LOW-PROFILE EMBOLIC PROTECTION DEVICE AND SYSTEM

Abstract

An example embolic protection system and method for deploying an embolic protection device are provided. An example embolic protection system for deploying a device in a diseased vessel of a vascular system includes an embolic protection device having a catheter shaft and an expandable filter provided at a distal end of the catheter shaft. The expandable filter includes a side port provided in a sidewall of the expandable filter and a filter actuator located at or toward the proximal end of the embolic protection device. The filter actuator is operable to open and close an orifice of the expandable filter. In some examples, a snare guidewire is also provided.

Description

PRIORITY CLAIM

[0001] This patent application claims priority over U.S. Provisional Application Serial No. 63 / 432,250, filed December 13, 2022, which is hereby incorporated by reference in its entirety. FIELD OF THE INVENTION

[0002] This application relates generally to devices for medical interventions performed through vessels such as the great arteries or veins, and more particularly to devices having deployment configurations for performing percutaneous procedures such as percutaneous valve replacement or other vascular or cardiac interventions. BACKGROUND

[0003] Treating native heart valves using percutaneous transcatheter techniques may require advancing a catheter or device through the vasculature to the native target valve. The native target valve may be calcified or contain other pathologies, such as unwanted plaque or thrombi lodged in the native leaflets, annulus, or other anatomical regions adjacent to the native valve. Friction, scraping, or contact between the treatment catheter and the calcifications, plaque, or thrombi may result in unwanted dislodgement of these materials from the tissue, followed by embolization to other parts of the body. Embolization can lead to serious complications, such as ischemia, stroke, tissue damage, impaired lung function, and more.

[0004] In addition, the vessels surrounding the heart itself, such as the aorta, may also be diseased and contain similar undesirable deposits of plaque, thrombi, calcium, etc., and advancing the catheter through the vessel can also lead to unwanted detachment of these materials from the vessel walls, resulting in embolization. The risk of detachment is further increased with the use of conventional catheters, devices, or other high-profile conventional instruments.

[0005] It would therefore be desirable to either prevent the detachment of plaques, thrombi, calcifications, etc. from the native heart and adjacent vessels, and in situations where this occurs, to capture the materials or prevent them from embolizing in the patient. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 shows different parts of a diseased aorta. Fig. Figure 2 shows a native aortic valve (AV), illustrating some of the challenges in treating a heart valve. Fig. 3 shows a schematic view of a low-profile embolic protection device according to an embodiment. Fig. 3 contains inset views Fig. 3A-3C. Fig. Figure 4 shows a schematic view of the embolic protection device of Fig. 3 used in conjunction with a dilator, according to one embodiment. Fig. Figure 5 shows a schematic view of the embolic protection device and dilator of Fig. 4 in connection with a loading tool according to an embodiment. Fig. 6A-6B show pictorial representations of a filter dilator according to an exemplary embodiment. Fig. 7A-7B show sectional views of the filter dilator of the Fig. 6A-6B. Fig. 8 shows a pictorial representation of an atraumatic distal tip of a filter dilator according to an embodiment. Fig. 9-10 show pictorial representations of open and closed configurations of a filter according to an exemplary embodiment. Fig. 11A-11D show pictorial and sectional views of a loading tool according to an exemplary embodiment. Fig. 12A-12B show respective side and top views of an exemplary expandable introducer. Fig. 12C shows a pictorial representation of a sheath dilator according to one embodiment. Fig. 13A-13B show respective pictorial representations of loaded and deployed configurations of a sheath dilator and a mesh sheath of an expandable introducer according to embodiments. Fig. 14A-14B show respective sectional and enlarged partial sectional views of an expandable introducer according to an example embodiment. Fig. 15 shows a pictorial representation of an introducer hub adapter according to an example embodiment. Fig. 16A-16M illustrate various aspects and operations in preparing and deploying an embolic protection device and other embolic system components for use in a medical procedure, according to embodiments. Fig. 17 shows a pictorial representation of a therapeutic device deployed by an embolic protection device and other components of an embolic protection system, according to embodiments. Fig. 18 shows a schematic view of a loop guidewire used in conjunction with an embolic protection device and other embolic system components and TAVR devices in a medical procedure, according to embodiments. Fig. 19A-19H illustrate various aspects and operations in the preparation and deployment of a snare guidewire used in conjunction with an embolic protection device and other embolic system components, guidewires, and therapeutic devices (such as a TAVR device) in a medical procedure, according to embodiments. DETAILED DESCRIPTION

[0006] The present disclosure describes the use of the devices and methods disclosed herein during treatment in or adjacent to the aorta. One of skill in the art will understand that this is not limiting and that the devices and methods disclosed herein may be used in other anatomical regions of the body. Furthermore, the present disclosure describes an embolic protection system that includes multiple components (e.g., a low-profile embolic protection device, an introducer, an introducer dilator, a loading tool, a dilator for the embolic protection device, and so on). In some examples, the embolic protection system may be used to install a therapeutic device, such as an artificial heart valve, in a human heart. Other uses and applications are possible in a variety of people.These components can be used all together as a kit, or they can be provided and used individually, or they can be provided and used in any combination.

[0007] With reference to Fig. Figure 1 shows an illustrative view of a diseased aorta (2) with deposits (4) distributed in multiple locations, including adjacent to or within the left (6) and right (8) iliac arteries, and adjacent to the aortic arch junctions with the left subclavian artery (10), the left common carotid artery (12), and the innominate artery (14). Navigating a diseased aorta (2) such as the one shown is challenging with conventional intravascular diagnostic and / or interventional hardware.

[0008] Fig. Figure 2 shows a native aortic valve (AV), illustrating some of the challenges of treating a heart valve. Here, the aortic valve (AV) comprises native leaflets (L), which normally oppose each other to close the valve during contraction of the left ventricle (LV) and to push blood out of the heart via the ascending aorta (AA). The aorta adjacent to the aortic valve includes the sinus of Valsalva (SV) and the sinotubular junction (SJ). Blood is shunted from the left atrium (LA) via the mitral valve (MV) into the left ventricle (LV). The native valves and walls of the aorta may be covered or lined with discrete or diffuse plaques (P) composed of materials such as calcium, lipids, thrombi, or other undesirable materials.When a diagnostic or therapeutic device is advanced through the vasculature to the aortic valve, the device may scrape or otherwise contact the plaques P and cause the plaques to detach from the tissue and then embolize downstream to other parts of the body, causing complications such as ischemia, stroke, etc. It would therefore be desirable to provide methods and devices that prevent the unwanted detachment of plaques from the native valve, the aorta, or other adjacent tissue that might embolize, and in the event that embolism does occur, it would be desirable for such methods and devices to capture the emboli and prevent them from flowing downstream.Although the aortic valve is the primary focus in this example, one of ordinary skill in the art will understand that this is not a limitation and that the devices and methods disclosed herein may be used with other heart valves, such as the mitral or tricuspid valve, or with other valves of the body, including venous valves, or with other organs and anatomical structures in the body.

[0009] In some examples, an embolic protection system is provided for deployment of a device within a diseased vessel of a vascular system. An example of an embolic protection system comprises an embolic protection device including: a catheter shaft; an expandable filter provided at a distal end of the catheter shaft, the expandable filter including a side port provided in a sidewall of the expandable filter; and a filter actuator located at or toward a proximal end of the embolic protection device, the filter actuator operable to open and close an orifice of the expandable filter.

[0010] In some examples, the embolic protection system also includes a dilator.

[0011] In some examples, the embolic protection system also includes a loading tool.

[0012] In some examples, the embolic protection system also includes an introducer.

[0013] In some examples, the embolic protection system further includes an introducer hub adapter.

[0014] In some examples, the introducer is an expandable introducer comprising a mesh sheath made of expandable porous mesh material, an introducer hub having a hemostasis valve, and a sheath dilator for dilating the mesh sheath, the sheath dilator being insertable into the introducer hub and having a sheath dilator tip at a distal end of the sheath dilator that covers a distal open end of the mesh sheath in a loaded configuration of the sheath dilator.

[0015] In some examples, a method for deploying an embolic protection device into a patient's vasculature is provided. An example method includes establishing access to the vasculature; inserting a guidewire into the vasculature to assist in guiding the embolic protection device through the vasculature; advancing the embolic protection device into the vasculature and over the guidewire toward a target treatment area, the embolic protection device comprising a catheter shaft, an expandable filter disposed at a distal end of the catheter shaft, the expandable filter including a side port provided in a sidewall of the expandable filter, and a filter actuator disposed adjacent a proximal end of the catheter shaft, the filter actuator operable to open and close an orifice of the expandable filter;Actuating the filter actuator, thereby radially expanding the expandable filter at the target treatment area and opening the orifice of the expandable filter; and capturing emboli in the expandable filter.

[0016] In some examples, the method further comprises inserting a therapeutic device through the embolic protection device and advancing the therapeutic device toward the target treatment area.

[0017] In some examples, the target treatment area includes a native aortic valve.

[0018] In some examples, the method further comprises, after inserting the therapeutic device through the embolic protection device, closing the expandable filter and removing the embolic protection device from the vasculature.

[0019] With reference to the accompanying drawings, various aspects of deployment steps and configurations utilizing examples of the present embolic protection devices and systems will now be described.

[0020] In some examples, the method further comprises inserting a loop guidewire into the vasculature to assist in guiding a guidewire or device through the side port of the embolic protection device.

[0021] Examples of an embolic protection system can be found with reference to Fig. 3 may comprise an embolic protection device 300 including a catheter shaft 302, a filter 304 provided at a distal end of the catheter shaft 302, and a filter actuator 306 located at or toward a proximal end of the embolic protection device 300. Referring to Fig. 4, further examples of an embolic protection system may include a filter dilator 402 that is insertable into the filter 304 of the embolic protection device 300 through a side port 308. With reference to Fig. 5, further examples of an embolic protection system may include a loading tool 502. In some examples, the loading tool 502 includes a removable loading sleeve 504 that can be attached around an exterior of the embolic protection device 300 to assist in loading the embolic protection device 300 into a hub of an introducer, for example, as described further below. In some examples, each of these components may be provided or used separately, or provided and used in combination, for example, as part of a kit.

[0022] It will now Fig. 3 of the accompanying drawings, which shows a schematic view of an exemplary "low-profile" embolic protection device 300 according to an example of the present disclosure. In this application, the low-profile embolic protection device 300 is also referred to simply as "embolic protection device 300." In some examples, such as the illustrated example, the embolic protection device 300 is provided as part of an embolic protection system.

[0023] As in Fig. 3, the embolic protection device 300 includes a flexible backbone 310 attached to a distal end of the catheter shaft 302. The flexible backbone 310 is hollow and supports the filter 304 during use. The flexible backbone 310 carries an actuation wire 312 that extends through the catheter shaft 302 from a proximal location on an actuation slide 314 provided in a handle 316 of the filter actuator 306 to a distal location where it connects to a ring wire 318 of the filter 304. In some examples, the flexible backbone 310 comprises a stainless steel braided polymer material.

[0024] In some examples, the catheter shaft 302 is very slender (needle-like) and highly flexible, with an outer diameter in the range of 0.020-0.040 inches and an inner diameter in the range of 0.007-0.018 inches. The small outer dimensions of the catheter shaft 302 contribute to the "low profile" characteristic of the embolic protection device 300. In some examples, the usable length of the catheter shaft 302 between the filter actuator 306 and the proximal end of the filter 304 is in the range of 60-100 cm, but this length may be shorter or longer as needed to accommodate different sizes of the human anatomy. A suitable material for the catheter shaft 302 may be, for example, nitinol, stainless steel, polyethylene, polypropylene, a fluorinated polymer, polyurethane, or a stainless steel braided polymer.

[0025] As in Fig. 3, the filter 304 is provided at the distal end of the embolic protection device 300. In this view, the filter 304 is depicted in an open or expanded configuration. The filter 304 is opened and closed by actuating the actuating slide 314 in the handle 316 of the filter actuator 306, as described in more detail below. In some examples, the filter 304 is configured as a closable basket or net. The filter 304 includes braided filter material or a mesh or net filter material to capture emboli and other waste materials such as plaque flakes and blood clots (when open) and retain them (when closed). The filter 304 may have a porosity that allows blood or other fluids to pass through the filter while retaining the embolic or other materials. The filter material may be polyester, polyurethane, nylon, nitinol, or other materials.The filter can be coated with heparin, a hydrophilic polymer, silicone, or another material to prevent platelet adhesion and / or increase lubrication.

[0026] In some examples, the filter 304 has a frusto-conical shape when it is flat, e.g., when it is substantially open, as in Fig. 3. Other shapes and configurations of the filter 304 are possible. In some examples, e.g., with reference to the Fig. 4-5, a shape or configuration of the filter 304 enables it to assume an elongated, tubular or narrow, serpentine shape when collapsed, e.g., when an orifice 322 of the filter 304 defined by the ring wire 318 at the distal end of the filter 304 is closed while the filter 304 is being repositioned or removed from a site, e.g.,

[0027] In some examples, a proximal end 320 of the filter 304 is permanently closed and attached to a proximal location of the flexible spine 310, as shown in Fig. 3. Other attachment positions are possible. The closed proximal end 320 of the filter 304 allows for the capture and retention of embolic material while the filter 304 is being repositioned or removed from a site, for example.

[0028] As previously mentioned, the orifice 322 of the filter 304 can be opened and closed by an operator actuating the actuating slide 314 of the filter actuator 306. The movement of the actuating slide 314 serves to apply or release tension to the actuating wire 312 to which it is connected. The corresponding movement of the actuating wire 312 opens or closes the orifice 322 of the filter 304 as desired.

[0029] In the example shown, the filter 304 is held in the embolic protection device 300 by the flexible backbone 310. The flexible backbone 310 may consist of or include an elongated, thin tube 324 with an outer diameter in the range of 0.050-0.100 inches and an inner diameter in the range of 0.030-0.050 inches. The narrow outer dimensions of the flexible backbone 310 also contribute to the "low profile" of the embolic protection device 300. The flexible backbone 310 is attached to the distal end of the catheter shaft 302, as shown, for example, in Fig. 3 shown.

[0030] The flexible spine 310 supports the actuating wire 312. At its distal end, the actuating wire 312 is connected at 326 to the ring wire 318. When the actuating slide 314 is pushed forward (or distally) toward the position of the filter 304, the ring wire 318 expands and, under the action and control of the actuating wire 312, opens the orifice 322 of the filter 304, as shown. In this position, the filter 304 is open. The orifice 322 of the filter 304 can be resized and closed as needed by manually operating the actuating slide 314. Conversely, retraction of the actuating slide 314 pulls the actuating wire 312 in a proximal direction, thereby applying tension to the ring wire 318 to collapse and close the orifice 322 of the filter 304, if desired.Here, the filter 304 is completely closed to safely retain the captured embolic material in its volume while the embolic protection device is, for example, relocated or removed.

[0031] In some examples, the ring wire 318 is integrally formed as an extension of the actuating wire 312. In some examples, the ring wire 318 is formed as a separate ring, for example, as shown in Fig. 3. The mouth 322 of the filter 304 may include or be attached to self-expanding elements to bias the mouth 322 into an open configuration. In some examples, the mouth 322 of the filter 304 may include or be attached to self-contracting elements to bias the mouth 322 into a closed configuration. In some examples, the mouth 322 of the filter 304 may be closed and retained in a circumferential groove or channel 404 provided at or toward the distal end of the filter dilator 402, for example, as shown in Fig. 4. In this enclosed, closed position of filter 304, embolic protection device 300 can be deployed in a "low-profile" manner to or from the surgical site within a diseased vessel. At the surgical site, filter 304 can be opened to capture any embolic material that may have dislodged itself from the vessel walls. In some examples, the self-expanding or self-extracting elements can cooperate to enclose orifice 322 within or release orifice 322 from circumferential channel 404.

[0032] As mentioned above, the filter 304 includes a side port 308. In some examples, the side port 308 is formed in a wall of the filter 304 or as an opening in the filter material. The side port 308 is located at or toward the proximal end 320 of the filter 304. This proximal position leaves a trapped interior volume 328 of the filter 304 that has no opening or openable orifice to form a "dead zone" that can safely contain deposited embolic material without risk of it becoming dislodged from the filter 304 during movement or deployment of the embolic protection device 300.

[0033] With reference to Fig. 4, in some examples, the side port 308 allows passage of a guidewire 406 and / or the filter dilator 402 (e.g., disposed on the guidewire 406 as shown) and / or the passage of other devices to allow such devices (or other tools and instruments) to migrate through the side port 308 and move into or completely traverse the filter 304 as required for use at a surgical site.

[0034] In some examples, the side port 308 includes a seal 330. The seal 330 helps retain embolic material within the filter 304, even if the filter dilator 402 or other device can pass through the filter 304. The inspection views Fig. 3A-3C from Fig. 3 show three examples of a seal 330 provided in the side port 308. An example of a seal 330 may be made of a silicone material, e.g., a silicone disk, as shown, or another flexible sealing material. In some examples, the silicone disk of the seal 330 may include one or more deformable holes, openings, or slots 332 through which the filter dilator 402 or other device may be sealingly passed. A cruciform or cross-shaped arrangement of one or more slots 332 is shown in the inspection view in Fig. 3A. A dog bone shaped slot 332 is shown in the inspection view in Fig. 3B. The dogbone-shaped slot 332 contains stress-relieving formations 334. Fig. 3C shows a hole 332. Other side port configurations may include a flap or other sealing element that opens and closes to allow the passage of devices. Other arrangements and configurations of the side port 308, the seal 330, the one or more slots 332, and the stress-relieving formations 334 are possible.

[0035] As mentioned above, Fig. 4 also shows a schematic view of a filter dilator 402. Fig. 6A-6B show further pictorial representations of an exemplary filter dilator 402, with some parts of the filter dilator 402 in Fig. 6B are shown enlarged. Cross-sectional views of the filter dilator 402 are shown in Fig. 7A-7B.

[0036] In the Fig. 6A-6B, the example filter dilator 402 includes a Luer fitting 408 provided at a proximal end 410 of the dilator and a filter dilator tip 412 provided at a distal end 414 of the filter dilator 402. The filter dilator 402 includes a flexible shaft 416 constructed of one or more polymers (e.g., polyethylene, polypropylene, ABS, PVC, FEP, combinations thereof, etc.).

[0037] With reference to Fig. 8, the filter dilator tip 412 of the filter dilator 402 is connected to the flexible shaft 416 and, as mentioned above, includes a circumferential channel 404 (or other formation) that can engage and retain the ring wire 318 and the orifice 322 of the filter 304 when the filter 304 is closed. Pictorial representations of open and closed configurations of the filter 304 are shown in Fig. 9-10 shown.

[0038] In Fig. 10, the orifice 322 of the filter 304 can be captured in the closed state under a pulling action of the actuating slider 314 away from the filter 304 and retained within the circumferential channel 404 of the filter dilator tip 412 under locking tension in the actuating wire 312 or the ring wire 318, respectively. The locking tension can be maintained by engaging a slider locking mechanism (not shown) of the filter actuating member 306. The closed orifice 322 of the filter 304 can be securely retained within the circumferential channel 404 of the filter dilator 402, thereby axially supporting the filter 304 along its length to prevent collapse as the filter 304 is advanced into the human vasculature and through the confines of an introducer or loading tool.

[0039] Again with reference to Fig. 5, the embolic protection device 300 may be used in conjunction with a loading tool 502. In some examples, the loading tool 502 may be referred to as a "peel-away loader" in view of its ability to be removed from the embolic protection device 300 after use. The loading tool 502 has three primary purposes.

[0040] First, the loading tool 502 enables insertion of the embolic protection device 300 into the hub of an introducer, as described in more detail below. An introducer may be used to deploy the embolic protection device 300 (and other devices and instruments) into the human vasculature, typically over a guidewire 406. The loading tool 502 facilitates loading the embolic protection device 300 into an introducer. In some examples of the present disclosure, an embolic protection system includes an adapter for a hub of the introducer to facilitate the interaction and use of the loading tool 502 with various types of introducers, which in some examples may be conventional or generic. The scope and applications of the described embolic protection devices and systems are expanded accordingly.An example of an introducer set and adapter is described below.

[0041] A second purpose of the loading tool 502 is to enable the flushing of the embolic protection device 300 and the filter dilator 402 prior to introduction into the human vascular system. This allows the components to be vented and prevents air bubbles from entering the patient's bloodstream. Accordingly, the loading tool 502 may be equipped with a flushing port (for simplicity, Fig. 5 not shown). A third purpose of the loading tool 502 is to prevent blood loss during insertion of the embolic protection device 300 and the filter dilator 402 into the introducer and / or the human vasculature.

[0042] In some examples, the loading tool 502 includes a removable hub 506. In some examples, the removable hub 506 can be pulled off the loading tool 502. The hub 506 includes a removable seal 508 to prevent blood loss. In some examples, the removable seal 508 includes two openings 510 and 512 that allow the catheter shaft 302, the embolic protection device 300, and the filter dilator 402 to pass through the hub 506 while the openings 510 and 512 remain in sealing engagement with the outer walls of these two components.

[0043] It is now time to Fig. 11A-11D of the accompanying drawings, which contain pictorial and sectional views of another example of a loading tool 502 for the embolic protection device 300. The loading tool 502 is tubular and consists of two separable (or peelable) parts 1102A and 1102B, each having a semicircular cross-section and arranged along the frangible parting lines 1104A and 1104B (best shown in Fig. 11B). The interconnected parts 1102A and 1102B together form a tip 1106 and a lumen 1107 of the loading tool 502, into which the embolic protection device 300 can be inserted and prepared for use. The detachable parts 1102A and 1102B can be separated from each other and pulled off the embolic protection device 300 by actuating two separating handles 1108A and 1108B. In the illustrated example of Fig. 11C, the handle 1108B includes a flushing line 1110 that is in fluid communication with the three-way stopcock 1112 and the lumen 1107 of the loading tool 502.

[0044] As illustrated, the separation handles 1108A and 1108B are connected by two separation lines 1114 that align with the separation lines 1104A and 1104B. Movement of the separation handles 1108A and 1108B to initiate removal of the loading tool 502 can be unlocked by rotating the hub 506, which (when locked) holds the two halves together and prevents inadvertent separation. Removing the hub 506 from the loading tool 502 allows the separation handles 1108A and 1108B to be twisted and split apart by an operator along the separation lines (which may be perforated or have a frangible separation line), allowing subsequent splitting and removal of the parts 1102A and 1102B to fully release the loading sleeve from the embolic protection device 300. In some examples, the hub 506 may be easily detached from the separable parts 1102A and 1102B to enable their separation (pulling off).In some examples, the hub 506 has a slot or gap (507 in . Fig. 16H) in its peripheral wall, which allows the hub 506 to be removed from the guide wire 406 after being released from the loading tool 502.

[0045] As mentioned above, in some examples, the embolic protection device 300 may be deployed into the human vasculature using an introducer. The introducer may be conventional or generic. An adapter for an introducer hub may be provided. In some examples, the introducer is an expandable introducer.

[0046] Fig. 12A-12B show a side view and a top view of an expandable introducer 1200. The expandable introducer 1200 includes a mesh sheath (or sleeve) 1202 made of expandable, porous mesh material. In some examples, the mesh material is expandable in the radial and longitudinal directions of the mesh sheath 1202. In some examples, the mesh material is expandable only in the radial direction of the mesh sheath 1202. In some examples, the mesh material is expandable only in the longitudinal direction of the mesh sheath. In some examples, the mesh sheath 1202 has a usable length of approximately 30 cm to correspond to an arterial dimension of the human vasculature. Some examples of this disclosure include a mesh sheath with a usable length in the range of 25-35 cm to accommodate variations in vessel size.In some examples, the mesh sheath 1202 has a contracted diameter in the range of 3-7 mm and an expanded diameter in the range of 7-10 mm.

[0047] In some examples, a first region 1203 of the mesh lock 1202 is expandable and porous. The first porous region 1203 may include mesh material that is expandable only in the radial direction and may or may not be axially expandable. In some examples, the material properties of the mesh lock may be selected such that there is no axial expansion or contraction. In other examples, the material properties may be selected such that there is some axial expansion or contraction. In some examples, the mesh may shorten by 10 mm or less in the axial direction upon radial expansion. Other arrangements are possible. In some examples, the mesh material of the first porous region 1203 includes open pores through which fluids (e.g., blood) can pass while preventing embolic material such as plaque and blood clots from passing through the mesh sheath 1202.In other examples, the mesh may not be used to capture embolic material, but rather allows blood to continue to flow through the membrane so that blood flow is not interrupted. A suitable mesh material for the first porous region 1203 may be polyester, nylon, or nitinol mesh. The pore size may range from 70 to 300 microns to allow blood to flow through the pores while retaining emboli or other particles. A marker 1205 may be attached to the distal end of the first porous region 1203 of the mesh sheath 1202. The marker 1205 may be radiopaque, echogenic, or visible using other imaging techniques known in the art. The marker 1205 may facilitate positioning of the expandable introducer 400 during use.

[0048] In some examples, a second region 1204 of the mesh sheath 1202 is non-expandable and non-porous. The second region 1204 may include a non-porous elastomeric sealing material. The second non-porous region 1204 may include a continuation of the mesh material of the first porous region 1203, but the presence of the elastomeric sealing material makes the second region 1204 non-porous, and it may be expandable or non-expandable. In one example, the second region 1204 may be expandable, but less than the first region in which the mesh is disposed. The sealed second non-porous region 1204 of the mesh sheath 1202 does not allow the passage of fluid or embolic material through the walls of the mesh sheath 1202. In some examples, the second non-porous region 1204 of the mesh lock 1202 has a length of about 11 cm.Other lengths are possible to accommodate different applications and sizes of the human vascular system.

[0049] Relative to the first porous region 1203, the second non-porous region 1204 of the mesh sheath 1202 can be maintained in or assume an expanded or partially expanded configuration of the mesh material, as shown. The first porous region 1203 and the second non-porous region 1204 of the mesh sheath 1202 can taper in a distal direction along their length, as shown, to facilitate advancement of the expandable introducer 1200 into the human vasculature.

[0050] With further reference to Fig. 12A to 12B, the expandable introducer 1200 further comprises an introducer hub 1206 which includes a hemostasis valve 1224 (visible in Fig. 14A to 14B). The introducer hub 1206 is connected to a flushing three-way stopcock 1208. An internal volume of the introducer hub 1206 within the seal of the hemostasis valve 1224 and including the mesh sheath 1202 (including the first porous region 1203 and the second non-porous region 1204) can be flushed using the three-way stopcock 1208.

[0051] With reference to Fig. 12C, the expandable introducer 1200 further includes a sheath dilator 1210 for closing the mesh sheath 1202 or for providing a removable dilating tip for insertion into the body. The sheath dilator 1210 can be removed by a manually removable clip 1212 (visible in Fig. 12B) can be locked within the mesh sheath 1202 of the expandable introducer 1200. The clip 1212 engages the introducer hub 1206 and can be removed by an operator to allow the sheath dilator 1210 to be advanced or retracted through the expandable introducer 1200 during use. A dilator Luer fitting 1214 is provided at the proximal end of the sheath dilator 1210. The dilator Luer fitting 1214 can be manipulated by an operator to advance or retract the sheath dilator 1210 once the clip 1212 is released, allowing a detachable fluid connection to additional tubing, syringes, pumps, etc. A sheath dilator tip 1216 is provided at the opposite distal end of the sheath dilator 1210. The tip 1216 is soft and tapered to facilitate penetration into the body and also to provide an atraumatic tip during distal advancement through the vessel.

[0052] In a loaded configuration of the sheath dilator 1210, which is Fig. 13A, the tip of the sheath dilator 1216 extends beyond such a restricted open end 1218 of the mesh sheath 1202 and fits as a cap thereover. As described in more detail below, the expandable introducer 1200 can be introduced into the human vasculature in the loaded configuration and then deployed after positioning. In a deployed configuration of the expandable introducer 1200, which is shown in Fig. As can be seen more clearly in Figure 13B, the sheath dilator 1210 has been advanced through the mesh sheath 1202 to expand the sheath 1202 and force the tip of the sheath dilator 1216 out of the restricted open end 1218 of the mesh sheath 1202. This release of the sheath dilator tip 1216 allows the now open end 1218 of the mesh sheath 1202 to enlarge in size. In some examples, the enlargement is caused or driven by a natural or inherent elasticity of the mesh sheath material. The enlarged open end 1218 of the mesh sheath 1202 is larger than the outer diameter of the sheath dilator tip 1216.As a result, the sheath dilator 1210 can be retracted by an operator to withdraw the sheath dilator tip 1216 through the enlarged open end 1218 of the mesh sheath 1202 and withdraw the sheath dilator 1210 and sheath dilator tip 1216 as a whole from the expandable introducer 400, leaving the sheath open and expanded. The introducer hub 1206 of the introducer 1200 is now ready to accept insertion of the loading tool 502 and the embolic protection device.

[0053] In some examples, the introduction of the loading tool is enabled or at least facilitated by an introducer hub adapter. An example hub adapter may also be configured to accommodate and seal two (or more) parallel catheters, dilators, or other instruments that are not coaxial and instead lie side by side during use. For example, in Fig. 5 that the embolic protection device 300 and the filter dilator 402 are not coaxial and may extend substantially parallel over at least a portion of their length.

[0054] A pictorial representation of an exemplary introducer hub adapter 1500 is shown in Fig. 15. The hub adapter 1500 includes an adapter shaft 1502 (or an extension tube) insertable into the introducer hub 1206 of an introducer 1200. The adapter shaft 1502 can be interchanged, for example, using the screw thread 1504, with a different adapter shaft 1502 of a different size to conform to the sizes and configurations of various other types of introducers 1200 and / or introducer hubs 1206. The adapter shaft 1502 contains a lumen in fluid communication with the interior volume of the introducer hub adapter 1500. A purge valve 1506 is provided to vent the interior volume of the introducer hub adapter 1500.

[0055] In some examples, the introducer hub adapter 1500 includes a multi-catheter seal 1508 located adjacent to an adapter port 1510. The adapter port 1510 is configured to allow insertion of the tip of the loading tool 502. In some examples, the adapter port 1510 is lockable to the loading tool 502 by a rotational motion applied to the adapter port 1510. The multi-catheter seal 1508 allows passage of one or more catheters, but may also include an internal inflatable bladder (not shown) that can be inflated, for example, by an external inflation valve. Inflation of the inflatable bladder causes the walls of the inflatable bladder to seal against the external surfaces of the one or more catheters passed through it.The one or more catheters passing therethrough may include the catheter shaft 302 of the embolic protection device 300, the filter dilator 402, and / or one or more catheters of devices and instruments deployed at the site of surgery in a diseased vessel.

[0056] In some examples, other types of multi-catheter seals 1508 may also be provided. For example, the multi-catheter seal 1508 may comprise a mechanically compressible or deformable material, such as a low-hardness material, e.g., a silicone material, that can be deformed to move into and be held in sealing engagement with the outer surfaces of one or more catheters passing through the multi-catheter seal 1508 of the introducer hub adapter 1500. The deformable or compressible material may be compressed by a manually operable restriction band or other device. The mechanically compressible or deformable material may have one or more openings through which one or more corresponding catheters may be passed. Other arrangements and configurations of a multi-catheter seal 1508 are possible.

[0057] With reference to Fig. 16A-16M, exemplary aspects of the preparation and deployment of an embolic protection device 300 and other embolic system components for use in a medical procedure will now be described.

[0058] In Fig. 16A, an introducer 1200 is loaded onto a guidewire 406 and deployed as described above. The introducer 1200 may have a fixed inner diameter or be expandable.

[0059] In Fig. 16B, an introducer hub adapter 1500 is loaded onto the guide wire 406 and prepared for insertion into the introducer hub 1206 of the introducer 1200.

[0060] In Fig. 16C, the embolic protection device 300 is prepared for deployment with the guidewire 406 extending through the side port 308 of the filter 304.

[0061] In Fig. 16D, the filter 304 of the embolic protection device 300 is configured open and the side port 308, including a seal 330, is visible.

[0062] In Fig. 16E, the filter dilator 402 is inserted into the filter 304 through the side port 308.

[0063] In Fig. 16F, the filter dilator 402 is advanced through the side port 308 such that the circumferential channel 404 in the tip 412 of the filter dilator 402 is substantially adjacent to the ring wire 318.

[0064] In Fig. 16G, the ring wire 318 is tightened by actuating the actuating slide 314 in the filter actuating device 306 so that the mouth 322 of the filter 304 closes onto and is enclosed within the circumferential channel 404 and the actuating slide 314 is locked in the closed position.

[0065] In Fig. 16H the filter 304 is loaded into the loading tool 502.

[0066] In Fig. 16I, the loading tool 502 is locked (the hub 506 is engaged) and prepared for insertion into an introducer set (not visible in the view) with or without an introducer hub adapter.

[0067] In Fig. 16J, an introducer hub adapter 1500 is used, and the tip of the loading tool 502 is inserted into the introducer hub adapter 1500. An enlarged view of this arrangement is shown in Fig. 16K. The introducer hub 1206 of the introducer 1200 is visible in both views.

[0068] In Fig. 16L, the filter 304 of the embolic protection device 300 is pushed through the introducer 1200 and the loading tool is removed (peeled off).

[0069] In Fig. 16M, a therapeutic device (such as a TAVR device 1600) is advanced over the guidewire 406 through the side port 308 of the filter 304 and out through the open orifice 322 of the filter 304 and moved to a target treatment area.

[0070] Fig. Figure 17 shows a pictorial representation of a therapeutic device deployed by an embolic protection device 300 and other components of an embolic protection system in the target treatment area. An example of a TAVR 1600 device is shown being routed through the side port 308.

[0071] Fig. 18 shows a schematic view of a loop guidewire 1802 that may be used in conjunction with an embolic protection device and / or other embolic system components and TAVR devices in a medical procedure, according to embodiments.

[0072] The snare guidewire 1802 includes a solid guidewire tip 1804 at its forward or distal end. The snare guidewire 1802 also includes a snare ring 1806 that can open and close under the action of an actuator 1810. The actuator 1810 controls the snare ring 1806 by means of actuating wires 1812 that extend through a hollow guidewire catheter 1808 of the snare guidewire 1802. The snare ring 1806 can be manipulated (opened or closed) by an operator using the actuator 1810 to capture or engage other guidewires (such as a regular guidewire) and other components (such as a TAVR device) to assist in introducing these other guidewires and components through a side port (or side window) of an expandable filter of an embolic protection device, e.g., an embolic protection device of the examples described above.

[0073] Some of these facilitation methods include establishing access to the human vascular system via a femoral artery (for example, at a TAVR femoral access point, Fig. 19A) and a contralateral femoral artery (for example, at a contralateral femoral access point, Fig. 19A). An example procedure is described below.

[0074] Fig. 19A-19H illustrate various aspects and operations in the preparation and deployment of a snare guidewire 1802 used in conjunction with an embolic protection device and other embolic system components, guidewires, and therapeutic devices (such as a TAVR device) in a medical procedure, according to embodiments.

[0075] In Fig. 19A, the loop guidewire 1802 is inserted into the human vasculature through an introducer sheath 1920 via a contralateral femoral approach. The introducer sheath 1920 may comprise a mesh sheath of an introducer 1200 described above.

[0076] In Fig. 19B, an embolic protection device (such as embolic protection device 300 described above) is deployed over the loop guidewire 1802 via the contralateral femoral approach.

[0077] In Fig. 19C, the snare ring 1806 of the snare guidewire 1802 is aligned just outside the side window (e.g., a side port 308 described above) of the filter of the embolic protection device (e.g., a filter 304 as described above) and the snare ring 1806 is opened.

[0078] In Fig. 19D, a standard guidewire 1924 is advanced from the femoral TAVR access so that the tip of the standard guidewire 1924 is located in the open sling ring 1806.

[0079] In Fig. In Figure 19E, the loop ring 1806 is closed to clamp the tip of the standard guidewire 1924, and an operator advances the loop guidewire 1802 through the side window of the filter, which also advances the standard guidewire 1924 through the side window. Passage of the standard guidewire 1924 through the side window is thus facilitated by the loop guidewire 1802. In some examples, other components may be similarly advanced through the side window.

[0080] In Fig. 19F, the snare ring 1806 is opened to release the standard guidewire 1924. The released standard guidewire 1924 can then be advanced through the filter to a desired location, as shown. The snare ring 1806 is then closed to minimize its profile to facilitate or allow the passage of other components and guidewires, for example, as described below.

[0081] In Fig. 19G, a pigtail catheter 1926 is advanced over the loop guide wire 1802 (with the loop ring 1806 closed) and the loop guide wire 1802 is then removed.

[0082] In Fig. 19H, a therapeutic device, e.g., a TAVR device 1928, can then be advanced through the filter via the standard guidewire 1924 from the femoral TAVR access.

[0083] In summary, as described above, the protective configurations of the embolic protection device and system of the present invention provide a means of performing a procedure while protecting the underlying tissue and associated anatomy.

[0084] Various exemplary embodiments of the invention are described herein. These examples are referred to in a non-limiting sense. They are provided to illustrate broader applicable aspects of the invention. Various changes may be made to the described invention without departing from the scope of the invention as defined by the appended claims. Furthermore, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act, or process step to the objective(s) or scope of the present subject matter.Furthermore, those skilled in the art will recognize that each of the variants described and illustrated herein includes individual components and features that can be readily separated from or combined with the features of the other various embodiments without departing from the scope of the present embodiments. All such modifications are intended to fall within the scope of the claims that may be appended to this disclosure.

[0085] Each of the described devices for performing the diagnostic or interventional procedures under investigation may be provided in a packaged combination for use in performing such procedures. These delivery kits may further include instructions for use and be packaged in sterile trays or containers commonly used for such purposes.

[0086] The present application discloses methods that can be performed using the subject devices. The methods may comprise the act of providing such a suitable device. Such provision may be performed by the end user. In other words, the act of "providing" merely requires that the end user obtain, access, approach, position, set up, activate, turn on, or otherwise act to provide the required device in the subject method. The methods described herein may be performed in any logically possible order of events, as well as in the described order of events.

[0087] Exemplary aspects of the invention, along with details regarding material selection and manufacturing, have been set forth above. Other details of the present invention may be learned in connection with the above-referenced patents and publications, as well as being generally known or appreciated by those skilled in the art. For example, those skilled in the art will appreciate that one or more lubricious coatings (e.g., hydrophilic polymers such as polyvinylpyrrolidone-based compositions, fluoropolymers such as tetrafluoroethylene, hydrophilic gel, or silicones) may be used in conjunction with various portions of the devices, such as relatively large interfaces of movably coupled portions, if desired, to facilitate, for example, low-friction manipulation or advancement of such objects relative to other portions of the instrumentation or nearby tissue structures.The same applies to the method-based aspects of the present disclosure with respect to additional acts that are commonly or logically employed.

[0088] Although the invention has been described with reference to several examples optionally incorporating various features, the invention is not intended to be limited to what is described or indicated with respect to each variant of the invention. Various changes may be made to the described invention without departing from the scope of the invention as defined by the appended claims. Furthermore, where a range of values ​​is provided, it is to be understood that any intermediate value, between the upper and lower limits of this range, and any other indicated or intermediate value within this indicated range, is included within the scope of the invention.

[0089] It is also contemplated that each optional feature of the described inventive variations may be set forth and claimed independently or in combination with one or more of the features described herein. Reference to a single item of subject matter includes the possibility of having a plurality of the same items. In particular, the singular forms "a," "an," "said," and "the" used herein and in the appended claims include the plural unless expressly stated otherwise. In other words, the use of the items enables "at least one" of the subject matter in the above description as well as in the claims appended to this disclosure. It is further understood that such claims may be drafted to exclude any optional element.As such, this statement is intended to serve as a preemptive basis for the use of exclusionary terms such as "sole," "only," and the like in connection with the enumeration of claim elements or the use of a "negative" limitation.

[0090] Without using such exclusive terminology, the term "comprising" in claims assigned to this disclosure is intended to permit the inclusion of any additional element, regardless of whether a specific number of elements are enumerated in such claims or whether the addition of a feature could be considered to change the nature of an element recited in such claims. Unless expressly defined herein, all technical and scientific terms used herein are intended to be construed as broadly as possible without affecting the validity of the claims.

[0091] The scope of the present invention is not limited to the examples given and / or the subject matter of the specification, but only by the scope of the claim language associated with this disclosure as defined by the appended claims. QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] US 63 / 432,250

[0001]

Claims

[1] An embolic protection system for use in a diseased vessel of a vascular system, the embolic protection system comprising: an embolic protection device that includes: a catheter shaft; an expandable filter provided at a distal end of the catheter shaft, the expandable filter including a side port provided in a side wall of the expandable filter; and a filter actuator located at or toward a proximal end of the embolic protection device, the filter actuator operable to open and close an orifice of the expandable filter. [2] The embolic protection system of claim 1, further comprising: a dilator. [3] The embolic protection system of claim 1, further comprising: a loading tool. [4] The embolic protection system of claim 1, further comprising: an introducer set. [5] The embolic protection system of claim 4, further comprising: an introducer hub adapter. [6] Embolic protection system according to claim 4, wherein: the introducer is an expandable introducer. [7] A method of deploying an embolic protection device into a vascular system of a patient, the method comprising: Establishing access to the vascular system; Inserting a guidewire into the vasculature to assist in guiding the embolic protection device through the vasculature; Advancing the embolic protection device into the vasculature and over the guidewire toward a target treatment area, the embolic protection device comprising a catheter shaft, an expandable filter disposed at a distal end of the catheter shaft, the expandable filter including a side port provided in a side wall of the expandable filter, and a filter actuator disposed adjacent a proximal end of the catheter shaft, the filter actuator operable to open and close an orifice of the expandable filter; Actuating the filter actuator, whereby the expandable filter radially expands at the target treatment area and the mouth of the expandable filter is opened; and Trapping emboli in the expandable filter. [8] The method of claim 7, further comprising inserting a therapeutic device through the embolic protection device and advancing the therapeutic device toward the target treatment area. [9] The method of claim 7, wherein the target treatment region comprises a native aortic valve. [10] The method of claim 8, further comprising, after inserting the therapeutic device through the embolic protection device, closing the expandable filter and removing the embolic protection device from the vasculature. [11] The method of claim 1, further comprising inserting a loop guidewire into the vasculature to assist in guiding a guidewire or device through the side port of the embolic protection device.

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