Devices and methods for treating vascular occlusions

Abstract

Systems and methods for removing a thrombus from a blood vessel in a patient are disclosed herein. The method can include providing a thrombus extraction device including a proximal self-expanding member formed from a fenestrated structure, a substantially cylindrical portion formed from a mesh filament mesh structure having a proximal end connected to a distal end of the fenestrated structure, advancing a catheter confining the thrombus extraction device through a blood vessel thrombus, advancing the self-expanding assembly distally until the self-expanding assembly exits the catheter to stack a portion of the mesh filament mesh structure outside the catheter, thereby deploying the thrombus extraction device, retracting the self-expanding assembly to unstack a portion of the mesh filament mesh structure and capture a portion of the thrombus, and removing the thrombus extraction device from the body.

Description

[0001] This application is a divisional application of Chinese patent application No. 201780080361.3, entitled "Apparatus and Method for Treating Vascular Occlusion", filed on April 26, 2017.

[0002] Cross-references to related applications

[0003] This application claims the benefit of PCT application No. PCT / US2016 / 058536, filed October 24, 2016, entitled “Endovascular treatment of vascular occlusion and related devices, systems and methods”, and U.S. Provisional Application No. 62 / 444,705, filed January 10, 2017, entitled “Inverted or self-administered device and method for treating vascular occlusion”, both of which are incorporated herein by reference in their entirety.

[0004] This application relates to U.S. Provisional Application No. 62 / 245,935, filed October 23, 2015, entitled "Endovascular Treatment of Vascular Occlusion and Related Devices, Systems, and Methods"; U.S. Patent Application No. 15 / 268,296, filed September 16, 2016, entitled "Endovascular Treatment of Vascular Occlusion and Related Devices, Systems, and Methods"; U.S. Patent Application No. 15 / 268,406, filed September 16, 2016, entitled "Endovascular Treatment of Vascular Occlusion and Related Devices, Systems, and Methods"; and International Patent Application No. PCT / US2016 / 058536, filed October 24, 2016, entitled "Endovascular Treatment of Vascular Occlusion and Related Devices, Systems, and Methods", each of which is incorporated herein by reference in its entirety. Background Technology

[0005] Thrombosis is the term for a blood clot that forms inside a blood vessel; venous thrombosis is a blood clot (thrombus) that forms inside a vein. A common type of venous thrombosis is deep vein thrombosis (DVT). DVT is a blood clot (thrombus) that forms primarily in the deep veins of the leg. Nonspecific signs may include pain, swelling, redness, heat, and congestion in the superficial veins.

[0006] If a blood clot breaks off (embolizes) and travels to the lungs, it can become a life-threatening pulmonary embolism (PE), a type of blood clot in the lungs. In addition to the potential loss of life due to PE, deep vein thrombosis (DVT) can cause significant health problems such as post-thrombotic syndrome, which can cause chronic swelling, pressure, pain, and ulceration due to damage to valves and blood vessels. Furthermore, DVT can directly or indirectly lead to significant healthcare costs due to treatment-related complications and the patient's inability to work.

[0007] Three processes are believed to lead to venous thrombosis (DVT). These are decreased blood flow rate (venous stasis), increased clot tendency (hypercoagulability), and changes in the vessel wall. DVT formation typically begins within the valves of the veins in the lower leg, where the blood is relatively hypoxic, which activates certain biochemical pathways. Several medical conditions increase the risk of DVT, including diabetes, cancer, trauma, and antiphospholipid syndrome. Other risk factors include older age, surgery, immobilization (such as bed rest, orthotic braces, and long-distance air travel), combined use of oral contraceptives, pregnancy, postpartum period, and genetic factors. The incidence of DVT increases significantly from childhood to old age, and it occurs in approximately 1 in 1,000 adults each year.

[0008] While devices and methods exist for the prevention and / or treatment of deep vein thrombosis (DVT), several unresolved drawbacks exist, such as a high recurrence rate of DVT, the use of devices not designed to remove large clot volumes, and / or complex treatments involving multiple devices and / or medications. Therefore, new devices, systems, and methods for treating thrombosis, particularly DVT, are needed. Summary of the Invention

[0009] Various aspects of this disclosure relate to systems and methods for thrombus extraction, particularly for extracting thrombi from the peripheral vascular system. The thrombus extraction apparatus of the present invention is designed to remove large clot volumes, including mature and organized clots, reducing the need for drugs such as thrombolytic agents. This reduces the risk of bleeding, shortens post-treatment recovery time, and lowers the cost of healthcare procedures. The thrombus extraction apparatus may include a self-expanding coring section connected to a braided mesh to efficiently cork and separate large amounts of thrombi from large vessels, such as in the venous or arterial systems, while simultaneously capturing the separated thrombi within the braided mesh.

[0010] One aspect of this disclosure relates to a method for removing a thrombus from a blood vessel in a patient. The method includes providing a thrombus extraction device. The thrombus extraction device may include: a proximal self-expanding component formed of a porous structure, and a generally cylindrical portion formed of a mesh structure having a proximal end coupled to a distal end of the porous structure. The method includes: advancing a catheter that limits the thrombus extraction device through the vascular thrombus; advancing the self-expanding component distally until the self-expanding component extends beyond the distal end of the catheter to stack a portion of the mesh structure outside the catheter, thereby unfolding the thrombus extraction device; retracting the self-expanding component relative to the distal end of the mesh structure to destabilize the portion of the mesh structure, separating a portion of the thrombus from the vessel wall and trapping a portion of the thrombus in the mesh structure; and retrieving the thrombus extraction device from the body to remove the thrombus from the patient.

[0011] In some examples, advancing the catheter through a vascular thrombus involves inserting the catheter into the blood vessel until the distal, radiopaque tip of the catheter passes the thrombus portion. In some examples, a portion of the stacked mesh structure includes: fixing the position of the distal end of the mesh structure; and advancing the self-expanding component distally relative to the distal end of the mesh structure.

[0012] In some examples, the distal end of the reticular mesh structure is fixed proximally relative to one or more valves within the patient's body. In some examples, the distal end of the reticular mesh structure is fixed at one or more valves in the inferior vena cava and / or distal to one or more valves. In some examples, the valve is located in a vessel containing a thrombus. In some examples, the valve is located in a secondary vessel connected to the vessel containing the thrombus.

[0013] In some examples, the stacked mesh structure includes variations in the braiding angle of a portion of the mesh structure. In some examples, the braiding angle of a portion of the mesh structure is greater than 45° when stacked. In some examples, the diameter of this portion of the mesh structure is larger than the diameter of the porous structure. In some examples, the catheter is inserted into the blood vessel through a posterior patellar entry site, and the catheter is advanced distally from the posterior patellar entry site. In some examples, the mesh structure is interwoven on the porous structure.

[0014] In some examples, the method includes moving the perforated structure to full expansion. In some examples, moving the perforated structure to full expansion includes retracting a stop shaft relative to the perforated structure. In some examples, the stop shaft retracts relative to the perforated structure by movement of a plunger from a first position to a second position. In some examples, the stop shaft retracts relative to the perforated structure by movement of a shuttle from a first position to a second position. In some examples, the shuttle moves from a first position to a second position by a force applied to the shuttle by a spring. In some examples, the stop shaft applies a constant pressure on a stop ring. In some examples, the stop shaft is replaced by a cord or filament to engage with the perforated structure. In some examples, the stop shaft may comprise a filament, such as a metal or polymer filament, monofilament, and / or braided or woven strand. The cord or filament may be attached proximal to the guide hub or handle and may apply a constant tension when the perforated structure is deployed.

[0015] In some examples, advancing a catheter through a vascular thrombus includes inserting the catheter into the blood vessel via a funnel-shaped catheter, the funnel-shaped catheter comprising: an elongated sheath; and a self-expanding funnel coupled to the distal end of the elongated sheath. In some examples, retrieving the thrombus extraction device from the body to remove the thrombus from the patient includes retracting the thrombus extraction device until at least a portion of the self-expanding component is contained within the self-expanding funnel. In some examples, at least a portion of the self-expanding component contained within the self-expanding funnel includes an opening of the self-expanding component. In some examples, the method includes simultaneously retracting the thrombus extraction device and the funnel-shaped catheter proximally from the patient. In some examples, the opening of the thrombus extraction device remains within the self-expanding funnel while simultaneously retracting the thrombus extraction device and the funnel-shaped catheter from the patient.

[0016] One aspect of this disclosure relates to a thrombus extraction device for removing vascular thrombi from a patient's blood vessel. The thrombus extraction device includes: a catheter having a proximal end and a distal end; an outer shaft defining a first lumen; a core-retrieving element shaft defining a second lumen; a stop shaft; and a tip shaft. In some examples, the stop shaft may define a third lumen, and in some examples, the tip shaft may define a tip lumen. In some examples, the core-retrieving element shaft is coaxial with the first lumen, and the tip shaft is coaxial with the second lumen. The thrombus extraction device includes a self-expanding core-retrieving element formed of a porous structure having an opening at its proximal end and configured to core and separate a portion of the vascular thrombus from the blood vessel. In some examples, the proximal end of the porous structure is coupled to the distal end of the core-retrieving element shaft. The thrombus extraction device may include an expandable cylindrical portion formed of a fine mesh structure capable of capturing portions of the vascular thrombus. In some examples, the proximal end of the mesh structure is coupled to the distal end of the porous structure. In some examples, the stop shaft can move independently of the tip shaft relative to the core element shaft and the proximal end of the self-expanding core element, so that the self-expanding core element is in an expanded state.

[0017] In some examples, the fine mesh structure is interwoven on the porous structure. In some examples, the thrombus extraction device also includes a dilation mechanism that maintains the required radial force on the vessel wall using a self-dilatating core-retrieval element. In some examples, the dilation mechanism ensures that the porous structure is always fully dilated. In some examples, the dilation mechanism includes an annular feature and a stop feature of the porous structure, the stop feature engaging with the annular feature when the porous structure is fully dilated. In some examples, the stop feature engages with the annular feature when the porous structure is fully dilated and extends throughout the entire stroke and / or diameter range of the porous structure. In some examples, the stop feature may be a tab on a stop shaft. In some examples, the tab engages with the annular feature, and the stop shaft is coaxial with the first lumen.

[0018] In some examples, the thrombus retrieval device may include a handle comprising a plunger capable of controlling the relative position of the stop shaft relative to the core element shaft and selectively fixing the relative position of the stop shaft relative to the core element shaft. In some examples, the thrombus retrieval device further includes a handle having a spring connected to the stop shaft via a movable shuttle. In some examples, the shuttle is movable between a first position, in which the self-expanding core element retracts, and in the second position, the self-expanding core element expands. In some examples, the spring comprises at least one of the following: a constant force spring; a tension spring; or a compression spring. In some examples, the spring may include any means for applying force to the stop, including, for example, an elastomer, a pressure chamber, a hydraulic or pneumatic piston, or a torsion spring.

[0019] One aspect of this disclosure relates to a funnel catheter for reaching and removing thrombi within a patient's blood vessel. The funnel catheter includes: an elongated sheath having a proximal end, a distal end, and an inner lumen extending between the proximal and distal ends; a self-expanding funnel coupled to the distal end of the elongated sheath; and a dilator assembly capable of being received within the lumen of a trapping sheath. The dilator assembly includes: an occluder having an elongated shaft having a proximal end, a distal end, and a trapping sheath proximal to the distal end, the trapping sheath capable of holding the self-expanding funnel in a confined configuration. In some examples, the dilator assembly may include a movable shaft extending coaxially between the proximal end of the occluder and the trapping sheath along a portion of the elongated shaft of the occluder. In some examples, the movable shaft includes a matching feature at the distal end of the movable shaft that can mate with the trapping sheath.

[0020] In some examples, the funnel-shaped conduit includes a sealing hub located proximal to the elongated sheath. In some examples, the sealing hub may include a suction port. In some examples, when the self-expanding funnel is in a confined configuration, the diameter of the self-expanding funnel is equal to or smaller than the diameter of the trapping sheath. In some examples, the diameter of the movable shaft is equal to the diameter of the trapping sheath. In some examples, the movable shaft is movable between a loaded position and a retracted position. In some examples, the movable shaft includes a connecting feature that, when the movable shaft is in the loaded position, connects the movable shaft to the proximal end of the elongated shaft. In some examples, when the movable shaft is in the retracted position, a mating feature of the movable shaft can mate with the trapping sheath.

[0021] One aspect of this disclosure relates to a method for reaching and removing a thrombus from a patient's vein. The method includes percutaneous access to the patient's vein via an entry site using a funnel catheter. In some examples, the funnel catheter includes an elongated sheath defining an inner lumen, a self-expanding funnel coupled to the distal end of the elongated sheath, and a dilator assembly comprising: an elongating occluder extending through the lumen and retaining the self-expanding funnel in a restricted configuration within a trapping sheath of the occluder; and a movable axis extending coaxially along a portion of the elongated occluder. In some examples, the entry site may be a posterior genicular entry site, a femoral entry site, a mid-femoral entry site, a tibial entry site, a contralateral entry site, or an internal jugular vein entry site. The method includes: advancing the distal end of the funnel catheter to a location proximal to the thrombus; deploying the self-expanding funnel from a restricted configuration within the trapping sheath to an expanded configuration detached from the trapping sheath; trapping the thrombus in the self-expanding funnel; and aspirating the trapped material through the lumen of the elongated sheath.

[0022] In some examples, deploying the self-expanding funnel includes: distally advancing the expander assembly relative to the elongated sheath to withdraw the self-expanding funnel from a confined configuration to an expanded configuration; moving the movable shaft from a loaded position to a retracted position; and removing the expander assembly from the funnel conduit by proximally retracting the expander assembly through the deployed self-expanding funnel and through the lumen of the elongated sheath. In some examples, deploying the self-expanding funnel may include: proximally retracting the elongated sheath over the expander assembly to withdraw the self-expanding funnel from a confined configuration to an expanded configuration; moving the movable shaft from a loaded position to a retracted position; and removing the expander assembly from the funnel conduit by proximally retracting the expander assembly through the deployed self-expanding funnel and through the lumen of the elongated sheath. In some examples, when the movable shaft is in the retracted position, the matching features of the movable shaft match the trapping sheath.

[0023] In some examples, the method includes inserting a catheter restricting the thrombus extraction device through the lumen of a slender sheath such that the distal tip of the catheter passes distally through the thrombus portion of the vessel, deploying the thrombus extraction device from the catheter, and retracting the thrombus extraction device proximally relative to the funnel catheter until the opening of the thrombus extraction device is located within the self-expanding funnel. In some examples, the method includes percutaneous access to the patient's vein via an entry site using a guiding sheath. In some examples, percutaneous access to the patient's vein via an entry site using a funnel catheter includes inserting the funnel catheter into the vein using a guiding sheath. In some examples, the method includes simultaneously retracting the thrombus extraction device and the funnel catheter proximally from the patient using a guiding sheath. In some examples, during the simultaneous retraction of the thrombus extraction device and the funnel catheter from the patient, the opening of the thrombus extraction device remains within the self-expanding funnel.

[0024] One aspect of this disclosure relates to a method for removing a thrombus from a blood vessel in a patient. The method includes providing a thrombus extraction device having a proximal self-expanding member formed of a unitary porous structure; a generally cylindrical portion formed of a mesh structure having a non-elapped portion coupled to the distal end of the unitary porous structure and an elapped portion extending proximally within the unitary porous structure; and an inner shaft member coupled to the distal end of the mesh structure. The method may include: advancing a catheter that restricts the thrombus extraction device through the vascular thrombus; advancing the unitary porous structure beyond the distal end of the catheter or retracting the catheter relative to the unitary porous structure, thereby exposing the non-elapped portion of the unitary porous structure and the mesh structure extending distally through the thrombus portion, and causing the unitary porous structure to expand to conform to the vessel wall, thereby deploying the thrombus extraction device. The method may include: advancing at least a portion of the everted portion of a mesh structure distally through a single porous structure; retracting the thrombus extraction device to separate a portion of the thrombus from the vessel wall and capture the portion of the thrombus within the mesh structure; and retrieving the thrombus extraction device from the body to remove the thrombus from the patient.

[0025] In some examples, advancing the catheter through a thrombus involves inserting the catheter into the vessel until the distal, radiopaque tip of the catheter passes through the thrombus portion. In some examples, advancing at least a portion of the everted portion distally includes: fixing the position of the radiopaque tip on the inner axis; and retracting proximally into a single perforated structure. In some examples, the position of the radiopaque tip is fixed proximally relative to the valve of the vessel. In some examples, the catheter is inserted into the vessel through a posterior patellar entry site, and the catheter is advanced distally from the posterior patellar entry site.

[0026] In some examples, advancing at least a portion of the everted portion of the mesh structure distally through a single porous structure increases the size of the non-everted portion of the mesh structure relative to the size of the everted portion. In some examples, at least a portion of the everted portion of the mesh structure is advanced distally through the single porous structure until the thrombus portion is completely contained within the mesh structure.

[0027] In some examples, the mesh-like filament structure itself everts. In some examples, the method includes restricting proximal movement of the inner axis relative to the single porous structure to prevent complete eversion of the mesh-like filament structure. In some examples, the mesh-like filament structure is integrally formed on the single porous structure. In some examples, the mesh-like filament structure everts both inside and outside the single porous structure and / or everts on the single porous structure. In some examples, the method includes: retracting the intermediate axis member relative to the catheter and the single porous structure until a stop feature fixed to the intermediate axis member engages with a corresponding feature on the porous structure; and locking the intermediate axis member relative to the single porous structure to allow the single porous structure to fully expand. In some examples, the method includes unlocking the intermediate axis member relative to the single porous structure before retrieving the thrombus extraction device from the body. In some examples, the thrombus extraction device confined within the catheter includes a non-evertated portion and an evertated portion extending proximally through the single porous structure.

[0028] One aspect of this disclosure relates to a thrombus extraction device for removing vascular thrombi from a patient's blood vessel. The thrombus extraction device may include a catheter having a proximal and distal end, an outer axis defining a first lumen, a first intermediate axis defining a second lumen, and an inner axis. In some examples, the first intermediate axis is coaxial with the first lumen, and the inner axis is coaxial with the second lumen. The thrombus extraction device may include a self-expanding core-retrieval element formed of a single porous structure having an opening at its proximal end that allows a portion of the vascular thrombus to be cored and separated from the vessel. In some examples, the proximal end of the porous structure is coupled to the distal end of the first intermediate axis. The thrombus extraction device may include an expandable cylindrical portion formed of a braided mesh structure having an everted portion. In some examples, the braided mesh structure is capable of capturing portions of the vascular thrombus. In some examples, the proximal end of the mesh structure is coupled to the distal end of the porous structure, and the everted portion of the mesh structure extends proximally through the opening of the single porous structure. In some examples, the length of the everted portion relative to the non-everted portion of the braided mesh structure varies based on the position of the first intermediate axis relative to the inner axis of the catheter.

[0029] In some examples, the mesh structure is integrally formed on a single perforated structure. In some examples, the mesh structure is turned outwards on a single perforated structure. In some examples, the woven mesh structure includes a non-turned-out portion coupled to the distal end of the perforated structure. In some examples, the distal end of the woven mesh is coupled to an inner axis. In some examples, the distal end of the woven mesh is fixedly coupled to an inner axis. In some examples, the distal end of the woven mesh is slidably coupled to an inner axis.

[0030] In some examples, the thrombus removal device may include a dilation mechanism that maintains the required radial force on the vessel wall using a single porous structure. In some examples, the dilation mechanism ensures that the single porous structure is always fully dilated. In some examples, the dilation mechanism includes an annular feature and a stop feature of the single porous structure, the stop feature engaging with the annular feature when the single porous structure is fully dilated. In some examples, the stop feature may be a tab on a second intermediate axis. In some examples, the tab may engage with the annular feature, and the second intermediate axis may be coaxial with the first lumen. In some examples, the stop feature may be a tension spring dynamically coupled to the annular feature.

[0031] In some examples, the mesh-like filament structure is everted on itself. In some examples, the thrombus retrieval device may include an eversion stop that restricts proximal movement of the inner axis relative to the single porous structure to prevent complete eversion of the mesh-like filament structure. In some examples, the mesh-like filament structure may include multiple filaments and may have a first aperture in the proximal portion and a second aperture in the distal portion. In some examples, the first aperture is different from the second aperture. In some examples, at least some of the multiple filaments are longitudinally overlapped in the distal portion. In some examples, a self-expanding core retrieval element and an expandable cylindrical portion are included within the outer axis of the catheter such that the everted portion of the mesh structure extends proximally through the opening of the single porous structure.

[0032] One aspect of this disclosure relates to a method for removing a thrombus from a blood vessel in a patient. The method includes advancing a catheter that restricts a thrombus extraction device through the thrombus in the blood vessel. In some examples, the thrombus extraction device includes a proximal self-expanding member formed of a porous structure and a generally cylindrical portion formed of a mesh structure having a proximal end coupled to the distal end of the porous structure. The method includes: deploying the thrombus extraction device by advancing the self-expanding member distally relative to the catheter until the self-expanding member extends beyond the distal end of the catheter; retracting the self-expanding member relative to the distal end of the mesh structure to increase the distal length of the mesh structure, thereby separating a portion of the thrombus from the vessel wall and trapping the portion of the thrombus within the mesh structure; and retrieving the thrombus extraction device from the body to remove the thrombus from the patient.

[0033] Other areas of application of this disclosure will become apparent from the detailed description provided below. It should be understood that the detailed description and specific examples, while indicating various examples, are intended for illustrative purposes only and are not intended to necessarily limit the scope of this disclosure. Attached Figure Description

[0034] Figure 1 This is a perspective view of an example of a thrombectomy system used to remove blood clots from a patient's blood vessels.

[0035] Figure 2 This is a side view of an example of a thrombus extraction catheter with an unfolded thrombus extraction device.

[0036] Figure 3 This is a side view of an example thrombus extraction catheter with a fully expanded unfolded structure for thrombus extraction.

[0037] Figure 4 This is a side view of an example of a self-expanding core-taking element.

[0038] Figure 5 This is a top view of an example of a self-expanding core-taking element.

[0039] Figure 6 This is a front view of an example of a self-expanding core-taking element.

[0040] Figure 7 This is a side view of an example of a thrombus extraction device with a fully expanded structure.

[0041] Figure 8 This is a view of a spherical thrombus captured in a thrombus extraction device.

[0042] Figure 9 This is a side view of an example of a woven fine mesh structure with multiple aperture sizes.

[0043] Figure 10 This is a side view of an example of a thrombus extraction device that includes multiple circumferential grooves.

[0044] Figure 11 This is a schematic diagram of an example of a braided and / or woven pattern used to form cylindrical portions and / or woven fine mesh structures on a self-expanding core element.

[0045] Figure 12 This is a cross-sectional view of an example of a handle with a plunger in the first position.

[0046] Figure 13 This is a cross-sectional view of an example of a handle with a plunger in the second position.

[0047] Figure 14 This is a close-up cross-sectional view of a portion of the handle with the plunger in the second position.

[0048] Figure 15 This is a side view of an example of a slender shaft with fixed dimensions.

[0049] Figure 16 This is a side view of an example of a slender shaft occluder with variable dimensions.

[0050] Figure 17This is a detailed cross-sectional view of an example of the trapping sheath of a slug.

[0051] Figure 18 This is a side view of an example of a guide sheath in its unexpanded configuration.

[0052] Figure 19 This is a side view of an example of a guide sheath with a partially unfolded structure.

[0053] Figure 20 This is a side view of an example of a guide sheath with an unfolded structure.

[0054] Figure 21 This is a side view of an example of a guide sheath containing an inflatable airbag.

[0055] Figure 22 This is a schematic diagram illustrating an example of entering a blood vessel through the popliteal fossa.

[0056] Figures 23-A to 23-H This is an example view illustrating a method for fully expanding a thrombus extraction device in a blood vessel.

[0057] Figures 24-A to 24-B This is a view describing alternative steps in a method for fully expanding a thrombus extraction device in a blood vessel.

[0058] Figures 25-A to 25-H This is a view illustrating an example of a method for removing thrombi using an expanded thrombus extraction device.

[0059] Figure 26 This is a schematic diagram illustrating an example of entry into a blood vessel via the internal jugular vein.

[0060] Figure 27 This is a schematic diagram illustrating an example of using an extended sheath 2300 to enter a blood vessel through the popliteal fossa.

[0061] Figure 28 This is a schematic diagram illustrating an example of blood vessel entry via the popliteal fossa and femoral entry points.

[0062] Figure 29 This is a side view of an example of a thrombus extraction device with an everted portion.

[0063] Figure 30 It is a side sectional view of a thrombus extraction device with an everted portion and a dilation mechanism.

[0064] Figure 31 This is a side sectional view of an example of a thrombus extraction device with an everted portion and a coupling element.

[0065] Figure 32This is a side view of an example of a thrombus extraction device including an everted portion of a first length.

[0066] Figure 33 This is a side view of an example of a thrombus extraction device including an everted portion with a second length.

[0067] Figures 34-A to 34-D This is a view illustrating an example of a method for influencing the relative lengths of the everted and non-everted portions of a thrombus extraction device in a blood vessel.

[0068] Figure 35 This is a schematic illustration of an example of a funnel-shaped conduit.

[0069] Figure 36 This is a schematic illustration of an example of an expander assembly in the loaded position with a movable sheath.

[0070] Figure 37 This is a schematic illustration of an example of an expander assembly with a movable sheath in the retracted position.

[0071] Figures 38-A to 38-D This is an example view of the steps in a method for deploying a self-expanding funnel into a funnel-shaped conduit.

[0072] Figure 39 This is a top view of an example of a stackable thrombus extraction device.

[0073] Figure 40 This is a cross-sectional view of an example of the handle and shuttle of a thrombectomy system.

[0074] Figures 41-A to 41-F This is an example view illustrating steps in a method for expanding a stackable thrombus extraction device in a blood vessel.

[0075] Figures 42-A to 42-B This is a view depicting the steps in a method for retracting a stackable thrombus extraction device that has passed through a blood vessel. Invention Details

[0076] This disclosure relates to a thrombectomy system for removing vascular thrombi from a patient's blood vessels. The thrombectomy system removes thrombi from blood vessels, particularly from a patient's veins, by core extraction and / or separation of the thrombus from the vessel wall, which may occur as the thrombectomy system retracts through the thrombus. The cored and / or separated thrombus can be captured within the thrombectomy system and removed from the patient.

[0077] A thrombectomy system may include a thrombus extraction catheter comprising a thrombus extraction device (TED). The TED may include a proximal self-expanding core element, which may be a stent portion and / or formed from a porous structure such as a single porous structure. In some examples, the self-expanding core element may be a semi-rigid structure, for example, a semi-rigid foldable structure. The TED may include a distal expandable cylindrical portion formed from a braided mesh structure, which in some examples may include everted and non-everted portions. The braided mesh structure may be formed, looped, and / or interwoven on the core element to form a single TED, also referred to herein as an interwoven TED. This direct formation of the braided mesh structure on the core element eliminates problems such as inconsistent material properties, reduced flexibility, reduced strength, and / or quality control issues arising from, for example, the process of connecting the braided mesh structure to the core element by welding or gluing.

[0078] Thrombectomy systems including TEDs with and without eversion portions allow for use in vessels with diameters smaller than other possible diameters, reducing potential damage to valves within the vessel. Specifically, this thrombus extraction device limits the length of the vessel used to deploy the TED, particularly limiting the length of the vessel beyond the thrombus used to deploy the device, allowing the TED to extract thrombi located more distally. This reduces the number of valves the thrombus extraction device must traverse, preventing potential valve damage. Furthermore, due to the eversion characteristic of the TED, the device can operate in the same direction as venous blood flow or in the opposite direction. In some examples, operation in the same direction as venous blood flow further reduces potential damage to venous valves.

[0079] The expansion of the TED can be controlled by the relative movement of portions of the thrombus retrieval catheter. For example, the proximal end of the TED, specifically the proximal end of the self-expanding core element, can be connected to an intermediate shaft that slides within the outer shaft of the thrombus retrieval catheter. The distal end of the TED, specifically the distal end of the expandable cylindrical portion, can be fixedly or slidably connected to an inner shaft that slides within the intermediate shaft of the thrombus retrieval catheter. Because the inner and intermediate shafts can slide relative to the outer shaft, the TED can be retrieved back into the outer shaft to confine it to an unexpanded configuration, also referred to herein as a restricted configuration. Similarly, the TED can be expanded from the outer shaft by the relative movement of the intermediate shaft relative to the outer shaft. In some examples, after the TED has expanded from the outer shaft, the inner and intermediate shafts can be moved relative to each other to cause the expandable cylindrical portion of the TED to expand or contract, and to allow the self-expanding core element to reach full expansion. In some examples, after the TED has expanded from the outer shaft, the inner and intermediate shafts can be moved relative to each other to change the length of the everted and non-everted portions.

[0080] In some examples, the self-expanding core element can be controlled independently of the expandable cylindrical portion, and / or the expandable cylindrical portion can be controlled independently of the self-expanding core element. In some examples, for instance, the TED can be a self-expanding core element that can be advanced relatively distally toward the expandable cylindrical portion. In such examples, the expandable cylindrical portion can be compressed, also referred to herein as "stacking," which in some examples can result in a reduction in the length of the expandable cylindrical portion, and in some examples can result in an increase in the diameter of at least a portion of the expandable cylindrical portion. In some examples, the ability to control the self-expanding core element independently of the expandable cylindrical portion and the ability to stack the expandable cylindrical portion enable the use of a thrombectomy system, specifically allowing the capture of large and / or long thrombi without causing the TED, in particular the expandable cylindrical portion, to extend far beyond the location of the thrombus. In some examples, this limited extension of the expandable cylindrical portion beyond the thrombus location can mitigate the use of the thrombectomy system by limiting the extension of the thrombectomy system beyond the thrombus. In some examples, for instance, limiting the extension of the thrombectomy system beyond the thrombus can mitigate the risk of damage to tissues, blood vessels, and / or organs beyond the thrombus. Specifically, this thrombus extraction device can limit the length of the vessel used to deploy the TED (thrombus extraction device), particularly limiting the length of the vessel beyond the thrombus used to deploy the thrombus extraction device. Therefore, the risk of damage to blood vessels, tissues, and / or organs beyond the thrombus can be minimized through the stacking of TEDs.

[0081] A thrombectomy system may include a guide sheath sized to slidably receive the outer sheath of a thrombus retrieval catheter. In some examples, the guide sheath may include a sealing orifice and a self-expanding funnel at the proximal end of the guide sheath. In some examples, the guide sheath may include a sealing orifice at the proximal end and an open distal end, and the thrombectomy system may include a funnel catheter with a self-expanding funnel. The self-expanding funnel may be located distal to the guide sheath and may be selectively held in a confined position by a catching sheath. In some examples, the self-expanding funnel can be slidably received within the guide sheath and may specifically slide relative to the distal end of the guide sheath. In some examples, the self-expanding funnel may slide distally from the confined configuration within the guide sheath to an expanded configuration, in which case the self-expanding funnel extends distally from the catching sheath.

[0082] As the TED retracts toward the funnel, the self-expanding funnel can be sized to mate with the self-expanding core retrieval element. When the TED retracts into the funnel, the funnel compresses the TED, and specifically the core retrieval element, guiding it into the lumen defined by the guide sheath. The TED can retract until it is fully contained within the guide sheath, and then the TED and any thrombus trapped within it can be removed from the patient through a sealing port. Alternatively, in some examples, the TED can retract until the core retrieval element is wholly or partially contained within the funnel attached to the funnel catheter, and then the funnel catheter and TED can retract simultaneously, and in some examples, retract through the guide sheath.

[0083] Thrombectomy systems can be accessed through multiple entry sites into blood vessels containing thrombi. These may include, for example, the internal jugular vein (IJ) entry site, the femoral entry site, the posterior genu entry site, or other venous or arterial entry sites. Thrombectomy systems can be used to extract thrombi and / or emboli from various venous and / or arterial vessels, which can be peripheral vessels, including any vessel, including, as a non-limiting example, veins with a diameter of at least 3 millimeters (mm). The thrombectomy system can be inserted into the patient's circulatory system through the entry point and advanced to a location close to the thrombus. The TED (Thrombectomy Device) can then be advanced through the thrombus, and after distal expansion of the thrombus, the TED can retract through the thrombus, thereby capturing all or part of the thrombus.

[0084] For reference Figure 1 An example 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 vein containing a thrombus, and can be used to remove all or part of the thrombus from the blood vessel. The thrombectomy system 100 may include a guide sheath 102 and a thrombus extraction catheter 104.

[0085] The guiding sheath 102 includes an elongated member 106, also referred to herein as the 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 examples, 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 dimensions.

[0086] The elongated member 106 may include a non-transparent marking, which may be, for example, part of the distal end 110 of the elongated member 106. The elongated member 106 defines an inner cavity extending between the proximal end 108 and the distal end 110. The inner cavity 1701 of the elongated member 106 may be defined (e.g., Figure 17 The dimensions shown are for slidably receiving the thrombus extraction catheter 104. In some examples, 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 to 12 French, 10 to 22 French, 14 to 21 French, 16 to 20 French, and / or any other or intermediate dimensions. The lumen 1701 may terminate at a sealing orifice 112, also referred to herein as a sealing hub 112, located at the proximal end 108 of the elongated member 106. In some examples, the sealing orifice 112 may be self-sealing and / or may include a self-sealing seal.

[0087] The guide sheath 102 may also include a suction port 114, which may be located at the proximal end 108 of the elongated member 106 and / or connected to the proximal end 108 of the elongated member 106 via, for example, a connecting tube 116. In some examples, the suction port 114 may be part of and / or connected to a sealing hub 112. In some examples, the suction port 114 may be selectively fluidly connected to the lumen 1701 via, for example, a valve 118, also referred to herein as a suction valve 118, which may be a tube clamp located along the connecting tube 116 between the lumen 1701 and the suction port 114.

[0088] The guide sheath 102 may further retain the occluder 120, also referred to herein as the expander 120. The occluder 120 may be configured to retain a self-expanding funnel that may be attached to and released from the distal end 110 of the elongated member 106 via a confined configuration. The occluder 120 may include a proximal end 122, a distal end 124, and an elongated shaft 126 extending therebetween. In some examples, the length of the elongated shaft 126 may be greater than the length of the elongated member 106 of the guide sheath 102. The occluder 120 may further define an inner lumen extending through the occluder 120 for receiving a guidewire. In some examples, the guidewire may have any desired size, and in some examples, may have a diameter of approximately 0.035 inches. The occluder 120 may be sized and shaped to allow slidable movement through the inner lumen of the elongated member 106.

[0089] 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 to herein as an unfolding 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 to herein as catheter 136.

[0090] The catheter 136 may include an outer shaft 138, an intermediate shaft 140 (also referred to herein as a first intermediate shaft 140 or core element shaft 140), a second intermediate shaft (also referred to herein as a stop shaft), a third intermediate shaft, and an inner shaft (also referred to herein as a tip shaft). The outer shaft 138 may have various lengths and sizes. In some examples, the outer shaft 138 may be sized to allow it to slidably fit within the guide sheath 102. In some examples, the outer shaft 138 may have a size 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, between 8 and 14 French, between 11 and 12 French, and / or any other or intermediate size.

[0091] Each of the outer shaft 138, one or more intermediate shafts 140, 3000, 3002, and the inner shaft may define an inner cavity, which may be a central axial cavity. In some examples, the intermediate shaft 140 may be sized and / or shaped to slidably fit within the inner cavity 802 of the outer shaft 138. Figure 8 As shown in the diagram, the intermediate shaft 140 and the outer shaft 138 are coaxial. Similarly, in some examples, the dimensions and / or shape of the inner shaft can be designed to slidably fit within the cavity 804 of the intermediate shaft 140. Figure 8 (As shown in the diagram) so that the inner shaft and the intermediate shaft 140 are coaxial. In this configuration, each of the outer shaft 138, the intermediate shaft 140 and the inner shaft can be displaced relative to the other shafts of the outer shaft 138, the intermediate shaft 140 and the inner shaft.

[0092] In some examples, the size and / or shape of the first intermediate shaft 140 may be designed to allow it to slidably fit into the cavity 802 of the outer shaft 138. Figure 8As shown in the diagram, the intermediate shaft 140 and the outer shaft 138 are coaxial. The dimensions and / or shape of the second intermediate shaft 3000 (also referred to herein as the stop shaft 3000) can be designed to slidably fit within the first intermediate shaft 140, and / or the dimensions and / or shape of the third intermediate shaft 3002 can be designed to slidably fit within the second intermediate shaft 3000. Similarly, in some examples, the dimensions and / or shape of the inner shaft can be designed to slidably fit within the second intermediate shaft 3000 or the third intermediate shaft 3002, so that the inner shaft and the intermediate shaft 140 are coaxial. In this configuration, each of the outer shaft 138, intermediate shafts 140, 3000, 3002, and inner shaft can be displaced relative to the other shafts among the outer shaft 138, intermediate shafts 140, 3000, 3002, and inner shaft.

[0093] In some examples, each of the outer shaft 138, intermediate shafts 140, 3000, 3002, and inner shaft may have the same length, and in some examples, some or all of the outer shaft 138, intermediate shafts 140, 3000, 3002, and inner shaft may have different lengths. In some examples, for instance, one or more of the intermediate shafts 140, 3000, 3002 may be relatively longer than the outer shaft 138, and in some examples, the inner shaft may be relatively longer than the intermediate shaft 140.

[0094] The thrombus extraction catheter 104 may also include a thrombus extraction device (TED). In some examples, the TED may be connected to an intermediate shaft 140 and an inner shaft and may be received in an unexpanded configuration within the lumen 802 of an outer shaft 138. In some examples, the TED may be connected to a first intermediate shaft, and one of a second intermediate shaft 3000, a third intermediate shaft 3002, and an inner shaft. In some examples, the relative positions of the outer shaft 138 and one or more of the intermediate shafts 140, 3000, 3002, and / or the inner shaft may result in the TED being in an unexpanded configuration, an expanded configuration, a partially expanded configuration, and / or a fully expanded configuration. In some examples, the expanded configuration of the TED may be a fully expanded configuration or a partially expanded configuration.

[0095] The handle 134 may include a distal end 142 (also referred to herein as the locking end 142) and a proximal end 144 (also referred to herein as the plunger end 144). In some examples, an intermediate shaft 140 is connected to the distal end 132 of the thrombus extraction catheter 104 and extends distally from the distal end 142 of the handle 134 toward the distal end 132 of the thrombus extraction catheter 104. In some examples where the TED includes an everted or partially everted braided mesh structure, the handle is not used to deploy or drive the braided mesh structure. In some examples, the force of the clot on the braided mesh structure causes the braided mesh structure to expand and / or deploy as the TED retracts through the clot.

[0096] like Figure 1As shown, the distal end 142 of the handle 134 may include a locking feature 146, such as a spin lock. The locking feature 146 may selectively engage and / or lock with a matching feature 148 located on the proximal end 150 of the outer sheath 138. In some examples, for instance, the outer sheath 138 may slide proximally on the intermediate sheath until the locking feature 146 engages with the matching feature 148, thereby securing the position of the outer sheath 138 relative to the intermediate sheath 140. In examples where the intermediate shaft 146 is relatively longer than the outer shaft 138, a portion of the intermediate shaft 146 extends distally from the distal end 152 of the outer shaft 138 when the outer shaft 138 locks with the locking feature 146.

[0097] Handle 134 may include plunger 154, which is movable between a first non-extended position and a second extended position. In some examples, plunger 154 can be moved from a first position to a second position by displacing plunger 154 proximally relative to handle 134. Plunger 154 may be locked in one or both of the first and / or second positions. In some examples, plunger 154 may be connected to one or more features of TED, which may lock TED in a fully extended configuration and / or move TED to a fully extended configuration.

[0098] The plunger 154 may be connected to one of the second intermediate shaft 3000, the third intermediate shaft 3002, and the inner shaft, thereby connecting the inner shaft to one of the second intermediate shaft 3000, the third intermediate shaft 3002, and the inner shaft, which may be movable relative to the handle 134, the outer shaft 138, and / or the intermediate shaft 140 by movement of the plunger 154 from a first position to a second position. In some examples, the inner shaft may be relatively longer than the intermediate shaft 140 and / or the outer shaft 138, such that the inner shaft extends distally through the distal end of the intermediate shaft 140, regardless of whether the plunger 154 is in the first or second position.

[0099] 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 examples, the first flushing port 155 is fluidly connected to the inner lumen 802 of the outer shaft 138 to flush the inner lumen 802 of the outer shaft 138. In some examples, the second flushing port 156 is fluidly connected to an internal portion of the handle 134, thereby connecting to the inner lumen of the intermediate shaft 140 to flush the inner lumen of the intermediate shaft 140.

[0100] The thrombus extraction system 100 may further include a loading funnel 158. The loading funnel 158 may include a funnel portion 160 and a shaft portion 162. The funnel portion 160 may define a funnel-shaped internal volume connected to the lumen of the shaft portion 162. The funnel-shaped internal volume and shape may be designed to receive a self-expanding funnel and move the self-expanding funnel to a confined position as it advances through the funnel portion 160. The dimensions of the funnel-shaped internal volume and lumen may be designed such that the distal end 124 of the occluder 120 can completely pass through the loading funnel 158.

[0101] In some examples, the loading funnel 158 may be configured to load the self-expanding funnel into the occluder 120. In some examples, the self-expanding funnel may be loaded by inserting the occluder 120 through the elongated member 106, such that the occluder 120 extends from the distal end 110 of the elongated member 106 and beyond the self-expanding funnel. The loading funnel 158 may then slide proximally over the occluder 120 and the self-expanding funnel until the self-expanding funnel is completely enclosed by the loading funnel 158 and / or until the self-expanding funnel is in a confined configuration. The occluder 120 may then be retracted to load and / or trap the self-expanding funnel within a portion of the occluder 120, and the loading funnel 158 may then be removed from the occluder 120 and the elongated member 106.

[0102] The thrombectomy system 100 may also include a sealing hub dilator 170, also referred to herein as a sealing dilator 170 and / or a bore dilator 170. Figure 1 A cross-sectional view of a sealing dilator 170 is shown. The sealing dilator 170 can be sized and shaped to be inserted into the sealing hole 112 before the thrombus is removed through the sealing hole 112. By inserting the sealing hole 112 in this way, the sealing dilator 170 can expand the sealing hole 112. In some examples, this expansion of the sealing hole can prevent force from being applied to the thrombus from the sealing hole 112 during thrombus removal through the sealing hole 112. In some examples, the sealing dilator 170 may include an insertion portion 172 configured to facilitate insertion of the sealing dilator 170 into the sealing hole 112. The sealing dilator 170 may also include a body portion 174, which may define an extraction lumen 176, either alone or together with the insertion portion 172, through which the thrombus can be removed from the lumen 1701 of the elongated member 106. In some examples, the inner diameter of the extraction lumen 176 may be larger than the diameter of the sealing hole 112 in the sealing configuration.

[0103] For reference Figure 2 The image shows a side view of an example thrombus extraction catheter 104. The thrombus extraction catheter 104 includes a handle 134, an outer shaft 138, an intermediate shaft 140, an inner shaft 200, and a thrombus extraction device 202, also referred to herein as TED 202. Figure 2As shown, the outer shaft 138 is displaced proximally relative to the handle 134, such that the mating 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 TED 202 each extend distally beyond the distal end 204 of the outer shaft 138. Figure 2 The thrombus extraction device 202 shown is in an unfolded and partially expanded configuration.

[0104] The thrombus extraction device 202 may include a self-expanding core element 206 and an expandable cylindrical portion 208. The self-expanding core element 206 may be located more laterally on the thrombus extraction catheter 104 than the expandable cylindrical portion 208. The self-expanding core 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.

[0105] In some examples, the distal end 218 of the inner shaft 200 may also include a tip 220 such as a non-traumatic tip and / or a radiopaque marker 222. In some examples, the tip 220 may include a radiopaque marker 222. Further radiopaque markings 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 examples, one or both of the distal end 204 of the outer shaft 138 and the distal end 212 of the intermediate shaft 140 may include radiopaque markings. In some examples, the non-traumatic tip 220 may define a channel configured to allow a guidewire to pass through the non-traumatic tip 220.

[0106] Now for reference Figure 3 The image shows a side view of an example thrombus extraction catheter 104, with the thrombus extraction device 202 in an deployed and fully expanded configuration. Figure 2 In contrast, the plunger 154 is in the second position, retracted proximally from the handle 134, and the inner shaft 200 is thus retracted proximally relative to the intermediate shaft 140, thereby fully expanding the expandable cylindrical portion 208 and securing the expandable cylindrical portion 208 and the self-expanding core element 206 to a fully expanded configuration and / or fully expanded.

[0107] The thrombus extraction catheter 104 may include one or more features configured to secure the thrombus extraction device 202, specifically the self-expanding core element 206 and / or the expandable cylindrical portion 208, in a fully expanded position and / or to be fully expanded. As used herein, in the case described by full expansion, the thrombus extraction device 202 is in a state where, in addition to the self-expanding force generated by the thrombus extraction device 202, it is continuously biased or toward expansion by one or more forces. In some examples, full expansion occurs when the thrombus extraction device 202 is deployed and the plunger 154 is in a second position, or when the thrombus extraction device 202 is deployed and biased toward expansion by a spring directly or indirectly connected to the thrombus extraction device. In examples where the thrombus extraction device 202 is biased toward expansion by a spring, a force less than a minimum radial compressive force does not change the diameter of the thrombus extraction device 202. In some examples, such as when retrieving the thrombus extraction device 202 through a blood vessel, the fully expanded thrombus extraction device 202 maintains at least the required radial force on the blood vessel. In some examples, one or more dimensions of the thrombus extraction device 202 may change when it is fully expanded. In some examples, this may facilitate the adhesion of the thrombus extraction device 202 to the vessel wall and / or the desired force or level of force applied by the thrombus extraction device 202 to the vessel wall.

[0108] In some examples, plunger 154 can be locked in a second position, for example, by rotating plunger 154 relative to handle 134, thereby engaging one or more locking features on plunger 154 or in handle 134. In some examples, by locking plunger 154 in the second position, the thrombus extraction device 202, specifically the self-expanding core element 206 and / or the expandable cylindrical portion 208, can be secured to full expansion by fixing the position of inner shaft 200 relative to intermediate shaft 140. In some examples, fixing the position of inner shaft 200 relative to intermediate shaft 140 may include locking inner shaft 200 relative to intermediate shaft 140 and / or coupling the position of inner shaft 200 to the position of intermediate shaft 140. In some examples, the locking and / or coupling can be static, referred to herein as static locking and / or static coupling, in which case the position of the inner shaft 200 relative to the intermediate shaft 140 is fixed. In some examples, the locking and / or coupling can be dynamic, referred to herein as dynamic locking and / or dynamic coupling, in which case the position of the inner shaft 200 relative to the intermediate shaft 140 is restricted. In some examples, and as will be discussed in more detail below, the inner shaft 200 can be dynamically locked to the plunger 154 by a flexible spring 1214, which can be, for example, a tension spring or a compression spring, allowing the inner shaft 200 to move relative to the intermediate shaft 140 when the plunger is locked in the second position. Thus, in such examples, the inner shaft 200 is dynamically locked and / or dynamically coupled to the intermediate shaft 140 and / or dynamically locked and / or dynamically coupled relative to the intermediate shaft 140.

[0109] For reference Figure 4 The image shows a side view of an example of a self-expanding core element 206. The self-expanding core element 206 can include various shapes and sizes and can be made of various materials. In some examples, the self-expanding core element can be made of shape memory materials, such as shape memory alloys and / or shape memory polymers. In some examples, the self-expanding core element 206 can include nitinol and / or nitinol alloys. In some examples, the self-expanding core element 206 can include a braid that can, for example, form a semi-rigid foldable structure.

[0110] The self-expanding core element 206 can be manufactured using various techniques, including, for example, welding, laser welding, cutting, laser cutting, braiding, stretching, etc. In some examples, the self-expanding core element 206 can be laser-cut from a piece of nitinol (e.g., a nitinol tube), after which it can be blown and / or expanded. In some examples, the self-expanding core element 206 can be laser-cut from a nitinol piece, such as from a nitinol tube, after which it can be blow-molded and / or stretched. In some examples, the self-expanding core element 206 can be laser-cut nitinol, laser-cut polymer tube, one or more filament structures, metal or polymer, or one or more injection-molded polymer structures. In some examples, the self-expanding core element 206 can be a castellated nitinol filament braid, a nitinol braided structure, laser-cut nitinol, laser-cut polymer tube, injection-molded polymer structure, an inflatable balloon, or one or more other metal or polymer structures.

[0111] The self-expanding coulometric element 206 may include a perforated structure 400, which may be a single perforated structure, a non-single perforated structure, and / or a stent or stent portion, configured to coulometrically extract and separate a portion of a thrombus, such as from a vascular thrombus containing a thrombus. The perforated structure 400 may include a plurality of struts 402 that collectively define a plurality of voids 404. The struts may include various shapes and sizes, and in some examples, 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.

[0112] In some examples, the self-expanding core element 206 may include a first region 406 and a second region 408. The second region 408 may be generally tubular and may include a plurality of interconnected struts 402. The first region 406 is as follows: Figure 5 As shown, the second region may include fewer struts 402 to allow the self-expanding core retrieval element 206 to retract into a non-expanding configuration and maintain core retrieval orientation when the blood vessel is bent. In some examples, the first region may further include two bent struts 410-A, 410-B that are twisted in opposite directions about the central axis 412 (also referred to herein as the longitudinal axis 412) of the self-expanding core retrieval element 206 to define the opening 414 of the self-expanding core retrieval element 206.

[0113] In some examples, the self-expanding core retrieval element 206 is connected to the intermediate shaft 140 via two curved supports 410-A, 410-B. Flexible connection of the self-expanding core retrieval element to the intermediate shaft 140 can improve the operation of the thrombus retrieval device 202. Specifically, removing the supports from region 420 of the self-expanding core retrieval element 206 allows the self-expanding core retrieval element 206 to bend around the connecting member 415 located at the proximal end 210 of the self-expanding core retrieval element 206, connecting the self-expanding core retrieval element 206 to the intermediate shaft 140 of the thrombus retrieval catheter 104. This bending capability helps maintain core orientation when the vessel is bent. In some examples, this bending of the self-expanding core retrieval element 206 allows region 420 to function as an opening 414.

[0114] like Figure 4 As shown, the curved support 410 extends relative to the central axis 412 from the bottom 416 of the self-expanding core element 206 to the top 418 of the self-expanding core element at an angle θ (also referred to herein as the core angle). In some examples, this angle may be between 20 and 50 degrees, or between 30 and 45 degrees, when fully expanded.

[0115] In some examples, the core angle can advantageously or disadvantageously affect the operation of the TED 202. For example, an excessively steep core angle can prevent the self-expanding core element 206 from becoming retractable and thus prevent its retraction into the guide sheath 102. Conversely, an excessively shallow core angle can cause the self-expanding core element 206 to retract too easily, which reduces its core-retrieving capability. In some examples, this reduction in the core-retrieving capability of the self-expanding core element 206 can cause it to no longer effectively retrieve thrombi.

[0116] In some examples, the nearest side edge (referred to herein as the front edge 411) of the two curved pillars 410-A, 410-B may be sharp and / or the front edge 411 of the two curved pillars 410-A, 410-B may include cutting elements, blades, etc.

[0117] The self-expanding core retrieval element 206 may include various sizes. In some examples, the self-expanding core retrieval element 206 may include a minimum distance defined as the distance between the proximal end 210 and the distal end 214 of the self-expanding core retrieval element 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 examples, the self-expanding core retrieval element 206 may include a full expansion diameter 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 examples, the self-expanding core retrieval element may be applied to debulking of an artery or vein, such as the inferior vena cava. In some examples, such debulking may be performed in response to occlusion and / or partial occlusion of one or more filters in the inferior vena cava.

[0118] In some examples, the length and diameter of the self-expanding core retrieval element 206 may be selected based on the size of the blood vessel, particularly the diameter of the vessel from which the thrombus is to be retrieved. In some examples, the length of the self-expanding core retrieval element 206 may be selected based on its fully expanded diameter to prevent undesirable tilting and / or rotation within and relative to the blood vessel. As used anywhere herein, “about” means using a range of + / -10% of an “approximate” value and / or a range of + / -10% of a numerical range.

[0119] For reference Figure 7 A side view of an example of the thrombus extraction device 202 is shown. Figure 7 As shown, the self-expanding core retrieval element 206 is connected to the distal end 212 of the intermediate shaft 140 via a connecting member 415 at its proximal end 210. The proximal end of the expandable cylindrical portion 208 is connected to the distal end 214 of the self-expanding core retrieval element 206. In some examples, the expandable cylindrical portion 208, and particularly its proximal end 216, is formed on the distal end 214 of the self-expanding core retrieval element 206, thereby forming a single thrombus retrieval device 202. The distal end 217 of the expandable cylindrical portion 208 is connected to the distal end 218 of the inner shaft 200.

[0120] In some examples, such as Figure 7As shown, the self-expanding core element 206 may mate entirely or partially with the inner shaft 200 to influence the expansion of the self-expanding core element 206. Specifically, in some examples, the self-expanding core element 206 may include one or more features that may collectively form the expansion mechanism 701. In some examples, the expansion mechanism 701 may include a ring 700, also referred to herein as an annular feature 700. The material of the ring 700 may be the same as or different from the material of the self-expanding core element 206. The ring 700 may be integrally formed with the self-expanding core element 206 and / or may be attached to the self-expanding core element by, for example, one or more fluxes, adhesives, one or more mechanical fasteners, etc. The diameter of the ring 700 may be larger than the diameter of the inner shaft 200, so that the ring 700 may slide along the inner shaft 200.

[0121] like Figure 7As further shown, the expansion mechanism 701 may include a stop 702, which may be located on one of the shafts, such as a second intermediate shaft 3000, a third intermediate shaft 3002, and an inner shaft 200. In some examples, the stop 702 may include a polymeric member and / or a metallic member fixed to a portion of the inner shaft 200. In some examples, the stop 702 may be in the form of a tab, a protrusion, a flange, a bulge, etc. In some examples, the size and shape of the stop 702 may be designed to mate with the ring 700, thereby applying a proximal force to the self-expanding core element 206 when the shafts 200, 3000, 3002 to which the stop 702 is connected are displaced proximally by, for example, movement of a plunger to a second position and / or displacement according to a spring (e.g., a constant force spring connected to a shuttle). In some examples, a portion of the self-expanding core retrieval element 206 located between the ring 700 and the connecting member 415 can be forcibly expanded by applying a proximal force to the ring 700, thereby moving the self-expanding core retrieval element 206 to full expansion. In another example, the expansion mechanism 701 does not include the ring 700, and the stop 702 is not attached to one of the intermediate shafts 140, 3000, 3002; instead, the expansion mechanism 701 includes a wire or filament, which may be, for example, a metallic or polymeric material. The wire or filament wraps around the self-expanding core retrieval element 206 and may be attached (e.g., fixedly attached) to one of the shafts, such as the outer shaft 138 of the thrombus extraction catheter 104. In this example, the stop 702 is engaged when the self-expanding core retrieval element 206 is fully expanded by the wire or filament that generates tension on the self-expanding core retrieval element 206. In some examples, the terminating end of the filament may be secured to one of the shafts, for example, by a compression or tension spring to the outer shaft 138 of the thrombus extraction catheter 104, which allows the diameter of the self-expanding core extractor 206 to be slightly reduced without disengaging from the stop 702. In some examples, the wire or filament is made of an elastic material to include the function of a compression or tension spring.

[0122] In some examples, the inner shaft 200 of the thrombus extraction catheter 104 may be selectively connected to the distal end 217 of the expandable cylindrical portion 208. This allows movement of the inner shaft 200 to cause the self-expanding core retrieval element 206 to fully expand via the engagement of the annular feature 700 with the stop 702. In some examples, and while the self-expanding core retrieval element 206 is fully expanded, the inner shaft 200 may be recoupled to the distal end 217 of the expandable cylindrical portion 208 such that when the plunger 154 moves from the second position to the first position, the expandable cylindrical portion 208 is fully expanded and / or recoupled to the distal end 217 of the expandable cylindrical portion 208 to compress the expandable cylindrical portion 208.

[0123] In some examples, the expandable cylindrical portion 208 may include a braided mesh structure 704, which may be configured to trap thrombi. In some examples, the braided mesh structure may extend together with the expandable cylindrical portion 208, thus sharing a proximal end 216 and / or a distal end 217. Figure 7 In the example shown, the braided mesh structure 704 is a braid of elastic filaments of a generally tubular elongated portion 706 and a distally tapered portion 708. In other examples, the braided mesh structure 704 can be any porous structure and / or can have other suitable shapes, sizes, and constructions (e.g., the distal portion 708 can be generally cylindrical, etc.).

[0124] Since the braided mesh structure 704 is connected to the distal end 218 of the inner shaft 200, axial movement of the inner shaft 200 causes the braided mesh structure 704 of the TED200 to expand / shrink or contract / lengthen radially. For example, as long as the intermediate shaft 140 is fixed and / or restricted to axial movement at a rate less than that of the inner shaft 200: (1) distal movement of the inner shaft 200 causes the braided mesh structure 704 to extend along its longitudinal axis, thereby reducing the radius of the braided mesh structure 704 and increasing its length; (2) proximal movement of the inner shaft 200 causes the braided mesh structure 704 to compress along its longitudinal axis, thereby increasing the radius of the braided mesh structure 704 and decreasing its length. The mesh structure 704 can be placed in a variety of configurations, including, for example, stacked configurations, contracted configurations, and expanded configurations. The length of the mesh structure 704 in the stacked configuration may be shorter than the length of the mesh structure 704 in the expanded configuration, and the length of the mesh structure 704 in the expanded configuration may be shorter than the length of the mesh structure 704 in the contracted configuration. In some examples, the braided mesh structure 704 may have any desired length in the contracted configuration, including, for example, lengths of about 1 to 80 inches, 2 to 60 inches, 3 to 50 inches, about 5 to 30 inches, about 10 to 20 inches, and / or about 16 inches in the contracted configuration, and in some examples, the braided mesh structure 704 has a length of about 1 to 25 inches, about 10 to 20 inches, and / or about 11 inches in the expanded configuration. In some examples, the mesh structure 704 may have any desired length in the stacked configuration, including, for example, lengths of 1 to 50 inches, 1 to 30 inches, 1 to 20 inches, 1 to 15 inches, 2 to 10 inches, and / or about 5 inches in the stacked configuration.

[0125] In some examples, the weave angle of the fine mesh structure 704 can be varied depending on the construction. In some examples, for instance, the fine mesh structure 704 can be made of... Figure 7The braiding angle θ is defined as shown. The braiding angle θ can be the angle between the yarn / filament 750 of the braid and the center line 752 of the braid. As the length of the mesh structure 704 increases, the braiding angle θ can decrease, and as the length of the mesh structure 704 decreases, the braiding angle θ can increase. In some examples, when the mesh structure 704 is in a contracted configuration, the braiding angle θ of the mesh structure 704 can be less than about 10°, less than about 20°, less than about 30°, less than about 40°, and / or less than about 50°. In some examples, when the mesh structure 704 is in an expanded configuration, the braiding angle of the mesh structure 704 can be from 20° to 85°, 30° to 70°, 35° to 60°, 40° to 50°, and / or about 45°. In some examples, when the mesh structure 704 is in a stacked configuration, the weaving angle of the mesh structure 704 may be greater than about 45°, greater than about 60°, greater than about 70°, and / or greater than about 80°.

[0126] In some examples, the braided filament mesh structure 704 can be formed by a braiding machine and / or a weaving machine, and in some examples, the braided filament mesh structure 704 can be hand-braided and / or hand-woven. It may be advantageous to use a braiding machine and / or a weaving machine that does not employ bobbin or other filament winding mechanisms, which are typical features of many conventional braiding machines, as these make forming the braid on the self-expanding core element 206 significantly more difficult. The filaments in the braiding machine and / or weaving machine are freely suspended, making it easier to load them directly onto the self-expanding core element 206. In some examples, the woven mesh structure 704 can be woven using methods or apparatus included in the following documents: U.S. Patent No. 8,833,224, filed May 8, 2013, entitled "Weaving Mechanism and Method of Use"; U.S. Patent No. 8,826,791, filed September 10, 2012, entitled "Weaving Mechanism and Method of Use"; and U.S. Patent No. 8,261, filed October 17, 2011, entitled "Weaving Mechanism and Method of Use". U.S. Patent No. 648, entitled “Weaving Mechanism and Method of Use”, filed April 26, 2013; U.S. Patent Publication No. 2016 / 0030155, entitled “Aneurysm Transplantation and Stabilization”, filed September 14, 2015; and U.S. Patent Publication No. 2014 / 0318354, entitled “Weaving Mechanism and Method of Use”, filed July 11, 2014, the entire contents of which are incorporated herein by reference.

[0127] In some examples, the woven mesh structure 704 may be formed as a tubular braid, which may then be further shaped using a heat-setting process. In some examples, 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 examples, the woven mesh structure 704 may be at least partially formed of a cylindrical braid of elastic filaments. Therefore, the braid may be radially confined without plastic deformation and will self-expand upon release of radial confinement. This elastic filament braid is also referred to herein as a "self-expanding braid."

[0128] In some examples, the thickness of the braided filaments may be less than about 0.15 mm. In some examples, the braid may be made of filaments and / or threads with a diameter ranging from about 0.05 mm to about 0.25 mm. In some examples, braided filaments of different diameters may be combined to impart different properties, including: stiffness, elasticity, structure, radial force, pore size, embolism trapping or filtering capacity, etc. In some examples, the number of braided filaments is 20 to 80, greater than 30, and / or about 24. The pore size of the braided mesh in the elongated portion 706 may be in the range of about 0.4 mm to 4.0 mm. In some examples, the pore size may be in the range of 0.5 mm to 2.5 mm.

[0129] In some cases, when a thrombus is within the woven mesh structure 704, it may form a shape that is difficult to retract into the guide sheath 102. Figure 8 This situation is depicted in the image, where the thrombus extraction device 202, specifically a woven fine mesh structure 704, is partially retracted into the guide sheath 102. (As...) Figure 8 As shown, thrombus 800 forms a ball with a diameter larger than that of the guiding sheath 102. This behavior of thrombus 800 may prevent the removal of TED200 and thrombus 800 from the patient's body. Figure 9 and 10 It indicates the characteristics of the behavior that prevents blood clots.

[0130] Figure 8 A cross-sectional view of the elongated member 106 is also shown, so that the inner cavity 1702 of the elongated member is visible; a cross-section of the outer shaft 138 is shown, so that the inner cavity 802 of the outer shaft 138 is visible; and a cross-section of the intermediate shaft 140 is shown, so that the inner cavity 804 of the intermediate shaft 140 is visible.

[0131] For reference Figure 9The image shows a side view of an example of a braided mesh structure 704 including multiple apertures. As shown, the braided mesh structure 704 includes a first portion 900 and a second portion 902, the first portion 900 including a first plurality of apertures 904, and the second portion 902 including a second plurality of apertures 906. In some examples, the first portion 900 may correspond to an elongated portion 706, and the second portion 902 may correspond to a distally tapered portion 708.

[0132] like Figure 9 As shown, the first portion 900 of the woven mesh structure 704 is closer to the proximal side than the second portion 902. As further shown, the holes in the first plurality of holes 904 of the first portion 900 are smaller than the holes in the second plurality of holes 906 of the second portion 902. In some examples, the larger holes in the distal second portion 902 may have an average size greater than or equal to 1.5 mm, and in some examples, approximately 1.0 mm to 4.0 mm.

[0133] In this example, the larger aperture size of the second plurality of apertures 906 allows and / or facilitates the extrusion of thrombus portions as the braided mesh structure 704 moves to the unexpanded configuration and / or retracts into the guide sheath 102. In some examples, this extrusion of thrombus portions prevents the thrombus from failing to retract into the guide sheath 102. Furthermore, in some examples, relatively newer portions of the thrombus may be extruded before relatively older portions, as the relatively newer portions are more flexible and malleable. These relatively newer portions of the thrombus can then be captured and / or fragmented by features of the guide sheath 102.

[0134] In some examples, and such as Figure 9As shown, the woven mesh structure 704 can transition from a first portion 900 to a second portion 902 by longitudinal coverage of one or more first filaments 910 or second filaments 912 having one or more second filaments 912. In some examples, for instance, the first filament 910 can longitudinally overlap with the second filament 912 to form a filament pair 914. In some examples, the first filament 910 and the second filament 914 forming the filament pair 914 can subsequently be woven into a single filament, thereby increasing the aperture in the portion of the woven mesh structure 704 woven with the filament pair 914. In some examples, for instance, the first portion 900 can include a 48-wire mesh. In the second portion 902, one-half of the filaments or filaments forming the 48-wire mesh can be the first filament 910, while the other half can be the second filament 912. The first filament 910 can be longitudinally covered by one of the second filaments 912, thereby forming 24 filament pairs 914. These filament pairs 914 can then be woven to form a 24-filament mesh with a larger aperture than that of a 48-filament mesh.

[0135] For reference Figure 10 The image shows a side view of an example TED 200, which includes a plurality of circumferential recesses 1000, also referred to herein as circumferential grooves, radial ribs, and / or radial recesses. In some examples, some or all of the plurality of circumferential recesses 1000 may extend inwardly toward the central axis 1002 and / or midline 1002 of the thrombus extraction device 202. In some examples, the plurality of circumferential recesses 1000 may be longitudinally spaced or equally spaced along the length of the expandable cylindrical portion 208 and / or the length of the woven filament mesh 704 between the proximal end 216 and the distal end 217 of the cylindrical portion 208 and / or the length of the woven filament mesh 704. In some examples, as the thrombus extraction device 202 moves from the expanded configuration to the unexpanded configuration, these circumferential recesses 1000 may engage with the thrombus portion contained within the cylindrical portion 208 and / or the woven mesh structure 704 to inhibit movement of the thrombus relative to one or both of the proximal 216 and distal 217 of the cylindrical portion 208 and / or the woven mesh structure 704. This inhibition of thrombus movement reduces the likelihood of forming a thrombus that cannot retract into the guide sheath 102.

[0136] Although depicted in a separate figure, some examples of the thrombus extraction device 202 may include those involving Figure 10 The discussion involves multiple circumferential depressions and related Figure 9 The two are discussed in terms of multiple apertures.

[0137] For reference Figure 11This diagram illustrates an example of a woven pattern for forming a cylindrical portion 208 and / or a woven mesh structure 704 on a self-expanding core element 206 at one or more forming points 1103. As shown, the self-expanding core element 206 includes a plurality of pillars 402 connected at forming points 1103 including peaks 1100 (also referred to herein as peak pillars 1100). As shown, each peak 1100 is formed by a first pillar 402-A and a second pillar 402-B, with intersecting pillars 402-A and 402-B forming a peak opening 1101.

[0138] In some examples, the self-expanding core element 206 may include a plurality of peaks 1100 extending around the distal end of the self-expanding core element 206. The plurality of peaks 1100 may include 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.

[0139] The cylindrical portion 208 and / or the braided mesh structure 704 may include a plurality of filaments 1102 woven and / or braided together to form the cylindrical portion 208 and / or the braided mesh structure 704. In some examples, for each peak 1100 of the self-expanding core element, the plurality of filaments may include a first filament 1104 and a second filament 1106. The first filament 1104 and the second filament 1106 may be woven and / or braided onto their respective peaks. In some examples, the first and second filaments 1104, 1106 may be woven and / or braided onto their respective peaks, such that one or both of the first and second filaments 1104, 1106 form a loop around their respective peaks. Thus, in some examples, only the first filament 1104 forms a loop around its peak, only the second filament 1106 forms a loop around its peak, or both the first filament 1104 and the second filament 1106 form loops around their peaks. (Reference) Figure 11 For example, the first filament 1104 can be directly inserted into the peak hole 1101 of its peak, so that the first filament 1104 does not form a loop on itself directly near its peak, or more specifically, directly at the distal end of its peak.

[0140] When viewed from the outside of the self-expanding core element 206 to the inside of the self-expanding core element 206, the first filament 1104 can be inserted through the peak hole 1101 of its peak 1100, such that the first filament 1104 passes over the top of the first post 402-A and below the second post 402-B.

[0141] The second filament 1106 can be inserted through the peak aperture 1101, so that a portion of the second filament 1106 passing through the peak aperture 1101 is separated from the peak by the first filament 1104. Alternatively, the second filament 1106 can be inserted through the peak aperture 1101, so that the second filament 1106 passes below the first support 402-A and above the second support 402-B. After insertion through the peak aperture 1101, the second filament 1106 can loop on itself to form a loop 1108 directly away from its peak 100.

[0142] In some examples, because each filament 1104, 1106 is inserted through the peak 1101, each filament 1104, 1106 can be processed for weaving or knitting purposes to include a first filament extending from its peak 1100 to a first end of the filament 1104, 1106 and a second filament extending from its peak to a second end of the filament 1104, 1106. Thus, in some examples where the self-expanding core portion 206 includes 12 peaks, the cylindrical portion 208 and / or the woven mesh structure can be formed from 24 filaments 1104, 1106, which can be woven and / or knitted into 48 filaments to form a 48-filament mesh and / or fabric.

[0143] In some examples, the cylindrical portion 208 and / or the braided mesh structure 704 can be woven / woven by identifying a plurality of forming points 1103 formed by a plurality of pillars 402 of the self-expanding core element 206. Unique pairs of filaments can pass through each forming point 1103, specifically through the peak 1101 adjacent to each forming point 1103. In some examples, each unique pair of filaments may include a first filament 1104 and a second filament 1106 covering the first filament 1104. The first and second filaments can then be woven and / or braided from the unique pairs of filaments into a mesh structure of the cylindrical portion 208 and / or the braided mesh structure 704, such that the first filament 1104 does not form a loop around the forming point 1103 through which the first filament 1104 passes, and the second filament 1106 forms a loop 1108 around the forming point 1103 through which the second filament 1106 passes.

[0144] For reference Figure 12 A cross-sectional view of an example of the handle 134 with the plunger 154 in the first position is shown, and reference is made to... Figure 13The diagram shows a cross-sectional view of an example of a handle 134 with the plunger 154 in a second position. The handle 134 may include a housing 1200 defining an internal volume 1202. The plunger shaft 1204 may extend through the entirety or a portion of the internal volume 1202 and may be connected to a shaft that connects and / or couples some or all of the expansion features, including portions of an expansion mechanism 701, such as a ring 700 or a stop 702. In some examples, this shaft may include, for example, a second intermediate shaft 3000, a third intermediate shaft 3002, or an inner shaft 200, which may define the aforementioned cavity 1400, also referred to herein as the inner shaft cavity 1400. The plunger shaft 1204 may terminate at a plunger guide 1208 fixed to the plunger shaft 1204. In some examples, and as... Figure 12 and 13 As shown, the plunger 154 can be biased toward a first position by the plunger spring 1209, which can cooperate with a portion of the handle 134 and the plunger guide 1208. Therefore, when the plunger 154 is... Figure 12 When the plunger 154 is in the first position, the compression of the plunger spring 1209 is relatively small. Figure 13 As shown in the second position, the plunger spring 1209 is under greater compression. In some examples, this bias toward the first position can cause deviation as the thrombus extraction device 202 moves toward the partially expanded structure.

[0145] like Figure 14 As shown, Figure 13 In the close-up view of the circled portion "A", the plunger guide 1208 is positioned between a proximal stop 1210 and a distal stop 1212, each of which can be secured to a shaft connected to and / or coupled to some or all of the expansion features. This shaft may include, for example, a second intermediate shaft 3000, a third intermediate shaft 3002, or an inner shaft 200 including an inner shaft cavity 1400. The plunger guide 1208 can be dynamically connected to the proximal stop 1210 via a support compliant spring 1214 (also referred to herein as compliant spring 1214). In some examples, using compliant spring 1214 to connect the plunger guide 1208 and the proximal stop 1210 allows the diameter of the self-expanding core element 206 to be varied according to the compressive force applied to it.

[0146] In some examples, for instance, the radial compressive force applied to the self-expanding core element 206 can be transmitted from the self-expanding core element 206 to the compliant spring 1214 via the interaction of the annular feature 700 and the stop 702. In examples where the compressive force is greater than the spring force, the flexible spring 1214 can be compressed, and the shaft connected and / or coupled to some or all of the expansion features can advance distally relative to the intermediate shaft 140, which may include, for example, a second intermediate shaft 3000, a third intermediate shaft 3002, or an inner shaft 200, thereby reducing the diameter of the self-expanding core element 206 until the compressive force equals the spring force. This flexibility achieved by the flexible spring 1214 enables the use of the thrombus extraction catheter 104 in vessels that may be arteries or veins of non-constant diameter, while maintaining the required contact of the self-expanding core element 206 with the wall of the vessel, vein, or venous vessel. In some examples, when the vessel diameter is approximately 1 to 30 mm, 2 to 25 mm, 5 to 20 mm, and / or any other or intermediate diameter, this flexibility can cause the self-expanding core retrieval element 206 to apply a constant outward force to the vessel wall. In some examples, this constant outward force can be constant because it is within a predetermined range. In some examples, for instance, when the diameter of the self-expanding core retrieval element 206 is approximately 20 mm, the outward force can be approximately 5 N, and when the diameter of the self-expanding core retrieval element 206 is approximately 5 mm, the outward force can be approximately 20 N. Therefore, in some examples, a locking mechanism, including a plunger 154 and a flexible spring 1214, can be configured to maintain the required radial force on the vessel wall when the stent is compressed by the vessel wall. In some examples, when the self-expanding core retrieval element 206 is fully expanded, this required force can be a sufficient radial force on the vessel wall to retrieve the core from the vessel wall and / or separate all or part of the thrombus.

[0147] For reference Figure 15 and 16 The image shows a side view of an example of a occluder 120. As shown, the occluder 120 includes a proximal end 122, a distal auxiliary member 124, and an elongated shaft 126. As further shown, the occluder 120 may include a trapping sheath 1500 extending proximally from the distal end 124 of the occluder 120.

[0148] The occluder 120 may also include a tip, such as a damage-resistant tip 1502 located at the distal end 124 of the occluder 120. In some examples, the damage-resistant tip 1502 may be non-transmissive. The occluder 120 may also include a connecting fitting 1504 located at the proximal end 1506 of the trapping sheath 1500. In some examples, the connecting fitting 1504 may be configured to sealably connect to the distal end 110 of the elongated sheath 106 of the guide sheath 102.

[0149] The occluder 120 may also include a stop portion 1508 located at the proximal end 122 of the occluder 120. In some examples, the diameter of the stop portion 1508 may be larger than the lumen 1701 of the elongated member 106 of the guide sheath 102 and / or larger than the diameter of the sealing hole 112 located at the proximal end 108 of the guide sheath 102, to prevent the stop portion 1508 from entering the lumen 1701 of the elongated member 106 and / or the sealing hole 112.

[0150] In some examples, the elongated shaft 126 may include a constant size and / or diameter, and in other examples, the elongated shaft 126 may include multiple sizes and / or diameters. For example, Figure 15 The diameter 1510 of the slender shaft 126 shown is constant along its length. Conversely, Figure 16 The elongated shaft 126 shown has at least a first diameter 1512 along one or more first portions 1512 of the elongated shaft 126, and a second diameter 1514 along one or more second portions 1515 of the elongated shaft 126.

[0151] In some examples, one or more second portions 1515 of the elongated shaft may be positioned along the length of the elongated shaft 126 such that when the occluder 120 is received within the elongated member 106 of the guide sheath 102 and positioned such that the connecting fitting 1504 seals with the distal end 110 of the elongated sheath 106, the one or more second portions 1515 extend through the sealing bore 112. In such an example, a second diameter 1514 may be selected so that the one or more second portions do not contact and / or expand the sealing bore 112 and / or the seal within the sealing bore 112. Because this example of the occluder 120 does not expand the seal of the sealing bore 112 when the one or more second portions extend through the sealing bore 112. The guide sheath 102 may be stored, packaged, and / or sold together with such an occluder 120, which is pre-positioned and extends through the lumen 1701 of the elongated member 106.

[0152] For reference Figure 17 A detailed cross-sectional view of an example of a trapping sheath 1500 is shown. As shown, the trapping sheath 1500 includes a non-damaging tip 1502 and an elongated shaft 126 connected to an occluder 120, the elongated shaft 126 extending through a lumen 1701 of an elongated member 106. As further shown, the lumen 1700 extends through the non-damaging tip 1502 and the elongated shaft 126, and the lumen 1700 is configured to receive a guidewire.

[0153] The trapping sheath 1500 includes a trapping shell 1702 that extends distally from the non-damaging tip 1502 to the proximal end 1506 of the trapping sheath 1500. The trapping shell 1702 terminates at a connecting fitting 1504. The inner diameter 1704 of the trapping shell 1702 is larger than the diameter 1706 of the portion extending through the elongated shaft 126 of the trapping shell 1702. Due to the larger inner diameter 1704 of the trapping shell 1500, a receiving space is created between the trapping shell 1702 and the portion extending through the elongated shaft 126 of the trapping shell 1702. In some examples, the size and shape of this receiving space may be designed to receive and / or retain a self-expanding funnel 1708 in a confined configuration. In some examples, when the self-expanding funnel 1708 is in a confined configuration, the self-expanding funnel 1708 may have a diameter matching the inner diameter 1704 of the trapping shell 1702. In some examples, the diameter of the self-expanding funnel may be less than or equal to the diameter 1716 of the elongated member 106.

[0154] The self-expanding funnel 1708 may include various shapes and sizes and may be made of various materials. In some examples, the maximum diameter of the self-expanding funnel 1708 may be greater than and / or equal to the diameter of the self-expanding core extractor 206 when fully expanded, and in some examples, the minimum diameter of the self-expanding funnel 1708 may be equal to the diameter 1716 of the elongated member 106 and / or the diameter of the inner cavity 1701 of the elongated member 106. In some examples, the length of the self-expanding funnel 1708 may be greater than and / or equal to the length of the self-expanding core extractor 206, so that the self-expanding core extractor 206 can be received and accommodated within the self-expanding funnel 1708.

[0155] In some examples, the self-expanding funnel 1708 may have a tapered portion, specifically a truncated tapered portion. In some examples, the self-expanding funnel may be formed from at least one of a honeycomb nitinol braid, a nitinol braided support, laser-cut nitinol, a laser-cut polymer tube, an injection-molded polymeric structure, or an inflatable balloon. In some examples, the self-expanding funnel 1708 may include a mesh with sufficiently small pores to prevent dangerous blood clots from passing through the mesh. In some examples, the self-expanding funnel 1708 may be blood-permeable.

[0156] For reference Figures 18 to 20 A side view of an example of a guide sheath 102 in a different configuration is shown. Figure 18 In the diagram, the guiding sheath 102 is shown in an undeployed configuration. Figure 19 In the diagram, the guiding sheath 102 is shown in a partially deployed configuration, and... Figure 20 In the image, the guide sheath 102 is shown in a fully deployed and / or deployed configuration.

[0157] In particular, such as Figure 18As shown, the occluder 120 extends through the inner cavity 1701 of the elongated member 106 and is contained within the trapping sheath 1500 in a confined configuration from the expanding funnel 1708. Figure 19 In this configuration, the occluder 120 has been advanced distally, thereby releasing and / or deploying the self-expanding funnel 178 from the confined structure. In some examples, the length of the occluder 120, specifically the length of the elongated axis between the proximal end of the trapping sheath 1500 and the stop portion 1508, is sufficient to deploy the self-expanding funnel 1708 from the trapping sheath 1500 before further distal movement of the occluder 120 is prevented by the abutment of the stop portion 1508 and the sealing hole 112.

[0158] After the self-expanding funnel 1708 has expanded, the occluder 120 can retract proximally through the inner cavity 1701 and sealing hole 112 of the elongated member 106 and can detach from the guide sheath 102. After the occluder 120 detaches from the guide sheath 102, the guide sheath is in a fully expanded configuration, as... Figure 20 As shown.

[0159] In some examples, and such as Figure 21 As shown, the guiding sheath 102 may include an inflatable balloon 2100 located at or near the proximal end 110 of the elongated member 106. In some examples, the balloon 2100 may include a tapered inner portion 2012, the size and shape of which may be designed to receive the thrombus extraction device 202, and specifically, its length may be greater than or equal to the length of the self-expanding core extractor 206.

[0160] For reference Figure 22 This illustrates a guiding technique for accessing the thrombus 2200. As shown, the thrombus 2200 may be located in a blood vessel and accessed through an entry point 2260, such as a posterior patellar fossa entry point or other venous or arterial entry point. A guiding sheath 102 may extend from the posterior patellar fossa entry point 2260 or other venous or arterial entry point to a deployed position 2262, where a self-expanding funnel 1708 can be deployed and can be brought into proximity to the thrombus 2200. A TED 202 may pass through the clot 2200 in the direction of blood flow, and a TED 202 may retract through the clot 2200 in the direction opposite to blood flow. The retraction of the TED 202 through the clot 2200 may result in the self-expanding core retrieval element 206 core retrieval of the clot and the capture of the clot in the expandable cylinder 208.

[0161] In some such examples, TED 202 may extend wholly or partially into one of the iliac veins and / or the inferior vena cava, as shown in Figure 23. Furthermore, as TED 202 retracts from a proximal position relative to the heart to a distal position relative to the heart, the diameter of vessel 2202 decreases as TED 202 retracts toward entry site 2260. This can result in an increase in compressive forces on TED 202, specifically an increase in compressive forces on the self-expanding core retrieval element 206. These compressive forces can be transmitted to the flexible spring 1214 via the annular feature 700 and the stop 702. Through the extension or compression of the flexible spring 1214, the diameter of TED 202, specifically the diameter of the core retrieval element 206, can be altered to match the diameter of the vessel and the desired radial force, and / or the force level can be maintained.

[0162] Figures 23-A to 23-H , Figure 24-A and 24-B , Figures 25-A to 25-H , Figures 34-A to 3 4-H, Figures 41-A to 41-F and Figure 42-A and 42-B The process of removing a thrombus from a patient's body, particularly from a blood vessel (which may be a vein), using a thrombus extraction system 100 is described. This may include: entering the blood vessel through one or more percutaneous access sites, which may provide a direct access route or an indirect access route via one or more other blood vessels; advancing a guide sheath to a position close to the thrombus; deploying the self-expanding funnel of the guide sheath; advancing the distal end 132 of the thrombus extraction catheter 104 to a position close to the thrombus; deploying the thrombus extraction device 202; trapping the thrombus in the thrombus extraction device 202 by retracting the thrombus extraction device 202 through the thrombus; retracting the thrombus extraction device 202; and removing the thrombus extraction device 202 and the trapped thrombus from the guide sheath 102 and the patient's body. In some examples, these one or more access sites may include, for example, a posterior patellar access site, a femoral access site, a mid-femoral access site, a tibial access site, a contralateral access site, an internal jugular vein access site, and / or other venous or arterial access sites. In some examples, the thrombolytic agent may be injected into and / or aspirated into a blood vessel or removed from a blood vessel before, during, or after the removal or extraction of the thrombus. The thrombolytic agent may include, for example, tissue plasminogen activator (TPA) or other clot-dissolving agents.

[0163] In any of the examples disclosed herein, the device and / or delivery system may be adapted to deliver energy at the treatment site to the device and surrounding thrombus or tissue to facilitate thrombus removal or tissue healing near the device, or both. In some examples, energy may be delivered to the device via the delivery system to treat a patient's vascular system, such that the device is heated or actuated by the energy. Examples of energy that may be delivered include, but are not limited to, light, heat, vibration, electromagnetic, radiofrequency, and ultrasound. In some examples, the energy delivered to the device may trigger the release of a chemical or biological agent to facilitate the separation of the thrombus from the vessel wall and / or release into the patient's tissue to treat the patient's vascular system, tissue adjacent to such device, or a combination thereof.

[0164] use Figures 23-A to 23-H , Figure 24-A and 24-B , Figures 25-A to 25-H , Figures 34-A to 34-D , Figures 41-A to 41-F as well as Figure 42-A and 42-B The method of the thrombus extraction system 100 shown can be implemented using the direction of blood flow or against the direction of blood flow. Therefore, in some examples, Figures 23-A to 23-H , Figure 24-A and 24-B , Figures 25-A to 25-H , Figures 34-A to 34-D , Figures 41-A to 41-F ,as well as Figure 42-A and 42-B The direction of blood flow in the middle can be from left to right or from right to left.

[0165] For reference Figures 23-A to 23-H This paper illustrates a method for expanding a thrombus extraction device 202 in a blood vessel, such as a vein. The method for expanding the thrombus extraction device 202 in a blood vessel can be performed using all or part of a thrombus extraction system 100. In some examples, the method for expanding the thrombus extraction device 202 in a blood vessel can be performed using detection techniques such as fluorescence examination, angiography, and / or ultrasound monitoring. In some examples, monitoring techniques can monitor the expansion of the TED 202 in the blood vessel by observing one or more radiopaque markers located on the guide sheath 102 and / or the thrombus extraction catheter 104.

[0166] This method begins Figure 23-AThe thrombus 2200 is identified in a vessel 2202, such as a vein. In some examples, the thrombus 2200 may be located in the peripheral vascular system of a patient's body. The thrombus 2200, also referred to herein as clot 2200, may include a proximal end 2204 and a distal end 2206. In some examples, the identification of the vessel 2202 may also include determining whether the thrombus 2200 in the vessel is suitable for thrombus extraction. In some examples, the thrombus 2200 in the vessel 2202 is suitable for extraction when the diameter of the vessel 2202 is at least 5 mm. In some examples, the thrombus 2200 in the vessel 2202 is suitable for extraction when the diameter of the vessel 2202 is at least 5 mm and is at least one of the femoral vein, iliac vein, posterior genicular vein, posterior tibial vein, anterior tibial vein, or peroneal vein.

[0167] After identifying the thrombus, the method proceeds to... Figure 23-B The steps shown involve advancing the guide sheath 102 in or against the direction of blood flow in the vessel, such that the distal end 110 of the guide sheath 102 and / or the occluder 120 are brought close to the thrombus 2200, particularly at a location proximal to the thrombus 2200. In some examples, this may include providing the guide sheath 102 and percutaneously entering the patient's circulatory system through an entry site 2208, which may be one of the aforementioned entry sites, specifically a blood vessel or vein.

[0168] After the guide sheath 102 has been advanced to the desired position, the self-expanding funnel 1708 can be deployed and / or withdrawn from the confined structure. Figure 23-C The expansion configuration is shown. In some examples, the self-expanding funnel 1708 can be deployed by the relative distal movement of the occluder 120 relative to the elongated member 106 until the funnel 1708 is no longer confined to the trapping sheath 1500, and then the occluder 120 can be retracted proximally through the lumen 1701 of the elongated member 106 until the occluder 120 is removed from the guide sheath 102.

[0169] In some examples, the relative distal movement of the occluder 120 relative to the elongated member may include fixing the position of the occluder 120 relative to the blood vessel 2202 and retracting the elongated member 106 proximally on the occluder 120 to withdraw the self-expanding funnel 1708 until the stop 1508 contacts the sealing hole 112 and / or until monitoring (may be fluorescence monitoring) of 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 been deployed and / or is no longer confined to the trapping sheath 1500. Alternatively, in some examples, the relative distal movement of the occluder 120 relative to the elongated member may include fixing the position of the elongated member 106 relative to the blood vessel 2202 and advancing the occluder 120 distally to withdraw the self-expanding funnel 1708 until the stop 1508 contacts the sealing hole 112 and / or until monitoring (may be fluorescence monitoring) of 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 been deployed and / or is no longer confined to the trapping sheath 1500.

[0170] After the self-expanding funnel 1708 is deployed, a portion of the thrombus extraction catheter 104 (e.g., the outer shaft 138) can be accessed via... Figure 23-D The sealing orifice 112 shown is inserted into the lumen 1701 of the guide sheath 102. In some examples, this may include providing a thrombus extraction catheter 104 containing a thrombus extraction device 202. In some examples, the thrombus extraction device 202 may be confined within an outer shaft 138 and may be inserted into the lumen of the elongated member 106 via the sealing orifice 112, together with the outer shaft 138. In some examples, the outer shaft 138 of the thrombus extraction catheter 104 may have a diameter to expand the seal of the sealing orifice 112, such that the sealing orifice 112 seals around and to the outer shaft 138.

[0171] After the outer shaft 138 has been inserted into the lumen 1701 of the guide sheath 102, a portion of the thrombus extraction catheter 104 can be inserted into the blood vessel 2202 via the guide sheath 102, such as... Figure 23-E As shown. In some examples, the distal end 132 of the thrombus extraction catheter 104 may be advanced to a location close to and / or proximal to the thrombus 2200. In some examples, the insertion and / or advancement of the thrombus extraction catheter 104 may be monitored, specifically by fluorescence monitoring. In some examples, the location of one or more radiopaque markers may be monitored, including radiopaque marker 222 of the thrombus extraction catheter 104.

[0172] After a portion of the thrombus extraction catheter 104 has been inserted into the blood vessel 2202, the portion of the thrombus extraction catheter 104 can be advanced distally through the clot 2200, such as... Figure 23-FAs shown. In some examples, the distal advancement through clot 2200 may be in the same or opposite direction to the blood flow. In some examples, the portion of the thrombus extraction catheter 104 advanced distally through clot 2000 may include and / or restrict the thrombus extraction device 202. In some examples, distal advancement of a portion of the thrombus extraction catheter 104 through the clot may include advancing a portion of the thrombus extraction catheter 104 until a radiopaque marker 222, which can be fluorescently monitored and may be located at the distal end 218 of the inner axis 200, distally penetrates the thrombus 2200 and / or a portion of the thrombus 2200.

[0173] After a portion of the thrombus extraction catheter 104 is advanced distally through the clot 2200, it can be as follows: Figure 23-G The thrombus extraction device 202 is shown to be deployed. In some examples, the thrombus extraction device 202 can be deployed by advancing the thrombus extraction device 202 beyond the distal end 204 of the outer axis 138 or by retracting the thrombus extraction device 202 relative to the outer axis 138 until the thrombus extraction device 202 extends beyond the distal end 204 of the outer axis 138. In some examples, the thrombus extraction device can be deployed such that the thrombus extraction device 202 extends distally through the thrombus 2200 and / or through a desired portion of the thrombus 2200.

[0174] In some examples, the intermediate shaft 140 is advanced distally relative to the outer shaft 138, thereby advancing the thrombus extraction device beyond the distal end 204 of the outer shaft 138. In some examples, the intermediate shaft 140 may be advanced distally until the locking feature 146 contacts the matching feature 148, and the locking feature 146 may be matched and / or fixed to the matching feature 148 to fix the relative position of the intermediate shaft 140 relative to the outer shaft 138.

[0175] In some examples, the deployment of the thrombus extraction device 202 can be monitored, specifically by fluorescence monitoring, for example, by a radiopaque marker 222 and a radiopaque marker located at one or both of the distal end 204 of the outer sheath 138 and the distal end 212 of the intermediate sheath 140. In some examples, the deployment of the thrombus extraction device 202, specifically by advancing the thrombus extraction device 202 beyond the distal end 204 of the outer shaft 138 or retracting the outer shaft 138 relative to the thrombus extraction device 202, can be stopped according to the position of the distal end 204 of the outer sheath 138, including the radiopaque marker (first radiopaque marker), relative to the radiopaque marker 222 (second radiopaque marker) located on the thrombus extraction device 202.

[0176] After the thrombus extraction device 202 is deployed, the thrombus extraction device 202 can fully expand, such as... Figure 23-HAs shown. In some examples, this may include fully expanding the thrombus extraction device 202, thereby engaging with the wall 2220 of the blood vessel 2202. In some examples, the thrombus extraction device 202 may 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 examples, 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 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 may further engage the stop 702 with the annular feature 700, thereby fully expanding the self-expanding core-retrieval element 206. In some examples, the plunger 154 is secured in the second position by the engagement of the stop 702 with the annular feature 700, which secures the self-expanding core extractor 206 and the thrombus extraction device 202 to a fully expanded state.

[0177] For reference Figure 24-A and 24-B , showed Figure 23-G and 23-H Alternative examples of the steps shown are provided. In some examples, these alternative examples may be performed when the diameter of the vessel 2202 containing the thrombus 2200 is reduced to less than the level required to extend distally beyond the thrombus 2200. In some examples, for example, the diameter of the vessel 2202 may decrease as the distance to the heart increases. In some examples, the diameter may be reduced to the point where the thrombus extraction device 202 can no longer be used.

[0178] In this example, the extension sheath 2300 (also referred to herein as the posterior fossa sheath 2300) may be percutaneously inserted into the vessel 2202 through the wall 2220, such that at least a portion of the extension sheath 2300 extends from the patient. In some examples, the extension sheath 2300 may be percutaneously inserted into the vessel 2202 before the vessel diameter is reduced to below a desired value (e.g., below 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 8 mm, 10 mm, or any other arbitrary or intermediate value). In some examples, the extension sheath 2300 may be inserted into the vessel 2202 via a posterior fossa entry site or other venous or arterial entry site.

[0179] Thrombus extraction device 202 can be used as Figure 24-AThe thrombus extraction device 202 can be deployed as shown. In some examples, the thrombus extraction device 202 can be deployed by advancing the thrombus extraction device 202 beyond the distal end 204 of the outer shaft 138 and into the extension sheath 2300, or by advancing the outer shaft 138 containing the thrombus 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 extends beyond the distal end of the outer shaft 138. In some examples, the thrombus extraction device can be deployed such that the thrombus extraction device 202 extends distally through the thrombus 2200 and / or through a desired portion of the thrombus 2200. In some examples, all or part of the thrombus extraction can be contained within the extension sheath 2300.

[0180] In some examples, the outer shaft 138 of the thrombus extraction catheter 104 can be separable into a first component and a second component. In some examples, this separation can occur at a separation point, which may include any features configured to separate the first and second components. These features may include partial depth cuts or notches in the outer shaft 138, overlapping friction fittings in the outer shaft 138, etc. In some examples, the separable outer shaft 138 can be used at the location of the extension sheath 2300. In this example, the outer shaft 138 can exit the blood vessel 2202 via an entry site, such that the separable portion extends from within the blood vessel 2202 out of the patient's body at the entry point. In this example, the separable portion of the outer sheath 138 can be used as the extension sheath 2300 and can remain in the entry point when the thrombus extraction device 202 is retracted. Thus, the thrombus extraction device 202 can be deployed by fixing the position of the separable portion of the outer sheath 138 and retracting the thrombus extraction device 202 from the separable portion of the outer sheath 138.

[0181] In some examples, the thrombus extraction device can be advanced beyond the distal end 204 of the outer axis 138 by advancing the intermediate axis 140 distally relative to the outer axis 138. In some examples, the intermediate axis 140 can be advanced distally until the locking feature 146 contacts the matching feature 148. In some examples, the locking feature 146 can be matched and / or secured to the matching feature 148 to fix the relative position of the intermediate axis 140 relative to the outer axis 138.

[0182] In some examples, the deployment of the thrombus extraction device 202 can be monitored by fluorescence. Specifically, the deployment of the thrombus extraction device 202 can be monitored by fluorescence, for example, by a radiopaque marker 222 and a radiopaque marker located at one or both of the distal ends of the outer sheath 138 and the distal ends 212 of the intermediate sheath 140. In some examples, the deployment of the thrombus extraction device 202, specifically the advancement of the distal end 204 of the thrombus extraction device 202 beyond the outer axis 138 or the retraction of the outer axis 138 relative to the thrombus extraction device 202, can be stopped according to the position of the distal end 204 of the outer sheath 138, including the radiopaque marker (first radiopaque marker), relative to the radiopaque marker 222 (second radiopaque marker) located on the thrombus extraction device 202.

[0183] After the thrombus extraction device 202 is deployed, the thrombus extraction device 202 can be fully expanded, such as... Figure 24-B As shown. In some examples, the thrombus extraction device 202 can be fully expanded while all or part of the thrombus extraction device 202 is contained within the extension sheath 2300. In this example, the extension sheath prevents the portion of the thrombus extraction device 202 contained within the extension sheath 2300 from reaching full expansion. In this example, the thrombus extraction device 202 can reach full expansion when it is retracted proximally from the extension sheath 2300.

[0184] In some examples, full expansion of the thrombus extraction device 202 may include expanding the thrombus extraction device 202 so that it engages with the wall 2220 of the blood vessel 2202. In some examples, moving the plunger 154 from a first position to a second position and fixing the plunger 154 in the second position fixes the relative position of the inner shaft 200 with respect to the intermediate shaft 140, thereby fully expanding the thrombus extraction device. The movement 154 of the plunger 154 from the first position to the second position may retract the inner shaft 200 proximally relative to the intermediate shaft 140, thereby expanding the expandable cylindrical portion 208 of the thrombus extraction device 202. In some examples, the proximal retraction of the inner shaft 200 relative to the intermediate shaft 140 may further engage the stop 702 with the annular feature 700, thereby fully expanding the self-expanding core extractor element 206. In some examples, the plunger 154 is secured in the second position by the engagement of the stop 702 with the annular feature 700 to secure the self-expanding core extractor 206 and the thrombus extraction device 202 to a fully expanded state.

[0185] In some examples where the TED202 is wholly or completely contained within the extension sheath 2300, the TED202 can retract until the self-expanding core element 206 is outside the extension sheath 2300, and at this point the inner shaft 200 can disengage from the expandable cylindrical portion 208 and the plunger 154 can move from a first position to a second position to fully expand the self-expanding core element 206. Then, as the expandable cylindrical portion 208 leaves the extension sheath 2300 until it is completely disengaged from the extension sheath and fully expanded, and the distal end 217 of the expandable cylindrical portion 208 is recoupled to the inner shaft 140, the TED 202 can further retract and the expandable cylindrical portion 208 can be expanded by gradually recoupled to the inner shaft 200 by the distal end 217 of the expandable cylindrical portion 208. Alternatively, in some examples, the distal end 217 of the expandable cylindrical portion 208 may remain detached from the inner shaft until the expandable cylindrical portion 208 is completely disengaged from the extension sheath 2300. Once the expandable cylindrical portion 208 is completely disengaged from the extension sheath 2300, the distal end 217 of the expandable cylindrical portion 208 may be recoupled to the inner shaft 200 and the expandable cylindrical portion 208 may expand to a fully expanded state.

[0186] For reference Figures 25-A to 25-H The process of removing a thrombus 2200 using an expanded thrombus extraction device 202 is illustrated. In some examples, the thrombus 2200 can be removed by trapping it within the thrombus extraction device 202 through a proximal retraction of the thrombus extraction device 202, which can be, for example, in the direction of blood flow through the vessel 2202 or against the direction of blood flow through the vessel 2202. In some examples, the proximal retraction of the thrombus extraction device 202 through the thrombus 2200 can result in trapping the distal end 2206 of the thrombus 2200 before trapping the proximal end 2204 of the thrombus 2200.

[0187] In some examples, proximal retraction of the thrombus retrieval device 202 can result in the separation and / or core retrieval of at least a portion of the thrombus 2200 from the wall 2220 of the vessel 2202, for example via the self-expanding core retrieval element 206 and / or the stent portion, and the capture of the separated portion of the thrombus 2200 within the expandable cylindrical portion 208. In some examples, the expandable cylindrical portion 208 may be formed of a woven mesh structure, which may be, for example, a mesh-like filament structure. In some examples, a portion of the thrombus can be captured within the expandable cylindrical portion 208 by accessing the expandable cylindrical portion 208 via the opening 414 of the self-expanding core retrieval element 206 and / or via one or more gaps 404 of the self-expanding core retrieval element 206.

[0188] like Figure 25-AAs shown, the distal end 2206 of the thrombus 2200 is separated from and / or cored from the wall 2220 of the vessel 2202 by the self-expanding core-retrieval element through the proximal retraction of the thrombus extraction device 202. Figure 25-B As shown, the distal end 2206 of the thrombus 2200 is captured in the expandable cylindrical portion 208 of the thrombus extraction device by continuous proximal retraction through the thrombus 2200. Further separation and capture of the thrombus 2200 and / or core extraction and capture by continuous proximal retraction of the thrombus extraction device 202 are shown in... Figure 25-C 25-D and 25-E. For example... Figure 25-E As shown, when the thrombus extraction device 202 retracts proximally to the self-expanding funnel 1708, the proximal end 2204 of the thrombus 2200 is cored and captured.

[0189] In some examples, the thrombus extraction device 202 can retract proximally until a portion of the self-expanding core retrieval element 206 is accommodated within the self-expanding funnel 1708, such as... Figure 25-F As shown, specifically, until the opening 414 of the self-expanding core extractor 206 is contained within the self-expanding core extractor funnel 1708. In some examples, the containment of the opening 414 within the self-expanding funnel 1708 can be verified by fluorescence. In some examples, based on the alignment and relative positioning of the distal end 212 of the intermediate shaft 140, including radiopaque markers 2450 and / or 222, with respect to the radiopaque markers 2452 of the elongated member 106 including the guide sheath 102, complete containment of the opening 414 within the self-expanding funnel 1708 can be determined by fluorescence monitoring.

[0190] When the self-expanding core extractor 206 is partially housed within the self-expanding funnel 1708, or specifically when the opening 414 of the self-expanding core extractor 206 is fully housed within the self-expanding funnel 1708, the plunger 154 can be unlocked from the second position and moved from the second position to the first position, thereby moving the thrombus extraction device 202 from the expanded configuration to the unexpanded configuration. In some examples, unlocking the plunger 154 from the second position can unlock and / or decouple the inner shaft 200 relative to the intermediate shaft 140, and the movement of 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.

[0191] In some examples, before retrieving the thrombus extraction device 202 from the patient's body, the device can be contracted by moving it from an expanded configuration to an unexpanded configuration to compress the thrombus 2200 captured by the device. In some examples, the compression of the thrombus 2200 by the thrombus extraction device 202 may be achieved by the engagement of one or more of a plurality of circumferential recesses 1000 with the thrombus 2200 to ensure the thrombus's position within the device.

[0192] After the thrombus extraction device 202 contracts, it can retract proximally through the self-expanding funnel 1708 and enter the elongated member 106, such as Figure 25-G As shown. In some examples, the contraction of the thrombus extraction device 202 and / or its retraction into the self-expanding funnel 1708 and / or elongated member can cause all or part of the thrombus 2200 to be extruded through orifices in the expandable cylindrical portion 208 of the thrombus extraction device 202, said orifices including, for example, some or all of a first plurality of orifices 904 and / or a second plurality of orifices 906. In some examples, all or part of the thrombus 2200 can be extruded through some or all of the second plurality of orifices 906, which may be larger than the first plurality of orifices 904. In some examples, the orifices in the second plurality of orifices 906 may be designed to be small enough that any thrombus portion of the thrombus 2200 extruded through the orifice is small enough to be of little or no clinical significance. In some examples, all or part of these extruded thrombi 2200 may be captured by the self-expanding funnel 1708.

[0193] Thrombus extraction device 202 can be used as Figure 25-H The device continues to retract proximally until the thrombus extraction device 202 and the captured thrombus 2200 are completely contained within the elongated member 106. In some examples, the sealing dilator 170 can be inserted into the sealing hole 112 and the thrombus extraction device 202, and the captured thrombus 2200 can then be retrieved or removed from the patient's body and the elongated member 106 through the sealing hole 112 in the sealing dilator 170. In some examples, the thrombus captured by the self-expanding funnel 1708 can be guided into the elongated member 106, specifically into the lumen 1701 of the elongated member 106, or further compressed and / or broken by the self-expanding funnel 1708, and then able to pass through the self-expanding funnel 1708, specifically through the mesh of the self-expanding funnel 1708. In some examples, the thrombus can be aspirated through the lumen 1701 of the elongated member 106 and the aspiration port 114. In some examples, aspiration of the thrombus through the aspiration port 114 may include an opening in the aspiration valve 118. After the thrombus captured by the self-expanding funnel 1708 has been aspirated, the guide sheath 102 may be removed from the patient's body.

[0194] For reference Figure 26-28The diagram illustrates guidance techniques for accessing the thrombus 2200. In some examples, these guidance techniques can utilize larger guide sheaths 102 because the vessels leading to the thrombus are large. In some examples, the larger guide sheath 102 allows the thrombus to be easily passed through and removed because, in some examples, the size of the lumen 1701 of the guide sheath 102 can increase with the size of the guide sheath 102. Furthermore, in some examples, the user of the larger guide sheath 102 can remove larger thrombi. In some examples, the lengths of the components of the thrombus retrieval system 100, particularly the guide sheath 102 and the thrombus retrieval catheter 104, can vary based on the selected technique for reaching the thrombus and / or based on the location of the thrombus.

[0195] like Figure 26 As shown, the guiding sheath 102 can be inserted into the patient through the internal jugular vein entry site 2500. The guiding sheath 102 can extend from the internal jugular vein entry site 2500 to a deployment position 2502 that can be close to the thrombus 2200. In an example where the guiding sheath 102 includes a self-expanding funnel 1708, the self-expanding funnel 1708 can deploy at the deployment position 2502. Figure 26 In the example shown, the guiding sheath extends from the internal jugular entry site 2500 through the superior and inferior vena cava to a spreading position 2502 in a common iliac vein. In some examples, the spreading position 2502 may be located, for example, in the inferior vena cava, one of the iliac veins, the femoral vein, the posterior genicular vein, not reaching or beyond the iliac arch, or any other location near and / or close to the thrombus 2200. In some examples, the use of the internal jugular entry site 2500 allows the elongated member 106 to have a larger diameter.

[0196] like Figure 27 As shown, in some examples, the use of the internal jugular vein 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 posterior patellar fossa access site 2600. In some such examples, the thrombus extraction device can be completely or partially removed from the patient's body while contained in the extension sheath 2300 before retracting through the thrombus 2200.

[0197] like Figure 28 As shown, in some examples, the guiding sheath can be inserted into the patient and enters the access site via the common iliac vein to the vessel 2202 containing the thrombus. Figure 28In the specific example shown, this can be achieved by insertion into the patient via the femoral entry point 2700. In some examples, the use of the entry point connected to the blood vessel 2202 via the common iliac vein, specifically the use of the femoral entry point 2700, can be combined with the use of an extension sheath 2300, which can be inserted into the blood vessel 2202 at the posterior patellar fossa entry point 2600. In some such examples, the thrombus removal device can be completely or partially removed from the patient's body and accommodated in the extension sheath 2300 before retraction through the thrombus 2200.

[0198] For reference Figure 29 The image shows a side view of another example of the thrombus extraction device 202. Figure 29 The TED 202 shown can be used with other components of the thrombectomy system 100 shown and discussed above. The thrombus extraction device 202 may include a self-expanding core element 206 and an expandable cylindrical portion 208, which may be a braided mesh structure 704. The self-expanding core element 206 may include a port 414, also referred to herein as an opening 414, positioned relatively laterally on the thrombus extraction catheter 104 compared to the expandable cylindrical portion 208. The self-expanding core 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.

[0199] The distal end 217 of the expandable cylindrical portion 208 can be connected to one of the following: a second intermediate shaft 3000, a third intermediate shaft 3002, and an inner shaft 200. In some examples, the connection can be connected to the distal end 218 of one of the following: the second intermediate shaft 3000, the third intermediate shaft 3002, and the inner shaft 200. In some examples, the connection can be located at an intermediate position between the proximal end and the distal end 218 of one of the following: the second intermediate shaft 3000, the third intermediate shaft 3002, and the inner shaft 200. In some examples, the connection can be a fixed connection, and in some examples, the connection can be a slidable connection.

[0200] The expandable cylindrical portion 208 may include an everted portion 2900 and a non-everted portion 2902. In some examples, the non-everted portion may be located near the proximal end 216 of the expandable cylindrical portion 208 and may be connected to the self-expanding core extractor 206. In some examples, the everted portion 2900 may extend proximally through the non-everted portion 2902 and / or through the self-expanding core extractor 206, particularly through the opening 414 of the self-expanding core extractor 206. The distal end 217 of the expandable cylindrical portion 208 may be movable relative to the self-expanding core extractor 206, thereby varying the relative size and / or length of the everted portion 2900 relative to the size and / or length of the non-everted portion 2902. In an example of the distal end 217 of the expandable cylindrical portion 208, which is one of the second intermediate shaft 3000, the third intermediate shaft 3002, and the inner shaft 200, the length of the outward-facing portion 2900 relative to the non-outward-facing portion 2902 varies based on the position of the first intermediate shaft 140 relative to one of the following: the second intermediate shaft 3000, the third intermediate shaft 3002, and the inner shaft 200 to which the self-expanding core element 206 is connected.

[0201] The distal end 218 of the inner shaft 200 may also include a tip 220, such as a non-abrasive tip and / or a radiopaque marker 222. In some examples, the tip 220 may include a radiopaque marker 222. Further radiopaque markings may be located, for example, on the outer shaft 138, specifically the distal end 204 of the outer shaft 138 and / or the distal end 212 of the intermediate shaft 140. In some examples, one or both of the distal end 204 of the outer shaft 138 and the distal end 212 of the intermediate shaft 140 may each include a radiopaque marker. In some examples, the non-abrasive tip 220 may define a channel configured to allow a guidewire to pass through the non-abrasive tip 220.

[0202] Now for reference Figure 30 and 31 Other examples of the thrombus extraction device 202 and a portion of the thrombus extraction catheter 104 are shown. Specifically, Figure 30 An example of a thrombus extraction device 202 is depicted, wherein an expandable cylindrical portion 208 is everted. As shown, the everted portion 2900 of the expandable cylindrical portion 208 is everted such that the everted portion 2900 extends through the non-everted portion 2902 and through the self-expanding core retrieval element 206. Specifically, the everted portion 2900 is everted such that the everted portion 2900 extends proximally through the non-everted portion 2902 and proximally through the self-expanding core retrieval element 206.

[0203] exist Figure 30In this embodiment, the thrombus extraction device 202 includes a self-expanding core extractor 206 and an expandable cylindrical portion 208. The self-expanding core extractor 206 includes an opening 414. Furthermore, the distal end 217 of the expandable cylindrical portion 208 is connected to the distal end 3004 of a third intermediate shaft 3002, which extends coaxially through the lumen of a second intermediate shaft 3000, which similarly extends coaxially through a first intermediate shaft 140. As further shown, the thrombus extraction device 202 includes an inner shaft 200 having a non-traumatic tip 220. In one example, the inner shaft 200 is not connected to the expandable cylindrical portion 208 but is movable independently of it. In another example, the inner shaft 200 is fixed to the proximal end of the expandable cylindrical portion 208 and can be manipulated to purposefully expand or retract the cylindrical portion 208.

[0204] The second intermediate shaft 3000 includes a stop 702, which, together with the ring 700 of the self-expanding core-taking element 206, forms part of the expansion mechanism 701. In some examples, the stop 702 may be a tab, protrusion, flange, ridge, etc. The expansion mechanism 701 and the above-described... Figure 12-14 The components discussed herein can be configured to maintain the desired radial force on the vessel wall using a single porous structure and / or to keep the thrombus extraction device 202 and / or the self-expanding core retrieval element 206 in a fully expanded and / or fully expanded state.

[0205] In some examples, the stop 702 may directly mate with the ring 700, and in other examples, the stop 702 may be coupled to the ring 700 via a force transmission feature such as a spring, which may be a compression spring or a tension spring. In some examples, for instance, the stop 702 may be located proximal to the ring 700, and the stop and the ring may be coupled via a tension spring, so that when the stop 702 is in the position to be fully expanded, a force is applied to the ring 700 via the spring.

[0206] In some examples, the expandable cylindrical portion 208 may be coupled and / or connected to the distal end 218 of one of the following: a second intermediate shaft 3000; a third intermediate shaft 3002; and an inner shaft 200. In some examples, the expandable cylindrical portion 208 may be coupled and / or connected to the distal end 218 of one of the following: a second intermediate shaft 3000; a third intermediate shaft 3002; and an inner shaft 200 located between the proximal and distal ends 218 of one of the second intermediate shaft 3000, the third intermediate shaft 3002, and the inner shaft 200. In some examples, this connection may be a fixed connection, and in some examples, the connection may be a slidable connection.

[0207] The expandable cylindrical portion 208 may include an everted portion 2900 and a non-everted portion 2902. In some examples, the non-everted portion 2902 may be located near the proximal end 216 of the expandable cylindrical portion 208 and may be connected to the expandable core element 206. In some examples, the everted portion 2900 may extend proximally through the non-everted portion 2902 and / or through the self-expanding core element 206, particularly through the opening 414 of the self-expanding core element. The distal end 217 of the expandable cylindrical portion 208 may be movable relative to the self-expanding core element 206, such that the relative size and / or length of the everted portion 2900 varies relative to the size and / or length of the non-everted portion 2902. In some examples, the distal end 217 of the expandable cylindrical portion 208 is fixed to one of: a second intermediate shaft 3000; a third intermediate shaft 3002; and an inner shaft 200. The length of the outward-facing portion 2900 relative to the non-outward-facing portion 2902 varies based on the length of the first intermediate shaft 140 relative to one of the following: the second intermediate shaft 3000; the third intermediate shaft 3002; or the inner shaft 200 to which the self-expanding core-taking element 206 is connected.

[0208] The distal end 218 of the inner shaft 200 may further include a tip 220, such as a non-abrasive tip and / or a radiopaque marker 222. In some examples, the tip 220 may include a radiopaque marker 222. Further radiopaque markings 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 examples, one or both of the distal end 204 of the outer shaft 138 and the distal end 212 of the intermediate shaft 140 may each include a radiopaque marker. In some examples, the non-abrasive tip 220 may define a channel configured to allow a guidewire to pass through the non-abrasive tip 220.

[0209] In some examples, the thrombus extraction catheter 104 may include an eversion stop 3006. The eversion stop 3006 may include one or more features that limit proximal displacement of the distal end 217 of the expandable cylindrical portion 208 to prevent excessive eversion of the TED 202. In some examples, the eversion stop 3006 may be configured to limit proximal movement of one of the following: a second intermediate axis 3000; a third intermediate axis 3002; and an inner axis 200 coupled to the distal end 217 of the expandable cylindrical portion 208. In some examples, this prevents complete eversion of the expandable cylindrical portion 208.

[0210] The eversion stop 3006 can increase the effectiveness of the thrombus extraction device 202. In some examples, such as the eversion of the expandable cylindrical portion 208 on the self-expanding core extractor 206, the distal end 217 of the expandable cylindrical portion 208 cannot be advanced distally to fully expand the expandable cylindrical portion 208.

[0211] Figure 31 An example of a thrombus extraction device 202 is depicted, wherein an expandable cylindrical portion 208 is everted over a self-expanding core-retrieval element 206. (See example...) Figure 31 As shown, the everted portion 2900 of the expandable cylindrical portion 208 is directly connected to the distal end 214 of the self-expanding core retrieval element 206 and everted so that the everted portion 2900 of the expandable cylindrical portion 208 extends through the self-expanding core retrieval element 206. Specifically, the everted portion 2900 is everted so that the everted portion 2900 extends proximally through the self-expanding core retrieval element 206. As further shown, the thrombus extraction device 202 includes an inner shaft 200 having a non-traumatic tip 220. The inner shaft 200 is coupled to the expandable cylindrical portion 208 via a coupling member 3100, which can fixably couple the distal end 217 of the expandable cylindrical portion 208 to the inner shaft 200 and / or the coupling member 3100 can slidably couple the distal end 217 of the expandable cylindrical portion 208 to the inner shaft 200. In some examples, the distal end 217 of the expandable cylindrical portion 208 may be similarly coupled to the second intermediate shaft 3000 or the third intermediate shaft 3002. In some examples where the coupling 3100 fixes the distal end 217 of the expandable cylindrical portion 208 to the inner shaft 200, the relative lengths of the everted portion 2900 and the non-everted portion 2902 can be changed by the relative displacement of the inner shaft 200 relative to the first intermediate shaft 140. In examples where the coupling 3100 slidably couples the distal end 217 of the expandable cylindrical portion 208 to the inner shaft 200, the relative lengths of the everted portion 2900 and the non-everted portion 2902 can be changed by applying a force to the expandable cylindrical portion 208, for example, when the thrombus extraction device 202 retracts through the thrombus, the force is applied to the expandable cylindrical portion 208 through the portion of the thrombus.

[0212] Although Figure 31 The example depicts an expandable cylindrical portion 208 connected to the inner shaft 200, but the expandable cylindrical portion 208 may be coupled and / or connected to a distal end 218 of one of the following: a second intermediate shaft 3000; a third intermediate shaft 3002; and the inner shaft 200. In some examples, the expandable cylindrical portion 208 may be coupled and / or connected to a distal end 218 of one of the following: a second intermediate shaft 3000; a third intermediate shaft 3002; and the inner shaft 200, with the inner shaft 200 positioned between the proximal and distal ends 218 of one of the second intermediate shaft 3000, the third intermediate shaft 3002, and the inner shaft 200.

[0213] Now for reference Figure 32 and 33 An example of TED 202 is shown, where the relative dimensions and / or lengths of the everted portion 2900 and the non-everted portion 2902 differ. Therefore, Figure 32The relative length of the valgus portion 2900 to the non-valgus portion 2902 is greater than Figure 33 The relative length in the text. For example... Figure 32 and 33 As shown, with Figure 32 compared to, Figure 33 The relative length and / or dimensions of the outward-folding portion 2900 relative to the non-outward-folding portion 2902 are changed by the relative position of the inner shaft 200 relative to the first intermediate shaft 140 as the inner shaft 200 advances distally relative to the first intermediate shaft 140, thereby Figure 33 The inner axis 200 extends distally from the first intermediate axis 140.

[0214] like Figure 33 As further shown, the length of the flared portion 2900 extends from the furthest turning point between the flared portion 2900 and the non-flared portion 2902, to the furthest end 217 of the expandable cylindrical portion 208, which may include, for example, a coupling member 3100. Figure 32 In the example, although the distal end 217 is within the first intermediate axis 140 and is therefore not visible, the everted portion 2900 still extends to the distal end 217 of the expandable cylindrical portion. As further shown, the everted portion 2900 extends from the furthest inflection point between the everted portion 2900 and the non-everted portion 2902 to the proximal end 216 of the expandable cylindrical portion 208.

[0215] Now for reference Figures 34-A to 34-D An example of a method for influencing the relative lengths of the everted portion 2900 and the non-everted portion 2902 of a thrombus extraction device in a blood vessel 2202 is depicted. In some examples, Figures 34-A to 34-D The method can be used as Figures 23-A to 23-H The method shown is implemented in part or in lieu of the method, particularly replacing steps 23-G and 23-H. In some examples, Figures 34-A to 34-D The method can be used as Figure 24-A and 24-B or Figures 25-A to 25-H It is part of or substitutes for the implementation of a method. In some examples, such as Figures 34-A to 34-D The method can advantageously eliminate the need for execution. Figure 24-A and 24-B The necessity of this method stems from the fact that the expandable cylindrical portion 208 of the thrombus extraction device 202 can be controlled to limit the extension of the thrombus extraction device 202 beyond the thrombus 2200. When the thrombus 2200 forms near a feature 3400, such as a valve 3400, Figures 34-A to 34-D This benefit of the method is particularly advantageous.

[0216] The thrombus extraction system 100, in whole or in part, can be used to perform methods for influencing the relative lengths of the everted portion 2900 and the non-everted portion 2902 in the vessel 2202. In some examples, the methods for influencing the relative lengths of the everted portion 2900 and the non-everted portion 2902 in the vessel 2202 can be combined with monitoring techniques, such as fluorescence examination, angiography, and / or ultrasound monitoring. In some examples, the monitoring techniques can monitor the deployment of the thrombus extraction device 202 in the vessel by observing one or more radiopaque markers located on the guide sheath 102 and / or the thrombus extraction catheter 104.

[0217] This method begins Figure 34-A The thrombus 2200 is identified in a vessel 2202, such as a vein. In some examples, the thrombus 2200 may be located in the peripheral vascular system of a patient's body. The thrombus 2200 may include a proximal end 2204 and a distal end 2206. In some examples, the identification of the vessel 2202 may further include determining whether the thrombus 2200 in the vessel 2202 is suitable for thrombus extraction. In some examples, the thrombus 2200 in the vessel 2202 may be suitable for extraction when the vessel 2202 has a diameter of at least 3 mm. In some example cases, the thrombus 2200 in the vessel 2202 may be suitable for extraction when the vessel 2202 has a diameter of at least 3 mm and is at least one of the femoral vein, iliac vein, posterior genicular vein, posterior tibial vein, anterior tibial vein, or peroneal vein. In some examples, and as part of the identification of the thrombus 2200, a feature 3400 may be identified, which may be located distal to the distal end 2206 of the thrombus 2200.

[0218] After the thrombus 2200 has been identified, a guidewire 3402 can be inserted through the vessel 2202 and through the thrombus 2200, and in some examples, through feature 3400. In some examples, the guidewire 3402 can be inserted into the vessel through an entry site such as the internal jugular vein (IJ), femoral entry site, posterior patellar fossa entry site, or other venous or arterial entry sites. In some examples, the guidewire 3402 can be inserted using one or more imaging and / or monitoring techniques, including, for example, fluorescein imaging, angiography, and / or ultrasound monitoring.

[0219] After the thrombus 2200 has been identified, a portion of the thrombus extraction catheter 104 (e.g., outer shaft 138) can be inserted into the blood vessel 2202, such as... Figure 34-BAs shown. In some examples, the thrombus extraction catheter 104, including the thrombus extraction device, can be inserted into a blood vessel via an entry site such as the internal jugular vein (IJ), femoral entry site, posterior patellar fossa entry site, or other venous or arterial entry site. In some examples, the thrombus extraction catheter 104, including the thrombus extraction device, can be inserted into the posterior patellar fossa entry site and advanced distally toward the patient's foot. In some examples, the thrombus extraction device housed within the thrombus extraction catheter 104 may include an eversion portion and a non-eversion portion.

[0220] In some examples, the insertion of the thrombus extraction catheter 104 (e.g., outer shaft 138) may be inserted into the blood vessel 2202, and may include performing the procedures described above regarding... Figures 23-B to 23-D The steps discussed. In some examples, inserting a portion of the thrombus extraction catheter 104 into the blood vessel 2202 may include providing the thrombus extraction catheter 104 including the thrombus extraction device 202. In some examples, the thrombus extraction device 202 may be confined within an outer shaft and may be inserted into the blood vessel 2202 via a sealing hole 112, together with the outer shaft 138, into the lumen of the elongated member 106. In some such examples, the outer shaft 138 of the thrombus extraction catheter 104 may have a diameter to expand the seal of the sealing hole 112, such that the sealing hole 112 seals the surrounding area and seals to the outer shaft 138.

[0221] After a portion of the thrombus extraction catheter 104 has been inserted into the blood vessel 2202, a portion of the thrombus extraction catheter 104 can be advanced distally through the clot 2200, such as... Figure 34-B As shown. In some examples, the distal advancement through clot 2200 may be in the same or opposite direction to the blood flow. In some examples, the portion of the thrombus extraction catheter 104 distally passing through clot 2000 may include and / or restrict the thrombus extraction device 202. In some examples, the distal advancement of the thrombus extraction catheter 104 through the clot may include advancing a portion of the thrombus extraction catheter 104 until the tip 220 reaches a desired location near and / or close to feature 3400. In some examples, the distal advancement of the thrombus extraction catheter 104 through the clot may include advancing a portion of the thrombus extraction catheter 104 until the tip 220 reaches a desired location distal to feature 3400.

[0222] In some examples, the desired location may be between feature 3400 and the distal end 2206 of thrombus 2200. In some examples, the desired location may be sufficiently remote from the distal end 2206 of thrombus to allow deployment of thrombus retrieval device 202, particularly deployment of self-expanding core element 206 between the distal end 2206 of thrombus 2200 and feature 3400. In some examples, the desired location may be sufficiently remote from the distal end 2206 of thrombus to allow deployment of thrombus retrieval device 202, particularly deployment of self-expanding core element 206 between the distal end 2206 of thrombus 2200 and feature 3400, without allowing all or part of tip 220 or all or part of thrombus retrieval device 202 to extend through feature 3400. In some examples, this positioning that does not extend through feature 3400 protects the valve from potential damage caused by insertion or retraction of all or part of tip 220 or thrombus retrieval device 202.

[0223] In some examples, fluorescence monitoring can be performed on a portion of the thrombus extraction catheter 104 inserted into a blood vessel 2202 based on one or more radiopaque markers, for example, located in a portion of the thrombus extraction catheter 104, including, for example, radiopaque marker 222, and the radiopaque markers are located at one or both of the distal ends 204 of the outer sheath 138 and the distal ends 212 of the intermediate sheath 140, such as radiopaque marker 2450.

[0224] After the portion of the thrombus extraction catheter 104 is advanced distally to the desired position, it can be as follows: Figure 34-C The thrombus extraction device 202 is shown to be deployed. In some examples, the thrombus extraction device 202 can be deployed by advancing the thrombus extraction device 202 beyond the distal end 204 of the outer shaft 138 or by retracting the thrombus extraction device 202 relative to the outer shaft 138 until the thrombus extraction device 202 extends beyond the distal end 204 of the outer shaft 138. In some specific examples, the position of the tip 220 can be fixed and / or pinned to a desired position, and the thrombus extraction device 202 can be deployed by retracting the outer shaft 138 relative to the proximal end of the thrombus extraction device 202, said proximal retraction proceeding to any portion of the self-expanding core element 206 and the expandable cylindrical portion 208 extending distally from the self-expanding core element 206 beyond the distal end 204 of the outer shaft 138. In some examples, the thrombus extraction device can be deployed such that the self-expanding core element 206 extends distally past the thrombus 2200 and / or distally past a desired portion of the thrombus 2200.

[0225] In some examples, the thrombus extraction device 202 deploys when the locking feature 146 contacts the matching feature 148. In this example, the locking feature 146 may be matched and / or fixed to the matching feature 148 to fix the relative position of the intermediate axis 140 with respect to the outer axis 138.

[0226] In some examples, the deployment of the thrombus extraction device 202 can be monitored. Specifically, the deployment of the thrombus extraction device 202 can be monitored by fluorescence detection, for example, by the removal of the radiopaque marker 222 and the radiopaque marker located at the distal end 204 of the outer sheath 138 and the distal end 212 of the intermediate sheath 140, or both. In some examples, the deployment of the thrombus extraction device 202, particularly the advancement 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 stopped based on the position of the distal end 204 of the outer sheath 138, including the radiopaque marker (first radiopaque marker), relative to the radiopaque marker 222 (second radiopaque marker) located on the thrombus extraction device 202.

[0227] After the thrombus extraction device 202 is deployed, or as part of such deployment, the thrombus extraction device 202 can be fully expanded. In some examples, this may include allowing the self-expanding core retrieval element 206 to fully expand such that the self-expanding core retrieval element 206 engages with the wall 2220 of the blood vessel 2202. In some examples, the thrombus extraction device 202, specifically the self-expanding core retrieval element 206, can be fully expanded by engaging the locking mechanism 701, and in some examples, the relative position of the stop 702 with respect to the annular feature 700 is secured by moving the plunger 154 from a first position to a second position and securing the plunger 154 in the second position. In some examples, the movement of the plunger 154 from the first position to the second position causes the stop 702 to retract proximally relative to the annular feature 700, thereby fully deploying the self-expanding core retrieval portion 700 of the thrombus extraction device 202. The proximal retraction of the plunger 154 relative to the intermediate shaft 140 further engages the stop 702 with the annular feature 700, thereby fully deploying the self-expanding core extractor 206. In some examples, securing the plunger 154 in a second position can be achieved by engaging the stop 702 with the annular feature 700 to secure the self-expanding core extractor 206 and the thrombus extraction device 202 to full expansion.

[0228] After the thrombus extraction device 202 is deployed, the thrombus extraction device 202 can be fully expanded, such as... Figure 23-HAs shown. In some examples, this may include allowing the thrombus extraction device 202 to fully expand, such that the thrombus extraction device 202 engages with the wall 2220 of the blood vessel 2202. In some examples, the thrombus extraction device 202 can be fully expanded by fixing the relative position of the inner shaft 200 with respect to the intermediate shaft 140 by moving the plunger 154 from a first position to a second position and fixing the plunger 154 in the second position. In some examples, 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 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 can further engage the stop 702 with the annular feature 700 to fully expand the self-expanding core extractor 206. In some examples, the plunger 154 is secured in the second position by the engagement of the stop 702 with the annular feature 700, thereby securing the self-expanding core extractor 206 and the thrombus extraction device 202 in the fully expanded state.

[0229] After the thrombus extraction device 202 has been deployed, the thrombus can be removed by capturing the thrombus within the thrombus extraction device 202. This is achieved by the proximal retraction of the thrombus extraction device 202 through the thrombus 2200. Figure 34-D As shown, the proximal retraction can be, for example, in the direction of blood flow through vessel 2202 or in the opposite direction of blood flow through vessel 2202. In some examples, the thrombus extraction device 202 passing through the proximal retraction of the thrombus 2200 can result in the distal end 2206 of the thrombus 2200 being captured before the proximal end 2204 of the thrombus 2200 is captured.

[0230] In some examples, proximal retraction of the thrombus extraction device 202 can cause at least a portion of the thrombus 2200 to detach from and / or be cored from the wall 2220 of the vessel 2202, for example by means of the self-expanding core retrieval element 206 and / or the stent portion, and the capture of the detached portion of the thrombus 2200 within the expandable cylindrical portion 208. In some examples, the expandable cylindrical portion 208 may be formed of a woven mesh structure, such as a mesh-like filament structure. In some examples, a portion of the thrombus can be captured within the expandable cylindrical portion 208 by accessing the expandable cylindrical portion 208 via the opening 414 of the self-expanding core retrieval element 206 and / or via one or more gaps 404 of the self-expanding core retrieval element 206.

[0231] The distal end 2206 of the thrombus 2200 is separated from and / or cored from the wall 2220 of the vessel 2202 by the self-expanding core retrieval element 206 via the proximal retraction of the thrombus retrieval device 202, and the thrombus 2200 is captured within the expandable cylindrical portion 208 of the thrombus retrieval device 202 by the thrombus retrieval device through the continuous proximal retraction of the thrombus 2200. In some examples, the everted portion 2900 of the expandable cylindrical portion 208 may be advanced distally relative to and through the self-expanding core retrieval element 206 and / or through the non-everted portion 2902 of the expandable cylindrical portion 208, which is associated with the proximal retraction of the thrombus retrieval device 202 to elongate the non-everted portion 2902 to allow the thrombus 2200 to be captured within the expandable cylindrical portion 208, particularly within the non-everted portion 2902 of the expandable cylindrical portion 208. In some examples, the distal end 217 of the expandable cylindrical portion 208 is slidably coupled to one of: a second intermediate shaft 3000; a third intermediate shaft 3002; and an inner shaft 200. When the thrombus extraction device 202 retracts proximally, the relatively distal advancement of the everted portion 2900 of the expandable cylindrical portion 208 can be achieved by applying a force to the expandable cylindrical portion 208. In some examples, these forces can overcome friction and thus allow the coupling 3100 to move distally relative to one of: the second intermediate shaft 3000; the third intermediate shaft 3002; and the inner shaft 200 coupled to the coupling 3100.

[0232] In some examples, the distal advancement of the outwardly flared portion 2900 of the expandable cylindrical portion 208 relative to the self-expanding core element 206 can be achieved by advancing the relatively distal end of one of the following relative to the first intermediate shaft 140: a second intermediate shaft 3000; a third intermediate shaft 3002; and an inner shaft 200. In some examples, the distal end 217 of the expandable cylindrical portion 208 is fixedly coupled to one of the following: the second intermediate shaft 3000; the third intermediate shaft 3002; and the inner shaft 200. The relatively distal advancement can be achieved by proximal retraction of the first intermediate shaft 140 and fixation and / or pinning in one of the following positions: the second intermediate shaft 3000; the third intermediate shaft 3002; and the inner shaft 200. Figure 34-D In the example, the distal end 217 of the expandable cylindrical portion 208 is coupled to a second intermediate axis 3000, the second intermediate axis 3000 being pinned relative to the blood vessel 2202, the thrombus 2200 and / or feature 3400, and the first intermediate axis 140 being retracted proximally relative to the second intermediate axis 3000 to increase the length of the non-eversion portion 2902.

[0233] In some examples, the length of the non-elapped portion 2902 of the expandable cylindrical portion 208 can be increased until the thrombus 2202 and / or a portion of the thrombus 2202 is completely captured by the thrombus extraction device 202, specifically captured within the expandable cylindrical portion 208, or until the length of the non-elapped portion 2902 no longer increases. In some examples, the thrombus 2202 can then be removed from the patient's body, such as... Figures 25-E to 25-H As shown.

[0234] For reference Figure 35 A schematic diagram illustrating an example of a funnel catheter 3500 is shown. The funnel catheter 3500 may be part of a thrombus extraction system 100. The funnel catheter 3500 includes an elongated funnel member 3502, also referred to herein as an elongated funnel sheath 3502 or elongated sheath 3502, having a proximal end 3504 and a distal end 3506. The elongated funnel member 3502 may be elastic and / or flexible. The elongated funnel member 3502 may include any desired length and any desired diameter. In some examples, the elongated funnel member 3502 may have a 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.

[0235] The elongated funnel member 3502 may include a radiopaque marker, which may be, for example, part of the distal end 110 of the elongated funnel member 3502. The elongated funnel member 3502 defines an inner lumen extending between a proximal end 3504 and a distal end 3506. The size of the inner lumen of the elongated funnel member 3502 may be configured to slidably receive the thrombus extraction catheter 104. In some examples, the inner lumen 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 to 12 French, 10 to 22 French, 14 to 21 French, 16 to 20 French, and / or any other or intermediate size. The inner cavity may terminate at a sealing bore 3508, also referred to herein as a sealing hub 3508, located at the proximal end 3504 of the elongated funnel member 3502. In some examples, the sealing bore 3508 may be self-sealing and / or may include a self-sealing seal.

[0236] The elongated funnel member 3502 may also include a suction port 3510, which may be located at the proximal end 3504 of the elongated funnel member 3502 and / or connected to the proximal end 3504 of the elongated funnel member 3502 via, for example, a connecting tube 3512. In some examples, the suction port 3510 may be part of and / or connected to a sealing hub 3508. In some examples, the suction port 3510 may be selectively fluidly connected to the inner cavity via, for example, a valve 3514 (also referred to herein as a suction valve 3514), which may be a tube clamp located along the connecting tube 3512 between the inner cavity and the suction port 3510.

[0237] The elongated funnel member 3502 may further retain the expander assembly 3516. The expander assembly 3516 may be configured to retain a self-expanding funnel 1708, which may be confined to and attached to the distal end 3506 of the elongated funnel member 3502, and to release the self-expanding funnel 1708 from that confined configuration. The expander assembly 3516, as... Figure 36 As shown, it may include a proximal end 3518 and a distal end 3520. The dilator assembly 3516 may also include an occluder 3522 having a proximal end 3524, a distal end 3526, and an elongated shaft 3528 extending therebetween. In some examples, the length of the dilator assembly 3526 may be greater than the length of the elongated funnel member 3502, and in some examples, the length of the elongated shaft 3528 may be greater than the length of the elongated member 3502 of the funnel conduit 3500. The occluder 3522 may further define an inner lumen extending through the occluder 3522 for receiving a guidewire. In some examples, the guidewire may include any desired size, and in some examples, may have a diameter of about 0.035 inches, about 0.018 inches, less than about 0.1 inches, and / or less than about 0.05 inches. The size and shape of the dilator assembly 3516 may be designed to slidably move through the inner lumen of the elongated member 3502.

[0238] The occluder 3522 may include a trapping sheath 1500 extending proximally from a distal end 3526 of the occluder 3522, and a tip, such as a non-damaging tip 1502, located at the distal end 3526 of the occluder 3522. The non-damaging tip 1502 may be radiopaque. The occluder 120 may also include a connecting fitting 1504 located at a proximal end 1506 of the trapping sheath 1500. In some examples, the connecting fitting 1504 may be configured to sealably connect to the distal end 3506 of the elongated funnel member 3502 of the funnel conduit 3500.

[0239] The occluder 3522 may also include a stop portion 1508 located at the proximal end 3524 of the occluder 3522. In some examples, the diameter of the stop portion 1508 may be larger than the inner cavity of the elongated funnel member 3502 of the funnel guide 3500 and / or larger than the diameter of the sealing hole 3508 to prevent the stop portion 1508 from entering the inner cavity of the elongated funnel member 3502 and / or the sealing hole 3508.

[0240] The expander assembly 3516 may further include a propulsion sheath 3530, also referred to herein as a movable sheath 3530, which in some examples extends along a portion of an elongated shaft 3528 of the occluder 3522 between, for example, a proximal end 3524 and a distal end 3526 of the occluder 3522, specifically between a stop portion 1508 and a proximal end 1506 of the trapping sheath 1500. The propulsion sheath 3530 may include a proximal end 3532, a distal end 3534, and a tubular shaft 3536 extending between the proximal end 3532 and the distal end 3534 of the propulsion sheath 3530. The tubular shaft 3536 may define an inner lumen sized to receive the occluder 3522, such that the propulsion shaft 3530 can be extended along the occluder 3533 from... Figure 36 The loading position shown has been moved to Figure 37 The retracted position is shown. In some examples, the propulsion sheath 3530 in the loaded position is closer to the occluder 3522 than the propulsion sheath 3530 in the retracted position.

[0241] The propulsion sheath 3530 also includes a stop 3538 located at its proximal end 3532. The stop 3538 may interact with one or more features of the occluder 3522 to secure the propulsion sheath 3530 to the occluder 3522 and fix the relative position of the propulsion sheath 3530 to the occluder 3522. In some examples, the stop 3538 may cooperate with a locking member 3540, which may, for example, be connected to a stop portion 1508 of the occluder 3522.

[0242] The propulsion sheath 3530 may further include a mating feature 3542, which may be located, for example, at the distal end 3534 of the propulsion sheath 3530. The size, shape, and configuration of the mating feature 3542 may be designed to mate with the proximal end 1506 of the trapping sheath 1500, specifically with the connecting fitting 1504 of the trapping sheath 1500. In some examples, the mating feature 3542 may be configured to be hermetically connected to the connecting fitting 1504 of the trapping sheath. In some examples, the outer diameter of the propulsion sheath 3530 may be equal to or approximately equal to the outer diameter of the trapping sheath 1500.

[0243] refer to Figures 38-A to 38-DA method for deploying a self-expanding funnel 1708 is illustrated. The method may include providing an expander assembly 3516 and a funnel conduit 3500, with the funnel 1708 secured to a distal end 3506 of the funnel conduit 3500. Figure 38-A The image shows a funnel conduit 3500 including an elongated funnel member 3502. An expander assembly 3516 includes a stopper 3522 in a loaded position and an advance sheath 3530, such that a stopper 3538 of the advance sheath 3530 engages with and / or cooperates with a locking member 3540 of the stopper 3522. Figure 38-A As shown, the funnel 1708 is contained within a trapping sheath 1500 in a confined configuration. When performed in a patient, the funnel catheter 3500 can be used, for example, percutaneously to enter a patient's vein from an entry site, which may be, for example, a posterior patellar entry site, a femoral entry site, or an internal jugular vein entry site. In some examples, the funnel catheter may be percutaneously entered into the vein via a guide sheath 102 inserted into the vein at the entry site. In some examples, percutaneous entry into the vein via the guide sheath may include inserting the funnel catheter 3500 into the vein through the guide sheath. The distal end 3506 of the funnel catheter 3500 may be advanced within the vein to a location near the thrombus, and in some examples, the distal end 3506 of the funnel catheter 3500 may be advanced within the vein to a location proximal to the thrombus.

[0244] exist Figure 38-B In this configuration, the self-expanding funnel 1708 unfolds from a confined configuration with a trapping sheath 1500 to an expanded configuration without the trapping sheath 1500. This may include distally advancing the trapping sheath 1500 relative to the funnel conduit 3500 to disengage the self-expanding funnel 1708 from the confined configuration to an unconfined configuration. In some examples, distally advancing the trapping sheath 1500 may include distally advancing the dilator assembly 3516 relative to the funnel conduit 3500. In some examples, unfolding the self-expanding funnel 1708 may include proximally retracting the elongated sheath 3502 and / or retracting the dilator assembly 3516 on the occluder 3522 to disengage the self-expanding funnel 1708 from the confined configuration to the expanded configuration.

[0245] After unfolding the self-expanding funnel 1708, as Figure 38-CAs shown, the propulsion shaft 3530 is movable from the loaded position to the retracted position. In some examples, this movement of the propulsion shaft 3530 can occur by the proximal retraction of the occluder 3522 relative to the propulsion shaft 3530, and in some examples, this displacement of the propulsion shaft 3530 can occur by the distal advancement of the propulsion shaft 3530 relative to the occluder 3522. In some examples, the propulsion shaft can be moved from the loaded position to the retracted position such that the mating feature 3542 mates with the proximal end 1506 of the trapping sheath 1500, specifically with the connecting fitting 1504 of the trapping sheath 1500. In some examples, the positioning of the propulsion sheath 3530 in the retracted position prevents damage caused by the trapping sheath 1500 or other components of the occluder 3522 during the retraction of the occluder 3522 from the funnel conduit 3500. Specifically, the positioning of the propulsion sheath 3530 in the retracted position provides a constant diameter for a portion of the expander assembly 3516, which retracts through the sealing hub 3508.

[0246] After moving the propulsion shaft 3530 to the retracted position, as Figure 38-D As shown, the dilator assembly 3516 is retractable from the funnel conduit 3500. In some examples, the dilator assembly 3516 may retract proximally through the lumen of the funnel conduit 3500 and retract to the outside of the sealing hub 3508 of the funnel conduit 3500. In some examples where the funnel conduit 3500 is used to access a venous vessel, the thrombus extraction catheter 104, which restricts the TED 202, may be inserted into the venous vessel through the lumen of the elongated sheath 3502 of the funnel conduit 3500. In some examples, the thrombus extraction catheter 104 may be inserted into the venous vessel and advanced through the venous vessel until the distal tip 132 of the thrombus extraction catheter 104 approaches the thrombus, and in some examples, advanced until the distal tip 132 of the thrombus extraction catheter 104 passes distally past the thrombus or a portion of the thrombus. The TED 202 may then be unfolded and retracted proximally relative to the funnel conduit 3500 to dissect the thrombus from the venous vessel wall and trap the thrombus within the TED 202. TED 202 can be retracted proximally relative to the funnel catheter 3500 until the opening 414 of the thrombus extraction device 202 is located within the self-expanding funnel 1708. The thrombus extraction device 202 can then be retracted through the funnel catheter 3500, or in some examples, the thrombus extraction device 202 can be held so that the opening 414 of TED 202 remains in the funnel 1708 when both TED 202 and the funnel catheter 3500 are simultaneously retrieved from the patient through the inserter sheath. In some examples, the thrombus can be captured within the self-expanding funnel 1708, and the thrombus can be aspirated from the patient through the funnel catheter 3500, specifically through the lumen of the funnel catheter 3500, the connecting tube 3512, and the aspiration port 3510.

[0247] For reference Figure 39A top view of an example of the thrombus extraction device 202 is shown. Specifically, Figure 39 This is a top view of an example of a thrombus extraction device 202, wherein the expandable cylindrical portion 208 is in at least a partially stacked configuration. A self-expanding core retrieval element 206 is connected via a connecting member 415 at its proximal end 210 to the distal end 212 of the core retrieval element shaft 140. Figure 39 As shown, the core element shaft 140 may include a radiopaque marker 2450 extending from the distal end 204 of the outer shaft 138.

[0248] The proximal end 216 of the expandable cylindrical portion 208 is connected to the distal end 214 of the self-expanding core retrieval element 206. In some examples, the expandable cylindrical portion 208, and more specifically, the proximal end 216 of the expandable cylindrical portion 208, is formed and / or woven onto the distal end 214 of the self-expanding core retrieval element 206, thereby forming a single thrombus retrieval device 202, also referred to herein as an interwoven thrombus retrieval device 202. The distal end 217 of the expandable cylindrical portion 208 is connected to the distal end 218 of the tip shaft 200.

[0249] In some examples, such as Figure 39 As shown, the self-expanding core element 206 may engage with all or part of the stop shaft 3000 to influence the expansion of the self-expanding core element 206. Specifically, in some examples, the self-expanding core element 206 may include one or more features that may collectively form an expansion mechanism 701, which may include a ring 700 and a stop 702. In some examples, the ring 700 may be made of the same material as the self-expanding core element 206, or it may be made of a different material. The ring 700 may be integrally formed with the self-expanding core element 206 and / or may be attached to the self-expanding core element by one or more fluxes, adhesives, one or more mechanical fasteners, etc. The diameter of ring 700 may be larger than the diameter of stop shaft 3000, so that ring 700 can slide along stop shaft 3000. Alternatively, in some examples, the diameter of ring 700 may be smaller than the diameter of stop shaft 3000, so that ring 700 is connected to stop shaft 3000 by an interference fit that fixes and / or partially fixes the position of ring 700 relative to stop shaft 3000.

[0250] The stop 702 may include various shapes and sizes and may be made of a variety of materials. In some examples, the stop 702 may include a polymeric member and / or a metal member fixed to a portion of the stop shaft 3000. In some examples, the stop 702 may have the form of a tab, protrusion, flange, ridge, etc. In some examples, the size and shape of the stop 702 may be designed to mate with the ring 700, thereby applying a proximal force to the self-expanding core element 206 when the stop shaft 3000 moves proximally relative to the self-expanding core element 206. In some examples, the stop shaft 3000 may be moved by, for example, the plunger 154 moving to a second position and / or the shuttle moving to a second position. In some examples, the shuttle may be attached to a spring, for example, a constant force spring, which may cause this displacement of the shuttle. In some examples, at least a portion of the self-expanding core retrieval element 206 located between the ring 700 and the connecting member 415 can be forcibly expanded by applying a proximal force to the ring 700, thereby moving the self-expanding core retrieval assembly 206 to full expansion. In other examples, the engagement of the ring 700 and the stop 702 connects the thrombus extraction device 202 to a spring, thereby causing the TED 202 to fully expand. In yet another example, the expansion mechanism 701 does not include the ring 700, and the stop 702 is not connected to the stop shaft 3000; instead, the expansion mechanism 701 comprises a wire or filament, which may be, for example, a metal or polymer material. The wire or filament wraps around and passes through the self-expanding core retrieval element 206 and can be attached, for example, by securing it to the stop shaft 3000. In some examples, for example, the terminating end of the filament can be secured to the stop shaft 3000 by compressing or stretching a spring that causes a slight reduction in the diameter of the self-expanding core retrieval element 206 without disengaging it from the stop 702. In some examples, the filaments or strands are made of an elastic material to include the function of a compression or tension spring.

[0251] The expandable cylindrical portion 208 may include a braided mesh structure 704, which can be configured to trap thrombi. In some examples, the braided mesh structure may extend together with the expandable cylindrical portion 208, thus sharing a proximal end 216 and / or a distal end 217. Figure 7 In the example shown, the woven mesh structure 704 may be an elastic filament braid having a generally tubular elongated portion 706 and a distally tapered portion 708. In an example where the expandable cylindrical portions 208 are at least partially stacked, the expandable cylindrical portions 208 may also include a proximal tapered portion 710. In other examples, the woven mesh structure 704 may be any porous structure and / or may have other suitable shapes, sizes, and constructions (e.g., the distal portion 708 may be generally cylindrical, etc.).

[0252] In some examples, the tip shaft 200 may be movable relative to the core element shaft 140, thereby changing the length of the expandable cylindrical portion 208. In some examples, as described above, the change in the length of the expandable cylindrical portion 208 may cause the expandable cylindrical portion 208 to move between two or more of the following: a stacked configuration; an expanding configuration; and a contracting configuration. In some examples, the configurational change of the expandable cylindrical portion 208 may cause a change in the diameter of the expandable cylindrical portion 208. Specifically, in some examples, the expandable cylindrical portion 208 may have a diameter under a stacked configuration that is larger than the diameter of the self-expanding core element 206. In some examples, the diameter of the expandable cylindrical portion 208 may be 1 mm to 20 mm larger than the diameter of the self-expanding core element 206, or 2 mm to 10 mm larger than the diameter of the self-expanding core element 206, and / or 2 mm to 6 mm larger than the diameter of the self-expanding core element 206.

[0253] For reference Figure 40 A cross-sectional view of an example handle 134 is shown. Handle 134 includes a distal end 142 and a proximal end 144. A core element shaft 140 is connected to the distal end 142 of handle 134 and extends distally away from handle 134. A locking feature 146 is located at the distal end 142 of handle 134. Locking feature 146 may be configured to engage with a component and / or portion of an outer shaft 138 to secure the outer shaft 138 to handle 134. In some examples, the outer shaft 138 may slide proximally on the core element shaft 140 and be secured to the handle by the locking feature to deploy and / or partially deploy the thrombus extraction device 202. The handle may also include a second flushing port 156. The second flushing port 156 may be fluidly connected to an internal portion of handle 134, thereby connecting to the interior of the core element shaft 140 to allow flushing of the interior of the core element shaft 140.

[0254] The handle 134 may include a housing 1200 defining an internal volume 1202. For example... Figure 40 As shown, the stop shaft 3000 extends through the inner cavity of the core retrieval element shaft 140 into the inner volume 1202 of the handle 134 and is connected to and / or coupled to the shuttle 4000, which slides along a track 4002 within the housing 1200 of the handle 134. The shuttle 4000 can move between a first position relatively closer to the distal end 142 of the handle 134 and a second position relatively closer to the proximal end 144 of the handle 134. In some examples, the shuttle 4000 may be in the first position when the self-expanding core retrieval element 206 is in an unexpanded configuration, and in the second position when the self-expanding core retrieval element 206 is fully expanded. In some examples, movement of the shuttle 4000 from the first position to the second position can move the thrombus extraction device 202, and in particular the self-expanding core retrieval element 206, into an expanded state, which can be fully expanded.

[0255] The shuttle 4000 may be connected to and / or coupled to a force-generating component, such as a spring 4004. The spring 4004 may include, for example, a compression spring, a tension spring, a torsion spring, or a constant-force spring such as a watch spring. In some examples, the spring 4004 may apply a force to the shuttle 400 to bias the thrombus extraction device 202, particularly the self-expanding core element 206, into an expanded state; more specifically, to hold the thrombus extraction device 202, and more specifically, to hold the self-expanding core element 206, in a fully expanded state.

[0256] like Figure 40 As shown, the tip shaft 200 may extend into and / or through the handle 134. In some examples, for instance, the tip shaft 200 and / or features such as a plunger connected to the tip shaft 200 may extend through the handle 134. In some examples, the features of the tip shaft 200 and / or the tip shaft 200 connected through the handle 134 may allow control of the position of the tip shaft 200 relative to one or more other shafts 138, 140, 3000, 3002 and / or relative to the handle 134 or the self-expanding core element 206. In some examples, this control of the relative position of the tip shaft 200 also controls the expandable cylindrical portion 208, specifically the braided mesh structure 704. In some examples, this control may enable the expandable cylindrical portion 208 to move, specifically controlling the braided mesh structure 704 to contract, expand, and stack.

[0257] Due to the connection between the braided mesh structure 704 and the distal end 218 of the tip shaft 200, the axial movement of the tip shaft 200 radially expands / shortens or contracts / lengthens the braided mesh structure 704 of the TED 200. For example, provided that the core element shaft 140 is fixed and / or restricted to axial movement at a rate less than that of the tip shaft 200: (1) the distal movement of the tip shaft 200 causes the braided mesh structure 704 to extend along its longitudinal axis, thereby reducing the radius of the braided mesh structure 704 and increasing its length; (2) the proximal movement of the tip shaft 200 causes the braided mesh structure 704 to compress along its longitudinal axis, thereby increasing the radius of the braided mesh structure 704 and decreasing its length. The mesh structure 704 can be positioned in a variety of configurations, including, for example, stacked configurations, contracted configurations, and expanded configurations. The length of the mesh structure 704 in the stacked configuration may be shorter than the length of the mesh structure 704 in the expanded configuration, and the length of the mesh structure 704 in the expanded configuration may be shorter than the length of the mesh structure 704 in the contracted configuration. In some examples, the woven mesh structure 704 may have any desired length in the contracted configuration, including, for example, lengths of about 1 to 80 inches, 2 to 60 inches, 3 to 50 inches, about 5 to 30 inches, about 10 to 20 inches, and / or about 16 inches in the contracted configuration, and in some examples, the woven mesh structure 704 may have lengths of about 1 to 25 inches, about 10 to 20 inches, and / or about 11 inches in the expanded configuration. In some examples, the mesh structure 704 may have any desired length in the stacked configuration, including, for example, lengths of 1 to 50 inches, 1 to 30 inches, 1 to 20 inches, 1 to 15 inches, 2 to 10 inches, and / or about 5 inches.

[0258] In some examples, the braiding angle of the fine mesh structure 704 can vary with the construction. As the length of the fine mesh structure 704 increases, the braiding angle θ can decrease, and as the length of the fine mesh structure 704 decreases, the braiding angle θ can increase. In some examples, when the fine mesh structure 704 is in a contracted construction, the braiding angle θ of the fine mesh structure 704 can be less than about 10°, less than about 20°, less than about 30°, less than about 40°, and / or less than about 50°. In some examples, when the fine mesh structure 704 is in an expanded construction, the braiding angle of the fine mesh structure 704 can be 20° to 85°, 30° to 70°, 35° to 60°, 40° to 50°, and / or about 45°. In some examples, when the fine mesh structure 704 is in a stacked construction, the braiding angle of the fine mesh structure 704 can be greater than about 45°, greater than about 60°, greater than about 70°, and / or greater than about 80°.

[0259] For reference Figures 41-A to 41-FThe image shows a view illustrating an example of a method for expanding a stackable thrombus extraction device 202 within a blood vessel 2200. In some examples, Figures 41-A to 41-F The method can be used as Figures 23-A to 23-H This is implemented as a part of or in lieu of the method shown. In some examples, Figure 41-E and 41-F A portion of the method shown can be implemented at step 23, particularly at steps 23-G and 23-H. In some examples, Figures 41-A to 41-F The method can be used as Figure 24-A and 24-B or Figures 25-A to 25-H It is part of or substitutes for the implementation of a method. In some examples, such as Figures 41-A to 41-F The method can advantageously eliminate the implementation Figure 24-A and 24-B The necessity of this process stems from the fact that the expandable cylindrical portion 208 of the thrombus extraction device 202 can be controlled to limit the extension of the thrombus extraction device 202 beyond the thrombus 2200. When the thrombus 2200 forms near feature 3400, Figures 41-A to 41-F This benefit of the method is particularly advantageous.

[0260] The method for expanding the stackable thrombectomy device 202 in a vessel 2200 can be implemented using all or part of the thrombectomy system 100. In some examples, the method for expanding the stackable thrombectomy device 202 in a vessel 2200 can be implemented in conjunction with monitoring techniques such as fluorescence detection, angiography, and / or ultrasound monitoring. In some examples, monitoring techniques can be used to monitor the expansion of the thrombectomy device 202 in the vessel by observing one or more radiopaque markers located on the guide sheath 102 and / or the thrombectomy catheter 104.

[0261] This method begins Figure 41-A The thrombus 2200 is identified in a vessel 2202, such as a vein. In some examples, the thrombus 2200 may be located in the peripheral vascular system of a patient's body. The thrombus 2200 may include a proximal end 2204 and a distal end 2206. In some examples, the identification of the vessel 2202 may further include determining whether the thrombus 2200 in the vessel 2202 is suitable for thrombus extraction. In some examples, the thrombus 2200 in the vessel 2202 is suitable for extraction when the vessel 2202 has a diameter of at least 3 mm. In some examples, the thrombus 2200 in the vessel 2202 is suitable for extraction when the vessel 2202 has a diameter of at least 3 mm and is at least one of the femoral vein, iliac vein, posterior genicular vein, posterior tibial vein, anterior tibial vein, or peroneal vein. In some examples, as part of the identification of the thrombus 2200, a feature 3400 may be identified, which may be located distal to the distal end 2206 of the thrombus 2200.

[0262] After the thrombus 2200 has been identified, a guidewire 3402 can be inserted through the vessel 2202 and the thrombus 2200, and in some examples, the guidewire 3402 is inserted through the feature 3400. In some examples, the guidewire 3402 can be inserted as follows: Figure 34-A The guidewire 3402 is inserted through entry sites such as the internal jugular vein (IJ), femoral entry site, posterior genu entry site, or other venous or arterial entry sites. In some examples, one or more imaging and / or monitoring techniques may be used to insert the guidewire 3402, including, for example, fluorescence examination, angiography, and / or ultrasound monitoring.

[0263] After the bleeding thrombus has been identified, such as Figure 41-A As shown, the guide sheath 102 is advanced with or against the direction of blood flow in the vessel, thereby bringing the distal end 110 of the guide sheath 102 and / or the occluder 120 close to the thrombus 2200, particularly at a proximal location to the thrombus 2200. In some examples, this may include providing a guide sheath 102 that may include an expander shaft 4100 extending through the lumen of an elongated member 106 of the guide sheath 102. In some examples, the expander shaft 4100 may seal or partially seal the lumen of the elongated member 106 at the distal end 110 of the guide sheath 102. In some examples, insertion... Figure 41-A The guide sheath 102 can be used in conjunction with the funnel catheter 3500. In some examples, the guide sheath 102 used in conjunction with the funnel catheter 3500 may include a funnel 1708, and in some examples, the guide sheath 102 used in conjunction with the funnel catheter 3500 may not include a funnel 1708. The guide sheath can be percutaneously inserted into the patient's circulatory system, specifically the peripheral vascular system, including, for example, the patient's arteries and blood vessels or veins, through an entry site 2208, which may be one of the aforementioned entry sites.

[0264] After the guide sheath 102 has been advanced to the desired position, the self-expanding funnel 1708 can be deployed from the confined structure and / or withdrawn to the expansion structure, such as Figure 41-B As shown. In some examples, this may include inserting a funnel-shaped catheter 3500 into a vein via an access site for percutaneous access to the patient's vein. Figure 41-B In some examples, percutaneous access to a patient's vein using a funnel catheter 3500 may include inserting the funnel catheter 3500 into the vein through a guide sheath. The distal end 3506 of the funnel catheter 3500 may be advanced within the vein to a location near the thrombus, and in some examples, the distal end 3506 of the funnel catheter 3500 may be advanced within the vein to a location proximal to the thrombus. After the funnel catheter 3500 has reached the desired position, the funnel 1708 may be... Figures 38-A to 38-D It unfolds as described.

[0265] After the self-expanding funnel 1708 has unfolded, a portion of the thrombus extraction catheter 104 (e.g., the outer shaft 138) can be inserted into the lumen 1701 of the guide sheath 102 via the sealing hole 112. In some examples, this may include providing the thrombus extraction catheter 104, which includes a thrombus extraction device 202. In some examples, the thrombus extraction device 202 may be confined within the outer shaft 138 and may be inserted together with the outer shaft 138 into the lumen of the elongated member 106. In some examples, the outer shaft 138 of the thrombus extraction catheter 104 may have a diameter to expand the seal of the sealing hole 112, such that the sealing hole 112 seals around and to the outer shaft 138.

[0266] After the outer shaft 138 has been inserted into the lumen 1701 of the guide sheath 102, a portion of the thrombus extraction catheter 104 may be inserted into the blood vessel 2202 via the guide sheath 102. In some examples, the distal end 132 of the thrombus extraction catheter 104 may be advanced to a position close to and / or proximal to the thrombus 2200. In some examples, the insertion and / or advancement of the thrombus extraction catheter 104 may be monitored, specifically by fluorescence monitoring. In some examples, the location of one or more radiopaque markers may be monitored, including radiopaque marker 222 of the thrombus extraction catheter 104.

[0267] After a portion of the thrombus extraction catheter 104 has been inserted into the blood vessel 2202, a portion of the thrombus extraction catheter 104 can be advanced distally through the clot 2200, such as... Figure 41-C As shown. In some examples, this distal advancement through clot 2200 may be with or against the direction of blood flow. In some examples, distal advancement of a portion of the thrombus extraction catheter 104 through clot 2000 may accommodate and / or restrict the thrombus extraction device 202. In some examples, distal advancement of a portion of the thrombus extraction catheter 104 through the clot may include advancing a portion of the thrombus extraction catheter 104 until reaching a portion of the radiopaque marker 222 (which may be fluorescently detectable and may be located at the distal end 218 of the tip axis 200) distally through thrombus 2200 and / or a portion of thrombus 2200.

[0268] After a portion of the thrombus extraction catheter 104 is advanced distally through the clot 2200, the thrombus extraction device 202 can be partially deployed, such as... Figure 41-D As shown. In some examples, the thrombus extraction device 202 can be partially deployed by advancing a portion of the thrombus extraction device 202 beyond the distal end 204 of the outer axis 138 or by retracting the thrombus extraction device 202 relative to the outer axis 138 until a portion of the thrombus extraction device 202 extends beyond the distal end 204 of the outer axis 138. In some examples, the thrombus extraction device can be partially deployed such that a portion of the thrombus extraction device 202 extends distally past the thrombus 2200 and / or past a desired portion of the thrombus 2200.

[0269] In some examples, by advancing the core element shaft 140 distally relative to the outer shaft 138, a portion of the thrombus extraction device 202 is advanced beyond the distal end 204 of the outer shaft 138. In some examples, the core element shaft 140 may be advanced distally until the locking feature 146 contacts the mating feature 148, and the locking feature 146 may mate and / or fix to the mating feature 148 to fix the relative position of the core element shaft 140 relative to the outer shaft 138.

[0270] In some examples, partial deployment of the thrombus extraction device 202 can be monitored. Specifically, deployment of the thrombus extraction device 202 can be monitored by fluorescence detection, for example, by a radiopaque marker 222 and radiopaque markers (e.g., radiopaque marker 2450) located at one or both distal ends 204 of the outer sheath 138 and at the distal end 212 of the core extraction element sheath 140. In some examples, partial deployment of the thrombus extraction device 202, specifically the advancement of the thrombus extraction device 202 beyond the distal end 204 of the outer axis 138 or retraction of the thrombus extraction device 202 relative to the outer axis 138, can be stopped based on the position of the distal end 204 of the outer sheath 138, including the radiopaque marker (first radiopaque marker), relative to the radiopaque marker 222 (second radiopaque marker) on the thrombus extraction device 202.

[0271] In some examples, the core extraction element shaft 140 and / or tip shaft 200 can be manipulated to cause a desired portion of the thrombus extraction device 202, specifically the expandable cylindrical portion 208 of the thrombus extraction device 202, to extend beyond the outer shaft 138. In some examples, this can include any desired extension of the thrombus extraction device 202 beyond the outer shaft 138, including, for example, a distance of less than about 20 inches, less than about 16 inches, less than about 10 inches, less than about 5 inches, less than about 2 inches, or less than about 2 inches.

[0272] In some examples, the thrombus extraction device 202 may be partially deployed until the distal end 217 of the cylindrical portion 208 of the thrombus extraction device 202 reaches a desired location, such as a desired location relative to a feature 3400 of the blood vessel 2202 or relative to an anatomical structure (e.g., a valve). In some examples, the feature 3400 of the blood vessel may include, for example, a transition from one blood vessel to another at a branching point, a desired blood vessel diameter, etc. In some examples, the thrombus extraction device 202 may be deployed until the distal end 217 of the cylindrical portion 208 of the thrombus extraction device 202 reaches a desired point beyond the blood vessel branching point, such that the cylindrical portion 208 is fully or partially accommodated in a different blood vessel or a blood vessel with a diameter larger than the diameter of the remaining portion of the thrombus extraction device 202. In some examples, when the distal end 217 of the cylindrical portion 208 of the thrombus extraction device 202 reaches the desired position, the tip shaft 200 can be pinned and the position of the distal end 217 of the cylindrical portion 208 of the thrombus extraction device 202 can be maintained.

[0273] After the thrombus extraction device 202 is partially deployed, a portion of the thrombus extraction device 202 can be stacked. Specifically, in some examples, the deployed portion of the thrombus extraction device may include all or part of the cylindrical portion 208 of the thrombus extraction device 202, specifically including all or part of the fine wire mesh structure 704. In some examples, the deployed portion of the cylindrical portion 208 of the thrombus extraction device 202, specifically the deployed portion 208 of the fine wire mesh structure 704, can be stacked or partially stacked, such as... Figure 41-E As shown. In some examples, this stacking can be achieved by advancing the core element shaft 140 distally relative to the tip shaft 200, which can change the braiding angle θ, shortening the length of the cylindrical portion 208 of the thrombus extraction device 202, specifically the length of the fine mesh structure 704, and increasing the diameter of the cylindrical portion 208 of the thrombus extraction device 202, specifically the diameter of the fine mesh structure 704. In some examples, this stacking can occur when the tip shaft 200 is pinned and / or when the distal end 217 of the cylindrical portion 208 of the thrombus extraction device 202 is held in the desired position.

[0274] The thrombus extraction device 202 can be continuously deployed until it extends from the outer shaft 138, as shown. Figure 41-F As shown. In some examples, this can be achieved by the continuous distal advancement of the core element shaft 140, which in some examples can be the relatively distal advancement of the core element shaft 140 relative to the tip shaft 200 and / or the outer shaft 138. In some examples, this continuous unfolding of the thrombus extraction device 202 can result in the continuous stacking of portions of the cylindrical portion 208 of the thrombus extraction device 202, specifically portions of the fine mesh structure 704.

[0275] For reference Figure 42-A and 42-B The image shows an example view depicting a method for retracting a stackable thrombus extraction device 202 through a blood vessel 2200. Figure 42-A and 42-B The method can be used as Figures 25-A to 25-H This can be a part of or an alternative to the method shown.

[0276] After the thrombus extraction device 202 is deployed, or as part of the deployment of the thrombus extraction device 202, the thrombus extraction device 202 can be fully expanded. In some examples, this may include allowing the thrombus extraction device 202 to fully expand such that the thrombus extraction device 202 engages the wall 2220 of the blood vessel 2202. In some examples, 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 to fix the relative position of the stop shaft 3000 with respect to the core element shaft 140. In some examples, the movement of the plunger 154 from the first position to the first position causes the stop shaft 3000 to retract relative to the core element shaft 140, thereby fully expanding the expandable cylindrical portion 208 of the thrombus extraction device 202. The proximal retraction of the stop shaft 3000 relative to the core element shaft 140 can further cause the stop 702 to engage the annular feature 700, thereby fully expanding the self-expanding core element 206. In some examples, the plunger 154 is secured in the second position by the engagement of the stop 702 with the annular feature 700, which secures the self-expanding core extractor 206 and the thrombus extraction device 202 to a fully expanded state.

[0277] In some examples, the thrombus extraction device can be fully expanded by moving the shuttle 4000 from a first position to a second position. In some examples, the shuttle 4000 can be moved along the track 4002 by the spring 4004, thereby moving the stop shaft 3000 relative to the self-expanding core extractor 206. In some examples, this movement of the stop shaft 3000 allows the stop 702 to engage with the annular feature 700, thereby fully expanding the self-expanding core extractor 206. In some examples, the spring 4004 can secure the self-expanding core extractor 206 and the thrombus extraction device 202 in the fully expanded state by the engagement of the stop 702 with the annular feature 700. In some examples, the shuttle 4000 moves from the first position to the second position until the compressive force applied to the self-expanding core extractor 206 is equal to the expansion force of the self-expanding core extractor 206 and the expansion force of the spring 4004. In some examples, when the self-expanding core-taking element 206 engages with the wall 2220 of the blood vessel 2202, these compressive forces are equal to the expansion forces.

[0278] After the thrombus extraction device 202 is fully expanded, it can retract proximally through the thrombus 2200, as... Figure 42-B As shown. In some examples, the proximal retraction of the thrombus extraction device 202 may be, for example, in the direction of blood flow through the vessel 2202 or against the direction of blood flow through the vessel 2202. In some examples, the proximal retraction of the thrombus extraction device 202 through the thrombus 2200 may 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.

[0279] In some examples, proximal retraction of the thrombus retrieval device 202 can cause at least a portion of the thrombus 2200 to detach from and / or be cored from the wall 2220 of the vessel 2202, for example via the self-expanding core retrieval element 206 and / or the stent portion, resulting in the detached portion of the thrombus 2200 being captured within the expandable cylindrical portion 208. In some examples, the expandable cylindrical portion 208 may be formed of a woven mesh structure, which may be, for example, a mesh-like filament structure. In some examples, a portion of the thrombus can be captured within the expandable cylindrical portion 208 by accessing it via the opening 414 of the self-expanding core retrieval element 206 and / or through one or more gaps 404 of the self-expanding core retrieval element 206.

[0280] The distal end 2206 of the thrombus 2200 is separated from and / or cored from the wall 2220 of the vessel 2202 by the self-expanding core retrieval element 206 through the proximal retraction of the thrombus retrieval device 202, and the thrombus 2200 is captured within the expandable cylindrical portion 208 by the thrombus retrieval device through the continuous proximal retraction of the thrombus 2200. In some examples, the expandable cylindrical portion 208 may be dislodged during the proximal retraction of the thrombus retrieval device 202. In some examples, this dislodging may be achieved by retracting the core retrieval element shaft 140 proximally relative to the tip axis 200. In some examples, this may be achieved by retracting only the core retrieval element shaft 140 and allowing the obstruction caused by the thrombus entering the expandable cylinder to prevent the tip axis 200 from moving co-moving with and / or moving with the core retrieval element shaft 140 to the same extent. In some examples, this unstacking can be achieved by retracting the core element shaft relative to the tip shaft 200 while keeping the tip shaft 200 in place.

[0281] The thrombus extraction device 202 can be destabilized until the entire thrombus extraction device 202 is destabilized or until a desired level of destabilization is achieved. The thrombus extraction device 202 can then be retracted proximally via the thrombus extraction catheter 104, the outer shaft 138, and / or the core-retrieving element shaft 140. In some examples, the thrombus extraction device 202 can be retracted until all or part of the thrombus extraction device 202 is within the funnel catheter 3500, specifically within the funnel 1708. In some examples, for instance, the thrombus extraction device can be retracted until the self-expanding core-retrieving element 206 is within the funnel 1708 and / or until the orifice 414 is within the funnel. In some examples, the occlusion of the orifice 414 within the self-expanding funnel 1708 can be verified by fluorescence examination. In some examples, based on the alignment and relative positioning of the intermediate shaft 140, including radiopaque markers 2450 and / or radiopaque markers 222, with respect to the distal end 110 of the radiopaque marker 2452 of the elongated member 106 including the guide sheath 102, fluorescence monitoring can be used to determine that the mouth 414 is fully contained within the self-expanding funnel 1708.

[0282] After the opening 414 of the thrombus extraction device 202 is positioned within the funnel 1708, the thrombus extraction device 202 can be maintained in this position, with the opening 414 remaining within the funnel 1708, while the thrombus extraction device 202 and the funnel catheter 3500 are retrieved from the patient simultaneously via the inserted sheath 102. In some examples, the thrombus can be captured within the self-expanding funnel 1708 and can be withdrawn from the patient through the funnel catheter 3500, specifically through the lumen of the funnel catheter 3500, the connecting tube 3512, and the aspiration port 3510.

[0283] Other variations are included within the spirit of the invention. Therefore, while the invention is readily adaptable to various modifications and alternative constructions, some illustrative examples are shown in the accompanying drawings and have been described in detail above. However, it should be understood that the invention is not intended to be limited to a particular form or the form disclosed, but rather is intended to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention, as defined in the appended claims.

[0284] Various examples of the invention have been described above. Specific constructions and details have been set forth for illustrative purposes to provide a thorough understanding of the examples. However, it will be apparent to those skilled in the art that the invention can be practiced without specific details. Furthermore, well-known features may be omitted or simplified so as not to obscure the described examples.

[0285] In the context of describing this invention (particularly in the context of the following claims), the terms “a,” “an,” and “the,” and similar indications, should be interpreted to cover both singular and plural forms, unless otherwise stated herein or obviously contradicted by the context. Unless otherwise stated, the terms “comprising,” “having,” “including,” and “containing” should be interpreted as open-ended terms (i.e., meaning “including but not limited to”). The term “connected” should be interpreted as partially or wholly contained within, attached to, or joined together, even with some intervening elements. Unless otherwise stated herein, descriptions of numerical ranges herein are intended only as a way of abbreviating each individual value falling within that range, and each individual value is incorporated into this specification as if it were individually referenced herein. Unless otherwise stated herein or obviously contradicted by the context, all methods described herein can be performed in any suitable order. Unless otherwise stated, the use of any and all examples or exemplary language (e.g., “such as”) provided herein is intended only to better illustrate examples of the invention and does not constitute a limitation on the scope of the invention. No language in the specification should be construed as indicating that any unclaimed element is essential to the practice of the invention.

[0286] This document describes preferred embodiments of the invention, including the best mode known to the inventors for carrying out the invention. Variations of those preferred embodiments will become apparent to those skilled in the art upon reading the foregoing description. The inventors anticipate that those skilled in the art will appropriately employ these variations, and the inventors intend to practice the invention in ways other than those specifically described herein. Therefore, the invention includes all modifications and equivalents of the subject matter described in the appended claims as permitted by applicable law. Furthermore, unless otherwise stated herein or the context clearly contradicts it, the invention covers any combination of all possible variations of the foregoing elements.

[0287] All references cited in this article, including publications, patent applications and patents, are incorporated herein by reference to the extent that each reference is individually and specifically indicated by reference and fully elaborated in this article.

Claims

1. A thrombus extraction device, comprising: A core-retrieving element comprising a plurality of interconnected pillars, wherein the core-retrieving element includes a distal portion defining a plurality of openings; as well as A mesh structure comprising a plurality of filaments extending distally from the distal portion of the core element, wherein each filament passes through a corresponding opening such that a first portion of each filament extends distally from the distal portion of the core element and a second portion of each filament extends distally from the distal portion of the core element, and wherein the first and second portions of the filaments are woven together.

2. The thrombus extraction device of claim 1, wherein the opening extends circumferentially around the longitudinal axis of the core extraction element.

3. The thrombus extraction device of claim 1, wherein the first portion of each filament includes a first distal portion, the second portion of each filament includes a second distal portion, and wherein the first distal portion and the second distal portion of each filament are fixed together.

4. The thrombus extraction device of claim 3, wherein the first distal portion and the second distal portion of each of the filaments are fixed together at the hub.

5. The thrombus extraction device of claim 3, wherein the first distal portion and the second distal portion of each filament are fixed together at a non-damaging tip.

6. The thrombus extraction device as described in claim 3, further comprising: A first shaft is coupled to the proximal portion of the core-taking element; as well as The second shaft, wherein the first distal portion and the second distal portion of each of the filaments are fixed together and fixed to the second shaft.

7. The thrombus extraction device of claim 6, wherein the first axis and the second axis are movable relative to each other.

8. The thrombus extraction device of claim 1, wherein the core extraction element is configured to self-expand when unrestrained.

9. The thrombus extraction device of claim 1, wherein at least some of the filaments form a ring around the corresponding opening.

10. The thrombus extraction device of claim 1, wherein at least some of the filaments do not form a loop around the corresponding opening.

11. The thrombus extraction device of claim 1, wherein the filament comprises a first filament and a second filament, wherein each of the first filaments forms a loop around the corresponding opening, and wherein each of the second filaments does not form a loop around the corresponding opening.

12. The thrombus extraction device of claim 1, wherein the first and second portions of the filament are woven together to have a generally cylindrical shape.

13. The thrombus extraction device of claim 1, wherein the number of filaments is the same as the number of openings.

14. The thrombus extraction device of claim 1, wherein the number of filaments is greater than the number of openings.

15. A method for manufacturing a thrombus extraction device, the method comprising: Provided multiple filaments and a core element, wherein the core element includes (a) multiple interconnected pillars and (b) a distal portion having multiple openings; Each of the filaments is passed through a corresponding opening such that a first portion of each filament extends distally from the distal portion of the core element, and a second portion of each filament extends distally from the distal portion of the core element. as well as The first and second portions of the filaments are woven together to form a mesh structure extending distally from the distal portion of the core element.

16. The method of claim 15, wherein the method further comprises securing a first distal portion of the first portion of each filament and a second distal portion of the second portion of each filament together and securing them to a hub, a non-damaging tip, or an elongated shaft.

17. The method of claim 15, wherein weaving the first and second portions of the filaments together to form the web structure comprises weaving the first and second portions of the filaments together such that at least some of the filaments form loops around the corresponding openings.

18. The method of claim 15, wherein weaving the first and second portions of the filaments together to form the web structure comprises weaving the first and second portions of the filaments together such that at least some of the filaments do not form loops around the corresponding openings.

19. The method of claim 15, wherein weaving the first and second portions of the filaments together to form the web structure comprises automatically weaving the first and second portions of the filaments together.

20. The method of claim 15, wherein weaving the first and second portions of the filaments together to form the web structure comprises manually weaving the first and second portions of the filaments together.

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