Flexible tip for aspiration catheters
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2026-02-02
- Publication Date
- 2026-08-13
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Figure US2026013506_13082026_PF_FP_ABST
Abstract
Description
Attorney Docket No. 57856-711.601FLEXIBLE TIP FOR ASPIRATION CATHETERS CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 753,829, filed February 4, 2025. The aforementioned application is incorporated by reference herein in its entirety and is hereby expressly made a part of this specification.BACKGROUND
[0002] To treat a blockage (e.g., embolus) in a blood vessel in an individual, catheters are often inserted into the blood vessel to the blockage to provide treatment. In some cases, the catheters are used to apply aspiration in order to remove the blockage. For aspiration catheters, the capability to engage with an embolus to effectively remove the embolus would be valuable. As such, a catheter comprising a flexible tip with extensions that can engage with the embolus would be helpful in removing the embolus and treating such a blockage.SUMMARY
[0003] Individuals may develop a blockage (e.g., embolus) in a blood vessel that can have deleterious effect on their health. Catheters are often inserted into the blood vessel to provide a treatment, such as reducing or removing the blockage. The treatment may be performed with an application of aspiration through the catheter, and an end of the catheter may engage with an embolus in order to remove the embolus. In some cases, the engagement of the catheter may be facilitated by a flexible tip that increase engagement with the embolus to aid in removal of the embolus and reduction of the blockage.
[0004] Provided herein are catheters for use in an aspiration catheter, the catheter comprising: a catheter body comprising a tube having a lumen; and a tip extending distally from the tube, the tip comprising a tip base, a frame extending distally from the base, and a plurality of extensions extending distally from the frame, wherein the catheter body and the tip are a unitary piece. In some embodiments, the catheter body and the tip are formed from a unitary piece of a material. In some embodiments, an extension of the plurality of extensions is coupled to the frame by one or more arms of the extension. In some embodiments, the one or more arms of the extension is a single arm. In some embodiments, an extension comprises an extension frame extending distally from the one or more arms. In some embodiments, the extension frame has an extension frame opening. In some embodiments, the extension frame opening is filled with a radiopaque material. In some embodiments, an extension of the plurality of extensions extends from the frame at an angle of a longitudinal axis of the tip. In some embodiments, the angle ranges from about 0° to about 90° from the longitudinal axis of the tip. In some embodiments, the angle ranges fromAttorney Docket No. 57856-711.601about 15° to about 60° from the longitudinal axis of the tip. In some embodiments, the one or more arms allows for bending of the arm in the direction of a longitudinal axis of the tip (e.g., proximal-distal direction of the tip). In some embodiments, the one or more arms allows for bending of the arm in the direction away from a longitudinal axis of the tip. In some embodiments, the single arm allows for increased degrees of freedom in bending than two or more arms. In some embodiments, the tip base comprises one or more base openings. In some embodiments, the one or more openings are encompassed by one or more struts. In some embodiments, the tip base comprises at least two rings connected by the one or more struts. In some embodiments, the one or more struts are configured to provide a mechanical continuity between the tip and the catheter body. In some embodiments, the tip base comprises one or more circumferential slits. In some embodiments, the one or more circumferential slits provide a mechanical stress relief. In some embodiments, the one or more circumferential slits are proximal to one or more base openings. In some embodiments, the base opening is filled with a marker band. In some embodiments, the marker band is configured to snap into the base opening. In some embodiments, the marker band comprises a radiopaque marker. In some embodiments, the marker band comprises one or more cutouts. In some embodiments, the one or more cutouts is configured to be filled with a polymer. In some embodiments, the polymer comprises a polymer of an outer jacket lining an outer surface of the tip. In some embodiments, the polymer contacts a polymer of a liner lining a lumen of the tip. In some embodiments, the polymer of the outer jacket lining the outer surface of the tip comprises an elastomer. In some embodiments, the polymer of the outer jacket lining is fluid resistant. In some embodiments, the polymer of the outer jacket lining makes the tip fluid resistant. In some embodiments, the unitary piece comprises a metal. In some embodiments, the unitary piece comprises nitinol. In some embodiments, the catheter body comprises a tube having one or more cuts. In some embodiments, the catheter is formed by laser cutting. In some embodiments, the frame comprises a plurality of closed cells. In some embodiments, the frame comprises a plurality of connecting struts configured to form a cylindrical shape. In some embodiments, the frame comprises a helical frame. In some embodiments, a radiopaque marker comprises tungsten, platinum, iridium, or a combination thereof. In some embodiments, the catheter comprises a tip for a catheter of any one of preceding embodiments.
[0005] Provided herein are methods for preparing a catheter of any one of preceding embodiments, the method comprising: (a) applying to a proximal portion of a tube a plurality of cuts in an interrupted spiral pattern to form the catheter body of any one of preceding claims; (b) applying to a distal portion of the tube a plurality of cuts to form the tip of any one of precedingAttorney Docket No. 57856-711.601claims; (c) laminating a polymer sheet over an outer surface of the catheter body; and (d) laminating a second polymer sheet over an outer surface of the tip.
[0006] Provided herein are methods for advancing catheter of any one of preceding embodiments to a target site in an individual, the method comprising: (a) positioning the catheter of any one of preceding claims into a vessel in the individual remote from the target site; (b) advancing the catheter through a vasculature in the individual to the target site; (c) approaching an occlusion at the target site with a distal end of the tip of the catheter; (d) providing a pressure change sufficient to move the occlusion proximally into the tip; and (e) withdrawing the catheter from the vasculature. In some embodiments, the tip is configured to compress when in contact with the occlusion. In some embodiments, one or more extensions of the plurality of extensions is configured to bend when in contact with the occlusion. In some embodiments, one or more extensions of the plurality of extensions is configured to bend longitudinally when in contact with the occlusion.INCORPORATION BY REFERENCE
[0007] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the present disclosure are utilized, and the accompanying drawings (also “Figure” and “FIG.” herein), of which:
[0009] FIG. 1A shows an example of a flat pattern design of an aspiration catheter tip comprising extension frames, a frame opening attached to the tip with two arms, longitudinal extensions, and a thin elastomeric covering over the distal end of the tip, in accordance with some embodiments described herein.
[0010] FIG. IB shows an example of a three-dimensional aspiration catheter tip comprising extension frames, a frame opening attached to the tip with two arms, and longitudinal extensions, in accordance with some embodiments described herein.
[0011] FIG. 1C shows an example of a three-dimensional aspiration catheter tip comprising extension frame, a frame opening attached to the tip with two arms, longitudinal extensions that snap into recesses, and a radiopaque marker band, in accordance with some embodiments described herein.Attorney Docket No. 57856-711.601
[0012] FIG. 2A shows an example of a flat pattern design of an aspiration catheter tip comprising extension frames, a frame opening attached to the rest of the tip by a single arm, and a thin elastomeric covering over the distal end of the tip, in accordance with some embodiments described herein.
[0013] FIG. 2B shows an example of a three-dimensional aspiration catheter tip comprising extension frames, and a frame opening attached to the rest of the tip by a single arm, in accordance with some embodiments described herein.
[0014] FIGS. 3A-3B show an example of a three-dimensional aspiration catheter tip comprising two base openings, a pair of marker band halves that are placed and fastened into the base openings, and struts that are unitary to the construction of the tip and the proximal portion of the catheter, in an assembled configuration, in a side view and a cross-sectional view, in accordance with some embodiments described herein.
[0015] FIGS. 3C-3D show an example of a three-dimensional aspiration catheter tip comprising two base openings, a pair of marker band halves that are placed and fastened into the base openings, and struts that are unitary to the construction of the tip and the proximal portion of the catheter, in an expanded configuration, in accordance with some embodiments described herein.
[0016] FIGS. 4A-4B show an example of a three-dimensional aspiration catheter tip comprising marker band halves comprising a plurality of cutouts in an assembled configuration and an expanded configuration, in accordance with some embodiments described herein.
[0017] FIGS. 4C-4D show an example of a three-dimensional aspiration catheter tip comprising marker band halves comprising a plurality of cutouts in an expanded configuration, in accordance with some embodiments described herein.
[0018] FIGS. 5A-5B show an example of a three-dimensional aspiration catheter assembly comprising a catheter body comprising a tube having a lumen and a catheter tip, in accordance with some embodiments described herein.DETAILED DESCRIPTION
[0019] A blockage (e.g., embolus) in a blood vessel presents a significant health issue that may require a treatment to reduce or remove the blockage. When the blockage occurs in the brain, the individual may suffer from a stroke, where the poor blood flow to the brain may result in cell death. In some applications, such as but not limited to acute ischemic stroke, where an artery is occluded, the ability to quickly reach the target site and provide treatment (e.g., remove occlusion, restore blood flow) may be critical to the success of the treatment.
[0020] Catheters are often inserted into the blood vessel to provide a treatment. Depending on the anatomy and the treatment, a catheter having a tip having a tuned flexibility and / or stiffnessAttorney Docket No. 57856-711.601may be valuable to reduce or remove the blockage. In some cases, the tip of the catheter may engage with the blockage in order to remove the blockage. In some cases, the engagement of the catheter may be facilitated by a flexible tip that increase engagement with the embolus to aid in removal of the embolus and reduction of the blockage. The treatment may be performed with an application of aspiration through the catheter. In some cases, the catheter has a flexible tip having a plurality of engagement members that connected to a tip frame. In some cases, an engagement member is connected to the tip body by one or more arms. Such a catheter may allow for providing faster treatment by engaging with the blockage more effectively. In some cases, the treatment may lead to improved outcomes as measured by improved neurological and functional outcomes and / or reduced procedural complications (e.g., hemorrhage, perforation).
[0021] Disclosed herein are catheters having flexible tips for use in aspiration and methods of preparing such catheters. In some embodiments, the catheter comprises a catheter body comprising a tube having a lumen, and a tip. In some embodiments, the catheter body and the tip may be a unitary piece. In some embodiments, the tip comprises a tip base, a frame, and a plurality of engagement extensions extending distally from the frame. In some embodiments, the tip extends distally from the tube. In some embodiments, the tip base is the most proximal element of the tip. In some embodiments, the tip base comprises one or more base openings. In some embodiments, the tip base comprises at least two rings connected by the one or more struts. In some embodiments, the one or more struts are configured to provide a mechanical continuity between the tip and the catheter body. In some embodiments, the tip base comprises one or more circumferential slits. In this instance, the one or more circumferential slits provide a mechanical stress relief. In some embodiments, the base opening is filled with a marker band. In some embodiments, the marker band can be made of a radiopaque material to allow detection and visualization of the tip during use. In some embodiments, the marker band may have one or more cutouts in some instances. In some embodiments, the cutouts allow for the passage of the polymer of an outer jacket through the cutout and come into contact with a liner of the catheter. In some embodiments, the contact with the liner promotes adhesion of the liner to the rest of the catheter. In some embodiments, the polymer is an elastomer. In some embodiments, a thin elastomeric covering covers the distal end of the tip, making the tip fluid impermeable.
[0022] In some embodiments, the frame extends distally from the tip base. In some embodiments, an extension of a plurality of extensions extend distally from the frame. In some embodiments, an extension of the plurality of extensions is coupled to the frame by one or more arms of the extensions. In some embodiments, an extension of the plurality of extensions is coupled to the frame by a single arm. In some embodiments, the arms can bend with greater degree of freedom relative to embodiments that couple the extension using two arms. In someAttorney Docket No. 57856-711.601embodiments, the single arm may be configured to bend in the direction of the long axis of the catheter and in one or more directions not in the long axis of the catheter. In some embodiments, the one or more arms comprise more than one arm, the arm may be configured to bend with fewer degrees of freedom compared to embodiments comprising a single arm. In some embodiments, the arms may be configured to provide more resistance to bending in the direction of the long axis of the catheter compared to embodiments comprising a single arm.I. Overview
[0023] In order to reach and provide treatment in a difficult-to-reach target site of a body of an individual, catheters are commonly used to reach and treat the target site. Depending on the anatomy to the target site and the treatment, a catheter having a flexible distal tip tuned to provide a desired level of maneuverability when engaging with a blockage may be valuable. In these instances, the improved maneuverability can help to reduce vascular tissue damage during treatment. The individual may have improved outcomes as measured by improved neurological and functional outcomes and / or reduced procedural complications (e.g., hemorrhage, perforation).
[0024] Usually, the use of catheters for treatment for neurovascular applications involves navigating through tortuous paths of arteries in the brain. Occlusions requiring treatment may be located in throughout the neurovasculature of the brain. Sometimes, the occlusion is located in the internal carotid artery (ICA), the posterior cerebral artery (PCA), middle cerebral artery (MCA), anterior cerebral artery (ACA), intracranial vertebral artery (VA). Sometimes, the occlusion is located in the Ml, M2, M3, or M4 segment of the MCA. Occlusions in the neurovasculature may range in size, shape, composition, and location. For example, clots may have a composition that is red blood cell (RBC) dominant, fibrin dominant, or somewhere in between. Since clot morphologies may vary, it may be beneficial to use a catheter with a flexible tip capable of engaging unique clot morphologies. Usually, the occlusion may be wholly ingested by the catheter; otherwise, pieces of the occlusion / thrombus may break off and travel to other areas of an individual’s neurovasculature, which may lead to future complications. In such instances, a flexible catheter tip may accommodate for unique or irregular clot shapes compared to a rigid structure tip. So, a flexible catheter tip may increase the likelihood of occlusion ingestion. In combination, axial compression of the tip may increase occlusion engagement, which can further aid in ingestion of the occlusion. Sometimes, occlusions are located in tight curves, complicating the already tortuous path the catheter must travel to remove the occlusion. In these instances, increased clot engagement is critical, especially off axis to the clot. The ability to adapt the tip to engage the occlusion off axis may be beneficial in removing occlusions located in tight curves.Attorney Docket No. 57856-711.601
[0025] Often when navigating the tortuous vasculature of the brain, visibility of the advancement of the catheters helps to provide the healthcare provider critical feedback. Real-time or synchronous feedback may allow for healthcare provider to increase the speed of catheter advancement, which may lead to faster occlusion removal. The individual may have improved outcomes as measured by improved neurological and functional outcomes and / or reduced procedural complications (e.g., hemorrhage, perforation).
[0026] Delivery tools may be used in advancing the catheter through the vasculature of an individual. Usually, the delivery tool is placed in the catheter. In some embodiments, a guidewire is also used. In some instances, the delivery tool is advanced through the vasculature before the catheter; as the catheter advances through vasculature, it tracks over the delivery tool. While navigating through tortuous vasculature, an advancing catheter may encounter a bend in the vessel and / or a branching vessel. Tortuous vasculature with many bends and branches is common in neurovasculature and the ophthalmic region. Sometimes, as the catheter is advancing through the vasculature, it may get caught on the bend or branch. In this instance, the catheter may cause damage to the branching vessel and / or surrounding tissue, as well as potentially increasing procedure time. An assembly with a minimal difference between the inner diameter of the catheter and outer diameter of the delivery tool may decrease the chance of the catheter getting caught on tortuous vasculature, potentially leading to improved outcomes and / or reduced procedural complications. Sometimes, a straight (i.e., non-tapered) catheter distal end may get caught on a bend in the vessel and / or a branching vessel while travelling through tortuous vasculature. In this instance, a catheter with a lower profile and / or tapered distal end may decrease the likelihood of getting caught on bends or branches in the vasculature, which can lead to a faster procedure time, improved outcomes, and / or reduced procedural complications.
[0027] The aspiration system provided herein may be used in a peripheral location within the body to evacuate clot and other unwanted material in body lumens. In some embodiments, the systems described herein may be used in both arterial and venous systems. In some embodiments, the systems described herein may be used in an arterial system. In some embodiments, the systems described herein may be used in a venous system. These peripheral locations may include, but are not limited to, extremities, such a as a location in an arm or a leg of the subject. In some embodiments, the aspiration system provided herein is for an intervention. In some embodiments, the intervention comprises a removal of a clot from an artery. In some embodiments, the clot is in an artery in a lower leg. The intervention may be performed in a subject in an older patient or in a patient having diabetes, who may have a clot in an artery. In some embodiments, the intervention comprises a removal of a clot from a vein. The system provided herein may be used to perform an intervention in a subject having deep veinAttorney Docket No. 57856-711.601thrombosis, where the aspiration system may be used to remove a clot from a vessel in the venous system. For applications in the arms and legs, the catheter may be appropriately sized for the vessel in which it is being used. In some embodiments, the catheter may have an outer diameter of about 5 French to about 8 French. The system provided herein may be used to perform an intervention in a subject having pulmonary embolism, where a clot or an unwanted material may be occluding a portion of a pulmonary vessel in the lungs. For this application, the catheter outside diameter should be significantly larger due to the large vessel diameters. In some embodiments, the catheter may have an outer diameter of about 16 French to about 24 French.
[0028] Provided herein are devices, systems, and methods comprising a catheter for use in aspiration procedures. The catheter comprises a catheter body comprising a tube having a lumen; and a tip extending distally from the tube, the tip comprising a tip base, a frame extending distally from the base, and a plurality of extensions extending distally from the frame. In some embodiments, the catheter body and the tip are a unitary piece.II. Tip
[0029] The devices, systems, and methods provided herein comprise a catheter for use in aspiration procedures. In some embodiments, the device comprises a catheter body comprising a tube having a lumen; and a tip extending distally from the tube, the tip comprising a tip base, a frame extending distally from the base, and a plurality of extensions extending distally from the frame. In some embodiments, the catheter body and the tip are a unitary piece. In some embodiments, the catheter body and the tip are made of the same material. In some embodiments, the unitary piece comprises the catheter body and the tip connected as a single piece. In some embodiments, the unitary piece comprises the catheter body and the tip connected as a single piece without any seams. In some embodiments, the unitary piece is manufactured from one piece of material. In some embodiments, the one piece of material has been cut. In some embodiments, the one piece of material comprises a metal. In some embodiments, the unitary piece is configured to have fewer connection points compared to a catheter body and tip comprising a non-unitary piece. In some embodiments, the unitary piece is configured to have fewer bonding parts compared to a catheter body and tip comprising a non-unitary piece. In some embodiments, the unitary piece is configured to have fewer mechanical weak points. In some embodiments, the unitary piece is configured to have fewer mechanical failure points. In some embodiments, when manufacturing the catheter, the unitary piece may offer ease of manufacturing relative to a catheter and tip comprising a non-unitary piece. In some embodiments, when manufacturing the catheter, the unitary piece may offer a more efficient manufacturing process relative to manufacturing a catheter and tip comprising a non-unitary piece. In some embodiments, when manufacturing the catheter, the unitary piece may offer aAttorney Docket No. 57856-711.601lower cost of manufacturing relative to manufacturing a catheter and tip comprising a non-unitary piece. In some embodiments, when manufacturing the catheter, the unitary piece may offer a more cost-efficient manufacturing process relative to manufacturing a catheter and tip comprising a non-unitary piece. In some embodiments, when manufacturing the catheter, the unitary piece may offer a faster manufacturing process relative to manufacturing a catheter and tip comprising a non-unitary piece.Base
[0030] Described herein are catheter tips having a tip base. In some embodiments, the base is proximal to the tip frame. In some embodiments, the frame is secured to the base. In some embodiments, the frame is secured to a distal end of the base. In some embodiments, the base is secured to the catheter body. In some embodiments, a proximal end of the base is secured to the catheter body. In some embodiments, the base and the catheter body are a unitary piece. In some embodiments, the base and the catheter body are formed of a unitary piece of material.
[0031] In some embodiments, the base comprises one or more rings. In some embodiments, at least one ring of the one or more rings is coupled to the frame. In some embodiments, the one or more rings comprises at least two rings. In some embodiments, at least one ring of the at two least rings is coupled to the frame. In some embodiments, at least one ring of the at least rings is coupled to the catheter body. In some embodiments, the one or more rings and the catheter body are a unitary piece. In some embodiments, the one or more rings and the catheter body are formed of a unitary piece of material. In some embodiments, the at least two rings are connected by the one or more struts. In some embodiments, the one or more struts are configured to provide a mechanical continuity between the tip and the catheter body. In some embodiments, the tip base comprises one or more base openings. In some embodiments, the base comprises one or more struts. In some embodiments, the one or more base openings are encompassed by the one or more struts. In some embodiments, the tip base comprises one or more circumferential slits. In some embodiments, the one or more circumferential slits provide a mechanical stress relief. In some embodiments, the one or more circumferential slits are proximal to the one or more base openings. In some embodiments, the base opening is filled with a marker band. In some embodiments, the marker band is configured to snap into the base opening. In some embodiments, the marker band comprises a radiopaque marker. In some embodiments, the radiopaque material of the extension frame opening comprises tungsten, platinum, iridium, or a combination thereof. In some embodiments, the marker band comprises one or more cutouts. In some embodiments, the one or more cutouts is configured to be filled with a polymer. In some embodiments, the polymer comprises a polymer of an outer jacket lining an outer surface of the tip. In some embodiments, the polymer contacts a polymer of a liner lining a lumen of the tip. InAttorney Docket No. 57856-711.601some embodiments, the polymer of the outer jacket lining the outer surface of the tip comprises an elastomer. In some embodiments, the polymer of the outer jacket lining is fluid resistant. In some embodiments, the polymer of the outer jacket lining makes the tip fluid resistant. In some embodiments, the polymer is an elastomer.
[0032] FIGS. 1A-1C illustrates a catheter tip 100 comprising a tip base 105 and a tip frame 110.In some embodiments, the tip 100 further comprises longitudinal extensions 130 extending proximally from the base 105. In some embodiments, the base 105 comprises a marker band 310.In some embodiments, the marker band 310 comprises one or more recesses 145. In some embodiments, the one or more recesses 145 is configured to allow one or more longitudinal extensions 130. In some embodiments, the one or more recesses comprise a complementary geometry configured to allow a mating element to snap together.Rings
[0033] The tip 300 base described herein comprises one or more rings 320, as illustrated in FIGS. 3A-3D. In some embodiments, at least one ring of the one or more rings 320 is coupled to the frame. In some embodiments, at least one ring of the one or more rings 320 is coupled to the catheter body. In some embodiments, the one or more rings 320 comprises at least two rings. In some embodiments, at least one ring of the at two least rings is coupled to the frame. In some embodiments, at least one ring of the at least two rings is coupled to the catheter body. In some embodiments, at least one of the one or more rings 320 and the catheter body are a unitary piece. In some embodiments, at least one of the one or more rings 320 and the catheter body are formed of a unitary piece of material. In some embodiments, the at least two rings are connected by the one or more struts. In some embodiments, the one or more rings 320 and the catheter body are a unitary piece. In some embodiments, the one or more rings 320 and the catheter body are formed of a unitary piece of material. In some embodiments, the at least two rings are connected by the one or more struts. In some embodiments, the rings 320 may extend completely 360° around the circumference of the tip. In some embodiments, the rings 320 may be a unitary piece. In some embodiments, the rings 320 may be segmented. In some embodiments, the rings 320 may be an assembly of arcuate segments. In some embodiments, the rings 320 may have the same thickness as a connecting strut of the plurality of connecting struts configured to form the frame.
[0034] In some embodiments, the at least two rings comprise a distal ring. In some embodiments, the distal ring is distal to one or more base openings. In some embodiments, the distal ring is secured to the tip frame. In some embodiments, the distal ring is secured to a proximal end of the tip frame. In some embodiments, the distal ring and the tip frame are a unitary piece. In some embodiments, the distal ring and the tip frame are formed of a unitary piece of material. In some embodiments, the at least two rings comprise a proximal ring. In some embodiments, theAttorney Docket No. 57856-711.601proximal ring is proximal to one or more base openings. In some embodiments, the proximal ring is secured to the catheter body. In some embodiments, the proximal ring is secured to a distal end of the catheter body. In some embodiments, the proximal ring and the catheter body are a unitary piece. In some embodiments, the proximal ring and the catheter body are formed of a unitary piece of material. In some embodiments, the proximal ring comprises one or more circumferential slits. In some embodiments, the one or more circumferential slits are proximal to the one or more base openings. In some embodiments, the one or more circumferential slits may be configured to provide a mechanical stress relief. In some embodiments, the one of more circumferential slits may be symmetric about a longitudinal axis 330 of the catheter, as illustrated in FIG. 3A. In some embodiments, the one or more circumferential slits may be asymmetric about a longitudinal axis of the catheter. In some embodiments, the one or more circumferential slits may have an approximate length as the length of a base opening. In some embodiments, cutting the pattern into the tube comprises one or more non-mechanical cutting methods. In some embodiments, the notches, holes or cuts may be formed in the tube using a laser (solid-state, femtosecond laser, or YAG laser, for example), electrical discharge (electrical discharge machining (EDM)), plasma blade, pressurized fluid jet (waterjet), a lathe, a saw, a blade, chemical etching, photo-etching, or a combination thereof. In some embodiments, methods of cutting a pattern into a tube may comprise laser cutting, plasma cutting, hydrocutting, thermal cutting, mechanical cutting, or a combination thereof.
[0035] In some embodiments, the proximal ring comprises at least two circumferential slits. In some embodiments, the one or more circumferential slits may have equal lengths. In some embodiments, at least one of the at least two circumferential slits may be longer than the remaining circumferential slits. In some embodiments, each circumferential slit of the at least two circumferential slits are of a different length. In some embodiments, each circumferential slit of the at least two circumferential slits are equidistant apart from each circumferential slit. In some embodiments, the one or more circumferential slits comprise a soft edge shape. In some embodiments, the one or more circumferential slits may comprise a fillet shape.Struts
[0036] The base described herein comprises one or more rings connected by one or more struts. In some embodiments, the one or more struts comprise a distal end. In some embodiments, the distal end of the one or more struts is coupled to a distal ring. In some embodiments, the one or more struts comprise a proximal end. In some embodiments, the proximal end of the one or more struts is coupled to a proximal ring. In some embodiments, at least one of the one or more struts and the one or more rings are a unitary piece. In some embodiments, at least one of the one or more struts and the one or more rings are a formed of a unitary material. In some embodiments,Attorney Docket No. 57856-711.601the one or more struts and the one or more rings are a unitary piece. In some embodiments, the one or more struts and the one or more rings are a formed of a unitary material. In some embodiments, at least one of the one or more struts are bonded to the one or more rings. In some embodiments, at least one of the one or more struts are welded to the one or more rings. In some embodiments, the one or more struts are welded to the one or more rings. In some embodiments, at least one of the one or more struts are adhesively bonded to the one or more rings. In some embodiments, the one or more struts are adhesively bonded to the one or more rings. In some embodiments, at least one of the one or more struts are thermally bonded to the one or more rings. In some embodiments, the one or more struts are thermally bonded to the one or more rings. In some embodiments, the one or more struts comprises a rectilinear shape. In some embodiments, the one or more struts comprises a rectangular shape. In some embodiments, the one or more struts comprises a rectilinear with rounded edges shape. In some embodiments, the one or more struts are T-shaped. In some embodiments, the one or more struts have a greater width at a distal end of the strut. In some embodiments, each strut of the one or more struts comprises the same shape. In some embodiments, each strut of the one or more struts comprises a different shape. In some embodiments, at least two of the one or more struts comprise the same shape. In some embodiments, the one or more struts have the same thickness as the one or more rings. In some embodiments, where there are at least two rings, and at least one ring is of different thickness than another ring, the one or more struts may have the same thickness as the at least one ring of a lesser thickness. In some embodiments, where there are at least two rings, and at least one ring is of different thickness than another ring, the one or more struts may have the same thickness as the at least one ring of a greater thickness. In some embodiments, where there are at least two rings, and at least one ring is of different thickness than another ring, the one or more struts may have a thickness less than the at least one ring of greater thickness, but greater than the thickness of the at least one right of lesser thickness.
[0037] In some embodiments, the one or more struts, also referred herein as base struts, comprises at least two struts. In some embodiments, the one or more struts comprises at least three struts. In some embodiments, the one or more struts comprises at least four struts. In some embodiments, the one or more struts comprises at least five struts. In some embodiments, the one or more struts are equidistant apart.
[0038] FIGS 3A-3D illustrates an example of a tip 300 base comprising at least two rings 320 connected by one or more struts 315. In some embodiments, the one or more struts 315 provide a mechanical continuity between the tip and the proximal portion of the catheter. In some embodiments, the struts 315 encompass the one or more base openings 305. In some embodiments, the proximal portion of the catheter ends immediately behind the one or more baseAttorney Docket No. 57856-711.601openings 305. In some embodiments, where the proximal portion of the catheter ends immediately behind the one or more base openings 305, the one or more struts 315 are configured to carry a tensile load. In some embodiments, when the one or more struts 315 carry the tensile load, the tensile load does not need to be carried by a weld, adhesive, or thermal bond. In some embodiments, the tensile load is applied to the tip 300. In some embodiments, the struts 315 are unitary to the construction of the tip 300 and the proximal portion of the catheter. In some embodiments, the struts are formed from a unitary piece of material as the construction of the tip 300 and the proximal portion of the catheter. In some embodiments, the unitary piece comprises a metal. In some embodiments, the metal comprises stainless steel, or nitinol, or a combination thereof. In some embodiments, the metal comprises nitinol.Base Openings
[0039] The base described herein comprises one or more base openings encompassed by the one or more struts. In some embodiments, the one or more base openings are distal to the one or more circumferential slits. In some embodiments, the one or more base openings are encompassed by the one or more struts. In some embodiments, the one or more base openings are of equal size. In some embodiments, the proximal portion of the catheter ends immediately behind the one or more base openings. In some embodiments, the proximal portion of the catheter extends proximally to the one or more base openings. In some embodiments, the proximal portion of the catheter extends distally to the one or more base openings. In some embodiments, at least one of the one or more base openings are filled with a marker band. In some embodiments, at least one of the one or more base openings are at least partially filled with a marker band. FIGS. 3A-3D illustrate a tip 300 comprising one or more base openings 305 encompassed by one or more struts 315Marker Band
[0040] The base described herein comprises one or more marker bands filling with the one or more base openings. In some embodiments, the one or more base openings are filled with one or more marker bands. In some embodiments, at least one of the one or more base openings are at least partially filled with a marker band. In some embodiments, the marker band 310 is configured to snap into the base opening 305, as illustrated in FIGS 3A-3D. In some embodiments, the marker band is configured to provide visualization of the tip during use of the catheter. In some embodiments, the marker band is configured to provide visualization of the tip when viewed under fluoroscopic guidance during use of the catheter. In some embodiments, the marker band comprises a radiopaque marker. In some embodiments, the radiopaque material of the extension frame opening comprises tungsten, platinum, iridium, or a combination thereof. In some embodiments, the radiopaque marker is configured to be visible during imaging. In someAttorney Docket No. 57856-711.601embodiments, the radiopaque marker is configured to be visible during x-ray imaging. In some embodiments, the radiopaque marker is configured to be visible under fluoroscopy. In some embodiments, the radiopaque marker is configured to be visible during real-time imaging. In some embodiments, the radiopaque marker is configured to provide real-time feedback. In some embodiments, the radiopaque marker is configured to provide confirmation of a location of the catheter tip. In some embodiments, the radiopaque marker is configured to provide confirmation of engagement of an occlusion. In some embodiments, the radiopaque marker is configured to provide continuous confirmation of engagement of an occlusion.
[0041] In some embodiments, the marker band comprises a circular marker. In some embodiments, the marker band comprises a semi-circular marker. In some embodiments, the marker band comprises a non-circular marker. In some embodiments, the one or more marker bands comprises at least two marker bands. In some embodiments, the at least two marker bands comprise equal dimensions.
[0042] FIGS. 1A-1C illustrates a tip 100 comprising a tip base 105 and a tip frame 110, further comprising longitudinal extensions 130 extending proximally from the base 105. In some embodiments, the marker band 310 comprises one or more recesses 145. In some embodiments, the one or more recesses 145 is configured to allow one or more longitudinal extensions 130. In some embodiments, the one or more recesses comprise a complementary geometry configured to allow a mating element to snap together. In some embodiments, the tip 100 comprises a plurality of extensions 150. In some embodiments, an extension of the plurality of extensions 150 extends distally from the frame 110. In some embodiments, an extension the plurality of extensions 150 is coupled to the frame 110 by one or more arms 155 of the extension. In some embodiments, an extension the plurality of extensions 150 comprises an extension frame 115. In some embodiments, the extension frame 115 extends distally from the one or more arms 155. In some embodiments, the extension frame 115 comprises an extension frame opening 120. In some embodiments, the tip 100 comprises a covering 160 that covers the outer surface of the distal end of the tip 100. In some embodiments, the covering 160 comprises a polymer. In some embodiments, the polymer of the covering 160 comprises an elastomer. In some embodiments, the polymer of the covering 160 is fluid resistant. In some embodiments, the polymer of the covering 160 makes the tip fluid resistant.
[0043] In some embodiments, the tip 400 comprises a marker band 310 comprising one or more cutouts 450, as illustrated in FIGS. 4A-4D. In some embodiments, the one or more cutouts 450 comprise a plurality of cuts. In some embodiments, the one or more cutouts 450 comprise a plurality of slots. In some embodiments, a plurality of cutouts have equal dimensions. In some embodiments, a plurality of cutouts is equidistant from one or more cutouts 450. In someAttorney Docket No. 57856-711.601embodiments, at least one of the one or more cutouts 450 are parallel to the at least two rings of the tip base. In some embodiments, the one or more cutouts 450 comprise one or more major cutouts 460. In some embodiments, at least one of the cutouts is larger than at least one of the plurality of cutouts. In some embodiments, the one or more major cutouts 460 are larger than a plurality of cutouts. In some embodiments, each marker band comprises at least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 cutouts. In some embodiments, each marker band comprises 3, 4, 5, 6, 7, 8, or 9 cutouts. In some embodiments, each marker band comprises at least one major cutout in addition to 3, 4, 5, 6, 7, 8, or 9 cutouts. In some embodiments, each marker band comprises at least one major cutout in addition to 3, 4, 5, 6, 7, 8, or 9 cutouts of equal size. In some embodiments, at least one of the one or more cutouts 450 is configured to be filled with a polymer. In some embodiments, at least one of the one or more cutouts 450 are configured to allow for the passage of a polymer through the one or more cutouts. In some embodiments, the polymer comprises a polymer of an outer jacket. In some embodiments, the outer jacket polymer lines an outer surface of the tip. In some embodiments, at least one of the one or more cutouts are configured to allow for the passage of the polymer through the at least one of the one or more cutouts such that the polymer may contact a liner. In some embodiments, at least one of the one or more cutouts 450 are configured to allow for the passage of the polymer through the at least one of the one or more cutouts such that the polymer may contact a liner to promote adhesion of the liner to the catheter. In some embodiments, the liner lines the lumen of the tip. In some embodiments, the liner comprises a liner polymer. In some embodiments, at least one of the one or more cutouts 450 are configured to allow for the passage of the polymer through the at least one of the one or more cutouts 450 such that the polymer may contact the liner polymer. In some embodiments, at least one of the one or more cutouts 450 are configured to allow for the passage of the polymer through the at least one of the one or more cutouts 450 such that the polymer may contact the liner polymer to promote adhesion of the liner to the catheter. In some embodiments, the polymer comprises the same composition as the liner polymer.
[0044] In some embodiments, the polymer of the outer jacket lining the outer surface of the tip comprises an elastomer. In some embodiments, the polymer of the outer jacket lining is fluid resistant. In some embodiments, the polymer of the outer jacket lining makes the tip fluid resistant. In some embodiments, the polymer comprises one or more of polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene, polyether block ester, polyurethane, polypropylene, polyvinylchloride, polyether-ester, ether or ester based copolymers, phthalate and / or other polyester elastomers, polyamide, elastomeric polyamides, block polyamide / ethers, polyether block amide, ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene,Attorney Docket No. 57856-711.601Marlex low-density polyethylene, linear low density polyethylene, polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR), poly sulfone, nylon, nylon- 12, perfluoro(propyl vinyl ether) (PF A), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene), polycarbonates, ionomers, biocompatible polymers. In some embodiments, the one or more layers of the liner comprises mixtures, combinations, copolymers, polymer / metal composites of any of the aforementioned materials. In some embodiments, the liner comprises a liquid crystal polymer (LCP).Circumferential Slits
[0045] The base described herein may comprise one or more circumferential slits. In some embodiments, the one or more circumferential slits 210 are proximal to the one or more base openings, as illustrated by FIGS. 2A-2B. In some embodiments, the proximal ring comprises at least one of the one or more circumferential slits 210. In some embodiments, the proximal ring comprises the one or more circumferential slits 210. In some embodiments, the one or more circumferential slits 210 may be configured to provide a mechanical stress relief. In some embodiments, the one of more circumferential slits 210 may be symmetric about a longitudinal axis of the catheter. In some embodiments, the one or more circumferential slits 210 may be asymmetric about a longitudinal axis of the catheter. In some embodiments, the one or more circumferential slits 210 may have an approximate length as the length of a base opening. In some embodiments, cutting the pattern into the tube comprises one or more non-mechanical cutting methods. In some embodiments, the notches, holes or cuts may be formed in the tube using a laser (solid-state, femtosecond laser, or YAG laser, for example), electrical discharge (electrical discharge machining (EDM)), plasma blade, pressurized fluid jet (wateijet), a lathe, a saw, a blade, chemical etching, photo-etching, or a combination thereof. In some embodiments, methods of cutting a pattern into a tube may comprise laser cutting, plasma cutting, hydrocutting, thermal cutting, mechanical cutting, or a combination thereof.
[0046] In some embodiments, the proximal ring comprises at least two circumferential slits. In some embodiments, the one or more circumferential slits may have equal lengths. In some embodiments, at least one of the at least two circumferential slits may be longer than the remaining circumferential slits. In some embodiments, each circumferential slit of the at least two circumferential slits are of a different length. In some embodiments, each circumferential slit of the at least two circumferential slits are equidistant apart from each circumferential slit. InAttorney Docket No. 57856-711.601some embodiments, the one or more circumferential slits comprise a soft edge shape. In some embodiments, the one or more circumferential slits may comprise a fillet shape.Frame
[0047] The catheter tip described herein comprises a frame extending distally from the tip base. In some embodiments, an extension of a plurality of extensions are coupled to the frame. In some embodiments, an extension of the plurality of the extensions are coupled to the frame by one or more arms of the extensions. FIGS. 1A-1C illustrates a tip 100 comprising a tip base 105 and a tip frame 110. In some embodiments, the tip 100 comprises a plurality of extensions 150. In some embodiments, an extension of the plurality of extensions 150 extends distally from the frame 110. In some embodiments, an extension of the plurality of extensions 150 is coupled to the frame 110 by one or more arms 155 of the extension. In some embodiments, an extension of the plurality of extensions 150 comprises an extension frame 115. In some embodiments, the extension frame 115 extends distally from the one or more arms 155. In some embodiments, the extension frame 115 comprises an extension frame opening 120.
[0048] In some embodiments, the tip frame comprises a helical configuration. In some embodiments, the helical configuration comprises one or more helical frame elements. In some embodiments, at least one of the one or more helical frame elements is made of a metal. In some embodiments, the tip frame comprises a mesh configuration. In some embodiments, the mesh configuration comprises a mesh network. In some embodiments, the mesh network comprises an unstructured mesh. In some embodiments, the mesh network comprises a structured mesh. In some embodiments, the mesh network comprises a hybrid mesh. In some embodiments, the hybrid mesh comprises at least one structured mesh portion and at least one unstructured mesh portion. In some embodiments, the mesh configuration comprises a mesh made of metal. In some embodiments, the tip frame comprises some combination of a helical configuration and a mesh configuration.
[0049] In some embodiments, the tip frame comprises a plurality of connecting struts. In some embodiments, the plurality of connecting struts are configured to form a cylindrical shape. In some embodiments, a connecting strut of the plurality of connecting struts are configured to connect to an adjacent connecting strut. In some embodiments, a connecting strut of the plurality of connecting struts are configured to connect to an adjacent connecting strut at a node. In some embodiments, the tip frame comprises a plurality of closed cells. In some embodiments, a closed cell of the plurality of closed cells is encompassed by at least one connecting strut and at least one node. In some embodiments, a closed cell of the plurality of closed cells comprises a cell frame. In some embodiments, a closed cell of the plurality of closed cells comprises a cell opening.Attorney Docket No. 57856-711.601
[0050] In some embodiments, the tip frame 300 comprises a plurality of connecting struts 340, as illustrated in FIGS. 3A-3D. In some embodiments, the plurality of connecting struts 340 are configured to form a cylindrical shape. In some embodiments, a connecting strut of the plurality of connecting struts 340 is configured to connect to an adjacent connecting strut at a node 345. In some embodiments, the tip frame 300 comprises a plurality of nodes 345. In some embodiments, the tip frame 300 comprises a plurality of closed cells 350. In some embodiments, a closed cell of the plurality of closed cells 350 is encompassed by at least one connecting strut 340 and at least one node 345. In some embodiments, a closed cell of the plurality of closed cells 350 comprises a cell frame 352. In some embodiments, a closed cell of the plurality of closed cells comprises a cell opening 354. In some embodiments, a closed cell of the plurality of closed cells 350 is configured to flex to reduce likelihood of breaking an occlusion. In some embodiments, a closed cell of the plurality of closed cells 350 is configured to compress. In some embodiments, a closed cell of the plurality of closed cells 350 is configured to axially compress. In some embodiments, a closed cell of the plurality of closed cells 350 is configured to axially compress an occlusion. In some embodiments, axial compression of the closed cells 350 is configured to increase engagement with an occlusion. In some embodiments, a closed cell of the plurality of closed cells 350 is configured to change shape. In some embodiments, a closed cell of the plurality of closed cells 350 comprises a material configured to allow a closed cell of the plurality of closed cells 350 to change shape. In some embodiments, the frame 300 comprises a helical frame.
[0051] In some embodiments, a closed cell of the plurality of closed cells comprises one or more cell openings. In some embodiments, a cell opening of has a circular shape. In some embodiments, a cell opening has an oval shape. In some embodiments, a cell opening hashave a triangular, rectilinear, rectangular, square, rhomboid, or other polygonal shape. In some embodiments, a cell opening has a parallelogram configuration. In some embodiments, the parallelogram configuration comprises a plurality of parallelogram structures. In some embodiments, a cell opening in the axial direction form the length of the frame. In some embodiments, the plurality of cell openings in the axial direction form the length of the frame comprises at least 1, P / 2, 2, 2k2, 3, 3> / 2, 4, 4> / 2, 5, 5> / 2, 6, 6> / 2, 7, 7> / 2, 8, 8> / 2, 9, 9> / 2, or 10 cell openings. In some embodiments, the plurality of cell openings in the axial direction form the length of the frame comprises about 1, l’ / 2about, about 2, about 2’ / 2, about 3, about 3’ / 2, about 4, about 4’ / 2, or about 5 cell openings. In some embodiments, the plurality of cell openings in the axial direction form the length of the frame comprises about 1, about l’ / 2, about 2, about 2’ / 2, or about 3 cell openings. In some embodiments, the plurality of cell openings in the axial direction form the length of the frame comprises l’ / 2cell openings. In some embodiments, the plurality of cell openings in the axial direction form the length of the frame comprises 2’ cell openings. InAttorney Docket No. 57856-711.601some embodiments, the plurality of cell openings form the circumference of the frame. In some embodiments, the plurality of cell openings in the circumferential direction comprises at least 1, V / 2, 2, 2 / 2, 3, 3k2, 4, 4> / 2, 5, 5y2, 6, 6y2, 7, 7 / 2, 8, 8y2, 9, 9k2, or 10 cell openings. In some embodiments, the plurality of cell openings in the circumferential direction comprises at about 3, 3’ / 2, 4, 41 / 2, 5, 5’ / 2, 6, 6’ / 2, or 7 cell openings. In some embodiments, the plurality of cell openings in the circumferential direction comprises at about 5 cell openings.Arms
[0052] As illustrated in FIGS. 2A-2B, the catheter tip 200 described herein comprises one or more arms 205 that couple one or more extensions to the frame. In some embodiments, an extension of the plurality of extensions comprises an extension frame 115. In some embodiments, an extension of the plurality of extensions comprises an extension frame opening 120. In some embodiments, an extension of the plurality of extensions is coupled to the frame by one or more arms 205 of the extension. In some embodiments, at least one extension of the plurality of extensions differs from the remaining plurality of extensions. In some embodiments, at least one arm of the one or more arms 205 differs from the remaining arms. In some embodiments, the one or more arms 205 of the extension is a single arm.
[0053] In some embodiments, in a flat projection of the tip 200, an arm of the one or more arms 205 are coupled to the frame at an angle 255 relative to the plane 250 made by the circumference formed from the distal end of the distal tip. In some embodiments, the angle is at least 0°, 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, 120°, 125°, 130°, 135°, 140°, 145°, 150°, 155°, 160°, 165°, 170°, 175°, or 180°. In some embodiments, the angle is at most 0°, 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, 120°, 125°, 130°, 135°, 140°, 145°, 150°, 155°, 160°, 165°, 170°, 175°, or 180°. In some embodiments, the angle is about 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, 120°, 125°, 130°, 135°, 140°, 145°, or 150°. In some embodiments, the angle ranges between about 30° to about 150°, about 35° to about, 40° to about 145°, 45° to about 140°, 50° to about 135°, 55° to about 130°, 60° to about 125°, 65° to about 120°, 70° to about 115°, 75° to about 110°, 80° to about 105°, 85° to about 100°, 90° to about 95°, or 95° to about 100°.
[0054] In some embodiments, in a flat projection of the tip, the one or more arms are coupled to an extension of the plurality of extensions at an angle relative to the tip base. In some embodiments, the angle is at least 0°, 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, 120°, 125°, 130°, 135°, 140°, 145°, 150°, 155°, 160°, 165°, 170°, 175°, or 180°. In some embodiments, the angle is at most 0°, 5°, 10°,Attorney Docket No. 57856-711.60115°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, 120°, 125°, 130°, 135°, 140°, 145°, 150°, 155°, 160°, 165°, 170°, 175°, or 180°.Extensions
[0055] The catheter tip described herein comprises a plurality of extensions coupled to the frame by one or more arms. In some embodiments, an extension of the plurality of extensions extends distally from the frame. In some embodiments, an extension of the plurality of extensions comprises an extension frame. In some embodiments, the extension frame extends distally from an arm of the one or more arms. In some embodiments, an arm of the one or more arms is a single arm. In some embodiments, an arm of the one of more arms are configured to allow for bending of the arm. In some embodiments, bending of the single arm may be in the direction away from a longitudinal axis of the tip. In some embodiments, the longitudinal axis of the tip may be in the proximal-distal direction of the tip. In some embodiments, where the one or more arms is a single arm, a single arm may allow for an increased degrees of freedom in bending compared to two or more arms. In some embodiments, the increased degrees of freedom in bending is an increase in independent ways the single arm can bend or rotate. In some embodiments, a single arm comprises a material having favorable properties in how the material bends. In some embodiments, a single arm is configured to bend in the direction of a long axis of the catheter. In some embodiments, a single arm is configured to bend in directions not in the long axis of the catheter. In some embodiments, a single arm may be configured to bend in the direction of the long axis of the catheter and in directions not in the long axis of the catheter. In some embodiments, at least one single arm couples at least one extension to the tip frame. FIGS.2A-2B illustrate a catheter tip 200 comprising one or more arms 205 that comprises a single arm that couple the one or more extensions to the tip frame.
[0056] In some embodiments, the extension frame comprises an extension frame opening. In some embodiments, the extension frame opening is filled with a radiopaque material. In some embodiments, the radiopaque material of the extension frame opening comprises tungsten, platinum, iridium, or a combination thereof. In some embodiments, the radiopaque material is configured to be visible during imaging. In some embodiments, the radiopaque material is configured to be visible during x-ray imaging. In some embodiments, the radiopaque material is configured to be visible under fluoroscopy. In some embodiments, the radiopaque material is configured to be visible during real-time imaging. In some embodiments, the radiopaque material is configured to provide real-time feedback. In some embodiments, the radiopaque material is configured to provide confirmation of a location of the catheter tip. In some embodiments, the radiopaque material is configured to provide confirmation of engagement of an occlusion. InAttorney Docket No. 57856-711.601some embodiments, the radiopaque material is configured to provide continuous confirmation of engagement of an occlusion.
[0057] In some embodiments, the extension frame may comprise a rectilinear shape. In some embodiments, the rectilinear shape comprises one or more vertices. In some embodiments, the one or more vertices of the rectilinear shape may be rounded. In some embodiments, the extension frame comprises a symmetrical shape about the longitudinal axis. In some embodiments, the rectilinear shape comprises a rectangle with at least one semicircle-shaped end. In some embodiments, the rectilinear shape comprises a rectangle with two semicircles at opposite ends, herein referred to as a stadium shape. In some embodiments, the extension frame comprises an oval shape. In some embodiments, the shape of the extension frame may be circular. In some embodiments, the shape of the extension frame may be oblong. In some embodiments, the shape of the extension frame may be elliptical. In some embodiments, the shape of the extension frame may be s-shaped.
[0058] FIGS. 1A-1C illustrate a tip 100 comprising a tip base 105 and a tip frame 110. In some embodiments, the tip 100 comprises a plurality of extensions 150. In some embodiments, an extension of the plurality of extensions 150 extends distally from the frame 110. In some embodiments, an extension of the plurality of extensions 150 is coupled to the frame 110 by one or more arms 155 of the extension. In some embodiments, an extension of the plurality of extensions 150 comprises an extension frame 115. In some embodiments, the extension frame 115 extends distally from the one or more arms 155. In some embodiments, the extension frame 115 comprises an extension frame opening 120.
[0059] In some embodiments, the one of more arms are configured to allow for bending of the arm. In some embodiments, bending of the arm may be in the direction away from a longitudinal axis of the tip. In some embodiments, the longitudinal axis of the tip may be in the proximal-distal direction of the tip. In some embodiments, where the one or more arms is a single arm, the single arm may allow for an increased degrees of freedom in bending compared to two or more arms. In some embodiments, the single arm is configured to bend in the direction of a long axis of the catheter. In some embodiments, the single arm is configured to bend in directions not in the long axis of the catheter. In some embodiments, the single arm may be configured to bend in the direction of the long axis of the catheter and in directions not in the long axis of the catheter.
[0060] In some embodiments, an extension of the plurality of extensions is configured to bend when in contact with the occlusion. In some embodiments, an extension of the plurality of extensions is configured to bend longitudinally when in contact with the occlusion.
[0061] In some embodiments, an extension of the plurality of extensions extends radially outwardly from the frame at an angle 255 relative to the plane 250 made by the circumferenceAttorney Docket No. 57856-711.601formed from the distal end of the distal tip, as illustrated in FIGS. 2A-2B. In some embodiments, the angle is at least 0°, 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, 120°, 125°, 130°, 135°, 140°, 145°, 150°, 155°, 160°, 165°, 170°, 175°, or 180°. In some embodiments, the angle is at most 0°, 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, 120°, 125°, 130°, 135°, 140°, 145°, 150°, 155°, 160°, 165°, 170°, 175°, or 180°. °In some embodiments, the angle is about 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, 120°, 125°, 130°, 135°, 140°, 145°, or 150°. In some embodiments, the angle ranges between about 30° to about 160°, about 40° to about 150°, about 50° to aboutl40°, about 60° to about 130°, about 70° to about 120°, about 80° to about 110°, or about 90° to about 100°. In some embodiments, the angle is about 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, or 120°. In some embodiments, the angle ranges between about 60° to about 120°, about 65° to about 115°, about 70° to 110°, about 75° to about 105°, about 80° to about 100°, or about 85° to about 95°.Distal Tip Covering
[0062] Described herein are catheters having a distal end of the tip. FIG. 1A a covering 160 covers the outer surface of the distal end of the tip 100. In some embodiments, the covering 160 comprises a polymer. In some embodiments, the polymer of the covering 160 comprises an elastomer. In some embodiments, the polymer of the outer jacket lining is fluid resistant. In some embodiments, the polymer of the covering 160 makes the tip fluid resistant. In some embodiments, the polymer comprises one or more of polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene, polyether block ester, polyurethane, polypropylene, polyvinylchloride, polyether-ester, ether or ester based copolymers, phthalate and / or other polyester elastomers, polyamide, elastomeric polyamides, block polyamide / ethers, polyether block amide, ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene, polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR), polysulfone, nylon, nylon-12, perfluoro(propyl vinyl ether) (PF A), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene), polycarbonates, ionomers, biocompatible polymers. In some embodiments, the one or more layers of the liner comprises mixtures, combinations, copolymers, polymer / metal composites of any of the aforementioned materials. In some embodiments, theAttorney Docket No. 57856-711.601liner comprises a liquid crystal polymer (LCP). In some embodiments, the polymer comprises an elastomer. In some embodiments, elastomer may include polyether block amide (PEB A), polyurethane, or similar material. In some embodiments, the polymer is extruded onto the distal end of the tip. In some embodiments, the polymer formed through injection molding. In some embodiments, the polymer formed through compression molding. In some embodiments, the polymer formed through transfer molding. In some embodiments, the polymer formed through rotational molding.III. Catheter Assembly
[0063] The devices, systems, and methods provided herein comprise a device assembly comprising a catheter body comprising a tube having a lumen, and a tip extending distally from the tube, the tip comprising a tip base, a frame, and a plurality of extensions, wherein the catheter body and the tip are a unitary piece. In some embodiments, the base is secured to the catheter body. In some embodiments, a proximal end of the base is secured to the catheter body. In some embodiments, the base and the catheter body are a unitary piece. In some embodiments, the base and the catheter body are formed of a unitary piece of material. In some embodiments, at least one ring of the at two least rings is coupled to the frame. In some embodiments, at least one ring of the at least rings is coupled to the catheter body. In some embodiments, the one or more rings and the catheter body are a unitary piece. In some embodiments, the one or more rings and the catheter body are formed of a unitary piece of material. In some embodiments, the at least two rings comprise a proximal ring. In some embodiments, the proximal ring is secured to the catheter body. In some embodiments, the proximal ring is secured to a distal end of the catheter body.
[0064] FIGS 5A-5B illustrate a catheter assembly 500 comprising a catheter body 505. In some embodiments, the catheter body 505 comprises a tube 510. In some embodiments, the catheter tube comprises a lumen 515. In some embodiments, the catheter assembly comprises a helical frame 520. In some embodiments, the catheter 500 comprises a tip lumen 550. In some embodiments, the catheter 500 comprises a radiopaque marker 555.
[0065] In some embodiments, the catheter body has a diameter configured to traverse through tortuous vasculature. In some embodiments, the catheter body comprises an inner diameter configured to receive guide wires. In some embodiments, the catheter body comprises a distal hydrophilic coating. In some embodiments, the hydrophilic coating is configured to enhance lubricity and trackability. In some embodiments, the hydrophilic coating may comprise a hydrophilic polymer. Hydrophilic polymer coatings can include, but are not limited to, polyelectrolyte and / or a non-ionic hydrophilic polymer, where the polyelectrolyte polymer can include poly(acrylamide-co-acrylic acid) salts, a poly(methacrylamide-co-acrylic acid) salts, aAttorney Docket No. 57856-711.601poly(acrylamide-co-methacrylic acid) salts, etc., and the non-ionic hydrophilic polymer may be poly(lactams), for example polyvinylpyrollidone (PVP), polyurethanes, homo- and copolymers of acrylic and methacrylic acid, polyvinyl alcohol, polyvinylethers, snapic anhydride based copolymers, polyesters, hydroxypropylcellulose, heparin, dextran, polypeptides, etc. In some embodiments, the hydrophilic coating may be applied by a dip coating process or by spraying the coating onto the tube outer and inner surfaces.
[0066] In some embodiments, a tube comprises one material. In some embodiments, the tube comprises two or more materials. In some embodiments, the tube comprises a metal, metal alloy, polymer, or combination thereof. The tube may comprise nitinol, stainless steel, or a combination thereof. In some embodiments, the tube comprises stainless steel, nickel titanium (nitinol), or polymers. In some embodiments, the tube comprises, super elastic NiTi alloy super elastic nickel titanium, shape memory nickel titanium, TiNi, nickel titanium, NiTiHf, NiTiPd, NiMnGa, stainless steel. In some embodiments, the stainless steel may comprise Stainless having an SAE grade in the 200, 300, or 400 series, precipitation hardened (PH) stainless steel, other spring steel or other high tensile strength material or other biocompatible metal material. In some embodiments, the material of a tube comprises superelastic or shape memory metal (e.g., nickel titanium). Alternatively or in combination, the material of a tube comprises stainless steel.
[0067] In some embodiments, the catheter comprises a liner covering at least a portion of a lumen of the catheter body. In some embodiments, the liner comprises a material having a low coefficient of friction. In some embodiments, the material is a polymer having a low coefficient of friction. Such material may help to advance one or more structures through the lumen of the catheter body. For example, the liner may comprise a polymer having a low coefficient of friction. In some embodiments, the low coefficient of friction allows a guide wire to be advanced through the central lumen with little to no resistance caused by contact between guidewire with the liner.
[0068] The catheter may be modified to have different configurations to allow for navigation through different internal tissue structures, including but not limited to arteries, veins, capillaries, organs, or tissue layers. In some embodiments, the lumen of the catheter is configured to allow the passage of a second catheter and / or a guidewire through it. In some embodiments, the second catheter and / or a guidewire may be introduced through the lumen of the catheter during a procedure. In some embodiments, the second catheter and / or a guidewire may be removed from the lumen of the catheter during a procedure. In some embodiments, one or more of the catheter body, the liner, and the outer jacket may be configured to achieve a desired flexibility and / or stiffness per unit of length along the catheter. In some embodiments, the second catheter may have a tapered tip. In some embodiments, the catheter provided herein may be delivered to theAttorney Docket No. 57856-711.601target site through a lumen of a sheath. In some embodiments, the catheter provided herein may fit within a lumen of a sheath.
[0069] Usually, the catheter is advanced to a target site in an individual. Often, the target site is located in a vasculature of the individual. In some embodiments, an occlusion is located at the target site. In some embodiments, the occlusion is aspirated from the blood vessel into the catheter. In some embodiments, where the occlusion is aspirated from the blood vessel into the catheter, the catheter is withdrawn from the vasculature.
[0070] In some embodiments, a plurality of cuts are applied to a proximal portion of a tube, forming a catheter body. In some embodiments, the plurality of cuts are applied in an interrupted spiral pattern. In some embodiments, a second plurality of cuts are applied to a distal portion of the tube, forming a tip. In some embodiments, a polymer sheet is laminated over an outer surface of the catheter body. In some embodiments, a second polymer sheet is laminated over an outer surface of the tip. In some embodiments, the catheter is positioned into an individual. In some embodiments, the catheter is inserted into a vessel in the individual. In some embodiments, the catheter is inserted into a vessel in the individual remote from a target site. In some embodiments, the catheter is advanced through a vasculature in the individual. In some embodiments, the catheter is advanced through the vasculature towards the target site. In some embodiments, the catheter approaches the target site with a distal end of the tip of the catheter. In some embodiments, an occlusion is located at the target site. In some embodiments, a pressure change is provided at the target site. In some embodiments, the pressure change is sufficient to move the occlusion proximally. In some embodiments, the pressure change is sufficient to move the occlusion proximally into the tip. In some embodiments, the tip is configured to compress when in contact with the occlusion. In some embodiments, an extension of the plurality of extensions is configured to bend when in contact with the occlusion. In some embodiments, an extension of the plurality of extensions is configured to bend longitudinally when in contact with the occlusion. In some embodiments, where the occlusion is moved into the tip, the catheter is withdrawn from the vasculature.System
[0071] Provided herein is a system for advancing a catheter to a target site in an individual, the system comprising: an aspiration catheter comprising a catheter body, a catheter body comprising a tube, and a tip comprising a tip base, a frame, and a plurality of extensions; a delivery tool positioned in the aspiration catheter; and an aspiration system. In some embodiments, the delivery tool is inserted into the aspiration catheter until approximately 5cm to 10cm of the delivery tool exits the distal end of the aspiration catheter. In some embodiments, the delivery tool comprises an outer diameter. In some embodiments, the delivery tool outer diameter isAttorney Docket No. 57856-711.601between about 0.060” to about 0.072”. In some embodiments, the delivery tool outer diameter is between about 3F to about 8F, about 4F to about 7F, or about 4F to 6F. In some embodiments, the delivery tool outer diameter is between about 0.067” to about 0.069”. In some embodiments, the delivery tool outer diameter is about 0.068”. In some embodiments, the delivery tool outer diameter is about 4F, 5F, or 6F. In some embodiments, the aspiration catheter comprises an inner diameter. In some embodiments, the aspiration catheter inner diameter is between about 0.068” to about 0.076”. In some embodiments, the aspiration catheter internal diameter is about 0.071” or 0.072”. In some embodiments, a difference in the aspiration catheter inner diameter and the delivery tool outer diameter forms a gap. In an exemplary embodiment, the gap is minimized such that damage to vasculature tissue is minimized. In some embodiments, the gap is between about 0.001” to about 0.016”. In some embodiments, the gap is between about 0.0012” to about 0.005”. In some embodiments, the gap is between about 0.003” and about 0.004”. In some embodiments, the gap is about 0.004”. In some embodiments, the system comprises a guide wire. In some embodiments, the maximum diameter for a guide wire is 0.014”.
[0072] In some embodiments, the delivery tool is used to navigate to a target site in the vasculature. In some embodiments, an occlusion is present at a target site. In some embodiments, the delivery tool is removed. In some embodiments, where the delivery tool is removed, the aspiration system is activated to initiate aspiration of the occlusion. In some embodiments, a pressure change is provided at the target site. In some embodiments, the pressure change is sufficient to move the occlusion proximally. In some embodiments, the pressure change is sufficient to move the occlusion proximally into the tip. In some embodiments, where the occlusion is moved into the tip, the catheter is withdrawn from the vasculature.IV. Methods
[0073] Provided herein are methods of manufacturing, preparing, and using an aspiration catheter using the catheter described herein.Methods of Manufacturing
[0074] Provided herein are methods of preparing an aspiration catheter and advancing the aspiration catheter to a target site using the devices and systems described herein. Provided herein are methods for preparing an catheter, the method comprising: (a) applying to a proximal portion of a tube a plurality of cuts in an interrupted spiral pattern to form the catheter body of any one of preceding claims; (b) applying to a distal portion of the tube a plurality of cuts to form the tip of any one of preceding claims; (c) laminating a polymer sheet over an outer surface of the catheter body; and (d) laminating a second polymer sheet over an outer surface of the tip. In some embodiments, the method further comprises the step of applying a first stretch to a first section of the cut tube, wherein the first stretch increases an average kerf of the plurality of cutsAttorney Docket No. 57856-711.601in the first section from a first initial kerf to a first final kerf. In some embodiments, the method further comprises the step of applying a second stretch to a second section of the cut tube proximal to the first section, wherein the second stretch increases an average kerf of the plurality of cuts in the second section from a second initial kerf to a second final kerf, wherein the first final kerf is larger than the second final kerf. In some embodiments, the plurality of cuts is applied by laser cutting. In some embodiments, the plurality of cuts is applied by laser cutting. In some embodiments, the laser cutting uses a solid-state, femtosecond laser, YAG laser, or some combination thereof. In some embodiments, the plurality of cuts may be formed in the tube by using electrical discharge (electrical discharge machining (EDM)), plasma blade, pressurized fluid jet (waterjet), a lathe, a saw, a blade, chemical etching, photo-etching, or a combination thereof. In some embodiments, cutting the pattern into the tube comprises one or more nonmechanical cutting methods. In some embodiments, methods of cutting a pattern into a tube may comprise laser cutting, plasma cutting, hydrocutting, thermal cutting, mechanical cutting, or a combination thereof.
[0075] In some embodiments, a tube comprises one material. In some embodiments, the tube comprises two or more materials. In some embodiments, the tube comprises a metal, metal alloy, polymer, or combination thereof. The tube may comprise nitinol, stainless steel, or a combination thereof. In some embodiments, the tube comprises stainless steel, nickel titanium (nitinol), or polymers. In some embodiments, the tube comprises, super elastic NiTi alloy super elastic nickel titanium, shape memory nickel titanium, TiNi, nickel titanium, NiTiHf, NiTiPd, NiMnGa, stainless steel. In some embodiments, the stainless steel may comprise Stainless having an SAE grade in the 200, 300, or 400 series, precipitation hardened (PH) stainless steel, other spring steel or other high tensile strength material or other biocompatible metal material. In some embodiments, the material of a tube comprises superelastic or shape memory metal (e.g., nickel titanium). Alternatively or in combination, the material of a tube comprises stainless steel.
[0076] In some embodiments, wherein the first polymer sheet comprises a first layer of a first polymer and a second layer of a second polymer. In some embodiments, the first polymer layer is more elastic than the second polymer layer. In some embodiments, the first polymer layer fills the plurality of cuts in the portion of the stretched cut tube. In some embodiments, the second polymer layer allows for easy handling of the first polymer layer. In some embodiments, the method further comprises lining a portion of a lumen of the cut tube with a liner polymer. In some embodiments, the liner polymer contacts the first polymer layer filling the plurality of cuts. In some embodiments, the second polymer sheet over an outer surface of the tip comprises the same polymer as the first polymer layer. In some embodiments, the second polymer sheet over an outer surface of the tip comprises the same polymer as the second polymer layer. In some-n-Attorney Docket No. 57856-711.601embodiments, the second polymer sheet over an outer surface of the tip comprises a third polymer layer. In some embodiments, the second polymer sheet is fluid resistant. In some embodiments, the second polymer sheet is configured to make the tip fluid resistant. In some embodiments, the second polymer sheet comprises one or more of polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene, polyether block ester, polyurethane, polypropylene, polyvinylchloride, polyether-ester, ether or ester based copolymers, phthalate and / or other polyester elastomers, polyamide, elastomeric polyamides, block polyamide / ethers, polyether block amide, ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene, polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR), poly sulfone, nylon, nylon- 12, perfluoro(propyl vinyl ether) (PF A), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene), polycarbonates, ionomers, biocompatible polymers. In some embodiments, the one or more layers of the liner comprises mixtures, combinations, copolymers, polymer / metal composites of any of the aforementioned materials. In some embodiments, the liner comprises a liquid crystal polymer (LCP). In some embodiments, the second polymer sheet comprises an elastomer. In some embodiments, elastomer may include poly ether block amide (PEBA), polyurethane, or similar material. In some embodiments, the second polymer sheet is extruded onto the distal end of the tip. In some embodiments, the second polymer sheet formed through injection molding. In some embodiments, the second polymer sheet is formed through compression molding. In some embodiments, the second polymer sheet is formed through transfer molding. In some embodiments, the second polymer sheet is formed through rotational molding.Preparation for Use
[0077] Provided herein are methods for preparing for use of an aspiration catheter, the method comprising: attaching a rotating hemostatic valve (RHV) to the catheter; attaching a flow switch to the RHV in the “Off’ position; loading a delivery tool into the catheter; and delivering as s system into a vessel. In some embodiments, the delivery tool is loaded into the catheter until approximately 1 cm to 20 cm of the delivery tool exits the catheter. In some embodiments, the delivery tool is loaded into the catheter until approximately 3 cm to 15 cm of the delivery tool exits the catheter. In some embodiments, the delivery tool is loaded into the catheter until approximately 5 cm to 10 cm of the delivery tool exits the catheter. In some embodiments, theAttorney Docket No. 57856-711.601method further comprises attaching aspiration tubing. In some embodiments, the method further comprises submerging the catheter in a bowl comprising a solution. In some embodiments, the method further comprises submerging the delivery tool in a bowl comprising a solution. In some embodiments, the method further comprising submerging the catheter, the delivery tool, or both in a bowl comprising a solution. In some embodiments, the solution comprises an anticoagulant. In some embodiments, the anticoagulant comprises heparin. In some embodiments, the solution comprises saline. In some embodiments, the solution comprises an anticoagulant and saline. In some embodiments, the solution comprises heparinized saline. In some embodiments, the catheter is submerged for at least 1 second, 5 seconds, 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, 35 seconds, 40 seconds, 45 seconds, 50 seconds, 55 seconds, or 60 seconds. In some embodiments, the delivery tool is submerged for at least 1 second, 5 seconds, 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, 35 seconds, 40 seconds, 45 seconds, 50 seconds, 55 seconds, or 60 seconds.
[0078] In some embodiments, the method further comprises flushing an inner lumen of the catheter. In some embodiments, the method further comprises flushing an inner lumen of the delivery tool. In some embodiments, the method further comprises tightening the RHV around the delivery tool. In some embodiments, the method further comprises inspecting the catheter for any kinks. In some embodiments, the method further comprises inspecting the catheter for any damage. In some embodiments, the method further comprises inspecting the delivery tool for any kinks. In some embodiments, the method further comprises inspecting the delivery tool for any damage.Methods of Use
[0079] Provided herein are methods for advancing an aspiration catheter to a target site in an individual, the method comprising: (a) positioning the catheter of any one of preceding claims into a vessel in the individual remote from the target site; (b) advancing the catheter through a vasculature in the individual to the target site; (c) approaching an occlusion at the target site with a distal end of the tip of the catheter; (d) providing a pressure change sufficient to move the occlusion proximally into the tip; and (e) withdrawing the catheter from the vasculature.
[0080] In some embodiments, the vessel in the individual remote from the target site is an artery. In some embodiments, the artery is an artery in the groin, neck, arm, or wrist of the individual. In some embodiments, the target site comprises the location of an occlusion in a blood vessel. In some embodiments, the blood vessel is an artery. In some embodiments, the blood vessel comprises neurovasculature. In some embodiments, the blood vessel comprises neurovasculature located in the brain of the individual. In some embodiments, the blood vessel comprises the internal carotid artery (ICA), the posterior cerebral artery (PCA), the middle cerebral arteryAttorney Docket No. 57856-711.601(MCA), the anterior cerebral artery (ACA), or the intracranial vertebral artery (VA) of the individual. In some embodiments, the blood vessel comprises the Ml, M2, M3, or M4 segment of the MCA. In some embodiments, the occlusion at the target site comprises a deep vein thrombosis, an acute upper or lower extremity arterial limb ischemia, an acute mesenteric ischemia, a renal artery occlusion, a myocardial infarction, or a pulmonary embolism. In some embodiments, approaching the occlusion at the target site comprises navigating through tortuous vasculature. In some embodiments, providing a pressure change sufficient to move the occlusion comprises applying a pressure gradient to a lumen of the catheter. In some embodiments, providing a pressure change sufficient to move the occlusion comprises using an aspiration system. In some embodiments, the frame is configured to maintain its shape during aspiration. In some embodiments, the occlusion in its entirety is moved proximally into the tip. In some embodiments, the tip is configured to axially compress during occlusion engagement. In some embodiments, axial compression of the tip is configured to increase engagement of the occlusion. In some embodiments, the tip is configured to adapt off axis to the occlusion. In some embodiments, where the target site is located near a tight curve in the vasculature, the tip is configured to adapt off axis to the occlusion. In some embodiments, axial compression of the tip is configured to reduce the loss of the occlusion. In some embodiments, the tip is configured to compress when in contact with the occlusion. In some embodiments, one or more extensions of the plurality of extensions is configured to bend when in contact with the occlusion. In some embodiments, one or more extensions of the plurality of extensions is configured to bend longitudinally when in contact with the occlusion.V. Definitions
[0081] Unless defined otherwise, all terms of art, notations and other technical and scientific terms or terminology used herein are intended to have the same meaning as is commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some cases, terms with commonly understood meanings are defined herein for clarity and / or for ready reference, and the inclusion of such definitions herein should not necessarily be construed to represent a substantial difference over what is generally understood in the art.
[0082] Throughout this application, various embodiments may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure.Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc.,Attorney Docket No. 57856-711.601as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
[0083] As used in the specification and claims, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a sample” includes a plurality of samples, including mixtures thereof.
[0084] The terms “determining”, “measuring”, “evaluating”, “assessing,” “assaying,” and “analyzing” are often used interchangeably herein to refer to forms of measurement and include determining if an element is present or not (for example, detection). These terms can include quantitative, qualitative, or quantitative and qualitative determinations. Assessing is alternatively relative or absolute. “Detecting the presence of’ includes determining the amount of something present, as well as determining whether it is present or absent.
[0085] The terms “subject,” “individual,” or “patient” are often used interchangeably herein. A “subject” can be a biological entity containing expressed genetic materials. The biological entity can be a plant, animal, or microorganism, including, for example, bacteria, viruses, fungi, and protozoa. The subject can be tissues, cells and their progeny of a biological entity obtained in vivo or cultured in vitro. The subject can be a mammal. The mammal can be a human. The subject may be diagnosed or suspected of being at high risk for a disease. The disease can be endometriosis. In some cases, the subject is not necessarily diagnosed or suspected of being at high risk for the disease.
[0086] The term “zw vivo" is used to describe an event that takes place in a subject’s body.
[0087] The term “ex vivo" is used to describe an event that takes place outside of a subject’s body. An “ex vivo" assay is not performed on a subject. Rather, it is performed upon a sample separate from a subject. An example of an “ex vivo" assay performed on a sample is an “in vitro” assay.
[0088] Whenever the term “at least,” “greater than,” or “greater than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “at least,” “greater than” or “greater than or equal to” applies to each of the numerical values in that series of numerical values. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.
[0089] Whenever the term “no more than,” “less than,” or “less than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “no more than,” “less than,” or “less than or equal to” applies to each of the numerical values in that series of numerical values. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.Attorney Docket No. 57856-711.601
[0090] The term “about” or “approximately” may mean within an acceptable error range for the particular value, which will depend in part on how the value is measured or determined, e.g., the limitations of the measurement system. For example, “about” may mean within 1 or more than 1 standard deviation, per the practice in the art. Alternatively, “about” may mean a range of up to 20%, up to 10%, up to 5%, or up to 1% of a given value. Where particular values are described in the application and claims, unless otherwise stated the term “about” meaning within an acceptable error range for the particular value may be assumed.
[0091] In some embodiments, flexibility refers to the ability of a material to deform elastically and return to its original shape when the applied stress is removed. In some embodiments, flexibility refers to the ability of a material to deform or bend without breaking. In some embodiments, a more flexible material may allow for a material to navigate through curved or tortuous pathways. In some embodiments, flexibility may be measured in terms of the catheter's bending radius, ability to recover its original form after deformation, and / or resistance to kinking under various conditions. In some embodiments, the flexibility may be measured as yield strength, elastic modulus, and / or flexural modulus. In some embodiments, the flexibility may be measured by a durometer. In some embodiments, the flexibility may be measured as according to the American Society for Testing and Materials (ASTM) Standard Guide for Three-Point Bending of Balloon -Expandable Vascular Stents and Stent Systems, ASTM F2606-08(2021).
[0092] In some embodiments, compression refers to the application of inward forces on a material. In some embodiments, compression may refer to uniaxial compression in which the application of inward forces are directed along one direction. In some embodiments, compressive stress refers to the compressive force related to the initial cross-section of the material. In some embodiments, compressive strength refers to the extent to which a material resists failure in response to a compressive stress.
[0093] In some embodiments, stiffness refers to the extent to which a material resists deformation in response to an applied force. In some embodiments, stiffness may refer to hardness of the material. In some embodiments, the flexibility may be measured as elastic modulus, Young’s modulus, and / or tensile modulus. In some embodiments, stiffness is calculated as a ratio of force to deflection.
[0094] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.
[0095] While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. It should be understood that various alternatives toAttorney Docket No. 57856-711.601the embodiments of the disclosure described herein may be employed in practicing the disclosure.
[0096] All publications, patent applications, issued patents, and other documents referred to in this specification are herein incorporated by reference as if each individual publication, patent application, issued patent, or other document was specifically and individually indicated to be incorporated by reference in its entirety. Definitions that are contained in text incorporated by reference are excluded to the extent that they contradict definitions in this disclosure.VI. Examples
[0097] The following examples are included for illustrative purposes only and are not intended to limit the scope of the present disclosure.
[0098] Example 1: Aspiration Catheter with Single Arm and Circumferential Slits
[0099] In an exemplary embodiment, the frame comprises 1 / i parallelogram structures in the axial direction and 5 parallelograms take up the circumference of the frame. The one or more arms of the plurality of extensions is a single arm. The one or more arms are coupled to the frame at an angle relative to the tip base at about 45°±15°. The single arm allows for an increased degrees of freedom in bending. The extension frame opening is filled with tungsten as a radiopaque material. The extension frame opening is stadium shaped. The base comprises two base openings and two rectilinear struts. The base comprises two circumferential slits. The circumferential slits have a soft edge shape and have equal lengths. The base further comprises two marker bands configured to snap into each base opening. A thin elastomeric covering is extruded onto the distal tip, making the distal tip impermeable to fluids.
[0100] Example 2: Aspiration Catheter with Marker Band Cutouts
[0101] In an exemplary embodiment, the frame comprises 2 ’A parallelogram structures in the axial direction and 5 parallelograms take up the circumference of the frame. The one or more arms of the plurality of extensions comprises two arms, which provides resistance to bending in the direction of the long axis of the catheter as compared to bending away from the long axis of the catheter. The extension frame opening is filled with a platinum / iridium alloy as a radiopaque material. The extension frame opening is oblong shaped and symmetric along the longitudinal axis of the catheter. The base comprises two base openings and two rectilinear struts. The base comprises two circumferential slits. The circumferential slits have a soft edge shape and have equal lengths. The base further comprises two marker bands configured to snap into each base opening. The marker bands comprise 7 ±2 cutouts, with 1 ± 1 cutouts being larger than the remaining cutouts. The larger cutout is located distally compared to the remaining cutouts. A thin elastomeric covering is extruded onto the distal tip, making the distal tip impermeable to fluids.Attorney Docket No. 57856-711.601
[0102] Example 3: Aspiration Catheter with Longitudinal Extensions
[0103] In an exemplary embodiment, the frame comprises 2 ’A parallelogram structures in the axial direction and 5 parallelograms take up the circumference of the frame. The one or more arms of the plurality of extensions comprises two arms, which provides resistance to bending in the direction of the long axis of the catheter as compared to bending away from the long axis of the catheter. The extension frame opening is filled with a platinum / iridium alloy as a radiopaque material. The extension frame opening is oblong shaped and symmetric along the longitudinal axis of the catheter. The tip comprises a covering the covers the outer surface of the distal end of the tip. The covering is a fluid resistant elastomer that makes the tip fluid resistant. The base comprises approximately five longitudinal extensions extending proximally from the base. The base also comprises a marker band. The marker band comprises approximately five recesses of a complementary geometry to the longitudinal extensions. The recesses are configured to allow a mating element to snap together.
[0104] While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions can occur to those skilled in the art without departing from the present disclosure. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in practicing the present disclosure. It is intended that the following claims define the scope of the disclosure and that methods and structures within the scope of these claims and their equivalents be covered thereby.
[0105] Additional aspects and advantages of the present disclosure will become readily apparent to those skilled in this art from the following detailed description, wherein only illustrative embodiments of the present disclosure are shown and described. As will be realized, the present disclosure is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the disclosure.Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.
Claims
Attorney Docket No. 57856-711.601CLAIMS WHAT IS CLAIMED IS:
1. An aspiration catheter, the catheter comprising:a catheter body comprising a tube having a lumen; anda tip extending distally from the tube, the tip comprising a tip base, a frame extending distally from the base, and a plurality of extensions extending distally from the frame,wherein the catheter body and the tip are a unitary piece.
2. The catheter of claim 1, wherein the catheter body and the tip are formed from a unitary piece of a material.
3. The catheter of claim 1 or 2, wherein an extension of the plurality of extensions is coupled to the frame by one or more arms of the extension.
4. The catheter of claim 3, wherein the one or more arms of the extension is a single arm.
5. The catheter of claim 3 or 4, wherein an extension comprises an extension frame extending distally from the one or more arms.
6. The catheter of claim 5, wherein the extension frame has an extension frame opening.
7. The catheter of claim 6, wherein the extension frame opening is filled with a radiopaque material.
8. The catheter of any one of preceding claims, wherein an extension of the plurality of extensions extends from the frame at an angle of a longitudinal axis of the tip.
9. The catheter of claim 8, wherein the angle ranges from about 0° to about 90° from the longitudinal axis of the tip.
10. The catheter of claim 9, wherein the angle ranges from about 15° to about 60° from the longitudinal axis of the tip.
11. The catheter of any one of claims 3 to 10, wherein the one or more arms allows for bending of the arm in the direction of a longitudinal axis of the tip (e.g., proximal -distal direction of the tip).
12. The catheter of any one of claims 3 to 11, wherein the one or more arms allows for bending of the arm in the direction away from a longitudinal axis of the tip.
13. The catheter of any one of claims 4 to 12, wherein the single arm allows for increased degrees of freedom in bending than two or more arms.
14. The catheter of any one of preceding claims, wherein the tip base comprises one or more base openings.Attorney Docket No. 57856-711.60115. The catheter of claim 14, wherein the one or more openings are encompassed by one or more struts.
16. The catheter of claim 15, wherein the tip base comprises at least two rings connected by the one or more struts.
17. The catheter of claim 15 or 16, wherein the one or more struts are configured to provide a mechanical continuity between the tip and the catheter body.
18. The catheter of any one of preceding claims, wherein the tip base comprises one or more circumferential slits.
19. The catheter of claim 18, wherein the one or more circumferential slits provide a mechanical stress relief.
20. The catheter of claim 18 or 19, wherein the one or more circumferential slits are proximal to one or more base openings.
21. The catheter of any one of claims 14 to 20, wherein the base opening is filled with a marker band.
22. The catheter of claim 21, wherein the marker band is configured to snap into the base opening.
23. The catheter of claim 21, wherein the marker band comprises a radiopaque marker.
24. The catheter of any one of claims 21 to 23, wherein the marker band comprises one or more cutouts.
25. The catheter of claim 24, wherein the one or more cutouts is configured to be filled with a polymer.
26. The catheter of claim 25, wherein the polymer comprises a polymer of an outer jacket lining an outer surface of the tip.
27. The catheter of claim 25 or 26, wherein the polymer contacts a polymer of a liner lining a lumen of the tip.
28. The catheter of claim 26, wherein the polymer of the outer jacket lining the outer surface of the tip comprises an elastomer.
29. The catheter of claim 26, wherein the polymer of the outer jacket lining is fluid resistant.
30. The catheter of claim 29, wherein the polymer of the outer jacket lining makes the tip fluid resistant.
31. The catheter of any one of preceding claims, wherein the unitary piece comprises a metal.
32. The catheter of any one of preceding claims, wherein the unitary piece comprises nitinol.Attorney Docket No. 57856-711.60133. The catheter of any one of preceding claims, wherein the catheter body comprises a tube having one or more cuts.
34. The catheter of any one of preceding claims, wherein the catheter is formed by laser cutting.
35. The catheter of any one of preceding claims, wherein the frame comprises a plurality of closed cells.
36. The catheter of any one of preceding claims, wherein the frame comprises a plurality of connecting struts configured to form a cylindrical shape.
37. The catheter of any one of preceding claims, wherein the frame comprises a helical frame.
38. The catheter of any one of preceding claims, wherein a radiopaque marker comprises tungsten, platinum, iridium, or a combination thereof.
39. A tip for a catheter of any one of preceding claims.
40. A method for preparing a catheter of any one of preceding claims, the method comprising (a) applying to a proximal portion of a tube a plurality of cuts in an interrupted spiral pattern to form the catheter body of any one of preceding claims;(b) applying to a distal portion of the tube a plurality of cuts to form the tip of any one of preceding claims;(c) laminating a first polymer sheet over an outer surface of the catheter body; and (d) laminating a second polymer sheet over an outer surface of the tip.
41. A method for advancing catheter of any one of preceding claims to a target site in an individual, the method comprising(a) positioning the catheter of any one of preceding claims into a vessel in the individual remote from the target site;(b) advancing the catheter through a vasculature in the individual to the target site; (c) approaching an occlusion at the target site with a distal end of the tip of the catheter;(d) providing a pressure change sufficient to move the occlusion proximally into the tip; and(e) withdrawing the catheter from the vasculature.
42. The method of claim 41, wherein the tip is configured to compress when in contact with the occlusion.Attorney Docket No. 57856-711.60143. The method of claim 41 or 42, wherein one or more extensions of the plurality of extensions is configured to bend when in contact with the occlusion.
44. The method of claim 43, wherein one or more extensions of the plurality of extensions is configured to bend longitudinally when in contact with the occlusion.