CN117942136A

CN117942136A - Deep vein thrombotic thrombectomy device with embolic protection

Info

Publication number: CN117942136A
Application number: CN202410116160.6A
Authority: CN
Inventors: 艾伦·托马斯; 请求不公布姓名; 麦口·泰; 阮涛
Original assignee: Acotec Scientific Co Ltd
Current assignee: Acotec Scientific Co Ltd
Priority date: 2023-01-26
Filing date: 2024-01-26
Publication date: 2024-04-30

Abstract

The thrombectomy device includes: a coring member configured to break up thrombus in a blood vessel into fragments; and a capture member configured to be anchored to a distal side of the thrombus to provide embolic protection. The coring member and the capture member are operable independently of each other. Methods of removing thrombus from a blood vessel employ a rotary coring device to break up the thrombus into fragments.

Description

Deep vein thrombotic thrombectomy device with embolic protection

Cross Reference to Related Applications

The present application claims priority from U.S. provisional patent application No. 63/481,648, entitled "deep vein thrombosis clot thrombectomy device with embolic protection," filed on month 1, 2023, and priority from U.S. patent application No. 18/416,788 filed on month 1, 2024, the disclosures of which are incorporated herein by reference in their entirety.

Technical Field

The present disclosure relates generally to medical devices and methods of treating diseases using medical devices. In particular, various embodiments of thrombectomy systems, devices, and methods for removing an occlusion (e.g., a clot) from a blood vessel are described.

Background

Thrombus or blood clots can lead to a variety of medical conditions including peripheral thrombosis, pulmonary embolism, stroke, heart attack, and the like. Thrombus is a static blood clot along the vessel wall that results in a vascular occlusion. Deep vein thrombosis (Deep vein thrombosis, DVT) is a condition in which blood clots form in veins located deep inside the body, typically at the thighs or calves. This may lead to pain and swelling in this area. Pulmonary embolism (Pulmonary embolism, PE) is a life threatening complication of DVT in which a blood clot in a vein loosens, flows in the blood, and blocks the blood flow in the lungs.

In acute DVT, the clot is in the blood vessel for less than 2 weeks. In subacute DVT, the clot has been present in the blood vessel for about 2 weeks to 1 month. In chronic DVT, the clot has been in the blood vessel for more than one month. In subacute to chronic DVT cases, the consistency of the clot is relatively low, which makes it more difficult to clear. Often, different parts of the thrombus will stay in the vessel for different times, resulting in uneven clot loading.

DVT may be treated with thrombolytic drugs or by percutaneous mechanical thrombectomy (percutaneous mechanical thrombectomy, PMT), which includes the use of aspiration and stent recovery devices. Thrombolytic drugs can sometimes produce life threatening side effects, making the PMT-free thrombolytic approach a safer, less risky option. Furthermore, PMT reduces recovery time and medical costs compared to the administration of thrombolytic drugs.

Some conventional mechanical thrombectomy solutions rely on delivering a catheter to the target clot and applying negative pressure through the catheter lumen to remove the clot. These aspiration-based solutions do not provide protection against distal embolization of the clot, which may lead to PE.

Some conventional mechanical thrombectomy solutions rely on delivering a thrombectomy device close to the target clot and grasping the clot and pulling it into the interior of the catheter using a reverse retractor. These solutions do not provide protection against distal embolization of the clot, which may lead to PE.

Thus, despite advances in the treatment of DVT, there remains a general need for improved thrombectomy devices and methods of treatment to overcome these and other problems of conventional devices and methods.

Disclosure of Invention

In one aspect, the present disclosure provides a thrombectomy device. In general, embodiments of the thrombectomy device include: a coring member configured to break up thrombus in a blood vessel into fragments; and a capture member configured to be anchored to a distal side of the thrombus to provide embolic protection. The coring member and the capture member are operable independently of each other.

In various embodiments of this aspect, the coring member is coupled to a shaft, the capture member is coupled to the shaft, and the shaft of the coring member and the shaft of the capture member are movable independently of each other.

In various embodiments of this aspect, the shaft of the coring member comprises a tubular shaft slidably movable on the shaft of the capture member to allow the shaft of the coring member and the shaft of the capture component, respectively, to move longitudinally in a generally coaxial path.

In various embodiments of this aspect, the shaft of the coring member and the shaft of the capture member are configured to move longitudinally in non-coaxial paths, respectively.

In various embodiments of this aspect, the shaft of the coring member includes one or more removable or replaceable portions.

In various embodiments of this aspect, the shaft of the coring member is rotatable independently of the shaft of the capture member, allowing the coring member to rotate to promote thrombolysis and allowing the capture component to remain stationary to provide embolic protection.

In various embodiments of this aspect, the capture member comprises a deployable basket having a pore size in a deployed state that prevents thrombus fragments from escaping to provide embolic protection.

In various embodiments of this aspect, the capture member further comprises a reinforcing structure configured to provide radial support to the basket, wherein the reinforcing structure has an expanded state providing a maximum diameter substantially equal to or greater than a vessel diameter, and the proximal end of the reinforcing structure remains substantially open in the expanded state to allow for entry of thrombus fragments, and wherein the basket is coupled at the maximum diameter of the reinforcing structure.

In various embodiments of this aspect, the shaft of the capture member comprises an inner shaft and an outer shaft slidably movable over the inner shaft; the basket of the capture member is coupled to the distal end of the inner shaft, and the reinforcing structure of the capture component is coupled to the distal end of the outer shaft; and relative movement of the inner shaft and the outer shaft causes the basket and/or the reinforcing structure to expand or contract.

In various embodiments of this aspect, the reinforcing structure of the capture member comprises a self-expanding structure.

In various embodiments of this aspect, the reinforcing structure of the capture member comprises an open-celled tube cutting structure and the basket is comprised of a plurality of wires, wherein the plurality of wires of the basket are woven into the open-celled tube cutting structure.

In various embodiments of this aspect, the reinforcing structure of the capturing member comprises a braided structure, the basket of the capturing member is comprised of a plurality of wires, and wherein the plurality of wires of the basket are braided into the braided structure.

In various embodiments of this aspect, the thrombectomy device further comprises a handle coupled to the proximal end of the inner shaft and the proximal end of the outer shaft, wherein the handle is operable to extend and/or retract the inner shaft and the outer shaft to cause relative movement of the inner shaft and the outer shaft, respectively, to allow the basket and the reinforcement structure to collapse or expand.

In various embodiments of this aspect, the handle is removable from the proximal end of the inner shaft and the proximal end of the outer shaft.

In various embodiments of this aspect, the proximal end of the inner shaft and the proximal end of the outer shaft include locking features for preventing relative movement of the inner shaft and the outer shaft.

In various embodiments of this aspect, the locking feature comprises one or more notches at the proximal end of the outer shaft and a plurality of pins at the proximal end of the inner shaft.

In various embodiments of this aspect, the coring member comprises a self-expanding structure. The self-expanding structure of the coring member includes a tapered first end fixedly coupled to a shaft of the coring member and a tapered second end freely slidable on the shaft of the coring member. The coring member includes a braided structure or an apertured tube cutting structure.

In various embodiments of this aspect, the thrombectomy device may further comprise a handle coupled to the proximal end of the shaft of the coring member to facilitate manipulation of the coring member.

In various embodiments of this aspect, the thrombectomy device may further comprise a catheter configured to receive and/or deliver the coring member and the capture member.

In various embodiments of this aspect, the thrombectomy device may further comprise a hub member coupled to the proximal end of the catheter, wherein the hub member includes a first port connecting the lumen of the catheter to a vacuum source and a second port receiving the coring member and/or the capture member. The hub member includes a hemostatic valve.

In another aspect of the present disclosure, a thrombectomy device is provided. Generally, the thrombectomy device includes: an elongate shaft having a proximal end and a distal end; a deployable structure coupled to the distal end of the elongate shaft; and a catheter configured to deliver the expandable structure in a contracted state to a location in a vessel containing thrombus. The expandable structure in the expanded state is rotatable with the elongate shaft to break up thrombus into fragments.

In various embodiments of this aspect, the expandable structure includes a first end fixedly coupled to the elongate shaft and a second end freely slidable along the elongate shaft.

In various embodiments of this aspect, the expandable structure is self-expanding.

In various embodiments of this aspect, the catheter has an inner diameter, and the diameter of the expandable structure in the expanded state is greater than the inner diameter of the catheter.

In various embodiments of this aspect, the expandable structure comprises a plurality of cells, and in the expanded state, cells adjacent the second end of the expandable structure have a larger opening than openings of cells adjacent the first end of the expandable structure.

In various embodiments of this aspect, in the deployed state, the opening of the cell adjacent the first end of the expandable structure has a maximum dimension equal to or less than 0.6 inches.

In various embodiments of this aspect, the expandable structure comprises an open-celled tube cutting structure.

In various embodiments of this aspect, the expandable structure comprises a braided structure.

In various embodiments of this aspect, the expandable structure includes a tapered first portion and a tapered second portion in the expanded state. The taper angle of the tapered first portion and/or the tapered second portion of the expandable structure is in the range of about 5 degrees to about 25 degrees, respectively. The expandable structure comprises a length and a maximum diameter in an expanded state, and a ratio of the maximum diameter to the length is between about 0.2 and about 0.6.

In various embodiments of this aspect, the expandable structure comprises a plurality of cells, and in the expanded state, cells adjacent the second end of the expandable structure have a larger opening than openings of cells adjacent the first end of the expandable structure. The expandable structure may comprise a plurality of cells, and in the expanded state one or more of the plurality of cells has a generally diamond-shaped opening. In the deployed state, the opening of the cell adjacent the first end of the expandable structure has a maximum dimension equal to or less than 0.6 inches.

In various embodiments of this aspect, the expandable structure comprises a plurality of cells, and in the expanded state, cells adjacent the second end of the expandable structure have smaller openings than openings of cells adjacent the first end of the expandable structure.

In various embodiments of this aspect, the thrombectomy device may further include a handle coupled to the proximal end of the elongate shaft to assist a user in rotating and/or linearly moving the elongate shaft and the expandable structure.

In various embodiments of this aspect, the catheter includes a proximal end configured to be connected to a vacuum source, thereby allowing for removal of the debris by aspiration through the catheter.

In various embodiments of this aspect, the elongate shaft comprises a tubular shaft.

In various embodiments of this aspect, the elongate shaft includes one or more removable or replaceable portions.

In various embodiments of this aspect, at least a portion of the elongate shaft includes a lubricious coating on an outer surface of the elongate shaft.

In various embodiments of this aspect, the thrombectomy device may further comprise an atraumatic tip at the distal end of the elongate shaft.

In another aspect, embodiments of the present disclosure provide a method for removing a thrombus from a blood vessel of a patient. In general, embodiments of the method include the steps of: a) Introducing a catheter into a vessel containing a thrombus; b) Advancing the catheter through a thrombus to position a distal end of the catheter on a distal side of the thrombus; c) Delivering the capture member in a contracted state to a distal side of the thrombus through the catheter; d) Expanding the capture member to an expanded state; e) Retracting the catheter to position the distal end of the catheter on the proximal side of the thrombus; f) Delivering the coring member in a contracted state through the catheter to a proximal side of the thrombus; g) Advancing the coring member into the thrombus to break up the thrombus into fragments; and h) applying negative pressure to the catheter to aspirate debris out of the vessel.

In various embodiments of this aspect, after step d), the method further comprises locking the capture member in the deployed state.

In various embodiments of this aspect, after step e) and before step f), the method further comprises applying negative pressure to the catheter to aspirate thrombus.

In various embodiments of this aspect, in step g), the coring member is advanced into the thrombus while rotating to break the thrombus into fragments.

In various embodiments of this aspect, after step g), the method further comprises retracting the coring member into the conduit and repeating steps g) and h).

In various embodiments of this aspect, in step g), the advancing, rotating and/or retracting of the coring member is performed simultaneously with the applying of the negative pressure in step h).

In another aspect, embodiments of the present disclosure provide a method for removing a thrombus from a blood vessel of a patient. In general, embodiments of the method include the steps of: a) Introducing a catheter into a vessel containing a thrombus; b) Advancing the catheter through the thrombus to position a distal end of the catheter on a distal side of the thrombus; c) Delivering the coring device in a collapsed state through the catheter to a distal side of the thrombus; d) Retracting the catheter to position the distal end of the catheter on the proximal side of the thrombus; e) Applying negative pressure to the lumen of the catheter to aspirate thrombus; and f) retracting the coring device while rotating through the thrombus, thereby breaking up the thrombus into fragments, and the fragments are aspirated out of the vessel by the catheter.

In various embodiments of this aspect, the method further comprises the step of retracting the coring device into the conduit to extrude fragments trapped within the coring device.

In various embodiments of this aspect, after the step of retracting the coring device into the catheter, the method further comprises advancing the coring device while rotating through the thrombus to further break up the thrombus.

In various embodiments of this aspect, after step b) and before step c), the method further comprises delivering the capture member in a contracted state to a distal side of the thrombus through the catheter and deploying the capture member to a deployed state.

In another aspect, embodiments of the present disclosure provide a method for removing a thrombus from a blood vessel of a patient. In general, embodiments of the method include the steps of: a) Introducing a catheter into a vessel containing a thrombus; b) Advancing the catheter to position a distal end of the catheter on a proximal side of the thrombus; c) Delivering the coring device in a collapsed state through the catheter to a proximal side of the thrombus; d) Applying negative pressure to the lumen of the catheter to aspirate thrombus; and e) advancing the coring device while rotating into the thrombus, thereby breaking up the thrombus into fragments and drawing the fragments out of the vessel through the catheter.

In various embodiments of this aspect, the method further comprises step f) retracting the coring device into the conduit to extrude fragments trapped within the coring device.

In various embodiments of this aspect, the method further comprises repeating step e) and step f).

The summary is provided to introduce selected aspects and embodiments of the present disclosure in a simplified form and is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. The aspects and embodiments selected are presented solely to provide the reader with an overview of certain forms that the disclosure may take and are not intended to limit the scope of the disclosure. Other aspects and embodiments of the disclosure are described in the detailed description section.

These and various other aspects, embodiments, features and advantages of the present disclosure will be better understood upon reading the following detailed description taken in conjunction with the accompanying drawings.

Drawings

Fig. 1 is a simplified illustration of a thrombectomy device deployed in a vessel containing a thrombus, according to an embodiment of the present disclosure.

Fig. 2A and 2B are cross-sectional views taken along line A-A in fig. 1, showing an example arrangement of a delivery shaft inside a catheter of a thrombectomy device.

Fig. 3A illustrates a delivery catheter and an example capture member in a contracted state according to an embodiment of the present disclosure.

Fig. 3B illustrates the introduction of an example capture member in a contracted state into a delivery catheter according to an embodiment of the present disclosure.

Fig. 3C shows an example capture member in a contracted state on the distal side of a thrombus. Fig. 3D shows an example capture member in a deployed state at a distal side of a thrombus.

Fig. 4A and 4B illustrate an example delivery of a coring member through a conduit in accordance with an embodiment of the present disclosure.

Fig. 4C, 4D and 4E illustrate an example delivery of a coring member through a conduit in accordance with an alternative embodiment of the present disclosure.

Fig. 5A illustrates an example capture member in a contracted state according to an embodiment of the disclosure. Fig. 5B illustrates an example capture member in a deployed state according to an embodiment of the disclosure. Fig. 5C is an enlarged view of a portion of the capture member of fig. 5B.

Fig. 5D illustrates an example capture member in a deployed state according to an alternative embodiment of the present disclosure.

Fig. 5E is an enlarged view of a portion of the capture member of fig. 5D.

Fig. 6A and 6B illustrate an example basket of a capture member according to embodiments of the present disclosure.

Fig. 7A to 7D illustrate example reinforcing structures of a capturing member according to an embodiment of the present disclosure.

Fig. 8A and 8B illustrate operation of an example capture member according to an embodiment of the present disclosure.

Fig. 8C and 8D illustrate operation of an example capture member according to alternative embodiments of the present disclosure.

Fig. 9A-9G illustrate the use of a handle for delivering and/or deploying a capture member according to an embodiment of the present disclosure.

Fig. 10A-10B illustrate example locking features in a delivery shaft of a capture member according to embodiments of the present disclosure.

FIG. 11 illustrates an example coring device, according to an embodiment of the present disclosure.

Fig. 12A and 12B illustrate an example coring device coupled with a handle in accordance with an embodiment of the present disclosure.

FIG. 13A illustrates an example deployable structure of the coring device in a deployed state, showing a diameter greater than an inner diameter of the delivery catheter. Fig. 13B illustrates retraction of the expandable structure into the delivery catheter.

14A, 14B and 14C illustrate an example coring member or coring device in accordance with an embodiment of the present disclosure.

15A, 15B and 15C illustrate exemplary deployable structures of a coring member or device in accordance with an embodiment of the present disclosure.

16A, 16B, and 16C illustrate operation of an example coring device in accordance with an embodiment of the present disclosure.

Fig. 17 is a flowchart illustrating an example method according to an embodiment of the present disclosure.

Fig. 18 is a flowchart illustrating an example method according to an embodiment of the present disclosure.

Fig. 19 is a flowchart illustrating an example method according to an embodiment of the present disclosure.

Detailed Description

Various embodiments of thrombectomy devices, systems, and methods are now described with reference to the drawings. The drawings are intended to facilitate describing embodiments of the present disclosure and are not necessarily drawn to scale. Certain specific details may be set forth in the accompanying drawings in order to provide a thorough understanding of the present disclosure. It will be apparent to one of ordinary skill in the art that some of these specific details may not be used to practice embodiments of the present disclosure. In other instances, structures, components, systems, materials, and/or operations commonly associated with known medical procedures may not be shown or described in detail to avoid unnecessarily obscuring descriptions of the embodiments of the present disclosure.

Fig. 1 illustrates an example thrombectomy device or system 100 according to embodiments of the present disclosure. The thrombectomy device 100 may be used to remove thrombi from a patient's venous or arterial vasculature, cardiovascular system, neurovasculature, and other treatment sites. In the present disclosure and claims, the term "thrombus" is used to broadly include blood clots in a patient's blood vessel, including, but not limited to, acute, subacute, chronic thrombus, and any other obstruction, blockage, calculi, foreign matter that impedes the passage of blood or fluid in any anatomical structure of the patient. Fig. 1 shows a thrombectomy device 100 in a deployed state deployed in a vessel 102 containing a thrombus 104. In general, the thrombectomy device 100 as shown includes a coring member 200 and a capture member 300. The coring member 200 operates to break up, shear, macerate, and/or reduce the thrombus 104 into fragments 106. The capture member 300 operates to provide embolic protection during thrombectomy. The thrombectomy device 100 may further include a catheter 150 extending between the proximal end 152 and the distal end 154 for delivering the capture member 300 and/or the coring member 200, respectively, to a target site and/or for aspirating the thrombus 104 or resulting fragments 106 from the blood vessel 102. The hub member 160 may be coupled to the proximal end 152 of the catheter 150, providing a first port 162 for connecting the lumen of the catheter 150 to a vacuum source (not shown) and a second port 164 configured for introducing the capture member 300 and/or the coring member 200 into the catheter 150 for delivery to a target site, respectively. The hub member 160 may include a hemostasis valve having a side port for connecting the lumen of a catheter to, for example, a syringe or suction pump and a port having a fluid seal configured to prevent or minimize blood loss during introduction of a thrombectomy device or component of the device through the port. In use, the coring member 200 may be operable to break up thrombus 104 from the proximal side 108 of the thrombus 104. The coring member 200 may be rotated to break up the thrombus 104 and/or macerate the thrombus 104 into fragments or smaller pieces 106. Alternatively or additionally, the coring member 200 may be moved linearly back and forth through the thrombus 104 to break up the thrombus 104. According to embodiments of the present disclosure, the coring member 200 may be advanced into the thrombus 104 and retracted from the thrombus 104 while rotating to effectively break up the thrombus 104 and macerate the thrombus 104. The debris 106 may be aspirated out of the vessel 102 through the catheter 150. The capture member 300 may be anchored at the distal side 110 of the thrombus 104 in the deployed state and remain stationary during operation of the coring member 200, rather than advancing, moving, or rotating with the coring member to provide effective embolic protection.

According to an embodiment of the present disclosure, the coring member 200 and the capture member 300 are configured to be operable independently of each other. For example, as shown in fig. 1, the coring member 200 may be coupled to a distal portion of the shaft 202 and the capture member 300 may be coupled to a distal portion of one or more shafts 302, 304. The coring member shaft 202 may have a length extending from the distal end portion 204 to the proximal end portion 206, which may be maintained external to the patient, to allow a user to manipulate the coring member shaft 202. One or more capture member shafts 302, 304 have a length extending from, for example, a distal end portion 306 to a proximal end portion 308, which may be maintained external to the patient to allow a user to manipulate the capture member shafts 302, 304. The coring member shaft 202 and the one or more capture member shafts 302, 304 may be configured or arranged to allow independent movement relative to each other, such as when transporting and positioning the coring member 200 and the capture member 300, as will be described in greater detail below, when rotating or linearly moving the coring member 200 to break up thrombus, and when retracting the coring member 200 and the capture member 300 after the procedure, thereby allowing the coring member 200 coupled to the shaft 202 and the capture member 300 coupled to the one or more shafts 302, 304 to operate independently. Making the coring member 200 and the capture member 300 separate entities allows for better clot coring/maceration and better embolic protection. Which allows the coring member 200 to be manipulated without fear of clot fragments moving distally to the capture member 300. Furthermore, due to concerns about distal embolization, coring member 200 may be designed without limitation.

Fig. 2A and 2B illustrate an example arrangement of the coring member shaft 202 and the capture member shafts 302/304, allowing the coring member 200 and the capture member 300 to operate independently in the conduit 150. In the embodiment shown in FIG. 2A, the coring member shaft 202 comprises a tubular shaft having an inner diameter that is greater than the outer diameter of the capture member shaft 302/304. This allows the user to move the coring member shaft 202, e.g., slide or rotate independently of the capture member shafts 302/304, thereby allowing the user to operate the coring member 200 and the capture member 300 independently or separately. In the embodiment shown in fig. 2A, the coring member shaft 202 and the capture member shafts 302/304 may be longitudinally movable (e.g., advanced and/or retracted) in a generally coaxial path. Alternatively, in the embodiment shown in fig. 2B, the coring member shaft 202 and the capture member shafts 302/304 may be sized or configured adjacent to each other in the lumen of the catheter 150 to allow the shafts to move independently, thereby allowing a user to operate the coring member 200 and the capture member 300 independently or separately. In the embodiment shown in fig. 2B, the coring member shaft 202 and the capture member shafts 302/304, respectively, may be longitudinally movable (e.g., advanced and/or retracted) in a non-coaxial path.

Fig. 3A-3D illustrate an example delivery of a capture member 300to a target site according to an embodiment of the present disclosure. Fig. 3A illustrates an example capture member 300, catheter 150, and hub member 160 coupled to a proximal end of catheter 150 in a contracted state. As shown in fig. 3B, the capture member 300 in the contracted state may be introduced into the catheter 150 through the opening 164 of the hub member 160. The capture member 300 in the contracted state may then be advanced, for example, by pushing the capture member shaft 302/304 through the catheter 150 with minimal or reduced friction. In thrombectomy, as shown in fig. 3C, the capture member 300 may be positioned on the distal side of the thrombus 104, as shown in fig. 3D, deployed or actuated in the deployed state. The capture member 300 may be self-expanding or expanded/contracted by relative movement of the proximal and distal ends of the capture member 300, as will be described in more detail below.

Fig. 4A-4B illustrate an example delivery of a coring member 200 to a target site in accordance with an embodiment of the present disclosure. In the embodiment shown in fig. 4A-4B, the coring member 200 is coupled to a tubular shaft 202, the tubular shaft 202 having an inner diameter that is greater than an outer diameter of the capture member shaft 302, allowing the coring member shaft 202 to slidingly travel over the capture member shaft 302. The coring member 200 may be introduced into the catheter 150 through the hub member 160 as shown in fig. 4A. The coring member 200 may then be advanced, for example, by pushing the coring member shaft 202 through the catheter 150 in a path that is generally coaxial with the path of the capturing member shaft 302, as also shown in fig. 2A. The coring member 200 may be positioned on the proximal side of the thrombus 104. The coring member 200 includes a deployable structure that can be in a deployed state when released from the catheter 150. The expandable structure in the expanded state may be moved back and forth through the thrombus 104 and/or rotated to break up the thrombus 104 and macerate fragments of the thrombus 104 into smaller fragments to be aspirated out, with the capture member 300 deployed on the distal side of the thrombus 104 to provide embolic protection, as shown in fig. 4B.

Fig. 4C-4E illustrate an example delivery of the coring member 200 to a target site in accordance with an alternative embodiment of the present disclosure. In the embodiment shown in fig. 4C-4E, the capture member 300 has been introduced, delivered, or deployed at a target site. The coring member 200 may be introduced into the catheter 150 through the hub member 160 as shown in fig. 4C and 4D, and may be advanced, for example, by pushing the coring member shaft 202 through the catheter 150. The coring member shaft 202 may be located near or beside the capture member shaft 302 in the lumen of the catheter 150. As also shown in fig. 2B, the coring member shaft 202 may be advanced in the catheter 150 in a path that is not coaxial with the path of the capture member shaft 302. The coring member 200 may be positioned on the proximal side of the thrombus 104, as shown in fig. 4E. The coring member 200 includes a deployable structure that can be in a deployed state when released from the catheter 150. The expandable structure in the expanded state may be moved back and forth through the thrombus 104 and/or rotated to break up the thrombus 104 and macerate fragments of the thrombus 104 into smaller fragments to be aspirated out, with the capture member 300 deployed on the distal side of the thrombus 104 to provide embolic protection.

Referring now to fig. 5A to 5E, 6A to 6B, and 7A to 7D, various embodiments of the capture member 300 and components of the capture member 300 are described. In general, the capture member 300 is configured to anchor at the distal side of the thrombus to provide embolic protection by capturing and/or collecting fragments of the clot that may escape from the proximal side of the thrombus during operation. Fig. 5A illustrates an example capture member 300 in a contracted state, according to an embodiment of the disclosure. Fig. 5B shows capture member 300 in an expanded state. Fig. 5C is an enlarged view of a portion of capture member 300 of fig. 5B in an expanded state. Fig. 5D and 5E illustrate an example capture member 300 in a deployed state according to an alternative embodiment of the present disclosure.

As shown in fig. 5A-5C, the capture member 300 generally includes an expandable basket 310 configured for capturing and/or collecting fragments of a clot during a thrombectomy procedure. Thus, in the deployed state, basket 310 may have a pore size that retains fragments of a clot in the basket. The mesh basket 310 in the expanded state may have a pore size in the range of about 0.5 millimeters to about 4 millimeters, depending on the application. As used herein, pore size refers to a radial measurement of a circle defined by the pores or cells of a basket as is commonly understood by one of ordinary skill in the art. The expandable basket 310 may be constructed of any suitable material, including metallic materials, polymeric materials, or a combination of metallic and polymeric materials. Example materials suitable for constructing the expandable basket include nitinol, platinum, metal alloys, and the like. The expandable basket 310 may include a braided structure comprised of threads or filaments 312 interwoven in various patterns. By way of example, the wire 312 used to construct the basket may have a diameter in the range of 0.002 inch to 0.010 inch. The expandable basket 310 in the expanded state may have any suitable shape. For example, in the deployed state, the basket 310 may include a generally cylindrical body as shown in fig. 6A. In another example, the basket 310 in the deployed state may include a funnel shape that tapers in a distal direction, as shown in fig. 6B.

Referring to fig. 5A-5C, the capture member 300 may include reinforcement structures 320 for providing radial support to the basket 310. For example, the reinforcing structure 320 may be a deployable structure that provides a maximum diameter substantially equal to or greater than the diameter of the vessel to be treated. Thus, the reinforcing structure 320 in the deployed state may be fixed in place in the vessel by radial forces or remain stationary, allowing the basket 310 coupled to the reinforcing structure 320 to be anchored in the vessel. The reinforcing structure 320 in the deployed state also allows the basket 310 coupled to the reinforcing structure 320 to remain in an open position.

The reinforcing structure 320 may be a self-expanding structure. Alternatively, the reinforcing structure 320 may be deployed by relative movement of its proximal and distal ends, and the deployed state of the reinforcing structure may be locked, as will be described in more detail below. Fig. 7A-7D illustrate an example reinforcing structure 320 in an expanded state according to an embodiment of the present disclosure. The reinforcing structure 320 may be an open-celled tube cutting structure, as shown in fig. 7A. For example, a laser, physical blade, or other suitable means may be used to cut multiple openings of various shapes in the nitinol tube. Alternatively, the reinforcing structure 320 may be a woven structure composed of a plurality of filaments 322, as shown in fig. 7B-7D. As shown in fig. 7C-7D, filaments 322 may be grouped into strands to provide sufficient strength to reinforcing structure 320. The filaments 322 used to make the reinforcing structure 320 may have a diameter in the range of 0.004 inches to 0.020 inches.

Referring to fig. 7A-7D, the reinforcing structure 320 may be configured to provide various shapes or configurations in the deployed state. For example, as shown in fig. 7A and 7B, the reinforcing structure 320 may be configured to include a body having a generally cylindrical shape. As shown in fig. 7C and 7D, the reinforcing structure 320 may also be configured to include a body having a generally funnel shape, e.g., a distally tapered shape. In the example shown in fig. 7B, the braided reinforcing structure 320 (e.g., 16x0.010 "nitinol filaments) may be heat set on a cylindrical mandrel having tapered ends, wherein the maximum diameter of the mandrel is equal to or greater than the diameter of the vessel to be treated. In another example shown in fig. 7C and 7D, braided reinforcing structure 320 may be initially heat set on a mandrel having a tapered shape with a maximum diameter less than the diameter of the vessel to be treated, thereby forming a structure having the deployed configuration shown in fig. 7C. The structure may then be removed from the mandrel and again heat set in a second mandrel having a maximum diameter equal to or greater than the diameter of the vessel to be treated, thereby forming a reinforcing structure 320 as shown in fig. 7D. The reinforcing structure 320 may have a relatively large opening or lumen 324 at the proximal end to allow fragments of the clot to enter the basket 310 having a smaller pore size and be captured or collected by the basket 310. The size of the opening in the reinforcing structure 320 may decrease toward the distal end of the structure.

Returning to fig. 5A-5B, the example capture member 300 includes a reinforcing structure 320 and a basket 310 coupled to the reinforcing structure 320. The proximal end of the reinforcing structure 320 can be coupled to the first or outer shaft 302. The distal end of the reinforcing structure 320 can be coupled to the second shaft or inner shaft 304. The first shaft 302 and the second shaft 304 may be longitudinally movable relative to each other. For example, the outer shaft 302 can be a tubular shaft having an inner diameter that is greater than an outer diameter of the inner shaft 304 to allow the outer shaft 302 to travel over the inner shaft 304. The distal end of the basket 310 may be coupled to the second or inner shaft 304. The proximal end of basket 310 may be coupled to reinforcing structure 320 at an outer diameter of reinforcing structure 320, for example. The relative movement of the outer shaft 302 and the inner shaft 304 may cause the capture member 300 or the reinforcing structure 320 and basket 310 to collapse or expand. In some embodiments, the reinforcing structure 320 is a self-expanding structure, or has a configuration that expands when in a natural state. Thus, extending the inner shaft 304 relative to the outer shaft 302, or retracting the outer shaft 302 relative to the inner shaft 304, will cause the capture member 300 or reinforcing structure 320 and basket 310 to collapse. In an alternative embodiment, the reinforcing structure 320 is configured such that deployment of the reinforcing structure 320 may be actuated from the outside. For example, reinforcing structure 320 may be configured to have a configuration that contracts when in a natural state. Thus, retracting the inner shaft 304 relative to the outer shaft 302, or extending the outer shaft 302 relative to the inner shaft 304, may result in deployment of the capture member 300 or reinforcing structure 320 and basket 310.

Referring to fig. 5A-5C, the basket 310 may be coupled to the reinforcing structure 320 in various ways. According to embodiments of the present disclosure, the reinforcing structure 320 comprises a woven structure, and the basket 310 may be woven or knitted into the reinforcing structure 320. For example, basket 310 may be comprised of a plurality of wires 312. At the proximal end of basket 310, the plurality of wires 312 of basket 310 may be grouped, braided or woven into filaments 322 or multiple strands of reinforcing structure 320 (fig. 5C).

With reference to fig. 5D and 5E, an example capture member 300 according to an alternative embodiment of the present disclosure is described. Fig. 5D shows capture member 300 in an expanded state. Fig. 5E shows an enlarged view of a portion of the capture member of fig. 5D. As shown, the example capture member 300 includes a reinforcing structure 320 and a basket 310 coupled to the reinforcing structure 320. In contrast to fig. 5A-5C, the capture member 300 shown in fig. 5D and 5E includes an apertured tube cutting enhancement structure 320. Basket 310 may be coupled to perforated tube cutting structure 320 by braiding or braiding wires or wire sets of the basket into the perforated tube cutting structure. The perforated tube cutting enhancement structure 320 may be self-expanding, i.e., have a configuration that expands when in a natural state. In the deployed state, the diameter or maximum diameter of the fenestrated, tube-cutting enhancement structure 320 is equal to or greater than the diameter of the vessel to be treated. The proximal end of the tube cutting structure 320 may be coupled to the first or outer shaft 302 and the distal end of the tube cutting structure may be coupled to the second or inner shaft 304. The first shaft 302 and the second shaft 304 may be longitudinally movable relative to each other. For example, the outer shaft 302 can be a tubular shaft having an inner diameter that is greater than an outer diameter of the inner shaft 304 to allow the outer shaft 302 to travel over the inner shaft 304. The proximal end of basket 310 can be coupled to a tube cutting structure and the distal end of basket 310 can be coupled to inner shaft 304. The relative movement of the outer shaft 302 and the inner shaft 304 may cause the capture member 300 or the tube cutting structure 320 and basket 310 coupled thereto to collapse or over-expand. As an example, extending the inner shaft 304 relative to the outer shaft 302, or retracting the outer shaft 302 relative to the inner shaft 304, may result in retraction of the capture member 300 or reinforcing structure 320 and basket 310. Retracting the inner shaft 304 relative to the outer shaft 302, or extending the outer shaft 302 relative to the inner shaft 304, may result in over-deployment of the capture member 300 or reinforcement structure 320 and basket 310.

Referring to fig. 8A-8B, the operation of an example capture member 300 is shown. As shown in fig. 8A, the example capture member 300 shown in fig. 8A-8B is self-expanding, i.e., the capture member 300 is in an expanded state when the capture member 300 is in a natural state or uncompressed. The proximal end of the capture member 300 can be coupled to the outer shaft 302 and the distal end of the capture member 300 can be coupled to the inner shaft 304. To deliver capture member 300 to a target site, capture member 300 may be compressed to a contracted state, as shown in fig. 8B. For example, the retaining member 300 may be contracted by retracting the outer shaft 302 relative to the inner shaft 304, or by pushing the inner shaft 304 relative to the outer shaft 302. The capture member 300 in the contracted state may then be introduced into a catheter and delivered to a target site, such as the distal side of a thrombus. After being properly positioned at the target site, the delivery catheter may be retracted, allowing the capture member to exit the catheter. Upon exiting the catheter, the capture member 300 self-deploys to a deployed state and the radial forces generated by deployment of the capture member are anchored in the vessel.

Referring to fig. 8C-8D, the operation of another example capture member 300 is shown. The example capture member 300 shown in fig. 8C-8D is non-self-expanding, i.e., when the capture member 300 is in a natural state, the capture member is in a contracted state, as shown in fig. 8C. The non-self-expanding capture member 300 in its natural or contracted state may be introduced into a catheter and delivered to a target site, such as the distal side of a thrombus. After being properly positioned at the target site, the delivery catheter may be retracted, allowing the capture member 300 to exit the catheter. The capture member 300 can then be deployed by relative movement of the outer shaft 302 and the inner shaft 304. For example, the capture member 300 can be deployed by retracting the inner shaft 304 relative to the outer shaft 302, or by pushing the outer shaft 302 relative to the inner shaft 304. The deployed capture member 300 may be anchored in the vessel by the radial force created by the deployment of the capture member 300. The deployed state of the capture member 300 may be maintained by locking features in handles coupled to the proximal ends of the inner shaft 304 and the outer shaft 302, or by locking features in the proximal ends of the inner shaft 304 and the outer shaft 302.

Referring to fig. 9A through 9G, a handle 330 may be provided for assisting in the operation of the capture member 300, according to an embodiment of the present disclosure. For example, in embodiments where capture member 300 includes a self-expanding structure, handle 330 may be used to deliver by placing the self-expanding structure under tension to collapse the self-expanding structure. In embodiments where capture member 300 is a non-self-expanding structure, handle 330 may be used to deploy by placing the non-self-expanding member under compression to actuate the expansion of the non-self-expanding structure. In some embodiments, the handle 330 may place the heat-set reinforcing structure under tension and compression to contract or over-expand the reinforcing structure, thereby reducing or increasing its radial force. The handle 330 may be coupled to a proximal end of the capture member shaft, such as the inner shaft and the outer shaft of the capture member 300. The handle 330 may include a button, slider or the like 332 that may be actuated to cause relative movement of the shafts. According to an embodiment of the present disclosure, handle 330 is removable from the capture member shaft.

Fig. 9A-9G illustrate an example use of a handle 330 with a self-expanding capture member 300. To simplify the illustration, the self-expanding capture member 300 is coupled to a distal end of a shaft 303 (e.g., representing the outer and inner shafts 302/304) and a handle 330, the handle 330 being coupled to a proximal end of the shaft. In the natural state, the capturing member 300 is in the deployed state, as shown in fig. 9A. To prepare for delivery, a user may actuate a button or slider 332 on handle 330 to, for example, move inner/outer shafts 302/304 relative to one another to place capture member 300 in the contracted state, as shown in fig. 9B. The capture member 300 in the contracted state may then be introduced into a catheter for delivery to a target site, as shown in fig. 9C. After the capture member 300 is properly positioned at the target site, the user may retract the catheter 150 as shown in fig. 9D and deactivate the button or slider 332 on the handle 330 to allow the capture member 300 to self-deploy as shown in fig. 9E. According to an embodiment of the present disclosure, as shown in fig. 9F, the handle 330 may be removed to allow the coring member or coring member shaft 202 to be loaded onto the capture member shaft 303 and introduced into the catheter 150 for delivery, as shown in fig. 9G. The coring member 200 may then be delivered to the target site, for example, by advancing the coring member shaft 202 over the capture member shaft 303.

Referring to fig. 10A-10B, according to embodiments of the present disclosure, the proximal end of the inner shaft 304 and the proximal end of the outer shaft 302 may be provided with locking features to prevent relative movement of the inner shaft 304 and the outer shaft 304 after deployment of the non-self-expanding capture member. As an example, one or more notches 305 may be provided at the proximal end of the outer shaft 302 that indicate a locked position. One or more pins 307 may be provided at the proximal end of the inner shaft 304. The relative movement and/or rotation of the outer shaft 302 and the inner shaft 304 may cause the pin 307 on the inner shaft 304 to lock in the recess 305 on the outer shaft 302. One advantage of the locking feature on the capture member shaft 302/304 is that in embodiments where the capture member 300 is not self-expanding, the locking feature 305/307 of the capture member shaft 302/304 allows for removal of the handle 330 after expansion of the capture element 300 via external actuation. The deployed state of the non-self-deploying capture member 300 may be maintained by a locking feature 305/307 in the proximal end of the capture member shaft 302/304. In this way, the handle 330 may be removed to allow the coring member 200 to be loaded and delivered to the target site. According to alternative embodiments of the present disclosure, the coupling and actuation handle 330 may be maintained to maintain the non-self-expanding capture member 300 in the expanded state. The coring member 200 may be introduced into the catheter 150 and delivered along a path that is not coaxial with the path of the capture member shaft, as described above in connection with fig. 2B. Although various embodiments are described in connection with a handle, one of ordinary skill in the art will appreciate that capture member 300 may be operated by directly acting on capture member shaft 302/304 without the need for a handle.

Referring now to fig. 11-16A-16C, various embodiments of coring members or coring devices are described. It should be noted that while the example coring device may be described in connection with a capture member, coring devices according to embodiments of the present disclosure may be used without a capture member. For example, during thrombectomy, the coring device of the present disclosure may be used to break up and/or macerate a thrombus from the proximal side of the thrombus, and fragments of the generated clot may be removed from the blood vessel by aspiration. In some embodiments, the coring device may be configured to break down a thrombus from a distal side of the thrombus and capture or collect fragments of the generated clot at the distal end of the thrombus. By retrieving the coring device in a proximal direction, the collected clot fragments can be removed from the blood vessel.

Fig. 11 illustrates an example coring device or thrombectomy device 200 according to an embodiment of the present disclosure. As shown, the coring device 200 generally includes an elongate shaft 202 extending from a proximal end 206 to a distal end 204, and a deployable structure 210 coupled to the distal end 204 of the elongate shaft 202. The expandable structure 210 includes a proximal portion 212 and a distal portion 214. The proximal portion 212 of the expandable structure 210 can be fixedly coupled to the elongate shaft 202. The distal portion 214 of the expandable structure can slide freely along the elongate shaft 202 when the expandable structure 210 is contracted or expanded. Alternatively, the distal end 214 of the expandable structure 210 may be fixedly coupled to the elongate shaft 202. The proximal portion 212 of the expandable structure 210 is free to slide along the elongate shaft 202. The expandable structure 210 is sized or dimensioned for deployment in a blood vessel containing a thrombus or other target site containing an occlusion, and is configured to be rotatable by the elongate shaft 202 or rotatable with the elongate shaft 202 in operation. A handle 260 may be coupled to the proximal end 206 of the elongate shaft 202 to assist in the operation of the coring device 200, such as to provide better grip for advancement and/or retraction (linear movement) and/or to assist in rotation of the elongate shaft 202 and the deployable structure 210. The handle 260 may be a manual torque handle as shown in fig. 12A, or may be an electric or automatic torque handle including a trigger or button that may be actuated by a user as shown in fig. 12B. The coring device 200 may also include a catheter 150 for delivery devices and/or for aspiration. The delivery or aspiration catheter 150 includes a proximal end 152, a distal end 154, and a lumen extending between the proximal end 152 and the distal end 154. The proximal end 152 of the catheter 150 may be connected to a vacuum source (not shown) to allow negative pressure to be applied to the catheter 150 to aspirate fragments of a thrombus or clot. In operation, the coring device 200 may break up a thrombus, such as shearing a wall block attached to a subacute to chronic clot, and macerating the clot into smaller fragments by rotational movement, linear movement (advancement/retraction), or a combination of rotational and linear movement of the expandable structure 210.

Referring to fig. 11, the elongate shaft 202 has a length sufficient to allow the distal end 204 to reach a target site within a patient and to allow the proximal end 206 to remain outside the patient for user control. In some embodiments, at least a portion of the elongate shaft 202 is coated with a lubricating material, such as Polytetrafluoroethylene (PTFE), polyethylene polymer, or the like, to reduce friction when the coring device 200 is delivered through the catheter 150. For example, a majority of the elongate shaft 202 may be covered with a lubricious polymer, with the uncovered portion at the proximal end 206 for attachment to the handle 260. Alternatively or additionally, the coring device 200 may include a guidewire (not shown) for delivery, and the elongate shaft 202 may be a tubular shaft. The diameter or outer diameter of the elongate shaft 202 may be smaller or significantly smaller than the diameter of the lumen of the catheter 150 to allow a large amount of residual volume within the catheter 150 for efficient aspiration.

Referring to fig. 13A-13B, in accordance with an embodiment of the present disclosure, the diameter or maximum diameter (D) of the deployable structure 210 of the coring device 200 in the deployed state is greater than the inner diameter (D) of the delivery or aspiration catheter 150. The expandable structure 210 of the coring device 200 does not have a fixed diameter that is smaller than the inner diameter of the aspiration catheter, but rather has a larger diameter in the expanded state, and yet can be delivered through the aspiration catheter 150 in the collapsed state, allowing the coring device 100 to treat vessels having a larger cross-section. With the larger diameter of the expandable structure 210 and the linear and rotational motion capabilities, the coring device 200 of the present disclosure may more effectively and efficiently break down thrombi.

Referring to fig. 14A-14C, the deployable structure 210 of the coring device 200 may be a self-expanding structure in accordance with an embodiment of the disclosure. For example, the expandable structure 210 may be composed of a shape memory material such as nitinol and a heat setting such that the configuration of the expandable structure changes from a reduced shape in a contracted state (e.g., when compressed in a catheter) to a preset expanded shape in a natural state (e.g., when released from the catheter). Alternatively or additionally, the expandable structure may be configured to be expanded and/or contracted by external actuation.

Referring to fig. 14A-14C, the expandable structure 210 of the coring device 200 in the expanded state may have various shapes. For example, the expandable structure 210 may include a stent-like structure. In some embodiments, the expandable structure 210 may include a substantially cylindrical body, as shown in fig. 14B. In some embodiments, the expandable structure 210 may have a tapered cross-section or region at the proximal and/or distal ends, as shown in fig. 14C. The tapered proximal end 212 allows for easy re-nesting of the expandable structure 210 into the delivery catheter. The tapered distal end 214 allows for better thrombus penetration.

Referring to fig. 14A-14C, the proximal end 212 of the deployable structure 210 of the coring device 200 may be fixedly coupled to the elongate shaft 202. The distal end 214 of the expandable structure 210 may be an open end, as shown in fig. 14A. In accordance with an embodiment of the present disclosure, the distal end 214 of the deployable structure 210 of the coring device 200 may be freely slidable along the elongate shaft 202, as shown in fig. 14C. The freely slidable distal end 214 of the expandable structure 210 may facilitate collapsing and expanding of the expandable structure 210. An atraumatic tip 216 may be provided or coupled to the distal end of the elongate shaft 202 to prevent damage to healthy tissue. According to an alternative embodiment of the present disclosure, the distal end 214 of the expandable structure 210 may be fixedly coupled to the elongate shaft 202, and the proximal end 212 of the expandable structure may be free to slide along the elongate shaft 202.

15A-15C, the deployable structure 210 of the coring device 200 may be an open-celled tube cutting structure. For example, the nitinol tube may be cut using a laser, blade, or other suitable means to form the self-expanding structure. Alternatively, the expandable structure 210 may be braided from a plurality of filaments, such as nitinol or other metal or polymer wires. The expandable structure 210 includes a plurality of cells 218a/218b that, in an expanded state, have openings of various shapes and sizes. By way of example, the openings of the cells 218a/218b may be diamond, square, or other regular or irregular shapes. The openings of the cells 218a/218b may have a size range from 0.1 inch to 2 inches as measured by the largest dimension of the opening. The size and/or shape of the cell openings may be different. Alternatively, the size and/or shape of the cell openings may generally be the same. As an example, the proximal side 212 of the expandable structure 210 may include cells 218a, the cells 218a having a generally diamond-shaped opening and an opening dimension (maximum diagonal length) of less than 0.6 inches.

Referring to fig. 15A, according to embodiments of the present disclosure, the opening of the one or more cells 218b adjacent the distal end 214 of the deployable structure 210 of the coring device 200 may be larger than the opening of the one or more cells 218a adjacent the proximal end 212 of the deployable structure 210. Thus, when the expandable structure 210 is retracted into the tip of the catheter 150, the proximal region 212 of the expandable structure will compress first and any clot fragments trapped within the structure 210 will be pushed toward the distal region 214 of the structure 210 and then pushed out through the larger distal unit 218 b. As shown in fig. 16A-16C, this has the effect of wringing out/squeezing out the clot from inside the expandable structure 210, thereby further macerating and reducing the clot as the structure 210 is contracted as the structure 210 is introduced into the catheter 150. In addition, by pushing fragments of the clot out of the structure 210 through the larger distal unit 218b, it ensures that the expandable structure 210 can collapse without interference from the trapped clot and retract into the catheter tip.

According to alternative embodiments of the present disclosure, the opening of the one or more cells adjacent the distal end of the expandable structure may be smaller than the opening of the one or more cells adjacent the proximal end of the expandable structure. Thus, clot fragments entering through a larger proximal unit will be too large to escape through a smaller distal unit and will therefore be captured and collected by the expandable structure. This may be advantageous when the coring device is used to break down thrombus from the distal side of the thrombus, capture or collect the generated clot fragments at the distal side, and remove the clot fragments from the blood vessel by withdrawing the coring device in the proximal direction.

Referring to fig. 15B, the expandable structure 210 of the coring device 200 in the expanded state may have a diameter (D) and a length (L) that are suitable for a particular application and vessel size. As used herein, the diameter (D) of the expandable structure 210 of the coring device 200 in the expanded state refers to the maximum diameter of the structure 210 in the expanded state. The length (L) of the deployed structure 210 of the coring device 200 in the deployed state refers to the length of the deployed portion of the deployed structure 210 in the deployed state, which may be measured between the ends of the structure 210 showing the taper angle. By way of example, the deployable structure 210 of the coring device 200 in the deployed state may have a diameter (D) ranging from 1mm to 25mm and a length (L) ranging from, for example, 0.2 inches to 4 inches. By way of example, the diameter (D) of the expandable structure 210 may be 2 millimeters, 4 millimeters, 6 millimeters, 8 millimeters, 10 millimeters, 14 millimeters, 18 millimeters, 20 millimeters, 24 millimeters, and the like. The length (L) of the deployable structure may be 0.3 inches, 0.6 inches, 0.8 inches, 1.0 inches, 1.5 inches, 2 inches, 2.5 inches, 3 inches, etc. According to embodiments of the present disclosure, the ratio of the diameter (D) of the expandable structure 210 to the length (L) of the expandable structure 210 may be in the range of 0.2 to 0.6.

Referring to fig. 15C, the deployable structure 210 of the coring device 200 may include a tapered portion at the proximal end 212 and/or the distal end 214. The proximal tapered portion 212 and/or the distal tapered portion 214 have a taper angle (α) ranging from, for example, 5 degrees to 25 degrees, respectively, as measured from the longitudinal axis 203 of the elongate shaft 202 of the coring device 200.

It should be noted that the specific details described above with respect to diameter, length, taper angle, and cell opening size and shape are provided for a thorough understanding of the present disclosure. The appended claims are not limited to a particular diameter, length, taper angle, and size and shape of the cell opening. It will be apparent to one of ordinary skill in the art that some of these specific details may not be used to practice embodiments of the present disclosure.

Advantageously, the coring device 200 of the present disclosure may be used in conjunction with aspiration to perform a more efficient thrombectomy procedure. In general, aspiration alone is less effective in removing harder, subacute to chronic thrombi because it is difficult to break the clot into small enough fragments or pieces to aspirate. In addition, the tip of the aspiration catheter is often blocked by a large clot. The coring device of the present disclosure may advantageously macerate the clot into smaller pieces that are more easily aspirated.

The coring device 200 of the present disclosure may be advantageously used to treat large blood vessels. Because the coring device 200 includes a deployable structure 210, such as a self-expanding stent-like structure, it provides a diameter in the deployed state that is greater than the inner diameter of the delivery catheter or aspiration catheter. Since the expandable structure 210 is collapsible, it can still be delivered through the aspiration catheter. When deployed upon exiting the catheter, the expandable structure 210 may treat vessels having a cross-sectional diameter greater than the inner diameter of the aspiration catheter.

In addition to the linear motion of the deployable structure 210, the rotational capability also allows the coring device 200 of the present disclosure to more effectively break up wall-adhering thrombi. Traditional mechanical devices may be able to "bite" a small opening from the clot by linear movement rather than rotation. Conventional devices offer very little assistance in removing large amounts of subacute to chronic clots by aspiration. Due to the stent-like structure and larger size, the coring device 200 of the present disclosure may use rotational and linear motion to reduce a greater amount of clot to smaller fragments. When the stent-like structure is rotated, its open cells provide the effect of cutting the clot into smaller fragments, allowing easier aspiration.

The coring device 200 of the present disclosure may also be used to "withdraw" a clot in conjunction with aspiration. Conventional solutions that rely on stent retrieval devices deployed on the distal side of the clot require multiple passes without suction assistance. Each pass requires complete removal of the device from the delivery system and cleaning of the device to remove the clot. In contrast, the coring device 200 of the present disclosure, when used in conjunction with aspiration, may remove the clot from the distal side without completely removing the device. This greatly shortens the treatment time.

Conventional thrombectomy devices either do not provide embolic protection or provide embolic protection coupled with a clot coring element. Embodiments of the thrombectomy device 100 of the present disclosure make the coring member and the capture member two separately or independently operable entities, allowing for better clot coring/maceration and better embolic protection. The capture member may remain stationary rather than travel or move with the coring member, allowing the coring member to move back and forth through the clot and rotate without fear of clot fragments moving distally past the capture member. Furthermore, since there is no concern about distal embolization, the coring member may be designed without limitation.

In conventional solutions using a coring element and an embolic protection element coupled together, removal may require cleaning to remove the clot from the device or aspiration of the coring element, leaving the treatment site free of embolic protection. By maintaining the coring member and the capture member as separate entities, multiple coring and aspiration cycles may be achieved while continuing to maintain embolic protection, according to embodiments of the present disclosure.

Conventional solutions not only core the clot from the vessel wall, but also macerate the clot into smaller fragments. Thus, the clot being cored is typically too large to be aspirated. In accordance with embodiments of the present disclosure, the combination of rotational and linear movement of the coring member or device through the expandable structure of the coring device, in addition to releasing the clot from the vessel wall, may macerate the clot into smaller fragments or pieces, allowing for easier removal of the clot by aspiration.

Further, embodiments of the capture members or reinforcing structures of the capture members of the present disclosure may be heat set in a deployed state, wherein their maximum diameter is equal to or greater than the vessel diameter. Thus, external actuation of the capture member may not be required to maintain embolic protection, thus allowing removal of the handle without any risk of embolism to the patient. Furthermore, since the capture member or the reinforcement structure of the capture member is heat set in the deployed state, it will maintain its position in the blood vessel, and the capture member shaft can be used as a guidewire to deliver the coring member to the target site, eliminating the need for an over-the-wire system to maintain access to the treatment site. This results in a smaller reduction of space within the lumen of the delivery catheter, thereby greatly increasing its aspiration volume and effectiveness.

Various embodiments of methods according to the present disclosure are now described with reference to fig. 17-19. Although the embodiments are described in connection with removing a thrombus from a patient's blood vessel, these methods may be used to remove any occlusion, blockage, calculus, or foreign body in other treatment sites of the patient. Furthermore, while the various steps may be described in connection with the thrombectomy device shown in fig. 1-16, other thrombectomy devices may be used to practice the methods of the present disclosure.

Fig. 17 is a flowchart illustrating an example thrombectomy method 1700 in which a coring device is used to break down a thrombus and a capture device provides embolic protection during the procedure, according to an embodiment of the present disclosure.

At step 1702, a catheter is introduced into a vessel containing a thrombus. The catheter may be introduced via an appropriate access point in the patient's body (e.g., in the neck, pelvis, or other area) using an introducer sheath. A guidewire may be used to gain access and guide the catheter to the target site.

At step 1704, the catheter is advanced through the thrombus to position the distal end of the catheter distal to the thrombus. To facilitate advancement of the catheter, a dilator may be used to puncture the thrombus, creating a path for the catheter. Once the catheter is properly positioned at the distal end of the thrombus, the dilator may be removed.

At step 1706, the capture member in a contracted state is delivered through the catheter to the distal side of the thrombus. The capture member is configured to provide embolic protection during thrombectomy by capturing and collecting fragments of the clot that may escape from the proximal side of the thrombus. The capture member may be compressed into a contracted state by relative movement of the proximal and distal ends of the capture member and introduced into the catheter for delivery. The capture member in the contracted state may then be advanced through the catheter and positioned distally of the thrombus. As an example, the capture member may include a basket and a reinforcing structure supporting the basket. In the deployed state, the reinforced structure of the capture member allows the basket to anchor in the vessel and remain open to capture and collect clot fragments on the distal side of the thrombus. Suitable capture devices and uses are described above in connection with fig. 5A to 5E, 6A to 6B and 7A to 7D, fig. 8A to 8D, 9A to 9G and 10A to 10B.

At step 1708, the capture member is deployed to a deployed state. According to embodiments of the present disclosure, the capture member or the reinforcing structure of the capture member is self-expanding and expands upon exiting the catheter or upon retraction of the catheter. The deployed capture member may be anchored in the vessel and the radial force generated by the capture member against the vessel wall remains stationary. According to an alternative embodiment of the present disclosure, the capture member may be deployed by external actuation, for example by relative movement of an outer shaft and an inner shaft, the proximal and distal ends of the capture member being attached to the outer shaft and the inner shaft, respectively. Thus, as described above in connection with fig. 8A-8D, 9A-9G, and 10A-10B, deployment of the capture member may be maintained by locking features provided in the proximal ends of the inner and outer shafts of the capture member or in handles coupled to the outer and inner shafts of the capture member.

At step 1710, the catheter is retracted to position the distal end of the catheter at the proximal end of the thrombus. Alternatively, negative pressure may be applied to the lumen of the catheter to aspirate thrombus from the proximal side of the thrombus.

At step 1712, the coring member in a contracted state is delivered to the proximal side of the thrombus through the catheter. The coring member may be compressed and introduced into the catheter and advanced through the catheter. According to embodiments of the present disclosure, a coring member may be coupled to the distal end of the tubular shaft. A tubular coring member shaft may be loaded onto the capturing member shaft and advanced through the catheter in a path coaxial with the capturing member shaft as described above in connection with fig. 2A. Alternatively, the coring member shaft may be configured to lie alongside the capturing member shaft and advance through the conduit in a path that is not coaxial with the capturing member shaft, as described above in connection with fig. 2B. Various suitable coring members or devices are described above in connection with fig. 11, 12A-12B, 13A-13B, 14A-14C, 15A-15C, and 16A-16C.

At step 1714, the coring member is advanced to the thrombus to break up the thrombus into fragments. The coring member may include a deployable structure. The expandable structure may be self-expanding and expands upon exiting the distal end of the catheter. Alternatively, the expandable structure may be expanded by external actuation. The coring member or the deployable structure of the coring member may be repeatedly advanced into the thrombus and retracted back to the distal end of the catheter to "eat," "bite," or break up the thrombus. Thus, a large mass of thrombus may be broken into small fragments or pieces and carried toward the distal end of the catheter for aspiration. According to embodiments of the present disclosure, the coring member or the deployable structure of the coring member may be advanced into the thrombus while the coring member is rotated. The combination of linear and rotational movement of the coring member may more effectively break up the thrombus mass and reduce it to fragments or smaller pieces.

At step 1716, negative pressure is applied to the lumen of the catheter to aspirate clot fragments out of the blood vessel. According to embodiments of the present disclosure, during the breaking up of the thrombus, negative pressure is applied simultaneously as the coring member is advanced into the thrombus and/or retracted into the distal end of the catheter. Alternatively, negative pressure may be applied after the coring member is retracted and removed from the catheter to allow for a larger aspiration path. If desired, the breakdown of the thrombus (step 1714) and aspiration of clot fragments (step 1716) may be repeated until the vessel lumen is cleared.

Once the thrombus is removed, the coring member may be withdrawn from the vessel by re-telescoping the catheter and retracting through the catheter. The capture member, still in the deployed state, may then be retracted to remove any remaining clot that may adhere to the vessel wall. The handle may be reattached to the capture member to assist in retraction of the capture member. Then, with suction, the capture member may be compressed into a contracted state and re-cannulated into the catheter and withdrawn from the patient. If desired, a negative pressure may be applied to the catheter after extraction of the capture member to remove any remaining clot fragments.

Fig. 18 is a flow chart illustrating an example thrombectomy method 1800 in which a coring device is used in conjunction with aspiration, according to an embodiment of the present disclosure.

At step 1802, a catheter is introduced into a vessel containing a thrombus. The catheter may be introduced via an appropriate access point in the patient's body (e.g., in the neck, pelvis, or other area) using an introducer sheath. A guidewire may be used to gain access and guide the catheter to the target site.

At step 1804, the catheter is advanced through the thrombus to position the distal end of the catheter distally of the thrombus. To facilitate advancement of the catheter, a dilator may be used to puncture the thrombus, creating a path for the catheter. Once the catheter is properly positioned at the distal end of the thrombus, the dilator may be removed.

At step 1806, the coring device in a collapsed state is delivered to the distal side of the thrombus via the catheter. The coring device may be compressed and introduced into the catheter in a collapsed state and advanced to the distal side of the catheter. The coring device may include a handle coupled to the shaft to facilitate transport of the coring device. Various suitable coring devices are described above in connection with fig. 11, 12A-12B, 13A-13B, 14A-14C, 15A-15C, and 16A-16C, and these coring devices may be used in the method.

At step 1808, the catheter is retracted to position the distal end of the catheter on the proximal side of the thrombus. Alternatively, negative pressure may be applied to the lumen of the catheter to aspirate the thrombus. The coring device is deployed to a deployed state. The coring member may include a deployable structure. The expandable structure may be self-expanding and expand as the catheter is retracted. Alternatively, the deployable structure may be deployed by external actuation through relative movement of the proximal and distal ends of the coring device.

At step 1810, negative pressure is applied to the catheter to aspirate the thrombus. The negative pressure may be applied before, during, or after deployment of the coring device.

At step 1812, the coring device is retracted from the distal end of the thrombus and passed through the thrombus. According to embodiments of the present disclosure, the coring device or the deployable structure of the coring device may be retracted through the thrombus while the deployable structure is rotated. The combination of linear and rotational movement of the coring device may more effectively break up the thrombus mass and reduce it to fragments or smaller pieces for aspiration. The expandable structure may include a plurality of open cells that are sized and/or shaped to facilitate reduction of the clot into fragments or small pieces. In accordance with embodiments of the present disclosure, one or more of the cells adjacent the distal end of the expandable structure may have an opening that is smaller than the opening of one or more of the cells adjacent the proximal end of the expandable structure. Thus, small pieces of clot entering through a larger proximal unit will likely be too large to escape through a smaller distal unit and will therefore be captured and collected by the structure.

After step 1812, the coring device may be retracted into the catheter. The coring device collapses and is removed when retracted into the catheter. If desired, the coring device may be advanced again out of the catheter and the decomposition and aspiration steps repeated.

Fig. 19 is a flowchart illustrating an example thrombectomy method 1900 according to an alternative embodiment of the present disclosure, wherein a coring device is used in conjunction with aspiration.

At step 1902, a catheter is introduced into a vessel containing a thrombus. The catheter may be introduced via an appropriate access point in the patient's body (e.g., in the neck, pelvis, or other area) using an introducer sheath. A guidewire may be used to gain access and guide the catheter to the target site.

At step 1904, the catheter is advanced to position the distal end of the catheter on the proximal side of the thrombus.

At step 1906, the coring device in a contracted state is delivered to the proximal side of the thrombus through the catheter. The coring device may be compressed and introduced into the catheter and advanced to the distal side of the catheter. The coring device may include a handle coupled to the shaft to facilitate transport of the coring device. Various suitable coring devices are described above in connection with fig. 11, 12A-12B, 13A-13B, 14A-14C, 15A-15C, and 16A-16C, and these coring devices may be used in the method.

At step 1908, the coring device is deployed to a deployed state. The coring device may include a deployable structure. The expandable structure may be self-expanding and expands upon exiting the distal end of the catheter. Alternatively, the deployable structure may be deployed by external actuation through relative movement of the proximal and distal ends of the coring device.

At step 1910, negative pressure is applied to the lumen of the catheter to aspirate the thrombus.

At step 1912, the coring device is advanced against the proximal side of the thrombus while rotating. The combination of linear and rotational movement of the coring device allows the thrombus mass to be broken up and reduced to fragments or smaller pieces. The coring device may include a deployable structure composed of a plurality of open cells, each of which is sized and/or shaped to facilitate reduction of the clot into fragments or small pieces. In accordance with embodiments of the present disclosure, one or more of the cells adjacent the distal end of the expandable structure may have an opening that is larger than the opening of one or more of the cells adjacent the proximal end of the expandable structure. Thus, when the expandable structure is retracted into the tip of the catheter, the proximal region of the expandable structure will compress first and any clot trapped inside the structure will be pushed toward the distal region of the structure and then pushed out through the larger distal unit. This has the effect of wringing out/squeezing out the clot from the interior of the expandable structure, thereby further macerating and reducing the clot as the structure is collapsed into the catheter. In addition, by pushing the small pieces of clot distally through the larger unit out of the structure, it ensures that the expandable structure can collapse and retract into the catheter tip without interference from the trapped clot.

Upon maceration/maceration of the thrombus by the coring device, a negative pressure may be applied to the lumen of the catheter to aspirate the fragments. The negative pressure may be applied simultaneously as the coring device disintegrates and macerates the thrombus. Alternatively, negative pressure may be applied after the coring member is retracted and removed from the catheter to allow for a larger aspiration path. If desired, the breakdown of the thrombus (step 1910) and aspiration of clot fragments (step 1912) may be repeated until the vessel lumen is cleared. Once the thrombus is removed, the coring device may be withdrawn from the vessel through the catheter.

Various embodiments of thrombectomy systems, devices, and methods are described with reference to the accompanying drawings. It should be noted that aspects described in connection with a particular embodiment are not necessarily limited to that embodiment, but may be practiced in any other embodiment. The drawings are intended to be illustrative of embodiments and are not intended to be exhaustive of the description or limitation of the scope of the disclosure. Alternative structures, components, and materials will be readily recognized as viable without departing from the principles of the present disclosure as claimed.

Unless otherwise defined explicitly, all technical and scientific terms used herein have the meanings commonly understood by one of ordinary skill in the art. As used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The term "or" refers to a non-exclusive "or" unless the context clearly indicates otherwise. The term "proximal" and grammatical equivalents thereof refers to a position, direction, or orientation toward the user or physician's side. The term "distal" and grammatical equivalents thereof refers to a location, direction, or orientation away from the user or physician's side. The terms "first" or "second" and the like may be used to distinguish one element from another element when describing various similar elements. It should be noted that the terms "first" and "second" as used herein include references to two or more. Moreover, the use of the terms first or second should not be interpreted as having any particular order unless the context clearly indicates otherwise. In alternative embodiments, the order in which the method steps are performed may be changed. One or more method steps may be skipped altogether and one or more optional steps may be included. All numerical values, whether explicitly indicated or not, are provided for purposes of illustration and are assumed to be modified by the term "about". The term "about" generally refers to a range of values that one of ordinary skill in the art would consider equivalent to the recited value, e.g., having the same function or result. The term "about" may include numerical values rounded to the nearest significant figure. The recitation of numerical ranges by endpoints includes all numbers subsumed within that range.

Those skilled in the art will appreciate that various other modifications may be made. The inventors contemplate all these and other variations and modifications, and these and other variations and modifications are within the scope of the present disclosure.

Claims

1. A thrombectomy device, comprising:

a coring member configured to break up thrombus in a blood vessel into fragments; and

A capture member configured to be anchored to a distal side of the thrombus to provide embolic protection,

Wherein the coring member and the capture member are operable independently of each other.

2. A thrombectomy device according to claim 1, wherein the coring member is coupled to a shaft, the capturing member is coupled to a shaft, and the shaft of the coring member and the shaft of the capturing member are movable independently of one another.

3. A thrombectomy device according to claim 2, wherein the shaft of the coring member comprises a tubular shaft slidably movable on the shaft of the capturing member to permit longitudinal movement of the shaft of the coring member and the shaft of the capturing component, respectively, in a generally coaxial path.

4. A thrombectomy device according to claim 2, wherein the shaft of the coring member and the shaft of the capture member are configured to move longitudinally in non-coaxial paths, respectively.

5. A thrombectomy device according to claim 2, wherein the shaft of the coring member comprises one or more removable or replaceable portions.

6. A thrombectomy device according to claim 2, wherein the shaft of the coring member is rotatable independently of the shaft of the capture member, thereby allowing the coring member to rotate to promote thrombolysis and allowing the capture component to remain stationary to provide embolic protection.

7. The thrombectomy device of claim 2, wherein the capture member comprises a deployable basket having a pore size in a deployed state that prevents thrombus debris from escaping to provide embolic protection.

8. The thrombectomy device of claim 7, wherein the capture member further comprises a reinforcing structure configured to provide radial support to the basket, wherein the reinforcing structure has an expanded state providing a maximum diameter substantially equal to or greater than a vessel diameter, and a proximal end of the reinforcing structure remains substantially open in the expanded state to allow entry of thrombus fragments, and wherein the basket is coupled at the maximum diameter of the reinforcing structure.

9. The thrombectomy device of claim 8, wherein,

The shaft of the capture member includes an inner shaft and an outer shaft slidably movable over the inner shaft;

the basket of the capture member is coupled to the distal end of the inner shaft, and the reinforcing structure of the capture component is coupled to the distal end of the outer shaft; and

Relative movement of the inner shaft and the outer shaft causes the basket and/or the reinforcing structure to expand or contract.

10. The thrombectomy device of claim 9, wherein the reinforcing structure of the capture member comprises a self-expanding structure.

11. The thrombectomy device of claim 10, wherein the reinforcing structure of the capture member comprises an open-celled tube cutting structure and the basket is comprised of a plurality of wires, wherein the plurality of wires of the basket are woven into the open-celled tube cutting structure.

12. The thrombectomy device of claim 10, wherein the reinforcing structure of the capturing member comprises a braided structure, the basket of the capturing member is comprised of a plurality of wires, and wherein the plurality of wires of the basket are braided into the braided structure.

13. The thrombectomy device of claim 9, further comprising a handle coupled to the proximal end of the inner shaft and the proximal end of the outer shaft, wherein the handle is operable to extend and/or retract the inner shaft and the outer shaft to cause relative movement of the inner shaft and the outer shaft, respectively, to allow the basket and the reinforcing structure to collapse or expand.

14. The thrombectomy device of claim 13, wherein the handle is removable from the proximal end of the inner shaft and the proximal end of the outer shaft.

15. The thrombectomy device of claim 9, wherein the proximal end of the inner shaft and the proximal end of the outer shaft include locking features for preventing relative movement of the inner shaft and the outer shaft.

16. The thrombectomy device of claim 15, wherein the locking feature comprises one or more notches at the proximal end of the outer shaft and a plurality of pins at the proximal end of the inner shaft.

17. A thrombectomy device according to claim 6, wherein the coring member comprises a self-expanding structure.

18. A thrombectomy device according to claim 17, wherein the self-expanding structure of the coring member comprises a tapered first end fixedly coupled to the shaft of the coring member and a tapered second end freely slidable on the shaft of the coring member.

19. A thrombectomy device according to claim 17, wherein the coring member comprises a braided structure or an open-celled tube cutting structure.

20. A thrombectomy device according to claim 2, further comprising a handle coupled to a proximal end of the shaft of the coring member to facilitate manipulation of the coring member.

21. A thrombectomy device according to claim 2, further comprising a catheter configured to receive and/or deliver the coring member and the capture member.

22. The thrombectomy device of claim 21, further comprising a hub member coupled to a proximal end of the catheter, wherein the hub member comprises a first port connecting a lumen of the catheter to a vacuum source and a second port receiving the coring member and/or the capture member.

23. The thrombectomy device of claim 22, wherein the hub member comprises a hemostatic valve.

24. A thrombectomy device, comprising:

an elongate shaft having a proximal end and a distal end;

a deployable structure coupled to the distal end of the elongate shaft; and

A catheter configured to deliver the expandable structure in a collapsed state to a location in a vessel containing a thrombus, wherein,

The expandable structure in the expanded state is rotatable with the elongate shaft to break up thrombus into fragments.

25. The thrombectomy device of claim 24, wherein the expandable structure includes a first end fixedly coupled to the elongate shaft and a second end freely slidable along the elongate shaft.

26. The thrombectomy device of claim 25, wherein the expandable structure is self-expanding.

27. The thrombectomy device of claim 26, wherein the catheter has an inner diameter and the expandable structure has a diameter in the expanded state that is greater than the inner diameter of the catheter.

28. The thrombectomy device of claim 27, wherein the expandable structure comprises a plurality of cells, and in the expanded state, cells adjacent the second end of the expandable structure have openings that are larger than openings of cells adjacent the first end of the expandable structure.

29. The thrombectomy device of claim 28, wherein in the deployed state, the opening of the cell adjacent the first end of the expandable structure has a maximum dimension equal to or less than 0.6 inches.

30. The thrombectomy device of claim 27, wherein the expandable structure comprises an open-celled tube cutting structure.

31. The thrombectomy device of claim 27, wherein the expandable structure comprises a braided structure.

32. The thrombectomy device of claim 24, wherein the catheter has an inner diameter and the expandable structure has a diameter in the expanded state that is greater than the inner diameter of the catheter.

33. The thrombectomy device of claim 32, wherein the expandable structure is self-expanding.

34. The thrombectomy device of claim 33, wherein the expandable structure comprises a tapered first portion and a tapered second portion in the expanded state.

35. The thrombectomy device of claim 34, wherein the taper angle of the tapered first portion and/or the tapered second portion of the expandable structure is in a range of about 5 degrees to about 25 degrees, respectively.

36. The thrombectomy device of claim 34, wherein the expandable structure comprises a length and a maximum diameter in the expanded state, and a ratio of the maximum diameter to the length is between about 0.2 and about 0.6.

37. The thrombectomy device of claim 34, wherein the expandable structure comprises a plurality of cells, and in the expanded state, cells adjacent the second end of the expandable structure have openings that are larger than openings of cells adjacent the first end of the expandable structure.

38. The thrombectomy device of claim 37, wherein the expandable structure comprises a plurality of cells, and in the expanded state one or more of the plurality of cells has a generally diamond-shaped opening.

39. The thrombectomy device of claim 38, wherein in the deployed state, the opening of the cell adjacent the first end of the expandable structure has a maximum dimension equal to or less than 0.6 inches.

40. The thrombectomy device of claim 34, wherein the expandable structure comprises a plurality of cells, and in the expanded state, the cells adjacent the second end of the expandable structure have smaller openings than the openings of the cells adjacent the first end of the expandable structure.

41. The thrombectomy device of claim 24, wherein the expandable structure is self-expanding.

42. The thrombectomy device of claim 24, further comprising a handle coupled to the proximal end of the elongate shaft to assist a user in rotating and/or linearly moving the elongate shaft and the expandable structure.

43. The thrombectomy device of claim 24, wherein the catheter comprises a proximal end configured to be connected to a vacuum source to allow removal of the debris by aspiration through the catheter.

44. The thrombectomy device of claim 24, wherein the elongate shaft comprises a tubular shaft.

45. The thrombectomy device of claim 44, wherein the elongate shaft comprises one or more removable or replaceable portions.

46. The thrombectomy device of claim 24, wherein at least a portion of the elongate shaft comprises a lubricious coating on an outer surface of the elongate shaft.

47. The thrombectomy device of claim 24, further comprising an atraumatic tip at the distal end of the elongate shaft.

48. A method for removing a thrombus from a blood vessel of a patient, comprising:

a) Introducing a catheter into a vessel containing a thrombus;

b) Advancing the catheter through a thrombus to position a distal end of the catheter on a distal side of the thrombus;

c) Delivering the capture member in a contracted state to a distal side of the thrombus through the catheter;

d) Expanding the capture member to an expanded state;

e) Retracting the catheter to position the distal end of the catheter on the proximal side of the thrombus;

f) Delivering the coring member in a contracted state through the catheter to a proximal side of the thrombus;

g) Advancing the coring member into the thrombus to break up the thrombus into fragments; and

H) Negative pressure is applied to the catheter to aspirate debris out of the vessel.

49. The method of claim 48, wherein after step d), the method further comprises locking the capture member in the deployed state.

50. The method of claim 48, wherein after step e) and before step f), the method further comprises applying negative pressure to the catheter to aspirate thrombus.

51. A method as set forth in claim 48 wherein in step g) the coring member is advanced into the thrombus while rotating to break the thrombus into fragments.

52. A method as set forth in claim 51 wherein after step g), the method further comprises retracting the coring member into the conduit and repeating steps g) and h).

53. A method as set forth in claim 52 wherein in step g) the advancing, rotating and/or retracting of the coring member occurs simultaneously with the applying of the negative pressure in step h).

54. A method for removing a thrombus from a blood vessel of a patient, comprising:

a) Introducing a catheter into a vessel containing a thrombus;

b) Advancing the catheter through the thrombus to position a distal end of the catheter on a distal side of the thrombus;

c) Delivering the coring device in a collapsed state through the catheter to a distal side of the thrombus;

d) Retracting the catheter to position the distal end of the catheter on the proximal side of the thrombus;

e) Applying negative pressure to the lumen of the catheter to aspirate thrombus; and

F) The coring device is retracted while rotating through the thrombus, thereby breaking the thrombus into fragments, and the fragments are aspirated out of the vessel by the catheter.

55. A method as set forth in claim 54 further comprising the step of retracting the coring device into the conduit to extrude fragments trapped within the coring device.

56. A method as set forth in claim 55 wherein, after the step of retracting the coring device into the catheter, the method further comprises advancing the coring device while rotating through the thrombus to further break up the thrombus.

57. The method of claim 54, wherein after step b) and before step c), the method further comprises delivering the capture member in a contracted state through the catheter to a distal side of a thrombus and deploying the capture member to a deployed state.

58. A method for removing a thrombus from a blood vessel of a patient, comprising:

a) Introducing a catheter into a vessel containing a thrombus;

b) Advancing the catheter to position a distal end of the catheter on a proximal side of the thrombus;

c) Delivering the coring device in a collapsed state through the catheter to a proximal side of the thrombus;

d) Applying negative pressure to the lumen of the catheter to aspirate thrombus; and

E) Advancing the coring device while rotating into the thrombus breaks the thrombus into fragments and aspirates the fragments out of the vessel through the catheter.

59. A method as set forth in claim 57 further comprising the step f) retracting the coring device into the conduit to extrude fragments trapped within the coring device.

60. The method of claim 58, further comprising repeating steps e) and f).