Devices, systems, and methods for performing thrombectomy procedures

Abstract

A thrombectomy device is provided that includes an elongate shaft including a proximal end coupled to a motor configured to rotate the shaft, a distal end sized for introduction into a body cavity of a patient, and a longitudinal axis extending therebetween, the shaft configured to rotate about the axis; and a rotator tip on the distal end configured to generate a local suction near the distal end upon rotation of the shaft. The rotator tip may be introduced or disposed within a lumen of a catheter that includes an outlet in a distal end thereof that is positioned proximate a clot. Positioning the rotator tip near the outlet, such as within the catheter lumen, may activate the motor to create local suction, such as to dissolve clots, reduce clot size, and / or prevent clot fragmentation.

Description

[0001] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

[0002] This invention was made with Government support under Contract 2145601 awarded by the National Science Foundation. The Government has certain rights in this invention.

[0003] Related application data

[0004] This application claims the benefit of co-pending U.S. Provisional Application Serial Nos. 63 / 339,504, filed May 8, 2022, 63 / 418,449, filed October 21, 2022, and 63 / 453,152, filed March 19, 2023. The entire disclosures of Serial Nos. 63 / 418,449 and 63 / 452,152 are expressly incorporated herein by reference. Technical Field

[0005] The present application relates to medical devices and, more particularly, to thrombectomy devices, and systems and methods for performing thrombectomy or other medical procedures using such devices. Background Art

[0006] Thromboembolism, commonly called a blood clot, is the result of blood clotting in a vein or artery (see, e.g. Figure 1A ), which disrupts the normal flow of blood to parts of the body. Blood clots can occur in many parts of the body (e.g. Figure 1B For example, a clot located in a deep vein in the leg or arm may result in deep vein thrombosis (DVT), from which the clot may travel to the lungs, causing pulmonary embolism (PE), or from the arteries to the brain, causing a stroke, all of which are life-threatening conditions. Depending on the location within the subject's vasculature, a clot may result in venous thromboembolism, pulmonary embolism, cerebrovascular stroke, peripheral artery occlusion, coronary artery thrombosis, and / or acute myocardial infarction.

[0007] According to the CDC, venous thromboembolism affects approximately 900,000 Americans each year. As many as 100,000 people die each year from blood clots. One in four people who have PE die without warning. Even sadder, PE is the leading cause of death among women during pregnancy or just after having a baby. Blood clots are also the leading cause of death among cancer patients, second only to the cancer itself. In the United States, up to $10 billion is spent each year to address problems related to blood clots, and treatment can cost as much as $15,000 to $20,000 per person and often results in readmission to the hospital.

[0008] Acute ischemic stroke (AIS) is the leading cause of disability and the fifth leading cause of death in the United States. AIS is caused by blockage or interruption of blood flow within the carotid or cerebral arteries. This lack of blood flow to the brain may result in irreversible brain damage (core infarction) or impaired neuronal function in ischemic but potentially salvageable brain tissue (penumbra). AIS can be treated with intravenous thrombolysis within 3-4.5 hours of symptom onset, but less than 5% of patients with AIS receive medical care within this time frame.

[0009] Percutaneous thrombectomy is a minimally invasive intervention during which a surgeon inserts a catheter into a patient's blood vessels to remove the blood clot and restore blood flow to the affected area. There are two commonly used mechanical thrombectomy techniques to remove large clots: (i) aspiration thrombectomy, in which continuous vacuum aspiration is induced through a guiding catheter to suck out the clot; and (ii) stent retriever thrombectomy, in which a mesh tube is used to pull out the clot, e.g. Figure 2A However, the use of stent retrievers and suction devices is always associated with the risk of thrombus fragmentation, e.g. Figure 2B As shown, during this period, large clots may break into smaller pieces (100 μm to 1000 μm) and travel downstream in the vessel, potentially blocking blood flow at multiple other locations and / or causing new life-threatening emboli that may require urgent open surgery.

[0010] Recently, endovascular thrombectomy using aspiration or stent retriever devices, e.g. Figure 2A As shown, thrombectomy has been shown to be an effective treatment for AIS involving large vessel occlusions of the internal carotid artery, proximal middle cerebral artery, proximal anterior cerebral artery, or basilar artery (AIS-LVO) from symptom onset up to 24 hours. Thrombectomy has resulted in significant improvements in outcomes for patients with AIS-LVO and has become the standard of care for patients with AIS-LVO.

[0011] Despite recent advances in the treatment of AIS, significant gaps in knowledge and available devices remain that limit optimal treatment of AIS. Current thrombectomy techniques fail to restore any or insufficient blood flow in approximately 15% of patients after multiple passes, with aspiration methods failing at rates of approximately twenty-five to thirty-three percent (25-33%). Common reasons for thrombectomy failure include clots having a high fibrin content, clot fragmentation that prevents complete removal, and clot resistance to modern thrombectomy devices. Furthermore, recent data suggest that to be maximally effective, thrombectomy should restore approximately ninety-five to one hundred percent (95-100%) of blood flow distal to the site of arterial occlusion, and that this blood flow should be restored in a single thrombectomy attempt (the "first-pass effect") to maximize the likelihood of a good outcome. However, less than fifty percent (50%) of patients undergoing thrombectomy achieve a first-pass effect, and there is a great need to develop new thrombectomy devices to improve the thrombectomy process.

[0012] Therefore, improved devices and methods for performing thrombectomy procedures would be useful. Summary of the invention

[0013] The present application relates to medical devices, and more specifically, to thrombectomy devices, and systems and methods for performing thrombectomy or other medical procedures using such devices. In one example, the device may include a rotator device introduced through a catheter or other tubular member (or directly introduced into a body cavity), which rotator device mechanically reduces or compresses the volume and / or separates components of a clot (e.g., red blood cells from fibrin or other residual fibrous material) and / or dissolves or partially dissolves the clot, such as by inducing compression and shear loads through the suction force of the connection applied to the clot by the rotator. That is, it should be understood that the terms "reducing, reduce, or reducers" with respect to a clot include any manner of reducing the volume of the clot, including by separating components of the clot (e.g., red blood cells) from fibrin or other residual fibrous material and / or compressing the clot and / or dissolving or partially dissolving the clot and / or reducing the volume of residual clot material, for example, to facilitate removal of residual material. For example, the spinner may be rotated rapidly to squeeze out red blood cells (RBCs) in a clot, leaving behind a compacted network of fibrin fibers, which may then be captured by the spinner tip, drawn into a catheter, and / or otherwise removed from the vessel.

[0014] Additionally or optionally, suction can be applied to enhance clot reduction and / or prevent fragmentation, the suction being generated by applying a vacuum to the treatment site from a rotator or other source. Optionally, an additional device can be provided that can engage the clot to enhance rotation, for example, one or more wires extending from the rotator or another device separately introduced into the treatment site. Optionally, a jet of saline or other fluid can also be directed to the treatment site to rotate and / or otherwise enhance dissolution of the clot. Thus, the devices and systems herein can help dissolve clots, reduce clot size, reduce thrombus fragments, and / or prevent large fragments from traveling downstream, which can reduce risk during interventional / endovascular procedures.

[0015] According to one example, a thrombectomy device is provided, comprising an elongated shaft including a proximal end configured to be coupled to a controller to rotate the shaft, a distal end sized to be introduced into a patient's body cavity, and a longitudinal axis extending therebetween, the shaft being configured to rotate about the axis; and a rotator member or element on the distal end configured to generate local suction and / or shear forces near the distal end when the shaft rotates to reduce or dissolve the clot, reduce the size of the clot, and / or prevent the clot from fragmenting within the body cavity. For example, the rotator tip may include an annular body extending distally from the distal end so that an opening communicating with a cavity within the annular body may be positioned near the clot to apply local suction and / or shear forces to the clot. Optionally, the rotator tip may include one or more blades or other external features on the annular body and / or one or more slits or other openings in the annular body wall, for example, to enhance the local suction generated at the opening and within the cavity.

[0016] According to another example, a thrombectomy device is provided, comprising a catheter or other tubular member including a proximal end, a distal end sized for introduction into a body cavity near a clot, and a lumen extending from the proximal end to an outlet in the distal end; an elongated shaft including a proximal end configured to be coupled to a controller to rotate the shaft, a distal end sized for introduction into the lumen, and a longitudinal axis extending therebetween, the shaft configured to rotate about the axis; optionally, a sleeve surrounding the shaft; and a rotator tip on the distal end of the shaft configured to generate local suction and / or shear forces near the outlet when the shaft rotates to reduce the clot size of the clot within the body cavity near the outlet, for example, by applying local compression and / or shear forces to the clot to squeeze out red blood cells (RBCs), leaving behind a compacted fibrin fiber network. Optionally, the fibrin network or other residual material can be removed, for example, by being sucked into the tubular member and / or captured by the rotator tip, and the rotator tip can be withdrawn to remove the residual material.

[0017] According to still another example, a system for performing a thrombectomy procedure is provided, the system comprising a tubular member including a proximal end, a distal end sized for introduction into a body cavity to which a clot is attached, and a lumen extending from the proximal end to an outlet into the distal end; an elongated shaft including a proximal end, a distal end sized for introduction into the lumen, and a longitudinal axis extending therebetween; a motor and / or controller coupled to the proximal end of the shaft to rotate the shaft about the axis; and a rotator tip on the distal end of the shaft configured to generate local suction and / or shear forces near the outlet when the shaft rotates to reduce the size of the clot within the body cavity near the outlet.

[0018] According to yet another example, a method of performing thrombectomy is provided, the method comprising introducing a rotator device into a body cavity proximate a target blood clot; and rotating the rotator device to generate localized suction to dissolve the clot, reduce the size of the clot, and / or prevent the clot from fragmenting.

[0019] According to another example, a tethered biomedical device is provided, comprising an elongated tether having a proximal end and a distal end, and a tool head disposed on the distal end of the tether. The tether is an elongated flexible member, such as a shaft, a cable, a tubular member, a guidewire, or a similar device. The tether is configured to be advanced along a path within the body, including a body lumen and / or a body cavity, and optionally, one or more catheters, introducer sheaths, guidewires, or other delivery devices introduced into any such path. For example, the tether can be navigated by a combination of pushing, pulling, and rotating to guide the device to a target location, such as within a catheter or other delivery device. The tether is also configured to be rotated by a rotary drive to rotate the tool head.

[0020] The tool head can be configured to perform ablation of body tissue and / or generate suction, such as to reduce or dissolve a clot. For example, the tool head can include a tubular body having a lumen extending axially along a central axis of the tubular body. Optionally, the tool head can include one or more blades disposed on an outer surface of the tool head and extending radially outward therefrom, which can enhance the suction and / or ablation function of the tool head.

[0021] In one example, the vanes may be straight ribs on the outer surface of the tubular body and aligned parallel to the central axis of the tubular body.

[0022] In another example, the tubular body can include a plurality of holes through the wall of the tubular body. The holes in the tubular body can improve the local suction capability of the tethered biomedical device. The holes can be slits, apertures, or other through-holes in the tubular body that can help facilitate clot removal. If the device has blades, the holes may be between the blades. The holes are angularly spaced around the tubular body. For example, the tubular body can have 2 holes angularly spaced 180° around the tubular body, or 4 holes angularly spaced 90° around the tubular body.

[0023] In the example that the tool head has blades and holes, the holes can be located between the blades. For example, the tubular body can have two blades and two holes located between adjacent blades, or the tubular body can have four blades and four holes spaced apart between adjacent blades.

[0024] According to yet another example, a method for using a tethered biomedical device is provided. The tethered medical device is introduced into a patient's body through a small incision. Optionally, an introducer is inserted into the incision, and a tool head is inserted into the body through the introducer. The tethered medical device is navigated by advancing a tether and guiding the tether through a path within the body, including a body cavity and / or a body cavity, to position the tool head adjacent to a target location within the body. Once the tool head is advanced to the target location, the tool head is used to perform a biomedical procedure, such as a diagnostic or therapeutic procedure. After performing the biomedical procedure, the tethered medical device is retracted from the body by retracting the tether, the same or similar to advancing the device to the target location, but in the opposite direction.

[0025] In another aspect of the method, the biomedical procedure is an ablation procedure performed by rotating the tool head while pressing the tool against body tissue at a target location to remove body tissue. The tool head can be translated and oriented to position the tool head to ablate body tissue by manipulating the tether. The tool head is rotated by rotating the tether using a rotary drive. In still another aspect, the body tissue is an occlusion within a blood vessel, such as a thrombus and / or plaque.

[0026] In another aspect, the method can include capturing and removing an object (e.g., material such as a blood clot or tissue that is ablated by a tool head) at a target location using a tethered medical device. In this regard, the tool head is positioned adjacent to the object and then the tool head is rotated by rotating a tether using a rotary drive. The rotating tool head creates suction (a low pressure area) within the lumen of the tubular body that pressurizes and / or compresses the object toward a distal aspect of the tool head. The object may be drawn into the lumen of the tubular body, or pressed proximate to the tool head. The tool head can then be retracted along a path by pulling on the tether, for example while the tool head is rotating or the tool head is stationary, to pull the object along the path and out of the body.

[0027] Other aspects and features of the present invention will become apparent from the following description considered in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] It is believed that the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals represent like elements, and in which:

[0029] Figure 1A An example of a blood clot in a blood vessel is shown.

[0030] Figure 1B is a schematic diagram showing how blood clots at different locations in the body can cause deep vein thrombosis (legs / arms), pulmonary embolism (lungs), and stroke (brain).

[0031] Figure 2A and 2B An example of mechanical thrombectomy using a stent retriever is shown, illustrating the thrombus fragmentation that may result during such a procedure.

[0032] Figure 3 An example of a thrombectomy device is shown that includes a catheter or sheath and a rotator connected to a flexible shaft that can be inserted into the catheter.

[0033] Figure 4 An exemplary rotator tip is shown attached to the distal end of a shaft, which may include Figure 3 in the device.

[0034] Figures 4A-4C shows that it can be included in Figure 3 An exemplary spinner tip in a device of .

[0035] Figure 4D Shows Figure 4C The spinner tip is loaded with a drug delivery member.

[0036] Figure 5A and 5B is a cross-sectional view of a blood vessel showing the use of Figure 3 An exemplary method of dissolving a blood clot with a device.

[0037] Figures 6A-6C The use of a thrombectomy device including a rotator (such as Figure 3 An example of clot size reduction that can be achieved is shown in FIG. Fig. 6A In the example shown, the spinner successfully removed substantially all of the RBCs from the clot in approximately three minutes. Figure 6B and 6C As shown, a size reduction to less than 10% of the initial volume is shown.

[0038] Figure 7 is an exemplary SEM image of a blood clot, which shows that the clot is mainly composed of RBCs trapped in a network of fibrin fibers.

[0039] Fig. 8A and 8B SEM images of the clots are shown, for example Figure 6B and 6C The clot in the figure shows that the original clot contained >80 vol% RBCs. After spinning, the white clot was a highly dense network of fibrin fibers.

[0040] Fig.9A is a graph showing an example of CFD results for pressure drop in a spinner at different rotation frequencies, indicating that higher frequency rotation results in a greater pressure drop, thus achieving better suction.

[0041] Fig. 9B is a graph showing examples of centerline pressure profiles for a spinner device rotating at different frequencies.

[0042] Fig. 9C is a graph showing an example of a comparison of maximum centerline pressure drops at different blade lengths for a spinner device rotating at different frequencies.

[0043] Fig.10 Examples of CFD results showing the pressure distribution at the centerline of a milli-spinner with different blade sizes during rotation are shown.

[0044] Fig.11A and 11B Shown are exemplary images from a particle image velocimetry (PIV) system used to evaluate and optimize the pumping performance of a nanospinner. In this example, the pumping performance of a 2.5 mm spinner is shown, with a rotation frequency of 1600 rpm. Arrows represent fluid velocity fields.

[0045] Fig. 12A and 12B A thrombectomy device (such as Figure 3 An example of a pusher device on the proximal end of the device shown.

[0046] Fig.13 is a graph showing experimental efficacy results of a spinner device at a rotation speed of 40,000 rpm to reduce 0.03 gram, 0.05 gram, 0.07 gram and 0.09 gram formed clots to 30% of the initial volume within a tube, with water flowing to represent blood flow within a vessel.

[0047] Fig.14 is a graph showing exemplary release rates of a drug carried within a spinner tip as a function of the rotational speed of the spinner tip.

[0048] Fig.15A and 15B It is intuitively demonstrated that at 40000rpm ( Fig.15A ) and 10000rpm( Fig. 15B ) during an experiment at a rotator speed of 20 rpm and 100 rpm, with color intensity representing differences in release rate.

[0049] Fig.16 It is a comparison Figures 4A-4C A diagram of the local suction forces that may be generated by the spinner tip is shown.

[0050] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be implemented in a variety of other ways, including ways not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and form a part of the specification, illustrate several aspects of the invention and together with the description serve to explain the principles of the invention; however, it should be understood that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION

[0051] The following description of some examples of the present invention should not be used to limit the scope of the present invention. Through the following description, it will be clear to those skilled in the art that other examples, features, aspects, embodiments and advantages of the present invention, and the following description is one of the best modes for implementing the present invention by way of illustration. As will be appreciated, the present invention can have other different and obvious aspects, all of which do not depart from the present invention. Therefore, the drawings and description should be considered illustrative, rather than restrictive.

[0052] Before describing the examples, it should be understood that the present invention is not limited to the specific examples described, which, of course, can vary. It should also be understood that the terms used herein are only for the purpose of describing specific examples and are not intended to be limiting, because the scope of the present invention will only be limited by the appended claims.

[0053] If a range of values ​​is provided, it is understood that, unless the context clearly dictates otherwise, each intermediate value (to one-tenth of the unit of the lower limit) between the upper and lower limits of the range is also specifically disclosed. Each smaller range between any stated value or intermediate value in the specified range and any other stated value or intermediate value in the specified range is included in the present invention. The upper and lower limits of these smaller ranges may be independently included in or excluded from the range, and each range in which one, none or both limits are included in the smaller range is also included in the present invention, subject to any explicitly excluded limits in the stated range. Where the stated range includes one or two limits, the present invention also includes ranges that do not include one or both of these included limits.

[0054] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials are now described.

[0055] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a compound" includes a plurality of such compounds, reference to "a polymer" includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.

[0056] Certain ranges are given herein, and numerical values ​​are preceded by the term "about." The term "about" is used herein to provide literal support for the exact number preceding it, as well as for numbers that are close to or approximately the number preceding the term. In determining whether a number is close to or approximately a specifically stated number, a number that is close to or approximately an unstated number may be a number that, in the context in which it is presented, provides a substantial equivalence to the specifically stated number.

[0057] Go to the attached picture, Figure 3 An example of a thrombectomy device or apparatus 10 is shown that can be used with the systems and methods described throughout this document. Generally, the device 10 includes an outer catheter, sheath, sleeve or other member 20, and a rotator device 30 that includes a rotator tip or member 40 coupled to a shaft 32 that can be introduced through the catheter 20 or otherwise positioned in the catheter 20. Optionally, the device 10 can include a sleeve ( Figure 3 Not shown, see e.g. Fig. 12A and 12B 32 ), which may be positioned and / or otherwise disposed about the shaft 32. The sleeve may help protect the inner surface of the catheter 20 when the shaft 32 rotates at high speeds, may reduce vibration caused by the rotation of the shaft 32 and / or the rotator device 30, and / or may facilitate centering and / or stabilization of the rotator device 30.

[0058] Typically, as shown, the catheter 20 is an elongated tubular member including a proximal end 22, a distal end 24 and one or more lumens 26, the proximal end 22 including a handle or hub 50, the distal end 24 being sized to be introduced into a blood vessel or other body cavity, the lumen 26 extending between the proximal end 22 and the distal end 24, for example extending along a longitudinal axis 28. For example, as shown, a main lumen 26 can be provided, which is communicated with one or more ports 52 in the handle 50 and extends to an outlet 25 in the distal end 24. Optionally, the catheter 20 can include one or more additional lumens extending at least partially between the proximal end 22 and the distal end 24, for example, a guidewire lumen, a guide element lumen, etc. (not shown) for receiving a guidewire or other track. It should also be understood that although the catheter 20 is shown as tubular here, it does not need to have a perfect circular cross-section. In fact, it can be partially tubular, or have any other suitable geometry. Similarly, when referring to a lumen, it should be understood that the lumen can be a partial lumen, a groove or a slit.

[0059] The catheter 20 can be constructed using conventional biocompatible materials and / or methods, such as being formed of plastics, various polymers, metals, composite materials, with a substantially uniform configuration between the proximal end 22 and the distal end 24. Optionally, the configuration can vary along the length of the catheter 20 to provide desired properties, such as providing a substantially rigid or semi-rigid proximal portion, such as providing sufficient column strength to allow the distal end 24 of the catheter 20 to be pushed or otherwise manipulated from the proximal end 22, while the distal portion adjacent to the distal end 24 can be substantially flexible to facilitate advancement through tortuous anatomical structures. In either configuration, the catheter 20 can also be coated or layered (e.g., with a lubricating material) to aid advancement.

[0060] The shaft 32 of the rotator device 30 can be an elongated flexible member including a proximal end 34 and a distal end 36 that are sized to be received within the lumen 26 of the catheter 20. The shaft 32 can be long enough to allow the distal end 36 to be introduced into a target vessel, such as through or with the catheter 20, while the proximal end 34 remains outside the patient's body. For example, the shaft 32 can be a solid or tubular cable, such as including a plurality of helically wound inelastic fibers, filaments, etc., that is configured to translate rotation from the proximal end 34 to the distal end 36 to rotate the rotator tip 40, such as having sufficient torsional strength such that when coupled to a motor 60 and / or controller 62 as further described elsewhere herein, rotation of the proximal end 34 directly results in corresponding rotation of the distal end 36, thereby rotating the rotator tip 40 at a relatively high speed, such as described elsewhere herein.

[0061] Optionally, a sleeve or other tubular member (not shown) may be disposed around the shaft 32, for example, to prevent the shaft 32 from contacting the inner wall of the catheter 20 when introduced into the lumen 26 and rotated by the motor. The sleeve may be formed of a lubricating material, such as PTFE, and / or may include a coating on its inner surface to reduce friction and / or otherwise facilitate rotation of the shaft 32 in the sleeve. The sleeve may be axially fixed relative to the shaft 32, for example, such that the sleeve extends from the proximal end 34 to the distal end 36 proximate to the rotator tip 40. Optionally, the sleeve may be separate from the rotator device 30, for example, such that the sleeve may be introduced into the lumen 26 of the catheter 20 before the rotator tip 40 and the shaft 32 are introduced.

[0062] Generally speaking, if Figure 4A As shown, the spinner tip 40 can include a cylindrical or other annular body 42 including a closed proximal end 44 that can be connected to the shaft 32 and an open distal end 4646 including an inlet 47 that communicates with the inner cavity 48 of the body 42. Optionally, a hub 41 can be provided on the proximal end 44, which can facilitate attaching the spinner tip 40 to the distal end 36 of the shaft 32. For example, the hub 41 can be used to substantially permanently attach the tip 40 to the shaft 32, such as by one or more of overmolding, melting, sonic welding, cooperating connectors, etc. For example, as shown, the hub 41 can include a recess that can receive the distal end 36 of the shaft 32, and the hub 41 can be bonded, melted, crimped, and / or otherwise permanently attached to the shaft 32.

[0063] Optionally, the rotator device 30 can include one or more markers, such as radiopaque rings or deposited materials, at desired locations, such as on the distal end 36 of the shaft 32 and / or the rotator tip 40, which can assist in monitoring the introduction and / or operation of the device 30 during a procedure, such as using fluoroscopy, x-ray, ultrasound, or other external imaging. Additionally or alternatively, the shaft 32 can be constructed of a radiopaque material, which can assist in monitoring the shaft 32 during introduction and / or operation during a procedure.

[0064] Go to Figures 4A-4C , shows an example of a rotator tip 40 that can be used with the devices, systems, and methods provided herein, such as at the distal end 36 of the shaft 32. For example, at Figure 4A In the embodiment of the present invention, the spinner tip 40a includes a cylindrical body 42a including a substantially uniform annular wall extending between a proximal end 44a and a distal end 46a, the distal end 46a including an inlet 47a communicating with an inner cavity 48a. The body 42a can have a substantially flat, e.g., atraumatic, distal surface, which can facilitate placement against a clot without macerating the clot as the body 42a rotates. Optionally, as Figure 4BAs shown, the tip 40b may include one or more blades, pillars or other external features on the cylinder 42b to enhance the local suction and / or shearing force on the clot, for example, a plurality of elongated blades 43b extend at least partially between the proximal end 44b and the distal end 46b of the cylinder 42b. As shown, four blades 43b are shown, which are evenly spaced around the cylinder 42b, for example, offset from each other by about 90 degrees around the circumference of the wall of the body 42b. Also as shown, the blades 43b can extend the length of the cylinder 42b, or can extend only partially between the proximal end 44b and the distal end 46b. It should be understood that, although equal spacing is shown here, unequal spacing can also be considered. In addition, although four blades are shown, any number of blades can be used, such as two, three, four, five, six, seven, etc. Similarly, it should be understood that the blades do not need to have equal sizes (e.g., length, width, height). In some variations, the blades may have unequal sizes.

[0065] Additionally or alternatively, such as Figure 4C As shown, the tip 40c can include one or more slits or other openings in the wall of the cylinder 42c, for example, extending radially outward from the cavity 48c through the wall to the outer surface of the annular body 42c. For example, as shown, an elongated slit 45c is provided between each adjacent blade 43c, and the slit 45c extends partially between the proximal end 44c and the distal end 46c of the cylinder 42c. The slit 45c can enhance the local suction within the cavity 48c and the inlet 47c, as described elsewhere herein. Optionally, as desired, slits can be provided only between some of the blades and / or multiple slits can be provided in a cylinder without blades (not shown). Although four slits and blades are shown in these examples, it should be understood that any desired number of slits and / or blades, such as two, three, four or more, can be provided on the spinner tip spaced around the annular body. Similarly, it should be understood that the slits do not need to be of equal size. Adding blades to the spinner tip and adding blades and slits can significantly increase the suction provided by the spinner tip. Figures 4A-4C The local suction generated by the spinner tips 40a-40c is shown. For example, Fig.16 Experimental results are shown comparing the local suction generated by a spinner tip without blades (hollow cylinder only, similar to 40a) and a spinner tip including blades (similar to 40b) and including blades and slits (similar to 40c) at 40,000 rom.

[0066] The various sizes of the rotator tip 40 can be sized to be inserted into a target vessel and / or to generate a desired local suction pressure, as further described elsewhere herein. In some instances, the body 42 can have a length between about 1 and 5 millimeters (1.0-5.0 mm), for example about 4.2 mm, and a wall thickness between about 0.05-0.15 mm, for example about 0.09 mm or 0.15 mm; the diameter of the inlet 47 can be between about 0.5-1.2 mm, for example about 0.72 mm or 1.2 mm. The height of the blade 43 can be between about 0.1-0.7 mm, for example, about 0.31 mm or 0.51 mm, and the width can be between about 0.1-0.5 mm, for example, about 0.24 mm or 0.40 mm. The slit 45 can have a length around a radius between about 0.5-2.5 mm, for example about 2.1 mm, and a width between about 0.2-0.8 mm, for example about 0.45 mm or 0.75 mm.

[0067] In another alternative, the spinner tip may include a plurality of spiral blades (not shown), for example, extending at least partially around the circumference of the annular body and / or along the length of the annular body. Optionally, in this alternative, one or more spiral slits or other openings may be provided between one or more spiral blades. It should be understood that in addition to or in lieu of the blades and / or slits, one or more additional features may be provided on the outer surface of the annular body that may enhance the local suction generated by the spinner tip.

[0068] Back to Figure 4 , the spinner tip 40 (or any other example described herein) can be integrally formed as a single piece, such as made from plastic, metal, composite materials, etc., such as using 3D printing, by one or more of molding, micro injection molding, casting, machining, etc. Optionally, the annular body 42 and / or hub 41 can be formed by one or more substantially continuous processes, such as extrusion, etc., for example to allow for the manufacture of a single component that can be separated into individual tips. Optionally, the annular body can be formed without slits and / or blades, which can be added or formed during subsequent processing of the annular body if desired.

[0069] The rotator tip 40 can be substantially rigid, or, alternatively, the material of the rotator tip 40 can be flexible or semi-rigid, for example, formed from a relatively soft material, such as an elastomeric material, such as silicone or a soft plastic, such that the distal end 46 of the annular body 42 provides a substantially atraumatic tip that can minimize the risk of damaging tissue contacted by the tip. For example, the rotator tip 40 can be formed from a relatively soft material, such as an elastomeric material having a stiffness of less than 40 MPa. Thus, the rotator tip 40 can be able to recover from deformation and maintain its shape, such as by bending less than about one hundred eighty degrees (180 degrees) and / or twisting less than about five hundred forty degrees (540 degrees).

[0070] Similarly, blades 43 may be formed of a flexible and / or pliable material and / or may include rounded or otherwise atraumatic outer edges, for example, to prevent damage to vessel walls and / or clot maceration as rotator tip 40 rotates.

[0071] The diameter or other outer cross-sectional dimensions of the rotator tip 40 can be sized to be received within the lumen 26 of the catheter 20 while allowing the tip 40 to rotate freely, such as by providing clearance within the lumen around the tip 40. For example, the tip 40 can have an outer diameter of between about 1.2-2.5 millimeters, such as about 2 millimeters (2 mm) or less.

[0072] Optionally, as Figure 4D As shown, the spinner tip 40 may include a drug delivery member 49, for example, for delivering one or more therapeutic and / or diagnostic agents. For example, the drug delivery member 49 may include a cylinder sized to be received in the cavity 48 of the spinner tip 40. In one example, the drug delivery member 49 may be formed of a porous material, for example, so that one or more agents can be loaded into the porous material and released, for example, when the spinner tip 40 is rotated within a blood vessel. Additionally or alternatively, the drug delivery member 49 may be formed of a bioabsorbable or dissolvable material, for example, releasing one or more agents when the material dissolves or otherwise decomposes.

[0073] Back to Figure 3, the spinner tip 40 is connected to the shaft 32, which is in turn coupled to the motor 60, which provides torque to rotate the spinner tip 40. For example, the proximal end 34 of the shaft 32 may include a connector (not shown) to couple the shaft 32 to the motor 60, such as via an external drive shaft, cable, etc. (also not shown). The motor 60 can be configured to rotate the spinner tip 40 at a desired speed, such as at least 1,000 rpm, or at least 10,000 rpm, such as between about 1,000 and 200,000 rpm, between about 4,000 and 50,000 rpm, between about 10,000 and 40,000 rpm, between about 20,000 and 40,000 rpm, or between about 30,000 and 40,000 rpm, such as about 10,000 rpm or about 40,000 rpm, which can produce a desired local suction pressure at the inlet 47 of the tip 40. For example, with the spinner tip rotating at 40,000 rpm, a local suction force of about seven thousand Pascals (7 kPa) can be generated, while at 10,000 rpm, a suction force of five hundred Pascals (0.5 kPa) can be generated, as shown in FIG. Figures 9A-9C as shown in .

[0074] In one example, the motor 60 may be configured to rotate the spinner tip 40 at a single set speed. Alternatively, the speed of the motor 60 may be variable, for example, manually operated using an actuator of a controller 62 coupled to the motor 60, which a user may adjust to modify the rotation speed of the spinner tip 40. Alternatively, the controller 62 may be configured to initially operate the motor 60 at a relatively low speed, and then may automatically increase the speed to rotate the spinner tip 40 at a desired active speed. For example, the initial speed may be used to mechanically engage a clot, and then the speed may be increased, for example, to rapidly remove red blood cells from the clot and reduce the clot size, as described elsewhere herein.

[0075] Unlike prior aspiration thrombectomy devices that require continuous extraction of blood from the treated vessel, the rotator devices herein can generate a high degree of localized suction without removing any fluid from the vessel. Optionally, these devices can be used in conjunction with aspiration, such as by connecting a vacuum source 64 to the catheter 20 or introducing a separate suction device (not shown), as further described elsewhere herein.

[0076] The controller 62 can be coupled to the motor 60 to control the operation of the device 10, for example, to allow a user to turn the motor 60 off and on in order to rotate the rotator tip 40 and generate local suction with the blood vessel. Optionally, if desired, the controller 62 can include one or more actuators, such as switches, etc. (not shown), to activate / deactivate the motor and / or adjust the speed. Additionally or alternatively, the controller 62 can include an actuator (also not shown) to axially advance and / or retract the shaft 32, for example relative to the catheter 20, for example, using a pusher device 150, such as Fig. 12A and 12B In another alternative, controller 62 may include a robotic control system to remotely control axial movement of shaft 32, if desired.

[0077] In one example, the rotator device 30 and the catheter 20 are assembled together, for example, so that the catheter 20 and the rotator device 30 are introduced into the patient's body together, for example, similar to Fig. 12A and 12B 150 shown in . Thus, the device described herein is part of a preassembled system or kit. Optionally, the rotator device 30 can be separate from the catheter 20, i.e., including the shaft 32 and the rotator tip 40, such that, for example, the catheter 20 can be initially introduced into the patient's body, and once the distal end 24 and the outlet 25 are positioned near the target clot, the rotator device 30 can be introduced into the catheter 20 and advanced to position the rotator tip 4 near the outlet 25. In this way, the device described herein can be assembled before or during use. In this example, the handle 50 of the catheter 20 can include a port 52a that allows the rotator device 30 to be inserted into or removed from the lumen 26 of the catheter 20, and the lumen 26 can include one or more hemostatic seals, for example, to prevent fluid from leaking from the port 52a while allowing the shaft 32 of the rotator device 30 to be advanced into the lumen 26 through the port 52a. Alternatively, the rotator device 30 may be permanently integrated with the catheter 20 , for example, such that the rotator device 30 cannot be removed but may be axially advanced and / or retracted within the lumen 26 , for example using the pusher device 150 .

[0078] Optionally, the catheter 20 and / or the shaft 32 may include one or more stops or other safety features (not shown) to limit the axial movement of the shaft 32, thereby helping to prevent accidental shearing of non-clot tissue during use. For example, a stop may be provided within the handle 50 that prevents the rotator device 30 from advancing, thereby exposing the rotator tip 40 from the outlet 25 of the catheter 20. Optionally, if desired, the stop may allow the rotator tip 40 to be partially or completely exposed from the outlet 25. Optionally, another stop may be provided that allows the rotator tip 40 to be retracted proximally from the outlet 25 a desired distance, for example, to allow residual fibers from a reduced or dissolved clot to be drawn into or otherwise directed into the outlet 25, as further described elsewhere herein. In another alternative, the rotator device 30 may be axially fixed relative to the catheter 20, for example, so that the rotator tip 40 is located within the lumen 26, and the distal end 46 of the rotator tip 40 is located proximal to the outlet 25.

[0079] If the rotator device 30 is permanently integrated with the catheter 20, the proximal end 34 of the shaft 32 can extend from the port 52a on the handle 50 (regardless of whether the shaft 32 is axially movable or axially fixed). The proximal end 34 of the shaft 32 can include a connector configured to couple the shaft 32 to a drive shaft (not shown) of the motor 60, for example, to allow the thrombectomy device 10 to be connected and disconnected from the motor 60. In this example, the thrombectomy device 10 can be a single-use unitary device that can be provided to the user for use during a surgical procedure, after which the device 10 can be discarded. Alternatively, if the rotator device 30 is provided separately from the catheter 20, both can be single-use and / or disposable, or one or both can be reused, for example after cleaning and / or sterilization. In a further alternative, the rotator device 30 can be positioned in the patient's body and / or introduced into the patient's body without the catheter 20, if desired.

[0080] Optionally, as Fig. 12A and 12B As shown, the pusher device 150 can be disposed on the proximal end of the thrombectomy device, for example, instead of Figure 3 10. Generally, the pusher device 150 includes a fixed handle portion 152 coupled to the proximal end 122 of the catheter 120, and a slider portion 154 coupled to the shaft 132, which carries a rotator tip (not shown) at its distal end. The catheter 120, shaft 132, and rotator tip can be generally similar to any other device described herein, similar to Figure 3The device 10 is configured as shown. Optionally, a sleeve 121 may be disposed around the shaft 132 and extending through the conduit 120 to protect the inner surface of the conduit 120 as the shaft 132 rotates, similar to other devices herein.

[0081] The components of the pusher device 150 can be disposed within a housing, for example, including a clamshell or other parts (not shown) that can be attached together, for example, to protect the internal components. Optionally, the outer surface of the housing can be contoured to provide a grip to facilitate holding and / or manipulating the device, or the housing can include a base or other structure for stabilizing the housing relative to the patient during the procedure. Optionally, as shown in FIG. Fig. 12B As shown, the pusher device 150 may include a motor 160 and / or a battery 162 or other power source, for example, for driving the shaft 132 to rotate the spinner tip, similar to other devices described herein.

[0082] As shown, the slider 154 is slidably received in a track or other guide in the stationary portion 152, for example, so that the slider 154 can be axially guided between a first or proximal position and a second or distal position, for example, to advance and retract the rotator tip relative to the distal end (not shown) of the catheter 120, similar to other devices herein. As shown, a screw 156 or other actuator can be coupled to the slider 154, for example, to allow an operator to manually guide the slider 154 between the first and second positions. Optionally, the screw 156 can include a fastener that can be actuated to secure the slider 154 in a desired position, for example, to secure the rotator tip relative to the distal end of the catheter 120 once deployed during a surgical procedure. Although a slider is shown here, any suitable actuation member and / or method can be used, such as a button, a knob, and / or a combination thereof.

[0083] During use, with the rotator tip retracted into the catheter 120, the distal end of the catheter 120 can be introduced into the patient and advanced to a target location, for example, near a clot in the patient's vascular system (not shown). Once positioned, the screw 156 can be actuated to advance the rotator tip relative to the catheter 120, for example, to place the distal side of the rotator tip against the clot or in close proximity to the clot, similar to other devices herein. Once advanced to the desired position, the screw 156 can be used to lock the relative position of the rotator tip in the catheter 120. The motor 160 can then be activated to rotate the rotator tip to dissolve and / or reduce the clot, similar to other devices herein. Once the clot is treated, the screw 156 can be actuated to retract the rotator tip into the catheter 120, and the device can be removed (or directed to one or more additional locations to treat additional clots).

[0084] Any of the devices, systems, and methods described herein can optionally include a vacuum source. Figure 3 As shown, the device 10 may include a vacuum source 64, such as a syringe, aspiration line, etc. (not shown), which can be coupled to the proximal end 22 of the catheter, such as to the port 52b on the handle 50, for drawing material into the lumen. For example, the port 52b may include a Luer connector or other connector that allows a tube from the vacuum source 64 to be removably connected to the port 52b. Before or during the advancement and / or activation of the rotator tip 40 to reduce or dissolve the clot, the vacuum source 64 may be activated (or if desired, immediately after the rotator tip 4 is advanced) to draw dissolved fibrin or other remaining clot material into the lumen 26 of the catheter 20, as further described elsewhere herein. The rotator tip 40 may also help reorient and / or reposition the clot relative to the catheter 20, for example, to enhance contact between the clot and the outlet 25, which may enhance vacuum aspiration from the lumen 26.

[0085] Additionally or alternatively, a fluid source, such as a syringe of saline, contrast media, etc., can be connected to port 52b (or, if desired, to a separate dedicated port, not shown). Thus, during use of catheter 20, lumen 26 can be flushed and / or fluid delivered through outlet 25, if desired.

[0086] Optionally, the thrombectomy device 10 and / or the rotator device 30 can be included in a system or kit that includes one or more additional devices for use during a thrombectomy procedure. For example, the system can include an occlusion device and / or capture member (not shown) to prevent fragments of the clot being treated from migrating elsewhere within the patient's vasculature. For example, such a device can be introduced and deployed from the catheter 20, such as through the lumen 26 or a secondary lumen. Alternatively, these devices can be introduced and deployed independently of the rotator device, for example, through a separate catheter, sheath, or other device (not shown) downstream of the target clot.

[0087] Suitable additional devices for the systems or kits described herein may include, for example, a device may be provided to carry a balloon or other expandable member that can be introduced into a body cavity spaced apart from and / or near the rotator tip 40 and / or catheter outlet 25, and the expandable member can be expanded to at least partially block the body cavity to prevent the migration of clotted material from the body cavity. Optionally, a capture member may be provided for introduction into the body cavity near the rotator tip, for example, to capture residual fibrin material from a clot being treated by the rotator tip. Such capture members may include filters, snares, cages, etc.

[0088] The devices and systems herein can be used during thrombectomy procedures. For example, the rotator device 30 can be introduced into a body cavity near a target blood clot, such as a vein, artery, etc., and the rotator tip 40 can be rotated to generate local suction, for example, to generate a local fluid dynamic force that combines compression and shear forces to dissolve the clot, reduce the size of the clot, and / or prevent the clot from fragmenting in the body cavity. For example, the rotator device can be deployed to reduce or otherwise dissolve the clot, such as by separating red blood cells from fibrin and / or other fibrous materials. The red blood cells can be simply released within the blood vessel, for example, so that the cells are metabolized by the body, and the fibrin can be captured, such as directly captured by the cavity of the rotator device, or captured using suction, capture devices, etc., and / or treated with thrombolytic drugs or other agents to decompose, dissolve, and / or otherwise neutralize the residual material before the rotator device is removed from the patient's vascular system.

[0089] exist Figure 5A and 5B In the exemplary method shown, the distal end 24 of the catheter 20 can be initially introduced into the patient from a percutaneous access site, such as over a guidewire or other track (not shown) positioned within the patient's vasculature. The distal end 24 can be advanced to position the outlet 25 within the blood vessel 90 near the target clot 92, such as Figure 5A shown.

[0090] The rotator tip 40 can be introduced into the lumen 26 from the proximal end of the catheter 20 and advanced to position the inlet 47 near the outlet 25 of the catheter 20 and thus near the clot 92, such as Figure 5A Optionally, as described elsewhere herein, the rotator device 30 can be disposed within the catheter 20, for example, such that the rotator tip 40 is positioned proximate the clot 92 while the catheter 20 is introduced. Optionally, a sleeve (not shown) can be disposed within the lumen 26 around the shaft 32, which can be introduced with the rotator device 30 or can be introduced into the lumen 26 prior to inserting the rotator device 30.

[0091] Optionally, manipulation of the catheter 20 and / or rotator device 30 can be monitored using external imaging, such as fluoroscopy, x-ray, ultrasound, etc. For example, as described elsewhere herein, the rotator device 30 can include one or more radiopaque markers, such as on the distal end 36 of the shaft 32 and / or the rotator tip 40, and / or the shaft 32 can be formed of a radiopaque material, which can be monitored to facilitate positioning the rotator tip 40 near the clot 92. Optionally, a contrast agent can be introduced into the vessel 90, such as through port 52b, a separate port on the proximal end 22 of the catheter 20, or a separate device (not shown) to facilitate locating the clot 92 and positioning the rotator tip 40, which can be introduced through the catheter 20 (e.g., through the main lumen 26 or a separate lumen) or through a separate device. Additionally or alternatively, the catheter 20 and / or rotator device 30 can be monitored using intravascular imaging systems and methods, such as intravascular ultrasound imaging, optical coherence tomography, etc.

[0092] Once the device is positioned as desired relative to the clot 92, the spinner tip 40 can be rotated, for example by activating the motor 60 (e.g. Figure 3 24 ) to generate local suction within the inlet 47, thereby drawing the clot 92 toward the distal end 24 of the catheter 20, for example, pressing the clot 92 toward the distal end 46 of the rotator tip 40. As described above, the speed of the rotator tip 40 can be fixed or adjustable, for example, manually by a user and / or automatically by the controller 60. For example, the rotator tip 40 can be positioned against or adjacent to the clot 92 and rotated to generate a shear force that separates red blood cells from the clot. In one approach, only the distal side of the rotator tip 40 is placed in contact with the clot, and the rotator tip 42 does not rotate within the clot 92, for example to prevent maceration.

[0093] Unlike other thrombectomy devices that attempt to capture or macerate the entire clot (causing the clot to break into fragments), the devices and systems of the present disclosure help separate the red blood cells of the clot from the complex fibrin network, resulting in greater efficiency and efficacy. That is, the rotational motion of the rotator tip 40 can generate shear forces that, combined with the compression of the suction force, squeeze out the red blood cells captured in the clot 92, which can escape from the cavity 48 of the rotator tip 40 into the blood vessel through the slit 43 and / or otherwise. Therefore, unlike the macerator device that mechanically breaks the clot into fragments and places the fragments at risk of traveling to other locations in the patient's body, the device herein allows the removal of red blood cells to reduce the volume of the clot without breaking up the residual fibrin material. As described elsewhere herein, the residual material can remain substantially intact and then be removed. Additionally, whereas macerator devices may be unable to disrupt the rich and / or hard fibrin network of some clots and thus may be unable to remove these clots, the devices herein allow for capture and / or otherwise removal of these residual fibrin networks regardless of the hardness of the residual material.

[0094] For example, Figures 9A-9C As shown in Figure 2, increased rotation speed may result in higher local suction forces. Fig.13 As shown in Figure 2, the suction force is positively correlated with the efficiency of clot dissolution. Fig.13 As shown, the reduction effect is expressed as the time taken for the clot to reach a certain volume reduction (in this experiment, 70% volume reduction was chosen as the evaluation criterion). At 40000 rpm, no thrombus fragmentation was observed. At even higher rotation speeds, the clot lysis efficiency is expected to increase. Fig.11A and 11B FIG. 4 shows exemplary pressures and local flows that may occur when the spinner tip 40 is rotated at various speeds, for example, as shown in FIG. Figures 9A-9C and 10.

[0095] Thus, the spinner tip 40 can separate the red blood cells quickly, for example in less than two minutes, leaving behind a compacted fibrin fiber network 94, for example Figure 5B Optionally, additional vacuum may be applied, for example, by connecting a vacuum source 64 to the proximal end 22 of the catheter 20, as shown. Figure 3As shown, the catheter 20 can be moved out of the vessel 90 once the residual fibrous network 94 has been captured, for example, and completely removed from the patient's body. As described above, for safety, the methods described herein may also utilize a device having one or more stops.

[0096] Figures 6A-6C An example of the changes in a blood clot (generated from porcine blood in this example) during rotation of the rotator tip of a thrombectomy device from zero to three minutes (0-3 minutes) is shown. Figure 6B and 6C As shown, it can be clearly seen that the size of the clot is significantly reduced and the color of the clot changes from red to white. This is due to the shear force generated by the rotational suction, which effectively spins all the red blood cells (RBCs) out of the original clot. Since the blood clot is mainly composed of RBCs trapped in the fibrin fiber network, such as Figure 7 As shown, removal of the RBCs leaves only a fibrin fiber network that is less than 10% of the initial clot volume. Fig. 8A and 8B The SEM images of the clot before and after rotation are included, respectively, further showing that the original clot is rich in RBCs and the clot after rotation is a highly dense network of fibrin fibers.

[0097] The spinner tip can be flexible or semi-rigid and operated at relatively low rpm (e.g., between about 4,000 and 50,000) for separating red blood cells from the fibrin network, rather than sharp blades that rotate at high rpm (e.g., 150,000 to 200,000) to perform maceration. The holes and cutting features of the spinner can enhance suction to press the clot firmly against the distal surface of the spinner tip, thereby ensuring maximum shearing of the clot.

[0098] Figures 9A-9C Examples of the performance of various spinner tips under different simulation conditions are shown, for example, involving positioning the spinner device within a tube, such as a three-millimeter tube, for simulating intravascular spinner tip operation. Fig.9AThe local suction force that can be generated when the spinner tip is rotated at different speeds is shown. The local pressure drop indicates the amount of compressive force generated and can be adjusted by changing the rotation speed, thus showing that clot lysis efficiency is adjustable and can be improved using higher rotation speeds. Fig. 9B Examples of centerline pressure curves for a spinner device with a normalized blade length of 0.87 (blade length, L normalized to the inner diameter r) at rotational speeds of 10k, 20k, 30k and 40k rpm are shown. Fig. 9C Various blade lengths were compared at a rotation speed of 40k rpm. Fig. 9C As shown, simulations were performed to optimize the spinner suction capacity for a normalized blade length. When the normalized blade length was 0.87 and was selected as the geometric design of the spinner tip, the optimized suction was achieved. Fig.10 Additional examples of pressure distribution at the centerline of a spinner device with different blade sizes during rotation are shown.

[0099] Optionally, as Figure 4D As shown, the drug delivery member 49 can be disposed in the cavity 48 of the rotator tip 40. For example, a cylinder preloaded with one or more desired reagents can be inserted into the rotator tip 40 just before surgery, or can be disposed in the rotator tip 40 during manufacturing. Alternatively, one or more reagents can be loaded into the drug delivery member 49 just before surgery and inserted into the cavity 48 during surgery to deliver the reagents. For example, as described elsewhere, when the rotator tip 40 rotates, the reagent can be released, and optionally, the release rate of the reagent can be adjusted to the rotation speed of the rotator tip 40. In another option, if necessary, a fluid, such as saline, etc., can be introduced through the lumen 26 of the catheter 20 to facilitate the release of the reagent from the rotator tip 40 into the blood vessel.

[0100] Optionally, additional references Figure 3 , a controller 62 coupled to the motor 60 may be used to adjust the rotational speed of the shaft 28, for example, to control the release rate of one or more agents carried by the drug delivery member, for example, one or more of a clot dissolving agent, a diluent, an anti-inflammatory agent, a dye, a contrast agent, and / or other therapeutic and / or diagnostic agent. For example, Fig.14 Results of experiments using a spinner tip to control drug release (e.g., release of the clot-dissolving drug tPA (tissue plasminogen activator), the first line of treatment for acute ischemic stroke) are shown, showing drug release rates at different rotation speeds. At relatively low rotation speeds, such as about 10,000 rpm, the drug release rate (expressed as the percentage of drug stored in the spinner tip that is released per second) is lower than when the spinner tip is rotated at a high rotation speed (e.g., about 40,000 rpm). Fig.15A and 15B As shown, the intensity of the released dye color indicates different release rates, e.g. Fig.15A The greater intensity shown indicates a faster release rate at 40,000 rpm, Fig. 15B The lighter intensity shown indicates a slower release rate. Thus, the operator can manually adjust the speed to control the release rate, and / or the controller 62 can be configured to automatically adjust the speed to provide a predetermined release rate.

[0101] Although the invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and described in detail herein. However, it should be understood that the invention is not limited to the specific forms or methods disclosed, but rather, the invention will cover all modifications, equivalents and alternatives falling within the scope of the appended claims.

Claims

1. A thrombectomy device, comprising: an elongated shaft including a proximal end configured to be coupled to a controller for rotating the shaft, a distal end sized for introduction into a body cavity of a patient, and a longitudinal axis extending therebetween, the shaft being configured to rotate about the axis; and A rotator tip on the distal end is configured to generate localized suction near the distal end when the shaft is rotated to reduce clot size, separate red blood cells from fibrin, and / or prevent clot fragmentation within the body cavity.

2. The device according to claim 1, wherein the rotator comprises an annular body extending distally from the distal end, so that an opening communicating with a cavity within the annular body can be positioned near the clot to apply the local suction force to the clot.

3. The device of claim 2, further comprising one or more blades on the annular body.

4. The device of claim 3, wherein the one or more blades include a plurality of blades on an outer surface of the annular body.

5. The device according to claim 4, wherein the blades extend axially and / or helically along the annular body.

6. The device according to any one of claims 2-5, further comprising one or more slits in the wall of the annular body.

7. The device of claim 6, wherein the one or more slits comprise a plurality of slits extending axially along the annular body between the cavity and the outer surface of the annular body.

8. A thrombectomy device, comprising: an elongated shaft including a proximal end configured to be coupled to a controller for rotating the shaft, a distal end sized for introduction into a body cavity of a patient, and a longitudinal axis extending therebetween, the shaft being configured to rotate about the axis; and a spinner tip at the distal end configured to generate localized suction near the distal end when the shaft is rotated to reduce clot size, separate red blood cells from fibrin, and / or prevent clot fragmentation within the body cavity, the spinner tip comprising: an annular body extending distally from the distal end so that an opening communicating with a lumen within the annular body can be positioned proximate to the clot to apply the localized suction force to the clot; a plurality of vanes on an outer surface of the annular body; and A plurality of slots proximate the vanes extend between the cavity and an outer surface of the annular body.

9. The device of claim 8, wherein the annular body and blades are formed of a flexible material.

10. The device of claim 9, wherein the blade comprises a substantially atraumatic outer edge.

11. The device of claim 8, wherein the distal surface of the annular body is substantially flat.

12. The device of any one of claims 2-5 and 8-11, further comprising a drug delivery member received within the cavity carrying one or more agents.

13. The device of claim 12, wherein the drug delivery member comprises a porous body carrying the one or more agents.

14. The device of claim 12, wherein the drug delivery member is configured to dissolve to release the one or more agents.

15. The device of claim 14, further comprising a controller coupled to the shaft, the controller configured to adjust the rotational speed of the shaft to control the release rate of the one or more agents.

16. The device of any one of claims 1-5 and 8, wherein the spinner tip is formed of a flexible or rigid material.

17. The device of any one of claims 1-5 and 8-11, further comprising a motor coupled to the proximal end for rotating the shaft about the axis, and a controller coupled to the motor end for controlling the rotation of the shaft.

18. The apparatus of claim 17, wherein the controller is configured to rotate the shaft at a speed of at least 1000 rpm.

19. The apparatus of claim 17, wherein the controller is configured to rotate the shaft at a speed of at least 10,000 rpm.

20. The device according to any one of claims 1-5 and 8-11 further includes a tubular member, wherein the tubular member includes a proximal end, a distal end sized to be introduced into a body cavity, and a lumen extending between the proximal end and the distal end, wherein the lumen is sized to receive the shaft so that the rotator tip can be advanced from the distal end within the body cavity.

21. The device of claim 20, further comprising a vacuum source coupled to the tubular member for drawing material from the distal end into the lumen.

22. The device of claim 20, further comprising a pusher device coupled to the proximal end of the tubular member.

23. The device of claim 22, wherein the pusher device comprises an actuator coupled to the proximal end of the shaft for advancing the shaft relative to the catheter to deploy the rotator tip from the distal end of the catheter.

24. The device of claim 23, wherein the actuator comprises a slider movable between a first position and a second position for advancing the rotator tip from the distal end of the catheter and retracting the rotator tip to the distal end of the catheter.

25. The device of claim 22, further comprising a motor within the housing of the pusher device, the motor coupled to the proximal end of the shaft for rotating the shaft.

26. The apparatus of claim 25, further comprising a power source within the housing, the power source coupled to the motor to provide power to the motor for rotating the shaft.

27. The device according to any one of claims 1-5 and 8-11 further includes an expandable member configured to be introduced into a body cavity near the tip of the rotator, the expandable member being expandable to at least partially occlude the body cavity to prevent material from the clot from migrating from the body cavity.

28. The device of any one of claims 1-5 and 8-11, further comprising a tubular member configured to be introduced into a body cavity proximate the rotator tip to prevent material from the clot from migrating from the body cavity.

29. The device of claim 28, wherein the tubular member is configured to be advanced on the shaft such that an inlet of the tubular member is positioned proximate the rotator tip.

30. The device of claim 28, wherein the tubular member is configured to be introduced separately from the rotator device such that an inlet of the tubular member is spaced distally from the rotator tip.

31. The device according to any one of claims 1-5 and 8-11 further includes a capture member configured to be introduced into a body cavity near the spinner tip, and the capture member is configured to capture material from the clot processed by the spinner tip.

32. The device of claim 31, wherein the capture member comprises one of a filter, a snare, and a cage.

33. The device according to any one of claims 1-5 and 8-11 further includes a suction member configured to be introduced into a body cavity near the rotator tip, and the capture member is connected to a material source to suck material from the clot processed by the rotator tip.

34. A thrombectomy device, comprising: a tubular member comprising a proximal end, a distal end sized for introduction into a body cavity proximate a clot, and a lumen extending from the proximal end to an outlet in the distal end; an elongated shaft including a proximal end configured to be coupled to a controller for rotating the shaft, a distal end sized for introduction into the lumen, and a longitudinal axis extending therebetween, the shaft being configured to rotate about the axis; and A spinner tip on the distal end of the shaft is configured to generate localized suction near the outlet when the shaft is rotated to reduce clot size of a clot within the body cavity near the outlet.

35. The device of claim 34, wherein the shaft is axially movable within the lumen to position the rotator tip proximate the outlet.

36. The device of claim 35 further comprising one or more stops that limit axial movement of the shaft to prevent advancement of the spinner tip from the outlet.

37. The device of claim 34, wherein the rotator tip is positioned within the lumen proximate to the outlet to generate the localized suction.

38. The device of claim 37, wherein the shaft is axially fixed relative to the tubular member.

39. The device of claim 34, further comprising a port on the proximal end of the tubular member, the port configured to be connected to a vacuum source, the port communicating with the lumen to generate suction into the outlet.

40. The device of claim 39, wherein the spinner tip is positioned within the lumen proximate to the outlet to generate the local suction and shear forces to squeeze red blood cells from the clot, and wherein the suction is generated to draw the remaining fiber network into the lumen.

41. A system for performing a thrombectomy procedure, comprising: The thrombectomy device according to any one of claims 1-5, 8-11 and 34-40; and a motor coupled to the proximal end of the shaft to rotate the shaft about an axis; and A controller is coupled to the motor to control operation of the motor.

42. The system of claim 41 further comprising a vacuum source coupled to the proximal end of the tubular member and in communication with the lumen for generating suction into the outlet.

43. A system according to claim 42, wherein the rotator tip is positioned within the tubular cavity adjacent to the outlet to generate the local suction force to squeeze the red blood cells from the clot, and the system further includes an actuator for guiding the rotator tip proximally when the vacuum source is activated to draw the remaining fiber network into the tubular cavity.

44. A system for performing a thrombectomy procedure, comprising: a tubular member comprising a proximal end, a distal end sized for introduction into a body cavity proximate a clot, and a lumen extending from the proximal end to an outlet in the distal end; an elongated shaft comprising a proximal end, a distal end sized for introduction into the lumen, and a longitudinal axis extending therebetween; a motor coupled to the proximal end of the shaft to rotate the shaft about the axis; and A rotator tip on the distal end of the shaft is configured to generate localized suction near the outlet when the shaft is rotated to reduce clot size of clots within the lumen near the outlet.

45. The system of claim 44, further comprising a controller coupled to the motor to control operation of the motor.

46. ​​The system of claim 44, further comprising a vacuum source coupled to the proximal end of the tubular member and in communication with the lumen for generating suction into the outlet.

47. A system according to claim 46, wherein the rotator tip is positioned within the tubular cavity adjacent to the outlet to generate the local suction force to squeeze red blood cells from the clot, and the system further includes an actuator for guiding the rotator tip proximally when the vacuum source is activated to draw the remaining fiber network into the tubular cavity.

48. The system of claim 44, wherein the shaft and rotator tip comprise a thrombectomy device according to any one of claims 1-5 and 8-11.

49. A system according to any one of claims 44-47, wherein the rotator tip includes an annular body, the annular body including a cavity and an inlet, the inlet being positioned near the clot to apply the local suction and shear forces to the clot when the rotator device rotates.

50. The system of any one of claims 44-47, further comprising a drug delivery member carrying one or more agents within the cavity, and wherein the one or more agents are released upon rotation of the rotator device.

51. The system of any one of claims 44-47, further comprising a sleeve received around the shaft.

52. A system according to claim 51, wherein the sleeve includes a proximal end, a distal end sized to be introduced into the cavity independently of the shaft, and a sleeve lumen sized to receive the rotator tip, the sleeve having a sufficient length so that the sleeve distal end can be positioned near the outlet and the sleeve proximal end is exposed from the proximal end of the tubular member before the rotator tip and the shaft are introduced into the sleeve lumen.

53. A system according to claim 51, wherein the sleeve is connected to the shaft so that the sleeve can be introduced into the tubular cavity simultaneously with the shaft, and the sleeve includes a proximal end arranged near the proximal end of the shaft and a distal end positioned near the tip of the rotator so that when the shaft rotates, the sleeve surrounds the shaft to prevent contact with the inner surface of the tubular member.

54. A method for performing thrombectomy, comprising: introducing a spinner device into a body cavity proximate to a target blood clot; and The rotator device is rotated to generate localized suction, such as to generate compression and / or shear forces, thereby lysing the clot, separating red blood cells from fibrin, reducing clot size, and / or preventing the clot from fragmenting.

55. The method of claim 54, wherein the spinner device rotates at a speed of at least 1000 rpm.

56. The method of claim 54, wherein the spinner device rotates at a speed of at least 10,000 rpm.

57. The method of claim 54, further comprising introducing the distal end of the tubular member into the body cavity until an outlet thereof is positioned proximate to the target blood clot, wherein the rotator device is positioned within the lumen of the tubular member proximate to the target blood clot prior to rotating the rotator device to generate the local suction.

58. The method of claim 57, wherein the rotator device is introduced simultaneously with the introduction of the tubular member into the body cavity.

59. The method of claim 57, wherein after introducing the tubular member into the body cavity, the rotator device is introduced into the lumen of the tubular member and advanced to position the rotator device proximate the outlet.

60. The method of claim 57, further comprising aspirating residual clot material from the clot into the lumen of the tubular member after rotating the rotator device.

61. The method of claim 57 further comprising creating a vacuum within the lumen of the tubular member, wherein the rotator device creates the local suction to squeeze red blood cells from the clot, and wherein the vacuum draws the remaining fiber network into the lumen.

62. The method of claim 54, wherein the rotator device comprises: An annular body includes a cavity and an inlet, the inlet being positioned adjacent the clot to apply the localized suction to the clot as the rotator device rotates.

63. The method of claim 62, further comprising a drug delivery member carrying one or more agents within the cavity, and wherein the one or more agents are released upon rotation of the rotator device.

64. The method of claim 54, wherein the rotator generates a fluid dynamic force that combines compression and shear forces to separate red blood cells from the clot.

65. A method for performing thrombectomy, comprising: introducing a thrombectomy device into a body cavity proximal to a target blood clot; and The device is activated to generate localized suction, producing compression and shear forces that separate red blood cells from the clot, leaving behind a compacted network of fibrin fibers.

66. The method of claim 65, wherein activating the device comprises rotating the device about its longitudinal axis to generate the localized suction.

67. The method of claim 65, further comprising removing the compacted fibrin fiber network from the body cavity.

68. A tethered biomedical device comprising: an elongated flexible tether having a proximal end and a distal end; a tool head disposed on a distal end of the tether, the tool head comprising a tubular body having a lumen extending axially along a central axis of the tubular body of the tool head, the tool head being configured to perform ablation of body tissue and generate suction when the tool head is rotated; The tether is configured to be rotated by a rotary drive coupled to a proximal end of the tether to rotate the tool head to generate suction.

69. The tethered biomedical device of claim 68, wherein: The tether is one of a catheter and a guidewire configured to be advanced along a path within the body by navigating the tether using a combination of pushing, pulling, and turning to guide the tether to position the tool head at a target location.

70. The tethered biomedical device of claim 68, wherein: The tool head has one or more blades disposed on an outer surface of the tool head and extending radially outwardly therefrom.

71. The tethered biomedical device of claim 70, wherein the tubular body has a plurality of holes through the tubular body wall.

72. The tethered biomedical device of claim 71, wherein the holes in the tubular body are angularly spaced around the tubular body.

73. The tethered biomedical device of claim 72, wherein the apertures in the tubular body are positioned between the blades.

74. The tethered biomedical device of claim 72, further comprising a tubular member comprising a proximal end, a distal end sized for introduction into a body cavity near a clot, and a lumen extending from the proximal end to an outlet in the distal end, the shaft and tool head being disposed within the lumen.

75. The tethered biomedical device of claim 74, wherein the shaft is axially movable relative to the tubular member to advance the tool head from the distal end of the tubular member.

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