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

Abstract

Providing endovascular treatments for vascular occlusion and related devices, systems, and methods. [Solution] A system and method for removing thrombi from blood vessels in a patient's womb are disclosed herein. The method includes providing a thrombus extraction device comprising a proximal self-expanding member formed from an integrated fenestrated structure, a distal substantially cylindrical portion formed from a reticular filament mesh structure, and an inner shaft member connected to the distal end of the reticular filament mesh structure; advancing a catheter that restrains the thrombus extraction device through the vascular thrombus; deploying the thrombus extraction device; retracting the thrombus extraction device to separate a portion of the thrombus from the blood vessel wall and capture a portion of the thrombus within the reticular filament mesh structure; and withdrawing the thrombus extraction device from the body to remove the thrombus from the patient.

Description

Technical Field

[0001] (Citation of Related Applications) This application claims the benefit of U.S. Provisional Application No. 62 / 245,935, filed Oct. 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 Sep. 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 Oct. 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 / 268,406, filed Sep. 16, 2016, entitled "INTRAVASCULAR TREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS", which is a continuation of U.S. Application No. 15 / 268,296, filed Sep. 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 Oct. 23, 2015, entitled "INTRAVASCULAR TREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS AND METHODS"; the entirety of each of the above applications is hereby incorporated by reference herein.

Background Art

[0002] A thrombus is a term for a blood clot that forms inside a blood vessel, and a venous thrombus is a blood clot that forms within a vein. The most common type of venous thrombosis is deep vein thrombosis (DVT). DVT is primarily the formation of blood clots (thrombi) in the deep veins of the legs. Nonspecific signs may include pain, swelling, redness, warmth, and hyperemia of the superficial veins.

[0003] If a blood clot breaks down (causes an embolism) and travels towards the lungs, it can become a life-threatening pulmonary embolism (PE), a blood clot in the lungs. In addition to the potential death from PE, deep vein thrombosis (DVT) can lead to significant health problems, including post-thrombotic syndromes, which can cause chronic bulging, pressure, pain, and ulcers due to valve and vascular damage. Furthermore, DVT can result in significant healthcare costs, either directly or indirectly, through the treatment of associated complications and the patient's inability to work.

[0004] Three processes are thought to lead to venous thrombosis (DVT): reduced blood flow (venous stasis), increased tendency to form clots (hypercoagulation), and changes in the vascular wall. DVT formation typically begins inside the valves of the calf veins, where the blood becomes relatively oxygen-deficient, which activates a certain biochemical pathway. Several medical conditions, including diabetes, cancer, trauma, and antiphospholipid syndrome, increase the risk of DVT. Other risk factors include aging, surgery, immobilization (bed rest, orthopedic casts, sitting during long-distance flights, etc.), mixed oral contraceptives, pregnancy, postpartum period, and genetic factors. The rate of DVT increases dramatically from childhood to old age, with approximately 1 in 1,000 adults developing it annually.

[0005] While current devices and methods exist for the prevention and / or treatment of DVT, several unresolved shortcomings remain, including a high incidence of DVT recurrence, the use of devices not designed to remove large clots, and / or complex procedures involving multiple treatment devices and / or pharmaceuticals. Therefore, new devices, systems, and methods for treating thrombosis, particularly DVT, are desired. [Overview of the project] [Problems that the invention aims to solve]

[0006] Aspects of this disclosure relate to thrombus extraction, particularly systems and methods for thrombus extraction from the peripheral vascular system. The thrombus extraction device of the present invention is designed to remove large quantities of thrombi, including mature and organized thrombi, with reduced need for pharmaceuticals such as thrombolytic agents. This reduces the risk of bleeding, post-procedure recovery time, and medical procedure costs. The thrombus extraction device may include a self-expanding cardioverter connected to a braided net to effectively cardioverte and separate large quantities of thrombi, for example, from major vessels in the venous or arterial system, while capturing the separated thrombi within the braided net. [Means for solving the problem]

[0007] In some embodiments, thrombi can be extracted via the use of a thrombectomy system comprising a thrombectomy catheter, which includes an introducer sheath having a self-expanding funnel and a thrombectomy extraction device. The thrombectomy extraction device may include a self-expanding cardioverteri portion, which may be a stent portion, and an expandable cylindrical portion, which may be a braided filament mesh. The expandable cylindrical portion may be formed on the distal end of the self-expanding cardioverteri portion to form an integrated thrombectomy extraction device. In some embodiments, the cardioverteri element may have sharp cutting edges to further enhance its ability to remove thrombi from vascular walls.

[0008] One aspect of this disclosure relates to a method for treating deep vein thrombosis in the peripheral vascular system of a patient. The method includes providing a thrombus extraction device comprising a proximal self-expanding cardiovertergaseous portion, which may be a stent formed from an integrated fenestrated structure, and a distal expandable cylindrical portion, which may be tubular formed from a braided filament mesh structure. In some embodiments, the mesh structure is formed integrally with the fenestrated structure such that the proximal end of the mesh structure is attached to the distal end of the fenestrated structure. The method includes advancing a catheter that restrains the thrombus extraction device through a vascular thrombus in a venous vessel. In some embodiments, an intermediate shaft extends slidably through the catheter, its distal end being coupled to the proximal end of the fenestrated structure. In some embodiments, an inner shaft extends slidably through the intermediate shaft, its distal end being coupled to the distal end of the mesh structure. The method includes deploying the thrombus extraction device from the catheter from a restrained configuration to an expanded configuration. In some embodiments, when fully expanded, the thrombus extraction device penetrates distally past a portion of the vascular thrombus and engages with at least the wall of a venous vessel. This method includes the step of retracting the thrombus extraction device proximal to the cardioverter so that the cardioverterter portion decardiates a portion of the vascular thrombus and separates it from the venous vessel wall, while the mesh structure captures the vascular thrombus portion. This method also includes the step of withdrawing the thrombus extraction device from the patient and removing the vascular thrombus portion from the venous vessel.

[0009] In some embodiments, the step of advancing the catheter includes inserting the catheter into a venous vessel until the radiopaque distal tip of the catheter has passed distal to the vascular thrombus. In some embodiments, the step of deploying the thrombus extraction device from the catheter from a constrained configuration to an extended configuration includes advancing the intermediate shaft distally until the decardiocele portion of the thrombus extraction device has passed the distal end of the catheter.

[0010] In some embodiments, the step of deploying the thrombus extraction device further includes locking the intermediate shaft with respect to the catheter; engaging a stop feature fixed on the inner shaft with a corresponding feature on a stent portion slidably connected to the inner shaft for full expansion of the thrombus extraction device; retracting the inner shaft with respect to the catheter and intermediate shaft until the stent portion maintains sufficient radial force on the venous vessel wall when fully expanded, decardializing and separating the vascular thrombus; and dynamically coupling the inner shaft with respect to the intermediate shaft. In some embodiments, the decardializing portion has a decardializing angle of 30 to 45 degrees when the thrombus extraction device is fully expanded. In some embodiments, the step of deploying the thrombus extraction device further includes determining the position of the thrombus extraction device with respect 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, inner shaft, stent portion, or mesh structure.

[0011] In some embodiments, the vascular thrombus is captured within the mesh structure by entering the expandable tubular and / or cylindrical portion through an opening or opening located at least at the proximal end of the self-expanding stent portion. In some embodiments, the method includes the step of inserting a catheter into a venous vessel through an access site, which is a popliteal access site, a femoral access site, or an internal jugular access site. In some embodiments, the venous vessel has a diameter of at least 5 millimeters and is at least one of the femoral vein, iliac vein, popliteal vein, posterior tibial vein, anterior tibial vein, or peroneal vein.

[0012] In some embodiments, the method further includes the steps of: percutaneously accessing the patient's venous vessels using an induction sheath through an access site within the patient's venous vessels; advancing the distal end of the induction sheath to the proximal position of the vascular thrombus; deploying a self-expanding funnel on the distal end of the induction sheath; and inserting a catheter through the lumen of the induction sheath so that the distal tip of the catheter passes distally to the vascular thrombus. In some embodiments, the step of deploying the self-expanding funnel includes advancing an occlusion having a capture sheath feature on its distal end to withdraw the self-expanding funnel from a constrained configuration within the capture sheath feature to an expanded configuration freed from the capture sheath feature; and removing the occlusion from the induction sheath by retracting the occlusion through or outside the expanded self-expanding funnel and through or outside the lumen of the induction sheath. In some embodiments, the step of withdrawing the thrombus extraction device from the patient includes the steps of retracting the thrombus extraction device against the introducer sheath until the opening of the self-expanding stent portion is inside the self-expanding funnel; crushing the stent portion and mesh structure so as to compress the vascular thrombus portion into it; retracting the stent portion and mesh structure into the introducer sheath; and removing the thrombus extraction device from the introducer sheath.

[0013] In some embodiments, the method further includes the step of extruding at least some of the vascular thrombus portions through pores located in the distal portions of the expandable tubular and / or cylindrical portions to capture at least some of the vascular thrombus portions in the self-expanding funnel, or further compressing at least one fragment of the vascular thrombus portion through the mesh of the self-expanding funnel. In some embodiments, the method further includes the step of aspirating at least one fragment of the vascular thrombus portion remaining in the self-expanding funnel from the venous vessel through a suction port connected to the proximal end of the inlet sheath.

[0014] In some embodiments, the method further includes verifying, via fluoroscopy, that the opening of the self-expanding stent portion is within the self-expanding funnel, prior to the step of collapsing the stent portion and mesh structure. In some embodiments, the step of collapsing the stent portion and mesh structure includes separating the inner shaft and the intermediate shaft, and advancing the inner shaft distally relative to the intermediate shaft. In some embodiments, the method includes injecting or aspirating a thrombolytic agent into or from a venous vessel before, during, or after thrombus extraction.

[0015] One aspect of this disclosure relates to a method for treating deep vein thrombosis in a patient's peripheral vascular system. The method includes the steps of: percutaneously accessing the patient's venous vessel through a popliteal access site to the patient's venous vessel using an introducer sheath; and inserting a catheter constrained with a thrombus extraction device through the lumen of the introducer sheath so that the distal end of the catheter distally passes a portion of the vascular thrombus in the venous vessel, wherein the thrombus extraction device includes a proximal self-expanding stent portion formed from an integrated fenestrated structure and a distal expandable tubular and / or cylindrical portion formed from a braided filament mesh structure. In some embodiments, the proximal end of the mesh structure is attached to the distal end of the fenestrated structure. The method includes the step of deploying the thrombus extraction device from the catheter to an expanded configuration by advancing an intermediate shaft distally until the stent portion of the thrombus extraction device passes the distal end of the catheter, wherein the intermediate shaft extends slidably through the catheter and its distal end is coupled to the proximal end of the fenestrated structure. The method includes the step of retracting the thrombus extraction device proximal to the stent portion so that it decardiages a portion of the vascular thrombus and separates it from the venous wall, while the mesh structure captures the vascular thrombus portion. The method also includes the step of withdrawing the thrombus extraction device from the patient.

[0016] In some embodiments, the step of deploying the thrombus extraction device further includes retracting the inner shaft relative to the catheter and intermediate shaft until a stopping feature on the inner shaft engages with a corresponding feature on the stent portion for full expansion of the thrombus extraction device. In some embodiments, the stent portion maintains sufficient radial force on the venous vessel wall to decardiate and separate the vascular thrombus portion upon full expansion, and in some embodiments, the inner shaft extends slidably through the intermediate shaft, its distal end being coupled to the distal end of a mesh structure. In some embodiments, the method includes deploying a self-expanding funnel on the distal end of the injector sheath proximal to the vascular thrombus. In some embodiments, the step of deploying a self-expanding funnel includes advancing an occlusion device having a capture sheath feature on its distal end to withdraw the self-expanding funnel from a constrained configuration within the capture sheath feature to an deployed configuration freed from the capture sheath feature, and removing the occlusion device from the introducer sheath by retracting the occlusion device through or outside the deployed self-expanding funnel and through or outside the lumen of the introducer sheath.

[0017] One aspect of the present disclosure relates to a method for removing a thrombus from a blood vessel in a patient's body, the blood vessel may be an artery or a vein. The method includes providing a thrombus extraction device comprising a proximal self-expanding member formed from an integrated fenestrated structure, a distal substantially cylindrical portion formed from a reticular filament mesh structure attached to the integrated fenestrated structure, and an inner shaft member connected to the distal end of the reticular filament mesh structure; advancing a catheter that restrains the thrombus extraction device through a vascular thrombus; deploying the thrombus extraction device by either advancing the thrombus extraction device beyond the distal end of the catheter or retracting the catheter relative to the thrombus extraction device, thereby exposing the thrombus extraction device distally past a portion of the thrombus and allowing the expansion of the thrombus extraction device to engage with the wall of the blood vessel. The method includes retracting the thrombus extraction device to separate a portion of the thrombus from the vascular wall and to capture a portion of the thrombus within the reticular filament mesh structure; and withdrawing the thrombus extraction device from the body and removing the thrombus from the patient.

[0018] In some embodiments, the step of advancing the catheter includes inserting the catheter into the blood vessel until the radiopaque distal tip of the catheter has passed distal to the thrombus. In some embodiments, the reticular filament mesh structure is formed integrally with the fenestrated structure such that the proximal end of the reticular filament mesh structure is attached to the distal end of the fenestrated structure. In some embodiments, the self-expanding member of the thrombus extraction device includes a stent portion, and the step of retracting the thrombus extraction device further includes decardiacing the thrombus portion from the blood vessel wall using the stent portion. In some embodiments, the thrombus portion is captured using the reticular filament mesh structure by entering the reticular filament mesh structure through at least one opening or opening located at the proximal end of the stent portion.

[0019] In some embodiments, the thrombus extraction 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 is coupled to the proximal end of a fenestrated structure. In some embodiments, the method includes the step of retracting the inner shaft member relative to the catheter and the intermediate shaft until a stop feature fixed on the inner shaft member engages with a corresponding feature on the fenestrated structure for full extension of the thrombus extraction device, locking the inner shaft member against the intermediate shaft. In some embodiments, the inner shaft member can be dynamically locked against the intermediate shaft.

[0020] In some embodiments, the method includes a step of crushing the thrombus extraction device so as to compress the thrombus portion into it, prior to the step of withdrawing the thrombus extraction device from the body. In some embodiments, the crushing step includes a step of disengaging the inner shaft member and the intermediate shaft and advancing the inner shaft member distally relative to the intermediate shaft.

[0021] In some embodiments, the method includes the step of fluoroscopically monitoring the deployment of the thrombus extraction device and, based on the position of a first radiopaque marker located on the catheter relative to a second radiopaque marker located on the thrombus extraction device, stopping the advancement of the thrombus extraction device beyond the distal end of the catheter or the retraction of the catheter relative to the thrombus extraction device. In some embodiments, the thrombus is located in the patient's peripheral vascular system, and the vessel has a diameter of at least 5 millimeters and includes at least one of the femoral vein, iliac vein, popliteal vein, posterior tibial vein, anterior tibial vein, or peroneal vein.

[0022] In some embodiments, the method includes the steps of percutaneously accessing a potentially venous vessel in the patient through a popliteal access site using an induction sheath, and inserting a catheter into the patient's venous vessel through the lumen of the induction sheath. In some embodiments, the method includes percutaneously accessing a patient's venous vessel through a femoral access site using an induction sheath, and inserting a catheter into the patient's venous vessel through the lumen of the induction sheath, wherein the thrombus extraction device extends into the popliteal sheath, and the retraction of the thrombus by the extraction device is in the direction of blood flow. In some embodiments, the method includes percutaneously accessing a patient's venous vessel through an internal jugular access site using an induction sheath, and inserting a catheter into the patient's venous vessel through the lumen of the induction sheath, wherein the thrombus extraction device extends into the popliteal sheath extending from the patient, and the retraction of the thrombus by the extraction device is in the direction of blood flow. In some embodiments, the method includes the step of injecting or aspirating a thrombolytic agent into or from the blood vessel before, during, or after thrombus extraction.

[0023] One aspect of this disclosure relates to a thrombus extraction device for removing vascular thrombi from a patient's blood vessels. The thrombus extraction device is a catheter having a proximal end and a distal end, an outer shaft defining a first lumen, an intermediate shaft defining a second lumen, and an inner shaft, wherein the intermediate shaft is coaxial with the first lumen and the inner shaft is coaxial with the second lumen; a proximal self-expanding cardioverter-element formed from an integrated fenestrated structure having a proximal end and a distal end, configured to decardiaconstrict and separate a portion of a vascular thrombus from the blood vessel, wherein the proximal end of the fenestrated structure is coupled to the distal end of the intermediate shaft; and a distal expandable cylindrical portion formed from a braided filament mesh structure having a proximal end and a distal end, configured to capture a portion of the vascular thrombus, wherein the proximal end of the mesh structure is attached to the distal end of the fenestrated structure and the distal end of the mesh structure is coupled to the distal end of the inner shaft. In some embodiments, the full expansion of the mesh structure and the fenestrated structure varies based on the position of the intermediate shaft relative to the inner shaft of the catheter.

[0024] In some embodiments, the decongestant element includes a stent. In some embodiments, the stent includes a ring feature slidably coupled to an inner shaft and / or one or more supports of the stent, the inner shaft includes a stop feature fixed to the inner shaft, the stop feature being configured to engage with the ring feature when the mesh structure and the stent are in full extension.

[0025] In some embodiments, the device includes a mesh structure and a locking mechanism that can secure the inner shaft to the intermediate shaft when the stent is fully extended. 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 secures the inner shaft movably to the intermediate shaft via a spring.

[0026] In some embodiments, the proximal end of the mesh structure is integrally formed with the distal end of the fenestrated structure to create an integral structure. In some embodiments, the debulking element and the mesh structure are receivable within the outer shaft. In some embodiments, the debulking element and the mesh structure are in a constrained configuration when received within the outer shaft and in an expanded configuration when released from the constraint of the outer shaft.

[0027] In some embodiments, the mesh structure includes a plurality of radially spaced ribs or grooves longitudinally spaced between the proximal and distal ends of the mesh structure. In some embodiments, the mesh structure has a first pore size at a proximal portion and a second pore size at a distal portion, and the first pore size is different from the second pore size. In some embodiments, the second pore size is greater than the first pore size.

[0028] In some embodiments, the proximal end of the fenestrated structure is coupled to the distal end of the intermediate shaft via a plurality of struts extending at a debulking angle relative to the longitudinal axis of the thrombectomy device. In some embodiments, the debulking angle is in the range of 30 degrees to 45 degrees. In some embodiments, the debulking element has a length in the range of 25 millimeters to 100 millimeters, for example, in a crushed state, and the mesh structure has a length in the range of 100 millimeters to 500 millimeters. In some embodiments, the debulking element has a diameter in the range of 8 millimeters to 25 millimeters when fully expanded, and the mesh structure has a diameter in the range of 8 millimeters to 25 millimeters when fully expanded.

[0029] In some embodiments, the fenestrated structure includes a plurality of interconnected struts. In some embodiments, the proximal end of the fenestrated structure has fewer struts than the distal end of the fenestrated structure, thereby promoting the collapse of the decagonal element and promoting the maintenance of the decagonal orientation when the vessel is tortuous. In some embodiments, the fenestrated structure includes a plurality of interconnected struts that define an opening at the proximal end of the fenestrated structure. In some embodiments, at least some of the plurality of interconnected struts defining the opening include a sharp proximal margin.

[0030] In some embodiments, the device includes a first radiopaque marker located on the outer shaft and a second radiopaque marker located on the distal end of the inner shaft. In some embodiments, the device includes a locking mechanism that can fix the relative position of the outer shaft with respect to the intermediate shaft. In some embodiments, the device includes a handle that includes a plunger that can control and selectively fix the relative position of the inner shaft with respect to the intermediate shaft.

[0031] One aspect of the present disclosure relates to an introducer sheath for accessing and removing a thrombus in a patient's blood vessel. The introducer sheath includes an elongated sheath having a proximal end, a distal end, and a lumen extending between them; and an occluder having an elongated shaft having a self-expanding funnel attached to the distal end of the elongated sheath and a capture sheath positioned close to the distal end of the occluder, wherein the capture sheath can hold the self-expanding funnel in a constrained configuration and the occluder is configured to be received into the lumen of the elongated sheath.

[0032] In some embodiments, the introducer sheath includes a sealed hub located at the proximal end of the elongated sheath. In some embodiments, the sealed hub includes a suction port. In some embodiments, the self-expanding funnel has a diameter equal to or smaller than the diameter of the elongated sheath when the self-expanding funnel is in a constrained configuration. In some embodiments, the occlusion device includes a non-traumatic tip located at the distal end of the occlusion device, and the non-traumatic tip is radiopaque. In some embodiments, the occlusion device includes a connecting fitting configured to seal with 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 conical shape formed from at least one of the following: castle-style nitinol braid, nitinol braid stent, laser-cut nitinol, laser-cut polymer tubing, injection-molded polymer structure, or inflatable balloon.

[0033] One aspect of the present disclosure relates to a method for accessing a patient's venous vessel and removing a thrombus therefrom. The method includes the steps of: providing an introducer sheath, which includes an elongated sheath defining a lumen; a self-expanding funnel attached to the distal end of the elongated sheath; and an elongated occluder extending through the lumen and holding the self-expanding funnel in a constrained configuration within the occluder's capture sheath; percutaneously accessing a patient's venous vessel through an access site using the introducer 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 introducer sheath to the proximal position of the thrombus; deploying the self-expanding funnel from a constrained configuration within the capture sheath to an expanded configuration released from the capture sheath; capturing the thrombus within the self-expanding funnel; and aspirating the captured material through the lumen of the elongated sheath.

[0034] In some embodiments, the step of deploying the self-expanding funnel includes removing the occlusion from the introducer sheath by advancing the occlusion distally to the elongated sheath, withdrawing the self-expanding funnel from a constrained configuration to an expanded configuration, and retracting the occlusion proximally through the deployed self-expanding funnel and through the lumen of the elongated sheath. In some embodiments, the step of deploying the self-expanding funnel includes retracting the sheath proximally over the occlusion by retracting the occlusion proximally through or outside the deployed self-expanding funnel and through or outside the lumen of the elongated sheath, withdrawing the self-expanding funnel from a constrained configuration to an expanded configuration, and removing the occlusion from the introducer sheath.

[0035] In some embodiments, the method includes inserting a catheter that restrains a thrombus extraction device through the lumen of an elongated sheath so that the distal tip of the catheter passes distal to the vascular thrombus; deploying the thrombus extraction device from the catheter; and retracting the thrombus extraction device proximal to the introducer sheath until the opening of the thrombus extraction device is in a self-expanding funnel. In some embodiments, the method includes pushing out 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 the pushed-out portion of the thrombus captured by the thrombus extraction device.

[0036] One aspect of this disclosure relates to a thrombectomy system for removing vascular thrombi from a patient's blood vessels. The thrombectomy system includes a thrombectomy catheter, which includes a thrombectomy device. The thrombectomy device includes a proximal self-expanding cardioverter, which is formed from an integrated fenestrated structure, and a distal expandable cylindrical portion, which is formed from a braided filament mesh structure having a proximal end attached to the distal end of the fenestrated structure. The thrombectomy system includes a catheter, which includes a lumen that restrains the thrombectomy device, an intermediate shaft connected to the proximal end of the self-expanding cardioverter, and an inner shaft connected to the distal end of the expandable cylindrical portion, which is slidably displaceable relative to the intermediate shaft and controls the expansion of the expandable cylindrical portion. The thrombectomy system includes an introduction sheath, which includes an elongated sheath defining an insertion lumen, an elongated occlusion device, which includes a self-expanding funnel attached to the distal end of the elongated sheath, and a sheath capture feature configured to hold the self-expanding funnel in a restrained configuration.

[0037] In some embodiments, the occlusion device includes a connecting fitting configured to be received into the lumen of an elongated sheath and to seal with the distal end of the elongated sheath. In some embodiments, the self-expanding funnel has a length at least equal to the length of the self-expanding decardiaconite element. In some embodiments, the inlet sheath includes a self-sealing opening located at the proximal end of the inlet sheath.

[0038] In some embodiments, the thrombectomy system includes an opening dilator sized to be receivable within a self-sealing opening and having an inner diameter larger than the diameter of the self-sealing opening in a sealed configuration. In some embodiments, the inlet sheath includes a suction port located at the proximal end of the inlet sheath, the suction port being selectively fluidly connected to the insertion lumen via a suction valve.

[0039] In some embodiments, the insertion lumen is sized to slidably receive the thrombus extraction catheter. In some embodiments, an expandable cylindrical portion is formed on a self-expanding cardioverter-cardiac element to form an integrated thrombus extraction device.

[0040] One aspect of the present disclosure relates to a method for manufacturing an integrated thrombus extraction device, comprising a proximal fenestrated structure including a plurality of supports, and a distal reticular filament mesh structure formed on the distal end of the fenestrated structure. The method includes the steps of: identifying a plurality of formation points formed by some of the plurality of supports of the integrated fenestrated structure; passing a specific pair of wires, including a first wire and a second wire overlapping the first wire, through each of the formation points; and braiding a reticular filament mesh structure from the specific pair of wires such that one of the first and second wires does not form a loop around the formation point through which the first and second wires are screwed, and the other of the first and second wires does form a loop around the formation point through which the first and second wires are screwed.

[0041] In some embodiments, the mesh filament structure is braided from specific pairs of wires such that the first wire does not form loops around the formation points through which the first wire is threaded, and the second wire does form loops around the formation points through which the second wire is threaded. In some embodiments, each formation point includes a ridge post. In some embodiments, the windowed structure includes 12 ridge posts. In some embodiments, the mesh filament mesh includes 48 wires. In some embodiments, the mesh filament structure is braided manually. In some embodiments, the mesh filament structure is braided automatically.

[0042] Further areas of availability of this disclosure will become apparent from the modes for carrying out the invention provided hereafter herein. It should be understood that the modes for carrying out the invention and specific examples illustrating various embodiments are intended for illustrative purposes only and are not necessarily intended to limit the scope of this disclosure. This specification also provides, for example, the following items: (Item 1) A method for removing a blood clot from a blood vessel in a patient's body, wherein the method is To provide a thrombus extraction device comprising a proximal self-expanding member formed from an integrated fenestrated structure, a distal substantially cylindrical portion formed from a mesh filament structure attached to the integrated fenestrated structure, and an inner shaft member connected to the distal end of the mesh filament structure, The catheter that restrains the thrombus extraction device is advanced through the vascular thrombus, The thrombus extraction device is deployed by either advancing the thrombus extraction device beyond the distal end of the catheter or retracting the catheter relative to the thrombus extraction device, thereby exposing the thrombus extraction device distally past a portion of the thrombus and enabling the expansion of the thrombus extraction device to engage with the wall of the blood vessel, The thrombus extraction device is retracted to separate a portion of the thrombus from the vascular wall, and a portion of the thrombus is captured within the reticular filament mesh structure. The thrombus extraction device is withdrawn from the body, and the thrombus is removed from the patient. Methods that include... (Item 2) The method according to item 1, wherein advancing the catheter includes inserting the catheter into the blood vessel until the radiopaque distal tip of the catheter has passed distal to the thrombus. (Item 3) The method according to any one of items 1 to 2, wherein the mesh filament structure is integrally formed with the fennel structure such that the proximal end of the mesh filament structure is attached to the distal end of the fennel structure. (Item 4) The method according to any one of items 1 to 3, wherein the self-expanding member of the thrombus extraction device comprises a stent portion, and retracting the thrombus extraction device further comprises using the stent portion to decardiate the thrombus portion from the blood vessel wall. (Item 5) The method according to item 4, wherein the thrombus portion is captured by the reticular filament mesh structure by entering the reticular filament mesh structure through at least one opening or opening located at the proximal end of the stent portion. (Item 6) The thrombus extraction device is advanced beyond the distal end of the catheter by advancing an intermediate shaft distally through the catheter, the intermediate shaft extends slidably through the catheter, and the distal end of the intermediate shaft is coupled to the proximal end of the fenestrated structure, according to any one of items 1 to 5. (Item 7) The method of item 6, further comprising retracting the inner shaft member relative to the catheter and the intermediate shaft until a stop feature fixed on the inner shaft member engages with a corresponding feature on the fenestrated structure for full expansion of the thrombus extraction device, thereby locking the inner shaft member against the intermediate shaft. (Item 8) The method of item 7, further comprising crushing the thrombus extraction device so as to compress the thrombus portion into it, prior to withdrawing the thrombus extraction device from the body. (Item 9) The method according to item 8, wherein the crushing includes disengaging the inner shaft member from the intermediate shaft and advancing the inner shaft member distally relative to the intermediate shaft. (Item 10) The method according to any one of items 1 to 9, further comprising fluoroscopically monitoring the deployment of the thrombus extraction device and, based on the position of a first radiopaque marker located on the catheter relative to a second radiopaque marker located on the thrombus extraction device, discontinuing the advance of the thrombus extraction device beyond the distal end of the catheter or the retraction of the catheter relative to the thrombus extraction device. (Item 11) The method according to any one of items 1 to 10, wherein the thrombus is located in the peripheral vascular system of the patient, the vessel has a diameter of at least 5 millimeters, and the vessel comprises at least one of the femoral vein, iliac vein, popliteal vein, posterior tibial vein, anterior tibial vein, or peroneal vein. (Item 12) The method according to any one of items 1 to 11, further comprising percutaneously accessing the patient's venous vessel through a popliteal access site using an introduction sheath, and inserting the catheter into the patient's venous vessel through the lumen of the introduction sheath. (Item 13) The method according to any one of items 1 to 12, wherein the patient's venous vessel is accessed percutaneously through a thigh access site using an introduction sheath, the catheter is inserted into the patient's venous vessel through the lumen of the introduction sheath, the thrombus extraction device extends into the popliteal sheath, and the retrieval of the thrombus by the extraction device is in the direction of blood flow. (Item 14) The method according to any one of items 1 to 13, wherein the patient's venous vessel is accessed percutaneously through an internal jugular access site using an introduction sheath, the catheter is inserted into the patient's venous vessel through the lumen of the introduction sheath, the thrombus extraction device extends into a popliteal sheath extending from the patient, and the retrieval of the thrombus by the extraction device is in the direction of blood flow. (Item 15) The method according to any one of items 1 to 14, further comprising injecting a thrombolytic agent into or aspirating from the blood vessel before, during, or after thrombus extraction. (Item 16) A thrombus extraction device for removing vascular thrombi from a patient's blood vessels, wherein the thrombus extraction device is A catheter having a proximal end and a distal end, an outer shaft defining a first lumen, an intermediate shaft defining a second lumen, and an inner shaft, wherein the intermediate shaft is coaxial with the first lumen, and the inner shaft is coaxial with the second lumen. A proximal self-expanding cardioverter-element is formed from an integrated fenestrated structure having a proximal and distal end, and is configured to decardiate a portion of the vascular thrombus and separate it from the blood vessel, wherein the proximal end of the fenestrated structure is connected to the distal end of the intermediate shaft, A distal expandable cylindrical portion is formed from a braided filament mesh structure having a proximal end and a distal end, and is configured to capture the vascular thrombus portion. Equipped with, A thrombus extraction device wherein the proximal end of the mesh structure is attached to the distal end of the fenestrated structure, the distal end of the mesh structure is coupled to the distal end of the inner shaft, and the full expansion of the mesh structure and the fenestrated structure varies based on the position of the intermediate shaft relative to the inner shaft of the catheter. (Item 17) The cardioverter-cardiac element is a thrombus extraction device according to any one of items 1 to 16, comprising a stent. (Item 18) The thrombus extraction device according to item 17, wherein the stent includes a ring feature slidably coupled to the inner shaft, the inner shaft comprises a stop feature fixed to the inner shaft, the stop feature being configured to engage with the ring feature when the mesh structure and the stent are in full extension. (Item 19) The thrombus extraction device according to item 18, further comprising a locking mechanism configured to fix the inner shaft relative to the intermediate shaft when the mesh structure and the stent are in full expansion. (Item 20) The thrombus extraction device according to item 19, wherein the locking mechanism is configured to maintain a desired radial force on the blood vessel wall when the stent is compressed. (Item 21) The thrombus extraction device according to item 19, wherein the locking mechanism fixes the inner shaft movably relative to the intermediate shaft via a spring. (Item 22) The thrombus extraction device according to any one of items 1 to 21, wherein the proximal end of the mesh structure is integrally formed with the distal end of the fenestrated structure to create an integrated structure. (Item 23) A thrombus extraction device according to any one of items 1 to 22, wherein the decardiocardial element and the mesh structure are receivable within the outer shaft, and the decardiocardial element and the mesh structure are in a constrained configuration when receivable within the outer shaft, and in an extended configuration when released from the constraint of the outer shaft. (Item 24) The thrombus extraction device according to any one of items 1 to 23, wherein the mesh structure comprises a plurality of radial ribs or grooves spaced longitudinally between the proximal and distal ends of the mesh structure. (Item 25) The thrombus extraction device according to any one of items 1 to 24, wherein the mesh structure has a first pore size in the proximal portion and a second pore size in the distal portion, and the first pore size is different from the second pore size. (Item 26) The thrombus extraction device according to item 25, wherein the second pore size is larger than the first pore size. (Item 27) The thrombus extraction device according to any one of items 1 to 26, wherein the proximal end of the fenestrated structure is connected to the distal end of the intermediate shaft via a plurality of supports extending at a certain decardiate angle with respect to the longitudinal axis of the thrombus extraction device. (Item 28) The thrombus extraction device described in item 27, wherein the cardiovertermination angle is in the range of 30 to 45 degrees. (Item 29) The thrombus extraction device according to any of items 1 to 28, wherein the cardioverter-cardiac element has a length in the range of 25 mm to 100 mm, and the mesh structure has a length in the range of 100 mm to 500 mm. (Item 30) The thrombus extraction device according to any of items 1 to 29, wherein the cardioverter-cardiac element has a diameter in the range of 8 mm to 25 mm when fully expanded, and the mesh structure has a diameter in the range of 8 mm to 25 mm when fully expanded. (Item 31) The thrombus extraction device according to any one of items 1 to 30, wherein the fenestrated structure comprises a plurality of interconnected supports, the proximal end of the fenestrated structure having fewer supports than the distal end of the fenestrated structure, thereby promoting the collapse of the cardioverter and promoting the maintenance of the cardioverterinary orientation when the blood vessel is tortuous. (Item 32) The thrombus extraction device according to any one of items 1 to 31, wherein the fenestrated structure comprises a plurality of interconnected pillars defining an opening at the proximal end of the fenestrated structure, and at least some of the plurality of interconnected pillars defining the opening have a sharp proximal edge. (Item 33) A thrombus extraction device according to any one of items 1 to 32, further comprising a first radiopaque marker located on the outer shaft and a second radiopaque marker located on the distal end of the inner shaft. (Item 34) A thrombus extraction device according to any one of items 1 to 33, further comprising a locking mechanism configured to fix the relative position of the outer shaft with respect to the intermediate shaft. (Item 35) A thrombus extraction device according to any one of items 1 to 34, further comprising a handle having a plunger configured to control the relative position of the inner shaft with respect to the intermediate shaft and to selectively fix the relative position of the inner shaft with respect to the intermediate shaft. (Item 36) An induction device sheath for accessing and removing a thrombus in a patient's blood vessel, wherein the induction device sheath is An elongated sheath having a proximal end, a distal end, and a lumen extending between them, A self-expanding funnel is attached to the distal end of the elongated sheath, A closure device equipped with a long, slender shaft Equipped with, An introducer sheath having an elongated shaft having a capture sheath located close to the distal end of the occluding device, the capture sheath being configured to hold the self-expanding funnel in a restrained configuration, and the occluding device being received into the lumen of the elongated sheath. (Item 37) An introducer sheath according to any one of items 1 to 36, further comprising a sealed hub located at the proximal end of the elongated sheath. (Item 38) The sealed hub is provided with a suction port, as described in item 37 of the introducer sheath. (Item 39) The self-expanding funnel is an introducer sheath according to any one of items 1 to 38, having a diameter equal to or smaller than the diameter of the elongated sheath when the self-expanding funnel is in the constrained configuration. (Item 40) The occlusion device comprises a non-traumatic tip located at the distal end of the occlusion device, and the non-traumatic tip is radiopaque, as described in any of items 1 to 39. (Item 41) The introducer sheath according to any one of items 1 to 40, wherein the occlusion device comprises a connecting fitting configured to seal with the distal end of the elongated sheath. (Item 42) The self-expanding funnel is permeable to blood, and is an introduction device sheath as described in any of items 1 to 41. (Item 43) The self-expanding funnel is an inlet sheath according to any one of items 1 to 42, having a conical shape formed from at least one of a castle-style nitinol braid, a nitinol braid stent, laser-cut nitinol, a laser-cut polymer tube, an injection-molded polymer structure, or an inflatable balloon. (Item 44) A method for accessing a patient's venous blood vessels and removing a thrombus therefrom, the method is To provide an introduction device sheath comprising an elongated sheath defining a lumen, a self-expanding funnel attached to the distal end of the elongated sheath, and an elongated occlusion device, wherein the occlusion device extends through the lumen and holds the self-expanding funnel in a restrained configuration within the capture sheath of the occlusion device. The method involves percutaneously accessing the patient's venous blood vessels through an access site using the introduction device sheath, wherein the access site includes a popliteal access site, a femoral access site, or an internal cervical access site. The distal end of the introduction device sheath is advanced to the proximal position of the thrombus, To unfold the self-expanding funnel from a configuration constrained within the capture sheath to an expanded configuration released from the capture sheath, The thrombus is captured in the self-expanding funnel, The captured substance is aspirated through the lumen of the elongated sheath. Methods that include... (Item 45) The method according to any one of items 1 to 44, wherein deploying the self-expanding funnel includes withdrawing the self-expanding funnel from the constrained configuration to the expanded configuration by advancing the occluding device distally to the elongated sheath, and removing the occluding device from the introducer sheath by retracting the occluding device proximal to the deployed self-expanding funnel and through the lumen of the elongated sheath. (Item 46) The method according to any one of items 1 to 45, wherein deploying the self-expanding funnel includes withdrawing the self-expanding funnel from the constrained configuration to the expanded configuration by retracting the sheath proximal to cover the occluding device, and removing the occluding device from the introducer sheath by retracting the occluding device proximal to the expanded configuration through the deployed self-expanding funnel and through the lumen of the elongated sheath. (Item 47) The method according to any one of items 1 to 46, further comprising: inserting a catheter that restrains a thrombus extraction device through the lumen of the elongated sheath such that the distal tip of the catheter passes distal to the vascular thrombus; deploying the thrombus extraction device from the catheter; and retracting the thrombus extraction device proximal to the introducer sheath until the opening of the thrombus extraction device is inside the self-expanding funnel. (Item 48) The method according to item 47, further comprising pushing out a portion of the thrombus captured by the thrombus extraction device through the thrombus extraction device, wherein the thrombus captured by the self-expanding funnel comprises the pushed-out portion of the thrombus captured by the thrombus extraction device. (Item 49) A thrombectomy system for removing vascular thrombi from a patient's blood vessels, wherein the thrombectomy system is A thrombus extraction catheter, wherein the thrombus extraction catheter is A thrombus extraction device, wherein the thrombus extraction device is A proximal self-expanding decardiocele element formed from an integrated fenestrated structure, A distally expandable cylindrical portion is formed from a braided filament mesh structure having a proximal end attached to the distal end of the aforementioned windowed structure. A thrombus extraction device equipped with, Catheter and The catheter comprises a lumen that restrains the thrombus extraction device, an intermediate shaft connected to the proximal end of the self-expanding cardioverter-cardiac element, and an inner shaft connected to the distal end of the expandable cylindrical portion and slidably displaceable relative to the intermediate shaft to control the expansion of the expandable cylindrical portion. Thrombectomy catheter and Introducer sheath and Equipped with, The aforementioned introduction device sheath is A long, slender sheath defines the insertion lumen, A self-expanding funnel is attached to the distal end of the elongated sheath, An elongated occlusion device having a sheath-capturing feature configured to hold the self-expanding funnel in a restrained configuration, A thrombectomy system equipped with [the necessary equipment / features]. (Item 50) A thrombectomy system according to any one of items 36 to 49, wherein the occlusion device is configured to be received into the lumen of the elongated sheath, and the occlusion device comprises a connecting fitting configured to seal with the distal end of the elongated sheath. (Item 51) The thrombectomy system according to any one of items 36 to 50, wherein the self-expanding funnel has a length at least equal to the length of the self-expanding cardiopulmonary bypass element. (Item 52) A thrombectomy system according to any one of items 36 to 51, wherein the introduction device sheath has a self-sealing opening located at the proximal end of the introduction device sheath. (Item 53) The thrombectomy system according to item 52, further comprising an opening dilator sized to be receivable within the self-sealing opening and having an inner diameter larger than the diameter of the self-sealing opening in the sealed configuration. (Item 54) A thrombectomy system according to any one of items 36 to 53, wherein the introducer sheath comprises a suction port located at the proximal end of the inserter sheath, the suction port being selectively fluidly connected to the insertion lumen via a suction valve. (Item 55) A thrombectomy system according to any one of items 36 to 54, wherein the insertion lumen is sized to slidably receive the thrombectomy catheter. (Item 56) A thrombectomy system according to any one of items 36 to 55, wherein the expandable cylindrical portion is formed on the self-expanding cardiopulmonary bypass element to form an integrated thrombus extraction device. (Item 57) A method for manufacturing an integrated thrombus extraction device comprising a proximal fenestrated structure having multiple support columns and a distal reticular filament mesh structure formed on the distal end of the fenestrated structure, wherein the method is: Identifying multiple forming points formed by some of the multiple support columns of the aforementioned integrated windowed structure, Passing a specific pair of wires through each of the forming points, wherein the specific pair of wires comprises a first wire and a second wire overlapping the first wire, The mesh filament structure is braided from the specific pair of wires such that at least one of the first wire and the second wire does not form a loop around the formation point through which the first wire and the second wire pass, and the other of the first wire and the second wire does form a loop around the formation point through which the first wire and the second wire pass. Methods that include... (Item 58) The method according to item 57, wherein each of the aforementioned forming points is provided with a mountain support. (Item 59) The windowed structure is provided with 12 mountain supports, as described in item 58. (Item 60) The method according to item 59, wherein the mesh filament has 48 wires. (Item 61) The aforementioned lattice filament mesh structure is assembled manually, as described in item 57. (Item 62) The aforementioned lattice filament mesh structure is automatically braided, according to the method of item 57. [Brief explanation of the drawing]

[0043] [Figure 1] Figure 1 is a perspective view of one embodiment of a thrombectomy system for removing blood clots from a patient's blood vessels. [Figure 2] Figure 2 is a side view of one embodiment of a thrombus extraction catheter having a thrombus extraction device in an unfolded configuration. [Figure 3] Figure 3 is a side view of one embodiment of a thrombus extraction catheter having a thrombus extraction device in its fully extended and deployed configuration. [Figure 4] Figure 4 is a side view of one embodiment of a self-expanding decardiocardial element. [Figure 5] Figure 5 is a top view of one embodiment of a self-expanding decentralizing element. [Figure 6] Figure 6 is a front view of one embodiment of a self-expanding decentralizing element. [Figure 7] Figure 7 is a side view of one embodiment of a thrombus extraction device in a fully extended configuration. [Figure 8] Figure 8 shows one embodiment of a ball-shaped thrombus captured within a thrombus extraction device. [Figure 9] Figure 9 is a side view of one embodiment of a braided filament mesh structure having multiple pore sizes. [Figure 10] Figure 10 is a side view of one embodiment of a thrombus extraction device that includes multiple circumferential grooves. [Figure 11] Figure 11 is a schematic diagram of one embodiment of a braiding and / or weaving pattern for forming a cylindrical portion and / or braided filament mesh structure on a self-expanding decentering element. [Figure 12] Figure 12 is a cross-sectional view of an embodiment of the handle with the plunger in a first position. [Figure 13] Figure 13 is a cross-sectional view of an embodiment of the handle with the plunger in a second position. [Figure 14] Figure 14 is an enlarged cross-sectional view of a portion of the handle with the plunger in the third position. [Figure 15] Figure 15 is a side view of one embodiment of a closure device having an elongated shaft of a certain size. [Figure 16] Figure 16 is a side view of one embodiment of a closure device having a variable-length elongated shaft. [Figure 17] Figure 17 is a detailed cross-sectional view of one embodiment of the capture sheath of the occlusion device. [Figure 18] Figure 18 is a side view of one embodiment of the introducer sheath in a non-deployed configuration. [Figure 19] Figure 19 is a side view of one embodiment of the introducer sheath in a partially unfolded configuration. [Figure 20] Figure 20 is a side view of one embodiment of the inlet sheath in its deployed configuration. [Figure 21] Figure 21 is a side view of one embodiment of an inlet sheath equipped with an inflatable balloon. [Figure 22] Figure 22 is a schematic diagram of one embodiment in which blood vessels are accessed via the popliteal access site. [Figure 23-1] Figures 23-A and 23-H illustrate one embodiment of the process for fully expanding a thrombus extraction device within a blood vessel. [Figure 23-2] Figures 23-A and 23-H illustrate one embodiment of the process for fully expanding a thrombus extraction device within a blood vessel. [Figure 23-3] Figures 23-A and 23-H illustrate one embodiment of the process for fully expanding a thrombus extraction device within a blood vessel. [Figure 23-4]Figures 23-A and 23-H illustrate one embodiment of the process for fully expanding a thrombus extraction device within a blood vessel. [Figure 24] Figures 24-A and 24-B illustrate alternative steps in the process for fully expanding a thrombus extraction device within a blood vessel. [Figure 25] Figures 25-A and 25-H illustrate one embodiment of a process for thrombus removal using an extended thrombus extraction device. [Figure 26] Figure 26 is a schematic diagram of one embodiment in which blood vessels are accessed via an internal jugular access site. [Figure 27] Figure 27 is a schematic diagram of one embodiment in which a blood vessel is accessed via the popliteal access site using an extension sheath 2300. [Figure 28] Figure 28 is a schematic diagram of one embodiment in which blood vessels are accessed via popliteal access sites and femoral access sites. [Modes for carrying out the invention]

[0044] This disclosure relates to a thrombectomy system for removing vascular thrombi from a patient's blood vessels. The thrombectomy system can remove thrombi from blood vessels, particularly from a patient's venous blood vessels, by decardiase and / or separation of the thrombus from the vessel wall, which may occur when the thrombectomy system is retracted through the vascular thrombus. The thrombus, decardiased and / or separated from the vessel wall, can be captured within the thrombectomy system and removed from the patient.

[0045] A thrombectomy system may include a thrombectomy catheter, which may include a thrombectomy device ("TED"). The TED may include a proximal self-expanding cardioverter-angiotensin element, which may be a stent portion and / or may be formed from an integrated fenestrated structure. The TED may include a distal expandable cylindrical portion formed from a braided filament mesh structure. The braided filament mesh structure may be formed on the cardioverter-angiotensin element, thereby forming an integrated TED. Direct formation of the braided filament mesh structure on the cardioverter-angiotensin element can eliminate problems such as inconsistent material properties, reduced flexibility, reduced strength, and / or quality control issues that arise from connecting the braided filament mesh structure to the cardioverter-angiotensin element, for example, via welding or adhesive.

[0046] The expansion of the TED can be controlled by the relative movement of a portion of the thrombus extraction catheter. For example, the proximal end of the TED, specifically the proximal end of the self-expanding cardioverter-cardiac element, can be connected to an intermediate shaft that is slidable within the outer shaft of the thrombus extraction catheter. The distal end of the TED, specifically the distal end of the self-expanding cylindrical portion, can be connected to an inner shaft that is slidable within the intermediate shaft of the thrombus extraction catheter. Because the inner and intermediate shafts are slidable relative to the outer shaft, the TED can be withdrawn into the outer shaft and constrained to a non-expanded configuration, also referred herein to as a constrained configuration. 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 and intermediate shafts can be moved relative to each other to either expand or contract the expandable cylindrical portion of the TED, bringing the self-expanding cardioverter-cardiac element to full expansion.

[0047] A thrombectomy system may include an introducer sheath, which may be sized to slidably receive the outer sheath of a thrombus extraction catheter. The introducer sheath may include a sealed opening at the proximal end of the introducer sheath and a self-expanding funnel. The self-expanding funnel may be located at the distal end of the introducer sheath and may be selectively held in a constrained position by a capture sheath. In some embodiments, the self-expanding funnel may be slidably constrained within the introducer sheath, specifically slidable relative to the distal end of the introducer sheath. In some embodiments, the self-expanding funnel may slide distally from a constrained configuration within the introducer sheath to an expanded configuration extending from the distal end of the capture sheath.

[0048] A self-expanding funnel can be sized to engage with a self-expanding cardioverter-causing element as the TED is retracted into the funnel. As the TED is retracted into the funnel, the funnel compresses the TED, specifically the cardioverter-causing element, and guides it into a lumen defined by the inletter sheath. The TED can be retracted until it is completely confined within the inletter sheath, at which point the TED and any thrombus trapped within it can be removed from the patient through a sealed opening.

[0049] A thrombectomy system can access blood vessels containing thrombi through multiple access sites. These may include, for example, an internal jugular (IJ) access site, a femoral access site, a popliteal access site, or other venous or arterial access sites. In non-limiting embodiments, a thrombectomy system can be used to extract thrombi and / or embolus from various veins and / or arterial vessels, including peripheral vessels, any vessels, including venous vessels having a diameter of at least 5 millimeters (mm). A thrombectomy system can be inserted into the patient's circulatory system through an access point and advanced to a position proximal to the thrombus. The TED can then be advanced through the thrombus and, after being dilated distal to the thrombus, the TED can be retracted through the thrombus, thereby capturing all or part of the thrombus.

[0050] Referring here to Figure 1, an embodiment of a thrombectomy system 100, also referred to herein as a thrombus extraction system 100, is shown. The thrombectomy system 100 can be used to access a portion of a blood vessel, such as a venous vessel, containing a thrombus, and the thrombectomy system 100 can be used to remove all or part of a thrombus from a blood vessel. The thrombectomy system 100 may include an introduction sheath 102 and a thrombus extraction catheter 104.

[0051] The introducer sheath 102 comprises 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 have any desired length and any desired diameter. In some embodiments, the elongated sheath 106 may have an outer diameter of at least 10 French, at least 12 French, at least 14 French, at least 18 French, at least 20 French, at least 22 French, 14 to 24 French, 15 to 21 French, 16 to 22 French, and / or any other or intermediate size.

[0052] The elongated member 106 may have a radiopaque marker, which may be, for example, part 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 of the elongated member 106 (shown in Figure 17) can be sized to slidably receive the thrombus extraction catheter 104. In some embodiments, the lumen 1701 of the elongated member 106 may have an inner diameter of at least 2 French, at least 10 French, at least 14 French, at least 18 French, at least 20 French, at least 22 French, 11-12 French, 10-22 French, 14-21 French, 16-20 French, and / or any other or intermediate size. The lumen 1701 may terminate at a sealed opening 112, also referred to herein as a sealed hub 112, located at the proximal end 108 of the elongated member 106. In some embodiments, the sealed opening 112 may be self-sealing and / or may have a self-sealing seal.

[0053] The introducer sheath 102 may further include a suction port 114 located at the proximal end 108 of an 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 suction port 114 may be part of a sealed hub 112 and / or connected to it. In some embodiments, the suction port 114 may be selectively fluidly connected to a lumen 1701 via a valve 118, also referred to herein as a suction valve 118, which may be a pipe clamp located along the connecting tube 116 between the lumen 1701 and the suction port 114.

[0054] The inlet sheath 102 can further hold an occluder 120, also referred to herein as an expander 120. The occluder 120 can be configured to hold a self-expanding funnel, which can be attached to the distal end 110 of the elongated member 106, in a constrained configuration, and to release the self-expanding funnel from its constrained configuration. The occluder 120 may comprise a proximal end 122, a distal end 124, and an elongated shaft 126 extending between them. In some embodiments, the elongated shaft 126 may have a length exceeding the length of the elongated member 106 of the inlet sheath 102. The occluder 120 can further define a lumen extending through the occluder 120, the lumen of which a guidewire can receive. In some embodiments, the guidewire may have any desired dimensions, and in some embodiments may have a diameter of about 0.035 inches. The occluder 120 may be sized and molded to be slidably movable through the lumen of the elongated member 106.

[0055] The thrombectomy system 100 may include a thrombectomy catheter 104. The thrombectomy catheter 104 may have a proximal end 130 and a distal end 132. A handle 134, also referred herein to as a deployment handle 134, may be located at the proximal end 130 of the thrombectomy catheter 104 and may be connected to a catheter portion 136, also referred herein to as a catheter 136.

[0056] The catheter 136 may include an outer shaft 138, an intermediate shaft 140, and an inner shaft. The outer shaft 138 may have various lengths and sizes. In some embodiments, the outer shaft 138 may be sized to slidably fit into the inlet sheath 102. In some embodiments, the outer shaft 138 may have sizes of at least 8 French, at least 10 French, at least 11 French, at least 12 French, at least 14 French, at least 16 French, 8 French to 14 French, 11 French to 12 French, and / or any other or intermediate size.

[0057] Each of the outer shaft 138, the intermediate shaft 140, and the inner shaft can define a lumen, which may be a central axial lumen. In some embodiments, the intermediate shaft 140 can be sized and / or molded to slidably fit into the lumen 802 (shown in Figure 8) of the outer shaft 138, such that the intermediate shaft 140 and the outer shaft 138 are coaxial. Similarly, in some embodiments, the inner shaft can be sized and / or molded to slidably fit into the lumen 804 (shown in Figure 8) of the intermediate shaft 140, such 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 of the outer shaft 138, the intermediate shaft 140, and the inner shaft.

[0058] In some embodiments, the outer shaft 138, the intermediate shaft 140, and the inner shaft may each 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.

[0059] The thrombus extraction catheter 104 may further include a thrombus extraction device (TED). The TED can be connected to the intermediate shaft 140 and the inner shaft and may be contained in a non-expanded configuration within the lumen 802 of the outer shaft 138. 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 a non-expanded configuration, an expanded configuration, a partially expanded configuration, and / or a fully expanded configuration. In some embodiments, the TED in an expanded configuration may be either a fully expanded configuration or a partially expanded configuration.

[0060] 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, an intermediate shaft 140 is connected to the distal end 132 of the thrombus extraction catheter 104 and extends distally toward it from the distal end 142 of the handle 134.

[0061] As shown in Figure 1, the distal end 142 of the handle 134 may include a locking feature 146, such as a spin lock. The locking feature 146 can selectively engage with and / or lock into a meshing feature 148 located on the proximal end 150 of the outer sheath 138. In some embodiments, for example, the outer sheath 138 can slide proximal across the intermediate sheath 140 until the locking feature 146 engages with the meshing 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 once the outer shaft 138 is lock into the locking feature 146.

[0062] The handle 134 may include a plunger 154 that is movable between a first non-extended position and a second extended position. In some embodiments, the plunger 154 can be moved from the first position to the second position by displacing the plunger 154 proximal to the handle 134. The plunger 154 may be lockable in either the first position or / or the second position.

[0063] The plunger 154 can be connected to the inner shaft such that the inner shaft is displaceable relative to the handle 134, the outer shaft 138, and / or the intermediate shaft 140 via the movement of 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 inner shaft may have a length such that the inner shaft extends distally beyond the distal end of the intermediate shaft 140, regardless of whether the plunger 154 is in the first or second position.

[0064] The thrombus extraction catheter 104 may further include a first flushing port 155 connected to the outer shaft 138 and a second flushing port 156 connected to the handle 134. In some embodiments, the first flushing port 155 may be fluidly connected to the lumen 802 of the outer shaft 138 so as to allow flushing of the lumen 802 of the outer shaft 138 via the first flushing port 155. In some embodiments, the second flushing port 156 may be fluidly connected to the internal portion of the handle 134, thereby to allow flushing of the lumen of the intermediate shaft 140.

[0065] The thrombectomy system 100 may further include a refillable funnel 158. The refillable funnel 158 may include a funnel portion 160 and a shaft portion 162. The funnel portion 160 can define a funnel-shaped internal volume that connects to the lumen of the shaft portion 162. The funnel-shaped internal volume may be sized and shaped to accommodate a self-expanding funnel and to move the self-expanding funnel into a constrained position as it advances through the funnel portion 160. The funnel-shaped internal volume and lumen may be sized to allow the distal end 124 of the occlusion device 120 to pass completely through the refillable funnel 158.

[0066] In some embodiments, the loading funnel 158 can be configured to facilitate the loading of the self-expanding funnel into the occluder 102. In some embodiments, the self-expanding funnel can be loaded by inserting the occluder 120 through the elongated member 106 such that the occluder 120 extends beyond the self-expanding funnel from the distal end 110 of the elongated member 106. The loading funnel 158 can then be slid proximal across the occluder 120 and the self-expanding funnel until the self-expanding funnel is fully sealed by the loading funnel 158 and / or until the self-expanding funnel is in a restrained configuration. The occluder 120 can then be retracted, thereby loading and / or capturing the self-expanding funnel within a portion of the occluder 120, and the loading funnel 158 can then be removed from the occluder 120 and the elongated member 106.

[0067] The thrombectomy system 100 may further include a sealed hub expander 170, also referred to herein as a seal expander 170 and / or an opening expander 170. A cross-sectional view of the seal expander 170 is shown in Figure 1. The seal expander 170 may be sized and molded for insertion into the sealed opening 112 prior to the removal of the thrombus through the sealed opening 112. This insertion into the sealed opening 112 allows the seal expander 170 to expand the sealed opening 112. In some embodiments, this expansion of the sealed opening 112 can prevent the application of force from the sealed opening 112 onto the thrombus during the removal of the thrombus through the sealed opening 112. In some embodiments, the seal expander 170 may include an insertion portion 172 configured to facilitate the insertion of the seal expander 170 into the sealed opening 112. The seal expander 170 may further include a body portion 174 that can define an extraction lumen 176 through which a thrombus can be removed from the lumen 1701 of the elongated member 106, either alone or together with the insertion portion 172. In some embodiments, the inner diameter of the extraction lumen 176 may be larger than the diameter of the sealed opening 112 in the sealed configuration.

[0068] Referring here to Figure 2, a side view of one embodiment of the 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 herein to as TED202. As shown in Figure 2, the outer shaft 138 is displaced proximal to the handle 134 such that the interlocking feature 148 of the outer shaft 138 contacts the locking feature 146 of the handle 134. Due to this positioning of the outer shaft 138 relative to the handle 134, the intermediate shaft 140, the inner shaft 200, and the TED202 each extend distally beyond the distal end 204 of the outer shaft 138. The thrombus extraction device 202 shown in Figure 2 is in an unfolded and partially extended configuration.

[0069] The thrombus extraction device 202 may include a self-expanding cardioverteric element 206 and an expandable cylindrical portion 208. The self-expanding cardioverteric element 206 may be positioned relatively proximal to the expandable cylindrical portion 208 on the thrombus extraction catheter 104. The self-expanding cardioverteric element 206 may include a proximal end 210 connected to the distal end 212 of the intermediate shaft 140 and a distal end 214 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.

[0070] In some embodiments, the distal end 218 of the inner shaft 200 may further include a tip 220 such as a non-traumatic tip and / or a radiopaque marker 222. In some embodiments, the tip 220 may include a radiopaque marker 222. Furthermore, the radiopaque marker may be located, for example, on the outer shaft 138, specifically on the distal end 204 of the outer shaft 138 and / or the distal end 212 of the intermediate shaft 140. In some embodiments, each of the distal end 204 of the outer shaft 138 and the distal end 212 of the intermediate shaft 140 may be equipped with a radiopaque marker. In some embodiments, the non-traumatic tip 220 may define a channel configured to allow the guidewire to pass through the non-traumatic tip 220.

[0071] Referring here to Figure 3, a side view of one embodiment of a thrombus extraction catheter 104 with a thrombus extraction device 202 in deployed and fully expanded configurations is shown. In contrast to the embodiment in Figure 2, the plunger 154 is in a second position, retracted proximal to the handle 134, thereby retracting the inner shaft 200 proximal to the intermediate shaft 140, thereby fully expanding the expandable cylindrical portion 208 and fixing the expandable cylindrical portion 208 and the self-expanding cardiopulmonary bypass element 206 in a fully expanded configuration and / or fully expanded.

[0072] The thrombus extraction catheter 104 may have one or more features configured to fix the thrombus extraction device 202, specifically the self-expanding cardioverter-cardiac element 206 and / or expandable cylindrical portion 208, in a fully expanded position and / or fully expanded. As used herein, full expansion occurs when the thrombus extraction device 202 is deployed and the plunger 154 is in a second position. In some embodiments, one or more dimensions of the thrombus extraction device 202 may vary when the thrombus extraction device 202 is in full expansion. In some embodiments, this can facilitate the thrombus extraction device 202's contact with the vessel wall and / or a desired force or force level applied to the vessel wall by the thrombus extraction device 202.

[0073] In some embodiments, the plunger 154 can be locked in a second position, for example, by rotating the plunger 154 relative to the handle 134, thereby engaging one or more locking features on the plunger 154 and within the handle 134. In some embodiments, by locking the plunger 154 in the second position, the thrombus extraction device 202, specifically the self-expanding cardioverter-cardiac element 206 and / or expandable cylindrical portion 208, can be locked in full expansion by fixing the position of the inner shaft 200 relative to the intermediate shaft 140. In some embodiments, the step of fixing the position of the inner shaft 200 relative to the intermediate shaft 140 may include the step of 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, the locking and / or coupling can be static in that the position of the inner shaft 200 is fixed relative to the position of the intermediate shaft 140, and is referred to herein as statically locked and / or statically coupled; and in some embodiments, the locking and / or coupling can be dynamic in that the position of the inner shaft 200 relative to the intermediate shaft 140 is limited, and is referred to herein as dynamically locked and / or dynamically coupled. In some embodiments, as will be discussed in more detail below, the inner shaft 200 can be dynamically locked to the plunger 154 via a responsive spring 1214 that allows some movement of the inner shaft 200 relative to the intermediate shaft 140 when the plunger is locked in a second position. Thus, in such embodiments, the inner shaft 200 is dynamically locked and / or dynamically coupled to the intermediate shaft 140 and / or relative to the intermediate shaft 140.

[0074] Referring here to Figure 4, a side view of one embodiment of the self-expanding decompression element 206 is shown. The self-expanding decompression element 206 can have various shapes and sizes and can be made from various materials. In some embodiments, the self-expanding decompression element can be made from a shape memory material such as a shape memory alloy and / or a shape memory polymer. In some embodiments, the self-expanding decompression element 206 can be made of nitinol and / or a nitinol alloy.

[0075] The self-expanding decompression element 206 can be fabricated using a variety of techniques, including, for example, welding, laser welding, cutting, laser cutting, expansion, or equivalent. In some embodiments, the self-expanding decompression element 206 can be laser-cut from, for example, a piece of nitinol such as a nitinol tube, and then the self-expanding decompression element 206 can be blown and / or expanded.

[0076] The self-expanding cardioverter-cardiac element 206 may comprise an integrated fenestrated structure 400 and / or a stent or stent portion, which can be configured to decardiacontate a portion of a thrombus, such as a vascular thrombus, and separate it from the blood vessel containing the thrombus. The integrated fenestrated structure 400 may comprise a plurality of struts 402 that together define a plurality of gaps 404. The struts may have various shapes and sizes, and in some embodiments, the struts may have a thickness and / or diameter of about 0.05 to 0.15 inches, about 0.075 to 0.125 inches, about 0.09 to 0.1 inches, and / or about 0.096 inches.

[0077] In some embodiments, the self-expanding cardioverter 206 may comprise a first region 406 and a second region 408. The second region 408 may be substantially tubular and may include a plurality of interconnected struts 402. The first region 406, as shown in Figure 5, may comprise a reduced number of struts 402 compared to the second region, facilitating the collapse of the self-expanding cardioverter 206 into a non-expanding configuration and maintaining the cardioverter direction when the vessel is tortuous. In some embodiments, the first region may further comprise two curved struts 410-A, 410-B that twist in opposite directions around the central axis 412 of the self-expanding cardioverter 206, also referred to herein as the longitudinal axis 412, and define the opening 414 of the self-expanding cardioverter 206.

[0078] In some embodiments, the connection of the self-expanding cardioverter 206 to the intermediate shaft 140 via two curved supports 410-A and 410-B can improve the operation of the thrombus extraction device 202 by flexibly connecting the self-expanding cardioverter 206 to the intermediate shaft 140. In particular, the removal of the supports from the region 420 of the self-expanding cardioverter 206 allows the self-expanding cardioverter 206 to flex around a connecting member 415 located at the proximal end 210 of the self-expanding cardioverter 206, which connects the self-expanding cardioverter 206 to the intermediate shaft 140 of the thrombus extraction catheter 104. This flexural capability can facilitate the maintenance of the cardioverter orientation when the blood vessel is tortuous. In some embodiments, such flexure of the self-expanding cardioverter 206 can result in a region 420 that functions as a mouth 414.

[0079] As shown in Figure 4, the curved support 410 extends from the bottom 416 of the self-expanding decentering element 206 toward the top 418 of the self-expanding decentering element 206 at an angle θ with respect to the central axis 412, which is also referred to herein as the decentering angle. In some embodiments, this angle can be 20 to 50 degrees and / or 30 to 45 degrees when fully extended.

[0080] In some embodiments, the defecator angle can have either a positive or negative effect on the operation of the TED202. For example, a defecator angle that is too steep may prevent the self-expanding defecator element 206 from becoming crushable and thus prevent its retraction into the introducer sheath 102. In addition, a defecator angle that is too slow may result in the self-expanding defecator element 206 being easily crushed, which may reduce the defecator capacity of the self-expanding defecator element 206. In some embodiments, this reduction in the defecator capacity of the self-expanding defecator element 206 may result in the self-expanding defecator element 206 no longer effectively decardiacing the thrombus.

[0081] In some embodiments, the nearest edges of two curved struts 410-A, 410-B, referred to herein as the leading edge 411, may be sharpened, and / or the leading edge 411 of the two curved struts 410-A, 410-B may be equipped with a cutting element, a scalpel, or equivalent.

[0082] The self-expanding cardioverter 206 can be provided in various sizes. In some embodiments, the self-expanding cardioverter 206 can have lengths defined as the shortest distance between the proximal end 210 and the distal end 214 of the self-expanding cardioverter 206, approximately 1 to 3 inches, approximately 1.5 to 2.5 inches, approximately 1.75 to 2.25 inches, approximately 1.9 to 2.0 inches, and / or approximately 1.96 inches. In some embodiments, the self-expanding cardioverter 206 can have fully expanded diameters of approximately 2 to 50 mm, approximately 4 to 25 mm, approximately 6 to 20 mm, and / or approximately 8 to 16 mm. In some embodiments, the self-expanding cardioverter 206 can be applied to decompression of an artery or vein, such as the inferior vena cava. In some embodiments, such decompression can be performed in response to occlusion and / or partial occlusion of one or more filters within the inferior vena cava.

[0083] In some embodiments, the length and diameter of the self-expanding cardioverter 206 may 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 cardioverter 206 may be selected based on the fully expanded diameter of the self-expanding cardioverter 206 to prevent undesirable inclination and / or rotation of the self-expanding cardioverter in and relative to the blood vessel. As used in any of the herein, “approximately” refers to a range of + / - 10% of the value and / or range of values ​​from which “approximately” is used.

[0084] Referring now to Figure 7, a side view of one embodiment of the thrombus extraction device 202 is shown. As seen in Figure 7, the self-expanding cardioverter-cardiac element 206 is connected to the distal end 212 of the intermediate shaft 140 via a connecting member 415 at the proximal end 210 of the self-expanding cardioverter-cardiac element 206. The proximal end 216 of the expandable cylindrical portion 208 is connected to the distal end 214 of the self-expanding cardioverter-cardiac element 206. In some embodiments, the expandable cylindrical portion 208, specifically the proximal end 216 of the expandable cylindrical portion 208, is formed on the distal end 214 of the self-expanding cardioverter-cardiac element 206, thereby forming an integrated thrombus extraction device 202. The distal end 217 of the expandable cylindrical portion 208 is connected to the distal end 218 of the inner shaft 200.

[0085] In some embodiments, as shown in Figure 7, the self-expanding decompression element 206 can engage with all or part of the inner shaft 200 and affect the expansion of the self-expanding decompression element 206. Specifically, in some embodiments, the self-expanding decompression element 206 may include a ring 700, also referred herein to as a ring feature 700. The ring 700 may be made of the same material as the self-expanding decompression element 206, or it may be made of a different material. The ring 700 may be formed integrally with the self-expanding decompression element 206 and / or may be attached to the self-expanding decompression element by, for example, one or more welds, adhesives, one or more mechanical fasteners, or equivalent. The ring 700 may have a diameter larger than the diameter of the inner shaft 200 so that the ring 700 is slidable along the inner shaft 200.

[0086] As further shown in Figure 7, the inner shaft 200 may include a stopper 702. In some embodiments, the stopper 702 may comprise a polymer member and / or a metal member attached to a portion of the inner shaft 200. In some embodiments, the stopper 702 may be sized and molded to engage with the ring 700 when the inner shaft 200 is displaced proximal to a second position via the movement of the plunger 154, thereby applying a proximal-directed force to the self-expanding decentering element 206. In some embodiments, a portion of the self-expanding decentering element 206 located between the ring 700 and the connecting member 415 is forcibly expanded by the application of this proximal-directed force to the ring 700, thereby moving the self-expanding decentering element 206 to full expansion.

[0087] 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 allows displacement of the inner shaft 200 to bring the self-expanding cardioverter 6 to full expansion via engagement of the ring feature 700 and the stop 702. In some embodiments, after the self-expanding cardioverter 6 has reached full expansion, the inner shaft 200 can be reconnected to the distal end 217 of the expandable cylindrical portion 208 so that the expandable cylindrical portion 208 is fully expanded, and / or, when the plunger 154 is moved from a second position to a first position, it can be reconnected to the distal end 217 of the expandable cylindrical portion 208 so that the expandable cylindrical portion 208 is compressed.

[0088] In some embodiments, the expandable cylindrical portion 208 may comprise a braided filament mesh structure 704 configured to capture thrombi. In some embodiments, the braided filament mesh structure may extend co-located with the expandable cylindrical portion 208 and thus share a proximal end 216 and / or a distal end 217. In the embodiment shown in Figure 7, the braided filament mesh structure 704 is a braid of elastic filaments having a substantially tubular elongated portion 706 and a distal tapered portion 708. In other embodiments, the braided filament mesh structure 704 may be any porous structure and / or have other preferred shapes, sizes, and configurations (for example, the distal portion 708 may be substantially cylindrical, etc.).

[0089] Due to the connection between the braided filament mesh structure 704 and the distal end 218 of the inner shaft 200, axial movement of the inner shaft 200 causes the braided filament mesh structure 704 of TED200 to expand / shorten and compress / extend radially. For example, as long as the intermediate shaft 140 is fixed and / or limited to axial movement at a rate less than that of the inner shaft 200, (1) distal movement of the inner shaft 200 stretches the braided filament mesh structure 704 along its longitudinal axis such that the radius of the braided filament mesh structure 704 decreases and the length of the braided filament mesh structure 704 increases, and (2) proximal movement of the inner shaft 200 compresses the braided filament mesh structure 704 along its longitudinal axis such that the radius of the braided filament mesh structure 704 increases and the length of the braided filament mesh structure 704 decreases. In some embodiments, the braided filament mesh structure 704 may have lengths of approximately 5 to 30 inches, approximately 10 to 20 inches, and / or approximately 16 inches in a compressed configuration, and in some embodiments, the braided filament mesh structure 704 may have lengths of approximately 1 to 25 inches, approximately 10 to 20 inches, and / or approximately 11 inches in an expanded configuration.

[0090] In some embodiments, the braided filament mesh structure 704 can be formed by a braiding machine and / or knitting machine, and in some embodiments, the braided filament mesh structure 704 can be braided and / or woven manually. It may be advantageous to use a braiding machine and / or knitting machine that does not employ a bobbin or other filament winding mechanism, which is typical of many conventional braiding machines, in order to make it significantly more difficult to form the braid on the self-expanding coreless element 206. A braiding machine and / or knitting machine in which the filaments are freely suspended allows for much easier loading directly onto the self-expanding coreless element 206. In some embodiments, the braided filament mesh structure 704 is titled "BRAIDING MECHANISM AND METHOD OF USE" and is U.S. Patent No. 8,833,224, filed May 8, 2013; "BRAIDING MECHANISM AND METHOD OF USE" and is U.S. Patent No. 8,826,791, filed September 10, 2012; "BRAIDING MECHANISM AND METHOD OF USE" and is U.S. Patent No. 8,261,648, filed October 17, 2011; "BRAIDING MECHANISM AND METHOD OF USE" and is U.S. Patent No. 8,820,207, filed April 26, 2013; "ANEURYSM GRAFT WITH Braiding may be carried out using methods or devices included in part or in whole of U.S. Patent Publication No. 2016 / 0030155, titled “STABILIZATION,” which entered the U.S. national phase on September 14, 2015, and U.S. Patent Publication No. 2014 / 0318354, titled “BRAIDING MECHANISM AND METHOD OF USE,” filed on July 11, 2014 (each incorporated herein by reference in its entirety).

[0091] In some embodiments, the braided filament mesh structure 704 may be formed as a tubular braid, which can then be further molded using a heat-solidifying process. In some embodiments, the braid may be a tubular braid of fine metal wires such as nitinol (nickel-titanium alloy), platinum, cobalt-chromium alloy, stainless steel, tungsten, or titanium. In some embodiments, the braided filament mesh structure 704 can be formed at least partially from a cylindrical braid of elastic filaments. Thus, the braid may be radially constrained without plastic deformation and will self-expand in response to the release of the radial constraint. Such a braid of elastic filaments is referred to herein as a “self-expanding braid”.

[0092] In some embodiments, the thickness of the braided filament can be less than about 0.15 mm. In some embodiments, the braid can be fabricated from filaments and / or wires with diameters ranging from about 0.05 mm to about 0.25 mm. In some embodiments, braided filaments of different diameters can be combined to impart different properties, including stiffness, elasticity, structure, radial strength, pore size, embolus capture or filtration capacity, etc. In some embodiments, the number of braided filaments is 20 to 80, greater than 30, and / or about 24. The pore size of the braided mesh within the elongated portion 706 may be in the range of about 0.4 mm to 4.0 mm. In some embodiments, the pore size may be in the range of 0.5 mm to 2.5 mm.

[0093] In some cases, a thrombus may form a shape that makes it difficult to retract into the introducer sheath 102 when the thrombus is within the braided filament mesh structure 704. In such cases, as depicted in Figure 8, the thrombus extraction device 202, specifically the braided filament mesh structure 704, is partially retracted into the introducer sheath 102. As depicted in Figure 8, the thrombus 800 forms a ball with a diameter larger than the diameter of the introducer sheath 102. Such behavior by the thrombus 800 can hinder the removal of the TED200 and the thrombus 800 from the patient's body. Figures 9 and 10 address features to prevent such behavior by the thrombus.

[0094] Figure 8 further shows a cross-sectional view of the elongated member 106 in which the lumen 1702 of the elongated member is visible, a cross-sectional view of the outer shaft 138 in which the lumen 802 of the outer shaft 138 is visible, and a cross-sectional view of the intermediate shaft 140 in which the lumen 804 of the intermediate shaft 140 is visible.

[0095] Referring now to Figure 9, a side view of one embodiment of a braided filament mesh structure 704 having multiple pore sizes is shown. As can be seen from the figure, the braided filament mesh structure 704 comprises a first portion 900 having a first plurality of pores 904 and a second portion 902 having a second plurality of pores 906. In some embodiments, the first portion 900 may correspond to an elongated portion 706, and the second portion 902 may correspond to a distally tapered portion 708.

[0096] As shown in Figure 9, the first portion 900 of the braided filament mesh structure 704 is relatively proximal to the second portion 902. As further shown, the pores in the first plurality of pores 904 of the first portion 900 are smaller than the pores in the second plurality of pores 906 of the second portion 902. In some embodiments, the larger pores of the distal second portion 902 may be greater than or equal to 1.5 mm, and in some embodiments, they may have an average size of about 1.0 mm to 4.0 mm.

[0097] In such embodiments, the larger pore size of the second plurality of pores 906 can enable and / or facilitate the extrusion of a portion of the thrombus when the braided filament mesh structure 704 is moved to a non-expanded configuration and / or when the braided filament mesh structure 704 is retracted into the introducer sheath 102. In some embodiments, this extrusion of a portion of the thrombus can prevent the thrombus from being retracted into the introducer sheath 102. Furthermore, in some embodiments, a relatively new portion of the thrombus can be pushed out in front of a relatively old portion of the thrombus because the relatively new portion of the thrombus may be softer and / or more malleable. These relatively new portions of the thrombus can then be captured and / or destroyed by the features of the introducer sheath 102.

[0098] Referring here to Figure 10, a side view of one embodiment of the TED200 is shown, which comprises 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 inward toward the central axis 1002 and / or midline 1002 of the thrombus extraction device 202. In some embodiments, the plurality of circumferential recesses 1000 may be longitudinally spaced and / or equally spaced along the length of the expandable cylindrical portion 208 and / or braided filament mesh structure 704 between the proximal end 216 and the distal end 217 of the cylindrical portion 208 and / or braided filament mesh structure 704. In some embodiments, these circumferential recesses 1000 can engage with a portion of the thrombus contained within the cylindrical portion 208 and / or braided filament mesh structure 704 when the thrombus extraction device 202 is moved from an expanded configuration to a non-expanded configuration, thereby preventing the thrombus from moving toward one or both of the proximal end 216 and distal end 217 of the cylindrical portion 208 and / or braided filament mesh structure 704. This prevention of thrombus movement can reduce the likelihood of thrombus formation that cannot be retracted into the introducer sheath 102.

[0099] Although depicted in separate figures, some embodiments of the thrombus extraction device 202 may include both a plurality of circumferential recesses, which are discussed with respect to Figure 10, and a plurality of pore sizes, which are discussed with respect to Figure 9.

[0100] Referring here to Figure 11, a schematic diagram of one embodiment of a weaving pattern for forming a cylindrical portion 208 and / or a braided filament mesh structure 704 on a self-expanding decentering element 206 at one or more forming points 1103. As can be seen from the figure, the self-expanding decentering element 206 comprises a plurality of posts 402 connected to the forming point 1103, each having a peak 1100, also referred to herein as a peak post 1100. As can be seen from the figure, each of the peaks 1100 is formed by the intersection of a first post 402-A and a second post 402-B, and the intersecting posts 402-A, 402-B form a peak opening 1101.

[0101] In some embodiments, the self-expanding decardiocardial element 206 may comprise a plurality of peaks 1100 extending around the distal end of the self-expanding decardiocardial element 206. The plurality of peaks 1100 may comprise 4 peaks 1100, 6 peaks 1100, 8 peaks 1100, 10 peaks 1100, 12 peaks 1100, 16 peaks 1100, 20 peaks 1100, 24 peaks 1100, 4 to 50 peaks, 8 to 20 peaks, and / or any other or intermediate number of peaks.

[0102] The cylindrical portion 208 and / or the braided filament mesh structure 704 may comprise a plurality of filaments 1102 that are woven and / or braided together to form the cylindrical portion 208 and / or the braided filament mesh structure 704. In some embodiments, the plurality of filaments may include a first filament 1104 and a second filament 1106 for each crest 1100 of the self-expanding decentering element 206. The first and second filaments 1104, 1106 may be woven and / or braided on their respective crests. In some embodiments, the first and second filaments 1104, 1106 may be woven and / or braided on their respective crests such that one or both of the first and second filaments 1104, 1106 form loops around their respective crests. Therefore, in some embodiments, only the first filament 1104 forms a loop around its crest, only the second filament 1106 forms a loop around its crest, or both the first and second filaments 1104 and 1106 form a loop around its crest. Referring to the embodiment in Figure 11, the first filament 1104 can be inserted linearly through the crest opening 1101 of its crest, so that the first filament 1104 does not form a loop on itself directly adjacent to, or more specifically, directly distal to, its crest.

[0103] The first filament 1104 can be inserted through the crest opening 1101 of its crest 1100 so that, when viewed from the outside of the self-expanding decompression element 206 toward the inside of the self-expanding decompression element 206, the first filament 1104 passes over the first support 402-A and below the second support 402-B.

[0104] The second filament 1106 can be inserted through the crest opening 1101 of the crest such that a portion of the second filament 1106 passing through the crest opening 1101 is separated from the crest by the first filament 1104. Furthermore, the second filament 1106 can be inserted through the crest opening 1101 such that it passes directly beneath the first support 402-A and across the second support 402-B. After insertion through the crest opening 1101, the second filament 1106 can be looped over itself to form a loop 1108 directly distal to the crest 100.

[0105] In some embodiments, since each filament 1104, 1106 is inserted through a crest opening 1101, each filament 1104, 1106 can be processed to include a first wire extending from its crest 1100 to a first end of the filament 1104, 1106 and a second wire extending from its crest to a second end of the filament 1104, 1106 for braiding or knitting purposes. Thus, in some embodiments, where the self-expanding decored portion 206 has 12 crests, the cylindrical portion 208 and / or braided filament mesh structure 704 can be formed from 24 filaments 1104, 1106 which can be woven and / or braided as 48 wires to form a 48-wire mesh and / or fabric.

[0106] In some embodiments, the cylindrical portion 208 and / or the braided filament mesh structure 704 can be braided / woven by identifying a plurality of forming points 1103 formed by some of the supports 402 of the self-expanding decentering element 206. A unique pair of wires can be screwed through each of the forming points 1103, specifically through the crescent openings 1101 adjacent to each of the forming points 1103. In some embodiments, each unique pair of wires may comprise a first wire 1104 and a second wire 1106 overlaying the first wire 1104. The first and second wires can then be woven and / or braided from their respective pairs into a mesh filament mesh structure of the cylindrical portion 208 and / or braided filament 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 screwed, and the second wire 1106 forms a loop 1108 around the forming point 1103 through which the second wire 1106 is screwed.

[0107] Referring here to Figure 12, a cross-sectional view of an embodiment of the handle 134 is shown with the plunger 154 in a first position, and referring to Figure 13, a cross-sectional view of an embodiment of the handle 134 is shown with the plunger 154 in a second position. The handle 134 may include a housing 1200 that defines an internal volume 1202. The plunger shaft 1204 may extend through all or part of the internal volume 1202 and may be connected to an inner shaft 200, which may define a previously referenced lumen 1400, also referred to herein as the inner shaft lumen 1400. The plunger shaft 1204 may be terminated with a plunger guide 1208 attached to the plunger shaft 1204. In some embodiments, as seen in Figures 12 and 13, the plunger 154 may be biased toward the first position by a plunger spring 1209 that can engage with the handle 134 and part of the plunger guide 1208. Therefore, the plunger spring 1209 is not compressed much when the plunger 154 is in a first position as shown in Figure 12, and is more compressed when the plunger 154 is in a second position as shown in Figure 13. In some embodiments, this biasing force toward the first position may result in a biasing force toward a partial expansion configuration within the thrombus extraction device 202.

[0108] As seen in Figure 14, an enlarged view of the circled portion "A" shown in Figure 13, the plunger guide 1208 can be positioned between the proximal stop 1210 and the distal stop 1212, each of which can be attached to the inner shaft 200, which includes the inner shaft lumen 1400. The plunger guide 1208 can be dynamically connected to the proximal stop 1210 via a stent-responsive spring 1214, also referred to herein as a responsive spring 1214. In some embodiments, the use of the responsive spring 1214 to connect the plunger guide 1208 and the proximal stop 1210 can allow for a change in the diameter of the self-expanding defracing element 206 according to the compressive force applied to the self-expanding defracing element 206.

[0109] In some embodiments, for example, a radial compressive force applied to the self-expanding cardioverter 206 via the interaction of the ring feature 700 and the stop 702 can be transmitted from the self-expanding cardioverter 206 to the responsive spring 1214 via the ring feature 700 and the stop 702. In embodiments where the compressive force exceeds the spring force, the responsive spring 1214 can be compressed, causing the inner shaft 200 to advance distally relative to the intermediate shaft 140, thereby reducing the diameter of the self-expanding cardioverter 206 until the compressive force equals the spring force. This responsiveness achieved via the responsive spring 1214 allows for the use of the intravascular thrombectomy catheter 104, which may be an artery or venous vessel of non-constant diameter, while maintaining the desired contact of the self-expanding cardioverter 206 with the vessel wall, vein, or venous vessel. In some embodiments, this responsiveness can result in a constant outward force applied to the vascular wall by the self-expanding defibrillator element 206 when the blood vessel has a diameter of about 1–30 mm, 2–25 mm, 5–20 mm, and / or any other or intermediate diameter. In some embodiments, this constant outward force can be constant in that the outward force is within a predetermined range. In some embodiments, for example, the outward force can be about 5 N when the diameter of the self-expanding defibrillator element 206 is about 20 mm, and the outward force can be about 20 N when the diameter of the self-expanding defibrillator element 206 is about 5 mm. Thus, in some embodiments, a locking mechanism, which may include a plunger 154 and a responsive spring 1214, can be configured to maintain a desired radial force on the vascular wall when the stent is compressed by its vascular wall. In some embodiments, the desired force may be a sufficient radial force on the vascular wall to decardiate all or part of the thrombus and / or separate it from the vascular wall when the self-expanding decardiocardial element 206 is fully expanded.

[0110] Referring now to Figures 15 and 16, side views of an embodiment of the occlusion device 120 are shown. As can be seen from the figures, the occlusion device 120 includes a proximal end 122, a distal end 124, and an elongated shaft 126. Furthermore, as can be seen from the figures, the occlusion device 120 may include a capture sheath 1500 extending proximal from the distal end 124 of the occlusion device 120.

[0111] The occlusion device 120 may further include a tip such as a non-traumatic tip 1502 located at the distal end 124 of the occlusion device 120. In some embodiments, the non-traumatic tip 1502 may be radiopaque. The occlusion device 120 may further include a connecting joint 1504 located at the proximal end 1506 of the capture sheath 1500. In some embodiments, the connecting joint 1504 may be configured to seal with the distal end 110 of the elongated sheath 106 of the introducer sheath 102.

[0112] The occluder 120 may further include a stop portion 1508 located at the proximal end 122 of the occluder 120. In some embodiments, the stop portion 1508 may have a diameter larger than the lumen 1701 of the elongated member 106 of the inleter sheath 102 and / or larger than the diameter of the sealed opening 112 located at the proximal end 108 of the inleter sheath 102, so as to prevent the stop portion 1508 from entering the lumen 1701 of the elongated member 106 and / or the sealed opening 112.

[0113] In some embodiments, the elongated shaft 126 may have a constant size and / or diameter, and in some embodiments, the elongated shaft 126 may have multiple sizes and / or diameters. For example, the diameter 1510 of the elongated shaft 126 shown in Figure 15 is constant along the length of the elongated shaft 126. In contrast, the elongated shaft 126 shown in Figure 16 has at least a first diameter 1512 along one or more first portions 1513 of the elongated shaft 126 and a second diameter 1514 along one or more second portions 1515 of the elongated shaft 126.

[0114] In some embodiments, one or more second portions 1515 of the elongated shaft can be positioned along the length of the elongated shaft 126 such that one or more second portions 1515 extend through the sealed opening 112 when the occluding device 120 is received into the elongated member 106 of the introducer sheath 102 and the connecting fitting 1504 is positioned to seal with the distal end 110 of the elongated sheath 106. In such embodiments, the second diameter 1514 can be selected so that one or more second portions do not contact and / or expand the sealed opening 112 and / or seal within the sealed opening 112. Such embodiments of the occluding device 120 do not expand the seal of the sealed opening 112 when one or more second portions extend through the sealed opening 112, so that the introducer sheath 102 can be stored, packaged, and / or sold with such occluding devices 120 pre-positioned and extending through the lumen 1701 of the elongated member 106.

[0115] Referring now to Figure 17, a detailed cross-sectional view of one embodiment of the capture sheath 1500 is shown. As can be seen from the figure, the capture sheath 1500 includes a non-traumatic tip 1502 connected to an elongated shaft 126 of the occlusion device 120, the elongated shaft 126 extending through a lumen 1701 of an elongated member 106. As can also be seen from the figure, the lumen 1700 extends through the non-traumatic tip 1502 and the elongated shaft 126, and the lumen 1700 can be configured to receive a guidewire.

[0116] The capture sheath 1500 includes a capture shell 1702 that extends distally from a non-traumatic tip 1502 to the proximal end 1506 of the capture sheath 1500. The capture shell 1702 terminates at a connecting joint 1504. The capture shell 1702 has an inner diameter 1704 that exceeds the diameter 1706 of the portion of the elongated shaft 126 extending through the capture shell 1702. Due to the larger inner diameter 1704 of the capture shell 1500, a receptive space is created between the capture shell 1702 and the portion of the elongated shaft 126 extending through the capture shell 1702. In some embodiments, this receptive space can be sized and molded to receive and / or hold a self-expanding funnel 1708 in a constrained configuration. In some embodiments, the self-expanding funnel 1708 may have a diameter that matches the inner diameter 1704 of the capture shell 1702 when the self-expanding funnel 1708 is in a constrained configuration. In some embodiments, the main diameter of the self-expanding funnel may be less than or equal to the diameter 1716 of the elongated member 106.

[0117] The self-expanding funnel 1708 can have various shapes and sizes and can be made from various materials. In some embodiments, the self-expanding funnel 1708 can have a maximum diameter that is greater than and / or equal to the diameter of the self-expanded decompression element 206 in full expansion, and in some embodiments, the self-expanding funnel 1708 can have a minimum diameter that is 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 self-expanding funnel 1708 can have a length that is greater than and / or equal to the length of the self-expanding decompression element 206 so that the self-expanding decompression element 206 can be received and contained within the self-expanding funnel 1708.

[0118] In some embodiments, the self-expanding funnel 1708 may have a conical portion, specifically a truncated conical portion. In some embodiments, the self-expanding funnel may be formed from at least one of the following: a castle-style nitinol braid, a nitinol braid stent, 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 be equipped with 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.

[0119] Referring here to Figures 18 to 20, side views of embodiments of the injector sheath 102 in different configurations are shown. In Figure 18, the injector sheath 102 is shown in a non-deployed configuration; in Figure 19, the injector sheath 102 is shown in a partially deployed configuration; and in Figure 20, the injector sheath 102 is shown in a fully deployed and / or deployed configuration.

[0120] Specifically, as shown in Figure 18, the occluding device 120 extends through the lumen 1701 of the elongated member 106, and the self-expanding funnel 1708 is contained within the constrained configuration of the capture sheath 1500. In Figure 19, the occluding device 120 is advanced distally, thereby freeing the self-expanding funnel 1708 from its constrained configuration and / or deploying the self-expanding funnel 1708. In some embodiments, the length of the occluding device 120, specifically the length of the elongated shaft 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 occluding device 120 is prevented by collision of the stop portion 1508 with the sealed opening 112.

[0121] After the self-expanding funnel 1708 is deployed, the occluding device 120 can be retracted proximal through the lumen 1701 and sealed opening 112 of the elongated member 106 and removed from the inlet sheath 102. After the occluding device 120 is removed from the inlet sheath 102, the inlet sheath is in a fully deployed configuration, as shown in Figure 20.

[0122] In some embodiments, as shown in Figure 21, the inlet sheath 102 may include an inflatable balloon 2100 located at or near the distal end 110 of the elongated member 106. In some embodiments, the balloon 2100 may have a conical internal portion 2102 that can be sized and molded to receive the thrombus extraction device 202, specifically having a length greater than or equal to the length of the self-expanding cardiopulmonary bypass element 206.

[0123] Referring here to Figure 22, an introduction technique for accessing the thrombus 2200 is shown. As depicted, the thrombus 2200 is located within a blood vessel and can be accessed through an access site 2260, such as a popliteal access site. The introducer sheath 102 can extend from the popliteal access site 2260 to an deployment position 2262, where a self-expanding funnel 1708 can be deployed and brought into close proximity to the thrombus 2200. The TED 202 can be passed through the mass 2200 in the direction of blood flow, and the TED 202 can be retracted through the mass 2200 in the opposite direction of blood flow. Retraction of the TED 202 through the mass 2200 can result in decardiotomy of the mass using a self-expanding decardiotomy element 206 and capture of the mass into an expandable cylindrical body 208.

[0124] In some such embodiments, all or part of the TED202 may extend into one of the iliac veins and / or inferior vena cava, as depicted in Figure 23. Furthermore, as the TED202 is retracted from a proximal position relative to the heart to a distal position relative to the heart, the diameter of the vessel 2202 will decrease as the TED202 is retracted toward the access site 2260. This can result in increased compressive forces on the TED202, specifically on the self-expanding decardiocardial element 206. These compressive forces can be transmitted to a responsive spring 1214 via the ring feature 700 and the stopper 702. Through the extension or compression of the responsive spring 1214, the diameter of the TED202, specifically the decardiocardial element 206, can be changed to match the diameter of the vessel, and a desired radial force and / or force level can be maintained.

[0125] Figures 23-A to 23-H, Figures 24-A and 24-B, and Figures 25-A to 25-H illustrate the process of removing a thrombus from a patient's body, specifically from a blood vessel, which may be a venous blood vessel within the patient's body, using the thrombus extraction system 100. This includes the steps of accessing a blood vessel through one or more percutaneous access sites that can provide direct access to the blood vessel or indirect access to a blood vessel via one or more other blood vessels; advancing an introducer sheath to a position close to the thrombus; deploying a self-expanding funnel of the introducer sheath; advancing the distal end 132 of the thrombus extraction catheter 104 to a position close to the thrombus; deploying a thrombus extraction device 202; trapping the thrombus within the thrombus extraction device 202 by retracting the thrombus extraction device 202 through the thrombus; crushing the thrombus extraction device 202; and removing the thrombus extraction device 202 and the trapped thrombus from the introducer sheath 102 and the patient's body. In some embodiments, one or more of these access sites may include, for example, a popliteal access site, a femoral access site, and / or an internal cervical access site. In some embodiments, a thrombolytic agent may be injected into a blood vessel and / or aspirated from it before, during, or after the removal or extraction of a thrombus. The thrombolytic agent may comprise, for example, tissue plasminogen activator (TPA) or other thrombolytic agents.

[0126] 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 the purpose of removing a thrombus or promoting the healing of tissue adjacent to the device or both. In some embodiments, energy may be delivered to the device through the delivery system for treatment of the patient's vascular system, such that the device is heated or activated by the energy. Examples of energy that may be delivered include, but are not limited to, light energy, thermal energy, vibrational energy, electromagnetic energy, radiofrequency energy, and ultrasonic energy. With respect to some embodiments, the energy delivered to the device may trigger the release of a chemical or biological agent in the patient's tissue to facilitate the separation of a thrombus from the vascular wall and / or for treatment of the patient's vascular system, healing of tissue located adjacent to such device, or a combination thereof.

[0127] The process for using the thrombus extraction system 100 shown in Figures 22-A to 22-H, Figures 24-A and 24-B, and Figures 25-A to 25-H can be carried out with or against the direction of blood flow. Therefore, in some embodiments, the direction of blood flow in Figures 22-A to 22-H, Figures 24-A and 24-B, and Figures 25-A to 25-H can be from left to right or from right to left.

[0128] Referring here to Figures 23-A to 23-H, the process for expanding the thrombus extraction device 202 within a blood vessel, such as a venous vessel, is shown. The process for expanding the thrombus extraction device 202 within a blood vessel can be carried out using all or part of the thrombus extraction system 100. In some embodiments, the process for expanding the thrombus extraction device 202 within a blood vessel can be carried out in conjunction with monitoring techniques such as fluoroscopy, angiography, and / or ultrasound monitoring. In some embodiments, the monitoring technique can be used to monitor the deployment of the TED 202 within a blood vessel by observing one or more radiopaque markers located on the introducer sheath 102 and / or the thrombus extraction catheter 104.

[0129] The process begins in Figure 23-A, where the thrombus 2200 is identified within a blood vessel 2202, such as a venous vessel. In some embodiments, the thrombus 2200 may be located within the peripheral vascular system of the patient's body. The thrombus 2200, also referred to herein as the mass 2200, may have a proximal end 2204 and a distal end 2206. In some embodiments, the identification of the blood vessel 2202 may further include determining whether the thrombus 2200 within the blood vessel 2202 is suitable for thrombus extraction. In some embodiments, the thrombus 2200 within the blood vessel 2202 may be suitable for extraction when the blood vessel 2202 has a diameter of at least 5 millimeters. In some embodiments, the thrombus 2200 within the blood vessel 2202 may be suitable for extraction when the blood vessel 2202 has a diameter of at least 5 millimeters and is at least one of the femoral vein, iliac vein, popliteal vein, posterior tibial vein, anterior tibial vein, or peroneal vein.

[0130] After the thrombus is identified, the process proceeds to the steps shown in Figure 23-B, in which the introducer sheath 102 is advanced either with or against the direction of intravascular blood flow so that the distal end 110 of the introducer sheath 102 and / or the occluder 120 are in close proximity to the thrombus 2200, particularly in a proximal position to the thrombus 2200. In some embodiments, this may include the step of providing the introducer sheath 102 and percutaneously accessing the patient's circulatory system, specifically the patient's vascular or venous vessels, via an access site 2208, which may be one of the aforementioned referenced access sites.

[0131] After the introduction sheath 102 has been advanced to the desired position, the self-expanding funnel 1708 can be deployed and / or withdrawn from a constrained configuration to an expanded configuration, as depicted in Figure 23-C. In some embodiments, the self-expanding funnel 1708 can be deployed by the distal relative movement of the occluder 120 relative to the elongated member 106 until the funnel 1708 is no longer constrained by the capture sheath 1500, and the occluder 120 can then be retracted proximal through the lumen 1701 of the elongated member 106 until the occluder 120 is removed from the introduction sheath 102.

[0132] In some embodiments, the distal relative movement of the occluder 120 with respect to the elongated member may include steps to fix the position of the occluder 120 relative to the vessel 2202 until the stop 1508 contacts the sealed opening 112 and / or until monitoring, which may be radiopaque markers located, for example, at the tip 1502 of the occluder 120 and the distal end 110 of the elongated member 106, indicates that the self-expanding funnel 1708 has deployed and / or is no longer constrained by the capture sheath 1500, and to retract the elongated member 106 proximal to the occluder 120 and withdraw the self-expanding funnel 1708. Alternatively, in some embodiments, the distal relative movement of the occluder 120 relative to the elongated member may include steps to fix the position of the elongated member 106 relative to the blood vessel 2202, advance the occluder 120 distally, and withdraw the self-expanding funnel 1708, until the stop 1508 contacts the sealed opening 112 and / or, for example, fluoroscopic monitoring of radiopaque markers located at the tip 1502 of the occluder 120 and the distal end 110 of the elongated member 106, indicating that the self-expanding funnel 1708 has deployed and / or is no longer constrained by the capture sheath 1500.

[0133] After the self-expanding funnel 1708 is deployed, a portion of the thrombus extraction catheter 104, such as the outer shaft 138, can be inserted into the lumen 1701 of the introducer sheath 102 through the sealed opening 112, as depicted in Figure 23-D. In some embodiments, this may include providing the thrombus extraction catheter 104 equipped with a thrombus extraction device 202. In some embodiments, the thrombus extraction device 202 can be confined within the outer shaft 138 and, together with the outer shaft 138, can be inserted into the lumen of the elongated member 106 through the sealed opening 112. In some embodiments, the outer shaft 138 of the thrombus extraction catheter 104 may have a diameter such that the sealed opening 112 expands to seal and seal the outer shaft 138.

[0134] After the outer shaft 138 is inserted into the lumen 1701 of the introducer sheath 102, a portion of the thrombus extraction catheter 104 can be inserted into the blood vessel 2202 via the introducer sheath 102, as depicted in Figure 23-E. 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 proximal to the thrombus 2200. In some embodiments, the insertion and / or advancement of the thrombus extraction catheter 104 can be monitored, specifically 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.

[0135] After a portion of the thrombus extraction catheter 104 is inserted into the blood vessel 2202, the portion of the thrombus extraction catheter 104 can be advanced distally through the mass 2200, as depicted in Figure 23-F. In some embodiments, this distal advancement through the mass 2200 can be either with or against the direction of blood flow. In some embodiments, the portion of the thrombus extraction catheter 104 advanced distally through the mass 2000 may contain and / or restrain the thrombus extraction device 202. In some embodiments, the step of advancing the portion of the thrombus extraction catheter 104 distally through the mass may include advancing the portion of the thrombus extraction catheter 104 until a radiopaque marker 222, which may be located at the distal end 218 of the inner shaft 200 and / or portion of the thrombus 2200, has passed distal to the thrombus 2200.

[0136] After a portion of the thrombus extraction catheter 104 has been advanced distally through the blob 2200, the thrombus extraction device 202 can be deployed as depicted in Figure 23-G. In some embodiments, the thrombus extraction device 202 can be deployed by either advancing the thrombus extraction device 202 beyond the distal end 204 of the outer shaft 138, or by retracting the outer shaft 138 relative to the thrombus extraction device 202 until the thrombus extraction device 202 has passed the distal end 204 of the outer shaft 138. In some embodiments, the thrombus extraction device can be deployed so that the thrombus extraction device 202 has passed distal to the thrombus 2200 and / or a desired portion of the thrombus 2200 distally.

[0137] In some embodiments, the thrombus extraction 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 engagement feature 148, and the locking feature 146 engages with and / or locks into the engagement feature 148, thereby fixing the relative position of the intermediate shaft 140 with respect to the outer shaft 138.

[0138] In some embodiments, the deployment of the thrombus extraction device 202 can be monitored, specifically, the deployment of the thrombus extraction device 202 can be monitored fluoroscopically via radiopaque markers 222 and radiopaque markers located on one or both of the distal end 204 of the outer sheath 138 and the distal end 212 of the intermediate sheath 140, for example. In some embodiments, the deployment of the thrombus extraction device 202, specifically, the advance of the thrombus extraction device 202 beyond the distal end 204 of the outer shaft 138 or the retraction of the outer shaft 138 relative to the thrombus extraction device 202, can be aborted based on the position of the distal end 204 of the outer sheath 138, which includes a radiopaque marker (first radiopaque marker) relative to a radiopaque marker 222 (second radiopaque marker) located on the thrombus extraction device 202.

[0139] After the thrombus extraction device 202 is deployed, it can be fully expanded as shown in Figure 23-H. In some embodiments, this may include a step to allow the full expansion of the thrombus extraction device 202 so that it engages with the wall 2220 of the blood vessel 2202. In some embodiments, the thrombus extraction device 202 can be fully expanded by moving the plunger 154 from a first position to a second position and fixing the plunger 154 in the second position, thereby fixing the relative position of the inner shaft 200 with respect to the intermediate shaft 140. In some embodiments, the movement of the plunger 154 from the first position to the second position causes the inner shaft 200 to retract proximal to the intermediate shaft 140, thereby fully expanding the expandable cylindrical portion 208 of the thrombus extraction device 202. The proximal retraction of the inner shaft 200 relative to the intermediate shaft 140 further engages the stop 702 with the ring feature 700, thereby allowing the self-expanding cardioverter 206 to fully expand. In some embodiments, the fixation of the plunger 154 in the second position can fix the self-expanding cardioverter 206 and the thrombus extraction device 202 in full expansion via the engagement of the stop 702 and the ring feature 700.

[0140] Referring here to Figures 24-A and 24-B, alternative embodiments of the steps shown in Figures 23-G and 23-H are shown. In some embodiments, these alternative embodiments can be performed when the diameter of the vessel 2202 containing the thrombus 2200 decreases distal to the thrombus 2200 and falls below a desired level. In some embodiments, for example, the diameter of the vessel 2202 may decrease as the distance from the heart increases. In some embodiments, this diameter may decrease to a point where the use of the thrombus extraction device 202 may no longer be possible.

[0141] In such embodiments, an extension sheath 2300, also referred to herein as a popliteal sheath 2300, can be percutaneously inserted into the blood vessel 2202 through the 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 position before the blood vessel diameter decreases to a desired value, such as below 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 through an access site, such as a popliteal access site.

[0142] The thrombus extraction device 202 can be deployed as depicted in Figure 24-A. In some embodiments, the thrombus extraction device 202 can be deployed by either advancing the thrombus extraction device 202 into the extension sheath 2300 beyond the distal end 204 of the outer shaft 138, or by advancing the outer shaft 138 containing the thrombus extraction device 202 into the extension sheath, and then retracting the outer shaft 138 relative to the thrombus extraction device 202 until the thrombus extraction device 202 has passed the distal end 204 of the outer shaft 138. In some embodiments, the thrombus extraction device can be deployed so that the thrombus extraction device 202 has passed distal to the thrombus 2200 and / or a desired portion of the thrombus 2200 has passed distally. In some embodiments, all or part of the thrombus extraction device can be contained within the extension sheath 2300.

[0143] In some embodiments, the outer shaft 138 of the thrombus extraction catheter 104 may be separable into a first and a second component. In some embodiments, this separation may occur at a separation point, which may have any features configured to allow separation of the first and second components, for example. These features may include partial depth gaps or notches within the outer shaft 138, overlapping friction fittings within the outer shaft 138, or equivalents. In some embodiments, the separable outer shaft 138 may be used in place of an extension sheath 2300. In such embodiments, the outer shaft 138 may exit the vessel 2202 via an access site, such that the separable portion extends from inside the vessel 2202 to outside the patient's body at the access point. In such embodiments, the separable portion of the outer sheath 138 may serve as an extension sheath 2300 and remain within the access point when the thrombus extraction device 202 is retracted. Therefore, the thrombus extraction device 202 can be deployed by fixing the position of the separation portion of the outer sheath 138 and retracting the thrombus extraction device 202 from that separation portion of the outer sheath 138.

[0144] In some embodiments, the thrombus extraction device can be 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 engagement feature 148. In some embodiments, the locking feature 146 can engage and / or be fixed to the engagement feature 148, thereby fixing the relative position of the intermediate shaft 140 relative to the outer shaft 138.

[0145] In some embodiments, the deployment of the thrombus extraction device 202 can be monitored fluoroscopically, specifically, via radiopaque markers 222 and radiopaque markers located on 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 extraction device 202, specifically, the advance of the thrombus extraction device 202 beyond the distal end 204 of the outer shaft 138 or the retraction of the outer shaft 138 relative to the thrombus extraction device 202, can be aborted based on the position of the distal end 204 of the outer sheath 138, which includes a radiopaque marker (first radiopaque marker) relative to a radiopaque marker 222 (second radiopaque marker) located on the thrombus extraction device 202.

[0146] After the thrombus extraction device 202 is deployed, it can be fully expanded as shown in Figure 24-B. In some embodiments, the thrombus extraction device 202 can be fully expanded while all or part of it remains contained within the extension sheath 2300. In such embodiments, the portion of the thrombus extraction device 202 contained within the extension sheath 2300 can be prevented from reaching full expansion by the extension sheath 2300. In such embodiments, the thrombus extraction device 202 can reach full expansion as it is retracted proximal to the extension sheath 2300.

[0147] In some embodiments, the full expansion of the thrombus extraction device 202 may include a step that allows the thrombus extraction device 202 to expand so that it engages with the wall 2220 of the blood vessel 2202. In some embodiments, the thrombus extraction device 202 can be fully expanded by moving the plunger 154 from a first position to a second position and fixing the plunger 154 in the second position, thereby fixing the relative position of the inner shaft 200 with respect to the intermediate shaft 140. The movement of the plunger 154 from the first position to the second position causes the inner shaft 200 to retract proximally relative to the intermediate shaft 140, thereby expanding the expandable cylindrical portion 208 of the thrombus extraction device 202. In some embodiments, the proximal retraction of the inner shaft 200 relative to the intermediate shaft 140 may further engage the stop 702 with the ring feature 700, thereby fully expanding the self-expanding cardioverter 206. In some embodiments, the fixation of the plunger 154 in the second position allows the self-expanding cardioverter-cardiac element 206 and the thrombus extraction device 202 to be fixed in full expansion via the engagement of the stop portion 702 and the ring feature 700.

[0148] In some such embodiments, where the TED202 is contained all or entirely within the extension sheath 2300, the TED202 can be retracted until the self-expanding cardioverter 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 a first position to a second position, allowing the self-expanding cardioverter 206 to be fully expanded. TED202 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 retracts from the extension sheath 2300 until the expandable cylindrical portion 208 is fully retracted and 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 dispersed within the inner shaft 140 until the expandable cylindrical portion 208 is fully retracted from the extension sheath 2300. Once the expandable cylindrical portion 208 has completely retracted from the extension sheath 2300, the distal end 217 of the expandable cylindrical portion 208 can be reattached to the inside of the shaft 200, and the expandable cylindrical portion 208 can be fully expanded.

[0149] Referring here to Figures 25-A to 25-H, a process for removing a thrombus 2200 using an extended thrombus extraction device 202 is shown. In some embodiments, the thrombus 2200 can be removed by capturing the thrombus into the thrombus extraction device 202 via proximal retraction of the thrombus extraction device 202 through the thrombus 2200, and the proximal retraction of the thrombus extraction device 202 can be, for example, in the direction of blood flow through a blood vessel 2202 or against the direction of blood flow through a blood vessel 2202. In some embodiments, the proximal retraction of the thrombus extraction device 202 through the thrombus 2200 can result in the capture of the distal end 2206 of the thrombus 2200 before the capture of the proximal end 2204 of the thrombus 2200.

[0150] In some embodiments, proximal retraction of the thrombus extraction device 202 can result in the separation and / or decardiocardialization of at least a portion of the thrombus 2200 from the wall 2220 of the blood vessel 2202 by, for example, a self-expanding cardioverter-cardiac element 206 and / or a stent portion, and the capture of the separated portion of the thrombus 2200 into an expandable cylindrical portion 208. In some embodiments, the expandable cylindrical portion 208 can be formed from a braided filament mesh structure, which may be, for example, a reticular filament mesh structure. In some embodiments, a portion of the thrombus can be captured into the expandable cylindrical portion 208 by entering the expandable cylindrical portion 208 through the opening 414 of the self-expanding cardioverter-cardiac element 206 and / or through one or more of the gaps 404 of the self-expanding cardioverter-cardiac element 206.

[0151] As shown in Figure 25-A, the distal end 2206 of the thrombus 2200 is separated and / or decardialized by the self-expanding decardial element 206 via the proximal retraction of the thrombus extraction device 202. As shown in Figure 25-B, the distal end 2206 of the thrombus 2200 is captured within the expandable cylindrical portion 208 of the thrombus extraction device by the continued proximal retraction of the thrombus extraction device through the thrombus 2200. The separation and capture of further portions of the thrombus 2200, as well as decardialization and capture, by the continued proximal retraction of the thrombus extraction device 202 are shown in Figures 25-C, 25-D, and 25-E. As shown in Figure 25-E, the proximal end 2204 of the thrombus 2200 is decardialized and captured as the thrombus extraction device 202 is retracted proximally toward the self-expanding funnel 1708.

[0152] In some embodiments, the thrombus extraction device 202 can be retracted proximal to the self-expanding cardioverter 206 until a portion of it is contained within the self-expanding funnel 1708, as shown in Figure 25-F, specifically until the opening 414 of the self-expanding cardioverter 206 is contained within the self-expanding funnel 1708. In some embodiments, the inclusion of the opening 414 within the self-expanding funnel 1708 can be determined via fluoroscopic monitoring. In some embodiments, the opening 414 can be determined to be contained as a whole within the self-expanding funnel 1708 based on the alignment / relative positioning of the distal end 212 of the intermediate shaft 140, which has radiopaque markers 2450 and / or radiopaque markers 222, relative to the distal end 110 of the elongated member 106 of the introducer sheath 102, which has radiopaque markers 2452.

[0153] When a portion of the self-expanding cardioverter-cardiac element 206 is contained within the self-expanding funnel 1708, or more specifically, when the mouth 414 of the self-expanding cardioverter-cardiac element 206 is contained entirely within the self-expanding funnel 1708, the plunger 154 can be disengaged from a second position and moved from the second position to a first position, thereby moving the thrombus extraction device 202 from an expanded configuration to a non-expanded configuration. In some embodiments, disengaging the plunger 154 from the second position can disengage and / or separate the inner shaft 200 from the intermediate shaft 140, and moving the plunger 154 from the second position to the first position can cause distal advancement of the inner shaft 200 relative to the intermediate shaft 140.

[0154] In some embodiments, the thrombus extraction device 202 can be crushed by moving it from an expanded configuration to a non-expanded configuration prior to the step of withdrawing the thrombus extraction device 202 from the patient's body, so as to compress the thrombus 2200 captured by the thrombus extraction device 202. In some embodiments, the compression of the thrombus 2200 by the thrombus extraction device 202 can, in some embodiments, fix the position of the thrombus within the thrombus extraction device 202 via engagement of the thrombus 2200 with one or more of a plurality of circumferential recesses 1000.

[0155] After the thrombus extraction device 202 is crushed, it can be retracted proximal to the elongated member 106 through the self-expanding funnel 1708, as depicted in Figure 25-G. In some embodiments, the crushing of the thrombus extraction device 202 and / or its retraction into the self-expanding funnel 1708 and / or elongated member can result in the extrusion of all or part of the thrombus 2200 through the pores of the expandable cylindrical portion 208 of the thrombus extraction device 202, which 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 can 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 pores in the second plurality of pores 906 can be sized to be sufficiently small such that any thrombus portion of the thrombus 2200 extruded through the pores is small enough to have little or no clinical significance. In some embodiments, all or part of these extruded thrombi 2200 can be captured by a self-expanding funnel 1708.

[0156] The thrombus extraction device 202 can be continuously retracted proximal to the elongated member 106 until the thrombus extraction device 202 and the captured thrombus 2200 are completely contained within the elongated member 106, as depicted in Figure 25-H. In some embodiments, a seal expander 170 can be inserted into the sealed opening 112 and the thrombus extraction device 202, and the captured thrombus 2200 can then be extracted or removed from the patient's body and the elongated member 106 through the sealed opening 112 within the seal expander 170. In some embodiments, the thrombus captured by the self-expanding funnel 1708 can then be either 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, in particular through the mesh of the self-expanding funnel 1708. In some embodiments, the thrombus can be aspirated through the lumen 1701 and suction port 114 of the elongated member 106. In some embodiments, aspiration of the thrombus through the suction port 114 may include opening the suction valve 118. After the thrombus captured by the self-expanding funnel 1708 has been aspirated, the inlet sheath 102 can be removed from the patient's body.

[0157] Referring here to Figures 26-28, introduction techniques for accessing the thrombus 2200 are shown. In some embodiments, these introduction techniques may allow the use of a larger size introducer sheath 102 due to the larger size of the blood vessel in the pathway to the thrombus. In some embodiments, a larger size introducer sheath 102 may facilitate the removal of the thrombus through the introducer sheath 102, as in some embodiments the size of the lumen 1701 of the introducer sheath 102 may increase as the size of the introducer sheath 102 increases. Furthermore, in some embodiments, the use of a larger size introducer sheath 102 may allow the removal of larger thrombi. In some embodiments, the lengths of the components of the thrombus extraction system 100, in particular the lengths of the introducer sheath 102 and the thrombus extraction catheter 104, may vary based on the selected technique for accessing the thrombus and / or based on the location of the thrombus.

[0158] As shown in Figure 26, the induction sheath 102 can be inserted into the patient's body through the internal jugular access site 2500. The induction sheath 102 may extend from the internal jugular access site 2500 to a deployment position 2502, which may be proximal to the thrombus 2200. In embodiments in which the induction sheath 102 is equipped with a self-expanding funnel 1708, the self-expanding funnel 1708 may be deployed at the deployment position 2502. In the embodiment shown in Figure 26, the induction sheath may extend from the internal jugular access site 2500 through the superior and inferior vena cava to a deployment position 2502 in one of the common iliac veins. In some embodiments, the deployment position 2502 may be located in the inferior vena cava, which is, for example, one of the iliac veins, femoral vein, or popliteal vein, anterior to or beyond the iliac arch, or in close proximity to and / or proximal to the thrombus 2200. In some embodiments, the use of the internal cervical access portion 2500 can allow for a larger diameter of the elongated member 106.

[0159] As shown in Figure 27, in some embodiments, the use of the internal cervical 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 extraction device can be removed from the patient's body, whole or in part, while remaining contained within the extension sheath 2300 before being retracted through the thrombus 2200.

[0160] As shown in Figure 28, in some embodiments, the introduction device sheath can be inserted into the patient's body through an access site connected to a blood vessel 2202 containing the thrombus via the common iliac vein. In the specific embodiments shown in Figure 28, this can be achieved through insertion into the patient's body via a femoral access site 2700. In some embodiments, the use of an access site connected to a blood vessel 2202 via the common iliac vein, specifically 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 blood vessel 2202 at a popliteal access site 2600. In some such embodiments, the thrombus extraction device can be withdrawn from the patient's body, whole or in part, while remaining contained within the extension sheath 2300 before being retracted through the thrombus 2200.

[0161] Other modifications are also within the spirit of the invention. Thus, the invention is subject to various modifications and alternative structures, some illustrated embodiments of which are shown in the drawings and described in detail above. However, it should be understood that the invention is not intended to be limited to the specific or multiple embodiments disclosed, but rather intended to encompass all modifications, alternative structures, and equivalents that fall within the spirit and scope of the invention as defined in the appended claims.

[0162] The above description illustrates various embodiments of the present invention. For the purpose of explanation, specific configurations and details are described to provide a complete understanding of the embodiments. However, it will also be apparent to those skilled in the art that the present invention can be put into practice without specific details. Furthermore, well-known features may be omitted or simplified so as not to obscure the embodiments described.

[0163] In the context describing the present invention (in particular, in the context of the following claims), the use of the terms “a,” “an,” and “the,” as well as similar reference terms, should be interpreted as encompassing both singular and plural forms, unless otherwise indicated herein or unless explicitly contradicted by the context. The terms “~equipped with,” “~having,” “~containing,” and “~including,” should be interpreted as non-restrictive terms (i.e., “~containing, but not restrictive”), unless otherwise noted. The term “conjugated,” whether partially or whole, should be interpreted as being included in, attached to, or joined together with, where any intervention is present. The enumeration of value ranges herein is intended merely as a simple way of referring individually to each isolated value within the range, unless otherwise indicated herein, and each isolated value is incorporated herein as if it were individually enumerated herein. All methods described herein may be performed in any preferred order, unless otherwise indicated herein or unless explicitly contradicted by the context. The use of any and all examples or illustrative language provided herein (e.g., "etc.") is intended solely to better illustrate embodiments of the invention and, unless otherwise asserted, does not impose limitations on the scope of the invention. No language herein should be construed as indicating any non-assertive element as essential to the practice of the invention.

[0164] Preferred embodiments of the present invention, including the best modes known to the inventors for carrying out the invention, are described herein. Modifications of these preferred embodiments may become obvious to those skilled in the art upon careful reading of the foregoing description. The inventors anticipate that those skilled in the art will adopt such modifications as needed, and the inventors intend that the invention may be practiced in ways other than those specifically described herein. Thus, the invention includes, to the extent permitted by applicable law, all modifications and equivalents of the subject matter enumerated in the claims appended herein. Furthermore, any combination of the aforementioned elements in all possible modifications is also encompassed by the invention, unless otherwise shown herein or otherwise clearly contradicted by context.

[0165] All references cited herein, including publications, patent applications, and patents, are individually and specifically indicated so as to be incorporated by reference, and are incorporated herein by reference to the same extent as they would be if they were described herein as a whole.

Claims

1. A thrombus extraction device, wherein the thrombus extraction device is A centering element comprising a plurality of interconnected support columns, wherein the centering element includes a distal end portion defining a plurality of openings, A mesh structure comprising a plurality of filaments, wherein the mesh structure extends distally from the distal end portion of the decompression element, and each of the plurality of filaments extends through a corresponding opening of the plurality of openings, thereby the first portion of each of the plurality of filaments extending distally from the distal end portion of the decompression element, and the second portion of each of the plurality of filaments extending distally from the distal end portion of the decompression element, and the first and second portions of the plurality of filaments are woven together. A thrombus extraction device equipped with the following features.

2. The thrombus extraction device according to claim 1, wherein the plurality of openings extend circumferentially around the longitudinal axis of the decardiotomy element.

3. The thrombus extraction device according to claim 1, wherein each of the plurality of filaments has a first portion comprising a first distal end portion, each of the plurality of filaments has a second portion comprising a second distal end portion, and the first distal end portion and the second distal end portion of each of the plurality of filaments are fixed together.

4. The thrombus extraction device according to claim 3, wherein the first distal end portion and the second distal end portion of each of the plurality of filaments are fixed together in a hub.

5. The thrombus extraction device according to claim 3, wherein the first distal end portion and the second distal end portion of each of the plurality of filaments are fixed together at their tips.

6. The thrombus extraction device is A first shaft connected to the proximal end portion of the decentrating element, A second shaft, wherein the first distal end portion and the second distal end portion of each of the plurality of filaments are fixed together to the second shaft. Furthermore, The thrombus extraction device according to claim 3, wherein the first shaft and the second shaft are movable relative to each other.

7. The thrombus extraction device according to claim 1, wherein the decardiocardial element is configured to self-expand when not restrained.

8. The thrombus extraction device according to claim 1, wherein at least some of the plurality of filaments form loops around the corresponding openings of the plurality of openings.

9. The thrombus extraction device according to claim 1, wherein at least some of the plurality of filaments do not form loops around corresponding filaments of the plurality of filaments.

10. The thrombus extraction device according to claim 1, wherein the plurality of filaments comprises a first plurality of filaments and a second plurality of filaments, the individual filaments of the first plurality of filaments forming a loop around the corresponding opening of the plurality of openings, and the individual filaments of the second plurality of filaments not forming a loop around the corresponding opening of the plurality of openings.

11. The thrombus extraction device according to claim 1, wherein the first portion and the second portion of the plurality of filaments are woven together to have a substantially cylindrical shape.

12. The thrombus extraction device according to claim 1, wherein the number of the plurality of filaments is the same as the number of the plurality of openings.

13. The thrombus extraction device according to claim 1, wherein the number of the plurality of filaments is greater than the number of the plurality of openings.

14. A thrombus extraction device, wherein the thrombus extraction device is A centering element comprising a plurality of interconnected support columns, wherein the centering element has a distal end portion, and the plurality of interconnected support columns form a plurality of closed cells at the distal end portion of the centering element. A mesh structure comprising a plurality of filaments, wherein the mesh structure extends distally from the distal end portion of the decompression element, and each of the plurality of filaments extends through the corresponding closed cell of the plurality of closed cells, thereby the first portion of each of the plurality of filaments extending distally from the distal end portion of the decompression element, and the second portion of each of the plurality of filaments extending distally from the distal end portion of the decompression element, and the first and second portions of the plurality of filaments are woven together. A thrombus extraction device equipped with the following features.

15. The thrombus extraction device according to claim 14, wherein the plurality of closed cells extend circumferentially around the longitudinal axis of the decardiocardial element, the first portion of each of the plurality of filaments comprises a first distal end portion, the second portion of each of the plurality of filaments comprises a second distal end portion, and the first distal end portion and the second distal end portion of each of the plurality of filaments are fixed together.

16. The thrombus extraction device according to claim 15, wherein the first distal end portion and the second distal end portion of each of the plurality of filaments are fixed together at a hub or at the tip.

17. The thrombus extraction device is A first shaft connected to the proximal end portion of the decentrating element, A second shaft, wherein the first distal end portion and the second distal end portion of each of the plurality of filaments are fixed together to the second shaft. Furthermore, The thrombus extraction device according to claim 15, wherein the first shaft and the second shaft are movable relative to each other.

18. The thrombus extraction device according to claim 14, wherein the first portion and the second portion of the plurality of filaments are woven together to have a substantially cylindrical shape.

19. The thrombus extraction device according to claim 14, wherein the number of the plurality of filaments is the same as the number of the plurality of closed cells.

20. The thrombus extraction device according to claim 14, wherein the number of the plurality of filaments is twice the number of the plurality of closed cells.

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