SUMMARY OF THE INVENTION

According to the invention there is provided an embolic protection device comprising:

a collapsible filter element for delivery through a vascular system of a patient;

the filter element comprising a collapsible filter body and a filter support for the filter body;

the filter body having an inlet end and an outlet end, the inlet end of the filter body having one or more inlet openings sized to allow blood and embolic material enter the filter body, the outlet end of the filter body having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter body;

the filter support being movable between a collapsed position for movement through the vascular system, and an extended outwardly projecting position to support the filter body in an expanded position;

the filter support comprising a number of segments at least some of which are interconnected by a strain distributing linking element.

In one embodiment at least some of the segments are of wire.

The linking element may be of wire. The linking element may be of the same wire as that of the support segments.

In one embodiment the linking element extends normally of adjacent segments. The linking element may extend longitudinally of the axis of the filter and/or the linking element extends radially inwardly of the adjacent segments.

In a preferred embodiment the linking element comprises a loop. The loop may be of generally omega shape.

In one embodiment at least portion of the linking element is radiopaque. Alternatively or additionally at least portion of at least some of the support segments are radiopaque.

In one embodiment the linking element is of multifilament construction. Alternatively or additionally at least one of the support segments is of multifilament construction.

In one embodiment the support frame is defined by at least two wire segments terminating distally, the distal terminations of adjacent segments being fixed relative to one another and extending generally parallel.

The support frame may be defined by at least two wire segments terminating proximally, the proximal terminations of adjacent segments being fixed relative to one another and extending generally parallel.

In one embodiment the support frame comprises a support arm for one end of the filter body which extends towards on opposite end of the filter body in the deployed configuration.

In one embodiment the device comprises a carrier extending longitudinally of the frame. The carrier may be a tubular member, sleeve or sleeves or may comprise a guidewire.

A flexible tether may extend between the carrier and the support frame.

In one embodiment the support frame comprises a support loop or hoop.

In another aspect the invention provides an embolic protection device comprising:

- a collapsible filter element for delivery through a vascular system of a patient;
- the filter element comprising a collapsible filter body and a filter support for the filter body;
- the filter body having an inlet end and an outlet end, the inlet end of the filter body having one or more inlet openings sized to allow blood and embolic material enter the filter body, the outlet end of the filler body having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter body;
- the filter support being movable between a collapsed position for movement through the vascular system, and an extended outwardly projecting position to support the filter body in an expanded position;
- the filter support comprising a support frame having at least two longitudinally spaced-apart segments which are interconnected by at least one flexible linking element.

The support frame segments may be of wire.

In a further aspect the invention provides an embolic protection device comprising:

- a collapsible filter element for delivery through a vascular system of a patient;
- the filter element comprising a collapsible filter body and a filter support for the filter body;
- the filter body having an inlet end and an outlet end, the inlet end of the filter body having one or more inlet openings sized to allow blood and embolic material enter the filter body, the outlet end of the filter body having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter body;
- the filter support being movable between a collapsed position for movement through the vascular system, and an extended outwardly projecting position to support the filter body in an expanded position;
- the filter support comprising a support frame defined by at least two wire segments having terminations, the terminations of adjacent segments being fixed relative to one another and extending generally parallel.

The wire segments may terminate distally, the distal terminations of adjacent segments being fixed relative to one another and extending generally parallel. Alternatively or additionally the wire segments terminate proximally, the proximal terminations of adjacent segments being fixed relative to one another and extending generally parallel.

The terminations may extend axially in relation to the filter. The distal terminations may be free to move axially. Alternatively or additionally the proximal terminations are free to move axially.

In one embodiment the proximal terminations of adjacent wire segments are configured to meet in a loop formation. The distal terminations of adjacent wire segments may be configured to meet in a loop formation.

In one embodiment the wire segments are of substantially the same length.

The wire segments may be fixed relative to one another by soldering, or welding, or bonding the wire segments to one another. Alternatively or additionally the device comprises a clamp around the wire segments to fix the wire segments relative to one another. The clamp may comprise a tubular sleeve. The clamp may comprise a clamp wire wound around the wire segments. The clamp may be at least partially of radiopaque material.

In one embodiment the wire segments are provided by a single wire bent back on itself.

Terminations may be located on an outer circumference of the filter frame. Alternatively or additionally terminations are located on an axis of the filter.

One of the proximal or distal terminations may be located on an outer circumference of the filter frame and the other of the proximal or distal terminations located on an axis of the filter.

In one embodiment each wire element has a circumferentially extending portion, and together the circumferentially extending portions of the wire elements define a cell which forms a substantially complete loop.

The wire elements may together define a number of cells axially spaced-apart. The support frame may have a connector between a first cell and a second cell.

The wire element may extend in an irregular path such as in a substantially wave-like pattern.

In one embodiment the wire element extends in an arcuate path.

In one embodiment the filter support comprises at least one support leg extending radially inwardly from the support frame, the leg being defined by at least one wire. The cross-sectional area of the support leg may decrease radially inwardly.

In one embodiment at least part of the support leg is integral with at least part of the support frame. The support leg may be provided as an extension of one wire element and/or the support leg is provided as an extension of two or more adjacent wire elements.

In one embodiment the support leg extends at least partially distally inwardly from the support frame.

The wire element may have a round cross-section.

Alternatively, the wire clement has an elongate cross-section with a long dimension and a short dimension. The short dimension of the wire element cross-section may be aligned substantially along the radial direction of the filter support. The wire element may be rectangular in cross-section.

In one embodiment the filter body comprises a flap wrappable around a wire element of the filter support to fix the filter body to the filter support.

In another aspect the invention provides a method of collapsing an embolic protection device for delivery and/or retrieval of the device through a vascular system, the method comprising the steps of:

- providing an embolic protection device comprising a collapsible filter body and a filter support for the filter body; and
- collapsing the filter support to a low-profile configuration with an associated torqueing of at least part of the filter support upon elongation of the filter support.

In another aspect the invention, an embolic protection device, comprises:

- a collapsible filter element for delivery through a vascular system of a patient; the filter element comprising a collapsible filter body and a filter support for the filter body;
- the filter body having an inlet end and an outlet end, the inlet end of the filter body having one or more inlet openings sized to allow blood and embolic material enter the filter body, the outlet end of the filter body having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter body;
- the filter support being movable between a collapsed position for movement through the vascular system, and an extended outwardly projecting position to support the filter body in an expanded position; the filter support comprising a support frame, a carrier, and
- a flexible tether extending between the carrier and the support frame.

In one embodiment the carrier extends longitudinally of the frame. The carrier may be a tubular member or sleeve(s). Alternatively the carrier is a guidewire. The filter support may comprise a number of segments, at least some of which are interconnected by a strain distributing element.

The filter support may comprise a loop.

In one embodiment at least some of the segments are of wire. The linking element may be of wire. The linking element may be of the same wire as that of the support segments. The linking element may extend normally of adjacent segments, for example longitudinally of the axis of the filter and/or radially inwardly of the adjacent segments.

In one embodiment the linking element comprises a loop which may be of generally omega shape.

At least portion of the linking element may be radiopaque. At least some of the support segments may be radiopaque.

In one embodiment the linking element is of multifilament construction.

In another embodiment at least one of the support segments is of multifilament construction.

In one embodiment the support frame is defined by at least two wire segments having terminations, the terminations of adjacent segments being fixed relative to one another and extending generally parallel. The support frame may be defined by at least two wire segments terminating distally, the distal terminations of adjacent segments being fixed relative to one another and extending generally parallel. The support frame may be defined by at least two wire segments terminating proximally. the proximal terminations of adjacent segments being fixed relative to one another and extending generally parallel.

In one embodiment the support frame comprises a support arm for one end of the filler body which extends towards on opposite end of the filter body in the deployed configuration.

In one embodiment the device comprises a carrier extending longitudinally of the frame. A flexible tether may extend between the carrier and the support frame.

In one embodiment the support frame comprises a support loop.

- a collapsible filter element for delivery through a vascular system of a patient;
- the filter element comprising a collapsible filter body and a filter support for the filter body;
- the filter body having an inlet end and an outlet end. the inlet end of the filter body having one or more inlet openings sized to allow blood and embolic material enter the filter body, the outlet end of the filter body having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter body;
- the filter support being movable between a collapsed position for movement through the vascular system, and an extended outwardly projecting position to support the filter body in an expanded position;
- the filter support comprising a support frame,
- a support arm for one end of the filter body which extends towards an opposite end of the filter body in the deployed configuration.

The support arm may be a proximal support arm that extends distally in the deployed configuration. Alternatively or additionally the support arm is a distal support arm that extends proximally in the deployed configuration.

- a collapsible filter element for delivery through a vascular system of a patient;
- the filter element comprising a collapsible filter body and a filter support for the filter body;
- the filter body having an inlet end and an outlet end, the inlet end of the filter body having one or more inlet openings sized to allow blood and embolic material enter the filter body, the outlet end of the filter body having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter body;
- the filter support being movable between a collapsed position for movement through the vascular system, and an extended outwardly projecting position to support the filter body in an expanded position;
- the filter support comprising a generally tubular support frame defined by at least one wire.

The at least one wire of the tubular support frame becomes torqued during collapse of the filter support. This torque induced upon collapse is evenly distributed along the wire without resulting in stress concentrations on the filter support. ‘thus, the wires may be of a small cross-sectional area which advantageously collapse down to a very low profile.

In addition, small wires enable greater flexibility for the filter element, which allow for ease of advancement through the vascular system.

The frame may comprise a number of cells, at least one of the cells defining a segment of a tube. Each cell may define a segment of a tube.

In one embodiment at least portion of an element of one cell is connected to an element of another cell. The connection means may be provided by an extension wire between the cells. At least portion of an element of one cell may be directly fixed to an element of another cell.

The or each cell may be defined by two wire elements. The two wire elements may be of substantially the same length. The or each wire element may have a proximal termination and a distal termination, and the proximal terminations of adjacent wire elements are fixed relative to one another, and/or the distal terminations of adjacent wire elements are fixed relative to one another.

The terminations of adjacent wire elements may extend generally axially and parallel. The proximal terminations may be circumferentially aligned with the distal terminations. Alternatively the proximal terminations are circumferentially offset from the distal terminations.

In one embodiment each wire element has an axially extending portion and a circumferentially extending portion.

In one embodiment at least one wire element has an S-shaped portion for distributed filter body support.

The wire elements may be provided by a single wire bent back on itself. The single wire may have a strain relief means at the bend in the wire. The wire may be treated to minimize stress at the bend in the wire.

In one embodiment the filter support comprises at least one support leg extending radially inwardly from the tubular support frame, the leg being defined by at least one wire. At least part of the support leg is integral with at least part of the tubular support frame. The support leg may extend distally inwardly from the support frame.

According to a further aspect of the invention, there is provided an embolic protection device comprising:

- a collapsible filter element for delivery through a vascular system of a patient;
- the filter element comprising a collapsible filter body and a filter support for the filter body;
- the filter body having an inlet end and an outlet end, the inlet end of the filter body having one or more inlet openings sized to allow blood and embolic material enter the filter body, the outlet end of the filter body having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter body;
- the filter support being movable between a collapsed position for movement through the vascular system, and an extended outwardly projecting position to support the filter body in an expanded position;
- the filter support comprising a support frame defined by at least two wire elements, each wire element having a proximal termination and a distal termination, the terminations of adjacent elements extending generally axially and parallel.

According to the invention, there is provided a medical device having a collapsed configuration for transport through a body passageway, and an expanded configuration for deployment in a body;

- the medical device comprising a support movable from the collapsed configuration to the expanded configuration to support the medical device in the expanded configuration;
- the support comprising a radiopaque core.

The second moment of area of the radiopaque material is proportional to the fourth power of its diameter. Therefore because the radiopaque material is provided as the core of the support, this greatly reduces the diameter and thus the second moment of area of the radiopaque material. Correspondingly the forces required to facilitate deployment of the medical device are also greatly reduced.

In this manner the invention minimizes the dampening effect of the radiopaque material on the medical device.

By locating the radiopaque material as the core of the support, this also results in a low-profile medical device.

In one embodiment of the invention the core is located substantially along the neutral axis of bending of the support.

Preferably the support comprises at least one support element. The support element may be of a superelastic material. Ideally the radiopaque core is provided as a core embedded within at least one support element. In one case the radiopaque core is in powder form. In another case the radiopaque core is in liquid form.

In a preferred embodiment the radiopaque core comprises a radiopaque element amongst a plurality of support elements. The element may comprise a wire. Ideally the elements are wound together.

The radiopaque core may be of mercury, or gold, or platinum.

In another aspect. the invention provides a medical device having a collapsed configuration for transport through a body passageway, and an expanded configuration for deployment in a body;

the medical device comprising a support movable from the collapsed configuration to the expanded configuration to support the medical device in the expanded configuration;

the support comprising a reservoir enclosing a fluid, the fluid being expandable upon an increase in temperature to bias the support to the expanded configuration.

According to a further aspect of the invention, there is provided a medical device having a collapsed configuration for transport through a body passageway. and an expanded configuration for deployment in a body;

the support comprising a reservoir enclosing a fluid, the fluid being pressurized to bias the support to the expanded configuration upon release of a constraint.

In one case the reservoir comprises an enclosed tube. The tube may extend at least partially circumferentially around the device. Ideally the ends of the tube meet to form an enclosed loop.

The fluid may be of a radiopaque material. Preferably the fluid is liquid mercury.

In a preferred embodiment of the invention the device is an intravascular medical device for transport through a vasculature and deployment in a vasculature. Most preferably the device is an embolic protection filter. Ideally the filter comprises a filter body supported by the support, the filter body having an inlet end and an outlet end, the inlet end of the filter body having one or more inlet openings sized to allow blood and embolic material enter the filter body, and the outlet end of the filter body having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter body.

at least part of the support being of a multifilament wire construction.

In the multifilament wire construction of the invention, each filament bends independently of the other filaments. Correspondingly, the overall force required to bend the support is a summation of the forces required to bend each filament. Because the force required to bend a wire is proportional to the fourth power of the diameter of the wire, the overall force required to bend the multifilament support is much less than the force which would be required to bend a single wire with the same overall diameter as the multifilament support.

In this manner, the medical device of the invention achieves enhanced trackability during transport through even tortuous body passageways, while ensuring the medical device is moved by the support from the collapsed configuration to the expanded configuration upon deployment in the body.

The multifilament wire construction also provides the medical device with greater deformability in the expanded configuration. This enables the medical device to adapt to the particular characteristics of the body passageway in which it is deployed.

In one embodiment of the invention at least one filament is wound around at least one other filament. By winding the filament, the bending stress induced in the filament is reduced. Preferably at least some of the filaments arc braided together.

In a particularly preferred embodiment at least one filament is of a radiopaque material. The radiopaque nature of the filament provides visualization of the medical device during transport through and deployment in a body. The radiopaque filament is ideally located substantially along the neutral axis of bending of the support.

In another case at least one filament may comprise a radiopaque core embedded within the filament.

In a further embodiment of the invention the support comprises a jacket around the filaments. The jacket helps to maintain the structure of the multifilament wire construction intact and ensure the filaments move in a coordinated manner. Preferably the filaments are embedded within the jacket. Ideally the jacket is at least partially of a radiopaque material. The jacket may be at least partially of a polymeric material.

Desirably the support is of the multifilament wire construction at a point of high curvature in the expanded support.

The device is preferably an intravascular medical device for transport through a vasculature and deployment in a vasculature. Ideally the device is an embolic protection filter. Most preferably the filter has an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter.

In a preferred case the filter comprises a filter body supported by the support, and the inlet openings and the outlet openings are provided in the filter body to retain undesired embolic material within the filter body. The filaments may define a mesh. Ideally the inlet openings and the outlet openings are provided by openings through the mesh.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more clearly understood from the following description of some embodiments thereof, given by way of example only. with reference to the accompanying drawings, in which:

FIG. 1 is a perspective view of an embolic protection device according to the invention;

FIGS. 2 and 3 are perspective views of a filter support of the embolic protection device ofFIG. 1;

FIG. 4 is an end view of the filter support ofFIGS. 2 and 3;

FIGS.5 to7 are perspective views illustrating collapse of the filter support of FIGS.1 to4;

FIG. 8A is an enlarged view of part of the filter support ofFIG. 5;

FIG. 8B is an enlarged view of part of the filter support ofFIG. 6;

FIG. 9 is a perspective view of the filter support of FIGS.1 to7;

FIGS.10 to20 are views of various alternative strain distributing linkage elements;

FIG. 21 is a perspective view of another filter support;

FIG. 22 is an end view of the filter support ofFIG. 21;

FIGS.23 to25 are perspective views of part of other filter supports:

FIG. 26 is a perspective view of a further filter support;

FIG. 27 is a perspective view of part of the filter support ofFIG. 26 in use;

FIG. 28 is a view along line A-A inFIG. 27;

FIGS. 29 and 30 are enlarged perspective views of part of other filter supports;

FIG. 31 is a perspective view of another device of invention;

FIG. 32 is a perspective view of the device ofFIG. 31, in use;

FIG. 33 is a cross sectional view on the line A-A inFIG. 31;

FIG. 34 is a cross sectional view on the line B-B inFIG. 31;

FIG. 35 is a cross sectional view similar toFIG. 34 of an alternative embolic protection device.

FIGS. 36 and 37 are perspective views of other embolic protection devices according to the invention;

FIG. 38 is a perspective view of another embolic protection device;

FIG. 39 is a perspective view of an embolic protection device;

FIG. 40 is a perspective view of a further embolic protection device;

FIG. 41 is a perspective view of another embolic protection device;

FIG. 42 is a longitudinal cross-sectional view of the device ofFIG. 41;

FIG. 43 is a cross-sectional view on the line A-A inFIG. 41;

FIG. 44 is a perspective view of another embolic protection device;

FIG. 45 is a cross-sectional view of the device ofFIG. 44;

FIG. 46 is a perspective view of a support frame of the invention;

FIG. 47 is an end view in the direction of the arrow A inFIG. 46;

FIGS.48 to51 are views similar toFIGS. 46 and 47 of further support frames;

FIGS.52 to62 are various views of linkage elements rendered radiopaque;

FIG. 63 is a perspective view of a portion of a frame element or a linkage element;

FIG. 64 is a perspective view of the element ofFIG. 63, in use;

FIGS. 65 and 66 are perspective views of alternative frame elements or linkage elements;

FIG. 67 is a perspective view of a portion of another frame element or linkage element of the invention;

FIG. 68 is a perspective view of the element ofFIG. 67, in use;

FIGS.69 to77 are perspective views of portions of frame elements or linkage elements;

FIGS.78 to81 are perspective views of portions of other frame elements or linkage elements;

FIG. 82 is a perspective view of a support frame of the invention;

FIG. 83 is a perspective view of another support frame of the invention;

FIGS.84 to86 are perspective views of portions of other frame elements or linkage elements;

FIGS.87 to99 are perspective views of various support frames of the invention. most of which include tether elements;

FIGS. 100A to100D are perspective views illustrating one attachment of a tether to a support frame;

FIG. 101 is a perspective view of another support frame including tethers;

FIG. 102 is a perspective view of portion of a further support frame;

FIG. 103 is a perspective view of another embolic protection device of the invention;

FIG. 104 is a perspective view of another support frame;

FIG. 105 is a perspective view of a further support frame;

FIG. 106 is a perspective view of another embolic protection device;

FIG. 107 is a perspective view of another support;

FIG. 108 is a perspective view of a further support

FIG. 109 is a perspective view illustrating the wrapping down of the frame ofFIG. 108;

FIGS. 110 and 111 are views similar toFIGS. 108 and 109 of another support frame;

FIGS.112 to115 are perspective views illustrating termination details;

FIG. 116 is a perspective view of another support frame;

FIG. 117 is a perspective view of another embolic protection device;

FIG. 118 is a perspective view of a further embolic protection device;

FIGS.119 to125 are perspective views of various terminations;

FIG. 126 is a perspective view of another embolic protection device of the invention;

FIG. 127 is a perspective view of the support frame ofFIG. 126;

FIGS. 128 and 129 are perspective views illustrating the wrap-down of the frame ofFIG. 127;

FIG. 130 is a perspective view of another embolic protection device;

FIG. 131 is a perspective view of a further embolic protection device;

FIGS.132 to134 illustrate steps in the method for forming embolic protection devices ofFIG. 131;

FIG. 135 is a perspective view of another embolic protection device;

FIG. 136 is a perspective view of an embolic protection device;

FIG. 137 is a perspective view of another embolic protection device;

FIG. 138 is a perspective view of a further embolic protection device;

FIG. 139 is a perspective view of another embolic protection device;

FIG. 140 is a perspective view of another support frame of the invention;

FIG. 141 is a perspective view of another embolic protection device;

FIG. 142 is a perspective view of a support frame of the device ofFIG. 141;

FIG. 142A is a detail view of portion of the support frame ofFIG. 142B;

FIG. 142B is a plan view of an offset variant of the support frame ofFIG. 142;

FIG. 143 is a perspective view of an alternative support frame;

FIG. 144 is a perspective view of an embolic protection device with a single loop support frame;

FIG. 145 is a perspective view of another embolic protection device;

FIGS.146 to148 are perspective views of support frames of the invention;

FIG. 149 is a perspective view of another support frame;

FIG. 150 is a view of a detail of the frame ofFIG. 149;

FIG. 151 is a view of an alternative detail of the frame ofFIG. 149;

FIG. 152 andFIG. 153 are views of the frame ofFIG. 149 being wrapped down;

FIG. 154 is a perspective view of another embolic protection device;

FIG. 155 is a perspective view of a support frame of the device ofFIG. 154;

FIG. 166 is a perspective view of the filter support ofFIG. 164;

FIG. 167 is a schematic side view illustrating collapse of the embolic protection device ofFIG. 162;

FIG. 168 is a schematic plan view illustrating collapse of the embolic protection device ofFIG. 162;

FIGS. 169A to169C are perspective views illustrating collapse of the embolic protection device ofFIG. 162;

FIG. 170 is a perspective view of another filter support and the inner tube ofFIG. 164;

FIGS.171 to173 are plan, side and perspective views respectively of a further filter support;

FIGS. 174 and 175 are side and perspective views respectively of another filter support;

FIGS.176 to178 are plan, side and perspective views of a further filter support;

FIG. 179 is a perspective view of another embolic protection device according to the invention;

FIG. 180 is a schematic view of another filter support;

FIG. 181 is a development view of the filter support ofFIG. 180;

FIG. 182 is an enlarged view of part of the filter support ofFIG. 181;

FIG. 183 is a perspective view of another filter support and inner tube; and

FIG. 184 is a perspective view of the filter support ofFIG. 183.

DETAILED DESCRIPTION OF THE INVENTION

Referring to the drawings, there are illustrated several embolic protection devices according to the invention. In general the embolic protection devices comprise a collapsible filter element for delivery through a vascular system of a patient. The filter clement comprises acollapsible filter body102 and afilter support103 for thefilter body102, and a carrier which may comprise atubular member108 to which thefilter support103 may be mounted.

Thefilter body102 has aninlet end104 and anoutlet end105. Theinlet end104 has one or morelarge inlet openings106 which are sized to allow blood and embolic material enter thefilter body102. Theoutlet end104 has a plurality ofsmall outlet openings107 which are size to allow through passage of blood but to retain undesired embolic material within thefilter body102. In this way, the filter element captures and safely retains any undesired embolic material in the blood stream within thefilter body102 while facilitating continued flow of blood through the vascular system. Emboli are thus prevented from flowing further downstream through the vascular system, which could otherwise have potentially catastrophic results.

Thefilter body102 may be of an oriented polymeric material, as described in WO O1/97714A and US 2002/0042627A, the relevant contents of which are incorporated herein by reference.

Thefilter support103 is movable between a low-profile, collapsed position for movement through the vascular system, and an extended outwardly projecting position. In this outwardly projecting position, thefilter body102 is supported in an expanded position by thefilter support103, so as to maximize the internal volume of thefilter body102 to capture and safely retain as much embolic material as possible. Theinner tube108 has aguidewire lumen112 there through, through which a guidewire may pass for exchange of thefilter element1 over the guidewire. Alternatively, in all embodiments the carrier may comprise a guidewire.

Oneembolic protection device100 according to the invention is illustrated in FIGS.1 to9. A proximal end of thefilter support103 may be fixed to theinner tube108. Upon collapse of the filter element, the proximal end of thefilter support103 may remain fixed relative to theinner tube8, and thefilter support103 collapses distally against theinner tube108. In this collapsed position, thefilter support103 is axially elongated relative to the expanded position.

Thefilter support103 in this case comprises tworound wires116 which extend from theproximal end109. Thewires116 extend together axially and radially outwardly in aleg118 from theproximal end109, where thewires116 are fixed to theinner tube108. The junction of theleg118 with the support hoop is referred to in this specification as theproximal termination point119.

At aproximal termination point119, thewires116 separate, and extend circumferentially around to form support hoops.

This arrangement of the circumferential hoop formed by thewires116 ensures that in the expanded position, thefilter body102 will be supported by thesupport frame103 in circumferential apposition with the interior wall of the vasculature.

The length of eachwire116 around the hoop is equal. At theproximal termination point19, thewires116 are fixed to each other, and extend generally axially and parallel in a bi-filar arrangement.

As thefilter support103 collapses down against theinner tube108, thewires116 become torqued. This torqueing action is similar to the process of elongation of a coiled spring. Because thesupport frame103 is defined byround wires116, the torque developed in eachwire116 will be evenly distributed along the length of eachwire116. In addition, the bi-filar connection of thewires116 to each other at thetermination point19, further assists in torque distribution along thewires116. Thus, collapse of thefilter support103 does not induce high, localized stresses in thefilter support103. In this way, thefilter support103 may be constructed ofwires116 of a small cross-sectional area which will collapse down to a very low profile. Furthermore, the collapsed filter element withsmall wires116 has greater flexibility for ease of advancement of thefilter clement1 through the vascular system.

Thewires116 are preferably of a self-expanding material, such as Nitinol™.

Thewires116 may have a strain distributing linkage element. In this case, the linkage element comprises aloop120 in each wire. Theloop120 in this case extends axially and distally of the wire hoop. Theloop120 is of generally omega shape as illustrated and is formed integrally in awire116. Theloop120 acts as a strain reliever or distributor when thewires116 are wrapped down as illustrated inFIGS. 6, 7 and8B. Theloop120 has a relatively large radius resulting in highly efficient strain distribution. Radii R1, R2, R3 are provided at key points in the support frame to relieve strain as illustrated inFIG. 9. In addition, theloop120 allows the support frame to accommodate varying vessel contours and sizes. In effect theloop120 acts as a diameter or circumference adjuster allowing an embolic protection device to adapt to difference vessel contours and sizes whilst maintaining apposition with the vessel wall. The strain relieving geometry of the loops enhances the compliance of the bend points without creating a weakened hinge point, thus ensuring that there is no discontinuity in the circumferential seal against the vessel wall.

Theloops120 can also be regarded as distal termination points which have a pair of arms which extend axially and generally parallel. The loopedterminations120 enhance the ability of thefilter support103 to be wrapped down to a low profile.

In addition, the looped configuration of thedistal termination120 spreads the force exerted by thefilter support103 on thefilter body102 over a greater area. In this way, the local pressures applied by thefilter support103 on thefilter body102 and the walls of a vasculature are more evenly distributed, this minimizing the possibility of vessel trauma.

Another important advantage of the strain distributing features such asloops120 is that they provide an anchor to which connecting elements such as tethers may be readily attached as described in more detail below.

In use, the filter element is collapsed down and loaded into a delivery catheter with an associated torqueing of thewires116 around the hoop. The filter element is then delivered through a vasculature fixed to or over a guidewire using the delivery catheter until the filter element is located at a desired site in the vasculature.

By moving the delivery catheter proximally relative to thefilter element1, the element is deployed out of the delivery catheter at the desired site in the vasculature. Thefilter support103 expands radially outwardly to support thefilter body102 in circumferential apposition with the interior wall of the vasculature. In the fully expanded position, thewires116 of thesupport frame103 are substantially free of torque.

The site of deployment of the filter element in the vasculature is typically downstream of a treatment site, such as a region of stenosis in the vasculature. During the performance of a treatment procedure, the filter element captures and safely retains any embolic material in the blood stream within thefilter body102.

The delivery, deployment and retrieval of the embolic protection device of the invention, as described above, is similar to the described in our WO99/23976, WO 01/80776A (US 2002-0052626A) and WO 01/80773A (US 2002-0049467A), the relevant contents of which are incorporated herein by reference. The filter element may be slidably exchanged over the guidewire without any attachment means between the filter element and the guidewire. A distal stop on the guidewire assists in retrieval of the filter element. The guidewire may remain in the vasculature after retrieval of the filter element.

The support comprises a segmented ring structure which may have two circumferential wire segments. The wire segments may be connected by a strain distributing linkage element at one end and by a bifilar joint at the other end. The bifilar joint may be coupled to the carrier by a single or multiple struts and/or tethers. In one case the strut is attached to the carrier. The connection may permit rotation relative to the carrier either longitudinally distal or proximal to the point of attachment to the segmented ring.

In some cases the attachment to the carrier is rigid, in other cases a flexible joint is provided using a tether, a loop, a thinned wire section or the like. A focal tether may be utilized. A focal tether implies that the strut has tensile and compressive integrity but the joint is not rigid. The joint can thus flex in all directions but it cannot translate.

Individual wires may taper towards the proximal or distal end.

The support frames may have distal, proximal and/or intermediate anchors. One anchor may be fixed and another translatable and/or rotatable relative to the carrier. For example a proximal anchor may be translatable or in arrangements in which both proximal and distal anchors are provided both may be translatable.

The support frame may comprise a segmented ring or hoop which may have an elliptical cross-section in the free expanded state. The support ring may be angulated relative to the axis of the inner member.

Various strain distributing linkage elements are illustrated in FIGS.10 to20. InFIG. 10 the strain distribution is provided by a zigzag linkage element103. The omega shape of thepreferred loop120 will be apparent inFIG. 11 however the loop may approximate to acurved V shape131 as illustrated inFIG. 12. Various arrangements in which a strain distributing element is provided by a separate component defining aloop135 are illustrated in FIGS.13 to19. Theloops135 may be attached or formed in a number of ways, as illustrated. Another strain distributing diameter/adjustingfeature136 is illustrated inFIG. 20.

Referring toFIGS. 21 and 22, there is illustrated afurther filter support140, which is similar to the filter support of FIGS.1 to9, and similar elements inFIGS. 21 and 22 are assigned the same reference numerals. In this case thefilter support140 comprises twowires141 which have an elongate cross-section, in this case a rectangular cross-section, along theirproximal section118. Thewires141 are arranged such that the shorter dimension of the rectangle is aligned along the radial direction of the filter support, as illustrated inFIG. 22.

This flattened wire configuration provides for afilter support140 with enhanced flexibility. This is achieved because the second moment of area of thewires118 is reduced in the flattened configuration.

In addition, the flattenedwires141 minimize the influence of thesupport leg118 on the outward radial force R1 exerted by the support frame. This results in afilter support140 which exerts a relatively constant outward radial force R1 around the circumference of the filter support (FIG. 22).

InFIG. 24, there is illustrated afilter support145 in which the cross-sectional area of theround wire141 decreases radially inwardly along thesupport leg118 from theproximal termination point119 to the proximal end of thefilter support145. Thistapered support leg118 also achieves the enhanced flexibility, and the relatively constant outward radial force R1 around the circumference of thefilter support145, similar to that discussed previously with reference toFIGS. 21 and 22.

As illustrated inFIG. 23, thesupport leg118 may be provided by only one of the tworound wires116, with the otherround wire116 terminating at theproximal termination point119 where thewires16 are fixed together. Another arrangement of this type is illustrated inFIG. 25.

The configuration of a singlewire support leg118 also achieves the enhanced flexibility, and the relatively constant outward radial force R1 around the circumference of thefilter support340, similar to that discussed previously with reference toFIGS. 21 and 22.

FIGS.26 to28 illustrate anotherfilter support150, which is similar to the filter support described above, and similar elements are assigned the same reference numerals. In thefilter support150, theround wires116 extend circumferentially around the support frame in an irregular, wave-like pattern. This configuration increases the area of contact between thewires116 and thefilter body102. As illustrated inFIG. 28 this increased area of contact assists in more evenly distributing the radial forces R1 from thesupport wires116 to thefilter body102 and hence to the vessel wall. In this way, the risk of vessel trauma due to the forces exerted by thefilter support150 is minimized.

The radial forces exerted by the filter support on thefilter body102 and the walls of a vasculature depend on a number of factors, such as the diameter of theround wires116, the material chosen for thewire116 and the properties of that material, the number ofwires116 in the filter support, the angle of inclination a of the support leg118 (FIG. 9), and the radii R1, R2, R3 of the bends in the filter support. By suitably varying these factors, the radial force exerted by thefilter support301 may be accurately controlled.

Another important influencing factor on the radial force exerted by the filter support is the fixing of thewires116 relative to one another at the proximal termination points119 and/or at the distal termination points120. It may be advantageous to securely fix thewires116 relative to one another at theproximal termination point119 to achieve the required radial force perpendicular to theproximal termination point119.

One means of fixing the twowires116 of the filter support relative to one another at theproximal termination point119 is to clamp thewire116 together using a tubularpolymeric sleeve151, as illustrated inFIG. 29. Thesleeve151 provides a durable means of fixing thewires116 together which will effectively resist peeling of thewires116 apart, thus resulting in a highly robust filter element.

Thesleeve151 may be partially of a radiopaque material, such as platinum, or iridium, to provide visualization of the filter element during use.

Alternatively thewires116 may be clamped together by winding awire152 around thesupport wires16, and then bonding or soldering thewire152 in place around the clampedsupport wires16, as illustrated inFIG. 30. Thewire152 may be radiopaque.

Another suitable means of fixing the twowires116 together is to directly solder, weld or bond thetow wires116 together.

It will be appreciated that a variety of different means may be used to effectively fix thewires116 relative to one another at theproximal termination point119 and/or at thedistal termination point120.

As illustrated inFIG. 32, the loopedtermination120 may be configured to fold radially inwardly upon collapse of thefilter160, so that the loopedtermination120 will engageemboli161 which have collected in thefilter body102. In this manner, the loopedterminations120 will assist in holding theemboli161 in place within thefilter body2 and in preventing extrusion of theemboli161 out of thefilter body102 during retrieval of thefilter160. Thus thefilter160 will safely retain theemboli161 for removal from the vasculature.

Furthermore, as illustrated in FIGS.31 to35, the loopedtermination120 may be folded radially inwardly to engage against theinner tube108. This arrangement provides enhanced radial support for thefilter body102.

Upon collapse of thefilter162, the loopedterminations120 slide over theinner tube108 until the filter support is in the fully collapsed, elongated configuration.

Theloops120 may be attached at163 to constrain their freedom of movement to the axis of the tube108 (FIG. 35).

Anotherfilter170, is illustrated inFIG. 36, and similar elements to those in previous drawing are assigned the same reference numerals. The filter support comprises asingle round wire116 which extends axially and radially outwardly in asingle leg118 to theproximal termination point119. Thewire116 extends circumferentially around the support frame, looping at thedistal termination120.

Thefilter body102, has a single,large inlet opening106 defined at theinlet end104. This arrangement further minimizes the possibility of any embolic material becoming caught or hung-up on any parts of the filter at theinlet end104. This arrangement also further reduces the overall longitudinal length of thefilter170.

In this case thefilter body102 is fixed directly to the filter support at theinlet end104 by wrapping twoflaps171 of thefilter body102 around thesupport wires116 and then fixing theflaps171 to thefilter body102 in this wrapped position (FIG. 36).

In thefilter element175 ofFIG. 37, thesupport leg118 is fixed to theinner tube108 at aninner foot section176. Theinner section176 is inverted to extend distally along theinner tube108. In addition, thefilter body102 is configured to slide distally over thetimer tube108 upon collapse by means of asleeve177 fixed to thefilter body102 at thedistal end105. Thesleeve117 is also inverted to extend proximally along theinner tube108.

In this way, by inverting theinner section176 of theleg118 and thesleeve177, the overall longitudinal length of the filter support is minimized. This results in less “parking space” in a vasculature being required to deploy the filter.

Furthermore, by extending theinner section176 of theleg118. distally, the possibility of embolic material becoming caught or hung-up at theinlet end104 of the filter element is reduced.

Referring toFIG. 38 anotherfilter180 which has a more enhanced transition to thefoot176 is illustrated.

Thefilter185 ofFIG. 39 has aproximal support leg118 that extends distally to minimize the length and hence the parking space of the filter. Asupport foot176 is again provided for load distribution.

Thefilter190 ofFIG. 140 has two

proximal support legs

191,192 which are axially offset.

Referring to FIGS.41 to43 anotherfilter195 has a singleproximal support arm196 which terminates in anopen collar197 which is slidably engagable with thetubular member108. This arrangement provides a large single inlet opening on deployment. The support frame is held in alip198 of the filter body/membrane102.

Anotherfilter200 is illustrated inFIGS. 44 and 45 which has a construction similar to that ofFIG. 40 but with the support frame having neither proximal nor distal support arms. The frame design provides a very short wrapped length for superior trackability. The stepped filter arms provide a large inlet opening on deployment.

Various alternative support frames are illustrated in FIGS.46 to51. In each case, the support hoop is of generally elliptical shape.

In thesupport205 ofFIGS. 46 and 47 the hoop is biased towards an elliptical shape in its unconstrained state. When constrained within a vessel the major axis of the ellipse will be compressed, which will tend to expand the minor axis. This action may assist in the even distribution of radial force to the vessel wall in the case where the support frame is inherently more flexible at the loops than at the top of its proximal arms.

In thesupport215 ofFIGS. 48 and 49 the proximal arms of the support frame are staggered so that the hoop is inclined at an angle to the axis of the filter in side view.

Thus although the hoop is actually elliptical it appears circular in end view as shown inFIG. 51.

In thesupport210 ofFIGS. 50 and 51 the loops of the support frame are offset so that the hoop is inclined at an angle to the axis of the filter in top view. Thus although the hoop is actually elliptical it appears circular in end view as shown inFIG. 51.

To enhance visualization of the filter the wire segments and/or the linkage elements may be rendered radiopaque. Referring toFIG. 52 a

section

250 is of a different material or has different properties than that of the wire orlinkage element251. Thesection250 is ductile and radiopaque. InFIG. 53 thesection250 is formed bystraight wires252 some or all of which may be radiopaque. InFIG. 54 thesection250 is of braided construction, some or all of which may be radiopaque. Aradiopaque coil260 is provided inFIG. 55. InFIG. 56 a

linkage element

120 is rendered radiopaque by using a radiopaque braid. Thelinkage element120 may be of different material and/or have a similar radiopacifying arrangement as shown in FIGS.52 to55.

Methods of rendering terminations and/or linkage element radiopaque are illustrated in FIGS.57 to62. InFIG. 57 a radiopaque band orcup270 may be used. Aradiopaque solder271 may also be used (FIG. 58). Similarly aradiopaque band275 may be crimped around the heck of aloop120 as illustrated inFIG. 59. Acoil280 of radiopaque material may be wound around theloop120 as illustrated inFIG. 60 or across the loop as illustrated inFIGS. 61 and 62.

As illustrated inFIG. 63, at least part of the support may be of a multifilament wire construction. In this case sevenNitinol™ wires300 are wound in a spiral around a singleradiopaque wire301, theradiopaque wire301 being located substantially along the axis of bending of the support. The support may have the multifilament wire construction along the entire length of the support in this instance.

During bending of the support (FIG. 64), for example upon movement of the support to the expanded configuration, each

wire

300,301 bends independently of the other wires. As a result, the force required to bend the multifilament support is minimized, and thus the filter achieves enhanced trackability during transport through a tortuous vasculature, such as in coronary applications.

Because theNitinol™ wires300 are wound in a spiral around theradiopaque wire301. This configuration acts to decrease the bending stresses induced in each

wire

300,301 upon bending (FIG. 64).

Theradiopaque wire301 provides visualization for a clinician during transport of thefilter1 through a vasculature and deployment of the filter in the vasculature. Because theradiopaque wire301 is located along the neutral axis of the support, the forces required to plastically deform theradiopaque wire301 as the support moves from the collapsed configuration to the expanded configuration, upon deployment of thefilter1, are minimized. In this way the dampening effect of the radiopaque material is minimized.

FIG. 65 illustrates portion of asupport310 of another embolic protection filter according to the invention. In this case, the support comprises tworadiopaque wires311 around which are wound in a spiral a plurality ofNitinol™ wires312.

Asupport315 of a further embolic protection filter according to the invention is illustrated inFIG. 65. TheNitinol™ wires318 and theradiopaque wire317 are braided together to form themultifilament wire support35.

Referring toFIGS. 67 and 68 there is illustrated asupport320 of another embolic protection filter according to the invention. The support comprises a singleradiopaque wire321 which extends substantially longitudinally, and a singleNitinol™ wire322 which is wrapped around theradiopaque wire321 in a coil. As illustrated inFIG. 68, the bending stress induced in theNitinol™ wire322 upon bending is substantially less than the bending stresses induced in a solid wire bent through the same angle.

A portion of awire support330 of another embolic protection filter is illustrated inFIG. 69. In this case, a singleNitinol™ wire331 extends substantially longitudinally, and a singleradiopaque wire332 is wrapped around theNitinol™ wire331 in a coil.

FIG. 70 illustrated part of asupport340 of another embolic protection filter according to the invention. Thesupport340 does not have any radiopaque wire filaments, instead radiopacity is achieved by aradiopaque core341 embedded within at least one of thewires342. Theradiopaque core341 is located substantially along the neutral axis of theNitinol™ wire342, and thus the force required to plastically deform the radiopaque core during movement of the support from the collapsed configuration to the expanded configuration is minimized, and the dampening effect of the radiopaque material is minimized.

Referring to FIGS.71 to72 alinking element loop120 may be provided with radiopacity in a similar manner.

Referring toFIG. 73 or74 aradiopaque material345 may be sandwiched between two outer layers. Such a frame could be constructed by laser machining an entire frame (or portion thereof) from a large diameter bi-metal or tri-metal tube. The frame cross section could thus be square or rectangular as shown inFIG. 73, or could be electropolished to create an elliptical or round wire shape as shown inFIG. 74.

The support wire(s) may be of any suitable superelastic material, or alternatively of a high strength material, such as stainless steel.

Referring toFIG. 75, there is illustrated portion of asupport350 of another embolic protection filter according to the invention. In this case, thesupport350 comprises ajacket351 of a polymeric material around

multifilament wires

352,353. TheNitinol™ wires352 and theradiopaque wire353 are embedded within thepolymeric jacket351. A variety of manufacturing procedures, such as ovenmoulding, heat-shrinking, dipping, spraying, painting, depositing may be used to fabricate the wires embedded within thejacket351. Thejacket351 acts to maintain the structure of the multifilament wire construction intact, and ensures that the wires move in a coordinated manner.

FIG. 76 illustrates asupport360 of another embolic protection filter which comprises fiveNitinol™ wires361 wound together in a spiral without any radiopaque wire filaments. A radiopaque material, such as tungsten, bismuth subcarbonate, barium sulphate, may be loaded into thepolymeric jacket362 to achieve visualization.

It will be appreciated that a jacket may be used with any of support structure described previously. For example,FIG. 77 illustrated a support370 of a further embolic protection filter in which theNitinol™ wires371 and theradiopaque wire372 are braided together and embedded in thepolymeric jacket373.

Various ways of rendering a wire, linkage element or tubular member of the embolic protection devices of the invention radiopaque are illustrated in FIGS.78 to83. In general aradiopaque material390 is provided around the element or may itself define the element such as in the case of the tubular member ofFIG. 83.

Referring toFIG. 84 a portion of asupport400 may be in the form of one ormore wires401 of superelastic material, such as Nitinol™. A core of radiopaque material is embedded within at least portion of at least one of thesupport wires401. In this case, the core is also in the form of awire402 of a suitable radiopaque material, such as gold, or platinum, or mercury and extends along the length of a support wire. Theradiopaque wire402 is located substantially along the neutral axis of bending of thesupport wire401. Theradiopaque wire402 provides visualization for a clinician during transport of the filter through a vasculature and deployment of the filter in the vasculature. By providing theradiopaque wire402 as the core of thesupport wire401, this minimizes the diameter of theradiopaque wire402 and its distance from the neutral axis. Because the second moment of area of theradiopaque wire402 is proportional to the fourth power of its diameter, the second moment of area of theradiopaque wire402 is also minimized. Correspondingly, the forces required to plastically deform theradiopaque wire402 as thesupport wire401 moves from the collapsed configuration to the expanded configuration. upon deployment of the filter, are also minimized. In this manner, the radiopaque core configuration of the invention acts to minimize the dampening effect of the radiopaque material, which is necessary to achieve visualization of the filter.

The radiopaque material may also be provided inpowder form405, as illustrated inFIG. 85, or inliquid form406, as illustrated inFIG. 86. Because the

radiopaque core

405,406 is embedded within thesupport wire401, the radiopaque powder or radiopaque liquid26 will be safely retained and controlled within thesupport wire401.

By using a powder or liquid for the radiopaque material, the yield stress of the radiopaque material is reduced. Thus the forces required to move thesupport wire401 from the collapsed configuration to the expanded configuration are further reduced.

The support may comprise a reservoir for enclosing a fluid, the reservoir being provided, which extends circumferentially around the filter at theinlet end104 to form an enclosed loop around the inlet opening.

The tube may enclose a fluid such as mercury. The temperature of the fluid increases towards body temperature upon deployment of the filter in a vasculature, which causes the fluid to expand. This expansion of the fluid forces the support tube towards the expanded configuration until the support tube is fully expanded and the filter is supported in the expanded configuration.

It will be appreciated that the expansible fluid may be of any suitable material. By using a radiopaque material, such as mercury, this provides the additional advantage that visualization of the filter will be possible during transport of the filter through a vasculature and deployment of the filter in a vasculature.

In another embolic protection filter according to the invention, the fluid enclosed in the reservoir may be pressurized. In this case, upon release of a constraint on the filter, such as upon deployment of the filter out of the pod of the delivery catheter, the pressurized fluid in the support reservoir forces the support towards the expanded configuration until the filter is supported in the fully expanded configuration.

It will be appreciated that the radiopaque core aspect of the invention, and/or the temperature expansible fluid aspect of the invention, and/or the pressurized fluid aspect of the invention may be used in any suitable manner or combination with any appropriate medical device.

It will further be appreciated that aspects of the invention may be applied with any medical device for transport through a body passageway and deployment in a body.

Referring to FIGS.87 to105 there are illustrated various alternative support frames incorporating tethering features for connecting the support frame distally and/or proximally and/or intermediately to a carrier. Tethers may also be used additionally or alternatively for connecting various elements of a support frame.

In all cases the tethers may be of any suitable material such as fine gauge wire, for example Nitinol™ wire, fiber or polymers. The tethers may be of solid or braided construction, for example.

Referring to FIGS.87 to89 two

distal tethers

500,501 are used to connect asupport hoop503 to atubular member504. The distal tethers provide added safety and stability to the frame without any increase in the length of the device when wrapped down as illustrated inFIG. 89.

FIG. 90 illustrates an alternative arrangement ofdistal tethers505.

The tethers may be connected to the support frame and carrier in any suitable fashion. For example, the distal tethers may be double stranded and looped around the support frame as shown inFIG. 87.

Referring to FIGS.91 to96 there are illustrated various constructions with proximal tethers, withFIG. 90 illustrating a basic construction of twotethers520 and a simple hoop support frame.

FIG. 92 illustrates a similar frame to that shown inFIG. 9 previously, but with the proximal frame arms replaced withtethers520. Additional strain relieving loops are provided at the tether connection points to assist in the wrap down of the device as discussed previously in relation to the distal loops. The use of flexible tethers in place of wire arms enables the length and stiffness of the wrapped down frame to be reduced, enhancing the trackability of the device. The flexibility of the tethers also enables an even radial force to be provided around the circumference of the frame without interference from the proximal arms.

InFIG. 97 there areproximal tethers530 anddistal tethers531. This construction provides the benefits described in relation toFIG. 92 with the added benefit of the safety and stability provided by the distal tethers. Again the tethers provide a means of anchoring the support frame to the carrier without affecting the stiffness or profile of the wrapped device.

InFIG. 98 an offsetloop support540 has adistal tether541 to prevent the support frame from moving too far proximally and outside the filter body.

InFIG. 99 another offsetloop550 has aproximal tether551 to restrain the movement of the loop section of the frame and thus reduce the overall length of the wrapped device.

Referring now toFIGS. 100A to100D there is illustrated one type ofknot600 in atether605 being tied to alinkage element loop601 of asupport hoop602.

Referring toFIG. 101 there is illustrated a support frame with circumferentially extending tethers610 which allows the frame to move circumferentially to accommodate a broad vessel size range. The tethers610 also assist in providing added support to a filter body, especially in large vessels. There is also anaxially extending tether615 interconnecting elements of the support frame.

Referring toFIG. 102, there is illustrated a filter support620 comprising ahollow tube605 which extends circumferentially around the support frame to define a hoop. Atether626 is looped through thetube605, passing out of thetube605 at theproximal termination point119. Thetether626 extends proximally and radially inwardly from theproximal termination point119 to theinner tube108 to which the ends627 of thewire626 are fixed. Thetether626 could be of wire and/or of a radiopaque material.

Torqueing of thetether626 within thetube605 is possible during collapsing and expanding of the filter. In the filter support, thetube605 exerts the outward radial force to support thefilter body102 in the extended outwardly projecting position, and theelement626 acts as a flexible tether to maintain safe, reliable control over thesupport tube605.

Thesupport tube605 may be of any suitable material, such as polyamide or a superelastic material, for example Nitinol™. Thetube605 may be flexible or rigid. Thetube605 strengthens theproximal termination point119 while permitting a degree of flexibility at theproximal termination point119.

One end of thetether626 may terminate at theproximal termination point119 where the end is attached to the other side of the loopedtether626, with the other end of thetether626 fixed to theinner tube605.

The invention incorporates circumferential wire angulation into support structure design to give maximum circumferential support to the filter membrane.

Referring now toFIG. 103 a

filter

650 with aproximal tether651 extending from the support hoop is illustrated. Other details of this filter are as described with reference ofFIGS. 36 and 41.

Referring toFIG. 104 there is illustrated an alternative support frame in which axiallyadjacent frame elements660 are interconnected bytethers661 which provide additional support for the filter body. Thetethers661 may be of light gauge thread or wire to facilitate ease of wrapping down.

Referring toFIG. 105 there is illustrated another filter support frame comprising two axially spaced-apartsupport hoops670 interconnected by axially extendingtethers671. Thetethers671 provide membrane support but are of light and flexible material which will add very little to the wrapped profile or stiffness of the support frame. Referring next toFIG. 106, there is illustrated anotherfilter element700. In this case, the filter support comprises fourround wires116 which extend axially and radially outwardly in twolegs118 from the proximal end to two opposed proximal termination points119.

Thewires116 separate at the proximal termination points119 and extend circumferentially around thesupport frame115 until two opposed distal termination points120 are reached. Thewires116 then regroup intolegs121 at the distal termination points120. thelegs121 extending axially and radially inwardly to thesleeve111 to which thewires116 are fixed.

In this case, the proximal termination points119 are 90° offset from the distal termination points120.

FIG. 107 illustrates asupport frame710 of simpler construction that than ofFIG. 106.

FIGS. 108 and 109 illustrate the wrapping down of the support frame of the filter ofFIG. 106.

FIGS. 110 and 111 illustrate anothersupport frame720 in which thesleeve111 is located proximally resulting in a shorter wrapped down configuration.

FIGS.112 to115 illustrate various terminations for the wires in the wire frames of the invention which could be employed to connect a single proximal or distal frame arm to the circumferential hoop portion of the frame. A construction such as that shown inFIG. 114 allows rotation of the hoop relative to the arm, reducing the stresses induced during wrapping.

Referring toFIG. 116 there is illustrated another support frame comprising asingle hoop800 with twostrain distributing loops801. One of theloops801 has an arm ortether802 connecting thehoop800 to atubular member803. This arrangement provides a support frame with a very short parking space in use. Thus, it can be deployed even if only a short segment of vessel is available downstream of a treatment location. The support can wrap down in either direction for loading and/or retrieval.

It will be appreciated that thewires116 may be slidably mounted to theinner tube108 at both theproximal support leg118 and thedistal support leg121.

It will be further appreciated that by increasing the number ofwires116 which define the complete loopedcell117 of thesupport frame115, the elongation of the overall filter support, when collapsed down, will be reduced. For example, the filter support ofFIG. 117 comprises eightround wires116 which extend axially and radially outwardly in fourlegs118. In this manner, the space required in a vasculature to deploy and retrieve the embolic protection device is correspondingly reduced.

Depending on the configuration of the filter element, the inner tube may or may not be present. In this case the filter support may be mounted directly onto a guidewire for exchange of the filter element over the guidewire.

It will also be appreciated that the shape of onewire116 of acell117 does not have to be symmetrical or similar to the shape of theother wire116 of thecell117, provided that the length of eachwire116 is equal.

Furthermore it will be appreciated that asingle wire116, bent back on itself, may be used to define the support frame, in which case thecells117 of the support frame are defined by elements of the single wire, as illustrated inFIG. 118.

FIGS.119 to121 illustrate possible means by which thesingle wire116 may be bent back on itself and wrapped around theinner tube108. This single wire arrangement enables case of attachment to theinner tube108 without stress concentration points occurring at the regions of looping of thewire116 around theinner tube108.

The fixing of twoseparate wires116 to each other in a bi-filar arrangement is illustrated inFIG. 122. The fixing means may be provided by, for example, welding, brazing, soldering, or an adhesive joint at the point offixation820. In the case of asingle wire116 bent back on itself to define the support frame, a 180° U-bend at the end of thewire116 may be formed in multiple strain-temperature stages to prevent plastic deformation of the wire116 (FIG. 123). A strain relief means821, such as solder, braze or adhesive, may be provided at the base of the U-bend, as illustrated inFIG. 124. Alternatively, astrain relief tube822 may be provided at the end of the single wire116 (FIG. 125).

Referring to FIGS.126 to129 there is illustrated anotherembolic protection filter830. Thewires116 of thefilter support830 are connected to theinner tube108 by twolegs121, in this case, which are fixed directly to theinner tube108. The fourround wires116 of the filter support extend axially proximally and radially outwardly in the twolegs121 to the two opposed distal termination points120. Thewires116 then separate and extend circumferentially around the support frame until the two opposed proximal termination points119 are reached. Upon collapse of the filter element, the support frame flips distally over thelegs121 until the filter support is fully collapsed against theinner tube108 with thelegs121 at the proximal end of the filter support.

By locating thesupport legs121 distally of theinlet end104 of thefilter body102, this arrangement minimizes the possibility of embolic material becoming caught or hung-up at theinlet openings106. In this manner, substantially all of the embolic material is retained safely with thefilter body102 for subsequent retrieval from the vascular system using aretrieval catheter832 as illustrated inFIGS. 128 and 129.

As illustrated with thefilter840 ofFIGS. 130 and 131, aproximal neck841 of the filter body may be inverted to extend distally rather than proximally, as is the case with the filter element ofFIG. 129. This arrangement reduces the overall longitudinal length of the filter element, and thus the filter element may be deployed and retrieved with a shorter “parking space” in the vasculature.

FIGS.132 to134 illustrate the process of inverting theproximal neck841. Theneck841 is split along each side842 (FIG. 133), and theneck841 is then pushed distally into the interior of the filter body (FIG. 134).

In addition, the longitudinal length of the filter element ofFIG. 130 is further shortened by providing a hemi-spherically shapedproximal nose845 instead of a conical nose, as is the case with the filter element ofFIG. 129. Furthermore, the overall crossing profile of the filter element is reduced by means of the hemi-spherical nose845.

Referring toFIG. 135 there is illustrated a filter with aproximally extending neck847 which is split into twoparts847.

Referring toFIGS. 136 and 137 there is illustrated afilter870 in which the filter body is connected directly to the frame by means of folded filter seams.

FIG. 137 shows avariant filter875 in which a second frame provides additional body support to the filter.

Referring toFIG. 138, there is illustrated anotherfilter element880, with a filter body which, in this case, has a single,large inlet opening881 defined at theinlet end104. This arrangement further minimizes the possibility of any embolic material becoming caught or hung-up on any parts of the filter element at theinlet end104. This arrangement also further reduces the overall longitudinal length of the filter element.

FIGS. 139 and 140 illustrate afurther filter element885, in which theproximal end9 of the filter support is fixed to theinner tube108, while thedistal end110 of the filler support remains unconnected to theinner tube108. The filter support comprises fourround wires116 which extend axially and radially outwardly in twolegs118 from theproximal end109 to the proximal termination points119. At the proximal termination points119, thewires116 separate and extend circumferentially around the support frame until the two distal termination points120 are reached. The proximal termination points119 are circumferentially offset by 90° from the distal termination points120.

Theproximal end109 of thefilter support103 is fixed to theinner tube108, and thedistal end110 of thefilter support103 is fixed to asleeve111 which is slidable over theinner tube108. Upon collapse of the filter clement, theproximal end109 of thefilter support103 remains fixed relative to theinner tube108, and thedistal sleeve111 slides over thetube108, until thefilter support103 is fully collapsed against theinner tube108. In this collapsed position, thefilter support103 is axially elongated relative to the expanded position.

Thefilter support103 is illustrated inFIG. 142. Thefilter support103 comprises tworound wires116 which extend from theproximal end109 to thedistal end110. Thewires116 extend together axially and radially outwardly in aleg118 from theproximal end109, where thewires116 are fixed to theinner tube108, to acentral support hoop115. The junction of theleg118 with thesupport hoop115 is referred to in this specification as theproximal termination point119.

At theproximal termination point119, thewires116 separate, and extend circumferentially around thesupport hoop115 until a symmetricaldistal termination point120 is reached. In this way, the twowires116 define thesupport hoop115.

At thedistal termination point120, thewires116 regroup into aleg121 which extends axially, and then axially and radially inwardly to thesleeve111 to which thewires116 are fixed.

The path of the twowires116 around thesupport hoop115 together define acell116 which forms a complete loop, as illustrated inFIG. 142. This arrangement of the circumferential loopedcell117 ensures that in the expanded position, thefilter body102 will be supported by thesupport hoop115 in circumferential apposition with the interior wall of the vasculature.

The length of eachwire116 around thecell117 is equal. At the proximal and distal termination points119,120, thewires116 are fixed to each other, and extend generally axially and parallel in a bi-filar arrangement.

As thefilter support103 collapses down against theinner tube108, thewires116 around thecell117 become torqued. This torqueing action is similar to the process of elongation of a coiled spring.

Because thesupport frame115 is defined byround wires116, the torque developed in eachwire116 will be evenly distributed along the length of eachwire116. In addition, the bi-filar connection of thewires116 to each other at the termination points119,120 further assists in torque distribution along thewires116.

Thus, collapse of thefilter support103 does not induce high, localized stresses in thefilter support103. In this way, thefilter support103 may be constructed ofwires116 of a small cross-sectional area which will collapse down to a very low profile.

Furthermore the collapsed filter element withsmall wires116 has greater flexibility for ease of advancement of the filter element through the vascular system.

As illustrated inFIG. 142, theproximal termination point119 is circumferentially offset by 180° from thedistal termination point120.

Thewires116 are preferably of a self-expanding material, such as Nitinol™, and theinner tube108 is preferably of gold. This arrangement provides for radiopacity.

In use, the filter element is collapsed down and loaded into a delivery catheter with an associated torqueing of thewires116 around thecell117. The filter element is then delivered through a vasculature fixed to or over a guidewire using the delivery catheter until the filter element is located at a desired site in the vasculature.

By moving the delivery catheter proximally relative to the filter element, the filter element is deployed out of the delivery catheter at the desired site in the vasculature. Thefilter support103 expands radially outwardly to support thefilter body102 in circumferential apposition with the interior wall of the vasculature. In the fully expanded position, thewires116 of thesupport frame115 are substantially free of torque.

After completion of the treatment procedure, the filter element is collapsed down and retrieved into a retrieval catheter with any retained embolic material within thefilter body102. Thewires116 around thesupport frame115 are again torqued during collapse.

The retrieval catheter is then withdrawn from the vasculature with the filter element within the retrieval catheter.

Referring toFIGS. 142A and 142B there is illustrated a lower portion and a top view of a modified support frame similar toFIG. 142 in which the loops defined by thewires115 are offset atpoint120. This offset could also be applied topoint119. Such a design may be of benefit in broadening the area of circumferential apposition and sealing provided by the filter.

Referring toFIG. 143 there is illustrated a support frame.910 similar to that ofFIG. 142 except that in this case the distal and

proximal legs

121,118 are defined by a single wire, the second wire extending only a short distance distally or proximally from the distal and proximal termination points respectively.

Referring toFIG. 144 there is illustrated anotherembolic protection filter920 which comprises a singlehoop support frame921 with additional

wire support anus

922,923. In this case the distal support leg is connected to the proximal end of the carrier. Thus additional support is provided to the hoop without any impact on the wrapped length of the device.

Referring toFIG. 145 there is illustrated a furtherembolic protection filter930 comprising

support hoops

931,932 which are offset.

Referring to FIGS.146 to148 there are illustrated various filter frames comprising a wire support hoops which may have strain distribution features and/or tethers as described above.

Theframe935 ofFIG. 146 comprises a single wire offsethoop936. Theframe938 ofFIG. 147 is preferred because parking space is minimized while facilitating wrapdown. It will be noted the support comprises an offsetwire support hoop939 with an axially extending proximally extendingwire section940 and an inwardly extendingsupport arm941. Theframe945 ofFIG. 148 is similar to that ofFIG. 147 except that there are two oppositely directed offset

hoops

946,947 similar to the frame used in the filter ofFIG. 145.

Anothersupport frame950 is illustrated in FIGS.149 to150 which is again of wire and includes strain distributing loop features951 which may be of any suitable type as described above and exemplified inFIGS. 150 and 151.

Thesupport frame960 ofFIGS. 152 and 153 again has an offsethoop961 which can wrap down as illustrated inFIG. 153.

Referring toFIGS. 154 and 155, there is illustrated anotherfilter element970, in which thefilter support972 comprises fourround wires116. At theproximal termination point119, two of thewires116 extend circumferentially around thesupport frame115 to define afirst call117, and the other twowires116 extend axially and then extend circumferentially around the support frame to define asecond cell117.

In this manner, thewires116 define two axially spaced-apartcells117, eachcell117 forming a complete loop, as illustrated inFIG. 155. This arrangement ensures that in the expanded position, thefilter body102 will be supported by the support frame in tubular apposition with the interior wall of the vasculature. The tubular apposition further minimizes the possibility of any flow path for blood occurring between thefilter body102 and the vasculature wall to bypass the filter element. At thedistal termination point120, all fourwires116 regroup intoleg121.

It will be appreciated that as thewires116 extend circumferentially around thesupport frame115, thewires116 may also extend partially axially, so that the definedcell117 partially slopes axially. Furthermore, thewires116 may be at least partially of an arcuate shape, as illustrated in thesupport frame973 ofFIG. 156. In either case, the sloping or arcuate configuration of thewires116 increases the contact area between thewires116 and thefilter body102, and in this way, the supporting force exerted by thewires116 on thefilter body102 is more evenly distributed. This arrangement minimizes any trauma experienced by the vasculature due to the apposition of the filter element with the vasculature.

FIG. 157 illustrates anotherfilter support975, which is similar to the filter support ofFIGS. 154 and 155, and similar elements inFIG. 157 are assigned the same reference numerals. In this case, the filter support comprises sixround wires116. Thewires116 extend axially and radially outwardly in twolegs118 from theproximal end109 to two opposed proximal termination points119. As illustrated inFIG. 157, thewires116 are arranged to define two axially spaced-apart,complete loop cells117. In addition, two of thewires116 act as axial bridges to connect the twocells117. At the distal termination points120, thewires116 regroup into twolegs121. The proximal termination points119 are circumferentially aligned with the distal termination points120, in this case.

Thesupport frame980 ofFIG. 158 is similar to that ofFIG. 157 except that in this case there are no proximal support arms with consequential reduced filter length.

Referring to FIGS.159 to161, there is illustrated anotherfilter support990, which is similar to the filter support ofFIGS. 154 and 155, and similar elements are assigned the same reference numerals. In this case, thefilter support990 comprises only tworound wires116. Thewires116 extend together axially and radially outwardly in asingle leg118 from theproximal end109 to theproximal termination point119. Thewires116 then separate and extend circumferentially around thesupport frame115 to define thefirst cell117. Thewires116 extend axially, and then circumferentially around thesupport frame115 to define thesecond cell117. At thedistal termination point120, thewires116 regroup into asingle leg121.

As illustrated inFIG. 161, theproximal termination point119 is circumferentially aligned with thedistal termination point120.

Referring to the drawings, and initially to FIGS.162 to169 thereof; there is illustrated an embolic protection device according to the invention. The embolic protection device comprises acollapsible filter element1 for delivery through a vascular system of a patient.

Thefilter element1 comprises acollapsible filter body2 and afilter support3 for thefilter body2, and aninner tube8, around which thefilter support3 is mounted.

Thefilter body2 has aninlet end4 and anoutlet end5. Theinlet end4 has one or more, and in this case two,large inlet openings6 which are sized to allow blood and embolic material enter thefilter body2. Theoutlet end5 has a plurality ofsmall outlet openings7 which are sized to allow through passage of blood but to retain undesired embolic material within thefilter body2. In this way, thefilter element1 captures and safely retains any undesired embolic material in the blood stream within thefilter body2 while facilitating continued flow of blood through the vascular system. Emboli are thus prevented from flowing further downstream through the vascular system, which could otherwise have potentially catastrophic results. Thefilter body2 may be of an oriented polymeric material. as described in our WO 01/97714A and US 2002/0042627A, the relevant contents of which are incorporated herein by reference.

Thefilter support3 is movable between a low profile, collapsed position (FIG. 169C) for movement through the vascular system, and an extended outwardly projecting position (FIG. 169A). As particularly illustrated inFIG. 2, in this outwardly projecting position, thefiler body2 is supported in an expanded position by thefilter support3 so as to maximize the internal volume of thefilter body2 to capture and safely retain as much embolic material as possible.

Theinner tube8 has aguidewire lumen12 there through, through which a guidewire may pass for exchange of thefilter element1 over the guidewire.

Theproximal end9 of thefilter support3 is fixed to theinner tube8, and thedistal end10 of thefilter support3 is fixed to asleeve11 which is slidable over theinner tube8, as illustrated inFIG. 164. As illustrated in FIGS.167 to169C, upon collapse of thefilter element1, theproximal end9 of thefilter support3 remains fixed relative to theinner tube8, and thedistal sleeve11 slides over the tube8 (FIG. 169B), until thefilter support3 is fully collapsed against the inner tube8 (FIG. 169C). The partially and fully collapsed positions of thefilter support3 are illustrated by dashed lines inFIGS. 167 and 168. In the fully collapsed position of (FIG. 169C), thefilter support3 is axially elongated relative to the expanded position.

Thefilter support3 is illustrated in detail in FIGS.164 to166. Thefilter support3 comprises eightround wires16 which extend from theproximal end9 to thedistal end10. Thewires16 extend axially and radially outwardly in twolegs18 from theproximal end9, where thewires16 are fixed to theinner tube8, to a central tubularsupport frame portion15. The junction points of thelegs18 with thetubular frame15 are referred to in this specification as the proximal termination points19.

At eachproximal termination point19, thewires16 separate, and then extend axially along and circumferentially around thetubular frame15 until symmetrical distal termination points20 are reached. At these distal termination points20, thewires16 regroup into twolegs21 which extend axially and radially inwardly to thesleeve11, to which thewires16 are fixed. In this way, thewires16 define the centraltubular frame portion15.

The path of thewires16 around and along thetubular frame portion15 defines fourcells17, with eachcell17 forming a segment of the tubular frame15 (FIG. 166). Together the fourcells17 extend circumferentially around thetubular frame15 in a complete loop.

This arrangement of thetubular frame15 ensures that in the expanded position, thefilter body2 will be supported by thetubular frame15 in tubular apposition with the interior wall of the vasculature. The tubular apposition further minimizes the possibility of any flow path for blood occurring between thefilter body2 and the vasculature wall to bypass thefilter element1.

Eachcell17 is defined by two of thewires16 which are arranged, in the expanded position. in a generally parallelogram, “hysteresis loop” shape. The length of eachwire16 around thecell17 is equal. At the proximal and distal termination points19,20,adjacent wires16 are fixed to each other, and extend generally axially and parallel in a bi-filar arrangement.Adjacent cells17 within thetubular frame15 are also connected together by fixing awire16 in onecell17 to awire16 in anadjacent cell17.

As thefilter support3 collapses down against theinner tube8, thewires16 around eachcell17 become torqued. This torqueing action is similar to the process of elongation of a coiled spring.

Because thetubular support frame15 is defined byround wires16, the torque developed in eachwire16 will be evenly distributed along the length of eachwire16. In addition, the bi-filar connection of thewires16 to each other at the termination points19,20 further assists in torque distribution along thewires16.

Thus, collapse of thefilter support3 does not induce high, localized stresses in thefilter support3. In this way, thefilter support3 may be constructed ofwires16 of a small cross-sectional area which will collapse down to a very low-profile. Furthermore thecollapsed filter element1 withsmall wires16 has greater flexibility for ease of advancement of thefilter element1 through the vascular system.

As illustrated inFIGS. 165 and 166, the proximal termination points19 are circumferentially offset by 90° from the distal termination points20.

In use, thefilter element1 is collapsed down and loaded into a delivery catheter with an associated torqueing of thewires16 around thecells17. Thefilter element1 is then delivered through a vasculature fixed to or over a guidewire using the delivery catheter until thefilter element1 is located at a desired site in the vasculature.

By moving the delivery catheter proximally relative to thefilter element1, thefilter element1 is deployed out of the delivery catheter at the desired site in the vasculature. Thefilter support3 expands radially outwardly to support thefilter body2 in tubular apposition with the interior wall of the vasculature. In the fully expanded position, thewires16 of thetubular support frame15 are substantially free of torque.

The site of deployment of thefilter element1 in the vasculature is typically downstream of a treatment site, such as a region of stenosis in the vasculature. During the performance of a treatment procedure, thefilter element1 captures and safely retains any embolic material in the blood stream within thefilter body2.

After completion of the treatment procedure, thefilter element1 is collapsed down and retrieved into a retrieval catheter with any retained embolic material within thefilter body2. Thewires16 around the tubularwire support frame15 are again torqued during collapse.

The retrieval catheter is then withdrawn from the vasculature with thefilter element1 within the retrieval catheter.

The delivery, deployment and retrieval of the embolic protection device of the invention, as described above, is similar to that described in our WO 99/23976A; WO 01/80776A (US 2002-0052676A) and WO 01/80773A (US 2002-0049467A), the relevant contents of which are incorporated herein by reference. Thefilter element1 may be slidably exchanged over the guidewire without any attachment means between thefilter element1 and the guidewire. A distal stop on the guidewire assists in retrieval of thefilter element1. The guidewire may remain in the vasculature after retrieval of thefilter element1.

FIG. 170 illustrates anotherfilter support30, which is similar to thefilter support3 of FIGS.162 to168, and similar elements inFIG. 170 are assigned the same reference numerals.

In this case, thefilter support30 comprises only sixwires16, which define only threetubular segment cells17 as thewires16 extend axially along and circumferentially around thetubular frame15. The threecells17 do not form a complete 360° loop around thetubular frame15. Anextension wire31 is provided, in this case, to provide support to thefilter body2 between the two circumferentially spaced-apartcells17. Thelinkage element31 may provide a diameter adjusting feature.

Referring to FIGS.171 to173, there is illustrated anotherfilter support35, which is similar to thefilter support3 of FIGS.162 to169, and similar elements in FIGS.171 to173 are assigned the same reference numerals.

Thewires16 extend, in this case, circumferentially around thetubular frame15 in an “S-shape”. The S-shape increases the contact area between thewires16 and thefilter body2, and in this way, the supporting force exerted by thewires16 on thefilter body2 is more evenly distributed. This arrangement minimizes any trauma experienced by the vasculature due to the apposition of thefilter element1 with the vasculature.

Analternative filter support40 havingwires16 with a more exaggerated S-shapedportion41 is illustrated inFIGS. 174 and 175.

It will be appreciated that the shape of onewire16 of acell17 does not have to be symmetrical or similar to the shape of theother wire16 of thecell17, provided that the length of eachwire16 is equal.

Referring to FIGS.176 to178, there is illustrated anotherfilter support45, which is similar to thefilter support3 of FIGS.162 to169, and similar elements in FIGS.176 to178 are assigned the same reference numerals.

In this case, thefilter support45 comprises only fourwires16, which extend circumferentially around and axially along thetubular support frame15 to define two cells. The two cells have a hexagonal, hysteresis loop shape, and together the twocells17 extend circumferentially around thetubular frame15 in a complete loop.

The proximal termination points19 are circumferentially aligned with the distal termination points20.

Anothersupport frame50, illustrated inFIG. 179, is similar to thesupport frame3 of FIGS.161 to169, and similar elements ifFIG. 179 are assigned the same reference numerals.

In this case, thewires16 are fixed toinner tube8 at apoint51 distally of the tubularsupport frame portion15. Thewires16 extend from thefixation point51 axially proximally and radially outwardly in asingle leg52 to the tubularsupport frame portion15.

By providing a singleproximal support leg52, and by locating thisleg52 distally of theinlet end4 of thefilter body2. this arrangement minimizes the possibility of embolic material becoming caught or hung-up on theleg18 at theinlet openings6. In this manner, substantially all of the embolic material is retained safely within thefilter body2 for subsequent retrieval from the vascular system.

Thewires16 are preferably of a self-expanding material, such as Nitinol™, and theinner tube8 is preferably of gold. This arrangement provides for radiopacity.

It will be appreciated that a plurality ofcells17 may be defined by thewires16 around thetubular support frame15, as illustrated inFIG. 18. Eachwire16 may be fixed to awire16 in an adjacent cell17 (FIG. 181) by welding, or by adhesive means57 (FIG. 182), or by any other suitable means.

Thewires16 may be slidably mounted to theinner tube8 at both theproximal support leg18 and thedistal support leg21.

By increasing the number ofwires16 which define thecells17 of thetubular support frame15, the elongation of the overall filter support, when collapsed down, is reduced. In this way, the space required in a vasculature to deploy and retrieve the embolic protection device is also reduced.

Depending on the configuration of the filter element, the inner tube may not be present. In this case the filter support will be mounted directly onto the guidewire for exchange of the filter element over the guidewire.

It will be appreciated that asingle wire16, bent back on itself, may be used to define thetubular support frame15, in which case thecells17 of thetubular support frame15 are defined by elements of thesingle wire16, as illustrated inFIGS. 21 and 22. Thesupport frame90 ofFIGS. 183 and 184 is similar to thesupport frame3 above, with the exception that the support frame is defined by asingle wire16 bent back on itself.

A proximal neck of the filter body may be inverted to extend distally rather than proximally. This arrangement reduces the overall longitudinal length of the embolic protection device, and thus the embolic protection device may be deployed and retrieved with a shorter “parking space” in the vasculature. To invert the proximal neck, the neck may be split along each side, and then the pushed distally into the interior of the filter body.

In addition, the longitudinal length of the embolic protection device may be further shortened by providing a hemi-spherically shaped proximal nose instead of a conical nose. Furthermore, the overall crossing profile of the embolic protection device may be reduced by means of the hemi-spherical nose.

The angulated hysteresis structure/cell configurations of the invention are particularly suitable as support structures because the strain energy is distributed over long lengths of the wire structure. The wrapping/loading mechanisms of these hysteresis structures are both a bending/straightening of the constituent wires as well as a twisting/torsion of the wires. The energy applied/introduced during the loading process is both bending and torsional strain energy. These energies due to their nature and the method by which the support structure folds/loads are distributed over long lengths of the wire as opposed to concentrated focal points so that the level of energy within the wire at any point does not exceed the elastic strain energy limits. Hysteresis designs optimize the strain distribution along the wire lengths. With these designs there is distributed bending and torsional strain along the wires. The component of radial force is converted to torque strain energy. The corollary of this principle. that the torsional strain energy provides radial stiffness, also applies.

Angulated hysteresis structures also enable large radial forces to be achieved from structures with small wire diameters. The reason for this is that these designs use a greater proportion of the wires' torsional strain resistance. The wires offer far greater resistance to torsional strain than to bending strain and therefore these designs optimize this feature. The angulated hysteresis structure design arranges the wires so that the load induces torsional strain and therefore delivers far higher performance with small wire diameters than those designs that rely on the bending strain/resistance.

The hysteresis support structure of the invention has sections of wire curvature that can be defined in 3D planes. These sections of wire have geometrical properties such as a radius of curvature and a centre of radius of curvature. As the hysteresis structure designs are loaded and deployed, the geometrical properties of these sections change that is the radius of curvature changes and the center for the radius of curvature moves in a path that can only be defined within a 3D plane.

Even relatively simple hysteresis designs are made up of numerous sections of curvature with their corresponding radius of curvature joined end to end to form a complete hysteresis loop. These sections of curvature depending on the complexity of the design may be combinations of concave and convex elements/segments. The hysteresis loops themselves can be various shapes and there are multitudes of hysteresis loop/cell geometries.

A wire or laser cut support structure design based on a hysteresis cell type design typically may have four arms acting to provide uniform radial force to give good vessel apposition In attempting to provide support over the complete body length structure designs tend to have multiple arms/cells providing the support. The problems with many of these designs is the excessive elongation associated with them during loading. The advantage with the invention in suit is that it only extends the same length whether one/two or multiple arms are used. The invention also lends itself to low wrapping profiles, because during loading it contracts both radially and circumferentially leaving parallel straight wires which often prove to be the easiest for loading.

Further advantages of the round wire arrangements include:

Using a round wire allows for substantially more of the strain energy induced during loading/wrapping down into a low profile to be stored as torque along the wire lengths. This means that the strain energy is more evenly distributed within the wires than with conventional section designs, in which the strain energy generally becomes concentrated around the bend points which can cause problems such as exceeding the elastic strain energy limit at these locations.

The invention also has the advantage of being more trackable and flexible. This design achieves this by allowing the structure to hinge at points. Planes through these points demonstrate that bending at these hinge points is very easy.

Furthermore. the radial force may be altered by:

a) changing the wire diameter;

b) changing the proximal and distal cone angles.

Points of stress concentration can become strained plastically and result in poor support structure performance.

Conventional approaches to dealing with these issues involve designing in strain distributing geometric features to spread these strains over a greater area of the structure. Another approach involves the use of thinning out sections in the area of high strain. At a given radius of curvature the strain in a thin section is less than that of a thick section. Thinning however compromises the overall support provided by the structure.

The filter support of the invention provides for torsional strain and thus eliminates the need to use section thinning or thickening to distribute strain.

When collapse strains are evenly distributed, it is possible that the overall level of strain in the system can be increased without inducing plastic deformation. This makes it possible to achieve a high level of radial support from small diameter support members.

Designs that induce torque-strain into the support structure during collapse are particularly advantageous. Bending strains tend very often to have a strong cantilever effect with the strain becoming localized at points of stress concentration.

The torque strain in the wire can be released in a variety of expansion pathways. This means that the release of the torque is not inhibited when uniaxial resistance is encountered. This feature helps the support structure deliver good apposition to eccentric vessels. This is an important aspect of the invention, especially when the filter is placed in diseased vessel segments.

The geometric configuration of the filter support aligns the wires of the cell in a substantially circumferential direction in the expanded state. This ensures that radial pressure applied by the vessel is initially transmitted as compressive hoop stress to the structure.

The compressive component of applied stress decreases as the system collapses, however the torsional resistance increases resulting in a relatively flatter loading stress curve.

It will be appreciated that the body maybe attached to or independent of the support frame.

The invention is not limited to the embodiments hereinbefore described which may be varied in detail.