Patent Description:
Particles such as emboli may form, for example, as a result of the presence of particulate matter in the bloodstream. Particulate matter may originate from for example a blood clot occurring in the heart. The particulate may be a foreign body, but may also be derived from body tissues. For example, atherosclerosis, or hardening of the blood vessels from fatty and calcified deposits, may cause particulate emboli to form. Moreover, clots can form on the luminal surface of the atheroma, as platelets, fibrin, red blood cells and activated clotting factors may adhere to the surface of blood vessels to form a clot.

Blood clots or thrombi may also form in the veins of subjects who are immobilized, particularly in the legs of bedridden or other immobilized patients. These clots may then travel in the bloodstream, potentially to the arteries of the lungs, leading to a common, often-deadly disease called pulmonary embolus. Thrombus formation, and subsequent movement to form an embolus, may occur in the heart or other parts of the arterial system, causing acute reduction of blood supply and hence ischemia. The ischemia damage often leads to tissue necrosis of organs such as the kidneys, retina, bowel, heart, limbs, brain or other organs, or even death.

Since emboli are typically particulate in nature, various types of filters have been proposed in an attempt to remove or divert such particles from the bloodstream before they can cause damage to bodily tissues.

Various medical procedures may perturb blood vessels or surrounding tissues. When this occurs, potentially harmful particulates, such as emboli, may be released into the blood stream. These particulates can be damaging, e.g., if they restrict blood flow to the brain. Devices to block or divert particulates from flowing into particular regions of the vasculature have been proposed but may not eliminate the risks associated with the release of potentially harmful particulates into the blood stream during or after particular medical procedures.

Improved devices for blocking or diverting vascular particulates are under development, but each intravascular procedure presents unique risks.

As intravascular devices and procedures, such as transcatheter aortic valve implantation (TAVI), become more advanced, there is an emerging need for features that provide these devices with improved ease of use, intravascular stability, and embolic protection.

Possible areas of improvements of such devices and procedures include "windsailing" of devices with pulsatile blood flow, leakage of fluid and/or particulate matter at peripheral portions of devices during use thereof, secure positioning in a patient during use and/or retrievability, etc..

Hence, an improved intravascular device, system and/or method would be advantageous and in particular allowing for increased flexibility, cost-effectiveness, and/or patient safety would be advantageous.

<CIT> discloses an intra-vascular device for filtering or deflecting emboli other large objects from entering a protected secondary vessel or vessels. The device may include a filter to prevent a particle in a blood vessel from passing through the filter, a lateral structure to hold the filter, and two wires attached the lateral structure, one each at its distal and proximal ends. These wires may be used to control the deflection or orientation of the filter upon its installation within a blood vessel.

Accordingly, examples of the present disclosure preferably seek to mitigate, alleviate or eliminate one or more deficiencies, disadvantages or issues in the art, such as the above-identified, singly or in any combination by providing a device, system or method according to the appended patent claims for providing a collapsible embolic protection device for transvascular delivery to an aortic arch of a patient, for protection of side branch vessels of the aortic arch from embolic material.

In some aspects of the disclosure, an embolic protection device for transvascular delivery to an aortic arch of a patient for protection of side branch vessels of the aortic arch from embolic material is described. The device includes a support frame, wherein at least a distal or a proximal portion of the support frame may be a spring section configured for providing a radial force between the support frame and a wall of the aortic arch when in an expanded state. The device may further include a filter member attached to the support frame, and configured for preventing the embolic material from passage with a blood flow into the side branch vessels of the aortic arch.

Further examples of the embolic protection device are disclosed in accordance with the description and the dependent claims.

These and other aspects, features and advantages of which examples of the disclosure are capable of will be apparent and elucidated from the following description of examples of the present disclosure, reference being made to the accompanying drawings, in which the schematic illustrations of.

The following disclosure focuses on examples of the present disclosure applicable to an embolic protection device, such as a collapsible embolic protection device, for transvascular delivery to an aortic arch of a patient for protection of side branch vessels of the aortic arch from embolic material.

<FIG> is illustrating an embolic protection device <NUM>. The embolic protection device is collapsible, such as crimpable, to be arranged in a transvascular delivery unit. The protection device <NUM> includes a support frame <NUM> and a filter member <NUM> attached to the support frame <NUM>. The support frame may be, in some examples, a complete hoop completely surrounding a periphery of the filter member <NUM>. In some examples, the filter member <NUM> may extend (partly or entirely) outside the periphery defined by support fame <NUM>, and thereby create a collar or rim, as illustrated in <FIG>. The collar or rim may improve apposition with the vessel wall rough texture. In some examples, the collar or rim may be made from a different material than the filter member <NUM>.

The protection device <NUM> may further include a connection point either at the support frame <NUM> or at the filter member <NUM>. The connection point is used for connecting the embolic protection device <NUM> to a transvascular delivery unit. Preferably the connection point is arranged off-centre at a proximal portion of the embolic protection device <NUM>. In some examples, a connection point may be arranged on a stem at distance from the filter membrane <NUM> and the support frame <NUM>.

For positioning a protection device <NUM> in an aorta, the device <NUM> of the disclosure may be attached to and delivered by a transvascular delivery unit, for example as illustrated in <FIG>. The transvascular delivery unit may be, for example, a catheter or sheath, and the protection device <NUM> may be attached to the transvascular delivery unit according to methods known in the art, or by a connector mechanism <NUM>. In some examples, the transvascular delivery unit may comprise a connector mechanism <NUM>, such as a wire, rod or tube, for example, a tether, a delivery wire, or a push wire etc. The connector mechanism <NUM> may be connected to the connection point. In some examples, the connector mechanism <NUM> may be permanently connected to the embolic protection device <NUM>. Thereby the embolic protection device <NUM> may be delivered and withdrawn using the same connector mechanism <NUM>. Further, the connector mechanism <NUM> may be used to hold the embolic protection device <NUM> in place during a medical procedure. In some examples, the connector mechanism <NUM> may be detachably connected to the embolic protection device <NUM>.

The distal end and/or the proximal end of the support frame <NUM> may be made from a spring section <NUM>, <NUM>. Each spring section <NUM>, <NUM> is a pre-loaded spring that function as an engine and is configured for quickly expand or open-up a collapsed or crimped embolic protection device <NUM> from a collapsed state to an expanded state and for providing a radial force between the support frame <NUM> and a wall of the aortic arch, when the support frame <NUM> is in an expanded state. The spring sections <NUM>, <NUM> are engines being pre-shaped open springs. The spring sections <NUM>, <NUM> may have a radius wider than the embolic protection device. Different radius of the opening may provide different forces.

The spring sections may provide improved apposition with aortic arch walls which may improve fixation of the device <NUM> and the sealing between the device and the wall of the aorta, which may reduce paraframe leakage. The force from the spring sections may also avoid distortion of the support frame <NUM> when a radial force is applied. The force from the spring sections <NUM>, <NUM> also tends to position the embolic protection device <NUM> at about mid-vessel diameter, as illustrated for example in <FIG>. Hence provides an embolic protection device with improved self-positioning and alignment properties.

The force provided by the spring sections <NUM>, <NUM> may also reduce windsailing, in most cases to none.

The spring sections <NUM>, <NUM> are preferably heat treated to form the spring sections and to provide spring properties. The spring sections are in some examples, formed as open springs and are wider than the protection device before the device is assembled.

By arranging a spring section <NUM> proximally, there will be an improved coverage of the landing zone. The landing zone is the area every guidewire will hit the aortic arch, see reference <NUM> in <FIG>. An improved coverage and sealing of the landing zone may help to prevent the passage of devices over (along) the protection device <NUM> (through the aortic arch), for example by leading a guide wire below the protection device <NUM>.

Each spring section <NUM>, <NUM> has a bend shape, such as a shallow U-shape, or is curved. In examples where the support frame <NUM> only has one spring section <NUM>, <NUM> at either the distal or the proximal end, the rest of the support frame <NUM> has a deeper U-shaped form. This deeper U-shaped form does not have the same springy properties as the spring section <NUM>, <NUM>. In examples where the support frame <NUM> has a spring section <NUM>, <NUM> at both the distal and the proximal ends, the support frame may have straight central sections <NUM>, <NUM> formed between spring sections <NUM>, <NUM>. When using straight central sections <NUM>, <NUM>, these are substantially straight before the device is assembled. After the device is assembled, the straight central sections <NUM>, <NUM> may bulge or obtain a curvature due to forces in the support frame from the spring sections, compare e.g. <FIG>.

In some examples, the support frame <NUM> may be made of two parts, wherein the first part may be a distal spring section <NUM> which may be pre-shaped to a shallow U-shape. The second part may be the proximal spring section <NUM> and the side sections <NUM>, <NUM>, which may be pre-shaped to a deeper U-shape than the first part.

Alternatively, and/or additionally, in some examples, the support frame <NUM> may be made of two parts, wherein the first part may be a distal spring section <NUM> which may be pre-shaped to a shallow U-shape. The second part may be the proximal spring section <NUM> and the side sections <NUM>, <NUM> which may be a straight wire (apart from a possible spring element) which get shaped into a deeper U-shape when attached to the distal spring section <NUM>.

Alternatively, the support frame <NUM> may be made of two parts, wherein the first part may be a proximal spring section <NUM> which may have a shallow U-shape. The second part may be the distal spring section <NUM> and the side sections <NUM>, <NUM> which may be shaped to a deeper U-shape than the first part. In some examples, the straight central sections may function as spring engines in a longitudinal direction of the embolic protection device.

Additionally, and/or alternatively, in some examples, the spring sections <NUM>, <NUM> are heat treated to form the spring sections, while the rest of the support frame <NUM> is not heat treated. This will give the support frame <NUM> a flexibility that may further improve apposition of the embolic protection device <NUM> with the aortic arch walls as it complies better with the rough texture of the vessel wall.

Further, by heat treating all sections there may be forces at the transitions between the segments, such as at joints between segments, applicable to the wall of the aortic arch. Also, if the wire is made from a single wire being heat treated, there will be fewer connectors for joining the different sections, which may also improve the forces from the transitions between the segments to the wall of the aortic arch.

An advantage of only heat treating the spring sections <NUM>, <NUM>, and not the other sections, is that the forces from the spring sections will be comparatively stronger.

To further improve the force, some segments may be made thicker than others, for example, at the distal end of the support frame <NUM>, the distal spring section <NUM> may be thicker than the rest of the support frame, and weaker proximally. This may also make it easier to crimp the support frame <NUM>, e.g. into a catheter lumen for delivery, or for improved exiting such lumen when deploying the embolic protection device.

Alternatively, in some examples, both the distal and the proximal spring sections are made thicker than the rest of the support frame. This will improve the spring forces at both the proximal and the distal end. The thicker spring sections may open up the support frame while the thinner sections are more compliant with the vessel wall.

Alternatively, in some examples, the distal spring section <NUM> may be made thicker than the proximal spring section <NUM>. Additionally, in some examples, the middle sections <NUM>, <NUM>, may be made of the same thickness as the proximal section <NUM>. In some other examples, are the middle sections <NUM>, <NUM>, made of the same thickness as the distal section <NUM>.

Alternatively, in some examples, both the spring sections and the central sections are made thicker than the joints or transition segment(s) between the thicker sections that may be made thinner. This will provide strong forces on all sides while avoiding the issues of making the whole support frame rigid. Making the whole support frame rigid may force the spring sections to close and not efficiently cover tortuous anatomies with the embolic protection device.

By utilizing different thicknesses or cross sections of different sections, a support frame may be obtained having a configuration with different forces at different segments. Additionally, and or alternatively, the at least distal or proximal spring section <NUM>, <NUM> may include a spring element <NUM>, <NUM>. The spring element <NUM>, <NUM> may in some examples be a loop or helix, a small spring or any other type of spring arranged at about the centre of each of the distal or proximal spring section <NUM>, <NUM>. The spring element, <NUM>, <NUM> is used for increasing the force applied by the support frame <NUM> on the walls of the aortic arch.

As previously described, the spring sections <NUM>, <NUM> are used for applying a force by the support frame <NUM> on the wall of aortic arch which may improve the sealing effect between the collapsible embolic protection device and the wall of the aortic arch, as well as provide an improved self-stabilizing effect. Additionally, the use of spring sections <NUM>, <NUM> may improve the positioning and self-alignment of the device in the aortic arch.

Additionally and/or alternatively, in some examples, the connector mechanism <NUM> may be attached to the support frame <NUM> allowing the protection device to pivot axially but not radially at the joint between the support frame and the connector mechanism <NUM>, for example by attaching the connector element via the proximal loop <NUM>.

The spring element, especially the proximal spring element <NUM>, may in some examples function as a crimp element to improve the collapsibility of the embolic protection device by elongating the device longitudinally. Thereby allows to embolic protection device <NUM> to be crimped into a sheath with small diameter.

Spring elements <NUM>, <NUM> may in some examples, for example when the spring elements <NUM>, <NUM> are loops, be formed to either protruding outwards (relative the periphery/footprint defined by the support frame) or formed to be protruding inwards (relative the periphery/footprint defined by the support frame) as illustrated in <FIG>. Arranging or forming one or more of the spring elements <NUM>, <NUM> to protrude inwards improves attachment of the filter member <NUM> to the support frame <NUM>. Also, having one or more of the spring elements <NUM>, <NUM> arranged to protrude inwards improves the contact between the support frame <NUM> and the walls of the aortic arch as there is nothing protruding or extending further than the support frame <NUM> (smooth apposition to the aortic wall vessel tissue, further improvable by a collar mentioned herein).

The support frame <NUM> may be made from a wire, such as a spring wire, or being laser cut from a tube, ribbon, sheet, or flat wire, etc. The support frame <NUM> may be of a single wire. In some examples, the support frame <NUM> is made from a twisted single wire. Alternatively, in some examples the support frame <NUM> may be made of at least two wires being twisted, braided or knitted.

The support frame <NUM> may be in some examples made from joint free ring. In other examples the support frame <NUM> made be formed from a ring having at least one joint <NUM>. A joint <NUM> may be for example a fixation like a soldering, welding, or a clamp.

The support frame <NUM> may be shaped into an elongated shape, substantially elliptical, oblong, oval, or cone slot shaped. Alternatively, other shapes may be used, such as circular or rectangular. Because the aortic anatomy can vary between individuals, examples of the intra-aortic device of the disclosure may be shaped to adapt to a variety of aortic anatomies.

An example of an elongated or oblong shaped support frame <NUM> may be a slot shaped support frame <NUM> as illustrated in <FIG>. A collapsible embolic protection device <NUM> having a cone slot shaped support frame <NUM> is illustrated in <FIG>. A collapsible embolic protection device <NUM> having an elliptic shaped support frame <NUM> is illustrated in <FIG>.

The size of the collapsible device may be pre-sized and pre-formed to accommodate various patient groups (e.g., children and adults) or a particular aortic anatomy. The support frame <NUM> may be, in some examples, substantially planar. In some examples, the support frame <NUM> may have a width greater than the diameter of the aortic arch into which it is configure to be positioned in use, such as about <NUM>% greater than the diameter of the aortic arch, such as <NUM> % greater than the cross-sectional chord of an aorta of a subject, in which the collapsible embolic protection device <NUM> may be placed. Additionally, in some examples, a support frame <NUM> may be longer than the aortic arch opening, such as about <NUM>% longer than the arch opening, such as <NUM> % longer than an approximate distance between an upper wall of an ascending aorta of a subject, distal to an opening of an innominate artery, and an upper wall of a descending aorta of a subject, proximal to an opening of a left subclavian artery.

By making the support frame <NUM> wider than the diameter of the arch, such as about <NUM>% wider, and longer than the aortic arch opening, such as about <NUM>% longer, as defined above, the self-positioning of the device positioning about mid vessel diameter may be improved and thus improve the apposition with aortic arch walls. This will make it easier to deploy the embolic protection device and improve the sealing against the walls. It may also improve the coverage of all three side vessels, innominate (brachiocephalic) artery, left common carotid artery, or left subclavian artery) which are supplying blood to the brain.

The support frame <NUM> may be fabricated in whole or in part from, e.g., nitinol or metal, superelastic or shape memory alloy material, readily malleable material, or polymer, e.g., nylon. The metal may include, e.g., tantalum or platinum.

The filter member <NUM> prevents particles (e.g., emboli) typically having a dimension between about <NUM> and about <NUM> (e.g., <NUM> pm, <NUM> pm, <NUM> pm, <NUM> pm, <NUM> pm, <NUM>, <NUM> pm, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>) in an aorta from passing into blood vessels (e.g., innominate (brachiocephalic) artery, left common carotid artery, or left subclavian artery) supplying blood to the brain. Accordingly, one or more lateral dimensions of the pores of the filter can be between about <NUM> and about <NUM> (e.g., <NUM> pm, <NUM>, <NUM> pm, <NUM> pm, <NUM> pm, <NUM> pm, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>). The filter may be, e.g., a mesh made from a plurality of fibers made of polymer, nylon, nitinol, or metal, or a combination thereof. The mesh may be made from woven fibers. Fibers may be from about <NUM> to <NUM> in thickness. Alternatively, the filter may be a perforated film. When a perforated film is present, the pores formed in the perforated film may include pores of varied or unvaried shape (e.g., rectilinear or rhomboid pores), have a varied or constant density across the film, and/or have a constant or varied size. The size of the pores of the filter allows passage of blood cells (e.g., red blood cells (erythrocytes), white blood cells (leukocytes), and/or platelets (thrombocytes)) and plasma, while being impermeable to particles (e.g., emboli) larger than the pore dimensions. Emboli filtered by the mesh of the filter of the present disclosure are typically particles larger in one or more dimensions than an aperture of the mesh of the filter.

In some embodiments, a filter member or mesh may be configured from woven fibers and is affixed to a support frame so that its yarn orientation is at angles that are not right angles to the support frame. For example, in some embodiments, the mesh may be affixed to the support frame so that the weave (warp and weft) of the mesh or weave may be at for example <NUM>° angles from a base or lateral portion of the support frame. In some examples, the weave (warp and weft) of mesh may be at for example <NUM>-<NUM>°, such as <NUM>-<NUM>°, angles from a base or lateral portion of the support frame. When set at a non-right angle to the support frame, the mesh may stretch, expand or contract with greater flexibility than when such weave is at right angles to the support frame. Collapsibility or crimpability of the embolic protection device is advantageously improved in this manner.

Various catheters or sheath may be used as part of the present disclosure. Any catheter or sheath known in the art to be configured for guiding medical instruments through vasculature may be used (e.g., stent installation catheter, ablation catheter, or those used for transcatheter aortic valve implantation (TAVI) or percutaneous aortic valve replacement (PAVR) procedures, e.g., as described in <CIT>). Additionally or alternatively, the device may include a pigtail catheter, which may be of size 6F or smaller (e.g., 1F, 2F, 3F, 4F, 5F, or 6F) and include a radiopaque material to facilitate tracking the progress of various elements of the device. Other catheters that can be used as part of the disclosure include any catheter used in procedures associated with a risk of embolism, which would benefit by including an intravascular filter as part of the procedure.

The filter member <NUM> may be substantially flat or dome shaped. The dome shape of the filter member <NUM> may be in some examples about the size of the support frame <NUM>. Alternatively, in some examples, the filter member <NUM> may be dome shaped at either the distal or proximal end. A dome shaped filter membrane <NUM> may improve the space underneath the embolic protection device <NUM>. It may also improve the filtering due to a larger filter area.

A device of the disclosure may incorporate radiopaque elements. Such radiopaque elements can be affixed to, or incorporated into the device. For example, portions of the frame, filter, or catheter may be constructed of OFT wire. Such wire can contain, e.g., a core of tantalum and/or platinum and an outer material of, e.g., nitinol.

<FIG> is illustrating a system <NUM> of a collapsible embolic protection device <NUM> in accordance to the description, such as illustrated in <FIG>. The embolic protection device <NUM> is connected to a transvascular delivery unit. The transvascular delivery unit is here illustrated with a connection mechanism <NUM> being a wire or tether. The connection mechanism <NUM> may be made from a biocompatible metal and is attached to the support frame of the embolic protection device <NUM>. The frame connection mechanism <NUM> is here illustrated as connected directly to the spring element of the support frame. The attachment may be made by a loop, latch or with a clamp. The attachment should be strong and flexible enough to push the device out of the sheath. <FIG> further illustrates a tube or sheath <NUM> used for delivering the embolic protection device <NUM> used for delivering the embolic protection device <NUM> to the working zone.

<FIG> is illustrating one way of manufacturing the support frame of the protection device. <FIG> illustrates here a wire <NUM>, such as a spring wire, that has been heat treated to form the different sections of the support frame. <NUM> and <NUM> are spring sections that will form the distal and proximal spring section when the two ends of the wire are joined. The spring sections are pre-loaded and shaped to be straight; hence they are open springs with an opening larger than the width of the final device. When the two ends of the wire are joined, the straight sections <NUM> and <NUM> will provide one straight central section, while the straight section <NUM> will provide the second straight central section. In some examples, the straight sections are heat treated to be straight. Alternatively, in some examples, the straight sections are not heat treated.

<FIG> is illustrating an alternative way of manufacturing the support frame of the protection device from a wire <NUM>, such as a spring wire. In this example the wire <NUM> has been heat treated to form the different sections of the support frame. <NUM> and <NUM> are spring sections that will form the distal and proximal spring section when the two ends of the wire are joined. The spring sections are pre-loaded and shaped to be curved. The openings of the spring sections are here larger than the width of the final device. When the two ends of the wire are joined, the straight sections <NUM> and <NUM> will provide one straight central section, while the straight section <NUM> will provide the second straight central section. In some examples, the straight sections are heat treated to be straight. Alternatively, in some examples, the straight sections are not heat treated.

<FIG> is illustrating an alternative way of manufacturing the support frame of the protection device from a wire <NUM>. The wire <NUM> is a grinded wire having more than one tapered section. In illustration there are three thicker sections and two thinner sections <NUM>, <NUM>. The thinner sections may be forms into two straight central sections while the three thicker sections <NUM>, <NUM>, <NUM> will form two spring sections when the two ends of the wire <NUM> are joined.

Additionally, and/or alternatively, in some examples, the thicker sections <NUM>, <NUM>, <NUM> that will form the two spring sections may have spring elements. In some examples the thicker sections <NUM>, <NUM>, <NUM> that will form the two spring sections may be curved as in <FIG>.

Additionally, and/or alternatively, in some examples, the wire <NUM> may include thicker tapered sections, similar as the sections used for the spring sections, to be used for the straight central sections. Between the thicker tapered sections there will be thinner sections forming joints or transitions between the different spring sections and the straight central sections.

A wire <NUM> with tapered thicker sections with thinner sections between may allow one wire <NUM> to be configured to result in a support frame with different forces at different segments.

Further, instead of having one single grinded wire <NUM> as in <FIG> each section may be formed from a single grinded wire with only one tapered thicker section and thinner segments at the sides. These sections may then be joined as illustrated in <FIG>.

<FIG> is illustrating an embolic protection device <NUM> wherein the support frame is made from <NUM> separate segments, functioning as engines. The segments include, a distal spring section <NUM>, a proximal spring section <NUM>, and two central straight sections 24a, 24b. A filter member <NUM> is attached to the support frame.

Each of the distal and proximal spring sections <NUM>, <NUM> may have a spring element <NUM>, <NUM>. The spring sections <NUM>, <NUM> are engines being pre-shaped open springs, which in some examples has a shallow U-shape. In some other examples the spring sections are straight before the support frame is assembled. The spring sections <NUM>, <NUM> may have a radius wider than the embolic protection device. Different radius of the opening may provide different forces.

In between the spring sections <NUM>, <NUM> are straight central segments 24a, 24b arranged. In some examples, the straight central segments 24a, 24b are not heat treated while the spring sections <NUM>, <NUM> are.

In some examples, the proximal <NUM> and distal <NUM> spring section may differ, for example by providing different amount of forces. The distal spring section <NUM> may provide improved apposition with aortic arch walls which may improve fixation of the device <NUM> and the sealing between the device and the aortic wall, which may reduce paraframe leakage. The proximal spring section <NUM> covers the landing zone of the embolic protection device. The landing zone is the area every guidewire will hit the aortic arch inner vessel wall when femorally introduced into the aortic arch. Hence a better apposition between the embolic protection device and the walls of the aortic arch is obtained as an advantage.

Due to the positioning of the proximal end, a strong force is not as important as at the distal end of the device. The different forces may be provided by making the distal spring section <NUM> thicker than the proximal spring section <NUM>. The spring element <NUM> at the distal section <NUM> may also be configured to provide a stronger force than the spring element <NUM> at the proximal spring section <NUM>.

In some examples only one of the spring sections <NUM>, <NUM> includes a spring element <NUM>, <NUM>. The spring element <NUM>, <NUM> may also be used to improve the crimping of the device. Further, having the proximal spring section <NUM> being made of a thinner material than the distal spring section <NUM>, may also improve the crimping of the device as the force will be weaker at the proximal section <NUM>.

<FIG> is illustrating a collapsible embolic protection device <NUM> having a filter element <NUM> may extend outside the support fame <NUM>, and thereby create a collar or rim <NUM>. The collar or rim <NUM> may improve apposition with the vessel wall rough texture. Peripheral sealing may thus be improved, in particular as pulsatile flow presses the collar or rim against the inner aortic arch vessel tissue. In some examples, the collar or rim may be made from a different material than the filter member <NUM>, such as PTFE or a fabric, e.g. Dacron. The collar may have in addition or alternatively a non-filtering configuration, such as a sheet of material without filter, e.g. a film.

<FIG> are illustrating two examples of spring elements <NUM> at the distal spring section of the device <NUM>. The same type of spring element may be used at the proximal spring section.

In some examples, different spring elements are used at the distal and the proximal end.

Those skilled in the art will readily appreciate that other spring elements than those illustrated here may be used to achieve the same effect of improving the force of the spring section against the wall of the aortic arch.

<FIG> is illustrating a spring element <NUM> being a loop <NUM> formed from the material <NUM> used to shape the distal spring section, here it is illustrated as a wire, such as a spring wire.

<FIG> is illustrating a spring element <NUM> being a spring <NUM> attached to a gap in the distal spring section by clamps 29a, 29b. Cross section of the frame may in this manner be held at that of the frame by having an intermediate spring, such as crimped in <FIG>.

<FIG> are illustrating two examples of connecting the device <NUM> to a connector mechanism <NUM>, such as a wire, rod or tube, for example, a tether, a delivery wire, or a push wire etc..

<FIG> is illustrating the connection point <NUM> is arranged at the proximal spring section of the support frame. The connector mechanism <NUM> is here a twisted wire <NUM> twisted around the support frame. In some examples, the connector mechanism <NUM> is locked at a pre-set angle. In some other examples, the connector mechanism <NUM> is made so that the protection device may pivot in an axial direction at the connection point. In some examples, the device is prevented to pivot in a radial direction. In some examples, the connection is made to fixate the protection device in a predefined angle.

<FIG> is illustrating the connection point <NUM> is arranged at the proximal spring section of the support frame. The connector mechanism <NUM> is here a single wire <NUM> connected to a loop at the proximal spring section. In some other examples, the connector mechanism <NUM> is made so that the protection device may pivot in an axial direction at the connection point. In some examples, the device is prevented to pivot in a radial direction. In some examples, the connection is made to fixate the protection device in a predefined angle.

<FIG> are illustrating an example of embolic protection device <NUM> being arranged over a wire, ribbon, or tube, such as a leading tube or shaft tube, <NUM>. The wire, ribbon, or tube, such as a leading tube or shaft tube, <NUM> is used for delivering the embolic protection device <NUM>. The wire, ribbon, or tube, may be made from either plastic commonly used for catheters or metal, such as a shape memory alloy, such as Nitinol.

In <FIG> a twisted wire <NUM> is used as a connector mechanism. The twisted wire <NUM> is shaped into a loop <NUM> at the distal end being connected to the spring element <NUM>, which here also function as a connector point. The twisted wire <NUM>, is attached to the wire, ribbon or tube <NUM> using at least tone ring 34a, 34b.

The wire <NUM> may be made from a shape memory alloy, such as Nitinol. The wire <NUM> may be a wire twisted and heat treated on a jig and thereby formed into flexible connector mechanism. The wire <NUM> may place the embolic protection device <NUM> perpendicular to the wire tube bend <NUM>, as seen in <FIG>. In some examples, the device may pivot at the connection point in an axial direction, for example during deployment in the aortic arch. In some examples, the device is prevented to pivot in a radial direction. The over the wire arrangement helps to support the filter member by pushing or forcing the filter member or support frame upwards by a dedicated bent tube or wire <NUM>. The arrangement also helps to keep the embolic protection device <NUM> in place by the same upward push or force by the bent tube or wire <NUM>. The arrangement may also improve the positioning of the embolic protection device <NUM> in the aortic arch.

<FIG> are illustrating a further example of embolic protection device <NUM> being connected to be arranged over a wire or tube <NUM> used for delivering the embolic protection device <NUM>.

In the illustrated example, the connection mechanism <NUM> is made from a laser cut tube. The distal end of the connection mechanism <NUM> is cut as a loop or hole <NUM> used for attaching the connection mechanism <NUM> to the embolic protection device <NUM>. The connection mechanism <NUM> may be attached either to the frame or to a spring section <NUM> shaped as a loop. The distal end of the connection mechanism <NUM> may be shaped to have two branches as seen in <FIG>, each branch having a loop or hole.

The proximal end of the connection mechanism <NUM> is formed as a connector <NUM> and used to connect the connection mechanism <NUM> to the wire or tube <NUM>. To fixate the connection mechanism <NUM> to the wire or tube <NUM> a stopper <NUM> is used. An example of a stopper <NUM> is illustrated in <FIG>.

In some examples, the stopper <NUM> is welded to wire or tube <NUM> to better fixate the connection mechanism <NUM> at the needed position.

In some examples, the device may pivot at the connection point in an axial direction, for example during deployment in the aortic arch. In some examples, the device is prevented to pivot in a radial direction.

<FIG> are illustrating a further example of embolic protection device <NUM> connected to be arranged over a wire or tube <NUM> used for delivering the embolic protection device <NUM>.

In the illustrated example, the connection mechanism <NUM> is made from a laser cut tube. The distal end of the connection mechanism <NUM> has a ring <NUM> welded to it. The ring <NUM> is used for attaching the connection mechanism <NUM> to the embolic protection device <NUM>. The connection mechanism <NUM> may be attached either to the frame or to a spring section <NUM> shaped as a loop.

In some examples, the stopper <NUM> is welded to wire or tube <NUM> to better fixate the connection mechanism <NUM> at the needed position. In some examples, the device may pivot at the connection point in an axial direction, for example during deployment in the aortic arch. In some examples, the device is prevented to pivot in a radial direction.

<FIG> is illustrating a protection device <NUM> arranged in the aortic arch. The device is delivered and held by the catheter or sheath <NUM> during the procedure. In the illustrated example the protection device <NUM> covers all three side branches of the aortic arch.

<FIG> are illustrating a protection device <NUM> arranged in the aortic arch. The device is connected to a wire or, ribbon or tube <NUM> by a connection mechanism <NUM>. The device is delivered by the catheter or sheath <NUM>.

The wire or, ribbon or tube <NUM> has a dilator tip <NUM>. The dilator tip <NUM> may be an atraumatic tip.

<FIG> are illustrating that the bend of the wire or, ribbon or tube <NUM> helps to support the filter member by pushing or forcing the filter member or support frame upwards. The arrangement also helps to keep the embolic protection device <NUM> in place using the same upward push or force by the bent tube or wire <NUM>. <FIG> is illustrating the landing zone <NUM>.

In some examples, the wire, ribbon or tube <NUM> may be pre-bend. The pre-bend may be calculated based on the curvature of the anatomy of the aortic arch. An advantage of this is that it may prevent the embolic protection device from flipping during insertion or during a procedure when the embolic protection device is arranged in the aortic arch.

<FIG> are illustrating a method for making a dome shaped filter element <NUM>. The dome-shaped filter member <NUM> may be made from a woven mesh <NUM> made from, for example a polymer, such as Polyetereterketon (PEEK). The dome-shaped filter member <NUM> may be formed by cutting openings or wedges 51a to 51d into the mesh material <NUM>, see e.g. four wedges in <FIG>.

The dome-shape is then shaped by attaching the edges of each openings or wedges 51a to 51d. By gluing, heat welding, ultrasonic welding etc., <NUM> seams 52a to 52d will be obtained, as illustrated in <FIG>.

The heat forming allows the dome-shaped filter member <NUM> to obtain a three-dimensional shape from a flat 2d mesh layer. The three-dimensional dome-shape is illustrated in <FIG>. In some examples, the three-dimensional dome-shape is seamless. In some examples the three-dimensional dome-shape is thus formed without creases as illustrated in <FIG>.

In some examples, the three-dimensional structure, such as the dome-shape, may appear almost flat when attached to the frame and the frame is not constrained. When the frame is constrained, such as by the walls of the aortic arch, mesh will go back to the formed three-dimensional structure.

<FIG> are illustrating an example of stickers or patches <NUM>, <NUM> that may be arranged at a distal and/or a proximal end of the embolic protection device <NUM>. The sticker or patch <NUM>, <NUM> may preferably be made from an elastic material, such as polyurethane. The sticker or patch <NUM>, <NUM> may be either solid or porous, such as made as a mesh. The sticker or patch <NUM>, <NUM> may be shaped like a square or rhombus, such as having a diamond-like shape.

In <FIG> the distal patch <NUM> and the proximal patch <NUM>, are dimensioned as rhombuses but with a cut out in the middle, creating a waist section <NUM>. The waist section <NUM>, <NUM> makes it easier to attach the sticker or patch <NUM>, <NUM> to the embolic protection device <NUM>, since there will be less material folded over or stretched around the frame <NUM> and thereby attached thereto. Because of the curvature of the frame, the patch or sticker <NUM>, <NUM> may not be smoothly folded or stretched over and attached to the frame <NUM>, which may cause wrinkles in the sticker or patch <NUM>, <NUM> at the frame <NUM>. This may be prevented by having a waist section <NUM>, <NUM> as illustrated in <FIG>.

Alternatively, in some examples, the stickers or patches <NUM>, <NUM> may be triangular. When triangular, the sticker or patch <NUM>, <NUM> is not folded around the frame <NUM>, instead they are only attached to one side of the filter of the embolic protection device <NUM>.

The proximal patch <NUM>, illustrated in <FIG>, has a cut-out in the middle <NUM>, which allows a connection mechanism <NUM> to be used to connect the embolic protection device <NUM> to a wire, ribbon or tube, as previously described herein.

The stickers or patch <NUM>, <NUM> is adhered to the filter mesh of the embolic protection device <NUM>. The sticker or patch <NUM>, <NUM> may adhered to the embolic protection device using glue or an adhesive layer. The sticker or patch <NUM>, <NUM> may also be attached using heat. In some examples both glue or an adhesive layer, is used with heat to attach the sticker or patch <NUM>, <NUM> to the embolic protection device <NUM>.

The sticker or patch <NUM>, <NUM>, may provide more strength to the embolic protection device <NUM> when crimped. The sticker or patch covers part of the structure from blood where otherwise thrombus may be formed.

The sticker or patch <NUM>, <NUM>, may also be used to attach the mesh of the embolic protection device <NUM> to the frame <NUM> at the distal and/or proximal end. This may have an advantage when the distal and/or proximal spring section has a spring element, such as a loop or helix. By avoid gluing the mesh to the spring element and instead using the sticker or patch <NUM>, <NUM> to attach the distal end proximal end of the mesh to the frame <NUM> at these point, the spring elements may be more effective, because they are not restricted by the mesh or by glue. This may be archived by not having any adhesive means, such as glue at the waist section <NUM>, <NUM> which is stretched over the frame and the spring element.

<FIG> are illustrating a further example of connecting the device to a delivery unit. The example illustrated in <FIG> is similar to the examples described in relation to <FIG>. The connector mechanism <NUM> illustrated in <FIG> has a distal end section <NUM> and a proximal end section <NUM>. The distal end section is designed to be connected to the frame of an embolic protection device and the proximal end section is designed to be connected to a wire, tube or ribbon which goes under the embolic protection device, see for example <FIG> and <FIG>. The proximal end section <NUM> of the connector mechanism <NUM> forms a hollow cylindrical body which may be slide over the wire, tube or ribbon <NUM> (in the illustrations only a small portion of the wire, tube or ribbon is shown) until it is securely locked.

The locking may be made by a first locking member <NUM> of the proximal end section of the connector mechanism <NUM> engaging with a second locking member <NUM> of the wire, tube or ribbon. The first locking member <NUM> may be a letch which is angled into the hollow cylindrical body and engages with a hole or window <NUM> of the wire. The hole or window may have the same width as the letch, preventing rotation of the connector mechanism <NUM> around the wire, tube or ribbon after the letch has engaged with the hole or window.

Alternatively, the second locking element <NUM> of the wire, tube or ribbon may be a letch which is angled outwards so it may engage with a first locking element <NUM> of the proximal end section <NUM> of the connector mechanism <NUM>, being a hole or window. Again, the hole or window may have the same width as the letch to avoid rotation of the embolic protection device.

The distal end section <NUM> of the connecting mechanism is formed by a portion of the connector mechanism <NUM> being folded back over itself providing a gap <NUM> therebetween in which a frame of an embolic protection device, such as a wire, may be slide. The distal end of the distal end section <NUM> may have a wider gap <NUM>. The wider gap <NUM> may be configured to have a similar diameter as the diameter of the frame of the embolic protection device.

This arrangement is allowing the frame to be arranged firmly at the distal end section <NUM> while still provide pivotability axially but not radially at the joint between the frame and the connector mechanism <NUM> when applying a force on the embolic protection device.

To lock the frame in the gap <NUM>, <NUM> and prevent it from slipping out, a locking ring <NUM> is slipped over the fold backed portion of the distal end section <NUM>. The locking ring <NUM> is the locked by having a section <NUM> of the fold backed portion being wider than the hole through the locking ring. The wider section of the fold backed portion will be crimped when the locking ring <NUM> is slipped over, and will thereafter expand preventing the locking ring <NUM> form slipping off. To enhance the flexibility of the wider section of the fold backed portion, and thereby allow it to crimp and expand easier, a slit <NUM> may be arranged at the middle of at least the wider section.

The connection mechanism <NUM> illustrated in <FIG>, is designed to providing stability and flexibility and to allow a certain degree of freedom without rotation, which allows the wire, tube or ribbon to stay in the right position while the embolic protection device is arranged in the intended position.

Claim 1:
An embolic protection device for transvascular delivery to an aortic arch of a patient, for protection of side branch vessels of said aortic arch from embolic material, said device including:
a support frame (<NUM>), wherein at least a distal or a proximal portion of said support frame (<NUM>) is a spring section (<NUM>, <NUM>) configured for providing a radial force between said support frame (<NUM>) and a wall of said aortic arch when in an expanded state;
a filter member (<NUM>, <NUM>) attached to said support frame (<NUM>), and configured for preventing said embolic material from passage with a blood flow into said side branch vessels of said aortic arch, characterized in that said filter member (<NUM>, <NUM>) has a heat set three-dimensional shape and wherein said filter member (<NUM>, <NUM>) is substantially flat when the support frame (<NUM>) is not constrained such as by said wall of said aortic arch.