US20070167976A1

Movatterモバイル変換

Info

Publication number: US20070167976A1
Application number: US11/698,516
Authority: US
Inventors: William Boyle; John Papp; Francisco Sanchez; Steven Saville
Original assignee: Individual
Current assignee: Individual
Priority date: 2002-06-27
Filing date: 2007-01-25
Publication date: 2007-07-19
Also published as: US7172614B2; US20040006361A1

Abstract

An inner support structure for an embolic filtering device includes a tubular member having a first support region for supporting the proximal portion of a filter assembly and a second support region for supporting the distal portion of the filter assembly. The inner support structure facilitates rotation and restricts longitudinal movement of the embolic filtering device relative to a guide wire. Alternatively, the inner support structure includes a bushing coupled to the guide wire and a sleeve with a head on its proximal end positioned within a cavity in the bushing, thereby facilitating rotation and restricting longitudinal movement of the sleeve. The proximal portion of the filter assembly is supported on the sleeve. A sleeve for retaining the struts of an expandable cage of the embolic filtering device includes a central lumen for positioning the sleeve onto a guide wire and peripheral lumens for positioning and retaining the struts.

Description

BACKGROUND OF THE INVENTION

The present invention relates generally to filtering devices used when an interventional procedure is being performed in a stenosed or occluded region of a body vessel to capture embolic material that may be created and released into the vessel during the procedure. The present invention is more particularly directed to a support and retention apparatus for embolic filtering devices. The present invention also is directed to an embolic filtering device having a half-basket type expandable cage which has good flexibility and bendability and allows the embolic filtering device to be readily navigated through tortuous body lumens of a patient.

Numerous procedures have been developed for treating occluded blood vessels to allow blood to flow without obstruction. Such procedures usually involve the percutaneous introduction of an interventional device into the lumen of the artery, usually by a catheter. One widely known and medically accepted procedure is balloon angioplasty in which an inflatable balloon is introduced within the stenosed region of the blood vessel to dilate the occluded vessel. The balloon dilatation catheter is initially inserted into the patient's arterial system and is advanced and manipulated into the area of stenosis in the artery. The balloon is inflated to compress the plaque and press the vessel wall radially outward to increase the diameter of the blood vessel, resulting in increased blood flow. The balloon is then deflated to a small profile so that the dilatation catheter can be withdrawn from the patient's vasculature and the blood flow resumed through the dilated artery. As should be appreciated by those skilled in the art, while the above-described procedure is typical, it is not the only method used in angioplasty.

Another procedure is laser angioplasty which utilizes a laser to ablate the stenosis by super heating and vaporizing the deposited plaque. Atherectomy is yet another method of treating a stenosed body vessel in which cutting blades are rotated to shave the deposited plaque from the arterial wall. A vacuum catheter is usually used to capture the shaved plaque or thrombus from the blood stream during this procedure.

In the procedures of the kind referenced above, abrupt reclosure may occur or restenosis of the artery may develop over time, which may require another angioplasty procedure, a surgical bypass operation, or some other method of repairing or strengthening the area. To reduce the likelihood of the occurrence of abrupt reclosure and to strengthen the area, a physician can implant an intravascular prosthesis for maintaining vascular patency, commonly known as a stent, inside the artery across the lesion. The stent can be crimped tightly onto the balloon portion of the catheter and transported in its delivery diameter through the patient's vasculature. At the deployment site, the stent is expanded to a larger diameter, often by inflating the balloon portion of the catheter.

The above non-surgical interventional procedures, when successful, avoid the necessity of major surgical operations. However, there is one common problem which can become associated with all of these non-surgical procedures, namely, the potential release of embolic debris into the bloodstream that can occlude distal vasculature and cause significant health problems to the patient. For example, during deployment of a stent, it is possible that the metal struts of the stent can cut into the stenosis and shear off pieces of plaque that can travel downstream and lodge somewhere in the patient's vascular system. Pieces of plaque material are sometimes generated during a balloon angioplasty procedure and become released into the bloodstream. Additionally, while complete vaporization of plaque is the intended goal during laser angioplasty, sometimes particles are not fully vaporized and enter the bloodstream. Likewise, not all of the emboli created during an atherectomy procedure may be drawn into the vacuum catheter and, as a result, enter the bloodstream as well.

When any of the above-described procedures are performed in the carotid arteries, the release of emboli into the circulatory system can be extremely dangerous and sometimes fatal to the patient. Debris carried by the bloodstream to distal vessels of the brain can cause cerebral vessels to occlude, resulting in a stroke, and in some cases, death. Therefore, although cerebral percutaneous transluminal angioplasty has been performed in the past, the number of procedures performed has been somewhat limited due to the justifiable fear of an embolic stroke occurring should embolic debris enter the bloodstream and block vital downstream blood passages.

Medical devices have been developed to attempt to deal with the problem created when debris or fragments enter the circulatory system following vessel treatment utilizing any one of the above-identified procedures. One approach which has been attempted is the cutting of any debris into minute sizes which pose little chance of becoming occluded in major vessels within the patient's vasculature. However, it is often difficult to control the size of the fragments which are formed, and the potential risk of vessel occlusion still exists, making such a procedure in the carotid arteries a high-risk proposition.

Other techniques include the use of catheters with a vacuum source which provides temporary suction to remove embolic debris from the bloodstream. However, as mentioned above, there can be complications associated with such systems if the vacuum catheter does not remove all of the embolic material from the bloodstream. Also, a powerful suction could cause trauma to the patient's vasculature.

Another technique which has had some success utilizes a filter or trap downstream from the treatment site to capture embolic debris before it reaches the smaller blood vessels downstream. The placement of a filter in the patient's vasculature during treatment of the vascular lesion can reduce the presence of the embolic debris in the bloodstream. Such embolic filters are usually delivered in a collapsed position through the patient's vasculature and then expanded to trap the embolic debris. Some of these embolic filters are self expanding and utilize a restraining sheath which maintains the expandable filter in a collapsed position until it is ready to be expanded within the patient's vasculature. The physician can retract the proximal end of the restraining sheath to expose the expandable filter, causing the filter to expand at the desired location. Once the procedure is completed, the filter can be collapsed, and the filter, with the trapped embolic debris, can then be removed from the vessel. While a filter can be effective in capturing embolic material, the filter still needs to be collapsed and removed from the vessel. During this step, there is a possibility that trapped embolic debris can backflow through the inlet opening of the filter and enter the bloodstream as the filtering system is being collapsed and removed from the patient. Therefore, it is important that any captured embolic debris remain trapped within this filter so that particles are not released back into the body vessel.

Some prior art expandable filters are attached to the distal end of a guide wire or guide wire-like member which allows the filtering device to be steered in the patient's vasculature as the guide wire is positioned by the physician. Once the guide wire is in proper position in the vasculature, the embolic filter can be deployed to capture embolic debris. The guide wire can then be used by the physician to deliver interventional devices, such as a balloon angioplasty dilatation catheter or a stent delivery catheter, to perform the interventional procedure in the area of treatment. After the procedure is completed, a recovery sheath can be delivered over the guide wire using over-the-wire techniques to collapse the expanded filter for removal from the patient's vasculature.

Many prior art expandable filters include a cage to which a filtering element is coupled. The cage may include struts which, in turn, are coupled to a sleeve or collar mounted to the guide wire or guide wire-like member. The process for securing the struts to the sleeve is referred to herein as end termination. Current methods for terminating the ends of the struts for a cage for an embolic filtering device include sandwiching the ends of the struts of the cage between two sleeves or soldering the ends of the struts to a sleeve. The struts must first be positioned around the sleeve at desired locations and then held in place for the sandwiching or soldering operation. To achieve optimal performance of the cage, the struts should be positioned accurately. However, with the current methods of strut end termination, accuracy is sometimes difficult to achieve.

When a combination of an expandable filter and guide wire is utilized, it is important that the expandable filter portion remains flexible in order to negotiate the often tortuous anatomy through which it is being delivered. An expandable filter which is too stiff could prevent the device from reaching the desired deployment position within the patient's vasculature or cause damage to the patient's vessels. As a result, there is a need to increase the flexibility of the expandable filter without compromising its structural integrity once in position within the patient's body vessel. As the lumens within the patient's vasculature are narrow, it is also preferable to minimize the size of delivery devices for expandable filters, however, the size of the delivery device is partially dictated by the size of the collapsed filter. Reducing the size of the collapsed filter and the delivery device may increase the flexibility of the delivery device. To prevent accidental or intended rotation of the guide wire from being transmitted to the deployed filtering device, it is also desirable to have the guide wire independently rotatable from the filtering device. However, when a filtering device having a half-basket support for the filter element is utilized, it is also desirable to include a continuous support structure between the proximal end and the distal end of the filter element to prevent the filter element from rotating separately from the basket and becoming tangled.

What has been needed is an expandable filter assembly having a reduced profile in the collapsed condition while maintaining structural continuity between the proximal end of the cage and the distal end of the filter to collect embolic debris which may be released into the patient's vasculature. Also, there is a need to simplify the manufacturing process for making expandable cages for embolic filtering devices. The present invention satisfies these and other needs.

SUMMARY OF THE INVENTION

The present invention provides embolic protection filters designed to have a relatively small cross profile in the collapsed condition which permits the use of a delivery catheter having a relatively small cross profile in comparison to current catheters for delivering embolic protection filters. The present invention attains a smaller cross profile while maintaining structural continuity between the proximal end of a cage portion of the filter device and the distal end of a filter element. The present invention also provides means for coupling strut portions of the cage to a delivery device.

In one aspect of the present invention, an embolic filtering device made in accordance with the present invention includes an inner support structure. The inner support structure includes a first support region, a second support region and a transition portion. The first support region includes a substantially cylindrical tubular member having an exterior surface, a first end, a second end and a cavity therebetween. The exterior surface of the first support region has a first diameter and is substantially longitudinally aligned with a longitudinal axis of the inner support structure. A cross section of the cavity of the first support region which is perpendicular to the longitudinal axis of the inner support structure has a substantially circular shape. There is also at least one deflectable tab positioned on the first support region.

The second support region includes a substantially cylindrical tubular member having an exterior surface, a first end, a second end and a lumen therebetween. At least one slot extends substantially longitudinally throughout the length of the second support region to add flexibility. The exterior surface of the second support region has a second diameter which is smaller than the first diameter of the first support region. The second support region is positioned substantially longitudinally aligned with the longitudinal axis of the inner support structure. A cross section of the lumen of the second support region which is perpendicular to the longitudinal axis of the inner support structure has a substantially circular shape which is smaller than the cross section of the cavity of the first support region.

The transition portion is coupled to the second end of the first support region and the first end of the second support region. In this manner, the transition portion forms a surface at the second end of the cavity of the first support region.

In a detailed aspect of the present invention, the slot within the second support region of the inner support structure includes four slots substantially equally spaced about a periphery of the second support region. In another detailed aspect, the inner support structure includes an elastic jacket coupled to the second support region to facilitate retaining the shape of the second support region.

In another aspect of the present invention using the inner support structure having the first and second support regions, the embolic filtering device includes an elongate guide wire having a proximal end and a distal end. A marker band is positioned on the guide wire within the distal portion of the guide wire. The inner support structure is positioned along the distal portion of the guide wire with the guide wire positioned within the cavity of the proximal support region and the lumen of the distal support region. The marker band is positioned with a clearance fit within the cavity of the proximal support region proximate the surface at the distal end of the cavity. The deflectable tab of the proximal support region is deflected radially into the cavity of the proximal support region. An apex on the deflectable tab projects into the cavity of the proximal support region at a position proximal to the marker band.

In a detailed aspect, the deflectable tab of the proximal support region of the inner support structure includes two deflectable tabs which are positioned substantially diametrically opposed to each other. The distance between the apices of the two tabs after radial deflection into the cavity of the proximal support region is smaller than the distance across the periphery of the marker band. In a further aspect, the embolic filtering device includes an annular plug having a proximal surface, a distal surface and a lumen therebetween. The guide wire is positioned within the lumen of the plug. The distal surface of the plug is positioned within the cavity of the proximal support region of the inner support structure and the plug is coupled to the cavity. A proximal surface of the plug includes an atraumatic shape.

In an additional aspect of the present invention, attachment of the embolic filtering device to a delivery device, such as a guide wire, is accomplished through a sleeve. The sleeve includes a longitudinal member having a central lumen extending substantially longitudinally throughout the length of the longitudinal member. The central lumen is sized to receive a delivery device and is positioned substantially centered along a longitudinal axis of the longitudinal member. The sleeve also includes at least one peripheral lumen which extends substantially longitudinally throughout the length of the longitudinal member and substantially parallel to the longitudinal axis of the longitudinal member. The at least one peripheral lumen is sized to receive and retain a strut of an embolic filtering device.

In a detailed aspect, the sleeve includes a substantially cylindrical shape. The at least one peripheral lumen may include four peripheral lumens substantially equally spaced about the central lumen and positioned a substantially equal distance from the longitudinal axis of the tubular member.

In another detailed aspect, the longitudinal member of the sleeve may include an outer sleeve and an inner sleeve. The outer sleeve may include a substantially cylindrical shape and a lumen throughout its length. The lumen of the outer sleeve is positioned substantially centered along a longitudinal axis of the outer sleeve. The inner sleeve may include a substantially cylindrical shape and a lumen throughout its length. The outside diameter of the inner sleeve is sized to be secured within the lumen of the outer sleeve. The lumen of the inner sleeve is sized to receive a delivery device and is positioned substantially centered along a longitudinal axis of the inner sleeve. The inner sleeve includes at least one slot which extends longitudinally along the outside surface of the inner sleeve substantially parallel to the longitudinal axis of the inner sleeve. The outer surface of the inner sleeve is coupled to the lumen surface of the outer sleeve, such that the lumen of the inner sleeve forms the central lumen of the sleeve. In this configuration, the at least one peripheral lumen is formed by the surfaces of the at least one slot on the outside surface of the inner sleeve and the lumen surface of the outer sleeve. In a more detailed aspect, the at least one slot includes four slots substantially equally spaced about the lumen of the inner sleeve. In a similar aspect, the outer sleeve includes at least one slot extending longitudinally along the surface of the lumen while the inner sleeve has no slots on its exterior surface. In this configuration, the at least one peripheral lumen is formed by the surfaces of the at least one slot on the surface of the lumen of the outer sleeve and the outside surface of the inner sleeve. In a more detailed aspect, the at least one slot includes four slots substantially equally spaced about the lumen of the outer sleeve.

Another aspect of the present invention includes a method of coupling a strut of an embolic filtering device to a delivery device. The method includes providing a delivery device, providing a sleeve having a central lumen and at least one peripheral lumen, and providing an embolic filtering device having at least one strut. The at least one strut is inserted into and coupled to the at least one peripheral lumen of the sleeve. The delivery device is inserted into the central lumen of the sleeve and the sleeve is coupled to the delivery device.

In yet another detailed aspect, the strut includes an end portion having smooth surfaces and inserting the strut into the peripheral lumen includes advancing the strut through the peripheral lumen until an end of the strut extends out of the peripheral lumen and beyond an end surface of the sleeve. Coupling the strut to the peripheral lumen includes bonding the strut to the peripheral lumen with an adhesive within the peripheral lumen and adding a bead of the adhesive between the end portion of the strut and the end surface of the sleeve. An end portion of the strut may include an aperture on a side of the strut proximate the end of the strut so that coupling the strut to the peripheral lumen with the bead of the adhesive includes the adhesive filling the aperture in the strut.

It is to be understood that the present invention is not limited by the embodiments described herein. The present invention can be used in arteries, veins, and other body vessels. Other features and advantages of the present invention will become more apparent from the following detailed description of the invention, when taken in conjunction with the accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embolic filtering device embodying features of the present invention.

FIG. 2 is a perspective view of the expandable cage which forms part of the embolic protection device ofFIG. 1.

FIG. 3 is an elevational view, partially in cross section, of an embolic filtering device embodying features of the present invention as it is being delivered within a body vessel downstream from an area to be treated.

FIG. 4 is an elevational view, partially in cross section, similar to that shown inFIG. 3, wherein the embolic filtering device is deployed within the body vessel.

FIG. 5 is an elevational view, in cross section, of an embolic filtering device embodying features of the present invention with an apparatus for rotatably mounting the embolic filter device to a guide wire.

FIG. 6ais an elevational view, in cross section, of an embolic filtering device embodying features of the present invention with an alternative apparatus for rotatably mounting the embolic filter device to a guide wire.

FIG. 6bis an elevational view, in cross section, of an embolic filtering device embodying features of the present invention with an alternative apparatus for rotatably mounting the embolic filter device to a guide wire, similar to that shown inFIG. 6a.

FIG. 7 is a perspective view of an embolic filtering device embodying features of the present invention and having an alternative expandable cage configuration.

FIG. 8 is a perspective view of an embolic filtering device embodying features of the present invention and having a full basket expandable cage configuration.

FIG. 9ais an exploded perspective view of the components for a sleeve for retaining the struts of an embolic filtering device embodying features of the present invention.

FIG. 9bis a perspective view of the assembled sleeve for retaining the struts of an embolic filtering device including the components depicted inFIG. 9b.

FIG. 10ais an exploded perspective view of the components for a sleeve for retaining the struts of an embolic filtering device embodying features of the present invention.

FIG. 10bis a perspective view of the assembled sleeve for retaining the struts of an embolic filtering device including the components depicted inFIG. 10b.

FIG. 11 is a perspective view of a sleeve for retaining the struts of a cage of an embolic filtering device embodying features of the present invention.

FIG. 12 is a elevation view, partially in cross section, depicting the struts of a cage of an embolic filtering device coupled with a sleeve similar to that shown inFIG. 11.

FIG. 13ais an elevational view, partially in cross section, depicting a strut of a cage of an embolic filtering device coupled with a peripheral lumen of a sleeve similar to that shown inFIG. 11.

FIG. 13bis an elevational view, partially in cross section, depicting a strut of a cage of an embolic filtering device coupled with a peripheral lumen of a sleeve similar to that shown inFIG. 11.

FIG. 13cis an elevational view, partially in cross section, depicting a strut of a cage of an embolic filtering device coupled with a peripheral lumen of a sleeve similar to that shown inFIG. 11.

FIG. 13dis an elevational view, partially in cross section, depicting a strut of a cage of an embolic filtering device coupled with a peripheral lumen of a sleeve similar to that shown inFIG. 11.

FIG. 13eis an elevational view, partially in cross section, depicting a strut of a cage of an embolic filtering device coupled with a peripheral lumen of a sleeve similar to that shown inFIG. 11.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to the drawings, in which like reference numerals represent like or corresponding elements in the drawings,FIGS. 1 and 2 illustrate one particular embodiment of anembolic filtering device20 incorporating features of the present invention. Theembolic filtering device20 is designed to capture embolic debris which may be created and released into a body vessel during an interventional procedure. Theembolic filtering device20 includes anexpandable filter assembly22 having a self-expanding basket orcage24 and afilter element26 attached thereto. In this particular embodiment, theexpandable filter assembly22 is rotatably mounted onto the distal portion of a delivery device including an elongated (solid or hollow) cylindrical shaft, such as aguide wire28. The guide wire has a proximal end (not shown) which extends outside the patient and is manipulated by the physician to deliver the filter assembly into the target area in the patient's vasculature. A restraining or delivery sheath30 (FIG. 3) extends coaxially along theguide wire28 in order to maintain theexpandable filter assembly22 in its collapsed position until it is ready to be deployed within the patient's vasculature. Theexpandable filter assembly22 is deployed by the physician by simply retracting the restrainingsheath30 proximally to expose the expandable filter assembly. Once the restraining sheath is retracted, the self-expandingcage24 immediately begins to expand within the body vessel (seeFIG. 4), causing thefilter element26 to expand as well.

Anobturator32 affixed to the distal end of thefilter assembly22 can be implemented to prevent possible “snowplowing” of theembolic filtering device20 as it is being delivered through the vasculature. The obturator can be made from a soft polymeric material, such as Pebax 40D, and includes a smooth surface to help theembolic filtering device20 travel through the vasculature and cross lesions while preventing the distal end of the restrainingsheath30 from “digging” or “snowplowing” into the wall of the body vessel.

Theguide wire28 extends through theexpandable cage24, through theobturator32, and to thecoil tip34 of the guide wire. The full-length guide wire allows the physician to control the proximal end of the guide wire in order to steer thedistal coil tip34 into the desired vessel when delivering theembolic filtering device20 through the patient's vasculature.

InFIGS. 3 and 4, theembolic filtering device20 is shown as it is being delivered within anartery36 or other body vessel of the patient. Since theembolic filtering device20 made in accordance with the present invention possesses excellent bendability and flexibility, it will conform well to the shape of the vasculature while allowing the filter assembly to more easily negotiate a curved radius in the patient's vasculature.

Referring now toFIG. 4, theembolic filtering device20 is shown in its expanded position within the patient'sartery36. This portion of theartery36 has an area of treatment38 (FIG. 3) in whichatherosclerotic plaque40 has built up against theinside wall42 of anartery36 of the patient. Thefilter assembly22 is to be placed distal to, and downstream from, the area oftreatment38. For example, the therapeutic interventional procedure may include the implantation of a stent (not shown) to increase the diameter of an occluded artery and increase the flow of blood therethrough. It should be appreciated that the embodiments of theembolic filtering device20 described herein are illustrated and described by way of example only and not by way of limitation. Also, while the present invention is described in detail as applied to an artery of the patient, those skilled in the art will appreciate that it can also be used in other body vessels, such as the coronary arteries, carotid arteries, renal arteries, saphenous vein grafts and other peripheral arteries. Additionally, the present invention can be utilized when a physician performs any one of a number of interventional procedures which generally require an embolic filtering device to capture embolic debris created during the procedure, such as balloon angioplasty, laser angioplasty or atherectomy.

Thecage24 includes self-expandingstruts44 which, upon release from the restrainingsheath30, expand thefilter element26 into its deployed position within the artery36 (FIG. 4).Embolic particles46 created during the interventional procedure and released into the bloodstream are captured within the deployedfilter element26. The filter may includeperfusion openings48, or other suitable perfusion means, for allowing blood flow through thefilter element26. The filter element will capture embolic particles which are larger than the perfusion openings while allowing blood to perfuse downstream to vital organs. Although not shown, a balloon angioplasty catheter can be initially introduced within the patient's vasculature in a conventional SELDINGER technique through a guiding catheter (not shown). Theguide wire28 is disposed through the area of treatment and the dilatation catheter can be advanced over the guide wire within theartery36 until the balloon portion is directly in the area oftreatment38. The balloon of the dilatation catheter can be expanded, expanding theplaque40 against thewall42 of theartery36 to expand the artery and reduce the blockage in the vessel at the position of the plaque. After the dilatation catheter is removed from the patient's vasculature, a stent (not shown) could be implanted in the area oftreatment38 using over-the-wire techniques to help hold and maintain this portion of theartery36 and help prevent restenosis from occurring in the area of treatment. The stent could be delivered to the area of treatment on a stent delivery catheter (not shown) which is advanced from the proximal end of the guide wire to the area of treatment. Any embolic debris created during the interventional procedure will be released into the bloodstream and should enter thefilter element26. Once the procedure is completed, the interventional device may be removed from the guide wire. Thefilter assembly22 can also be collapsed and removed from theartery36, taking with it any embolic debris trapped within thefilter element26. A recovery sheath (not shown) can be delivered over theguide wire28 to collapse thefilter assembly22 for removal from the patient's vasculature.

Theexpandable cage24 ofFIGS. 1 and 2 is shown rotatably mounted to the distal portion of a delivery device, such as theguide wire28, to allow theentire filtering assembly22 to remain stationary once deployed in the body vessel. This feature prevents the filtering assembly from rotating in the event that the proximal end of the guide wire is accidentally rotated by the physician during use. As a result, the possibility that the deployedfiltering assembly22 could be rotated to cause trauma to the wall of the vessel is minimized. Referring specifically toFIG. 5, a first end50 (proximal end) of thestruts44 forming thecage24 are coupled to aninner support structure52 which is rotatably mounted to the distal portion of the guide wire.

Theinner support structure52 may include a substantially longitudinaltubular member54 having a first support region56 (proximal support region) and a second support region58 (distal support region). The proximal support region includes a first end60 (proximal end), a second end62 (distal end) and acavity64 therebetween. The distal support region includes a first end66 (proximal end), a second end68 (distal end) and alumen70 therebetween. A cross section of the proximal support region which is perpendicular to a longitudinal axis of the inner support structure is larger than a cross section of the distal support region which is perpendicular to the longitudinal axis.

In one embodiment, theproximal support region56 and thedistal support region58 each include a substantially cylindrical shape positioned adjacent each other and substantially longitudinally aligned along the longitudinal axis of theinner support structure52. In this embodiment, anexterior surface72 of the proximal support region includes a first diameter and anexterior surface74 of the distal support region includes a second diameter which is smaller than the first diameter of the proximal support region. Atransition portion76 may couple the proximal support region to the distal support region. More particularly, the transition portion couples thedistal end62 of the proximal support region to theproximal end66 of the distal support region, thereby creating asurface78 at the distal end of the cavity within the proximal support region.

Thecavity64 within theproximal support region56 may be sufficiently large to house amarker band80 which is positioned on a distal portion of theguide wire28 with a clearance fit between the cavity and the marker band. A cross section of the cavity of the proximal support region which is perpendicular to the longitudinal axis of theinner support structure52 may be larger than a cross section of thelumen70 of thedistal support region58 which is perpendicular to the longitudinal axis of the inner support structure. In one embodiment, the cavity includes a substantially circular shape in a cross section that is perpendicular to the longitudinal axis of the inner support structure. The lumen of the distal support region may have a larger cross section than the guide wire such that the inner support structure can be introduced onto the guide wire with a clearance fit and be capable of rotating independently on the guide wire. In another embodiment, the lumen within the distal support region may include a circular shape in a cross section that is perpendicular to a longitudinal axis of the inner support structure.

To introduce theinner support structure52 onto the distal portion of theguide wire28, the guide wire may be inserted into thecavity64 within theproximal support region56 and into thelumen70 within thedistal support region58. The inner support structure may be translated proximally along the guide wire until themarker band80 on the guide wire is positioned next to thesurface78 of the cavity at thedistal end62 of the proximal support region. Thelumen70 within thedistal support region58 may be sufficiently small to prevent entry of the marker band into the lumen.

Theproximal support region56 may include at least onedeflectable tab82. To permanently retain theinner support structure52 on theguide wire28, the tab may be deflected radially into thecavity64 to entrap themarker band80 between the tab and thedistal surface78 of the cavity. The deflected tabs restrict longitudinal movement of the inner support structure on the guide wire.

Thetab82 may be formed by machining aslot84 having a shape, such as a U-shape, through awall86 of theproximal support region56 such that the slot extends from theexterior surface72 of the proximal support region to the surface of thecavity64. The shape of the slot may be such that the tab includes abend line88 forming a connecting portion positioned between two end points of the shaped slot. The distance between the two end points is sufficient to permit deflection of the tab without experiencing structural failure along the connecting portion. The distance between the connecting portion and an apex90 of the tab is sufficient that with the tab deflected radially into the cavity, the tab creates interference with themarker band80 and prevents removal of theinner support structure52 from theguide wire28. More particularly, with thetab82 deflected radially into thecavity64, the distance between the apex90 of the tab and theguide wire28 is less than the distance between aperiphery92 of themarker band80 and the guide wire. In one embodiment, the shaped slot may be oriented longitudinally along the surface of the proximal support region. The tab is positioned longitudinally along the proximal support region such that the tab clears the marker band during deflection of the tab when assembling.

In one particular embodiment, theproximal support region56 includes twotabs82 positioned substantially diametrically opposed to each other. The distance between theapices90 of the two tabs after deflection into thecavity64 is smaller than the distance across theperiphery92 of themarker band80. Those familiar in the art may recognize that other tab designs may be utilized with theinner support structure52 without departing from the scope of the present invention. Accordingly, it is not intended that the invention be limited to the tab configuration disclosed herein.

Anannular plug94 having a first surface96 (proximal surface), a second surface98 (distal surface) and alumen100 therebetween may be inserted into the cavity to provide a ramp for the delivery sheath and recovery sheath to ride up on when collapsing the cage. To install the plug, the proximal end of theguide wire28 may be inserted into the lumen in the plug and the plug translated distally along the guide wire to the proximal support region of theinner support structure52. The plug may be retained within the cavity through methods which are well known in the art, such as bonding or an interference fit between the plug and the cavity. To provide a smooth proximal surface for the inner support structure, theproximal surface96 of theplug94 may include an atraumatic shape, such as a substantially conical or rounded shape. The plug may be made from a radiopaque material to facilitate tracking of the embolic filter through the patient's vasculature.

To improve flexibility through thedistal support region58 of theinner support structure52, at least oneslot102 which extends substantially longitudinally throughout the length of the distal support region may be included. In one particular embodiment, four slots are distributed substantially equally spaced about the periphery of the distal support region. Although the slots reduce the surface area of the distal support region, sufficient material remains for theobturator32 to be coupled to the distal portion of the distal support region through methods which are well known in the art, such as bonding. Anelastic jacket104 may be coupled to thedistal support region58 to facilitate shape retention of the distal support region having the slots during flexure of the inner support structure.

Thecage24 may include a half-basket configuration (FIGS. 1 and 2) having self-expandingstruts44 which help to deploy thefilter element26. The first ends50 (proximal ends) of the struts may be coupled to theexterior surface72 of theproximal support region56 of theinner support structure52. The second ends106 (distal ends) of the struts are coupled to acircumferential member108 which may be adapted to move from an unexpanded delivery position (FIG. 3) to an expanded deployed position (FIG. 4). Alternatively, in another embodiment thecage24 may include at least one loop110 (FIG. 7) havingend portions112 at a proximal end which may be coupled to theexterior surface72 of theproximal support region56, and an apex114 at the distal end of the loop. A first end116 (proximal end) of thefilter element26 is coupled to adistal portion118 of thecage24, such as at the circumferential member108 (FIGS. 1 and 2), or to the loop110 (FIG. 7) of the alternative embodiment. Thefilter element26 tapers to adistal end120 which is, in turn, bonded or otherwise adhesively attached to theexterior surface74 of thedistal support region58 at a position proximate thedistal end68 of the distal support region. In one embodiment, the distal end of the filter can be bonded both to the exterior surface of the distal support region and also to alumen122 surface of theobturator32, the distal end of the distal support region being positioned within the lumen of the obturator. The deployment of thecage24 results in the filter element being placed against the wall of the artery or other body vessel preparatory to catching embolic debris within the patient's artery. Theinner support structure52 provides continuity of support between thecage24 and thefilter element26, thereby preventing the filter element from rotating separately from the cage and becoming tangled. The inner support structure also protects the filter element by preventing the filter element from contacting theguide wire28.

Referring specifically now toFIG. 5, thefirst end50 of thestruts44 are attached to theinner support structure52 which is rotatably mounted onto theguide wire28. The retention method of the inner support structure allows theexpandable cage24 to spin on the guide wire but restricts the longitudinal movement of the cage on the wire. This particular mechanism is but one way to rotatably mount the expandable cage to the guide wire.

Referring toFIG. 6a, another configuration of aninner support structure124 mechanism for rotatably mounting theexpandable cage24 to the delivery device, such as theguide wire28, includes astop assembly126 coupled to a distal portion of the guide wire. The stop assembly may include a bushing portion128 having anexterior surface130, a first end132 (proximal end), a second end134 (distal end) and alumen136 therebetween. The exterior surface of the bushing portion may include a shape, such as a cylindrical shape, which is substantially centered about the longitudinal axis of the bushing portion. The lumen may be positioned substantially centered along a longitudinal axis of the bushing portion and sized to receive and be coupled to theguide wire28. Theexterior surface130 toward theproximal end132 of the bushing portion may include a conical shape.

The bushing portion128 may include a cavity138 positioned on a distal surface140 at the distal end134 of the bushing portion. The cavity may be positioned substantially centered along the longitudinal axis of the bushing portion and project into the bushing portion. The cavity may include a first region142 (distal region) having a first periphery proximate the distal end of the bushing portion, and a second region144 (proximal region) with a second periphery larger than the first periphery positioned adjacent the first region. Anedge146 between the distal surface of the bushing portion and the first region of the cavity may be chamferred.

In this particular embodiment, thesleeve148 may include at least one longitudinal slot (not shown) which extends longitudinally from the proximal end152 of the sleeve toward thedistal end154 of the sleeve to facilitate insertion of the head158 of the sleeve into the cavity138 of the bushing portion128. Insertion of the head of the sleeve into the cavity of the bushing portion may be further facilitated by the inclusion of a chamfer at an outer,proximal edge160 of the head of the sleeve. To assemble the sleeve of this embodiment with the bushing portion, the head of the sleeve is pressed against the cavity opening at the distal end of the bushing portion in a proximal direction, thereby causing the slot in the sleeve to compress and the periphery of the proximal portion of the sleeve to be reduced. When the periphery of the head is at least as small as the first periphery of the distal region of the cavity of the bushing portion, the head of the sleeve may be inserted into the second region of the cavity. Upon complete insertion of the head of the sleeve into the second region of the cavity, the head of the sleeve springs to a larger size, thereby trapping the head of the sleeve within the cavity of the bushing portion.

In an alternative embodiment (FIG. 6b), the bushing portion128 of thestop assembly126 may include abushing162 having anexterior surface164, a first end166 (proximal end), a second end168 (distal end) and alumen170 therebetween. The lumen may be substantially centered along a longitudinal axis of the bushing and sized to receive and be attached to theguide wire28. The exterior surface may include a shape, such as a cylindrical shape, which is substantially centered about the longitudinal axis of the bushing. In one embodiment, the exterior surface of the bushing toward the proximal end of the bushing may include a substantiallyconical shape172 to facilitate retrieval of theembolic filtering device20 into a sheath at the end of a surgical procedure. Thebushing162 may be coupled to theguide wire28 through methods which are well known in the art, such as soldering or bonding.

With continued reference toFIG. 6b, this alternative embodiment of thestop assembly126 also includes atubular collar174 having an exterior surface176, a first end178 (proximal end), a second end180 (distal end), and alumen182 therebetween. The lumen is shaped to mate with and be coupled to theexterior surface164 of thebushing162. At the distal end of the collar is aring portion184 having anaperture186 positioned substantially centered about the longitudinal axis of the collar. The ring portion projects inward toward the longitudinal axis of the collar and corresponds with thedistal region142 of the cavity138 of the bushing portion. In one embodiment, the collar includes a substantially cylindrical exterior surface and a substantially circular lumen. The collar may be coupled to the bushing through methods which are well known in the art, such as soldering, bonding or through a press fit. The proximal end, of the collar may be chamferred to be flush with the conical surface of the bushing. Anedge188 between the distal surface of the collar ring portion and the inside surface of the collar ring portion may be chamferred.

Upon assembly of thebushing162 and thecollar174 to form the bushing portion128, theproximal end166 of the bushing is substantially flush with theproximal end178 of the collar and thering portion184 of the collar is a positioned a distance from the distal end168 of the bushing. The cavity138 of the bushing portion is formed by the ring portion of the collar, the lumen of the collar and a surface190 at the second end of the bushing. With this embodiment of the stop assembly, the sleeve does not require a slot to facilitate insertion of the head of the sleeve into the cavity of the bushing portion.

To assemble thesleeve148 with the bushing portion128 of the alternative embodiment, thedistal end154 of the sleeve is inserted into thelumen182 of thecollar174 and through theaperture186 in thecollar ring portion184 such that the head158 of the sleeve is housed within thecollar lumen182 prior to the installation of the collar onto the bushing. The collar is then coupled to the bushing, thereby trapping the head of the sleeve within the cavity138 between the distal surface190 of the bushing and theproximal surface192 of the collar ring portion. In this manner, the sleeve is restricted longitudinally but can rotate freely.

The first ends50 (proximal ends) of thestruts44 of thecage24 may be coupled to the exterior surface150 of thesleeve148 of thestop assembly126. The second ends106 (distal ends) of the struts may be coupled to the circumferential member108 (FIGS. 1 and 2) which is adapted to move from the unexpanded delivery position (FIG. 3) to the expanded deployed position (FIG. 4). Alternatively, in another embodiment, thecage24 may include at least one loop110 (FIG. 7) havingproximal end portions112 which may be coupled to thesleeve148 of the stop assembly and an apex114 at the distal end of the loop. The first end116 (proximal end) of thefilter element26 is coupled to the circumferential member of the cage (FIGS. 1 and 2), or to the loop (FIG. 7) of the alternative embodiment.

Thefilter element26 tapers to adistal end120 which is, in turn, bonded or otherwise adhesively attached to anexterior surface206 of the distal portion of the innertubular member194. In one embodiment, the distal end of the filter can be bonded both to the exterior surface of the distal portion of the inner tubular member and also to thelumen122 surface of theobturator32. The deployment of thecage24 results in the filter element being placed against the wall of the artery or other body vessel preparatory to catching embolic debris within the patient's artery. The continuity of support between thecage24 and thefilter element26 provided by the innertubular member194 prevents the filter element from rotating separately from the cage which can cause the filter element to become tangled. The inner tubular member also protects the filter element by preventing the filter element from contacting theguide wire28.

Referring toFIG. 8, in a further embodiment utilizing thestop assembly126 ofFIGS. 6aand6b, thecage24 may include a full-basket configuration. In this embodiment, theembolic filtering device20 obtains continuity of support between the cage and thefilter element26 through the cage itself. Therefore, it is not necessary for the innertubular member194 to be attached directly to thesleeve148 of the stop assembly, and the inner tubular member need only be long enough to be coupled with thedistal portion118 of thecage24, thefilter element26 and theobturator32. As with the half-basket configuration ofFIGS. 6aand6b, the proximal ends50 of thestruts44 of the cage are coupled to the sleeve of the stop assembly.

Theinner support structure52 ofFIG. 5 or thestop assembly126 ofFIGS. 6aand6beach provide for restriction of longitudinal movement of thecage24 andfilter element26 at a location proximal to the cage. With the restriction of longitudinal movement controlled proximal to the cage and filter element, thedistal support region58 of the inner support structure52 (FIG. 5) and the inner tubular member194 (FIGS. 6aand6b) do not carry compressive loads during retrieval of theembolic filter device20. As a result, the only purpose of the distal support region and the inner tubular member is to prevent the filter element from rotating separately from the proximal end of the cage and to protect the filter element from therotating guide wire28. Therefore, the distal support region58 (FIG. 5) and the inner tubular member194 (FIGS. 6aand6b) can be made from thin and flexible materials. By using thinner materials for the distal support region and the inner tubular member, and by having the restriction of longitudinal movement controlled proximal to the cage and filter, the cross profile of the collapsed filter and cage on theguide wire28 may be reduced, which in turn permits the use of a delivery sheath having a smaller crossing profile.

The expandable cage of the present invention can be made in many ways. One particular technique for making the cage is to cut a thin-walled tubular member, such as nickel-titanium hypotube, to remove portions of the tubing in the desired pattern for each strut, leaving relatively untouched the portions of the tubing which are to form each strut. The tubing may be cut into the desired pattern by means of a machine-controlled laser. The tubing used to make the cage could possibly be made of suitable biocompatible material such as spring steel. Elgiloy is another material which could possibly be used to manufacture the cage. Also, very elastic polymers possibly could be used to manufacture the cage.

The strut size is often very small, so the tubing from which the cage is made may have a small diameter. Typically, the tubing has an outer diameter on the order of about 0.020-0.040 inches in the unexpanded condition. Also, the cage can be cut from large diameter tubing. The wall thickness of the tubing is usually about 0.076 mm (0.001-0.006 inches). As can be appreciated, the strut width and/or depth at the bending points will be less. For cages deployed in body lumens, such as PTA applications, the dimensions of the tubing may be correspondingly larger. While it is preferred that the cage be made from laser cut tubing, those skilled in the art will realize that the cage can be laser cut from a flat sheet and then rolled up in a cylindrical configuration with the longitudinal edges welded to form a cylindrical member.

Generally, the tubing is put in a rotatable collet fixture of a machine-controlled apparatus for positioning the tubing relative to a laser. According to machine-encoded instructions, the tubing is then rotated and moved longitudinally relative to the laser which is also machine-controlled. The laser selectively removes the material from the tubing by ablation and a pattern is cut into the tube. The tube is therefore cut into the discrete pattern of the finished struts. The cage can be laser cut much like a stent is laser cut. Details on how the tubing can be cut by a laser are found in U.S. Pat. Nos. 5,759,192 (Saunders), 5,780,807 (Saunders) and 6,131,266 (Saunders) which have been assigned to Advanced Cardiovascular Systems, Inc.

The process of cutting a pattern for the strut assembly into the tubing generally is automated except for loading and unloading the length of tubing. For example, a pattern can be cut in tubing using a CNC-opposing collet fixture for axial rotation of the length of tubing, in conjunction with a CNC X/Y table to move the length of tubing axially relative to a machine-controlled laser as described. The entire space between collets can be patterned using the CO₂or Nd:YAG laser set-up. The program for control of the apparatus is dependent on the particular configuration used and the pattern to be ablated in the coding.

A suitable composition of nickel-titanium which can be used to manufacture the strut assembly of the present invention is approximately 55% nickel and 45% titanium (by weight) with trace amounts of other elements making up about 0.5% of the composition. The austenite transformation temperature is between about 0° C. and 20° C. in order to achieve superelasticity at human body temperature. The austenite temperature is measured by the bend and free recovery tangent method. The upper plateau strength is about a minimum of 60,000 psi with an ultimate tensile strength of a minimum of about 155,000 psi. The permanent set (after applying 8% strain and unloading), is less than approximately 0.5%. The breaking elongation is a minimum of 10%. It should be appreciated that other compositions of nickel-titanium can be utilized, as can other self-expanding alloys, to obtain the same features of a self-expanding cage made in accordance with the present invention.

In one example, the cage of the present invention can be laser cut from a tube of nickel-titanium (Nitinol) whose transformation temperature is below body temperature. After the strut pattern is cut into the hypotube, the tubing is expanded and heat treated to be stable at the desired final diameter. The heat treatment also controls the transformation temperature of the cage such that it is super elastic at body temperature. The transformation temperature is at or below body temperature so that the cage is superelastic at body temperature. The cage is usually implanted into the target vessel which is smaller than the diameter of the cage in the expanded position so that the struts of the cage apply a force to the vessel wall to maintain the cage in its expanded position. It should be appreciated that the cage can be made from either superelastic, stress-induced martensite NiTi or shape-memory NiTi.

The cage could also be manufactured by laser cutting a large diameter tubing of nickel-titanium which would create the cage in its expanded position. Thereafter, the formed cage could be placed in its unexpanded position by backloading the cage into a restraining sheath which will keep the device in the unexpanded position until it is ready for use. If the cage is formed in this manner, there may be no need to heat treat the tubing to achieve the final desired diameter. This process of forming the cage could be implemented when using superelastic or linear-elastic nickel-titanium.

Polymeric materials which can be utilized to create the filtering element include, but are not limited to, polyurethane and Gortex, a commercially available material. Other possible suitable materials include ePTFE. The material can be elastic or non-elastic. The wall thickness of the filtering element can be about 0.00050-0.0050 inches. The wall thickness may vary depending on the particular material selected. The material can be made into a cone or similarly sized shape utilizing blow-mold technology or dip technology. Theperfusion openings48 can be any different shape or size. A laser, a heated rod or other process can be utilized to create the perfusion openings in the filter material. The perfusion openings would, of course, be properly sized to catch the particular size of embolic debris of interest. Holes can be lazed in a spinal pattern or some similar pattern which will aid in the re-wrapping of the media during closure of the device. Additionally, the filter material can have a “set” put in it much like the “set” used in dilatation balloons to make the filter element re-wrap more easily when placed in the collapsed position.

The materials which can be utilized for the restraining sheath can be made from polymeric material such as cross-linked HDPE. The sheath can alternatively be made from a material such as polyolifin which has sufficient strength to hold the compressed strut assembly and has relatively low frictional characteristics to minimize any friction between the filtering assembly and the sheath. Friction can be further reduced by applying a coat of silicone lubricant, such as Microglide®, to the inside surface of the restraining sheath before the sheath is placed over the filtering assembly.

Current methods for terminating the ends of the struts for a cage for an embolic filtering device include sandwiching the ends of the struts of the cage between two sleeves or soldering the ends of the struts to a sleeve. The struts must first be positioned around the sleeve and then held in place for the sandwiching or soldering operation. To achieve optimal performance of the cage, the struts should be positioned accurately. However, with the current methods of strut end termination, accuracy is difficult to achieve.

FIGS. 9a-9b,10a-10band11 depict embodiments of sleeves which provide a accurate method for the end termination of the struts of cages for embolic filtering devices and other similar devices. Referring toFIG. 9a, portions of the sleeve include aninner sleeve208 and anouter sleeve210. The outer sleeve may include a hollow cylindrical shape having alumen212 throughout its length. The lumen of the outer sleeve may be positioned substantially centered along a longitudinal axis of the outer sleeve. The inner sleeve may also include a hollow cylindrical shape having alumen214 throughout its length, with the outside diameter of the inner sleeve being sized to be secured within the lumen of the outer sleeve and the lumen of the inner sleeve being sized to receive a delivery device, such as a guide wire (not shown). The lumen of the inner sleeve may be positioned substantially centered along a longitudinal axis of the inner sleeve. The inner sleeve includes at least oneslot216 which extends longitudinally along the exterior surface of the inner sleeve (FIG. 9adepicts four slots evenly spaced about the circumference of the inner sleeve). The inner sleeve may be substantially the same length as the outer sleeve (as shown) or alternatively longer so that the designs ofFIGS. 6aandbwhich utilize the head158 of thetubular sleeve148 could also be incorporated with the embodiment ofFIGS. 9aandb.

Referring toFIG. 9b, theinner sleeve208 is inserted into thelumen212 of theouter sleeve210 and coupled thereto, thereby forming asingle sleeve218. The single sleeve may include a circular lumen220 (defined by thelumen214 of the inner sleeve) along a longitudinal axis of the sleeve. The single sleeve may also include at least oneperipheral lumen222 defined by the at least oneslot216 on the inner sleeve and the surface of thelumen212 of the outer sleeve. The peripheral lumens are sized to receive and retain struts of a cage for an embolic filtering device, or other similar device.

FIG. 10adepicts portions of a sleeve including aninner sleeve224 and anouter sleeve226 which is similar to the sleeve ofFIGS. 9aand9b. However, in this embodiment the outer sleeve may include a hollow cylindrical shape which includes at least oneslot228 which extends longitudinally along the surface of thelumen230 of the outer sleeve (FIG. 10adepicts four slots evenly spaced about the circumference of the lumen of the outer sleeve). Theinner sleeve224 may also include a hollow cylindrical shape having alumen232, with the outside diameter of the inner sleeve being sized to be secured within the lumen of the outer sleeve and the lumen of the inner sleeve being sized to receive a delivery device, such as a guide wire (not shown). The inner sleeve may be substantially the same length as the outer sleeve (as shown) or alternatively longer so that the designs ofFIGS. 6aandbwhich utilize the head158 of thetubular sleeve148 could also be incorporated with the embodiment ofFIGS. 10aandb.

Referring toFIG. 10b, theinner sleeve224 is inserted into thelumen230 of theouter sleeve226 and coupled thereto, thereby forming asingle sleeve234. The single sleeve may include a circular lumen236 (defined by thelumen232 of the inner sleeve) along a longitudinal axis of the sleeve. The single sleeve may also include at least oneperipheral lumen238 defined by the at least oneslot228 on the lumen of the outer sleeve and the external surface of the inner sleeve. The peripheral lumens are sized to receive and retain struts of a cage for an embolic filtering device, or other similar device.

FIG. 11 depicts asingle sleeve240 including a hollow cylindrical shape with acentral lumen242 extending along a longitudinal axis of the sleeve. The central lumen is sized to receive a delivery device, such as a guide wire (not shown). The sleeve may also include at least one peripheral lumen244 (FIG. 11adepicts four peripheral lumens substantially equally spaced about the longitudinal axis with each peripheral lumen positioned a substantially equal distance radially from the longitudinal axis). The peripheral lumens are sized to receive and retain struts of a cage for an embolic filtering device, or other similar device.

FIG. 12 depicts thestruts44 of thecage24 inserted into theperipheral lumens244 of thesleeve240 ofFIG. 11. Using the sleeve of the depicted embodiment, each of the struts is confined to the radial and angular location dictated by a corresponding peripheral lumen. The longitudinal location of the struts may also be controlled, such as by positioning thefirst end50 of each of the struts substantially flush with anend surface246 of the sleeve.

FIGS. 13a-13edepict methods of coupling the struts to a sleeve. For example,FIG. 13adepicts astrut248 having smooth surfaces within anend portion250 of the strut. The end portion is positioned within aperipheral lumen252 of a sleeve254. Anend256 of the strut is depicted flush with anend surface258 of the sleeve. The strut of this embodiment may be coupled to the sleeve through means which are well known in the art, such as by soldering or adhesive bonding.

FIG. 13bdepicts sides of astrut260 havingbarbed surfaces262 within anend portion264 of the strut. The barbed end portion of the strut is inserted into a peripheral lumen266 of asleeve268 with the barbs positioned adjacent towalls270 of the peripheral lumen. Anend272 of the strut is depicted flush with anend surface274 of the sleeve. The barbs facilitate retention of the strut within the peripheral lumen. To further ensure retention of the barbed strut within the peripheral lumen, the strut may be coupled to the sleeve through means which are well known in the art, such as be soldering or adhesive bonding. Alternatively, the barbs may interfere with thesurfaces270 and bite into the material for retension.

FIG. 13cdepicts astrut276 havingperforations278 within anend portion280 of the strut. The perforated end portion of the strut is positioned within aperipheral lumen282 of asleeve284. Anend286 of the strut is depicted flush with anend surface288 of the sleeve. The strut of this embodiment may be coupled to the sleeve through means which are well known in the art, such as by adhesive bonding. When adhesive bonding is used, the adhesive may flow into and fill the perforations, thereby aiding retention of the strut within the peripheral lumen.

FIG. 13ddepicts astrut290 havingslots292 through theedges294 within anend portion296 of the strut. The slotted end portion of the strut is positioned within aperipheral lumen298 of asleeve300. Anend302 of the strut is depicted flush with anend surface304 of the sleeve. The strut of this embodiment may be coupled to the sleeve through means which are well known in the art, such as by adhesive bonding. When adhesive bonding is used, the adhesive may flow into and fill the slots, thereby aiding retention of the strut within the peripheral lumen.

FIG. 13edepicts astrut306 having smooth surfaces within anend portion308 of the strut. The end portion is positioned within aperipheral lumen310 of asleeve312. Anend314 of the strut extends out of the peripheral lumen and beyond anend surface316 of the sleeve. The strut of this embodiment may be coupled to the sleeve through means which are well known in the art, such as by adhesive bonding. When adhesive bonding is used, abead318 of the adhesive may be added between the end surface of the sleeve and the portion of the strut which extends beyond the end surface of the sleeve. To further facilitate retention of the strut within the peripheral lumen, an end portion of the strut may include anaperture320 on a side of the strut proximate the end. The adhesive within the bead may flow into and fill the aperture.

Further modifications and improvements may additionally be made to the device and method disclosed herein without departing from the scope of the present invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.

Claims

1-32. (canceled)

33. A sleeve for coupling an embolic filtering device to a delivery device, the sleeve comprising:

a longitudinal member having a central lumen extending substantially longitudinally throughout the length of the longitudinal member, the central lumen being sized to receive a delivery device and being positioned substantially centered along a longitudinal axis of the longitudinal member; and

at least one peripheral lumen extending substantially longitudinally throughout the length of the longitudinal member and substantially parallel to the longitudinal axis of the longitudinal member, the at least one peripheral lumen being sized to receive and retain a strut of an embolic filtering device.

34. The sleeve ofclaim 33, the sleeve including a substantially cylindrical shape.

35. The sleeve ofclaim 33, the at least one peripheral lumen comprising four peripheral lumens substantially equally spaced about the central lumen and positioned a substantially equal distance from the longitudinal axis of the tubular member.

36. The sleeve ofclaim 33, the longitudinal member further comprising:

an outer sleeve having a substantially cylindrical shape and a lumen throughout its length, the lumen of the outer sleeve being positioned substantially centered along a longitudinal axis of the outer sleeve; and

an inner sleeve having a substantially cylindrical shape and a lumen throughout its length, the outside diameter of the inner sleeve being sized to be secured within the lumen of the outer sleeve, the lumen of the inner sleeve being sized to receive a delivery device, the lumen of the inner sleeve being positioned substantially centered along a longitudinal axis of the inner sleeve, the inner sleeve including at least one slot extending longitudinally along the outside surface of the inner sleeve substantially parallel to the longitudinal axis of the inner sleeve;

wherein the outer surface of the inner sleeve is coupled to the lumen surface of the outer sleeve;

wherein the lumen of the inner sleeve forms the central lumen; and

wherein the at least one peripheral lumen is formed by the surfaces of the at least one slot on the outside surface of the inner sleeve and the lumen surface of the outer sleeve.

37. The sleeve ofclaim 36, the at least one slot comprising four slots substantially equally spaced about the lumen of the inner sleeve.

38. The sleeve ofclaim 33, the longitudinal member further comprising:

an outer sleeve having a substantially cylindrical shape and a lumen throughout its length, the lumen of the outer sleeve being positioned substantially centered along a longitudinal axis of the outer sleeve, the outer sleeve including at least one slot extending longitudinally along the surface of the lumen of the outer sleeve substantially parallel to the longitudinal axis of the outer sleeve; and

an inner sleeve having a substantially cylindrical shape and a lumen throughout its length, the outside diameter of the inner sleeve being sized to be secured within the lumen of the outer sleeve, the lumen of the inner sleeve being sized to receive a delivery device, the lumen of the inner sleeve being positioned substantially centered along a longitudinal axis of the inner sleeve;

wherein the lumen of the inner sleeve forms the central lumen; and

wherein the at least one peripheral lumen is formed by the surfaces of the at least one slot on the surface of the lumen of the outer sleeve and the outside surface of the inner sleeve.

39. The sleeve ofclaim 38, the at least one slot comprising four slots substantially equally spaced about the lumen of the outer sleeve.

40. A method of coupling a strut of an embolic filtering device to a delivery device, comprising:

providing a delivery device;

providing a sleeve, the sleeve including,

a longitudinal member having a central lumen extending substantially longitudinally throughout the length of the longitudinal member, the lumen being sized to receive a delivery device and being positioned substantially centered along a longitudinal axis of the longitudinal member, and

at least one peripheral lumen extending substantially longitudinally throughout the length of the longitudinal member and substantially parallel to the longitudinal axis of the longitudinal member, the at least one peripheral lumen being sized to receive and retain a strut of an embolic filtering device;

providing an embolic filtering device having at least one strut;

inserting the at least one strut of the embolic filtering device into the at least one peripheral lumen of the sleeve;

coupling the at least one strut of the embolic filtering device to the at least one peripheral lumen of the sleeve;

inserting the delivery device into the central lumen of the sleeve; and

coupling the sleeve to the delivery device.

41. The method ofclaim 40, wherein:

providing an embolic filtering device having at least one strut includes an end portion of the strut having smooth surfaces; and

inserting the at least one strut of the embolic filtering device into the at least one peripheral lumen includes advancing the strut through the peripheral lumen until an end of the strut is substantially flush with an end surface of the sleeve.

42. The method ofclaim 41, wherein coupling the at least one strut of the embolic filtering device to the at least one peripheral lumen of the sleeve includes bonding the strut to the peripheral lumen with an adhesive.

43. The method ofclaim 40, wherein:

providing an embolic filtering device having at least one strut includes an end portion of the strut having barbed surfaces; and

inserting the at least one strut of the embolic filtering device into the at least one peripheral lumen includes advancing the strut through the peripheral lumen until an end of the strut is substantially flush with an end surface of the sleeve and the barbs are positioned adjacent to walls of the peripheral lumen.

44. The method ofclaim 43, wherein coupling the at least one strut of the embolic filtering device to the at least one peripheral lumen of the sleeve includes bonding the strut to the peripheral lumen.

45. The method ofclaim 40, wherein:

providing an embolic filtering device having at least one strut includes an end portion of the strut having perforations; and

46. The method ofclaim 45, wherein coupling the at least one strut of the embolic filtering device to the at least one peripheral lumen of the sleeve includes bonding the strut to the peripheral lumen with an adhesive and the adhesive filling the perforations in the end portion of the strut.

47. The method ofclaim 40, wherein:

providing an embolic filtering device having at least one strut includes an end portion of the strut having slots through edges of the strut; and

48. The method ofclaim 47, wherein coupling the at least one strut of the embolic filtering device to the at least one peripheral lumen of the sleeve includes bonding the strut to the peripheral lumen with an adhesive and the adhesive filling the slots in the edges of the end portion of the strut.

49. The method ofclaim 40, wherein:

inserting the at least one strut of the embolic filtering device into the at least one peripheral lumen includes advancing the strut through the peripheral lumen until an end of the strut extends out of the peripheral lumen and beyond an end surface of the sleeve.

50. The method ofclaim 49, wherein coupling the at least one strut of the embolic filtering device to the at least one peripheral lumen of the sleeve includes bonding the strut to the peripheral lumen with an adhesive within the peripheral lumen and adding a bead of the adhesive between the end portion of the strut and the end surface of the sleeve.

51. The method ofclaim 49, wherein providing an embolic filtering device having at least one strut includes an end portion of the strut having an aperture on a side of the strut proximate the end of the strut.

52. The method ofclaim 51, wherein coupling the at least one strut of the embolic filtering device to the at least one peripheral lumen of the sleeve includes bonding the strut to the peripheral lumen with an adhesive within the peripheral lumen and adding a bead of the adhesive between the end portion of the strut and the end surface of the sleeve with the adhesive filling the aperture in the strut.