Aspiration system including a preformed nonlinear dilator for embolic aspiration - Patents.com

Abstract

Aspiration systems and associated methods are described, including an aspiration system having a support tube and a preformed nonlinear dilator. For example, the support tube provides access into a blood vessel and can include a straight elongate body and an inner tube passage. The preformed nonlinear dilator can include an elongate body including a preformed nonlinear distal portion disposed adjacent a distal end. For example, the preformed nonlinear distal portion can include a preformed nonlinear shape that deforms into a substantially linear shape as it extends along the inner tube passage of the support tube. The preformed nonlinear distal portion can reform into the preformed nonlinear shape as it extends out of the inner tube passage and into the blood vessel to guide the distal end of the elongate body to an embolus disposed a distance from the access site.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 63 / 322,772, filed March 23, 2022, entitled “ASPIRATION SYSTEM INCLUDING PREFORMED NON-LINEAR DILATOR FOR ASPIRATION OF EMBOLI,” the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] Some vascular diseases may include plaque buildup that increases the risk of emboli or embolic particles being generated and entering the cerebral vasculature, causing neurological outcomes such as transient ischemic attacks (TIAs), ischemic strokes, or death. Various procedures involve accessing the inner lumens of blood vessels that may contain plaque buildup, which may increase the risk of embolic particle generation.

[0003] For example, when a severed access site is created during a procedure for vascular access (e.g., access in the common carotid artery), a distal or downstream portion of the vessel can be clamped to form an occlusion along the vessel to prevent embolic particles from migrating to the brain or other organs. In some instances, common carotid artery access and cutdown can be used with a conduit or graft for vascular access.

[0004] Additionally, the space and / or length along the vessel between the vascular access site, including the arteriotomy site, and the clamp forming the closure may include areas or volumes of stagnant or static blood flow. Such static flow may include emboli (e.g., thrombus, air, plaque, tissue, calcified material, embolic particles, etc.) that may accumulate during the procedure. If the emboli are not removed prior to removal of the vascular closure and the clamp forming the closure, the emboli may cause an ischemic event. Some physicians use a standard flushing process with a straight rigid tube to degas and flush the vessel prior to closure, such as to attempt to remove residual emboli and prevent an ischemic event. Summary of the Invention [Problem to be solved by the invention]

[0005] Clamping of a vessel can cause flow arrest locations at distances along the vessel away from the access site. As such, it may be difficult to degas and remove emboli adjacent to the occluded portion of the vessel prior to closure of the vessel, causing a risk of ischemic events. For example, a straight tube that can be used prior to closure of the vessel may be able to degas and remove emboli from a portion of the vessel at the access site, but may not be able to safely and effectively degas and / or remove emboli from other locations along the vessel, e.g., along the length of the vessel adjacent to and extending to the occluded portion. As such, methods and devices for reducing or preventing ischemic events are desired to improve vascular access procedures and patient care. [Means for solving the problem]

[0006] Aspects of the present subject matter can include embodiments of an aspiration system for removing emboli spaced along a blood vessel from an access site. In one aspect, the aspiration system can include a support tube configured to provide access to an inner lumen of the blood vessel. The support tube can include a straight elongate body and an inner tube passage. The aspiration system can further include a preformed non-linear dilator including an elongate body extending between a proximal end and a distal end. The elongate body can include a preformed non-linear distal portion disposed adjacent the distal end, the preformed non-linear distal portion including a preformed non-linear shape that deforms into a substantially linear shape as it extends along the inner tube passage of the support tube. The preformed non-linear distal portion can reform to the preformed non-linear shape as it extends out of the inner tube passage and into the blood vessel, thereby guiding the distal end of the elongate body to an emboli spaced along the access site.

[0007] In some variations, one or more of the following features may be optionally included in any workable combination: The support tube may be formed of a first material that is stiffer than a second material forming at least the preformed nonlinear distal portion of the dilator. The preformed nonlinear distal portion may be formed of a shape memory material and / or a Nitinol material. The shape of the preformed nonlinear distal portion may include an L-shape and / or an approximately 90 degree bend. The shape of the preformed nonlinear distal portion may include an S-shape. The shape of the preformed nonlinear distal portion may include a distal length of the elongate body that extends at an angle to the support tube. The distal length may extend approximately the same distance. The preformed nonlinear distal portion may be steerable such that the position of the distal end is controllable within the vessel. The elongate body may include an inner diameter that is sized to allow an embolus to pass along the elongate body. The inner diameter of the elongate body may be about 10 French to about 14 French. The distal end of the preformed nonlinear dilator can include a smooth and / or rounded end.

[0008] In another interrelated aspect of the present subject matter, a method includes removing emboli located a distance along a blood vessel from an access site. The method can include advancing a support tube into an inner lumen of the blood vessel, the support tube can include a straight elongate body and an inner tube passage. The method can further include advancing a preformed nonlinear dilator along the inner tube passage of the support tube, thereby causing a preformed nonlinear distal portion of the preformed nonlinear dilator to extend out of the support tube and reform within the blood vessel into a preformed nonlinear shape. The preformed nonlinear dilator can include an elongate body extending between a proximal end and a distal end, the elongate body can include a preformed nonlinear distal portion disposed adjacent the distal end. The preformed nonlinear distal portion can include a preformed nonlinear shape that deforms into a substantially linear shape as it extends along the inner tube passage of the support tube. The preformed nonlinear distal portion reforms to the preformed nonlinear shape as it extends out of the inner tube passage and into the blood vessel, thereby guiding the distal end of the elongate body to an embolus positioned a distance from the access site.

[0009] In some variations, one or more of the following features may optionally be included in any workable combination: The method may further include positioning the distal ends of the elongate bodies at a distance along the vessel or adjacent to a distance along the vessel. The method may further include aspirating at least one embolus along the preformed nonlinear distal portion. The method may further include supplying fluid into the vessel from the preformed nonlinear distal portion or the support tube. The method may further include drawing the preformed nonlinear distal portion of the preformed nonlinear dilator into the inner tube passage, thereby forming the preformed nonlinear distal portion into a substantially linear shape. The support tube may be formed of a first material that is stiffer than a second material forming at least the preformed nonlinear distal portion of the dilator. The preformed nonlinear distal portion may be formed of a shape memory material or a Nitinol material. The shape of the preformed nonlinear distal portion may include an L-shape and / or an approximately 90 degree bend. The shape of the preformed nonlinear distal portion may include an S-shape. The shape of the preformed nonlinear distal section may include a distal length of the elongate body extending at an angle relative to the support tube. The distal length may span approximately the same distance. The preformed nonlinear distal section may be steerable such that the position of the distal end is controllable within the vessel. The elongate body may include an inner diameter sized to allow emboli to pass along the elongate body. The inner diameter of the elongate body may be from about 10 French to about 14 French. The distal end of the preformed nonlinear dilator includes a smooth and / or rounded end.

[0010] The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will become apparent from the description and drawings, and from the claims. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 illustrates one embodiment of an access device that includes a sheath for providing access to the inner lumen of a blood vessel. [Diagram 2] FIG. 2 shows a sheath stopper equipped with the sheath of FIG. [Figure 3A] FIG. 3A illustrates an example of the access system of FIG. 1 accessing the inner lumen of a blood vessel to which a vascular clamp is secured. [Figure 3B] FIG. 3B illustrates an example of a portion of the access system of FIG. 1 extending along the inner lumen of a blood vessel. [Figure 4A] FIG. 4A illustrates one embodiment of an aspiration system that includes a preformed nonlinear dilator. [Figure 4B] FIG. 4B shows the distal end of a preformed nonlinear dilator positioned along a section of a blood vessel containing static blood flow to aspirate emboli.

[0012] Wherever practical, like reference numerals refer to like structures, features or elements. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The disclosed methods, devices, and systems limit or prevent the release of emboli into the vasculature, such as by safely and effectively aspirating and removing emboli from the vasculature to reduce or prevent ischemic events. For example, the present disclosure includes various embodiments of an aspiration system that provides improved performance for accessing and removing emboli within a blood vessel. In some embodiments, the aspiration system may be used in conjunction with an access system that creates and / or provides access to the inner lumen of a blood vessel. The aspiration systems disclosed herein may be used to access and remove emboli from various vasculature systems, including the carotid artery, femoral artery, and the like, without departing from the scope of the present disclosure. Additionally, the aspiration system may be used in conjunction with, prior to, or following any of a number of different procedures that involve accessing the inner lumen of a blood vessel.

[0014] In some embodiments, the aspiration system can include a support tube configured to at least assist in providing access to an inner lumen of a blood vessel. The support tube can include a straight elongate body and an inner tube passage. The aspiration system can also include a preformed nonlinear dilator including an elongate body extending between a proximal end and a distal end. The elongate body can include a preformed nonlinear distal portion disposed adjacent the distal end. The preformed nonlinear distal portion can include a preformed nonlinear shape for guiding the distal end of the elongate body to an embolus disposed along a section of the blood vessel that includes a static flow. For example, the section can be adjacent a vascular clamp that forms an occluded portion of the blood vessel, such as to prevent blood flow therethrough.

[0015] In some embodiments, the support tube is formed of a material that is stiffer than at least the preformed nonlinear distal portion of the dilator such that the support tube deforms the preformed nonlinear distal portion into a generally linear shape as it moves along the inner tube passageway. Further, the preformed nonlinear distal portion can reform into the preformed nonlinear shape when not positioned along the inner tube passageway, such as when it extends distally to the distal end of the support tube.

[0016] In some embodiments, the preformed nonlinear distal portion can be made from a shape memory material and / or can include reinforcing features that allow the preformed nonlinear distal portion to deform, such as to a linear configuration, and reform to the preformed nonlinear shape. For example, the preformed nonlinear shape can include one or more of an L-shape, an S-shape, and an approximately 90 degree bend.

[0017] In some embodiments, the preformed nonlinear distal portion can be steerable such that the position of the distal end of the preformed nonlinear dilator is controllable, such as by a proximal steering feature that is controllable by a user. The elongate body of the preformed nonlinear dilator can include an inner dilator passageway that is sized to allow an embolus to pass therealong, such as about 10 French to about 14 French. The support tube and the preformed nonlinear dilator can include a variety of sizes and dimensions without departing from the scope of the present disclosure.

[0018] The suction assembly can be used alone or in combination with one or more other devices, such as various access systems, grafts, conduits, fluid systems, vacuum systems, etc. Additionally, the suction assembly can be used in a number of different procedures, such as a number of procedures that include accessing an inner lumen of a blood vessel and creating an occlusion in the blood vessel. For example, an occlusion can be created by clamping, tying, etc., a portion of the blood vessel to prevent blood flow therethrough. Creating an occlusion can create an area of ​​the blood vessel adjacent the occlusion that includes static flow, such as between an access site (e.g., a location along the blood vessel where one or more devices can be inserted into the vessel) and the occlusion.

[0019] For example, access to the blood vessel can be achieved percutaneously via an incision or puncture in the skin through which an embodiment of the access system and / or aspiration system can be inserted. In another embodiment, access to the blood vessel can be achieved via a direct surgical approach. For example, access to the blood vessel can be established by placing a sheath or other tubular access cannula of the access system and / or aspiration system within the inner lumen of the blood vessel (e.g., carotid artery, femoral artery, etc.). A clamp can be placed along the blood vessel to limit or prevent the movement of emboli that may cause an ischemic event. For example, flow through the blood vessel can be occluded using either an external vascular loop or tape, a vascular clamp, an internal occlusion member such as a balloon, or other type of occlusion means. In some embodiments, when flow through the blood vessel is blocked, the natural pressure gradient between the internal carotid artery and the venous system can cause blood to flow retrogradely or in the opposite direction.

[0020] In some embodiments, the aspiration system can be used with an access system configured to form an access site along a blood vessel and provide an access passageway into the blood vessel. As such, exemplary embodiments of an access system are disclosed herein that can be used with embodiments of the aspiration system during one or more procedures, including simultaneously or sequentially. For example, the access system can aid in accessing an inner lumen of a blood vessel, such as to remove an embolus. In some embodiments, one or more components of the aspiration assembly can be part of the access system without departing from the scope of the present disclosure.

[0021] 1 shows an exemplary embodiment of an access system 110 including a distal sheath 605, a proximal extension 610, a flow line 615, an adapter or Y-connector 620, and a hemostasis valve 625. The access system 110 may also include a dilator 645 with a tapered tip 650 and an introducer guidewire 611. The access system 110, along with the dilator 645 and introducer guidewire 611, may be used together to access blood vessels. The features of the access system may be optimized for access into various blood vessels, such as via transfemoral and transcarotid access.

[0022] The distal sheath 605 can be adapted to be introduced through an incision or puncture in the wall of a blood vessel (e.g., femoral artery, common carotid artery, etc.), either an open surgical incision or a percutaneous puncture established, for example, using the Seldinger technique. As shown in FIG. 1, the proximal extension 610, which includes an elongate body, can have an inner lumen that is continuous with the inner lumen of the sheath 605. The lumens can be joined by a Y-connector 620 that also connects the lumen of the flow line 615 to the sheath. For example, the flow line 615 can be connected to form a first leg of a retrograde shunt.

[0023] A flush line 635 can be connected to the side of the hemostasis valve 625 and can have a stopcock 640 at its proximal or distal end. The flush line 635 can allow for the introduction of saline, contrast fluid, or the like during the procedure. The flush line 635 can also allow for pressure monitoring during the procedure. For example, to facilitate the introduction of the distal sheath 605 into the vessel, a dilator 645 can be provided having a tapered distal end 650. The dilator 645 can be introduced through the hemostasis valve 625 such that the tapered distal end 650 extends through the distal end of the sheath 605, as best seen in FIG. 2. The dilator 645 can have a central lumen to accommodate a guidewire. Typically, the guidewire is placed into the vessel first, and the dilator / sheath combination travels over the guidewire as it is introduced into the vessel.

[0024] Optionally, a sheath stop 705, such as in the form of a tube coaxially received over the exterior of the distal sheath 605, may be provided, as also seen in FIG. 2. The sheath stop 705 is configured to act as a position limiter to prevent the sheath from being inserted too far into the vessel. The sheath stop 705 is sized and shaped to be placed over the sheath 605 to cover a portion of the sheath 605 and leave a distal portion of the sheath 605 exposed. The sheath stop 705 may have a flared proximal end 710 and a distal end 715 that engage the adapter 620. The sheath stop 705 may serve at least two purposes. First, the length of the sheath stop 705 limits the introduction of the sheath 605 to an exposed distal portion of the sheath 605 such that the sheath insertion length is limited to the exposed distal portion of the sheath. Second, the sheath stopper 705, if present, can engage a pre-deployed puncture closure device positioned in the carotid artery wall to allow withdrawal of the sheath 605 without dislodging the closure device. The sheath stopper 705 may be removable from the sheath 605.

[0025] The access system may provide access to the inner lumen of a blood vessel, such as for performing at least a portion of a number of different procedures. For example, during a transcarotid artery revascularization (TCAR) procedure, an arterial sheath 605 may be inserted into a patient's common carotid artery (CCA). To achieve retrograde flow of blood, the common carotid artery may be occluded to stop antegrade blood flow from the aorta through the common carotid artery. Flow through the common carotid artery may be occluded using an external vascular loop or tape, a vascular clamp, an internal occlusion member such as a balloon, or other type of occlusion means. When blood flowing through the common carotid artery is blocked, the natural pressure gradient between the internal carotid artery (ICA) and the venous system causes blood to flow retrogradely or in the opposite direction from the cerebral vasculature. Blood from the internal carotid artery and the external carotid artery (ECA) flows in a retrograde direction. Some loose embolic material may be carried into the arterial sheath 605 with the retrograde blood flow, while some embolic material may remain adjacent to the occluded portion of the blood vessel.

[0026] 3A-3B show an embodiment of an access system 110 including an embodiment of a sheath 605 inserted into a blood vessel V, such as a carotid artery, exposed through an incision I. For example, a sheath stopper 705 can be used with the sheath 605 to help guide and position the sheath 605 within the blood vessel V, as shown in FIG. 3A. A sheath guidewire 611 and a dilator 645 can protrude from a distal opening 641 of the sheath 605. Manual occlusion of the blood vessel V by a clinician at an occlusion location proximate the distal tip of the sheath 605 can be provided from outside the blood vessel V using a vascular clamp 800, such as a Rummel tourniquet or a vascular loop, placed proximate the sheath insertion site. Occlusion of the blood vessel can form a closed portion of the blood vessel that prevents blood from flowing. In some embodiments, an occlusion device can fit outside the blood vessel V around the sheath tip, such as, for example, an elastic loop, an inflatable cuff, or a mechanical clamp that can be tightened around the blood vessel and the distal sheath tip. A vessel segment containing static blood flow and emboli can be created adjacent to the occlusion.

[0027] FIG. 3B illustrates a system for retrograde blood flow into the distal opening 641 of the sheath 605 after removal of the dilator 645. The location of the vascular clamp 800 in FIG. 3B is partially obscured by the presence of the sheath stopper 705. Embolic material in the retrograde blood flow may drift and become trapped in a zone 905 containing static blood flow in the vessel V. For example, the zone 905 may be between the distal opening 641 of the arterial sheath 605 and the location of the vascular clamp 800 proximal to the sheath insertion location (e.g., access site). The zone 905 of static blood flow where emboli may accumulate may extend, for example, between the access site (e.g., formed by the access assembly) and the vascular clamp 800 or an occluded portion of the vessel. Embolic material may remain in this zone 905. Once the target vessel V has been treated by the operator, the vascular clamp 800 may be released to allow resumption of antegrade blood flow. Embolic material from this area 905 may be carried into the neurovasculature when vascular clamp 800 is released and antegrade blood flow resumes. Embolic material trapped within area 905 may cause an ischemic event despite the use of retrograde embolic protection during the procedure, as emboli may not enter the lumen of arterial sheath 605 during retrograde flow.

[0028] Described in detail below are various embodiments of an aspiration system that safely and effectively accesses and removes (e.g., aspirates) emboli located adjacent to blocked portions of a blood vessel, for example along areas containing static blood flow within the vessel, to reduce or prevent ischemic events.

[0029] 4A-4B illustrate an embodiment of an aspiration system 400 configured to safely and effectively access and remove emboli located adjacent to an occluded portion of a blood vessel, for example, along an area 905 containing static blood flow within the vessel, as described above with respect to FIG. 3B. As shown in FIG. 4A, the aspiration system 400 can include a support tube 402 and a preformed nonlinear dilator 404 that can extend and move along an inner tube passageway 403 of the support tube 402. In some embodiments, the support tube 402 can include an embodiment of a sheath of an access system, such as the sheath 605 of the access system 110 described above with respect to FIG.

[0030] The aspiration system 400 can be configured for use with a number of different transvascular procedures, including transcatheter aortic valve implantation (TAVI) and transcatheter aortic valve replacement (TAVR). As shown in FIG. 4A, the support tube 402 and / or the preformed nonlinear dilator 404 can be coupled to one or more of a luer 405, a flush line 635, and a plug 640. For example, the luer 405 can provide a connection to a vacuum source to provide suction through the dilator 404 to aspirate and remove emboli from the blood vessel. In some embodiments, the luer 405 can be in fluid communication with either the support tube 402 or the dilator 404, such as to enable either dual or selective suction through either the support tube 402 or the dilator 404.

[0031] The flush line 635 and the plug 640 can provide a fluid path for supplying one or more fluids to the vessel. For example, the flush line 635 and the plug 640 can be in fluid communication with either the support tube 402 or the preformed nonlinear dilator 404, such as for dual or selective supply of fluid to the vessel from either the support tube 402 or the preformed nonlinear dilator 404.

[0032] In this manner, in some embodiments, suction can be applied only along the preformed nonlinear dilator 404. In some embodiments, suction can be applied along both the support tube 402 and the preformed nonlinear dilator 404. In some embodiments, the support tube 402 and / or the preformed nonlinear dilator 404 can deliver one or more fluids to the vessel and / or area 905, such as to aid in flushing the vessel and / or maximizing removal of emboli within the vessel.

[0033] As shown in FIG. 4A, the support tube 402 can include a straight elongate body 401 including an inner tube passageway 403 that can have a straight or linear configuration. As also shown in FIG. 4A, the preformed nonlinear dilator 404 can include an elongate body 406 extending between a proximal end 408 and a distal end 410. The elongate body 406 can include an inner passageway 407 and a distal opening 411 in fluid communication with the inner passageway 407. The distal opening 411 and the inner passageway 407 can be sized to allow emboli to travel along the elongate body 406, such as to remove emboli from a blood vessel. For example, in some embodiments, the inner diameter of the inner passageway 407 can be about 10 French to about 14 French.

[0034] The elongate body 406 of the preformed nonlinear dilator 404 can include a preformed nonlinear distal portion 412 adjacent the distal end 410. The preformed nonlinear distal portion 412 can include a preformed nonlinear shape. For example, the preformed nonlinear distal portion 412 can be manufactured (e.g., thermoformed) to include and maintain a preformed nonlinear shape. In some embodiments, the preformed nonlinear distal portion 412 can be made from a shape memory material (e.g., Nitinol) and / or can include reinforcing features that allow the preformed nonlinear distal portion 412 to deform (e.g., as it extends along the support tube 402), such as into a linear configuration, and reform to the preformed nonlinear shape. The preformed nonlinear shape can include one or more of an L-shape, an S-shape, and an approximately 90 degree bend. The nonlinear distal portion 412 can be shaped to direct the distal length 415 of the elongate body 406 away from a vessel wall, such as a vessel wall facing from an access site where the preformed nonlinear dilator 404 is introduced into the vessel (e.g., through the support tube 402). In this manner, the distal length 415 can include a length of the elongate body 406 that can be bent and / or oriented to extend along the vessel after extending from the distal end of the support tube 402. For example, as the distal length 415 of the preformed nonlinear distal portion 412 extends from the support tube 402 into the vessel, the distal length 415 can extend along the vessel at an angle relative to the support tube 402. In some embodiments, the distal length 415 can be approximately the same length as the length of the section 905 (e.g., the distal end 410 of the elongate body can be positioned along any portion of the section 905 to remove emboli along the section 905). In some embodiments, the distal length 415 can be less than the length of the section 905 (e.g., the distal end 410 can be disposed adjacent to and / or along a portion of the section 905), but the distal length 415 can be long enough to efficiently and effectively remove emboli disposed along the section 905. This can reduce and / or prevent damage to the blood vessel, including the vessel wall facing away from the access site.Additionally, the shape of the preformed nonlinear distal portion 412 can direct the distal end 410 toward an embolus positioned adjacent to an occluded portion of a blood vessel, such as an embolus positioned along an area 905 including static flow within the blood vessel, as shown in FIG. 4B.

[0035] The preformed nonlinear distal portion 412 may be deformable and reshapeable, for example, to allow the nonlinear shape of the preformed nonlinear distal portion 412 to move along the inner tube passageway 403 of the support tube 402. For example, the support tube 402 may be made from a first material that is stiffer than a second material that forms at least the preformed nonlinear distal portion 412 of the dilator 404. This may allow the preformed nonlinear distal portion 412 to deform into a straight or linear configuration while being advanced along the support tube 402. The preformed nonlinear distal portion 412 may reshape into the preformed nonlinear shape when it is no longer held by the support tube 402 and / or other support elements having greater stiffness. In this manner, when the preformed nonlinear distal portion 412 of the expander exits the support tube 402 and extends into the blood vessel, the preformed nonlinear distal portion 412 extending out of the support tube 402 reforms into its preformed nonlinear shape, thereby avoiding or reducing contact forces against the opposing blood vessel wall and directing the distal end 410 toward the embolism E located along section 905.

[0036] 4B, the preformed nonlinear distal portion 412 of the dilator can be reformed into a bend or L-shape that directs the dilator distal portion 415 toward an embolus E disposed along the area 905 adjacent to an embodiment of the vascular clamp 800. Once the distal end 410 is positioned adjacent to the embolus E in the area 905, suction can be initiated along the elongate body 406 to aspirate and remove the embolus from the blood vessel, including the embolus along the area 905 and adjacent the occlusion created by the vascular clamp 800. Additional steps can be performed, such as providing a fluid through the preformed nonlinear dilator 404 and / or the support tube 402, such as to flush the blood vessel. For example, in some embodiments, a vacuum can be activated to fluidly communicate with the preformed nonlinear dilator 404, such as to aspirate the embolus E along the area 905. In some embodiments, the preformed nonlinear expander 404 and / or the support tube 402 can be in fluid communication with a fluid source, such as to supply fluid from the nonlinear expander 404 and / or the support tube 402 to the inner lumen of the blood vessel.

[0037] In some embodiments, the preformed nonlinear dilator 404 is configured to allow steering or articulation of the distal end 410, such as to articulate the distal end 410 and / or the distal portion 415. Such steering can be accomplished using an actuator, such as a concentric tube, a pull wire, or the like, associated with the suction system 400. In some embodiments, at least a portion of the preformed nonlinear dilator 404 can be formed from a homogenous malleable tubular material including metals and polymers. In some embodiments, at least a portion of the preformed nonlinear dilator 404 can be formed from one or more of polyether block amides (e.g., PEBAX® materials having a Shore durometer of about 25D to 35D), thermoplastic polyurethane elastomers (e.g., Pellethane® materials having a Shore durometer of about 80A to 90A), aliphatic polyether polyurethanes (e.g., Tecoflex® materials having a Shore durometer of about 80A), and polymeric materials having a Shore durometer of about 55A to 90A.

[0038] In some embodiments, at least a portion of the preformed nonlinear dilator 404 can be manufactured to include a preformed nonlinear shape by heating at least a portion of the dilator above a glass transition temperature, for example, for about 2 minutes to about 15 minutes, while configured into a desired preformed nonlinear shape, and then rapidly cooling the heated portion of the dilator. Such heating and cooling of the preformed nonlinear dilator 404 can fix the preformed nonlinear orientation of the preformed nonlinear dilator 404, and thus achieve a set nonlinear shape. In some embodiments, the preformed nonlinear dilator 404 can include coil or braid reinforcement to achieve a desired nonlinear shape retention and kink resistance, such as for transition between formations (e.g., from linear to nonlinear). For example, the preformed nonlinear dilator 404 can include a radiopaque coil (e.g., a platinum-tungsten (PT-W) coil) that can provide structural reinforcement and allow visualization of at least a portion of the preformed nonlinear dilator 404 (e.g., distal end 410 and / or distal portion 415) under fluoroscopy. In some embodiments, the distal end 410 of the preformed nonlinear dilator 404 includes a smooth and / or rounded end to enable atraumatic movement of the preformed nonlinear dilator 404 within the blood vessel and minimize the risk of dissection.

[0039] The preformed nonlinear dilator 404 can provide active suction of blood to enhance the extraction of embolic material. The preformed nonlinear dilator 404 can also be useful for delivering material into the vessel through the distal end 410. In some embodiments, the injection of saline into the vessel through the distal end of the preformed nonlinear dilator 404 can create turbulence / agitation in the area 905. For example, the flush of fluid can be induced to draw particles trapped in the area 905 into the inner passageway 407 of the dilator as a result of the suction.

[0040] The length of the support tube 402 and preformed nonlinear dilator 404 may be sufficient to allow access into the vessel through any of the various access system features, sheaths, conduits, and / or grafts. As shown in FIG. 4B, the support tube 402 and preformed nonlinear dilator 404 may extend along and through a graft conduit 500 attached to a vessel V at an access site. In some embodiments, the support tube 402 and / or preformed nonlinear dilator 404 are configured to include a guidewire that may allow the guidewire to extend therealong and help provide structural support for selectively deforming the preformed nonlinear dilator 404 into a linear configuration.

[0041] In some methods of use of the aspiration system 400, the preformed nonlinear dilator 404 can be delivered through the support tube 402 or conduit prior to closure of the vessel or conduit. Aspiration through the support tube 402 or conduit can occur simultaneously with aspiration through the preformed nonlinear dilator 404. In some embodiments, the support tube 402 or conduit can deliver fluid to irrigate a portion of the vessel and the preformed nonlinear dilator 404 can aspirate the fluid and debris (e.g., emboli). In some embodiments, the preformed nonlinear dilator 404 can deliver fluid and the support tube 402 or conduit can aspirate the fluid and debris.

[0042] Although this specification contains many specifics, these should not be construed as limitations on the scope of the claimed invention or what may be claimed, but rather as descriptions of features particular to particular embodiments. Certain features described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although features may be described above as acting in a particular combination and may initially be claimed as such, one or more features from the claimed combination may in some cases be deleted from the combination, and the claimed combination may be directed to a subcombination or variation of the subcombination. Similarly, although operations are depicted in the figures in a particular order, this should not be understood as requiring such operations to be performed in the particular order depicted, or in a sequential order, or to perform all of the depicted operations, in order to achieve desired results.

[0043] Although various method and device embodiments have been described in detail herein with respect to several versions, it should be understood that other versions, embodiments, methods of use, and combinations thereof are possible, and therefore the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.

Claims

1. A suction system for removing an embolus positioned at a distance along a blood vessel from an access site, wherein the suction system is A support tube configured to provide access to the inner lumen of the aforementioned blood vessel, comprising a straight, elongated body and an inner tube passage, A preformed nonlinear dilator comprising an elongated body extending between a proximal and distal end, wherein the elongated body includes a preformed nonlinear distal portion positioned adjacent to the distal end, the preformed nonlinear distal portion includes a preformed nonlinear shape that deforms into a substantially linear shape as it extends along the inner tube passage of the support tube, and the preformed nonlinear distal portion reshapes into the preformed nonlinear shape as it exits the inner tube passage and extends into the blood vessel, thereby guiding the distal end of the elongated body to an embolus positioned at a distance from the access site, Suction system.

2. The support tube is made of a first material that is more rigid than the second material that forms at least the pre-formed nonlinear distal portion of the expander. The suction system according to claim 1.

3. The aforementioned pre-formed nonlinear distal portion is formed from a shape memory material or a nitinol material. The suction system according to claim 1.

4. The shape of the pre-formed nonlinear distal portion includes an L-shape and / or a bend of about 90 degrees. The suction system according to claim 1.

5. The shape of the aforementioned pre-formed nonlinear distal portion includes an S-shape. The suction system according to claim 1.

6. The shape of the pre-formed nonlinear distal portion includes the distal length of the elongated body that extends obliquely with respect to the support tube. The suction system according to claim 1.

7. The distal length is approximately the same length as the distance. The suction system according to claim 6.

8. The pre-formed nonlinear distal portion is maneuverable so that the position of the distal end can be controlled within the blood vessel. The suction system according to claim 1.

9. The inner diameter of the elongated body is such that the embolus can pass along the elongated body. The suction system according to claim 1.

10. The inner diameter of the aforementioned elongated body is approximately 10 French to 14 French. The suction system according to claim 1.

11. The distal end of the pre-formed nonlinear expander includes a smooth and / or rounded end. The suction system according to claim 1.

Images