System for protecting brain blood vessels

Abstract

Methods and devices for isolating all of the left subclavian artery, the left common carotid artery, and the brachial artery from embolic debris that may flow through the aortic arch via a single access point are disclosed. The system may include an elongate flexible tubular sheath having a proximal end and a distal end; and an inner member extending through the sheath and movable relative to the sheath. The left subclavian element may be supported by the inner member. The filter membrane may be configured to isolate the aorta from the brachial artery, the left common carotid artery, and the left subclavian artery when the left subclavian element is expanded within the left subclavian artery and the sheath is retracted to expose the membrane. The left subclavian element may include a self-expandable frame that may carry a left subclavian filter.

Description

[0001] This application is a divisional application of application number 201980042133.6, application date 2019.4.26, and name “System for protecting cerebral blood vessels”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Application Serial No. 62 / 663,117, filed on April 26, 2018, the entire contents of which are incorporated herein by reference. Technical Field

[0004] The present invention generally relates to medical devices for filtering blood and, more particularly, in certain embodiments, to methods and systems of filters and deflectors for protecting cerebral arteries from emboli, debris, etc., that may be dislodged during intravascular or cardiac surgery. Background Art

[0005] Thromboembolic diseases, such as stroke, pulmonary embolism, peripheral thrombosis, atherosclerosis, etc., affect many people. In the United States and around the world, these diseases are the main causes of morbidity and mortality. Thromboembolic events are characterized by vascular occlusion. Occlusion can be caused by a viscoelastic (jelly-like) clot that includes platelets, fibrinogen, and other coagulation proteins.

[0006] Percutaneous aortic valve replacement is common, but the stroke rate associated with this procedure is between 4 and 20 percent. During catheter delivery and valve implantation, plaque or other material may break off from the blood vessels and can travel through the carotid circulation and into the brain. When an artery is occluded by a clot or other embolic material, tissue ischemia (lack of oxygen and nutrients) develops further. If the occlusion persists, local ischemia develops into tissue infarction (cell death). If blood flow is quickly reestablished, the infarction will not develop or will be greatly limited. Failure to reestablish blood flow may result in amputation, angina, myocardial infarction, stroke, and even death.

[0007] Various surgical or endovascular techniques and drugs have been developed to remove or dissolve the obstructing material and thus reestablish blood flow. However, additional surgery can be invasive and is best avoided when possible. In addition, the use of certain devices carries risks, such as the risk of foreign matter being dislodged, damage to the lining of the blood vessel when manipulating the catheter, and hemodilution.

[0008] A variety of filtering or deflection devices have been proposed to prevent debris from entering the cerebral circulation. Some isolate only the brachiocephalic artery and the left common carotid artery, while others may additionally isolate the left subclavian artery, but this is usually done by using multiple catheters. Others are said to isolate all three arteries leading to the cerebral circulation by a single catheter, but the catheter is introduced via the femoral artery, so none of them have been used.

[0009] Therefore, there remains a need for a simple, single catheter, preferably accessed from an access point other than the femoral artery, that enables intravascular isolation of the intact cerebral circulation. Summary of the invention

[0010] The present invention provides a three-vessel cerebral protection catheter introduced through the brachiocephalic artery and through the aortic arch via the right radial artery or the right brachial artery. The distal element of the catheter is anchored in the left subclavian artery, and the membrane is deployed so that a single catheter isolates all three of the left subclavian artery, the left common carotid artery, and the brachiocephalic artery from embolic debris that may flow through the aortic arch.

[0011] In one embodiment, the catheter may include an elongated flexible tubular sheath having a proximal end and a distal end; and an inner member extending through the sheath and movable relative to the sheath and supporting the left subclavian element. A filter membrane may be carried between the inner member and the sheath, the membrane and the left subclavian element configured to isolate the aorta from the brachiocephalic artery, the left common carotid artery, and the left subclavian artery when the left subclavian element is expanded within the left subclavian artery and the sheath is retracted to expose the membrane. An aortic support ring may be provided, configured to seal the membrane against the wall of the aorta.

[0012] The left subclavian element may include a self-expanding frame and may carry the filter membrane, which may have a conical configuration.The catheter may also include at least one pull wire for laterally deflecting the distal steering region on the sheath.

[0013] A method of isolating cerebral circulation from embolic debris is also provided. The method may include the steps of advancing a catheter through the brachiocephalic artery and into the left subclavian artery; deploying an anchor in the left subclavian artery; and retracting an outer sheath over the catheter to expose a filter extending from the anchor, through an orifice to the left common carotid artery and into the brachiocephalic artery. The filter may include a body, a peripheral edge, and a self-expandable frame carried by at least a portion of the peripheral edge; wherein the frame brings the edge into proximity with the aortic wall in response to the retracting step. The frame may be in the form of a ring.

[0014] The step of advancing the catheter may include the step of proximally retracting the pull wire to laterally deflect the distal portion of the catheter to enter the ostium of the left subclavian artery. The anchor may be carried by the tubular inner member, and the step of retracting may include retracting the outer sheath relative to the inner member to expose the anchor. The step of deploying the anchor may include deploying a self-expandable frame, and the self-expandable frame may carry the left subclavian filter.

[0015] In a first example, an embolic protection system for isolating a cerebral blood vessel may include an elongated outer sheath having a proximal end and a distal end; an inner member extending through a lumen of the outer sheath; a distal anchoring mechanism coupled to a distal region of the inner member; a proximal filter membrane carried between the inner member and the outer sheath and configured to extend from a left subclavian artery to a brachiocephalic artery; an aortic support ring coupled to the proximal filter membrane and configured to seal the proximal filter membrane against a wall of the aorta; and a handle including a first actuation mechanism coupled to the proximal end of the inner member and a second actuation mechanism coupled to the proximal end of the outer sheath.

[0016] Alternatively or additionally to any of the above examples, in another example, the distal anchoring mechanism includes a self-expanding frame.

[0017] Alternatively or additionally to any of the above examples, in another example, the embolic protection system can further include a distal filter membrane coupled to the self-expanding frame.

[0018] Alternatively or additionally to any of the above examples, in another example, the embolic protection system may further include a proximal coupling tube coupled to a proximal filter bag terminal end of the proximal filter membrane.

[0019] Alternatively or additionally to any of the above examples, in another example, the embolic protection system may further include an aortic annulus connector extending from a proximal end of the aortic annulus to a proximal coupling tube.

[0020] Alternatively or additionally to any of the above examples, in another example, the embolic protection system can further include a delivery wire coupled to the tube and extending proximally to the handle.

[0021] Alternatively or additionally to any of the above examples, in another example, the handle may further include a third actuation mechanism coupled to the proximal end of the delivery wire.

[0022] Alternatively or additionally to any of the above examples, in another example, the inner member is slidably disposed within the lumen of the proximal coupling tube.

[0023] Alternatively or additionally to any of the above examples, in another example, the embolic protection system may further include a distal support strut extending between a distal end of the aortic annulus and the self-expanding framework of the distal anchoring mechanism.

[0024] Alternatively or additionally to any of the above examples, in another example, the embolic protection system may also include an aortic annulus connector extending from a proximal end of the aortic annulus to a connecting tube disposed around the inner member and the aortic annulus connector, the connecting tube being distal to a proximal filter bag terminal of the proximal filter membrane.

[0025] Alternatively or additionally to any of the above examples, in another example, the embolic protection system may further include a proximal coupling tube connected to a proximal filter bag terminal of the proximal filter membrane, and a delivery line connected to the proximal coupling tube and extending proximally to the handle.

[0026] Alternatively or additionally to any of the above examples, in another example, the embolic protection system can further include an aortic annulus deployment wire coupled to the aortic annulus connector that extends proximally to the handle.

[0027] Alternatively or additionally to any of the above examples, in another example, the outer sheath, inner member, delivery wire, and aortic annulus deployment wire are individually actuatable.

[0028] Alternatively or additionally to any of the above examples, in another example, the distal region of the outer sheath is deflectable.

[0029] Alternatively or additionally to any of the above examples, in another example, a cross-sectional shape of the inner member adjacent to the proximal junction tube may be non-circular, and at least a portion of the proximal junction tube may have a non-circular cross-sectional shape.

[0030] In another illustrative example, an embolic protection system for isolating a cerebral blood vessel may include an elongated outer sheath having a proximal end and a distal end; an inner member extending through a lumen of the outer sheath; a distal filter assembly coupled to a distal region of the inner member, comprising a self-expanding frame and a distal filter membrane coupled to the self-expanding frame; a proximal filter membrane carried between the inner member and the outer sheath and configured to extend from the left subclavian artery to the brachiocephalic artery; an aortic support ring coupled to the proximal filter membrane and configured to seal the proximal filter membrane against the wall of the aorta; a proximal coupling tube coupled to a proximal filter bag terminal of the proximal filter membrane; an aortic annulus connector coupled to and extending between the proximal end of the aortic annulus and the proximal coupling tube; a delivery line coupled to the proximal coupling tube and extending proximally therefrom; and a handle comprising a first actuation mechanism coupled to the proximal end of the inner member, a second actuation mechanism coupled to the proximal end of the outer sheath, and a third actuation mechanism coupled to the proximal end of the delivery line.

[0031] Alternatively or additionally to any of the above examples, in another example, the embolic protection system can further include a distal anchoring structure positioned distally of the distal filter assembly.

[0032] Alternatively or additionally to any of the above examples, in another example, the aortic annulus connector can include a curved shape.

[0033] In another example, a method of isolating cerebral circulation from embolic debris may include the steps of advancing an embolic protection system through the brachiocephalic artery and into the left subclavian artery; deploying a distal anchor within the left subclavian artery; and retracting an outer sheath of the embolic protection system to expose a filter extending from the distal anchor, through the ostium to the left common carotid artery and into the brachiocephalic artery.

[0034] Alternatively or additionally to any of the above examples, in another example, the distal anchor can be carried by the inner member, and the inner member can be actuatable separately from the outer sheath.

[0035] The above summary of exemplary embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The present invention may be more fully understood by considering the following detailed description of various embodiments in conjunction with the accompanying drawings, in which:

[0037] Figures 1 to 4 A method of deploying a filter system to protect cerebrovascular architecture is shown.

[0038] Figure 5A A first embodiment of a filter system is shown.

[0039] Figure 5B Another alternative embodiment of a filter system is shown.

[0040] Figure 6 yes Figure 5A A partial cross-sectional view of an illustrative filter system taken along line 6-6.

[0041] Figure 7 yes Figure 5A A cross-sectional view of an illustrative filter system taken along line 7-7.

[0042] Figure 8 yes Figure 5A A cross-sectional view of an illustrative filter system taken along line 8-8.

[0043] Fig. 9 Another alternative embodiment of a filter system is shown.

[0044] Fig.10 yes Fig. 9 A cross-sectional view of an illustrative filter system taken along line 10 - 10 .

[0045] Fig.11 yes Fig. 9 A partial cross-sectional view of an illustrative filter system taken along line 11 - 11 .

[0046] Fig.12 Another alternative embodiment of a filter system is shown.

[0047] Fig.13 Another alternative embodiment of a filter system is shown.

[0048] Fig.14 yes Fig.13 A cross-sectional view of an illustrative filter system taken along line 13 - 13 .

[0049] Fig.15 yes Fig.13 A partial cross-sectional view of an illustrative filter system taken along line 15 - 15 .

[0050] Fig.16 is a cross-sectional view of an alternative expanded tube.

[0051] Fig.17 yes Fig.16 Partial side view of an illustrative deployment tube.

[0052] Fig.18 is a cross-sectional view of an alternative internals keying system.

[0053] Figures 19 to 21 An alternative distal anchoring mechanism is shown.

[0054] Figures 22A to 22C Alternative aortic ring connector configurations are shown.

[0055] Fig.23 Alternative aortic ring connector configurations are shown.

[0056] Although the present invention can make various modifications and alternative forms, its specific details have been shown in the drawings by way of example and will be described in detail. However, it should be understood that the present invention is not intended to limit the various aspects of the present invention to the specific embodiments described. On the contrary, the present invention covers all modifications, equivalents and substitutes that fall within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0057] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0058] It is assumed herein that all numerical values ​​are modified by the term "about", whether or not explicitly indicated. The term "about" generally refers to a numerical range that one skilled in the art considers to be equivalent to the value (i.e., having the same function or result). In many cases, the term "about" may be expressed as including numbers rounded to the nearest significant figure.

[0059] Numerical ranges recited by endpoints include all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0060] Although some suitable size ranges and / or values ​​are disclosed for various components, features and / or specifications, those skilled in the art, motivated by the present invention, will appreciate that the desired sizes, ranges and / or values ​​may be derived from those explicitly disclosed.

[0061] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0062] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different drawings have the same numbering. The specific implementation and the drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the invention. The illustrative embodiments shown are intended to be examples only. The selected features of any illustrative embodiment may be incorporated into another embodiment unless expressly indicated to the contrary.

[0063] The present invention generally relates to devices and methods for filtering fluids and / or deflecting debris contained in fluids (including body fluids such as blood). The filtering or deflecting devices can be positioned in an artery upstream of the brain before and / or during an endovascular procedure (e.g., transcatheter aortic valve implantation (TAVI) or replacement (TAVR), transcatheter mitral valve implantation (TAMI) or replacement (TAMR), surgical aortic valve replacement (SAVR), other surgical valve repair, implantation or replacement, cardiac ablation (e.g., ablation of pulmonary veins to treat atrial fibrillation) using multiple energy modalities (e.g., radiofrequency (RF), energy, cryo, microwave, ultrasound), heart bypass surgery (e.g., open heart, percutaneous), transthoracic graft placement around the aortic arch, valvuloplasty, etc.) to inhibit or prevent the generation of embolic material, such as debris, emboli, thrombus, etc., from entering the cerebral vasculature.

[0064] Devices and methods for filtering blood flowing to the innominate artery and the left common carotid artery have been developed, which provide about 90% of the blood entering the cerebral vessels. Examples are given in U.S. Patent No. 8,876,796, which is incorporated herein by reference in its entirety. Some such devices and methods do not consider the left subclavian artery, and therefore do not consider the left vertebral artery, which is exposed to possible embolic materials, providing about 10% of the blood entering the cerebral vessels. Other embodiments described in U.S. Patent No. 8,876,796 filter the blood flowing to the left common carotid artery and the left subclavian artery 16. Some such devices and methods do not consider the innominate artery 12, and therefore do not consider both the right common carotid artery 18 and the right vertebral artery 20, which are exposed to possible embolic materials, providing even about 50% of the blood entering the cerebral vessels. Assuming perfect use and operation, any of these options may make potential stroke rates as high as 2% to 10% due to the exposed arteries that provide blood flow to the cerebral vessels.

[0065] Several single-access multi-vessel embodiments of brain protection devices that provide complete brain protection (e.g., protecting all four blood vessels supplying blood to the brain) with minimal arch interference are described below. The device can be used to capture and / or deflect particles in other blood vessels within a subject, and it can also be used outside of a blood vessel. The devices described herein are generally suitable for percutaneous delivery to a target location within a subject, but can be delivered in any suitable manner and are not limited to minimally invasive surgery.

[0066] Figure 1 Schematic diagram of the aortic arch 10. The aortic arch 10 is downstream of the aortic valve 11. The aortic arch 10 typically includes three large branching arteries: the brachiocephalic or innominate artery 12, the left common carotid artery 14, and the left subclavian artery 16. The innominate artery 12 branches into the right carotid artery 18, then the right vertebral artery 20, and then the right subclavian artery 22. The right subclavian artery 22 supplies blood to the right arm and can be accessed directly from the right arm (called right radial access). The left subclavian artery 16 typically branches into the left vertebral artery 24 in the shoulder area. The left subclavian artery 16 supplies blood to the left arm and can be accessed directly from the left arm (called left radial access).

[0067] Figure 1 Four of the arteries shown in the figure supply blood to the brain: (1) the left carotid artery 14 (accounting for about 40% of the brain's blood supply); (2) the right carotid artery 18 (accounting for about 40% of the brain's blood supply); (3) the right vertebral artery 20 (accounting for about 10% of the brain's blood supply); and (4) the left vertebral artery 24 (accounting for about 10% of the brain's blood supply). The devices and methods described herein are also compatible with the common (27%) bovine variety.

[0068] Figure 1Additionally shown is an example three-vessel protection system 100 extending via a right radial artery access over the top of the aortic arch and into the left subclavian artery 16. Although the illustrative protection system 100 is described as being introduced via a right radial artery access, it is contemplated that the protection system 100 may also be advanced via a left radial artery access. In this case, the protection system 100 may be advanced from the left subclavian artery over the top of the aortic arch 10 and into the innominate artery 12.

[0069] Generally, the protection system 100 may include an outer sheath 110, an inner member 118, a guidewire 102, a distal filter assembly 112 (see, e.g., Figure 2 ) and the proximal filter assembly 124 (see e.g. Figure 3 ). The outer sheath 110 and the inner member 118 can be guided over or along the guidewire 102 (in a rapid exchange configuration) to position the distal end of the outer sheath 110 within the left subclavian artery 16. The inner member 118 can be radially inward of the outer sheath 110 and can be actuated separately therefrom (e.g., slidably disposed within the lumen of the outer sheath 110). It is contemplated that the guidewire 102 can be positioned within the lumen of the inner member 118 or within the lumen of the outer sheath 110, as desired. In some cases, the lumen of the inner member 118 can be configured to receive a 0.014" (0.3556 mm) diameter guidewire 102, as desired, although guidewires 102 of other diameters can also be used. Each of the guidewire 102, the outer sheath 110, and the inner member 118 can be actuated separately.

[0070] The protection system 100 may include a distal region 101 and a proximal region 103. The guidewire 102, the outer sheath 110, and the inner member 118 may be configured to extend from the proximal region 103 to the distal region 101. The proximal region 103 may be configured to be held and manipulated by a user, such as a surgeon. The distal region 101 may be configured to be positioned at a target location, such as, but not limited to, the left subclavian artery 16 (or the innominate artery 12 for left radial artery access surgery). The proximal region 103 may include a handle 105, a control 107 (such as a slider), the outer sheath 110, a port 109, an inner member translation control 111 (such as a knob), and a hemostasis valve control 113 (such as a knob). In some embodiments, the handle 105 may include a knob such as a knob. Figure 1104 and / or the inner member 118. For example, the handle 105 may include controls such that the inner member 118 may translate relative to the outer sheath 110 and / or the handle 105 (e.g., advance distally or retract proximally), the outer sheath 110 may translate relative to the handle 105 and / or the inner member 118, the outer sheath 110 may bend or deflect, etc. The handle 105 may include other controls for translating and / or deflecting other components of the system 100, as will be described herein. The proximal region 103 may also include the inner member 118 radially inward of the outer sheath 110. Although not explicitly shown, the proximal region 103 may also include a filter wire (not shown) radially inward of the outer sheath 110 (and sometimes radially outward of the inner member 118). Figure 1 Some illustrative filter lines are described in commonly assigned U.S. Patent No. 9,566,144, the entire contents of which are incorporated herein by reference.

[0071] Slider 107 may be used to translate outer sheath 110 and / or filter assembly (not shown). Figure 1 110 ). For example, the slider 107 can retract the outer sheath 110 proximally, the slider 107 can push the filter assembly distally out of the outer sheath 110, or the slider 107 can retract the outer sheath 110 proximally and advance the filter assembly distally (e.g., simultaneously or continuously), which can allow the filter assembly to expand radially, as will be described in more detail herein. The slider 107 can also be configured to have an opposite translational effect, which can allow the filter assembly to collapse radially (e.g., due to compression of the outer sheath 110) when the filter assembly is pulled into the outer sheath 110. Other deployment systems are also possible, for example, including gears or other features, such as a spiral track (e.g., configured to compensate for any differential lengthening due to shortening of the filter assembly, configured to convert rotational motion into longitudinal motion), mechanical elements, pneumatic elements, hydraulic elements, etc., for opening and / or closing the filter assembly. The slider 107 can be independent of the inner member 118, so that the inner member 118 can move longitudinally independently of the outer sheath 110 (and / or filter wire). Inner member translation control 111 can be used to longitudinally translate inner member 118, for example, before, after, and / or during filter assembly deployment. Inner member translation control 111 can include a slider in handle 105 (eg, separate from slider 107).

[0072] Port 109 can be in fluid communication with outer sheath 110 (e.g., via a Y-shaped connector in handle 105). Port 109 can be used to flush the device (e.g., with saline) before, during, and / or after use, for example, to remove air. Additionally or alternatively, port 109 can be used to monitor blood pressure at a target location, for example, by connecting an arterial pressure monitoring device in fluid communication with the lumen of outer sheath 110. Port 109 can also or alternatively be used to inject contrast agents, dyes, thrombolytic agents, such as tissue plasminogen activator (t-PA), etc.

[0073] The rotatable hemostasis valve control 113 can be used to reduce or minimize fluid loss through the protection system 100 during use. For example, the proximal portion and / or the intermediate region of the protection system can be positioned in the right subclavian artery 22, and the direction of blood flow relative to the system 100 is from distal to proximal, so blood may tend to follow the pressure drop of the system 100. The hemostasis valve control 113 is shown as rotatable, but other arrangements are possible (e.g., longitudinally displaceable). The hemostasis valve control 113 can be configured to fix the relative position of the outer sheath 110 and the filter assembly, such as described in U.S. Patent No. 8,876,796 regarding hemostasis valves. The hemostasis valve 113 can include, for example, an elastomeric seal and an HV nut.

[0074] In order to position the protection system 100 in vivo, an incision may be made in the right radial artery of the subject or alternatively in the right brachial artery. An introducer (not explicitly shown) may be placed in the incision and the protection system 100 may be inserted into the introducer. The protection system 100 may be advanced through a blood vessel in a delivery configuration in which the filter assembly is collapsed or encased within the outer sheath 110. The outer sheath 110, the inner member 118, and the filter assemblies 112, 124 may be advanced over the guide wire 102 to a target location. In some cases, the guide wire 102 may be positioned at a target location, whereupon the outer sheath 110, the inner member 118, and the filter assemblies 112, 124 are then advanced over the guide wire 102 to a target location. In other cases, guidewire 102 and outer sheath 110 , inner member 118 , and filter systems 112 , 124 may be advanced substantially simultaneously while guidewire 102 (eg, positioned most distally) guides outer sheath 110 , inner member 118 , and filter systems 112 , 124 .

[0075] The delivery catheter or outer sheath 110 may have a diameter sized to navigate along the vessel from the incision to the target location. An outer sheath 110 sized to be used for right radial artery access may have a diameter in the range of about 6 French (F). An outer sheath 110 sized to be used for femoral artery access may be larger, however this is not required. These are just some examples. In some cases, the outer sheath 110 (or other components of the protection system 100) may include a deflectable end or an articulated distal end. It is conceivable that the distal end of the outer sheath 110 may be deflected (e.g., using the handle 105) to navigate the system 100 through the vessel and to cannulate the target vessel. In some cases, the deflectable end may be configured to deflect by about 90°. However, as desired, the end of the outer sheath 110 may be deflected less than 90° or greater than 90°. As described above, the deflection may be controlled by a rotating knob or control mechanism at the handle 105. In some cases, outer sheath 110 can include a pre-shaped and / or non-deflectable tip.

[0076] The left subclavian artery 16 may be cannulated by a combination of advancement and twisting of the catheter 110. In some cases, the left subclavian artery 16 may be cannulated first using the guidewire 102. It is contemplated that in some cases, the deflection of the catheter tip may be released to advance the outer sheath 110 into the left subclavian artery 16. Once the protection system 100 (e.g., the distal end 104 of the outer sheath 110) has been advanced to the target location (which is the left subclavian artery 16 in the illustrated embodiment), the outer sheath 110 may be retracted proximally to expose a distal filter assembly 112 beyond the distal end 104 of the outer sheath 110, as shown. Figure 2 As shown. Alternatively or additionally, the inner member 118 can be advanced distally to deploy the distal filter assembly 112. The distal filter assembly 112 can be configured to be deployed in the most distal great vessel relative to the incision location. For example, when the right radial artery approach is used, the most distal great vessel is the left subclavian artery 16. However, when the left radial artery approach is used, the most distal great vessel is the innominate artery 12.

[0077] Additional references Figure 2A , which shows an enlarged view of a distal filter assembly 112, which may include a self-expanding filter assembly (e.g., including a superelastic material having stress-induced martensite due to being confined in an outer sheath 110). The distal filter assembly 112 may include a shape memory material configured to self-expand upon a change in temperature (e.g., heated to body temperature). The distal filter assembly 112 may include a shape memory or superelastic frame 114 (e.g., including a nitinol ring) and a microporous filter element 120 (e.g., comprising a polymer that includes laser drilled holes) attached to the frame, such as a filter assembly similar to that described in U.S. Pat. No. 8,876,796.

[0078] The frame 114 can generally provide expansion support to the filter element 120 in an expanded state. In the expanded state, the filter element 120 is configured to filter the fluid (e.g., blood) flowing through the filter element 120 and inhibit or prevent particles (e.g., embolic materials) from flowing through the filter element 120 by capturing particles in the filter element 120. The frame 114 can be configured to anchor the distal filter assembly 112 by engaging or juxtaposing the inner wall of a cavity (e.g., a blood vessel), in which the distal filter assembly 112 expands. In some cases, the distal filter assembly 112 can also anchor the proximal filter assembly 124. For example, the distal filter assembly 112 can be a distal anchoring mechanism. As desired, the anchoring mechanism may include a filter membrane or may not have a filter membrane. As will be described in more detail herein, other anchoring mechanisms may be provided in addition to or in place of the distal filter assembly 112. The frame 114 may include, for example, nickel titanium (e.g., nitinol), nickel titanium niobium, chromium cobalt (e.g., MP35N, 35NLT), copper aluminum nickel, iron manganese silicon, silver cadmium, gold cadmium, copper tin, copper zinc, copper zinc silicon, copper zinc aluminum, copper zinc tin, iron platinum, manganese copper, platinum alloy, cobalt nickel aluminum, cobalt nickel gallium, nickel iron gallium, titanium palladium, nickel manganese gallium, stainless steel, combinations thereof, or the like or be composed thereof. The frame 114 may include a wire (e.g., having a circular (e.g., perfect circle, elliptical) or polygonal (e.g., square, rectangular) cross-section). For example, in some embodiments, the frame 114 may include a straight piece of nitinol wire, which is shaped as a perfect circle or elliptical ring or a ring having one or two straight legs extending along the longitudinal axis of the distal filter assembly 112 or at an angle thereto. The frame 114 may be attached to the support struts 121. If so configured, the straight legs may be on the long side of the distal filter assembly 112 and / or on the short side of the distal filter assembly 112. The frame 114 can form the shape of the opening 115 of the distal filter assembly 112. The opening 115 can be a perfect circle, an ellipse, or any shape that can properly juxtapose the side wall of a blood vessel (such as the left subclavian artery 16). The distal filter assembly 112 can have an opening 115 that faces generally proximally. In other embodiments, the opening 115 can face distally. For example, the orientation of the opening 115 can vary depending on the location of the access incision.

[0079] The frame 114 may include radiopaque markers, such as small coils wrapped around or attached to the rings, to aid in visualization under fluoroscopy. In some embodiments, the frame 114 may include shapes other than rings, such as spirals. In some embodiments, the distal filter assembly 112 may not include a frame or may be substantially free of a frame.

[0080] In some embodiments, the frame 114 and filter element 120 form a truncated cone having a non-uniform or unequal length around and along the length of the distal filter assembly 112. In this configuration (e.g., along the line of a windsock), the filter assembly 112 has a larger opening 115 (upstream) diameter and a reduced end (downstream) diameter.

[0081] The filter element 120 may include pores that are configured to allow blood to flow through the filter element 120, but that are also small enough to inhibit or prevent particles, such as embolic material, from passing through the filter element 120. The filter element 120 may include a filter membrane, such as a polymer (e.g., polyurethane, polytetrafluoroethylene (PTFE)) membrane, mounted to the frame 114. The filter element 120 may have a thickness between about 0.0001 inches (0.00254 mm) and about 0.03 inches (0.76 mm) (e.g., only about 0.0001 inches (0.00254 mm), about 0.001 inches (0.0254 mm), about 0.005 inches (0.127 mm), about 0.01 inches (0.254 mm), about 0.015 inches (0.381 mm), about 0.02 inches (0.51 mm), about 0.025 inches (0.635 mm), about 0.03 inches (0.76 mm), ranges between these values, etc.).

[0082] The membrane may include multiple holes or holes or pores extending through the membrane. The membrane may be formed by weaving or braiding filaments or thin films, so the hole may be the space between the filaments or thin films. The filaments or thin films may include the same material or may include other materials (e.g., polymers, non-polymer materials, such as metals, alloys such as nitinol, stainless steel, etc.). The hole of the filter element 120 is configured to allow fluid (e.g., blood) to pass through the filter element 120 and prevent the embolic material carried by the fluid from passing through. The hole may be a perfect circle, an ellipse, a square, a triangle or other geometric shapes. Certain shapes such as equilateral triangles, squares and slots may provide geometric advantages, for example, limiting a portion greater than an inscribed circle, but providing an area for fluid flow that is almost twice the size of an inscribed circle, thereby making the shape more effective in terms of filtration and fluid volume. The hole may be laser drilled into or through the filter element 120, but other methods are also possible (e.g., piercing with microneedles, loosely braiding or weaving). The pores may have a lateral dimension (e.g., diameter) between about 10 micrometers (μm) and about 1 mm (e.g., only about 10 μm, about 50 μm, about 100 μm, about 150 μm, about 200 μm, about 250 μm, about 300 μm, about 400 μm, about 500 μm, about 750 μm, about 1 mm, ranges between these values, etc.). Other pore sizes are also possible, for example, depending on the desired minimum size of the material to be captured.

[0083] The material of filter element 120 may include a smooth and / or textured surface, which is folded or contracted to a delivery state by tensioning or being compressed into a cavity. Reinforced fabric may be added or embedded in filter element 120 to adapt to the stress placed on filter element 120 during compression. Reinforced fabric may reduce the stretching that may occur during the expansion and / or contraction of distal filter assembly 112. Embedded fabric may promote the folding of filter, so as to capture embolic debris and enable recapture of elastomeric film. Reinforcement material may include, for example, polymer and / or metal woven fabric to increase local strength. Reinforcement material may be embedded in filter element 120 to reduce thickness. For example, embedded reinforcement material may include polyester woven fabric, which is mounted to a part of filter element 120 near the longitudinal elements of framework 114, wherein during the expansion and retraction of distal filter assembly 112 from outer sheath 110, tension acts on framework 114 and filter element 120.

[0084] The distal filter assembly 112 can be connected (e.g., crimped, welded, brazed, etc.) to the distal end of the deployment line or filter line (not explicitly shown) via a support or wire 121, although this is not required. When both or all of the filter line and support 121 are provided, the filter line and support 121 can be connected to the inner member 118 on the proximal side of the filter assembly 112 using a crimping mechanism 119. In other embodiments, the filter line and support 121 can be a single integral structure. The filter line and / or support 121 can include a rectangular band, a round (e.g., a perfect circle, an elliptical) filament, a portion of a hypotube, a braided structure (e.g., as described herein), a combination thereof, etc. The distal filter bag terminal 116 or distal end 116 of the distal filter assembly can also be connected to the inner member 118. In some cases, the distal end 116 can be connected to the inner member using a nose cone 117. Nose cone 117 can both secure distal end 116 of distal filter assembly 112 and reduce injury and / or vessel perforation during insertion of system 100. In some cases, inner member 118 can decrease in diameter in the distal direction. The diameter can be stepped or gradual.

[0085] The distal filter assembly 112 in an expanded, unconstrained state may have a maximum diameter or effective diameter (e.g., if the mouth is elliptical, the effective diameter is the diameter of the filter's approximately circular opening 115 as seen from an end view). The diameter may be between about 1 mm and about 15 mm (e.g., at least about 2 mm, about 4 mm, about 6 mm, about 8 mm, about 10 mm, or more, but typically less than about 15 mm or 12 mm or less, depending on the potential target vessel). In some embodiments (e.g., when the distal filter assembly 112 is configured to be positioned in the left subclavian artery 16), the diameter may be between about 7 mm and about 12 mm (e.g., about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, ranges between these values, etc.). In some embodiments (e.g., when distal filter assembly 112 is configured to be positioned in left vertebral artery 24), the diameter may be between about 2 mm and about 4.5 mm (e.g., about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, ranges between these values, etc.). Other diameters d or other types of transverse dimensions are also possible. Different diameters may allow treatment of selected subjects with different blood vessel sizes.

[0086] The filter assembly 112 may have a maximum length from the proximal limit of the ring 114 to the distal end or convergence point 116 with the inner member 118. The length may be between about 7 mm and about 50 mm (e.g., at least about 7 mm, about 8 mm, about 10 mm, about 12 mm, 16 mm, about 20 mm or more, but typically less than about 40 mm or 30 mm or 20 mm or less, depending on the potential target vessel). Other lengths are also possible, for example, based on the diameter or effective diameter. For example, the length of the distal filter assembly 112 may increase with increasing diameter, and the length of the distal filter assembly 112 may decrease with decreasing diameter.

[0087] In the illustrated embodiment, as described herein, the distal filter assembly 112 includes a self-expanding support, such as a ring or frame 114, which supports the open proximal end of a roughly conical filter membrane 120. Support struts 121 can be provided to connect the ring 114 to a portion of the system 100, such as the inner member 118, in order to rewrap the filter assembly 112 and orient the ring or frame 114. In the illustrated embodiment, the distal filter assembly 112 can be used to filter blood entering the left subclavian artery 16 and anchor the system, as will be discussed in more detail herein.

[0088] Continued proximal actuation of outer sheath 110 while inner member 118 is secured relative to handle 105 (thereby securing the deployment wire and proximal junction, as will be described in greater detail herein) can subsequently deploy the aortic arch assembly or proximal filter assembly 124, as described in greater detail herein. Figure 3It is contemplated that the distal end 104 of the outer sheath 110 can be withdrawn into the innominate artery 12 or the right subclavian artery 22 to fully expose the proximal filter assembly 124. When the outer sheath 110 is withdrawn, the distal filter assembly 112 remains in the left subclavian artery 16, which is supported by the inner member 118 and helps anchor the proximal filter assembly 124.

[0089] The proximal filter assembly 124 may include an aortic ring 126 or support element and a filter membrane or filter element 128. The aortic ring 126 may be similar in form and function to the frame 114 of the distal filter assembly 112, although it is larger in scale. Similarly, the filter membrane 128 may be similar in form and function to the filter element 120 described herein. The aortic ring 126 generally provides expansion support to the filter membrane 128 in its expanded form, and the filter membrane 128 is suitable for filtering fluids, such as blood, and capturing particles flowing through it. The aortic ring 126 may include an approximately elliptical ring of a shape memory wire (such as nitinol). The aortic ring 126 may be configured to engage the aortic wall and seal against the top of the aortic arch outside the mouths of all three great vessels 12, 14, 16 to isolate cerebral vessels. For example, the size and shape of the aortic ring 126 may be arranged to extend from the mouth of the left subclavian artery 16 to the mouth of the innominate artery 12. The center 125 of the aortic ring 126 is open to allow blood and debris to enter the device 124, and the ring 126 is attached to the filter membrane 128 around its periphery. The aortic ring 126 can be self-expanding so that when the outer sheath 110 is withdrawn proximally, the aortic ring 126 automatically expands, although this is not required. As will be described in more detail herein, the aortic ring 126 can be connected to different parts of the protection system 100.

[0090] Once the proximal filter assembly 124 has been deployed, the inner member 118 may be retracted to minimize intrusion into the aorta 10, such as Figure 4 As shown. The position of the inner member 118 can be adjusted using the control 111 on the handle 105. As will be described in more detail herein, the mechanism that couples the proximal filter 124 to the system 100 can be adjusted by retracting the handle 105 proximally or advancing the handle 105 distally to ensure that the proximal filter 124 is fully deployed, the aortic annulus 126 is juxtaposed with the top of the aortic arch 10, and the inner member 118 is pulled upward against the top of the aortic arch 10 to ensure that the membrane 128 is fully against the top of the arch 10. Thus, during an endovascular procedure such as TAVR, the proximal filter assembly 124 is positioned to protect the cerebral vessels 14, 18, 20, 24 from embolic debris.

[0091] Once the protection system 100 has been deployed, a TAVR or other index procedure may be performed. Once the index procedure is envisioned, the inner member 118 may be advanced relative to the handle 105 to apply tension to the proximal filter element 128 and / or the distal filter element 120. The outer sheath 110 may then be advanced relative to the handle 105 while fixing the position of the inner member 118 relative to the handle 105 until the proximal filter assembly 124 and the distal filter assembly 112 are fully enclosed. The protection system 100 may then be removed from the introducer sheath.

[0092] Figure 5A and 5B A first mechanism for connecting the proximal filter assembly 124 to the protection system is shown. In the illustrated embodiment, the proximal end 130 of the aortic ring 126 is connected to the proximal junction tube 132 with an aortic ring connector 134. The proximal junction tube 132 can be a tubular structure configured to link or connect several structures of the system 100. In some cases, the structure connected to the proximal junction tube 132 can extend into the cavity of the proximal junction tube 132 and be connected thereto, as will be described in more detail herein. The aortic ring connector 134 can be formed as an integral or one-piece structure with the aortic ring 126. Alternatively, the aortic ring connector 134 can be formed separately from the aortic ring 126 and be connected thereto. It is conceivable that the aortic ring connector 134 can be formed by nitinol wire or other suitable materials. The proximal region 136 of the film 128 or the proximal filter bag terminal 136 can also be connected to the proximal junction tube 132.

[0093] The proximal coupling tube 132 can be connected to a delivery wire 138 configured to extend proximally to the handle 105. The handle 105 can include at least three controls (which can be sliding controls), including a control for translating the inner member 118 relative to the handle 105, a control for translating the delivery catheter 110 relative to the handle 105 to allow the filter assemblies 112, 124 to be deployed and retrieved, and a control for deflecting the distal tip of the delivery catheter 110. The delivery wire 138 is connected to both the proximal coupling tube 132 and the handle 105. Thus, the position of the aortic annulus 126 and the proximal filter bag terminal end 136 are fixed relative to the handle 105. In this regard, the position of the proximal coupling tube 132 relative to the patient's body can be moved by advancing or retracting the handle 105. As described above, the distal filter frame 114, and thus the distal region 116 or distal filter bag terminal end 116 of the distal filter element 120, is connected to the inner member 118 and is advanced and retracted relative to the outer sheath 110 by the first handle control 111. The steerable outer sheath or delivery catheter 110 can be withdrawn relative to the handle 105 using the second handle control 107 to deploy the device. The tip 104 of the outer sheath or delivery catheter 110 can be deflected using a third handle control (not explicitly shown) to assist in cannulation of the left subclavian artery 16 (or brachiocephalic artery 12).

[0094] exist Figure 5A In the embodiment of the present invention, the aortic annulus connector 134 can be formed by joining together two proximally extending segments of the wire forming the hoop of the aortic annulus 126 to produce a single relatively more rigid strut 134. Alternatively, as shown in FIG. Figure 5B As shown, two wires 134, 135 extending proximally from the aortic annulus 126 are movable relative to each other. This allows the minor axis of the aortic annulus 126 to self-adjust to the aorta 10 when the two wires 134, 135 are moved toward or away from each other. The excess of the film 128 or the overlapping portion of the film 128 carried by the wires 134, 135 allows continuity of the film 128 coverage regardless of the spacing between the wires 134 and 135.

[0095] Figure 6 yes Figure 5AA partial cross-sectional view of the illustrative system 100 taken along line 6-6. As seen, the proximal junction tube 132 defines a cavity 133. The inner member 118 is slidably disposed within the cavity 133 so that the inner member 118 can be moved separately from the proximal junction tube 132. The proximal filter bag terminal 136 can be connected to the inner surface of the proximal junction tube 132. However, other connection configurations can be used as needed. Moreover, the deployment or control line 138 can also be connected to the proximal junction. As needed, the control line 138 can be directly connected to the proximal junction or indirectly connected (e.g., the proximal filter bag terminal 136 is disposed therebetween). In some cases, the control line 138 and the aortic annulus connector 134 can form an integral structure. In other embodiments, the deployment or control line 138 and the aortic annulus connector 134 can be separate and distinct components.

[0096] Figure 7 yes Figure 5A 7-7. As seen, a membrane 128 can be attached to the aortic annulus 126 around its periphery to define an opening 125 that allows blood and debris to enter the proximal filter assembly 124. The membrane 128 also forms a mesh that prevents debris from leaving the proximal filter assembly 124. In some cases, the aortic annulus 126 can include a radiopaque coil or marker to allow visualization of the aortic annulus 126.

[0097] As described herein, the distal steering section of the steerable delivery catheter 110 can be laterally deflected in response to manipulation of a steering control on the proximal manifold or handle 105. Figure 8 , which shows Figure 5A A cross-sectional view of the illustrative system 100 taken along line 8-8, in the illustrated embodiment, the sidewall of the delivery catheter or outer sheath 110 is provided with a pull wire lumen 144 for axially movably receiving a pull wire 140, which can be retracted proximally to deflect the distal tip laterally. Alternatively, a second pull wire may be provided, such as around the catheter 110 at 180 degrees from the first pull wire, so as to straighten or deflect the catheter in a second opposite direction. Moreover, in some embodiments, the outer sheath 110 may include a reinforcing braid 131, however this is not required.

[0098] Fig. 9 Show Figures 1 to 8 Another alternative embodiment of the system. In system 100', handle 105 may include at least three controls (which may be sliding controls), including a control for translating inner member 118 relative to handle 105, a control for translating delivery catheter 110 relative to handle 105 to allow deployment and retrieval of filter assemblies 112, 124, and a control for deflecting the distal tip of delivery catheter 110. In system 100', proximal filter bag terminal 136 is connected to proximal coupling tube 132. As shown in FIG. Fig.11 (It is Fig. 9 As seen in the partial cross-sectional view of the system 100' taken along line 11-11, the delivery line 138 is also connected to the proximal coupling tube 132 and the handle 105. Therefore, the movement of the handle 105 is transferred to the proximal coupling tube 132. However, in Fig. 9 In the embodiment of the present invention, the proximal end 130 of the aortic annulus 126 is connected to the inner member 118 via the aortic annulus connectors 134, 135. For example, referring to Fig.10 (It is Fig. 9 System 100' is a partial cross-sectional view taken along line 10-10), the aortic ring connectors 134, 135 can be connected to the inner member 118 via a connecting tube 137 (which can be a heat shrink tube). The distal end 139 of the aortic ring 126 can be connected to the distal filter frame 114 via a distal support strut 142. Therefore, the aortic ring 126, the distal filter frame 114, the distal filter membrane 120 and the inner member 118 can all be advanced and retracted relative to the delivery catheter or outer sheath 110 by the first control element 111 in the handle 105. The manipulable delivery catheter 110 can be withdrawn relative to the handle 105 using the second handle control 107 to deploy the devices 112, 124. The end of the delivery catheter 110 can be deflected using a third handle control (not explicitly shown) to assist in cannulation of the left subclavian artery 16 (or the brachiocephalic artery 12).

[0099] Fig.12 Show Figures 1 to 8 Another alternative embodiment of the system. Fig.12 In the illustrative system 100", the handle 105 may include at least three controls (which may be sliding controls), including a control for translating the inner member 118 relative to the handle 105, a control for translating the delivery catheter 110 relative to the handle 105 to allow the filter assemblies 112, 124 to be deployed and retrieved, and a control for deflecting the distal tip of the delivery catheter 110. The proximal filter bag terminal 136 is connected to the proximal junction tube 132. The delivery line 138 and the aortic ring connector 134 are also connected to the proximal junction tube 132 and the handle 105. Therefore, the movement of the handle 105 is translated to the proximal junction tube 132. In Fig.12In an embodiment of the present invention, the distal end 139 of the aortic annulus 126 can be coupled to the distal filter frame 114 via the distal support struts 142. Thus, the proximal filter bag terminal 136, the aortic annulus 126, and the distal filter frame 114 are all fixed relative to the handle 105. In other words, movement of the handle 105 is translated to the proximal binding tube 132 via the delivery wire 138, and since the aortic annulus 126 is coupled to the proximal binding tube 132 and the distal filter frame, the aortic annulus 126 and the distal filter frame 114 also move with the handle 105. The distal filter bag terminal 116 is connected to the inner member 118 and is advanced and retracted relative to the delivery catheter 110 using the first handle control 111 (e.g., via movement of the inner member 118). The steerable delivery catheter 110 can be withdrawn relative to the handle 105 using the second handle control 107 to deploy the device. The distal end of the delivery catheter 110 may be deflected using a third handle control (not expressly shown) to assist in cannulation of the left subclavian artery 16 (or the brachiocephalic artery 12).

[0100] Fig.13 Show Figures 1 to 8 Another alternative embodiment of the system. Fig.13 In the illustrative system 100'', the proximal filter bag terminal 136 is connected to the first proximal coupling tube 132 and is fixed relative to the handle 105 via a deployment line 138 that is also connected to the first proximal coupling tube 132 and the handle 105. The distal filter frame 114, and thereby the distal filter bag terminal 116, is connected to the inner member 118. Both the distal filter frame 114 and the distal filter bag terminal 116 are advanced and retracted relative to the delivery catheter 110 by the first handle control 111. The steerable delivery catheter 110 can be moved relative to the second handle control 107. The handle 105 is withdrawn to deploy the devices 112, 124. The end of the delivery catheter 110 can be deflected using a third handle control (not explicitly shown) to assist in cannulation of the left subclavian artery 16 (or the brachiocephalic artery 12). The proximal end 130 of the aortic annulus 126 is connected to a sliding aortic annulus coupling tube 143 via an aortic annulus connector 134. The sliding second coupling tube 143 is also connected to the aortic annulus deployment line 145. The sliding second coupling tube 143 can be advanced and retracted relative to the delivery catheter 110 using a fourth handle control (not explicitly shown).

[0101] The handle 105 of the system 100"' may include at least four controls (which may be sliding controls), including a control for translating the inner member 118 relative to the handle 105, a control for translating the delivery catheter 110 relative to the handle 105 to allow the filter assemblies 112, 124 to be deployed and retrieved, a control for deflecting the distal tip of the delivery catheter 110, and a control for translating the aortic annulus deployment wire 145 relative to the handle 105. This may allow the aortic annulus connector 134 (and thereby the aortic annulus 126), the inner member 118, and the proximal coupling tube 132 (and thereby The proximal membrane 128) can be all adjusted relative to each other. This can allow the juxtaposition of the aortic ring 126 to the top of the aortic arch 10 to be further optimized. In one technique, the position of the aortic ring connector 134 can be fixed, and the position of the proximal connecting tube 132 (and thus the proximal terminal end of the filter membrane 136) is withdrawn toward the handle 105. This tension applied on the proximal membrane 128 can pull the aortic ring 126 toward the top or aortic arch 10 and increase the curvature of the aortic ring connector 134, thereby improving the juxtaposition between the aortic ring 126 and the top of the aortic arch 10.

[0102] Fig.14 Show Fig.13 Illustrative system 100'' is a cross-sectional view taken along line 14-14. In the illustrated embodiment, the sidewall of the delivery catheter or outer sheath 110 is provided with a pull wire lumen 144 for axially movably receiving a pull wire 140, which can be retracted proximally to laterally deflect the distal tip. A second pull wire may alternatively be provided, such as around the catheter 110 at 180 degrees from the first pull wire, so as to straighten or deflect the catheter in a second, opposite direction. Moreover, in some embodiments, the outer sheath 110 may include a reinforcing braid 131, however this is not required. The deployment wire 138 and the aortic annulus deployment wire 145 may extend within the lumen of the outer sheath 110, but outside of the inner member 118.

[0103] Fig.15 yes Fig.13'' is a cross-sectional view of the illustrative system 100 taken along line 15-15. As seen, the proximal coupling tube 132 defines a lumen 133. The inner member 118 is slidably disposed within the lumen 133 such that the inner member 118 can be moved separately from the proximal coupling tube 132. Moreover, the aortic annulus deployment line 145 can also extend through the lumen 133 such that the aortic annulus deployment line 145 (and thereby the second coupling tube 143) can be moved separately from the proximal coupling tube 132. The proximal filter bag terminal 136 can be attached to the inner surface of the proximal body 132. However, other attachment configurations can be used as desired. Moreover, a deployment or control line 138 can also be attached to the proximal coupling tube 132. As desired, the control line 138 can be directly attached to the proximal coupling or indirectly attached (e.g., with the proximal filter bag terminal 136 disposed therebetween). Both the proximal coupling tube 132 and the aortic annulus coupling tube 143 can slide freely on (and / or relative to) the inner member 118.

[0104] In the protection system 100, 100', 100", 100'", it may be necessary to properly deploy, operate and retrieve the filter assemblies 112, 124 to control the rotational orientation between the delivery catheter 110, the proximal binding tube 132 and the inner member 118. Controlling the orientation of the inner member 118 (and thereby the distal filter assembly 112) relative to the aortic annulus 126 (and thereby the proximal binding tube 132) can prevent the distal filter frame 114 from rotating relative to the aortic annulus 126 and / or the proximal binding tube 132, and the resulting distortion of the membrane 128 between the aortic annulus 126 and the distal filter assembly 112, thereby potentially restricting the flow of blood and / or debris into the distal filter assembly 112 and thereby restricting the flow into the left subclavian artery. It may be desirable to control the orientation of the inner member 118 (and thereby the distal filter assembly 112) and the aortic annulus 126 (and thereby the proximal junction 132) relative to the delivery catheter 110, thereby controlling the deflection direction of the deflectable outer sheath 110 to ensure that the devices 112, 124 are deployed from the end of the delivery catheter 110 in the correct orientation in the aortic arch 10.

[0105] It is contemplated that the orientation may be controlled by fixing the rotational orientation of the deployment wire 138 (and thus the proximal binding tube 132) relative to the inner member 118 at an attachment point within the handle 105. If the orientation of the deployment wire 138 and the inner member 118 attached to the handle 105 is fixed, the orientation of the proximal binding tube 132 and the distal filter assembly 112 may be controlled. However, the handle 105 may be separated from the distal filter assembly 112 by a certain distance, and the connected inner member 118 and deployment wire 138 may twist or twist relative to each other, thereby causing the distal filter assembly 112 to be misaligned with the aortic annulus 126. This twisting may be reduced by replacing the deployment wire 138 with a deployment tube 150 extending in the annular space between the delivery catheter 110 and the inner member 118. Fig.16 A cross-sectional view showing such a feature. Constructing the deployment wire from tube 150 may have the following advantages: a tube resists torque more effectively than a wire and may result in better alignment between the proximal binding tube 132 and the aortic annulus 126 because the tube structure 150 rotationally deflects to a lesser extent than a wire. Tube 150 may be constructed of a polymer, a braided reinforced polymer, stainless steel, or other metal. Fig.17 A partial side view of an illustrative delivery tube 150 constructed of stainless steel, nitinol or other metal hypotube having laser cut slots 152 to increase flexibility while maintaining axial and torsional stiffness to maintain the position (axially and rotationally) of the proximal coupling tube 132 relative to the handle 105 is shown.

[0106] In another illustrative embodiment, the orientation can be controlled by keying the proximal coupling tube 132 to the inner member 118 so that the proximal coupling tube 132 can slide freely on the inner member 118, but cannot rotate relative to the inner member 118. For example, as an alternative or supplement to the handle 105, the orientation of the proximal coupling tube 132 relative to the inner member 118 can be controlled at the proximal coupling tube 132. This can be done by creating a non-circular or non-perfectly circular profile (e.g., a non-perfectly circular cross-sectional shape) of the inner member 118 at least in the area where the proximal coupling tube 132 slides on the inner member 118. The profile (e.g., cross-sectional shape) can be a square, hexagonal, triangular or other non-circular profile. The inner opening of the proximal coupling tube 132 can be profiled or keyed to match the cross section of the inner member 118 so that it can slide along the inner member 118, but will not rotate relative to the inner member 118. Fig.18 A cross-sectional view of such a keying arrangement between the inner member 118 and at least a portion of the proximal coupling tube 132 is shown. Although not explicitly shown, when so configured, the aortic annulus coupling tube 143 and the inner member 118 can be similarly keyed. In some cases, the proximal coupling tube 132 can have a perfect circular outer contour, and the shape of the lumen can be keyed or shaped to match the shape of the outer surface of the inner member 118 to limit the rotation of the inner member 118.

[0107] The inner member 118 can be made of polymer, metal, composite material, wire, braided reinforced polymer (such as polyimide, nylon, Pebax, etc.) or other suitable materials. The inner member 118 can be configured to have variable rigidity, so that, for example, the rigidity of the distal portion is less than the rigidity of the proximal portion. However, this is not necessary. In some embodiments, a limit stop can be added to the inner member 118 to limit the travel of the aortic ring connector 134, 135 (and therefore the aortic ring 126) relative to the inner member 118 in both the proximal and distal directions. The inner member 118 can move freely through the proximal joint tube 132. The limit stop can prevent the operator from extending the inner member 118 to the extent that the inner member 118 will protrude from the aortic ring 126 and / or prevent the operator from withdrawing the inner member 118 to the extent that the distal filter assembly 112 is pulled out from the correct position in the left subclavian artery 16. By placing hard stops (eg, structural features extending from an outer surface of the inner member 118 ) on the inner member 118 on either side of the proximal binding tube 132 , the distance an operator can pull or push the inner member 118 can be controlled.

[0108] The proximal end 136 of the proximal filter membrane 128 may terminate at the proximal junction tube 132. The juxtaposition and sealing of the proximal filter membrane 128 in the brachiocephalic artery 12 may be achieved by a combination of sealing the aortic annulus 126 to the top of the aortic arch 10 and blood flowing through the filter membrane 128 such that the filter membrane 128 expands against the wall of the brachiocephalic artery 12. In alternative embodiments, a proximal filter frame (e.g., similar in form and function to the distal filter frame 114) may be added to ensure that the filter membrane 128 is fully opened in the brachiocephalic artery 12. The proximal filter frame may be configured to provide positive circumferential contact between the membrane 128 and the wall of the brachiocephalic artery 12, or may function to ensure that the filter is open without circumferentially pressing the membrane 128 against the vessel wall. As with the distal filter frame 114, the proximal filter frame may be bonded to the membrane or may float freely within the membrane.

[0109] In some embodiments, the self-expanding distal filter frame 114 may alternatively not be bonded to the filter membrane 120, such that the distal filter frame 114 may be rotated relative to the membrane 120 to prevent the membrane from twisting, but still keep the membrane 120 open within the left subclavian artery 16 (or brachiocephalic artery 12). The inner member 118 may extend beyond the distal filter assembly 112 to stabilize the distal filter assembly 112. Moreover, the guidewire 102 may extend beyond the distal filter assembly 112 to stabilize the distal filter assembly 112 in the left subclavian artery 16 and help maintain the apposition of the filter frame to the vessel wall.

[0110] The distal filter assembly 112 is anchored in the left subclavian artery 16 by expansion of the distal filter frame 114 to stabilize the device during delivery of the proximal filter assembly 124. Alternatively or additionally, this anchoring function can be performed by an anchoring element that expands within or distal to the filter membrane 120. This can take the form of a self-expanding stent structure, an expanding coil, an expandable balloon, etc. This feature can help maintain the position of the filter assembly 112 when the inner member 118 is tensioned, thereby maintaining the distal portion of the device.

[0111] Fig.19 1 is a first illustrative alternative distal anchoring structure 160 positioned distal to the distal filter assembly 112. A self-expanding nitinol mesh anchor 160 or similar assembly helps maintain the position of the distal end of the device. The nitinol mesh 160 can be located between the distal filter assembly 112 and the catheter end or at the very end of the catheter. The mesh anchoring structure 160 can also be any shape, including but not limited to conical, cylindrical, etc.

[0112] Fig. 20 Another alternative distal anchoring structure is shown that includes an expandable balloon 170 positioned distal to the distal filter assembly 112. In some cases, the expandable balloon 170 can be located on one side of the inner member 118 distal to the distal filter assembly 112. When in place, the balloon 170 can be expanded to help maintain the position of the distal end of the inner member 118. Placing the balloon 170 on one side of the inner member 118 can allow blood flow to continue along the other side of the inner member 118.

[0113] Fig.21 Another alternative distal anchoring structure is shown that includes one or more nitinol rings 180 that can be expanded after the outer sheath 110 is withdrawn. These nitinol rings 180 can then help anchor the distal end of the inner member 118 in the left subclavian artery 16.

[0114] The filter membranes 120, 128 may be made of laser drilled or perforated polymer films, woven nitinol wire mesh, other metal meshes, woven PEEK or other polymer meshes, etc. The porosity of the filter membranes 120, 128 may be about 140 microns, however other porosities (larger or smaller) are also possible. The hole pattern of the film may be uniform, or the film may be selectively perforated in given areas of the film 120, 128 to allow or restrict flow in those selected areas to improve flow through the cavity, promote juxtaposition, etc. The filter membranes 120, 128 may have fabric or other reinforcements or stiffeners in selected areas to improve the film's sheathing, unsheathing, folding, and juxtaposition performance, see, for example, the proximal filter membrane 128 may include a strip of fabric reinforcement in the film material, which extends from the point where the aortic annulus connector 134 meets the aortic annulus 126 to the proximal binding tube 132. The fabric reinforcement may prevent or reduce bunching of the film 128 during rewrapping and may help the film 128 fold in a controlled manner during wrapping.

[0115] As described herein, the aortic annulus 126 and / or distal filter frame 114 may be constructed from nitinol wire, however, they may also be constructed from other flexible materials, such as polymers, stainless steel, composites of multiple materials, woven or braided rope, etc. The aortic annulus 126 and / or distal filter frame 114 may also be laser cut from a flat sheet of metal, polymer, etc. and subsequently formed or shaped into the desired final shape.

[0116] The aortic ring 126 can be configured so that it is stiffer or more flexible in some portions than in other portions. For example, if the aortic ring 126 is composed of nitinol wire, it can be selectively ground to reduce diameter or thickness to change stiffness to improve performance, improve apposition, make wrapping easier, etc.

[0117] Radiopaque markers may be added to the filter frame 114, the aortic annulus 126, the aortic annulus connectors 134, 135, and / or other portions of the device to allow for visualization under fluoroscopy. The markers may be placed at selected locations as desired or may take the form of coils placed throughout the aortic annulus 126, the filter ring 114, or the connector structures 134, 135 to aid in positioning and visualization.

[0118] The aortic connectors 134, 135 may be constructed of a more rigid material, such as nitinol, stainless steel, polymers, etc. or may be constructed of a more flexible material, such as suture, fabric, or other flexible material that still supports tension to allow for encapsulation of the aortic annulus but allows for improved apposition of the aortic annulus to the aortic crest. The aortic annulus 126 may be constructed of a ring of material, such as a nitinol wire, and the aortic annulus connectors 134, 135 may be formed from two ends of the ring and then terminated at the proximal junction tube 132. The mechanical properties of the aortic annulus connectors 134, 135 may be altered in a number of ways, including adding heat shrink 190 to the wire 134, 135, such as Fig.22A As shown, a stiffening tape 192 is added (with or without a heat shrink layer 190), such as Fig. 22B As shown, or using multiple layers of polymer 190, 194 (with or without stiffening band 192), such as Fig. 22C shown.

[0119] The aortic ring connectors 134, 135 may be curved or shaped to improve the apposition of the aortic ring on the proximal edge of the ostium of the brachiocephalic artery 12 or the left subclavian artery 16. The aortic ring connector may be formed into a curved shape (as opposed to a straight connector) which may allow the aortic ring 126 to completely cover the brachiocephalic artery 12 without leaving a gap on the proximal edge 130.

[0120] In some embodiments, the aortic annulus connectors 134, 135 may improve the apposition of the aortic annulus 126 to the top of the aortic arch 10 by including a recurved shape. Fig.23 The aortic ring connector 134 is shown to include a curved shape that curves back on itself. In addition, the shape and curvature of the aortic ring connector 134 can be adjusted. For example, the aortic ring connector 134 can include an adjustable tensioning member to allow adjustment of the apposition of the aortic ring 126 to the top of the aortic arch and to optimize subsequent deployment.

[0121] Although the methods and devices described herein are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and described in detail herein. However, it should be understood that the subject matter of the present invention is not limited to the specific form or method disclosed, but rather covers all modifications, equivalents and alternatives falling within the spirit and scope of the various embodiments and the appended claims. Moreover, any specific features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc. disclosed in one embodiment or embodiment herein can be used in all other embodiments or embodiments. In any method disclosed herein, the actions or operations can be performed in any suitable order, and are not necessarily limited to any specific order disclosed, and are not performed in the order described. Various operations can be described in sequence as multiple discrete operations in a manner that helps to understand certain embodiments; however, the order of description should not be interpreted as implying that these operations are order-dependent. Additionally, the structures described herein may be embodied as integrated components or separate components. For the purpose of comparing various embodiments, certain aspects and advantages of these embodiments are described. All these aspects or advantages are not necessarily achieved by any particular embodiment. Thus, for example, an embodiment can be completed in a manner that achieves or optimizes one advantage or a group of advantages, but other advantages or multiple groups of advantages do not have to be achieved. The methods disclosed herein may include certain actions taken by a practitioner; however, the methods may also include any third-party instructions of these actions, whether express or implied. For example, an action such as "deploy a self-expanding filter" includes "instructing to deploy a self-expanding filter." The ranges disclosed herein also include any and all overlaps, sub-ranges, and combinations thereof. Language such as "up to," "at least," "greater than," "less than," "between," and the like includes the listed numbers. Numbers prefixed with "about" or "approximately" include the listed numbers and should be interpreted based on the circumstances (e.g., as accurately as reasonably possible under the circumstances, e.g., ±5%, ±10%, ±15%, etc.). For example, "about 7 mm" includes "7 mm." Phrases prefixed with "substantially" include the referenced phrase and should be interpreted based on the circumstances (e.g., as much as reasonably possible under the circumstances). For example, "substantially straight" includes "straight."

[0122] Those skilled in the art will recognize that the present invention may be embodied in many forms other than the specific embodiments described and contemplated herein. Accordingly, departures may be made in form and details without departing from the true and spirit of the present invention as described in the appended claims.

Claims

1. An embolic protection system for isolating cerebral blood vessels, the system comprising: an outer sheath having a proximal end and a distal end; an inner member extending through the lumen of the outer sheath; a distal anchoring mechanism coupled to a distal region of the inner member; a proximal filter carried between the inner member and the outer sheath, the proximal filter configured to extend from the left subclavian artery to the brachiocephalic artery; an aortic ring coupled to the proximal filter membrane and configured to seal the proximal filter membrane against the aortic wall; as well as A handle includes an actuation mechanism coupled to the proximal end of the inner member and configured to adjust the position of the inner member.

2. The embolic protection system of claim 1, wherein the actuation mechanism is configured to retract the inner member proximally relative to the proximal filter membrane such that the inner member is pulled upward against the top of the aortic arch.

3. The embolic protection system of any of the preceding claims, wherein the center of the aortic annulus is open to allow debris to enter the proximal filter membrane.

4. The embolic protection system of any of the preceding claims, wherein the distal anchoring mechanism comprises a self-expanding frame.

5. The embolic protection system of claim 4, further comprising a distal filter membrane coupled to the self-expanding frame.

6. The embolic protection system of claim 4 or 5, wherein the anchoring mechanism comprises a self-expanding nitinol mesh, a balloon, or one or more self-expanding rings.

7. The embolic protection system of any one of the preceding claims, further comprising a proximal coupling tube coupled to a proximal end of the proximal filter membrane.

8. The embolic protection system of claim 7, further comprising an aortic annulus connector extending from a proximal end of the aortic annulus to the proximal coupling tube.

9. The embolic protection system of claim 7 or 8, further comprising a delivery wire coupled to the tube and extending proximally to the handle.

10. The embolic protection system of claim 9, wherein the handle further comprises an actuation mechanism coupled to the proximal end of the delivery wire.

11. The embolic protection system according to any one of claims 7 to 10, wherein the inner member is slidably disposed within the lumen of the proximal coupling tube.

12. The embolic protection system of any of the preceding claims, further comprising an aortic annulus deployment wire coupled to the aortic annulus and extending proximally to the handle.

13. The embolic protection system of claim 12, wherein the outer sheath, the inner member, the delivery wire, and the aortic annulus deployment wire are individually actuatable.

14. The embolic protection system of any one of claims 1 to 13, wherein the distal region of the outer sheath is deflectable.

15. The embolic protection system of claim 11, wherein a cross-sectional shape of the inner member adjacent to the proximal coupling tube is non-perfectly circular, and at least a portion of the proximal coupling tube has a non-perfectly circular cross-sectional shape.

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