HK1237240B - Temporary embolic protection device and medical procedure for delivery thereof - Google Patents

Description

Temporary anti-embolic protection device and medical method of providing the same

This application is a divisional application of Chinese invention patent application No. 200980143474.9, which is based on international application PCT/EP2009/061509, filed on September 4, 2009, and entitled "Temporary Anti-Emboembolic Protection Device and Medical Method for Providing the Same."

Technical Field

The present invention is generally in the field of medical devices and medical methods using such medical devices. More particularly, the present invention relates to an anti-embolic protection device for preventing harmful embolic material from entering one or more branches of a major blood vessel, such as the aortic arch, and a method of deploying such a device in the aortic arch to protect the brain.

Background Art

Cerebral embolism is a well-known complication of cardiac surgery, cardiopulmonary bypass, and catheter-based cardiology and electrophysiology procedures. Embolic particles, which can include thrombi, atheromas, and lipids, can be dislodged by surgery or catheterization procedures and enter the bloodstream, where they can embolize in the brain or other vital organs downstream. Cerebral embolism can lead to neuropsychological deficits, stroke, and even death. Preventing cerebral embolism benefits patients and improves the outcomes of these procedures.

Various embolic protection devices are well known in the art. For example, US 2004/0215167 discloses an embolic protection device for a side branch of the aortic arch. This embolic protection device comprises an expandable tube structure that supports a filter material. The embolic protection device is compressed to a small diameter suitable for insertion into a patient's aorta. The device is then deployed within the aorta, along with the positioned filter material, to allow blood to enter the side branch connected to the aorta while preventing embolic material from entering the side branch. The device is deployed and left in place for long-term protection. Alternatively, the device can be compressed and withdrawn from the aorta.

However, the anti-embolic protection device disclosed in US2004/0215167 has some disadvantages. The device can be difficult to remove from the aortic arch because the stent of this design is a permanent implant and removing the stent may damage the implant site. The device is also formed along the aorta and is at least partially pressed against or into the orifice area of the side branch. These orifice areas are often affected by deposits of plaque on the outside of the tissue in these orifice areas. When a stent like this device is pressed against this plaque, the plaque is loosened from the tissue in which it is located and is broken into fragments that are flushed along the side branch. However, this fragmentation is a harmful embolic material, and the device should prevent this embolic material from entering the side branch.

U.S. Patent No. 6,258,120 discloses an implantable brain protection device for diverting emboli from the carotid arteries above the aorta. The disclosed devices are aortic shunts, which generally comprise a hollow tube with a substantially cylindrical or conical wall. The tube is impermeable to the embolism and has an open end that allows blood to enter one end, flow through the tube, and exit the other end. The circumference of the hollow tube is sized to completely fill the lumen of the aorta. In addition, snowshoe-shaped aortic shunts that are planar rather than cylindrical are also disclosed. The method disclosed in U.S. Patent No. 6,258,120 includes the following steps: providing an aortic shunt delivered by an intravascular catheter, introducing the intravascular catheter into the arterial vascular system, advancing the intravascular catheter into the aortic arch to reach the carotid artery region, and deploying the aortic shunt.

However, like the device disclosed in US2004/0215167, the device and method of US Patent No. 6,258,120 can damage the aortic wall. Furthermore, there is a risk of embolic material leaking into the side branches of the aortic arch, for example, through the periphery of the tubular structure or, as in the case of the disclosed embodiment, the snowshoe structure. Furthermore, the disclosed device can at least partially contact the orifice of the side branch, allowing embolic debris released from the orifice to be carried into the carotid artery, potentially causing brain damage. Furthermore, backflow of embolic material from the distal end of the device of US Patent No. 6,258,120 into the side branch can occur. This snowshoe-like device has an attached handle or cannula and requires installation through open-chest surgery involving aortic incision, which presents numerous disadvantages compared to intravascular access, including the risk of aortic damage. The device must be secured to the lumen of the aorta using mechanical mechanisms including sutures, surgical clips, hooks, adhesives, a substantially rigid cannula, or frictional fastening. Such fixation is difficult to accomplish in a reliable manner through transarterial access.

US2008/0065145 discloses an anti-embolic protection device and a method of use. A thrombus deflector umbrella structure with a blood-permeable cover is disclosed. The umbrella structure extends over the brachiocephalic artery and the left carotid artery. The deflector is inserted percutaneously and positioned with the aid of a catheter, which enters the brachiocephalic artery and the right subclavian artery through the right subclavian artery or the femoral artery that terminates on the aortic arch passing through the brachiocephalic artery. However, the device always has a guide wire that is arranged to extend between the aortic arch and the brachiocephalic artery protected by the device. This means that, as mentioned above, the device will inevitably be operated within the blood vessel, whereby the device is likely to come into contact with the orifice of the brachiocephalic artery, i.e., the side branch of the aorta leading to the right carotid artery. Thus, there is a risk of medically induced embolism, that is, when the doctor uses the device, it is likely that embolic fragments or particles will be released from the orifice of the brachiocephalic artery. The embolic fragments or particles are carried to the right carotid artery and can cause brain damage. Furthermore, the dome-shaped device of US2008/0065145 appears difficult to implement in practice due to the anatomy and the aforementioned access route through the brachiocephalic artery. The device must be very large to cover the ostia of the brachiocephalic and left carotid arteries. Consequently, the volume of the device within the aortic arch would be very large.

Thus, existing devices for preventing cerebral embolism have several disadvantages, including: they are difficult to position within a vessel, and even more difficult to position between two vessels; these devices may cause damage to the vessel walls and may themselves produce embolic material; these devices may hinder the surgeon when attempting to achieve a good outcome with certain desired insertions/procedures; visualization of the protective device may prevent viewing of other components being used during concurrent medical procedures; and these devices may reduce blood flow if designed to collect this embolic material.

Thus, there is a need to provide a new, improved or alternative device or method for preventing embolic material from entering side branches, such as aortic arch side branches, and/or preventing embolic fragments or particles from being generated from the orifices of aortic arch side branches, which would be transported to the patient's brain during the medical procedure.

Therefore, an improved device or method for embolic protection would be beneficial.

Summary of the Invention

Therefore, embodiments of the present invention preferably seek to mitigate, alleviate or eliminate one or more of the defects, shortcomings or problems in the prior art as described above by providing a device or method according to the attached patent claims, alone or in combination, to provide temporary anti-embolic protection to the patient's aortic arch vessels during medical procedures such as cardiac surgery and interventional cardiology and electrophysiology procedures.

Embolic particles in the aortic bloodstream can be prevented from entering the blood vessels of the aortic arch side branches, including the carotid arteries leading to the brain.

According to one aspect of the present invention, a device is provided. The device is a collapsible anti-embolic protection device designed for temporary transvascular access to the aortic arch of a patient with a transvascular supply, the device comprising: a protection unit comprising a selectively permeable material or unit suitable for preventing embolic material from entering a plurality of aortic side branches on the aortic arch with blood flow, and a first support member for the protection unit, wherein the protection unit is permanently or releasably (for assembly prior to introduction into the body) attached to the transvascular supply unit at a connection point or region, or attachment point, provided at the selectively permeable unit, the first support member being at least partially disposed on the periphery of the selectively permeable unit. When the device is in an expanded state, the connection point is enclosed by or integrated with the first support member, wherein the transvascular supply unit is eccentrically connected to the protection unit at the connection point. In certain embodiments, the connection point, connection region, or attachment point is enclosed by the first support member.

In some embodiments, the device is designed to, when in the deflated state, percutaneously transvascularly supply the aortic arch through one of the aortic side branches different from the aortic side branches leading to the patient's head or neck, such as the brachiocephalic artery and the left carotid artery.

In some embodiments, the device is designed to be delivered percutaneously transvascularly through one of the aortic side branches other than the aortic side branch temporarily protected by the device when delivered to the aortic arch.

In some embodiments, the aortic side branch used for supply is the patient's left subclavian artery, for example directly accessed through a puncture in the vessel of the patient's left arm.

In some embodiments, the device is designed to deploy over the ostia of a first, second, and third side branch, wherein the first side branch is the left subclavian aorta, the second side branch is the left common carotid artery, and the third side branch is the brachiocephalic artery.

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

The first support member can be formed to be juxtaposed to tissue of the vascular wall portion of the aortic arch or to be releasably coupled to tissue of the vascular wall portion, and wherein the first support member is formed to surround multiple orifice areas of the aortic side branches entering the aortic arch and be at a distance from the orifice areas, so that when the protection unit is located in the aortic arch, the selectively permeable unit is arranged to separate a first fluid volume of the aortic side branches from a second fluid volume within the aortic arch.

The connection point may be provided on a surface of the selectively permeable unit, the selectively permeable unit being designed to be positioned from inside the aortic arch towards the aortic side branch and at a distance from the orifice region when the protection unit is located in the aortic arch.

The selectively permeable element, in one embodiment, is non-tubular in the expanded state, but rather is expanded into a substantially planar shape.

The selective permeability unit can be non-tubular, extending basically in the form of a flat umbrella, a parachute or a mushroom, with its opening edge formed by the first support member, and its opening is designed to be positioned from the inside of the aortic arch toward the aortic side branch when the protection unit is in the expanded state. The supply unit is at least partially arranged in the left subclavian artery.

The selectively permeable unit may be designed to be arranged at a distance from the orifice region of the aortic side branch of the aortic arch when the protection unit is located in the expanded state within the aortic arch.

The first support may be disposed on a periphery of the device and configured to be apposed to tissue within the aortic arch, wherein the shape is oval, elongated, or configured according to the interior of the patient's aortic arch.

In some embodiments the oval shape has a width that increases towards the distal end of the device.

In some embodiments, the feed device is arranged at an angle to the support in the longitudinal direction of the device.

In some embodiments, the selectively permeable element is designed to be repellent to embolic materials.

In some embodiments, the selectively permeable unit is stretched over the first support member in a double layer configuration like a sock.

In some embodiments, the protection unit is sized and shaped to extend beyond the apex of the aortic arch.

In some embodiments, the device has a periphery adapted for placement toward tissue of the aortic arch, wherein a tissue protection unit is at least partially disposed on the periphery of the device. The tissue protection unit can be a cuff structure that is expandable via an expansion lumen or is self-expandable; a hollow, porous, soft, and/or elastic unit; or a soft and/or elastic unit in the form of a thin layer or surface disposed along at least a portion of the periphery of the protection device.

In some embodiments, the selectively permeable element is made of a rigid, non-elastic, substantially inflexible material, whereby the permeable element does not conform to the orifice region of the side branch.

The device may comprise a plurality of struts extending from the support member and arranged to support the selective permeability unit in a frame-like manner. The struts may be elastic.

In some embodiments, the device includes at least one wing shaped and configured to extend at its end a distance downward from the aortic arch into the ascending and descending aorta.

In some embodiments, the device comprises a plurality of subsections of the protective device, the plurality of subsections being arranged in multiple layers, wherein a plurality of peripheral support units and/or sealing units are provided continuously.

The selectively permeable element may comprise a mesh material or a fabric containing a wire mesh, and/or a hydrophobic material and/or a hydrophobic medium. The selectively permeable element may be designed to substantially not capture embolic material within the selectively permeable element. The selectively permeable element may be designed to releasably capture at least a portion of embolic material from blood flow within the aortic arch.

In some embodiments, the selectively permeable unit comprises a first portion and a second portion, the first portion being designed to extend from the connection point in a first direction toward the descending aorta of the aortic arch, and the second portion being designed to extend from the connection point in a second direction opposite to the first direction toward the ascending aorta of the aortic arch when the protection unit is placed in the aortic arch in an expanded state.

In some embodiments, the selectively permeable unit is arranged to extend 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 within the aortic arch in the expanded state.

In some embodiments, the selectively permeable unit is designed to be delivered percutaneously through one of the aortic side branches to the aortic arch in a collapsed state.

In some embodiments, the protection device includes a safety connection structure for preventing the device from becoming loosened into the descending aorta.

In some embodiments, the distal portion of the device is configured in an angled flared or nose-shaped manner.

According to another aspect of the present invention, a method is provided, wherein the method is a medical method. A method for preventing embolic material from entering a side branch of a patient's aortic arch with blood flow, the method comprising: introducing a collapsible embolic protection device in a collapsed state into a peripheral blood vessel in fluid communication with a first side branch of the side branch; transvascularly feeding the collapsible embolic protection device in a collapsed state through the peripheral blood vessel and the first side branch and through an orifice of the first side branch into the aortic arch while avoiding contact with the orifice, and attaching it to a transvascular feeding unit at a connection point or connection region or attachment point thereof; deploying a protection unit of the collapsible embolic protection device within the aortic arch, wherein the deploying comprises asymmetrically deploying a first portion of the protection unit and a second portion of the protection unit from the connection point or connection region or attachment 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; thereby positioning the protection unit within the aortic arch in the deployed state and preventing embolic material from entering a plurality of aortic side branches of the aortic arch with blood flow through the selectively permeable material of the protection unit.

The second side branch is different from the side branch through which it is supplied and is prevented from entering by the anti-embolic protection device. Specifically, it enters through the left arm and left subclavian artery, effectively protecting one or more of the left carotid artery or the right carotid artery.

The method may include delivering the anti-embolic protection to the aortic arch percutaneously in a crimped state through one of the aortic side branches, such as the brachiocephalic artery and the left carotid artery, different from the aortic side branches that lead to the patient's head or neck.

The method may include providing the anti-embolic protection percutaneously through a vessel through one of the aortic side branches other than the aortic side branch temporarily protected by the device while supplying the aortic arch.

In an embodiment of the method, the aortic side branch for supply is the patient's left subclavian artery, for example, directly accessed via a puncture in a vessel in the patient's left arm.

The method can include positioning the device to deploy over the ostia of first, second, and third side branches, wherein the first side branch is the left subclavian artery, the second side branch is the left common carotid artery, and the third side branch is the brachiocephalic artery.

In one embodiment, the protection unit is fed eccentrically via a transvascular feed unit which is connected eccentrically at the connection point.

In one embodiment, the embolic protection device is attached to a guide blade within the subclavian artery such that the embolic protection device is properly positioned within the aortic arch to protect the carotid artery.

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

The particle size or diameter of the embolic material typically ranges from 0.02 mm (20/μm) to 5 mm.

The embolic material is mainly composed of atherosclerotic fragments or particles driven away from the aortic wall, but also includes platelet aggregates formed during cardiac surgery, usually thrombi, oil droplets, bacterial clots and/or other foreign matter, tumor cells or other small pieces of tissue. These embolic materials are transported with the blood flow and enter the cerebral blood circulation or the systemic arterial system. Those embolic materials that enter the cerebral blood circulation will block small arteries and cause systemic (macroscopic) or local (microscopic) cerebral infarction, accompanied by neurocognitive dysfunction. Specifically, cerebral embolism significantly induces problems such as stroke, long-term hospitalization and death in some cases. The term "embolic material" used throughout this application means a substance in the blood with the aforementioned structural characteristics and/or effects; in a broad sense, the term refers to any substance that is not expected to be produced in or blocks a vessel or other body cavity.

A tributary is an entirely new vessel that branches off from the first vessel and is usually given a different name.

The present invention addresses the risks particularly associated with cerebral embolism.

The device is used during cardiovascular procedures/procedures within the fields of invasive cardiology or cardiac surgery, where it is desirable to prevent embolic particles from entering the cephalic vessels. The device improves patient safety during medical procedures such as cardiovascular interventions or cardiac surgery, where manipulation of the aorta, coronary vessels, bypass grafts, and other areas of heart valves may result in embolic particles entering the cephalic vessels and causing ischemic damage. These procedures may themselves be minimally invasive.

The device can be positioned within the aortic arch using a standard Seldinger technique and fluoroscopy via an introducer into the radial or brachial artery. The protective device is delivered using a catheter positioned within the aorta via the subclavian artery. Once the collapsible protective device is delivered/released from the catheter, it unfolds and can be positioned to cover the head vessels as a "blocking device," allowing blood to pass but not embolic particles. The device is retracted into the catheter at the conclusion of the cardiovascular intervention or heart surgery.

Some embodiments of the present invention provide a reliable and safe protection against cerebral embolism. The leakage of embolic material into the brain is effectively prevented. Some embodiments provide a mechanical protection function for certain tissues or certain organs near the device when the device is in its proper position in the body. Some embodiments of the device provide, for example, protection for the orifices of the aortic side branches, that is, protection for the tissue islands of the side branches in the aortic arch, wherein protection refers to preventing physical entry into the orifice from the aortic side, for example, by surgical tools operated in or near the aortic arch. The tissue island is protected from mechanical compression by means of the anti-embolic protection device. Mechanical compression can be caused, for example, by other devices being operated in the aortic arch when the protection device is positioned in the aortic arch. Other devices include medical devices that penetrate blood vessels, such as surgical instruments, guide wires, medical catheters, etc.

Some embodiments provide a device that is more suitable for supplying through other side branches than through one of the at least one side branches to be protected.

Some embodiments provide for devices that are smaller in size, for example due to having attachment or connection points that are eccentrically arranged on the anti-embolic protection device.

The eccentric position of the embolic protection device provides the possibility of connecting it to a guide piece. For example, if working through a guide piece in the subclavian artery, the embolic protection device can be in a suitable position to protect the carotid artery when inserted.

As used throughout this application, the term "eccentric" means not coaxial, or not arranged or disposed at a center. The center is, for example, the center of a circular element, the focus of an elliptical element, a point on a centerline such as the longitudinal centerline of an elongated element, etc. The periphery of a cell is arranged "eccentrically" if the periphery of the cell is arranged at a distance relative to the center of the cell.

As used throughout this application, the term "collapseable" refers to a device that can be reduced to a smaller size so that it can be placed in a tubular delivery unit, such as a catheter. A collapsible unit is expandable when released or pulled out of the delivery unit. Expandable includes self-expandable, such as through shape memory effects and/or elastic expansion with resilience. A collapsible unit is re-collapsed to be retracted into the delivery unit and removed from the patient.

Some embodiments provide a device adapted for delivery via the left arm and the left subclavian artery as an access point.

Using the left subclavian artery as an entry point has advantages in certain insertions because it provides a shorter distance and a smaller angle than using, for example, the femoral artery as an entry point.

It should be emphasized that the terms "comprise" and "comprising" are used in this specification to specify the existence of the features, integers, steps or components, but do not exclude 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 the embodiments of the present invention will be apparent from and can be clearly illustrated by the following detailed description of the embodiments of the present invention taken in conjunction with the accompanying drawings, in which:

Figure 1 is a schematic diagram of the aortic arch and side branches;

FIG2 is a schematic diagram of a protective device connected to a transvascular supply unit in an expanded configuration;

FIG3 is a schematic diagram of a protection device connected to a transvascular supply unit in an expanded configuration deployed within the aortic arch;

4A and 4B are more detailed schematic views from the perspective of the interior of the aorta toward the side branch orifice, and a cross-sectional view of the protection device connected to the transvascular supply unit in a deployed configuration deployed within the aortic arch;

5A to 5C are schematic diagrams of different stages of a transvascular supply process in which a protection device is introduced through a side branch into a patient's aortic arch;

6A to 6C are schematic diagrams of different stages of the process of withdrawing the protection device from the patient's aortic arch through the side branch;

7A and 7B are schematic diagrams of a collapsible and deployable protective device and an attached supply unit;

8 is a detailed schematic diagram of the connection point of the supply unit to the protection device including the protection cuff structure;

FIG9 is a perspective view of another embodiment;

10A to 10C are perspective views, plan views, and side views of another embodiment;

FIG11 is a perspective view of another embodiment;

12A and 12B are different perspective views of an aortic arch arrangement from an animal test conducted to verify the functionality of the concepts of an embodiment of the present protection device; and

FIG13 is a flow chart illustrating a medical process.

DETAILED DESCRIPTION

The specific embodiments 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.

To better understand the anatomical situation in which the present invention is implemented, FIG. 1 schematically shows 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 .

The aortic arch 100 describes the large curved configuration of the ascending aorta 112 after exiting the heart 110 through the aortic valve. The ascending aorta 112 forms a sharply curved, double-twisted curve toward the dorsal surface of the body. This twisting and curvature ultimately results in a generally 180° bend or arched structure, the aortic arch 100 that transitions into the descending aorta 114. The side branches 116, 118, 120 comprise the vital arteries that supply oxygenated blood to the neck and head. The side branches 116, 118, 120 originate from branches of the aortic arch 100. The openings in the aorta that lead to the side branches are called orifices.

Typically, the three branches of the aorta are separated from the main trunk of the aortic arch at three separate orifices 116a, 118a, and 120a. 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, which typically separate from the aortic arch as three separate arterial trunks formed at different locations on the aortic arch 100. This is shown in detail in Figure 1.

The brachiocephalic artery 116 is the largest 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 supplying arterial blood to 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 that provide oxygenated blood to the chest wall, spinal cord, upper arms, neck, meninges, and brain.

The spacing between the orifices 116a, 118a, 120a relative to each other can vary from patient to patient. It is also common for one or more of these major arteries to be temporarily joined together. For example, two of these branches can be separated from the common trunk, or the number of branches can be increased to four or more if, for example, the right common carotid artery 117 branches directly from the aortic arch 100 rather than from the brachiocephalic artery 116 at the bifurcation with the right subclavian artery 115.

In an embodiment of the present invention, a collapsible embolic protection device is provided, designed to be temporarily inserted through a blood vessel supplying a patient's aortic arch or temporarily positioned within the aortic arch 100. Several embodiments of the device are described below. These devices include a collapsible protection unit 140, which, when properly positioned within the aortic arch 100, is configured to, in its deployed state, prevent embolic material 150 from entering at least one of the side branches 116, 118, and 120 of the aortic arch 100. Preferably, embolic material 150 present in the aortic arch 100 is prevented from entering at least the left and right carotid arteries 118 and 117.

The protection unit 140 includes a selectively permeable material or element 132 adapted to selectively prevent embolic material 150 from entering the aortic side branches 116, 118, 120 of the aortic arch 100 along with blood flow (indicated by arrows in FIG. 3 ). Blood flow into the side branches is substantially unimpeded while passing through the embolic protection device 200. The protection unit 140 is permanently connected or attached to the transvascular supply unit 130 at a connection point or connection region or an attachment point 131 provided on the selectively permeable element 132. For example, when the protection unit is integral with its support member, but the support member is not attached to the protection unit but rather is transferred from the transvascular supply unit 130 to the protection unit 140, the connection point or connection region can be provided, for example, on the support member of the protection unit 140, such as described below.

As shown in FIG2 , the attachment point or connection point can be positioned in the center of the protective device 200. Alternatively, in some embodiments, the attachment point can be positioned off-center relative to the center of the protective device 200 or its selectively permeable material, as shown in, for example, FIG3 or FIG4A . The attachment point can even be positioned on the device 200 so that the device is positioned off-center within the aortic arch 100 relative to the orifice through which it is supplied. The attachment point can be positioned so that, when the protective device is supplied in the aortic arch, the attachment point is positioned upstream or downstream of the supply orifice within the aortic arch, for example, at a distance from the orifice, such as at another orifice, or, for example, within the descending aorta. This is shown, for example, in FIG3 , FIG4B , or FIG6A .

The anti-embolic protection device 200 further includes a first support member 133 for the protection unit 140, which is at least partially disposed on the periphery 180 of the selectively permeable member 132. The selectively permeable member 132 is permeable to blood but impermeable to embolic material. The selectively permeable member 132 can be connected or attached to the first support member 133 by suitable means, such as bonding, welding, or stretching over the periphery, for example, in a sock-like manner, in a double or single layer. Alternatively, the selectively permeable member 132 can be integrally formed with the first support member 133, for example, by suitable braiding techniques, laser perforation, or puncturing a flat sheet serving as the selectively permeable member. The first support member 133 can be provided in the form of a wire. The wire can have a circular diameter or be flat, for improved tissue-friendly apposition. When the transvascular supply unit comprises an elongated wire delivered to the protection unit 140, the wire can be integral with the transvascular supply unit 130.

When the device 200 is in the deployed state, the attachment point 131 is surrounded by the first support 133. Alternatively, the connection point or attachment point 131 is arranged at at least one point of the first support 133. Alternatively, or in addition, the connection point is integral with the first support 133, as shown in Figures 9, 10, or 1.

In some embodiments, the attachment point 131 is disposed on a plane different from the plane surrounded by the periphery 180 of the selectively permeable element 132, as shown, for example, in FIG5C , FIG7B , or FIG8 . The attachment point 131 is disposed on a plane oriented away from the orifices 116 a, 118 a, 120 a relative to the periphery 180. The attachment point is disposed, for example, on the first surface 135 of the selectively permeable element 132 oriented toward the orifices 116 a, 118 a, 120 a in the deployed and delivery state of the device 200, as shown, for example, in FIG8 .

In this way, supply through one of the side branches is facilitated. The device 200 can thus be reliably positioned. Leakage of blood and embolic material beyond the periphery 180 can advantageously be minimized or avoided. According to the characteristics of the selectively permeable element 132, embolic material can be temporarily captured on the selectively permeable element 132. The selectively permeable element 132 may include a filter material. Alternatively, or in addition, the selectively permeable element 132 may include or be made of a porous material, such as a sintered material, including a sintered metal. Alternatively, or in addition, the selectively permeable element 132 may have such characteristics that embolic material slides or glides along the second surface 136 of the selectively permeable element directed away from the orifice 116a, 118a, 120a.

In some embodiments of the collapsible embolic protection device, the transvascular supply element is attached to the selectively permeable material eccentrically at the attachment point. The attachment point 131 is, for example, located at a different location than the center point of the selectively permeable element 132 on its first surface 135, as shown in FIG3 , as opposed to FIG2 .

The first support member 133 is shaped to be juxtaposed with tissue of the vessel wall portion of the aortic arch 100. The first support member 133 can be releasably coupled to the tissue of the vessel wall portion. The first support member 133 is formed to surround the plurality of orifices 116a, 118a, 120a of the aortic side branches 116, 118, 120 within the aortic arch 100 and is located at a distance from the orifices 116a, 118a, 120a. In this manner, the selectively permeable unit 132 is arranged to separate a first fluid volume of the aortic side branches 116, 118, 120 from a second fluid volume within the aortic arch 100 when the protection unit 140 is positioned within the aortic arch 100, as shown in FIG3 .

Figures 4A and 4B are more detailed schematic diagrams, viewed from within the aortic arch toward the side branch orifices, and cross-sectional views of the protective device attached to the transvascular supply unit deployed within the aortic arch in its deployed configuration. As can be seen, the device 200 is arranged so that the support element 133 is juxtaposed with the vascular tissue of the aortic arch and surrounds the orifices 116a, 118a, 120a of the side branches 116, 118, and 120 at a distance. The selectively permeable element 132 is also positioned within the aortic arch at a distance from the orifices 116a, 118a, 120a of the side branches 116, 118, and 120. Thus, the device 200 is positioned in the direction of blood flow within the aortic arch, as indicated by the dashed arrows in Figure 4B. The deployed device is typically deployed longitudinally along and within the aorta at the apex of the aortic arch 100.

The area of plaque accumulated on the orifices 116a, 118a, 120a is not contacted by the device 200. Thus, the plaque is held in place and does not release. The protection unit 200 is released from the distal end of the catheter 160 of the transvascular supply unit, and the distal end of the catheter can be further positioned into the aortic arch, as shown in FIG4B , thereby further improving the protection of the area of plaque accumulated 320 on the supply vessel due to the relative stiffness of the provided catheter sheath.

Before describing other embodiments of the device 200 below, a flowchart of a medical procedure in which the device 200 is positioned within the aortic arch is described in more detail below in conjunction with FIG. 13 and FIGS. 5A-5C and 6A-6C.

5A-5C are schematic diagrams illustrating different stages of a transvascular feeding process of a protection device 200 through a side branch into a patient's aortic arch 100. FIG.

In embodiment 600, the device is positioned within the aortic arch 100 using a standard Seldinger technique and fluoroscopic access via an introducer in the left radial artery. The protection device 200 is delivered using a catheter positioned within the aorta via the left subclavian artery. Once the collapsible protection device is delivered/released from the catheter, it is deployed and positioned to cover the left and right carotid arteries, allowing blood to pass but preventing embolic particles from passing. The device is retracted back into the catheter upon completion of the cardiovascular intervention or cardiac surgery.

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 step is illustrated in FIG5A. The peripheral blood vessel is the first side branch 120, i.e., the left subclavian artery, of the plurality of side branches of the aortic arch, which is in downstream fluid communication with the first side branch 120. As viewed in the direction of blood flow within the aortic arch, the first side branch 120 is oriented downstream of the second and third side branches 118, 116. This point of entry via the first side branch, which is downstream of the side branch or branches to be protected by the device 200, provides a significant advantage in that medically induced debris or particles are not flushed toward the patient's brain.

The collapsible embolic protection device 200 is delivered in a collapsed state through the surrounding blood vessels and the first side branch 120 into the aortic arch 100, as shown in step 620. To this end, the device 200 is collapsed into a delivery catheter 160 and introduced through the delivery catheter to the deployment site within the aortic arch 100. The delivery path includes the orifice 120a of the first side branch 120. To prevent any plaque or debris from being released from the orifice 120a and surrounding tissue, contact with the orifice and tissue is avoided. However, if any debris or particles are generated due to inadvertent contact with the orifice 120a of the left subclavian artery 120, they will be flushed away from the carotid artery or into the first side branch with the blood flow in the aorta, thereby preventing the risk of ischemic brain damage or major stroke caused by debris being flushed into the carotid artery.

The device 200 is attached at its attachment point to a transvascular supply unit 130 such as a pusher or wire. As shown in FIG5B and further in FIG5C , the embolic protection unit 200 of the collapsible embolic protection device is deployed within the aortic arch, as shown in step 630 .

In the illustrated embodiment, the deployment includes asymmetrically deploying a first portion 145 of the protection unit from the attachment point 131 and a second portion 146 of the protection unit away from the attachment point 131. The first portion 145 is deployed in a first direction toward the descending aorta 114 of the aortic arch 100. The second portion 146 is deployed in a second direction toward the ascending aorta 112 of the aortic arch 100. This asymmetrical arrangement facilitates positioning of the device 200 relative to the other side branches 116, 118 to be protected by the feeding vessel 120. This method stage is shown as step 640.

An alternative device may be deployed only in the direction of the second and third side branches, providing a diverter for embolic material.

Positioning the protection unit 200 within the aortic arch 100 includes juxtaposing the first support 133 of the selectively permeable cell 132 of the protection unit 200 to tissue of a 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 on the periphery 180 of the selectively permeable cell 132 of the protection unit. The first support 133 surrounds the attachment point 131 to which the first support is attached when the device is in the deployed state.

The method includes surrounding the plurality of openings 116a, 118a, 120a of the aortic side branches 116, 118, 120 within the aortic arch 100 with the first support 133, and positioning the protection unit 200 at a distance from the openings 116a, 118a, 120a. This method stage is shown in step 660. Alternatively, only the openings 116a, 118a may be protected.

Therefore, the protection unit 200 is positioned within the aortic arch 100 in the expanded state, as shown in FIG6A and method step 670. The selectively permeable material of the protection unit 200 effectively prevents embolic material 150 from entering the aortic side branches 116, 118, and 120 of the aortic arch 100 along with the blood flow, as shown in method step 680.

Thus, the method provides for simultaneously separating a first fluid volume of the aortic side branch from a second fluid volume within the aortic arch when the protection unit 200 is positioned within the aortic arch 100 .

The method may include pulling the deployed protection unit 200 in a direction opposite to the feeding direction, thereby tensioning and tightening a vascular tissue portion of the aortic arch 100 surrounding the orifice of the side branch. This stage of the method is shown in step 690.

The tightening and sealing around the periphery 180 of the protection unit 200 is further supported by the blood pressure and blood flow within the aortic arch, causing the protection unit to press against the vascular tissue portion.

Positioning the protection unit 200 within the aortic arch may include releasably coupling the protection unit 200 to tissue of a vessel wall portion of the aortic arch, see step 700 .

This step can be accomplished by dragging the supply unit 130 in the opposite direction of the supply as described above. This achieves a further improved seal to prevent embolic material from entering the side branch. The tissue of the aortic tube is not damaged and can be effectively protected from trauma. The first support member 133 can, for example, have a circular diameter and/or have a soft outer material or include a suitable covering layer to even further improve these properties. The first support member 133 can be provided in the form of a peripheral collar structure or cuff structure to protect the vascular tissue of the aortic wall without damage.

The method includes placing the permeable unit at a distance from the orifice of the side branch entering the aortic arch. Such placement includes, for example, not contacting the orifice of the side branch entering the aortic arch.

By covering all side branches and not contacting the orifices of the side branches that enter the aortic arch, it is possible to effectively prevent embolic substances, such as debris or particles, from being released from the orifices. Preventing embolic substances from entering the side branches along with blood flow from the patient's aortic arch includes, when the protection unit is positioned within the aortic arch in the expanded state, guiding the embolic substances along the surface of the selectively permeable unit designed to face away from the orifices of the aortic side branches, so as to pass through the orifices of the aortic side branches of the aortic arch.

6A-6C illustrate different stages in the process of retrieving a protection device from a patient's aortic arch through a side branch.

After the protection unit is temporarily placed, the protection device is pulled out through the transvascular supply unit to prevent embolic material from entering the side branch.

As shown in FIG. 6B and FIG. 6C , the extraction step includes releasing the protection unit 200 from the engagement with the vascular tissue portion of the aortic arch 100 by pushing the transvascular supply unit 130 in the supply direction (see step 710 ).

Embolic material captured on the protection unit 200 is released or flushed into the body's bloodstream from the aortic arch 100 toward the descending aorta 114 before the protection unit is collapsed into the catheter sheath.

Furthermore, the removal continues as the sheath of the catheter 160 is slid over the protection unit to allow the protection unit to collapse into the sheath. The collapsible embolic protection device is then removed from the patient within the sheath through the first side branch 120 and the peripheral blood vessel, see step 720.

The collapsible embolic protection device used in the method is, in some embodiments, the device of the embodiments described herein.

7A and 7B schematically illustrate a collapsible and expandable protection device and an attached supply unit.

FIG8 is a detailed view of the attachment point of a supply unit to a protective device 200. In the illustrated embodiment, the attachment point comprises two arms 171, 172. This embodiment provides improved directional stability, facilitating positioning within the aortic arch 100. The two arms 171, 172 may also be arranged eccentrically or asymmetrically. These arms may include struts that support the selectively permeable unit of the protective device.

The attachment points of some embodiments of the protection device are provided on the surface of the selectively permeable unit 132, which is designed to be positioned from the interior of the aortic arch 100 toward the aortic side branches 116, 118, 120 when the protection unit is positioned within the aortic arch. This is shown, for example, in Figures 3, 4B, and 6A.

Some embodiments of the protective device may include a tissue protection unit, as shown in Figure 8. The tissue protection unit is arranged around the circumference of the protective device and positioned to juxtapose the tissue of the aortic arch. In Figure 8, the tissue protection unit is shown as a cuff structure 210 that is expandable by expanding the inner lumen 211. The cuff structure 210 may also be self-expandable. The cuff structure 210 may, for example, be made of a material. When expanded, the cuff structure 210 provides a protective cushion that allows specific tissue to be harmoniously juxtaposed to the inner aortic arch wall. Even when the cuff structure 210 is not expanded, it still provides a certain degree of tissue protection because it is hollow. In other embodiments, the tissue protection unit may be a soft and/or elastic material in the form of a covering or surface layer around the periphery of the protective device. The tissue protection unit may be hollow, porous, soft, and/or elastic. The tissue protection unit may be made of an expandable material that expands when in contact with blood. Such expandable materials are, for example, expandable polymers, such as those disclosed in International Application No. PCT/EP2007/061116, which is incorporated herein by reference in its entirety for all purposes. The degree of expansion is appropriately selected to provide a protective cushioning effect. Such devices, or devices having an expandable cuff structure, are advantageously provided in a compact form.

Due to the tissue protection unit, the protection device is advantageously sealed during its delivery or when positioned in the aortic arch 100 without damaging the aortic wall.

The selectively permeable element 132, and thus the protective element 200, is not tubular in the expanded state, but rather is expanded into a substantially planar shape, which may include a flat cup, an inverted umbrella, a mushroom, or a parachute, as shown in the figure.

“Flat” in this context means that the thickness of the device 200 is substantially less than its longitudinal extension. Furthermore, “flat” refers to such a dimension perpendicular to the longitudinal extension of the protective material that the blood flow through the aortic arch is not obstructed by the protective device 200.

The periphery of the device 200 is configured to be juxtaposed with tissue within the aortic arch. The shape of the periphery can be circular, oval, elongated, or even customized to the patient's specific anatomy to be protected by the protective device. The device can be based on data from imaging modalities such as CT, MR, or ultrasound.

The device can thus be provided in a variety of longitudinal and transverse extensions and symmetries. The device can be shaped to fit the side branch orifice, see for example FIG4A or FIG5B .

The wings of the protection device may be shaped and configured to extend a distance downward into the ascending and descending aorta to further improve stability and/or sealing at the periphery 180 of the protection device 200. Examples of the wings are shown in Figures 12A and 12B.

The multiple subsections of the protector can be arranged in layers within each other. In this way, multiple peripheral support units and/or sealing units can be continuously provided to further improve stability and/or sealing effect on the periphery 180 of the protector 200.

In one embodiment, the selectively permeable element is non-tubular, but rather extends substantially planarly, with its perimeter formed by the first support member 133. The first side of the device 200 is designed to be positioned from within the aortic arch toward the aortic side branches when the protective element is positioned within the aortic arch in the deployed state.

The selectively permeable unit 132 is designed to be arranged at a distance from the orifice of the aortic side branch of the aortic arch when the protection unit 200 is positioned within the aortic arch in the expanded state.

In some embodiments, the selectively permeable element 132 is a rigid, inelastic, substantially inflexible material that is incompatible with the orifice of the side branch. Alternatively, or in addition, a peripheral support frame of the device 200 can provide such rigidity. The selectively permeable element 132 can be extended through the support frame in the deployed state of the device 200.

Thus, when the device is in its proper position in the body, a mechanical protection function is provided for certain tissues or certain organs in the vicinity of the device. Protection is provided for the orifice of the aortic side branch, i.e., the tissue island of the side branch within the aortic arch. The tissue island is protected from mechanical compression by means of the protective device. Mechanical compression can, for example, be caused by other devices being operated within the aortic arch when the protective device is positioned within the aortic arch. Other devices include medical devices that penetrate blood vessels, such as surgical instruments, guide wires, medical catheters, balloons, filters, ablation instruments, intracardiac electrodes, etc.

Because the protection device unfolds like a cover or lid over the orifice (flat or in an inverted flat umbrella/mushroom/parachute shape), it is allowed to move towards the orifice at a certain distance from the orifice due to mechanical pressure from inside the aortic arch.

The protective device can include a plurality of struts over which the selectively permeable material of the unit 132 is arranged. The struts are configured to provide a counterforce, causing the selectively permeable unit to elastically return to its initial position under mechanical stress. The plurality of struts can be arranged like the struts of an umbrella. The struts can be made of an elastic material.

If the protective device is made of a heat-set braid, the struts can be applied in the form of thick wires on the braid. The remaining braid can be made of thin wires, thereby providing the selective permeability of the selectively permeable unit.

The struts hold and support the selectively permeable material of unit 132 .

The support can be applied as a plurality of arms 171, 172. The support is provided as a protection frame for the selectively permeable unit of the protection device.

In one embodiment, the selectively permeable element 132 is a mesh material of a wire mesh. The wire mesh can be made of a metallic material such as stainless steel or nitinol. Alternatively, or in addition, at least some of the wires of the mesh can be made of a polymeric material such as a shape memory polymer.

The wire mesh forming the protective device can be made of a heat-set braid. Here, the expanded configuration of the device is set. The crumpled device returns to the heat-set shape when it is supplied. This can be based on elastic return or shape memory. A modified method for manufacturing the protective device of the present invention is disclosed in the international application publications WO9742878A1 and WO9912478A1 of AGA Medical, and for all purposes of the present invention, these disclosed contents are cited herewith. A fabric of elastic metal fabric material is made into the required expanded configuration by a mold used in the heat setting process. The shape of the mold corresponds to the shape of the protective device in its expanded state, for example a plane shape, or a flat parachute, mushroom or umbrella shape as described herein.

The metal fabric is formed from a plurality of metal wires and is heat treated within the mold to substantially form the desired shape of the device. The medical device may include a fastener for attaching to the end of a guide wire or a supply catheter. The shape of the medical device may be formed such that the fastener attaches to the metal fabric within a recess formed in the shape of the medical device.

The device can take both expanded and collapsed configurations. Once forced out of the delivery conduit, the device returns to its expanded configuration, such as a flat surface, or a generally flat umbrella-like configuration, or a generally flat mushroom-like configuration, or a generally flat parachute-like configuration.

The protective device can be made from multiple layers of fabric, such as disclosed in AGA Medical's International Patent Application WO07149107A1, the disclosure of which is incorporated herein by reference for all purposes of the present invention. The collapsible medical protective device is formed from multiple layers of heat-treatable metal fabric. Each fabric layer is formed from a plurality of metal wires, and the assembly is heat-treated in a mold to substantially define the desired shape of the device. By incorporating multiple layers into the thus formed medical device, the device's ability to be securely selectively permeable and mechanically protective is significantly enhanced.

The wire mesh of the braid of the protective device is made of, for example, NiTinol, a superelastic material that ensures that the compressed device reliably returns to its heat-set shape when released from the delivery catheter.

The protective frame may be implemented in the form of thick metal wires provided within the braid.The protective frame may be implemented in the form of a layered, multi-layer braided structure.

The braid may have rounded edges on the periphery 180, similar to the structure shown in FIG8 . In this way, the braid has edges configured as tissue protection elements that are suitable for apposition to the aortic wall tissue without damaging the aortic wall tissue. Alternatively, the braid may have a support frame, such as shown in FIG10A or FIG11 .

The selectively permeable element 132 may include a hydrophobic material, or include a hydrophobic medium, or be made of such a material, which is particularly useful in preventing embolic material from being trapped on the selectively permeable element 132 .

The selectively permeable element 132 can be designed to substantially not capture embolic material thereon.

Alternatively, or in addition, the selectively permeable element 132 is designed to releasably capture at least a portion of embolic material 150 from blood flow within the aortic arch 100. The embolic material may be captured on the pores or filtering structure of the permeable element 132, for example.

Alternatively, or in addition, the selectively permeable element 132 is designed to repel embolic material. Thus, embolic material slides away from the selectively permeable element 132 when the protection device 200 is positioned within the aortic arch. Such materials are, for example, polytetrafluoroethylene (PTFE), which is commercially available as well as Teflon®.

The selectively permeable element 132 includes a first portion and a second portion. When the protective element is positioned within the aortic arch in the deployed state, the first portion is configured to extend in a first direction from the attachment point toward the descending aorta of the aortic arch, and the second portion is configured to extend in a second direction, opposite to the first direction, from the attachment point toward the ascending aorta of the aortic arch. The first and second portions may have different longitudinal extensions.

In some embodiments, when the protection unit is positioned within the aortic arch in the deployed state, the selectively permeable unit is arranged to extend asymmetrically from the attachment 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.

Furthermore, the selectively permeable unit is designed to be delivered percutaneously, transvascularly, to the aortic arch through one of the aortic side branches in the deflated state.

The protective device may include an additional safety connection structure to prevent the device from being loosened and entering the descending aorta 114. The safety connection structure may include a fuse, thread, chain bolt, wire, rope, or the like. The safety connection structure may be connected to the supply unit or extend from the beginning to the end through the sheath of the catheter.

In a specific implementation, the device has a substantially oval or elliptical shape of about 6-10 cm in the longitudinal direction and about 3-6 cm in the transverse direction.The wing-shaped structure or the multi-layer structure as described above may be additionally provided.

The mesh or pore size of the material of the selectively permeable element 132 can be between 20 μm and 100 μm, for example, 30-90 μm or 60-80 μm. In this manner, embolic material is effectively prevented from entering the side branch, while the passage of blood is not substantially prevented. However, as described above, the capture, i.e., the collection and accumulation, of embolic particles is not primarily provided by the selectively permeable element 132.

The selectively permeable material can be made of a flat sheet of material, such as PTFE, that has been perforated with holes of a suitable diameter to allow blood to permeate therethrough. These holes are provided in a suitable number so as not to impede blood flow through the material while providing anti-embolic protection. FIG10A shows a schematic diagram of a permeable material 132 in the form of such a flat sheet of material. Here, the film is laser perforated to obtain the desired permeability.

FIG9 is a perspective view of another embodiment of a support member 133 having a generally oval configuration. The support member 133 is made from a single wire that is bent into a suitable shape. FIG9 shows the deployed configuration of the protective device. The two branches of the wire cross each other at a junction 196 toward the supply unit 130. The wires are joined at an attachment point 131, for example, by clamping, welding, or gluing. Thus, the supply device is arranged at an angle to the support member 133 in the longitudinal direction of the device 200. This configuration provides particular convenience for introduction into the aortic arch via the left subclavian artery. The angled configuration provides improved protection against leaks because it facilitates application of force from the supply unit 130 to the aortic wall. The junction 196 provides a certain degree of elasticity or flexibility away from the longitudinal direction of the device.

FIG10A-FIG10C are perspective, plan, and side views of another embodiment of the device 200. The units of measurement in millimeters in FIG10B and FIG10C are provided as examples only and are not to be construed as limiting the present invention in any way. However, general dimensions for specific embodiments can be seen in these figures.

The device shown in Figures 10A-10C is also angled (here 106 degrees) and has a crossover point 196 of the wire of the support 133. The wire has a first branch 197 and a second branch 198. The oval shape has a width that increases toward the distal end of the device. This shape allows for better retraction when the device is retracted into the delivery catheter.

A tongue structure 199 is disposed at the distal end of the device. This tongue structure 199 is formed by appropriately bending the wire of the support member 133. The tongue structure has a width B. This tongue structure facilitates the introduction of the device into the supply catheter by bending the two branches 197, 198 toward each other while simultaneously pushing the distal end into the nearest catheter lumen opening. Width B is preferably the same length as, or smaller than, the inner diameter of the catheter lumen. This allows the tongue structure 199 to be easily introduced into the catheter, leaving the device advantageously pushed into the catheter.

The tongue structure 199 is further arranged at an angle that is longitudinally offset from the protection plane of the permeable element 132 extending between the two side branches 197, 198 thereof, see Figures 10A and 10C. This angled arrangement provides that the tongue structure 199 will be arranged in the aortic arch in a manner that is smooth and flat against the vascular wall of the aortic arch without damaging the vascular wall of the aortic arch.

In some alternative embodiments, the tongue structure may be attached to the distal end as a separate element.

Figure 11 is a perspective view of another embodiment consisting of two wires 197, 198. The attachment point 131 is integral with the device. The two wires are fixed to each other at their proximal portions to form a bi-wire feed device. The two wires can be soldered, welded, press-fitted or connected to each other at the proximal and distal portions of the device by other suitable means. This form of device is particularly advantageous to manufacture because it saves time and reduces costs. The distal portion of the device is provided in the form of an angled extension or nose structure 199. The selectively permeable unit 132 is arranged in a substantially planar shape between the two side wires 197, 198 extending between the attachment point 131 and the nose structure 199.

Typically, the device lasts about an hour.

A kit comprises such a collapsible embolic protection device and a transvascular delivery unit adapted to deliver the collapsible embolic protection device into the aortic arch through a side branch of the aortic arch.

To prevent debris or particles from the orifice (120a in the exemplary figure) (which may be released during placement of the device 200, regardless of the care taken) from reaching the brain, a particle trap or filter can be positioned adjacent to the delivery unit, in combination with the delivery unit. This trap or filter can be positioned within a separate lumen of the catheter for release into the delivery vessel upstream of the delivery orifice to the aortic arch 100. The trap or filter can, for example, be a vascular filter positioned within a lumen of the type disclosed in WO2007/035885 or US2006/0025806, the disclosures of which are incorporated herein by reference for all purposes of the present invention. Suitable commercially available vascular filters, traps, or embolic protection devices are, for example, the SpiderFX ^™ or EP system. Thus, any embolic material that accidentally ends up in the delivery vessel can be safely captured and removed upon retraction of the combined device 200 and vascular trap.

The kit includes such a vascular particle trap or filter.

Figures 12A and 12B are different perspective views of an aortic arch 100 device from animal testing conducted to demonstrate the functionality of the concepts of an embodiment of the present protection device. The device includes a wing 139 located distal to the distal end 192. Five devices were successfully positioned within the aortic arch via the subclavian artery 120. When the protection device is properly positioned, the risk of embolic material entering the carotid artery is significantly reduced.

As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless otherwise specified. It is further understood that the terms "includes," "comprises," "including," and/or "comprising," when used in this specification, identify the presence of stated features, integers, steps, operations, elements, and/or parts, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, parts, and/or combinations thereof. It is understood that when an element is referred to as being "connected" or "coupled" to other elements, there may also be direct connection or coupling to the other element or intervening elements. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by those skilled in the art. It is further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology and should not be interpreted in a fanciful or formal manner unless specifically defined herein.

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. Different method steps beyond those described above may also be provided within the scope of the present invention. In addition to the above description, the different features and steps of the present invention may be combined into other combinations. The scope of the present invention is limited solely by the appended patent claims.

Claims (15)

1. A collapsible anti-embolism protection device (200) having a protective unit (140) for insertion through a blood vessel into a patient's aortic arch (100), and when the protective unit (140) is in an deployed state within the aortic arch (100), the device is adapted to cover three lateral branches (116, 118, 120) of the aortic arch (100) for temporary protection of the three lateral branches of the aortic arch from the entry of embolic material (150), the protective unit (140) comprising: A selectively permeable unit (132) is made of a porous filter material comprising sintered material; and A support member (133) is arranged at least partially on the periphery (180) of the selectively permeable unit (132). The protective unit (140) is configured to be connected to the transvascular supply unit (130) at a connection point (131) on the support (133) located on the periphery of the selectively permeable unit (132). 2. The apparatus according to claim 1, wherein the sintering material is a sintered metal. 3. A collapsible anti-embolism protection device (200) having a protective unit (140) for insertion through a blood vessel into a patient's aortic arch (100), and when the protective unit (140) is in an deployed state within the aortic arch (100), the device is adapted to cover three lateral branches (116, 118, 120) of the aortic arch (100) for temporary protection of the three lateral branches of the aortic arch from the entry of embolic material (150), the protective unit (140) comprising: A selectively permeable unit (132) adapted to prevent the embolic material (150) from passing through the bloodstream; a support (133) at least partially disposed on the periphery (180) of the selectively permeable unit (132) for supporting the protective unit (140); and A connection point (131) is provided on the support member arranged on the periphery of the selectively permeable unit (132), wherein the protection unit (140) is connected at the connection point (131) to the transvascular supply unit (130), the supply unit (130) being arranged at an angle to the support member (133) in the longitudinal direction of the anti-embolism protection device (200). 4. The device according to claim 3, wherein the selectively permeable unit (132) is adapted to be located in the aortic arch (100) in an deployed state. 5. The device according to claim 3 or 4, wherein the transvascular supply unit (130) is releasably connected to the support of the protection unit (140). 6. The device according to claim 3 or 4, wherein the transvascular supply unit (130) is permanently and non-releasably eccentrically connected to the support of the protection unit (140). 7. The device according to claim 3 or 4, wherein the selectively permeable unit (132) is designed not to trap the embolic material within the selectively permeable unit (132), and/or to releasably trap at least a portion of the embolic material from the blood flow within the aortic arch (100). 8. The device according to claim 3 or 4, wherein the support (133) is shaped to be juxtaposed with the tissue of the vascular wall portion of the aortic arch (100), and wherein the support is shaped to surround and distance from a plurality of orifice regions (116a, 118a, 120a) of the aortic lateral branches (116, 118, 120) entering the aortic arch (100) such that when the protection unit (140) is located within the aortic arch (100), the selectively permeable unit (132) is arranged to separate a first fluid volume of the aortic lateral branches (116, 118, 120) from a second fluid volume within the aortic arch (100). 9. The device according to claim 3 or 4, wherein the support is disposed on the periphery of the device and configured to be juxtaposed with tissue within the aortic arch, the support being elongated, configured according to the interior of the patient's aortic arch, or oval and/or having a width that gradually increases toward the distal end of the device. 10. The apparatus according to claim 3 or 4, wherein the apparatus comprises a plurality of struts extending from the support and arranged in a frame-like manner to support the selectively permeable unit (132). 11. The device of claim 10, wherein the support is elastic. 12. The device according to claim 3 or 4, wherein the distal portion of the device is arranged in an angled manner. 13. The device according to claim 3 or 4, wherein the distal portion of the device is provided in the form of a nose (199) or a tongue structure. 14. The device according to claim 3 or 4, wherein the device is adapted to be delivered into the aortic arch via one of the lateral branches. 15. A kit comprising a collapsible anti-embolism protection device according to any one of claims 1 to 14 and a transvascular supply unit and/or guiding unit adapted to deliver the collapsible anti-embolism protection device into the aortic arch (100).