HK1237241B - Improved embolic protection device and method - Google Patents

Description

Improved anti-embolism protection device and method

Background of the Invention

Technical Field

The present invention generally relates to the field of embolic protection devices and catheters for cardiac surgery. More specifically, the present invention generally relates to devices, systems, and methods for brain protection by deflecting embolic debris during endovascular procedures, as well as introducers for use in such procedures, particularly cardiac procedures (e.g., TAVI procedures, electrophysiology procedures, or ablation procedures).

Existing technology

This section is intended to introduce various aspects of the technology that may be related to various aspects of the present disclosure described and/or claimed below. It is believed that this detailed description helps provide background information to facilitate a better understanding of the various aspects of the present disclosure. Therefore, it should be understood that these descriptions should be read from this perspective, rather than being admitted as prior art.

Endovascular procedures are increasingly used to treat a variety of cardiac and vascular surgical problems. Blocked arteries can be treated using minimally invasive endovascular methods with angioplasty, endarterectomy, and/or stent implantation. Aneurysms can be repaired using endovascular techniques. Another use for endovascular procedures is to treat heart valve disease. Valvuloplasty is performed within a blood vessel, and percutaneous valve replacement is becoming a routine procedure. Transcatheter aortic valve implantation (TAVI) is a procedure involving a collapsible aortic heart valve that can be manipulated into place using minimally invasive techniques.

Cerebral embolism is a known complication caused by such intravascular surgery, and other cardiac surgery, cardiopulmonary bypass and catheter-based interventional cardiology, electrophysiology surgery, etc. Embolic particles may include thrombi, atherosclerosis and lipids, plaques found in diseased vessels and valves (which shift and cause embolism). Embolic particles can shift and enter the bloodstream because of surgical or catheter manipulation. Therefore, displaced embolic particles can embolize the brain downstream. Cerebral embolism can cause neuropsychological deficits, stroke and even death.

Preventing cerebral embolism benefits the patient and improves the outcome of these procedures.Anti-embolic protection devices should be compatible with endovascular procedures and, for example, not obstruct access to the heart through the aortic arch.

Various anti-embolic protection devices are known in the art.

Some embolic protection devices are disclosed in WO 2012/009558 A2 or WO 2012/085916 A2, the disclosures of which are incorporated herein by reference for all purposes of the present invention. However, these devices can cause iatrogenic damage to the vessel in which they are placed (e.g., by being placed in a vessel via an arch or arm extending into a side branch of the aortic arch). While these arches or arms provide anchoring within the arch, they increase the risk of scraping embolic particles, particularly from around the orifice into the side branch. The devices also have a relatively high profile within the aortic arch, which limits the endovascular procedures that can be performed through the arch.

More advantageous low-profile planar devices for anti-embolic protection of side branches of the aortic arch have, for example, been disclosed in document WO 2010/026240A1 or described in international patent application PCT/EP2012/058384, which was published as WO2012152761 after the priority date of the present application, and for all purposes of the present invention, these disclosed contents are cited herewith.

Document WO2012009558 discloses an umbrella-shaped deflection device having a delivery line connected to a central hub. The device is delivered through a side branch to be protected, and the guidewire remains in the side branch. The guidewire connected to the central hub can be pulled back to put the device in place. However, due to the movement of the aorta with each heartbeat, this may lead to the disadvantage of a so-called wind sucker. Debris may accumulate at the edge of the umbrella, and when the guidewire is pulled back and the hub is locked and cannot follow the movement of the aorta well enough, the debris may occasionally be sucked into the side branch. Therefore, the anti-embolic protection efficiency of the device described in WO2012009558 is not optimal.

US 2004/0073253 A1 discloses an embolic particle trap that is positioned in the aortic arch via the femoral artery. The hoop at the distal end of the device has a larger diameter than the aorta at the implant site and presses radially outward against the aortic wall. The device occludes the aortic arch when in place and does not allow for guided procedures in the femoral artery.

WO00/43062 describes a shunt that separates the aortic arch and seals the side branch space separated from the aortic arch. In addition to shunts, embolic filters can be used to filter blood flowing into the side branch space or to filter blood in the aortic arch. However, this device is complex because blood cannot flow directly from the aortic arch to the side branch space and requires an extracorporeal blood treatment device.

In document US 2002/0133115 A1 a method for capturing a pharmaceutical agent is provided, comprising a magnet.

However, the devices of the prior art can be further improved.One problem is that blood, which may include embolic particles, may impair the efficiency of the device by bypassing the device around the carotid artery due to an inadequate seal at the periphery.

Another problem that the examples of the present disclosure seek to avoid is the "navigation" of the device in the high pressure blood flow exiting the heart. The device needs to provide stable positioning of the deflection device in the aortic arch.

Yet another problem with prior art devices is that catheter devices, such as introducers, cannot be positioned accurately enough prior to the procedure, which increases the risk of complications and thereby reduces patient safety.

Therefore, despite the efforts made in the prior art, there remains a need for a further improved anti-embolic protection device that can allow endovascular surgery, in particular cardiac surgery, while protecting the cerebral vasculature during surgery; and for an improved catheter device (e.g., an introducer) for use in such surgery.

Summary of the Invention

Therefore, embodiments of the present invention preferably seek to mitigate, alleviate or eliminate one or more of the above-mentioned deficiencies, drawbacks or problems of the prior art by providing, either alone or in combination, an apparatus or method according to the appended patent claims to provide temporary anti-embolic protection of aortic arch vessels of a patient during medical procedures such as cardiac surgery and interventional cardiology and electrophysiology procedures. Embolic particles in the aortic blood flow can be prevented from entering the aortic arch side branches, including the carotid arteries leading to the brain.

Disclosed herein are systems and methods for embolic deflection, including systems for deployment and removal.

According to one aspect of the present disclosure, a catheter device is disclosed, comprising: an elongated sheath (503) having an inner lumen and a distal end for positioning at a heart valve (6); an anti-embolic protection device (200) for temporarily positioning in the aortic arch to deflect embolic debris from the ascending aorta to the descending aorta, the anti-embolic protection device being connectable to a transluminal delivery unit (130), the transluminal delivery unit (130) extending proximally from a connection point (131) with the anti-embolic protection device, and the anti-embolic protection device comprising: a frame having an outer periphery; a blood-permeable unit located within the outer periphery for preventing embolic particles from passing therethrough with blood flow downstream of the aortic valve. The invention relates to a device for providing a catheter device for providing a stabilizing force to the patient's brain by connecting a side branch of the aortic arch to the patient's brain; and at least one tissue apposition maintaining unit (300, 350) extending from the catheter into the aortic arch and attached to the anti-embolic protection device at a maintaining point (502), for applying a stabilizing force at the anti-embolic protection device, such as at the periphery, away from the connection point, and for providing the stabilizing force toward the inner wall of the aortic arch, away from the heart, and in a direction perpendicular to the longitudinal extension of the periphery when the catheter device is positioned within the aortic arch, so that the tissue apposition of the periphery to the inner wall of the aortic arch is supported by the stabilizing force to improve stability and peripheral sealing. In addition, related methods are also disclosed.

The frame can be elongated as shown. Thus, the device 200 can be substantially planar. In specific embodiments, it can also include an aspect ratio between 8:1 and 18:7. The device can vary in length from 10mm to 120mm, such as 25mm, 45mm, 60mm, 75mm, 90mm or 105mm, and in width from 5mm to 70mm, such as 10mm, 20mm, 30mm, 40mm, 50mm or 60mm. In a specific instance, the length of the device 200 can be approximately 80mm to 90mm, such as 80mm, 82mm, 84mm, 86mm, 88mm or 90mm, or as needed to approximate the distance between the upper wall of the ascending aorta, upstream of the opening of the brachiocephalic artery and downstream of the opening of the left subclavian artery. The width of the device 200 can be from 10 mm to 35 mm, for example, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, or 35 mm, or can approximate the inner diameter of the aorta. The term "substantially flat" can refer to a radius of curvature of no more than 80 mm, for example, 0 mm, 5 mm, 10 mm, 20 mm, 30 mm, 40 mm, 50 mm, 60 mm, or 70 mm. The delivery unit 130 can also be pre-shaped to gently press against the top aortic wall, thereby allowing the device to remain along the vessel wall and avoid the passage of transfemoral appendages that can be used in therapeutic cardiovascular procedures (e.g., TAVI procedures). The pre-shape can include a bend, for example, 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, or 90°, to further facilitate the device deployment flush with the aortic vessel wall.

Connection point 131 can be used to connect the intravascular device 200 to a plunger, such as a plunger connected to a delivery wire disposed within a catheter. A locking mechanism with a latch can be provided at connection point 131. A threaded attachment can be provided at connection point 131 to attach the delivery unit. For example, a screw at the connection point can mate with a screw on the plunger. In one example, connection point 131 can include a release and retrieval hook for connecting the device 200 to the plunger. In some exemplary embodiments, the hook can include a latch or wire that can be part of the device 200. In other examples, the blood-permeable unit, catheter, or delivery wire can terminate in a loop and pass through the latch. When so passed, the wire or catheter equipped with a looped end can snap into the hook, allowing the device to be securely pushed into place or pulled out of its position in the aorta. In some examples, the hook can terminate in a spherical tip so that the strands from the blood-permeable unit do not abrade or unravel, or scratch the vessel wall or inner tube of the catheter. In other embodiments, a clasp at the end of the device may be pressed into or onto a clasp, such as at the end of a catheter or delivery wire, and the two clasps may be connected by such pressing.

In still other examples, the device 200 may be adapted for use with other anti-embolic protection devices, such as those described in US Patent Nos. 8,062,324 and 7,232,453, the disclosures of each of which are incorporated herein by reference for all purposes.

In some embodiments, the device can be rotated clockwise or counterclockwise, respectively.

The device also includes at least one tissue apposition maintaining unit, which is not the device's delivery shaft or guidewire. The tissue apposition maintaining unit is configured to apply a force to the device away from the connection point. This force can be referred to as a stabilizing force because it helps securely position the anti-embolic protection device in the aortic arch. The offset from the connection point can be, for example, at the periphery. It can also be adjacent to the periphery. It can also be at the center of the blood-permeable unit within the periphery. When the device is positioned in the aortic arch, the force is applied to or directed toward the inner wall of the aortic arch. In this way, tissue apposition from the periphery to the inner wall of the aortic arch is supported by the force. For example, the traction force applied in this manner can pull the periphery of the device toward the inner wall. This traction force can be applied to a delivery catheter or the like and lift the anti-embolic protection device in a direction away from the heart, preferably in a coronary direction ("upward"/toward the patient's neck or head) toward the aortic wall. This (stabilizing) force supports locking the device in place during implantation.

The embolic protection device can thus be securely placed across the apex of the aorta to prevent emboli from flowing into the carotid artery. The present invention's solution is non-iatrogenic because it prevents the generation of debris from, for example, a side branch orifice. Iatrogenicity refers to adverse patient outcomes caused by a physician or surgeon's treatment. Secondary embolic protection devices, such as arms, anchors, delivery shafts, arches, and the like, that extend into a side branch and risk scraping plaque from the inner vessel wall or orifice are unnecessary and can be avoided thanks to the present disclosure.

Embolic particles are effectively prevented from bypassing the device at its periphery and entering the carotid artery due to the improved seal at the periphery. This prevents the device from "navigating" in the high-pressure blood flow discharged from the heart. This provides stable positioning of the deflection device in the aortic arch.

Preferably, the anti-embolic protection device may be a deflector for deflecting embolic particles. Alternatively or additionally, it may be a filter for capturing embolic particles.

In an example, the device can be delivered via a side channel catheter (e.g., through the femoral artery). Such a side channel catheter is described in PCT/EP2012/0058384, which is disclosed in WO2012152761 after the priority date of the present application, and is incorporated herein by reference in its entirety for all purposes. The catheter can also be improved by multiple side channels, one for the anti-embolic protection device. The tether can be advanced in the same channel or other channels of the catheter. A pigtail catheter can be arranged in this auxiliary side channel. The pigtail catheter can be used to further stabilize the catheter against the annulus of the aortic valve and/or the inner wall of the aortic arch, as described in WO 2012/094195 A1, the entire contents of which are incorporated herein by reference for all purposes, with particular reference to Figures 10A and 10B of WO 2012/094195 A1 and the relevant description paragraphs in WO 2012/094195 A1.

In an example, the device may be delivered via a side branch, such as described in WO 2010/026240 A1.

In an example, the device can be delivered through the aorta (e.g., in a direct aortic approach), such as described in a concurrently filed U.S. application by the same applicant entitled "METHOD FOR DELIVERY OF AN EMBOLIC PROTECTION UNIT," and which is a priority application to application No. 61/726,540, filed on November 14, 2012. Both applications are incorporated herein by reference in their entirety for all purposes.

The aforementioned force, also referred to as a stabilizing force, may include or be a traction force. The juxtaposed maintenance/support unit may be an active traction unit, for example, having at least one operable tether 300 whose distal end is connected at the location of the offset connection point 131. The distal connection location 310 of the traction unit or tether may be located at the frame 133, the periphery 180, and/or the blood-permeable element 132 of the anti-embolic protection device 200, for providing traction to the device. The tether 300 has one or more distal ends. The distal end is connected, for example, to the periphery 180 of the anti-embolic protection device 200. The distal end of the tether 300 may be connected to the blood-permeable element 132, such as a filter or a deflection membrane. For example, if the membrane is flexible and/or elastic, the membrane can be moved by traction. Thus, the traction force can lift the membrane.

A tether, or more accurately, a traction cord, is provided to control the degree of peripheral sealing. The tether cord provides orientation toward the aortic tissue/cerebral artery apposition. The tether cord can provide active traction by pulling on the tether cord, which is connected to the embolic protection device attached at its distal end. The traction force can be different from the pulling force of the delivery device of the embolic protection device, thereby advantageously avoiding a suction effect because the force can be selected so that the periphery of the device follows the movement of the aortic arch to a greater extent than the delivery device to which it is attached.

The tether is movable relative to the delivery unit 130. The delivery unit 130 in these examples provides a counting point for being able to apply a stabilizing force, for example, as in the Bowden wire principle. Alternatively or additionally, a collection device in the form of, for example, a conical filter coaxially arranged around the delivery device that is anchored in the side branch during use can provide a counting point to be able to provide the required stabilizing force to the embolic protection device. In this way, the device 200 can be positioned in the aortic arch so that the delivery device can be locked in a "delivery" position (e.g., at its proximal end at the orifice or outside of the introducer). The tether can then still be movable and improve sealing as described herein.

In any of the devices of the present invention, the delivery unit 130 may also include a preformed curve, such as shown in Figure 1. The preformed curve may be between 5° and 90°. In some aspects, the device 100 further includes a filter (not shown), such as the filter that can be extended from the outside of the catheter 160, adjacent to the anti-embolic protection device 200 that can be delivered transluminally for temporary positioning in the aortic arch, and, for example, adjacent to the preformed curve. The filter can be sized to filter the side branch vessels. The delivery unit 130 (e.g., the centerpiece at the anti-embolic protection device 200 that can be delivered transluminally) can thus pass through a second filter. The filter can prevent particles from passing through the aortic arch downstream of the side branch. The filter can be expandable for engaging the vessel wall of the side branch. It can provide a fixed point that allows traction to be applied while preventing the disadvantages associated with the suction effect. The filter can be conical in shape, with the catheter and/or delivery wire passing through the apex of the filter. The filter can also be substantially flat, so long as the catheter and/or delivery wire is connected to the filter (e.g., at all points along the outer perimeter of the catheter or delivery wire), with the catheter and/or delivery wire passing through any point within the filter. The width of the widest portion of the filter can be pre-sized and pre-formed to accommodate a specific subclavian artery anatomy, such as a width of 2, 4, 6, or 8 mm. Other shapes can also be used.

The tether may be a multifilament tether, which provides a particularly flexible solution that facilitates navigation through narrow lumens.

The tether can be extended in a straight line through the blood-permeable unit to the front end of the device. Thus, the midline can be pulled up, and the periphery is tightened against the inner wall. The tether provides a lifting force to the front end. When the tether is guided at the midline, it can provide a progressive lifting force distributed along the device, which allows for particularly effective sealing and/or stabilization at the periphery.

The at least one tether can be longitudinally elastic, meaning it can be longitudinally tensioned and elastically return to an untensioned longitudinal extension. The tether can be elastic along its entire length. The tether can include one or more elastic portions or elastic elements. The elastic portion can be a helically wound portion of the tether that acts as a spring. The elastic portion can be a tubular braid of double helically wound strands. The elastic portion can be made of an elastic material, preferably a biocompatible material such as rubber. In this manner, the traction force is variable. This can help prevent tether line breakage because the operator can "feel" the nonlinear extension. If the tether is tensioned, this variable traction force can also be advantageous, applying a desired traction force to improve the seal of the anti-embolic protection device. The tether can be locked in position at its proximal end, for example, extending beyond an orifice at the introducer end. The elasticity can provide compensation for physiological movement of the aortic arch relative to the device and/or the proximal end of the tether, while maintaining tissue apposition. This avoids the problems associated with the aforementioned suction effect. The force is applied within a range suitable for maintaining an improved peripheral seal as the aortic arch moves due to the beating heart and blood pulse waves. The applied force is provided within a range suitable for maintaining an improved peripheral seal as the aortic arch moves due to the beating heart and blood pulse waves.

The blood-permeable element can have at least one guide element, such as an eyelet, a tubular curved element, a roller, or the like. The guide element can receive a tether near its distal end (e.g., at the blood-permeable element, flange, or periphery) where it is attached to the device. The guide element (e.g., an eyelet, etc.) provides for localized control of apposition at the device. The traction force can be distributed to different areas of the device.

The device can have an attachment point where the distal end of the tether is connected to the device and traction can be transferred to the device peripherally through the attachment point. Optionally, one or more radiopaque fiducial markers can be provided on the device. Fiducial markers can be provided at the attachment point. Fiducial markers provide advantageous X-ray visibility and navigation, positional feedback, and control of the device.

In some examples, a tether extends proximally through an orifice into a selected side branch, such that traction forces the device to center relative to the orifice. When the tether is pulled, the tether pulls the device toward the inner wall of the aorta at its periphery, locking the device in place. In this way, the device self-aligns relative to the orifice of the selected side branch due to the tether. A person skilled in the art, upon reading this disclosure, can provide a suitable guide unit for the tether.

The device may comprise a plurality of tethers attached distally along the periphery. Alternatively or additionally, a single proximal tether may be separated at the distal end into a plurality of (sub-) tethers. For example, the tethers may be branched in a Y-form. A single tether to be operated proximally may then distribute traction to the distal end of the anti-embolic protection device via its two distal endpoints. An example with multiple endpoints is shown in FIG8 . Multiple tethers may be used or combined with tethers having multiple distal ends. The multiple tethers may be collected proximally at the device (e.g. at its base 330 ). In this way, the device provides a progressive force that is evenly distributed along the periphery of the device. The device may advantageously adapt to the internal shape of the aortic arch in this way. This adaptability may even be enhanced by providing longitudinal elastic portions at the tethers. For example, the branch (sub-) tethers may be provided by an elastic material, while the main line is essentially inelastic, but flexible.

In some examples, the device may have at least one rib extending between different (preferably opposite) junctions on the periphery, wherein the distal end of the tether is attached to the rib. The tether can thus apply traction to the rib, thereby transferring the force to the periphery of the device toward the inner wall tissue of the aorta. The rib can be a beam or yoke. It can be arranged longitudinally or transversely relative to the longitudinal axis of the expanded device. There can be multiple such ribs in the device. A device with multiple flaps or wings can have one or more ribs on one or more flaps or wings to obtain a favorable force distribution. The rib can be capable of providing structural support for the device. The term "providing structural support" refers to a property that contributes to the shape and stiffness of the device. The stiffness of the intravascular device 200 will be determined by the stiffness of the blood permeable unit, the periphery and/or the radial supports. For example, the device 200 can be reinforced by including a heavier gauge metal wire or by including a harder center piece, yoke or radial supports. In addition, multiple metal wires of a certain gauge can be twisted together to increase the stiffness of the device. For example, the device can include 2, 3, 4, 5 or more metal wires to increase the stiffness of the intravascular device 200.

For example, the device's flaps or wings can be positioned upstream relative to aortic blood flow. Alternatively or additionally, the device can have flaps or wings positioned downstream relative to aortic blood flow. One or more, or each, of the flaps or wings can include a tissue apposition-maintaining element, such as a tether, pusher, or spring as described herein. Providing a tissue apposition-maintaining element for flaps or wings positioned upstream relative to aortic blood flow may be sufficient. Flaps or wings positioned downstream can be adequately pushed against the aortic inner wall tissue by the pulsating blood flow in the aorta that travels along the device's blood-permeable element. However, including tissue apposition-maintaining elements in flaps or wings positioned downstream from the connection point can advantageously provide support during aortic pressure fluctuations. Aortic pressure is lower during diastole and may be prone to greater leakage than during systole. Tissue apposition-maintaining elements can be sized to provide adequate support during diastole and, therefore, be more convenient (smaller, lighter) for insertion into the body than if the flaps or wings were sized for systolic support.

The tissue apposition maintaining element can limit the movement of the blood-permeable element caused by pulsatile blood flow. The aforementioned "navigation" of the device is thus limited or prevented by the tissue apposition element. Ribs, for example, can provide this limited range of motion. Ribs and/or tethers can limit the movement of the blood-permeable element. Connecting the tether to the device can then provide a gradual traction force and, in particular, improve sealing because the forces on the periphery caused by pulsatile pressure changes are evenly distributed during the pulsatile flow of the heartbeat.

The rib can be, for example, a yoke extending proximally above the blood permeable unit. "Above" refers to the filtering side of the unit downstream of the blood flow through the unit. "Below" therefore means the opposite side in this context. The yoke can preferably extend in the longitudinal direction of at least a portion of the device. The distal tether end can be directly attached to the rib. The distal tether end can be guided to the periphery by a guide unit at the rib, thereby providing a favorable distribution of traction forces. The rib positioned "above" can simultaneously limit the movement of the blood permeable unit, thereby avoiding contact with tissue (e.g., an orifice) and avoiding the generation of debris by such avoided contact. The device of the examples of the present disclosure may include additional ribs located above and/or below the selectively permeable unit 132.

The device may include multiple tethers, or a single tether that is split into multiple strands from the distal end. In one example, two tethers or strands are attached to the periphery from the base of the device in a Y-shaped distal end.

The device may include at least one eyelet through which one or more of the tethers are passed. The eyelet may preferably be located at a pivot point and/or at the base of the device. Contact of the tether with tissue (e.g., an orifice) is thereby avoided by the eyelet, and debris generation is avoided by preventing the tether from contacting tissue when the tether is tensioned.

The blood permeation unit can be flexible. For example, it is a flat (substantially planar) membrane with a defined porosity or pores. The tether can be connected to the membrane at the distal end. The applied traction force can thus lift the membrane out of the plane of the membrane, forming, for example, a volcano shape at the connection point between the tether and the membrane. This volcano shape can advantageously improve the efficiency of the device. The top of the volcano shape can be arranged to extend into the orifice, into a portion of the side branch. Therefore, the internal funnel shape of the volcano, into which blood flows, can provide for the capture of particles. The result is improved filter efficiency.

The traction unit may optionally or additionally include a passive traction unit. A passive traction unit is not operated by an operator, but automatically provides a stabilizing force and improves the peripheral seal. The passive traction unit may be a spring. It may have a shape memory element, such as a part of a frame, activated by body temperature, for example, to provide traction relative to the delivery portion or device. For example, the device may include "winglets" extending from the periphery of the device with shape memory. Another example is a shape memory spring, which is activated to tension a tether, such as from the base of the device. A portion of the tether may be provided as a shape memory portion. Such a tether may be delivered in an elongated shape and then changed to a memory-induced shape, thereby shortening the tether to provide tension. The memory-induced shape may be in the shape of a helical coil, which additionally allows for memory-activated elasticity of the tether, which is particularly advantageous for pressure and/or motion compensation.

The device may have a flange unit extending radially outward from the periphery of the device (e.g., from the frame). The flange unit may be angled relative to the plane of the blood-permeable unit to form a pre-tensioned counteraction to the traction force provided. The flange unit may provide a further improved seal because the seal is supported by the blood pressure in the aorta. The flange unit may be made of fabric. The fabric may be a woven fabric. The fabric may be woven from PTFE threads that provide advantageous sealing and biocompatibility. The fabric may be arranged as a hoop around the frame of the device. The hoop may extend in a direction opposite to the filter membrane attached to the frame. The flange unit is used to prevent the periphery of the device from being recessed into the inner wall tissue. This is particularly advantageous because embolic particles may accumulate in such recesses. When the device is removed, these accumulated particles can then be flushed into the side branch. Preventing particles from accumulating at the periphery reduces this potential problem.

The tissue apposition maintaining unit may include a pushing unit, and the force may include a pushing force on the frame, the periphery and/or the blood permeable unit. The pushing unit provides the pushing force and presses the periphery toward the inner wall.

The tissue apposition maintaining unit may include a magnetic element, and the force may include a magnetic force.

According to another aspect of the present disclosure, a method (900) of positioning a catheter device (500) in an aortic arch is disclosed, comprising delivering (901) an embolic protection device (200), such as a deflector and/or filter, transluminally in the aortic arch, the embolic protection device being connected to a transluminal delivery unit (130) extending proximally from a connection point (131) of the embolic protection device; positioning (902) the embolic protection device in the aortic arch, comprising: expanding (903) a frame of the device in the aortic arch and flattening a blood permeable unit; juxtaposing (904) an outer periphery of the embolic protection device with an inner wall of the aortic arch to cover an orifice of a side branch including at least a carotid artery, for preventing embolic particles from passing therethrough into the side branch; a catheter reaching the patient's brain; and applying (905) a stabilizing force by at least one tissue apposition maintaining unit (300, 350) extending from the catheter into the aortic arch and attached to the anti-embolic protection device at a maintaining point (502), wherein the stabilizing force is applied to the anti-embolic protection device offset from the connection point, such as at the periphery, and when the catheter device is positioned at the aortic arch, the force is directed toward the inner wall of the aortic arch, providing the stabilizing force toward the inner wall of the aortic arch, away from the heart, and in a direction perpendicular to the longitudinal extension of the periphery, such that tissue apposition of the periphery to the inner wall of the aortic arch is supported by the stabilizing force for improving stability and peripheral sealing. In this manner, tissue apposition of the periphery to the inner wall of the aortic arch is supported by the force.

This method is less iatrogenic than known methods. It improves the seal of the periphery of the anti-embolic protection device. It also prevents the generation of debris from the orifice in the aortic arch.

The supported apposition improves apposition of the periphery to the inner wall of the aortic arch such that the improved apposition improves sealing of the periphery to the inner wall.

A force may be applied in a substantially proximal direction relative to the device to improve the seal.

Applying the force may include applying a traction force via a traction unit. The traction force may include pulling the periphery of the device toward the inner wall to lock the device in place within the aortic arch. The traction force may be applied via at least one tether distally connected to the frame, the periphery, and/or the blood permeable unit to provide the traction force.

The device can be delivered to the aortic arch through one of the side branches, such as the brachiocephalic artery, left carotid artery, or left subclavian artery from the right subclavian artery. It can be delivered to the aortic arch through the descending aorta (e.g., in the femoral artery), such as in a side channel of the main conduit. It can be delivered to the aortic arch through the wall of the ascending aorta, which is a method referred to as a "direct aortic" approach.

According to another aspect of the present disclosure, a method (1000) for preventing emboli flowing in an aortic arch from entering its side branches comprises advancing (1001) an embolic protection device toward the aortic arch; and manipulating (1002) the embolic protection device so as to cover the orifice of each side branch, comprising: applying (1003) a force to the embolic protection device to improve the sealing of the embolic protection device at the periphery, comprising: applying a force at the embolic protection device via a distal guide element (350) deviating from a connection point, the distal guide element (350) being connected between a distal maintenance point of the embolic protection device and a distal connection point (501) on a catheter; wherein the embolic protection device allows blood to flow from the aortic arch into each side branch, but prevents emboli from entering the first and second side branches and obstructing the lumen of the aortic arch.

According to another aspect of the present disclosure, a method for limiting the flow of emboli from the aorta into the carotid artery is provided. The method includes delivering an embolic protection device to the aortic arch for expansion between the ascending and descending aortas, positioning the embolic protection device or a component thereof within the aortic arch to prevent embolic debris from entering the carotid artery. Furthermore, the method includes proximally tightening at least one tether assembly distally connected to the embolic protection device to control the degree of apposition and fluid sealing of the embolic protection device against the inner wall of the aortic arch.

According to yet another aspect of the present disclosure, a method (1100) for performing an endovascular procedure on a heart comprises: delivering (1101) an embolic protection device to the aortic arch through the wall of the ascending aorta or through one of the following vessels: the brachiocephalic artery from the right subclavian artery, the left carotid artery, the left subclavian artery, or the descending aorta, such as the femoral artery, to position the embolic protection device in the aortic arch to prevent embolic debris from entering the carotid artery; applying (1101) a stabilizing force to the embolic protection device to improve the sealing of the embolic protection device at the periphery, including by at least one tissue apposition maintaining unit, other than the delivery axis of the embolic protection device, offset from the connection A method of claim 1103 comprising: applying a force at a point on the anti-embolic protection device to control the degree of apposition and fluid sealing of the anti-embolic protection device to the inner wall of the aortic arch by the force; delivering (1102) a first catheter to the heart through the aortic vessel wall at the descending aorta, the left subclavian artery or the aortic arch to affect at least one step related to an intravascular procedure on the heart, applying (1103) the stabilizing force by tightening at least one distal guiding element (350) connected between a distal maintenance point on the anti-embolic protection device and a distal connection point (501) on the catheter, wherein delivering the first catheter includes placing a balloon mounted on the first catheter so that the balloon expands in the ascending aortic arch.

The step of applying a force may comprise proximally tensioning at least one tether assembly or a pushing unit distally connected to the embolic protection device.

The step of delivering the embolic protection device may be performed transluminally, and the step of delivering the first catheter may be performed after delivering the embolic protection device.

Delivering the first catheter may include placing a balloon mounted on the first catheter, expanding the balloon in the ascending aortic arch to lock the distal end of the first catheter in place. The balloon may have an annular shape with a filter between the catheter and an inner ring of the annular shape.

The embolic protection device used in the method may extend from the distal end of the second catheter or a separate channel of the first catheter, such that the position of the embolic protection device may be adjusted independently from the position of the first catheter.

Delivering the first catheter may be performed simultaneously with delivering the embolic protection device via a separate channel of the first catheter, independent of the endovascular procedure.

Endovascular surgery on the heart may include at least steps related to the removal of a heart valve, the placement of a prosthetic heart valve, or the repair of a heart valve.After the endovascular surgery is performed, the anti-embolic protection device may be removed from the aortic arch.

Further embodiments of the disclosure are defined in the dependent claims, wherein features for the second and subsequent aspects of the invention are as for the first aspect mutatis mutandis.

Some examples of the present disclosure provide a low profile of the anti-embolic protection device within the aorta, which allows passage of a sheath, catheter, or wire used in endovascular procedures on the heart due to a tether.

Some examples of the present disclosure also provide for avoiding anchors, arms, bows, etc. extending from the device that may cause tissue damage/result in debris being scraped off and washed away.

Some examples of the present disclosure prevent additional portions of the anti-embolic protection device from contacting inner wall tissue of the aorta or side branches, particularly adjacent to or near an orifice in the aortic arch.

As used herein, the term "maintain" means to support, help, assist, hold, lift, etc. According to specific embodiments, tissue apposition according to the maintenance devices of the present disclosure can be provided by supporting, helping, or assisting apposition with a push or pull force.

The term "tether" as used herein should not be confused with a safety tether, which is a simple safety line used to allow retrieval of the anti-embolic protection device if necessary. A tether as used herein is a line that allows for controlled tensioning of the entire anti-embolic protection device or selected portions thereof. Traction is applied to the tether at the proximal end to tension the device to the inner vessel. The distal end of the tether is connected or attached to the anti-embolic protection device such that the traction support device is anchored to the inner vessel wall. In this way, fluid flow at the periphery of the device is controllable and can be completely stopped by the degree of traction on the tether, so that blood passes only through the blood-permeable cells of the device. As used herein, the term "tether" or "strand" refers to any elongated structure, such as ropes, fibers, yams, filaments, anchors, and lines, made of any non-degradable material, such as polycarbonate, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyvinylidene fluoride (PVDF), polypropylene, porous urethane, nitinol, fluoropolymer cobalt chromium alloy (CoCr), and para-aramid or fabrics such as nylon, polyester, or silk fabrics.

A device including an improved embodiment of the present invention comprises: a collapsible anti-embolic protection device designed for temporary transvascular delivery to a patient's aortic arch, the device comprising a protection unit comprising a selectively permeable material or unit adapted to prevent embolic material from entering a plurality of aortic side branches in the aortic arch with the bloodstream, wherein the protection unit is permanently or releasably attached (for assembly prior to introduction into the body) to the transvascular delivery unit at a connection point or region provided at or near the selectively permeable unit; and a first support member for the protection unit, which is at least partially disposed about the periphery of the selectively permeable unit. In the expanded state of the device, the connection point is enclosed by or integral with the first support member, wherein the transvascular delivery unit is connected to the protection unit off-center at the connection point. In some embodiments, the connection point or region, or the attachment point, is enclosed by the first support member.

The connection point may be provided at the selectively permeable unit or at the first support.

The connection points may be provided on a surface of the selectively permeable unit designed to be oriented towards the aortic side branches from inside the aortic arch and at a distance from the ostium region when the protection unit is positioned in the aortic arch.

In some embodiments, the selectively permeable unit includes a first portion and a second portion, wherein when the protective device is positioned at the aortic arch in an expanded state, the first portion is designed to expand in a first direction from the connection point toward the descending aorta of the aortic arch, and the second portion is designed to expand in a second direction (opposite to the first direction) from the connection point toward the ascending aorta of the aortic arch.

In some embodiments, the selectively permeable unit is arranged to expand asymmetrically from the connection point in a first direction toward the descending aorta of the aortic arch and in a second direction toward the ascending aorta of the aortic arch when the protection unit is positioned at the aortic arch in the expanded state.

The term "collapseable," as used in the context of this application, means that the device can be reduced to a smaller size so that it can be placed in a tubular delivery unit, such as a catheter. The collapsible unit is expandable when released or ejected from the delivery unit. Expandability includes self-expansion, shape memory effects, and/or resilient properties. The collapsible unit is re-collapseable for withdrawal into the delivery unit and removal from the patient.

It should be emphasized that the terms "include/have" used in this specification are intended to specify the existence of the features, integers, steps or components, rather than excluding the existence or addition of one or more other features, integers, steps, components or combinations thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of embodiments of the present invention will be apparent from and clearly illustrated by the following description of embodiments of the present invention taken in conjunction with the accompanying drawings, in which:

FIG1 is a schematic diagram of a protection device attached to a transvascular delivery unit in a deployed configuration within an aortic arch, the device including a tether;

FIG2 is a perspective view of an anti-embolic protection device with a tether;

FIG3 is a top plan view of an anti-embolic protection device with a tether;

FIG4 is a schematic diagram of an anti-embolic protection device delivered in a catheter, outside a catheter, and in an aortic arch;

FIG5 is an enlarged and detailed schematic diagram of the apparatus in FIG4 ;

FIG6 is a schematic diagram of an anti-embolic protection device delivered in a catheter, outside a catheter, and in an aortic arch;

FIG7 is an enlarged and detailed schematic diagram of the apparatus in FIG6 ;

FIG8 is a top plan view of an embolic protection device having multiple tethers;

9A and 9B are schematic diagrams of a catheter with a side channel and an anti-embolic protection device with a tether delivered via a side branch;

FIG10 is a schematic diagram of a catheter and an anti-embolic protection device with a tether via transfemoral delivery with a side channel;

FIG11 is a schematic diagram of a catheter with a side channel and an anti-embolic protection device delivered via a side branch with a hinge and a tether;

FIG12 is a schematic diagram of a transfemoral delivery catheter with a side channel and an anti-embolic protection device with multiple tethers;

FIG13 is a schematic diagram of a catheter with a side channel and an anti-embolic protection device delivered via the femoral artery with a push unit;

FIG14 is a schematic diagram of an anti-embolism protection device having a flange unit 400;

FIG15 is a flow chart of method 600;

16a-c are schematic diagrams of a catheter device according to an embodiment of the present invention;

17a-c are schematic diagrams of a catheter device according to an embodiment of the present invention;

18a-e are schematic diagrams of a catheter device according to an embodiment of the present invention;

19a-b are schematic diagrams of a catheter device according to an embodiment of the present invention;

20a-c are schematic diagrams of a catheter device according to an embodiment of the present invention;

FIG21 is a flow chart illustrating a method according to an embodiment of the present invention; and

22a-b are flow charts illustrating a method according to an embodiment of the present invention;

23a-d are schematic illustrations of catheter devices according to embodiments of the present invention.

DETAILED DESCRIPTION

Specific examples of the present invention will be described below with reference to the accompanying drawings. However, the present invention can be embodied in different forms and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are provided to fully and completely disclose the present invention and to fully convey the scope of the present invention to those skilled in the art. The terms used in the detailed description of the embodiments shown in the accompanying drawings are not intended to limit the present invention. In the accompanying drawings, the same reference numerals refer to the same elements.

Figure 1 is a schematic diagram of an aortic arch 100 and a plurality of side branches including a third side branch 116, a second side branch 118, and a first side branch 120. Some of the figures show the aortic valve 6. Typically, the three branches of the aorta separate from the main trunk of the aortic arch 100 at three separate orifices. The third side branch 116 is called the brachiocephalic artery, the second side branch 118 is called the left common carotid artery, and the first side branch 120 is called the left subclavian artery. The side branches typically separate from the aortic arch into three separate arterial trunks arising from different locations on the aortic arch 100. The brachiocephalic artery 116 is the largest diameter branch of the aortic arch and typically forms a bifurcation, with the right subclavian artery 115 branching out from the bifurcation to direct blood, for example, to the right arm, and the right common carotid artery 117 delivering arterial blood toward the neck and head. The left common carotid artery 118 typically branches directly from the aortic arch 100. The common carotid arteries 117, 118 then branch into the external and internal carotid arteries, which supply blood to the neck and head regions. The left and right subclavian arteries 120, 115 ultimately provide arterial pathways that supply blood to the vertebral arteries, internal thoracic arteries, and other blood vessels (to provide oxygenated blood to the chest wall, spinal cord, and upper arms, neck, meninges, and brain).

2 is a perspective view of an anti-embolic protection device with a wire support 133. Two branches of the wire cross each other at a crossing 196 towards the delivery unit 130. The two branch wires are joined at an attachment point 131, for example by clamping, welding, gluing.

A collapsible embolic protection device 200 is provided for temporary transvascular delivery to a patient's aortic arch 100 and for temporary positioning within or across the aortic arch 100. Several examples of the device are described below. The device comprises a collapsible protection unit 140 configured to prevent embolic material 150 from entering at least one of the side branches 116, 118, and 120 of the aortic arch 100 when properly positioned within the aortic arch 100 in its expanded state. Preferably, at least the left and right carotid arteries 118 and 117 are protected from embolic material 150 present within the aortic arch 100. All side branches 116, 118, and 120 may be covered.

The example of the anti-embolic protection device 200 further includes a first support 133 for the protection unit 140, which is at least partially arranged at the periphery 180 of the selectively permeable unit 132. The selectively permeable unit 132 is permeable to blood but impermeable to embolic substances. The selectively permeable unit 132 is connected or attached to the first support 133 in a suitable manner. Alternatively, the selectively permeable unit 132 can be formed integrally with the first support 133.

The protection unit 140 includes a selectively permeable material or cell 132 adapted to selectively prevent embolic material 150 from entering the plurality of side branches 116, 118, 120 of the aortic arch 100 along with the blood flow (arrow symbols in FIG1 ). The blood flow into the side branches is substantially unimpeded while passing through the anti-embolic protection device 200. The protection unit 140 is permanently connected or attached to the transvascular delivery unit 130 at a connection point or region, or attachment point 131, provided at the selectively permeable cell 132. The connection point or region can be provided, for example, when the protection unit is integral with its support element, without attachment, but rather as a transition from the transvascular delivery unit 130 to the protection unit 140, such as provided at a support member of the protection unit 140.

Depending on the properties of the selectively permeable element 132, embolic material can be temporarily trapped in the selectively permeable element 132. The selectively permeable element 132 may include a filter material. Alternatively or additionally, the selectively permeable element 132 may include or be made of a porous material. In any example of the device disclosed herein, the selectively permeable element 132 material may include a braided, woven, or bundled material. In certain aspects, the selectively permeable element 132 material may include a laminated mesh. For example, the mesh may include a polymer film, such as a perforated polymer film. Alternatively or additionally, the selectively permeable element 132 may have the property of allowing embolic material to slip or slide along a surface of the selectively permeable element 132 directed away from the orifice, thereby deflecting embolic fragments through the side branch. In any example of the device disclosed herein, the protective element 140 and/or the permeable element 132 may include a drawn filler tube, such as an outer layer including nitinol and/or a core including tantalum and/or platinum.

First support member 133 is shaped to be juxtaposed with tissue of a vessel wall portion of aortic arch 100. First support member 133 is formed to surround a plurality of openings of aortic side branches 116, 118, 120 within aortic arch 100 and to be spaced a distance from these openings. In this manner, selectively permeable member 132 is arranged to separate the first fluid space of aortic side branches 116, 118, 120 from the second fluid space within aortic arch 100 when protection member 140 is positioned within aortic arch 100, as shown in FIG1 . Blood flows from the second fluid space within aortic arch 100 through selectively permeable member 132, which prevents embolic particles of a selected size from passing through, into the first fluid space of the aortic side branches.

The embolic protection device is typically delivered transvascularly to the aortic arch via catheter 160. Delivery may be via different blood vessels in addition to those specifically shown as examples in the figures.

According to one aspect of the present disclosure, a collapsible, transluminally deliverable embolic protection device 200 for temporary placement in the aortic arch is connectable or fixedly attached to a transluminal delivery unit 130 extending proximally from a connection point 131. The device 200 comprises a frame-like first support member with an outer periphery 180, and a blood-permeable unit 132 positioned within the outer periphery 180 to prevent embolic particles 150 from passing through the blood-permeable unit 132 into the side branches of the aortic arch 100 and reaching the patient's brain. The device also includes at least one tissue apposition maintaining unit that is not the delivery axis of the device. The tissue apposition maintaining unit is configured to apply a force offset relative to the connection point at the device.

The tissue apposition maintaining unit provides for supporting tissue apposition of the device 200 to the inner wall of the aortic arch.

The offset to the connection point can be, for example, at the periphery 180. It can also be adjacent to the periphery 180. It can also be at the center of the blood permeable element 132 within the periphery 180.

When the device is positioned in the aortic arch, a force (also called a stabilizing force) is applied or directed to the inner wall of the aortic arch 100. This force is shown in the example shown by arrow 301 in the figure.

In this manner, the tissue apposition of periphery 180 to the inner wall of aortic arch 100 is supported by a force, as indicated by arrow 301. The aortic arch, due to its limited flexibility and elasticity, provides a counterforce. This balance of force and counterforce improves the seal of periphery 180. It also allows for limited movement of the aortic arch at the anti-embolic protection device when the device is approximately locked in place. However, movement of the aortic arch can still occur and be compensated for as described herein, for example to prevent the disadvantages of the so-called wind suction effect.

For example, the traction force thus applied can pull the outer periphery of the device toward the inner wall. This force supports the aforementioned locking of the device into place when the device is implanted.

Thus, the embolic protection device 200 can be reliably placed across the apex of the aorta to prevent emboli from flowing into the carotid artery. The present invention's approach is non-iatrogenic because it prevents debris from, for example, the orifices of a side branch. Iatrogenicity refers to adverse patient outcomes caused by a physician or surgeon's treatment. For example, poorly designed embolic protection devices with arms, anchors, delivery shafts, arches, etc., extending into a side branch, which risk scraping plaque from the inner vessel wall or orifice, are unnecessary and can be avoided thanks to the present disclosure.

The anti-embolic protection device 200 may be a deflector for deflecting embolic particles. Alternatively or additionally, it may be a filter for capturing embolic particles in an example.

In an example, the device can be delivered via a side channel 7 of the catheter 2 (e.g., via the femoral artery). Such a side channel catheter 2 is described in patent application PCT/EP2012/0058384, which was published as WO2012152761 after the priority date of the present application, the entire contents of which are incorporated herein by reference for all purposes. The catheter can also be improved by having multiple side channels, one of which side channel 7 is provided for delivering the anti-embolic protection device 200 to the aortic arch 100. The tether 300 can extend in the same channel of the catheter as the anti-embolic protection device 200 and the delivery unit 130, or in another channel. A pigtail catheter can be provided in such an auxiliary side channel. The pigtail catheter can further stabilize the catheter using a femoral artery delivery method to support the catheter 2 against the annulus of the aortic valve and the inner wall of the aortic arch, as described in WO 2012/094195A1, the entire contents of which are incorporated herein by reference for all purposes, particularly referring to Figures 10A and 10B of WO 2012/094195A1 and the relevant description paragraphs in WO 2012/094195A1.

In an example, the device 200 may be delivered via a side branch, such as described in WO 2010/026240 A1.

The device may in an example be delivered through the wall of the aorta 100, for example using a so-called direct aortic approach.

The force 301 may include or be a traction force, depending on the type of juxtaposition support unit. The juxtaposition maintenance/support unit may be an active traction unit, which, for example, has at least one operable tether 300 connected at a position offset relative to the connection point at its distal end. The distal connection location of the tether may be located at the frame, periphery and/or blood permeable unit of the anti-embolic protection device to provide the traction force. The tether has one or more distal ends. The distal end is, for example, connected to the periphery of the anti-embolic protection device. The distal end of the tether may be connected to a blood permeable unit (e.g., a filter or deflector membrane). For example, if the membrane is flexible and/or elastic, the membrane can be moved by traction.

A tether, or more accurately, a traction cord is provided to control the degree of peripheral sealing. The tether cord is provided to guide the apposition of the aortic tissue/cerebral artery. The tether cord can provide active traction by pulling on the tether cord associated with an anti-embolic protection device (distal connection).

The tether can be arranged to be longitudinally movable relative to the delivery unit 130. In this way, the device 200 can be positioned in the aortic arch so that the delivery device can be locked in a "delivery" position (e.g., at its proximal end, located on or outside the orifice of the introducer) by the delivery unit 130. The tether 300 can then still be movable and improve sealing as described herein.

The tether 300 may be a multi-filament structure, which provides a particularly flexible solution that facilitates navigation through narrow lumens.

Tether 300 can extend straight through the blood-permeable unit to the front end of the device. Thus, the midline can be pulled up, and the periphery is tightened against the inner wall. The tether provides a lifting force to the front end. When the tether is guided at the midline (e.g., through an eyelet), it can provide a progressive lifting force distributed along the device. See, for example, Figures 2, 6, 7, and 8.

The at least one tether 300 can be longitudinally elastic, meaning it can be longitudinally tensioned and elastically return to an untensioned longitudinal extension. The tether can be elastic along its entire length. The tether can include one or more elastic portions or elastic elements. The elastic portion can be a helically wound portion of the tether that acts as a spring. The elastic portion can be a tubular braid of double helically wound strands. The elastic portion can be made of an elastic material, preferably a biocompatible material such as rubber. In this manner, the traction force is variable. This can help prevent tether line breakage because the operator can "feel" the nonlinear extension. If the tether is tensioned, this variable traction force can also be advantageous, applying a desired traction force to improve the seal of the anti-embolic protection device. The tether can be locked in position at its proximal end, for example, extending beyond the orifice of the introducer. The elasticity can provide compensation for physiological movement of the aortic arch relative to the device and/or the proximal end of the tether, while maintaining tissue apposition. As the aortic arch moves due to heartbeat and blood pulse waves, a force suitable for maintaining an improved peripheral seal is applied within a certain range.

The blood-permeable element 132 can have at least one guide element 320, such as an eyelet, a tubular curved element, a roller, an open fabric portion, or the like. The guide element can receive a tether near its distal end where it is attached to the device (e.g., at the blood-permeable element, flange, or periphery). The guide element (e.g., an eyelet, etc.) provides for localized control of the apposition of the device. The traction force can be distributed to different areas of the device.

The device may have an attachment point where the distal end of the tether is connected to the device, and traction can be transmitted to the device peripherally through the attachment point. Optionally, one or more radiopaque fiducial markers may be provided on the device. A fiducial marker may be provided at the attachment point. Such a radiopaque element may be fixed to or incorporated into the intravascular device, for example, to the frame 133, the selectively permeable unit, the yoke, the skeleton or other radiation support, the tether, the eyelet, etc., to identify the orientation of the device when the device 200 is located within the patient's body. The radiopaque element may be a bead or a clamp. In the case of a clamp, the element may be crimped onto the device 200. The radiopaque material may be a portion of a wire or tether. Portions of the frame, yoke, or permeable unit 132 may be constructed from DFT wire. Such wire may comprise a core material such as tantalum and/or platinum and an outer material such as nitinol. Radiopaque elements or fiducial markers facilitate X-ray visibility and navigation, as well as positional feedback and control of the device.

In some examples, a tether extends proximally through an orifice into a selected side branch, such that traction forces the device to center relative to the orifice. When tether 300 is pulled, it pulls the device toward the inner wall of the aorta at its periphery, locking the device in place. In this manner, the device self-aligns relative to the orifice of the selected side branch due to the tether. A skilled artisan, upon reviewing this disclosure, can provide a suitable guide unit for the tether.

The device may include multiple tethers attached distally along the periphery. Alternatively or additionally, a single proximal tether may be separated into multiple (sub-) tethers at the distal end. For example, the tethers may be branched in a Y-formation. A single tether, to be operated proximally, may then distribute traction to the distal end of the anti-embolic protection device via its two distal ends.

FIG8 shows an example with multiple endpoints. Multiple tethers can be used or combined with tethers having multiple distal ends. The multiple tethers can be brought together at the proximal end of the device (e.g., at its base 330 ( FIG7 , 8 )). In this way, the device provides a progressive force that is evenly distributed along the periphery of the device. In this way, the device can advantageously adapt to the internal shape of the aortic arch 100. This adaptability can even be enhanced by providing longitudinal elastic portions at the tethers. For example, the branch (sub) tethers can be provided by an elastic material, while the main line is essentially inelastic, but flexible.

In some examples, the device can have an internal structure or external skeleton, such as at least one rib 135 extending between different (preferably opposing) junctions on the periphery, with the tether attached to the rib at the distal end. The tether 300 can thus apply traction to the rib 135, which in turn transmits the force toward the inner wall tissue of the aorta to the periphery 180 of the device 200. The rib 135 can be a beam or a yoke. It can be arranged longitudinally (Figures 6 and 7) or transversely (Figures 4 and 5) relative to the longitudinal axis of the expanded device 200.

There may be a plurality of such ribs 135 in the device.

For example, the internal structure (e.g., ribs 135) can allow the operator to control the orientation of the device within the aortic arch and allow the operator to push, press, or pull the device against certain features of the aortic arch, for example, to press the device against the aortic arch wall a distance above the orifices of one or more side branches. An external skeleton can be connected to the internal structure. The external skeleton can be a frame 133 and can provide additional structural support for the device and can help create a seal between the selectively permeable cells 132 of the device and the vessel wall. Alternatively, the permeable cells 132 themselves can create a seal against the vessel wall by extending beyond the periphery of the frame 133.

The device 200 can be collapsed along its longitudinal axis to facilitate delivery to the treatment site. The device 200 can also be compatible with conventional delivery methods used in interventional cardiology (e.g., TAVI surgery). The device can be integrated with a delivery system, such as a side channel catheter. Upon retrieval, the device 200 can be retracted in an orientation substantially similar to the orientation in which it was originally deployed.

A device 200 having multiple petals or wings may have one or more ribs on one or more petals or wings to achieve favorable force distribution.

For example, the device's flaps or wings can be positioned upstream relative to aortic blood flow. Alternatively or additionally, device 200 may have flaps or wings positioned downstream relative to aortic blood flow. All or some of the flaps or wings may include tissue apposition-maintaining elements, such as tethers, pushers, or springs as described herein. Providing tissue apposition-maintaining elements for flaps or wings positioned upstream relative to aortic blood flow may be sufficient. Flaps or wings positioned downstream can be adequately pushed against the aortic inner wall tissue by the pulsating blood flow in the aorta that travels along the device's blood-permeable elements. However, including tissue apposition-maintaining elements in flaps or wings positioned downstream from the connection point can advantageously provide support during aortic pressure fluctuations. Aortic pressure is lower during diastole and may be prone to greater leakage than during systole. Tissue apposition-maintaining elements can be sized to provide adequate support during diastole and, therefore, be more convenient (smaller, lighter) for insertion into the body than those designed for systolic support.

The tissue apposition maintaining element can limit the movement of the blood-permeable element 132 caused by pulsatile blood flow. For example, the presence of ribs 135 can provide this limited range of motion. The ribs and/or tether can limit the movement of the blood-permeable element. Connecting the tether 300 to the device 200 can thus provide a gradual traction force and, in particular, improve sealing because the force on the periphery 180 caused by pulsatile pressure changes is evenly distributed during the pulsatile flow of the heartbeat.

Rib 135 may be a yoke extending proximally above blood-permeable unit 132. The yoke may preferably extend in the longitudinal direction of at least a portion of device 200. The distal tether end may be directly attached to rib 135. The distal tether end may be guided to outer periphery 180 by a guide unit at the rib, thereby providing a favorable distribution of traction force.

Device 200 may include multiple tethers, or a single tether that branches into multiple strands from the distal end. In an example, two tethers or strands are attached to the periphery in a Y-shaped distal end from the base of the device (see FIG8 ).

The device 200 may comprise at least one eyelet through which one or more of the tethers are passed. The eyelet may preferably be provided at a pivot point and/or at the base 330 of the device 200.

The blood-permeable element can be flexible. For example, it is a flat membrane with a defined porosity or pores. The porosity or pores can be part of, or contained within, a fine wire mesh or netting, or a perforated membrane. For example, a mesh or sheet having pores or porosity of 50-950 microns (e.g., 50, 60, 70, 80, 85, 90, 100, 120, 135, 150, 250, 350, 450, 550, 650, 750, 850, 950, or even larger). The perforated membrane can be perforated before being added to the device. The membrane can also be perforated after being added to the device, for example, by laser drilling or electric sparking. In embodiments in which a perforated membrane is present, the pores can have a constant or varied pore pattern, a constant or varied porosity, and/or a constant or varied pore size. The blood-permeable element 132 can be braided, woven, gathered, knitted, or knotted. The blood permeable element 132 can be made of a non-degradable material such as polycarbonate, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyvinylidene fluoride (PVDF), polypropylene, porous urethane, nitinol, fluoropolymer cobalt chromium alloy (CoCr), and para-aramid or a fabric such as nylon, polyester or silk fabric. The blood permeable element 132 can be a combination of materials, such as a combination of DFT and nitinol wire. The blood permeable element 132 can also be coated with an anti-thrombotic agent to prevent thrombotic reactions. The size of the device 200 can be pre-sized and pre-formed to accommodate various patient groups, such as children or adults, or specific aortic anatomy.

The tether can be distally attached to the membrane. The applied traction can thereby raise the membrane out of its plane, forming, for example, a volcano shape, including raising the tether's attachment point to the membrane. This volcano shape can advantageously improve device efficiency. The top of the volcano can be arranged to extend into the orifice, into a portion of the side branch. This can improve particle capture due to the internal funnel shape of the volcano, into which blood flows. The result is improved filtration efficiency.

The traction unit may comprise a passive traction unit. The passive traction unit is not operated by the operator but automatically provides an improved seal. The passive traction unit may be a spring. It may have a shape memory element, such as part of a frame, activated, for example, by body temperature, for providing traction relative to the delivery portion or device. For example, the device may comprise "winglets" extending from the periphery of the device with shape memory. Another example is a shape memory spring, which is activated to tighten a tether, such as from the base of the device. A portion of the tether may be provided as a shape memory portion. Such a tether may be delivered in an elongated shape and then changed to a memory-inducing shape, thereby shortening the tether to provide tension. The memory-inducing shape may be a helical coil shape that additionally allows for memory-activated elasticity of the tether, which is particularly advantageous for pressure and/or motion compensation.

The device may include a flange unit 400 extending radially outward from the periphery 180 of the device 200 (e.g., from the frame 132), see FIG14 . This flange unit may be angled relative to the plane of the blood-permeable unit to create a pre-tensioned force to counteract traction. This flange unit can further improve the seal because the seal is supported by blood pressure in the aorta. Flange unit 400 may be made of fabric. The fabric may be a woven fabric. The fabric may be woven from PTFE yarn that provides favorable sealing and biocompatibility. The fabric may be arranged as a hoop around the frame of the device. The hoop may extend in a direction opposite to the filter membrane attached to the frame. Flange unit 400 serves to reduce or prevent the periphery of the device from indenting into the inner wall tissue. This is particularly advantageous because embolic particles may accumulate in such indentations. When the device is removed, these accumulated particles may then be flushed into the side branches. Preventing particle accumulation at the periphery reduces this potential problem.

FIG10 is a schematic diagram showing a catheter delivered via a side channel through the femoral artery and an anti-embolic protection device with a tether, the device including a hinge portion 340 that allows traction to be converted toward upward movement of the aortic inner wall tissue, as shown. The traction is thereby converted into a thrust.

The tissue apposition maintaining unit may include a pushing unit 350 ( FIG. 13 ), and the force may include a pushing force on the frame, the periphery, and/or the blood permeable unit. The pushing unit provides the pushing force and presses the periphery toward the inner wall.

The tissue apposition maintaining unit may include a magnetic element, and the force may include a magnetic force.

This magnetic force can be provided as follows: the device 200 includes a magnetic element having a first magnetic pole. A second magnetic element can be arranged outside the aortic arch. The second magnetic element has a magnetic pole opposite to the first magnetic polarity. In this way, the first and second magnetic elements attract each other. The device 200 will thus be pulled toward the aortic arch wall, thereby providing a force that improves the seal of the periphery 180. Those skilled in the art will recognize the appropriate time and location to apply the second magnetic element. For example, it can be arranged outside the body in a suitable orientation on the patient's chest after the anti-embolic protection device is positioned in the aortic arch.

The repulsive magnetic force can be obtained based on the same principle, but the polarity of the first and second magnetic elements is the same. When the device 200 is released and positioned from the side channel 7, the second magnetic element can, for example, be part of the catheter 7 or its side channel or be advanced through the catheter 7 or its side channel. In this way, a force is provided to push the device toward the inner aortic wall.

Magnetic elements may be provided in addition to or in addition to tethers, push rods, etc.

The medical devices described herein are typically packaged in sterile containers for distribution to medical professionals. The articles can be sterilized using various methods (e.g., electron beam radiation, gamma radiation, ultraviolet radiation, chemical sterilization, and/or using aseptic manufacturing and packaging procedures). For example, the articles can be labeled with an appropriate date by which the article is expected to remain in a fully functional state. Components can be packaged individually or together.

For convenience, the various devices described herein can be packaged together in a kit. The kit can also include a label with instructions for use and/or warnings, such as information specified by the Food and Drug Administration. Such labeling can be located on the outside of the package and/or on a separate sheet within the package.

Device 200 can be used in the disclosed method of positioning an anti-embolic protection device (e.g., a deflector and/or filter) in the aortic arch. The method includes delivering the anti-embolic protection device transluminally to the aortic arch, the device being connected to a transluminal delivery unit 130 extending proximally from a connection point 131 of the device. Furthermore, the method includes positioning the device in the aortic arch. This positioning includes expanding the device frame and flattening the blood-permeable unit in the aortic arch, and juxtaposing the periphery of the device with the inner wall of the aortic arch to cover the orifices of at least the side branches of the carotid artery. Thus positioned, the device can prevent embolic particles from entering the side branches of the aorta and reaching the patient's brain.

In the example of method 600, the device 200 is positioned in the aortic arch 100 via an introducer in the left radial artery using a standard transfemoral puncture (Seldinger) technique and fluoroscopy. Once the collapsible protective device is delivered/released from the catheter, it is expanded and positioned to cover the left and right carotid arteries, allowing blood to pass without allowing embolic particles to pass. When the cardiovascular intervention or cardiac surgery is completed, the device is retracted back into the catheter.

In a method 600 for preventing embolic material from entering a side branch with blood flow from a patient's aortic arch, a collapsible embolic protection device 200 is percutaneously introduced into a peripheral blood vessel in a collapsed state, as shown in step 610. This is schematically illustrated in FIG15. The collapsible embolic protection device 200 is transvascularly delivered into the aortic arch 100 through the peripheral blood vessel and the first side branch 120 in a collapsed state, as shown in step 620. To this end, the device 200 is collapsed into a delivery catheter 160 and introduced through the catheter to a deployment site within the aortic arch 100.

The device 200 is attached at its attachment point to the transvascular delivery unit 130 (eg a pusher or a wire). The embolic protection unit 200 of the collapsible embolic protection device is expanded in the aortic arch 100 , which is shown by step 630 .

The expansion can include asymmetrically deploying a first portion 145 and a second portion 146 of the protection unit from the attachment point 131 (see FIG. 1 ). The first portion 145 expands in a first direction toward the descending aorta 114 of the aortic arch 100. The second portion 146 expands in a second direction toward the ascending aorta 112 of the aortic arch 100. This asymmetrical arrangement facilitates positioning the device 200 from the delivery vessel relative to the other side branches 116, 118 to be protected. This method stage is illustrated by step 640.

Positioning the protection unit 200 in the aortic arch 100 includes juxtaposing the first support 133 of the selectively permeable unit 132 of the protection unit 200 with tissue of the vessel wall portion of the aortic arch 100, as shown in step 650. The first support 133 of the protection unit 200 is at least partially disposed at the periphery 180 of the selectively permeable unit 132 of the protection unit.

The method comprises surrounding a plurality of orifices of the aortic branch vessels 116 , 118 , 120 in the aortic arch 100 with the first support 133 and positioning the protection unit 200 at a distance from the orifices. This method stage is illustrated by step 660 .

Therefore, as shown in method step 670, the protection unit 200 is positioned in its expanded state in the aortic arch 100. The selectively permeable material of the protection unit 200 can effectively prevent the embolic material 150 from flowing through the blood flow path and entering the multiple aortic side branches 116, 118, 120 in the aortic arch 100, as shown in method step 680.

Thus, the method simultaneously separates the first fluid space of the aortic side branch from the second fluid space in the aortic arch when the protection unit 200 is positioned in the aortic arch 100 .

The method may include pulling the expanded protection unit 200 in a direction opposite to the delivery direction and thereby tightening and tightening the vascular tissue portion of the aortic arch 100 surrounding the orifice of the side branch. This embodied method stage is illustrated by step 690.

Furthermore, the method includes step 700 of applying a force to the device via at least one tissue apposition maintaining unit rather than the device's delivery axis. The force is applied to the device offset from the point of attachment, for example, peripherally. When the device is positioned in the aortic arch, the force is directed toward the inner wall of the aortic arch. In this manner, tissue apposition from the periphery to the inner wall of the aortic arch is supported by the force.

This approach is less iatrogenic than known approaches. It further improves the seal around the periphery of the embolic protection device. It also prevents the generation of debris from the orifice in the aortic arch, which can be a problem with some known embolic protection devices.

The post-stenting apposition improves apposition of the periphery to the inner wall of the aortic arch such that the improved apposition improves the sealing of the periphery to the inner wall.

The force may be applied in a substantially proximal direction relative to the device to improve sealing.

Applying the force may include applying a traction force via a traction unit. The traction force may include pulling the periphery of the device toward the inner wall to lock the device in place within the aortic arch. The traction force may be applied via at least one tether distally connected to the frame, the periphery, and/or the blood permeable unit to provide the traction force.

The device can be delivered to the aortic arch through one of the side branches, such as the brachiocephalic artery, the left carotid artery, or the left subclavian artery from the right subclavian artery. It can be delivered to the aortic arch through the descending aorta (e.g., in the femoral artery), for example, in a side channel of the main conduit. It can be delivered to the aortic arch through the wall of the ascending aorta, which is a method referred to as a "direct aortic" approach.

The device 200 can be used in a method 800 for preventing emboli flowing in the aortic arch from entering its side branches. The method includes step 801, advancing embolic protection to the aortic arch; and step 802, manipulating the protection device so that it covers the orifice of each side branch. The method also includes step 803, applying a force to the protection device to improve the seal of the device at its periphery. The application of the force includes applying a force to the device offset from the connection point by at least one tissue apposition maintenance unit (rather than the delivery axis of the device). In this way, the protection device allows step 804, i.e., allowing blood to enter each side branch from the aortic arch, but preventing emboli from entering the first and second side branches and not blocking the lumen of the aortic arch.

The device 200 can be used in a method 810 for limiting the flow of emboli from the aorta into the carotid artery. The method includes step 811 of delivering an embolic protection device to the aortic arch for expansion between the ascending aorta and the descending aorta to position the embolic protection device or a component thereof within the aortic arch, thereby preventing embolic debris from entering the carotid artery. Furthermore, the method includes step 812 of proximally tightening at least one tether member distally connected to the embolic protection device to control the degree of apposition and fluid sealing of the embolic protection device against the inner wall of the aortic arch.

Device 200 can be used in a method 820 for performing endovascular surgery on the heart. The method, step 821, includes delivering an anti-embolic protection device to the aortic arch via one of the following vessels: the brachiocephalic artery from the right subclavian artery, the left carotid artery, the left subclavian artery, or the descending aorta, such as the femoral artery; or through the wall of the ascending aorta. The method also includes step 822, positioning the anti-embolic protection device in the aortic arch to prevent embolic debris from entering the carotid artery. The method includes step 823, applying a force to the protection device to improve the seal of the device at its periphery. Step 823 includes applying a force to the device offset from the connection point via at least one tissue apposition maintaining element (rather than the delivery axis of the device). In this manner, the method allows the degree of apposition and fluid sealing of the anti-embolic protection device to the inner wall of the aortic arch to be controlled by the applied force. Furthermore, the method includes step 824, delivering a first catheter to the heart via the aortic vessel wall at the descending aorta, the left subclavian artery, or the aortic arch to effect at least one step associated with the endovascular surgery on the heart.

The applying step may include proximally tensioning at least one tether member distally connected to the embolic protection device.

The step of delivering the embolic protection device may be performed transluminally, and the step of delivering the first catheter may be performed after delivering the embolic protection device.

Delivering the first catheter may include placing a balloon mounted on the first catheter, expanding the balloon in the ascending aortic arch to lock the distal end of the first catheter in place. The balloon may be annular with a filter between the catheter and an inner ring of the annular shape.

The embolic protection device used in the method may extend from the distal end of the second catheter or a separate channel of the first catheter, such that the position of the embolic protection device may be adjusted independently from the position of the first catheter.

The delivery of the first catheter may be performed simultaneously with the delivery of the embolic protection device via a separate channel of the first catheter, independent of the endovascular procedure.

Endovascular surgery on the heart can include at least steps associated with the removal of a heart valve, placement of a prosthetic heart valve, or repair of a heart valve. This can include treatment of heart valve disease, such as valvuloplasty, including percutaneous valve replacement. The procedure can be a transcatheter aortic valve implant (TAVI), which involves implanting a collapsible aortic valve using minimally invasive techniques.

After the endovascular procedure, the anti-embolic protection device can be removed from the aortic arch.

Catheter device including an anti-embolic protection unit

Figures 16a-c, 17a-c, 18a-c, 19a-b, 20a-c show a catheter device (500) comprising: an elongated sheath (503) having an inner lumen and a distal end for positioning at a heart valve (6); an anti-embolic protection device (200) for temporary positioning in the aortic arch to deflect embolic debris from the ascending aorta to the descending aorta, the anti-embolic protection device being connectable to a transluminal delivery unit (130) extending proximally from a connection point (131) and comprising: a frame with a periphery, a blood-permeable unit within the periphery for preventing embolic particles from passing through the side branches of the aortic arch with blood flow downstream of the aortic valve and reaching the patient's brain; and at least one tissue apposition maintaining unit (300, 350) extending from the catheter into the aortic arch and at a sustaining point (sustaining point). point) (502) attached to the anti-embolic protection device for applying a stabilizing force at the anti-embolic protection device (e.g., at the periphery) offset from the point of attachment, and for providing the stabilizing force toward the inner wall of the aortic arch, away from the heart, and in a direction perpendicular to the longitudinal extension of the periphery when the catheter device is positioned in the aortic arch, such that tissue apposition of the periphery to the inner wall of the aortic arch is supported by the force to improve stability and peripheral sealing.

The stabilizing force may comprise a traction force, and the apposition maintaining unit may comprise an active traction unit having at least one operable tether (300), the distal end of the at least one operable tether being connected at the maintaining point offset from the connection point, for example connected to the frame, periphery and/or blood permeable unit, for providing the traction force.

The mechanical tissue apposition maintaining unit may include a pushing unit (350), and the force may include a pushing force on the frame, the periphery and/or the blood permeable unit for providing the pushing force and pressing the periphery toward the inner wall.

The at least one tether or pusher unit may be longitudinally elastic, whereby the force is variable for compensating for physiological movements of the aortic arch relative to the anti-embolic protection device while maintaining tissue apposition. This provides the advantages as described above.

The blood-permeable unit may have at least one guiding unit (e.g., an eyelet) near the distal end for receiving the tether or pusher unit, wherein the tether or pusher unit is attached to the blood-permeable unit, flange, or periphery at the distal end. This provides the advantages described above.

The embolic protection device may have an attachment point to which the distal end of the tether or push unit is connected and optionally a radiopaque fiducial marker at the attachment point. This provides the advantages described above.

In operation, the tether may be extended proximally through the orifice into the selected side branch so that the traction force centers the device relative to the orifice and pulls the device toward the inner wall to lock the device in place, whereby the device self-aligns relative to the orifice of the selected side branch. This provides the advantages described above.

The catheter device may comprise a plurality of tethers attached distally along the periphery.This provides the advantages as described above.

The frame may comprise at least one rib extending between different junctions at the periphery, wherein the tether or push unit is distally attached to the rib. This provides the advantages described above.

The different engagement points may be opposing engagement points. This provides the advantages described above.

The rib may be a yoke extending proximally above the blood permeable unit. This provides the advantages described above.

The yoke may extend in the longitudinal direction of at least a portion of the anti-embolic protection device. This provides the advantages described above.

The catheter device may comprise multiple tethers, or a single tether which is split into multiple strands at the distal end. This provides the advantages described above.

Two tethers or strands may be attached distally from the base of the embolic protection device to the periphery in a Y-shape. This provides the advantages described above.

The catheter device may comprise at least one eyelet, wherein one or more of the tether or the push unit is passed through the at least one eyelet. This provides the advantages as described above.

One or more of the tethers may be passed through at least one eyelet at a pivot point at the base of the device. This provides the advantages described above.

The blood permeable unit may be flexible, for example a flat membrane with defined porosity or pores, and the tether or push unit is distally attached to the membrane such that the traction or push force, when applied, lifts the membrane out of the plane of the membrane. This provides the advantages described above.

The pulling or pushing force, when applied, may lift the membrane from the plane of the membrane so as to provide a volcano shape of the membrane at the attachment location of the tether or pushing unit to the membrane. This provides the advantages as described above.

The pulling unit or pushing unit may comprise a passive pulling unit for providing said pulling force or pushing force. This provides the advantages as described above.

The passive pulling or pushing unit may be a spring or a shape memory element. This provides the advantages described above.

The outer periphery may comprise a flange unit extending radially outwardly from the frame. This provides the advantages described above.

The flange unit may be angled relative to the plane of the blood permeable unit for providing pre-tensioning against the stabilizing force provided. This provides the advantages as described above.

The tissue apposition maintaining unit may comprise a magnetic element, and the stabilizing force comprises a magnetic force. This provides the advantages as described above.

As shown in Figures 16a-c, 17a-c, 18c, and 19a-b, the push unit includes a distal guiding element (350) connected between the maintenance point of the anti-embolic protection device and the distal connection point (501) on the catheter, wherein the distal guiding element has a delivery state and an expanded state, in which the anti-embolic protection device is collapsed and substantially aligned with the sheath of the catheter, and in the expanded state, the anti-embolic protection device is expanded, whereby the periphery is substantially in apposition with the aortic arch, thereby guiding the anti-embolic protection device towards the inner wall when the distal guiding element moves from the delivery state to the expanded state. This improves the sealing of the anti-embolic protection device to the aortic wall because the guiding element effectively guides the protection device to the correct position. This movement of the guiding element and the associated force applied by the guiding element are shown by arrows 301, 301' in Figures 16b-c. In addition, the distal guiding element effectively stabilizes the anti-embolic protection device relative to the catheter, thereby effectively preventing misalignment.

The distal guide element may be connected to the distal portion of the anti-embolic protection device at the maintenance point. By having a support at the distal portion of the anti-embolic protection device, as shown in Figures 16a-c, the alignment of the anti-embolic protection device may be improved. Alternatively or additionally, further guide elements (350') may be provided along the length of the anti-embolic protection device as shown in Figure 18c.

The distal guide element may comprise a shape memory material and, when unconstrained, may be elastically movable from the delivery state to the deployed state by urging the guide element toward the deployed state. This allows for efficient and simple deployment of the guide element, and thereby efficient and simple expansion of the anti-embolic protection device. The elastic guide element may allow the anti-embolic protection filter to move relative to the catheter device, thereby following the motion of the beating heart and maintaining a seal.

Alternatively or additionally, the distal guiding element can be moved from the delivery state to the deployed state by a pushing action of the delivery unit. Thus, the delivery unit can effectively release the anti-embolic protection device together with the guiding element for safe deployment.

The distal guiding element is pivotally movable about the distal connection point. This allows for efficient deployment from the catheter.

The distal guiding element can be formed as a support strut for the anti-embolic protection device against the catheter. This maintains enhanced support for the filter without the risk of tissue damage, as is the case with prior art devices where the stabilizing element is in direct contact with the tissue. Consequently, the risk of tissue damage and embolic release that could occur when the support member is in direct contact with the tissue is significantly reduced.

The catheter device may comprise an opening (504) through which the anti-embolic protection device may be deployed. This allows a low profile catheter device to slide smoothly within the aortic arch and allows for more space to be available outside the catheter.

The opening may extend substantially along the length of the anti-embolic protection device in the longitudinal direction of the sheath. This allows easier release of the anti-embolic protection device.

The embolic protection device can be delivered out of the opening by pushing the delivery unit in the distal direction, whereby the distal guiding element assumes the deployed state for guiding and supporting the frame against the wall, thereby achieving easy deployment while providing a compact and easy-to-use device.

The catheter device may comprise a longitudinal compartment (505) for the embolic protection device. The embolic protection device may thus have a dedicated space before release, which ensures that the embolic protection device is correctly positioned before release and also avoids interference with other components or operating tools.

The embolic protection device may be preloaded in said longitudinal compartment. This further increases the certainty that the embolic protection device is correctly positioned and simplifies the procedure since it only needs to be expanded.

The anti-embolic protection device can be moved from a compressed shape in the compartment through the opening. The compartment is sized to accommodate the compressed filter, and the opening can be sized to constrain the filter in the compressed shape and allow the filter to be delivered therefrom when pushed by a delivery unit, either through an expander as described below, or by removing a constraining portion positioned above the compartment.

The catheter device may comprise a longitudinal dilator (506) movable within the sheath, wherein the longitudinal compartment is arranged in the longitudinal dilator, as shown in Figure 17b. This effectively provides space for the compressed anti-embolic protection device, which can then be removed once the anti-embolic protection device is deployed and the dilator is withdrawn, again making the catheter device compact and easy to use.

The opening can be arranged in the sheath and, when the longitudinal dilator is retracted in the proximal direction, the anti-embolic protection device can be pushed out of the longitudinal compartment through the opening. Thus, as described above, the release of the anti-embolic protection device and its deployment, the removal of the compartment, and the withdrawal of the dilator are provided in a single operating step for an enhanced and safer procedure.

Alternatively, as shown in FIG17c , or in addition, the catheter device may include an outer constraining sheath ( 507 ) radially outside the sheath and adapted to constrain the anti-embolic protection device in a compressed shape, the outer constraining sheath being retractable to release the anti-embolic protection device to an expanded state. This also provides an efficient way of deploying the anti-embolic protection device, which provides a safe procedure and increases patient safety.

The catheter device may include an outer constraining sheath (507) radially outside the sheath and adapted to constrain the anti-embolic protection device in a compressed shape, the outer constraining sheath being retractable in the proximal direction to release the anti-embolic protection device to an expanded state, whereby the distal guiding element assumes the expanded state for guiding and supporting the frame against the wall.

The catheter device may comprise a centering unit (508, 508') adapted to center the catheter in the ascending aorta, wherein the centering unit comprises a radially expandable structure. This allows the distal end portion of the catheter to be correctly positioned on the heart, which is essential for performing a correct operation. A synergistic effect is thereby provided that allows optimal positioning of the catheter while effectively protecting the side branches of the aortic arch from any emboli released during the operation, which optimizes and increases the safety of all operations performed through the aortic arch and reduces the risk of subsequent complications.

The radially expandable structure may include inflatable balloons 509, 509', 509'. This allows for secure centering and soft apposition of tissue.

The inflatable balloon may comprise a plurality of inflatable elements (509, 509', 509'') arranged circumferentially around the radial circumference of the catheter, as shown in Figure 18b. Thus, by being arranged circumferentially, for example by being evenly arranged with similar angles between each inflatable element, a safe and effective centering is provided. The device may comprise only one or two expandable elements. In this case, the expandable element may advantageously be attached to the catheter at position 512 (Figure 18c), which position will strive to push most strongly against the wall portion of the aortic arch when the catheter strives towards its relaxed straight shape, i.e., towards the left of Figure 18c (indicated by 512). Thus, a single or double expandable portion located near this side of the catheter may be sufficient to push the catheter towards the center of the aortic arch. Two expandable portions may increase the stability of the catheter position more than one expandable portion. One expandable portion may take up less space in the aortic arch. The free space can be increased by using an expansion portion that expands primarily in the radial direction in the expanded state, such as a balloon formed to be primarily elongated in the radial direction, as opposed to the example of a nearly spherical shape shown in Figure 18b. As described below, the expandable structure can also be formed of another flexible material, such as NiTinol or plastic (discussed further below), which does not need to be expanded, but rather is urged radially outward, such as a strip or ribbon of material extending in the longitudinal direction of the catheter, or an expandable mesh.

The expandable structure can be substantially confined to the outer surface of the catheter in a smooth manner, as shown in FIG18d. This results in less friction against the tissue wall when the catheter is advanced. In the case of a balloon, the balloon can be formed of a compliant material having a very smooth surface that is free of wrinkles when not inflated.

The plurality of expandable elements can be individually and independently expanded. Thus, the position of the distal tip of the catheter device can be adjusted relative to the heart by selectively expanding and contracting the various radial elements.

The radially expandable structures 508, 508' can optionally comprise a shape memory material, such as NiTinol or another shape memory alloy or plastic, and can elastically move from a compressed, constrained shape to an expanded, expanded state by striving toward the expanded state when unconstrained, wherein the shape memory material is circumferentially disposed around the radial periphery of the catheter in the expanded state for centering the catheter in the ascending aorta. This provides for safe and easy centering. An outer sheath 507 or additional outer sheath can be used over the expandable structure to inhibit expansion and then retracted proximally to allow the expandable structure to assume its expanded, memory shape.

The catheter may comprise a distal centering unit (508, 508') adapted to center the catheter in the ascending aorta and a proximal centering unit (not shown) adapted to center the catheter in the descending aorta, wherein the proximal centering unit comprises a radially expandable structure. This may further improve the positioning of the catheter.

The catheter devices described above may be used to deliver medical devices transvascularly to the heart valve region of a patient or to stabilize instruments for treatment thereof, such as electrophysiology procedures or ablation procedures.

Figures 23a-c show a central support structure 510 extending across the frame 133. This central structure 510 can increase the juxtaposition force on the aortic arch, and it can also support the blood-permeable material itself, so that a good seal is obtained. The central structure can extend through the frame 133 at any position between the proximal and distal ends of the frame 133. In Figures 23a and 23c, the delivery unit 130 is connected to the central structure. This can further increase the thrust at the center portion of the filter. In addition, as shown in Figure 23c, this allows for a proximal extension 512 that is juxtaposed with the proximal portion of the tissue at the most proximal branch of the aortic arch. Since there is no constraint from the delivery unit 130 applied to the proximal extension compared to the case where the delivery unit is connected to the proximal frame (Figure 23b), the proximal extension can be allowed to be very flexible and compliant with the tissue, which increases the sealing performance.

Figure 23d shows that the blood permeable material 132 can extend beyond the frame 133 by a distance 511. This allows for ease of manufacturing the device without the need to attach a separate cushioning unit, which can allow for soft apposition of the device to the tissue and enable a good seal.

Figure 21 shows a method (900) of positioning a catheter device (500) in an aortic arch, the method comprising transluminally delivering (901) an embolic protection device (200) such as a deflector and/or filter in the aortic arch, the embolic protection device being connected to a transluminal delivery unit (130) extending proximally from a connection point (131) of the embolic protection device.

Positioning (902) the anti-embolic protection device in the aortic arch comprises:

expanding (903) the frame of the device in the aortic arch and flattening the main blood permeable unit,

juxtaposing the outer periphery of the anti-embolic protection device to the inner wall of the aortic arch (904) to cover the orifices of the side branches including at least the carotid artery to prevent embolic particles from passing therethrough into the side branches and reaching the patient's brain; and

A stabilizing force is applied (905) by at least one tissue apposition maintaining unit (300, 350) extending from the catheter into the aortic arch and attached to the anti-embolic protection device at a maintaining point (502), wherein when the catheter device is positioned within the aortic arch, the force is biasedly applied to the connection point of the anti-embolic protection device (e.g., at the periphery) and toward the inner wall of the aortic arch to provide the stabilizing force toward the inner wall of the aortic arch, away from the heart, and in a direction extending longitudinally perpendicular to the periphery, so that tissue apposition of the periphery to the inner wall of the aortic arch is supported by the stabilizing force to improve stability and peripheral sealing.

The apposition of the supports improves apposition of the periphery to the inner wall of the aortic arch such that the improved apposition provides an improved seal of the periphery to the inner wall.

The method may include applying said stabilizing force in a substantially proximal direction relative to said device for said improved sealing.

Applying the stabilizing force may include applying a traction force by a traction unit.

The method may include pulling the periphery of the device away from the heart toward the inner wall via the traction force to lock the device in place in the aortic arch.

The method may include applying the traction force via at least one tether distally connected to the frame, periphery and/or blood permeable unit to provide the traction force.

The anti-embolic protection device can be delivered to the aortic arch via one of the side branches, such as the brachiocephalic artery from the right subclavian artery, the left carotid artery, the left subclavian artery, or the descending aorta, such as the femoral artery, or delivered to the aortic arch through the ascending aorta. Applying the stabilizing force can include applying (906) a pushing force by a pushing unit.

Applying the pushing force may include guiding (907) the anti-embolic protection device from a collapsed state to an expanded state in which the anti-embolic protection device is expanded to be juxtaposed with the inner wall of the aortic arch by a distal guiding element (350), the distal guiding element (305) being connected between the maintenance point of the anti-embolic protection device and a distal connection point (501) on the catheter. This provides the advantages described above.

The method may include supporting (908) the distal end of the frame by the distal guiding element. This provides the advantages described above.

The method may comprise pushing (909) the anti-embolic protection device out of a longitudinal compartment (505) in the catheter by the delivery unit, whereby the distal guiding element assumes a deployed state for guiding and supporting the frame against the wall. This provides the advantages as described above.

The method may comprise, when retracting the longitudinal dilator (506) in the proximal direction, pushing out (910) the anti-embolic protection device from a longitudinal compartment (505) arranged in the dilator (506) and movable in the catheter. This provides the advantages as described above.

The method may include centering the catheter in the ascending aorta (911) using a centering unit (508, 508', 509, 509', 509'') comprising a radially expandable structure. This provides the advantages described above.

The method may include centering the catheter (912) with a plurality of expandable elements (509, 509', 509'') circumferentially disposed around the radial periphery of the catheter. This provides the advantages described above.

The method may include centering the catheter with a shape memory material (913) that is elastically movable from a compressed, constrained shape to an expanded, deployed state when unconstrained by an effort toward a deployed state, wherein the shape memory material is axially disposed about a radial periphery of the catheter in the deployed state to center the catheter in the ascending aorta. This provides the advantages described above.

The method may include transvascularly delivering (914) a medical device to a patient's heart valve region or stabilizing an instrument for treatment thereof, such as treatment by an electrophysiology procedure (915) or an ablation procedure (916).

FIG22a shows a method (1000) of preventing emboli flowing in the aortic arch from entering its side branches, comprising advancing (1001) embolic protection toward the aortic arch; and

Manipulating (1002) the protection device so that it covers the opening of each side branch pipe, including:

applying (1003) a force to the protection device to improve the seal of the device at its periphery, including applying a biasing force to a connection point of the device via a distal guide element (350) connected between a distal maintenance point of the anti-embolic protection device and a distal connection point (501) on a catheter;

The protection device allows blood to flow from the aortic arch into each side branch, but prevents emboli from entering the first and second side branches without blocking the lumen of the aortic arch.

FIG22 b shows a method ( 1100 ) for performing an endovascular procedure on a heart, the method comprising:

delivering (1101) an anti-embolic protection device to the aortic arch through one of the following vessels: the brachiocephalic artery from the right subclavian artery, the left carotid artery, the left subclavian artery, or the descending aorta (e.g., in the femoral artery); or through the wall of the ascending aorta; to position the anti-embolic protection device in the aortic arch to prevent embolic debris from entering the carotid artery;

applying (1101) a stabilizing force to the protection device to improve the seal of the device at its periphery, including biasing the force applied to a connection point at the device rather than to a delivery shaft of the device via at least one tissue apposition maintaining unit, thereby controlling the degree of apposition and fluid sealing of the anti-embolic protection device to the inner wall of the aortic arch via the force;

and delivering (1102) a first catheter to the heart through the aortic vessel wall at the descending aorta, the left subclavian artery, or the aortic arch to effect at least one step associated with an endovascular procedure on the heart;

applying (1103) the stabilizing force by tightening at least one distal guiding element (350) connected between a distal maintenance point of the anti-embolic protection device and a distal connection point (501) on a catheter,

The delivering of the first catheter includes placing a balloon mounted on the first catheter and expanding the balloon in the ascending aortic arch.

The balloon may be a ring-shaped balloon having a filter between the catheter and the inner ring of the ring shape.

The embolic protection device may extend from the distal end of the second catheter or from a separate channel of the first catheter, such that the position of the embolic protection device may be adjusted independently of the position of the first catheter.

Delivering the first catheter may be performed simultaneously with delivering the embolic protection device, wherein the embolic protection device is delivered through a separate channel of the first catheter independently of the endovascular procedure.

Endovascular surgery on the heart may include at least one step associated with removing a heart valve, placing a prosthetic heart valve, or repairing a heart valve.

After the endovascular procedure, the anti-embolic protection device can be removed from the aortic arch.

The present invention has been described in detail above with reference to specific embodiments. However, other embodiments than those described above are also within the scope of the present invention. Method steps different from those described above may also be provided within the scope of the present invention, and the method may be performed by hardware or software. Besides what has been described, the various features and steps of the present invention may be combined in other combinations. The scope of the present invention is limited solely by the appended patent claims.

Claims (41)

1. A catheter device (2,500), comprising: The elongated sheath (503) has an inner lumen and a distal end for positioning at the heart valve (6); An anti-embolism protection device (200) for temporary positioning in the aortic arch to deflect embolic fragments from the ascending aorta to the descending aorta, the anti-embolism protection device being connectable to a transluminal delivery unit (130) extending proximally from a first connection point (131) with the anti-embolism protection device, the anti-embolism protection device having: A frame with an outer periphery, A blood-permeable unit located within the periphery prevents embolic particles from reaching the patient's brain via collateral vessels entering the aortic arch, carried downstream of the aortic valve; and At least one tissue juxtaposition support unit (300, 350) extends from the elongated sheath into the aortic arch and is attached to the anti-embolism protection device at a support point (502) for applying a stabilizing force at the anti-embolism protection device away from the first connection point, and for providing the stabilizing force toward the inner wall of the aortic arch, away from the heart, and in a longitudinal direction perpendicular to the periphery when the catheter device is positioned within the aortic arch, such that the tissue juxtaposition of the periphery and the inner wall of the aortic arch is supported by the stabilizing force to improve stability and peripheral seal; The elongated sheath includes an opening (504), through which the anti-embolism protection device can be deployed, and the opening extends along the longitudinal direction of the sheath along the length of the anti-embolism protection device. The tissue juxtaposition and maintenance unit includes a pushing unit, and the stabilizing force includes a thrust on the frame, periphery, and/or blood-permeable unit, for providing the thrust and pressing the periphery against the inner wall; and The actuation unit includes a distal guiding element connected between the maintenance point of the anti-embolism protection device and a second connection point (501) on the elongated sheath. The distal guiding element has a delivery state and an unfolded state. In the delivery state, the anti-embolism protection device is retracted and conforms to the elongated sheath. In the unfolded state, the anti-embolism protection device is expanded, thereby juxtaposed the periphery with the inner wall of the aortic arch, so that when the distal guiding element moves from the delivery state to the unfolded state, it guides the anti-embolism protection device toward the inner wall. 2. The catheter device according to claim 1, wherein the stabilizing force includes a traction force, and the tissue juxtaposition maintenance unit includes an active traction unit having at least one operable tether (300), the distal end of which is connected to the maintenance point offset from the first connection point for providing the traction force. 3. The catheter device according to claim 2, wherein the tether or the actuation unit is longitudinally elastic, thereby the stabilizing force is variable to compensate for the physiological movement of the aortic arch relative to the anti-embolism protection device while maintaining tissue juxtaposition. 4. The catheter device according to any one of claims 2-3, wherein the blood-permeable unit has at least one guiding unit near its distal end for receiving the tether or actuating unit, wherein the tether or actuating unit is attached to the blood-permeable unit, a flange of the frame, or the outer periphery of the frame. 5. The catheter device according to any one of claims 2-3, wherein the anti-embolism protection device has an attachment point connected to the distal end of the tether or actuation unit. 6. The catheter device according to any one of claims 2-3, wherein the tether extends proximally through an orifice into a selected side branch during operation, such that the traction force aligns the anti-embolism protection device relative to the orifice and pulls the anti-embolism protection device toward the inner wall to lock the anti-embolism protection device in place, thereby self-aligning the anti-embolism protection device with respect to the orifice of the selected side branch. 7. The catheter device according to any one of claims 2-3, wherein the at least one tether comprises a plurality of tethers attached distally along the periphery. 8. The catheter device according to any one of claims 2-3, wherein the frame includes at least one rib extending between different engagement points at the outer periphery, wherein the distal end of the tether or actuation unit is attached to the rib. 9. The catheter device according to claim 8, wherein the different engagement points are opposite engagement points. 10. The catheter device of claim 8, wherein the rib is a yoke extending proximally over the blood-permeable unit. 11. The catheter device of claim 10, wherein the yoke extends along the longitudinal direction of at least a portion of the anti-embolism protection device. 12. The catheter device according to any one of claims 2-3, wherein the at least one tether comprises a plurality of tethers or a single tether that branches into multiple strands from the distal end. 13. The catheter device of claim 12, wherein two tethers or two strands are attached in a Y-shape from the base of the anti-embolism protection device to the periphery at the distal end. 14. The catheter device according to any one of claims 2-3, wherein the blood-permeable unit includes at least one aperture, and wherein one or more of the tether or actuation unit passes through the at least one aperture. 15. The catheter device according to claim 14, wherein one or more of the tethers pass through at least one eyelet at the pivot point at the base of the anti-embolism protection device. 16. The catheter device of claim 2, wherein the blood-permeable unit is flexible, and the distal end of the tether or actuation unit is attached to the membrane such that the membrane is lifted from the plane of the membrane when the traction or thrust is applied. 17. The conduit device of claim 16, wherein, when the traction force or thrust is applied, the membrane is lifted from the plane of the membrane such that a volcano-like shape is formed at the attachment point of the tether or actuation unit to the membrane. 18. The catheter device according to any one of claims 1 to 3, wherein the outer periphery includes a flange unit extending radially outward from the frame. 19. The catheter device of claim 18, wherein the flange unit is angled relative to the plane of the blood-permeable unit to form a pre-tension counterforce against the provided stabilizing force. 20. The catheter device according to any one of claims 1 to 3, wherein the tissue juxtaposition maintenance unit includes a magnetic element, and the stabilizing force includes a magnetic force. 21. The catheter device of claim 1, wherein the distal guiding element is connected at the maintenance point to the distal portion of the anti-embolism protection device. 22. The catheter device according to claim 1 or 21, wherein the distal guiding element comprises a shape memory material and elastically moves from the delivery state to the deployed state by tending toward the deployed state when unconstrained. 23. The catheter device according to any one of claims 1-3, wherein the distal guiding element is movable from the delivery state to the unfolding state by a pushing action of the delivery unit. 24. The catheter device according to any one of claims 1-3, wherein the distal guiding element is pivotable about the distal connection point. 25. The catheter device according to any one of claims 1-3, wherein the distal guiding element is formed as a support post for the anti-embolism protection device to abut against the elongated sheath. 26. The catheter device of claim 1, wherein the anti-embolism protection device is capable of delivering the opening by pushing the delivery unit in the distal direction, thereby presenting the distal guiding element in the deployed state for guiding and supporting the frame against the inner wall. 27. The catheter device according to any one of claims 1-3, wherein the elongated sheath includes a longitudinal compartment (505) for the anti-embolism protection device. 28. The catheter device of claim 27, wherein the anti-embolism protection device is pre-loaded in the longitudinal compartment. 29. The catheter device of claim 27, wherein, in the longitudinal compartment, the anti-embolism protection device is capable of changing from a compressed shape through the opening. 30. The catheter device of claim 28, wherein, in the longitudinal compartment, the anti-embolism protection device is capable of changing from a compressed shape through the opening. 31. The catheter device of claim 27, comprising a longitudinal dilator (506) movable within the sheath, wherein the longitudinal compartment is arranged within the longitudinal dilator. 32. The catheter device of claim 31, wherein the opening is disposed in the elongated sheath, and the anti-embolism protection device is capable of being extended through the opening into the longitudinal compartment when the longitudinal dilator is retracted in the proximal direction. 33. The catheter device according to any one of claims 1-3, comprising an external restraint sheath (507) located radially outside the elongated sheath, the external restraint sheath being adapted to restrain the anti-embolism protection device into a compressed shape, and the external restraint sheath being telescopic to release the anti-embolism protection device into an deployed state. 34. The catheter device according to any one of claims 1-3, comprising an external restraint sheath (507) located radially outside the elongated sheath, the external restraint sheath being adapted to restrain the anti-embolism protection device into a compressed shape, and the external restraint sheath being extendable in a proximal direction to release the anti-embolism protection device into an deployed state, whereby the distal guiding element presents the deployed state for guiding and supporting the frame against the inner wall. 35. The catheter device according to any one of claims 1-3, comprising a centering unit (508, 508') adapted to center the elongated sheath in the ascending aorta, wherein the centering unit comprises a radially expandable structure. 36. The catheter device of claim 35, wherein the radially expandable structure includes an inflatable balloon. 37. The catheter device of claim 36, wherein the inflatable balloon comprises a plurality of inflatable elements (509, 509', 509'') arranged circumferentially around the radial periphery of the elongated sheath. 38. The catheter device of claim 37, wherein the plurality of expandable elements can expand individually and independently. 39. The catheter device of claim 35, wherein the radially expandable structure comprises a shape memory material and moves elastically from a compressive constrained shape to an expanded, deployed state by tending toward the deployed state when unconstrained, wherein the shape memory material is circumferentially disposed around the radial periphery of the elongated sheath in the deployed state for centering the elongated sheath in the ascending aorta. 40. The catheter device of claim 35, wherein the elongated sheath includes a distal alignment unit (508, 508') adapted to align the elongated sheath in the ascending aorta, and a proximal alignment unit adapted to align the elongated sheath in the descending aorta, wherein the proximal alignment unit includes a radially expandable structure. 41. The catheter device according to any one of claims 36-39, wherein the elongated sheath includes a distal alignment unit (508, 508') adapted to align the elongated sheath in the ascending aorta, and a proximal alignment unit adapted to align the elongated sheath in the descending aorta, wherein the proximal alignment unit includes a radially expandable structure.