Patent Grant
11439491
In general, the present disclosure relates to medical devices for filtering blood. And, more particularly, in certain embodiments, to a method and a system of filters and deflectors for protecting the cerebral arteries from emboli, debris and the like dislodged during an endovascular or cardiac procedure.
Thromboembolic 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.
Various surgical or endovascular techniques and medicaments to remove or dissolve obstructing material have been developed, to reestablish blood flow. However, additional procedures may be traumatic and are 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.
A variety of filtration or deflection devices have been proposed, to prevent entry of debris into the cerebral circulation. Some isolate only the brachiocephalic artery and left common carotid, while others might additionally isolate the left Subclavian but typically through the use of multiple catheters. Others are said to isolate all three arteries leading to the cerebral circulation, from a single catheter, but the catheter is introduced via the femoral artery and none have achieved adoption.
The need thus remains for a simple, single catheter to enable endovascular isolation of the complete cerebral circulation, preferably from an access point other than the femoral artery.
The present invention provides a three vessel cerebral protection catheter, for introduction through the brachiocephalic artery via the right radial or right brachial artery, and across the aortic arch. A distal element of the catheter is anchored in the left subclavian artery, and a membrane is deployed such that the single catheter isolates all three of the left subclavian, left common carotid and brachiocephalic arteries from embolic debris that might flow through the aortic arch.
In one implementation, a catheter may comprise an elongate flexible tubular sheath, having a proximal end and a distal end, and an inner member extending through the sheath and moveable relative to the sheath, and supporting a left subclavian element. A filter membrane may be carried between the inner member and the sheath, the membrane and the left subclavian element configured to isolate the aorta from the brachiocephalic, left common carotid and left subclavian arteries when the left subclavian element is expanded within the left subclavian artery and the sheath is retracted to expose the membrane. An aortic support hoop may be provided, configured to seal the membrane against the wall of the aorta.
The left subclavian element may comprise a self-expanding frame and may carry a filter membrane which may have a conical configuration. The catheter may further comprise at least one pull wire for laterally deflecting a distal steering zone on the sheath.
There is also provided a method of isolating the cerebral circulation from embolic debris. The method may comprise the steps of advancing a catheter through the brachiocephalic artery and into the left subclavian artery; deploying an anchor within the left subclavian artery; and retracting an outer sheath on the catheter to expose a filter extending from the anchor, across the ostium to the left common carotid artery and into the brachiocephalic artery. The filter may comprise a body, a peripheral edge and a self-expandable frame carried by at least a portion of the peripheral edge; wherein the frame brings the edge into proximity of the wall of the aorta in response to the retracting step. The frame may be in the form of a loop.
The step of advancing a catheter may include the step of proximally retracting a pull wire to laterally deflect a distal portion of the catheter to enter the ostium of the left subclavian artery. The anchor may be carried by a tubular inner member, and the retracting step may comprise retracting the outer sheath relative to the inner member to expose the anchor. The deploying an anchor step may comprise deploying a self-expandable frame, and the self-expandable frame may carry a left subclavian filter.
In a first example, an embolic protection system for isolating the cerebral vasculature may comprise an elongate outer sheath, having a proximal end and a distal end, an inner member extending through a lumen of the outer sheath, a distal anchoring mechanism coupled to a distal end region of the inner member, a proximal filter membrane carried between the inner member and the outer sheath, the proximal filter membrane configured to extend from the left subclavian artery to the brachiocephalic artery, an aortic support hoop coupled to the proximal filter membrane and configured to seal the proximal filter membrane against the wall of the aorta, and a handle including a first actuation mechanism coupled to proximal end of the inner member and a second actuation mechanism coupled to the proximal end of the outer sheath.
Alternatively or additionally to any of the examples above, in another example, the distal anchoring mechanism comprise a self-expanding frame.
Alternatively or additionally to any of the examples above, in another example, the embolic protection system may further comprise a distal filter membrane coupled to the self-expanding frame.
Alternatively or additionally to any of the examples above, in another example, the embolic protection system may further comprise a proximal bond tube coupled to a proximal filter bag termination of the proximal filter membrane.
Alternatively or additionally to any of the examples above, in another example, the embolic protection system may further comprise an aortic ring connector extending from a proximal end of the aortic ring to proximal bond tube.
Alternatively or additionally to any of the examples above, in another example, the embolic protection system may further comprise a delivery wire coupled to the tube and extending proximally to the handle.
Alternatively or additionally to any of the examples above, in another example, the handle may further comprise a third actuation mechanism coupled to a proximal end of the delivery wire.
Alternatively or additionally to any of the examples above, in another example, the inner member may be slidably disposed within a lumen of the proximal bond tube.
Alternatively or additionally to any of the examples above, in another example, the embolic protection system may further comprise a distal support strut extending between a distal end of the aortic ring and the self-expanding frame of the distal anchoring mechanism.
Alternatively or additionally to any of the examples above, in another example, the embolic protection system may further comprise an aortic ring connector extending from a proximal end of the aortic ring to a connection tube disposed about the inner member and the aortic ring connector, the connection tube distal to a proximal filter bag termination of the proximal filter membrane.
Alternatively or additionally to any of the examples above, in another example, the embolic protection system may further comprise a proximal bond tube coupled to the proximal bag termination of the proximal filter membrane and a delivery wire coupled to the proximal bond tube and extending proximally to the handle.
Alternatively or additionally to any of the examples above, in another example, the embolic protection system may further comprise an aortic ring deployment wire coupled to the aortic ring connector and extending proximally to the handle.
Alternatively or additionally to any of the examples above, in another example, the outer sheath, the inner member, the delivery wire, and the aortic ring deployment wire may be individually actuatable.
Alternatively or additionally to any of the examples above, in another example, a distal end region of the outer sheath may be deflectable.
Alternatively or additionally to any of the examples above, in another example, a cross-sectional shape of the inner member adjacent to the proximal bond tube may be non-circular and at least a portion of the proximal bond tube may have a non-circular cross-sectional shape.
In another illustrative example, an embolic protection system for isolating the cerebral vasculature may comprise an elongate outer sheath, having a proximal end and a distal end, an inner member extending through a lumen of the outer sheath, a distal filter assembly coupled to a distal end region of the inner member, the distal filter assembly including a self-expanding frame and a distal filter membrane coupled to the self-expanding frame, a proximal filter membrane carried between the inner member and the outer sheath, the proximal filter membrane configured to extend from the left subclavian artery to the brachiocephalic artery, an aortic support hoop coupled to the proximal filter membrane and configured to seal the proximal filter membrane against the wall of the aorta, a proximal bond tube coupled to a proximal filter bag termination of the proximal filter membrane, an aortic ring connector coupled to and extending between a proximal end of the aortic ring and the proximal bond tube, a delivery wire coupled to and extending proximally from the proximal bond tube, and a handle including a first actuation mechanism coupled to proximal end of the inner member, a second actuation mechanism coupled to the proximal end of the outer sheath, and a third actuation mechanism coupled to a proximal end of the delivery wire.
Alternatively or additionally to any of the examples above, in another example, the embolic protection system may further comprise a distal anchoring structure positioned distal to the distal filter assembly.
Alternatively or additionally to any of the examples above, in another example, the aortic ring connector may include a curved shape.
In another example, a method of isolating cerebral circulation from embolic debris may comprise advancing an embolic protection system through the brachiocephalic artery and into the left subclavian artery, deploying a distal anchor within the left subclavian artery, and retracting an outer sheath of the embolic protection system to expose a filter extending from the distal anchor, across the ostium to the left common carotid artery and into the brachiocephalic artery.
Alternatively or additionally to any of the examples above, in another example, the distal anchor may be carried by an inner member, the inner member separately actuatable from the outer sheath.
The above summary of exemplary embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure.
The invention may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:
While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” may be indicative as including numbers that are rounded to the nearest significant figure.
The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
Although some suitable dimension ranges and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art, incited by the present disclosure, would understand desired dimensions, ranges and/or values may deviate from those expressly disclosed.
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The detailed description and the drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention. The illustrative embodiments depicted are intended only as exemplary. Selected features of any illustrative embodiment may be incorporated into an additional embodiment unless clearly stated to the contrary.
The disclosure generally relates to devices and methods for filtering fluids and/or deflecting debris contained within fluids, including body fluids such as blood. The filtering or deflecting device can be positioned in an artery upstream from the brain before and/or during an endovascular procedure (e.g., transcatheter aortic valve implantation (TAVI) or replacement (TAVR), transcatheter mitral valve implantation (TAMI) or replacement (TAMR), surgical aortic valve replacement (SAVR), other surgical valve repair, implantation, or replacement, cardiac ablation (e.g., ablation of 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.
Devices and methods have been developed to filter blood flowing to the innominate artery and the left common carotid artery, which provide about 90% of the blood entering the cerebral vasculature. Examples are provided in U.S. Pat. No. 8,876,796, which is herein incorporated by reference in its entirety. Certain such devices and methods leave the left subclavian artery, and thus the left vertebral artery, 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 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.
Several single-access multi-vessel embodiments of cerebral protection devices that can provide full cerebral protection (e.g., protecting all four blood vessels supplying blood to the brain) with minimal arch interference are described below. The devices may be used to trap and/or deflect 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.
Four of the arteries illustrated in
Generally, the protection system 100 may include an outer sheath 110, an inner member 118, a guidewire 102, a distal filter assembly 112 (see, for example,
The protection system 100 may include a distal end region 101 and a proximal end region 103. The guidewire 102, the outer sheath 110, and the inner member 118 may be configured to extend from the proximal end region 103 to the distal end region 101. The proximal end region 103 may be configured to be held and manipulated by a user such as a surgeon. The distal end region 101 may be configured to be positioned at a target location such as, but not limited to, the left subclavian artery 16 (or the innominate artery 12 for a left radial access procedure). The proximal end region 103 may include a 105, a control 107 such as a slider, the outer sheath 110, a port 109, an inner member translation control 111, such as a knob, and a hemostasis valve control 113 such as a knob. In some embodiments, the handle 105 may include fewer or more control elements than those illustrated in
The slider 107 can be used to translate the outer sheath 110 and/or a filter assembly (not explicitly shown in
A port 109 may be in fluid communication with the outer sheath 110 (e.g., via a Y-shaped connector in the handle 105). The port 109 can be used to flush the device (e.g., with saline) before, during, and/or after use, for example to remove air. The port 109 can additionally, 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 of the outer sheath 110. The port 109 can be also or alternatively be used to inject contrast agent, dye, thrombolytic agents such as tissue plasminogen activator (t-PA), etc.
A rotatable hemostasis valve control 113 can be used to reduce or minimize fluid loss through the protection system 100 during use. For example, a proximal portion and/or intermediate region of the protection system may be positioned in the right subclavian artery 22 and the direction of blood flow with respect to the system 100 will be distal to proximal, so blood may be otherwise inclined to follow the pressure drop out of the system 100. The hemostasis valve control 113 is illustrated as being rotatable, but other arrangements are also possible (e.g., longitudinally displaceable). The hemostasis valve control 113 may be configured to fix relative positions of the outer sheath 110 and the filter assembly, for example as described with respect to the hemostasis valve in U.S. Pat. No. 8,876,796. The hemostasis valve 113 may comprise, for example, an elastomeric seal and HV nut.
To position the protection system 100 within the body, an incision may be made in the subject's right radial artery, or alternatively the right brachial artery. An introducer (not explicitly shown) may be placed into the incision and the protection system 100 inserted into the introducer. The protection system 100 may be advanced through the vasculature in a delivery configuration in which a filter assembly is collapsed or sheathed within the outer sheath 110. The outer sheath 110, inner member 118, and the filter assemblies 112, 124 may be advanced over a guidewire 102 to the target location. In some cases, the guidewire 102 may be positioned at the target location and the outer sheath 110, inner member 118, and the filter systems 112, 124 subsequently advanced over the guidewire 102 to the target location. In other instances, the guidewire 102 and the outer sheath 110, inner member 118, and the filter systems 112, 124 may be advanced substantially simultaneously with the guidewire 102 leading (e.g., positioned most distal to) the outer sheath 110, inner member 118, and the filter systems 112, 124.
The delivery catheter or outer sheath 110 may have a diameter sized to navigate the vasculature from the incision to the target location. An outer sheath 110 sized for right radial access may have a diameter in the range of about 6 French (F). An outer sheath 110 sized for femoral access may be larger, although this is not required. These are just some examples. In some cases, the outer sheath 110 (or other components of the protection system 100) may include deflectable tip or an articulatable distal tip. It is contemplated that the distal tip of the outer sheath 110 may be deflected (e.g., using the handle 105) to facilitate navigation of the system 100 through the vasculature and cannulation of the target vessel. In some cases, the deflectable tip may be configured to deflect by about 90°. However, the tip of the outer sheath 110 may be made to deflect by less than 90 or more than 90, as desired. As described above, the deflection may be controlled by a rotating knob at the handle 105, or the control mechanism. In some cases, the outer sheath 110 may include a pre-shaped and/or non-deflectable tip.
The left subclavian artery 16 may be cannulated through a combination of advancing and torqueing the catheter 110. In some cases, the left subclavian artery 16 may first be cannulated using the guidewire 102. It is contemplated that in some cases, the deflection of the catheter tip may be relaxed to advance the outer sheath 110 into the left subclavian artery 16. Once the protection system 100 (e.g., the distal end 104 of the outer sheath 110) has been advanced to the target location, which in the illustrated embodiment may be the left subclavian artery 16, the outer sheath 110 may be proximally retracted to expose a distal filter assembly 112 beyond the distal end 104 of the outer sheath 110, as shown in
Referring additionally to
The frame 114 may generally provide expansion support to the filter element 120 in the expanded state. In the expanded state, the filter element 120 is configured to filter fluid (e.g., blood) flowing through the filter element 120 and to inhibit or prevent particles (e.g., embolic material) from flowing through the filter element 120 by capturing the particles in the filter element 120. The frame 114 may configured to anchor the distal filter assembly 112 by engaging or apposing the inner walls of a lumen (e.g., blood vessel) in which the distal filter assembly 112 is expanded. In some cases, the distal filter assembly 112 may also anchor the proximal filter assembly 124. For example. the distal filter assembly 112 may be a distal anchoring mechanism. The anchoring mechanism may include a filter membrane or may lack a filter membrane, as desired. As will be described in more detail herein, other anchoring mechanisms may be provided in addition to or alternatively to the distal filter assembly 112. The frame 114 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 114 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 114 may comprise 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 filter assembly 112. The frame 114 may be coupled to a support strut 121. If so provided, the straight legs may be on a long side of the distal filter assembly 112 and/or on a short side of the distal filter assembly 112. The frame 114 may form a shape of an opening 115 of the distal filter assembly 112. The opening 115 may be circular, elliptical, or any shape that can appropriately appose sidewalls of a vessel such as the left subclavian artery 16. The distal filter assembly 112 may have a generally proximally-facing opening 115. In other embodiments, the opening 115 may be distally facing. For example, the orientation of the opening 115 may vary depending on where the access incision is located.
The frame 114 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 114 may comprise a shape other than a hoop, for example, a spiral. In some embodiments, the distal filter assembly 112 may not include or be substantially free of a frame.
In some embodiments, the frame 114 and the filter element 120 form an oblique truncated cone having a non-uniform or unequal length around and along the length of the distal filter assembly 112. In such a configuration (e.g., along the lines of a windsock), the filter assembly 112 has a larger opening 115 (upstream) diameter and a reduced ending (downstream) diameter.
The filter element 120 may include pores configured to allow blood to flow through the filter element 120, but that are small enough to inhibit prevent particles such as embolic material from passing through the filter element 120. The filter element 120 may comprise a filter membrane such as a polymer (e.g., polyurethane, polytetrafluoroethylene (PTFE)) film mounted to the frame 114. The filter element 120 may have a thickness between about 0.0001 inches (0.00254 millimeters) and about 0.03 inches (0.76 millimeters) (e.g., no more than about 0.0001 inches (0.00254 millimeters), about 0.001 inches (0.0254 millimeters), about 0.005 inches (0. millimeters), about 0.01 inches (0.254 millimeters), about 0.015 inches (0.381 millimeters), about 0.02 inches (0.51 millimeters), about 0.025 inches (0.635 millimeters), about 0.03 inches (0.76 millimeters), 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 120 are configured to allow fluid (e.g., blood) to pass through the filter element 120 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 120, 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 (μm) and about 1 mm (e.g., no more than about 10 μm, about 50 μm, about 100 μm, about μm, about 150 μm, about 200 μm, about 250 μm, about 300 μm, about 400 μm, about 500 μm, about 750 μm, about 1 mm, ranges between 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 120 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 120 to accommodate stresses placed on the filter element 120 during compression. A reinforcement fabric may reduce the stretching that may occur during deployment and/or retraction of the distal filter assembly 112. 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 120 to reduce thickness. For example, imbedded reinforcement material could comprise a polyester weave mounted to a portion of the filter element 120 near the longitudinal elements of the frame 114 where tensile forces act upon the frame 114 and filter element 120 during deployment and retraction of the distal filter assembly 112 from the outer sheath 110.
The distal filter assembly 112 may be coupled (e.g., crimped, welded, soldered, etc.) to a distal end of a deployment wire or filter wire (not explicitly shown) via a strut or wire 121, although this is not required. When both or all of the filter wire and the strut 121 are provided, the filter wire and the strut 121 may be coupled to the inner member 118 proximal to the filter assembly 112 using a crimp mechanism 119. In other embodiments, the filter wire and the strut 121 may be a single unitary structure. The filter wire and/or strut 121 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. A distal filter bag termination 116 or a distal end 116 of the distal filter assembly may also be coupled to the inner member 118. In some cases, the distal end 116 may be coupled to the inner member using a nose cone 117. The nose cone 117 may both secure the distal end 116 of the distal filter assembly 112 and reduce injury and/or vessel perforation during insertion of the system 100. In some cases, the inner member 118 may reduce in diameter in the distal direction. The diameter may be step-wise or gradual.
The distal filter assembly 112 in an expanded, unconstrained state may have a maximum diameter or effective diameter (e.g., if the mouth is in the shape of an ellipse the effective diameter is the diameter of the approximate circular opening 115 of the filter viewed from an end view) The diameter can be between about 1 mm and about 15 mm (e.g., at least about 2 mm, about 4 mm, about 6 mm, about 8 mm, about 10 mm or more, but generally less than about 15 mm or 12 mm or less depending upon the intended target vessel. In some embodiments (e.g., when the distal filter assembly 112 is configured to be positioned in the left subclavian artery 16), the diameter may be between about 7 mm and about 12 mm (e.g., about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, ranges between such values, etc.). In some embodiments (e.g., when the distal filter assembly 112 is configured to be positioned in the left vertebral artery 24), the diameter may be between about 2 mm and about 4.5 mm (e.g., about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, ranges between such values, etc.). Other diameters d or other types of lateral dimensions are also possible. Different diameters can allow treatment of a selection of subjects having different vessel sizes.
The filter assembly 112 may have a maximum length from a proximal limit of hoop 114 to the distal end or point of convergence 116 with the inner member 118. The length can be between about 7 mm and about 50 mm (e.g., at least about 7 mm, about 8 mm, about 10 mm, about 12 mm, 16 mm, about 20 mm or more, but generally less than about 40 mm or 30 mm or 20 mm or less depending upon the intended target vessel. Other lengths are also possible, for example based on the diameter or effective diameter. For example, the length of the distal filter assembly 112 may increase as the diameter increases, and the length of the distal filter assembly 112 may decrease as the diameter decreases.
In the illustrated embodiment, as described herein, the distal filter assembly 112 comprises a self-expanding support such as hoop or frame 114 which supports the open proximal end of an approximately conical filter membrane 120. A support strut 121 may be provided to connect the hoop 114 to a portion of the system 100 such as the inner member 118, to facilitate resheathing of the filter assembly 112 and also to orientate the hoop or frame 114. In the illustrated embodiment, the distal filter assembly 112 may function both to filter blood entering the left subclavian artery 16, and also to anchor the system as will be discussed in more detail herein.
Continued proximal actuation of the outer sheath 110 while fixing the inner member 118 relative to the handle 105 (and thus the deployment wire and proximal bond, as will be described in more detail herein) may then deploy the aortic arch component or proximal filter assembly 124, as shown in
The proximal filter assembly 124 may include an aortic ring 126 or support element and a filter membrane or filter element 128. The aortic ring 126 may be similar in form and function to the frame 114 of the distal filter assembly 112, although larger in scale. Similarly, the filter membrane 128 may be similar in form and function to the filter element 120 described in herein. The aortic ring 126 generally provides expansion support to the filter membrane 128 in its expanded configuration, while the filter membrane 128 is adapted to filter fluid, such as blood, and trap particles flowing therethrough. The aortic ring 126 may include an approximately elliptical hoop of a shape memory wire such as nitinol. The aortic ring 126 may be configured to engage the wall of the aorta and seal against the roof of the aortic arch outside of the ostia of all three great vessels 12, 14, 16 to isolate the cerebral vasculature. For example, the aortic ring 126 may be sized and shaped such that it extends from the ostium of the left subclavian artery 16 to the ostium of the innominate artery 12. The center 125 of the aortic ring 126 is open to allow blood and debris to enter the device 124, and the ring 126 is attached around its perimeter to the filter membrane 128. The aortic ring 126 may be self-expanding such that as the outer sheath 110 is proximally withdrawn, the aortic ring 126 automatically expands, although this is not required. As will be described in more detail herein, the aortic ring 126 may be coupled to different portions of the protection system 100.
Once the proximal filter assembly 124 has been deployed, the inner member 118 may be retracted to minimize intrusion into the aorta 10, as illustrated in
Once the protection system 100 has been deployed, the TAVR, or other index procedure, may be performed. Once the index procedure is contemplate, the inner member 118 may be advanced relative to the handle 105 to apply tension to the proximal filter element 128 and/or the distal filter element 120. The outer sheath 110 may then be advanced relative to the handle 105, while fixing the position of the inner member 118 relative to the handle 105, until the proximal filter assembly 124 and the distal filter assembly 112 are fully sheathed. The protection system 100 may then be removed from the introducer sheath.
The proximal bond tube 132 may be connected to a delivery wire 138 configured to extend proximally to the handle 105. The handle 105 may include at least three controls (which may be sliding controls) including a control for translation of the inner member 118 relative to the handle 105, a control for translation of the delivery catheter 110 relative to the handle 105 to allow for deployment and retrieval of the filter assemblies 112, 124, and a control for deflection of the distal tip of the delivery catheter 110. The delivery wire 138 is connected to both the proximal bond tube 132 and the handle 105. Thus the aortic ring 126 and proximal filter bag termination 136 positions are fixed relative to the handle 105. As such, the position of the proximal bond tube 132 relative to the patient's body can be moved by either advancing or retracting the handle 105. As described above, the distal filter frame 114, and thus the distal end region 116 of the distal filter element 120 or the distal filter bag termination 116, are connected to the inner member 118, and are advanced and retracted relative to the outer sheath 110 with a first handle control 111. The steerable outer sheath or delivery catheter 110 may be withdrawn relative to the handle 105 to deploy the device using a second handle control 107. The tip 104 of the outer sheath or delivery catheter 110 may be deflected to assist with cannulation of the left subclavian artery 16 (or the brachiocephalic artery 12) using a third handle control (not explicitly shown).
In
As described herein, a distal steering segment of steerable delivery catheter 110 may be deflected laterally in response to manipulation of a steering control on the proximal manifold or handle 105. Referring additionally to
The handle 105 of the system 100″′ may include at least four controls (which may be sliding controls) including a control for translation of the inner member 118 relative to the handle 105, a control for translation of the delivery catheter 110 relative to the handle 105 to allow for deployment and retrieval of the filter assemblies 112, 124, a control for deflection of the distal tip of the delivery catheter 110, and a control for translation of the aortic ring deployment wire 145 relative to handle 105. This may allow the aortic ring connector 134 (and thus the aortic ring 126), the inner member 118 and the proximal bond tube 132 (and thus the proximal filter membrane 128) to all be adjusted relative to each other. This may allow the apposition of the aortic ring 126 to the roof of the aortic arch 10 to be further optimized. In one technique, the position of the aortic ring connector 134 may be fixed, and the position of the proximal bond tube 132 (and thus the proximal termination of the filter membrane 136), to be withdrawn towards the handle 105. This applied tension on the proximal membrane 128 may draw the aortic ring 126 towards the roof or the aortic arch 10, and increase the bend in the aortic ring connector 134, thus improving apposition between the aortic ring 126 and the roof of the aortic arch 10.
In the protection systems 100, 100′, 100″, 100′″ it may be desirable for correct deployment, functioning and retrieval of the filter assemblies 112, 124 for the rotational orientation between the delivery catheter 110, the proximal bond tube 132, and the inner member 118 to be controlled. Control of the inner member 118 (and thus the distal filter assembly 112) orientation relative to the aortic ring 126 (and thus the proximal bond tube 132) may prevent the distal filter frame 114 from rotating relative to the aortic ring 126 and/or proximal bond tube 143132, and resulting in a twist in the membrane 128 between the aortic ring 126 and the distal filter assembly 112, leading to possible restriction of flow of blood and/or debris into the distal filter assembly 112 and thus the left subclavian artery. It may be desirable to control the inner member 118 (and thus the distal filter assembly 112) and the aortic ring 126 (and thus proximal bond 132) orientations relative to the delivery catheter 110, and thus to the deflection direction of the deflectable outer sheath 110, to ensure that the device 112, 124 deploys from the tip of the delivery catheter 110 in the aortic arch 10 in the correct orientation.
It is contemplated that the orientation may be controlled by fixing the rotational orientation of the deployment wire 138 (and thus the proximal bond tube 132) relative to the inner member 118 at the attachment points within the handle 105. If the orientation of the deployment wire 138 and the inner member 118, where they are attached to the handle 105, are fixed, the orientation of the proximal bond tube 132 and the distal filter assembly 112 may be controlled. However, the handle 105 may be separated from the distal filter assembly 112 by some distance, and the connecting inner member 118 and deployment wire 138 may twist or torque relative to each other resulting in a misalignment of the distal filter assembly 112 to the aortic ring 126. This twisting may be reduced by replacing the deployment wire 138 with a deployment tube 150 that runs in the annular space between the delivery catheter 110 and the inner member 118.
In another illustrative embodiment, the orientation may be controlled by keying the proximal bond tube 132 to the inner member 118 such that the proximal bond tube 132 can slide freely over the inner member 118, but cannot rotate relative to the inner member 118. For example, orientation of the proximal bond tube 132 relative to the inner member 118 may be controlled at the proximal bond tube 132 instead of, or in addition to, at the handle 105. This may be done by creating a non-round or non-circular profile (e.g., a non-circular cross-sectional shape) of the inner member 118 in at least the region where the proximal bond tube 132 slides over the inner member 118. This profile (e.g., cross-sectional shape) could be square, hexagonal, triangular, or other non-round profiles. The inner opening of the proximal bond tube 132 may be profiled or keyed to match the cross-section of the inner member 118 such that it can slide along the inner member 118, but not rotate relative to the inner member 118.
The inner member 118 may be constructed of a polymer, a metal, a composite, a wire, a braid reinforced polymer such as polyimide, nylon, Pebax, etc., or other suitable material. The inner member 118 may be constructed with variable stiffness so that, for example, the distal portion is less stiff than the proximal portion. However, this is not required. In some embodiments, limit stops may be added to the inner member 118 to limit travel of the aortic ring connector 134, 135 (and thus the aortic ring 126) relative to the inner member 118, in both the proximal and distal directions. The inner member 118 may moves freely through the proximal bond tube 132. The limit stops may prevent the operator from extending the inner member 118 to the extent that the inner member 118 would protrude out of the aortic ring 126 and/or prevent the operator from withdrawing the inner member 118 to the extent that the distal filter assembly 112 is pulled out of correct placement in the left subclavian artery 16. By placing hard stops (e.g., structural features extending from an outer surface of the inner member 118) on the inner member 118 on either side of the proximal bond tube 132, the distance that an operator can pull or push on the inner member 118 can be controlled.
The proximal end 136 of the proximal filter membrane 128 may be terminated at the proximal bond tube 132. Apposition and sealing of the proximal filter membrane 128 in the brachiocephalic artery 12 may be achieved through a combination of sealing of the aortic ring 126 to the roof of the aortic arch 10, and the expansion of the filter membrane 128 against the walls of the brachiocephalic artery 12 due to blood flow through the filter membrane 128. In alternate embodiments, a proximal filter frame (e.g., similar in form and function to the distal filter frame 114) may be added to ensure that the filter membrane 128 opens fully in the brachiocephalic artery 12. This proximal filter frame may be constructed to provide positive circumferential contact between the membrane 128 and the walls of the brachiocephalic artery 12 or may function to ensure that the filter is open yet not circumferentially press the membrane 128 against the vessel walls. As with the distal filter frame 114, the proximal filter frame may be bonded to the membrane or may freely float inside the membrane.
In some embodiments, the self-expanding distal filter frame 114 may alternately not be bonded to the filter membrane 120 so that the distal filter frame 114 may rotate relative to the membrane 120 to prevent twisting of the membrane but would still act to hold the membrane 120 open inside the left subclavian artery 16 (or the brachiocephalic artery 12). The inner member 118 may be extended past distal filter assembly 112 to stabilize distal filter assembly 112. Also, the guidewire 102 may be extended beyond the distal filter assembly 112 to stabilize the distal filter assembly 112 in the left subclavian artery 16 and help maintain apposition of the filter frame to the vessel wall.
The distal filter assembly 112 is anchored in the left subclavian artery 16 by the expansion of the distal filter frame 114 to stabilize the device during delivery of the proximal filter assembly 124. Alternatively, or additionally, this anchoring function could be performed by an expanding anchor element that is inside of or distal to the filter membrane 120. This could take the form of a self-expanding stent structure, expanding coil, inflatable balloon, etc. This feature may be helpful holding the position of the filter assembly 112 and thus the distal portion of the device when the inner member 118 is tensioned.
The filter membranes 120, 128 may be constructed of laser drilled or perforated polymer membrane, woven nitinol wire mesh, other metal mesh, woven PEEK or other polymer mesh, etc. The porosity of the filter membranes 120, 128 may be around 140 microns, however other porosities, either larger or smaller, are possible. The membrane hole pattern may be uniform, or the membrane may be perforated selectively in given regions of the membrane 120, 128 to either allow or restrict flow in those select regions to improve flow through lumens, encourage apposition, etc. The filter membrane 120, 128 may have fabric or other reinforcing or stiffening in selected areas to improve sheathing, unsheathing, folding of the membrane and apposition performance, see For example, the proximal filter membrane 128 may include is a strip of fabric reinforcement in the membrane material that extends from the point where the aortic ring connector 134 meets the aortic ring 126 to the proximal bond tube 132. The fabric reinforcement may prevent or reduce bunching of the membrane 128 during resheathing, and may help the membrane 128 fold in a controlled manner during sheathing.
The aortic ring 126 and/or the distal filter frame 114 may be constructed of nitinol wire, as described herein, however they may constructed with other flexible materials such as polymer, stainless steel, a composite of multiple material, woven or braided like a cable, etc. The aortic ring 126 and/or the distal filter frame 114 may also be laser cut from a flat sheet of metal, polymer, etc. and then formed or shape set to the desired final shape.
The aortic ring 126 may be constructed such that it is stiffer or more flexible in some section than in other. For example, if the aortic ring 126 is constructed of nitinol wire, it may be selectively ground to reduce the diameter or thickness to alter stiffness to improve performance, improve apposition, make sheathing easier, etc.
Radiopaque markers may be added to the filter frame(s) 114, the aortic ring 126, the aortic ring connectors 134, 135 and/or other portions of the device to allow visualization under fluoroscopy. The marker may be placed in selective locations or may be in the form of a coil placed over the entire aortic ring 126, filter hoop 114 or connector structures 134, 135 as needed to help with positioning and visualization.
The aortic connector 134, 135 may be constructed of more rigid materials such as nitinol, stainless steel, polymer, etc., or may be constructed of more flexible materials such as suture, fabric, or other flexible material that will still support tension to allow sheathing of the aortic ring but would allow improved apposition of aortic ring to the roof of the aorta. The aortic ring 126 may be constructed from a loop of material, for example nitinol wire, and thus the aortic ring connector 134, 135 may be formed by the two ends of the loop, and then terminated at the proximal bond tube 132. The mechanical characteristics of the aortic ring connector 134, 135 may be altered by many methods including the addition of heat shrink 190 over the wires 134, 135, as illustrated in
The aortic ring connector(s) 134, 135 may be curved or shaped to improve aortic ring apposition on the proximal edge of the brachiocephalic 12 or left subclavian 16 artery ostia. The aortic ring connector may be formed in a curved shape (as opposed to a straight connector) may allow the aortic ring 126 to fully cover the brachiocephalic artery 12 without leaving a gap on the proximal edge 130.
In some embodiments, the aortic ring connector 134, 135 may improve apposition of the aortic ring 126 to the roof of the aortic arch 10 by for including a back-bend shape
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.”
Those skilled in the art will recognize that the present invention may be manifested in a variety of forms other than the specific embodiments described and contemplated herein. Accordingly, departure in form and detail may be made without departing from the scope and spirit of the present invention as described in the appended claims.
This application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Application Ser. No. 62/663,117, filed Apr. 26, 2018, the entirety of which is incorporated herein by reference.
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| 2391303 | Dec 2011 | EP |
| 2480165 | Aug 2012 | EP |
| 2658476 | Nov 2013 | EP |
| 2732794 | May 2014 | EP |
| 2387427 | Aug 2014 | EP |
| 2859864 | Apr 2015 | EP |
| 2003505216 | Feb 2003 | JP |
| 2003526451 | Sep 2003 | JP |
| 2003290231 | Oct 2003 | JP |
| 3535098 | Jun 2004 | JP |
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| 9923976 | May 1999 | WO |
| 0021604 | Apr 2000 | WO |
| 0108743 | Feb 2001 | WO |
| 0167989 | Sep 2001 | WO |
| 2004026175 | Apr 2004 | WO |
| 2005118050 | Dec 2005 | WO |
| 2006026371 | Mar 2006 | WO |
| 2006076505 | Jul 2006 | WO |
| 2008033845 | Mar 2008 | WO |
| 2008100790 | Aug 2008 | WO |
| 2008113857 | Sep 2008 | WO |
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| 2016011267 | Jan 2016 | WO |
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| Entry |
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| Number | Date | Country | |
|---|---|---|---|
| 62663117 | Apr 2018 | US |
