Thrombectomy devices with lateral and vertical biases

Abstract

Thrombectomy systems having curved tubular cutting devices and methods for using them are provided. These systems, devices, and methods can effectively treat blood vessels by (i) effectively cutting and removing various thrombotic tissues, including soft tissue, tough tissue, and hard tissue, from blood vessels; (ii) safely self-collecting and removing tissue particles to avoid embolic dislodgement; and (iii) reducing the risk of suffering vascular damage that could lead to increased stenosis.

Description

[Technical Field]

[0001] Cross-reference of related applications This application claims priority to U.S. application No. 18 / 807,575, filed on 16 August 2024, with respect to U.S. Provisional Application No. 63 / 520,029, filed on 16 August 2023, which is incorporated herein by reference in its entirety.

[0002] Field of Invention The teachings in this specification generally pertain to medical devices and methods, including devices and methods for performing thrombectomy. [Background technology]

[0003] Explanation of related technologies Thrombectomy is the removal of blood clots from blood vessels. Blood clots are composed of a network structure of protein chains called platelets and fibrin. Arterial blood clots have a different composition from venous blood clots; arterial clots mainly contain platelets, while venous clots mainly contain fibrin. Common applications of thrombectomy include any location in a blood vessel where a thrombus may form. Thrombectomy helps to alleviate the symptoms of the disease, as well as further vascular complications, and possibly downstream complications that can even lead to death due to the release of the embolism.

[0004] There are still many requests and problems that need to be solved in this field of technology for state-of-the-art thrombectomy devices, including the following: (i) Dragging the expanded basket along the vein may damage the vein wall or valves, (ii) Suction blockage during device operation, (iii) Removing too much blood while removing a blood clot, (iv) Inability to remove a tough or mature thrombus, and (v) It is not versatile enough to effectively handle each of the various soft tissues, tough tissues, fibrous tissues, and hard tissues, and does not cut all types of tissue, or it may break down tissue into fragments, which can lead to dangerous embolisms that block downstream blood vessels and, in some cases, cause death. It includes.

[0005] A versatile device capable of effectively handling various soft, tough, fibrous, and hard tissues may also be useful in removing atheroma from the lumen of arteries. Atherosclerosis, also known as plaque, is a buildup of fatty substances, cholesterol, cellular waste, calcium, and fibrin deposits on the inner walls of arteries. Both atherosclerosis and thrombosis carry the risk of fragmentation into the bloodstream, traveling to the heart, brain, or lungs, causing health complications, which are often fatal.

[0006] Those skilled in the art will know that the devices and systems taught herein are as follows: (i) It must be able to effectively cut and remove all types of thrombi and atheromatous tissue, whether soft tissue, tough tissue or hard tissue. (ii) The ability to safely collect and remove tissue fragments such as emboli while avoiding their release, (iii) The ability to effectively treat the blood vessels while reducing the risk of vascular damage that could lead to increased stenosis. This will be understood. Of particular interest in this specification are, among the several indications taught for this technique, (i) removal of venous thrombi and (ii) removal of pulmonary artery thrombi, also known as pulmonary embolism. [Overview of the project]

[0007] overview Thrombectomy systems, devices, and methods for using them are provided. Several embodiments of the techniques described herein are taught, and these embodiments include systems, methods, and devices for (i) removal of arterial and venous thrombi, and (ii) removal of pulmonary thrombi, also known as pulmonary embolism. In some embodiments, the systems, devices, and methods taught herein may be used in atherectomy. The techniques taught herein can effectively cut and remove all types of thrombi and atheromatous tissue, whether soft tissue, tough tissue, or hard tissue, as will be understood by those skilled in the art.

[0008] A thrombectomy device is provided. In some embodiments, the thrombectomy device is A flexible rotating shaft having a proximal end, a distal end, and a lumen; It includes a curved tubular cutter operably connected to the distal end of a flexible rotating shaft, the tubular cutter being A head having an opening with an axis and a Z-axis, A neck connected to the head and having a rotation axis, The angle θz between the Z-axis and the rotation axis of the opening is in the range of 90° to 135°. The opening includes, The cutting edge with the highest height (leading edge height); The rear end cutting edge with the lowest height (rear edge height); A vertical bias ratio (leading edge height / trailing edge height) in the range of 1.05 to 2.0; Distance B between the axis of rotation and the tip blade L ; Distance B between the rotation axis and the rear end blade T ; and Lateral bias ratio B, which is in the range of 1.05 to 2.0. L / B T ; Composed of, The device also, A delivery sheath for delivering a cutter to a target site within an object containing tissue to be removed; And, It includes a vacuum port configured to be operationally connected to a vacuum source in order to facilitate the transfer of tissue from the target.

[0009] In some embodiments, the device includes a delivery sheath for safely delivering the cutter to a target site for tissue removal. However, in some embodiments, the device may, by preference or design, not include a delivery sheath.

[0010] In some embodiments, the cutter is deflected from the axis of rotation, forming a deflection distance between the tip of the cutter and the axis of rotation.

[0011] In some embodiments, the axis of the head makes an angle Φ perpendicular to the axis of rotation, where Φ ranges from 0° to 90°, forming a deflection distance between the tip of the cutter and the axis of rotation.

[0012] In some embodiments, the axis of the head makes a transverse angle θo with respect to the axis of rotation, where θo ranges from 0° to 90°, forming a deflection distance between the tip of the cutter and the axis of rotation.

[0013] In some embodiments, the flexible rotating shaft is deflected at an angle θm with respect to the axis of rotation, forming a curved region within the flexible rotating shaft where θm is in the range of 0 to 90 degrees, and forming a deflection distance between the tip blade of the cutter and the axis of rotation.

[0014] In some embodiments, the opening has a cross-sectional area equal to or smaller than the lumen of the flexible rotating shaft.

[0015] In some embodiments, the z-axis of the opening makes an angle θr from a plane containing a curved region, and the opening opens toward the target site of the tissue to be removed.

[0016] In some embodiments, the device further includes an orthodontic sheath.

[0017] A system is also provided. In some embodiments, the system includes a handle including a motor operably connected to a drive assembly including a flexible rotating shaft and a cutter, together with the devices taught herein, the motor being configured to provide rotational motion to the flexible rotating shaft in order to rotate the cutter.

[0018] In some embodiments, the system includes the device taught herein, and the delivery sheath is a straightening sheath.

[0019] In some embodiments, the system includes the device taught herein, wherein the z-axis of the opening makes an angle θr from a plane containing a curved region, opening the opening toward a target site of tissue to be removed.

[0020] In some embodiments, the system includes a vacuum source along with the devices taught herein, and a vacuum port is operably connected to a vacuum that removes tissue from the system.

[0021] In some embodiments, the system includes a delivery sheath for safely delivering the cutter to the target site for tissue removal. However, in some embodiments, the system may, by preference or design, not include a delivery sheath.

[0022] In some embodiments, the system includes the device taught herein, wherein the delivery sheath is a straightening sheath, and the system further includes a vacuum source; wherein the vacuum port is operably connected to a vacuum that removes tissue from the system.

[0023] Procedures are also provided, and any blood vessel can be treated using the devices and systems taught herein. In some embodiments, methods are provided for performing thrombectomy using any device taught herein. The methods include: Creating an entry point in the lumen of the target blood vessel; Inserting a thrombectomy device into the lumen of a blood vessel; To deliver the cutter within the delivery sheath to the target site containing the tissue to be removed; Using a thrombectomy device cutter to cut tissue from the lumen of a blood vessel, And, To remove the thrombectomy device from the lumen of the target blood vessel. It includes.

[0024] In some embodiments, the method includes using a delivery sheath to safely deliver the cutter to the target site for tissue removal. However, in some embodiments, the method does not include the use of a delivery sheath, depending on preference or design.

[0025] In some embodiments, the method further includes inserting a guidewire into an entry point, delivering the guidewire to a target location of the thrombus, and guiding a thrombectomy device to the location of the thrombus on the guidewire.

[0026] In some embodiments, the method further includes using a vacuum to remove tissue from the vascular lumen.

[0027] In some embodiments, the method includes the following: Creating an entry point in the lumen of the target blood vessel; Inserting a thrombectomy device with a deflection distance into the lumen of a blood vessel; To deliver the cutter to the target site containing the tissue to be removed; Cutting tissue from the lumen of a blood vessel using a cutter on a thrombectomy device; And, To remove the thrombectomy device from the lumen of the target blood vessel. It includes.

[0028] In some embodiments, the method includes inserting a guidewire into an entry point, delivering the guidewire to a target location in the tissue, and guiding a cutter to the location of the thrombus on the guidewire.

[0029] In some embodiments, the method involves using a vacuum to remove tissue from the lumen of a blood vessel.

[0030] Methods for fabricating thrombectomy tubular cutters, thrombectomy devices, and thrombectomy systems are also provided in the process of the above teachings in the detailed description below. Methods for treating any vein or artery are provided, which include, for example, (i) removal of venous thrombi, (ii) removal of pulmonary artery thrombi, also called pulmonary embolisms, and (iii) removal of arterial plaque. [Brief explanation of the drawing]

[0031] [Figure 1A-D] Figures 1A-1D and 1E illustrate a human leg containing a thrombus, partial occlusion of a blood vessel by the thrombus, embolus release, complete occlusion of a blood vessel by the thrombus, and platelet accumulation behind the thrombus. [Figure 1E] Figures 1A-1D and 1E illustrate a human leg containing a thrombus, partial occlusion of a blood vessel by the thrombus, embolus release, complete occlusion of a blood vessel by the thrombus, and platelet accumulation behind the thrombus.

[0032] [Figure 2A-F] Figures 2A-F and 2G-H illustrate several embodiments of thrombectomy tubular cutters. [Figure 2G-H] Figures 2A-F and 2G-H illustrate several embodiments of thrombectomy tubular cutters.

[0033] [Figure 3A-D] Figures 3A-D, 3E-F, 3G-H, and 3I illustrate several embodiments of a thrombectomy tubular cutter system. [Figure 3E-F]Figures 3A-D, 3E-F, 3G-H, and 3I illustrate several embodiments of a thrombectomy tubular cutter system. [Figure 3G-H] Figures 3A-D, 3E-F, 3G-H, and 3I illustrate several embodiments of a thrombectomy tubular cutter system. [Figure 3I] Figures 3A-D, 3E-F, 3G-H, and 3I illustrate several embodiments of a thrombectomy tubular cutter system.

[0034] [Figure 4A-D] Figures 4A to 4D illustrate the configuration of a rotating thrombectomy tubular cutter system for removing thrombi in several different configurations.

[0035] [Figure 5A-E] Figures 5A to 5L illustrate various opening shapes and sweep offsets in several embodiments. [Figure 5F-L] Figures 5A to 5L illustrate various opening shapes and sweep offsets in several embodiments.

[0036] [Figure 6A-F] Figures 6A to 6F illustrate various rim and cutting blade shapes in several embodiments.

[0037] [Figure 7A-B] Figures 7A and 7B illustrate the size of the thrombus tubular cutter compared to the size of the lumen at the neck of the thrombus removal tubular cutter in several embodiments, showing how the size of the opening of the tubular cutter affects the passage of the thrombus through the lumen.

[0038] [Figure 8] Figure 8 illustrates several embodiments of a thrombectomy system having an electric handle for rotating a thrombectomy tubular cutter.

[0039] [Figure 9A-F] Figures 9A to 9F illustrate blood filtration ports within a thrombectomy tubular cutter in several configurations.

[0040] [Figure 10A] Figures 10A and 10B illustrate the rotating shaft of a thrombectomy tubular cutter system with a positive displacement pump in several embodiments. [Figure 10B] Figures 10A and 10B illustrate the rotating shaft of a thrombectomy tubular cutter system with a positive displacement pump in several embodiments.

[0041] [Figure 11] Figure 11 is a flowchart of several thrombectomy methods. [Modes for carrying out the invention]

[0042] Detailed explanation Thrombectomy devices and methods for using them are provided, that is, devices and methods that can (i) effectively cut and remove thrombotic tissue, (ii) safely collect and remove plaque particles to avoid embolic dislodgement, and (iii) effectively treat blood vessels with reduced risk of vascular damage. And importantly, those skilled in the art will undoubtedly appreciate having a thrombectomy device that can also (iv) treat tight or hard lesions with little or no luminal opening within the lesion. A thrombectomy device may have a cutting head including the shape of a tubular cutter with a cutting blade that removes thrombotic tissue from a blood vessel when the head is rotated within the lumen of the blood vessel. Several embodiments of the art described herein are taught, and these embodiments include systems, methods, and devices for (i) removal of venous thrombi, and (ii) removal of pulmonary artery thrombi, also known as pulmonary embolisms.

[0043] Those skilled in the art will understand that the “subject” undergoing thrombectomy may be the “patient” undergoing thrombectomy. Therefore, the terms “subject” and “patient” may be used interchangeably to refer to animals such as mammals, including but not limited to non-primates such as cattle, pigs, horses, cats, dogs, rabbits, rats, and mice; and primates such as monkeys or humans. The subject may also be a corpse, or in some embodiments, a part of a corpse.

[0044] Devices, systems, and methods taught herein can remove blood clots from arteries or veins in, for example, the heart, brain, lungs, abdomen, arms, and legs. Arterial blood clots can also take root in the kidneys, intestines, or eyes, though this is considered rare. In some embodiments, the blood clot is stationary, which is a “thrombosis” that can block blood flow, and the devices, systems, and methods taught herein can remove the thrombosis. When the blood clot becomes free and moves within the blood vessels, it becomes an “embolism,” which can travel to other parts of the body and be dangerous, and may even be fatal.

[0045] Arterial thrombi, also known as white thrombi, are characterized by a platelet-dominant composition. Venous thrombi, also known as red thrombi, are characterized by a red blood cell-dominant composition. Thrombi can begin soft and, over time, become more fibrous and harder. Thrombosis can play a significant role in the formation and histopathological damage of arteries and old saphenous vein grafts (SVGs). Non-occlusive thrombi can form from asymptomatic plaque rupture or plaque erosion. As the size of the thrombus increases and obstructs blood flow, a provisional matrix forms in the healed lesion as an organized thrombus, which may contain fibrin and be infiltrated with granulation tissue of smooth muscle cells containing proteoglycans and type III collagen. For example, proximal and distal thrombi to the site of plaque rupture can, in some embodiments, be replaced by fibrous plaque. In some embodiments, devices, systems, and methods can be used to treat SVGs. In some embodiments, devices, systems, and methods may be used to inhibit the development of plaque formation that follows the formation of a thrombus.

[0046] The devices, systems, and methods taught herein may be used, for example, to treat or prevent the onset of symptoms by removing a blood clot from an artery or vein of interest. Thus, the devices, systems, and methods taught herein may remove arterial or venous blood clots. In some embodiments, the devices, systems, and methods treat or prevent the onset of symptoms caused by blood clots in the arm or leg, including redness and warmth accompanied by swelling, tenderness, severe cramps, or any combination thereof. In some embodiments, the devices, systems, and methods treat or prevent the onset of symptoms caused by blood clots in the abdomen, including stomach pain, diarrhea, vomiting, or any combination thereof. In some embodiments, the devices, systems, and methods treat or prevent the onset of symptoms caused by blood clots in the heart, including shortness of breath, nausea, dizziness, sweating, chest pain and heaviness, or any combination thereof. In some embodiments, devices, systems, and methods treat or inhibit the onset of symptoms caused by blood clots in the lungs, including hemoptysis, palpitations, shortness of breath, sweating, fever, sharp chest pain, or any combination thereof. In some embodiments, devices, systems, and methods treat or inhibit the onset of symptoms caused by blood clots in the brain, including headache, dizziness, difficulty speaking, difficulty seeing clearly, weakness of the face, arms, or legs of an object, or any combination thereof.

[0047] The devices, systems, and methods taught herein may be used, for example, to remove three types of blood clots that form in veins. In some embodiments, the devices, systems, and methods taught herein may be used to remove (i) superficial vein thrombosis near the surface of the skin; (ii) deep vein thrombosis (DVT) that forms deep within the body, including the lower extremities, thighs, pelvis, arms, intestines, liver, kidneys, or brain; and (iii) pulmonary embolism (PE) in the lungs.

[0048] Figures 1A-1E illustrate a human leg containing a thrombus, partial occlusion of a blood vessel by the thrombus, embolus release, complete occlusion of a blood vessel by the thrombus, and platelet accumulation behind the thrombus. Figure 1A illustrates the subject leg 105 with symptomatic pain 110 due to a thrombus 100 in a blood vessel 115 of the subject leg 105. Figure 1B illustrates partial occlusion of a blood vessel 115 due to a thrombus 100 deposited on the wall of the blood vessel 115. Figure 1C illustrates the release of an embolus 101 within a blood vessel 115, which, as those skilled in the art would understand, can lead to a series of more serious symptoms, including death. Figure 1D illustrates complete occlusion of a blood vessel 115 by a thrombus 100, which results in reflux (or accumulation) 125 behind the thrombus 100 within the blood vessel 115. Figure 1E is a more anatomically accurate illustration of a blood vessel 115 containing a thrombus 100, which includes a platelet accumulation behind the thrombus 100.

[0049] The thrombectomy devices taught herein may include a flexible rotating shaft having a proximal end, a distal end and a lumen; a tubular cutter at the distal end of the rotating shaft, the tubular cutter having a proximal end and a distal end, as well as an upper and lower section, and the tubular cutter having an opening with a rim having cutting blades, the opening having (i) an inlet; and (ii) an outlet communicating with the lumen of the flexible rotating shaft, the device may also include a neck having a central axis, the neck being configured to be operably connected to and communicating with the lumen of the flexible rotating shaft. The system may also include a vacuum port configured to be operably connected to a vacuum source.

[0050] In several embodiments, methods for treating thrombosis are provided. These methods include creating an entry point in the vascular system of the subject, advancing a thrombectomy device taught herein through the entry point to the site of the thrombus, removing the thrombus with the thrombectomy device, and removing the thrombectomy device from the subject. In several embodiments, the method includes advancing a guidewire to the site of the thrombus, advancing a thrombectomy device beyond the guidewire to the thrombus, and removing the guidewire from the subject. In several embodiments, the method is used to treat venous thrombosis. In several embodiments, the method is used to treat superficial venous thrombosis. In several embodiments, the method is used to treat deep vein thrombosis (DVT). In several embodiments, the method is used to treat saphenous vein thrombosis. In several embodiments, the method is used to treat renal vein thrombosis. In several embodiments, the method is used to treat arterial thrombosis.

[0051] A thrombectomy tubular cutter may, in some embodiments, be called a “tubular cutter,” “cutter,” “cutting head,” or similar. Figures 2A–2H illustrate various views of the features of a thrombectomy tubular cutter in several embodiments. Figure 2A is a diagram showing the overall structure of a thrombectomy tubular cutter. As shown in Figure 2A, the tubular cutter 200 has a head 220 with an opening and a neck 225 having a lumen, or throat, 230, with a central axis 270, which in some embodiments is also called a “rotation axis.” The head, or opening 220, of the thrombectomy tubular cutter 200 may have a rim 221 having a cutting blade 205. In some embodiments, the thrombectomy tubular cutter 200 may have a guidewire port 215 positioned to guide the thrombectomy tubular cutter 200 on a guidewire (not shown) to the target site of the thrombus 100 in the lumen of the blood vessel. In some embodiments, the thrombectomy tubular cutter 200 does not have a guidewire port 215. In some embodiments, the rim 221 may have curvature.

[0052] In some embodiments, the rim 221 may have a rear end blade 210, but it should be noted that the relationship between the cutting blade 205 and the rear end blade 210 is a design feature that may be modified in the cutter taught herein. For example, the cutting blade 205 may also be called the “tip blade,” and the tip blade 205 is configured to reach the target site for tissue excision before the rear end blade 210 when the cutting head 200 rotates. The top and bottom of the cutter are shown in Figure 2B, showing the axis of the head and the axis of the neck (axis of rotation), where the axis of the head is concentric with the axis of the neck, and also describing how the term “vertical” describes orientation from top to bottom or bottom to top. From the user’s perspective, with the top of the cutter facing upwards and the cutting head 200 viewed from the proximal end, the tip blade 205 needs to be on the right side in order to rotate the cutting head 200 counterclockwise. Similarly, from the user's perspective, if the cutter is pointed upwards and the cutting head 200 is viewed from the proximal end, the tip blade 205 needs to be on the left side in order to rotate the cutting head 200 clockwise.

[0053] A desirable design feature that may be included in the cutter configuration is the "bias" of the cutting surface. The "bias" can be defined as an imbalance between the distance from the rotation axis 270 to the front cutting edge 205 (referred to as BL) and the distance from the rotation axis 270 to the rear cutting edge 210 (referred to as BT). In some embodiments, B L is B T Larger. B L This is measured on the tip blade at the point furthest from the axis of rotation and perpendicular to the axis of rotation. TIt is measured on the rear end blade at the point furthest from the axis of rotation and perpendicular to the axis of rotation. Since the actual relative difference between BL and BT may depend on the size of the cutting head, it should be understood that bias a can be expressed as a ratio and, in some embodiments, may be called the “lateral bias” ratio. In some aspects, the BL / BT ratio is as follows: 1.00 to 2.00, 1.05 to 2.00, 1.10 to 2.00, 1.15 to 2.00, 1.20 to 2.00, 1.25 to 2.00, 1.30 to 2.00, 1.35 to 2.00, 1.40 to 2.00, 1.45 to 2.00, 1.50 to 2.00, 1.00 to 1.95, 1.00 to 1.90, 1.00 to 1.85, 1.00 to 1.80, 1.00 to 1.75, 1.00 to It can be up to 1.70, 1.00 to 1.65, 1.00 to 1.60, 1.00 to 1.55, 1.00 to 1.50, 1.00 to 1.45, 1.00 to 1.40, 1.00 to 1.35, 1.00 to 1.30, 1.00 to 1.25, 1.00 to 1.20, 1.00 to 1.15, 1.00 to 1.10, 1.00 to 1.05, or any ratio or range within that range in increments of 0.01. In some embodiments, BL is greater than BT by 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, or any amount or range within that range in 0.1% increments.In some embodiments, BL is greater than BT by 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, 100%, or any amount or range within that range in 0.1% increments. In some embodiments, BL is larger than BT by any amount or range, such as 1.0 times, 2.0 times, 3.0 times, 4.0 times, or 0.1 times.

[0054] Figures 2B and 2F are side views of a thrombectomy tubular cutter 200, showing the overlap of curvatures of the cutting blade 205 and the rear end blade 210, which in some embodiments may be configured to facilitate the efficient removal of the thrombus 100. It should be noted that a smooth non-cutting surface 250 is present at the distal end of the head. In these embodiments, the curvature may include that of the cutting blade 205 and the rear end blade 210.

[0055] Figure 2C is a rear view of the thrombectomy tubular cutter 200 showing an optional guidewire port 215, cutting blade 205, and posterior end blade 210, and also illustrates how the term “lateral” describes the lateral orientation. Figure 2D is a distal-to-proximal perspective view of the thrombectomy tubular cutter 200 showing the lumen, i.e., the throat 230, configured with respect to an optional guidewire port 215 (in this embodiment, sharing a concentric axis with the throat 230), cutting blade 205, and posterior end blade 210.

[0056] Figure 2E illustrates the cutting head 200, which is configured for clockwise rotation from the user's proximal viewpoint. Please understand that counterclockwise rotation is a mirror image, and the front blade 205 and the rear blade 210 are swapped.

[0057] Figure 2E is a proximal-to-distal perspective view of the lumen, or throat, of the tubular cutter 200, configured with an optional guidewire port 215 (in this embodiment, sharing a concentric axis with the throat 230), a cutting blade 205, and a rear end blade 210. It should be understood that in some embodiments, the lumen 230 and the optional guidewire port 215 do not need to share a concentric axis.

[0058] Figures 2E and 2F provide perspective views of the front and rear blades 205 and 210, showing how the front blade 205 may be configured to precede the rear blade. Figure 2E is a perspective view representing the whole, rotated 0° from the central plane 227 of the neck 225, where the height of the front blade 205 (front edge height), measured from the bottom of the neck, is greater than the height of the rear blade 210 (rear edge height). The front edge height is measured perpendicular to the bottom surface of the cutter at the highest point of the front blade, and the rear edge height is measured perpendicular to the bottom surface of the cutter at the lowest point of the rear blade. It should be understood that the relative difference in height Δh may depend on the size of the cutting head, and therefore the relative difference in height Δh may be expressed as a ratio, which in some embodiments may be called the “vertical bias” ratio. In some aspects, the ratio of leading edge height to trailing edge height is 1.00 to 2.00, 1.05 to 2.00, 1.10 to 2.00, 1.15 to 2.00, 1.20 to 2.00, 1.25 to 2.00, 1.30 to 2.00, 1.35 to 2.00, 1.40 to 2.00, 1.45 to 2.00, 1.50 to 2.00, 1.00 to 1.95, 1.00 to 1.90, 1.00 to 1.85, 1.00 to 1.80, 1.00 to 1.75, 1.00 From 1.70 to 1.70, 1.00 to 1.65, 1.00 to 1.60, 1.00 to 1.55, 1.00 to 1.50, 1.00 to 1.45, 1.00 to 1.40, 1.00 to 1.35, 1.00 to 1.30, 1.00 to 1.25, 1.00 to 1.20, 1.00 to 1.15, 1.00 to 1.10, 1.00 to 1.05, or any ratio or range within that range in increments of 0.01. In some embodiments, the leading edge height is greater than the trailing edge height by 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, or any amount or range within that range in 0.1% increments.In some embodiments, the leading edge height is greater than the trailing edge height by 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, 100%, or any amount or range within that range in 0.1% increments. In some embodiments, the leading edge height is greater than the trailing edge height by any amount or range, such as 1.00 times, 2.00 times, 3.00 times, 4.00 times, or 0.01 times.

[0059] Figure 2G illustrates how a curved tubular cutter may be manufactured in several embodiments, in which a curved tube is cut to form a rim with a desired configuration. For example, the rim may be spirally configured in several embodiments and, in at least several embodiments, have a cutting blade 205 and a rear end blade 210. In several embodiments, the curvature of the tube may be used to configure the angle Θz between the Z-axis of the opening and the central axis 270 of the neck or throat 230.

[0060] The Z-axis of the opening is defined, with reference to Figure 2E, as (i) a line perpendicular to the line connecting the most distal point of the opening to the most proximal point of the opening on the y-axis, and (ii) a line perpendicular to the central plane on the x-axis.

[0061] It should be understood that the angle Θz between the Z-axis of the opening and the central axis 270 of the neck, or throat portion 230, is independent of the angle of curvature of the tube and is formed simply by angled the cut surface of the tube along the dashed line to form the rim. Using such variations in the manufacturing method, rims and openings of various desirable configurations can be formed.

[0062] The thrombectomy tubular cutter 200 can be made from any medical-grade material known to be useful for fabricating cutting devices for in vivo use in subjects under a sterile surgical environment. In some embodiments, the thrombectomy tubular cutter 200 can be made from polymers such as PEEK, polycarbonate, PET, polyacrylamide, PEBAX, polyethylene, or fluoropolymers such as FEP, PTFE, or PVDF. In some embodiments, the thrombectomy tubular cutter 200 can be made from surgical-grade metals such as stainless steel, titanium alloy, or cobalt alloy. In some embodiments, the cutter can be made from ceramic or glass. In some embodiments, the thrombectomy tubular cutter 200 can be coated with a smooth coating such as silicone oil, parylene, hydrophilic coating, diamond coating, fluoropolymer coating, ceramic coating, or any combination thereof. Such coatings can facilitate trouble-free use of the thrombectomy tubular cutter. For example, such coatings can help reduce friction when drawing blood clots into the shaft and transporting them.

[0063] In some embodiments, the angle θz between the central axis of the neck and the Z-axis of the opening may be from 0° to 180°, from 0° to 90°, from 90° to 180°, from 120° to 180°, or any amount or range within that range in 1° increments. In some embodiments, the angle θz between the central axis of the neck and the Z-axis of the opening may be from 1° to 30°, from 2° to 30°, from 3° to 30°, from 4° to 30°, from 5° to 30°, from 6° to 30°, from 7° to 30°, from 8° to 30°, from 9° to 30°, from 10° to 30°, from 15° to 30°, from 20° to 30°, from 25° to 30°, or any range or amount within that range in 1° increments. In some embodiments, the angle °θz between the central axis of the neck and the Z-axis of the opening can be from 1° to 45°, 2° to 45°, 3° to 45°, 4° to 45°, 5° to 45°, 6° to 45°, 7° to 45°, 8° to 45°, 9° to 45°, 10° to 45°, 15° to 45°, 20° to 45°, 25° to 45°, 30° to 45°, 35° to 45°, 40° to 45°, or any range or amount within that range in 1° increments. In some embodiments, the angle θz can be any range or quantity within the following ranges: 1° to 60°, 2° to 60°, 3° to 60°, 4° to 60°, 5° to 60°, 6° to 60°, 7° to 60°, 8° to 60°, 9° to 60°, 10° to 60°, 15° to 60°, 20° to 60°, 25° to 60°, 30° to 60°, 35° to 60°, 40° to 60°, 45° to 60°, 50° to 60°, 55° to 60°, or in increments of 1°.In some embodiments, the angle θz between the central axis of the neck and the Z-axis of the opening is 1° to 90°, 2° to 90°, 3° to 90°, 4° to 90°, 5° to 90°, 6° to 90°, 7° to 90°, 8° to 90°, 9° to 90°, 10° to 90°, 15° to 90°, 20° to 90°, 25° to 9 It could be up to 0°, from 30° to 90°, from 35° to 90°, from 40° to 90°, from 45° to 90°, from 50° to 90°, from 55° to 90°, from 60° to 90°, from 65° to 90°, from 70° to 90°, from 75° to 90°, from 80° to 90°, from 85° to 90°, or any range or quantity within that range in 1° increments. In some embodiments, the angle θz between the central axis of the neck and the Z-axis of the opening is 1° to 120°, 2° to 120°, 3° to 120°, 4° to 120°, 5° to 120°, 6° to 120°, 7° to 120°, 8° to 120°, 9° to 120°, 10° to 120°, 15° to 120°, 20° to 120°, 25° to 120°, 30° to 120°, 35° to 120°, 40° It could be from 1° to 120°, 45° to 120°, 50° to 120°, 55° to 120°, 60° to 120°, 65° to 120°, 70° to 120°, 75° to 120°, 80° to 120°, 85° to 120°, 90° to 120°, 95° to 120°, 100° to 120°, 110° to 120°, 115° to 120°, or any range or quantity within that range in 1° increments.

[0064] In some embodiments, the angle θz between the central axis of the neck and the z-axis of the opening may be 25° to 55°, 10° to 110°, 20° to 110°, 25° to 110°, 30° to 110°, 35° to 110°, 40° to 110°, 45° to 110°, 10° to 100°, 20° to 100°, 25° to 100°, 30° to 100°, 35° to 100°, 40° to 100°, 45° to 100°, or any range within that range in 1° increments. In some embodiments, the angle θz between the central axis of the neck and the z-axis of the opening can be 2° to 40°, 3° to 35°, 4° to 30°, 5° to 25°, 5° to 40°, 5° to 35°, 10° to 40°, 10° to 35°, 10° to 25°, 15° to 40°, 15° to 35°, 15° to 25°, or any range or amount within that range in 1° increments. In some embodiments, the angle θz between the central axis of the neck and the z-axis of the opening is 0°, 1.0°, 2.0°, 3.0°, 4.0°, 5.0°, 6.0°, 7.0°, 8.0°, 9.0°, 10.0°, 11.0°, 12.0°, 13.0°, 14.0°, 15.0°, 16.0°, 17.0°, 18.0°, 19.0°, 20.0°, 21.0°, 22.0°, 23.0°, 24.0°, 25.0°, 26.0°, 27.0°, 28.0°, 29.0°, 30.0°, 31.0°, 32.0°, 33.0°, 34.0°, 35.0°, 36.0°, 37.0°, 38.0°, 39.0°, 40.0°, 41.0°, 42.0°, 43.0°, 44.0°, 50.0°, 55.0°, 60.0°, 65.0°, 70.0°, 75.0°, 80.0°, 85.0°, 90.0°, 95.0°, 100.0°, 105.0°, 110.0°, 115.0°, 120.0°, 125.0°, 130.0°, 135.0°, 140.0°, 145.0°, 150.0°, 155.0°, 160.0°, 165.0°, 170.0°, 175.0°, 180.0°, or any angle θz or range within that range in 1° increments.

[0065] The lumen diameter of blood vessels takes on a wide range of sizes and is becoming considerably larger, and in some embodiments, it is probably becoming larger than practical for vascular access to the target. In larger diameter vessels, those skilled in the art can choose eccentric cutting to remove an area wider than the diameter of the cutter assembly without adding or replacing the cutter to use other larger tools for removal. The cutter can be deflected off-center in larger diameter vessels to create an additional sweep. By creating deflection in the system and device, a “sweep” can be created, which produces an effective “sweep diameter,” helping the cutter 200 to reach the lumen of larger diameter vessels, increasing the centrifugal force against the cutter wall realized by the excised tissue, and ensuring that the tissue remains within the cutter head 220. As the deflection increases, the sweep increases and the centrifugal force increases. Similarly, as the deflection decreases, the sweep decreases and the centrifugal force decreases. Therefore, by selecting and designing sweeps in systems and devices, users can obtain desired functions such as increased reach and centrifugal force.

[0066] In some embodiments, the deflection length, or sweep, may be referred to as the “deflection distance” and used to define the sweep made in a thrombectomy device. The sweep can be obtained in any way that a person skilled in the art can devise, and in some embodiments, it may be defined as the distance of the cutter head from the rotation axis 270. In some embodiments, the sweep may be defined as the deflection distance, which is the point on the tip blade 205 that is at the longest distance from the rotation axis 270.

[0067] In some embodiments, the sweep is adjustable, and the system and device may be provided with a gauge on the handle of the system and device indicating the sweep diameter obtained through the angle created on the components of the system to create the sweep. Creating a curvature on the components of the system can be done in various ways including those known to those skilled in the art, such as through the use of tendons that apply tension to the component to create the curvature or through the use of materials having memory that incorporate the curvature as a shape during formation. The cutting head may be configured to create a sweep and centrifugal force.

[0068] The sweep So can be designed into the cutting head by selecting the angle Φ between the head 220 and the neck 225 of the cutter 200, providing a desired deflection distance from the axis of rotation 270. The sweep increases the reach of the device within the blood vessel, i.e., the diameter that the cutting edge 205 of the tubular cutting head 220 of the device 200 can reach. Additionally, the sweep can apply centrifugal force to the cutting head so that the excised tissue will receive an additional force to be held within the cutting head 220. In some embodiments, the sweep So is given by the formula So = L D sin Φ and can be readily estimated using this. The sweep is what adds the "deflection distance" of the cutting edge 205 from the axis of rotation 270, where the sweep is 0 when Φ = 0 o and the sweep is L, the length of the deflected portion of the cutting device, when Φ = 90 o and is the maximum value of L D in this case.

[0069] Figure 2H illustrates how a sweep is introduced to the cutter 200 by inducing an angle Φ between the neck 225 and the head 220 in several embodiments. Introducing a sweep increases the reach of the cutting surface within the blood vessel and introduces additional centrifugal force that helps to retain the excised tissue within the head 220 of the tubular cutter 200 after the tissue has been excised from the target site within the object. The angle θz is selectable to increase the reach of the cutter 200 and generate centrifugal force inside the cutter opening, increasing the retention force of the excised tissue within the head 220 after the tissue has been excised from the object (e.g., a thrombus excised from a blood vessel). The tip blade 205 of the cutter 200 is further away from the axis of rotation 270, which increases the reach of the tip blade 205 and results in increased centrifugal force generated during rotation. In this embodiment, the sweep can be defined as the deflection distance So, which is the distance from the axis of rotation 270 to the point 205d that is furthest from the axis of rotation 270.

[0070] The angle θz correlates with the angle Φ that creates a sweep at the head 220 of the cutter 200. In some embodiments, the angle Φ can be any quantity or range within the following ranges in 1° increments: 0° to 90°, 1° to 90°, 2° to 90°, 3° to 90°, 4° to 90°, 5° to 90°, 6° to 90°, 7° to 90°, 8° to 90°, 9° to 90°, 10° to 90°, 15° to 90°, 20° to 90°, 25° to 90°, 30° to 90°, 35° to 90°, 40° to 90°, 45° to 90°, 50° to 90°, or any quantity or range within these ranges in 1° increments. In some embodiments, the angle Φ may be from 60° to 90°, from 70° to 90°, from 80° to 90°, or any quantity or range within that range in 1° increments. In some embodiments, the angle Φ may be from 0° to 60°, from 5° to 60°, from 10° to 60°, from 15° to 60°, from 20° to 60°, from 25° to 60°, from 30° to 60°, from 35° to 60°, from 40° to 60°, from 45° to 60°, from 50° to 60°, from 55° to 60°, or any quantity or range within that range in 1° increments. In some embodiments, the angle Φ can be any quantity or range within the following ranges: 0° to 45°, 5° to 45°, 10° to 45°, 15° to 45°, 20° to 45°, 25° to 45°, 30° to 45°, 35° to 45°, 40° to 45°, or in 1° increments. In some embodiments, the angle Φ can be any quantity or range within the following ranges: 5° to 30°, 10° to 30°, 15° to 30°, 20° to 30°, 25° to 30°, or in 1° increments. In some embodiments, the angle Φ can be 0°.In some embodiments, the angle Φ is 0°, 1.0°, 2.0°, 3.0°, 4.0°, 5.0°, 6.0°, 7.0°, 8.0°, 9.0°, 10.0°, 11.0°, 12.0°, 13.0°, 14.0°, 15.0°, 16.0°, 17.0°, 18.0°, 19.0°, 20.0°, 21.0°, 22.0°, 23.0°, 24.0°, 25.0°, 26.0°, 27.0°, 28.0°, 29.0°, 30.0°, 31.0°, 32.0°, 33.0°, 34.0°, 35.0°, 36.0°, 37.0°, 38.0°, 39 0°, 40.0°, 41.0°, 42.0°, 43.0°, 44.0°, 50.0°, 55.0°, 60.0°, 65.0°, 70.0°, 75.0°, 80.0°, 85.0°, 90.0°, 95.0°, 100.0°, 105.0°, 110.0°, 115.0°, 120.0°, 125.0°, 130.0°, 135.0°, 140.0°, 145.0°, 150.0°, 155.0°, 160.0°, 165.0°, 170.0°, 175.0°, 180.0°, or any angle or range within that range in 1° increments.

[0071] The thrombectomy device drives a cutter with a flexible rotating shaft having a proximal end, a distal end, and a lumen, and the tubular cutter is operably connected at the distal end of the flexible rotating shaft. In some embodiments, the tubular cutter is as follows: A head having a distal end with a smooth non-cutting surface, and an opening having a rim and a Z-axis, wherein the rim has a cutting blade configured to remove tissue from a target site within the target blood vessel when the tubular cutter is rotated within the target blood vessel, and A neck operably connected to a head, the neck having a throat having a central axis of angle θz in the range of 0° to 180° from the Z axis of the opening, the throat communicating with the lumen of a flexible rotating shaft for transporting tissue away from the target site. It can be composed of

[0072] The cutter 200 is mounted on a flexible rotating shaft 305. In some embodiments, the cutter may be operably mounted on the flexible rotating shaft using a friction fit. In some embodiments, the flexible rotating shaft may slide on the base of the cutter when engaged with the thrombus and meeting the maximum torque limit.

[0073] In some embodiments, the outer sheath 307, or outer catheter 307, may be used to safely deliver the flexible rotating shaft 305 and the cutting head 200 to a target site within the object for tissue removal. In some embodiments, any outer sheath used may be used to deliver the flexible rotating shaft and the cutting head and may be referred to as a “delivery sheath,” “delivery catheter,” “guide sheath,” “guide catheter,” etc. In some embodiments, the delivery catheter has greater bending stiffness than the flexible rotating shaft. In some embodiments, the combined stiffness of the flexible rotating shaft and the delivery catheter is minimized to help guide the flexible rotating shaft to the target site of the thrombus in the blood vessel.

[0074] The devices, systems, and methods taught herein may also include an annular portion between the outer sheath and the flexible rotating shaft, which enables the step of introducing a fluid (including, for example, a contrast agent, a drug, saline solution, or a combination thereof), visualizing the procedure, removing air, assisting in the removal of thrombi, smoothing the rotation of the flexible rotating shaft within the outer sheath, or a combination thereof. A flexible rotating shaft can be configured to create sweep and centrifugal force.

[0075] Another way to create a sweep, or deflection distance, is to create an angle θm on a flexible rotating shaft. The angle θm can be created on the flexible rotating shaft 305 using tendons in some embodiments, or perhaps using memory curvature in some embodiments, 0 o from 180 oIt can be up to, or any quantity or range within that range in 1° increments.

[0076] Figures 3A to 3H illustrate several embodiments of thrombectomy tubular cutter systems. Figures 3A and 3B show thrombectomy tubular cutter systems 300 and 310 that do not include an optional guidewire port 215. Figure 3A shows thrombectomy tubular cutter system 300, which includes a thrombectomy tubular cutter 200 operably connected to the distal end of a flexible rotating shaft 305. Figure 3B shows system 310, which includes system 300 with a delivery catheter 307. Figure 3C shows thrombectomy tubular cutter system 320, which includes a thrombectomy tubular cutter 200 operably connected to the distal end of a flexible rotating shaft 305, and the thrombectomy tubular cutter 200 has a guidewire port 215. Figure 3D shows system 330, which includes system 320 with a delivery catheter 307. The neck of the thrombectomy tubular cutter 225 and the flexible rotating shaft 305 may share a central axis 315.

[0077] As shown in Figure 3A, in some embodiments, the distal end of the rim of the tubular cutter 200 is at the top of the tubular cutter 200 at a distance D from the proximal end of the rim. T It can be configured to have a claw-like shape that extends only by a certain distance D. In some embodiments, the distance D TThese range from 0.1mm to 3.0mm, 0.2mm to 3.0mm, 0.3mm to 3.0mm, 0.3mm to 3.0mm, 0.4mm to 3.0mm, 0.5mm to 3.0mm, 0.6mm to 3.0mm, 0.7mm to 3.0mm, 0.8mm to 3.0mm, 0.9mm to 3.0mm, 1.0mm to 3.0mm, 1.1mm to 3.0mm, 1.2mm to 3.0mm, 1.3mm to 3.0mm, 1.4mm to 3.0mm, and 1.5mm to 3.0mm. It could be 1.6mm to 3.0mm, 1.7mm to 3.0mm, 1.8mm to 3.0mm, 1.9mm to 3.0mm, 2.0mm to 3.0mm, 2.1mm to 3.0mm, 2.2mm to 3.0mm, 2.3mm to 3.0mm, 2.4mm to 3.0mm, 2.5mm to 3.0mm, 2.6mm to 3.0mm, 2.7mm to 3.0mm, 2.8mm to 3.0mm, 2.9mm to 3.0mm, or any range or quantity within that range in 0.01mm increments. In some aspects, distance D T This can be 0.1mm to 2.0mm, 0.2mm to 2.0mm, 0.3mm to 2.0mm, 0.3mm to 2.0mm, 0.4mm to 2.0mm, 0.5mm to 2.0mm, 0.6mm to 2.0mm, 0.7mm to 2.0mm, 0.8mm to 2.0mm, 0.9mm to 2.0mm, 1.0mm to 2.0mm, 1.1mm to 2.0mm, 1.2mm to 2.0mm, 1.3mm to 2.0mm, 1.4mm to 2.0mm, 1.5mm to 2.0mm, 1.6mm to 2.0mm, 1.9mm to 2.0mm, 1.8mm to 2.0mm, 1.9mm to 2.0mm, or any range or quantity within that range in 0.01mm increments. In some manner, distance D TThis can be any range or quantity within that range, in increments of 0.01 mm, such as 0.1 mm to 1.0 mm, 0.2 mm to 1.0 mm, 0.3 mm to 1.0 mm, 0.3 mm to 1.0 mm, 0.4 mm to 1.0 mm, 0.5 mm to 1.0 mm, 0.6 mm to 1.0 mm, 0.7 mm to 1.0 mm, 0.8 mm to 1.0 mm, 0.9 mm to 1.0 mm, or any range or quantity within that range in increments of 0.01 mm.

[0078] In some embodiments, the angle θm created on the flexible rotating shaft may be from 0° to 180°, from 0° to 170°, from 0° to 160°, from 0° to 150°, from 0° to 140°, from 0° to 130°, from 0° to 120°, from 0° to 110°, from 0° to 100°, from 0° to 90°, from 0° to 45°, or any amount or range within that range in 1° increments. In some embodiments, the angle θm formed on the flexibly rotating shaft 305 can be from 0° to 30°, 1° to 30°, 2° to 30°, 3° to 30°, 4° to 30°, 5° to 30°, 6° to 30°, 7° to 30°, 8° to 30°, 9° to 30°, 10° to 30°, 15° to 30°, 20° to 30°, 25° to 30°, or any range or amount within that range in 1° increments. In some embodiments, the angle θm created on the flexibly rotating shaft 305 can be from 0° to 45°, 1° to 45°, 2° to 45°, 3° to 45°, 4° to 45°, 5° to 45°, 6° to 45°, 7° to 45°, 8° to 45°, 9° to 45°, 10° to 45°, 15° to 45°, 20° to 45°, 25° to 45°, 30° to 45°, 35° to 45°, 40° to 45°, or any range or amount within that range in 1° increments. In some embodiments, the angle θm created on the flexibly rotating shaft 305 can be from 0° to 60°, 1° to 60°, 2° to 60°, 3° to 60°, 4° to 60°, 5° to 60°, 6° to 60°, 7° to 60°, 8° to 60°, 9° to 60°, 10° to 60°, 15° to 60°, 20° to 60°, 25° to 60°, 30° to 60°, 35° to 60°, 40° to 60°, 45° to 60°, 50° to 60°, 55° to 60°, or any range or amount within that range in 1° increments.In some embodiments, the angle θm created on the flexibly rotating shaft 305 is from 0° to 90°, 1° to 90°, 2° to 90°, 3° to 90°, 4° to 90°, 5° to 90°, 6° to 90°, 7° to 90°, 8° to 90°, 9° to 90°, 10° to 90°, 15° to 90°, and 20° to 90°. , 25° to 90°, 30° to 90°, 35° to 90°, 40° to 90°, 45° to 90°, 50° to 90°, 55° to 90°, 60° to 90°, 65° to 90°, 70° to 90°, 75° to 90°, 80° to 90°, 85° to 90°, or any range or quantity within that range in 1° increments. In some embodiments, the angle θm formed on the flexibly rotating shaft 305 is 0°, 1.0°, 2.0°, 3.0°, 4.0°, 5.0°, 6.0°, 7.0°, 8.0°, 9.0°, 10.0°, 11.0°, 12.0°, 13.0°, 14.0°, 15.0°, 16.0°, 17.0°, 18.0°, 19.0°, 20.0°, 21.0°, 22.0°, 23.0°, 24.0°, 25.0°, 26.0°, 27.0°, 28.0°, 29.0°, 30.0°, 31.0°, 32.0°, 33.0°, 34.0°, 35.0°, 36.0°, 37. 0°, 38.0°, 39.0°, 40.0°, 41.0°, 42.0°, 43.0°, 44.0°, 50.0°, 55.0°, 60.0°, 65.0°, 70.0°, 75.0°, 80.0°, 85.0°, 90.0°, 95.0°, 100.0°, 105.0°, 110.0°, 115.0°, 120.0°, 125.0°, 130.0°, 135.0°, 140.0°, 145.0°, 150.0°, 155.0°, 160.0°, 165.0°, 170.0°, 175.0°, 180.0°, or any angle or range within that range in 1° increments.

[0079] Therefore, if an angle is created in the flexible rotating shaft, the outer sheath may be designed to straighten the flexible rotating shaft in order to deliver it into the target. In some embodiments, the outer sheath may be called a “corrective sheath,” “corrective catheter,” etc., as well as a “delivery sheath,” “delivery catheter,” “guidance sheath,” “guidance catheter,” etc. In some embodiments, the corrective catheter may have the same or similar bending stiffness as the flexible rotating shaft.

[0080] Figure 3E shows a memory shaft system 340, which includes an orthodontic catheter 307 that slides and translates on a shape-memory flexible rotating shaft 305C. In this embodiment, the flexible rotating shaft has a pre-formed, elastic memory C curve with an angle θm, and a curvature axis 370C located on a plane that shares the curve with the curvature. Due to the arrangement of the cutting blade 205, the device shown in Figure 3E needs to be rotated counterclockwise to cut, as viewed from a proximal viewpoint of the person using the device.

[0081] The corrective sheath has the function of correcting the memory-type C-curve of the shape-memory rotating shaft 305C and delivering it into the target blood vessel. The corrective sheath / catheter 307 has a proximal end (not shown) and a distal end. Sliding the corrective sheath / catheter 307 distally from a position where the distal end of the corrective sheath / catheter 307 is proximal to the angle created gradually removes the curvature of the C-curve. Similarly, sliding the corrective sheath / catheter 307 proximal from a position where the distal end of the corrective sheath / catheter 307 is distal to the memory-type C-curve gradually reconstructs the curvature of the C-curve.

[0082] In some embodiments, a braided pattern structure may be used to achieve desired material strength in a delivery catheter, a flexible rotating shaft, or a combination thereof. In some embodiments, a helical pattern structure may be used to achieve desired material strength in a delivery catheter, a flexible rotating shaft, or a combination thereof. In some embodiments, a corrective sheath may include a braided pattern structure that can be fabricated using any material known to be suitable to those skilled in the art. For example, the braided pattern structure may be selected to include any type of braiding material that is considered acceptable to those skilled in the art for the intended use. For example, the braided pattern or helical pattern may include the use of metal, polymer braids, fibers, or a combination thereof. Suitable medical-grade materials known to be suitable to those skilled in the art may be used.

[0083] Figure 3F shows a tendon-type shaft system 350, which includes creating a curve of angle θm on a flexible rotating shaft by applying tension to a tendon integrated with the flexible rotating shaft, in several embodiments. In some embodiments, the angle θm is created on the flexible rotating shaft by the tendon and can be corrected by releasing tension on the tendon. In some embodiments, the angle θm is created on the flexible rotating shaft by the tendon and can be corrected by pushing the tendon distally. In some embodiments, the angle θm is created on the flexible rotating shaft by the tendon and can be corrected using a corrective catheter 307 that slides and translates along the flexible rotating shaft 305C, in which embodiment the shaft has a curve on a curvature axis 370C located on a plane shared with the curve.

[0084] Regardless of how the angle θm is created on the flexible rotating shaft, the tubular cutter 200 may have a Z-axis 260 rotated by an angle θr from a position orthogonal to the Z-axis with respect to the plane, maintaining an orthogonal relationship with the curvature axis 370C, and as a result, the cutting blade 205 precedes the rear end blade 210 by an angle θr with respect to the plane where the curvature axis 370C is located. More precisely, the rotation of the cutter 200 to open an opening to the target area is created by rotating the central plane 227 from a plane shared with the curvature in the deflection, where θr=0 is when the central plane 227 coincides with the plane shared with the axis of the curvature formed by the deflection. A rotation θr>0 is a rotation of the central plane from a coincidence with the plane shared with the axis of the curvature formed by the deflection, and θr>0 functions to open the opening of the head 220 toward the target area.

[0085] The amount of angle θr is 0 when the position of the Z-axis 260 is perpendicular to the plane on which the curvature axis 370C is located. o Therefore, the 0 of the Z-axis relative to the plane. oAs the Z-axis 260 rotates relative to the orthogonal position, the angle increases while maintaining its orthogonal relationship with the curved axis 370C. As the angle increases, the cutting blade 205 leads the rear end blade 210 by an angle θr. In some embodiments, the angle θr can be from 1° to 90°, 2° to 90°, 3° to 90°, 4° to 90°, 5° to 90°, 6° to 90°, 7° to 90°, 8° to 90°, 9° to 90°, 10° to 90°, 15° to 90°, 20° to 90°, 25° to 90°, 30° to 90°, 35° to 90°, 40° to 90°, 45° to 90°, 50° to 90°, 55° to 90°, 60° to 90°, or any range or quantity within that range in 1° increments. In some embodiments, the angle θr can be from 1° to 60°, 2° to 60°, 3° to 60°, 4° to 60°, 5° to 60°, 6° to 60°, 7° to 60°, 8° to 60°, 9° to 60°, 10° to 60°, 15° to 60°, 20° to 60°, 25° to 60°, 30° to 60°, 35° to 60°, 40° to 60°, 45° to 60°, 50° to 60°, 55° to 60°, or any range or quantity within that range in 1° increments. In some embodiments, the angle θr can be from 1° to 45°, 2° to 45°, 3° to 45°, 4° to 45°, 5° to 45°, 6° to 45°, 7° to 45°, 8° to 45°, 9° to 45°, 10° to 45°, 15° to 45°, 20° to 45°, 25° to 45°, 30° to 45°, 35° to 45°, 40° to 45°, or any range or quantity within that range in 1° increments.In some embodiments, the angle θr can be from 1° to 45°, 2° to 40°, 3° to 35°, 4° to 30°, 5° to 25°, 5° to 45°, 5° to 40°, 5° to 35°, 5° to 30°, 10° to 45°, 10° to 40°, 10° to 35°, 10° to 30°, 10° to 25°, 15° to 45°, 15° to 40°, 15° to 35°, 15° to 30°, 15° to 25°, or any range or quantity within that range in 1° increments. In some embodiments, the angle θr is 1.0°, 2.0°, 3.0°, 4.0°, 5.0°, 6.0°, 7.0°, 8.0°, 9.0°, 10.0°, 11.0°, 12.0°, 13.0°, 14.0°, 15.0°, 16.0°, 17.0°, 18.0°, 19.0°, 20.0°, 21.0°, 22.0°, 23.0°, 24.0°, 25.0°, 26.0°, 27.0° °, 28.0°, 29.0°, 30.0°, 31.0°, 32.0°, 33.0°, 34.0°, 35.0°, 36.0°, 37.0°, 38.0°, 39.0°, 40.0°, 41.0°, 42.0°, 43.0°, 44.0°, 45.0°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, or any range or quantity within that range in 1° increments.

[0086] Figures 3G and 3H show, in several embodiments, the angle θm created as a memory curve on the flexibly rotating shaft 305 of the memory shaft system 340. Due to the arrangement of the cutting blade 205, the device shown in Figure 3G needs to be rotated counterclockwise to cut, as viewed from the viewpoint of the person using the device. In Figure 3G, the angles θm created as memory curves on the flexibly rotating shaft 305 of the memory shaft system 340 are: 0° to 180°, 0° to 90°, 90° to 180°, 5° to 45°, 10° to 45°, 15° to 30°, 20° to 60°, 25° to 55°, 30° to 45°, 10° to 120°, 20° to 120°, 25° to 120°, 30° to 120°, 35° to 120°, 40° to 120°, 45° to 120°, 10° to 110°, 20° to 110°, 25° to 110°, 30° to 110°, and 35°. It could be any range within that range in 1° increments, such as from 40° to 110°, from 45° to 110°, from 10° to 100°, from 20° to 100°, from 25° to 100°, from 30° to 100°, from 35° to 100°, from 40° to 100°, from 45° to 100°, from 10° to 90°, from 20° to 90°, from 25° to 90°, from 30° to 90°, from 35° to 90°, from 40° to 90°, from 45° to 90°, from 50° to 90°, from 55° to 90°, from 60° to 90°, from 65° to 90°, from 70° to 90°, from 75° to 90°, from 80° to 90°, or any range within that range in 1° increments. In some embodiments, the angle θm between the central axis of the neck and the z-axis of the opening can be 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, 120°, 125°, 130°, 135°, 140°, 145°, 150°, 155°, 160°, 165°, 170°, 175°, 180°, or any angle θm within that range in 1° increments.

[0087] The angle θm deflects the distal portion of the thrombectomy device, starting from the apex of the angle formed by the memory C-curve. As can be seen from Figures 3G and 3H, in some embodiments, the angle θm can be used to provide the “sweep” or “deflection distance” of the cutting blade 205 from the rotation axis 270. The sweep So is designed by selecting the angle θm of the memory C-curve or by selecting the angle θm made by the tendon, providing the desired deflection distance from the rotation axis 270. The sweep increases the reach of the device in the blood vessel, i.e., the diameter that the cutting blade 205 of the tubular cutting head 220 of the device 200 can reach. In Figures 3G and 3H, the sweep is the deflection distance So measured from the rotation axis 270 to point 205d on the tip blade 205, because point 205d is at the greatest distance from the rotation axis 270. The sweep is So = L D It can be easily estimated using sinθm, where θm=0 o In this case, the sweep is 0, and θm = 90 o In this case, the sweep is L, which is the length of the deflection portion of the cutting device. D This is the maximum value.

[0088] It should be understood that sweeping facilitates the use of thrombectomy devices in larger vascular systems. Therefore, any method of obtaining a sweep that extends the reach of the cutter and applies centrifugal force is contemplated within the embodiment. For example, two or more angles θm may be used to deflect a flexible rotating shaft. In some embodiments, the memory curve may be S-shaped, including angles θm1 and θm2, and the total sweep So is the sum of the effects of angles θm1 and θm2 on the deflection distance. Figure 3I provides an illustration of such an S-curve. When θm is less than or equal to 90°, So = L DWhile the estimated deflection distance using sinθm can be fairly accurate, it should be understood that as θm increases beyond 90°, these estimates begin to lose accuracy because the curvature at angles due to the physical properties of the flexible rotating shaft introduces errors. Moreover, this calculation is completely useless in Figure 3I because when both θm1 and θm2 are 180°, [So1 = L D [sinθm1] + [So2 = L D This is clearly not true, as sinθm² = 0, and the curvature at the combined angle, which is due to the physical properties of the flexible rotating shaft, actually generates the deflection distance.

[0089] The teachings provided herein include a method for forming a deflection distance such that the configuration of the device taught herein deflects the tip blade of the cutter away from the axis of rotation. Thus, the deflection distance can be created using any method devised by those skilled in the art to deflect the tip blade away from the axis of rotation, resulting in a sweep that increases the cutting diameter of the cutter. L Just as the deflection distance is measured at the point furthest from the rotation axis of the tip blade and perpendicular to the rotation axis, the deflection distance is ΔB L = B L (After bias, or B LAD )- B L (Before bias, or B LBD ) can be measured as. For example, referring to Figure 3I, in this embodiment, So = ΔB L It can be seen that this is the case. Therefore, in some embodiments, So = ΔB L It can be seen that = sweep = deflection distance.

[0090] In some aspects, the deflection distance is 0.1mm to 30.0mm, 0.2mm to 30.0mm, 0.3mm to 30.0mm, 0.4mm to 30.0mm, 0.5mm to 30.0mm, 1.0mm to 30.0mm, 2.0mm to 30.0mm, 3.0mm to 30.0mm, 4.0mm to 30.0mm, 5.0mm to 30.0mm, 6.0mm to 30.0mm, 7.0mm to 30.0mm, 8.0mm to 30.0mm. The range may be mm, 9.0 mm to 30.0 mm, 10.0 mm to 30.0 mm, 11.0 mm to 30.0 mm, 12.0 mm to 30.0 mm, 13.0 mm to 30.0 mm, 14.0 mm to 30.0 mm, 15.0 mm to 30.0 mm, 16.0 mm to 30.0 mm, 17.0 mm to 30.0 mm, 18.0 mm to 30.0 mm, 19.0 mm to 30.0 mm, or any range or quantity within that range in 0.1 mm increments. Several properties and deflection distances are as follows: 0.1mm to 20.0mm, 0.2mm to 20.0mm, 0.3mm to 20.0mm, 0.4mm to 20.0mm, 0.5mm to 20.0mm, 1.0mm to 20.0mm, 2.0mm to 20.0mm, 3.0mm to 20.0mm, 4.0mm to 20.0mm, 5.0mm to 20.0mm, 6.0mm to 20.0mm, 7.0mm to 20.0mm, 8.0mm to 20.0mm. mm, 9.0 mm to 20.0 mm, 10.0 mm to 20.0 mm, 11.0 mm to 20.0 mm, 12.0 mm to 20.0 mm, 13.0 mm to 20.0 mm, 14.0 mm to 20.0 mm, 15.0 mm to 20.0 mm, 16.0 mm to 20.0 mm, 17.0 mm to 20.0 mm, 18.0 mm to 20.0 mm, 19.0 mm to 20.0 mm, or any range or quantity within that range in 0.1 mm increments. In some embodiments, the deflection distance may be 0.5 mm to 19.0 mm, 1.0 mm to 18.0 mm, 2.0 mm to 17.0 mm, 3.0 mm to 16.0 mm, 4.0 mm to 15.0 mm, 5.0 mm to 14.0 mm, 6.0 mm to 13.0 mm, 7.0 mm to 12.0 mm, 8.0 mm to 10.0 mm, or any range or quantity within that range in 0.1 mm increments.In some aspects, the deflection distance may be 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 1.0 mm, 2.0 mm, 3.0 mm, 4.0 mm, 5.0 mm, 6.0 mm, 7.0 mm, 8.0 mm, 9.0 mm, 10.0 mm, 11.0 mm, 12.0 mm, 13.0 mm, 14.0 mm, 15.0 mm, 16.0 mm, 17.0 mm, 18.0 mm, 19.0 mm, 20.0 mm, 21.0 mm, 22.0 mm, 23.0 mm, 24.0 mm, 25.0 mm, 26.0 mm, 27.0 mm, 28.0 mm, 29.0 mm, 30.0 mm, or any quantity or range within these in 0.1 mm increments. Characteristics of the constituent elements

[0091] Device and system components can be designed to have desired characteristics. These desired characteristics can be obtained through material selection and material design, resulting in a desired range of functionality.

[0092] In some embodiments, the flexible rotating shaft may be fabricated from a polymer tube, a metal tube with slots for flexibility (e.g., Type 304 stainless steel tube or similar), or a composite material of polymer and metal. In the case of a composite material, corrosion resistance, contamination control, and thermal stability are improved by laminating metal coils, meshes, or braids, possibly using polymer coatings or molecular coatings. In some embodiments, the polymer may be PEBAX, nylon, polyimide, PEEK, polyethylene, fluoropolymers (PTFE, ETFE, PVDF, FEP), or any combination thereof. In some embodiments, the single molecule may be a fluorosilane. The dimensions of the tube may also depend, at least in part, on the intended application of the thrombectomy device / apparatus / system.

[0093] It should be understood that in some embodiments, the flexible rotating shaft 305 may have bending stiffness suitable for directing the cutting head towards the target site of the thrombus in the blood vessel. In some embodiments, the flexible rotating shaft 305 may have sufficient axial stiffness to transmit axial force to the tubular cutter during operation of the thrombectomy device. Similarly, in some embodiments, the flexible rotating shaft 305 may have sufficient torsional stiffness to transmit torque from the proximal end to the distal end of the flexible rotating shaft in order to rotate the tubular cutter during operation of the thrombectomy device.

[0094] The sheath / delivery catheter 307 can be "relatively rigid" compared to the flexible rotating shaft 305C, in that in some embodiments, it can be designed to be substantially rigider than the flexible rotating shaft 305C. Therefore, the sheath / delivery catheter 307 is relatively rigid compared to the flexible rotating shaft 305C, and for that reason, it can pull the tendon (thick dashed line) proximal to create a memory-type bending region. The sheath / delivery catheter 307 may have the same or similar rigidity as the flexible rotating shaft.

[0095] Those skilled in the art will understand that controlling the bending stiffness of a device allows the user of the device to have greater control over the cutter. Therefore, in some embodiments, any device taught herein may be designed to obtain a desired amount of deflection to direct the cutter toward a desired surface of the vascular lumen wall. Those skilled in the art will understand that there are ways to vary the bending stiffness of a flexible rotating shaft, a delivery sheath, or a combination thereof. The stiffness or flexibility of components may also be adjusted, for example, by changing the composition and / or structure of the materials. In some embodiments, bending stiffness can be increased (or decreased) by bonding the filaments on the flexible rotating shaft, delivery sheath, or a combination thereof with a stiffer material, or by increasing (or decreasing) the size of the filaments.

[0096] In addition to providing appropriate bending and torsional stiffness for operability and functionality, the thrombectomy device also requires a certain axial tensile stiffness for better responsiveness to pushing and pulling. Axial tensile stiffness is the resistance to elongation or contraction along the length of a component under axial load, and is measured in N / mm. In some embodiments, key components of the design include the desired axial tensile stiffness in the delivery sheath and the flexible rotating shaft.

[0097] In some embodiments, the bending stiffness of the delivery catheter may be equal to or greater than that of the flexible rotating shaft. The ratio of the bending stiffness of the flexible rotating shaft to the bending stiffness of the delivery catheter may be 0.03 to 1.0 in some embodiments, 0.03 to 0.30 in some embodiments, 0.05 to 0.25 in some embodiments, 0.06 to 0.30 in some embodiments, 0.5 to 1.0, 0.6 to 1.0, 0.7 to 1.0, 0.8 to 1.0, 0.9 to 1.0, or any range or amount within these in increments of 0.01. In some embodiments, the ratio of the bending stiffness of the flexible rotating shaft to the bending stiffness of the delivery catheter may be 0.10, 0.20, 0.30, 0.40, 0.40, 0.40, 0.40, 0.40, 0.40, 0.40, or any ratio or range within these in increments of 0.01. However, in some embodiments, the bending stiffness of the delivery catheter is two, three, or four times greater than the bending stiffness of the flexible rotating shaft, or is within any range or amount in 0.1-fold increments.

[0098] In some embodiments, the straightening sheath is simply configured to have a minimum stiffness suitable for straightening a flexible rotating shaft to deliver it to a target site. In some embodiments, the force required to bend the straightening sheath is greater than the force required to bend the flexible rotating shaft (for example, perhaps to bend the shape-memory C-curve portion of the flexible rotating shaft). In some embodiments, the force required to bend the straightening sheath is greater than the force required to bend the flexible rotating shaft, and in some embodiments, the shape-memory C-curve, by any amount or range within that range, such as 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, or 0.1%. In some embodiments, the force required to bend the straightening sheath is greater than the force required to bend the flexible rotating shaft and, in some embodiments, the shape memory C curve by 1%-50%, 2%-50%, 3%-50%, 4%-50%, 5%-50%, 6%-50%, 7%, 8%-50%, 9%-50%, 10%-50%, 11%-50%, 12%-50%, 13%-50%, 14%-50%, 15%-50%, 16%-50%, 17%-50%, 18%-50%, 19%-50%, 20%-50%, 21%-50%, 22%-50%, 23%-50%, 24%-50%, 25%-50%, or 0.1, by any amount or range within that range. In some embodiments, the force required to bend the straightening sheath is greater than the force required to bend the flexible rotating shaft, and in some embodiments, the shape memory C curve, and can be twice, three times, four times, or 0.1 times greater than the force required to bend the shape memory C curve, by any amount or range within that range.

[0099] The rigidity of the orthodontic sheath can affect its ability to remove the shape-memory C-curve of the flexible rotational shaft. However, it should be understood that the rigidity must be limited due to the negative friction that the combination of device components exerts on the vascular lumen wall. Therefore, it is desirable to minimize the rigidity of the device in order to target the tissue location for treatment and direct the tubular head towards the target area.

[0100] In some embodiments, the desired rigidity of the orthodontic sheath is 15 Nmm 2 From 900 Nm 2 Up to 30 Nm 2 From 800 Nm 2 Up to 20 Nm 2 From 200 Nm 2 Up to 400 Nmm 2 From 800 Nm 2 up to, or 1 Nmm 2 The increments can be any amount or range within them. In some embodiments, for example, to add flexibility to the distal region of the sheath and relative stiffness to the proximal region of the sheath, the desired stiffness of the orthodontic sheath may depend on the location of the stiffness measurement along the sheath, where the distal-proximal boundary is the midpoint of the sheath defined by the length of the sheath in the subject during the intervention procedure. In some embodiments, the desired stiffness in the distal region of the orthodontic sheath is 20 Nmm 2 From 200 Nm 2 Up to 30 Nm 2 From 100 Nm 2 up to, or 1 Nmm 2 The increments can be any amount or range within them. In some embodiments, the desired stiffness in the proximal region of the sheath is 300 Nmm 2 From 900 Nm 2 Up to 400 Nmm 2 From 800 Nm 2 up to, or 1 Nmm 2 The increments can be any amount or range within them. In some embodiments, the desired combined stiffness at any point of the thrombectomy device is 10 Nmm, whether it is the proximal or distal portion of the device. 2, 20Nmm 2 , 30Nmm 2 , 40Nmm 2 , 50Nmm 2 , 60Nmm 2 , 70Nmm 2 , 80Nmm 2 , 90Nmm 2 , 100Nmm 2 , 200Nmm 2 , 300Nmm 2 , 400Nmm 2 , 500Nmm 2 , 600Nmm 2 700Nmm 2 , 800Nmm 2 , 900Nmm 2 , or 1 Nmm 2 The increments can represent any quantity or range within them.

[0101] The axial strength of a flexible rotating shaft, delivery catheter, or combination thereof is also a design feature. In some embodiments, a flexible rotating shaft, delivery catheter, or combination thereof may be configured to have a column strength suitable for withstanding being pushed into an object without increasing the diameter of the flexible rotating shaft, delivery catheter, or combination thereof to an undesirable amount in some embodiments. Thus, in some embodiments, a flexible rotating shaft, delivery catheter, or combination thereof may be configured to have a column strength suitable for withstanding being withdrawn from an object without reducing the diameter of the flexible rotating shaft, delivery catheter, or combination thereof to an undesirable amount. In some embodiments, when pushing into the object, the undesirable increase in the diameter of the flexible rotating shaft, delivery catheter, or combination thereof is any amount or range within the following: less than 1%, less than 2%, less than 3%, less than 4%, less than 5%, less than 6%, less than 7%, less than 8%, less than 9%, less than 10%, less than 11%, less than 12%, less than 13%, less than 14%, less than 15%, less than 16%, less than 17%, less than 18%, less than 19%, less than 20%, or 0.1%; Furthermore, in some embodiments, when pushing into the object, the increase in diameter of the flexible rotating shaft, delivery catheter, or combination thereof may be any amount or range within the following ranges: 0%-20%, 1%-20%, 2%-20%, 3%-20%, 4%-20%, 5%-20%, 6%-20%, 7%-20%, 8%-20%, 9%-20%, 10%-20%, or 0.1%.In some embodiments, the undesirable reduction in the diameter of the flexible rotating shaft, delivery catheter, or combination thereof upon withdrawal from the subject is any amount or range within the following categories: less than 1%, less than 2%, less than 3%, less than 4%, less than 5%, less than 6%, less than 7%, less than 8%, less than 9%, less than 10%, less than 11%, less than 12%, less than 13%, less than 14%, less than 15%, less than 16%, less than 17%, less than 18%, less than 19%, less than 20%, or 0.1%; Furthermore, in some embodiments, when withdrawing from the object, the reduction in diameter of the flexible rotating shaft, delivery catheter, or combination thereof may be any amount or range within the following ranges: 0%-20%, 1%-20%, 2%-20%, 3%-20%, 4%-20%, 5%-20%, 6%-20%, 7%-20%, 8%-20%, 9%-20%, 10%-20%, or 0.1%.

[0102] Generally speaking, in some embodiments, the outer diameter of a tubular cutter and / or flexible rotating shaft may be 2.0 mm to 10.0 mm, 2.5 mm to 9.5 mm, 3.0 mm to 9.0 mm, 3.5 mm to 8.5 mm, 4.0 mm to 8.0 mm, 4.5 mm to 7.5 mm, 5.0 mm to 7.0 mm, or any amount or range within these in 0.1 mm increments. In some embodiments, the outer diameter of the tubular cutter may be 2.0 mm, 2.2 mm, 2.4 mm, 2.6 mm, 2.8 mm, 3.0 mm, 3.2 mm, 3.4 mm, 3.6 mm, 3.8 mm, 4.0 mm, 4.2 mm, 4.4 mm, 4.6 mm, 4.8 mm, 5.0 mm, 5.2 mm, 5.4 mm, 5.6 mm, 5.8 mm, 6.0 mm, 6.2 mm, 6.4 mm, 6.6 mm, 6.8 mm, 7.0 mm, 7.2 mm, 7.4 mm, 7.6 mm, 7.8 mm, 8.0 mm, 8.2 mm, 8.4 mm, 8.6 mm, 8.8 mm, 9.0 mm, 9.2 mm, 9.4 mm, 9.6 mm, 9.8 mm, 10.0 mm, or any quantity or range within these in 0.1 mm increments.

[0103] For example, in some variations, the outer diameter of the tube is limited to approximately 2.2 mm, while in other variations, it is limited to approximately 1.6 mm, and in others, it can be 2.0 mm to 10.0 mm, 3.0 mm to 9.0 mm, 4.0 mm to 8.0 mm, 5.0 mm to 7.0 mm, or any quantity or range within these ranges in 0.1 mm increments. In some embodiments, the wall thickness of the tube may also be limited to approximately 0.05 mm to 1 mm. In some embodiments, the wall thickness of the tube may also be limited to 0.1 mm to 0.2 mm. In some embodiments, the total length of the tube of the flexible rotating shaft may be approximately 500 mm to 1500 mm (approximately 20 inches to approximately 60 inches), approximately 500 mm to 1400 mm, approximately 500 mm to 1300 mm, approximately 500 mm to 1200 mm, approximately 500 mm to 1100 mm, approximately 500 mm to 1000 mm, or any amount or range within that range in 1 mm increments.

[0104] Figures 4A-4D illustrate the configuration of a rotating thrombectomy tubular cutter system for removing thrombi in several embodiments. Figure 4A shows the system 300 approaching a target site 402 and rotating (400) the head of the thrombectomy tubular cutter 200 to remove the thrombus 100 from within the blood vessel 115. The rotation 400 of the head of the thrombectomy tubular cutter 200 can be clockwise or counterclockwise when viewed from a position proximal to the thrombus 100. The rotation 400 separates the thrombus 100 from the blood vessel 115 by, for example, the cutting blade 205 making a tubular cut through the interface between the thrombus 100 and the luminal wall of the blood vessel 115. In some embodiments, the cutting blade 205 removes a portion of the thrombus 100 without contacting the luminal wall of the blood vessel 115 by cutting the thrombus 100 in such a way that only a portion of the thrombus is removed. After rotation 400 and tubular cutting of the thrombus 100, the thrombus 100 is captured within the opening 220 of the thrombectomy tubular cutter 200 and removed from the blood vessel 115. Figure 4B shows diameter D SThe figure shows the shape of the rim 221 of the opening 220, which can be any shape that facilitates tubular cutting of thrombi within blood vessels. The cutting blade 205 is positioned clockwise as viewed from the user's position proximal to the cutter head, and in Figure 4B, the cutting blade is highlighted by a dashed line.

[0105] Those skilled in the art will understand that the rim 221 of the opening 220 may have any shape that facilitates the removal of thrombi, and that often the shape is wavy, spiral, sawtooth, sinusoidal, linear, or a combination of such shapes. In some embodiments, all surfaces of the rim 221 may be in contact with the same plane. However, in some embodiments, some surfaces of the rim 221 may not be in contact with the same plane as other surfaces of the rim 221. In some embodiments, only a select few surfaces of the rim 221 of the opening 220 may be in contact with the same plane. For example, in some embodiments, only two, three, or four surfaces of the rim 221 of the opening 220 may be in contact with the same plane.

[0106] For example, Figure 4B shows the rim 221 of the opening 220, which has an ellipse shape with an axis rotated counterclockwise from the axis of the lumen of the neck of the thrombectomy tubular cutter, when viewed from above and below. A cutter with a rim 221, such as in Figure 4G, may have only two surfaces that contact a plane parallel to the horizontal plane that cuts the thrombectomy device. This configuration is a result of the "helical" nature of the relative shapes of the cutting blade 205 and the rear end blade 210. The cutting blade 205 is also designed to rotate clockwise using the right-handed helical shape of the cutting blade 205, again when viewed from the user's position proximal to the cutter head, and in Figure 4B, the cutting blade is shown by a dashed line. Conversely, a cutting blade for counterclockwise rotation when viewed from the proximal position of the cutter head would have a left-handed helical shape.

[0107] Figure 4C shows how the thrombectomy tubular cutter 200 is fabricated using a right-handed helical drill tip in several embodiments. The drill tip can be fabricated by selecting a surgical-grade metal using a well-known drill tip manufacturing technique. The distance between the edges of the opposing longitudinal grooves of the tip is the desired width of the tubular cutter of the thrombectomy tubular cutter 200, i.e., the diameter D S It will be made to a size that matches the following. The tip 405 of the cutting edge can function as the distal end of the thrombectomy tubular cutter 200, and the body of the cutting edge can be sharpened to form the opening 220 of the thrombectomy tubular cutter 200. The spiral shape of the longitudinal groove 410 can be sharpened to form the rim 221 of the opening 220, where the cutting edge 205 and the rear end edge 210 are formed by the longitudinal groove of the cutting edge. The shaft portion (not shown) of the cutting edge is hollowed out to form a desired diameter D in the neck of the thrombectomy tubular cutter 200. L A lumen 230 having the above characteristics can be created. Figure 4D illustrates a modified example of the drill bit shown in Figure 4C. As described above, when viewed from the proximal position of the cutter head, a right-handed spiral bit is used for clockwise rotation, while a left-handed spiral bit (not shown) is used for counter-clockwise rotation when viewed from the proximal position of the cutter head. The orientation of the opening can increase the sweep by applying a bias.

[0108] The opening is at an angle θ from the direction of the central axis of the neck of the tubular cutter. B It has a major axis that can be oriented at an angle θ. B This can be measured on a horizontal plane that bisects the central axis of the neck of the tubular cutter, separating the upper part of the tubular cutter from the lower part.

[0109] Figures 5A-5L illustrate various opening shapes and sweep offsets in several embodiments. It should be understood that any opening shape that facilitates the removal of thrombi from the luminal wall of a blood vessel can be used. As shown in Figure 5A, the rim 221 of the opening 220 may be an ellipse with an axis (major axis) and a mathematical center point.

[0110] In some embodiments, the major axis of the ellipse can be rotated around a mathematical center point. In some embodiments, the opening of the opening is at an angle θ from the direction of the central axis of the neck of the tubular cutter. B It has a major axis oriented at θ, where θ B This measurement is taken on a horizontal plane that bisects the central axis of the neck of the tubular cutter, separating the upper part of the tubular cutter from its lower part.

[0111] In some embodiments, the angle of the opening, i.e., the rotation θ, is B θ can be any range or quantity within that range in 1° increments, such as 1° to 90°, 2° to 90°, 3° to 90°, 4° to 90°, 5° to 90°, 6° to 90°, 7° to 90°, 8° to 90°, 9° to 90°, 10° to 90°, 15° to 90°, 20° to 90°, 25° to 90°, 30° to 90°, 35° to 90°, 40° to 90°, 45° to 90°, 50° to 90°, 55° to 90°, 60° to 90°, or any range or quantity within that range in 1° increments. In some embodiments, the angle θ B θ can be any range or quantity within that range in 1° increments, such as 1° to 60°, 2° to 60°, 3° to 60°, 4° to 60°, 5° to 60°, 6° to 60°, 7° to 60°, 8° to 60°, 9° to 60°, 10° to 60°, 15° to 60°, 20° to 60°, 25° to 60°, 30° to 60°, 35° to 60°, 40° to 60°, 45° to 60°, 50° to 60°, 55° to 60°, or any range or quantity within that range in 1° increments. In some embodiments, the angle θ B This can be from 1° to 45°, 2° to 45°, 3° to 45°, 4° to 45°, 5° to 45°, 6° to 45°, 7° to 45°, 8° to 45°, 9° to 45°, 10° to 45°, 15° to 45°, 20° to 45°, 25° to 45°, 30° to 45°, 35° to 45°, 40° to 45°, or any range or quantity within that range in 1° increments. In some embodiments, the angle θB This can be any range or quantity within that range in 1° increments, such as 1° to 45°, 2° to 40°, 3° to 35°, 4° to 30°, 5° to 25°, 5° to 45°, 5° to 40°, 5° to 35°, 5° to 30°, 10° to 45°, 10° to 40°, 10° to 35°, 10° to 30°, 10° to 25°, 15° to 45°, 15° to 40°, 15° to 35°, 15° to 30°, 15° to 25°, or any range or quantity within that range in 1° increments. In some embodiments, the angle θ B The available angles are 1.0°, 2.0°, 3.0°, 4.0°, 5.0°, 6.0°, 7.0°, 8.0°, 9.0°, 10.0°, 11.0°, 12.0°, 13.0°, 14.0°, 15.0°, 16.0°, 17.0°, 18.0°, 19.0°, 20.0°, 21.0°, 22.0°, 23.0°, 24.0°, 25.0°, 26.0°, 27.0°, 28.0°, 29.0°, and 30. θ can be 0.0°, 31.0°, 32.0°, 33.0°, 34.0°, 35.0°, 36.0°, 37.0°, 38.0°, 39.0°, 40.0°, 41.0°, 42.0°, 43.0°, 44.0°, 45.0°, 55.0°, 60.0°, 65.0°, 70.0°, 75.0°, 80.0°, 85.0°, 90.0°, or any range or quantity within that range in 1° increments. B The sweep can be increased by changing the orientation of the opening and applying a bias as described herein. Angle θ B As increases, the bias increases, and the sweep also increases.

[0112] In some embodiments, as shown in FIG. 5B, the rim 221 of the opening 220 can be circular with a mathematical center point that functions as a reference point for the orientation of the opening relative to the neck of the thrombus removal device. In some embodiments, as shown in FIGS. 5C - 5E, the rim 221 of the opening 220 can be pear-shaped with an axis (long axis) and a mathematical center point, where the wider portion of the pear shape can be positioned in a proximal or distal position around the mathematical center point without rotating the long axis. In some embodiments, the long axis of the pear shape can be rotated around the mathematical center point. Tilt the head to increase the sweep

[0113] FIGS. 5F - 5L show how to design the sweep offset S O by selecting the offset angle θ O which adds a "tilt of the head" to the cutter and offsets the central axis of the head 220 of the tubular cutter 200 from the central axis of the neck of the tubular cutter 225. The sweep offset allows the thrombus removal tubular cutter 200 to sweep beyond the diameter D S of the tubular cutter. Using the length L H of the head of the thrombus removal tubular cutter 200 as a constant, the offset angle θ O is selected to provide the desired sweep offset S O and increase the intravascular cutting diameter for removing blood clots from the target. In some embodiments, the diameter D S of the tubular cutter is limited to a maximum of 4 mm, restricting the size of the entry point of the thrombus removal tubular cutter into the target vessel. When the vessel is the iliac vein, its diameter can be, for example, about 10 mm. Therefore, it would be beneficial to offset the sweep of the head of the thrombus removal tubular cutter 200 to obtain a significantly larger cutting diameter for a 4 mm thrombus removal tubular cutter in the iliac vein. For example, S O = L H sin θ O is used; when D S is 4 mm and L H is 6 mm, then In Figure 5F, the offset angle θ O If 5 degrees is selected, S O = 6mm sin5 = 0.5mm. In Figure 5G, the offset angle θ O If 10 degrees is selected, S O = 6mm sin10 = 1.0mm. In Figure 5H, the offset angle θ O If 15 degrees is selected, S O = 6mm sin15 = 1.6mm. In Figure 5I, the offset angle θ O If 20 degrees is selected, S O = 6mm sin20 = 2.1mm. In Figure 5J, the offset angle θ O If 25 degrees is selected, S O = 6mm sin25 = 2.5mm. In Figure 5K, the offset angle θ O If 30 degrees is selected, S O = 6mm sin30 = 3.0mm. Offset angle θ O If 35 degrees is selected (not shown), S O = 6mm sin35 = 3.4mm.

[0114] For convenience of reference, Figure 5L shows a protractor illustrating angles in the range of 0 to 45 degrees. Using the above as an example of design options, an offset angle θo of 25 degrees, also called the lateral angle, lateral offset angle, or head tilt, provides a sweep offset of 2.8 mm, which means that for one rotation of the thrombectomy tubular cutter 200, the cutting diameter is 4 mm + 2.8 mm + 2.8 mm = 9.6 mm, meaning that the tubular cutter removes the thrombus 100 from the iliac vein of target more efficiently. As described above, those skilled in the art will see that the diameter D of the tubular cutter S , and head length L H , and offset angle θ OBy selecting this option, the sweep of the thrombectomy tubular cutter 200 can be controlled.

[0115] In some embodiments, the lateral offset angle θ O This can be any amount or range within the range of 0° to 90°, 1° to 90°, 2° to 90°, 3° to 90°, 4° to 90°, 5° to 90°, 6° to 90°, 7° to 90°, 8° to 90°, 9° to 90°, 10° to 90°, 15° to 90°, 20° to 90°, 25° to 90°, 30° to 90°, 35° to 90°, 40° to 90°, 45° to 90°, 50° to 90°, or any amount or range within that range in 1° increments. In some embodiments, the lateral offset angle θ O This can be from 60° to 90°, from 70° to 90°, from 80° to 90°, or any amount or range within that range in 1° increments. In some embodiments, the lateral offset angle θ O This can be any amount or range within the following ranges: 0° to 60°, 5° to 60°, 10° to 60°, 15° to 60°, 20° to 60°, 25° to 60°, 30° to 60°, 35° to 60°, 40° to 60°, 45° to 60°, 50° to 60°, 55° to 60°, or in 1° increments. In some embodiments, the lateral offset angle θ O This can be from 0° to 45°, from 5° to 45°, from 10° to 45°, from 15° to 45°, from 20° to 45°, from 25° to 45°, from 30° to 45°, from 35° to 45°, from 40° to 45°, or any amount or range within that range in 1° increments. In some embodiments, the lateral offset angle θ O This can be from 5° to 30°, from 10° to 30°, from 15° to 30°, from 20° to 30°, from 25° to 30°, or any amount or range within that range in 1° increments. In some embodiments, the lateral offset angle θ Oθ can be 0°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 11°, 12°, 13°, 14°, 15°, 16°, 17°, 18°, 19°, 20°, 21°, 22°, 23°, 24°, 25°, 26°, 27°, 28°, 29°, 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44°, 45°, or any quantity or range within that range in increments of 0.1°. In some embodiments, the lateral offset angle θ O This can be selected from 1 to 45 degrees, 1 to 40 degrees, 1 to 35 degrees, 1 to 30 degrees, 1 to 25 degrees, 1 to 20 degrees, 1 to 15 degrees, 1 to 10 degrees, 1 to 5 degrees, or any amount or range within that range in increments of 0.1 degrees. Cutting blade design

[0116] Figures 6A to 6F illustrate various rim and cutting blade shapes in several embodiments. In some embodiments, the cutting blade 205 and the rear end blade 210 are each of the general form y=a(xh) 2According to the parabolic equation of the form + k, where a = "+a" indicates that the parabola opens upward, -a indicates that the parabola opens downward, (h,k) indicates the position of the vertex of the parabola, the value of "a" determines the slope of the parabola, and the slope of the parabola increases as the absolute value of "a" increases. The slope of the parabola is the maximum possible slope on the line tangent to the parabola, regardless of whether the slope is positive or negative. If the cutting blade 205 and the rear end blade 210 coincide, or at least "substantially" coincide, then both parabolas have the same or similar vertex coordinates, which means that the cutting blades and both have the same or similar coefficient "a". The parabolas "substantially" coincide when their arrangements are similar enough that they can be believed to be identical, and there is little or no difference perceived by the device user in removing identical or similar thrombus types from a target. Figure 6A illustrates equal upward-opening parabolas where the cutting blade 205 and the rear end blade 210 on the rim 221 of the opening 220 coincide, meaning that both parabolas have the same or similar vertex coordinates and both have the same or similar coefficient "a". Figure 6B illustrates slightly unequal upward-opening parabolas when the cutting blade 205 and the rear end blade 210 on the rim 221 of the opening 220 coincide, and since the vertical alignment is the same or similar, the k values ​​appear to be the same or similar, but since the parabolas do not coincide horizontally and are offset to the left or right from each other, the h values ​​are significantly different; since the parabolas have similar slopes, the "a" coefficients appear to be the same or similar. Figure 6C can be described similarly to Figure 6B, except that the difference in the h values ​​of the vertices is even greater than in Figure 6B. Therefore, the shape of the rim (i.e., the cutting edge and the rear end edge) varies the relative values ​​of a, h, and / or k between the parabolic shapes of the cutting edge 205 and the rear end edge 210, resulting in the parabolic equation y=a(xh) 2 It can be described and modified using +k.

[0117] Figure 6D illustrates that in some embodiments, the cutting blade 205 may be linear, and that the linear cutting blade 205 may be located on a plane having a major axis parallel to the axis 270 of the lumen of the neck of the thrombectomy device. In some embodiments, the linear cutting blade 205 may be located on a plane having a major axis that makes an angle θ with respect to the axis 270 of the lumen of the neck of the thrombectomy device, where θ may be an angle in the range of 1 to 20 degrees, 1 to 18 degrees, 1 to 16 degrees, 1 to 14 degrees, 1 to 12 degrees, 1 to 10 degrees, 1 to 8 degrees, 1 to 6 degrees, 1 to 4 degrees, or any angle or range within that range in 1-degree increments. In some cases, the angle can be selected from the group consisting of 1 degree, 2 degrees, 3 degrees, 4 degrees, 5 degrees, 6 degrees, 7 degrees, 8 degrees, 9 degrees, 10 degrees, 11 degrees, 12 degrees, 13 degrees, 14 degrees, 15 degrees, 16 degrees, 17 degrees, 18 degrees, 19 degrees, and 20 degrees.

[0118] Figure 6E illustrates how the cutting blade 205 is wavy in some embodiments, where each wavy may be the same as the others and follow the same or similar parabolic equation, or each wavy may have an independently selected parabolic equation, resulting in only some of the wavy sharing the same or substantially similar parabolic equation, or no wavy sharing the same or similar parabolic equation. Note here that “substantially similar” parabolic equations may be close enough to visually conclude that they are the same and are not expected to perform different actions in thrombectomy. Figure 6F illustrates how the cutting blade 205 is sawtooth in some embodiments, where each sawtooth may be the same as the others or substantially similar. Note here that “substantially similar” sawtooths may be close enough to visually conclude that they are the same and are not expected to perform different actions in thrombectomy.

[0119] Figures 7A and 7B illustrate the size of the thrombus tubular cutter compared to the size of the lumen at the neck of the thrombus removal tubular cutter in several embodiments, showing how the size of the opening of the tubular cutter affects the passage of the thrombus through the lumen. Returning to Figure 4B for details, the opening of the cutter is within the lumen D of the flexible rotating shaft 305. L Smaller entrance diameter D M The tubular cutter may be designed to have a cross-sectional area equal to or smaller than the cross-sectional area of ​​the lumen of the flexible rotating shaft during thrombectomy.

[0120] D M and D L The actual relative difference between them can depend on the size of the cutting head, so please understand that the sizes of the opening and the lumen can be expressed as a ratio, and here D M / D L The ratios are as follows: 0.20 to 1.00, 0.30 to 1.00, 0.40 to 1.00, 0.50 to 1.00, 0.60 to 1.00, 0.70 to 1.00, 1.00 to 2.00, 1.00 to 1.90, 1.00 to 1.80, 1.00 to 1.70, 1.00 to 1.60, and 1.00 to It could be up to 1.50, 1.00 to 1.45, 1.00 to 1.40, 1.00 to 1.35, 1.00 to 1.30, 1.00 to 1.25, 1.00 to 1.20, 1.00 to 1.15, 1.00 to 1.10, 1.00 to 1.05, or any ratio or range within that range in increments of 0.01. In some aspects, D M is D LLarger by 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, or any amount or range within that range in 0.1% increments. In some embodiments, D M is D L Larger by 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, 100%, or any amount or range within that range in 0.1% increments.

[0121] In some embodiments, the lumen of the flexible rotating shaft can be approximated by the lumen of the neck of the thrombectomy tubular cutter 200. It is reasonable that the diameter of the lumen of the neck of the thrombectomy tubular cutter is probably smaller than that of the flexible rotating shaft, and therefore the size of the thrombus can also be limited. Therefore, the diameter D of the lumen of the neck 225 of the thrombectomy tubular cutter 200 L The diameter D of the entrance to the thrombectomy tubular cutter. M The size can be equal to or greater than that. In some embodiments, D M < D L In some embodiments, D M = D L In some embodiments, D M > D L That is the case.

[0122] Those skilled in the art will understand that the “post-pass diameter” of a blood vessel may be used to represent the diameter of the lumen of a blood vessel after a thrombectomy tubular cutter has passed through the lumen of the blood vessel. Since blood vessels are often elastic, the post-pass diameter of the lumen of the blood vessel may or may not be equal to the diameter of the cutter 200, i.e., the diameter of the head / opening 220. The post-pass diameter of the head / opening 220 may be larger than the outer diameter of the neck 225, and in some embodiments, the post-pass diameter of the head / opening 220 may also be equal to the outer diameter of the neck 225. In some embodiments, the post-pass diameter of the head / opening 220 may be smaller than the outer diameter of the neck 225.

[0123] In some embodiments, the relative size of the device components can significantly affect the movement of the device within the vascular lumen. In some embodiments, the cutter diameter may be larger than the diameter of the flexible rotating shaft, and in some embodiments, at least 10% larger, at least 20% larger, or at least 30% larger. The ratio of the cutter diameter to the diameter of the flexible rotating shaft may be 1.1–1.6 in some embodiments, 1.3–1.5 in some embodiments, 1.2–1.4 in some embodiments, 1.3–1.4 in some embodiments, or any range therein. In some embodiments, the ratio of the cutter diameter to the diameter of the flexible rotating shaft may be 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, or any ratio therein in increments of 0.05 in some embodiments. However, in some embodiments, the cutter diameter is 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, or any percentage within that range in 0.5% increments. system

[0124] It should be understood that the system may also be assembled to include any device taught herein. In some embodiments, the system may include a thrombectomy device and a delivery catheter as taught herein. In some embodiments, the system may include a thrombectomy device and a guidewire as taught herein. In some embodiments, the system may include a thrombectomy device, a guidewire, and a delivery catheter as taught herein.

[0125] In some embodiments, the system may include a vacuum port for connecting to a thrombectomy device and a vacuum source as taught herein. In some embodiments, the system may include a thrombectomy device, a guidewire, a delivery catheter, a vacuum port for connecting to a vacuum source, and a vacuum source as taught herein. In some embodiments, the thrombectomy device may include a vacuum port configured to operably communicate with any vacuum source to facilitate the delivery of tissue excised from the subject. In some embodiments, the system may include a thrombectomy device as taught herein having a vacuum port, wherein the vacuum port is operably connected to a suction manifold for removing thrombi from the system, and the suction manifold includes a vent shaft having suction holes configured for removing thrombi from a target site and from the subject.

[0126] In some embodiments, the thrombectomy device may have a handle including a motor operably connected to a flexible rotating shaft for rotating the flexible rotating shaft to excise tissue from the target. In some embodiments, the thrombectomy device may have a handle including a motor operably connected to a positive displacement pump having a flexible drive shaft, the motor configured to provide rotational torque to the flexible drive shaft to actuate the positive displacement pump to transport thrombus tissue from the target site and from the target.

[0127] In some embodiments, the thrombectomy device may have a handle including a motor operably connected to a screw pump having a flexible drive shaft operably connected to a helical screw, the motor configured to provide rotational torque to the flexible drive shaft in order to actuate the helical screw and transport thrombus tissue away from the target site and object.

[0128] In some embodiments, the thrombectomy device may have a handle with a motor; and a flexible drive shaft operably connected to a helical screw, where the motor is operably connected to: A drive assembly comprising a flexible rotating shaft and a tubular cutter, wherein a motor is configured to provide rotational torque to the flexible rotating shaft in order to rotate the tubular cutter and cut a thrombus; and A flexible drive shaft for rotating a helical screw to transport thrombus tissue from the target site and away from the object.

[0129] In some embodiments, the thrombectomy device may have a handle including a motor operably connected to a drive assembly including a flexible rotating shaft and a tubular cutter, the motor configured to provide rotational torque to the flexible rotating shaft to rotate the tubular cutter. The position of the cutting blade on the tubular cutter determines whether the cutting head rotates clockwise or counterclockwise with respect to the user's position proximal to the cutting head.

[0130] Figure 8 illustrates a thrombectomy system having an electric handle for rotating a thrombectomy tubular cutter in several embodiments. The thrombectomy tubular cutter 200 is operably connected to a flexible rotating shaft 310, which is operably connected to a manifold 820 via a joint 825. The manifold 820 has a suction port 830 for expelling the thrombus 100 through a vacuum discharge port 835 using vacuum. The manifold 820 is operably connected to a vent tube 810, which is connected to a vent port 820 in a handle 805. The handle 805 contains a motor M for rotating the vent tube 810 (840), which in turn rotates the flexible rotating shaft and the thrombectomy tubular cutter 200 for removing the thrombus 100. The motor can be operated using any power source, and in some embodiments, the power source is a battery power source (not shown) located in the handle 805. Operation of rotation 840 through the motor M is caused by pressing a switch 845. In some embodiments, the switch 845 may be actuated using a push lever 850. By placing a seal over the vent 820, a vacuum can be created in the lumen of the thrombectomy tubular cutter to remove the thrombus 100 under vacuum, and then discharged through the manifold 820 and the suction port 830.

[0131] Figures 9A–9D illustrate blood filtration ports within a thrombectomy tubular cutter in several embodiments. The blood filtration ports 905, 910 are mechanisms that facilitate the collection of thrombus tissue and allow the blood to be re-released into the blood vessels. Such ports can be of any shape desired for optimal blood release while the tubular cutter cuts and captures the thrombus under vacuum. In some embodiments, the blood filtration port 905 is circular or elliptical, as shown in Figures 9A and 9B. In some embodiments, the blood filtration port 910 is square or rectangular, as shown in Figures 9C and 9D. In some embodiments, any polygon or shape may be used. Several alternative shapes intended for optimal filtration of thrombus from blood are provided in Figure 9F. The blood filtration port must have a minimum size through which all blood cells can pass. For example, in some embodiments, the blood filtration port may have a small diameter (or effective diameter) of about 20 μm to allow monocytes to pass through.

[0132] In some embodiments, the blood filtration port may have a diameter of approximately 20 μm to 2 mm, approximately 20 μm to 1 mm, approximately 20 μm to 0.5 mm, approximately 20 μm to 0.2 mm, approximately 20 μm to 0.1 mm, approximately 20 μm to 90 μm, approximately 20 μm to 80 μm, approximately 20 μm to 70 μm, approximately 20 μm to 60 μm, approximately 20 μm to 50 μm, approximately 20 μm to 40 μm, approximately 20 μm to 30 μm, or any diameter or range within that range in an amount of 1 μm. In some embodiments, the shape of the blood filtration port is not, for example, circular or elliptical, with a minimum dimension of at least 20 μm, and the diameter is probably at least 20 μm to 200 μm, 20 μm to 100 μm, 50 μm to 100 μm, 50 μm to 150 μm, 75 μm to 125 μm, or any amount or range within that range in 1 μm increments.

[0133] In some embodiments, the blood filtration port may have a diameter ranging from approximately 40 μm to 2 mm, approximately 40 μm to 1 mm, approximately 40 μm to 0.5 mm, approximately 40 μm to 0.2 mm, approximately 40 μm to 0.1 mm, approximately 40 μm to 90 μm, approximately 40 μm to 80 μm, approximately 40 μm to 70 μm, approximately 40 μm to 60 μm, approximately 40 μm to 50 μm, or any diameter or range within that range in increments of 1 μm. In some embodiments, the shape of the blood filtration port is not, for example, circular or elliptical, and the diameter is at least 40 μm, at least 40 μm to 200 μm, 40 μm to 100 μm, or any amount or range within that range in increments of 1 μm. In some embodiments, the blood filtration port may have a minimum diameter of 10 μm, 15 μm, 20 μm, 25 μm, 30 μm, 35 μm, 40 μm, 45 μm, 50 μm, 55 μm, 60 μm, 65 μm, 70 μm, 75 μm, 80 μm, 85 μm, 90 μm, 95 μm, 100 μm, 105 μm, 110 μm, 115 μm, 120 μm, 125 μm, 130 μm, 135 μm, 140 μm, 145 μm, 150 μm, or any size or range within that range in 1 μm increments. The maximum dimensions of the blood filtration port can be, for example, 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, 350 μm, 400 μm, 450 μm, 500 μm, or any amount within that range in 10 μm increments.

[0134] In some embodiments, the blood filtration port may be positioned closer to the cutting blade of the thrombectomy tubular cutter than to the rear end blade of the thrombectomy tubular cutter. In some embodiments, the blood filtration port may cover the head 220 of the thrombectomy tubular cutter in any amount or range within that range, in increments of 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, or any amount or range within that range in increments of 0.1%. In some embodiments, the blood filtration port may cover the head 220 of the thrombectomy tubular cutter by 1% to 10%, 1% to 15%, 1% to 20%, 1% to 25%, 1% to 30%, 1% to 40%, 1% to 50%, or any amount or range within these ranges in 0.1% increments. In some embodiments, the blood filtration port may cover the head 220 of the thrombectomy tubular cutter by 3% to 10%, 3% to 15%, 3% to 20%, 3% to 25%, 3% to 30%, 3% to 40%, 3% to 50%, or any amount or range within these ranges in 0.1% increments. In some embodiments, the blood filtration ports can cover the head 220 of the thrombectomy tubular cutter by 5%-10%, 5%-15%, 5%-20%, 5%-25%, 5%-30%, 5%-40%, 5%-50%, or any amount or range within these ranges in 0.1% increments. Any number of blood filtration ports can be used. In some embodiments, this coverage rate can be converted to a number of ports of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, or more, or any range within these.

[0135] The blood filtration port may be an open port in some embodiments and a one-way valve in some embodiments. The one-way valve may be operable to allow blood to exit the lumen of the thrombectomy tubular cutter through the port, but not to enter the lumen of the thrombectomy tubular cutter through the port. In some embodiments, the one-way valve may be a flap valve or a butterfly valve. In some embodiments, the one-way valve is also called a check valve and may be selected from the group consisting of duckbill valves, cross-slit valves, dispensing valves, flange valves, flap valves, and combinations thereof. Any one-way valve known to those skilled in the art to operate in such a microenvironment may be used.

[0136] Those skilled in the art will understand that a guidewire can be used to locate the affected or target area within a blood vessel. Furthermore, a guidewire can be used to guide the thrombectomy device taught herein onto the target area. In some embodiments, the guidewire lumen diameter may range from 0.01 to 0.20 inches, 0.01 to 0.18 inches, 0.01 to 0.15 inches, 0.01 to 0.10 inches, or, in some embodiments, any size within that range. In some embodiments, the guidewire lumen diameter may range from 0.01 inches to 0.14 inches. In some embodiments, the guidewire lumen diameter is 0.01 inches (0.254 mm), 0.02 inches (0.508 mm), 0.04 inches (1.016 mm), 0.06 inches (1.524 mm), 0.08 inches (2.032 mm), 0.10 inches (2.540 mm), 0.12 inches (3.048 mm), 0.14 inches (3.556 mm), 0.16 inches (4.064 mm), 0.18 inches (4.572 mm), 0.20 inches (5.080 mm), or any diameter within that range in 0.01-inch (0.254 mm) increments.

[0137] The tissue to be removed by the devices taught herein may be removed mechanically, by vacuum displacement, by a positive displacement pump, or by a combination thereof. In some embodiments, the thrombectomy device has a handle including a motor operably connected to a positive displacement pump having a flexible drive shaft, the motor configured to provide rotational torque to a flexible rotating shaft in order to actuate the positive displacement pump and transport the thrombus tissue from the tubular cutter.

[0138] In some embodiments, a thrombectomy device may have a screw pump having a rotating helical screw for removing thrombus tissue from a blood vessel, and whether the screw is clockwise or counterclockwise determines whether the screw pump rotates clockwise or counterclockwise when viewed from a user's proximal position near the cutting head. In some embodiments, the cutting head and the screw pump may rotate in the same direction, or in other embodiments, they may rotate in opposite directions. When viewed from a proximal position near the cutter head, a clockwise helical screw is used for clockwise rotation of the screw, while when viewed from a proximal position near the cutter head, a counterclockwise helical screw (not shown) is used for counterclockwise rotation of the screw.

[0139] Figures 10A and 10B illustrate the rotating shaft of a thrombectomy tubular cutter system with a positive displacement pump in several embodiments. In some embodiments, the thrombectomy tubular cutter system 1000 includes a drive assembly including a flexible rotating shaft 305 (not shown) that is operably connected to a neck 225, for example by friction fit, mechanical coupling, or adhesive, to rotate the head / opening 220 clockwise as viewed from the user's perspective at the proximal end of the device, thereby cutting and removing the thrombus 100 (not shown) from the vascular lumen.

[0140] As shown in Figure 10A, the positive displacement pump 1050 is a helical screw 1050 which may be a helical wire fixedly attached to the lumen of the neck 225 of the thrombectomy tubular cutter 200, and therefore, rotation of the helical screw 1050 is required for the thrombectomy tubular cutter 200 to rotate, thereby transporting the thrombus tissue proximal through the thrombectomy tubular cutter 200. The helical wire may be designed to fit into the lumen of the neck 225 of the thrombectomy device 200 by selecting a radius r that matches the radius of the lumen of the neck 225 of the thrombectomy device 200. The pitch P of the helix may be selected to achieve efficient transport of the thrombus tissue. The positive displacement pump 1050 may be further assisted by configuring the system so that the positive displacement pump communicates with a vacuum source (not shown) to draw the excised tissue away from the object.

[0141] In some embodiments, the thrombectomy device has a handle including a motor operably connected to a screw pump having a drive assembly (not shown) operably connected to a thrombectomy tubular cutter 200, which rotates the head 200 to cut the thrombus tissue 100 and simultaneously rotates a helical screw 1050 fixedly mounted in the lumen of the neck 225 of the thrombectomy tubular cutter 200. The motor may be configured to provide the thrombectomy tubular cutter with rotational torque to drive the cutting of the thrombus tissue and the proximal transport of the thrombus tissue using the helical screw. The spiral-shaped wire can be a right-handed spiral, like a right-handed drill bit, or a left-handed spiral, like a left-handed drill bit, where the right-handed spiral is used to rotate the thrombectomy tubular cutter 200 clockwise when viewed from a position proximal to the thrombectomy tubular cutter 200, and the left-handed spiral is used to rotate the thrombectomy tubular cutter 200 counterclockwise when viewed from a position proximal to the thrombectomy tubular cutter 200. As mentioned, a vacuum source can be used to facilitate the removal of tissue excised from the target.

[0142] Figure 10B illustrates cross-sections of the neck and flexible rotating shaft of a thrombectomy tubular cutter system having a positive displacement pump in several embodiments. As shown in Figure 10B, the positive displacement pump can rotate together with the drive assembly and, in some embodiments, independently of the thrombectomy tubular cutter 200. For example, the positive displacement pump may have a rotating screw pump 1050 with a helical screw 1020 for moving thrombus tissue. In some embodiments, the positive displacement pump may rotate independently of the rotation of the drive assembly for the cutting head 200. In some embodiments, the positive displacement pump may also be a screw pump 1050 consisting of a helical screw 1020 positioned on a flexible drive shaft 1030 that rotates independently of the rotation of the cutting head 200. As mentioned, a vacuum source may be used to facilitate the removal of tissue excised from the object.

[0143] Therefore, the thrombectomy device may have a motorized handle and a flexible drive shaft operably connected to a helical screw; where the motor is operably connected to a drive assembly including a flexible rotating shaft and a tubular cutter, and the motor is configured to provide rotational torque to the flexible rotating shaft to rotate the tubular cutter and cut the thrombus; and the device may have a flexible drive shaft 1030 within the flexible rotating shaft 305 for rotating the helical screw to transport the thrombus tissue from the tubular cutter. Device adaptation and design

[0144] The versatile devices, systems, and methods taught herein can effectively handle various soft tissues, tough tissues, fibrous tissues, and hard tissues, and can therefore be used in thrombectomy and atherectomy. Thrombectomy is the removal of blood clots from blood vessels. Blood clots consist of a network structure of protein chains called platelets and fibrin. Arterial blood clots have a different composition from venous blood clots; arterial blood clots mainly contain platelets, while venous blood clots mainly contain fibrin. Common applications of thrombectomy include any location within a blood vessel where a thrombus may develop. Thrombectomy helps to alleviate the symptoms of disease, as well as further vascular complications, and possibly even downstream complications that could lead to death due to the release of the embolism, by removing the blood clot from the wall of the blood vessel. Atherosclerosis, also known as plaque, is a buildup of fatty substances, cholesterol, cellular waste, calcium, and fibrin deposits on the inner walls of arteries. Both atherosclerosis and thrombosis pose a risk because the plaque can fragment into bloodstream and travel to the heart, brain, or lungs, causing health complications that are often fatal. The devices, systems, and methods taught herein may be used to treat all such indications, including the removal of tissue from blood vessels.

[0145] Thrombi can be present in veins as venous thrombosis or in arteries as arterial thrombosis. A particularly important indication is the removal of a thrombus from the pulmonary artery, also known as pulmonary embolism. The size, i.e., the diameter, of the head 220 of the thrombectomy tubular cutter 200 can be selected using the size of the artery or vein. Peripheral vascular disease of the leg is an example of a condition that can be treated using the thrombectomy devices taught herein.

[0146] In some embodiments, the diameter of the target vessel is used as the diameter D of the head of the tubular cutter 200. SThe size can be determined. In some embodiments, the diameter of the target vessel can serve as a reference point for the maximum diameter to be used as the diameter of the head 220 of the tubular cutter. However, in some embodiments, the vessel is the diameter D of the tubular cutter 200. S It is much larger.

[0147] It should be understood that a wide range of luminal diameters can be treated. Luminal diameters can be, for example, from approximately 2.0 mm to 30.0 mm, from approximately 3.0 mm to 25.0 mm, from approximately 4.0 mm to 24.0 mm, from approximately 5.0 mm to 23.0 mm, from approximately 6.0 mm to 25.0 mm, from approximately 7.0 mm to 21.0 mm, from approximately 8.0 mm to 20.0 mm, or any range or quantity within that range in 0.1 mm increments. In some aspects, the luminal diameter of the vessel being treated may be 2.0 mm, 3.0 mm, 4.0 mm, 5.0 mm, 6.0 mm, 7.0 mm, 8.0 mm, 9.0 mm, 10.0 mm, 11.0 mm, 12.0 mm, 13.0 mm, 14.0 mm, 15.0 mm, 16.0 mm, 17.0 mm, 18.0 mm, 19.0 mm, 20.0 mm, 21.0 mm, 22.0 mm, 23.0 mm, 24.0 mm, 25.0 mm, 26.0 mm, 27.0 mm, 28.0 mm, 29.0 mm, 30.0 mm, or any range or amount within that range in 0.1 mm increments.

[0148] In some embodiments, the diameter D of the head 220 of the tubular cutter 200 S The diameter of the target blood vessel is selected to be reduced by at least 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, or any amount or range within that range in 1% increments. In some embodiments, the diameter D of the head 220 of the tubular cutter S The amount is selected to reduce the diameter of the target blood vessel by 1% to 10%, 1% to 15%, 1% to 20%, 1% to 25%, 1% to 30%, 1% to 40%, 1% to 50%, or by any amount or range within that range in 1% increments. In some embodiments, the diameter D of the head 220 of the tubular cutter SThe reduction is selected to be in the range of 5% to 10%, 5% to 15%, 5% to 20%, 5% to 25%, 5% to 30%, 5% to 40%, 5% to 50%, or any amount or range within that range in 0.1% increments, based on the diameter of the target blood vessel.

[0149] The primary subjects and indications for use with the devices, systems, and methods taught herein include venous thrombus removal. In some embodiments, the systems, devices, and methods may be configured for venous thrombus removal, and the luminal diameter of the vessel being treated may be, for example, from about 4.0 mm to about 16.0 mm, or any amount or range within that in 1.0 mm increments. In these embodiments, the outer diameter of the tubular cutter and / or flexible rotating tube may be from about 4 mm to about 8 mm, or any amount or range within that in 1.0 mm increments.

[0150] In some embodiments, the systems, devices, and methods taught herein may be configured for the removal of pulmonary artery thrombi, where the luminal diameter of the vessel being treated may be, for example, from about 6.0 mm to about 25.0 mm, or any amount or range within that in 0.1 mm increments. In these embodiments, the outer diameter of the tubular cutter and / or flexible rotating tube may be from about 4 mm to about 8 mm, or any amount or range within that in 0.1 mm increments.

[0151] Table 1 provides examples of several venous lumen diameters in millimeters for veins that can be treated with the devices taught herein.

[0152] Table 1. Examples of several venous lumen diameters in millimeters. [Table 1]

[0153] In some embodiments, the vein being treated may have a lumen diameter ranging from 4 mm to 18 mm. In some embodiments, the diameter of the vein may be 1 mm to 10 mm, 2.0 mm to 10 mm, 3.0 mm to 10 mm, 4.0 mm to 10 mm, 5.0 mm to 10 mm, 6.0 mm to 10 mm, 7.0 mm to 10.0 mm, 8.0 mm to 10.0 mm, or any range or amount within these in 1.0 mm increments. In some embodiments, the vein being treated may have a lumen diameter selected from the group consisting of 2.0 mm, 3.0 mm, 4.0 mm, 5.0 mm, 6.0 mm, 7.0 mm, 8.0 mm, 9.0 mm, 10.0 mm, or any amount or range within these in 1.0 mm increments. In some embodiments, the vein being treated may have a lumen diameter selected from a group consisting of 11.0 mm, 12.0 mm, 13.0 mm, 14.0 mm, 15.0 mm, 16.0 mm, 17.0 mm, 18.0 mm, 19.0 mm, 20.0 mm, 21.0 mm, 22.0 mm, 23.0 mm, 24.0 mm, 25.0 mm, 26.0 mm, 27.0 mm, 28.0 mm, 29.0 mm, 30.0 mm, or any amount or range within that group in 1.0 mm increments.

[0154] The size of blood clots within the venous system can vary considerably, and thrombectomy tubular cutters must be made to match this variation. In some embodiments, thrombi can have a diameter ranging from approximately 1.0 mm to approximately 18.0 mm. For example, in embodiments with deep vein thrombosis, thrombi are found in larger veins and have a diameter ranging from approximately 3.0 mm to approximately 8.0 mm. In some embodiments, thrombi are found in the common iliac vein and inferior vena cava and have a diameter ranging from approximately 7.0 mm to approximately 17.0 mm. In some embodiments, thrombi are found in the external iliac vein and common femoral vein and have a diameter ranging from approximately 5 mm to approximately 14 mm. In some embodiments, thrombi are found in the superficial femoral vein, deep femoral vein, and popliteal vein and have a diameter ranging from approximately 4 mm to approximately 10 mm. And, in some embodiments, thrombi ranging from approximately 4 mm to approximately 8 mm can be found in the sural vein.

[0155] Any vein can be treated using the devices, systems, and methods taught herein. In some embodiments, the devices, systems, and methods are designed to treat the iliac vein. And in some embodiments, the devices, systems, and methods are designed to treat the popliteal vein. In some embodiments, the devices, systems, and methods are designed to treat any vein from the popliteal vein to the iliac vein.

[0156] As stated, the devices, systems, and methods are primarily intended for thrombectomy. However, in some embodiments, the systems, devices, and methods may be configured for arterial treatment or atherectomy. Table 1 provides some examples of arterial lumen diameters in millimeters for arteries that can be treated with the devices taught herein.

[0157] Table 2. [Table 2]

[0158] The superficial femoral artery is located near the center of the femur and generally has a diameter of about 5–7 mm, or about 0.2–0.25 inches. As the artery descends below the knee, the popliteal artery generally has a diameter of about 4–4.5 mm (0.157–0.177 inches), but decreases to about 3.5 mm (0.137 inches) as it proceeds towards the foot in question. The popliteal artery again branches into the anterior tibial artery and the tibiofibular artery trunk, and its diameter decreases further to about 3.0 mm, then to about 2.5 mm, or about 0.118 inches to 0.098 inches. The tibiofibular artery trunk further subdivides into the posterior tibial artery and the peroneal artery, and its diameter further shrinks to about 2.0 mm (0.078 inches). In some embodiments, the diameter of the peripheral arteries of the leg can typically vary from about 2 mm to about 7 mm. Any blood vessel may contain plaque and can be a potential target area for the thrombectomy devices taught herein. For example, coronary arteries, which are approximately 3 mm in size and vary in diameter from 2.5 to 4.5 mm, could be a future target area for the devices taught herein if they are designed for use in atherectomy.

[0159] For smaller blood clots, the diameter of the cutter may be approximately 1.0 mm to 3.0 mm in some embodiments, 1.5 mm to 4.0 mm in some embodiments, or any range within that range in 0.1 mm increments.

[0160] For larger blood clots, the diameter of the cutter may be approximately 3.0 mm to 9.0 mm in some embodiments, 4.0 mm to 8.0 mm in some embodiments, and approximately 5.0 mm to 7.0 mm in some embodiments, or any amount or range within that range in 0.1 mm increments. In some embodiments, the diameter of the larger cutter may be approximately 3.0 mm, approximately 4.0 mm, approximately 5.0 mm, approximately 6.0 mm, approximately 7.0 mm, approximately 8.0 mm, approximately 9.0 mm, 10.0 mm, or any diameter within that range in 0.1 mm increments.

[0161] While it might seem reasonable to simply increase the cutter diameter for larger vessels, those skilled in the art will understand that the cutter diameter may be limited by physical complications of the patient's anatomical structure. For example, complications may occur during surgery due to bleeding at the puncture site, tortuous vessels, changes in vessel size, etc. Those skilled in the art can design a desired thrombectomy device to obtain the desired treatment outcome using the teachings described herein, including cutter size, cutter bias, ratio of the tip blade to the posterior blade, cutter deflection, stiffness selection, and any combination thereof.

[0162] Those skilled in the art will also understand that the length of the cutter needs to be limited in order to have the necessary operability. Those skilled in the art will also understand that the size of the cutter head may be any length known in the art to be suitable for a particular procedure. In some embodiments, the length of the cutter head may be from about 4.0 mm to about 20.00 mm, from about 4.0 mm to about 18.0 mm, from about 4.0 mm to about 16.0 mm, from about 4.0 mm to about 12.0 mm, or any range or amount within that range in 0.10 mm increments. In some embodiments, the length of the cutter head may be from about 6.0 mm to about 20.00 mm, from about 6.0 mm to about 18.0 mm, from about 6.0 mm to about 16.0 mm, from about 6.0 mm to about 12.0 mm, or any range or amount within that range in 0.10 mm increments. In some embodiments, the length of the cutter head may be from about 8.0 mm to about 20.00 mm, from about 8.0 mm to about 18.0 mm, from about 8.0 mm to about 16.0 mm, from about 8.0 mm to about 12.0 mm, or any range or quantity within that range in 0.10 mm increments. In some embodiments, the length of the cutter head may be from about 1.0 mm, from about 2.0 mm, from about 3.0 mm, from about 4.0 mm, from about 5.0 mm, from about 6.0 mm, from about 7.0 mm, from about 8.0 mm, or any diameter within that range or a range within that range in 0.1 mm increments.

[0163] Given the relative sizes of the blood vessels and devices taught herein, it will be understood by those skilled in the art that a thrombectomy device may have a shaft diameter twice the size of the shaft used in an atherectomy device. This is why, in some embodiments, the torsional stiffness of a thrombectomy device may be 16 times that of an atherectomy device, and the flexural stiffness of a thrombectomy device may be 8 times that of an atherectomy device. Similarly, the axial stiffness of a thrombectomy device may be about twice that of an atherectomy device.

[0164] As discussed, the devices, systems, and methods can be used for thrombectomy and atherectomy, but the focus is on thrombectomy. Therefore, methods for using thrombectomy devices and systems, as well as methods for using atherectomy devices and systems, are provided.

[0165] In some embodiments, this instruction relates to a method for removing tissue from blood vessels within a subject using the device taught herein, the method including: Creating an entry point in the lumen of the target blood vessel; Inserting a device into the lumen of a blood vessel; Cutting tissue from within a blood vessel lumen using the cutting head of a device; And, Remove the device from the lumen of the target blood vessel.

[0166] In some embodiments, this instruction relates to a method for performing a thrombectomy within a subject using the thrombectomy device taught herein, the method including: Creating an entry point in the lumen of the target blood vessel; Inserting a thrombectomy device into the lumen of a blood vessel; Cutting thrombus tissue from the lumen of a blood vessel using the cutting head of a thrombectomy device; And, Remove the thrombectomy device from the lumen of the target blood vessel.

[0167] In some embodiments, this instruction relates to a method for performing an atherectomy within a subject using the device taught herein, the method including: Creating an entry point in the lumen of the target blood vessel; Inserting a device into the lumen of a blood vessel; Cutting tissue from within a blood vessel lumen using the cutting head of a device; And,

[0168] Remove the device from the lumen of the target blood vessel.

[0169] In some embodiments, the method further includes inserting a guidewire into an entry point, delivering the guidewire to a target location within the lumen of the target blood vessel, and guiding a thrombectomy device to a target location on the guidewire.

[0170] In some embodiments, the method further includes using a vacuum to remove the excised tissue from the vascular lumen.

[0171] The devices taught herein include several methods for removing vascular lesions from a subject. In fact, lesions can be removed from any vessel. In some embodiments, the methods may include: creating an entry point in the lumen of the vessel of the subject; inserting the thrombectomy device taught herein into the lumen of the vessel; fitting in a flexible rotating shaft; cutting the thrombus from the wall of the lumen of the vessel with the device's cutter; draining the cut tissue from the lumen of the vessel (which in some embodiments may be facilitated by a vacuum pump); and removing the device from the lumen of the vessel of the subject.

[0172] In some embodiments, a method for removing a thrombus may include obtaining a thrombectomy device as taught herein, creating an opening in the vascular system of a subject having a thrombus, inserting the device into the vascular system of the subject, moving the distal end of the thrombectomy device to the site of the thrombus, removing the thrombus from the subject using the thrombectomy device, and removing the thrombectomy device from the subject.

[0173] In some embodiments, the method is as follows: This includes inserting the device taught herein into the lumen of a target blood vessel, the device being A flexible rotating shaft having a proximal end, a distal end, and a lumen; The distal end of the flexible rotating shaft has a cutting head, for example, in the shape of a tubular cutter, and the cutting head has a proximal end and a distal end, (i) comprising an opening communicating with the lumen of the rotating shaft, the opening having (1) an inlet defined on the opening by an asymmetric cutting end, the asymmetric cutting end having a second longitudinal plane that bisects the cutting end, and (2) an outlet communicating with the lumen of the rotating shaft; where the second longitudinal plane does not coincide with the first longitudinal plane that provides the asymmetric cutting end; the cutting head also, (ii) Consists of a vacuum port configured to be operationally in communication with a vacuum source; the device also, The device has a distal end, a proximal end, a longitudinal direction, and a guidewire lumen through the device in the longitudinal direction; the method also has, This involves advancing the cutter into the target region of the target blood vessel lumen, and the advancement is as follows: This involves cutting vascular tissue from the wall of the vascular lumen, the cutting including the rotation of the cutter; and advancement also, Removing vascular tissue from the lumen of a blood vessel using a positive displacement pump; and Remove the thrombectomy device from the subject. Includes.

[0174] Figure 11 is a flowchart of a thrombectomy method in several embodiments. Method 1150 can be used with a thrombectomy device taught herein to remove a thrombus from a blood vessel. A guidewire is advanced through a guide catheter and over the thrombus in the blood vessel within the target region (1174). Once the guidewire has reached the appropriate position in the target region, the thrombectomy device is advanced on the guidewire to the thrombus (1176). The thrombectomy device then advances to the appropriate position and cuts and removes the thrombus within the target region (1178). The thrombectomy device and guidewire are removed from the patient (1182) to complete the procedure. The dashed line around the guidewire advancement step 1174 indicates that the guidewire is optional. Therefore, in some embodiments, the use of a guidewire is not required.

Claims

1. A thrombectomy device, A flexible rotating shaft having a proximal end, a distal end, and a lumen; It includes a curved tubular cutter operably connected to the distal end of a flexible rotating shaft, the tubular cutter being A head having an opening with an axis and a Z-axis, A neck connected to the head and having a rotation axis, The angle θz between the Z-axis and the rotation axis of the opening is in the range of 90° to 135°. The opening includes, The cutting edge with the highest height (leading edge height); The rear end cutting edge with the lowest height (rear edge height); A vertical bias ratio (leading edge height / trailing edge height) in the range of 1.05 to 2.0; Distance B between the axis of rotation and the tip blade L ; Distance B between the rotation axis and the rear end blade T ; and Lateral bias ratio B, which is in the range of 1.05 to 2.

0. L / B T ; It consists of, and the device A vacuum port configured to be operationally connected to a vacuum source in order to facilitate the transfer of tissue from the target, The device, including the device.

2. The device according to claim 1, wherein the cutter is deflected from the axis of rotation, and a deflection distance is formed between the tip blade of the cutter and the axis of rotation.

3. The device according to claim 1, wherein the axis of the head forms an angle Φ perpendicular to the axis of rotation, and Φ is in the range of 0° to 90°, forming a deflection distance between the tip blade of the cutter and the axis of rotation.

4. The device according to claim 1, wherein the axis of the head makes a lateral angle θo with respect to the axis of rotation, and θo is in the range of 0° to 90°, forming a deflection distance between the tip blade of the cutter and the axis of rotation.

5. The device according to claim 1, wherein the flexible rotating shaft is deflected at an angle θm with respect to the axis of rotation, forming a curved region within the flexible rotating shaft, where θm is in the range of 0 to 90 degrees, and a deflection distance is formed between the tip blade of the cutter and the axis of rotation.

6. The device according to claim 1, wherein the opening has a cross-sectional area equal to or smaller than the lumen of the flexible rotating shaft.

7. The device according to claim 5, wherein the z-axis of the opening makes an angle θr with a plane containing a curved region, and the opening opens toward the target site of the tissue to be removed.

8. The device according to claim 5, further comprising an orthodontic sheath.

9. A system comprising the device described in claim 1, further comprising a handle including a motor operably connected to a drive assembly including a flexible rotating shaft and a cutter, wherein the motor is configured to provide rotational motion to the flexible rotating shaft in order to rotate the cutter. The aforementioned system.

10. A system comprising the device according to claim 5, further comprising a handle including a motor operably connected to a drive assembly including a flexible rotating shaft and a cutter, wherein the motor is configured to provide rotational motion to the flexible rotating shaft in order to rotate the cutter. The aforementioned system.

11. The system according to claim 10, wherein the z-axis of the opening makes an angle θr with a plane containing a curved region, and the opening opens toward the target site of the tissue to be removed.

12. The system according to claim 5, further comprising an orthodontic sheath.

13. A system comprising the device described in claim 1, further comprising a vacuum source, wherein a vacuum port is operably connected to a vacuum that removes tissue from the system, The aforementioned system.

14. A system comprising the device according to claim 5, further comprising a vacuum source; a vacuum port operably connected to a vacuum that removes tissue from the system, The aforementioned system.

15. A method for performing thrombectomy using the device described in claim 1, the method being as follows: Creating an entry point in the lumen of the target blood vessel; Inserting a thrombectomy device into the lumen of a blood vessel; To deliver the cutter to the target site containing the tissue to be removed; Cutting tissue from the lumen of a blood vessel using a cutter; And, To remove the thrombectomy device from the lumen of the target blood vessel. The method, including the method described above.

16. The method according to claim 15, further comprising inserting a guidewire into an entry point, delivering the guidewire to a target location of the thrombus, and guiding a thrombectomy device to the location of the thrombus on the guidewire.

17. The method according to claim 15, further comprising using a vacuum to remove tissue from the lumen of a blood vessel.

18. A method for performing thrombectomy within a subject using the device described in claim 5, the method being: Creating an entry point in the lumen of the target blood vessel; Inserting a thrombectomy device into the lumen of a blood vessel; To deliver the cutter to the target site containing the tissue to be removed; Cutting tissue from the lumen of a blood vessel using a cutter; And, To remove the thrombectomy device from the lumen of the target blood vessel. The method, including the method described above.

19. The method according to claim 18, further comprising inserting a guidewire into an entry point, delivering the guidewire to a target location in the tissue, and guiding a cutter to the location of the thrombus on the guidewire.

20. The method according to claim 18, further comprising using a vacuum to remove tissue from the lumen of a blood vessel.

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