Catheters with integrated embolic protection devices

Abstract

An artificial heart valve delivery catheter includes an embolic filter, which provides an integrated embolic protection function to prevent emboli from being released into the aorta, aortic arch or branch vessels and other vascular systems during transvascular heart valve replacement. The embolic filter is usually fixedly or movably attached to the delivery catheter shaft proximal to the artificial heart valve.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of prior provisional patent application serial number 62 / 844,941 filed on May 8, 2019 (attorney docket number 41959-714.102) and serial number 62 / 804,909 filed on February 13, 2019 (attorney docket number 41959-714.101), the entire disclosures of which are incorporated herein by reference. Background Art

[0003] 1. Technical Field The present invention relates to devices and methods for providing embolic protection in the cardiovascular system of a patient. In particular, the present invention relates to catheters used for transcatheter heart valve delivery and other intravascular interventional procedures that include embolic filters.

[0004] Cerebral embolism is a known complication of cardiac surgery, cardiopulmonary bypass and catheter-based interventional cardiology and electrophysiological treatment protocols. Embolic particles (which may include thrombus, atherosclerosis and lipids) may fall off and enter the bloodstream due to the operation of surgery or catheter, thereby forming embolism in the brain or other downstream organs related to life safety. Cerebral embolism can cause neuropsychological defects, apoplexy and even death. Other downstream organs can also be subject to the damage of embolism, causing functional impairment or organ failure.

[0005] Prevention of embolism is beneficial to patients and can improve the efficacy of treatment plans. Considering that potential emboli often fall off during the implementation of catheter-based treatment plans, it is advantageous to deploy embolic protection systems as part of catheter-based vascular treatment plans, such as transcatheter aortic valve replacement (TAVR). In addition, the use of transcranial Doppler (TCD) in TAVR shows that cerebral emboli are mainly generated in various steps of the treatment plan of passing through the native valve and deploying the TAVR valve (refer to Kahlert et al. Circulation, 2012). Therefore, integrating embolic protection devices on the TAVR delivery system itself has the beneficial effect of playing a protective role in most of the key steps of the treatment plan. Another advantage can be reflected in the integration of embolic protection systems into the catheter itself used in the implementation of the treatment plan, such as a transcatheter valve delivery system or an electrophysiological catheter. Other embolic protection systems require separate procedural steps to install the protection device before the intervention or diagnosis of the treatment plan and remove it after the treatment plan is completed. In many cases, different access sites are also required. The present invention avoids additional steps and additional access sites. Yet another benefit of the present invention is the provision of an integrated embolic protection device that does not increase the overall diameter of the catheter.

[0006] 2. Description of Background ArtDevices for preventing embolism and similar phenomena are described in the following patents and patent applications, which are incorporated herein by reference: U.S. Patent No. 10,166,094; U.S. Patent No. US 9,877,821; 9,744,023; 9,144,485; 8,968,354; 8,740,930; 8,420,902; 8,383,788; 8,337,519; 8,123,779; 8,052,717; 7,537,600; 7,044,958; 6,537,297; 6,499,487; 6,371,935; 6,361,545; 6,254,563; 6,139,51 7; U.S. Patent No. 5,769,816; U.S. Patent Application 2019 / 0015152; U.S. Patent Application 2018 / 0206970; U.S. Patent Application 2018 / 0042390; U.S. Patent Application 2016 / 0317277; U.S. Patent Application 2015 / 0366650; U.S. Patent Application 2014 / 0214069; U.S. Patent Application 2013 / 267993; U.S. Patent Application 2012 / 271340; U.S. Patent Application 2010 / 0312268; U.S. Patent Application 2010 / 0010535; U.S. Patent Application 2004 / 0215167; U.S. Patent Application 2003 / 0100940; and PCT Application WO2004 / 019817. Summary of the invention

[0007] According to the principles of the present invention, an artificial heart valve delivery catheter with integrated embolic protection function is provided to prevent emboli from being released into the aorta, aortic arch or branch vessels and other vascular systems, and to protect the brain and other downstream organs from embolism in the treatment of transvascular artificial heart valve replacement. Unlike most other embolic protection solutions, the embolic filter is integrated into an interventional or diagnostic catheter, such as a transcatheter heart valve delivery system.

[0008] In a first aspect, the present invention provides an artificial heart valve delivery catheter system with integrated embolic protection. The catheter system generally includes a catheter shaft having a distal portion, an artificial valve disposed at the distal portion of the catheter shaft; and an embolic filter disposed adjacent to the artificial valve at the distal portion of the shaft. The embolic filter has a contracted configuration and an expanded configuration, and the outer edge of the filter is configured to contact the blood vessel wall in the expanded configuration. In some embodiments, the embolic filter includes a filtering structure having a narrow end coupled to the shaft and an open end located distal to the narrow end.

[0009] In a specific embodiment, the narrow end of the filtering structure can be fixedly attached to the catheter shaft. In an alternative embodiment, the narrow end of the filtering structure can be slidably mounted to the catheter shaft. The catheter can also include at least one of a proximal stop member on the catheter shaft and a distal stop member on the catheter shaft, the proximal stop member being used to limit proximal movement of the embolic filter on the distal portion of the catheter shaft, and the distal stop member being used to limit distal movement of the embolic filter on the distal portion of the catheter shaft.

[0010] In other embodiments, the filter may include a filter membrane and a support structure. The support structure may include a plurality of self-expanding axial supports connected to the catheter shaft at their proximal ends so as to open the distal end of the filter membrane to form a cone when released from the constraint. The axial supports may have a non-traumatic distal tip.

[0011] In other embodiments, the filter may include a self-expanding conical filter. For example, the embolic filter includes a porous material including a fabric of braided, woven or non-woven fibers, filaments or wires. The porous material may be made of an elastic metal, a polymer material, a ductile material, a plastically deformable material, a shape memory material or a combination thereof. The porous material typically has a pore size selected to prevent passage of emboli exceeding a predetermined size.

[0012] In a second aspect, the present invention provides a system comprising a catheter as described above in combination with an external delivery sheath configured to maintain the embolic filter in a collapsed configuration.

[0013] In a third aspect, the present invention provides an artificial heart valve delivery catheter with integrated embolic protection. The artificial heart valve delivery catheter generally includes a catheter shaft having a distal portion, an artificial valve disposed at the distal portion of the catheter shaft; and an embolic filter disposed adjacent to the artificial valve at the distal portion of the shaft. The embolic filter has a contracted configuration and an expanded configuration, and in the expanded configuration, the outer edge of the filter contacts the blood vessel wall. The embolic filter generally includes a filter membrane and a support structure, wherein the support structure includes a cage having a distal collar and a proximal collar attached to the distal portion of the catheter shaft.

[0014] In certain embodiments, at least one of the proximal hoop-like structure and the distal hoop-like structure is slidably attached to the distal portion of the catheter shaft. In other embodiments, at least one of the proximal hoop-like structure and the distal hoop-like structure is fixedly attached to the distal portion of the catheter shaft. For example, at least one of the proximal hoop-like structure and the distal hoop-like structure is fixedly attached to the distal portion of the catheter shaft. In other embodiments, at least one of the distal hoop-like structure and the proximal hoop-like structure is configured to translate axially to expand and contract the cage. Typically, the cage is self-expanding, so that the cage is radially constrained for delivery and released from radial constraints for deployment. In other examples, the cage has a gradually tapered distal end, a gradually tapered proximal end, and a cylindrical wall portion therebetween, wherein the filter membrane covers at least the gradually tapered proximal end and does not cover the gradually tapered distal end.

[0015] In a fourth aspect, the present invention provides an artificial heart valve delivery catheter with integrated embolic protection. The catheter includes a catheter shaft having a distal portion, an artificial valve disposed at the distal portion of the catheter shaft, and an embolic filter disposed adjacent to the artificial valve at the distal portion of the shaft. The embolic filter typically has a collapsed configuration and an expanded configuration, wherein the outer edge of the filter contacts the vessel wall, and the embolic filter typically also includes a cylindrical wall portion located proximal to the artificial valve and configured to cover the patient's aortic branch vessels and a conical wall portion proximal to the cylindrical wall portion.

[0016] In certain embodiments, the cylindrical wall portion and the tapered wall portion are not continuous. For example, at least one of the cylindrical wall portion and the tapered wall portion is fixedly attached to the distal portion of the catheter shaft. In other examples, at least one of the cylindrical wall portion and the tapered wall portion is slidably attached to the distal portion of the catheter shaft. In other examples, at least one of the cylindrical wall portion and the tapered wall portion is self-expanding. In any of the above examples, at least one of the cylindrical wall portion and the tapered wall portion is balloon expandable.

[0017] In a fifth aspect, the present invention provides an artificial heart valve delivery catheter with integrated embolic protection, wherein the catheter includes a catheter shaft having a distal portion, an artificial valve disposed at the distal portion of the catheter shaft, and an embolic filter disposed adjacent to the artificial valve at the distal portion of the shaft. The embolic filter typically has a contracted configuration and an expanded configuration, wherein the outer edge of the filter is configured to contact a blood vessel wall. The embolic filter typically includes a cylindrical wall having a closed proximal end sealingly coupled to the catheter shaft and an open distal end, wherein the proximal region of the cylindrical wall is movably flipped and allows the open distal end to translate axially relative to the catheter shaft, while the closed proximal end remains stationary relative to the catheter shaft.

[0018] In certain embodiments, the closed proximal end is secured to a catheter shaft, e.g.

[0019] The closed proximal end may be slidably coupled to the catheter shaft.At least the distal portion of the cylindrical wall may be self-expanding, and at least the distal portion of the cylindrical wall may include a self-expanding filter.

[0020] Incorporation by reference

[0021] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The novel features of the present invention are particularly pointed out in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by referring to the following detailed description which sets forth illustrative embodiments utilizing the principles of the invention and the accompanying drawings in which:

[0023] Figures 1A to 1D A first embodiment of a valve delivery system according to the present invention is presented having a balloon-expandable prosthetic heart valve with integrated embolic protection.

[0024] FIG. 2A to FIG. 2D A second embodiment of a valve delivery system according to the present invention is shown having a self-expanding prosthetic heart valve with integrated embolic protection.

[0025] Figure 3 A third embodiment of a valve delivery system according to the present invention is presented having an integrated embolic protection function including both an embolic deflecting element and a separate embolic capture element.

[0026] Figure 4 Shows if Figure 3A valve delivery system deployed in the aortic arch implants a prosthetic aortic valve within the native aortic valve.

[0027] FIG. 5A to FIG. 5D A fourth embodiment of a valve delivery system according to the present invention is shown having an elongated cylindrical filter deployed on the aortic arch while delivering a prosthetic aortic valve into a native aortic valve.

[0028] Figure 6 A fifth embodiment of a valve delivery system according to the present invention is shown having an embolic filter mounted around the valve system catheter during the initial delivery procedure.

[0029] Figure 7 A sixth embodiment of a valve delivery system according to the present invention is shown, the system having Figure 6 Similar prosthetic valves and embolic filters wherein the filter delivery sheath is deployed and retrieved via a separate catheter within a separate lumen of a valve delivery catheter adjacent to a catheter containing the prosthetic valve.

[0030] Figure 8 A seventh embodiment of a valve delivery system according to the present invention is shown having an embolic filter mounted on the valve delivery system with both ends of its support structure attached to a delivery catheter.

[0031] 9A to 9D An eighth embodiment of a valve delivery system according to the present invention is shown, which is similar to the valve delivery system of FIG. 1 .

[0032] Fig.10 A ninth embodiment of a valve delivery system according to the present invention is shown, similar to the valve delivery system of FIG. 1 , wherein the embolic filter comprises a self-supporting basket without an attached support frame. DETAILED DESCRIPTION

[0033] For the purposes of this patent application, the term "distal" refers to the end of the device farthest from the operator and closest to the heart. This is also the "upstream" direction of blood flow. The term "proximal" refers to the end of the device near the operator, in the direction of the access site where the device is introduced into the body and farthest from the heart. This is also the "downstream" direction of blood flow.

[0034] Figures 1A to 1D An integrated valve delivery system 10 with integrated embolic protection according to the present invention is shown. A self-expanding conical embolic filter 12 is mounted on the shaft 14 of a balloon valve delivery catheter having a balloon-expandable artificial heart valve 20 mounted on a distal balloon 18. The balloon-expandable aortic valve can be one of various available and proposed balloon-expandable heart valves, such as the Edwards Valve. The conical embolic filter 12 can be assembled on the catheter shaft 14 with a fixed connection component or a sliding connection component. The fixed connection component simplifies the assembly and deployment process, but limits the ability to adjust the position of the conical filter relative to the aortic valve during delivery. In the case of fixed attachment, the distal end of the conical filter can be located 1cm to 20cm proximal to the proximal end of the artificial valve 20, and typically can be located 1cm to 10cm proximal to the proximal end of the artificial valve 20. In the case of sliding attachment, the distal end of the conical filter can be adjusted (before or during deployment) to be located 1cm to 30cm proximal to the proximal end of the artificial valve 20, and typically can be located 1cm to 20cm proximal to the proximal end of the artificial valve.

[0035] The self-expanding conical embolic filter 12 generally comprises a mesh or other filter material having a mesh size suitable for embolic capture and a self-expanding support structure, for example, a plurality of radially self-expanding supports 22 for ensuring full deployment of the mesh or other filter material. As shown, the radially self-expanding supports 22 have a non-traumatic distal tip that contacts the aortic wall, for example, the distal end of the support may be curved, coiled, have a protective cushion or have other structures to avoid tissue damage.

[0036] Typically, by retracting the restraining sleeve 26 (compare Figure 1A and Figure 1B ) to deploy the self-expanding tapered embolic filter 12 and can be collapsed by advancing the constraining sheath and / or retracting the catheter shaft 14 (compare Figure 1C and Figure 1D Optionally, after the valve 20 is deployed, a restraining sleeve may be used to encase the deflated balloon 18 and the conical filter ( Figure 1D ).

[0037] FIG. 2A to FIG. 2D A second embodiment of a valve system 210 having an integrated embolic protection filter 212 on a catheter shaft 214 according to the present invention is shown, such that the integrated valve system 210 is suitable for delivering a self-expanding valve 220, such as a Medtronic Vacuum ... Heart valve: The first telescopic restraining sleeve 226 initially restrains the self-expanding artificial valve 220, and the second telescopic sleeve 228 initially restrains the delivery of the embolic filter 212.

[0038] After positioning the first constraining sleeve 226 and the prosthetic valve 220 within the aortic valve V, the filter 212 is deployed by retracting the second sleeve 228, allowing the filter to expand ( Figure 2BThe artificial valve 220 is deployed by contracting the second telescopic sleeve 228 ( Figure 2C ). After the valve is deployed, the second telescoping sleeve 228 is advanced, thereby collapsing the filter 212 and the first sleeve 226 for removal from the system. Figure 2D As shown, the first containment sleeve 226 can be collapsed within the collapsed filter 212, which in turn is collapsed within the second restraining sleeve 228. Alternatively, the first retractable restraining sleeve 226 is advanced by advancing the second retractable sleeve 228 before the filter 212 is collapsed. In this alternative, the first retractable restraining sleeve 226 is located distal to the second retractable sleeve 228 with the catheter shaft 14 withdrawn from the aorta.

[0039] Figure 3 and Figure 4 A third embodiment of a valve system 310 having an integrated embolic filter assembly 312 on a catheter shaft 314 according to the present invention is shown. The embolic filter assembly includes a distal cylindrical or flat deflection member 312a (as described, for example, in US Pat. No. 8,114,114, the entire disclosure of which is incorporated herein by reference) deployed across the great vessels of the aortic arch AA and a separate conical or other capture basket 312b located downstream or proximal of the deflection member 312a in the descending aorta DA, such as Figure 4 The valve system 310 includes a prosthetic valve 320, which can be positioned and deployed in the patient's aortic valve V using a balloon-expandable or self-expandable technique as described above.

[0040] Figure 5A A fourth embodiment of a valve system 510 with an integrated embolic filter in accordance with the principles of the present invention is shown. The proximal portion 513 is flipped to form a flexible portion that can reversibly "roll up" to accommodate bi-directional axial movement of the catheter shaft 514 while maintaining the distal portion of the embolic filter statically against the vessel wall 516. This allows the proximal end of the embolic filter, which is secured to the delivery catheter at the attachment joint 517, to move with the catheter shaft 514 as the catheter is advanced and retracted to position the valve, for delivery without the distal filter portion moving and sliding along the vessel wall as the catheter is advanced and retracted. Comparison shows the filter 512 deployed within the aortic arch AA prior to deployment of the artificial aortic valve 520 Figure 5B 5 and showing the filter 512 after the artificial valve 520 is advanced to its deployed position within the native valve V. Figure 5C It is noted that the attachment joint 517 at the proximal end of the embolic filter 512 is advanced forward to allow the prosthetic valve 512 to be advanced into position without moving the body of the embolic filter covering the cerebral tributary vessels of the aortic arch AA. Figure 5DAs shown, after the valve 512 is deployed, the filter can be retracted into the deployment sleeve 526.

[0041] Figure 6 614 is a fifth embodiment of an embolic filter 612 according to the present invention, wherein the filter is mounted around a shaft 614 of a valve system 610 during initial delivery. After the filter 612 is deployed, the shaft 614 is free to pass through an access hole 616 that inhibits the release of embolic debris and accommodates a catheter. The filter 612 is secured in place and retracted with a bolting component 618 connected to the proximal end of the filter. The bolting component 618 can be rigid to allow proximal and distal repositioning and retrieval. Retrieval can be accomplished by pulling the filter into a separate lumen of a delivery system (not shown). A filter that can be retracted or retrieved by a mechanism such as a "purse string" ring 619 (shown) or extension of a support frame.

[0042] Figure 7 A sixth embodiment of a prosthetic valve and embolic filter 712 according to the present invention is shown, wherein a filter delivery sheath 726 is deployed and retrieved in a separate cavity 728 in a valve delivery catheter 730. The valve delivery catheter 730 also has a cavity for a valve delivery shaft 714, which carries a prosthetic valve 720. After the embolic filter 712 is deployed, the prosthetic valve 720 can be advanced through the embolic filter and to the valve implantation site. The filter catheter 726 can be advanced and retrieved independently, allowing it to be advanced in front of the valve catheter 714 to achieve deployment and positioning of the filter 720, and then withdrawn with the valve catheter advanced through the filter catheter and through the access hole of the filter screen or other filter material. After the deployment of the valve is completed, the valve catheter 714 can be withdrawn and the filter catheter 726 advanced to assist in the withdrawal of the filter screen or other filter material.

[0043] Figure 8 A seventh embodiment of an embolic filter 812 according to the present invention is shown, wherein the filter is mounted via two ends of a filter support structure 822. The filter support structure 822 may be, for example, a self-expanding cage attached to a delivery catheter 814. When deployed, the embolic filter 812 is open (disconnected from the filter screen) at its distal end and closed in the proximal direction for capture of debris. At least one of the proximal and distal ends of the filter support structure 822 is slidably attached to the delivery catheter 814 to allow radial opening and contraction. In some cases, both the proximal and distal ends of the support structure 822 are slidably attached to the catheter 814 to allow positioning of the balloon 818 and valve 820 after the filter 812 is deployed.

[0044] A tapered guide structure 827 ("funnel") at the end of the constraining sleeve 826 facilitates deployment and retrieval of the filter and support structure.

[0045] 9A to 9D An eighth embodiment of an embolic filter 912 according to the present invention is shown, wherein the artificial valve 920 and the filter 912 are balloon expandable. The embolic filter 912 is mounted to the most proximal balloon 916 of the double balloon catheter 914. The balloon expandable artificial valve 920 is mounted to the most distal balloon 922 of the catheter 914, and the valve may be, for example, an Edwards Lifesciences The deployment of the artificial valve 920 and the embolic filter 912 is achieved by a balloon, wherein the balloon is configured to be inflated and deflated, respectively. Fig.9A As shown, prior to deployment, the artificial valve 912 and the embolic filter 920 are crimped onto the balloon 916 and the balloon 922, respectively. Fig. 9B As shown, the deployment of filter 912 is achieved by the expansion of balloon 916. Then, the deployment of filter 920 is achieved by the expansion of balloon 922 ( Fig. 9C ), after the filter is deployed, balloon 922 is deflated. After the artificial valve is deployed, filter 912 remains in the expanded state, balloon 922 is deflated, and sleeve 926 (previously used to deploy the valve delivery system) is advanced to collapse filter 912 to allow the system to be removed.

[0046] Fig.10is a ninth embodiment of an embolic filter 1012 according to the present invention. The structure of the embolic filter 1012 is a self-supporting basket without an attached support frame. The deployment and retrieval of the embolic filter 1012 is achieved by retracting and advancing the restraining sleeve 1026, which is part of the delivery system of the balloon-expandable valve 1020. In this example, the deployment of the embolic filter 1012 is achieved by a self-expanding mechanism. The deployment of the artificial valve 1020 is achieved by the expansion of the deployment balloon 1022. The filter 1012 can be mounted to a separate filter deployment catheter 1014. The filter deployment catheter 1014 is deployed on the balloon catheter 1016 inside the restraining sleeve 1026. This configuration allows the balloon catheter to be advanced and withdrawn independently of the filter deployment catheter 1014 and related mechanisms. The deployment of the embolic filter 1012 can be completed by retracting the restraining sleeve 1026 or advancing the catheter 1014, releasing the embolic filter from the restraining sleeve. After the deployment of the filter is completed, the deployment of the artificial valve 1020 is completed by expanding the deployment balloon 1022. After the deployment of the valve 1020 is completed, the deployment balloon 1022 is deflated, and the embolic filter 1012 is collapsed by withdrawing the embolic filter into the restraining sleeve 1026 or advancing the restraining sleeve over the embolic filter. The above-mentioned components can also include a downstream or proximal stop component 1030 on the shaft of the catheter 1014 for limiting the proximal movement of the filter 1012 (in the case of being configured to slide on the shaft) on the shaft and an upstream or distal stop component 1032 on the shaft for limiting the distal movement of the filter.

[0047] The embolic filter can be a net or other filtering structure made of braided, woven or non-woven fibers, filaments or wires, the size of the holes of which is selected to allow blood to pass through and prevent emboli greater than a certain size from passing through. The embolic filter can also include a nonwoven layer, such as a thin layer of a perforated polymer or metal in a single or different size. The embolic filter material can be made of metal, polymer or a combination thereof, and optionally there can be an anti-thrombotic coating on its surface. The embolic filter can also include a perforated thin layer and a certain combination of a fiber-based net or other filter material or other filtering structure. The embolic filter can include one or more layers of the above-mentioned structure to improve filtration efficiency and reduce effective pore size.

[0048] The embolic protection device can be delivered in a non-deployed and non-retrieved condition. A tubular outer delivery sheath can be used to maintain the embolic protection device in a non-deployed condition ( FIG. 2A to FIG. 2DThe delivery catheter may optionally include a shoulder or stop feature located proximal to the embolic protection device to maintain the position of the embolic protection device on the catheter as the delivery sheath is withdrawn during deployment. Alternatively, deployment may be facilitated using a push catheter mounted between the catheter and the delivery sheath, e.g. Fig.10 The filter deployment catheter in the.

[0049] Alternatively, the filter can be deployed by inflation of a balloon within the filter, which can be cylindrical or conical, or other shape that matches the geometry of the filter, and the filter can be retracted or withdrawn into a retraction cannula (Fig. 9).

[0050] Another alternative delivery mechanism is to reduce the effective length of the embolic filter using components connected to the proximal or distal ends (or both). FIG. 2A to FIG. 2D In the embolic filter of the design shown in , longitudinal compression of the filter results in expansion of the structural diameter of the filter and final deployment of the filter. During retrieval, the filter can be stretched, thereby reducing its diameter and causing the filter to shrink. To achieve the above effect, two independent filter deployment catheters can be independently advanced and retracted to affect the change in length.

[0051] The catheter may be configured as a diagnostic catheter, a guide catheter, or a therapeutic catheter.One specific example is a delivery system for a transcatheter aortic valve.

[0052] The embolic filter generally has at least one open end and defines one or more internal collection areas to receive and capture emboli that enter with the blood through the open end. In other configurations, the embolic filter may include two open ends, for example, may have a cylindrical configuration that allows blood to flow in from one end and out from the other end.

[0053] In many embodiments, the filter is self-supporting in the deployed state. Self-supporting means that the filter membrane can be expanded without further support to form a three-dimensional configuration that maintains sufficient contact with the vessel wall to form an adequate seal to prevent emboli exceeding a certain size from being bypassed to the outside of the embolic protection device. In one example, an embolic filter can be made of an elastic mesh or other filter material that can be compressed to a non-deployed state and can self-expand to a deployed state. Such a structure is described in US9,877,821, which was previously incorporated herein by reference.

[0054] In another example, the embolic filter may include a filter membrane, a matrix or similar material and a separate support structure. The filter membrane may include any known structure for filtering emboli from blood, including a mesh, a perforated sheet, a porous sheet, a fibrous structure, and the like, or any combination thereof. The filter membrane may be elastic, relaxed, plastically deformable, or a combination thereof.

[0055] The support structure can be located outside the filter membrane, inside the filter membrane, or both outside and inside. For example, the support structure can include a frame including one or more longitudinal supports or annular structures that are attached to or otherwise engaged with the filter membrane to maintain the filter membrane in its open or expanded configuration in the presence of the aorta and other target vessels. The annular structures and / or supports can be made of elastic metals, polymers, or other materials, thereby providing a self-expanding frame that has a low profile and narrow morphology when delivered using a cannula constraint and has an expanded configuration or expanded configuration when released from the constraint. Alternatively, the frame or other support structure can include a ductile or plastically deformable material to achieve expansion by applying a radially outward force to the interior of the support structure, in typical cases, using an inflatable balloon or other expansion mechanism.

[0056] Hybrid configurations combining features of self-supporting structures and framework-supported structures may also be used. Hybrid deployment methods may also be used, for example, balloon-assisted self-expansion or longitudinal compression of the support structure.

[0057] The support structure and the filter membrane of the embolic filter often have the same length, but it is also possible to make an embolic filter using an embolic filter membrane that is longer or shorter than the support structure. The specific relative longitudinal dimensions of the filter membrane of the embolic filter are shown in the accompanying drawings. In another alternative configuration, the support structure and / or the filter membrane can be conical, and the enlarged end or base end of the cone is located on the upstream side.

[0058] After the diagnostic or interventional procedure is completed, the embolic filter can be retracted or withdrawn using a catheter. Optionally, the embolic filter can include features for withdrawing the device from the patient's aorta for retrieval. For example, a conical guide structure can be slidably attached to the catheter at the proximal end of the device, the purpose of which is to help keep the embolic filter in a retracted state when the retrieval sleeve is advanced along the conical guide structure. In another example, a tool such as a "purse string" or a lasso can be used to configure the retraction component around the periphery of the device to construct some parts of the embolic filter. A push ring or other graspable structure close to the downstream end of the embolic filter is connected to the retraction component with one or more connecting components. In a preferred embodiment, during the retrieval process, the embolic filter is configured to first close its upstream end to ensure that any captured emboli will not migrate out of the filter. Such a function can be accomplished by providing one or more pull rings for selectively retracting different parts of the device. Suture material, wire, plastic fiber or a combination of these materials can be used to make the retraction component and the connecting component. In an alternative configuration, the "cradle-like" support structure described above may also be configured for retracting components.

[0059] The embolic filter may be fixedly attached to the catheter, attached by a slidable attachment, or some combination of the two. The slidable attachment may include one or two rings, ball bearings, or other structures that allow the embolic protection device to slide freely on the catheter. The slidable attachment preferably has a low coefficient of friction and / or a lubricious coating so that movement of the catheter through the slidable attachment does not squeeze or dislodge the embolic protection device. Alternatively, the slidable attachment may include additional sealing components, such as elastic flaps, iris structures, or expandable sealing materials.

[0060] Preferably, the overall undeployed diameter of the collapsed embolic filter for delivery (including the diameter of its constraining sheath) is no larger than the largest portion of the catheter (e.g., the collapsed diameter of the prosthetic valve, including its constraining sheath), the largest portion of the catheter most likely being the distal portion of the catheter. In the case of a valve delivery system, the size of the catheter typically decreases proximal to the valve, which allows integration of the embolic filter with its constraining components without changing the overall trajectory profile of the valve delivery system.

[0061] The embolic filter is in a non-deployed state on the catheter when inserted into the patient's aorta. Ideally, the embolic filter is deployed in the ascending aorta in front of the entrance of the cerebral arteries. Optionally, a delivery sheath can be used to maintain the embolic filter in the non-deployed position. Constraining the embolic filter for delivery can be achieved by crimping the embolic filter on a balloon catheter or stretching its support structure to reduce its diameter.

[0062] In order to reduce the possibility of formation of clots that may become potential embolic, an anti-thrombotic coating, such as a bound heparin coating, may be applied to the entire embolic filter or a portion thereof. Alternatively or additionally, the embolic filter or a portion thereof may have a drug eluting coating containing an anti-inflammatory or anti-stenotic agent. The embolic filter of the present invention may also be used to protect against embolism in other organ systems. For example, an embolic filter may be deployed in the descending aorta of a patient to prevent embolic particles from entering the renal arteries from the aortic blood flow and preventing embolism from forming in the patient's kidneys.

[0063] Although preferred embodiments of the present invention have been shown and described herein, it will be readily appreciated by those skilled in the art that these embodiments are provided by way of example only. Various changes, modifications and substitutions may be envisioned by those skilled in the art without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention may be employed in the process of implementing the present invention. It is intended that the scope of the present invention be defined by the following claims, and that methods and structures and their equivalents within the scope of these claims be covered thereby.

Claims

1. An artificial heart valve delivery catheter with integrated embolic protection function, the catheter comprising: a catheter shaft having a distal portion; an artificial valve disposed at the distal portion of the catheter shaft; as well as an embolic filter disposed at the distal portion of the shaft at a location proximal to the prosthetic valve, the embolic filter having a collapsed configuration and an expanded configuration, wherein an outer edge of the filter is configured to contact a vessel wall; wherein the embolic filter comprises a filtering structure having a narrow end coupled to the shaft and an open end located distal to the narrow end; and The narrow end of the filtering structure is slidably mounted to the catheter shaft so that the catheter shaft can be advanced and retracted relative to the embolic filter to reposition the artificial valve relative to the embolic filter after the embolic filter has been deployed in a blood vessel.

2. The catheter of claim 1, further comprising a proximal stop member on the catheter shaft for limiting proximal movement of the embolic filter on the distal portion of the catheter shaft.

3. The catheter of claim 2, further comprising a distal stop member on the catheter shaft for limiting distal movement of the embolic filter on the distal portion of the catheter shaft. The catheter of claim 1 , wherein the filter comprises a filter membrane and a support structure.

5. The catheter of claim 4, wherein the support structure comprises a plurality of self-expanding axial supports connected at their proximal ends to the catheter shaft so as to open the distal end of the filter to form a cone when released from constraint.

6. The catheter of claim 5, wherein the axial support has an atraumatic distal tip.

7. The catheter of claim 1, wherein the filter comprises a self-expanding conical filter.

8. The catheter of claim 1, wherein the embolic filter comprises a porous material comprising a braided, woven or non-woven fabric of fibers, filaments or threads. 9 . The catheter according to claim 8 , wherein the porous material is made of elastic metal, polymer material, ductile material, plastic deformation material, shape memory material or a combination thereof.

10. The catheter of claim 8, wherein the porous material has a pore size selected to prevent passage of emboli exceeding a predetermined size.

11. A system comprising: The catheter of claim 1; and An outer delivery sheath is configured to maintain the embolic filter in a collapsed configuration.

12. A prosthetic heart valve delivery catheter with integrated embolic protection, the catheter comprising: a catheter shaft having a distal portion; an artificial valve disposed at the distal portion of the catheter shaft; as well as an embolic filter disposed at the distal portion of the shaft at a location proximal to the prosthetic valve, the embolic filter having a collapsed configuration and an expanded configuration, wherein an outer edge of the filter is configured to contact a vessel wall; wherein the embolic filter comprises a filter membrane and a support structure, wherein the support structure comprises a cage having a distal hoop structure and a proximal hoop structure attached to the distal portion of the catheter shaft; and Wherein the cage comprises a plurality of continuous struts extending between the proximal hoop structure and the distal hoop structure.

13. The catheter of claim 12, wherein at least one of the proximal hoop structure and the distal hoop structure is slidably attached to the distal portion of the catheter shaft.

14. The catheter of claim 12, wherein at least one of the proximal hoop structure and the distal hoop structure is fixedly attached to the distal portion of the catheter shaft.

15. The catheter of claim 12, wherein at least one of the distal hoop structure and the proximal hoop structure is configured to translate axially to expand and contract the cage.

16. The catheter of claim 12, wherein the cage is self-expanding, enabling it to be radially constrained for delivery and released from radial constraint for deployment.

17. The catheter of claim 12, wherein the cage has a tapered distal end, a tapered proximal end, and a cylindrical wall portion therebetween, wherein the filter membrane covers at least the tapered proximal end and does not cover the tapered distal end.

18. A prosthetic heart valve delivery catheter with integrated embolic protection, the catheter comprising: a catheter shaft having a distal portion; an artificial valve disposed at the distal portion of the catheter shaft; as well as an embolic filter disposed at the distal portion of the shaft at a location proximal to the prosthetic valve, the embolic filter having a collapsed configuration and an expanded configuration, wherein an outer edge of the filter is configured to contact a vessel wall; wherein the embolic filter comprises a cylindrical wall portion and a tapered wall portion, the cylindrical wall portion being located proximal to the artificial valve and configured to cover a branch vessel of the patient's aorta, the tapered wall portion being proximal to the cylindrical wall portion; The tapered wall portion has a proximal end slidably attached to the catheter shaft so that the catheter shaft can be advanced and retracted relative to the embolic filter to reposition the prosthetic valve relative to the embolic filter after the embolic filter has been deployed in a blood vessel.

19. The catheter of claim 18, wherein the cylindrical wall portion is discontinuous with the conical wall portion.

20. The catheter of claim 18, wherein at least one of a cylindrical wall portion and the tapered wall portion is fixedly attached to the distal end portion of the catheter shaft.

21. The catheter of claim 18, wherein at least one of a cylindrical wall portion and the tapered wall portion is slidably attached to the distal end portion of the catheter shaft.

22. The catheter of claim 18, wherein at least one of the cylindrical wall portion and the conical wall portion is self-expanding.

23. The catheter of claim 18, wherein at least one of the cylindrical wall portion and the conical wall portion is balloon expandable.

24. A prosthetic heart valve delivery catheter with integrated embolic protection, the catheter comprising: a catheter shaft having a distal portion; an artificial valve disposed at the distal portion of the catheter shaft; as well as an embolic filter disposed at the distal portion of the shaft at a location proximal to the prosthetic valve, the embolic filter having a collapsed configuration and an expanded configuration, wherein an outer edge of the filter is configured to contact a vessel wall; The embolic filter comprises a cylindrical wall having an open distal end not attached to the catheter shaft and a closed proximal end, the closed proximal end being sealingly coupled to the catheter shaft, wherein a proximal region of the cylindrical wall is movably flippable and allows the open distal end to translate axially relative to the catheter shaft while the closed proximal end remains stationary relative to the catheter shaft.

25. The catheter of claim 24, wherein the closed proximal end is secured to the catheter shaft.

26. The catheter of claim 24, wherein the closed proximal end is slidably coupled to the catheter shaft.

27. The catheter of claim 24, wherein at least the distal portion of the cylindrical wall is self-expanding.

28. The catheter of claim 24, wherein at least the distal portion of the cylindrical wall comprises a self-expanding filter.

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