Catheter with integrated embolic protection device

Abstract

To provide a catheter with a preferable integrated embolic protection device.SOLUTION: An artificial heart valve delivery catheter includes an embolic filter for providing integrated embolic protection in order to prevent embolus release into aorta, aortic arch or branched vessel, and other vascular systems during transvascular heart valve replacement procedure. Normally, the embolic filter will be attached fixedly or movably to a shaft of the delivery catheter proximal to the artificial heart valve.SELECTED DRAWING: Figure 10

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of prior provisional patent application Ser. No. 62 / 844,941 (Attorney Docket No. 41959-714.102), filed May 8, 2019, and Ser. No. 62 / 804,909 (Attorney Docket No. 41959-714.101), filed February 13, 2019, the entire disclosures of which are incorporated herein by reference.

[0002] The present invention relates to devices and methods for providing embolic protection within a patient's vasculature, and in particular to catheters intended for transcatheter heart valve delivery and other transvascular interventional procedures that incorporate embolic filters. [Background technology]

[0003] Cerebral embolism is a known complication of cardiac surgery, cardiopulmonary bypass and catheter-based interventional cardiology, and electrophysiology procedures. Embolic particles, which may include thrombus, atheroma, and lipids, may become dislodged by surgery or catheter manipulation, enter the bloodstream, and embolize in the brain or other vital organs downstream. Cerebral embolism can lead to neuropsychological deficits, stroke, and even death. Other downstream organs may also be damaged by embolism, resulting in functional impairment or organ failure.

[0004] Prevention of embolism would benefit patients and improve the outcomes of these procedures. Given that potential emboli are often liberated during catheter-based procedures, it would be advantageous to deploy an embolic protection system as part of a catheter-based vascular procedure, such as transcatheter aortic valve replacement (TAVR). Furthermore, the use of transcranial Doppler (TCD) during TAVR has shown that cerebral emboli primarily occur during the procedural steps of traversing the native valve and deploying the TAVR valve (see Kahlert, et al., Circulation, 2012). Therefore, integration of an embolic protection device onto the TAVR delivery system itself would have the advantage of providing protection for the most risky step of the procedure. Another advantage would arise from integrating an embolic protection system onto the catheter itself used to perform the procedure, such as a transcatheter valve delivery system or electrophysiology catheter. Other embolic protection systems require separate procedural steps to install the protector prior to an interventional or diagnostic procedure and to remove it after the procedure. In many cases, a different access site is required as well. The present invention avoids both the need for an extra step and an extra access site. Yet another advantage would result from providing an integrated embolic protection device that does not increase the overall diameter of the catheter.

[0005] Devices for preventing embolism and similar events are described in the following patents and patent applications (incorporated herein by reference): U.S. Pat. No. 10,166,094, U.S. Pat. No. 9,877,821, U.S. Pat. No. 9,744,023, U.S. Pat. No. 9,144,485, U.S. Pat. No. 8,968,354, U.S. Pat. No. 8,740,930, U.S. Pat. No. 8,420,902, U.S. Pat. No. 8,383,788, U.S. Pat. No. 8,337,519, U.S. Pat. No. 8,123,779, U.S. Pat. No. 8,052,717, U.S. Pat. No. 7,537,600, U.S. Pat. No. 7,044,958, U.S. Pat. No. 6,537,297, U.S. Pat. No. 6,499,487, U.S. Pat. No. 6,371,935, U.S. Pat. No. US Patent No. 6,361,545, US Patent No. 6,254,563, US Patent No. 6,139,517, US Patent No. 5,769,816, US Patent Application No. 2019 / 0015152, US Patent Application No. 2018 / 0206970, US Patent Application No. 2018 / 0042390, US Patent Application No. 2016 / 0317277, US Patent Application No. 2015 / 0366650, US US Patent Application No. 2014 / 0214069, US Patent Application No. 2013 / 267993, US Patent Application No. 2012 / 271340, US Patent Application No. 2010 / 0312268, US Patent Application No. 2010 / 0010535, US Patent Application No. 2004 / 0215167, US Patent Application No. 2003 / 0100940, and PCT Application No. WO2004 / 019817. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 10,166,094 Summary of the Invention [Means for solving the problem]

[0007] A prosthetic heart valve delivery catheter with integrated embolic protection according to the principles of the present invention prevents the release of emboli into the aorta, aortic arch or branch vessels, and other vasculature during transvascular prosthetic heart valve replacement procedures, protecting the brain and other downstream organs from embolization. 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 a prosthetic heart valve delivery catheter system with integrated embolic protection. The catheter system typically includes a catheter shaft having a distal portion, a prosthetic valve disposed on the distal portion of the catheter shaft, and an embolic filter disposed on the distal portion of the shaft at a location proximal to the prosthetic valve. The embolic filter has a collapsed configuration and a deployed configuration, and the outer periphery of the filter is configured to contact the vessel wall in the expanded configuration. In some embodiments, the embolic filter includes a filter 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 filter structure may be fixedly attached to the catheter shaft. In an alternative embodiment, the narrow end of the filter structure is slidably mounted on the catheter shaft. The catheter may further include at least one of a proximal stop on the catheter shaft for limiting proximal movement of the embolic filter on the distal portion of the catheter shaft and a distal stop on the catheter shaft for limiting distal movement of the embolic filter on the distal portion of the catheter shaft.

[0010] In a further specific embodiment, the filter may comprise a filter membrane and a support structure. The support structure may comprise a plurality of self-expanding axial struts connected at their proximal ends to the catheter shaft so as to open the distal end of the filter element and form a cone upon release from constraint. The axial struts may have atraumatic distal tips.

[0011] In other embodiments, the filter may comprise a self-expanding conical filter. For example, the embolic filter may comprise a porous material comprising a knitted, woven, or nonwoven fabric, filament, or wire. The porous material may be made of a resilient metal, polymeric material, malleable material, plastically deformable material, shape-memory material, or a combination thereof. The porous material will typically have a pore size selected to prevent emboli above a predetermined size from passing through.

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

[0013] In a third aspect, the present invention provides a prosthetic heart valve delivery catheter with integrated embolic protection. The prosthetic heart valve delivery catheter typically includes a catheter shaft having a distal portion, a prosthetic valve disposed on the distal portion of the catheter shaft, and an embolic filter disposed on the distal portion of the shaft at a location proximal to the prosthetic valve. The embolic filter typically has a collapsed configuration and a deployed configuration, and in the expanded configuration, the outer periphery of the filter contacts the vessel wall. The embolic filter typically includes a filter membrane and a support structure, the support structure including a cage having a distal collar attached to the distal portion of the catheter shaft and a proximal collar.

[0014] In a specific embodiment, at least one of the distal collar and the proximal collar is slidably attached to the distal portion of the catheter shaft. In other embodiments, at least one of the distal collar and the proximal collar is fixedly attached to the distal portion of the catheter shaft. For example, at least one of the distal collar and the proximal collar is fixedly attached to the distal portion of the catheter shaft. In other examples, at least one of the distal collar and the proximal collar is configured to be axially translated to expand and contract the cage. Typically, the cage is self-expanding so that it can be radially constrained for delivery and released from the radial constrain for deployment. In yet a further example, the cage has a conically elongated distal end, a conically elongated proximal end, and a cylindrical wall portion therebetween, and the filter membrane covers at least the conically elongated proximal end but does not cover the conically elongated distal end.

[0015] In a fourth aspect, the present invention provides a prosthetic heart valve delivery catheter with integrated embolic protection. The catheter includes a catheter shaft having a distal portion, a prosthetic valve disposed on the distal portion of the catheter shaft, and an embolic filter disposed on the distal portion of the shaft at a location proximal to the prosthetic valve. The embolic filter typically has a folded configuration and a deployed configuration, with the outer periphery of the filter configured to contact the vessel wall. The embolic filter also typically further includes a cylindrical wall portion located proximal to the prosthetic valve and configured to cover the patient's aortic branch vessel, and a conical wall portion proximal to the cylindrical wall portion.

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

[0017] In a fifth aspect, the present invention provides a prosthetic heart valve delivery catheter with integrated embolic protection, the catheter comprising: a catheter shaft having a distal portion; a prosthetic valve disposed on the distal portion of the catheter shaft; and an embolic filter disposed on the distal portion of the shaft at a location proximal to the prosthetic valve. The embolic filter typically has a folded configuration and a deployed configuration, with the outer periphery of the filter configured to contact the vessel wall. The embolic filter also typically further comprises a cylindrical wall having an open distal end and a closed proximal end sealingly coupled to the catheter shaft, the proximal region of the cylindrical wall being movably everted to allow 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 a specific embodiment, the closed proximal end is fixed to the catheter shaft.

[0019] For example, the closed proximal end can be slidably coupled to the catheter shaft. At least a distal portion of the cylindrical wall can be self-expanding, and at least a distal portion of the cylindrical wall can include a self-expanding filter. The present specification also provides, for example, the following items: (Item 1) 1. A prosthetic heart valve delivery catheter with integrated embolic protection, said catheter comprising: a catheter shaft having a distal portion; a prosthetic valve disposed on the distal portion of the catheter shaft; an embolic filter positioned on the distal portion of the shaft at a location proximal to the prosthetic valve; Equipped with the embolic filter has a folded configuration and a deployed configuration, and an outer periphery of the filter is configured to contact a vessel wall; The catheter, wherein the embolic filter comprises a filter structure having a narrow end coupled to the shaft and an open end distal to the narrow end. (Item 2) Item 1. The catheter of item 1, wherein the narrow end of the filter structure is fixedly attached to the catheter shaft. (Item 3) Item 1. The catheter of item 1, wherein the narrow end of the filter structure is slidably mounted on the catheter shaft. (Item 4) 4. The catheter of claim 3, further comprising a proximal stop on the catheter shaft, the proximal stop limiting proximal movement of the embolic filter on the distal portion of the catheter shaft. (Item 5) 5. The catheter of claim 4, further comprising a distal stop on the catheter shaft, the distal stop limiting distal movement of the embolic filter on the distal portion of the catheter shaft. (Item 6) Item 1, wherein the filter comprises a filter membrane and a support structure. (Item 7) 7. The catheter of claim 6, wherein the support structure comprises a plurality of self-expanding axial struts connected at their proximal ends to the catheter shaft and, upon release from a constraint, opening the distal end of the filter member to form a cone. (Item 8) 8. The catheter of item 7, wherein the axial strut has an atraumatic distal tip. (Item 9) Item 10. The catheter of item 1, wherein the filter comprises a self-expanding conical filter. (Item 10) Item 10. The catheter of item 1, wherein the embolic filter comprises a porous material comprising a knitted, woven, or nonwoven fabric, filament, or wire. (Item 11) Item 11. The catheter of item 10, wherein the porous material is made from a resilient metal, a polymeric material, a malleable material, a plastically deformable material, a shape memory material, or a combination thereof. (Item 12) Item 11. The catheter of item 10, wherein the porous material has a pore size selected to prevent emboli exceeding a predetermined size from passing therethrough. (Item 13) 1. A system comprising: The catheter according to item 1; an outer delivery sheath configured to maintain the embolic filter in a collapsed configuration; A system comprising: (Item 14) 1. A prosthetic heart valve delivery catheter with integrated embolic protection, said catheter comprising: a catheter shaft having a distal portion; a prosthetic valve disposed on the distal portion of the catheter shaft; an embolic filter positioned on the distal portion of the shaft at a location proximal to the prosthetic valve; Equipped with the embolic filter has a folded configuration and a deployed configuration, and an outer periphery of the filter is configured to contact a vessel wall; A catheter, wherein the embolic filter comprises a filter membrane and a support structure, the support structure comprising a cage, the cage having a distal collar and a proximal collar attached to the distal portion of the catheter shaft. (Item 15) Item 1, wherein at least one of the distal collar and the proximal collar is slidably attached to the distal portion of the catheter shaft. (Item 16) Item 10. The catheter of item 1, wherein at least one of the distal collar and the proximal collar is fixedly attached to the distal portion of the catheter shaft. (Item 17) Item 10. The catheter of item 1, wherein at least one of the distal collar and the proximal collar is fixedly attached to the distal portion of the catheter shaft. (Item 18) Item 10. The catheter of item 1, wherein at least one of the distal collar and the proximal collar is configured to be axially translated to expand and contract the cage. (Item 19) Item 14. The catheter of item 1, wherein the cage is self-expanding such that it can be radially constrained for delivery and released from radial constraint for deployment. (Item 20) Item 1. The catheter of item 1, wherein the cage has a conically elongated distal end, a conically elongated proximal end, and a cylindrical wall portion therebetween, and the filter membrane covers at least the conically elongated proximal end but does not cover the conically elongated distal end. (Item 21) 1. A prosthetic heart valve delivery catheter with integrated embolic protection, said catheter comprising: a catheter shaft having a distal portion; a prosthetic valve disposed on the distal portion of the catheter shaft; an embolic filter positioned on the distal portion of the shaft at a location proximal to the prosthetic valve; Equipped with the embolic filter has a folded configuration and a deployed configuration, and an outer periphery of the filter is configured to contact a vessel wall; The catheter, wherein the embolic filter is positioned proximal to the prosthetic valve and comprises a cylindrical wall portion configured to cover an aortic branch vessel of the patient, and a conical wall portion proximal to the cylindrical wall portion. (Item 22) 22. The catheter of item 21, wherein the cylindrical wall portion and the conical wall portion are not continuous. (Item 23) 22. The catheter of claim 21, wherein at least one of the cylindrical wall portion and the conical wall portion is fixedly attached to the distal portion of the catheter shaft. (Item 24) 22. The catheter of claim 21, wherein at least one of the cylindrical wall portion and the conical wall portion is slidably attached to the distal portion of the catheter shaft. (Item 25) 22. The catheter of claim 21, wherein at least one of the cylindrical wall portion and the conical wall portion is self-expanding. (Item 26) Item 10. The catheter of item 1, wherein at least one of the cylindrical wall portion and the conical wall portion is balloon expandable. (Item 27) 1. A prosthetic heart valve delivery catheter with integrated embolic protection, said catheter comprising: a catheter shaft having a distal portion; a prosthetic valve disposed on the distal portion of the catheter shaft; an embolic filter positioned on the distal portion of the shaft at a location proximal to the prosthetic valve; Equipped with the embolic filter has a folded configuration and a deployed configuration, and an outer periphery of the filter is configured to contact a vessel wall; The catheter includes an embolic filter having a cylindrical wall with an open distal end and a closed proximal end sealingly coupled to the catheter shaft, the proximal region of the cylindrical wall being movably everted to allow the open distal end to translate axially relative to the catheter shaft while the closed proximal end remains stationary relative to the catheter shaft. (Item 28) Item 28. The catheter of item 27, wherein the closed proximal end is fixed to the catheter shaft. (Item 29) Item 28. The catheter of item 27, wherein the closed proximal end is slidably coupled to the catheter shaft. (Item 30) Item 14. The catheter of item 1, wherein at least the distal portion of the cylindrical wall is self-expanding. (Item 31) Item 14. The catheter of item 1, wherein at least the distal portion of the cylindrical wall comprises a self-expanding filter. (Incorporated by reference)

[0020] 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 explanation of the drawings]

[0021] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings.

[0022] [Figure 1-1] 1A-1D illustrate a first embodiment of a valve delivery system according to the present invention involving a balloon-deployable prosthetic heart valve with integrated embolic protection. [Figure 1-2]1A-1D illustrate a first embodiment of a valve delivery system according to the present invention involving a balloon-deployable prosthetic heart valve with integrated embolic protection.

[0023] [Figure 2] 2A-2D show a second embodiment of a valve delivery system according to the present invention involving a self-expanding prosthetic heart valve with integrated embolic protection.

[0024] [Figure 3] FIG. 3 illustrates a third embodiment of a valve delivery system according to the present invention with integrated embolic protection including both an embolic deflector element and a separate embolic capture element.

[0025] [Figure 4] FIG. 4 illustrates the valve delivery system of FIG. 3 deployed in the aortic arch with a prosthetic aortic valve implanted within the native aortic valve.

[0026] [Figure 5A] 5A-5D show a fourth embodiment of a valve delivery system according to the present invention having an elongated cylindrical filter mesh deployed over the aortic arch during delivery of a prosthetic aortic valve into the native aortic valve. [Figure 5B] 5A-5D show a fourth embodiment of a valve delivery system according to the present invention having an elongated cylindrical filter mesh deployed over the aortic arch during delivery of a prosthetic aortic valve into the native aortic valve. [Figure 5C] 5A-5D show a fourth embodiment of a valve delivery system according to the present invention having an elongated cylindrical filter mesh deployed over the aortic arch during delivery of a prosthetic aortic valve into the native aortic valve. [Figure 5D] 5A-5D show a fourth embodiment of a valve delivery system according to the present invention having an elongated cylindrical filter mesh deployed over the aortic arch during delivery of a prosthetic aortic valve into the native aortic valve.

[0027] [Figure 6]FIG. 6 illustrates a fifth embodiment of a valve delivery system according to the present invention having an embolic filter mounted around the valve system catheter during initial delivery.

[0028] [Figure 7] Figure 7 shows a sixth embodiment of a valve delivery system according to the present invention having a prosthetic valve similar to that of Figure 6 and an embolic filter, in which the filter delivery sheath is deployed and retrieved via a separate catheter within a separate lumen of the valve delivery catheter located adjacent to the catheter containing the prosthetic valve.

[0029] [Figure 8] FIG. 8 illustrates a seventh embodiment of a valve delivery system according to the present invention having an embolic filter mounted on a valve delivery system in which both ends of a support structure are attached to a delivery catheter.

[0030] [Figure 9-1] 9A-9D illustrate an eighth embodiment of a valve delivery system according to the present invention that is similar to the valve delivery system of FIG. [Figure 9-2] 9A-9D illustrate an eighth embodiment of a valve delivery system according to the present invention that is similar to the valve delivery system of FIG.

[0031] [Figure 10] FIG. 10 shows a ninth embodiment of a valve delivery system according to the present invention similar to that of FIG. 1 in which the embolic filter comprises a free-standing mesh basket without an additional support frame. DETAILED DESCRIPTION OF THE INVENTION

[0032] For purposes of this patent application, the term "distal" refers to the end of the device furthest 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 nearest the operator and farthest from the heart, toward the access site where the device is introduced into the body. This is also the "downstream" direction of blood flow.

[0033] 1A-1D illustrate an integrated valve system 10 with integrated embolic protection according to the present invention. A self-expanding conical embolic filter 12 is mounted on the shaft 14 of a balloon valve delivery catheter, which has a balloon-expandable prosthetic heart valve 20 mounted on a distal balloon 18. The balloon-expandable aortic valve may be any one of various available and proposed balloon-expandable heart valves, such as the Edwards Sapien® valve. The conical embolic filter 12 may be mounted on the catheter shaft 14 using either a fixed or sliding mount. Fixed mounts simplify both the assembly and deployment protocol but limit the ability to adjustably position the conical filter relative to the aortic valve during delivery. When fixedly mounted, the distal end of the conical filter is positioned 1 cm to 20 cm proximal to the proximal end of the prosthetic valve 20, typically 1 cm to 10 cm proximal to the proximal end of the prosthetic valve. When slidably attached, the distal end of the conical filter can be adjusted to be positioned 1 cm to 30 cm proximal to the proximal end of the prosthetic valve 20 (before or during deployment), and typically can be located 1 cm to 20 cm proximal to the proximal end of the prosthetic valve.

[0034] The self-expanding conical embolic filter 12 typically comprises a mesh or other filter material having a mesh size suitable for emboli capture and a self-expanding support structure, such as a plurality of radially self-expanding struts 22, to ensure full expansion of the mesh or other filter material. As shown, the radially self-expanding struts 22 have atraumatic distal tips for contacting the aortic wall; for example, the distal ends of the struts may be curved, coiled, have protective padding, or have other structure to prevent tissue injury.

[0035] The self-expanding conical embolic filter 12 is typically deployed by retracting the constraining sheath 26 (compare FIGS. 1A and 1B), and may be collapsed by advancing the constraining sheath and / or retracting the catheter shaft 14 (compare FIGS. 1C and 1D). Optionally, after deployment of the valve 20, a constraining sheath may be used to cover the deflated balloon 18 and conical filter (FIG. 1D).

[0036] 2A-2D show a second embodiment of a valve system 210 according to the present invention having an embolic filter 212 integrated onto a catheter shaft 214. The integrated valve system 210 is adapted to deliver a self-expanding prosthetic valve 220, such as a Medtronic CoreValve® heart valve, mounted on the distal end of the catheter shaft 214. The self-expanding prosthetic valve 220 is initially constrained for delivery by a first retractable constraining sheath 226, and the embolic filter 212 is initially constrained for delivery by a second retractable sheath 228.

[0037] After positioning first constraining sheath 226 and prosthetic valve 220 within aortic valve V, filter 212 is deployed by retraction of second sheath 228, which allows the filter to expand ( FIG. 2B ). Prosthetic valve 220 is then deployed by retraction of second retractable sheath 228 ( FIG. 2C ). After valve deployment, second retractable sheath 228 is advanced to collapse filter 212 and first sheath 226 for removal of the system. As shown in FIG. 2D , first constraining sheath 226 can be collapsed into collapsed filter 212, which is then collapsed into second constraining sheath 228. Alternatively, first retractable constraining sheath 226 can be advanced prior to collapsing filter 212 by advancement of second retractable sheath 228. In this alternative, the first constraining sheath 226 would reside distally from the second retractable sheath 228 as the catheter shaft 14 is withdrawn from the aorta.

[0038] Figures 3 and 4 illustrate a third embodiment of a valve system 310 according to the present invention having an embolic filter assembly 312 integrated onto a catheter shaft 314. The embolic filter assembly, as shown in Figure 4, comprises a distal cylindrical or panel-shaped deflector 312a (e.g., as described in U.S. Pat. No. 8,114,114, the entire disclosure of which is incorporated herein by reference) that is deployed across the great vessel of the aortic arch AA, and a separate conical or other capture basket 312b that is placed downstream or proximal of the deflector 312a in the descending aorta DA. The valve system 310 may include a prosthetic valve 320 that may be positioned and deployed within a patient's aortic valve V using either the balloon-expanding or self-expanding protocols previously described.

[0039] Figure 5A shows a fourth embodiment of a valve system 510 with an integrated embolic filter in accordance with the principles of the present invention. The proximal portion 513 everts to form a flexible section that can be reversibly "rolled" to accommodate bidirectional axial movement of the catheter shaft 514, while the distal portion 516 of the embolic filter remains stationary relative to the vessel wall. This allows the proximal end of the embolic filter (which is secured to the delivery catheter at attachment joint 517) to move with the catheter shaft 514 as the catheter is advanced and retracted to position the valve for delivery, without requiring the distal filter portion to move and slide along the vessel wall as the catheter is advanced and retracted. Compare Figure 5B, which shows the filter 512 deployed in the aortic arch AA prior to deployment of the prosthetic aortic valve 520, with Figure 5C, which shows the filter 512 after the prosthetic valve 520 has been advanced to its deployed position within the native valve V. Note that the attachment joint 517 at the proximal end of the embolic filter 512 is advanced forward, allowing the prosthetic valve 512 to be advanced into position without displacing the main body of the embolic filter over the cerebral branch vessels of the aortic arch AA. After deployment of the valve 512, the filter can be retracted back into the deployment sheath 526, as shown in FIG. 5D.

[0040] FIG. 6 shows a fifth embodiment of an embolic filter 612 according to the present invention, in which the filter is mounted around the shaft 614 of a valve system 610 catheter during initial delivery. After deployment of the filter 612, the shaft 614 is free to move through an access port 616, which accommodates the catheter but prevents the release of embolic debris. The filter 612 is held in place and retrieved using a tether 618 that connects to the proximal end of the filter. The tether 618 can be rigid to allow both proximal and distal repositioning and retrieval. Retrieval can be accomplished by pulling the filter into a separate lumen of the delivery system (not shown). The filter can be collapsed for retrieval via mechanisms such as a "purse string" loop 619 (shown) or an extension of the support frame.

[0041] 7 illustrates a sixth embodiment of an embolic filter 712 according to the present invention in which a filter delivery sheath 726 is deployed and retrieved through a separate lumen 728 within a valve delivery catheter 730. The valve delivery catheter 730 also has a lumen for a valve delivery shaft 714 that carries a prosthetic valve 720. Upon deployment of the embolic filter 712, the prosthetic valve 720 can be advanced through the embolic filter and to the valve implantation site. The filter catheter 726 can be independently advanced and retracted, such that the filter catheter 726 can be advanced ahead of the valve catheter 714 for deployment and positioning of the filter 720, and then withdrawn while the valve catheter is advanced through the access port of the filter mesh or other filter material beyond the filter catheter. After valve deployment, the valve catheter 714 is withdrawn, and the filter catheter 726 can be advanced to assist in retrieval of the filter mesh or other filter material.

[0042] FIG. 8 shows a seventh embodiment of an embolic filter 812 according to the present invention, mounted with both ends of a filter support structure 822, such as a self-expanding cage, attached to a delivery catheter 814. When deployed, the embolic filter 812 is opened on its distal end (free of the filter mesh) and closed proximally for debris capture. At least one of the proximal or distal ends of the filter support structure 822 is slidably attached to the delivery catheter 814, allowing for radial opening and collapse. In some cases, both the distal and proximal ends on the support structure 822 will be slidably attached to the catheter 814, allowing the balloon 818 and valve 820 to be positioned after the filter 812 is deployed. A conical guiding structure 827 ("funnel") at the end of the restraining sheath 826 aids in the deployment and retrieval of the filter and support structure.

[0043] Figures 9A-9D show an eighth embodiment of an embolic filter 912 according to the present invention, in which both the prosthetic valve 920 and the filter 912 are balloon-expandable. The embolic filter 912 is mounted on the proximal-most balloon 916 of a dual-balloon catheter 914. A balloon-expandable prosthetic valve 920, such as the Edwards Lifesciences Sapien® valve, is mounted on the distal-most balloon 922 on the catheter 914. Both the prosthetic valve 920 and the embolic filter 912 are therefore deployed by balloons, which are configured to be inflated and deflated separately. As shown in Figure 9A, prior to deployment, the prosthetic valve 912 and the embolic filter 920 are crimped onto the balloons 916 and 922, respectively. As shown in Figure 9B, the filter 912 is deployed by inflation of the balloon 916. The filter 920 is then deployed by inflating the balloon 922 (Figure 9C), which is deflated once the filter is deployed. After deployment of the valve, while the filter 912 remains expanded, the balloon 922 is deflated and the sheath 926 (previously used to deploy the valve delivery system) is advanced, collapsing the filter 912 and allowing removal of the system.

[0044] FIG. 10 illustrates a ninth embodiment of an embolic filter 1012 in accordance with the present invention. The embolic filter 1012 is a free-standing mesh basket without an additional support frame. It is deployed and retrieved by retraction and advancement of a constraining sheath 1026 that is part of a delivery system for a balloon-expandable valve 1020, such as the Edwards Lifesciences Sapien® valve. In this example, the embolic filter 1012 is deployed via a self-expanding mechanism, whereas the prosthetic valve 1020 is deployed via inflation of the deployment balloon 1022. The filter 1012 may be mounted on a separate filter deployment catheter 1014 that is deployed over the balloon catheter 1016, but inside the constraining sheath 1026. This configuration allows the balloon catheter 1016 to be advanced and withdrawn independently of the filter deployment catheter 1014 and associated mechanisms. The embolic filter 1012 may be deployed by either retraction of the constraining sheath 1026 or advancement of the catheter 1014, releasing the embolic filter from the constraining sheath. After filter deployment, the prosthetic valve 1020 is deployed by inflation of the deployment balloon 1022. After the valve 1020 is deployed, the deployment balloon 1022 is deflated and the embolic filter 1012 is collapsed by either retracting the embolic filter into the constraining sheath 1026 or advancing the constraining sheath over the embolic filter. It may further include a downstream or proximal stop 1030 on the shaft of the catheter 1014 (when configured to slide on the shaft) that limits proximal movement of the filter 1012 on the shaft, and an upstream or distal stop 1032 that limits distal movement of the filter on the shaft.

[0045] The embolic filter may be a mesh or other filter structure made from knitted, woven, or nonwoven fabric, filaments, or wires that may have pore sizes selected to allow blood to pass through but prevent emboli above a certain size from passing through. The embolic filter may also consist of a nonwoven sheet, such as a thin sheet of polymer or metal perforated with holes of a single size or different sizes. The embolic filter material may be made from metal, polymer, or a combination thereof, and may optionally have an antithrombogenic coating on its surface. The embolic filter may also consist of some combination of a perforated sheet and a fiber-based mesh, or other filter material or structure. The embolic filter may consist of a single layer or multiple layers of any of the above configurations to improve filtration efficiency and reduce effective pore size.

[0046] The embolic protection device is delivered in an undeployed or retracted condition. A tubular outer delivery sheath may be used to maintain the embolic protection device in the undeployed condition (FIGS. 2A-2D). The delivery catheter may optionally include a shoulder or stop positioned proximally of the embolic protection device to maintain the position of the embolic protection device on the catheter when the delivery sheath is withdrawn during deployment. Alternatively, a pusher catheter that fits between the catheter and the delivery sheath, such as the filter deployment catheter of FIG. 10, may be used to facilitate deployment.

[0047] Alternatively, the filter may be deployed via inflation of a balloon inside the filter, which may be cylindrically or conically shaped or otherwise shaped to match the geometry of the filter. Such a filter may be retrieved by withdrawing it into a retrieval sheath (FIG. 9).

[0048] Another alternative delivery mechanism is for reducing the effective length of the embolic filter, with members attached to either the distal or proximal end (or both). In embolic filters with designs such as those shown in Figures 2A-2D, compressing the filter longitudinally will result in an expansion of the diameter of the filter structure and consequent deployment of the filter. During retrieval, the filter may be stretched, reducing its diameter and collapsing the filter. This can be accomplished using two independent filter deployment catheters that can be independently advanced or retracted to effect the change in length.

[0049] The catheter may be configured as a diagnostic catheter, a guide catheter, or a therapy catheter. A particular example would be a delivery system for a transcatheter aortic valve.

[0050] An embolic filter will typically have at least one open end and define one or more internal collection regions that receive and capture emboli that enter with blood flow through the open end. In other configurations, the embolic filter may have two open ends, for example, with a cylindrical configuration that allows blood to flow into one end and out the other end.

[0051] In many embodiments, the filter membrane will be self-supporting in the deployed condition. By "self-supporting," we mean that the filter membrane can be deployed without further support in a three-dimensional configuration that maintains sufficient contact with the vessel wall to form an adequate seal to prevent emboli above a certain size from passing around the outside of the embolic protection device. In one example, the embolic filter can be constructed of a resilient mesh or other filter material that can be compressed in the undeployed condition and will self-expand to the deployed condition. Such a structure is described in U.S. Pat. No. 9,877,821 (previously incorporated by reference herein).

[0052] In another example, the embolic filter may comprise a filter membrane, matrix, etc., and a separate support structure. The filter membrane may comprise any known structure for filtering emboli from blood, including a mesh, a perforated sheet, a porous sheet, a fibrous structure, etc., or any combination thereof. The filter membrane can be elastic, slack, plastically deformable, or a combination thereof.

[0053] The support structure may be located external to the filter membrane, internally within the filter membrane, or both external and internal. For example, the support structure may comprise a scaffold including one or more longitudinal struts or hoops attached to or otherwise engaging the filter membrane to hold it in its open or deployed configuration with the aorta or other target vessel. The hoops and / or struts may be formed from a resilient metal, polymer, or other material to provide a self-expanding scaffold that assumes a low-profile or slender configuration when constrained by a sheath for delivery and an expanded or deployed configuration when released from the constraint. Alternatively, the scaffold or other support structure may comprise a malleable or plastically deformable material to provide expansion, typically by applying a radially outward force to the interior of the support structure using an inflatable balloon or other expansion mechanism.

[0054] Hybrid constructions that combine features of freestanding and frame support structures may also be used. Hybrid deployment methods such as balloon-assisted self-expansion or longitudinal compression of the support structure may also be utilized.

[0055] The support structure and filter membrane of an embolic filter will often have the same length, although embolic filters can be constructed in which the embolic filter membrane is longer or shorter than the support structure. Specific relative longitudinal dimensions of the filter membrane of an embolic filter can be as shown in the drawings. In another alternative construction, the support structure and / or filter membrane can be conical, with the enlarged or proximal end of the cone positioned upstream.

[0056] The embolic filter can be retracted and withdrawn using a catheter after the diagnostic or interventional procedure is completed. Optionally, the embolic filter may include features to assist in retracting the device for retrieval from the patient's aorta. For example, a conical guide structure may be slidably attached to the catheter at the proximal end of the device to assist in collapsing the embolic filter as a retrieval sheath is advanced along the conical guide structure. In another example, a portion of the embolic filter may be constructed with a retraction member configured like a purse string or lasso around the circumference of the device. A pull loop or other graspable structure near the downstream end of the embolic filter is connected to the retraction member by one or more connecting members. In one preferred embodiment, the embolic filter is configured to first close its upstream end to ensure that any captured emboli do not migrate out of the filter during retrieval. This can be accomplished by providing one or more pull loops for selectively retracting different sections of the device. The retraction member and connecting members may be made of suture, wire, plastic filament, or a combination of these materials. In an alternative construction, the "stent" support structure described above may also be configured to act as a retraction member.

[0057] The embolic filter may be fixedly mounted to the catheter, mounted via a slidable mount, or some combination of the two. The sliding mount may consist of one or more rings, roller bearings, or other structures that allow the embolic protection device to slide freely on the catheter. The sliding mount preferably has a low coefficient of friction and / or a lubricious coating so that movement of the catheter through the sliding mount will push past the embolic protection device or will not dislodge it. Alternatively, the sliding mount may include additional sealing elements such as resilient flaps, iris structures, or expandable sealing materials.

[0058] When collapsed for delivery, the overall undeployed diameter of the embolic filter (including the diameter of its constraining sheath) will preferably be smaller than the largest section of the catheter (such as the collapsed diameter of the prosthetic valve including its constraining sheath), most likely at the distal section of the catheter. In the case of a valve delivery system, the catheter will typically be reduced in size proximal to the valve, which would potentially allow for integration of the embolic filter and its restraining member without altering the overall tracking profile of the valve delivery system.

[0059] The embolic filter is in an undeployed condition on the catheter when inserted into the patient's aorta. The embolic filter is ideally deployed in the ascending aorta prior to the ostia of the cerebral arteries. Optionally, a delivery sheath can be used to hold the embolic filter in an undeployed position. The embolic filter can be constrained for delivery by crimping it onto a balloon catheter or by stretching its support structure to reduce its diameter.

[0060] The entire embolic filter, or portions thereof, may be coated with an antithrombotic coating, such as a bonded heparin coating, to reduce the formation of blood clots that could potentially become embolic. Alternatively, or in addition, the embolic filter, or portions thereof, may have a drug-eluting coating containing an anti-inflammatory or anti-stenotic drug. The embolic filters of the present invention may also be used for embolic protection of other organ systems. For example, an embolic filter may be deployed in a patient's descending aorta to prevent embolic particles in the aortic bloodstream from entering the renal arteries and embolizing within the patient's kidneys.

[0061] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It is understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. The following claims define the scope of the invention, and it is intended that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

[Claim 1] The invention described in this specification.

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