HK1234638A1 - Intravascular devices and delivery systems and uses thereof - Google Patents

Description

Intravascular devices and delivery systems and uses thereof

Technical Field

The present invention relates to intravascular devices, systems, and methods for deflecting thrombi (emboli) in the aorta to prevent the thrombi from entering an artery (e.g., an artery leading to the brain).

Background

A device such as a vascular filter or other device may be inserted into a blood vessel before or during surgery or at another time. Such devices may be inserted through a catheter (cathter) that may be passed through a vein or artery and into, for example, the aorta or other blood vessels where the device may be released from the catheter and deployed. The device can filter, deflect or occlude thrombi or other objects from entering the blood supply system that supplies blood to the brain.

Disclosure of Invention

In a first aspect, the invention features an intravascular device for deflecting particles (e.g., thrombus) comprising: a substantially flat frame, for example, having a length of between about 80mm and 90mm and a width of about 20mm to 35 mm; a thrombus filter attached to the frame and extending its length; an upper stabilizer located above the horizontal plane of the filter; a lower stabilizer located below the horizontal plane of the filter; wherein one of the upper stabilizer or the lower stabilizer comprises a wire configured to extend along a horizontal plane of the filter and exert a force on the frame and/or the filter when disposed in the aorta of the subject. The frame of the device may define the shape of the filter and is generally sized and shaped to maintain contact with both the ascending and descending aorta. The upper stabilizer of the device may extend upward from the horizontal plane of the filter to contact the mesial surface of the innominate artery. The lower stabilizer of the device may extend downward from the horizontal plane of the filter to contact the mesial surface of the aorta. The device may comprise a plurality of upper and/or lower stabilisers.

In one embodiment, the lead is a tether (teter) made of a polymeric material, a metal, or any combination thereof, and has a diameter of, for example, less than 2 mm. The tether may include a flushing segment to allow release of fluid, such as saline, from the interior chamber of the tether. The tether may include a lumen through which the intravascular device is attached. For example, a wire may extend through this lumen and be attached to or integral with the intravascular device. In such an embodiment, this cavity may be substantially filled by the wire. In other embodiments, the tether may include a lumen that allows passage of a guide wire. Alternatively, the tether may include a separate lumen to connect with the intravascular device, pass a guidewire, or deliver or remove fluid. The lumen for the guide wire preferably does not extend the length of the tether, but is located at the distal end of the tether, e.g. below the lumen used to attach the endovascular device. Preferably, the lumen for the guide wire is longer than the length of the endovascular device. The lumen for the guide wire may be from 70mm to 160 mm. In such embodiments, the lateral dimension of the tether is preferably greater at the distal end of the tether where the lumen is located, relative to the proximal end. The tether may be passed over a guide wire via a lumen to advance the device through a delivery system. The guide wire may also be used to support the device when disposed in the subject's aorta, for example, by applying a force to the inner wall of the lumen of the tether. The stiffness of the guidewire may be varied along its length to produce a desired force on the inner wall of the lumen of the tether. For example, a portion of the guide wire may be less stiff and be in the lumen during deployment and/or positioning. During use, the guide wire may be advanced or retracted to place the stiffer portion in the lumen, which may be used to exert a force on the wall of the lumen. In some embodiments, the tether may be attached to the protected lip at its distal end. The protected lips may be dilator tips that can be expanded to dilate a blood vessel, for example, during introduction of the device into the aorta.

In embodiments where the lower stabilizer comprises a tether, the dilator tip may be inflated with a fluid, such as air or saline, or the guidewire may apply pressure to provide lift to the device when deployed within the aortic arch. In embodiments where the upper stabilizer comprises a tether, the dilator tip may be inflated by a fluid, such as air or saline, or the guide wire may exert a force along the frame and filter of the device to push it in the direction of the ascending aorta when disposed in the subject's aortic arch. In such embodiments, the dilator tip may contact the mesial surface of the innominate artery. The tether and dilator tip may have equal stiffness, or unequal stiffness, wherein the tether is harder than the dilator tip, or the dilator tip is harder than the tether.

In certain embodiments, the tether has a radius of curvature of no less than 80mm (e.g., no less than 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, or 150 mm).

In certain embodiments, the device includes a tether as a lower stabilizer and a single upper stabilizer that contacts, for example, the mesial surface of the innominate artery. In such embodiments, there may also be other lower stabilizers, for example, two other lower stabilizers attached to opposite sides of the frame and extending downward from the horizontal plane of the filter (e.g., to contact the mesial surface of the aorta). In other embodiments, the device includes a tether that is an upper stabilizer and two lower stabilizers, e.g., two other lower stabilizers attached to opposite sides of the frame and extending downward from the horizontal plane of the filter (e.g., to contact the mesial surface of the aorta). In such an embodiment, there may also be another superior stabilizer, for example, which contacts the mesial surface of the innominate artery.

In a second aspect, the invention features a delivery system that includes the device of the invention and an introducer sheath having a lumen for introducing the device to the aorta of a subject. The introducer sheath may be made of a braided or coiled material and may further include a Y-connector having three ports to allow introduction of the device into the lumen of the sheath. The introducer sheath can have a size in the range of 6F-10F (e.g., 6F, 7F, 8F, 9F, or 10F). In some embodiments, the delivery system includes a second guidewire. The delivery system may further include a pigtail catheter (cathter), e.g., 1F, 2F, 3F, 4F, 5F, and 6F pigtail catheters, e.g., which may have a blunt end and be delivered over a second guide wire. In other embodiments, the delivery system includes a deflector made of an expandable or malleable material. The deflector may comprise a frame, or may be frameless.

In one embodiment of the delivery system, the device is loaded into an introducer sheath, e.g., the frame, upper stabilizer, and/or lower stabilizer are compressed to fit within the lumen. In embodiments where the device includes a protected lip, the protected lip may be positioned at the distal end of the introducer sheath and the protected lip has a smaller diameter than the introducer sheath. When loaded into the introducer sheath, the device may be compressed within the introducer sheath and positioned behind any protected lips. Upon retraction of the introducer sheath relative to the endovascular device, the device can be expanded and deployed in the subject's aorta. In other embodiments, the pigtail catheter, tether, and intravascular device are loaded into a single lumen of an introducer sheath. In such embodiments, the tether may include a lumen for attaching an intravascular device, and/or a lumen for a guide wire, e.g., a guide wire located at the distal end of the tether and not extending the length of the tether. The tether having a guidewire lumen at a distal end may be sized such that a volume may be released at the distal end of the introducer sheath to allow other tools to pass through the introducer sheath, such as a pigtail catheter. In another embodiment, the intravascular device and tether are loaded into a first lumen of a dual lumen introducer sheath and the pigtail catheter is loaded into a second lumen of the dual lumen introducer sheath.

In a third aspect, the invention features a method of introducing the device or delivery system into a subject by: the device contained within the introducer sheath is inserted into a subject's vessel, such as the aorta, and the sheath is retracted relative to the device's intended location in the vessel to deploy the device in the subject's aortic arch. When deployed, the upper stabilizer may extend upward from the horizontal plane of the filter and contact the mesial surface of the innominate artery, and/or the lower stabilizer may extend downward from the horizontal plane of the device and contact the mesial surface of the wall of the aorta. In some embodiments, the devices of the present disclosure are passed through an introducer sheath by a tether advanced over a guide wire, e.g., a tether that includes a lumen for attaching an intravascular device and/or a lumen for a guide wire. In other embodiments, the pigtail catheter is guided through the guiding sheath and inserted over the second guide wire. The device and delivery system are preferably positioned over a guidewire system, wherein a guidewire is guided to a desired location and the device and delivery system are advanced over the guidewire to the desired location. The guide wire may then be retained in the device or removed after deployment. Preferably, the device and delivery system are guided via a peripheral artery (e.g., the femoral artery).

In another aspect, the invention features a catheter having a lumen for a guidewire at a distal end, where the lumen does not extend the length of the catheter. The transverse dimension of the catheter is preferably greater at the distal end where the lumen is located, relative to the proximal end. The size, shape and materials described herein for the tether may also be used in conjunction with the catheter of the present invention. The catheter may be attached to any tool for use within a blood vessel, for example, a tool comprising a filter, electrode, cutting element, imaging element, or balloon for thrombus, or the catheter may comprise a mechanism for attachment to such a tool. Preferably, the lumen for the guide wire is longer than the length of any attached endovascular tool. The lumen for the lead may be from 70mm to 160 mm. In some embodiments, the conduit may be attached at its distal end to the protected lip. The protected lips may be dilator tips that can be expanded to dilate a blood vessel, for example, during introduction of the device into the aorta.

As used herein, the term "wire" refers to any elongated structure (e.g., rope, fiber, yarn, filament, cable, and strand) made from: any non-degradable material (e.g., polycarbonate, Polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyvinylidene fluoride (PVDF), polypropylene, porous polyurethane, metal, nitinol, fluoropolymer (e.g., PTFE)) Cobalt chromium alloy (CoCr) and para-aramidOr textiles (e.g. nylon, polyester (e.g. nylon)) Or silk).

Drawings

Fig. 1A is an illustration of a side view of an intravascular device. The figure shows exemplary upper and lower stabilizers in addition to the wires.

Fig. 1B is an illustration of a three-quarter view of an intravascular device. The figure shows exemplary upper and lower stabilizers in addition to the wires.

Figures 2A-2B are diagrams indicating the force applied to the device by the guide wire.

Fig. 3A to 3D are diagrams illustrating alternative embodiments of the upper or lower stabilizer of the device and the placement of such device in the aortic arch. Fig. 3A is an illustration of a device having a tether attached to a dilator tip that serves as a lower stabilizer for an intravascular device, and fig. 3B is an illustration of the device of fig. 3A disposed in an aortic arch according to one embodiment of the present disclosure. Fig. 3C is an illustration of a device having a tether attached to a dilator tip that serves as an upper stabilizer (left side) for an intravascular device, according to one embodiment of the invention, and a delivery system having a dilator tip connected to a tether that serves as an upper stabilizer (right side) for an intravascular device, according to one embodiment of the invention. Fig. 3D is an illustration of a device having a dilator tip that serves as an upper stabilizer for placement in an aortic arch, according to one embodiment of the present invention.

Figure 4 is an illustration of a delivery system including an intravascular device, a Y-connector, a tether, a sheath, and a protected lip according to one embodiment of the present disclosure.

Fig. 5A is an illustration of a delivery system having a low profile tether with uniform stiffness according to one embodiment of the present invention.

Fig. 5B is an illustration of a delivery system having a tether with variable stiffness according to an embodiment of the present invention.

FIG. 6A is an illustration of a delivery system with a single lumen introducer sheath according to one embodiment of the invention. The insertion schematic provides a cross-sectional view of a tether located in a single lumen introducer sheath.

Fig. 6B is an illustration of a delivery system having a tether with an irrigation segment as seen in the inset, in accordance with an embodiment of the present invention. The insertion schematic provides an enlarged view of the irrigation section.

Fig. 7 is an illustration of a tether having an expandable dilator tip at its distal end.

Fig. 8 is an illustration of a delivery system for an intravascular device having a deflector according to an embodiment of the present invention.

Figure 9A is an illustration of an intravascular device loaded into an introducer sheath of a delivery system according to one embodiment of the present disclosure.

Fig. 9B is an illustration of deployment of an intravascular device by retracting an introducer sheath of a delivery system according to one embodiment of the present disclosure.

Fig. 10A is an illustration of an intravascular device attached to a first tether loaded into a single lumen of an introducer sheath of a delivery system through a second tether connected to a dilator tip, according to one embodiment of the present invention.

Fig. 10B is an illustration of an intravascular device attached to a first tether deployed from a single lumen of an introducer sheath by a delivery system according to one embodiment of the present disclosure.

FIG. 11 is an illustration of a dual lumen introducer sheath of a delivery system having an aspirator according to an embodiment of the present invention.

Fig. 12 is a set of illustrations of the orientation of the endovascular device deployment from the dual lumen introducer sheath of the delivery system (left side) and the orientation of the pigtail catheter deployment from the dual lumen introducer sheath of the delivery system (right side).

Figure 13 is an illustration of a tether with a first lumen for attachment of an intravascular device and a second lumen for passage of a guidewire under the intravascular device, in accordance with an embodiment of the present invention.

Fig. 14 is an illustration of an intravascular device attached to a tether loaded into a lumen of an introducer sheath by a delivery system according to one embodiment of the invention.

Detailed Description

The present invention relates to intravascular devices, delivery systems, and methods that inhibit the potentially harmful passage of particles through the blood stream. Particles that may be present in blood include, but are not limited to, blood clots, calcified fragments, and thrombi. While very small particles may not cause significant damage, passage of larger particles can cause a stroke or other detrimental consequences. The risk of injury from the passage of particles may increase in association with certain conditions or medical procedures that interfere with the vasculature. To mitigate these risks, the invention features an intravascular device (e.g., having the features of the intravascular device described in international publication No. WO 2012/085916) for preventing passage of particles from a primary blood vessel (e.g., the aorta) to one or more secondary blood vessels (e.g., the left subclavian, left common carotid, or innominate arteries). The intravascular device includes a thrombus filter that prevents particles in the blood vessel having a size greater than 50 μm (e.g., thrombus) from passing through the filter and includes a frame to retain the filter. The frame may be substantially planar and typically has a length of between about 80mm and 90mm and a width of from about 20mm to 35 mm. The length of the device may be from about 80mm to 90mm, or it may be necessary to approximate the distance between the superior wall of the ascending aorta of a subject upstream of the ostium of the innominate artery and the superior wall of the descending aorta of a subject downstream of the ostium of the left subclavian artery. The width of the device may be from 20mm to 35mm, or may be close to the inner diameter of the subject's aorta.

The frame may define the shape of a filter attached to the frame and is generally adapted to remain in contact with the ascending and descending aorta. The device further includes at least one upper stabilizer extending upwardly from or parallel to the horizontal plane of the filter and may be adapted to contact the medial surface of the innominate artery. The device includes at least one lower stabilizer extending downwardly from the horizontal plane of the filter, extending parallel to the horizontal plane of the filter, and may be adapted to contact the mesial surface of the inner wall of the aorta, e.g., opposite the ostia of the branch arteries (e.g., left subclavian, left common carotid, or innominate artery). One of the upper or lower stabilizers includes a wire that is connected to the frame and/or the filter and extends along the horizontal plane of the filter.

The filter, frame, upper stabilizer, lower stabilizer, and wire of the device are foldable along a longitudinal axis for delivery to a treatment site. Once deployed in the aortic arch, the lower stabilizer of the device may be used to provide lift to an endovascular device in the aortic arch to cover the ostium of the branch artery. When installed in the aortic arch, the upper stabilizer may contact the inner wall of the innominate artery to secure the device in position relative to blood flow in the aorta, prevent the device from rolling within the aorta, and/or prevent lifting the device from an entry point beyond a desired distance into the innominate artery of the aorta.

In some embodiments, the lead of the device comprises a tether. The tether of the device may be made of a polymeric material, a metal, or a combination thereof. The tether may be a solid rod or hollow tube with a lumen, and the diameter of the tether may be less than about 2mm (e.g., 1.5mm, 1.0mm, 0.5mm, or 0.25 mm). The tether may have one or more lumens (e.g., 1, 2, or 3 lumens). The lumen of the tether may or may not extend along the length of the tether. In certain embodiments, the tether includes a lumen for attaching an intravascular device that extends continuously along the length of the tether, and/or a lumen for a guidewire located at the distal end, e.g., located below any lumen for attachment, without extending the length of the tether. A lead for attachment to or integral with an intravascular device may substantially fill a lumen for attachment in a tether. In some embodiments, the tether of the device includes a guidewire having a diameter less than the diameter of the lumen of the tether and configured to pass through the lumen of the tether. In some embodiments, the lumen for the distally located lead may have a length of 70-160mm (e.g., 70mm, 80mm, 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm, or 160 mm). Preferably, any lumen for a guide wire is longer than the intravascular device. For a tether having a lumen for a guidewire at the distal end, the transverse dimension of the tether is preferably greater at the distal end relative to the proximal end. The tether and/or guide wire may be used to advance the intravascular device through the delivery system and further stabilize the device when deployed, for example, in the aortic arch. In some embodiments, the tether and/or wire are located below the level of the filter of the device. The tether may include an irrigation section consisting of openings along the length of the tether that allow fluid (e.g., saline) to pass through the openings when pressure is applied to the proximal end of the tether.

In addition, the tether may be attached to the protected lip, for example at its distal end, which allows the endovascular device to be advanced through the vessel without causing damage to the vessel wall, for example by widening the vessel. The protected lip may be a dilator tip, e.g., which is inflatable, configured to dilate a blood vessel during insertion, installation, and/or retraction of the device. The dilator tip may have a smaller diameter than the opening of the introducer sheath and protrude outside the distal end of the introducer sheath, e.g., to dilate the opening of the vessel to advance the introducer sheath. In devices having, for example, a dilator tip at the distal end, the tether may inflate the dilator by transferring fluid (e.g., air or saline) from the proximal end to the distal end.

The tether and dilator tip may be of equal hardness. In other embodiments, the tether is harder than the dilator tip, or alternatively, the tether may be less hard than the dilator tip, which may result in variable stiffness in the device.

The lower stabilizer of the device may be attached to (or made integral with) the frame, or may be formed from a wire (e.g., a tether) of the device that extends along the length of the intravascular device below the plane of the intravascular device. In some embodiments, the lead passes through the lumen of the tether and extends below the level of the filter. When placed in the aortic arch, the bending of the wire as it follows the shape of the aortic arch exerts a force on the inner wall of the lumen of the tether. The force is transferred from the tether to the frame and filter of the device to provide lift within the aortic arch. In addition, the dilator tip and/or attached tether can be inflated to a desired stiffness, which can act as a lower stabilizer to provide lift by exerting force on the device below the level of the filter. When the lower stabilizer comprises a tether of the device, the tether passes below the plane of the filter to extend along the length of the frame and beyond the distal end of the frame of the device. When used as a lower stabilizer, the tether may contact the mesial surface of the wall of the aorta, e.g., opposite the ostia of the branch arteries.

The guide wire (e.g., a tether) may also serve as an upper stabilizer for the device and exert a force on the frame of the device and the proximal end of the filter, thereby pushing the distal end of the device in the direction of the ascending aorta, e.g., by contacting the mesial surface of the ascending aorta, to prevent the device from rolling and/or to limit the device from lifting. When the device comprises, for example, a dilator tip, the dilator tip can have a size and shape to contact the wall of the innominate artery and prevent further lifting of the device by securing the device in the innominate artery. In embodiments having a dilator tip as an upper stabilizer, a guidewire surrounding the lumen of the tether may exert a force on the device in the direction of the ascending aorta to position the dilator tip in the ostium of the innominate artery. When used as an upper stabilizer, the tether of the device may pass below the level of the proximal end of the filter, e.g., transect the level of the filter at a midpoint, and extend above the level of the distal end of the filter. The tether may be passed through the filter and may extend parallel or perpendicular to the horizontal plane of the filter.

Any of the frame, upper stabilizer, and/or lower stabilizer of the device may be fabricated, in whole or in part, from a superelastic or shape memory alloy material, a ductile material, or a polymer (e.g., nylon), for example. The wire may comprise, for example, tantalum or platinum. The filter of the intravascular devices of the present disclosure may comprise a mesh (e.g., a mesh made from nitinol or a wire, nylon, or a combination thereof) or a perforated film. In devices where a mesh is present, the filter may be linear (e.g. square) or diamond shaped. In devices where the pores of the filter are linear or diamond shaped, one or both of the transverse dimensions of the pores may be between 50 and 1000 microns (e.g., 100, 200, 300, 400, 500, 600 or greater microns). When a perforated film is present, the apertures formed in the perforated film comprise a variable or constant shape, have a variable or constant density across the film, and/or have a constant or variable size. The pores of the filter are sized to allow passage of blood cells (e.g., red blood cells (erythrocytes), white blood cells (leukocytes), and/or platelets (thrombocytes)) and plasma, while being impermeable to particles (e.g., thrombus) larger than the size of the pores. Particles (e.g. thrombus) filtered by the mesh of the filter of the invention are typically particles that are larger in one or more dimensions than the pores of the mesh of the filter. The particles (e.g., thrombus) filtered by the intravascular device of the present disclosure may be sized to have a size greater than 50 μm, e.g., 50 μm, 60 μm, 70 μm, 80 μm, 90 μm, 100 μm, 200 μm, 300 μm, 400 μm, 500 μm, or 1000 μm, or more.

In some cases, a device may require one or more modifications to facilitate one or more methods of tracking the progress of all or a portion of the device. In particular embodiments, one or more radiopaque elements are attached to, included in, or integral with the device. For example, a pull fill pipe (DFT wire) may be used to form part of the frame or filter. Such a lead may include, for example, a core of tantalum and/or platinum and an outer material such as nitinol. In certain embodiments, the DFT leads may be included in all or a portion of the intravascular device frame, stabilizer, or filter. In embodiments where radiopaque wires (e.g., DFT wires) are used in the filter, they may be used throughout the filter or in some sub-portion of the filter.

In particular embodiments, including embodiments in which a plurality of radiopaque elements are attached to, included in, or integral with the device, it is possible to detect the advancement and specific orientation of all or part of the device. In still other particular embodiments, a plurality of radiopaque elements are attached to, included in, or integral with, the filter in such a way that they are irregular in two or three dimensions of one or more configurations of the filter, such that upon detection of the radiopaque elements, the position, orientation, and/or configuration of the filter is indicated.

The device may further be compatible with common delivery methods used in interventional cardiology, such as Transcatheter Aortic Valve Implantation (TAVI) procedures. The device may be integrated into a delivery system to enable insertion, installation and/or retrieval of the device. The delivery system of the present invention also features an introducer sheath, e.g., connected to a Y-connector, to facilitate introduction of the intravascular device into the sheath in conjunction with, e.g., a guide wire (e.g., a pigtail catheter).

The introducer sheath may be made of a braided or coiled material or a polymeric material, such as silicone rubber, nitinol, nylon, polyurethane, and polyethylene terephthalate (PETE) latex. The introducer sheath may have one or more lumens for, for example, a tether, an intravascular device, and/or a pigtail catheter. The insertion of the intravascular device including the tether into the introducer sheath along with the pigtail catheter is facilitated by a Y-connector having three distinct inlets sized and shaped to mate with openings at the proximal end of the introducer sheath. In some embodiments, the delivery system of the present invention includes an intravascular device, a tether, a protected lip, an introducer sheath, and a Y-connector. In another embodiment, the delivery system includes a tether having an irrigation section such that irrigation of the introducer sheath and/or the Y-connector is achieved by directing an irrigant (e.g., saline) through the tether. The delivery system may include a tether having a lumen for attaching an intravascular device (e.g., extending the length of the tether) and/or a lumen for a guide wire located, for example, at the distal end of the tether and not extending its length. The second lumen of the multi-lumen tether may extend continuously along the length of the multi-lumen tether. In embodiments where the lumen for the guide wire is located at the distal end of the tether, the placement of the tether preferably results in the free introduction of other instruments, such as a pigtail catheter, within the volume of the sheath. In some embodiments, the lumen for the distally located lead may have a length of 70-160mm (e.g., 70mm, 80mm, 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm, or 160 mm). Preferably, any lumen for a guide wire is longer than the intravascular device. In the proximal region where the lumen for the guide wire does not extend, the tether preferably also has a narrower transverse dimension. The guide sheath may have a size in the range of 6F to 10F (e.g., 6F, 7F, 8F, 9F, or 10F). Other delivery systems of the present invention may include an aspiration device that is introduced through, for example, a dual lumen introducer sheath.

The delivery system may also include a deflector to assist in the deployment and positioning of the endovascular device. The deflector may comprise, for example, a frame, or may be frameless and may be made of, for example, an expandable or extensible material. In embodiments where the delivery system includes a deflector, the intravascular device of the present invention is positioned proximal to the deflector. The deflector may protrude from the distal end of the introducer sheath and be deployed prior to the device, providing a landing zone for, for example, an intravascular device, and guiding other devices deployed from the introducer sheath under the filter of the deployed intravascular device.

In various embodiments, it is desirable to track the advancement of all or a portion of the apparatus of the present invention, or the advancement of the treatment device used in conjunction with the apparatus of the present invention. Various mechanisms for tracking the advancement of all or a portion of the device are contemplated, such as by visualizing the advancement. Tracking methods include, but are not limited to, X-ray, fluoroscopy, ultrasound, echocardiography, MRI (magnetic resonance imaging), direct transvascular, near-infrared angiography, intravascular ultrasound, CT (computed tomography) scanning, and/or any other suitable imaging technique.

An additional component of the delivery system of the present invention may include a pigtail catheter having radiopaque material to facilitate tracking of the advancement of the device and other elements of the delivery system. The pigtail catheter can have a size of 6F or less (e.g., 1F, 2F, 3F, 4F, 5F, or 6F). In some embodiments, a pigtail catheter is advanced over the guide wire with the intravascular device through the introducer sheath. For example, the delivery system may include a tether having a lumen for a guide wire located at a distal end of the tether to allow passage of the guide wire. After deployment of the device, the evacuated volume within the introducer sheath lumen allows other tools and/or devices (e.g., pigtail catheters) to pass through the delivery system. In other embodiments, the pigtail catheter is advanced over the guidewire in a first lumen of the introducer sheath while the endovascular device is advanced through a second lumen of the dual lumen introducer sheath. Once the introducer sheath reaches a desired location, such as the aortic arch, the intravascular device is deployed through the first lumen of the introducer sheath. Subsequently, the introducer sheath is rotated, advancing the pigtail catheter over the guide wire and disposing it under the deployed device.

The invention also features methods of using the intravascular devices and delivery systems of the invention. With the delivery system of the present invention, the device of the present invention is inserted into a blood vessel of a subject, such as the aortic arch. The device may be introduced into a vessel of a subject in a collapsed form and contained within an introducer sheath. The device may be loaded into the introducer sheath through a Y-connector attached to the proximal end of the introducer sheath. The lead of the device may be inserted into the introducer sheath through the first port of the Y-connector. The endovascular device may be inserted into the second port of the Y-connector, with or without a tether, to combine the endovascular device with the guide wire of the device. The endovascular device may be advanced through the introducer sheath with a guidewire and positioned, for example, in the aortic arch. The protected lips (e.g., dilator tip) can also be advanced through an introducer sheath at the distal end of the device to dilate the vessel, creating space for the advancing introducer sheath. Upon reaching the desired location within the subject's vessel, the introducer sheath may be withdrawn, enabling the device to assume an expanded form when it is released or deployed from the introducer sheath. In its expanded form, the superior stabilizer of the device (e.g., the attachment extension of the frame of the device, the guidewire, the tether, and/or the dilator tip) may contact the mesial surface of the innominate artery and secure the device within the aortic arch. In its expanded form, the lower stabilizer of the device (e.g., the attachment extension of the frame of the device, the guidewire, the tether, and/or the dilator tip) may contact the mesial surface of the descending aorta and provide lift to the device within the aortic arch. In an additional embodiment, a deflector of the delivery system is first deployed from the distal end of the introducer sheath to aid in the second deployment and positioning of the device behind the deflector in the introducer sheath. The position of the device in a desired location, such as the aortic arch, may be adjusted by a guide wire and/or a tether. The device may include a lumen for a guidewire, e.g., at the distal end, over which the endovascular device is to be deployed. In some embodiments, the lumen of the guidewire at the distal end may have a length of 70-160mm (e.g., 70mm, 80mm, 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm, or 160 mm). Preferably, any lumen for a guide wire is longer than the intravascular device. For a tether having a lumen for a guidewire at a distal end, the lateral dimension of the tether at the distal end is preferably greater relative to the proximal end. In the deployed configuration, the filter attached to the frame and the upper and lower stabilizers may be expanded such that the filter is at a position approximately at the midpoint between the upper wall of the aortic arch and the lower wall of the aortic arch, and the filter extends beyond the distance between the branch arteries of the aorta. A pigtail catheter may also be loaded through the third port of the Y-connector of the introducer sheath to enable visualization and positioning of the device. After deployment of the endovascular device, the pigtail catheter may be passed through the space vacated by the portion of the lumen housing the guide wire for the distal end of the tether. The pigtail catheter may be inserted over the second guide wire and then the second guide wire may be withdrawn through the guide sheath when the pigtail catheter is deployed. The positioned device filters particulate (e.g., thrombus) material from entering the branch arteries of the aorta. The device and delivery system may be introduced via any suitable blood vessel, for example, a peripheral blood vessel, such as the femoral artery.

In one embodiment, a device according to an embodiment of the present invention may be used to protect the brain from particles (e.g., thrombus) before, during and/or after a traumatic intracardiac procedure, such as, for example, an intra-aortic balloon dilatation, mitral balloon dilatation, electrophysiological examination, ablation with or without ectopic rhythmic sites, insertion of an automated defibrillator, percutaneous valve repair or replacement, or other procedure. For example, these embodiments of the device may be used in subjects with severe aortic atherosclerosis to protect the brain during conventional cardiac catheterization procedures, or to "clean" the vessels of atherosclerotic or thrombotic material. Such embodiments may be used in subjects with a higher risk or propensity for forming intracardiac thrombi, such as subjects with blood disorders, cardiac arrhythmias, artificial heart subjects, auxiliary device subjects, mechanical valve replacement subjects, subjects after undergoing intracardiac pathological repair, or subjects with congenital heart disease, such as patent foramen ovale, and the like. Other applications of blood particulate filters, medical procedures that benefit from the use of blood particulate filters, and patients at risk of injury from blood particulates are known in the art.

The device according to one embodiment of the invention may be used temporarily for e.g. acute situations. For example, the device may be temporarily inserted to prevent cardiogenic or embolic stroke. The device of the invention may be used to reduce the risk of injury caused by blood particles, for example, a thrombus in a subject suffering from a condition associated with an increased risk thereof, such as Acute Myocardial Infarction (AMI). Thus, in other embodiments, the device may be inserted during surgery or treatment. The result of the use of one particular use or many embodiments of the invention includes preventing particles from reaching the brain.

The invention also features catheters having a lumen for a guidewire at the distal end without extending the length of the catheter. The catheter is similar to the tether of the present invention, but it need not be used in conjunction with the intravascular device of the present invention, and the description of the tether provided herein is fully applicable to the catheter of the present invention. The catheter may be attached to any tool for intravascular use, for example, intravascular devices for filtering thrombi, or may include a mechanism for attaching, for example, a clasp, ring, hook, or thread to such a tool. The catheter may also include a lumen that extends the length of the catheter, e.g., for introducing or removing fluids, or for inserting, removing, or moving tools. In particular, the catheter of the present invention may be used with intravascular devices that filter thrombus, such as those described in US 7,232,453, US 2008/0255603, US8,062,324, US 2014/0074152, US 2014/0336695, US 2015/0039016, WO 2014/061013, WO 2014/188410 and WO 2014/199381. In some embodiments, an intravascular device may comprise: the method may further comprise preventing particles in the blood vessel from passing through the filter of the filter, the frame holding the filter, and more than one arch extending outwardly from a horizontal plane of the device such that a side of a lower arch of the more than one arch is in contact with a surface of a first blood vessel, such as a side of an ascending aorta, and a side of an upper arch of the more than one arch is in contact with a surface of a second blood vessel, such as a mesial plane of a subclavian artery, for example, as described in US8,062,324. Other tools that may be used include, for example, electrodes for sensing or ablation, imaging tools such as ultrasound imaging or optical imaging, cutting tools, and balloons.

The device of the invention may be used in combination with one or more pharmaceutical ingredients, such as drugs known to treat endocarditis or blood clots.

Reference is made to fig. 1A (a schematic illustration of a side view of an intravascular device) and fig. 1B (a three-quarter side view of an intravascular device). These devices are depicted without wires as upper or lower stabilizers. The frame, filter, upper stabilizer, and lower stabilizer may be used in devices having wires (e.g., tethers), as described herein. The intravascular device 100 may include a frame 102, a filter 104, and a series of stabilizers, such as lower stabilizers 106 and 108, and an upper stabilizer 110. A first end 112 of the device 100 facing upstream of blood flow in the aorta and a second end 114 of the intravascular device 100 facing downstream of blood flow in the aorta may curve downward below a side plane of the intravascular device 100. The second end 114 of the device 100 may include a hook 115 by which the intravascular device 100 may be attached to a tether 205 during insertion, installation, and/or retraction.

The dashed line 116 represents the theoretical horizontal plane of the intravascular device 100. The lateral plane of the intravascular device 100 may include an approximately horizontal line along the mid-section of the intravascular device 100 along the frame 102 ahead of the curve of the ends 112 and 114.

As may be at the proximal end of the frame 102, the first support portion 118 of the upper stabilizer 110 may rise away from the frame 102 at an angle toward the first end 112. The second fixing portion 120 of the upper stabilizer 110 may return back along the way at the bent portion 122 on such first supporting portion and may rise upward toward the direction of the second end 114. The second fixing portion 120 of the upper stabilizer 110 may be tapered in width toward a tip thereof, which may be rounded or flat.

The filter 104 serves to stop or deflect thrombi or other particles from entering, for example, the three branch arteries of the aorta (e.g., innominate, left common carotid and left subclavian), while still maintaining a space above the filter to allow blood to swirl and pool at such entry. The space below the filter 104 may allow unfiltered blood to pass through the branch arteries of the aorta. This space in the aorta on the left below the filter means that not all of the blood passing through the aorta is filtered or deflected by the filter 104. Being mounted in the middle of the aorta (e.g., between the upper wall of the aortic arch and the lower wall of the aortic arch), rather than directly adjacent to the entry point into the branch artery, can allow blood to flow continuously through the aorta and into the branch artery even if a portion of the filter 104 is clogged with thrombus or other material.

In some embodiments, the lower stabilizer 106 may be connected with the frame 102 on a first side (e.g., a dorsal side) and the lower stabilizer 108 may be connected with the frame 102 on a second side (e.g., a ventral side). A first portion of each of the lower stabilizer 106 and the lower stabilizer 108 proximate the frame 102 may extend from the frame 102 in substantially parallel lines. A second or lower portion of each of the lower stabilizers 106 and 108, as located at the distal end of the frame 102, may be curved toward each other at a point proximate to the midline of the frame 102. The lower ends of the lower stabilizers 106 and 108 may terminate in a small loop, such as a single strand of rope that each member comprises. Such a curved end may prevent the end of the lower stabilizer 106 or 108 from scraping or abrading arterial tissue. In some embodiments, the ends of each lower stabilizer 106 and 108 may be lightly touching together, although they may be separated by slight pressure.

In some embodiments, the device 100 may remain positioned in the aorta while performing a procedure (e.g., TAVI) in, for example, the heart, a blood vessel, or other body region, wherein such a procedure necessitates passing a lead (e.g., a catheter) through the aorta. The easy separation of the lower stabilizers 106 and 108 may allow for the removal of the arterial catheter or other device from the aorta while the intravascular device 100 remains in place and may serve to deflect or filter particles (e.g., thrombotic material) from entering the branch arteries of the aorta.

In some embodiments, a tether (205), such as a loop, may be passed over the hook 115 such that the hook passes between the contact point of the curved portion and the curved portion of the loop. When passed through in this manner, the looped end tether 205 can be snapped into the hook 115 and the device 100 can be safely pushed into place or the device 100 pulled out of place from the aorta. In some embodiments, the hooks may terminate in a balloon tip so that the strands of the frame do not abrade or scrape the vessel wall or inner tube of the catheter.

In some embodiments, the intravascular device 100 may prevent passage of clots, metastases, or filtered particles (e.g., blood clots, calcified debris, or other objects that may block blood flow). Other devices may also be supported or held in place with the frame 102 and intravascular device 100.

In some embodiments, the intravascular device 100 may be inserted into a blood vessel, such as through an introducer sheath, and the intravascular device 100 may be installed in the blood vessel by advancing the intravascular device 100 into the blood vessel, for example. Other methods of introducing the intravascular device 100 into a blood vessel are also possible.

In some embodiments, the frame 102 may comprise or be constructed of, for example, nitinol or other superelastic material or shape memory alloy or material. Other materials may be used. In some embodiments, the filter 104 may be (or include) a fine wire mesh or net, or a perforated film, such as a net with holes or pores of about 300 microns, such that particles larger than the pores or holes are prevented from passing through the filter. Other sizes of holes or eyes may be used. In some embodiments, the shape of the filter 104 may be defined or supported by the shape of the frame 102.

In some embodiments, one or more of the frame 102, the upper stabilizer 110, and the lower stabilizer 106 may be fabricated from a continuous wire having different thicknesses or characteristics in different regions of its length. For example, the upper stabilizer 110 may be fabricated from a wire or portion of a wire that is thin or otherwise very soft relative to the thickness or flexibility of one or more of the lower stabilizers 106 and 108 or other portions of the frame 102. This increased flexibility may allow the upper stabilizer 110 (and particularly the curved portion 122 and the second portion 120) to expand or contract upon application of even a small force, such as by the upper stabilizer 110 contacting the upper portion of the blood vessel with which it is in contact. In contrast, the lower stabilizers 106 and 108 may be fabricated with thicker or relatively stiffer wires or filaments to provide lift to the middle portion of the device 100.

In some embodiments, one or more wires making up the upper and lower stabilizers 110, 106 and 108 may be wrapped or woven around the frame 102, and no welding or adhesive connections may be required between the wrapped strands of the frame 102 and the members 110, 160 and 108.

Reference is made to fig. 2A-2B, which are schematic illustrations of the device of the present invention having wires that exert forces on the filter and frame of the device. In fig. 2A, the lead 202 is passed through the tether 205 and the lead 202 exerts a mechanical force 214 on the filter 104 and frame 102 of the device 100. When deployed, the device is supported by the mechanical force 214 exerted by the wire 202 on the inner wall of the tether 205. Fig. 2B shows that increasing the stiffness of the lead 202 may increase the mechanical force 214.

Referring to fig. 3A-3D, which are schematic illustrations of the intravascular device 100, the intravascular device 100 has a tether 205 and a dilator tip 209 that are either lower or upper stabilizers. Fig. 3A depicts one embodiment of the device 100 in which a tether 205 attached to a dilator tip 209 is connected to the device 100 along the length of the intravascular device 100 below the filter 104, the intravascular device 100 having an upper stabilizer 110 attached. The tether 205 and attached dilator tip 209 support the intravascular device 100 by providing lift under the device and act as a lower stabilizer to stabilize the device in, for example, the aortic arch. Fig. 3B is an illustration of the device 100 of fig. 3A disposed in an aortic arch 215. Device 100 is advanced over guide wire 202, through introducer sheath 203 and into aortic arch 215, where upper stabilizer 110 extends into and contacts the mesial surface of innominate artery 216, and filter 104 and frame 102 extend across the ostia of innominate artery 216, left common carotid artery 217, and left subclavian artery 218. The tether 205 and dilator tip 209 provide mechanical force 214 on the filter 104 and frame 102 to lift the device 100 as blood passes from the ascending aorta 219 to the descending aorta 220. In this embodiment, the lower stabilizer (106, 108) is optional, as the tether 205 and dilator tip 209 act as a lower stabilizer for the device 100.

Figure 3C illustrates one embodiment of the device of the present invention having a tether 205 with an attached dilator tip 209 through the filter 104 of the intravascular device 100. In the top embodiment, the tether 205 acts as an upper stabilizer for the intravascular device 100 to limit the lifting of the lower stabilizers 106 and 108. In the bottom embodiment, the dilator tip 209 acts as an upper stabilizer for the intravascular device 100 by penetrating up through the filter 104 from the horizontal surface 116 of the filter 104. In fig. 3D, the lower device 100 of fig. 3C is disposed in the aortic arch 215. The device 100 is advanced over the guide wire 202, through the introducer sheath 203 and into the aortic arch 215 where the dilator tip 209 extends into and contacts the mesial surface of the innominate artery 216 and the filter 104 and frame 102 extend across the ostia of the innominate artery 216, the left common carotid artery 217, and the left subclavian artery 218. The guidewire 202, which passes through the lumen of the tether 205 and exerts a force on the lumen wall of the tether 205, provides a mechanical force 214 on the filter 104 and frame 102 of the device 100 in the direction of the ascending aorta 219. Dilator tip 209 acts as an upper stabilizer for device 100 in innominate artery 216 to limit the lift force exerted by lower stabilizers 106 and 108 of device 100.

Referring to fig. 4, a schematic illustration of a delivery system combining a Y-connector 206 with an introducer sheath 203 to insert an intravascular device 100 (which includes upper stabilizer 110 and lower stabilizers 106 and 108) through a port of the Y-connector. The tether 205 may also be loaded over the guide wire 202 through the Y-connector and the tether 205 has a protected lip 201 that protrudes beyond the distal end of the guide sheath 203.

Reference is made to fig. 5A-5B, which are schematic illustrations of two embodiments of a tether 205, the tether 205 having a dilator tip 209 attached at its distal end. The embodiment of the delivery system depicted in fig. 5A is a schematic view of a low profile tether 205 having a constant stiffness extending along the length of the tether and dilator tip 209. The dilator tip 209 extends from the distal end of the introducer sheath 203 when the dilator tip 209 is advanced adjacent to the intravascular device 100 having the filter 104, the frame 102, the upper stabilizer 110, and the lower stabilizers 106 and 108. Fig. 5B is a schematic illustration of a tether 205 having a stiffness greater than the stiffness of the dilator tip 209, advancing the dilator tip 209 proximate the intravascular device 100, with the intravascular device 100, the upper stabilizer 110, and the lower stabilizers 106 and 108.

Reference is made to fig. 6A-6B, which are diagrams of an embodiment of a tether of the delivery system of the present invention. In fig. 6A, one embodiment of the delivery system of the present invention is depicted with the device 100 disposed from the distal end of the introducer sheath 203 and the tether 205 attached to the dilator tip 209, the dilator tip 209 fitting into a single lumen of the introducer sheath 203. The cross-sectional view of the introducer sheath 203 shows the tether 205 at the top of the lumen and the space remaining for introducing other devices, such as a pigtail catheter 204. Fig. 6B depicts one embodiment of a tether 205 having a flushing element 208 through which saline, for example, may be forced to flush the Y-connector 206 or introducer sheath 203 of the delivery system.

Referring to fig. 7, there is shown a schematic representation of a tether having an expandable dilator tip 209 at the distal end.

Referring to fig. 8, there is a schematic view of the delivery system of the present invention including a deflector. The tether 205 attached to the dilator tip 209 is enclosed by the introducer sheath 203. The deflector 210 is first deployed from the distal end of the introducer sheath 203 and the deflector 210 provides a parking area for the intravascular device 100, deploying the intravascular device 100 from the introducer sheath 203 and parking the intravascular device above the level of the deflector 210. The deflector 210 guides other devices to be subsequently disposed below the level of the deflector from the guide sheath 203 to prevent the ancillary device from becoming entangled with the intravascular device 100.

Reference is made to fig. 9A-9B, which are schematic illustrations of loading and deployment of an intravascular device from an introducer sheath of the present invention. In fig. 9A, a tether 205A attached to a dilator tip 209 is advanced through the introducer sheath 203, the dilator tip 209 protruding from the distal end of the introducer sheath 203. When loaded into the introducer sheath 203, the intravascular device 100 is folded along its longitudinal axis. Fig. 9B depicts retraction of the introducer sheath 203 to deploy the intravascular device 100 over the guidewire 202.

Reference is made to fig. 10A-10B, which are schematic illustrations of the loading and deployment of an intravascular device 100 attached to a tether 205, in addition to the tether 207 having a dilator tip 209. In fig. 10A, a tether 207 attached to a dilator tip 209 is advanced through the introducer sheath 203, the dilator tip 209 protruding from the distal end of the introducer sheath 203. When loaded into the introducer sheath 203, the intravascular device 100 attached to the tether 205 is folded along its longitudinal axis. In fig. 10B, the intravascular device 100 is advanced through the distal end of the introducer sheath 203 by pushing on the attached tether 205. The endovascular device 100 is deployed from the distal end of the introducer sheath 203 when the introducer sheath 203 and the tether 207 attached to the dilator tip 209 are retracted in a direction opposite to the advancing tether 205.

Referring to fig. 11, a schematic view of a dual lumen introducer sheath is shown. In the dual lumen introducer sheath 211 of the present invention, a first lumen is provided having a larger diameter than a second lumen to allow the pigtail catheter 204 to be advanced through the first lumen and the device 100 and tether 205 to be passed through the second lumen without tangling the two devices together. The dual lumen introducer sheath 211 may further enclose the aspirator 212 of the present invention for the intended purpose. In cross-sectional view, the pigtail catheter 204 is positioned in the first lumen above the second lumen, which includes the tether 205 and the aspirator 212.

Reference is made to fig. 12, which is a schematic illustration of the orientation of deployment of the intravascular device 100 and pigtail catheter 204 from a dual lumen introducer sheath 211. In the left drawing, second guidewire 222 is advanced through the first lumen of dual lumen introducer sheath 211 and second guidewire 222 exits through the distal opening of the first lumen of dual lumen introducer sheath 211. The endovascular device 100 is advanced through the second lumen of the dual lumen introducer sheath 211 by the tether 205 and the endovascular device 100 is deployed over the guide wire 222. In the right drawing, dual lumen introducer sheath 211 is rotated such that pigtail catheter 204 having blunt tip 213 is advanced over guidewire 222 and deployed from the first lumen of dual lumen introducer sheath 211 below intravascular device 100 while guidewire 222 is retracted into the first lumen of dual lumen introducer sheath 211.

Referring to fig. 13, there is a schematic illustration of a tether having a lumen at its distal end. In the tether 223, a first portion 224 (which may include a lumen) extends the length of the tether and provides a connection to the intravascular device 100, the intravascular device 100 being shown deployed from the introducer sheath 203. The second portion 225 (which includes a lumen for a guide wire) is located at the distal end of the tether 223 and does not extend the length of the tether. Portion 225 is located under intravascular device 100 and is attached to protected lip 201.

Reference is made to fig. 14, which is a schematic illustration of the loading of the intravascular device 100 and tether 223 shown in fig. 13 into an introducer sheath 203. When the tether and device are loaded into the sheath, the protected lip 201 extends beyond the distal end of the sheath. The sheath, tether, and device may be advanced over the lead 202 via a lumen in the portion 225.

It will be appreciated by persons skilled in the art that what has been particularly shown and described hereinabove is not intended to limit embodiments of the invention. Rather, the scope of at least one embodiment of the invention is defined by the following claims.

Claims (57)

1. An intravascular device for deflecting thrombus, comprising:

a. a substantially flat frame having a length of between about 80mm and 90mm and a width of about 20mm to 35 mm;

b. a thrombus filter attached to the frame and extending a length of the frame;

c. an upper stabilizer located above the horizontal plane of the filter; and

d. a lower stabilizer located below a horizontal plane of the filter;

wherein one of the upper stabilizer or the lower stabilizer comprises a wire configured to extend along a horizontal plane of the filter and exert a force on the frame and/or the filter when arranged in the aorta of a subject.

2. The device of claim 1, wherein the frame defines a shape of the filter, and wherein the frame is adapted to maintain contact with both the ascending aorta and the descending aorta.

3. The device of claim 1 or 2, wherein the superior stabilizer is adapted to contact the mesial surface of the innominate artery.

4. The device of any one of claims 1 to 3, wherein the lower stabilizer is adapted to contact the mesial surface of the ascending aorta.

5. The device of any one of claims 1 to 4, wherein the upper stabilizer comprises the wire, and wherein the wire is configured to apply a force downward from the horizontal plane of the filter.

6. The device of any one of claims 1 to 5, wherein the lower stabilizer comprises the wire, and wherein the wire is configured to exert a force upward from the horizontal plane of the filter.

7. The device of any one of claims 1-6, wherein the lead comprises a tether.

8. The device of claim 7, wherein the tether comprises a material selected from the group consisting of a polymer, a metal, and combinations thereof.

9. The device of any one of claims 1-8, wherein the tether comprises at least one lumen.

10. The device of claim 9, wherein the lumen is located at a distal end of the tether and does not extend a length of the tether.

11. The device of claim 8 or 9, wherein a guide wire is located within the lumen and is configured to exert a force on an inner wall of the lumen of the tether.

12. The device of any one of claims 7 to 11, wherein the diameter of the tether is less than 2 mm.

13. The device of any one of claims 7 to 12, wherein the tether comprises an attached protected lip.

14. The apparatus of claim 13, wherein the protected lip comprises a dilator tip.

15. The device of any one of claims 7 to 14, wherein the lower stabilizer comprises the tether and the tether is configured to apply a force below the horizontal plane of the filter.

16. The device of any one of claims 7 to 14, wherein the upper stabilizer comprises the tether and the tether is configured to exert a force above the horizontal plane of the filter.

17. The apparatus of any one of claims 14-16, wherein the upper stabilizer comprises the dilator tip, and wherein the dilator tip is configured to extend above the horizontal plane of the filter.

18. The device of any one of claims 7 to 17, wherein the tether comprises an irrigation section.

19. The device of any one of claims 13-18, wherein the protected lip is located at a distal end of the tether.

20. The device of any one of claims 14-19, wherein the tether and the dilator tip have a uniform stiffness.

21. The device of any one of claims 14 to 19, wherein the tether is stiffer than the dilator tip.

22. The device of any one of claims 14-19, wherein the tether is softer than the dilator tip.

23. A delivery system comprising the device of any one of claims 1 to 22 and an introducer sheath having a lumen for introducing the device to the aorta of a subject.

24. The delivery system of claim 23, wherein the introducer sheath comprises a braided or coiled material.

25. The delivery system of claim 23 or 24, comprising the introducer sheath having a size selected from the group consisting of 6F, 7F, 8F, 9F, and 10F.

26. The delivery system of any of claims 23-25, wherein the introducer sheath further comprises a Y-connector.

27. The delivery system of any of claims 23-26, further comprising a second guide wire.

28. The delivery system of any one of claims 23 to 27, further comprising a pigtail catheter.

29. The delivery system of claim 28, comprising the pigtail catheter having a size selected from the group consisting of 1F, 2F, 3F, 4F, 5F, and 6F.

30. The delivery system of claim 28 or 29, wherein the pigtail catheter further comprises a blunt tip.

31. The delivery system of any of claims 23 to 29, further comprising a deflector.

32. The delivery system of claim 31, wherein the deflector comprises an expandable material or a malleable material.

33. The delivery system of claim 31 or 32, wherein the deflector comprises a frame.

34. The delivery system of any of claims 23-33, wherein the device is encased in the introducer sheath.

35. The delivery system of any of claims 23-34, further comprising a protected lip at the distal end of the introducer sheath and having a smaller diameter than the introducer sheath.

36. The delivery system of claim 35, wherein the device is compressed within the guide sheath and positioned behind the protected lip.

37. The delivery system of any of claims 23-36, wherein the device expands when the introducer sheath is retracted relative to the device.

38. The delivery system of any of claims 28-37, wherein the pigtail catheter, the tether, and the device are encased in a single lumen of the introducer sheath.

39. The delivery system of claim 38, wherein the tether is the tether of claim 10 and the lumen is located below the device.

40. The delivery system of any of claims 28-39, wherein the device and the tether are loaded into a first lumen of the double lumen introducer sheath and the pigtail catheter is loaded into a second lumen of the double lumen introducer sheath.

41. A method of introducing the device or delivery system of any of claims 1-40 into a subject, the method comprising:

(i) inserting the device contained within the guiding sheath into a blood vessel of a subject,

(ii) and retracting the catheter at a desired location in the blood vessel, thereby deploying the device.

42. The method of claim 41, wherein the device is deployed from the introducer sheath in an aortic arch.

43. The method of claim 42, wherein the deploying of the device comprises the superior stabilizer contacting a mesial surface of a innominate artery.

44. The method of claim 42, wherein the disposing of the device comprises the lower stabilizer contacting a mesial surface of a wall of the aorta.

45. The method of any one of claims 41 to 44, wherein the upper or lower stabilizer of the device comprises the tether.

46. The method of claim 45, wherein the upper stabilizer comprises the dilator tip.

47. The method of any one of claims 41 to 46, further comprising guiding the pigtail catheter through the guide sheath.

48. The method of any one of claims 41 to 47, wherein the device is advanced through the guide sheath by the tether moving over the guide wire.

49. The method of claim 48, wherein the tether is the tether of claim 10, and the guide wire is passed through the lumen of the tether.

50. The method of claim 49, wherein the cavity is positioned below the device.

51. The method of any one of claims 47-50, where the pigtail catheter is inserted over the second guidewire.

52. The method of any one of claims 41 to 51, wherein the device or the delivery system is guided via a peripheral artery.

53. A catheter for intravascular insertion, the catheter having a proximal end and a distal end and a lumen for a guide wire at the distal end, wherein the lumen does not extend the length of the catheter.

54. The catheter of claim 53, further comprising a mechanism for attaching an endovascular tool at the distal end.

55. The catheter of claim 53, further comprising an intravascular tool attached to the distal end.

56. The catheter of claim 55, wherein the endovascular tool comprises a filter, an electrode, a cutting element, an imaging element, or a balloon for thrombus.

57. The catheter of any one of claims 53-56, wherein a transverse dimension of the distal end is greater than a transverse dimension of the proximal end.