Intravascular treatment of vascular occlusion and related devices, systems and methods

Abstract

Disclosed herein are systems and methods for removing a thrombus from a blood vessel in a patient. The method may include: providing a thrombus extraction device, the thrombus extraction device including a proximal self-expanding member, a distal generally cylindrical portion, and an inner shaft member, the proximal self-expanding member being formed of an integral porous structure, the distal generally cylindrical portion being formed of a mesh-like wire mesh structure, and the inner shaft member being connected to the distal end of the mesh-like wire mesh structure; advancing a catheter constraining the thrombus extraction device through a vascular thrombus to deploy the thrombus extraction device; retracting the thrombus extraction device to separate a portion of the thrombus from the vessel wall and capture the portion of the thrombus in the mesh-like wire mesh structure; and withdrawing the thrombus extraction device from the body to remove the thrombus from the patient.

Description

[0001] This invention patent application is a divisional application of the invention patent application with international application number PCT / US2016 / 058536, international application date October 24, 2016, application number 201680076244.5 entering the Chinese national phase, and name “Intravascular treatment of vascular occlusion and related devices, systems and methods”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 245,935, filed on October 23, 2015, entitled “INTRAVASCULAR TREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS AND METHODS”; this application claims the benefit of U.S. Application No. 15 / 268,296, filed on September 16, 2016, entitled “INTRAVASCULAR TREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS AND METHODS”, which claims the benefit of U.S. Provisional Application No. 62 / 245,935, filed on October 23, 2015, entitled “INTRAVASCULAR TREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS AND METHODS” METHODS (INTRAVASCULAR TREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS AND METHODS)”; and this application claims the benefit of U.S. Application No. 15 / 268,406, filed on September 16, 2016, entitled “INTRAVASCULAR TREATMENT OF VASCULAROCCLUSION AND ASSOCIATED DEVICES, SYSTEMS AND METHODS”, which is a patent application entitled “INTRAVASCULAR TREATMENT OF VASCULAROCCLUSION AND ASSOCIATED DEVICES, SYSTEMS AND METHODS” filed on September 16, 2016. METHODS” filed on October 23, 2015, which claims the benefit of U.S. Provisional Application No. 62 / 245,935, filed on October 23, 2015, entitled “INTRAVASCULAR TREATMENT OF VASCULAR OCCLUSION ANDASSOCIATED DEVICES, SYSTEMS AND METHODS”; each of which is incorporated herein by reference in its entirety. Background Art

[0004] Thrombosis is the term used for blood clots that occur inside blood vessels, and venous thrombosis is a blood clot (thrombus) that forms inside a vein. A common type of venous thrombosis is deep vein thrombosis (DVT). DVT is the formation of a blood clot (thrombus) inside a deep vein, primarily in the leg. Nonspecific signs can include pain, swelling, redness, warmth, and engorgement in superficial veins.

[0005] If a blood clot breaks off (becoming an embolism) and travels to the lungs, it can become a life-threatening pulmonary embolism (PE), a blood clot in the lungs. In addition to the possible loss of life caused by PE, DVT can lead to significant health problems, such as post-thrombotic syndrome, which can cause chronic swelling, pressure, pain, and ulcers due to valve and blood vessel damage. In addition, DVT can lead to significant health care costs, directly or indirectly, through related complications to treat and the patient's inability to work.

[0006] Three processes are thought to lead to venous thrombosis. These processes are reduced blood flow rate (venous stasis), increased clotting tendency (hypercoagulable state) and changes to the blood vessel wall. The formation of DVT usually begins inside the valves of the calf veins, where the blood is relatively hypoxic, thereby activating specific biochemical pathways. Several medical conditions increase the risk of DVT, including diabetes, cancer, trauma and antiphospholipid syndrome. Other risk factors include older age, surgery, immobility (such as bed rest, orthopedic casting, sitting on long-distance flights), combined oral contraceptives, pregnancy, the postpartum period and genetic factors. From childhood to old age, the incidence of DVT increases dramatically, and among adults, about 1 in 1000 people develop DVT each year.

[0007] Although there are existing devices and methods for preventing and / or treating DVT, there are many unresolved deficiencies, such as the high incidence of recurrent DVT, the use of devices not designed to remove large clot volumes, and / or complex treatments involving multiple treatment devices and / or drugs. Thus, new devices, systems, and methods for treating thrombosis, particularly DVT, are desired. Summary of the invention

[0008] Various aspects of the present application relate to systems and methods for thrombus extraction, particularly for extracting thrombi from peripheral vasculature. The thrombus extraction device of the present invention is designed to remove large clot volumes, including mature and organized clots, wherein the need for drugs such as thrombolytic agents is reduced. This reduces the risk of bleeding, recovery time after treatment, and reduces health care program costs. The thrombus extraction device may include a self-expanding coring portion connected to a braided mesh, thereby effectively coring and separating large volume thrombi from large vessels, such as in the venous system or arterial system, while capturing the separated thrombi in the braided mesh.

[0009] In some embodiments, a thrombus may be extracted by using a thrombectomy system, the thrombectomy system comprising an introduction sheath having a self-expanding funnel and a thrombus extraction catheter comprising a thrombus extraction device. The thrombus extraction device may include a self-expanding coring portion and a self-expanding cylindrical portion, the self-expanding coring portion may be a stent portion, and the self-expanding cylindrical portion may be a woven wire mesh. The self-expanding cylindrical portion may be formed on the distal end of the self-expanding coring portion to form an integral thrombus extraction device. In some embodiments, the coring element may have a sharp cutting edge to further enhance its ability to detach the thrombus from the vessel wall.

[0010] One aspect of the present application relates to a method for treating deep vein thrombosis in a patient's peripheral vasculature. The method includes providing a thrombus extraction device, the thrombus extraction device including a proximal self-expanding coring portion and a distal expandable cylindrical portion, the proximal self-expanding coring portion may be a stent and formed by an integral porous structure, and the distal expandable cylindrical portion may be tubular and formed by a woven wire mesh structure. In some embodiments, the mesh structure is integrally formed with the porous structure so that the proximal end of the mesh structure is attached to the distal end of the porous structure. The method includes advancing a catheter constraining the thrombus extraction device through a vascular thrombus in a venous vessel. In some embodiments, an intermediate shaft slidably extends through the catheter, and its distal end is connected to the proximal end of the porous structure. In some embodiments, an inner shaft slidably extends through the intermediate shaft, and its distal end is connected to the distal end of the mesh structure. The method includes deploying the thrombus extraction device from the catheter from a constrained structure to an expanded structure. In some embodiments, when fully expanded, the thrombus extraction device engages at least the venous vessel wall distally through a portion of the vascular thrombus. The method includes retracting the thrombus extraction device proximally so that the coring portion cores and separates a portion of the vascular thrombus from the venous vessel wall, while the mesh structure captures the vascular thrombus portion. The method includes withdrawing the thrombus extraction device from the patient's body to remove the vascular thrombus portion from the venous vessel.

[0011] In some embodiments, advancing the catheter comprises inserting the catheter into the venous vessel until the radiopaque distal tip of the catheter distally passes the thrombus portion of the vessel. In some embodiments, deploying the thrombus retrieval device from the catheter from the constrained configuration to the expanded configuration comprises distally advancing the intermediate shaft until the coring portion of the thrombus retrieval device exceeds the distal end of the catheter.

[0012] In some embodiments, deploying the thrombus retrieval device further comprises: locking the intermediate shaft relative to the catheter; retracting the inner shaft relative to the catheter and the intermediate shaft until a stop feature fixed to the inner shaft engages a corresponding feature for full expansion of the thrombus retrieval device on a stent portion slidably connected to the inner shaft, the stent portion maintaining sufficient radial force on the venous vessel wall to coring and separating the vascular thrombus portion when fully expanded; and dynamically coupling the inner shaft relative to the intermediate shaft. In some embodiments, when the thrombus retrieval device is in full expansion, the coring angle of the coring portion is between 30 degrees and 45 degrees. In some embodiments, deploying the thrombus retrieval device further comprises determining the position of the thrombus retrieval device relative to the catheter by imaging a first radiopaque marker located on the catheter and a second radiopaque marker located on at least one of the intermediate shaft, the inner shaft, the stent portion, or the mesh structure.

[0013] In some embodiments, a vascular thrombus is partially captured in the mesh structure by entering the expandable tubular portion and / or the cylindrical portion at least through an opening or hole located at the proximal end of the self-expanding stent portion. In some embodiments, the method includes inserting a catheter into a venous blood vessel through an entry site, which is a popliteal entry site, a femoral entry site, or an internal jugular entry site. In some embodiments, the diameter of the blood vessel is at least 5 mm and is at least one of a femoral vein, an iliac vein, a popliteal vein, a posterior tibial vein, anterior tibial vein, or a peroneal vein.

[0014] In some embodiments, the method further comprises: percutaneously accessing the patient's venous vessel by entering the patient's venous vessel through the access site with the aid of an introducer sheath; advancing the distal end of the introducer sheath to a position proximal to the vascular thrombus; deploying the self-expanding funnel on the distal end of the introducer sheath; and inserting a catheter through the lumen of the introducer sheath so that the distal tip of the catheter passes distally through the vascular thrombus portion. In some embodiments, deploying the self-expanding funnel comprises: advancing an obturator having a capture sheath feature on its distal end so that the self-expanding funnel is exposed from a constrained configuration within the capture sheath feature to an expanded configuration without the capture sheath feature; and removing the obturator from the introducer sheath by retracting the obturator through or outside the deployed self-expanding funnel and through or outside the lumen of the introducer sheath. In some embodiments, withdrawing the thrombus retrieval device from the patient's body includes: retracting the thrombus retrieval device relative to the introduction sheath until the opening of the self-expanding stent portion is within the self-expanding funnel; collapsing the stent portion and the mesh structure to compress the vascular thrombus portion therein; retracting the stent portion and the mesh structure into the introduction sheath; and removing the thrombus retrieval device from the introduction sheath.

[0015] In some embodiments, the method further comprises extruding at least some of the vascular thrombus portions through holes at the distal portion of the expandable tubular portion and / or the cylindrical portion and capturing a portion of at least some of the vascular thrombus portions in the self-expanding funnel or further compressing at least one of the vascular thrombus portions through a mesh piece of the self-expanding funnel. In some embodiments, the method further comprises withdrawing at least one of the vascular thrombus portions remaining within the self-expanding funnel from the venous vessel through an withdrawal port connected to the proximal end of the introduction sheath.

[0016] In some embodiments, the method further comprises verifying by fluoroscopy that the opening of the self-expanding stent portion is within the self-expanding funnel prior to collapsing the stent portion and the mesh structure. In some embodiments, collapsing the stent portion and the mesh structure comprises: disconnecting the inner shaft from the intermediate shaft; and advancing the inner shaft distally relative to the intermediate shaft. In some embodiments, the method comprises withdrawing a thrombolytic agent from the venous vessel or injecting a thrombolytic agent into the venous vessel before, during, or after thrombus extraction.

[0017] One aspect of the present application relates to a method for treating deep vein thrombosis in a patient's peripheral vascular system. The method includes: percutaneously entering a patient's venous vessel by entering the patient's venous vessel through a popliteal access site with the aid of an introduction sheath; and inserting a catheter of a constrained thrombus extraction device through the lumen of the introduction sheath so that the distal end of the catheter passes distally through a portion of the vascular thrombus in the venous vessel, the thrombus extraction device including a proximal self-expanding stent portion and a distal expandable tubular portion and / or cylindrical portion, the proximal self-expanding stent portion is formed by an integral porous structure, and the distal expandable tubular portion and / or cylindrical portion is formed by a woven wire mesh structure. In some embodiments, the proximal end of the mesh structure is attached to the distal end of the porous structure. The method includes deploying the thrombus extraction device from a constrained structure to an expanded structure from a catheter by advancing an intermediate shaft distally until the stent portion of the thrombus extraction device exceeds the distal end of the catheter, the intermediate shaft slidably extending through the catheter, and its distal end is connected to the proximal end of the porous structure. The method includes proximally retracting the thrombus extraction device so that the stent portion cores from the vein vessel wall and separates a portion of the vascular thrombus while the mesh structure captures the vascular thrombus portion. The method includes withdrawing the thrombus extraction device from the patient.

[0018] In some embodiments, deploying the thrombus retrieval device further comprises retracting the inner shaft relative to the catheter and the intermediate shaft until a stop feature on the inner shaft engages a corresponding feature on the stent portion for full expansion of the thrombus retrieval device. In some embodiments, the stent portion maintains sufficient radial force on the vein wall to coring and separate the vascular thrombus portion when fully expanded, and in some embodiments, the inner shaft slidably extends through the intermediate shaft and its distal end is connected to the distal end of the mesh structure. In some embodiments, the method comprises deploying a self-expanding funnel on the distal end of the introduction sheath proximal to the vascular thrombus. In some embodiments, deploying the self-expanding funnel comprises: advancing a plug having a capture sheath feature on its distal end to expose the self-expanding funnel from a constrained structure within the capture sheath feature to an expanded structure without the capture sheath feature; and removing the plug from the introduction sheath by retracting the plug through or outside the deployed self-expanding funnel and through or outside the lumen of the introduction sheath.

[0019] One aspect of the present application relates to a method for removing a thrombus from a blood vessel in a patient's body, which blood vessel may be an artery or a vein. The method includes: providing a thrombus extraction device, the thrombus extraction device including a proximal self-expanding member, a distal generally cylindrical portion, and an inner shaft member, the proximal self-expanding member is formed by an integral porous structure, the distal generally cylindrical portion is formed by a network-like wire mesh structure and attached to the integral porous structure, and the inner shaft member is connected to the distal end of the network-like wire mesh structure; advancing a catheter constraining the thrombus extraction device through a vascular thrombus, and deploying the thrombus extraction device by advancing the thrombus extraction device beyond the distal end of the catheter or retracting the catheter relative to the thrombus extraction device, thereby exposing a portion of the thrombus extraction device distally past the thrombus, and allowing the thrombus extraction device to expand to engage the vessel wall. The method includes: retracting the thrombus extraction device to separate a portion of the thrombus from the vessel wall and capturing the portion of the thrombus in the network-like wire mesh structure; and withdrawing the thrombus extraction device from the body to remove the thrombus from the patient's body.

[0020] In some embodiments, advancing the catheter comprises inserting the catheter into the blood vessel until the radiopaque distal end of the catheter passes distally past the thrombus portion. In some embodiments, the network-like wire mesh structure is integrally formed with the porous structure so that the proximal end of the network-like wire mesh structure is attached to the distal end of the porous structure. In some embodiments, the self-expanding member of the thrombus extraction device includes a stent portion, and retracting the thrombus extraction device also includes coring the thrombus portion from the blood vessel wall with the aid of the stent portion. In some embodiments, the thrombus portion is captured with the aid of the network-like wire mesh structure by entering the network-like wire mesh structure through at least one hole or opening located at the proximal end of the stent portion.

[0021] In some embodiments, the thrombus retrieval device is advanced beyond the distal end of the catheter by advancing an intermediate shaft distally through the catheter, the intermediate shaft slidably extending through the catheter, and the distal end of the intermediate shaft coupled to the proximal end of the apertured structure. In some embodiments, the method includes retracting the inner shaft member relative to the catheter and the intermediate shaft until a stop feature fixed to the inner shaft member engages a corresponding feature on the apertured structure, and locking the inner shaft member relative to the intermediate shaft for full extension of the thrombus retrieval device. In some embodiments, the inner shaft member can be dynamically locked relative to the intermediate shaft.

[0022] In some embodiments, the method includes: before withdrawing the thrombus extraction device from the body, collapsing the thrombus extraction device to compress the thrombus portion therein. In some embodiments, collapsing includes unlocking the inner shaft member and the intermediate shaft, and advancing the inner shaft member distally relative to the intermediate shaft.

[0023] In some embodiments, the method includes: monitoring deployment of the thrombus retrieval device by fluoroscopy, and stopping advancing the thrombus retrieval device beyond the distal end of the catheter or retracting the catheter relative to the thrombus retrieval device based on the position of a first radiopaque marker located on the catheter relative to a second radiopaque marker located on the thrombus retrieval device. In some embodiments, the thrombus is located in the patient's peripheral vasculature, and the vessel has a diameter of at least 5 mm and includes at least one of the femoral vein, iliac vein, popliteal vein, posterior tibial vein, anterior tibial vein, or peroneal vein.

[0024] In some embodiments, the method includes: percutaneously accessing a blood vessel through a popliteal access site with the aid of an introduction sheath, the blood vessel may be a venous blood vessel of a patient, and inserting a catheter through the lumen of the introduction sheath and into the venous blood vessel of the patient. In some embodiments, the method includes: percutaneously accessing a venous blood vessel of a patient through a femoral access site with the aid of an introduction sheath, and inserting a catheter through the lumen of the introduction sheath and into the venous blood vessel of the patient, the thrombus extraction device extending within the popliteal sheath, and the thrombus extraction device retracting in the direction of blood flow. In some embodiments, the method includes: percutaneously accessing a venous blood vessel of a patient through a popliteal access site with the aid of an introduction sheath, and inserting a catheter through the lumen of the introduction sheath and into the venous blood vessel of the patient, the thrombus extraction device extending within a popliteal sheath extending from the patient's body, and the thrombus extraction device retracting in the direction of blood flow. In some embodiments, the method includes: withdrawing a thrombolytic agent from a blood vessel or injecting a thrombolytic agent into a blood vessel before, during, or after thrombus extraction.

[0025] One aspect of the present application relates to a thrombus extraction device for removing vascular thrombus from a patient's blood vessel. The thrombus extraction device includes: a catheter, an outer shaft, an intermediate shaft and an inner shaft, the catheter having a proximal end and a distal end, the outer shaft defining a first lumen, the intermediate shaft defining a second lumen, the intermediate shaft being coaxial with the first lumen, and the inner shaft being coaxial with the second lumen; a proximal self-expanding coring element, the proximal self-expanding coring element being formed by an integral porous structure, the integral porous structure having a proximal end and a distal end, and being configured to coring and separating a portion of the vascular thrombus from the blood vessel, the proximal end of the porous structure being connected to the distal end of the intermediate shaft; and a distal expandable cylindrical portion, the distal expandable cylindrical portion being formed by a woven wire mesh structure, the woven wire mesh structure having a proximal end and a distal end, and being configured to capture a portion of the vascular thrombus, the proximal end of the mesh structure being attached to the distal end of the porous structure, and the distal end of the mesh structure being connected to the distal end of the inner shaft. In some embodiments, the full expansion of the mesh structure and the porous structure changes based on the position of the intermediate shaft of the catheter relative to the inner shaft.

[0026] In some embodiments, the coring element comprises a stent. In some embodiments, the stent comprises a ring feature slidably coupled to the inner shaft and / or one or more struts of the stent, and the inner shaft comprises a stop feature secured to the inner shaft, the stop feature being configured to engage the ring feature when the mesh structure and the stent are fully expanded.

[0027] In some embodiments, the device includes a locking mechanism that can secure the inner shaft relative to the intermediate shaft when the mesh structure and the stent are fully expanded. In some embodiments, the locking mechanism can maintain a desired radial force on the vessel wall when the stent is compressed. In some embodiments, the locking mechanism movably secures the inner shaft relative to the intermediate shaft via a spring.

[0028] In some embodiments, the proximal end of the mesh structure is integrally formed with the distal end of the porous structure to produce a unitary structure. In some embodiments, the coring element and the mesh structure can be received within the outer shaft. In some embodiments, the coring element and the mesh structure are in a constrained configuration when received within the outer shaft, and in an expanded configuration when the outer shaft is not constrained.

[0029] In some embodiments, the mesh structure includes a plurality of radial ribs or grooves spaced longitudinally between a proximal end and a distal end of the mesh structure. In some embodiments, the mesh structure has a first pore size at the proximal portion and a second pore size at the distal portion, the first pore size being different from the second pore size. In some embodiments, the second pore size is larger than the first pore size.

[0030] In some embodiments, the proximal end of the porous structure is connected to the distal end of the intermediate shaft via a plurality of struts extending at a coring angle relative to the longitudinal axis of the thrombus extraction device. In some embodiments, the coring angle ranges from 30 degrees to 45 degrees. In some embodiments, for example, in a collapsed state, the length of the coring element ranges from 25 mm to 100 mm and the length of the mesh structure ranges from 100 mm to 500 mm. In some embodiments, when fully expanded, the diameter of the coring element ranges from 8 mm to 25 mm and the diameter of the mesh structure ranges from 8 mm to 25 mm when fully expanded.

[0031] In some embodiments, the porous structure comprises a plurality of interconnected struts. In some embodiments, the proximal end of the porous structure has fewer struts than the distal end of the porous structure, thereby facilitating the maintenance of coring orientation and facilitating the collapse of the coring element when the vessel is tortuous. In some embodiments, the porous structure comprises a plurality of interconnected struts, the plurality of interconnected struts defining an opening at the proximal end of the porous structure. In some embodiments, at least some of the plurality of interconnected struts defining the opening comprise sharp proximal edges.

[0032] In some embodiments, the device comprises: a first radiopaque marker on the outer shaft and a second radiopaque marker on the distal end of the inner shaft. In some embodiments, the device comprises: a locking mechanism that can fix the relative position of the outer shaft relative to the intermediate shaft. In some embodiments, the device comprises: a handle that includes a plunger that can control the relative position of the inner shaft relative to the intermediate shaft and selectively fix the relative position of the inner shaft relative to the intermediate shaft.

[0033] One aspect of the present application relates to an introduction sheath for accessing a patient's blood vessel and removing a thrombus in the patient's blood vessel. The introduction sheath includes: an elongated sheath including a proximal end, a distal end, and an inner cavity extending therebetween; a self-expanding funnel affixed to the distal end of the elongated sheath; and an obturator including an elongated shaft having a capture sheath positioned proximal to the distal end of the obturator, the capture sheath can retain the self-expanding funnel in a constrained configuration, and the obturator is configured to be received within the inner cavity of the elongated sheath.

[0034] In some embodiments, the introduction sheath includes a sealing hub located at the proximal end of the elongated sheath. In some embodiments, the sealing hub includes an extract port. In some embodiments, when the self-expanding funnel is in a constrained configuration, the diameter of the self-expanding funnel is less than or equal to the diameter of the elongated sheath. In some embodiments, the obturator includes an anti-traumatic end positioned at the distal end of the obturator, the anti-traumatic end being radiopaque. In some embodiments, the obturator includes a connection fitting configured to be sealingly connected to the distal end of the elongated sheath. In some embodiments, the self-expanding funnel is permeable to blood. In some embodiments, the self-expanding funnel includes a cone consisting of at least one of a battlemented nitinol braid, a nitinol braided stent, a laser cut nitinol, a laser cut polymer tube, an injection molded polymer structure, or an inflatable sac.

[0035] One aspect of the present application relates to a method for accessing and removing a thrombus from a patient's venous vessel. The method includes: providing an introduction sheath, the introduction sheath including an elongated sheath defining an inner cavity, a self-expanding funnel attached to the distal end of the elongated sheath, and an elongated obturator extending through the inner cavity and retaining the self-expanding funnel in a constrained configuration within a capture sheath of the obturator; percutaneously accessing the patient's venous vessel through an access site with the introduction sheath, the access site including a popliteal access site, a femoral access site, or an internal jugular access site; advancing the distal end of the introduction sheath to a position proximal to the thrombus; expanding the self-expanding funnel from a constrained configuration within the capture sheath to an expanded configuration without the capture sheath; capturing the thrombus in the self-expanding funnel; and withdrawing the captured material through the inner cavity of the elongated sheath.

[0036] In some embodiments, deploying the self-expanding funnel comprises advancing an obturator distally relative to the elongated sheath to expose the self-expanding funnel from a constrained configuration to an expanded configuration, and removing the obturator from the introduction sheath by proximally retracting the obturator through the deployed self-expanding funnel and through the lumen of the elongated sheath. In some embodiments, deploying the self-expanding funnel comprises proximally retracting the sheath over the obturator to expose the self-expanding funnel from a constrained configuration to an expanded configuration, and removing the obturator from the introduction sheath by proximally retracting the obturator through or external to the deployed self-expanding funnel and through or external to the lumen of the elongated sheath.

[0037] In some embodiments, the method includes: inserting a catheter constraining a thrombus extraction device through the lumen of the elongated sheath so that the distal end of the catheter passes distally through a vascular thrombus portion, deploying the thrombus extraction device from the catheter, and retracting the thrombus extraction device proximally relative to the introduction sheath until the opening of the thrombus extraction device is within the self-expanding funnel. In some embodiments, the method includes: extruding a portion of the thrombus captured by the thrombus extraction device through the thrombus extraction device. In some embodiments, the thrombus captured by the self-expanding funnel includes an extruded portion of the thrombus captured by the thrombus extraction device.

[0038] One aspect of the present application relates to a thrombectomy system for removing a vascular thrombus from a patient's blood vessel. The thrombectomy system includes a thrombus extraction catheter, which includes a thrombus extraction device. The thrombus extraction device includes: a proximal self-expanding coring element formed by an integral porous structure; and a distal expandable cylindrical portion formed by a woven wire mesh structure, having a proximal end, which is attached to the distal end of the porous structure. The thrombectomy system includes: a catheter, an intermediate shaft and an inner shaft, the catheter includes an inner cavity that constrains the thrombus extraction device, the intermediate shaft is connected to the proximal end of the self-expanding coring element, and the inner shaft is connected to the distal end of the expandable cylindrical portion and can be slidably displaced relative to the intermediate shaft to control the expansion of the expandable cylindrical portion. The thrombectomy system includes: an introduction sheath, the introduction sheath includes: an elongated sheath that defines an insertion lumen; a self-expanding funnel that is attached to the distal end of the elongated sheath; and an elongated obturator that includes a sheath capture feature configured to retain the self-expanding funnel in a constrained structure.

[0039] In some embodiments, the obturator is configured to be received within the lumen of the elongated sheath and includes a connection fitting configured to sealingly connect to the distal end of the elongated sheath. In some embodiments, the length of the self-expanding funnel is at least equal to the length of the self-expanding coring element. In some embodiments, the introduction sheath includes a self-sealing hole located at the proximal end of the introduction sheath.

[0040] In some embodiments, the thrombectomy system includes a bore dilator sized to be received within the self-sealing bore, and in a sealed configuration, the bore dilator has an inner diameter greater than a diameter of the self-sealing bore. In some embodiments, the introduction sheath includes an aspiration port at a proximal end of the insertion sheath, the aspiration port selectively fluidly connected to the insertion lumen via an aspiration valve.

[0041] In some embodiments, the insertion lumen is sized to slidably receive a thrombus retrieval catheter. In some embodiments, an expandable cylindrical portion can be formed on a self-expanding coring element to form an integral thrombus retrieval device.

[0042] One aspect of the present application relates to a method for manufacturing an integral thrombus extraction device, the integral thrombus extraction device comprising a proximal porous structure having a plurality of struts and a distal network-like wire mesh structure formed on the distal end of the porous structure. The method comprises: identifying a plurality of forming points formed by some of the plurality of struts in the integral porous structure; threading a unique pair of wires including a first wire and a second wire superimposed on the first wire through each forming point; and weaving the network-like wire mesh structure by the unique pair of wires, so that one of the first wire and the second wire does not form a loop around the forming point through which the first wire and the second wire are threaded, and so that the other of the first wire and the second wire forms a loop around the forming point through which the first wire and the second wire are threaded.

[0043] In some embodiments, the network-like wire mesh structure is woven by a unique pair of wires, so that the first wire does not form a loop around the forming point through which the first wire is passed, and the second wire forms a loop around the forming point through which the second wire is passed. In some embodiments, each forming point includes a vertex support. In some embodiments, the porous structure includes 12 vertex supports. In some embodiments, the network-like wire mesh-like piece includes 48 wires. In some embodiments, the network-like wire mesh-like structure is woven by hand. In some embodiments, the network-like wire mesh-like structure is woven automatically.

[0044] Other areas of applicability of the present invention will become apparent from the detailed description provided hereinafter.It should be understood that the detailed description and specific examples are intended for illustration purposes only while indicating various embodiments and are not intended to necessarily limit the scope of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 is a perspective view of one embodiment of a thrombectomy system for removing a thrombus from a patient's blood vessel.

[0046] Figure 2 is a side view of one embodiment of a thrombus retrieval catheter with the thrombus retrieval device in a deployed configuration.

[0047] Figure 3 is a side view of one embodiment of a thrombus retrieval catheter with the thrombus retrieval device fully expanded in a deployed configuration.

[0048] Figure 4 is a side view of one embodiment of a self-expanding coring element.

[0049] Figure 5 is a top view of one embodiment of a self-expanding coring element.

[0050] Figure 6 is an elevation view of one embodiment of a self-expanding coring element.

[0051] Figure 7 is a side view of one embodiment of a thrombus retrieval device in a fully expanded configuration.

[0052] Figure 8 is a diagram of one embodiment of a spherical thrombus captured in a thrombus retrieval device.

[0053] Fig. 9 is a side view of one embodiment of a woven wire mesh structure having various pore sizes.

[0054] Fig.10 is a side view of one embodiment of a thrombus retrieval device including a plurality of circumferential grooves.

[0055] Fig.11 is a schematic diagram of one embodiment of a braiding and / or weaving pattern for forming a cylindrical portion and / or a braided mesh-like structure on a self-expanding coring element.

[0056] Fig.12 is a cross-sectional view of an embodiment of a handle with the plunger in a first position.

[0057] Fig.13 is a cross-sectional view of an embodiment of a handle with the plunger in a second position.

[0058] Fig.14 is a close-up cross-sectional view of a portion of the handle with the plunger in the second position.

[0059] Fig.15 is a side view of one embodiment of an obturator having an elongated shaft of constant size.

[0060] Fig.16 is a side view of one embodiment of an obturator having a variable size elongated shaft.

[0061] Fig.17 is a detailed cross-sectional view of one embodiment of a capture sheath of an obturator.

[0062] Fig.18 is a side view of one embodiment of an introducer sheath in a non-deployed configuration.

[0063] Fig.19 is a side view of one embodiment of an introducer sheath in a partially deployed configuration.

[0064] Fig. 20 is a side view of one embodiment of an introducer sheath in an expanded configuration.

[0065] Fig.21 is a side view of one embodiment of an introducer sheath including an inflatable balloon.

[0066] Fig. 22is a schematic diagram of one embodiment of accessing a vessel via a popliteal access site.

[0067] 23-A to 23-H are views illustrating one embodiment of a process for fully expanding a thrombus retrieval device in a blood vessel.

[0068] 24-A and 24-B are views showing alternative steps in a process for fully expanding a thrombus retrieval device in a blood vessel.

[0069] 25-A to 25-H are views showing one embodiment of a process for removing a thrombus by an expanded thrombus retrieval device.

[0070] Fig.26 is a schematic diagram of one embodiment of accessing a blood vessel via an internal jugular access site.

[0071] Fig. 27 is a schematic diagram of one embodiment of accessing a blood vessel via a popliteal access site using an extension sheath 2300 .

[0072] Fig.28 is a schematic diagram of one embodiment of accessing a vessel via a popliteal entry site and a femoral entry site. DETAILED DESCRIPTION

[0073] The present application relates to a thrombectomy system for removing a vascular thrombus from a patient's blood vessel. The thrombectomy system can remove a thrombus from a blood vessel, particularly a venous blood vessel of a patient, by coring the thrombus and / or separating the thrombus from the blood vessel wall, which can occur when the thrombectomy system is retracted through the vascular thrombus. The thrombus that is cored and / or separated from the blood vessel wall can be captured within the thrombectomy system and removed from the patient's body.

[0074] A thrombectomy system may include a thrombus retrieval catheter including a thrombus retrieval device ("TED"). The TED may include a proximal self-expanding coring element, which may be a stent portion and / or may be formed of an integral porous structure. The TED may include a distal expandable cylindrical portion, which may be formed of a woven wire mesh structure. The woven wire mesh structure may be formed on the coring element to form an integral TED. Such formation of the woven wire mesh structure directly on the coring element may eliminate the following issues, such as: inconsistent material properties, reduced flexibility, reduced strength and / or quality control device issues caused by connecting the woven wire mesh structure to the coring element, for example, by welding and adhesives.

[0075] The expansion of TED can be controlled by the relative movement of the various parts of the thrombus extraction catheter. For example, the proximal end of the TED, specifically the proximal end of the self-expanding coring element, can be connected to the intermediate shaft, and the intermediate shaft can slide in the outer shaft of the thrombus extraction catheter. The distal end of the TED, specifically the distal end of the expandable cylindrical portion, can be connected to the inner shaft, and the inner shaft can slide in the intermediate shaft of the thrombus extraction catheter. Since the inner shaft and the intermediate shaft can slide relative to the outer shaft, the TED can be withdrawn into the outer shaft to constrain the TED to an unexpanded structure, also referred to as a constrained structure in this article. Similarly, the TED can be deployed from the outer shaft by the relative movement of the intermediate shaft relative to the outer shaft. After the TED has been deployed from the outer shaft, the inner shaft and the intermediate shaft can move relative to each other to expand or contract the expandable cylindrical portion of the TED and fully expand the self-expanding coring element.

[0076] The thrombectomy system may include an introduction sheath sized to slidably receive an outer sheath of a thrombus extraction catheter. The introduction sheath may include a sealing hole at the proximal end of the introduction sheath and a self-expanding funnel. The self-expanding funnel may be positioned at the distal end of the introduction sheath and may be selectively retained in a constrained position by a capture sheath. In some embodiments, the self-expanding funnel may be slidably contained within the introduction sheath and may be specifically slidable relative to the distal end of the introduction sheath. In some embodiments, the self-expanding funnel may slide distally from a constrained configuration within the introduction sheath to an expanded configuration in which the self-expanding funnel extends from the distal end of the capture sheath.

[0077] The self-expanding funnel can be sized to engage the self-expanding coring element when the TED is retracted toward the funnel. As the TED is retracted into the funnel, the funnel compresses the TED, specifically the coring element, and guides the TED, specifically the coring element, into the lumen defined by the introduction sheath. The TED can be retracted until it is completely contained within the introduction sheath, and then the TED and the thrombus captured in the TED can be removed from the patient's body via the sealing hole.

[0078] The thrombectomy system can access a vessel containing a thrombus via multiple access sites. These access sites can include, for example, an internal jugular (IJ) access site, a femoral access site, a popliteal access site, or other venous or arterial access sites. The thrombectomy system can be used to extract thrombi and / or emboli from various venous and / or arterial vessels, which can be peripheral vessels, including any vessel, a non-limiting example being a venous vessel having a diameter of at least 5 millimeters (mm). The thrombectomy system can be inserted into the patient's circulatory system through the access point and can be advanced to a position close to the thrombus. The TED can then be advanced through the thrombus, and after expanding distally of the thrombus, the TED can be retracted through the thrombus, thereby capturing all or part of the thrombus.

[0079] Reference Figure 1, shows one embodiment of a thrombectomy system 100, also referred to herein as a thrombus extraction system 100. The thrombectomy system 100 can be used to access a portion of a blood vessel, such as a venous vessel, that contains a thrombus, and the thrombectomy system 100 can be used to remove all or part of the thrombus from the blood vessel. The thrombectomy system 100 may include an introduction sheath 102 and a thrombus extraction catheter 104.

[0080] The introduction sheath 102 includes an elongated member 106, also referred to herein as an elongated sheath 106, having a proximal end 108 and a distal end 110. The elongated member 106 may be elastic and / or flexible. The elongated member 106 may include any desired length and any desired diameter. In some embodiments, the outer diameter of the elongated sheath 106 may be at least 10 French, at least 12 French, at least 14 French, at least 18 French, at least 20 French, at least 22 French, between 14 French and 24 French, between 15 French and 21 French, between 16 French and 22 French, and / or any other or intermediate size.

[0081] The elongated member 106 may include a radiopaque marker, which may be, for example, a portion of the distal end 110 of the elongated member 106. The elongated member 106 defines a lumen extending between the proximal end 108 and the distal end 110. The lumen 1701 ( Fig.17 ) may be sized to slidably receive the thrombus extraction catheter 104. In some embodiments, the inner diameter of the lumen 1701 of the elongated member 106 may be at least 2 French, at least 10 French, at least 14 French, at least 18 French, at least 20 French, at least 22 French, between 14 French and 12 French, between 10 French and 22 French, between 14 French and 21 French, between 16 French and 20 French, and / or any other or intermediate size. The lumen 1701 may terminate at a sealing hole 112, also referred to herein as a sealing hub 112, located at the proximal end 108 of the elongated member 106. In some embodiments, the sealing hole 112 may be self-sealing and / or may include a self-sealing seal.

[0082] The introduction sheath 102 may also include an evacuation port 114, which may be at the proximal end 108 of the elongated member 106 and / or connected to the proximal end 108 of the elongated member 106, for example, via a connecting tube 116. In some embodiments, the evacuation port 114 may be part of and / or connected to the sealing hub 112. In some embodiments, the evacuation port 114 may be selectively fluidly connected to the inner cavity 1701, for example, via a valve 118, also referred to herein as an evacuation valve 118, which may be a tube clamp that may be positioned along the connecting tube 116 at a location between the inner cavity 1701 and the evacuation port 114.

[0083] The introduction sheath 102 may also hold a plugger 120, also referred to herein as a dilator 120. The plugger 120 may be configured to hold a self-expanding funnel that may be attached to the distal end 110 of the elongated member 106 in a constrained configuration and release the self-expanding funnel from the constrained configuration. The plugger 120 may include a proximal end 122, a distal end 124, and an elongated shaft 126 extending therebetween. In some embodiments, the length of the elongated shaft 126 may be greater than the length of the elongated member 106 of the introduction sheath 102. The plugger 120 may also define an inner cavity extending through the plugger 120 that may receive a guide wire. In some embodiments, the guide wire may include any desired size, and in some embodiments, the diameter may be about 0.035 inches. The plugger 120 may be sized and shaped to be able to slidably move through the inner cavity of the elongated member 106.

[0084] The thrombectomy system 100 may include a thrombus extraction catheter 104. The thrombus extraction catheter 104 may have a proximal end 130 and a distal end 132. A handle 134, also referred to herein as a deployment handle 134, may be located at the proximal end 130 of the thrombus extraction catheter 104 and may be connected to a catheter portion 136, also referred to herein as a catheter 136.

[0085] The catheter 136 may include an outer shaft 138, an intermediate shaft 140, and an inner shaft. The outer shaft 138 may include various lengths and sizes. In some embodiments, the outer shaft 138 may be sized to fit slidably within the introduction sheath 102. In some embodiments, the outer shaft 138 may be sized to be at least 8 French, at least 10 French, at least 11 French, at least 12 French, at least 14 French, at least 16 French, between 8 French and 14 French, between 11 French and 12 French, and / or any other or intermediate size.

[0086] Each of the outer shaft 138, the intermediate shaft 140, and the inner shaft can define an inner cavity, which can be a central axial inner cavity. In some embodiments, the size and / or shape of the intermediate shaft 140 can be determined to be slidably mounted in the inner cavity 802 ( Figure 8 ) such that the intermediate shaft 140 and the outer shaft 138 are coaxial. Similarly, in some embodiments, the size and / or shape of the inner shaft can be determined to be slidably fitted within the inner cavity 804 ( Figure 8 ) so that the inner shaft and the intermediate shaft 140 are coaxial. In this configuration, each of the outer shaft 138, the intermediate shaft 140, and the inner shaft can be displaced relative to the other shafts of the outer shaft 138, the intermediate shaft 140, and the inner shaft.

[0087] In some embodiments, each of the outer shaft 138, the intermediate shaft 140, and the inner shaft may have the same length, and in some embodiments, some or all of the outer shaft 138, the intermediate shaft 140, and the inner shaft may have different lengths. In some embodiments, for example, the intermediate shaft 140 may be relatively longer than the outer shaft 138, and in some embodiments, the inner shaft may be relatively longer than the intermediate shaft 140.

[0088] The thrombus extraction catheter 104 may also include a thrombus extraction device (TED). The TED may be connected to the intermediate shaft 140 and the inner shaft and may be contained within the lumen 802 of the outer shaft 138 in an unexpanded configuration. In some embodiments, the relative positioning of the outer shaft 138, the intermediate shaft 140, and / or the inner shaft may result in the TED being in an unexpanded configuration, an expanded configuration, a partially expanded configuration, and / or a fully expanded configuration. In some embodiments, the TED in the expanded configuration may be in a fully expanded configuration or a partially expanded configuration.

[0089] The handle 134 may include a distal end 142, also referred to herein as a locking end 142, and a proximal end 144, also referred to herein as a plunger end 144. In some embodiments, the intermediate shaft 140 is connected to the distal end 132 of the thrombus extraction catheter 104 and extends distally from the distal end 142 of the handle 134 toward the distal end 132 of the thrombus extraction catheter 104.

[0090] like Figure 1 14, the distal end 142 of the handle 134 may include a locking feature 146, such as a spin lock. The locking feature 146 may selectively and / or lockingly engage with a mating feature 148 located on a proximal end 150 of the outer sheath 138. In some embodiments, for example, the outer sheath 138 may be slid proximally over the intermediate sheath 140 until the locking feature 146 engages with the mating feature 148, thereby fixing the position of the outer sheath 138 relative to the intermediate sheath 140. In embodiments where the intermediate shaft 146 is relatively longer than the outer shaft 138, a portion of the intermediate shaft 146 extends distally from the distal end 152 of the outer shaft 138 when the outer shaft 138 is lockingly engaged with the locking feature 146.

[0091] The handle 134 may include a plunger 154 that may be movable between a first, non-extended position and a second, extended position. In some embodiments, the plunger 154 may be movable from the first position to the second position by displacing the plunger 154 proximally relative to the handle 134. The plunger 154 may be lockable in one or both of the first position and / or the second position.

[0092] The plunger 154 can be connected to the inner shaft so that the inner shaft can be displaced relative to the handle 134, the outer shaft 138, and / or the intermediate shaft 140 by moving the plunger 154 from a first position to a second position. In some embodiments where the inner shaft is relatively longer than the intermediate shaft 140 and / or the outer shaft 138, the length of the inner shaft can be such that the inner shaft extends distally past the distal end of the intermediate shaft 140 regardless of whether the plunger 154 is in the first position or the second position.

[0093] The thrombus extraction catheter 104 may also include a first flush port 155 connected to the outer shaft 138 and a second flush port 156 connected to the handle 134. In some embodiments, the first flush port 155 may be fluidly connected to the lumen 802 of the outer shaft 138, thereby allowing the lumen 802 of the outer shaft 138 to be flushed through the first flush port 155. In some embodiments, the second flush port 156 may be fluidly connected to the inner portion of the handle 134, and thereby connected to the lumen of the intermediate shaft 140, thereby allowing the lumen of the intermediate shaft 140 to be flushed.

[0094] The thrombectomy system 100 may also include a loading funnel 158. The loading funnel 158 may include a funnel portion 160 and a shaft portion 162. The funnel portion 160 may define a funnel-shaped inner volume connected to a lumen of the shaft portion 162. The funnel-shaped inner volume may be sized and shaped to receive the self-expanding funnel and to move the self-expanding funnel to a restrained position as the self-expanding funnel is advanced through the funnel portion 160. The funnel-shaped inner volume and lumen may be sized to allow the distal end 124 of the obturator 120 to pass completely through the loading funnel 158.

[0095] In some embodiments, the loading funnel 158 can be configured to facilitate loading the self-expanding funnel into the obturator 102. In some embodiments, the self-expanding funnel can be loaded by inserting the obturator 120 through the elongated member 106 so that the obturator 120 extends from the distal end 110 of the elongated member 106 and exceeds the self-expanding funnel. Next, the loading funnel 158 can be slid proximally over the obturator 120 and the self-expanding funnel until the self-expanding funnel is completely enclosed by the loading funnel 158 and / or until the self-expanding funnel is in a constrained configuration. Next, the obturator 120 can be retracted, thereby loading and / or capturing the self-expanding funnel within a portion of the obturator 120, and then the loading funnel 158 can be removed from the obturator 120 and the elongated member 106.

[0096] The thrombectomy system 100 may also include a sealing hub expander 170, also referred to herein as a sealing expander 170 and / or a hole expander 170. Figure 11. A cross-sectional view of the sealing expander 170 is shown in FIG. The sealing expander 170 may be sized and shaped to be inserted into the sealing hole 112 prior to removing a thrombus through the sealing hole 112. By being so inserted into the sealing hole 112, the sealing expander 170 may expand the sealing hole 112. In some embodiments, this expansion of the sealing hole 112 may prevent the application of force from the sealing hole 112 to the thrombus during the removal of the thrombus through the sealing hole 112. In some embodiments, the sealing expander 170 may include an insertion portion 172 configured to facilitate the insertion of the sealing expander 170 into the sealing hole 112. The sealing expander 170 may also include a body portion 174, which may define an extraction lumen 176 alone or together with the insertion portion 172, through which a thrombus may be removed from the lumen 1701 of the elongated member 106 through the extraction lumen 176. In some embodiments, in the sealing configuration, the inner diameter of the extraction lumen 176 may be greater than the diameter of the sealing hole 112.

[0097] Reference Figure 2 , a side view of one embodiment of a thrombus extraction catheter 104 is shown. The thrombus extraction catheter 104 includes a handle 134, an outer shaft 138, an intermediate shaft 140, an inner shaft 200, and a thrombus extraction device 202, also referred to herein as a TED 202. Figure 2 , the outer shaft 138 is displaced proximally relative to the handle 134 so that the mating features 148 of the outer shaft 138 contact the locking features 146 of the handle 134. Due to this positioning of the outer shaft 138 relative to the handle 134, each of the intermediate shaft 140, the inner shaft 200, and the TED 202 extends distally beyond the distal end 204 of the outer shaft 138. Figure 2 The thrombus retrieval device 202 is shown in an unfolded and partially expanded configuration.

[0098] The thrombus extraction device 202 may include a self-expanding coring element 206 and an expandable cylindrical portion 208. The self-expanding coring element 206 may be positioned relatively more proximally on the thrombus extraction catheter 104 than the expandable cylindrical portion 208. The self-expanding coring element 206 may include a proximal end 210 and a distal end 214, the proximal end 210 being connected to the distal end 212 of the intermediate shaft 140, and the distal end 214 being connected to the proximal end 216 of the expandable cylindrical portion 208. The distal end 217 of the expandable cylindrical portion 208 may be connected to the distal end 218 of the inner shaft 200.

[0099] In some embodiments, the distal end 218 of the inner shaft 200 may further include a tip 220, such as an atraumatic tip and / or a radiopaque marker 222. In some embodiments, the tip 220 may include a radiopaque marker 222. In addition, the radiopaque marker may be positioned on the outer shaft 138, specifically the distal end 204 of the outer shaft 138 and / or the distal end 212 of the intermediate shaft 140, for example. In some embodiments, one or both of the distal end 204 of the outer shaft 138 and the distal end 212 of the intermediate shaft 140 may each include a radiopaque marker. In some embodiments, the atraumatic tip 220 may define a channel configured to allow a guide wire to pass through the atraumatic tip 220.

[0100] Reference Figure 3 , shows a side view of one embodiment of a thrombus extraction catheter 104, wherein the thrombus extraction device 202 is in an unfolded and fully expanded configuration. Figure 2 Compared to the embodiment in FIG. 1 , the plunger 154 is in a second position retracted proximally from the handle 134, and the inner shaft 200 is thereby retracted proximally relative to the intermediate shaft 140 to thereby fully expand the expandable cylindrical portion 208 and fix the expandable cylindrical portion 208 and the self-expanding coring element 206 in a fully expanded structure and / or to be fully expanded.

[0101] The thrombus extraction catheter 104 may include one or more features configured to secure the thrombus extraction device 202, specifically the self-expanding coring element 206 and / or the expandable cylindrical portion 208, in a fully expanded position and / or to be fully expanded. As used herein, full expansion occurs when the thrombus extraction device 202 is deployed and when the plunger 154 is in the second position. In some embodiments, when the thrombus extraction device 202 is in full expansion, one or more dimensions of the thrombus extraction device 202 may change. In some embodiments, this may facilitate the thrombus extraction device 202 to abut against the vessel wall and / or the desired force or force level applied by the thrombus extraction device 202 to the vessel wall.

[0102] In some embodiments, the plunger 154 can be locked in the second position by, for example, rotating the plunger 154 relative to the handle 134 to thereby engage one or more locking features on the plunger 154 and in the handle 134. In some embodiments, by locking the plunger 154 in the second position, the thrombus extraction device 202, in particular the self-expanding coring element 206 and / or the expandable cylindrical portion 208, can be fixed in full expansion by fixing the position of the inner shaft 200 relative to the intermediate shaft 140. In some embodiments, fixing the position of the inner shaft 200 relative to the intermediate shaft 140 can include locking the inner shaft 200 relative to the intermediate shaft 140 and / or coupling the position of the inner shaft 200 relative to the position of the intermediate shaft 140. In some embodiments, such locking and / or coupling can be static, referred to herein as statically locking and / or statically coupling, because the position of the inner shaft 200 is fixed relative to the position of the intermediate shaft 140, and in some embodiments, such locking and / or coupling can be dynamic, referred to herein as dynamically locking and / or dynamically coupling, because the position of the inner shaft 200 relative to the intermediate shaft 140 is limited. In some embodiments, as will be discussed at greater length below, the inner shaft 200 can be dynamically locked to the plunger 154 by a compliance spring 1214 that allows some movement of the inner shaft 200 relative to the intermediate shaft 140 when the plunger is locked in the second position. Thus, in this embodiment, the inner shaft 200 is dynamically locked and / or dynamically coupled to and / or relative to the intermediate shaft 140.

[0103] Reference Figure 4 , a side view of one embodiment of a self-expanding coring element 206 is shown. The self-expanding coring element 206 may include a variety of shapes and sizes, and may be made of a variety of materials. In some embodiments, the self-expanding coring element may be made of a shape memory material, such as a shape memory alloy and / or a shape memory polymer. In some embodiments, the self-expanding coring element 206 may include Nitinol and / or a Nitinol alloy.

[0104] The self-expanding coring element 206 can be made using a variety of techniques, including, for example, welding, laser welding, cutting, laser cutting, expanding (expanding), etc. In some embodiments, the self-expanding coring element 206 can be laser cut from a Nitinol piece, such as a Nitinol tube, after which the self-expanding coring element 206 can be inflated and / or expanded.

[0105] The self-expanding coring element 206 may include an integral porous structure 400 and / or a stent or stent portion that may be configured to core and separate a thrombus, such as a portion of a vascular thrombus, from a blood vessel containing a thrombus. The integral porous structure 400 may include a plurality of struts 402 that collectively define a plurality of voids 404. The struts may include a variety of shapes and sizes, and in some embodiments, the thickness and / or diameter of each strut may be between about 0.05 and 0.15 inches, between about 0.075 and 0.125 inches, between about 0.09 and 0.1 inches, and / or about 0.096 inches.

[0106] In some embodiments, the self-expanding coring element 206 may include a first region 406 and a second region 408. The second region 408 may be generally tubular and may include a plurality of interconnected struts 402. Figure 5 As seen in FIG. 4 , the first region 406 may include a reduced number of struts 402 compared to the second region to facilitate the self-expanding coring element 206 to collapse to a non-expanded configuration and maintain the coring orientation when the vessel is twisted. In some embodiments, the first region may also include two curved struts 410-A, 410-B that twist in opposite directions around a central axis 412, also referred to herein as a longitudinal axis 412, of the self-expanding coring element 206 to define a mouth 414 of the self-expanding coring element 206.

[0107] In some embodiments, the connection of the self-expanding coring element 206 to the intermediate shaft 140 via two curved struts 410-A, 410-B can improve the operation of the thrombus extraction device 202 by flexibly connecting the self-expanding coring element 206 to the intermediate shaft 140. In particular, removing the struts from the region 420 of the self-expanding coring element 206 allows the self-expanding coring element 206 to flex around the connecting member 415 located at the proximal end 210 of the self-expanding coring element 206 and connecting the self-expanding coring element 206 to the intermediate shaft 140 of the thrombus extraction catheter 104. This flexing ability can facilitate maintaining the coring orientation in the event of a tortuous vessel. In some embodiments, such flexing of the self-expanding coring element 206 can cause the region 420 to act like the mouth 414.

[0108] like Figure 4 , the curved struts 410 extend from a bottom 416 of the self-expanding coring element 206 at an angle θ, also referred to herein as a coring angle, relative to the central axis 412 toward a top 418 of the self-expanding coring element 206. In some embodiments, when fully expanded, the angle may be between 20 and 50 degrees and / or between 30 and 45 degrees.

[0109] In some embodiments, the coring angle can favorably or unfavorably affect the operation of the TED 202. For example, a coring angle that is too deep can prevent the self-expanding coring element 206 from becoming collapsible and, thus, prevent the self-expanding coring element 206 from being retracted into the introducing sheath 102. Additionally, a bevel angle that is too shallow can cause the self-expanding coring element 206 to collapse too easily, which can reduce the coring ability of the self-expanding coring element 206. In some embodiments, this reduction in the coring ability of the self-expanding coring element 206 can cause the self-expanding coring element 206 to no longer effectively core a thrombus.

[0110] In some embodiments, the proximal-most edge of the two curved struts 410 -A, 410 -B, referred to herein as the leading edge 411 , may be sharp and / or the leading edge 411 of the two curved struts 410 -A, 410 -B may include a cutting element, blade, or the like.

[0111] The self-expanding coring element 206 may include various sizes. In some embodiments, the length of the self-expanding coring element 206, defined as the shortest distance between the proximal end 210 of the self-expanding coring element 206 and the distal end 214 of the self-expanding coring element 206, may be between about one and 3 inches, between about 1.5 and 2.5 inches, between about 1.75 and 2.25 inches, between about 1.9 and 2.0 inches, and / or about 1.96 inches. In some embodiments, the fully expanded diameter of the self-expanding coring element 206 may be between about 2 and 50 mm, between about 4 and 25 mm, between about 6 and 20 mm, and / or between about 8 and 16 mm. In some embodiments, the self-expanding coring element may be applied to debulking of an artery or vein, such as the inferior vena cava. In some embodiments, such debulking may be performed in response to a blockage and / or partial blockage of one or more filters in the inferior vena cava.

[0112] In some embodiments, the length and diameter of the self-expanding coring element 206 can be selected based on the size of the blood vessel, in particular the diameter of the blood vessel from which the thrombus is to be extracted. In some embodiments, the length of the self-expanding coring element 206 can be selected based on the fully expanded diameter of the self-expanding coring element 206 to prevent undesired flipping and / or rotation of the self-expanding coring element relative to the blood vessel within the blood vessel. As used anywhere herein, "about" refers to a range of + / - 10% of the value and / or range of values ​​to which "about" is applied.

[0113] Reference Figure 7 , shows a side view of an embodiment of a thrombus extraction device 202. Figure 7As seen in the figure, the self-expanding coring element 206 is connected to the distal end 212 of the intermediate shaft 140 at the proximal end 210 of the self-expanding coring element 206 by a connecting member 415. The proximal end 216 of the expandable cylindrical portion 208 is connected to the distal end 214 of the self-expanding coring element 206. In some embodiments, the expandable cylindrical portion 208, and specifically the proximal end 216 of the expandable cylindrical portion 208, is formed on the distal end 214 of the self-expanding coring element 206, thereby forming an integral thrombus extraction device 202. The distal end 217 of the expanded cylindrical portion 208 is connected to the distal end 218 of the inner shaft 200.

[0114] In some embodiments, and as Figure 7 2, the self-expanding coring element 206 can be engaged with all or part of the inner shaft 200 to affect expansion of the self-expanding coring element 206. Specifically, in some embodiments, the self-expanding coring element 206 can include a ring 700, also referred to herein as a ring feature 700. The ring 700 can be the same material as the self-expanding coring element 206 or can be a different material than the self-expanding coring element 206. The ring 700 can be integrally formed with the self-expanding coring element 206 and / or can be attached to the self-expanding coring element by, for example, one or more welds, an adhesive, one or more mechanical fasteners, etc. The diameter of the ring 700 can be greater than the diameter of the inner shaft 200 so that the ring 700 can slide along the inner shaft 200.

[0115] like Figure 7 As further seen in the drawings, the inner shaft 200 can include a stopper 702. In some embodiments, the stopper 702 can include a polymeric member and / or a metal member affixed to a portion of the inner shaft 200. In some embodiments, the stopper 702 can be sized and shaped to engage with the ring 700 to apply a proximally directed force to the self-expanding coring element 206 when the inner shaft 200 is displaced proximally by movement of the plunger 154 to the second position. In some embodiments, a portion of the self-expanding coring element 206 positioned between the ring 700 and the connecting member 415 can be forcibly expanded to the ring 700 by application of the proximally directed force, thereby moving the self-expanding coring element to full expansion.

[0116] In some embodiments, the inner shaft 200 of the thrombus extraction catheter 104 can be selectively connected to the distal end 217 of the expandable cylindrical portion 208. This can allow displacement of the inner shaft 200 to fully expand the self-expanding coring element 206 through the engagement of the ring feature 700 with the stopper 702. In some embodiments, after the self-expanding coring element 206 is fully expanded, the inner shaft 200 can be recoupled to the distal end 217 of the expandable cylindrical portion 208 so that the expandable cylindrical portion 208 is fully expanded, and / or the inner shaft 200 can be recoupled to the distal end 217 of the expandable cylindrical portion 208 so that the expandable cylindrical portion 208 compresses the expandable cylindrical portion 208 when the plunger 154 moves from the second position to the first position.

[0117] In some embodiments, the expandable cylindrical portion 208 may include a woven wire mesh structure 704 that may be configured to capture a thrombus. In some embodiments, the woven wire mesh structure may be coextensive with the expandable cylindrical portion 208 and may thus share a proximal end 216 and / or a distal end 217. Figure 7 In the embodiment shown in , the woven wire mesh structure 704 is an elastic wire braid having a generally tubular elongated portion 706 and a distal tapered portion 708. In other embodiments, the woven wire mesh structure 704 can be any porous structure and / or can have other suitable shapes, sizes, and configurations (e.g., the distal portion 708 can be generally cylindrical, etc.).

[0118] Due to the connection of the braided wire mesh structure 704 to the distal end 218 of the inner shaft 200, the axial movement of the inner shaft 200 radially expands / shortens and collapses / lengthens the braided wire mesh structure 704 of the TED 200. For example, as long as the intermediate shaft 140 is fixed and / or constrained to move axially at a rate less than the rate of the inner shaft 200, then: (1) the distal movement of the inner shaft 200 stretches the braided wire mesh structure 704 along the longitudinal axis of the braided wire mesh structure 704, such that the radius of the braided wire mesh structure 704 decreases and the length of the braided wire mesh structure 704 increases; and (2) the proximal movement of the inner shaft 200 compresses the braided wire mesh structure 704 along the longitudinal axis of the braided wire mesh structure 704, such that the radius of the braided wire mesh structure 704 increases and the length of the braided wire mesh structure 704 decreases. In certain embodiments, the length of the woven wire mesh structure 704 in the collapsed structure may be between about 5 and 30 inches, between about 10 and 20 inches, and / or about 16 inches, and in some embodiments, the length of the woven wire mesh structure 704 in the expanded structure may be between about 1 and 25 inches, between about 10 and 20 inches, and / or about 11 inches.

[0119] In some embodiments, the braided wire mesh structure 704 can be formed by a braiding machine and / or a weaving machine, and in some embodiments, the braided wire mesh structure 704 can be hand-braided and / or woven. Advantageously, a braiding machine and / or a weaving machine that does not employ a bobbin or other wire collection mechanism common in many conventional braiding machines is utilized, as these mechanisms make it much more difficult to form a braid on the self-expanding coring element 206. A braiding machine and / or a weaving machine in which the wire is freely suspended allows for much simpler loading directly on the self-expanding coring element 206. In some embodiments, the woven wire mesh structure 704 can be woven using methods or devices contained in some or all of the following documents: U.S. Patent No. 8,833,224, entitled “BRAIDING MECHANISM AND METHOD OF USE”, filed on May 8, 2013; U.S. Patent No. 8,826,791, entitled “BRAIDING MECHANISM AND METHOD OF USE”, filed on September 10, 2012; U.S. Patent No. 8,261,648, entitled “BRAIDING MECHANISM AND METHOD OF USE”, filed on October 17, 2011; U.S. Patent No. 8,820,207, entitled “BRAIDING MECHANISM AND METHOD OF USE”, filed on April 26, 2013; U.S. Patent No. 8,820,207, entitled “ANEURYSM GRAFT WITH and U.S. Patent Publication No. 2014 / 0318354, filed on July 11, 2014, entitled “BRAIDING MECHANISM AND METHOD OF USE”; each of which is incorporated herein by reference in its entirety.

[0120] In some embodiments, the braided wire mesh structure 704 can be formed into a tubular braid, which can then be further shaped using a heat setting process. In some embodiments, the braid can be a tubular braid of pure metal wires, such as nitinol (nickel-titanium alloy), platinum, cobalt-chromium alloy, stainless steel, tungsten or titanium. In some embodiments, the braided wire mesh structure 704 can be at least partially formed by a cylindrical braid of elastic wire. Thus, the braid can be radially constrained without plastic deformation, and will self-expand when the radial constraint is released. This elastic wire braid is referred to as a "self-expanding braid" in this article.

[0121] In some embodiments, the thickness of the braid wire may be less than about 0.15mm. In some embodiments, the braid may be made of wire and / or wire having a diameter in the range of about 0.05mm to about 0.25mm. In some embodiments, braid wires with different diameters may be combined to impart different features, including: rigidity, elasticity, structure, radial force, pore size, embolic capture or filtering capabilities, etc. In some embodiments, the count of the braid wire is between 20 and 80, greater than 30 and / or about 24. The pore size of the braid mesh in the elongated portion 706 may be in the range of about 0.4mm to 4.0mm. In some embodiments, the pore size may be in the range of 0.5mm to 2.5mm.

[0122] In some cases, when a thrombus is within the braided wire mesh structure 704, the thrombus may form a shape that is difficult to retract into the introducer sheath 102. Figure 8 This situation is shown in FIG. 1 , where the thrombus extraction device 202, specifically the braided wire mesh structure 704, is partially retracted into the introduction sheath 102. Figure 8 As shown in FIG. 8 , thrombus 800 has formed into a spherical shape, with a diameter larger than the diameter of introducing sheath 102. This behavior of thrombus 800 may hinder the removal of TED 200 and thrombus 800 from the patient. Fig. 9 and 10 Focus is placed on the features of this behavior that prevent thrombosis.

[0123] Figure 8 Also shown are a cross-sectional view of the elongated member 106 such that the lumen 1701 thereof is visible, a cross-sectional view of the outer shaft 138 such that the lumen 802 thereof is visible, and a cross-sectional view of the intermediate shaft 140 such that the lumen 804 thereof is visible.

[0124] Reference Fig. 9 , shows a side view of one embodiment of a woven wire mesh structure 704 including a plurality of hole sizes. As can be seen, the woven wire mesh structure 704 includes a first portion 900 including a first plurality of holes 904 and a second portion 902 including a second plurality of holes 906. In some embodiments, the first portion 900 may correspond to the elongated portion 706 and the second portion 902 may correspond to the distal tapered portion 708.

[0125] like Fig. 9As shown in the figure, the first portion 900 of the woven wire mesh structure 704 is relatively more proximal than the second portion 902. As further shown, the holes in the first plurality of holes 904 of the first portion 900 are smaller than the holes in the second plurality of holes 906 of the second portion 902. In some embodiments, the average size of the larger holes of the distal second portion 902 is greater than or equal to 1.5 mm, and in some embodiments is between about 1.0 mm and 4.0 mm.

[0126] In this embodiment, when the braided wire mesh structure 704 moves to the non-expanded configuration and / or when the braided wire mesh structure 704 is retracted into the introduction sheath 102, the larger size of the holes in the second plurality of holes 906 can allow and / or facilitate the extrusion of a portion of the thrombus. In some embodiments, such extrusion of a portion of the thrombus can prevent a situation in which the thrombus cannot be retracted into the introduction sheath 102. In addition, in some embodiments, relatively new portions of the thrombus can be extruded before relatively old portions of the thrombus, because relatively new portions of the thrombus may be softer and / or more ductile. These relatively new portions of the thrombus can then be captured and / or decomposed by the features of the introduction sheath 102.

[0127] Reference Fig.10 , shows a side view of one embodiment of a TED 200, which includes a plurality of circumferential recesses 1000, also referred to herein as circumferential grooves, radial ribs, and / or radial grooves. In some embodiments, some or all of the plurality of circumferential recesses 1000 may extend inwardly toward a central axis 1002 and / or a midline 1002 of the thrombus retrieval device 202. In some embodiments, the plurality of circumferential recesses 1000 may be longitudinally spaced and / or equidistantly spaced along the expandable cylindrical portion 208 and / or the woven wire mesh structure 704 between the proximal end 216 and the distal end 217 of the cylindrical portion 208 and / or the woven wire mesh structure 704. In some embodiments, these circumferential recesses 1000 can engage portions of a thrombus contained within the cylindrical portion 208 and / or the woven wire mesh structure 704 when the thrombus retrieval device 202 moves from the expanded configuration to the non-expanded configuration to inhibit movement of the thrombus relative to one or both of the proximal end 216 and the distal end 217 of the cylindrical portion 208 and / or the woven wire mesh structure 704. This inhibition of thrombus movement can reduce the likelihood of creating a thrombus that cannot be retracted into the introduction sheath 102.

[0128] Although shown in separate figures, some embodiments of the thrombus extraction device 202 may include both Fig.10 The plurality of circumferential recesses discussed further include Fig. 9 A variety of hole sizes are discussed.

[0129] Reference Fig.11, a schematic diagram of one embodiment of a weaving pattern for forming a cylindrical portion 208 and / or a woven wire mesh structure 704 at one or more forming points 1103 on a self-expanding coring element 206 is shown. As can be seen, the self-expanding coring element 206 includes a plurality of struts 402 connected at forming points 1103, and the forming points 1103 include vertices 1100, also referred to herein as apex struts 1100. As can be seen, each vertex 1100 is formed by the intersection of a first strut 402-A and a second strut 402-B, and these intersecting struts 402-A, 402-B form a vertex hole 1101.

[0130] In some embodiments, the self-expanding coring element 206 may include a plurality of vertices 1100 extending around a distal end of the self-expanding coring element 206. The plurality of vertices 1100 may include 4 vertices 1100, 6 vertices 1100, 8 vertices 1100, 10 vertices 1100, 12 vertices 1100, 16 vertices 1100, 20 vertices 1100, 24 vertices 1100, between 4 and 50 vertices, between 8 and 20 vertices, and / or any other or intermediate number of vertices.

[0131] The cylindrical portion 208 and / or the braided wire mesh structure 704 may include a plurality of wires 1102 that are woven and / or braided together to form the cylindrical portion 208 and / or the braided wire mesh structure 704. In some embodiments, for each vertex 1100 of the self-expanding coring element 206, the plurality of wires may include a first wire 1104 and a second wire 1106. The first wire 1104 and the second wire 1106 may be woven and / or braided onto their respective vertices. In some embodiments, the first wire 1104 and the second wire 1106 may be woven and / or braided onto their respective vertices such that one or both of the first wire 1104 and the second wire 1106 form a loop around their respective vertices. Thus, in some embodiments, only the first wire 1104 forms a loop around its vertex, only the second wire 1106 forms a loop around its vertex, or both the first wire 1104 and the second wire 1106 form loops around their vertices. Reference Fig.11 In the embodiment of FIG. 1 , the first wire 1104 can be inserted straight through the apex hole 1101 of its apex, so that the first wire 1104 does not loop on itself immediately adjacent to its apex, more specifically immediately distal to its apex.

[0132] The first wire 1104 may be inserted through the apex hole 1101 of the apex 1100 thereof such that the first wire 1104 passes above the first strut 402 -A and below the second strut 402 -B when viewed from the outside of the self-expanding coring element 206 to the inside of the self-expanding coring element 206 .

[0133] The second wire 1106 may be inserted through the vertex hole 1101 of its apex, such that a portion of the second wire 1106 passing through the vertex hole 1101 is separated from the apex by the first wire 1104. In addition, the second wire 1106 may be inserted through the vertex hole 1101, such that the second wire 1106 passes below the first strut 402-A and above the second strut 402-B. After being inserted through the vertex hole 1101, the second wire 1106 may be looped on itself to form a loop 1108 immediately distal to the apex 100 thereof.

[0134] In some embodiments, since each wire 1104, 1106 is inserted through the apex hole 1101, each wire 1104, 1106 can be processed for braiding or weaving purposes to include a first wire extending from its apex 1100 to a first end of the wire 1104, 1106 and a second wire extending from its apex to a second end of the wire 1104, 1106. Thus, in some embodiments where the self-expanding coring portion 206 includes 12 vertices, the cylindrical portion 208 and / or the braided wire mesh structure 704 can be formed by 24 wires 1104, 1106, which can be woven and / or braided into 48 wires to form a 48-wire mesh and / or weave.

[0135] In some embodiments, the cylindrical portion 208 and / or the braided mesh structure 704 may be woven / woven by identifying a plurality of forming points 1103 formed by some of the struts 402 of the self-expanding coring element 206. A unique pair of wires may be threaded through each forming point 1103, specifically adjacent to each forming point 1103 through the vertex hole 1101. In some embodiments, each unique pair of wires may include a first wire 1104 and a second wire 1106 superimposed on the first wire 1104. Thus, the first wire and the second wire may be woven and / or woven from the unique pair of wires into a network-like mesh structure of the cylindrical portion 208 and / or the braided mesh structure 704, such that the first wire 1104 does not form a loop around the forming point 1103 through which the first wire 1104 is threaded, and such that the second wire 1106 forms a loop 1108 around the forming point 1103 through which the second wire 1106 is threaded.

[0136] Reference Fig.12 , shows a cross-sectional view of an embodiment of the handle 134, wherein the plunger 154 is in a first position, and with reference to Fig.13, shows a cross-sectional view of an embodiment of the handle 134, wherein the plunger 154 is in the second position. The handle 134 may include a housing 1200 that defines an interior volume 1202. The plunger shaft 1204 may extend through all or part of the interior volume 1202 and may be connected to the inner shaft 200, which may define the previously mentioned lumen 1400, also referred to herein as the inner shaft lumen 1400. The plunger shaft 1204 may terminate at a plunger guide 1208, which is affixed to the plunger shaft 1204. In some embodiments, as Fig.12 and 13 As seen in FIG. 1 , the plunger 154 can be biased toward the first position by a plunger spring 1209, which can engage a plunger guide 1208 and a portion of the handle 134. Thus, when the plunger 154 is in the position shown in FIG. Fig.12 In the first position shown in FIG. , the plunger spring 1209 is less compressed and when the plunger 154 is in the Fig.13 In the second position shown in , the plunger spring 1209 is more compressed. In some embodiments, this bias toward the first position can produce a bias toward the partially expanded configuration in the thrombus extraction device 202.

[0137] like Fig.14 ,Right now Fig.13 14, the plunger guide 1208 can be positioned between a proximal stop 1210 and a distal stop 1212, which can each be affixed to the inner shaft 200 including the inner shaft lumen 1400. The plunger guide 1208 can be dynamically connected to the proximal stop 1210 via a stent compliance spring 1214, also referred to herein as a compliance spring 1214. In some embodiments, the use of the compliance spring 1214 to connect the plunger guide 1208 and the proximal stop 1210 can allow the diameter of the self-expanding coring element 206 to change depending on the compressive force applied to the self-expanding coring element 206.

[0138] In some embodiments, for example, through the interaction of the ring feature 700 and the stopper 702, a radial compressive force applied to the self-expanding coring element 206 can be transferred from the self-expanding coring element 206 through the ring feature 700 and the stopper 702 to the compliance spring 1214. In embodiments where the compressive force is greater than the spring force, the compliance spring 1214 can be compressed and the inner shaft 200 can be advanced distally relative to the intermediate shaft 140, thereby reducing the diameter of the self-expanding coring element 206 until the compressive force equals the spring force. This compliance achieved by the compliance spring 1214 enables the use of the thrombus extraction catheter 104 in a blood vessel while maintaining the desired contact of the self-expanding coring element 206 on the wall of the blood vessel, vein, or venous vessel, which can be an arterial or venous vessel with a non-constant diameter. In some embodiments, the compliance can result in a constant outward force applied to the vessel wall by the self-expanding coring element 206 when the vessel has a diameter between about 1 to 30 mm, 2 to 25 mm, 5 to 20 mm, and / or any other or intermediate diameter. In some embodiments, the constant outward force constant can mean that the outward force is within a predetermined range. In some embodiments, for example, when the diameter of the self-expanding coring element 206 is about 20 mm, the outward force can be about 5 N, and when the diameter of the self-expanding coring element 206 is about 5 mm, the outward force can be about 20 N. Thus, in some embodiments, the locking mechanism, which can include the plunger 154 and the compliance spring 1214, can be configured to maintain a desired radial force on the vessel wall when the stent is compressed by the vessel wall. In some embodiments, when the self-expanding coring element 206 is fully expanded, the desired force can be all or part of the radial force on the vessel wall sufficient to core and / or separate a thrombus from the vessel wall.

[0139] Reference Fig.15 and 16 , shows a side view of an embodiment of an obturator 120. As seen, the obturator 120 includes a proximal end 122, a distal end 124, and an elongated shaft 126. As further seen, the obturator 120 can include a capture sheath 1500 extending proximally from the distal end 124 of the obturator 120.

[0140] The obturator 120 may further include a tip, such as an atraumatic tip 1502, located at the distal end 124 of the obturator 120. In some embodiments, the atraumatic tip 1502 may be radiopaque. The obturator 120 may further include a connection fitting 1504, which may be located at the proximal end 1506 of the capture sheath 1500. In some embodiments, the connection fitting 1504 may be configured to sealably connect with the distal end 110 of the elongated sheath 106 of the introduction sheath 102.

[0141] The obturator 120 may further include a stopper portion 1508 at the proximal end 122 of the obturator 120. In some embodiments, the diameter of the stopper portion 1508 may be greater than the lumen 1701 of the elongated member 106 of the introduction sheath 102 and / or greater than the diameter of the sealing hole 112 at the proximal end 108 of the introduction sheath 102, thereby preventing the stopper portion 1508 from entering the lumen 1701 of the elongated member 106 and / or the sealing hole 112.

[0142] In some embodiments, the elongated shaft 126 may include a constant size and / or diameter, and in some embodiments, the elongated shaft 126 may include multiple sizes and / or diameters. For example, Fig.15 The diameter 1510 of the elongated shaft 126 shown in FIG is constant along the length of the elongated shaft 126. In contrast, Fig.16 The elongated shaft 126 shown in FIG. 1 has at least a first diameter 1512 along one or several first portions 1513 of the elongated shaft 126 and a second diameter 1514 along one or several second portions 1515 of the elongated shaft 126 .

[0143] In some embodiments, the one or more second portions 1515 of the elongated shaft can be positioned along the length of the elongated shaft 126 such that when the obturator 120 is received within the elongated member 106 of the introducing sheath 102 and positioned such that the connecting fitting 1504 is sealed with the distal end 110 of the elongated sheath 106, the one or more second portions 1515 extend through the sealing aperture 112. In such embodiments, the second diameter 1514 can be selected such that the one or more second portions do not contact and / or expand the sealing aperture 112 and / or the seal within the sealing aperture 112. Because such embodiments of the obturator 120 do not expand the seal of the sealing aperture 112 when the one or more second portions extend through the sealing aperture 112, the introducing sheath 102 can be stored, packaged, and / or sold with the obturator 120 pre-positioned to extend through the lumen 1701 of the elongated member 106.

[0144] Reference Fig.17 , shows a detailed cross-sectional view of one embodiment of a capture sheath 1500. As seen, capture sheath 1500 includes an atraumatic tip 1502 and is connected to elongated shaft 126 of obturator 120, which extends through lumen 1701 of elongated member 106. As further seen, lumen 1700 extends through atraumatic tip 1502 and elongated shaft 126, which lumen 1700 can be configured to receive a guide wire.

[0145] The capture sheath 1500 includes a capture housing 1702 that extends distally from the atraumatic tip 1502 to a proximal end 1506 of the capture sheath 1500. The capture housing 1702 terminates in a connection fitting 1504. The inner diameter 1704 of the capture housing 1702 is larger than the diameter 1706 of a portion of the elongated shaft 126 extending through the capture housing 1702. Due to the larger inner diameter 1704 of the capture housing 1500, a receiving space is created between the capture housing 1702 and the portion of the elongated shaft 126 extending through the capture housing 1702. In some embodiments, the receiving space can be sized and shaped to receive and / or retain the self-expanding funnel 1708 in a constrained configuration. In some embodiments, the diameter of the self-expanding funnel 1708 can match the inner diameter 1704 of the capture housing 1702 when the self-expanding funnel 1708 is in a constrained configuration. In some embodiments, the diameter of the self-expanding funnel may be less than or equal to the diameter 1716 of the elongated member 106 .

[0146] The self-expanding funnel 1708 may include a variety of shapes and sizes and may be made of a variety of materials. In some embodiments, the maximum diameter of the self-expanding funnel 1708 may be greater than and / or equal to the diameter of the self-expanding coring element 206 in the fully expanded state, and in some embodiments, the minimum diameter of the self-expanding funnel 1708 may be equal to the diameter 1716 of the elongated member 106 and / or the diameter of the lumen 1701 of the elongated member 106. In some embodiments, the length of the self-expanding funnel 1708 may be greater than and / or equal to the length of the self-expanding coring element 206, so that the self-expanding coring element 206 can be received and contained within the self-expanding funnel 1708.

[0147] In some embodiments, the self-expanding funnel 1708 may have a tapered portion, particularly a frusto-conical portion. In some embodiments, the self-expanding funnel may be constructed of at least one of a battlemented nitinol braid, a nitinol braided stent, a laser cut nitinol, a laser cut polymer tube, an injection molded polymer structure, or an inflatable balloon. In some embodiments, the self-expanding funnel 1708 may include a mesh having a pore size small enough to prevent dangerous thrombi from passing through the pores of the mesh. In some embodiments, the self-expanding funnel 1708 may be permeable to blood.

[0148] Reference Figures 18 to 20 , side views of embodiments of the introduction sheath 120 are shown in various configurations. Fig.18 In FIG. 1 , the introducing sheath 102 is shown in a non-deployed configuration. Fig.19 In FIG. 1 , the introducer sheath 102 is shown in a partially deployed configuration and in FIG. Fig. 20 , the introducer sheath 102 is shown in a fully deployed and / or expanded configuration.

[0149] Specifically, Fig.18 As seen in FIG. 1 , the obturator 120 extends through the lumen 1701 of the elongated member 106 and the self-expanding funnel 1708 is contained within the capture sheath 1500 in a constrained configuration. Fig.19 In some embodiments, the obturator 120 has been advanced distally, thereby releasing the self-expanding funnel 1708 from the constraining structure and / or deploying the self-expanding funnel 1708. In some embodiments, the length of the obturator 120, and in particular the length of the elongated member, between the proximal end of the capture sheath 1500 and the stop portion 1508 is sufficient to allow the self-expanding funnel 1708 to deploy from the capture sheath 1500 before further distal movement of the obturator 120 is prevented by a collision between the stop portion 1508 and the sealing aperture 112.

[0150] After the self-expanding funnel 1708 has been deployed, the obturator 120 can be retracted proximally through the lumen 1701 of the elongated member 106 and the sealing hole 112 and can be removed from the introducing sheath 102. After the obturator 120 has been removed from the introducing sheath 102, the introducing sheath is in a position such as Fig. 20 in the fully expanded configuration shown in .

[0151] In some embodiments, Fig.21 As seen in the drawings, the introducing sheath 102 may include an inflatable balloon 2100 positioned at or near the distal end 110 of the elongated member 106. In some embodiments, the balloon 2100 may include a tapered inner portion 2102, the size and shape of which may be set to receive the thrombus extraction device 202, and in particular, the length of the tapered inner portion 2102 may be greater than or equal to the length of the self-expanding coring element 206.

[0152] Reference Fig. 22 , an introduction technique for accessing a thrombus 2200 is shown. As shown, a thrombus 2200 can be positioned in a blood vessel and accessed through an access site 2260, such as a popliteal access site. The introduction sheath 102 can extend from the popliteal access site 2260 to a deployed position 2262, where the self-expanding funnel 1708 can be deployed, and the deployed position 2262 can be close to the thrombus 2200. The TED 202 can pass through the clot 2200 in the direction of blood flow, and the TED 202 can be retracted through the clot 2200 in the opposite direction of blood flow. The retraction of the TED 202 through the clot 2200 can result in coring the clot by the self-expanding coring element 206 and capturing the clot in the expandable cylinder 208.

[0153] In some such embodiments, as shown in FIG. 23 , all or a portion of the TED 202 may extend into one of the iliac veins and / or the inferior vena cava. Additionally, as the TED 202 is retracted from a proximal position to a distal position relative to the heart, the diameter of the vessel 2202 will decrease as the TED 202 is retracted toward the access site 2260. This may result in increased compressive forces on the TED 202, and in particular on the self-expanding coring element 206. These compressive forces may be transmitted to the compliance spring 1214 through the ring feature 700 and the stop 702. By stretching or compressing the compliance spring 1214, the diameter of the TED 202, and in particular the coring element 206, may be varied to match the diameter of the vessel, and a desired radial force and / or force level may be maintained.

[0154] 23-A to 23-H, 24-A and 24-B, and 25-A to 25-H illustrate a process of using the thrombus extraction system 100 to remove a thrombus from a patient, specifically from a blood vessel in the patient, which may be a venous blood vessel. The process includes: entering the blood vessel through one or more percutaneous access sites, which may provide direct access to the blood vessel or indirect access to the blood vessel via one or more other blood vessels; advancing the introduction sheath to a position close to the thrombus; deploying the self-expanding funnel of the introduction sheath; advancing the distal end 132 of the thrombus extraction catheter 104 to a position close to the thrombus; deploying the thrombus extraction device 202; capturing the thrombus in the thrombus extraction device 202 by retracting the thrombus extraction device 202 through the thrombus; collapsing the thrombus extraction device 202; and removing the thrombus extraction device 202 and the captured thrombus from the introduction sheath 102 and from the patient. In some embodiments, these one or more access sites may include, for example, a popliteal access site, a femoral access site, and / or an internal jugular access site. In some embodiments, a thrombolytic agent may be injected into a blood vessel and / or withdrawn from a blood vessel before, during, or after removal or extraction of a thrombus. The thrombolytic agent may include, for example, tissue plasminogen activator (TPA) or other clot dissolving drugs.

[0155] In any of the embodiments disclosed herein, the device and / or delivery system may be adapted to deliver energy to the device and the thrombus or tissue surrounding the device at the treatment site for facilitating removal of the thrombus or treatment of tissue adjacent to the device, or both. In some embodiments, energy may be delivered by the delivery system to a device for treating the patient's vasculature such that the device is heated or actuated by the energy. Examples of energy that may be delivered include, but are not limited to, light energy, thermal energy, vibration energy, electromagnetic energy, radiofrequency energy, and ultrasonic energy. For some embodiments, the energy delivered to the device may trigger the release of a chemical or biological agent to promote separation of the thrombus from the vessel wall and / or to the patient's tissue for treating the patient's vascular structure, treating tissue adjacent to where the device is disposed, or a combination thereof.

[0156] The process using the thrombus extraction system 100 shown in FIGS. 23-A to 23-H, FIGS. 24-A and 24-B, and FIGS. 25-A to 25-H can be performed in the direction of blood flow or against the direction of blood flow. Thus, in some embodiments, the direction of blood flow in FIGS. 23-A to 23-H, FIGS. 24-A and 24-B, and FIGS. 25-A to 25-H can be from left to right or from right to left.

[0157] Referring now to FIGS. 23-A to 23-H , a process for expanding a thrombus retrieval device 202 in a blood vessel, such as a venous blood vessel, is shown. The process for expanding a thrombus retrieval device 202 in a blood vessel may be performed using all or part of the thrombus retrieval system 100. In some embodiments, the process for expanding a thrombus retrieval device 202 in a blood vessel may be performed in conjunction with monitoring techniques, such as fluoroscopy, angiography, and / or ultrasound monitoring. In some embodiments, the monitoring techniques may be used to monitor the deployment of the TED 202 in the blood vessel by observing one or more radiopaque markers located on the introducing sheath 102 and / or the thrombus retrieval catheter 104.

[0158] The process begins at FIG. 23-A , where a thrombus 2200 is identified in a blood vessel 2202, such as a venous blood vessel. In some embodiments, the thrombus 2200 may be located in the peripheral vasculature of the patient's body. The thrombus 2200, also referred to herein as a clot 2200, may include a proximal end 2204 and a distal end 2206. In some embodiments, the identification of the blood vessel 2202 may also include determining whether the thrombus 2200 in the blood vessel 2202 is suitable for thrombus extraction. In some embodiments, the thrombus 2200 in the blood vessel 2202 may be suitable for extraction when the diameter of the blood vessel 2202 is at least 5 millimeters. In some embodiments, the thrombus 2200 in the blood vessel 2202 may be suitable for extraction when the diameter of the blood vessel 2202 is at least 5 millimeters and is at least one of the femoral vein, the iliac vein, the popliteal vein, the posterior tibial vein, the anterior tibial vein, or the peroneal vein.

[0159] After the thrombus has been identified, the process continues to the step shown in FIG23-B, in which the introducing sheath 102 is advanced along or against the direction of blood flow in the blood vessel so that the distal end of the introducing sheath 102 and / or the obturator 120 approaches the thrombus 2200, and particularly approaches the thrombus 2200 at a position proximal to the thrombus. In some embodiments, this may include providing the introducing sheath 102 and percutaneously entering the patient's circulatory system, particularly the patient's blood vessel or venous vessel, through an access site 2208, which may be one of the access sites described above.

[0160] As shown in FIG. 23-C , after the introducing sheath 102 has been advanced to the desired position, the self-expanding funnel 1708 can be deployed and / or exposed from the constrained configuration to the expanded configuration. In some embodiments, the self-expanding funnel 1708 can be deployed by relative distal movement of the obturator 120 relative to the elongated member 106 until the funnel 1708 is no longer constrained by the capturing sheath 1500, and then the obturator 120 can be retracted proximally through the lumen 1701 of the elongated member 106 until the obturator 120 is removed from the introducing sheath 102.

[0161] In some embodiments, the relative distal movement of the obturator 120 relative to the elongated member may include fixing the position of the obturator 120 relative to the blood vessel 2202 and retracting the elongated member 106 proximally on the obturator 120 to expose the self-expanding funnel 1708 until the stop 1508 contacts the sealing hole 112 and / or until monitoring of radiopaque markers, such as those located at the end 1502 of the obturator 120 and the distal end 110 of the elongated member 106 (which may be fluoroscopic monitoring), indicates that the self-expanding funnel 1708 is deployed and / or is no longer constrained by the capture sheath 1500. Alternatively, in some embodiments, relative distal movement of the obturator 120 relative to the elongated member may include fixing the position of the elongated member 106 relative to the vessel 2202 and advancing the obturator 120 distally to expose the self-expanding funnel 1708 until the stop 1508 contacts the sealing hole 112 and / or until monitoring of radiopaque markers (which may be fluoroscopic monitoring), for example, located at the end 1502 of the obturator 120 and the distal end 110 of the elongated member 106, indicates that the self-expanding funnel 1708 is deployed and / or is no longer constrained by the capture sheath 1500.

[0162] As shown in FIG. 23-D , after the self-expanding funnel 1708 has been deployed, a portion of the thrombus extraction catheter 104, such as the outer shaft 138, may be inserted into the lumen 1701 of the introduction sheath 102 via the sealing hole 112. In some embodiments, this may include providing a thrombus extraction catheter 104 that includes a thrombus extraction device 202. In some embodiments, the thrombus extraction device 202 may be constrained within the outer shaft 138 and may be inserted into the lumen of the elongated member 106 along with the outer shaft 138 via the sealing hole 112. In some embodiments, the diameter of the outer shaft 138 of the thrombus extraction catheter 104 may facilitate expansion of the seal of the sealing hole 112 so that the sealing hole 112 seals around and to the outer shaft 138.

[0163] As shown in FIG. 23-E , after the outer shaft 138 has been inserted into the lumen 1701 of the introduction sheath 102, a portion of the thrombus extraction catheter 104 can be inserted into the blood vessel 2202 via the introduction sheath 102. In some embodiments, the distal end 132 of the thrombus extraction catheter 104 can be advanced to a position close to the thrombus 2200 and / or to a position proximal to the thrombus 2200. In some embodiments, the insertion and / or advancement of the thrombus extraction catheter 104 can be monitored, in particular by fluoroscopy. In some embodiments, the position of one or more radiopaque markers (including the radiopaque marker 222) of the thrombus extraction catheter 104 can be monitored.

[0164] As shown in FIG. 23-F , after a portion of the thrombus retrieval catheter 104 has been inserted into the blood vessel 2202, the portion of the thrombus retrieval catheter 104 may be advanced distally through the clot 2200. In some embodiments, the distal advancement through the clot 2200 may be with or against the direction of blood flow. In some embodiments, the portion of the thrombus retrieval catheter 104 that is advanced distally through the clot 2000 may contain and / or constrain the thrombus retrieval device 202. In some embodiments, advancing the portion of the thrombus retrieval catheter 104 distally through the clot may include advancing the portion of the thrombus retrieval catheter 104 until a radiopaque marker 222 that may be monitored by fluoroscopy and may be located at the distal end 218 of the inner shaft 200 passes distally through the thrombus 2200 and / or a portion of the thrombus 2200.

[0165] As shown in FIG. 23-G , after a portion of the thrombus retrieval catheter 104 is advanced distally through the clot 2200, the thrombus retrieval device 202 can be deployed. In some embodiments, the thrombus retrieval device 202 can be deployed by advancing the thrombus retrieval device 202 beyond the distal end 204 of the outer shaft 138 or by retracting the outer shaft 138 relative to the thrombus retrieval device 202 until the thrombus retrieval device 202 exceeds the distal end 204 of the outer shaft 138. In some embodiments, the thrombus retrieval device can be deployed so that the thrombus retrieval device 202 passes distally through the thrombus 2200 and / or passes distally through a desired portion of the thrombus 2200.

[0166] In some embodiments, the thrombus retrieval device is advanced beyond the distal end 204 of the outer shaft 138 by advancing the intermediate shaft 140 distally relative to the outer shaft 138. In some embodiments, the intermediate shaft 140 can be advanced distally until the locking feature 146 contacts the mating feature 148, and the locking feature 146 can be matched and / or fixed to the mating feature 148 to fix the relative position of the intermediate shaft 140 relative to the outer shaft 138.

[0167] In some embodiments, the deployment of the thrombus retrieval device 202 can be monitored, specifically, the deployment of the thrombus retrieval device 202 can be monitored by fluoroscopy, for example, by the radiopaque marker 222 and the radiopaque marker located at one or both of the distal end 204 of the outer sheath 138 and the distal end 212 of the intermediate sheath 140. In some embodiments, the deployment of the thrombus retrieval device 202, specifically the advancement of the thrombus retrieval device 202 beyond the distal end 204 of the outer shaft 138 or the retraction of the outer shaft 138 relative to the thrombus retrieval device 202, can be stopped based on the position of the distal end 204 of the outer sheath 138 including the radiopaque marker (the first radiopaque marker) relative to the radiopaque marker 222 (the second radiopaque marker) located on the thrombus retrieval device 202.

[0168] As shown in FIG. 23-H , after the thrombus retrieval device 202 is deployed, the thrombus retrieval device 202 can be fully expanded. In some embodiments, this can include allowing full expansion of the thrombus retrieval device 202 so that the thrombus retrieval device 202 engages the wall 2220 of the blood vessel 2202. In some embodiments, the thrombus retrieval device 202 can be fully expanded by moving the plunger 154 from the first position to the second position and fixing the plunger 154 in the second position, thereby fixing the relative position of the inner shaft 200 relative to the intermediate shaft 140. In some embodiments, the movement of the plunger 154 from the first position to the second position retracts the inner shaft 200 proximally relative to the intermediate shaft 140, thereby fully expanding the expandable cylindrical portion 208 of the thrombus retrieval device 202. The proximal retraction of the inner shaft 200 relative to the intermediate shaft 140 can also engage the stopper 702 with the ring feature 700, thereby fully expanding the self-expanding coring element 206. In some embodiments, fixation of the plunger 154 in the second position can secure the self-expanding coring element 206 and the thrombus retrieval device 202 in a fully expanded state through engagement of the stop 702 with the ring feature 700 .

[0169] Referring now to FIGS. 24-A and 24-B, alternative embodiments of the steps shown in FIGS. 23-G and 23-H are shown. In some embodiments, these alternative embodiments may be implemented when the diameter of the vessel 2202 containing the thrombus 2200 is reduced to less than a desired level distally beyond the thrombus 2200. In some embodiments, for example, as the distance from the heart increases, the diameter of the vessel 2202 may decrease. In some embodiments, the diameter may decrease to a point where the thrombus extraction device 202 may no longer be usable.

[0170] In this embodiment, an extension sheath 2300, also referred to herein as a popliteal sheath 2300, can be percutaneously inserted into a blood vessel 2202 through a wall 2220 of the blood vessel 2202 such that at least a portion of the extension sheath 2300 extends from the patient. In some embodiments, the extension sheath 2300 can be percutaneously inserted into the blood vessel 2202 at a location before the blood vessel diameter is reduced to below a desired value, such as less than 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 8 mm, 10 mm, or any other or intermediate value. In some embodiments, the extension sheath 2300 can be inserted into the blood vessel 2202 via an access site, such as a popliteal access site.

[0171] As shown in FIG. 24-A , the thrombus retrieval device 202 can be deployed. In some embodiments, the thrombus retrieval device 202 can be deployed by advancing the thrombus retrieval device 202 beyond the distal end 204 of the outer shaft 138 and into the extension sheath 2300 or by advancing the outer shaft 138 containing the thrombus retrieval device 202 into the extension sheath and then retracting the outer shaft 138 relative to the thrombus retrieval device 202 until the thrombus retrieval device 202 exceeds the distal end 204 of the outer shaft 138. In some embodiments, the thrombus retrieval device can be deployed so that the thrombus retrieval device 202 passes distally through the thrombus 2200 and / or passes distally through a desired portion of the thrombus 2200. In some embodiments, all or part of the thrombus retrieval device can be contained within the extension sheath 2300.

[0172] In some embodiments, the outer shaft 138 of the thrombus extraction catheter 104 can be separated into a first piece and a second piece. In some embodiments, the separation can occur at a separation point, which can include, for example, any features configured to allow the first piece and the second piece to be separated. These features can include a partial depth slit or notch in the outer shaft 138, an overlapping friction fit in the outer shaft 138, and the like. In some embodiments, the detachable outer shaft 138 can be used to replace the extension sheath 2300. In such embodiments, the outer shaft 138 can leave the blood vessel 2202 via the entry site at the entry point, so that the detachable portion extends from the inside of the blood vessel 2202 to the outside of the patient's body. In such embodiments, when the thrombus extraction device 202 is retracted, the detached portion of the outer sheath 138 can be used as the extension sheath 2300 and can be maintained in the entry point. Thus, the thrombus extraction device 202 can be deployed by fixing the position of the detached portion of the outer sheath 138 and retracting the thrombus extraction device 202 from the detached portion of the outer sheath 138.

[0173] In some embodiments, by advancing the intermediate shaft 140 distally relative to the outer shaft 138, the thrombus retrieval device can be advanced beyond the distal end 204 of the outer shaft 138. In some embodiments, the intermediate shaft 140 can be advanced distally until the locking feature 146 contacts the mating feature 148. In some embodiments, the locking feature 146 can be mated and / or fixed to the mating feature 148 to fix the relative position of the intermediate shaft 140 relative to the outer shaft 138.

[0174] In some embodiments, the deployment of the thrombus retrieval device 202 can be monitored by fluoroscopy, specifically, the deployment of the thrombus retrieval device 202 can be monitored by fluoroscopy, for example, by the radiopaque marker 222 and the radiopaque marker located at one or both of the distal end 204 of the outer sheath 138 and the distal end 212 of the intermediate sheath 140. In some embodiments, the deployment of the thrombus retrieval device 202, specifically the advancement of the thrombus retrieval device 202 beyond the distal end 204 of the outer shaft 138 or the retraction of the outer shaft 138 relative to the thrombus retrieval device 202, can be stopped based on the position of the distal end 204 of the outer sheath 138 including the radiopaque marker (the first radiopaque marker) relative to the radiopaque marker 222 (the second radiopaque marker) located on the thrombus retrieval device 202.

[0175] As shown in FIG. 24-B , after the thrombus retrieval device 202 is deployed, the thrombus retrieval device 202 can be fully expanded. In some embodiments, the thrombus retrieval device 202 can be fully expanded when all or part of the thrombus retrieval device 202 is contained in the extension sheath 2300. In such embodiments, the portion of the thrombus retrieval device 202 contained in the extension sheath can be prevented from reaching full expansion by the extension sheath 2300. In such embodiments, as the thrombus retrieval device is withdrawn proximally from the extension sheath 2300, the thrombus retrieval device 202 can reach full expansion.

[0176] In some embodiments, full expansion of the thrombus retrieval device 202 may include allowing expansion of the thrombus retrieval device 202 such that the thrombus retrieval device 202 engages the wall 2220 of the blood vessel 2202. In some embodiments, the thrombus retrieval device 202 may be fully expanded by moving the plunger 154 from the first position to the second position and fixing the plunger 154 in the second position, thereby fixing the relative position of the inner shaft 200 relative to the intermediate shaft 140. Movement of the plunger 154 from the first position to the second position may retract the inner shaft 200 proximally relative to the intermediate shaft 140, thereby expanding the expandable cylindrical portion 208 of the thrombus retrieval device 202. In some embodiments, proximal retraction of the inner shaft 200 relative to the intermediate shaft 140 may also engage the stopper 702 with the ring feature 700, thereby fully expanding the self-expanding coring element 206. In some embodiments, fixation of the plunger 154 in the second position can secure the self-expanding coring element 206 and the thrombus retrieval device 202 in a fully expanded state through engagement of the stop 702 with the ring feature 700 .

[0177] In some such embodiments where the TED 202 is fully or entirely contained within the extension sheath 2300, the TED 202 can be retracted until the self-expanding coring element 206 is outside the extension sheath 2300, at which point the inner shaft 200 can be separated from the distal end 217 of the expandable cylindrical portion 208, and the plunger 154 can be moved from the first position to the second position to fully expand the self-expanding coring element 206. The TED 202 can then be further retracted, and the expandable cylindrical portion 208 can be expanded by gradually reconnecting the distal end 217 of the expandable cylindrical portion 208 to the inner shaft 200 as the expandable cylindrical portion 208 exits the extension sheath 2300, until the expandable cylindrical portion 208 has fully exited the extension sheath 2300 and is fully expanded, wherein the distal end 217 of the expandable cylindrical portion 208 is reconnected to the inner shaft 140. Alternatively, in some embodiments, the distal end 217 of the expandable cylindrical portion 208 can remain decoupled from the inner shaft 140 until the expandable cylindrical portion 208 has fully exited the extension sheath 2300. Once the expandable cylindrical portion 208 has fully exited the extension sheath 2300, the distal end 217 of the expandable cylindrical portion 208 can be recoupled to the inner shaft 200 and the expandable cylindrical portion 208 can be expanded to be fully expanded.

[0178] 25-A to 25-H, the process of removing a thrombus 2200 by an expanded thrombus retrieval device 202 is shown. In some embodiments, the thrombus 2200 can be removed by retracting the thrombus retrieval device 202 proximally through the thrombus 2200 and capturing the thrombus in the thrombus retrieval device 202, and the thrombus 2200 can be retracted proximally, for example, along the direction of blood flow through the blood vessel 2202 or in the opposite direction of blood flow through the blood vessel 2202. In some embodiments, the proximal retraction of the thrombus retrieval device 202 through the thrombus 2200 can cause the capture of the distal end 2206 of the thrombus 2200 to occur before the capture of the proximal end 2204 of the thrombus 2200.

[0179] In some embodiments, the proximal retraction of the thrombus extraction device 202 may result in separation and / or coring of at least a portion of the thrombus 2200 from the wall 2220 of the blood vessel 2202 by, for example, the self-expanding coring element 206 and / or the stent portion, and the capture of the separated portion of the thrombus 2200 within the expandable cylindrical portion 208. In some embodiments, the expandable cylindrical portion 208 may be formed of a woven wire mesh structure, which may be, for example, a network-like wire mesh structure. In some embodiments, a portion of the thrombus may be captured within the expandable cylindrical portion 208 by entering the expandable cylindrical portion 208 through the mouth 414 of the self-expanding coring element 206 and / or through one or more interstices 404 of the self-expanding coring element 206.

[0180] As seen in FIG. 25-A , the distal end 2206 of the thrombus 2200 is separated and / or cored from the wall 2220 of the blood vessel 2202 by the self-expanding coring element 206 through the proximal retraction of the thrombus retrieval device 202. As seen in FIG. 25-B , the distal end 2206 of the thrombus 2200 is captured in the expandable cylindrical portion 208 of the thrombus retrieval device through the thrombus 2200 through continued proximal retraction of the thrombus retrieval device. The separation and capture and / or coring and capture of other portions of the thrombus 2200 through continued proximal retraction of the thrombus retrieval device 202 are shown in FIGS. 25-C , 25-D , and 25-E . As seen in FIG. 25-E , the proximal end 2204 of the thrombus 2200 is cored and captured as the thrombus retrieval device 202 is proximally retracted toward the self-expanding funnel 1708.

[0181] In some embodiments, as seen in FIG. 25-F , the thrombus retrieval device 202 can be retracted proximally until a portion of the self-expanding coring element 206 is contained within the self-expanding funnel 1708, specifically until the ostium 414 of the self-expanding coring element 206 is contained within the self-expanding funnel 1708. In some embodiments, the ostium 414 can be verified to be contained within the self-expanding funnel 1708 by fluoroscopy. In some embodiments, based on the alignment / relative positioning of the distal end 212 of the intermediate shaft 140 including the radiopaque marker 2450 and / or the radiopaque marker 222 relative to the distal end 110 of the elongated member 106 of the introducing sheath 102 including the radiopaque marker 2452, it can be determined by fluoroscopic monitoring that the ostium 414 is entirely contained within the self-expanding funnel 1708.

[0182] When a portion of the self-expanding coring element 206 is contained within the self-expanding funnel 1708, or specifically when the mouth 414 of the self-expanding coring element 206 is entirely contained within the self-expanding funnel 1708, the plunger 154 can be unlocked from the second position and can be moved from the second position to the first position, thereby moving the thrombus extraction device 202 from the expanded configuration to the non-expanded configuration. In some embodiments, the unlocking of the plunger 154 from the second position can unlock and / or separate the inner shaft 200 relative to the intermediate shaft 140, and moving the plunger 154 from the second position to the first position can cause the inner shaft 200 to advance distally relative to the intermediate shaft 140.

[0183] In some embodiments, by moving the thrombus retrieval device 202 from the expanded configuration to the non-expanded configuration before withdrawing the thrombus retrieval device 202 from the patient's body, the thrombus retrieval device 202 can collapse, thereby compressing the thrombus 2200 captured by the thrombus retrieval device 202. In some embodiments, the compression of the thrombus 2200 by the thrombus retrieval device 202 can fix the position of the thrombus within the thrombus retrieval device 202, which is achieved in some embodiments by the engagement of one or more of the plurality of circumferential recesses 1000 with the thrombus 2200.

[0184] As shown in FIG. 25-G , after the thrombus retrieval device 202 has collapsed, the thrombus retrieval device 202 may be retracted proximally through the self-expanding funnel 1708 into the elongated member 106. In some embodiments, the collapse of the thrombus retrieval device 202 and / or the retraction of the thrombus retrieval device 202 into the self-expanding funnel 1708 and / or the elongated member may cause all or part of the thrombus 2200 to be extruded through the pores of the expandable cylindrical portion 208 of the thrombus retrieval device 202, which pores include, for example, some or all of the first plurality of pores 904 and / or the second plurality of pores 906. In some embodiments, all or part of the thrombus 2200 may be extruded through some or all of the second plurality of pores 906, which may be larger than the first plurality of pores 904. In some embodiments, the size of the pores in the second plurality of pores 906 may be sufficiently small that any portion of the thrombus 2200 that is extruded through the pores is sufficiently small to have little or no clinical significance. In some embodiments, all or portions of these extruded portions of the thrombus 2200 may be captured by the self-expanding funnel 1708 .

[0185] As shown in FIG. 25-H , the thrombus retrieval device 202 may continue to be retracted proximally until the thrombus retrieval device 202 and the captured thrombus 2200 are completely contained within the elongated member 106. In some embodiments, the sealing expander 170 may be inserted into the sealing hole 112, and then the thrombus retrieval device 202 and the captured thrombus 2200 may be withdrawn or removed from the patient and from the elongated member 106 through the sealing hole 112 in the sealing expander 170. In some embodiments, the thrombus captured by the self-expanding funnel 1708 may then be guided into the elongated member 106, specifically into the lumen 1701 of the elongated member 106, or further compressed and / or broken by the self-expanding funnel 1708, and then allowed to pass through the self-expanding funnel 1708 and specifically through the mesh of the self-expanding funnel 1708. In some embodiments, the thrombus may be extracted through the lumen 1701 of the elongated member 106 and the extract port 114. In some embodiments, extraction of the thrombus via the extraction port 114 may include opening the extraction valve 118. After the thrombus captured by the self-expanding funnel 1708 is extracted, the introducing sheath 102 may be removed from the patient.

[0186] Reference Fig.26-28, shows an introduction technique for accessing a thrombus 2200. In some embodiments, these introduction techniques may allow the use of a larger sized introduction sheath 102 due to the larger size of the blood vessels in the path to the thrombus. In some embodiments, since in some embodiments, the size of the lumen 1701 of the introduction sheath 102 may increase as the size of the introduction sheath 102 increases, the larger size of the introduction sheath 102 may facilitate the removal of the thrombus through the introduction sheath 102. In addition, in some embodiments, the use of a larger sized introduction sheath 102 may allow for the removal of larger thrombi. In some embodiments, the lengths of the components of the thrombus extraction system 100, particularly the lengths of the introduction sheath 102 and the thrombus extraction catheter 104, may vary based on the technique selected for accessing the thrombus and / or based on the positioning of the thrombus.

[0187] like Fig.26 As shown in FIG. 1 , the introducing sheath 102 can be inserted into the patient's body via the internal jugular access site 2500. The introducing sheath 102 can extend from the internal jugular access site 2500 to a deployment position 2502, which can be proximal to the thrombus 2200. In embodiments where the introducing sheath 102 includes a self-expanding funnel 1708, the self-expanding funnel 1708 can be deployed at the deployment position 2502. Fig.26 In the embodiment shown in , the introducer sheath can extend from the internal jugular access site 2500 through the superior vena cava and the inferior vena cava to a deployment location 2502 in one of the common iliac veins. In some embodiments, the deployment location 2502 can be located, for example, in the inferior vena cava, in one of the iliac veins, the femoral vein, the popliteal vein, in front of or beyond the iliac arch, or at any other location near the thrombus 2200 and / or proximal to the thrombus 2200. In some embodiments, the use of the internal jugular access site 2500 can allow for a larger diameter of the elongated member 106.

[0188] like Fig. 27 As seen in FIG. 25 , in some embodiments, the use of the internal jugular access site 2500 can be combined with the use of an extension sheath 2300, which can be inserted into the blood vessel 2202 at the popliteal access site 2600. In some such embodiments, the thrombus retrieval device can be fully or partially removed from the patient's body while being contained in the extension sheath 2300 before being retracted through the thrombus 2200.

[0189] like Fig.28 As shown in FIG. 2 , in some embodiments, an introducer sheath may be inserted into a patient via the common iliac vein into an access site connected to a blood vessel 2202 containing a thrombus. Fig.28In the specific embodiment shown in , this can be accomplished by inserting into the patient via a femoral access site 2700. In some embodiments, the use of an access site connected to the vessel 2202 via the common iliac vein, and in particular the use of a femoral access site 2700, can be combined with the use of an extension sheath 2300, which can be inserted into the vessel 2202 at a popliteal access site 2600. In some such embodiments, the thrombus retrieval device can be removed from the patient's body in whole or in part while being contained in the extension sheath 2300 before being retracted through the thrombus 2200.

[0190] Other variations are within the spirit and scope of the invention. Thus, while specific illustrative embodiments of the invention are shown in the drawings and have been described in detail above, the invention is susceptible to various modifications and alternative constructions. However, it should be understood that it is not intended to limit the invention to the particular form or forms disclosed, but on the contrary, it is intended to cover all modifications, alternative constructions and equivalent forms that fall within the spirit and scope of the invention as defined in the appended claims.

[0191] In the above description, various embodiments of the present invention are described. For illustration, specific configurations and details are provided to provide a thorough understanding of the embodiments. However, it will be apparent to those skilled in the art that the present invention may be practiced without these specific details. In addition, well-known features may be omitted or simplified so as not to obscure the described embodiments.

[0192] In the context of describing the present invention (especially in the context of the following claims), the use of the terms "a" and "an" and "the" and similar indicators is to be understood to cover the singular and the plural, unless otherwise indicated herein or clearly contradicted by the context. Unless otherwise indicated, the terms "include", "have", "have" and "include" are to be understood as open terms (i.e., meaning "including but not limited to"). Even if there are objects inserted in between, the term "connected" is to be understood as being partially or fully included in "attached to" or "linked together". Unless otherwise indicated herein, the enumeration of numerical ranges herein is intended only as a shorthand method of individually referring to each independent value falling within the range, and each independent value is included in the application document as if it were individually listed herein. Unless otherwise indicated herein or clearly contradicted by the context, all methods described herein may be performed in any suitable order. Unless otherwise stated, the use of any and all examples or exemplary language (e.g., "such as") herein is intended only to better illustrate the embodiments of the present invention without causing limitation to the scope of the present invention. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0193] Preferred embodiments of the present invention are described herein, including the best mode known to the inventor for carrying out the present invention. After reading the foregoing description, variations of these preferred embodiments may become apparent to those skilled in the art. The inventors expect that the technical personnel will appropriately adopt these variations, and the inventors expect that the present invention will be practiced differently from that specifically described herein. Thus, the present invention includes all modifications and equivalent forms of the subject matter described in the appended claims as permitted by applicable law. In addition, unless otherwise indicated herein or clearly contradictory to the context, the present invention encompasses any combination of the above-mentioned elements with all possible variations.

[0194] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

Claims

1. An introduction sheath assembly, the introduction sheath assembly comprising: an elongated sheath having a proximal portion and a distal portion, wherein the elongated sheath defines an insertion lumen extending between the proximal portion and the distal portion; an expandable funnel coupled to the distal portion of the elongated sheath and configured to expand from a constrained configuration to an expanded configuration; as well as A slender obturator configured to be positioned within the insertion lumen, wherein the obturator includes a capture feature configured to retain the expandable funnel in the constrained structure, wherein the obturator is distally advanceable through the insertion lumen and / or the slender sheath is proximally retractable relative to the obturator to move the capture feature from above the expandable funnel to allow the expandable funnel to self-expand to the expanded structure, and wherein the capture feature includes a connecting fitting configured to sealingly engage with the distal portion of the slender sheath when the capture feature extends above the expandable funnel to retain the expandable funnel in the constrained structure.

2. The introduction sheath assembly according to claim 1, characterized in that The obturator includes an elongated shaft and a capture shell coupled to a distal portion of the elongated shaft, wherein the elongated shaft and the capture shell define a lumen therebetween, and wherein the lumen includes the capture feature and is shaped and sized to retain the expandable funnel in the constrained structure.

3. The introduction sheath assembly according to claim 1, characterized in that Also included is a sealing hub fluidly coupled to the insertion lumen at a proximal end portion of the elongated sheath.

4. The introduction sheath assembly according to claim 3, characterized in that: The sealing hub includes an extract port.

5. The introduction sheath assembly according to claim 1, characterized in that: When the expandable funnel is in the constrained configuration, a diameter of the expandable funnel is equal to or less than a diameter of the elongated sheath.

6. The introduction sheath assembly according to claim 1, characterized in that The obturator includes an atraumatic tip positioned at a distal portion thereof.

7. The introduction sheath assembly according to claim 1, characterized in that: The expandable funnel is permeable to blood.

8. The introduction sheath assembly according to claim 1, characterized in that The expandable funnel has a tapered shape in the expanded configuration.

9. The introduction sheath assembly according to claim 1, characterized in that: The expandable funnel is constructed from at least one of a battlemented nitinol braid, a nitinol braided stent, laser cut nitinol, a laser cut polymer tube, an injection molded polymer structure, or an inflatable balloon.

10. A thrombectomy system for removing a vascular thrombus from a patient's blood vessel, the thrombectomy system comprising: A thrombus extraction device, the thrombus extraction device comprising: proximal self-expanding coring element; a distal expandable element formed of a mesh structure, the distal expandable element having a proximal portion attached to the distal portion of the coring element; a catheter defining a lumen configured to constrain the thrombus retrieval device; an intermediate shaft coupled to a proximal portion of the coring element; an inner shaft coupled to the distal portion of the expandable member and slidably displaceable relative to the intermediate shaft to control expansion of the expandable member; as well as An introduction sheath assembly, the introduction sheath assembly comprising— an elongated sheath defining an insertion lumen; an expandable funnel coupled to a distal portion of the elongated sheath; as well as A slender obturator, the slender obturator including a capture feature configured to retain the expandable funnel in a constrained structure, wherein the obturator is distally advanceable through the insertion lumen and / or the slender sheath is proximally retractable relative to the obturator to move the capture feature from above the expandable funnel to allow the expandable funnel to self-expand to an expanded structure, and wherein the capture feature includes a connecting fitting configured to sealingly engage with the distal portion of the slender sheath when the capture feature extends above the expandable funnel to retain the expandable funnel in the constrained structure.

11. The thrombectomy system according to claim 10, characterized in that: The coring element is formed of an integrally porous structure and is configured to core and separate a portion of a vascular thrombus from the blood vessel, and wherein the expandable element is configured to capture the portion of the vascular thrombus.

12. The thrombectomy system according to claim 10, characterized in that: The coring element includes a support.

13. The thrombectomy system according to claim 12, characterized in that: The stent includes a ring feature slidably coupled to the inner shaft, wherein the inner shaft includes a stop feature fixed to the inner shaft, and wherein the stop feature is configured to engage the ring feature when the expandable element and the stent are in a fully expanded state.

14. The thrombectomy system according to claim 13, characterized in that: Also included is a locking mechanism configured to secure the inner shaft relative to the intermediate shaft when the expandable member and the stent are in a fully expanded state.

15. The thrombectomy system according to claim 14, characterized in that: The locking mechanism is configured to maintain a desired radial force on the vessel wall when the stent is compressed.

16. The thrombectomy system according to claim 14, characterized in that: The locking mechanism movably fixes the inner shaft relative to the intermediate shaft via a spring.

17. The thrombectomy system according to claim 10, characterized in that: The proximal portion of the coring element is coupled to the intermediate shaft via a plurality of struts extending at a coring angle relative to a longitudinal axis of the thrombus retrieval device.

18. The thrombectomy system according to claim 10, characterized in that: The obturator comprises an elongated shaft having a distal end portion, wherein the elongated sheath capture feature is positioned proximate the distal end portion of the elongated shaft of the obturator, and wherein the obturator is configured to be received within the insertion lumen of the elongated sheath.

19. The thrombectomy system according to claim 10, characterized in that: The introducer sheath assembly also includes a sealing hub fluidly coupled to the insertion lumen at a proximal end portion of the elongated sheath.

20. The thrombectomy system according to claim 10, characterized in that: The obturator includes an elongated shaft and a capture shell coupled to a distal portion of the elongated shaft, wherein the elongated shaft and the capture shell define a lumen therebetween, and wherein the lumen includes the capture feature and is shaped and sized to retain the expandable funnel in the constrained structure.

21. The thrombectomy system according to claim 10, characterized in that: Also included is a sealing hub fluidly coupled to the insertion lumen at a proximal end portion of the elongated sheath.

22. The thrombectomy system according to claim 21, characterized in that: The sealing hub includes an extract port.

23. The thrombectomy system according to claim 10, characterized in that: When the expandable funnel is in the constrained configuration, a diameter of the expandable funnel is equal to or less than a diameter of the elongated sheath.

24. The thrombectomy system according to claim 10, characterized in that: The obturator includes an atraumatic tip positioned at a distal portion thereof.

25. The thrombectomy system according to claim 10, characterized in that: The expandable funnel is permeable to blood.

26. The thrombectomy system according to claim 10, characterized in that: The expandable funnel has a tapered shape in the expanded configuration.

27. The thrombectomy system according to claim 10, characterized in that: The expandable funnel is constructed from at least one of a battlemented nitinol braid, a nitinol braided stent, laser cut nitinol, a laser cut polymer tube, an injection molded polymer structure, or an inflatable balloon.

28. The thrombectomy system according to claim 10, characterized in that: The expandable funnel may have a length at least equal to the length of the coring element.

29. The thrombectomy system according to claim 10, characterized in that: The insertion lumen is sized to slidably receive the catheter.

30. The thrombectomy system according to claim 10, characterized in that: the expandable funnel comprising a proximal portion coupled to the distal portion of the elongated sheath and a distal portion defining an opening; and In the expanded configuration, the expandable funnel has a tapered shape with a diameter increasing from the proximal portion to the distal portion.

31. The thrombectomy system according to claim 10, characterized in that: The expandable funnel includes a proximal portion coupled to the distal portion of the elongated sheath and a distal portion defining an opening, and wherein the opening faces distally.

32. The thrombectomy system according to claim 10, characterized in that: The obturator includes an elongated shaft and a capture sheath coupled to the elongated shaft at a distal end portion of the obturator; The capture sheath includes a capture shell extending from a distal portion of the capture sheath to a proximal portion of the capture sheath; the capture housing having an inner diameter greater than a diameter of a portion of the elongated shaft extending through the capture housing, thereby defining a receiving space between the capture housing and the portion of the elongated shaft extending through the capture housing; the receiving space being configured to retain the expandable funnel in the constrained configuration; and The expandable funnel is configured to self-expand from the constrained configuration to the expanded configuration when the obturator is advanced distally to release the expandable funnel from the receiving space.

33. The introduction sheath assembly according to claim 1, characterized in that the expandable funnel comprising a proximal portion coupled to the distal portion of the elongated sheath and a distal portion defining an opening; and In the expanded configuration, the expandable funnel has a tapered shape with a diameter increasing from the proximal portion to the distal portion.

34. The introduction sheath assembly according to claim 1, characterized in that The expandable funnel includes a proximal portion coupled to the distal portion of the elongated sheath and a distal portion defining an opening, and wherein the opening faces distally.

35. The introduction sheath assembly according to claim 1, characterized in that The obturator includes an elongated shaft and a capture sheath coupled to the elongated shaft at a distal end portion of the obturator; The capture sheath includes a capture shell extending from a distal portion of the capture sheath to a proximal portion of the capture sheath; the capture housing having an inner diameter greater than a diameter of a portion of the elongated shaft extending through the capture housing, thereby defining a receiving space between the capture housing and the portion of the elongated shaft extending through the capture housing; the receiving space being configured to retain the expandable funnel in the constrained configuration; and The expandable funnel is configured to self-expand from the constrained configuration to the expanded configuration when the obturator is advanced distally to release the expandable funnel from the receiving space.

Images