Introduction The invention is particularly concerned with filter elements for transcatheter embolic protection devices of the type described in our previously filed PCT Patent Application No. PCT/IE98/00093 the contents of which are incorporated herein by reference. One type of such embolic filter essentially comprises a filter body mounted on an associated collapsible support frame which can be collapsed against the guide wire by means of a catheter for deployment of the filter through a patient's vascular system. Upon retraction of the catheter the support frame and filter body expand outwardly from the guidewire across a blood vessel within which the filter is positioned to filter blood flowing through the blood vessel.

One problem with the filter device is that there is a guidewire tip on the distal end which is required for guiding the filter into a desired position. The guidewire tip needs to be relative long to provide a smooth tip transition. However, the guidewire distal tip interferes with the optimal placement of the filter element.

The present invention is directed towards overcoming this problem.

Statements of Invention According to the invention there is provided a medical guidewire assembly comprising a guidewire have a flexible tip at a distal end of the guidewire, a medical device being mounted at the distal end of the guidewire proximally of the tip, the tip and the medical device being movable relative to each other for adjustment of the mount of the tip extending distally of the medical device.

In a preferred embodiment the tip and the device are slidable relative to each other.

In a particularly preferred embodiment the device has a receiver slot for reception of at least portion of the tip.

In another embodiment the medical device is an embolic filter mounted on a tubular sleeve which is slidably mounted on the guidewire adjacent the distal of the guidewire, the sleeve having a bore through which the guidewire passes, said bore forming a receiver slot for reception of the flexible tip of the guidewire which is at least partially retractable within the bore of the sleeve.

Preferably the tip is substantially fully retractable within the bore of the sleeve.

In a further embodiment a stop is provided at a proximal end of the sleeve, said stop being engagable with an inner end of the flexible tip and with a proximal stop spaced-apart from the tip to define the limits of sliding movement of the sleeve on the guidewire.

According to one aspect the invention provides an embolic protection device comprising: a collapsible filter element mounted on a filter carrier for delivery through a vascular system of a patient; the filter element being movable between a collapsed stored position against the filter carrier for movement through the vascular system, and an expanded position for occluding a blood vessel such that blood passing through the blood vessel is delivered through the filter element;

the filter element comprising a collapsible 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 collapsible filter element being slidably mounted on the filter carrier between a pair of spaced-apart stops for axial movement of the filter element along the filter carrier, the stops being arranged to allow a distal end of the filter carrier to be substantially retracted into the filter element.

In a preferred embodiment of the invention the filter carrier is a guidewire.

Preferably the distal end of the guidewire includes a guiding tip which may be substantially retracted into the filter element.

In a preferred embodiment of the invention a distal stop is provided on the guidewire for engagement on retraction of the guidewire against a stop on the filter element.

Preferably a proximal stop is provided on the guidewire.

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

Fig. 1 is partially sectioned elevational view an embolic protection device; Fig. 2 is a schematic sectional elevational view of the embolic protection device of Fig. 1; Fig. 3 is a detail sectional view of portion of the device of Fig. 1; Fig. 4 is a longitudinal cross sectional view of the device of Fig. 1; Fig. 5 is a cross sectional view of a distal end of the device of Fig. 1; Fig. 6 is a view on the line A-A in Fig. 5; Fig. 7 is a perspective view of a filter body of the device of Figs. 1 to 6; Fig. 8 is a side elevational view of the filter body of Fig. 7; Fig. 9 is a view on a proximal end of the filter body; Fig. 10 is a perspective view of a support frame of the device of Figs. 1 to 6; Fig. 11 is a side elevational view of the support frame; Fig. 12 is a perspective view illustrating the manufacture of the support frame; Fig. 13 is a view of the support frame and filter element assembly; Fig. 14 is a side partially cross sectional view of a filter body and guidewire according to the invention in one position of use; and

Fig. 15 is view similar to Fig. 14 in another position of use.

Detailed Description Referring to Figs. 1 to 13 there is illustrated an embolic protection device as described in our co-pending Application PCT/IE98/00093 indicated generally by the reference number 100. The device 100 has a guidewire 101 with a proximal end 102 and a distal end 103. A tubular sleeve 104 is slidably mounted on the guidewire 101. A collapsible filter 105 is mounted on the sleeve 104, the filter 105 being movable between a collapsed stored position against the sleeve 104 and an expanded position as shown in the drawings extended outwardly of the sleeve 104 for deployment in a blood vessel.

The sleeve 104 is slidable on the guidewire 101 between a pair of spaced-apart end stops, namely an inner stop 106 and an outer stop which in this case is formed by a spring tip 107 at the distal end 103 of the guidewire 101.

The filter 105 comprises a filter body 110 mounted over a collapsible support frame 111. The filter body 110 is mounted to the sleeve 104 at each end, the body 110 being rigidly attached to a proximal end 112 of the sleeve 104 and the body 110 being attached to a collar 115 which is slidable along a distal end 114 of the sleeve 104. Thus the distal end of the body 110 is longitudinally slidable along the sleeve 104. The support frame 111 is also fixed at the proximal end 112 of the sleeve 104. A distal end 116 of the support frame 111 is not attached to the sleeve 104 and is thus also free to move longitudinally along the sleeve 104 to facilitate collapsing the support frame 111 against the sleeve 104. The support frame 111 is such that it is naturally expanded as shown in the drawings and can be collapsed inwardly against the sleeve 104 for loading in a catheter 118 or the like.

The filter body 105 has large proximal inlet openings 117 and small distal outlet openings 119. The proximal inlet openings 117 allow blood and embolic material to enter the filter body, however, the distal outlet openings 119 allow through passage of blood but retain undesired embolic material within the filter body.

An olive guide 120 is mounted at a distal end of the sleeve 104 and has a cylindrical central portion 121 with tapered ends 122,123. The distal end 122 may be an arrowhead configuration for smooth transition between the catheter and olive surfaces. The support frame 111 is shaped to provide a circumferential groove 125 in the filter body 110. If the filter is too large for a vessel, the body may crease and this groove 125 ensures any crease does not propagate along the filter.

Enlarged openings are provided at a proximal end of the filter body 110 to allow ingress of blood and embolic material into an interior of the body 110.

In use, the filter 105 is mounted in a collapsed state within a distal end of the catheter 118 and delivered to a deployment site. When the filter is correctly positioned the catheter 118 is retracted allowing the support frame 111 to expand expanding the filter body 110 across the vessel in which the filter is mounted.

Blood and emboli can enter the enlarged openings at a proximal end of the filter body 110. The blood will pass through the net wall, however, the openings or pores in the net are sized so as to retain the embolic material. After use the catheter is delivered along the guidewire 101 and slid over the filter 105 engaging the proximal inlet end 112 first to close the openings and then gradually collapsing the filter body against the sleeve 104 as the catheter 118 advances over the filter 105. Once the filter 105 is fully loaded in the catheter 118, it can then be withdrawn.

It will be noted that a proximal end of the filter is fixed and a distal end of the filter is longitudinally movable along the sleeve to facilitate collapsing of the filter body.

Further, the catheter engages the proximal end of the filter body first thus closing the filter body inlet and preventing escape of embolic material from the filter body as the filter body is being collapsed.

The outer filter body 110 is preferably of a resilient biocompatible elastomeric material. The material may be a polyurethane based material. There are a series of commercially available polyurethane materials that may be suitable. These are typically based on polyether or polycarbonate or silicone macroglycols together with diisocyanate and a diol or diamine or alkanolamine or water chain extender.

Examples of these are described in EP-A-461,375 and US 5,621,065. In addition, polyurethane elastomers manufactured from polycarbonate polyols as described in US 5,254,622 (Szycher) are also suitable.

The filter material may also be a biostable polycarbonate urethane article an example of which may be prepared by reaction of an isocyanate, a chain extender and a polycarbonate copolymer polyol of alkyl carbonates. This material is described in our co-pending PCT Application No. IE98/00091, filed November 9, 1998, the entire contents of which are incorporated herein by reference. The filter material may be manufactured from a block and cut into a desired shape.

However the filter is preferably formed by dipping a rod of desired geometry into a solution of the material which coats the rod. The rod is then dissolved. The final geometry of the filter may be determined in the dipping step or the final geometry may be achieved in a finishing operation. Typically the finishing operations involve processes such as mechanical machining operations, laser machining or chemical machining.

The filter body is of hollow construction and is formed as described above by dipping a rod in a solution of polymeric material to coat the rod. The rod is then dissolved, leaving a hollow body polymeric material. The rod may be of an acrylic material which is dissolved by a suitable solvent such as acetone.

The polymeric body thus formed is machined to the shape illustrated in Figs. 1 to 13. The final machined filter body comprises an inlet or proximal portion 210 with a proximal neck 212, and outlet or distal portion 213 with a distal neck 214, and an intermediate portion 215 between the proximal and distal portions.

The inlet holes 117 are provided in the proximal portion 210 which allow the blood and embolic material to flow into the filter body. In this case the proximal portion 210 is of generally conical shape to maximise the hole size.

The intermediate portion 215 is also hollow and in this case is of generally cylindrical construction. This is important in ensuring more than simple point contact with the surrounding blood vessel. The cylindrical structure allows the filter body to come into soft contact with the blood vessel to avoid damaging the vessel wall.

The intermediate portion 215 is provided with a radial stiffening means, in this case in the form of a radial strengthening ring or rim 220. The ring 220 provides localised stiffening of the filter body without stiffening the material in contact with the vessel. Such an arrangement provides appropriate structural strength so that line apposition of the filter body to the vessel wall is achieved. It is expected that other geometrics of stiffening means will achieve a similar result.

The tubular intermediate portion 215 is also important in maintaining the stability of the filter body in situ to retain captured emboli and to ensure that flow around the filter is minimised. For optimum stability we have found that the ratio of the

axial length of the intermediate portion 215 of the filter body to the diameter of the intermediate portion 215 is preferably at least 0.5 and ideally greater than 1.0.

The collapsible support frame 111 has four foldable arms 290 which are collapsed for deployment and upon release extend outwardly to expand the filter body 110.

The support frame 111 can be manufactured from a range of metallic or polymeric components such as a shape memory alloy like nitinol or a shape memory polymer or a shaped stainless steel or metal with similar properties that will recover from the deformation sufficiently to cause the filter body 110 to open.

The support frame may be formed as illustrated in Fig. 12 by machining slots in a tube 291 of shape memory alloy such as nitinol. On machining, the unslotted distal end of the tube forms a distal collar 293 and the unslotted proximal end of the tube forms a proximal collar 294. In use, the distal collar 293 is slidably moveable along the tubular sleeve 104 which in turn is slidably mounted on the guidewire 101 for deployment and retrieval. The proximal collar 294 is fixed relative to the tubular sleeve 104.

To load the filter the sub assembly of the support frame and filter body is pulled back into the catheter 118 to engage the distal stop 107. The support arms 290 are hinged inwardly and the distal collar 293 moves forward along the tubular sleeve 104. As the support arms 290 enter the catheter 118 the filter body 110 stretches as the filter body collar 115 slides along the tubular sleeve 104 proximal to the olive 120. On deployment, the catheter 118 is retracted proximally along the guidewire 101 initially bringing the collapsed filter assembly with it until it engages the proximal stop 106. The catheter sleeve then begins to pull off the filter freeing the support arms 290 to expand and the filter body apposes the vessel wall.

For retrieval, a retrieval catheter is introduced by sliding it over the guidewire 101 until it is positioned at the proximal end of the filter body and support frame.

Pulling the guidewire 101 will initially engage the distal stop 107 with the filter element and begin to pull it into the retrieval catheter. The initial travel into the delivery catheter acts to close the proximal openings of the filter element, thus entrapping the embolic load. As the filter continues to be pulled back the filter body and the support frame are enveloped in the retrieval catheter. The collapsed filter may then be removed from the patient.

Referring to Figs. 14 and 15 there is illustrated a guidewire 30 on which is mounted a filter 31 and projecting from the distal end of the guidewire 30 is a guidewire tip 32. The guidewire tip 32 is slidable into the filter 31. When the filter 31 is being manoeuvred into place the guidewire tip 32 facilitates the manoeuvring of the filter device. By advancing and retracting the tip relative to the filter assembly 31 it is possible to manoeuvre the guidewire tip 32 around various portions of the anatomy, for example, where it is particularly tortuous, or where the guidewire tip 32 has to cross lesions. The tip 32 can be partially retracted to give a stiffer tip, or can be fully retracted in the deployment position.

The guidewire 30 is slidable between a proximal stop 35 on the guidewire 30 and a distal stop defined by a shoulder 36 of the tip 32 against a filter stop 37 provided at a proximal end of the filter 31.

The filter may be placed over or beyond the distal guidewire tip. Thus, the invention facilitates the optimal placement of a filter device in the limited arterial space available.

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