VASCULAR FILTERS, DEFLECTORS, AND METHODS
Vascular filters and deflectors and methods for filtering bodily fluids. A blood filtering assembly can capture embolic material dislodged or generated during an endovascular procedure to inhibit or prevent the material from entering the cerebral vasculature. A blood deflecting assembly can deflect embolic material dislodged or generated during an endovascular procedure to inhibit or prevent the material from entering the cerebral vasculature.
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This application is a continuation of U.S. patent application Ser. No. 16/596,201, filed Oct. 8, 2019, which is a continuation of U.S. patent application Ser. No. 15/399,470, filed Jan. 5, 2017, which is a divisional of U.S. patent application Ser. No. 14/693,763, filed on Apr. 22, 2015, Now U.S. Pat. No. 9,566,144, issued Feb. 14, 2017, which is hereby incorporated by reference in its entirety for all purposes.
BACKGROUND FieldThe disclosure relates to devices and methods for filtering body fluids such as blood and/or selectively deflecting potentially embolic particles from the body fluid. The devices can be catheter-based for insertion into a vascular system of a subject.
Description of Related ArtThromboembolic disorders, such as stroke, pulmonary embolism, peripheral thrombosis, atherosclerosis, and the like affect many people. These disorders are a major cause of morbidity and mortality in the United States and throughout the world. Thromboembolic events are characterized by an occlusion of a blood vessel. The occlusion can be caused by a clot which is viscoelastic (jelly-like) and comprises platelets, fibrinogen, and other clotting proteins.
Percutaneous aortic valve replacement procedures have become popular, but stroke rates related to this procedure are between four and twenty percent. During catheter delivery and valve implantation, plaque or other material may be dislodged from the vasculature and may travel through the carotid circulation and into the brain. When an artery is occluded by a clot or other embolic material, tissue ischemia (lack of oxygen and nutrients) develops. The ischemia progresses to tissue infarction (cell death) if the occlusion persists. Infarction does not develop or is greatly limited if the flow of blood is reestablished rapidly. Failure to reestablish blood-flow can lead to the loss of limb, angina pectoris, myocardial infarction, stroke, or even death.
Reestablishing blood flow and removal of the thrombus is highly desirable. Surgical techniques and medicaments to remove or dissolve obstructing material have been developed, but exposing a subject to surgery may be traumatic and is best avoided when possible. Additionally, the use of certain devices carry risks such as the risk of dislodging foreign bodies, damaging the interior lining of the vessel as the catheter is being manipulated, blood thinning, etc.
SUMMARYVascular filters and deflectors and methods for filtering bodily fluids are disclosed herein. A blood filtering assembly can capture embolic material dislodged or generated during an endovascular procedure to inhibit or prevent the material from entering the cerebral vasculature. A blood deflecting assembly can deflect embolic material dislodged or generated during an endovascular procedure to inhibit or prevent the material from entering the cerebral vasculature.
In some embodiments, a method of inhibiting embolic material from entering cerebral vasculature comprises positioning a guidewire in a left subclavian artery upstream of a left vertebral artery and tracking a distal portion of a protection device over the guidewire. The distal portion of the protection device comprises an outer sheath, an inner member radially inward of the outer sheath, and a self-expanding filter assembly radially between the outer sheath and the inner member. The inner member comprises a guidewire lumen. The method further comprises at least one of proximally retracting the outer sheath and distally advancing the self-expanding filter assembly to deploy the self-expanding filter assembly from the outer sheath in the left subclavian artery upstream of the left vertebral artery. The method may further comprise performing an endovascular procedure. The endovascular procedure may comprise mitral or atrial valve implantation or replacement. The deployed self-expanding filter assembly may inhibit embolic material from entering cerebral vasculature through the left vertebral artery during the endovascular procedure. The method may further comprise, after performing the endovascular procedure, withdrawing the self-expanding filter assembly from the left subclavian artery.
After deploying the self-expanding filter assembly, the inner member may prolapse into an aortic arch. The method may further comprise proximally retracting the inner member out of the aortic arch while the deployed self-expanding filter assembly remains in the left subclavian artery upstream of the left vertebral artery. The method may further comprise monitoring arterial pressure using the outer sheath. The method may further comprise providing fluid through the outer sheath. The method may further comprise positioning a filtering device in an innominate artery and a left common carotid artery. The filtering device may inhibit embolic material from entering cerebral vasculature through a right vertebral artery, a right common carotid artery, and the left common carotid artery during the endovascular procedure.
In some embodiments, a method of inhibiting embolic material from entering cerebral vasculature comprises positioning a distal portion of a protection device at a location. The location is in the left subclavian artery and/or the left vertebral artery. The distal portion of the protection device comprises an outer sheath and at least one of a self-expanding filter assembly and a self-expanding deflector assembly radially inward of the outer sheath. The method further comprises deploying the at least one of a self-expanding filter assembly and a self-expanding deflector assembly from the outer sheath at the location. The deployed self-expanding filter assembly and/or self-expanding deflector assembly inhibits embolic material from entering cerebral vasculature during an endovascular procedure.
The distal portion of the protection device may further comprise an inner member radially inward of the outer sheath. The inner member may comprise a guidewire lumen. Positioning the distal portion of the protection device at the location may comprise tracking the distal portion of the protection device over a guidewire. The method may further comprise monitoring arterial pressure using at least one of the inner member and the outer sheath. The distal portion of the protection device may comprise the self-expanding filter assembly. The distal portion of the protection device may comprise the self-expanding deflector assembly. The endovascular procedure may comprise atrial valve or mitral valve implantation or replacement. Deploying the at least one of a self-expanding filter assembly and a self-expanding deflector assembly may comprise proximally retracting the outer sheath. After deploying the at least one of a self-expanding filter assembly and a self-expanding deflector assembly, the inner member may prolapse into an aortic arch, and the method may further comprise proximally retracting the inner member out of the aortic arch while the deployed at least one of a self-expanding filter assembly and a self-expanding deflector assembly remains in the location. The method may further comprise positioning a filtering device in an innominate artery and a left common carotid artery. The filtering device may inhibit embolic material from entering cerebral vasculature through a right vertebral artery, a right common carotid artery, and the left common carotid artery during the endovascular procedure.
In some embodiments, an embolic material protection device configured to inhibit embolic material from entering cerebral vasculature through a left vertebral artery comprises an outer sheath, an inner member radially inward of the outer sheath, and a self-expanding filter assembly radially between the outer sheath and the inner member. The inner member comprises a lumen. The self-expanding filter assembly is deployable out of the outer sheath by at least one of proximally retracting the outer sheath and distally advancing the self-expanding filter assembly. The inner member may be longitudinally movable independent of the self-expanding filter assembly and the outer sheath.
The self-expanding filter assembly may have a diameter between 7 mm and 12 mm. The self-expanding filter assembly may have a diameter between 2 mm and 4.5 mm. The device may further comprise an arterial pressure monitoring device in fluid communication with the lumen of the outer sheath. A kit may comprising the device of and a filtering device configured to be positioned in an innominate artery and a left common carotid artery.
In some embodiments, an embolic material protection device configured to inhibit embolic material from entering cerebral vasculature through a left vertebral artery comprises an outer sheath and a deflector assembly. The deflector assembly may be deployable out of the outer sheath by at least one of proximally retracting the outer sheath and distally advancing the deflector assembly. The device may further comprise an inner member. The inner member may comprise a lumen. The deflector assembly may comprise a surface configured to be placed across an ostium of an artery. The deflector assembly may be coupled to a distal end of the outer sheath and a distal end of the inner member, and may comprise a frustoconical shape upon manipulation of at least one of the outer sheath and the inner member. The deflector assembly may comprise an at least partially arcuate surface configured to be placed across an ostium of the left vertebral artery.
The disclosure generally relates to devices and methods for filtering fluids and/or deflecting debris contained within fluids, including body fluids such as blood. A filtering or deflecting device can be positioned in an artery before and/or during an endovascular procedure (e.g., transcatheter aortic valve implantation (TAVI) or replacement (TAVR), transcatheter mitral valve implantation (TAMI) or replacement (TAMR), surgical aortic valve replacement (SAVR), other surgical valve repair, implantation, or replacement, cardiac ablation (e.g., ablation of the pulmonary vein to treat atrial fibrillation) using a variety of energy modalities (e.g., radio frequency (RF), energy, cryo, microwave, ultrasound), cardiac bypass surgery (e.g., open-heart, percutaneous), transthoracic graft placement around the aortic arch, valvuloplasty, etc.) to inhibit or prevent embolic material such as debris, emboli, thrombi, etc. resulting from entering the cerebral vasculature.
The devices may be used to trap particles in other blood vessels within a subject, and they can also be used outside of the vasculature. The devices described herein are generally adapted to be delivered percutaneously to a target location within a subject, but can be delivered in any suitable way and need not be limited to minimally-invasive procedures.
Devices and methods, some of which are compatible and/or synergistic with the devices and methods described herein, have been developed to filter blood flowing to the innominate artery 12 and the left common carotid artery 14, which provide about 90% of the blood entering the cerebral vasculature. Examples are provided in U.S. Pat. No. 8,876,796, which is incorporated herein by reference in its entirety, and most particularly with respect to disclosure directed to devices and methods for protecting aortic arch branch arteries and structures of filter devices. Certain such devices and methods leave the left subclavian artery 16, and thus the left vertebral artery 24, which provides about 10% of the blood entering the cerebral vasculature, exposed to potential embolic material. Other embodiments described in U.S. Pat. No. 8,876,796 filter blood flowing to the left common carotid artery 14 and the left subclavian artery 16. Certain such devices and methods leave the innominate artery 12, and thus both the right common carotid artery 18 and the right vertebral artery 20, which provide even about 50% of the blood entering the cerebral vasculature, exposed to potential embolic material. Assuming perfect use and operation, either of these options may leave potential stroke rates as high as two to ten percent due to exposed arteries that provide blood flow to the cerebral vasculature.
The protection device 200 comprises a proximal portion 202 and a distal portion 204. The proximal portion 202 is configured to be held and manipulated by a user such as a surgeon. The distal portion 204 is configured to be positioned at a target location such as the left subclavian artery or the left vertebral artery. The location is preferably proximate to the ostium of the artery. When the distal portion 204 is configured to be positioned at the left subclavian artery, the location is preferably upstream of the left vertebral artery.
The proximal portion 202 comprises a handle 206, a control 208 such as a slider, an outer sheath 210, a port 212, optionally an inner member translation control 214 such as a knob, and optionally a hemostasis valve control 216 such as a knob. Although not visible in
The slider 208 can be used to translate the outer sheath 210 and/or a filter assembly 218 (e.g., coupled to a filter wire). For example, the slider 208 may proximally retract the outer sheath 210, the slider 208 may distally advance the filter assembly 218 out of the outer sheath 210, or the slider 208 may proximally retract the outer sheath 210 and distally advance the filter assembly 218 (e.g., simultaneously or serially), which can allow the filter assembly 218 to radially expand. The slider 208 may also be configured to have an opposite translation effect, which can allow the filter assembly 218 to be radially collapsed (e.g., due to compression by the outer sheath 210) as the filter assembly 218 is drawn into the outer sheath 210. Other deployment systems are also possible, for example comprising gears or other features such as helical tracks (e.g., configured to compensate for any differential lengthening due to foreshortening of the filter assembly 218, configured to convert rotational motion into longitudinal motion), a mechanical element, a pneumatic element, a hydraulic element, etc. for opening and/or closing the filter assembly 218.
The port 212 is in fluid communication with the inner member 220 (e.g., via a Y-shaped connector in the handle 206). The port 212 can be used to flush the device (e.g., with saline) before, during, and/or after use, for example to remove air. The port 212 can also or alternatively be used to monitor blood pressure at the target location, for example by connecting an arterial pressure monitoring device in fluid communication with a lumen 221 (
The rotatable hemostasis valve control 216 can be used to reduce or minimize fluid loss through the protection device 200 during use. For example, when positioned in the left subclavian artery, the direction of blood flow with respect to the device 200 will be distal to proximal, so blood may be otherwise inclined to follow the pressure drop out of the device 200. The hemostasis valve control 216 is illustrated as being rotatable, but other arrangements are also possible (e.g., longitudinally displaceable). The hemostasis valve control 216 may be configured to fix relative positions of the outer sheath 210 and the filter assembly 218, for example as described with respect to the hemostasis valve in U.S. Pat. No. 8,876,796. The hemostasis valve 216 may comprise, for example, an elastomeric seal and HV nut.
The distal portion 204 comprises the outer sheath 210, a filter assembly 218 radially inward of the outer sheath 210, and optionally the inner member 220. The filter assembly 218 may be radially between the outer sheath 210 and the inner member 220 (e.g., radially inward of the outer sheath 210 and the inner member 220 radially inward of the filter assembly 218) in a delivery state or shape or position.
The filter assembly 218 may comprise a self-expanding filter assembly (e.g., comprising a superelastic material with stress-induced martensite due to confinement in the outer sheath 210). The filter assembly 218 may comprise a shape-memory material configured to self-expand upon a temperature change (e.g., heating to body temperature). The filter assembly 218 may comprise a shape-memory or superelastic frame (e.g., comprising a distal end hoop comprising nitinol) and a microporous material (e.g., comprising a polymer including laser-drilled holes) coupled to the frame, for example similar to the filter assemblies described in U.S. Pat. No. 8,876,796.
The filter assembly 218 may be coupled (e.g., crimped, welded, soldered, etc.) to a distal end of a deployment wire or filter wire 217. The filter wire 217 can comprise a rectangular ribbon, a round (e.g., circular, elliptical) filament, a portion of a hypotube, a braided structure (e.g., as described herein), combinations thereof, and the like. The filter wire 217 can be coupled to the handle 206 and/or the slider 208 to provide differential longitudinal movement versus the outer sheath 210, as shown by the arrows 222, which can sheathe and unsheathe the filter assembly 218 from the outer sheath 210.
The filter assembly 218 in an expanded, unconstrained state has a maximum diameter or effective diameter (e.g., if the mouth is in the shape of an ellipse) d. The diameter d can be between about 1 mm and about 15 mm (e.g., at least about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, ranges between such values, etc.). In some embodiments (e.g., when the filter assembly is configured to be positioned in the left subclavian artery), the diameter d is between about 7 mm and about 12 mm (e.g., about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, ranges between such values, etc.). In some embodiments (e.g., when the filter assembly is configured to be positioned in the left vertebral artery), the diameter d is between about 2 mm and about 4.5 mm (e.g., about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, ranges between such values, etc.). Other diameters d or other types of lateral dimensions are also possible. Different diameters d can allow treatment of a selection of subjects having different vessel sizes.
The filter assembly 218 has a maximum length l. The length l can be between about 7 mm and about 50 mm (e.g., at least about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, ranges between such values, etc.). Other lengths l are also possible, for example based on the diameter or effective diameter d. For example, the length l of the filter assembly 218 may increase as the diameter d increases, and the length l of the filter assembly 218 may decrease as the diameter d decreases. A distance from an apex of the mouth of the filter assembly 218 to an elbow in the frame may be about 35 mm. Different lengths l can allow treatment of a selection of subjects having different vessel sizes.
The inner member 220 is optional, but can provide additional uses and/or advantages in combination with the filter assembly 218. For example, the inner member 220 may comprise a guidewire lumen 221, allowing the device 200 to be tracked over a guidewire (e.g., the guidewire 226 comprising a pigtail distal end) without contacting the filter assembly 218. For another example, a lumen 221 of the inner member 220 may be fluidly coupled to the flush port 212, which can allow flushing of fluid through the inner member 220, for example to remove air. For yet another example, a lumen 221 of the inner member 220 may be connected to an arterial pressure monitoring device, allowing measurement of pressure proximate to the location of the filter assembly 218.
The distal portion 204 may include fluoroscopic markers 224a, 224b, 224c, 224d to aid a user in positioning the device 200, deploying the filter assembly 218, utilizing the inner member 220, etc. The fluoroscopic marker 224a is proximate to a distal end of the outer sheath 210. The fluoroscopic marker 224b is proximate to a proximal end of the filter assembly 218. The fluoroscopic marker 224c is proximate to a proximal end of a ring of the filter assembly 218. The fluoroscopic marker 224d is proximate to a distal end of the inner member 220. The fluoroscopic markers may comprise a radiopaque material (e.g., iridium, platinum, tantalum, gold, palladium, tungsten, tin, silver, titanium, nickel, zirconium, rhenium, bismuth, molybdenum, combinations thereof, and the like). More or fewer fluoroscopic markers are also possible.
The protection device 200 is illustrated as comprising a guidewire 226 therethrough, although the guidewire 226 may be characterized as being separate from the protection device 200, for example independently sold, packaged, and/or directed. The guidewire 226 may extend through a lumen of the outer sheath 210. The lumen may be configured to receive a guidewire 226 having a diameter between about 0.014 inches and about 0.025 inches. The guidewire 226 may extend through a lumen of the filter assembly 218. The guidewire 226 may extend through a lumen 221 of the inner member 220. For example, the protection device 200 may be tracked over the guidewire 226 to position the protection device 200 at a desired location.
The housing 302 can hold parts of the proximal portion 300 together, protect parts from contaminants (e.g., that may interfere with use of the proximal portion 300), and the like. The housing 302 may be omitted, for example providing a user of the proximal portion 300 unfettered access or control over every feature of the proximal portion 300. For example, many users are quite skilled at manipulating wires and tubes with respect to each other such that a slider 308 or the like may reduce manipulation dexterity. For other users, a slider 306 or the like may provide aid in proper use, for example providing a fail-safe limited range of movement.
A filter wire 322 that is coupled to a filter assembly (e.g., as described herein) may be coupled to the deployment tube 304 by a weld 324 or other coupling means. The housing 302 allows the slider 308 to move longitudinally, for example in a track in the housing 302, to deploy a filter assembly (e.g., out of a distal end of the outer sheath 306). The deployment housing 304 can help maintain positions of elements such as the filter wire 322 and the outer sheath 306 during movement such as translation of the slider 308. The proximal portion 300 may comprise a static seal 326 between the slider 308 and the deployment tube 304. The housing 302 can provide ergonomic interaction between a user and the proximal portion 300.
The luer fitting 320 allows the proximal portion 300 to be flushed (e.g., with saline) prior to use (e.g., through the lumen of the inner member 316), for example to remove air. The luer fitting 320 may be used to couple the inner member 316 to a pressure monitoring device. The proximal portion 300 is illustrated with a guidewire 328 extending through a lumen of the inner member 316, indicative that the lumen of the inner member 316 may be used to guide a protection device to a location by tracking over the guidewire 328. The stopcock 312 includes a luer fitting port 313 in fluid communication with the outer sheath lumen 221 and is suitable for use in monitoring arterial blood pressure. If the inner member 316 is too small for an accurate measurement or if the inner member 316 is omitted, the outer sheath 304 can provide the fluid lumen used to measure blood pressure.
A lock 315 may be provided to releasably engage the inner member 316 to inhibit or prevent the inner member 316 from moving with respect to the hub 310. Other interaction mechanisms are also possible.
The radiopaque marker 404 may be proximate to the distal end of the outer sheath 402 to help guide the distal end of the outer sheath 402 into a delivery location (e.g., the left subclavian artery upstream of the left vertebral artery, or the left vertebral artery). The radiopaque marker 404 may be positioned to aid a user in determining a deployed position of the filter assembly 406, for example accounting for foreshortening upon radial expansion. Once the radiopaque marker 404 is aligned with a target location or some distance proximal or distal to the target location, the filter assembly 406 can be deployed, or the distal portion 400 may be advanced or retracted a certain distance before the filter assembly 406 is deployed. The radiopaque marker 404 may be omitted (e.g., by using a radiopaque portion of the filter assembly 406). The radiopaque marker 404 may be used to determine a degree of deployment of the filter assembly 406. For example, if the proximal end of the filter assembly 406 comprises a radiopaque marker or band such as the radiopaque marker or band 224b in
In the delivery state illustrated in
The filter assembly 406 comprises a support element or frame 408 and a filter element 410. The frame 408 generally provides expansion support to the filter element 410 in the expanded state. In the expanded state, the filter element 410 is configured to filter fluid (e.g., blood) flowing through the filter element 410 and to inhibit or prevent particles (e.g., embolic material) from flowing through the filter element 410 by capturing the particles in the filter element 410.
The guide tube 414 and/or the outer sheath 402 may comprise a lumen in which portions of the frame 408 (e.g., longitudinal portions) are coupled (e.g., adhesively joined, banded, crimped, welded, soldered, etc.) to a filter wire 417. The coupled portions of the frame 408 and filter wire 417 may be in a lumen 423 of a crimp tube 422 that is in the guide tube 414.
The inner member 416 may extend the length of the filter assembly 406 in the compressed state, for example to inhibit or prevent the guidewire 418 from interacting with the filter assembly 406, thereby inhibiting or preventing the filter assembly 406 from binding the guidewire 418 during navigation. Foreshortening of the filter assembly 406 during deployment may result in the inner member 420 extending distally to the filter assembly 408 after deployment of the filter assembly 406, possibly into the aortic arch. The inner member 420 may be proximally retracted (e.g., out of the aortic arch and/or for other reasons such as positioning for use of a therapeutic, radiopaque, or other fluid, for use with a pressure monitor, etc.) after deployment of the filter assembly 406, for example as described with respect to
The frame 408 is configured to engage or appose the inner walls of a lumen (e.g., blood vessel) in which the distal portion 400 is expanded. The frame 408 may comprise or be constructed of, for example, nickel titanium (e.g., nitinol), nickel titanium niobium, chromium cobalt (e.g., MP35N, 35NLT), copper aluminum nickel, iron manganese silicon, silver cadmium, gold cadmium, copper tin, copper zinc, copper zinc silicon, copper zinc aluminum, copper zinc tin, iron platinum, manganese copper, platinum alloys, cobalt nickel aluminum, cobalt nickel gallium, nickel iron gallium, titanium palladium, nickel manganese gallium, stainless steel, combinations thereof, and the like. The frame 408 may comprise a wire (e.g., having a round (e.g., circular, elliptical) or polygonal (e.g., square, rectangular) cross-section). For example, in some embodiments, the frame 408 comprises a straight piece of nitinol wire shape set into a circular or oblong hoop or hoop with one or two straight legs running longitudinally along or at an angle to a longitudinal axis of the distal portion 400. At least one of the straight legs may be coupled to a filter wire 417, for example as shown in
The frame 408 may include a radiopaque marker such as a small coil wrapped around or coupled to the hoop to aid in visualization under fluoroscopy. In some embodiments, the frame may not comprise a shape other than a hoop, for example a spiral. In some embodiments, the filter assembly 406 may not include or be substantially free of a frame.
In some embodiments, the frame 408 and the filter element 410 form an oblique truncated cone having a non-uniform or unequal length around and along the length of the filter assembly 406. In such a configuration, along the lines of a windsock, the filter assembly 406 has a larger opening 420 (upstream) diameter and a reduced ending (downstream) diameter (e.g., proximate to the filter wire).
The filter element 410 comprises pores configured to allow blood to flow through the filter element 410, but that are small enough to inhibit prevent particles such as embolic material from passing through the filter element 410. The filter element 410 may comprise a filter membrane such as a polymer (e.g., polyurethane, polytetrafluoroethylene (PTFE)) film mounted to the frame 406. The filter element may have a thickness between about 0.0001 inches and about 0.03 inches (e.g., no more than about 0.0001 inches, about 0.001 inches, about 0.005 inches, about 0.01 inches, about 0.015 inches, about 0.02 inches, about 0.025 inches, about 0.03 inches, ranges between such values, etc.).
The film may comprise a plurality of pores or holes or apertures extending through the film. The film may be formed by weaving or braiding filaments or membranes and the pores may be spaces between the filaments or membranes. The filaments or membranes may comprise the same material or may include other materials (e.g., polymers, non-polymer materials such as metal, alloys such as nitinol, stainless steel, etc.). The pores of the filter element 410 are configured to allow fluid (e.g., blood) to pass through the filter element 410 and to resist the passage of embolic material that is carried by the fluid. The pores can be circular, elliptical, square, triangular, or other geometric shapes. Certain shapes such as an equilateral triangular, squares, and slots may provide geometric advantage, for example restricting a part larger than an inscribed circle but providing an area for fluid flow nearly twice as large, making the shape more efficient in filtration verses fluid volume. The pores may be laser drilled into or through the filter element 410, although other methods are also possible (e.g., piercing with microneedles, loose braiding or weaving). The pores may have a lateral dimension (e.g., diameter) between about 10 micron (.mu.m) and about 1 mm (e.g., no more than about 10 .mu.m, about 50 .mu.m, about 100 .mu.m, about 150 .mu.m, about 200 .mu.m, about 250 .mu.m, about 300 .mu.m, about 400 .mu.m, about 500 .mu.m, about 750 .mu.m, about 1 mm, ranges between such values, etc.). Other pore sizes are also possible, for example depending on the desired minimum size of material to be captured.
The material of the filter element 410 may comprise a smooth and/or textured surface that is folded or contracted into the delivery state by tension or compression into a lumen. A reinforcement fabric may be added to or embedded in the filter element 410 to accommodate stresses placed on the filter element 410 during compression. A reinforcement fabric may reduce the stretching that may occur during deployment and/or retraction of the filter assembly 406. The embedded fabric may promote a folding of the filter to facilitate capture of embolic debris and enable recapture of an elastomeric membrane. The reinforcement material could comprise, for example, a polymer and/or metal weave to add localized strength. The reinforcement material could be imbedded into the filter element 410 to reduce thickness. For example, imbedded reinforcement material could comprise a polyester weave mounted to a portion of the filter element 410 near the longitudinal elements of the frame 408 where tensile forces act upon the frame 408 and filter element 410 during deployment and retraction of the filter assembly 406 from the outer sheath 402.
A fluid (e.g., blood) flows through the opening 420 and passes through the pores in the filter element 410, while the filter element 410 traps particles (e.g., embolic material) to inhibit or prevent passage to a location downstream of the filter assembly 406 such as the cerebral vasculature.
The distal portion 400 is illustrated with a guidewire 418 extending through a lumen of the inner member 416, indicative that the lumen of the inner member 416 may be used to guide a protection device to a location by tracking over the guidewire 418.
Blood pressure may be taken inside of the deployment tube 572. For example, if an outer sheath around the deployment tube 572 is 5 Fr (approximately 1.67 mm), then measurement of blood pressure inside the deployment tube 572 may allow for true 5 Fr. Blood pressure may be taken outside of the deployment tube 572, although an outer sheath around the deployment tube 572 is preferably 6 Fr (approximately 2 mm) to obtain appropriate pressure measurements. Other diameters may also be appropriate (e.g., 5 Fr (approximately 1.67 mm) in an outer sheath or catheter or for a needle-based system.
In some embodiments in which a protection device comprises the coupling mechanism 570, a smaller guidewire may be used, for example to fit within a lumen of the deployment tube 572, which may be reduced where the deployment tube 572 is coupled to the wires 574a, 574b. A guidewire may be guided through the deployment tube 572 using a porous centering part, which can comprise a braid-reinforced shaft. The coupling may rely on an interference fit between the wires 574a, 574b and the braided shaft 572 when the band 576 is positioned over the wires 574a, 574b and the braided shaft 572. The band 576 may be mechanically swaged to hold the wires 574a, 574b in place. The filter assembly may be fixed to an inner member around which the deployment tube 572 is positioned, and the guidewire may be routed through a lumen of the inner member.
Lumens of the protection device 600, for example a lumen of the outer sheath 604 and a lumen of the inner member 606, may be flushed (e.g., using saline) once or several times before, during, and/or after the procedure. The filter assembly 602 of the protection device 600 may be flushed and/or submerged (e.g., in a bowl of saline). Flushing and/or submerging of the filter assembly 602 may be with the filter assembly 602 in the outer sheath 604 (e.g., in the compressed state) and/or with the filter assembly 602 out of the outer sheath 604 (e.g., in the deployed state). If the filter assembly 602 is flushed and/or submerged in the deployed state, the filter assembly 602 may be compressed into the outer sheath 604 before use.
An artery in the left arm is accessed, for example using a 5 Fr introducer. A guidewire (e.g., having a diameter between about 0.014 inches and about 0.25 inches) is steered, traversing retrograde to blood flow, into or towards the left subclavian artery 616. A proximal end of the guidewire may be inserted into a distal end of the protection device 600, for example into a distal end of an inner member 606. The protection device 600 may be tracked over the guidewire until the distal end of the protection device 600 extends beyond a distal end of the introducer. In some implementations, the guidewire and the protection device 600 may be tracked together, with the guidewire leading the device 600 (e.g., advance the guidewire a distance, then advance the device 600 over the guidewire approximately the same distance). The guidewire and the inner member 606 may both be floppy or lack rigidity, they may be introduced inside the outer sheath 604 and then advanced ahead of the device 600 in the vasculature. The guidewire may be advanced at least about 6 centimeters (cm) distal to the distal end of the protection device 600.
The protection device 600 may be tracked or distally advanced over the guidewire until the distal end of the protection device 600 is at a desired location such as proximate to the left subclavian artery ostium 617, just above the aortic arch 610. Tracking of the protection device 600 may be under fluoroscopy, for example using radiopaque markers (e.g., at a distal end of the outer sheath 604 and/or the inner member 606) and/or radiopaque fluid or contrast media. Radiopaque fluid may be provided through the inner member 606 or outer sheath 604. The protection device 600 is preferably positioned so that the filter assembly 602 is upstream of the left vertebral artery 624 or more preferably proximate to the ostium 617 so that the filter assembly 602 can inhibit or prevent embolic material from entering the cerebral vasculature through the left vertebral artery 624. Using terminology of the procedure rather than blood flow, the protection device 600 is preferably positioned so that the filter assembly 602 is distal to the point in the left subclavian artery 616 where the left vertebral artery 624 branches off. Positioning may be based on available anatomy.
Once the protection device 600 is in position, the filter assembly 602 may be deployed from the outer sheath 604. For example, the outer sheath 604 may be proximally retracted and/or the filter assembly 602 may be distally advanced. Radiopaque markers, for example on the filter assembly 602 can help determine when the filter assembly 602 achieves a deployed state. Differential longitudinal movement of the filter assembly 602 and the outer sheath 604 can cease upon full or appropriate deployment of the filter assembly 602. Apposition of the filter assembly 602 with sidewalls of the left subclavian artery 616 can be verified, for example using radiopaque fluid or contrast media. Radiopaque fluid may be provided through the inner member 606. If the radiopaque fluid is able to flow between the frame of the filter assembly 602 and the sidewalls of the left subclavian artery 616, then the filter assembly 602 may be improperly positioned (e.g., indicative of inadequate deployment, inadequate sizing, calcium, etc.). The filter assembly 602 may be retracted back into the outer sheath 604 and redeployed, or a different protection device may be used.
As shown in
The inner member 606 may be retracted to a position suitable for monitoring or sensing blood pressure. For example, a blood pressure monitoring device can be connected in fluid communication to the inner member 606 (e.g., using a luer fitting). In embodiments in which the protection device lacks an inner member, blood pressure may be monitored or sensed by connecting a blood pressure monitoring device to the outer sheath 604.
With the protection device 600 in place, the filter assembly 602 deployed, and the inner member 606 retracted, the user or a different user can perform an endovascular procedure (e.g., TAVI, TAVR, TAMI, TAMR, SAVR, other surgical valve repair, implantation, or replacement, cardiac ablation, cardiac bypass surgery, etc.). If the endovascular procedure accesses the heart via the aortic arch 610, such access is not impeded by the protection device 600. During the endovascular procedure, any embolic material that is dislodged or generated may be carried by blood into the left subclavian artery 616. The blood may continue to flow through the filter assembly 602 (e.g., through pores in a film of the filter assembly 602), but the embolic material is trapped or captured such that the embolic material is inhibited or prevented from continuing to flow through the left subclavian artery 616, into the left vertebral artery 624, and thus into the cerebral vasculature.
Once the endovascular procedure is complete, or at any appropriate point during the endovascular procedure, the filter assembly 602 may be retracted back into the outer sheath 604 (e.g., by distally advancing the outer sheath 604 and/or by proximally retracting the filter assembly). The action to resheathe the filter assembly 602 may by opposite to the action to unsheathe the filter assembly 602 (e.g., retraction of a slider and advancement of the slider, respectively) or may be a completely different action. The inner member 606 may be distally advanced before, during, or after resheathing the filter assembly 602. Radiopaque markers, for example on the filter assembly 602 can help determine when the filter assembly 602 achieves a compressed state. Differential longitudinal movement of the filter assembly 602 and the outer sheath 604 can cease upon full or appropriate capture of the filter assembly 602. Radiopaque fluid may be provided through the inner member 606. Embolic material trapped in the filter assembly 602 may also be captured by the resheathing process. Once the protection device 600 is in a compressed state, the protection device 600 may be proximally retracted out of the left subclavian artery 616.
The protection devices described herein may be used alone or in combination with other protection devices. For example, a second protection device as described herein may be advanced via the right subclavian artery and positioned in the innominate artery, providing protection to the right carotid artery and the right vertebral artery. For another example, an aortic arch filter or deflector such as the Embrella Embolic Deflector System, the TriGuard embolic protection system, or the like may be placed across the great branch artery ostia and/or apposing sidewalls of the aortic arch upstream of at least one of the great branch artery ostia.
For another example, the filter systems and methods described in U.S. Pat. No. 8,876,796 can be used in combination with the protection devices described herein to further protect the cerebral vasculature during an endovascular procedure.
The distal portion 800 comprises an outer sheath 802 (e.g., the outer sheath 210), a radiopaque marker band 804, a filter assembly 806 (e.g., the filter assembly 218), an inner member 816 (e.g., the inner member 220), and a slotted coupler 812. One or more of the illustrated features may optionally be omitted from the distal portion 800, for example to reduce cost, to reduce complexity, to remove features not used, etc. The addition of features not illustrated in
The outer sheath 802 may include a curvature and/or be steerable, for example to turn a distal end of the distal portion 800 from the left subclavian artery into the left vertebral artery. For example, the outer sheath 802 may include one or more features described with respect to the left common carotid artery filter assemblies in U.S. Pat. No. 8,876,796. The distal end of the outer sheath 802 may have a soft atraumatic tip. The slotted coupler 812, which couples wires of the frame 808 of the filter assembly 806 to a filter wire, for example as described with respect to any of the coupling mechanisms described herein, may comprise slots to aid the slotted coupler 812 in bending (e.g., into the left vertebral artery). The wires of the frame 808 may form an inclined strut connecting the open end of the filter assembly 806 to the slotted coupler 812, which can help to radially compress the filter assembly 806 upon interaction with outer sheath 802.
The radiopaque marker 804 may be proximate to the distal end of the outer sheath 802 to help guide the distal end of the outer sheath 802 into a delivery location (e.g., the left vertebral artery). The radiopaque marker 804 may be positioned to aid a user in determining a deployed position of the filter assembly 806, for example accounting for foreshortening upon radial expansion. Once the radiopaque marker 804 is aligned with a target location or some distance proximal or distal to the target location, the filter assembly 806 can be deployed, or the distal portion 800 may be advanced or retracted a certain distance before the filter assembly 806 is deployed. As described with respect to the radiopaque marker 404, the radiopaque marker 804 may be used as a landmark with reference to the radiopaque marker 224b, for example to determine a degree of deployment of the filter assembly 602. The radiopaque marker 804 may be omitted (e.g., by using a radiopaque portion of the filter assembly 806).
In a delivery state, which may appear the same as the delivery state of the distal portion 400 illustrated in
The filter assembly 806 comprises a support element or frame 808 and a filter element 810. The frame 808 generally provides expansion support to the filter element 810 in the expanded state. In the expanded state, the filter element 810 is configured to filter fluid (e.g., blood) flowing through the filter element 810 and to inhibit or prevent particles (e.g., embolic material) from flowing through the filter element 810 by capturing the particles in the filter element 810.
The frame 808 is configured to engage or appose the inner walls of a lumen in which the distal portion 800 is expanded. The frame 808 may comprise or be constructed of, for example, nickel titanium (e.g., nitinol), nickel titanium niobium, chromium cobalt (e.g., MP35N, 35NLT), copper aluminum nickel, iron manganese silicon, silver cadmium, gold cadmium, copper tin, copper zinc, copper zinc silicon, copper zinc aluminum, copper zinc tin, iron platinum, manganese copper, platinum alloys, cobalt nickel aluminum, cobalt nickel gallium, nickel iron gallium, titanium palladium, nickel manganese gallium, stainless steel, combinations thereof, and the like. The frame 808 may comprise a wire (e.g., having a round (e.g., circular, elliptical) or polygonal (e.g., square, rectangular) cross-section). For example, in some embodiments, the frame 808 comprises a straight piece of nitinol wire shape set into a circular or oblong hoop or hoop with one or two straight legs running longitudinally along or at an angle to the longitudinal axis of the distal portion 800. At least one of the straight legs may be coupled to a filter wire. The straight legs may be on a long side of the filter assembly 806 (e.g., the top side as illustrated in
The frame 808 may include a radiopaque marker such as a small coil to aid in visualization under fluoroscopy. In some embodiments, the frame may not comprise a shape other than a hoop, for example a spiral. In some embodiments, the filter assembly 806 may not include or be substantially free of a frame.
In some embodiments, the frame 808 and the filter element 810 form an oblique truncated cone having a non-uniform or unequal length around and along the length of the filter assembly 806. In such a configuration, along the lines of a windsock, the filter assembly 806 has a larger opening 820 (upstream) diameter (e.g., proximate to the filter wire) and a reduced ending (downstream) diameter.
The filter element 810 comprises pores configured to allow blood to flow through the filter element 810, but that are small enough to inhibit prevent particles such as embolic material from passing through the filter element 810. The filter element 810 may comprise a polymer (e.g., polyurethane, PTFE) film mounted to the frame 806. The filter element may have a thickness between about 0.0001 inches and about 0.03 inches (e.g., no more than about 0.0001 inches, about 0.001 inches, about 0.005 inches, about 0.01 inches, about 0.015 inches, about 0.02 inches, about 0.025 inches, about 0.03 inches, ranges between such values, etc.).
The polymer film may comprise a plurality of pores or holes or apertures extending through the film. The polymer film may be formed by weaving or braiding filaments or membranes and the pores may be spaces between the filaments or membranes. The filaments or membranes may comprise the same material or may include other materials (e.g., non-polymer materials such as metal, alloys such as nitinol, stainless steel, etc.). The pores of the filter element 810 are configured to allow fluid (e.g., blood) to pass through the filter element 810 and to resist the passage of embolic material that is carried by the fluid. The pores can be circular, elliptical, square, triangular, or other geometric shapes. Certain shapes such as an equilateral triangular, squares, and slots may provide geometric advantage, for example restricting a part larger than an inscribed circle but providing an area for fluid flow nearly twice as large, making the shape more efficient in filtration verses fluid volume. The pores may be laser drilled into or through the filter element 810, although other methods are also possible (e.g., piercing with microneedles, loose braiding or weaving). The pores may have a lateral dimension (e.g., diameter) between about 1 micron (.mu.m) and about 1 mm (e.g., about 1 .mu.m, about 5 .mu.m, about 10 .mu.m, about 50 .mu.m, about 100 .mu.m, about 150 .mu.m, about 200 .mu.m, about 250 .mu.m, about 300 .mu.m, about 800 .mu.m, about 500 .mu.m, about 750 .mu.m, about 1 mm, ranges between such values, etc.). Other pore sizes are also possible.
The material of the filter element 810 may comprise a smooth and/or textured surface that is folded or contracted into the delivery state by tension or compression into a lumen. A reinforcement fabric may be added to or embedded in the filter element 810 to accommodate stresses placed on the filter element 810 during compression. A reinforcement fabric may reduce the stretching that may occur during deployment and/or retraction of the filter assembly 806. The reinforcement material could comprise, for example, a polymer and/or metal weave to add localized strength. The reinforcement material could be imbedded into the filter element 810 to reduce thickness. For example, imbedded reinforcement material could comprise a polyester weave mounted to a portion of the filter element 810 near the longitudinal elements of the frame 808 where tensile forces act upon the frame 808 and filter element 810 during deployment and retraction of the filter assembly 806 from the outer sheath 802.
A fluid (e.g., blood) flows through the opening 820 and passes through the pores in the filter element 810, while the filter element 810 traps particles (e.g., embolic material) to inhibit or prevent passage to a location downstream of the filter assembly 806 such as the cerebral vasculature.
The distal portion 800 is illustrated with a guidewire 818 extending through a lumen of the inner member 816, indicative that the lumen of the inner member 816 may be used to guide a protection device to a location by tracking over the guidewire 818.
Lumens of the protection device 900, for example a lumen of the outer sheath 904 and a lumen of an inner member, may be flushed (e.g., using saline) once or several times before, during, and/or after the procedure. The filter assembly 902 of the protection device 900 may be flushed and/or submerged (e.g., in a bowl of saline). Flushing and/or submerging of the filter assembly 902 may be with the filter assembly 902 in the outer sheath 904 (e.g., in the compressed state) and/or with the filter assembly 902 out of the outer sheath 904 (e.g., in the deployed state). If the filter assembly 902 is flushed and/or submerged in the deployed state, the filter assembly 902 may be compressed into the outer sheath 904 before use.
An artery in the left arm is accessed, for example using a 5 Fr introducer. A guidewire 918 (e.g., having a diameter between about 0.014 inches and about 0.25 inches, preferably on the smaller side in view of intended navigation to the relatively small left vertebral artery 924) is steered, traversing retrograde to blood flow, into or towards the left subclavian artery 916. A proximal end of the guidewire 918 may be inserted into a distal end of the protection device 900, for example into a distal end of an inner member. The protection device 900 may be tracked over the guidewire 918 until the distal end of the protection device 900 extends beyond a distal end of the introducer. The guidewire 918 may be advanced at least about 6 cm distal to the distal end of the protection device 900.
The protection device 900 may be tracked or distally advanced over the guidewire 918 until the distal end of the protection device 900 is at a desired location such as in the left vertebral artery 924. Tracking of the protection device 900 may be under fluoroscopy, for example using radiopaque markers (e.g., at a distal end of the outer sheath 904 and/or an inner member) and/or radiopaque fluid or contrast media. Radiopaque fluid may be provided through an inner member. The protection device 900 is preferably positioned so that the filter assembly 902 is downstream of the left vertebral artery 924 ostium so that the filter assembly 902 can inhibit or prevent embolic material from entering the cerebral vasculature through the left vertebral artery 924. The location in the left vertebral artery 924 is preferably free or substantially free of calcium and straight or substantially straight. Positioning based on available anatomy that is not as preferred is also possible.
Once the protection device 900 is in position, the filter assembly 902 may be deployed from the outer sheath 904. For example, the outer sheath 904 may be proximally retracted and/or the filter assembly 902 may be distally advanced. Radiopaque markers, for example on the filter assembly 902 can help determine when the filter assembly 902 achieves a deployed state. Differential longitudinal movement of the filter assembly 902 and the outer sheath 904 can cease upon full or appropriate deployment of the filter assembly 902. Apposition of the filter assembly 902 with sidewalls of the left subclavian artery 916 can be verified, for example using radiopaque fluid or contrast media. Radiopaque fluid may be provided through an inner member. If the radiopaque fluid is able to flow between the frame of the filter assembly 902 and the sidewalls of the left vertebral artery 924, then the filter assembly 902 may be improperly positioned (e.g., indicative of inadequate deployment, inadequate sizing, calcium, etc.). The filter assembly 902 may be retracted back into the outer sheath 904 and redeployed, or a different protection device may be used.
If the protection device 900 comprises an inner member, the inner member may extend downstream in the left vertebral artery 924. Whether the inner member is retracted or not, the aortic arch 910 is free or substantially free of any equipment involved in protecting the left vertebral artery 924.
An inner member may be retracted to a position suitable for monitoring or sensing blood pressure. For example, a blood pressure monitoring device can be connected in fluid communication to an inner member (e.g., using a luer fitting). The distal end of an inner member may be in the left vertebral artery 924 to monitor pressure in the left vertebral artery 924. The distal end of an inner member may be in the left subclavian artery 916 to monitor pressure in the left subclavian artery 916. In embodiments in which the protection device lacks an inner member, blood pressure may be monitored or sensed by connecting a blood pressure monitoring device to the outer sheath 904. The distal end of the outer sheath 904 may be in the left vertebral artery 924 (e.g., as illustrated in
With the protection device 900 in place and the filter assembly 902 deployed, the user or a different user can perform an endovascular procedure (e.g., TAVI, TAVR, TAMI, TAMR, SAVR, other surgical valve repair, implantation, or replacement, cardiac ablation, cardiac bypass surgery, etc.). If the endovascular procedure accesses the heart via the aortic arch 910, such access is not impeded by the protection device 900. During the endovascular procedure, any embolic material that is dislodged or generated may be carried by blood into the left vertebral artery 924. The blood may continue to flow through the filter assembly 902 (e.g., through pores in a film of the filter assembly 902), but the embolic material is trapped or captured such that the embolic material is inhibited or prevented from continuing to flow through the left vertebral artery 924 and thus into the cerebral vasculature.
Once the endovascular procedure is complete, or at any appropriate point during the endovascular procedure, the filter assembly 902 may be retracted back into the outer sheath 904 (e.g., by distally advancing the outer sheath 904 and/or by proximally retracting the filter assembly). The action to resheathe the filter assembly 902 may by opposite to the action to unsheathe the filter assembly 902 (e.g., retraction of a slider and advancement of the slider, respectively) or may be a completely different action. Radiopaque markers, for example on the filter assembly 902 can help determine when the filter assembly 902 achieves a compressed state. Differential longitudinal movement of the filter assembly 902 and the outer sheath 904 can cease upon full or appropriate capture of the filter assembly 902. Radiopaque fluid may be provided through an inner member. Embolic material trapped in the filter assembly 902 may also be captured by the resheathing process. Once the protection device 900 is in a compressed state, the protection device 900 may be proximally retracted out of the left vertebral artery 924.
In any of the embodiments described herein, the filter assembly may be detached from the protection device, and the remainder of the protection device removed, leaving the filter assembly behind. The filter assembly can remain in the location permanently or can be retrieved by snaring with a retrieval catheter, for example following a post procedure treatment duration (e.g., at least one day, one week, three weeks, five weeks, or more, depending upon the clinical circumstances). Subjects receiving an indwelling filter assembly may be administered any of a variety of thrombolytic or anticoagulant therapies, including tissue plasminogen activator, streptokinase, coumadin, heparin, combinations thereof, and the like.
The deflector films 1206, 1256 may be placed across the ostium of the left subclavian artery, as shown in
In
In the deployed state, the deflector film 1302 forms a two-layered generally frustoconical shape that may have similar properties to the filter element 410 and/or other films, a woven mesh of strands (e.g., comprising one or more of shape memory (e.g., nitinol), metal, polymer, etc.), combinations thereof, and the like described herein (e.g., comprising pores configured to allow blood to flow through the deflector film 1302 but to resist the passage of embolic material that is carried by the fluid). While the deflector film 1302 forms a generally frustoconical shape in the deployed state, the protection device 1300 is described herein as comprising a deflector assembly rather than a filter assembly because the embolic material may not ultimately be captured by the deflector film 1302. For example, the embolic material may be deflected back into the aorta if the device 1300 is returned to the first option delivery or withdrawal state (e.g., as shown in
A third alternative delivery state may comprise inserting a guidewire into a distal end of the inner member 1310 in the state of
Regardless of the delivery shape or advancement method, the mouth of the generally frustoconical shape is preferably across the ostium of the left subclavian artery. After performing a vascular procedure, the inner member 1310 can the fully distally advanced (e.g., to the state of
Combinations of filter assemblies and deflector assemblies provided herein are also possible. For example, the protection device may comprise a filter assembly (e.g., the filter assembly 218, 406) and a deflector assembly (e.g., the deflector assembly 1402, 1502, 1602, 1702) proximal to the filter assembly, for example coupled to the same deployment wire such that relative movement of the deployment wire and the outer sheath can deploy both the filter assembly and the deflector assembly. The filter assembly can filter blood proximate to the ostium of the left subclavian artery and the deflector assembly can provide a second layer of protection by deflecting any embolic material that somehow passes through the filter assembly or that forms downstream of the filter assembly from entering the left vertebral artery.
A possible advantage of the protection devices described herein may be that the delivery and retrieval system are integrated into the same catheter that stays in place during the procedure. Unloading and loading of different catheters, sheaths, or other components is therefore unnecessary. Having a system that performs both delivery and retrieval functions can reduce procedural complexity, time, and fluoroscopy exposure time. The device is not in the aortic arch, which can reduce or eliminate the chance of interference with other catheters.
While the methods and devices described herein may be susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are described in detail herein. It should be understood, however, that the inventive subject matter is not to be limited to the particular forms or methods disclosed, but, to the contrary, covers all modifications, equivalents, and alternatives falling within the spirit and scope of the various implementations described and the appended claims. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with an implementation or embodiment can be used in all other implementations or embodiments set forth herein. In any methods disclosed herein, the acts or operations can be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence and not be performed in the order recited. Various operations can be described as multiple discrete operations in turn, in a manner that can be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures described herein can be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, embodiments can be carried out in a manner that achieves or optimizes one advantage or group of advantages without necessarily achieving other advantages or groups of advantages. The methods disclosed herein may include certain actions taken by a practitioner; however, the methods can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “deploying a self-expanding filter” include “instructing deployment of a self-expanding filter.” The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers and should be interpreted based on the circumstances (e.g., as accurate as reasonably possible under the circumstances, for example .+−.5%, .+−.10%, .+−.15%, etc.). For example, “about 7 mm” includes “7 mm.” Phrases preceded by a term such as “substantially” include the recited phrase and should be interpreted based on the circumstances (e.g., as much as reasonably possible under the circumstances). For example, “substantially straight” includes “straight.”
Claims
1. A kit adapted to inhibit embolic material from entering cerebral vasculature, the kit comprising:
- A first protection device comprising: A first filter assembly having a distal-facing opening, the first filter assembly being deployable from within an outer sheath, wherein the first filter assembly includes an inner member having a guidewire lumen and is configured to be deployed in a left vertebral artery or in a left subclavian artery upstream of the left vertebral artery; and
- a second protection device comprising: a distal filter assembly having a proximal-facing opening, the distal filter assembly being deployable from within a distal sheath, wherein the distal filter assembly is configured to be deployed in a left common carotid artery; and a proximal filter assembly having a distal-facing opening, the proximal filter assembly being deployable from within a proximal sheath, wherein the proximal filter assembly is configured to be deployed in an innominate artery.
2. The kit of claim 1, wherein the first filter assembly is self-expanding when not radially constrained.
3. The kit of claim 1, wherein the distal filter assembly is self-expanding when not radially constrained.
4. The kit of claim 1, wherein the proximal filter assembly is self-expanding when not radially constrained.
5. The kit of claim 1, wherein the first filter assembly is configured to be inserted and positioned independently of the distal filter assembly and the proximal filter assembly.
6. The kit of claim 1, wherein the first filter assembly is configured to be inserted via the left subclavian artery.
7. The kit of claim 1, wherein the distal filter assembly, the proximal filter assembly, and the distal sheath are disposed coaxially within the proximal sheath in a delivery configuration.
8. The kit of claim 7, wherein the distal filter assembly, the proximal filter assembly, and the distal sheath are configured to be inserted together and are configured to be moved and deployed independently.
9. The kit of claim 8, wherein the distal filter assembly, the proximal filter assembly, and the distal sheath are configured to be inserted via the innominate artery.
10. The kit of claim 1, further comprising an arterial pressure monitoring device in fluid communication with one of a lumen of the outer sheath and the lumen of the inner member.
11. A method of inhibiting embolic material from entering cerebral vasculature, the method comprising:
- positioning a guidewire in a left subclavian artery upstream of a left vertebral artery
- advancing over the guidewire a first protection device including first filter assembly disposed within an outer sheath through a left subclavian artery;
- deploying the first filter assembly within a left vertebral artery or within a left subclavian artery upstream of the left vertebral artery,
- wherein the first filter assembly is configured to self-expand upon removal from within the outer sheath,
- wherein the first filter assembly has a distal-facing opening;
- advancing a second protection device including a distal filter assembly disposed within a distal sheath and a proximal filter assembly disposed within a proximal sheath through an innominate artery;
- advancing the distal filter assembly into a left common carotid artery;
- deploying the distal filter assembly within the left common carotid artery,
- wherein the distal filter assembly is configured to self-expand upon removal from within the distal sheath,
- wherein the distal filter assembly has a proximal-facing opening;
- deploying the proximal filter assembly within the innominate artery,
- wherein the proximal filter assembly is configured to self-expand upon removal from within the proximal sheath, and
- wherein the proximal filter assembly has a distal-facing opening.
12. The method of claim 11, further comprising at least one of proximally retracting the outer sheath and distally advancing the first filter assembly to deploy the first filter assembly from the outer sheath in the left subclavian artery upstream of the left vertebral artery.
13. The method of claim 11, further comprising at least one of proximally retracting the distal sheath and distally advancing the distal filter assembly to deploy the distal filter assembly from the distal sheath.
14. The method of claim 11, further comprising at least one of proximally retracting the proximal sheath and distally advancing the proximal filter assembly to deploy the proximal filter assembly from the proximal sheath.
15. The method of claim 11, further comprising withdrawing the first protection device from the left subclavian artery.
16. The method of claim 11, further comprising withdrawing the distal filter assembly of the second protection device from the left common carotid artery.
17. The method of claim 16, further comprising withdrawing the proximal filter of the second protection device from the innominate artery.
18. The method of claim 11, further comprising monitoring arterial pressure.
19. The method of claim 18, wherein measuring arterial pressure is accomplished by a monitoring device in fluid communication with a lumen of the outer sheath.
20. The method of claim 18, wherein measuring arterial pressure is accomplished by a monitoring device in fluid communication with a lumen of an inner member of the first protection device.
Type: Application
Filed: Oct 17, 2022
Publication Date: Feb 16, 2023
Applicant: BOSTON SCIENTIFIC SCIMED, INC. (MAPLE GROVE, MN)
Inventors: CAMERON PAUL PURCELL (SANTA ROSA, CA), DANIEL WAYNE FIFER (WINDSOR, CA)
Application Number: 17/967,219
