Axially elongated thrombus capture system

Abstract

The present invention relates to an axially elongated thrombus capture system. Specifically, disclosed herein are systems and methods for removing substances of interest including blood clots from body parts including but not limited to the circulatory system for the treatment of pulmonary embolism (PE), deep vein thrombosis (DVT), cerebral vascular embolism, and other vascular obstructions.

Description

[0001] This application is a divisional application of Chinese patent application No. 201680052026.2, entitled “Axially Extended Thrombus Capture System”, filed on August 5, 2016.

[0002] Priority claim

[0003] Pursuant to 35 U.S.C. §119(e), this application is a nonprovisional application claiming the benefit of U.S. Provisional Application Nos. 62 / 202,074, filed on August 6, 2015, 62 / 273,418, filed on December 30, 2015, and 62 / 345,863, filed on June 6, 2016, each of which is incorporated herein by reference in its entirety. Technical Field

[0004] In some aspects, the present invention relates to systems and methods for removing substances of interest (including blood clots) from body sites (including but not limited to the circulatory system) for the treatment of pulmonary embolism (PE), deep vein thrombosis (DVT), cerebral vascular embolism, and other vascular obstructions. Background Art

[0005] Related Technology Introduction

[0006] It should be understood that unwanted material in the blood vessels, such as blood clots (which may be referred to herein as thrombi, thromboemboli, or emboli), may partially or completely block blood vessels in the coronary, cerebral, pulmonary, peripheral venous, and peripheral arterial circulatory system regions, leading to myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, and extremity infarction, respectively.

[0007] Various known therapies and devices are used to dissolve, remove and / or aspirate thromboemboli. For example, anticoagulants such as heparin and warfarin help stabilize blood clots and prevent further formation of blood clots, while thrombolytic agents such as urokinase, streptokinase and tPA help dissolve blood clots. These drugs can be delivered to a predetermined location by systemic infusion or catheter-based infusion. Although thrombolytic agents can effectively dissolve blood clots, they require a long time for the agent to dissolve the blood clot; therefore, the patient may need to stay in the hospital intensive care unit (ICU) during the thrombolytic infusion. Relatively long hospital stays can significantly increase medical costs. A major limitation of these thrombolytic agents is that they may cause bleeding in the brain, gastrointestinal tract, retroperitoneum and pericardium, and other parts, which are often life-threatening and cause significant morbidity and mortality risks.

[0008] Mechanical resection and / or aspiration devices may be used to remove the obstruction. These mechanical techniques may employ mincing, aspiration, or a combination thereof to remove the clot. One advantage of mechanical therapy is that it can remove the clot directly from the blocked area and eliminate the obstruction immediately, and may be superior to thrombolytic agents in some cases. However, current mechanical therapies have some major limitations. There is little or no blood flow during the procedure, so there is little time before the patient becomes hemodynamically unstable. Debris removed from mechanical therapy can travel distally and create additional emboli. Small size devices cannot remove large amounts of clots in a short period of time, so the patient may become hemodynamically unstable.

[0009] Compared with smaller vessels (such as coronary arteries), catheter-based removal of blood clots from larger vessels (such as pulmonary arteries) has limited success. Catheter pulmonary embolism removal is the percutaneous removal of pulmonary emboli using a variety of techniques. Fragmentation thrombectomy breaks the blood clot into smaller fragments, most of which travel further downstream, causing distal embolism. It is sometimes used in combination with thrombolytics. With rheolytic thrombectomy, a high-speed saline jet creates a Venturi effect and draws blood clot fragments into the catheter. This method has the risk of causing hemolysis. Finally, suction techniques draw clots into the catheter by suction. All of these techniques rely on catheters for removing blood clots from blood vessels. Users use small catheters to remove or break up large amounts of blood clots. This process is therefore time-consuming and inefficient. Once the blood clot is broken into fragments, the fragments may move distally and produce undesirable emboli. Rheotherapy poses a risk of hemolysis. In addition, due to the suction of large emboli with small catheter sizes, the suction capacity is limited. These limitations pose unnecessary threats to users and risks to patients.

[0010] In general, catheter-based clot removal also has significant limitations when the distal working space within a body lumen is restricted. Conventional devices may require full axial and / or radial deployment and expansion to function, and therefore, the flexibility to use such devices for a variety of clinical situations involving different clot or other material sizes to be removed is very limited. Therefore, these conventional devices may not be effective for situations where the distal space of the blood vessel is limited.

[0011] It is apparent that all treatment options available to patients with blood clots and other unwanted material within blood vessels and other body cavities have limitations. Anticoagulation only limits the spread of a clot but does not actively remove it. Thrombolytic therapy carries a risk of severe bleeding. Catheter embolectomy is not effective for controlled removal of material from large vessels. Furthermore, these devices require distal space to fully deploy in order to function in the distal space and are therefore ineffective in tight distal spaces. Surgical embolectomy can be highly effective but is highly invasive and carries a high morbidity and mortality rate. There is a need for a direct mechanical treatment that is as effective or more effective than surgical embolectomy for removing large clots but that can be performed using endovascular techniques and restore immediate blood flow with a lower incidence of complications. Summary of the invention

[0012] In some embodiments, disclosed herein is a capture system for selected materials within the body. The capture system may include a capture assembly configured to isolate unwanted materials such as blood clots, which may include a shape memory body, for example, made of a mesh material and having a distal end connected to a capture guide having a distal opening. The shape memory body may also include a proximal end connected to a first shaft and a tubular sidewall between the proximal and distal ends. The capture assembly may be configured to expand the capture guide and the distal open end when the proximal end of the shape memory body is compressed in a delivery system. The shape memory body may be movable from a first configuration having a first axial length and a second configuration having a second axial length. The shape memory body may be configured to roll, reverse, flip and / or variably lengthen from the first configuration to the proximal or distal end to the second configuration. The second axial length may be different from the first axial length. In some cases, the width of the capture assembly may be substantially unchanged from the first configuration to the second configuration. The capture system may also include a control line configured to independently move the capture assembly from the first configuration to the second configuration. The first shaft may extend within a longitudinal axis of the capture assembly.

[0013] In some embodiments, a material, such as a blood clot capture system, is disclosed herein. The system may include a first outer tubular shaft having a central lumen, the first outer tubular shaft including a proximal portion and a distal portion, the distal portion being more radially expanded than the proximal portion. The system may also include a second tubular shaft configured to be positioned within the central lumen of the first shaft. The system may also include a third tubular shaft configured to be positioned within the central lumen of the second shaft. The shape memory tubular body may include a first end, a second end, and an axial length therebetween, the first end having an opening facing the proximal end and an annular capture guide attached to the circumference of the opening facing the proximal end, the capture guide being operably attached to the second tubular shaft, the second end being attached to the outer wall of the third tubular shaft. In a first delivery configuration, the shape memory tubular body may be compressed within the central lumen of the second tubular shaft. The shape memory tubular body can be deformed into a second configuration, wherein the first end and the capture guide radially expand to a dynamic folding point, but the second end and a section of the shape memory tubular body extend in a different direction, such as proximally past the dynamic folding point, and remain radially compressed within the central lumen of the second tubular shaft, the second end is positioned proximal to the first end, and the shape memory tubular mesh body has a first expanded axial length. The shape memory tubular body can be deformed into a third configuration, wherein the shape memory tubular body has a second expanded axial length greater than the first expanded axial length, and the width of the shape memory tubular shaft along its second expanded axial length is the same or substantially the same as the width of the shape memory tubular shaft along its first expanded axial length. The first tubular shaft can be configured to be reversibly coupled relative to the second tubular shaft in the delivery configuration, and to be axially movable relative to the third tubular shaft in the second configuration. In some embodiments, the second extended axial length is about or at least about, for example, 105%, 110%, 115%, 120%, 125%, 130%, 150%, 200%, 250%, 300%, 350%, 400%, 450%, 500% or more of the first axial length. A capture system according to claim 1, wherein the shape memory body can be porous, semi-permeable and non-porous and comprises a nitinol braided, woven or non-woven mesh, or a nitinol wire. In some embodiments, the tubular body is coated or uncoated with a hydrophilic or hydrophobic agent and may not include a shape memory metal or material. In some embodiments, the tubular mesh body is configured to invert, flip or roll out relative to the first axis, the second axis and / or the third axis. The system may also include a control line extending proximally from the capture guide, the control line terminating at a sheath on one of the axes or extending proximally to the proximal end of the system. In some embodiments, the system includes a suction element configured to be operably connected to the proximal opening of the shape memory tubular body. The system may also include a mechanical thrombectomy element, such as a macerator.The system may further include a filter collection chamber configured to collect and filter blood obtained from the suction element. The system may further include.

[0014] An expansion guide catheter configured to receive a capture assembly in kit form. The expansion guide element may include an open funnel-shaped distal tip, which may be porous in some embodiments to allow blood flow around the distal tip of the funnel.

[0015] In some embodiments, disclosed herein is a material, such as a clot capture system, which may include: a first outer tubular shaft having a central lumen; a second tubular shaft configured to be positioned within the central lumen of the first shaft, the second tubular shaft including a proximal portion and a distal portion, the distal portion being radially more expanded than the proximal portion; a third tubular shaft configured to be positioned within the central lumen of the second shaft; a tubular mesh including a first end, a second end, and an axial length therebetween, the first end having a proximal-facing opening and an annular capture guide attached to the circumference of the proximal-facing opening, the capture guide being operably attached to the second tubular shaft, the second end being connected to an outer wall of the third tubular shaft. The tubular mesh may be compressed within the central lumen of the second tubular shaft in a delivery configuration, the second end being connected to an outer wall of the third tubular shaft. The tubular mesh may also be deformed into a second configuration in which the first end and the capture guide radially expand, but the second end and a portion (e.g., a small portion, half, or a large portion) of the tubular mesh remain radially compressed within the central lumen of the second tubular shaft, the second end is positioned proximal to the first end, and the tubular mesh has a first expanded axial length. The tubular mesh may be deformed into a third configuration in which the tubular mesh has a second expanded axial length greater than the first expanded axial length, wherein the width of the tubular mesh along its second expanded axial length is substantially equal to the width of the tubular mesh along its first expanded axial length, wherein the third tubular axial distal end extends through the proximal opening of the shape memory tubular body and the second axial expanded length. In some embodiments, in the second configuration or the third configuration, the tubular mesh is not under tension or is substantially not under tension to define an axial working range of the tubular mesh.

[0016] In some embodiments, a system for capturing material such as a blood clot comprises: a first outer tubular shaft including a central lumen; a second tubular shaft configured to be positioned within the central lumen of the first shaft, the second tubular shaft comprising a proximal portion and a distal portion, the distal portion being radially more expanded than the proximal portion; a third tubular shaft configured to be positioned within the central lumen of the second shaft; a tubular body comprising a shape memory material, comprising a first end, a second end, and an axial length therebetween, the first end having a proximal-facing opening and an annular capture guide attached to the circumference of the proximal-facing opening, the capture guide being operably attached to the second tubular shaft via a sheath surrounding a portion of the second tubular shaft, the second end being attached to an outer wall of the third tubular shaft. The shape memory tubular body can be compressed within the central lumen of the second tubular shaft in a delivery configuration, the shape memory tubular body comprising a first end, a second end, and an axial length therebetween. By axial movement of the second tubular shaft relative to the first tubular shaft, the shape memory tubular body can be deformed into a second configuration, wherein the first end and the capture guide radially expand, while the second end and a portion of the shape memory tubular body remain radially compressed within the central lumen of the second tubular shaft, the second end is positioned proximal to the first end, and the shape memory tubular mesh body has a first expanded axial length. By movement of the second tubular shaft relative to the third tubular shaft, the shape memory tubular body can be deformed into a third configuration, wherein the shape memory tubular body has a second expanded axial length greater than the first expanded axial length, wherein the width of the shape memory tubular shaft along its second expanded axial length is substantially the same as the width of the shape memory tubular shaft along its first expanded axial length, wherein the distal end of the third tubular shaft extends through the proximal opening of the shape memory tubular body and the second axial expanded length. By movement of the second tubular shaft relative to the third tubular shaft, the shape memory tubular body can in some cases be deformed into a fourth configuration. The shape memory tubular body can have a third expanded axial length greater than the second expanded axial length, wherein a width of the shape memory tubular shaft along its third expanded axial length is less than a width of the shape memory tubular shaft along its second expanded axial length. The clot capture system can also include a sheath comprising metal or a polymer, and the sheath can be partially or completely radiopaque or radiolucent under fluoroscopic or other imaging.

[0017] Also disclosed herein is a method for performing thrombectomy. The method may include, for example: accessing the interior of a blood vessel; advancing a thrombus capture device including a capture assembly through the blood vessel; positioning the thrombus capture device so that the distal end of the device is distal to the thrombus; actuating the capture assembly to isolate the thrombus within the capture device, wherein the capture assembly is movable from a first configuration having a first axial length and a second configuration having a second axial length, the second axial length being different from the first axial length, wherein the width of the capture assembly does not substantially change from the first configuration to the second configuration; and aspirating, macerating and / or mechanically removing the thrombus.

[0018] In some embodiments, a method for performing a thrombectomy procedure may include, for example: accessing the interior of a blood vessel; advancing an expanded guide catheter through the blood vessel; positioning the expanded guide catheter so that the distal end of the device is proximate to a thrombus; retracting the expanded guide catheter outer member to expand the funnel tip and expose the expandable inner member; advancing a thrombus capture device including a capture assembly through the expanded guide catheter; positioning the thrombus capture device so that the distal end of the device is distal to or within the thrombus; and actuating the capture assembly to isolate the thrombus within the capture device. The capture assembly may be movable from a first configuration having a first axial length and a second configuration having a second axial length, the second axial length being different from the first axial length. The width of the capture assembly may not substantially change from the first configuration to the second configuration. The method may also include retracting the capture assembly with the thrombus into the expanded guide catheter funnel tip and the expandable inner body. The method may also include axially extending the thrombus capture device distally and retracting the thrombus into the funnel tip of the expanded guide catheter. The method may also include radially shortening the thrombus capture device to compress the thrombus and facilitate removal of the thrombus.

[0019] In some embodiments, disclosed herein is a blood clot capture system, which may include a capture assembly configured to separate a blood clot. The system may include a shape memory having a distal end connected to a capture guide, the capture guide including a distal or proximal opening. The shape memory may also include a proximal end connected to the first axis and a sidewall between the proximal and distal ends. The capture guide and the distal region of the shape memory open end may also be completely or partially recaptured inside the outer sheath. The capture assembly may be configured to radially expand the distal region of the capture guide and the shape memory open end while the proximal end of the shape memory remains compressed in the delivery configuration. The capture assembly may be movable from a first configuration having a first axial length to a second configuration having a second axial length. The shape memory may be configured to roll out proximally from the first configuration, flip, reverse and / or variably extend to the second configuration. The second axial length may be different from the first axial length. The width of the capture assembly may be substantially unchanged from the first configuration to the second configuration in some cases.

[0020] Also disclosed herein is a capture assembly configured to isolate a blood clot, comprising a shape memory body, the shape memory body comprising a proximal end and a distal end connected to a capture guide, the capture guide comprising a distal opening, a proximal end connected to an axis, and a sidewall between the proximal and distal ends. The capture assembly can be configured to expand the capture guide and the distal shape memory body opening end when the proximal end of the shape memory body is compressed between the first axis and the second axis in the delivery configuration, and can be moved from a first configuration having a first axial length and a second configuration having a second axial length. The shape memory body can be configured to roll out / unfold, flip, reverse and / or variably extend from the first configuration to the second configuration proximally. The second axial length can be different from the first axial length. In some cases, the width of the capture assembly is substantially unchanged from the first configuration to the second configuration. In addition, once unfolded, the shape memory body can be completely or partially recaptured inside the outer sheath. The system can also include a sheath connected to a control line, the control line is connected to a second axis, and the second axis is configured to move the capture assembly from the first configuration to the second configuration. The first axis and the second axis may be off-axis relative to the capture assembly.

[0021] Also disclosed herein is a method for performing thrombectomy. The method may include any number of the following steps: accessing the interior of a blood vessel; advancing a thrombus capture device including a capture assembly through the blood vessel; positioning the thrombus capture device so that the distal end of the device is distal to the thrombus; actuating the capture assembly to isolate the thrombus within the capture device, wherein the capture assembly is movable from a first configuration having a first axial length and a second configuration having a second axial length, the second axial length being different from the first axial length, wherein the width of the capture assembly does not substantially change from the first configuration to the second configuration; and aspirating the thrombus.

[0022] In some embodiments, the method may include any number of the following steps: accessing the interior of a blood vessel; advancing the expanded guide catheter through the blood vessel; positioning the expanded guide catheter so that the distal end of the device is proximate to a thrombus; retracting the expanded guide catheter outer member to expand the funnel tip and expose the expandable inner member; advancing a thrombus capture device including a capture assembly through the expanded guide catheter; positioning the thrombus capture device so that the distal end of the device is distal to or within the thrombus; actuating the capture assembly to isolate the thrombus within the capture device, wherein the capture assembly is movable from a first configuration having a first axial length and a second configuration having a second axial length, the second axial length being different from the first axial length, wherein the width of the capture assembly does not substantially change from the first configuration to the second configuration; and retracting the thrombus into the expanded guide catheter funnel tip and expandable inner body. In some embodiments, the capture guide is first recaptured into the outer sheath of the delivery catheter and then retracted into the expanded guide catheter funnel tip and expandable inner body. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 Examples of conduit systems and various possible elements that may be included in a material capture system according to some embodiments of the present invention are shown.

[0024] Figure 2 Shows Figure 1 and Figure 2 Close-up view of the thrombus capture system.

[0025] Figure 3 An axially extended thrombus capture (ALTC) system is shown in an initial deployed configuration, wherein the ALTC device is expanded, according to some embodiments of the present invention.

[0026] Figure 4 A close-up view of the distal portion of the ALTC system in a delivery configuration is shown, indicating the outer sheath and nose tip, according to some embodiments of the present invention.

[0027] Figure 5 The distal end of an axially extended thrombus capture device is shown in an initial deployed position according to some embodiments of the present invention.

[0028] Figure 6 An axially elongated thrombus capture device is shown proximally retracted to deploy and extend, in accordance with some embodiments of the present invention.

[0029] Figure 7 An axially elongated thrombus capture device is shown fully deployed with the funnel tip of a guide catheter positioned inside the ALTC device, in accordance with some embodiments of the present invention.

[0030] Figure 8 and Fig. 9 Different views of the initial deployed position of an ALTC device and the funnel tip of an aspiration catheter are shown, according to some embodiments of the present invention.

[0031] Fig.10 A partially deployed ALTC device is shown according to some embodiments of the present invention.

[0032] Fig.11 An ALTC device deployed configuration is shown with the funnel tip of the aspiration catheter positioned within the ALTC device, according to some embodiments of the present invention.

[0033] Fig.12 An axially extended thrombus capture (ALTC) assembly according to some embodiments of the present invention is shown, wherein the distal end of the ALTC device is in an expanded (deployed) configuration and is secured to the thrombus capture introducer and capture pull wire. For illustration purposes, the proximal end is in a collapsed configuration and extends proximally.

[0034] Fig.13 An axially elongated thrombus capture device is shown in an initial deployed configuration according to some embodiments of the present invention.

[0035] Fig.14 A thrombus capture element of an ALTC device that may include a stent or a braided mesh is shown according to some embodiments of the present invention.

[0036] Figure 15A-Figure 15C Embodiments of an ALTC system, a distal portion of an ALTC system, and a proximal portion of an ALTC system are shown, respectively.

[0037] Fig.16A Another embodiment of an axially elongated thrombus capture device in a delivery configuration is shown in accordance with some embodiments of the present invention.

[0038] Fig. 16B The axially elongated thrombus capture device is shown in an initial deployed configuration, wherein the outer sheath is retracted to expand the axially elongated thrombus capture device. According to some embodiments of the present invention, the ring is coupled to a sheath, wherein it is coupled to a capture catheter shaft.

[0039] Fig. 16C An axially elongated thrombus capture device according to some embodiments of the present invention is shown proximally retracted and extended.

[0040] Fig.16D An axially elongated thrombus capture device according to some embodiments of the present invention is shown extended and in some cases fully deployed.

[0041] Figures 17A-17DDifferent configurations of ALTC devices according to some embodiments of the present invention are shown.

[0042] Figure 18A-18B An embodiment of an axially elongated distal portion of a thrombus capture system is shown having a cover element, which may be annular as shown, radially outward of and partially or completely surrounding the capture guide of an ALTC device.

[0043] Figure 19A-Figure 19C An embodiment of an axially elongated thrombus capture system is shown that is configured to allow a guidewire to exit the system distally before exiting a Luer port at the proximal end of the system.

[0044] Fig. 20A An expanded guide catheter system is shown in a delivery configuration according to some embodiments of the present invention.

[0045] Fig. 20B An expanded guide catheter system is shown with the funnel tip in a deployed position and an occluder positioned within the expanded guide catheter lumen according to some embodiments of the present invention.

[0046] Fig. 20C An expanded guide catheter according to some embodiments of the present invention is shown having a funnel tip, an expanded distal portion, and a non-expanded proximal portion.

[0047] Fig.20D Occluders according to some embodiments of the present invention are shown.

[0048] Figure 21A-Figure 21C An expansion guide catheter system according to some embodiments of the present invention is shown, which includes an expansion guide catheter, an outer cover, and an occluder.

[0049] Fig.21D An embodiment is shown in accordance with some embodiments of the present invention wherein a cap tip encapsulates a distal end of an outer cover of the expansion guide catheter system.

[0050] Fig. 22 An outer sheath assembly of a capture device according to some embodiments of the present invention is shown.

[0051] Fig.23 and Fig.24 The distal and proximal ends of the outer sheath assembly are shown, respectively.

[0052] Fig.25 A capture catheter assembly according to some embodiments of the present invention is shown.

[0053] Fig.26 The proximal end of a capture catheter according to some embodiments of the present invention is shown.

[0054] Fig. 27 An embodiment of a keycap assembly that enables anti-rotation of a hypotube thruster is shown.

[0055] Fig.28 and Fig.29 An aspiration catheter according to some embodiments of the present invention is shown and may include a funnel tip, a catheter shaft, and a connector with a seal.

[0056] Fig.30 The distal end of an aspiration catheter is shown, indicating the funnel tip and the catheter shaft, according to some embodiments of the present invention.

[0057] Fig.31 The proximal end of an aspiration catheter is shown, indicating a connector with a seal and a port for use with a filter chamber and access to the lumen of an irrigation catheter, according to some embodiments of the present invention.

[0058] Figure 32-Figure 41 Different chopper designs and shapes are shown according to some embodiments of the present invention.

[0059] Fig.42 A filter collection chamber according to some embodiments of the present invention is shown, which may include an inflow port connected to a syringe, an outflow port connected to an aspiration catheter, a plunger, a filter for filtering blood clots or debris and retaining them in the chamber, and a chamber for collecting blood clots or debris.

[0060] Fig.43 A blood clot lodged in the left side of the pulmonary system is shown in accordance with some embodiments of the present invention.

[0061] Fig.44A and Fig.44B A blood clot residing in the left pulmonary system and the capture device is illustrated, respectively, according to some embodiments of the present invention.

[0062] Fig.45 An initially deployed configuration of an axially elongated thrombus capture device according to some embodiments of the present invention is shown, with the device distal to a region of thrombus occlusion and the funnel tip proximal to the thrombus occlusion.

[0063] Fig.46 An axially elongated thrombus capture device is shown according to some embodiments of the present invention, which is extended proximally to capture a thrombus.

[0064] Fig.47 An axially-elongated thrombus capture device is shown fully capturing a thrombus, with the funnel tip located inside the axially-elongated thrombus capture device.

[0065] Fig.48A A capture catheter device is shown in a delivery configuration according to some embodiments of the present invention.

[0066] Fig.48B An initial deployed position of an axially elongated thrombus capture device according to some embodiments of the present invention is shown.

[0067] Fig.48C The elongation of an axially elongated thrombus capture device is illustrated in accordance with some embodiments of the present invention.

[0068] Fig.48D The final deployment of an axially elongated thrombus capture device according to some embodiments of the present invention is illustrated.

[0069] Fig.49A and Fig.49B Another embodiment of an axially-elongated thrombus capture device according to some embodiments of the present invention is illustrated, wherein the guidewire lumen and capture catheter are offset from the longitudinal axis of the axially-elongated thrombus capture device.

[0070] Figure 50A-50G An embodiment of retrieval of thrombus into the expansion guide catheter is shown, wherein the ALTC device is elongated distally and creates additional space, and the thrombus is redistributed and can be better retrieved into the expansion guide catheter. The funnel tip and expansion portion of the expansion guide catheter also facilitate easy thrombus retrieval. DETAILED DESCRIPTION

[0071] In some embodiments, the present invention provides systems and methods that can be delivered percutaneously in vivo to extract and remove blood clots, stones / calculi and / or foreign material in body cavities, including blood vessels, such as arteries or veins in the circulatory system. In some embodiments, the present invention can also be applied to non-vascular areas to treat, for example, gallstones, kidney stones, common bile duct stones, etc.

[0072] The system can be delivered percutaneously via a cut-down approach, a thoracoscopic approach, or via other routes, such as using a catheter system 35, Figure 1 A perspective view of one of the embodiments is shown. Figure 1 Also shown are examples of various possible elements that may be included in the material capture system according to some embodiments of the present invention. Figure 1As shown, included in some embodiments are any number of the following components, such as one, two or more: a first tubular member, such as an outer sheath 1, a second tubular member, such as a capture catheter 12, a third tubular member, such as a guidewire tube 6, an axially elongated thrombus capture device 8, a suction catheter 2 and a filter collection chamber 5. In some embodiments, the outer sheath 1 can be an elongated tubular member having a central lumen extending therethrough, and having a proximal end 1000 and a distal end 1001. The distal end 1001 of the outer sheath 1 can be operably connected to a capture device (e.g., a tubular mesh 8), which can be axially movable relative to the outer sheath 1. In some embodiments, the outer sheath 1 has a relatively rigid proximal portion, and a flexible distal portion compared to the relatively rigid proximal portion, which can be advantageously flexibly expanded to accommodate the passage of large blood clots and / or other materials if necessary. The proximal end 1000 of the outer sheath 1 can be connected to a proximal hub 1003, which can include any number of suction tubes 2, capture catheters 12, guidewire tubes 6 and filter collection chambers 5. (In Figure 1 Non-limiting examples of other optional elements (not shown in the figure) include a chopper tool (described elsewhere herein) and a separate expansion guide catheter (described elsewhere herein). In some embodiments, the outer sheath 1 has an inner cavity that is configured to accommodate an aspiration catheter 2, which in turn has an inner cavity configured to accommodate a capture catheter 4, which in turn has an inner cavity configured to accommodate a guidewire tube / guidewire inner cavity assembly 6 and an axially extended thrombus capture device (ALTC device) 8, which in turn has an inner cavity configured to accommodate a guidewire (not shown) passing therethrough. As defined herein, the ALTC device may include any structure, such as a mesh structure, that is configured to capture material in a body position, and axially extend and shorten throughout the working range depending on the desired clinical outcome, and have or have no radial shortening width or diameter throughout the working range. In some embodiments, the outer sheath 1 has an inner diameter configured to coaxially accommodate a capture catheter 12 therein, and the capture catheter 12 has an inner cavity configured to accommodate the guidewire tube 6 and the body of the ALTC device 8. In some embodiments, the ALTC device 8 may include a mesh mesh structure with a proximally facing opening at one end, which may be made of a shape memory metal or polymer, or a non-shape memory metal such as stainless steel or other non-shape memory articles, embodiments of which are described in detail elsewhere herein. In some embodiments, conventional mesh structures such as those used in IVC and other embolic filters may be used with the systems and methods herein. In some embodiments, the thrombus capture device may be configured in some embodiments to extend axially throughout the working range, with or without radial shortening of the device throughout the working range.

[0073] Figure 2 Shows Figure 1A close-up view of the proximal end 1000 of the thrombus capture system of FIG. An outer sheath 1 is shown, which is configured to accommodate a suction catheter 2 passing therethrough in some embodiments. A proximal end of the outer sheath 1 that can terminate at a connector 17 and a hemostatic seal 190 is also shown, wherein another tube, such as a suction catheter 2 (and / or a capture catheter 4), can be coaxially inserted therein. The proximal end of the suction catheter 2 can also include a connector 3 having a seal and an inner cavity into which the capture catheter 12 can be inserted. The capture catheter 4 can also include a connector having a seal 18 at its proximal end. The guidewire tube 6 has an inner cavity for accommodating a wire passing therethrough, and can be configured to coaxially fit within the capture catheter shaft 12. An optional filter collection chamber 5 is also shown, whose inner cavity is fluidically connected to the inner cavity of the suction catheter 2. A hub 17 and a flushing port 20 are also shown. In some embodiments, suction is not required (and thus the suction catheter 2 is not included in the system), and clots or other materials can be captured mechanically, hydraulically, and / or shredded by the ALTC device 8.

[0074] Figure 3 An axially elongated thrombus capture system 35 is shown in an initial deployment configuration according to some embodiments of the present invention, wherein the ALTC device 8 is radially expanded. A nose tip 7 at the distal end of the ALTC device 8 is also shown. Relative axial movement of the outer tube 1 relative to the capture catheter 4 can allow a first end of the ALTC device 8 (e.g., an expanded proximal end having a proximal-facing opening, or a distal-facing or lateral opening in other embodiments) to deform from a radially compressed configuration to a radially expanded configuration. In some embodiments, the proximal opening of the ALTC device 8 includes a capture guide 11, which in some embodiments takes the form of a radially expandable shape-memory partial or full annular ring structure that will expand along a portion of the ALTC device mesh 8 attached to the capture guide 11 once the outer tube 1 is absent. However, in the illustrated configuration, a significant portion of the surface area and / or axial length of the mesh of the ALTC device remains in a compressed configuration within the lumen of the capture catheter 4 because the other end of the ALTC device mesh 8 is still operably attached to (e.g., fixed to) the outer diameter sidewall of the guidewire catheter 6.

[0075] Figure 4 A close-up view of the distal end of the ALTC catheter system 35 in a delivery configuration is shown, including the distal end 1001 of the outer sheath 1 and the nose tip 7, which may be atraumatic and tapered as shown, according to some embodiments of the present invention.

[0076] The ALTC device 8 can function to retrieve and capture material such as thromboemboli. A capture catheter 4 is shown along with the ALTC device 8, capture catheter shaft 12, pull wire 10, and thrombus capture guide 11.

[0077] For example Figure 5-Figure 9As shown, the thrombus capture guide 11 can be attached to a portion of the ALTC device 8, such as an open end, and one, two or more capture pull wires 10, wherein the capture pull wire is positioned inside the side cavity of the suction catheter 2 or outside the inner cavity in other embodiments and extends proximally. As shown, the distal end of the capture pull wire 10 can be connected to the proximal end of the ALTC device 8 at the capture guide 11. The capture pull wire 10 can extend proximally through the length of the outer sheath 1, and the proximal end of the pull wire 10 can be pushed or pulled to allow the user to control (e.g., adjust) the axial length of the ALTC device 8, such as when the ALTC device is axially stretched in the proximal direction. In some embodiments, the capture pull wire 10 and the capture guide 11 are the only elements attached to the proximal end of the ALTC device 8. In some embodiments, the capture pull wire 10 and the capture guide 11 can be made into a single component, such as a ring. In some other embodiments, the capture guide and the proximal end of the ALTC device are sutured in place using silk or polymer filaments (e.g., ultra-high molecular weight polyethylene, nylon, PET, PTFE). In some embodiments, the open end of the ALTC device is covered with a low-hardness film or coating, which is then folded over the capture guide 11 and sutured to fix the assembly. In another embodiment, the open end of the ALTC device 8, the capture guide 11 and the suture assembly are coated with a low-hardness polymer material. Another method for fixing the end of the wire is to apply a polymer fabric to the outer surface or inner surface of the tubular structure and fix it by suturing with a suture thread. The fabric can be at least one piece, initially wrapped on the inner surface or outer surface of the tubular structure, and then folded to the opposite side to fix and protect the wire end. Both sides of the fabric can be fixed to the tubular structure using sutures. In some embodiments, other ways of fixing the fabric to the tubular structure can be used, such as thermal bonding, pressing, lamination, chemical fixation, mechanical fixation and laser. The closed end of the ALTC device can be attached to the outer surface of the guide wire tube 6, and the outer surface of the guide wire tube 6 can be positioned in the lumen of the capture catheter shaft 12. Therefore, the axial extension of the ALTC device in the distal direction can be achieved by, for example, the guide wire tube 6 and the pull wire 10 moving distally relative to the capture catheter shaft 12. Axial stretching of the ALTC device in the proximal direction can be achieved by, for example, capturing the wire and moving the axial proximal end of the capture catheter. The thrombus capture guide 11 can be formed of, for example, metal, shape memory or other suitable materials. In some embodiments, the thrombus capture guide 11 may include an annular configuration and may be formed of a nitinol shape memory wire having various geometric shapes (such as circular, elliptical, oval, flat, etc.). The thrombus capture guide 11 can be formed into different shapes such as a circular ring, an elliptical ring, a Z shape, etc. In some embodiments, the ring 11 can be formed into a coil, a plurality of full circles, a full circle or a partial circle, wherein the two ends of the wire form two legs. The partial circle can be formed, for example, from 180 degrees to 359 degrees or from 220 degrees to 359 degrees.The legs may be configured to be off-axis from the ring and may be at right angles, acute angles, or obtuse angles relative to the ring. It may be arcuate as shown and form a partial or full ring and may surround or otherwise form an outer diameter and define the proximal end of the ALTC device 8. In some embodiments, the thrombus capture guide 11 may include a single ring or multiple rings positioned along the length of the ALTC device 8 and may not necessarily be present or have the entire guide 11 at the proximal facing end open end of the ALTC device 8. In some embodiments, the thrombus capture guide 11 does not include a ring. The ALTC device tubular structure may be configured to be compressed and positioned within the lumen of the capture catheter shaft 12 during introduction into the vascular system, wherein the capture catheter shaft 12 is configured to be coaxially positioned within and extend through the tubular structure and the thrombus capture guide 11.

[0078] like Figure 5 As shown, the axially elongated thrombus capture device (ALTC device) 8 can, in some embodiments, be a generally tubular, net-like mesh structure that is foldable, expandable, and configured to, for example, be axially elongated or shortened within a working range while maintaining or substantially maintaining its diameter within the working range to retrieve and capture foreign matter or other unwanted matter, such as blood clots, thrombi, and / or foreign matter, within the body including the vascular system.

[0079] For example, Figure 6 As shown, the ALTC device 8 can also be extended in an appropriate direction (e.g., distally) by pushing the capture catheter 12 relative to the guidewire shaft 6, thereby allowing the additional radially compressed length of the tubular mesh 8 to be radially extended outward from the inner cavity range of the capture catheter 12 to axially extend the thrombus capture device 8 and maintain its constant or substantially constant diameter throughout the working range. The other end of the ALTC device 8 at its radially compressed end can be fixed to the outer side wall of the guidewire tube 6. For example, a combination of techniques ( Figure 6 ) can position the ALTC device at a desired location within the body cavity, and axial movement of the guidewire catheter 6 relative to the capture catheter shaft 12 will also axially lengthen or shorten the ALTC device 8 while maintaining its diameter within the working range. When the ALTC device 8 is in the deployed (expanded) configuration, the ALTC device 8 can also be stretched beyond the working range to an extended axial length to reduce its diameter.

[0080] Figure 7 The axially elongated thrombus capture device 8 according to some embodiments of the present invention is shown fully deployed such that the attachment site 128 of the ALTC device 8 on the outer diameter of the guidewire lumen 6 is distal to the distal end of the capture catheter shaft 12 and the funnel tip 9 of the aspiration catheter is positioned within the ALTC.

[0081] Figure 8 and Fig. 9 Different views of the initial deployed position of the ALTC device 8 and the optional funnel tip of the aspiration catheter 2 are shown according to some embodiments of the present invention.

[0082] Fig.10 A partially deployed ALTC device is shown according to some embodiments of the present invention, wherein the ALTC device 8 is axially elongated while maintaining its width perpendicular to the axial direction.

[0083] Fig.11 An expanded configuration of an ALTC device is shown with the funnel tip of the aspiration catheter positioned within the ALTC device, according to some embodiments of the present invention.

[0084] As shown, the guidewire lumen assembly 6 can include a nose tip 7, a shaft, an inner cavity and a proximal connector and a port into which a guidewire can be inserted. In certain embodiments, the central lumen can have a distal opening. The guidewire tube 6 can be used for navigating and tracking on a guidewire in a vascular system. The guidewire tube 6 can extend coaxially in the lumen of a catheter shaft 12. The nose tip 7 can be formed on or otherwise connected to the distal end of the guidewire tube 6 to help track the system when the system passes through the vascular system, and can be non-traumatic in some embodiments. The guidewire tube 6 can be made of a polymer material, such as but not limited to polyimide, nylon, polyurethane, Pebax (a kind of block polyetheramide elastomer), polyethylene, PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene) or ePTFE (a microporous membrane formed by expanding and stretching with polytetrafluoroethylene as a raw material). In certain embodiments, the guidewire tube 6 can have a radiopaque mark along its length for indicating the position, initial deployment, partial deployment, final deployment, percentage of deployment length and / or any combination thereof of the ALTC device.

[0085] Fig.12 An axially extended thrombus capture (ALTC) assembly 8 is shown without the outer sheath, capture catheter 4, or guidewire catheter 6 for clarity. As shown, the end 800 of the ALTC device 8 having a proximally facing opening 802 is in an expanded (deployed) configuration and is secured to the thrombus capture guide 11 and capture pull wire 10, according to some embodiments of the present invention. For purposes of illustration, the remaining portion of the unexpanded mesh 81, including the end 804, is in a collapsed configuration and extends proximally toward the attachment site 128.

[0086] In some embodiments, the tubular mesh structure 8 can be axially extended or shortened without reducing or substantially reducing its diameter within the working length / axial range because the radially expanded portion of the tubular mesh structure is not subjected to or is subjected to only minimal tension when it is axially extended or shortened over the axial working range. Without being limited by theory, this can be achieved at least in part because the tubular mesh structure can be axially extended throughout the working range by opening, flipping or otherwise expanding or deforming the radially compressed retained portion of the tubular mesh (e.g., the unexpanded mesh 81). Thus, the extended "end" opposite the end of the radial expansion device containing the capture guide and the proximal opening, such as the dynamic folding point 88 of the radially expanded portion of the tubular mesh 8, can be not the absolute end of the tubular mesh fixed to the tubular shaft at the region 128, but rather an intermediate dynamic folding point 88 that is not fixed to the tubular shaft at this point, and therefore is not subjected to or is substantially not subjected to any tension. Thus, the radially compressed remaining portion of the tubular mesh 81 extends rearwardly in a different or opposite direction (e.g., proximally in some cases) and terminates at a terminal fixation point to the tubular shaft (e.g., at position 128). The distance between the dynamic fold point 88 and the distal end of the entire catheter system (e.g., the nose tip) can increase as the radially expanded portion of the tubular mesh 8 is elongated and the radially compressed remaining portion is used up, if it does not exceed the working length of the expanded tubular shaft.

[0087] Once the compressed retention portion 81 of the tubular mesh 8 is almost or fully expanded to or almost reaches its actual end at 128, and the tubular mesh 8 is axially extended beyond its working length range, further axial extension can begin to exert significantly increased tension on the fully axially expanded tubular mesh structure 8, causing it to present a radially contracting configuration as it further extends axially.

[0088] A tubular mesh structure having one open end as disclosed above and elsewhere herein can be very advantageous because a relatively small axial portion of the tubular mesh can be radially expanded and fully function to capture emboli and / or other materials in a narrow working environment, such as within a restricted body cavity where there is only limited space to maneuver to the distal end of the treatment location of interest. If a greater axial length of the tubular mesh that needs to be radially expanded is desired, such as to capture a relatively long thromboembolic embolism, the compressed retention portion of the tubular mesh can be opened, everted or otherwise expanded or deformed to the desired specific axial length. Having a compressed retention portion that can be stored in a compact manner along the length of the catheter system can be very advantageous to provide a tubular mesh with a long effective capture length without requiring the entire capture system to have a long fixed length like a conventional filter / mesh, which can be fixed at both ends and thus function and fully radially expand when the first end is separated from the second end by a single specific axial distance.

[0089] like Fig.12 As shown, some or a majority of the axial length of the ALTC device (e.g., tubular mesh structure 8) remains radially compressed as part of a retained portion between the outer diameter of the guidewire catheter 6 and the inner diameter of the shaft 12 of the capture catheter (the distance therebetween is length L12B), wherein the radially expanded portion of the tubular mesh structure 8 is defined as the axial length along the proximal end 800 containing the proximal-facing opening 802 and the dynamic folding point (the distance therebetween is length L12A), and the sum of L12A and L12B is equal to the absolute length of the tubular mesh 8. In this initial configuration, the length L12B of the radially compressed retained portion 81 can be about or at least about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or more of the absolute length of the tubular mesh 8.

[0090] Fig.13 An axially extended thrombus capture device 35 is shown in an initial expanded configuration according to some embodiments of the present invention, wherein a radially expanded portion of the mesh 8 between the end 800 and the dynamic folding point 88 and a retained compression portion (not shown) extend axially proximally through the end 800 to a fixed point 128 on the outer surface of the guidewire shaft (not shown). Fig.14A thrombus capture element 15 of an ALTC device according to some embodiments of the present invention is shown, which may include a stent, braid, woven fabric, laser cut or other mesh, such as a mesh structure. The tubular mesh structure is not necessarily porous and may be covered by a non-porous or other layer. The tubular mesh structure 8 of the ALTC device may be made of any suitable polymeric material, such as but not limited to polyethylene terephthalate (PET), polyethylene (PE), polypropylene (PP), nylon, silk, UHMWPE (ultra-high molecular weight polyethylene), PTFE, Kevlar, cotton and / or metallic materials, including superelastic materials, Nitinol, stainless steel, cobalt-chromium-nickel-molybdenum-iron alloy or cobalt-chromium alloy, Chronichrome (chromium-chromium) or Elgiloy (Elgiloy non-magnetic alloy). In some embodiments, the tubular structure may be formed by braiding, extruding, weaving, weaving, laser cutting, shredding, film casting of polymer and / or metal flat sheets, wires, polymer filaments or fabrics. In some embodiments, the tubular structure can be film cast with laser cut holes. The tubular structure may also be woven from polymers and / or metal wires or any combination thereof. In some cases, the tubular structure may be made of a nitinol wire mesh having a plurality of strands. In addition, the tubular structure may include at least one strand made of a very radiopaque material, such as a filling tube drawn from tantalum, platinum, gold or nitinol with a platinum core, so that the tubular structure can be observed under fluoroscopy. In some embodiments, the tubular structure may include one, two or more radiopaque markers. Depending on the diameter of the ALTC device, the number of strands may be, for example, 1 to 576 strands. In some embodiments, the ALTC device may have 2, 4, 144, 288 or other numbers of strands. In some embodiments, the ALTC device is configured to have one strand. The diameter of the strand may range from, for example, 0.0002 inches to 0.015 inches. In some embodiments, the strand diameter is approximately 0.001 inches, and the tubular structure may be impermeable in some portions, permeable in other portions and / or a combination thereof. The tubular structure can be uncoated, or coated with one, two or more layers of an antithrombotic agent such as heparin to prevent clotting, or coated with other therapeutic agents. The tubular structure can also be coated with a hydrophilic agent or a hydrophobic agent. The tubular structure can have different pore sizes to help capture small emboli, or larger pore sizes to allow perfusion or blood flow. The tubular structure can have a uniform pore size throughout its length, or a combination of different pore sizes throughout its length. For example, when used as a brain protection filter, the pore size of the ALTC device can be large enough to capture clinically relevant embolic sizes, such as as small as about 200, 175, 150, 125, 100, 75, 50 microns or less, while maintaining perfusion or blood flow. During retrieval, the ALTC device 8 can be repositioned to a specific portion of the tubular structure with a smaller pore size and retrieve the clot / thrombus.In some embodiments, the ALTC device can be deployed and embedded in a blood clot to capture, for example, a blood clot in the neurovascular system. During retrieval, the ALTC device can be fully extended beyond the captured thrombus to form a protective filter at the distal end of the captured thrombus. This is clinically beneficial in preventing the thrombus from shifting during the removal process, thereby preventing secondary stroke. In some embodiments, the proximal end of the tubular structure 8 of the ALTC device can be attached to the outer surface of the guidewire tube 6, for example, near the attachment site 128. In some embodiments, the proximal end of the tubular structure of the ALTC device can be wrapped and sutured by a polymer filament and encapsulated with a low-hardness polymer material to fix the end of the wire to the shaft, such as a guidewire lumen assembly. Other connection methods for mounting the wire end can be used, such as mechanically, thermally or chemically bonding the polymer to fix the wire end. In another embodiment, the proximal end of the ALTC device can be fixed to the outer surface of the guidewire shaft using an adhesive and clamped between the outer surface of the guidewire shaft and the cover tube.

[0091] Figure 15A-Figure 15C Another embodiment of a clot capture system, a distal portion of an ALTC system, and a proximal portion of an ALTC system are illustrated, respectively. Fig.15A The catheter system 35 is schematically shown, and Fig. 15B A distal nose tip 7 is shown operably connected to the distal end of the guidewire shaft 6, which includes an inner cavity for the guidewire to pass therethrough. One end of the ALTC device 8 can be fixedly attached to the guidewire shaft 6 at one or more locations 128, while the other end 800 including a proximal or distal opening 802 is attached to a capture guide 11 in the form of, for example, a ring 11, and it can be moved axially distally and proximally via the capture guide 11. The ring may include, for example, one, two or more straight segments extending proximally from the ring 11 to the capture catheter shaft 12, which are proximally mounted on the capture catheter shaft 12 by a sheath 30. In some embodiments, there may be a sheath 30 instead of a pull wire extending all the way proximally through the device. This can be economically advantageous in some cases and allow for smoother control at the proximal end of the user. The axially expanded length of the tubular mesh 8 is shown extending from the end 800 to the dynamic folding point 88 , and the retained length of the compressed tubular mesh (not shown) extends proximally along the outer side wall of the guidewire shaft 6 to its proximal end at the fixing point 128 . Fig. 15CThe embodiment of the proximal end of the system is shown, which includes one or more flushing ports 13, the hub 55 of the outer sheath 1, the hub 155 of the capture catheter 12, and the hypotube propeller 14, and the most proximal hub 15 with the inner cavity configured to slide the guide wire therefrom. In some embodiments, the hypotube propeller 14 can extend together with the third tubular member (e.g., guidewire tube 6), such as welding or otherwise attached, and causes the guidewire tube 6 to move axially in the proximal or distal direction gap when manipulated by the operator. In some embodiments, there can be an integral guidewire tube 6 from the most proximal hub 15 to the distal nose tip 7. The third tubular member 14 can be configured to be placed in the inner cavity of the second tubular member (e.g., capture catheter shaft), such as at the proximal end at the hub 155. The second tubular member can be configured to be placed in the inner cavity of the first tubular member (e.g., outer sheath 1), such as at the proximal end at the hub 55. In some embodiments, hub 55 and hub 155 may include complementary threads or other reversible locking features to allow outer sheath 1 to be reversibly coupled to capture catheter 12 to allow the two tubular members to move axially in coordination with each other. Separating hubs 55, 155 may allow axial movement of capture catheter 12 relative to outer sheath 1, and vice versa.

[0092] Still refer to Figure 15A-Figure 15C In some of the embodiments shown, if the sheath 30 is present, no separate pull wire extends proximally from the capture guide 11 to the proximal end of the system. In some such embodiments, the proximal axial movement of the capture catheter shaft 12 relative to the guidewire shaft 6 facilitates radial expansion of at least a portion of the ALTC device 8 and positioning of the ALTC device 8 within the body cavity. In some embodiments, axial elongation and / or shortening of the ALTC device 8 can be achieved by movement of the guidewire 6 relative to the capture catheter 12 and / or movement of the capture catheter 12 relative to the guidewire 6 (wherein the other end of the ALTC device that is not attached to the capture catheter 12 by the sheath 30 is attached to the attachment site 128).

[0093] Fig.16A Another embodiment of a distal portion of an axially elongated thrombus capture device 35 in a delivery configuration is shown in accordance with some embodiments of the present invention.

[0094] Fig. 16BAn axially elongated thrombus capture device is shown in an initial deployed configuration, wherein the outer sheath 1 is retracted, e.g., proximally, to radially expand the end of the proximally facing opening 802 of the axially elongated thrombus capture device (e.g., tubular mesh 8) to a dynamic folding point 88, which serves as an effective extended distal end of the tubular mesh 8. According to some embodiments of the present invention, the capture guide 11 and associated terminal wire 10 are operably coupled to the sheath 30, and the sheath 30 is coupled to the outer wall of the capture catheter shaft 12. The compressed retained length portion of the tubular mesh (not shown) is, for example, about or at least about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% or more of the absolute axial length of the ALTC device 8 (e.g., tubular mesh) factored into the fold, remains flipped, rolled and / or otherwise radially compressed and surrounded by the inside of the capture catheter shaft 12 to the point where the other end of the ALTC device 8 is attached to the outer diameter of the guide tube 6 at the attachment site 128. As shown, the dynamic fold point 88 varies along the length of the tubular mesh 8, depending on the length of the compressed retained length portion being expanded. The dynamic fold point 88 is "floating" and is not directly attached to the guidewire shaft 6 and the capture catheter shaft 12, and therefore moves axially toward the proximal end when the expanded portion of the tubular mesh 8 is axially elongated.

[0095] Thus, when the guidewire shaft 6 with the distal tip 7 is maintained at a constant position, the axial elongation of the expanded tubular mesh 8 causes the axial distance D between the distal tip 7 and the dynamic folding point 88 to increase, so that the distance D3 is greater than D2, which in turn is greater than D1. Fig. 16B As shown, the first end 800 of the tubular mesh is the distal end of the unexpanded end of the tubular mesh, and the unexpanded end (at position 128) is fixed to the outer side wall of the guide wire tube 6, but at Fig. 16C Move closer to the proximal end and Fig.16D The dynamic folding point 88 moves proximally, but at Fig.16D In the embodiment, it is still slightly away from the unexpanded distal end of the tubular mesh 8, wherein the expanded axial length is even greater, or in some cases its maximum working length. As mentioned above, the diameter / width of the expanded tubular mesh is Figures 16A-16D After the compression retention portion of the expanded tubular mesh has been exhausted, continued axial expansion can result in an increase in the tensile force on the tubular mesh, resulting in a configuration in which radial contraction begins to occur.

[0096] Figures 17A-17DDifferent configurations of ALTC devices according to some embodiments of the present invention are shown. During delivery, a capture guide 11 (e.g., annular in some embodiments) connected to the expanded end 800 of the tubular mesh 8 can be configured to contract within the lumen of the outer sheath 1 during introduction into the vascular system, and is configured to first expand radially when the outer sheath 1 is retracted proximally, while the length of the retained tubular mesh structure 81 of the ALTC device 8 extending proximally from the dynamic folding point 88 to the fixed point 128 on the guidewire shaft 6 remains compressed in the inner lumen of the capture catheter shaft 12. The dynamic folding point 88 serves as the effective expanded distal end of the tubular mesh 8. When the thrombus capture guide 11 is further retracted by pulling the capture pull wire 10 (or the sheath 30 and capture catheter shaft 12 shown in the figure) proximally, the tubular structure portion of the ALTC device 8 compressed within the inner lumen of the capture catheter shaft 12 expands and can be deformed by, for example, rolling, flipping and / or inverting proximally and axially stretching the ALTC device 8. As previously described in Figures 7 to 9 As shown in FIG. 1 , the distal advancement of the capture catheter shaft 12 can collapse at least a portion of the tubular structure of the ALTC device 8 into the lumen of the capture catheter shaft 12. The ability of the ALTC device to expand, roll out, axially extend, and maintain a substantially constant diameter over a working range creates a cavity (or pocket) in the sidewall of the radially expanded portion of the ALTC device 8 to collect and capture foreign matter such as blood clots / thrombi. In another embodiment, a sheath 30 ( Figures 16A-16D and Figures 17A-17D ) The capture pull wire 10 is, for example, permanently connected to a portion of the capture catheter shaft 12 so that the two components operate together. Connecting the capture pull wire 10 and the capture catheter shaft 12 can allow the user to manage the capture device more effectively and easily. In another embodiment, the capture guide 11 is annular and can be connected to a sheath 30 that is connected to the capture catheter shaft 12.

[0097] Figure 18A-18BAn embodiment of the distal portion of an axially elongated thrombus capture system is shown, which has a covering element 80 that is radially outside and partially or completely surrounds the capture catheter shaft 12 or ring 11 of the ALTC device, which can be annular as shown. In some embodiments, the covering element 80 can be used to protect one or more of the luminal walls of the capture guide, the ALTC device, and the treated lumen. The ring 80 can also be configured to provide a seal to the luminal wall of, for example, a blood vessel to prevent leakage or migration or embolism of unwanted materials around the tubular mesh 8. In some embodiments, the cover 80 can also include a skirt. The cover 80 can be axially and / or radially expandable, such as an expandable balloon, soft polymer, gel, foam, fabric, shape memory material, and / or include other materials. If the cover 80 is expandable, it can be configured to reversibly contract to allow fluid flow around the cover 80 after the surgical procedure is completed. As also shown in the figure, the sheath 30 is used to attach the capture guide 11 connected to one or more wires 10. In some embodiments, the sheath 30 may include one or more holes 307 that serve as relatively radiolucent markers, and / or the sheath 30 may be made of a radiopaque material. Also as shown, the capture catheter 12 and the guidewire tube 6 may extend from the first end 800 through the tubular mesh 6 through the dynamic folding point 88. For clarity, the retained portion of the compressed tubular mesh is not shown.

[0098] Figure 19A-Figure 19C An embodiment of the thrombus capture system of axial elongation is shown, and the system is configured to allow guide wire 350 to leave the system distally before leaving the Luer / nearest port 15 at the proximal end of the system. Once the proximal end of guide wire passes through the hemostatic seal 55,155 of the reversible connection of outer sheath 1 assembly and capture catheter 12 respectively, the proximal end of guide wire can leave the system through the hole or groove 351 in the side wall. In certain embodiments, guide wire 350 is configured to leave laterally, i.e., leave laterally. In certain embodiments, key cap 36 is positioned at the distal end of hemostatic seal 55,155, and hemostatic seal 55,155 is again at the proximal end of shaft 14, and shaft 14 can be used as a hypotube propeller connected to guide wire tube or extending together with guide wire tube, and is made of metal in some embodiments. As shown in the figure, shaft 34 can include a sidewall groove 351 and / or one, two or more discrete grooves from port 15 to hub 155 that is completely or partially axial.

[0099] Such an embodiment can be advantageous, for example, to utilize a guidewire of a shorter required length as the overall length of the delivery system increases. In some embodiments, as the length of the ALTC capture device increases, the hypotube is also elongated to accommodate, thereby increasing the distance used to manage the guidewire and the system. The side guidewire component can minimize the distance, resulting in better operation, and the proximal end of the guidewire 350 does not necessarily need to extend beyond the proximal end of the entire system, such as port 15. Therefore, in some embodiments, the guidewire as part of the system can advantageously have an overall length that is the same as or even less than the axial length of the entire material capture system from the proximal port 15 to the distal nose tip 7, which is not possible in other cases.

[0100] The guide wire 350 can be located near the hemostatic seal 55, 155 area during the operation, so the entire operation / operation can be completed without the user having to look down to see where the components are located. In this way, the user can hold the hemostatic seal 55, 155 housing with one hand, while manipulating the guide wire 350 and the hypotube pusher 14 in the general area with the other hand, without substantially leaving the area. The user can hold and manipulate the hypotube pusher 14, or hold and manipulate the guide wire 350, or hold both the hypotube pusher 14 and the guide wire 350 at the same time. In some embodiments, the inner diameter of the shaft 14 with the groove can generally be larger than the guide wire 350 to allow the guide wire 350 to leave laterally. The key cap 36 with the boss profile can cooperate with the groove of the metal shaft 14 to prevent the metal shaft 14 from rotating and still allow the shaft 34 to slide back and forth axially.

[0101] In some embodiments, the expansion guide catheter 50 (eg, FIG. 20A to FIG. 20D - FIG. 21A to FIG. 21D) is a separate catheter that can be used with a clot capture system and is used to assist in the extraction of the ALTC device 8 (and associated catheter system 35) and the capture of clots and other unwanted materials. In some embodiments, the expansion guide catheter 50 can include a first tubular member, such as an outer sheath 49, such as having a proximal end, a distal end, a lumen extending from the proximal and distal ends, and a port on the proximal end, which can be coaxial with the longitudinal axis of the outer sheath 49 as shown or offset. A second tubular member, such as an inner catheter 54, can have a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, and can be configured to be placed within the lumen of the outer sheath 49. The inner catheter 54 can also have a proximal port, a removable obstruction 51 that can be positioned in the lumen of the inner catheter, a distal expandable funnel tip 52, an expandable shaft portion 53 proximal to the funnel tip 52, an inner shaft 54, and a connector with a seal 55. The obstruction 51 can be used to help insert and navigate the expansion catheter 50 into a vascular system. The occluder 51 can be made of a polymer material such as polyethylene, nylon, Pebax, polyurethane, PET or PTFE. In some embodiments, the occluder 51 can have a tapered distal end to help introduce the expansion guide catheter 50 into the vascular system or other body cavity. Alternatively, other embodiments of the occluder 51 include an expandable member such as a balloon operably connected to the distal end. Expansion of the expandable member, such as inflation of the balloon, can produce a smooth tip transition. The balloon can be made of a polymer material such as nylon, polyurethane, PET, etc. Inflation of the balloon can also secure the balloon occluder to the guide catheter so that when an axial load is applied to the proximal end of the occluder shaft, the tip of the guide catheter will be articulated. For example, in Figure 20B-Figure 20CThe funnel tip 52 shown in the figure may include a distal funnel-shaped portion and an adjacent expandable proximal portion 53, wherein it is connected to the more proximal portion of the inner shaft 54. The funnel tip 52 may be made of a polymeric material and / or a metal material in some embodiments. It may be tubular, braided or woven. The braiding configuration may be 1×1 or 1×2 or 2×1 or 2×2 or any combination thereof in some cases. In some embodiments, the number of needles per inch (PPI) may range from 5 to 60. In some embodiments, the number may be from one wire to 288 wires. The wire shape may be round, flat, oval, rectangular or square. The wire diameter may be from 0.0005 inches to 0.015 inches. The thickness of the flat wire may be from 0.0005 inches to 0.010 inches, and the width of the wire may be from 0.001 inches to 0.030 inches. The distal portion of the funnel tip 52 may have various shapes or configurations to allow better extraction of blood clots or thrombi. In some embodiments, the distal portion of the funnel tip 52 has a larger open end where it contacts the vessel wall when expanded and transitions to a smaller open proximal portion 53. The diameter of the open end of the distal portion can range from about 5 mm to about 80 mm. In some embodiments, the distal portion 52 of the funnel tip also has openings or holes (perforations) along the side to allow blood to flow. The distal portion 52 of the funnel can have one or more braided layers. In some embodiments, the distal portion of the funnel has two layers. In some one-layer embodiments, the distalmost open end of the funnel does not have a terminated or exposed wire end, so that the wire end is located at the proximal end of the funnel assembly. The proximal portion 53 of the funnel tip can be configured so that it can expand and receive an ALTC device and capture a blood clot or thrombus. The proximal portion 53 can be configured to expand to receive an object larger than its inner diameter and recover after passing. The proximal portion 53 may include an inner layer of PTFE and a compliant and / or low-hardness polymer material, such as polyurethane, silicone, Tecoflex (a thermoplastic polyurethane elastomer), Pebax 25D and / or 35D or a woven and / or non-woven outer layer such as Pebax / Propel / BaSO4. The proximal portion 53 may also include other polymer materials of lower hardness. The composite funnel tip and proximal portion may be laminated by a shredded coating, spraying or reflow process or any combination thereof. The braided material may be a metal and / or a polymer and / or a combination thereof. The braid may be configured as 1×1 or 1×2 or 2×1 or 2×2 or any combination thereof. The range of needles per inch (PPI) may be from, for example, 5 to 60. The number may be from one thread to 288 threads. The shape of the thread cross section may be, for example, round, flat, oval, rectangular or square. The thread diameter may be from 0.0005 inches to 0.015 inches. The thickness of the flat wire can range from 0.0005" to 0.010", and the width of the wire can range from 0.001" to 0.030".In some embodiments, the advantageous feature is the ability to expand and contract without buckling under compression. The inner diameter can range from, for example, 2F to 30F. In some embodiments, the inner diameter can range from, for example, 6F to 18F. The extended length portion can be as long as the entire catheter length. In some embodiments, the length is about 20cm. The distal end portion 52 and the proximal end portion 53 of the funnel can also be made into one element, wherein the braided configuration is continuous. Connected or continuous with the proximal end portion 53 of the funnel tip, the inner shaft 54 ​​can be made of materials such as, but not limited to, nylon, polyurethane, Pebax, polyethylene, PET, PTFE or ePTFE. The inner shaft 54 ​​can be braided or non-braided. The outer shaft 49 can play the role of sliding and contracting the tip of the funnel and provide support during the introduction of the vascular system. The outer shaft 49 retracts to expand the tip of the funnel. The outer shaft 49 can be made of polymeric materials such as nylon, polyurethane, Pebax, polyethylene, PET, PTFE, ePTFE, FEP or a combination thereof. The diameter range of the outer shaft 49 can range from, for example, 4F to 34F. The inner diameter range of outer shaft 49 can be from 3F to 32F, for example. In certain embodiments, the inner diameter is substantially the same throughout the lumen shaft. In certain embodiments, the inner diameter at the distal end is greater than the proximal inner diameter. The change of inner diameter can be at one, two or more positions. The outer diameter is substantially the same over the entire length of the outer sheath shaft. In certain embodiments, the diameter of outer shaft 49 is approximately 22F or less. Outer shaft 49 can include a radiopaque marker at the distal end or a radiopaque filler along its shaft length so as to be visible under fluoroscopy. In certain embodiments, the outer shaft can be deflectable (for example, by one, two or more pull lines at the distal end) in different positions and multiple deflectable directions along the shaft length to adapt to various tortuous paths, for example, entering the right atrium, right ventricle, main pulmonary artery, and left pulmonary artery and right pulmonary artery for pulmonary embolism applications.

[0102] Still refer to Figure 20A-Figure 22In some embodiments, the expansion guide catheter 50 can be used to retrieve a blood clot or thrombus. The expansion guide catheter 50 and the occluder 51 can be introduced into the vascular system and advanced to the vicinity of the treatment area by a silk thread. The occluder 51 is removed. The outer member 49 of the expansion guide catheter is retracted proximally to expand the funnel tip 52 and the expandable portion 53 of the guide catheter 50. In some embodiments, the guide outer shaft 49 is inserted into the blood vessel together with the occluder 51, and once the outer shaft 49 is in the desired position, the occluder 51 is removed. The inner guide member may include a funnel tip 52, and the proximal portion 53 and the inner shaft 54 ​​are then inserted into the outer shaft 49 until the distal tip of the outer shaft 49 is reached. The outer shaft 49 can then be retracted (or the inner shaft 54 ​​can be advanced) to expand and deploy the distal funnel 52 and the proximal portion 53. The capture catheter system 35 is inserted through the lumen of the expansion inner guide member 54 by a silk thread. Once the ALTC device 8 is deployed and the clot is captured, the ALTC device 8 is retracted together with the captured clot into the funnel tip 52 and the expansion guide inner member 53 (described later in Figure 50A-50G ). When high resistance is encountered at the tip of the funnel due to the location of a larger clot at the tip, the guidewire lumen can be advanced distally to extend the ALTC device. Extending the ALTC device can create additional space within the ALTC device, thereby redistributing the clot volume, thereby reducing large clots that collect at the tip of the extended guide catheter. The distal portion of the extended guide catheter also allows larger clots to be captured because its expandability increases the size of the lumen. Continued retraction of the ALTC device will extract additional captured clots within the extended guide catheter. Repeated extension of the ALTC during the procedure will continue to redistribute and retrieve clots within the extended guide catheter, facilitating improved handling and redistribution of thrombi. In some embodiments, the kit may include a capture catheter system 35 as described herein, and is configured to be reversibly placed in the lumen of a separate extended guide catheter system 50 described herein and moved axially relative to the lumen.

[0103] Fig.21D One embodiment is shown in which a capping tip 710 encapsulates the distal end of the outer cover of an expansion guide catheter system, according to some embodiments of the present invention.

[0104] Figure 22-Figure 24 The outer sheath assembly 1 of the capture device according to some embodiments of the present invention is shown. Fig. 22 As shown, the outer sheath 1 can be used to contain, protect and deliver an axially elongated thrombus capture device (tubular mesh 8 (not shown)) to a desired anatomical location. Fig. 22As shown, the outer sheath 1 can include a soft atraumatic distal tip, a tubular shaft body in some embodiments, an internal channel / lumen configured to accommodate and reversibly connect a second tubular member (such as a capture catheter described elsewhere herein) at its proximal end, and a proximal connector having a seal 55 and a flushing tube / port 13. The outer sheath 1 can be made of suitable medical grade materials, including but not limited to nylon, polyurethane, Pebax, polyethylene, PET, PTFE, ePTFE, PEEK, PEBAX / Propell and polypropylene. The polymer material can include a radiopaque material, such as barium sulfate, bismuth subcarbonate or bismuth trioxide, so as to be observed under fluoroscopy. In some embodiments, the radiopaque material can form one, two or more discrete marking elements, such as at the distal tip and / or spaced apart at regular or irregular intervals along the length of the outer sheath 1. The outer diameter of the outer sheath 1 can range from, for example, 3F to 30F. The inner diameter of the outer sheath 1 can be in the range of, for example, 2F to 28F. In some embodiments, the inner diameter is substantially constant throughout the inner channel, such as the inner cavity shaft. In some embodiments, the inner diameter at the distal end is about or at least about 10%, 20%, 30%, 40%, 50% or more of the proximal end. The change in inner diameter can be, for example, a step change or a gradual change at one position or two or more positions. In some embodiments, the outer diameter can be substantially the same as the entire length of the catheter. In some cases, the working length of the outer sheath 1 can be from about 10cm to about 150cm. In some embodiments, the working length of the outer sheath 1 is about 135cm in some embodiments. The shaft of the outer sheath 1 can be braided or non-braided. In some embodiments, the shaft of the outer sheath 1 can be deflected (for example, by one, two or more pull lines on the distal end) along the shaft length at various positions and multiple deflectable directions to adapt to various tortuous paths, such as entering the left or right atrium, ventricle, main pulmonary artery and left or right pulmonary artery for pulmonary embolism application, or veins such as the great saphenous vein, superficial femoral vein, common femoral vein, SVC, IVC or other upper or lower limbs, viscera or other superficial veins or deep veins for deep vein thrombosis removal applications. The distal end of the shaft of the outer sheath 1 can be configured to deflect up to 360 degrees in some cases. In addition, the distal end of the outer sheath 1 can be configured to deflect or bias toward the vessel wall or away from the vessel wall. The distal end of the outer sheath 1 can include one, two or more radiopaque markings to indicate the terminal position. Alternatively, the distal end can include radiopaque materials, such as barium sulfate, bismuth subcarbonate or bismuth trioxide. Fig.23 and Fig.24 The distal and proximal ends of the outer sheath assembly are shown, respectively. Fig.26 As shown, the proximal end of the outer sheath 1 is connected to the outer sheath connector 55 through a seal and coupled to the capture catheter connector and flush port 13.

[0105] Fig.25A capture catheter assembly 12 is shown, showing the catheter shaft 12 and the outer sheath 1, according to some embodiments of the present invention. Fig.26 The proximal end of a capture catheter is shown showing a connector having a seal 155 operably connected to a flush port 13 according to some embodiments of the present invention.

[0106] Fig. 27 An embodiment of a keycap 36 feature for preventing or inhibiting the rotation of a hypotube thruster 14 is shown. As shown, the keycap 36 can be a tubular member having an inner cavity to allow the hypotube thruster 14 to pass therethrough. In some embodiments, the inner cavity is non-circular, and / or has a non-circular area, or is otherwise configured to prevent or limit rotation. In some embodiments, as shown, the inner cavity includes teeth or other protrusions that enter the inner cavity to prevent undesirable rotation of the hypotube thruster. In some embodiments, the inner cavity or a portion thereof has a square, rectangle, triangle, ellipse, pentagon, hexagon or other non-circular geometry and is configured to limit rotation.

[0107] In some embodiments, for example, Figure 28-Figure 29 As shown, an optional aspiration catheter 2 can be used to aspirate thrombus within the ALTC device 8. The aspiration catheter 2 can include a distal funnel tip 9, an elongated shaft body 16, and a proximal connector having a seal 3 in some embodiments. Fig.30 A close-up view of a funnel tip 9 that can be connected to the distal end of the suction catheter shaft 16 is shown to help retrieve thrombi and allow effective suction. The funnel tip 9 can be made of, for example, polymer and / or metal materials. In some embodiments, it can be tubular, braided or woven. The funnel tip 9 can have various configurations to allow better retrieval and suction. In some embodiments, the funnel tip 9 has a funnel shape as shown, which has a first larger distal diameter, a transition portion, and a second smaller proximal diameter. The suction catheter shaft 16 creates a path for the suctioned thrombus to travel proximally and leave the body and enter an optional filter collection chamber in some embodiments. The shaft can have different diameters, lengths, and / or geometries to help remove substances such as blood clots. The suction catheter shaft can be made of suitable materials, such as, but not limited to, nylon, polyurethane, Pebax, polyethylene, PET, PTFE, ePTFE, PEEK, and polypropylene. In some embodiments, the distal end of the suction catheter shaft is expandable to accommodate a large amount of blood clots. Aspiration catheter 2 can be attached to the proximal end of filter collection chamber 5 to achieve thrombus aspiration (or removal). In some embodiments, aspiration catheter shaft 16 can be deflected at one, two or more locations along the length of the shaft to accommodate various tortuous paths, such as access to the right atrium, right ventricle, main pulmonary artery, and left and right pulmonary arteries. A proximal flushing port 13 is also shown.

[0108] In some embodiments, a mechanical thrombectomy tool, e.g. Figure 32-Figure 41 The chopper 19 shown in the figure can function to disrupt and break up the thrombus within the ALTC device 8. The chopper 20 can include the chopper 19, a shaft 22, and a proximal connector with a seal 21. A distal adjustable handle knob 23 is also shown just proximal to the chopper 19. The chopper 19 can be connected to the distal end of the shaft 22. Depending on the desired clinical outcome, the chopper 20 can have a plurality of configurations, such as: Figure 35-Figure 41 Various end effector tip configurations are shown for disrupting thrombi within the ALTC device 8, including spherical ( Fig.36 ), proximal and distal bulbs with narrow waists ( Fig.37 ), multiple proximal and distal bulbs with narrow waists and each bulb offset by an angle of, for example, about 90° ( Fig.38 ), a petal design with lobes radiating radially outward from a central hub ( Fig.39 ), half petal design( Fig.40 ), or a linear design substantially orthogonal to the longitudinal axis of shaft 22 ( Fig.41 ). The destroyer 19 is contracted during insertion through the suction catheter 2 system and expands once it leaves the catheter. The destroyer 19 can be made of metal materials such as stainless steel, nitinol, cobalt chromium alloy, etc. The chopper can be activated by manual rotation, manipulation and / or electric handle.

[0109] To fragment a thrombus, a chopper 19 is inserted into the aspiration catheter 2 and positioned within the ALTC device 8. A manual technique is employed by rotating the Luer connector 21 applied to the chopper 19 to rotate the disruptor 20 to break up the thrombus. Alternatively, the chopper 19 may be used with a motorized handle (not shown). Axially extending the disruptor 20 through the entire length of the ALTC device 8 may aid in disrupting the thrombus.

[0110] Filter collection chamber 5( Fig.42 ) can play the role of suction and collection of blood clots. The filter collection chamber 5 may include, for example, a collection chamber 325, a filter 324, a plunger 323, an inflow port 327 and an outflow port 326. The filter collection chamber 5 may have an outflow port 326 connected to the suction catheter 2 connector and an inflow port 327 to which a syringe or similar device may be attached for suction. The collection chamber 325 has a filter system 324 residing in the chamber 325 to allow filtering of blood and thrombus. The chamber 325 also has a plunger 323 for injecting a fluid such as saline to fill the chamber 325 and pushing the filtered blood back into the vascular system. The plunger 323 can be used as a seal on one side of the chamber.

[0111] To aspirate thrombus from the system, the aspiration catheter 2 is connected to the filter collection chamber 5 ( Fig.42). A large syringe is connected to the proximal end of the filter collection chamber 5. Applying suction using the syringe causes thrombi and blood clots to migrate into the filter collection chamber 5. Once all thrombi are contained within the chamber 5, the stopcock is closed, the syringe is detached and filled with saline, and the syringe is reconnected to the filter collection chamber 5. Alternatively, an extension tube and an external saline-filled syringe can be used to fill the aspiration syringe with saline. Saline is pushed into the chamber 325 via syringe injection, causing the plunger 323 to push blood back into the vessel. The chamber 325 will return the blood and retain the thrombus within the chamber 325. Alternatively, the filter collection chamber 5 can be detached without returning the filtered blood to the system. Once the thrombus is removed, the aspiration catheter 2 is retracted into the outer sheath 1. The ALTC device 8 is retracted into the outer sheath 1 and the entire system is removed from the body.

[0112] The catheter systems described herein can be used for a variety of indications depending on the desired clinical outcome. In some embodiments, the use is not limited to the venous system and can be applied to other arterial, venous or non-vascular areas, such as neurovascular, peripheral vascular, cardiovascular, temporary embolic protection for cardiovascular surgery such as valve replacement, carotid artery protection, lung protection during deep vein thrombosis or embolectomy), or to remove implants, medical devices or other materials.

[0113] Fig.43 A blood clot residing in the left pulmonary system is shown. Shown is a pulmonary embolism 256 in the right pulmonary artery 251, the left pulmonary artery 252, the inferior vena cava 253, the left iliac artery 254, the right iliac artery 255, the left pulmonary artery 252, and the superior vena cava 257.

[0114] Fig.44A and Fig.44B A blood clot residing in the left pulmonary system and a capture device, respectively, are illustrated according to some embodiments of the present invention. Fig.43 In addition to the anatomical features shown, guide catheter 264, right ventricle 266 and right atrium 267 are also shown. Fig.44B As shown, the capture device described and illustrated herein can be advantageously used when distal space is very limited because the device functions over a wide working axial range, as discussed elsewhere herein.

[0115] Figure 45-Figure 47 The capture of a thrombus within a blood vessel is shown according to some embodiments. Fig.45The initial deployment configuration of an axially extended thrombus capture device (e.g., tubular mesh) 8 is shown, having an end 800, a dynamic folding point 88, and a retained radially compressed portion (not shown) proximally terminating at point 128, where the radially compressed portion is shown to be fixedly connected to the outer side wall of the guidewire lumen 6. According to some embodiments of the present invention, the expanded portion of the tubular mesh 8 is located at the distal end of the thrombus 73 occlusion area and the expansion guide catheter 50, the expansion guide catheter 50 includes a distal funnel tip 52 with a proximal expandable portion, an inner catheter 54 and an outer catheter 49, or in some embodiments, the aspiration catheter funnel tip is located proximal to the thrombus occlusion 73. In some embodiments, depending on whether aspiration is required, an expansion guide catheter 50 or an aspiration catheter as described elsewhere herein can be used. The inner sheath 54 and the outer sheath 49 of the expansion guide catheter 50 are also shown at the proximal end. Activation of the capture pullwire 10 alone or in conjunction with the capture catheter 12 (or in the embodiment with a cannula as previously described, in conjunction with a capture catheter coupled to an outer sheath (not shown)) in an appropriate direction, such as axially, can result in axial extension or shortening of the ALTC device 8, depending on the desired clinical outcome. Fig.46 An expandable portion of an axially elongated tubular mesh 8 according to some embodiments of the present invention is shown proximally elongated to capture a thrombus, wherein the associated radially compressed portion is correspondingly shortened. Fig.47 An axially extended thrombus capture device is shown with the thrombus fully captured, and the guide catheter funnel tip is extended or alternatively the aspiration catheter funnel tip is located inside the axially extended thrombus capture device. In embodiments utilizing aspiration, subsequent aspiration through the aspiration catheter 2 may be performed to remove the clot or thrombus. The ALTC device can be extended to have a maximum length covering the entire length of the catheter system, for example from about 0.5 cm to about 125 cm. In some embodiments, the ALTC device can be extended to about or at least about 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20 centimeters or more. Depending on the vessel diameter, the outer diameter of the ALTC device can be in the range of about 1 mm to about 80 mm in some embodiments. For example, for large vessels such as the inferior vena cava, superior vena cava, descending and ascending aorta, the diameter can reach about 60, 70, 80, 90, 100 mm or more. Small blood vessels in the neurovasculature can have a diameter as small as about or less than about 5, 4.5, 4, 4.5, 3, 2.5, 2, 1.5, 1, 0.5 mm or less, for example. The diameter of the ALTC device can achieve a similar effect of reducing or lengthening the diameter of the ALTC device. In some embodiments, suction is not used or required, and the ALTC device encapsulates the clot, which can be mechanically pulled back into the capture catheter.

[0116] Fig.48AAnother delivery configuration of a clot capture system 35 is shown that may include features as previously described, according to some embodiments of the present invention. Fig.48B An initial deployed position of an axially elongated thrombus capture device and a reversible connection of hub 55 of capture catheter 155 to hub 55 of an outer sheath are shown according to some embodiments of the present invention. Fig.48C Further extension of the expanded portion of the axially elongated thrombus capture device according to some embodiments of the present invention is shown, with corresponding shortening of the retained compressed portion 81. As shown, the guidewire tube 6 with nose tip 7 remains in place while the capture catheter reversibly connected to the outer sheath can be withdrawn proximally. Fig.48D The final deployment of an axially elongated thrombus capture device at its maximum working length is shown in accordance with some embodiments of the present invention.

[0117] In some embodiments, the systems and devices disclosed herein can be used for general percutaneous surgery, cutting surgery or minimally invasive surgery or other surgery, such as, but not limited to, trans-apical, thoracoscopic, laparoscopic, such as, but not limited to, trans-femoral, trans-radial and / or internal jugular vein access. The technology can also be applied to the arterial system, including neurovascular, cardiovascular and peripheral vascular applications, and used as an embolic protection device, such as cardiovascular surgery, such as valve replacement or repair. In some embodiments, the thrombectomy system can be delivered downstream of the aortic root (such as before the aortic arch), and a variable length shape memory mesh structure (such as an ALTC device) with an open proximal end and a closed distal end is expanded before the index cardiovascular surgery to capture downstream emboli, calcification or other debris. In some embodiments, for example, the surgical system can be deployed to prevent embolism during deep vein thrombotomy or pulmonary embolectomy. In another embodiment, the system can be used to prevent embolism or retrieval during acute ischemic stroke. The systems and methods disclosed herein can also be used for non-vascular anatomical structures, such as bile duct structures, to capture gallstones, common bile duct stones and pancreatic duct stones, such as kidney stones in the ureter or bladder, or eggs or other substances in the fallopian tubes. Some embodiments of using the venous system to enter the pulmonary artery to treat pulmonary embolism are described herein. This technology can also be applied to other areas of the vascular system. Initially puncture to enter the femoral vein. A short access guide wire is inserted into the femoral vein. Next, insert an appropriate 5F or 6F introducer sheath. The guide wire is replaced with a 180cm, 260cm or 300cm guide wire and advanced through the inferior vena cava, right atrium, right ventricle and pulmonary artery to enter the obstruction treatment area. A longer guide / guide catheter may be required to pass through the tricuspid valve and pulmonary valve. Once the guide wire passes through the obstruction treatment area, the 5F or 6F introducer sheath is replaced with a long guide catheter and positioned near the obstruction area proximally. The catheter system 35 is inserted on the silk thread and passes through the guide catheter and advances to the obstruction area distally. The catheter system 35 can also utilize the outer sheath deflectable feature to navigate in the vascular system without the use of a guide catheter. Next, the nose tip 7 of the catheter system passes through the occluded treatment area and is positioned distal to the occluded treatment area. The outer sheath 1 is retracted to deploy the thrombus capture guide 11. The outer sheath 1 is retracted past the thrombus and positioned proximal to the thrombus (occluded area). The aspiration catheter 2 is advanced distally outside the outer sheath 1 and positioned proximal to the occluded area, if aspiration is used.

[0118] To retrieve and capture material such as a blood clot or thrombus, the thrombus capture guide 11 is retracted by pulling the capture pull wire 10 proximally while pushing / pulling the capture catheter 12 to axially extend the ALTC device 8 over the thrombus without substantially reducing the diameter of the device. As needed, advancing the capture catheter shaft 12 distally while pulling the capture pull wire will allow the ALTC device 8 to axially extend to capture the thrombus. In addition, the expandable funnel tip 9 of the aspiration catheter 2 (or the funnel tip of the expansion guide catheter) can be positioned proximal to the occluded area to support and minimize thrombus movement. This operation continues until all thrombi are within the ALTC device 8. Once the thrombus is completely within the ALTC device 8, pulling the ALTC device 8 out of the occluded area can immediately restore blood flow while containing the thrombus within the ALTC device 8.

[0119] In some embodiments, the capture catheter shaft 12 and the guidewire tube 6 are configured to be positioned adjacent to each other side by side (e.g., offset and not coaxial, and not passing through the opening 802 or other radially extended portion of the tubular mesh 6) to reach the ALTC device 8 and the capture guide (e.g., Fig.49A and Fig.49B Also shown are the dynamic folding point 88, the retained radial compression portion 81 and the compression end fixed to the outer wall of the guide wire tube 6 at 128.

[0120] Figure 50A-50G The retrieval of a thrombus into an extended guide catheter is shown, wherein the ALTC device is extended distally and creates additional space, and the thrombus is redistributed and enabled to be better retrieved into the extended guide catheter. The funnel tip 52 and the extended portion 53 of the extended guide catheter also facilitate the retrieval of the thrombus. For example, when the ALTC device (e.g., the tubular mesh 8) captures a blood clot inside, the ALTC device 8 can advantageously be axially stretched and radially compressed beyond its working length (e.g., when the retained radially compressed portion has been fully expanded, and / or advanced through the distal end of the guidewire tube 6) to effectively radially squeeze the blood clot to reduce its diameter / width. Fresh blood clots are typically soft and deformable. Applying axial stretch to the ALTC device can squeeze out the fluid within the blood clot, thereby reducing the size of the blood clot and making the blood clot more easily removed from the vascular system. For example Figure 50A-50GAs shown, the ability of the ALTC device to dynamically extend also provides another clinically effective method to eliminate the burden of large clots by redistributing the volume of the clot or thrombus. For example, with current interventional devices such as filters and baskets, when the clots or thrombi are collected and retrieved into a catheter such as a guide catheter or sheath, the clots or thrombi may aggregate together or pool at the bottom of the filter or basket into a large "ball-like" shape and prevent the large "ball-like" thrombus from entering the lumen of the guide catheter or sheath. A similar effect may occur when a smaller inner diameter guide catheter is used for breathing / aspiration. However, the ALTC device can be extended in series from the distal end to create additional length and space within the ALTC device (e.g., Fig.50B , Fig.50D and Fig.50F By extending the distal end of the ALTC device, the clot or thrombus is redistributed within the ALTC device, thereby reducing the globular size of the clot, thrombus or other material for better retrieval within the lumen of the guide catheter ( Fig.50C , Fig.50E , Figure 50G ). These steps may be repeated 2, 3, 4, 5 or more cycles until all clots and thrombi are retrieved into the catheter in a compressed form. Fig.50A and Fig.50CAs shown, the use of an expansion guide catheter with an expandable distal portion consistent with the ALTC device can allow for more effective clot or thrombus removal. The effectiveness of the ALTC device 8 can be further demonstrated in extreme vascular conditions where there is minimal or no distal space available for a conventional thrombectomy catheter to fully axially expand in order to function. The distal space beyond the distal end of the thrombectomy system can be less than about 3 cm, 2 cm, 1 cm, or less in some cases. In other words, the ALTC device 8 can be delivered in a first radially compressed configuration and compressed by the outer sheath. Upon removal of the outer sheath, the ALTC device 8 can be transformed into a radially expanded configuration and configured to capture a thromboembolic obstruction, even though the device can be in an axially compressed configuration. The ALTC device 8 can then be axially expanded, for example, by at least about 1.25x, 1.5x, 2x, 2.5x, 3x, 3.5x, 4x, 4.5x, 5x, 5.5x, 6x, 6.5x, 7x, 8x, 9x, 10x, or more relative to its fully functional axial compressed length, while still maintaining a constant or substantially constant radially expanded diameter throughout the working range, for example, between about 1 cm and about 50 cm, between about 1 cm and about 20 cm, or in some embodiments, about 1 cm to about 10 cm. In some embodiments, the ALTC device 8 has an open proximal end during delivery and / or throughout its working axial length. The thrombus capture guide 11 can advantageously be initially deployed in a compact space while the ALTC device body is retained within the capture catheter shaft 12. Subsequently, the thrombus capture guide is retracted proximally to begin deploying the ALTC device 8. The potential axial expansion length of the ALTC device 8 is not necessarily limited, and in some embodiments can extend to the entire length of the catheter system. The ALTC device 8 can be folded and contained within the capture catheter shaft 12 and the outer sheath 1 during introduction into the vascular system, and expand to deploy the ALTC device 8 when the outer sheath 1 is retracted proximally. The capture catheter shaft 12 can be made of a suitable material, such as but not limited to nylon, polyurethane, Pebax, polyethylene, PET, PTFE, ePTFE, PEEK, polypropylene. It is advantageous and feasible in some embodiments that, as previously described, the capture catheter shaft 12 is deflectable at various positions and in multiple deflectable directions along the length of the shaft to accommodate various tortuous paths, such as entering the right atrium, right ventricle, main pulmonary artery, left and right pulmonary arteries.

[0121] According to the above teachings, various other modifications, adaptations and alternative designs are certainly possible. Therefore, it should be understood that the present invention can be implemented in a manner different from that specifically described herein. It is conceivable that various combinations or sub-combinations of the specific features and aspects of the embodiments disclosed above can be made and still fall within one or more schemes of the present invention. In addition, the disclosure of any specific features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc. of the embodiments herein can be used for all other embodiments set forth herein. Therefore, it should be understood that the various features and aspects of the disclosed embodiments can be combined or replaced with each other to form different modes of the disclosed invention. Therefore, the scope of the present invention disclosed herein is intended not to be limited by the above-mentioned specific disclosed embodiments. Moreover, although the present invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and described in detail herein. However, it should be understood that the present invention is not limited to the specific forms or methods disclosed, but rather, the present invention will cover all modifications, equivalents and alternatives that fall within the spirit and scope of the various embodiments described. Any method disclosed herein does not need to be performed in the order described. The methods disclosed herein include certain actions taken by practitioners; however, they may also include instructions to these actions by any third party, whether express or implied. For example, an action such as "inserting a catheter through the femoral blood vessel" includes "indicating the insertion of a catheter through the femoral blood vessel." The ranges disclosed herein also encompass any and all overlaps, sub-ranges, and combinations thereof. Language such as "at most," "at least," "greater than," "less than," "between," and the like includes the listed numbers. Numbers such as "about," "approximately," and "substantially" preceding a term used herein include the listed numbers (e.g., approximately 10% = 10%), and also represent an amount close to the stated number that can still perform the desired function or achieve the desired result. For example, the terms "about," "approximately," and "substantially" may refer to within less than 10%, within less than 5%, within less than 1%, within less than 0.1%, and within less than 0.01% of the stated number.

Claims

1. A capture system for selected materials within a body, comprising: a capture assembly configured to isolate the unwanted material, the capture assembly including a shape memory and having a distal end connected to a capture guide having a distal opening; The capture assembly is configured to expand the capture guide and the distal open end when the proximal end of the shape memory body is compressed in the delivery system; The shape memory body moves from a first configuration having a first axial length and a second configuration having a second axial length; the shape memory body can be configured to roll, invert, flip and / or variably lengthen proximally or distally from the first configuration to the second configuration; the second axial length is different from the first axial length; and Includes a suction catheter with funnel tip.

2. The capture system of claim 1, further comprising a control line configured to independently move the capture assembly from the first configuration to the second configuration.

3. The capture system of claim 1, further comprising one, two or more capture pull lines.

4. The capture system according to claim 3, wherein: The capture pull wire is configured to extend proximally through the length of the outer sheath.

5. The capture system according to claim 3, wherein: The proximal end of the capture pullwire is configured to push or pull to allow a user to control the adjustment of the axial length of the shape memory body when the shape memory body is axially elongated in the proximal direction.

6. The capture system according to claim 3, wherein: The capture pull wire and capture guide are the only elements attached to the proximal end of the shape memory body.

7. The capture system according to claim 1, wherein: The funnel tip comprises a polymeric material and / or a metallic material.

8. The capture system according to claim 1, wherein: The aspiration catheter is configured to extract a thrombus within the shape memory body.

9. The capture system of claim 1, wherein: The funnel tip is tubular.

10. The capture system of claim 1, wherein: The funnel tip is woven or braided.

11. The capture system of claim 1, wherein: The distal end of the shaft of the aspiration catheter is expandable.

12. The capture system of claim 1, wherein: The funnel tip is attached to the distal end of the shaft of the aspiration catheter to aid in retrieval of thrombus and allow for effective aspiration.

13. The capture system of claim 1, wherein: The shaft of the aspiration catheter creates a path for the aspirated thrombus to travel proximally and out of the body.

14. The capture system of claim 1, wherein: The shaft of the aspiration catheter is deflectable at one or more locations along the length of the shaft.

15. The capture system of claim 1, further comprising a chopper configured to be inserted into the suction catheter.

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