Apparatus, system, and method for performing a thrombus removal treatment

Abstract

A thrombus removal device is provided. The thrombus removal device includes an elongated shaft having a proximal end coupled to a motor configured to rotate the shaft, a distal end sized to be introduced into a patient's body cavity, and a longitudinal axis extending between the proximal end and the distal end, the shaft being configured to rotate about this axis, and a spinachip provided at the distal end and configured to generate a local suction force adjacent to the distal end when the shaft rotates. The spinachip is introduced into or provided within the lumen of a catheter having an outlet at the distal end and is disposed adjacent to the thrombus. With the spinachip disposed adjacent to the outlet, for example, within the catheter lumen, the motor is actuated to generate a local suction force, thereby, for example, dissolving the thrombus, reducing the size of the thrombus, and / or preventing fragmentation of the thrombus.

Description

Technical Field

[0001] This application relates to medical devices, and more particularly, to thrombus removal devices, and systems and methods for performing thrombus removal or other medical procedures using such devices.

[0002] Statement on Federally Sponsored Research and Development This invention was made with government support under Contract No. 2145601 awarded by the National Science Foundation. The government has certain rights in this invention.

[0003] Related Application Data This application claims the benefit of U.S. Provisional Application No. 63 / 339,504, filed May 8, 2022, U.S. Provisional Application No. 63 / 418,449, filed October 21, 2022, and U.S. Provisional Application No. 63 / 453,152, filed March 19, 2023. The entire disclosures of U.S. Provisional Application No. 63 / 418,449 and U.S. Provisional Application No. 63 / 452,152 are hereby incorporated by reference in their entirety.

Background Art

[0004] Thromboembolism, commonly referred to as a blood clot, is the result of blood coagulation in a vein or artery (see, e.g., FIG. 1A), which impedes the normal flow of blood to a part of the body. Blood clots can occur in many places in the body (see, e.g., FIG. 1B), and for example, a blood clot in a deep vein in the leg or arm can cause deep vein thrombosis (DVT), and the blood clot can move from the deep vein to the lungs and cause pulmonary embolism (PE), or move from an artery to the brain and cause a stroke, which are life-threatening diseases. Blood clots can cause venous thromboembolism, pulmonary embolism, cerebrovascular stroke, peripheral arterial occlusion, coronary thrombosis and / or acute myocardial infarction depending on their location within the subject's vascular system.

[0005] According to the CDC, venous thromboembolism affects approximately 900,000 Americans each year. Every year, thromboembolism causes more than 100,000 deaths. One in four people who develop PE die without any warning signs. Even more tragically, for women during pregnancy or immediately after childbirth, PE is a leading cause of death. Additionally, thrombosis is the second leading cause of death for cancer patients after cancer itself. To address issues related to thrombosis, the United States spends up to $10 billion annually, with treatment costs ranging from $15,000 to $20,000 per person, and readmissions are not uncommon.

[0006] Acute ischemic stroke (AIS) is a major cause of physical disability in the United States and the fifth leading cause of death. AIS occurs due to the blockage or interruption of blood flow in the carotid or cerebral arteries. When blood flow to the brain is insufficient, irreversible brain damage (core infarction) or neuronal dysfunction in brain tissue in an ischemic state but potentially recoverable (penumbra) may occur. AIS can potentially be treated with intravenous thrombolysis within 3 to 4.5 hours of symptom onset, but less than 5% of AIS patients receive medical care within this time frame.

[0007] Percutaneous thrombectomy is a minimally invasive interventional treatment in which a surgeon inserts a catheter into a patient's blood vessel to remove a thrombus and restore blood flow to the affected area. Commonly used mechanical thrombectomy techniques for removing large thrombi include (i) aspiration thrombectomy, which induces continuous vacuum aspiration through a guiding catheter to aspirate the thrombus, and (ii) stent retriever thrombectomy, which uses a mesh tube to extract the thrombus as shown in Figure 2A. However, the use of stent retrievers and aspiration devices always carries the risk of thrombus fragmentation. For example, as shown in Figure 2B, a large thrombus may break into small fragments (100 μm to 1000 μm) and flow downstream in the blood vessel, blocking blood flow at multiple other locations or causing a life-threatening embolism that requires emergency laparotomy.

[0008] More recently, endovascular thrombectomy using an aspiration device or stent retriever as shown in FIG. 2A has been shown to be an effective treatment for acute ischemic stroke (AIS) with large vessel occlusion (AIS-LVO) of the internal carotid artery, proximal middle cerebral artery, proximal anterior cerebral artery, or vertebral artery within up to 24 hours from symptom onset. Thrombectomy has significantly improved the outcome of AIS-LVO patients, and such thrombectomy has become the standard treatment for AIS patients with AIS-LVO.

[0009] Despite recent advances in AIS treatment, there is a significant gap between knowledge and available devices, which limits the optimal treatment of AIS. In current thrombectomy, after multiple passes, blood flow does not recover or is insufficient in about 15% of patients, and the failure rate of the aspiration method is about 25 - 33%. Common reasons for thrombectomy failure include thrombi with high fibrin content, fragmentation of thrombi that prevents complete removal, and thrombi resistant to the latest thrombectomy devices. Furthermore, recent data indicate that to achieve maximum efficacy, thrombectomy needs to restore blood flow to about 95 - 100% distal to the arterial occlusion site, and to maximize the likelihood of good outcomes, this blood flow should be restored in a single thrombectomy (the "first pass effect"). However, the first pass effect has been achieved in less than about 50% of patients who undergo thrombectomy, and there is a strong need for the development of new thrombectomy devices to improve the thrombectomy process.

[0010] Therefore, improved devices and methods for performing thrombectomy procedures would be useful. SUMMARY OF THE INVENTION

[0011] This application is directed to medical devices, and more particularly, to thrombectomy devices, and systems and methods for performing thrombectomy or other medical procedures using such devices. In one example, the device includes a spinner device that is introduced via a catheter or other tubular member (or directly into a body cavity), and mechanically reduces or compresses the volume of a thrombus, and / or separates the components of the thrombus (e.g., separates red blood cells from fibrin or other residual fibrous material), and / or lyses or partially lyses the thrombus, by, for example, a combination of aspiration-induced compression and shear loading applied to the thrombus by the spinner. That is, the terms “reducing,” “reduce,” or “reduces” with respect to a thrombus include any method of decreasing the volume of the thrombus, which includes separating the components of the thrombus, such as red blood cells from fibrin or other residual fibrous material, and / or compressing the thrombus, and / or lysing or partially lysing the thrombus, and / or decreasing the volume of residual thrombus material (e.g., to facilitate removal of the residual material). For example, the spinner rapidly rotates to squeeze out red blood cells (RBCs) within the thrombus leaving behind a compressed fibrin fiber network, and then the fibrin fiber network can be captured by the spinner tip, aspirated into the catheter, and / or removed from the vessel by other means.

[0012] Additionally or alternatively, an aspiration force generated by another source that applies a vacuum to the spinner or the treatment site is applied to facilitate reduction and / or prevention of fragmentation of the thrombus. Optionally, additional devices that engage the thrombus to facilitate spinning, such as one or more wires extending from the spinner or another device, can be introduced separately to the treatment site. Optionally, a jet of saline or other fluid can be directed to the treatment site to spin the thrombus and / or otherwise facilitate lysis of the thrombus. Thus, the devices and systems described herein can lyse the thrombus, reduce the size of the thrombus, reduce fragmentation of the thrombus, and / or prevent large separated fragments from moving downstream, thereby reducing the risk during an intervention / endovascular procedure.

[0013] According to one embodiment, a thrombus removal device is provided, the device including an elongated shaft having a proximal end configured to be coupled to a controller for rotating the shaft, a distal end sized to be introduced into a patient's body cavity, and a longitudinal axis extending between the proximal end and the distal end, the shaft being configured to rotate about this axis, and a spinner member or element provided at the distal end, the spinner member or element being configured to generate local suction and / or shear forces adjacent to the distal end when the shaft rotates in order to reduce or dissolve a thrombus, reduce the size of the thrombus, and / or prevent fragmentation of the thrombus within the body cavity. For example, the spinner tip includes an annular body extending distally from the distal end, and an opening communicating with a cavity within the annular body is disposed adjacent to the thrombus in order to apply local suction and / or shear forces to the thrombus. Optionally, the spinner tip can include one or more blades or other external features on the annular body and / or one or more slits or other openings in the wall of the annular body, thereby, for example, enhancing the local suction generated within the opening and the cavity.

[0014] According to another embodiment, a thrombus removal device is provided, which includes a catheter or other tubular member having a proximal end, a distal end sized to be introduced into a body cavity adjacent to a thrombus, and a lumen extending from the proximal end to the outlet at the distal end, and an elongated shaft having a proximal end configured to be coupled to a controller for rotating the shaft, a distal end sized to be introduced into the lumen, and a longitudinal axis extending between the proximal end and the distal end, the shaft being configured to rotate about this axis, an optional sleeve surrounding the shaft, and a spin tip provided at the distal end of the shaft, the spin tip being configured to generate local suction and / or shear forces adjacent to the outlet when the shaft rotates, for example, applying local compression and / or shear forces to the thrombus to squeeze red blood cells (RBCs) out of the compressed fibrin fiber network, thereby reducing the thrombus size of the thrombus in the body cavity adjacent to the outlet. Thereafter, optionally, the fibrin network or other residual material is removed, for example, suctioned into the tubular member and / or captured by the spin tip, and the spin tip is withdrawn to remove the residual material.

[0015] According to yet another embodiment, a system for performing a thrombus removal procedure is provided, the system including a tubular member having a proximal end, a distal end sized to be introduced into a body cavity adjacent to a thrombus, and a lumen extending from the proximal end to the outlet at the distal end, an elongated shaft including a proximal end, a distal end sized to be introduced into the lumen, and a longitudinal axis extending between the proximal end and the distal end, a motor and / or controller coupled to the proximal end of the shaft for rotating the shaft about the axis, and a spin tip provided at the distal end of the shaft and configured to generate local suction and / or shear forces adjacent to the outlet when the shaft rotates to reduce the thrombus size of the thrombus in the body cavity adjacent to the outlet.

[0016] According to yet another embodiment, a method for performing thrombectomy is provided, the method including introducing a Spina device into a body cavity adjacent to a target thrombus, and rotating the Spina device to generate a local suction force, thereby dissolving the thrombus, reducing the size of the thrombus, and / or preventing fragmentation of the thrombus.

[0017] According to another embodiment, a tethered biomedical device is provided, the biomedical device including an elongated tether having a proximal end and a distal end, and a tool head disposed at the distal end of the tether. The tether is an elongated flexible member such as a shaft, cable, tubular member, guide wire or similar device. The tether is configured to advance along a path within the body including a lumen and / or body cavity, optionally along one or more catheters, introducer sheaths, guide wires or other delivery devices introduced into such a path. For example, the tether is navigated to a target location by manipulating the device, for example, within a catheter or other delivery device, by a combination of pushing, pulling and rotating. Also, the tether is configured to be rotated by rotating the tool head with a rotational drive device.

[0018] The tool head can be configured to perform ablation of body tissue and / or generate a suction force, for example, to reduce or dissolve a thrombus. 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 outwardly from the outer surface of the tool head, thereby enhancing the suction and / or ablation function of the tool head.

[0019] In one embodiment, the blade is a rib that projects straight up on the outer surface of the tubular body and is aligned parallel to the central axis of the tubular body.

[0020] In another embodiment, the tubular body includes a plurality of holes that penetrate the wall of the tubular body. The holes in the tubular body can improve the local suction ability of the tethered biomedical device. The holes are slits, openings, or other through-holes in the tubular body and may help to promote thrombus removal. If the device has blades, holes can be provided between the blades. The holes are angularly spaced around the tubular body. For example, the tubular body can have two holes spaced 180° apart around the tubular body, or four holes spaced 90° apart around the tubular body.

[0021] In an embodiment where the tool head has both blades and holes, the holes can be arranged between the blades. For example, the tubular body can have two blades and two holes arranged between adjacent blades, or the tubular body can have four blades and four holes spaced apart between adjacent blades.

[0022] According to yet another embodiment, a method of 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 the tool head is inserted into the body through the introducer. The tethered medical device is navigated to place the tool head in the vicinity of a target location within the body by pushing and steering the tether through a path within the body that includes a lumen and / or body cavity. Once the tool head has advanced to the target location, a biomedical procedure such as a diagnostic or therapeutic procedure is performed using the tool head. After performing the biomedical procedure, the tethered medical device is withdrawn from the body by pulling back the tether in the same or a similar manner as advancing the device to the target location except in the reverse direction.

[0023] In another aspect of the method, the biomedical treatment is an ablation treatment performed by rotating a tool head while pressing a tool against body tissue at a target location to remove the body tissue. By manipulating the tether, the tool head can be moved, its orientation adjusted, and the tool head positioned to perform ablation of the body tissue. The tool head rotates by spinning the tether using a rotational drive device. In yet another aspect, the body tissue is an occlusion within a blood vessel such as a thrombus and / or plaque.

[0024] In another aspect, the method can include using a medical device with a tether to capture and remove an object (such as a substance like a thrombus or tissue ablated by the tool head) at a target location. In this aspect, the tool head is positioned near the object, and then the tool head is rotated by spinning the tether using a rotational drive device. The rotating tool head generates a suction force (low-pressure region) within the lumen of the tubular body, thereby pressing and / or compressing the object toward the distal face of the tool head. The object may be suctioned into the lumen of the tubular body or pressed against the tool head. Thereafter, for example, while rotating the tool head or with the tool head stationary, the tether is pulled to retract the tool head along the path, thereby pulling the object out of the body along the path.

[0025] Other aspects and features of the present invention will become apparent by considering the following description in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0026] The present invention is considered to be better understood by reading the following description of specific examples in conjunction with the accompanying drawings. In the accompanying drawings, like reference numerals indicate the same elements.

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[0027] The drawings are not intended to be limiting in any sense, and it is contemplated that various examples of the present invention can be implemented in various other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated herein and constitute a part of this specification, illustrate some aspects of the present invention and, together with the description, serve to explain the principles of this specification. However, it should be understood that the present invention is not limited to the exact arrangements shown in the drawings.

Best Mode for Carrying Out the Invention

[0028] The following description of specific examples of the present invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which is for illustrative purposes and is one of the best modes contemplated for carrying out the present invention. As will be understood, the present invention is capable of various other obvious aspects without departing from the present invention. Therefore, the drawings and description are essentially illustrative and should not be considered limiting.

[0029] Before explaining the examples, it should be understood that the present invention is not limited to the specific examples described and can of course be modified. Also, since the scope of the present invention is limited only by the appended claims, it should be understood that the terms used in this specification are for the purpose of describing only specific examples and are not intended to be limiting.

[0030] When a range of values is given, unless the context clearly indicates otherwise, each intervening value between the upper and lower limits of that range to one tenth of the unit of the lower limit should be understood to be specifically disclosed. Each small range between any recited value or intervening value within a recited range and any other recited value or intervening value within a recited range is included in the present invention. The upper and lower limits of those small ranges may or may not be independently included in the range, and in the case where both or one of them is included in the small range, or where neither is included in the small range, each range is included in the present invention, subject to any specifically excluded limit values within the recited range. If the recited range includes one or both of the limit values, ranges excluding one or both of those included limit values are also considered to be included in the present invention.

[0031] 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 this 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, several exemplary methods and materials are described herein.

[0032] It should be noted that in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to "a compound" includes a plurality of such compounds, and a reference to "a polymer" includes a reference to one or more polymers known to those skilled in the art and their equivalents.

[0033] In this specification, a particular range is indicated with the term "about" preceding a numerical value. The term "about" is used in this specification to provide literal support for the exact numerical value following the term and for numerical values close to or approximate to the numerical value following the term. When determining whether a numerical value is close to or approximate to a specifically recited numerical value, the unrecited numerical value that is close or approximate may be a numerical value that provides a substantially equivalent amount as the specifically recited numerical value in the context in which it is presented.

[0034] Referring to the drawings, FIG. 3 shows an example of a thrombus removal device or apparatus 10 that may be used with the systems and methods described throughout this specification. Generally, the device 10 includes an outer catheter, sheath, sleeve or other member 20, and a spinner device 30 that includes a spinach tip or member 40 coupled to a shaft 32 that is introduced through or disposed within the catheter 20. Optionally, the device 10 can include a sleeve (not shown in FIG. 3. See, for example, sleeve 121 shown in FIGS. 12A and 12B), which can be disposed around the shaft 32 and / or provided in other ways. The sleeve serves to protect the inner surface of the catheter 20 when the shaft 32 rotates at high speed, reduce vibrations resulting from the rotation of the shaft 32 and / or the spinner device 30, and / or facilitate centering and / or stabilization of the spinner device 30.

[0035] Generally, as shown in the figures, the catheter 20 includes a proximal end 22 that includes a handle or hub 50, a distal end 24 that is sized to be introduced into a blood vessel or other body cavity, and one or more lumens 26 that extend between the proximal end 22 and the distal end 24, for example, along a longitudinal axis 28. For example, as shown in the figures, a main lumen 26 can be provided that communicates with one or more ports 52 within the handle 50 and extends to an outlet 25 at the distal end 24. Optionally, the catheter 20 can include one or more additional lumens that at least partially extend between the proximal end 22 and the distal end 24, for example, a guidewire lumen for receiving a guidewire or other rail, a steering element lumen, etc. (not shown). Also, although the catheter 20 is shown here as tubular, it should be understood that it need not have a completely circular cross-section. In fact, it can be partially tubular or have any other suitable shape. Similarly, when referring to a lumen, it should be understood that the lumen can be a partial lumen, groove, or slit.

[0036] The catheter 20 can be constructed using conventional biocompatible materials and / or methods, for example, it can be formed from plastics, various polymers, metals, composite materials having a substantially homogeneous structure between the proximal end 22 and the distal end 24. Alternatively, by varying the structure along the length of the catheter 20, desired properties can be provided, for example, a substantially rigid or semi-rigid proximal portion can be provided, thereby providing sufficient column strength to allow the distal end 24 of the catheter 20 to be pushed or otherwise manipulated, for example, from the proximal end 22 of the catheter 20, while the distal portion adjacent to the distal end 24 can be made substantially flexible to easily advance through tortuous anatomical structures. Also, in any structure, the catheter 20 can be coated (e.g., with a lubricious material) or laminated to assist in advancement.

[0037] The shaft 32 of the spinner device 30 can be an elongated flexible member including a proximal end 34 and a distal end 36 sized to be received within the lumen 26 of the catheter 20. The shaft 32 can have a sufficient length such that, for example, with the proximal end 34 remaining outside the patient's body, the distal end 36 can be introduced into the target blood vessel through or along the catheter 20. For example, the shaft 32 can be a solid or tubular cable configured to transmit rotation from the proximal end 34 to the distal end 36 to rotate the spinner tip 40, including, for example, a plurality of spirally wound inelastic fibers, wires, etc., and having sufficient torsional strength such that when connected to the motor 60 and / or the controller 62, as further described elsewhere in this specification, rotation of the proximal end 34 causes a directly corresponding rotation of the distal end 36, thereby causing a relatively high-speed rotation of the spinner tip 40.

[0038] Optionally, for example, a sleeve or other tubular member (not shown) can be provided around the shaft 32 to prevent the shaft 32 from contacting the inner wall of the catheter 20 when the shaft 32 is introduced into the lumen 26 and rotated by a motor. The sleeve can be formed from a lubricious material, such as PTFE, and / or can include a coating on its inner surface, thereby reducing friction and / or facilitating rotation of the shaft 32 within the sleeve. The sleeve can be axially fixed relative to the shaft 32 so as to extend, for example, from the proximal end 34 to the distal end 36 immediately proximal to the spinner tip 40. Alternatively, the sleeve can be separate from the spinner device 30 such that, for example, the sleeve can be introduced into the lumen 26 of the catheter 20 before introducing the spinner tip 40 and the shaft 32.

[0039] As shown in FIG. 4A, the spin chip 40 generally includes a closed proximal end 44 connectable to the shaft 32 and an open distal end 46 including an inlet 47 that communicates with the internal cavity 48 of the annular body 42, and can include a cylindrical or other annular body 42. Optionally, a hub 41 can be provided at the proximal end 44, which facilitates attaching the spin chip 40 to the distal end 36 of the shaft 32. For example, the hub 41 can be used to substantially permanently attach the chip 40 to the shaft 32 by one or more of, for example, overmolding, fusing, ultrasonic welding, cooperating connectors, etc. For example, as shown, the hub 41 can include a recess for receiving the distal end 36 of the shaft 32, and the hub 41 can be permanently attached to the shaft 32 by adhesion, melting, press-fitting and / or other methods on the shaft 32.

[0040] Optionally, the spin device 30 can include one or more markers, such as a radiopaque ring or deposited material, at a desired location, such as on the distal end 36 of the shaft 32 and / or on the spin chip 40, whereby, for example, fluoroscopy, X-ray, ultrasound or other external imaging can be used to easily monitor the introduction and / or operation of the device 30 during the procedure. Additionally or alternatively, the shaft 32 can be made of a radiopaque material, whereby the introduction and / or manipulation of the shaft 32 during the procedure can be easily monitored.

[0041] Referring to FIGS. 4A-4C, an example of a spinachip 40 that can be used with the apparatus, system, and method provided herein is shown, for example, provided at the distal end 36 of the shaft 32. For example, in FIG. 4A, the spinachip 40a includes a cylindrical body 42a having a substantially uniform annular wall extending between a proximal end 44a and a distal end 46a, and includes an inlet 47a that communicates with an internal cavity 48a. The body 42a can have a substantially flat distal surface, for example, a non-traumatic distal surface, whereby when the body 42a rotates, it can be easily positioned against the thrombus without crushing the thrombus. Optionally, as shown in FIG. 4B, the chip 40b can include one or more blades, struts, or other external features on the cylindrical body 42b to enhance local suction and / or shear forces against the thrombus, for example, can include a plurality of elongated blades 43b that at least partially extend between the proximal end 44b and the distal end 46b of the cylindrical body 42b. As shown, four blades 43b are equally spaced around the cylindrical body 42b, for example, offset from each other by approximately 90 degrees around the outer circumference of the wall of the body 42b. Also, as shown, the blades 43b can extend over the length of the cylindrical body 42b, or can extend only partially between the proximal end 44b and the distal end 46b. Although shown here at equal intervals, it should be understood that non-uniform intervals are also contemplated. Also, although four blades are shown, any number of blades can be used, for example, two, three, four, five, six, seven, etc. Similarly, it should be understood that the dimensions of the blades (e.g., length, width, height) need not be the same. In some aspects, the dimensions of the blades may vary.

[0042] Additionally or alternatively, as shown in FIG. 4C, the chip 40c can include, for example, one or more slits or other openings in the wall of the cylindrical body 42c that extend radially outward from the cavity 48c through the wall to the outer surface of the annular body 42c. For example, as shown, elongated slits 45c are provided between each adjacent blade 43c, and the slits 45c extend partially between the proximal end 44c and the distal end 46c of the cylindrical body 42c. The slits 45c can enhance the local suction force within the cavity 48c and the inlet 47c, as described elsewhere herein. Alternatively, slits can be provided only between some of the blades, and / or a plurality of slits can be provided in a cylindrical body without blades (not shown). In those examples, four slits and blades are shown, but it should be understood that any number of slits and / or blades, such as two, three, four, or more, can be provided at spaced intervals around the annular body on the spin chip. Similarly, it should be understood that the slits need not be of equal size. By adding blades to the spin chip, or both blades and slits, the local suction force generated by the spin chips 40a - 40c shown in FIGS. 4A - 4C can be significantly increased. For example, FIG. 16 shows the experimental results comparing the local suction force generated at 40,000 rpm by a spin chip without blades (only a hollow cylinder, similar to 40a) with a spin chip including blades (similar to 40b) and a spin chip including both blades and slits (similar to 40c).

[0043] The various dimensions of the spin chip 40 can be sized to be inserted into the target blood vessel and / or to generate a desired local suction pressure, as further described elsewhere in this specification. In some examples, the length of the body 42 is about 1 to 5 millimeters (1.0 to 5.0 mm), for example, about 4.2 mm, the wall thickness is about 0.05 to 0.15 mm, for example, about 0.09 mm or 0.15 mm, and the diameter of the inlet 47 is about 0.5 to 1.2 mm, for example, about 0.72 mm or 1.2 mm. The height of the blade 43 is about 0.1 to 0.7 mm, for example, about 0.31 mm or 0.51 mm, and the width is about 0.1 to 0.5 mm, for example, about 0.24 mm or 0.40 mm. The length of the slit 45 is about 0.5 to 2.5 mm, for example, about 2.1 mm, and the width is about 0.2 to 0.8 mm around the radius, for example, about 0.45 mm or 0.75 mm.

[0044] In another alternative, the spin chip can include a plurality of helical blades (not shown) that extend at least partially around the outer periphery of, for example, an annular body and / or along the length direction of the annular body. Optionally, in this alternative, one or more helical slits or other openings can be provided between one or more of the helical blades. It should be understood that one or more additional features can be provided on the outer surface of the annular body to enhance the local suction force generated by the spin chip in addition to and / or instead of the blades and / or slits.

[0045] Returning to FIG. 4, the spin chip 40 (or other examples described herein) may be integrally formed as a single part manufactured, for example, from plastic, metal, composite materials, etc., using, for example, one or more of 3D printing, molding, micro-injection molding, casting, machining, etc. Alternatively, the annular body 42 and / or the hub 41 may be formed from one or more substantially continuous processes, such as extrusion, so as to be able to manufacture a single separable assembly into individual chips. Optionally, the annular body can be formed without slits and / or blades, and they can be added or formed during subsequent processing of the annular body as needed.

[0046] The spin chip 40 may be substantially rigid. Alternatively, by making the material of the spin chip 40 flexible or semi-rigid, formed from a relatively soft material such as an elastomeric material, such as silicone, or a soft plastic, for example, the distal end 46 of the annular body 42 can be made into a substantially non-traumatic chip, minimizing the risk of damage to the tissue contacted by the chip. For example, the spin chip 40 can be formed from a relatively soft material such as an elastomeric material having a rigidity of less than 40 MPa. For this reason, the spin chip 40 can recover from deformations due to, for example, bending of less than about 180 degrees (180°) and / or torsion of less than about 540 degrees (540°) and retain its shape.

[0047] Similarly, the blade 43 may be formed from a flexible material and / or a soft material, and may include a rounded outer edge or other non-traumatic outer edge, for example, to prevent damage to the blood vessel wall or fragmentation of a blood clot when the spin chip 40 rotates.

[0048] The spin chip 40 can have a diameter or other outer cross-section sized to be received within the lumen 26 of the catheter 20 while allowing the chip 40 to rotate freely, for example, by providing clearance around the chip 40 within the lumen. For example, the chip 40 can have an outer diameter of about 1.2 to 2.5 millimeters, and for example, an outer diameter of about 2 millimeters (2 mm) or less.

[0049] Optionally, as shown in FIG. 4D, the spin chip 40 can include, for example, a drug delivery member 49 for releasing one or more therapeutic and / or diagnostic agents. For example, the drug delivery member 49 can include a cylindrical body sized to be received within the cavity 48 of the spin chip 40. In one example, the drug delivery member 49 is formed from a porous material, and for example, one or more drugs are loaded within the porous material and are released, for example, when the spin chip 40 is rotated within a blood vessel. Additionally or alternatively, the drug delivery member 49 can be formed from a bioabsorbable or soluble material and releases one or more drugs, for example, when the material dissolves or otherwise degrades.

[0050] Returning to FIG. 3, the spin chip 40 is connected to the shaft 32, and the shaft is coupled to a motor 60 that provides torque to rotate the spin chip 40. For example, the proximal end 34 of the shaft 32 can include a connector (not shown) for coupling the shaft 32 to the motor 60 via, for example, an external drive shaft, a cable, etc. (not shown). The motor 60 is configured to rotate the spin chip 40 at a desired speed, for example, at least 1000 rpm, or at least 10,000 rpm, for example, about 1,000 to 200,000 rpm, about 4,000 to 50,000 rpm, about 10,000 to 40,000 rpm, about 20,000 to 40,000 rpm, or about 30,000 to 40,000 rpm, for example, around 10,000 rpm or around 40,000 rpm, thereby generating a desired local suction pressure at the inlet 47 of the chip 40. For example, when the spin chip is rotating at 40,000 rpm, a local suction force of about 7,000 Pascals (7 kPa) is generated, as shown in FIGS. 9A - 9C, for example, and at 10,000 rpm, a local suction force of 500 Pascals (0.5 kPa) may be generated.

[0051] In one example, the motor 60 may be configured to rotate the spin chip 40 at a single set speed. Alternatively, the speed of the motor 60 may be variable, for example, the user may adjust it to change the rotational speed of the spin chip 40 manually using an actuator of a controller 62 coupled to the motor 60. Alternatively, the controller 62 may be configured to first operate the motor 60 at a relatively low speed and then automatically increase the speed to rotate the spin chip 40 at a desired operating speed. For example, the initial speed may be used to mechanically engage the thrombus, and then the speed may be increased to rapidly remove red blood cells from the thrombus and reduce the size of the thrombus, as described elsewhere in this specification, for example.

[0052] Unlike existing aspiration thrombectomy devices that require continuous extraction of blood from the blood vessels to be treated, the Spina device described herein can generate a very local suction force without removing fluid from the blood vessels. Optionally, the device can be used in combination with suction, for example, by connecting a vacuum source 64 to the catheter 20 or introducing a separate suction device (not shown), as described elsewhere herein.

[0053] The controller 62 is coupled to the motor 60 and can control the operation of the device 10, thereby enabling, for example, a user to turn the motor 60 on / off to rotate the Spina tip 40 and generate a local suction force in the blood vessels. Optionally, the controller 62 can include one or more actuators (not shown), such as a switch, to activate / deactivate the motor and / or adjust the speed as needed. Additionally or alternatively, the controller 62 can include an actuator (also not shown) for axially advancing and / or retracting the shaft 32 relative to the catheter 20, for example, using a propulsion device 150 as described elsewhere herein, such as shown in FIGS. 12A and 12B. As another option, the controller 62 can include a robotic control system for remotely controlling the axial movement of the shaft 32 as needed.

[0054] In one example, the spinner device 30 and the catheter 20 are assembled together and introduced into the patient's body together, for example, in a manner similar to the device 150 shown in FIGS. 12A and 12B. Thus, the devices described herein are part of a pre-assembled system or kit. Alternatively, the spinner device 30 (including, for example, the shaft 32 and the spinner tip 40) is separate from the catheter 20. For example, the catheter 20 is first introduced into the patient's body, and after the distal end 24 and the outlet 25 are positioned adjacent to the target thrombus, the spinner device 30 is advanced into the catheter 20 such that the spinner tip 40 is positioned adjacent to the outlet 25. In this way, the devices described herein can be assembled immediately before use or during use. In this example, the handle 50 of the catheter 20 includes a port 52a, whereby the spinner device 30 can be inserted into and removed from the lumen 26 of the catheter 20. This port includes one or more hemostatic seals, thereby allowing the shaft 32 of the spinner device 30 to be advanced from the port 52a into the lumen 26 while preventing fluid leakage, for example, from the port 52a. Alternatively, for example, the spinner device 30 cannot be removed, but the spinner device 30 can be permanently incorporated into the catheter 20 such that it can be axially advanced and / or retracted within the lumen 26, for example, using a propulsion device 150.

[0055] Optionally, the catheter 20 and / or the shaft 32 can include one or more stoppers or other safety features (not shown) that help limit axial movement of the shaft 32 to prevent tissue other than thrombus from being inadvertently cut during use. For example, a stopper can be provided within the handle 50 that prevents the spinner device 30 from advancing such that the spinner tip 40 is exposed from the outlet 25 of the catheter 20. Alternatively, one or more stoppers can be used to optionally expose the spinner tip 40 partially or fully from the outlet 25. Optionally, another stopper can be provided that allows the spinner tip 40 to be retracted proximally from the outlet 25 by a desired distance, thereby allowing, for example, residual fibers to be aspirated from a reduced or dissolved thrombus or otherwise directed to the outlet 25 as further described elsewhere herein. In another alternative, the spinner device 30 can be axially fixed relative to the catheter 20, in which case, for example, the spinner tip 40 is disposed within the lumen 26 and the distal end 46 of the spinner tip 40 is disposed immediately adjacent to the outlet 25.

[0056] If the spinner device 30 is permanently integrated with the catheter 20, the proximal end 34 of the shaft 32 may 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 (not shown) configured to couple the shaft 32 to the drive shaft of the motor 60, whereby, for example, the thrombus removal device 10 can be connected to or disconnected from the motor 60. In this example, the thrombus removal device 10 is a disposable integrated device provided to the user for use during a procedure, and this thrombus removal device 10 may be discarded after use. Alternatively, if the spinner device 30 is provided separately from the catheter 20, both may be single-use and / or disposable, or one or both may be reusable, for example, after cleaning and / or sterilization. As a further alternative, the spinner device 30 may be provided and / or introduced into the patient's body without the catheter 20, if necessary.

[0057] Optionally, as shown in FIGS. 12A and 12B, the propulsion device 150 can be provided at the proximal end of the thrombus removal device, for example, instead of the handle 50 shown in the device 10 of FIG. 3. The propulsion device 150 generally includes a fixed handle portion 152 coupled to the proximal end 122 of the catheter 120 and a slider portion 154 coupled to a shaft 132 that holds a spinner tip (not shown) at its distal end. The catheter 120, shaft 132, and spinner tip may be configured in the same manner as the other devices herein, such as the device 10 shown in FIG. 3. Optionally, a sleeve 121 can be provided around the shaft 132 extending through the catheter 120, similar to the other devices herein, to protect the inner surface of the catheter 120 when the shaft 132 rotates.

[0058] The components of the propulsion device 150 may be provided within an outer housing, for example, to protect internal components, and may include, for example, a clam shell or other parts (not shown) that can be connected to each other. Optionally, the outer surface of the housing may be contoured to provide a grip for easy holding and / or operation of the device, or the housing may include a base or other structure for stabilizing the housing against the patient during the procedure. Optionally, as shown in FIG. 12B, the propulsion device 150 may include a motor 160 and / or a battery 162 or other power source, similar to other devices herein, for driving, for example, the shaft 132 to rotate the spinachip.

[0059] As shown, the slider 154 is slidably received within a track or other guide of the fixed portion 152 and may be axially guided, for example, between a first or proximal position and a second or distal position, to advance or retract a spinachip (not shown) relative to the distal end of the catheter 120, similar to other devices herein. As shown, a screw 156 or other actuator may be coupled to the slider 154, thereby allowing, for example, an operator to manually guide the slider 154 between the first and second positions. Optionally, the screw 156 may include a fastener that operates to fix the slider 154 in a desired position, thereby, for example, fixing the spinachip relative to the distal end of the catheter 120 after deployment during the procedure. Although a slider is shown here, any suitable actuating member and / or method, for example, buttons, knobs, and / or combinations thereof, may be used.

[0060] In use, with the spinachip retracted within the catheter 120, the distal end of the catheter 120 can be introduced into the patient's body and advanced to a target location, e.g., adjacent to a thrombus (not shown) within the patient's vasculature. Once positioned, the screw 156 can be actuated to advance the spinachip relative to the catheter 120, whereby, similar to other devices herein, the distal face of the spinachip can be abutted against the thrombus or positioned immediately adjacent thereto. The screw 156 can be used to fix the relative position of the spinachip within the catheter 120 after advancing the spinachip to the desired position. Thereafter, similar to other devices herein, the motor 160 can be actuated to rotate the spinachip, whereby the thrombus can be lysed and / or reduced. Once treatment of the thrombus is complete, the screw 156 can be actuated to retract the spinachip into the catheter 120 and the device can be removed (or directed to one or more additional locations for treatment of further thrombi).

[0061] The devices, systems, and methods described herein can optionally include a vacuum source. For example, as shown in FIG. 3, device 10 can include a vacuum source 64, such as a syringe, suction line, etc. (not shown), and can be coupled to the proximal end 22 of the catheter, such as port 52b on handle 50, to suction a substance into the lumen. For example, port 52b can include a luer fitting or other connector for removably connecting a tube from the vacuum source 64 to port 52b. The vacuum source 64 can be activated before or during the advancement and / or actuation of the spinachip 40 to reduce or dissolve a thrombus (or, if necessary, can be activated immediately after advancing the spinachip 40), thereby suctioning the dissolved fibrin or other residual thrombus material into the lumen 26 of the catheter 20, for example, as described in more detail elsewhere herein. Also, the spinachip 40 can assist in changing the orientation and / or position of the thrombus relative to the catheter 20, thereby, for example, enhancing the contact between the thrombus and the outlet 25 and enhancing the vacuum suction from the lumen 26.

[0062] Additionally or alternatively, a fluid source, such as a syringe of saline or contrast agent, can be connected to port 52b (or, if necessary, another dedicated port not shown). Thus, during use of the catheter 20, the lumen 26 can be flushed and / or fluid can be delivered from the outlet 25, if necessary.

[0063] Optionally, the thrombus removal device 10 and / or the spinner device 30 can be included in a system or kit that includes one or more additional devices for use during a thrombus removal procedure. For example, the system can include an occlusion device and / or a capture member (not shown) for preventing fragments of the thrombus being treated from moving to other locations within the patient's vasculature. For example, such a device can be introduced and deployed from the catheter 20, e.g., via the lumen 26 or a secondary lumen. Alternatively, such a device can be introduced and deployed independently of the spinner device, e.g., via another catheter, sheath, or other device (not shown) downstream of the target thrombus.

[0064] Suitable additional devices for use within the systems or kits described herein include, for example, devices carrying a balloon or other expandable member that can be introduced into the body cavity spaced apart from and / or adjacent to the spinner tip 40 and / or the catheter outlet 25 to expand the expandable member to at least partially occlude the body cavity, thereby preventing substances from the thrombus from moving out of the body cavity. Alternatively, a capture member can be provided for introduction into the body cavity adjacent to the spinner tip, thereby, for example, capturing residual fibrin material from the thrombus being treated by the spinner tip. Such capture members can include filters, snares, cages, and the like.

[0065] The devices and systems described herein can be used during thrombus removal procedures. For example, after the Spina device 30 is introduced into a body cavity, such as a vein or artery, adjacent to a target thrombus, the Spina tip 40 is rotated to generate a local fluid force, such as a combination of compressive and shear forces, to generate a local suction force, thereby dissolving the thrombus, reducing the size of the thrombus, and / or preventing fragmentation of the thrombus within the body cavity. For example, the Spina device can be deployed to reduce or otherwise dissolve the thrombus by separating red blood cells from fibrin and / or other fibrous substances. The red blood cells may simply be released into the blood vessel, for example, the red blood cells are metabolized in the body, the fibrin is directly captured by the cavity of the Spina device, or captured by a capture device using suction, and / or before the Spina device is removed from the patient's vasculature, the residual substances are decomposed, dissolved, and / or otherwise inactivated by a thrombolytic agent or other agent.

[0066] In the exemplary methods shown in FIGS. 5A and 5B, the distal end 24 of the catheter 20 is first introduced into the patient's body via a guidewire or other rail (not shown) disposed within the patient's vasculature from a percutaneous access site. The distal end 24 can be advanced to position the outlet 25 adjacent to the target thrombus 92 within the blood vessel 90, as shown in FIG. 5A.

[0067] The spin chip 40 can be introduced into the lumen 26 from the proximal end of the catheter 20 and, as shown in FIG. 5A, the inlet 47 can be advanced adjacent to the outlet 25 of the catheter 20 and thereby adjacent to the thrombus 92. Alternatively, as described elsewhere herein, the spin device 30 can also be provided within the catheter 20 such that, for example, the spin chip 40 is positioned adjacent to the thrombus 92 simultaneously with the introduction of the catheter 20. Optionally, a sleeve (not shown) can be provided within the lumen 26 around the shaft 32 and can be introduced together with the spin device 30 or introduced into the lumen 26 prior to inserting the spin device 30.

[0068] Optionally, the operation of the catheter 20 and / or the spin device 30 can be monitored using external imaging, such as fluoroscopy, X-ray, ultrasound, etc. For example, as described elsewhere herein, the spin device 30 can include one or more radiopaque markers, for example, on the distal end 36 of the shaft 32 and / or on the spin chip 40, and / or the shaft 32 can be formed from a radiopaque material, and by monitoring it, the spin chip 40 can be easily positioned adjacent to the thrombus 92. Optionally, a contrast agent can be introduced into the blood vessel 90, for example, via the port 52b, another port at the proximal end 22 of the catheter 20, or another device (not shown), thereby easily identifying the location of the thrombus 92 and easily positioning the spin chip 40 introduced via the catheter 20 (e.g., through the main lumen 26 or another lumen) or another device. Additionally or alternatively, intravascular imaging systems and methods, such as intravascular ultrasound imaging, optical coherence tomography, etc., can be used to monitor the catheter 20 and / or the spin device 30.

[0069] Once the device is positioned at the desired location relative to the thrombus 92, the spin tip 40 can be rotated, for example, by activating a motor 60 (shown in FIG. 3), to create a local suction force within the inlet 47, thereby drawing the thrombus 92 towards the distal end 24 of the catheter 20. For example, the thrombus 92 can be pressed against the distal end 46 of the spin tip 40. As described above, the speed of the spin tip 40 can be fixed or, for example, adjustable manually by the user and / or automatically by the controller 60. For example, the spin tip 40 can be placed in contact with or immediately adjacent to the thrombus 92 and rotated, thereby generating a shearing force that separates red blood cells from the thrombus. In one method, only the distal surface of the spin tip 40 is positioned in contact with the thrombus, and the spin tip 40 is not rotated within the thrombus 92, for example, to prevent fragmentation.

[0070] Unlike other thrombus removal devices that attempt to capture or fragment the entire thrombus (which can lead to fragmentation of the thrombus), the devices and systems of the present disclosure help to separate the red blood cells of the thrombus from the complex fibrin network, thereby providing higher efficiency and effectiveness. That is, the spinning motion of the spin tip 40 generates a shearing force that, in combination with compression by suction, squeezes out the red blood cells captured in the thrombus 92, allowing those red blood cells to escape through the slit 43 and / or from the cavity 48 of the spin tip 40 into the blood vessel. Thus, unlike macerator devices that mechanically fragment the thrombus and risk having the fragments migrate to other locations within the patient's body, the devices described herein can reduce the volume of the thrombus by removing red blood cells without fragmenting the remaining fibrin material. The residual material remains substantially intact and is removed later, as described elsewhere in this specification. Further, while macerator devices may not be able to break down the rich and / or hard fibrin network of some thrombi and thus may not be able to remove such thrombi, the devices described herein enable such residual fibrin networks to be captured and / or removed by other means, regardless of the hardness of the residual material.

[0071] For example, as shown in FIGS. 9A-9C, increasing the spin speed may result in a higher local suction force. As shown in FIG. 13, the magnitude of the suction force has a positive correlation with the thrombolysis efficiency. As shown in FIG. 13, the reduction effect is represented as the time until the thrombus reaches a certain volume reduction amount (in this experiment, a 70% volume reduction amount was selected as the evaluation criterion). At 40,000 rpm, no degradation of the thrombus was observed. At even higher spin speeds, an increase in thrombolysis efficiency is expected. FIGS. 11A and 11B show exemplary pressures and local flows generated when the spin chip 40 is rotated at various speeds (e.g., the speeds shown in FIGS. 9A-9C and FIG. 10).

[0072] In this way, the spin chip 40 can rapidly separate red blood cells, for example, in less than 2 minutes, leaving behind a compressed fibrin fiber network 94, as shown in FIG. 5B for example. Optionally, for example, by connecting a vacuum source 64 to the proximal end 22 of the catheter 20 as shown in FIG. 3, additional vacuum can be applied to create a substantially continuous suction force from the outlet 25 into the lumen 26. For example, when the spin chip 40 is rotated while applying a suction force, the thrombus can be reduced within just 5 seconds. If necessary, the spin chip 40 can be rotated to mechanically break down the residual fiber network 94 and suction it into the lumen 26 by vacuum. Additionally or alternatively, the spin chip 40 can be retracted to draw the residual fiber network 94 into the lumen 26 using, for example, one or both of the local suction generated by the spin chip 40 and the vacuum in the lumen 26. In this alternative example, after capturing the residual fiber network 94 and pulling it out completely, for example, from the patient's body, the catheter 20 can be removed from the blood vessel 90. As described above, the methods described throughout this specification can also utilize an apparatus having one or more stoppers for safety.

[0073] Figures 6A - 6C show an example of the change in a thrombus (in this example, a thrombus created from porcine blood) when the spin tip of the thrombus removal device is spun for 0 - 3 minutes. As shown in FIGS. 6B and 6C, it can be clearly seen that the size of the thrombus has significantly decreased and the color of the thrombus has changed from red to white. This is because all red blood cells (RBCs) are effectively spun out and removed from the original thrombus by the shear force generated by spin aspiration. Since the thrombus is mainly composed of RBCs trapped in a fibrin fiber network, as shown in FIG. 7 for example, when the RBCs are removed, only a fibrin fiber network of less than 10% of the initial thrombus volume remains. For example, FIGS. 8A and 8B each include SEM images of the thrombus before and after spinning, further showing that the original thrombus is rich in RBCs and the thrombus after spinning is a high - density fibrin fiber network.

[0074] Instead of sharp blades rotating at high rpm (e.g., 150,000 - 200,000) for fragmentation, the spin tip is flexible or semi - rigid and operates at a relatively low rpm (e.g., about 4000 - 50,000) to separate red blood cells from the fibrin network. The holes and shear function of the spinner can enhance suction and firmly compress the thrombus against the distal surface of the spin tip, thereby ensuring maximum shear of the thrombus.

[0075] Figures 9A-9C show examples of the performance of various spin chips under various conditions by simulation, including placing a spinner device within a tube (e.g., a 3 millimeter tube) used to simulate the operation of a spin chip within a blood vessel. For example, Figure 9A shows the local suction generated when the spin chip is rotated at various speeds. The local pressure drop indicates the magnitude of the compressive force generated, which can be adjusted by varying the spin speed. This shows that the thrombolysis efficiency is adjustable and may be improved at higher spin speeds. Figure 9B shows an example of the centerline pressure profile of a spinner device with spin speeds of 10k, 20k, 30k, and 40 krpm and a normalized blade length (blade length L normalized with respect to the inner radius r) of 0.87. Figure 9C compares various blade lengths at a spin speed of 40 krpm. This simulation was performed for the optimization of the suction ability of the spinner with respect to the normalized blade length, as shown in Figure 9C. Optimal suction is achieved when the normalized blade length is 0.87 and is selected as the geometric design of the spin chip. Figure 10 shows additional examples of the pressure distribution along the centerline of a spinner device with various blade sizes during spinning.

[0076] Optionally, as shown in FIG. 4D, a drug delivery member 49 can be provided within the cavity 48 of the spin chip 40. For example, a cylindrical body pre-loaded with one or more desired drugs can be inserted into the spin chip 40 immediately prior to treatment, or provided within the spin chip 40 during manufacture. Alternatively, one or more drugs can be loaded into the drug delivery member 49 immediately prior to treatment, inserted into the cavity 48, and one or more drugs can be delivered during treatment. For example, as described elsewhere, one or more drugs can be released as the spin chip 40 rotates, and optionally, the release rate of one or more drugs can be adjusted in accordance with the rotational speed of the spin chip 40. As another option, if desired, the release of one or more drugs from the spin chip 40 into the blood vessel can also be facilitated by introducing a fluid, such as saline, through the lumen 26 of the catheter 20.

[0077] Optionally, as shown in FIG. 3, a controller 62 coupled to the motor 60 can be used to adjust, for example, the rotational speed of the shaft 28, thereby controlling, for example, the release rate of one or more drugs carried by the drug delivery member, such as one or more of a thrombolytic agent, a diluent, an anti-inflammatory agent, a dye, a contrast agent, and / or other therapeutic and / or diagnostic agents. For example, FIG. 14 shows experimental results of drug release controlled using a spin chip (such as the release of the thrombolytic drug tPA (tissue plasminogen activator), which is the first treatment for acute ischemic stroke), showing the drug release rates at various spin speeds. At relatively low spin speeds, such as about 10,000 rpm, the drug release rate (expressed as the rate of release per second of the drug stored in the spin chip) is lower than the release rate when the spin chip is at a high spin speed, such as about 40,000 rpm. As shown in FIGS. 15A and 15B, the color density of the released dye indicates various release rates. For example, the darker density shown in FIG. 15A indicates a faster release rate at 40,000 rpm, and the lighter density shown in FIG. 15B 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 preset release rate.

[0078] While the invention is susceptible to various modifications and alternative forms, specific examples thereof are shown in the drawings and are described in detail herein. However, it should be understood that the invention is not limited to the particular forms or methods disclosed, but on the contrary, the invention is intended to cover all modifications, equivalents, and alternatives included within the scope of the appended claims.

Claims

1. A thrombus removal device, comprising: An elongated shaft having a proximal end configured to be coupled to a controller for rotating the shaft, a distal end sized to be introduced into a body cavity of a patient, and a longitudinal axis extending between the proximal end and the distal end, the shaft being configured to rotate about this axis; A spinachip provided at the distal end, the spinachip being configured to generate a local suction force adjacent to the distal end when the shaft rotates, in order to reduce the size of the thrombus, separate red blood cells from fibrin, and / or prevent fragmentation of the thrombus in the body cavity. The thrombus removal device is characterized by comprising the spinachip.

2. The device according to claim 1, wherein: The spinner comprises an annular body extending distally from the distal end, and an opening communicating with a cavity within the annular body is disposed adjacent to the thrombus to apply a local suction force to the thrombus. The device is characterized by this.

3. The device according to claim 2, wherein: The annular body further comprises one or more blades. The device is characterized by this.

4. The device according to claim 3, wherein: The one or more blades include a plurality of blades on an outer surface of the annular body. The device is characterized by this.

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

6. The device according to any one of claims 2 to 5, wherein: The wall of the annular body further comprises one or more slits. The device is characterized by this.

7. The device according to claim 6, wherein: The one or more slits include a plurality of slits extending axially along the annular body between the cavity and an outer surface of the annular body. The device is characterized by this.

8. A thrombus removal device, comprising: An elongated shaft having a proximal end configured to be coupled to a controller for rotating the shaft, a distal end sized to be introduced into a body cavity of a patient, and a longitudinal axis extending between the proximal end and the distal end, the shaft being configured to rotate about this axis; A spinachip provided at the distal end, comprising a spinachip configured to generate a local suction force adjacent to the distal end when the shaft rotates to reduce the size of a thrombus, separate red blood cells from fibrin, and / or prevent fragmentation of the thrombus in the body cavity, wherein the spinachip is an annular body extending distally from the distal end, wherein an opening communicating with a cavity within the annular body is disposed adjacent to the thrombus to apply a local suction force to the thrombus; a plurality of blades on an outer surface of the annular body; and a plurality of slits adjacent to the blades and extending between the cavity and the outer surface of the annular body. A thrombus removal device characterized by comprising the above. **Claim 9** The device according to claim 8, characterized in that the annular body and the blades are formed of a flexible material. **Claim 10** The device according to claim 9, characterized in that the blades include a substantially non-traumatic outer edge. **Claim 11** The device according to claim 8, characterized in that a distal surface of the annular body is substantially flat. **Claim 12** In the device according to any one of claims 2-5, 8-11, further comprising a drug delivery member housed within the cavity holding one or more drugs. **Claim 13** The device according to claim 12, characterized in that the drug delivery member includes a porous body holding one or more drugs. **Claim 14** The device according to claim 12, characterized in that the drug delivery member is configured to dissolve and release one or more drugs. **Claim 15** The device according to claim 14, further comprising a controller coupled to the shaft, the controller being configured to adjust the rotational speed of the shaft to control the release rate of one or more drugs. **Claim 16** In the device according to any one of claims 1-5, 8, characterized in that the spinachip is formed of a flexible material or a rigid material. **Claim 17** In the device according to any one of claims 1-5, 8-11, An apparatus, 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 according to claim 17, wherein the controller is configured to rotate the shaft at a speed of at least 1000 rpm.

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

20. In the apparatus according to any one of claims 1 to 5, 8 to 11, further comprising a tubular member, the tubular member having 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 and sized to receive the shaft, the lumen being configured to advance the spinachip from the distal end within the body cavity.

21. The apparatus according to claim 20, further comprising a vacuum source coupled to the tubular member for sucking a substance into the lumen from the distal end.

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

23. The apparatus according to claim 22, wherein the propulsion device includes an actuator coupled to the proximal end of the shaft, the actuator being configured to advance the shaft relative to the catheter to deploy the spinachip from the distal end of the catheter.

24. The apparatus according to claim 23, wherein the actuator includes a slider movable between a first position and a second position to advance the spinachip from the distal end of the catheter and to retract the spinachip into the distal end of the catheter.

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

26. The apparatus according to claim 25, The apparatus further comprises a power source within the housing, the power source being connected to the motor to supply power to the motor for rotating the shaft. **Claim 27** In the apparatus according to any one of claims 1 to 5, 8 to 11, further comprising an expandable member configured to be introduced into the body cavity adjacent to the spin tip, the expandable member being expandable to at least partially occlude the body cavity to prevent substances from the thrombus from moving out of the body cavity. **Claim 28** In the apparatus according to any one of claims 1 to 5, 8 to 11, further comprising a tubular member configured to be introduced into the body cavity adjacent to the spin tip, the tubular member being configured to prevent substances from the thrombus from moving out of the body cavity. **Claim 29** In the apparatus according to claim 28, the tubular member is configured to travel on the shaft, and an inlet of the tubular member is disposed adjacent to the spin tip. **Claim 30** In the apparatus according to claim 28, the tubular member is configured to be introduced separately from the spin device, and an inlet of the tubular member is disposed at a distal distance from the spin tip. **Claim 31** In the apparatus according to any one of claims 1 to 5, 8 to 11, further comprising a capture member configured to be introduced into the body cavity adjacent to the spin tip, the capture member being configured to capture substances from the thrombus processed by the spin tip. **Claim 32** In the apparatus according to claim 31, the capture member includes one of a filter, a snare, and a cage. **Claim 33** In the apparatus according to any one of claims 1 to 5, 8 to 11, further comprising a suction member configured to be introduced into the body cavity adjacent to the spin tip, the capture member being coupled to a source of substances for sucking substances from the thrombus processed by the spin tip. **Claim 34** A thrombus removal device, a tubular member including a proximal end, a distal end sized to be introduced into the body cavity adjacent to the thrombus, and a lumen extending from the proximal end to an outlet of 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 to be introduced into the lumen, and a longitudinal axis extending between the proximal end and the distal end, the shaft being configured to rotate about this axis, A thrombectomy device comprising a spin tip provided at the distal end, the spin tip being configured to generate a local suction force adjacent to the outlet when the shaft rotates to reduce the thrombus size of a thrombus in the body cavity adjacent to the outlet.

35. The device according to claim 34, wherein the shaft is axially movable within the lumen, whereby the spin tip can be disposed adjacent to the outlet.

36. The device according to claim 35, further comprising one or more stoppers that limit the axial movement of the shaft to prevent the spin tip from advancing from the outlet.

37. The device according to claim 34, wherein the spin tip is disposed within the lumen immediately adjacent to the outlet to generate a local suction force.

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

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

40. The device according to claim 39, wherein the spin tip is disposed within the lumen immediately adjacent to the outlet to generate a local suction force and a shearing force to squeeze red blood cells out of the thrombus, and the suction force is generated to suction the remaining fibrous network into the lumen.

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

42. In the system according to claim 41, The system further includes a vacuum source coupled to the proximal end of the tubular member and communicating with the lumen to generate a suction force into the outlet.

43. In the system according to claim 42, The spin tip is disposed immediately adjacent to the outlet within the lumen to generate a local suction force to squeeze red blood cells from the thrombus, and the system further includes an actuator for guiding the spin tip in a proximal direction to suction the remaining fiber network into the lumen when the vacuum source is activated.

44. A system for performing a thrombus removal procedure, A tubular member including a proximal end, a distal end sized to be introduced into a body cavity adjacent to a thrombus, and a lumen extending from the proximal end to an outlet of the distal end; An elongated shaft including a proximal end, a distal end sized to be introduced into the lumen, and a longitudinal axis extending between the proximal end and the distal end; A motor coupled to the proximal end of the shaft for rotating the shaft about its axis; A spin tip provided at the distal end of the shaft and configured to generate a local suction force adjacent to the outlet when the shaft rotates to reduce the thrombus size of a thrombus in the body cavity adjacent to the outlet.

45. In the system according to claim 44, The system further includes a controller coupled to the motor for controlling the operation of the motor.

46. In the system according to claim 44, The system further includes a vacuum source coupled to the proximal end of the tubular member and communicating with the lumen to generate a suction force into the outlet.

47. In the system according to claim 46, The spin tip is disposed immediately adjacent to the outlet within the lumen to generate a local suction force to squeeze red blood cells from the thrombus, and the system further includes an actuator for guiding the spin tip in a proximal direction to suction the remaining fiber network into the lumen when the vacuum source is activated.

48. In the system according to claim 44, The system is characterized in that the shaft and the spin tip comprise the thrombus removal device according to any one of claims 1 to 5, 8 to 11.

49. In the system according to any one of claims 44 to 47, the spin tip comprises an annular body, and the annular body is provided with an inlet and a cavity which are arranged adjacent to the thrombus so as to apply local suction force and shear force to the thrombus when the spin device rotates. The system is characterized by this.

50. In the system according to any one of claims 44 to 47, the cavity further includes a drug delivery member for holding one or more drugs, and when the spin device rotates, the one or more drugs are released. The system is characterized by this.

51. In the system according to any one of claims 44 to 47, the system further includes a sleeve that is received around the shaft. The system is characterized by this.

52. In the system according to claim 51, the sleeve comprises a proximal end, a distal end sized to be introduced into the lumen independently of the shaft, and a sleeve lumen sized to receive the spin tip. Before introducing the spin tip and the shaft into the sleeve lumen, the proximal end of the sleeve is exposed from the proximal end of the tubular member, and the distal end of the sleeve is arranged adjacent to the outlet. The system is characterized by having a sufficient length such that this is the case.

53. In the system according to claim 51, the sleeve is coupled to the shaft such that the sleeve can be introduced into the lumen simultaneously with the shaft. The sleeve comprises a proximal end arranged adjacent to the proximal end of the shaft and a distal end arranged adjacent to the spin tip. When the shaft rotates, the sleeve surrounds the shaft to prevent contact with the inner surface of the tubular member. The system is characterized by this.

54. A method for performing thrombus removal, comprising: introducing a spin device into a body cavity adjacent to a target thrombus; Rotating the spinner device to generate a local suction force, thereby causing, for example, compressive force and / or shear force to dissolve a thrombus, separate red blood cells from fibrin, reduce the size of the thrombus, and / or prevent fragmentation of the thrombus.

55. In the method according to claim 54, The method is characterized in that the spinner device rotates at a speed of at least 1000 rpm.

56. In the method according to claim 54, The method is characterized in that the spinner device rotates at a speed of at least 10,000 rpm.

57. In the method according to claim 54, The method further comprises introducing the distal end of the tubular member into the body cavity until its outlet is disposed adjacent to the target thrombus, and before rotating the spinner device to generate a local suction force, the spinner device is disposed within the lumen of the tubular member adjacent to the target thrombus.

58. In the method according to claim 57, The method is characterized in that the spinner device is introduced simultaneously with the introduction of the tubular member into the body cavity.

59. In the method according to claim 57, The method is characterized in that the spinner device is introduced into the lumen of the tubular member after the tubular member is introduced into the body cavity and advanced so that the spinner device is disposed adjacent to the outlet.

60. In the method according to claim 57, The method further comprises, after rotating the spinner device, sucking residual thrombus material from the thrombus within the lumen of the tubular member.

61. In the method according to claim 57, The method further comprises generating a vacuum within the lumen of the tubular member, the spinner device generating a local suction force to squeeze red blood cells out of the thrombus, and the vacuum sucking the remaining fiber network into the lumen.

62. In the method according to claim 54, The spinner device comprises an annular body having an inlet and a cavity disposed adjacent to the thrombus for applying a local suction force to the thrombus when the spinner device rotates.

63. In the method according to claim 62, The method further includes a drug delivery member that holds one or more drugs in the cavity, and the one or more drugs are released when the spinner device rotates.

64. In the method according to claim 54, the method is characterized in that the spinner generates a fluid force combining a compressive force and a shear force to separate red blood cells from a thrombus.

65. A method for removing a thrombus, comprising: introducing a thrombus removal device into a body cavity adjacent to a target thrombus; operating the device to generate a local suction force to produce a compressive force and a shear force, thereby separating red blood cells from the thrombus while leaving a compressed fibrin fiber network.

66. In the method according to claim 65, the method is characterized in that operating the device includes rotating the device about the longitudinal axis of the device to generate a local suction force.

67. In the method according to claim 65, the method further includes removing the compressed 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 at the distal end of the tether, the tool head including a tubular body having a lumen extending axially along a central axis of the tubular body of the tool head, the tool head configured to perform ablation of body tissue and generate a suction force when the tool head is rotating; the tether is configured to rotate the tool head to generate a suction force by rotating the tether by a rotary drive device coupled to the proximal end of the tether.

69. In the tethered biomedical device according to claim 68, the tether is one of a catheter and a guide wire, and is configured to advance along a path in the body and place the tool head at a target position by manipulating the tether using a combination of pushing, pulling, and rotating to navigate the tether.

70. In the tethered biomedical device according to claim 68, The tethered biomedical device, wherein the tool head has one or more blades disposed on an outer surface of the tool head and extending radially outward from the outer surface of the tool head.

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

72. The tethered biomedical device according to claim 71, wherein the holes of the tubular body are arranged at angular intervals around the tubular body.

73. The tethered biomedical device according to claim 72, wherein the holes of the tubular body are arranged between the blades.

74. The tethered biomedical device according to claim 72, further comprising a tubular member, the tubular member including a proximal end, a distal end sized to be introduced into the body cavity adjacent to the thrombus, and a lumen extending from the proximal end to an outlet of the distal end, wherein the shaft and the tool head are disposed within the lumen.

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

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