Systems, devices, and methods for treating vascular occlusion

Abstract

Disclosed herein are systems and methods for endovascular treatment of clot material within a blood vessel of a human patient. An apparatus according to an embodiment of the present technology may include, for example, a plurality of interconnected struts forming a unitary structure having a proximal portion and a distal portion. The strut may form a plurality of first cells in the proximal portion and a plurality of second cells smaller than the first cells in the distal portion. The device may be pulled toward clot material within the blood vessel to mate, disrupt, and / or capture the clot material.

Description

[0001] This application is a divisional application of Chinese Patent Application for Invention (Application No.: 202080087833.X, Application Date: October 16, 2020, Invention Title: Systems, Devices, and Methods for Treating Vascular Occlusions).

[0002] Cross - Reference to Related Applications

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 916,044, filed on October 16, 2019, entitled "Systems, Devices, and Methods for Treating Vascular Occlusions", which is hereby incorporated by reference in its entirety. Technical Field

[0004] The present technology generally relates to systems, devices, and methods for endovascular treatment of clot material (e.g., embolisms and / or thrombi) within the blood vessels of a human patient. In particular, some embodiments of the present technology relate to expandable devices for engaging and removing clot material. Background Art

[0005] Thromboembolic events are characterized by occlusion of blood vessels. Thromboembolic disorders (such as stroke, pulmonary embolism, heart attack, peripheral thrombosis, atherosclerosis, etc.) affect many people. These disorders are major causes of morbidity and mortality.

[0006] When an artery is occluded by a clot, tissue ischemia occurs. If the occlusion persists, the ischemia will progress to tissue infarction. However, if blood flow is rapidly re - established, infarction will not occur or will be greatly limited. Failure to re - establish blood flow can correspondingly result in amputation, angina, myocardial infarction, stroke, or even death.

[0007] In the venous circulation, occluding material can also cause serious harm. Blood clots can form in the large veins of the legs and pelvis, which is a common condition known as deep vein thrombosis (DVT). DVT typically occurs where there is a tendency for blood stasis (e.g., long - haul flights, immobility, etc.) and clotting (e.g., cancer, recent surgery, such as orthopedic surgery, etc.). DVT can impede the drainage of venous blood from the legs, resulting in swelling, ulcers, pain, and infection. DVT can also form a reservoir where blood clots can accumulate and then travel to other parts of the body, including the heart, lungs, brain (stroke), abdominal organs, and / or extremities.

[0008] In the pulmonary circulation, unwanted substances can cause harm by blocking the pulmonary artery, which is a condition known as pulmonary embolism. If the blockage is upstream in the main pulmonary artery or a large branch pulmonary artery, it can severely endanger the total blood flow in the lungs and thus the entire body. This can lead to low blood pressure and shock. If the blockage is downstream in a large to medium pulmonary artery branch, it can prevent a large portion of the lungs from participating in gas exchange into the blood, resulting in low blood oxygen and an accumulation of blood carbon dioxide.

[0009] Many prior arts can reconstruct blood flow through occluded blood vessels. For example, embolectomy is a surgical technique involving cutting open the blood vessel and placing a device with a balloon at the end (such as a Fogarty catheter) at the occluded location. Then the balloon is inflated at a point outside the clot and used to suck the occluding substance back to the incision point. Then the surgeon removes the occluding substance. Although this surgical technique is useful, subjecting the patient to surgery can be traumatic and is preferably avoided as much as possible. Additionally, problems can arise with the use of a Fogarty catheter because there is a risk of damaging the inner wall of the blood vessel when withdrawing the catheter.

[0010] Percutaneous methods are also used to reconstruct blood flow. A common percutaneous technique is known as balloon angioplasty, in which a catheter with a balloon at the end is introduced into the blood vessel (e.g., usually introduced by introducing a catheter). Then the catheter with the balloon at the end is advanced to the occluded point and inflated to dilate the stenosis. Balloon angioplasty is suitable for treating vascular stenosis, but it is usually ineffective in treating acute thromboembolism because no occluding substance is removed and restenosis often occurs after dilation. Another percutaneous technique involves placing a catheter near the clot and injecting streptokinase, urokinase, or other thrombolytic agents to dissolve the clot. Unfortunately, thrombolysis usually takes several hours to several days to be successful. Additionally, thrombolytic agents can cause bleeding, and for many patients, thrombolytic agents cannot be used at all.

[0011] There are various devices for performing thrombectomy or removing other foreign bodies. However, it has been found that such devices have structures that are highly complex, can be traumatic to the treated blood vessel, or lack the ability to be properly fixed against the blood vessel. In addition, many devices have highly complex structures, and this high complexity can lead to manufacturing and quality control difficulties as well as delivery problems when passing through tortuous or small-diameter catheters. Less complex devices may allow the user to pull out the clot, especially for inexperienced users, and such devices may not be able to fully capture and / or collect all clot material.

[0012] Therefore, there is a need for improved systems and methods for embolism extraction. Description of the Drawings

[0013] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on clearly illustrating the principles of the present technology.

[0014] Figure 1A and Figure 1B are side views of a clot treatment system in a pre-deployment configuration and a deployed configuration, respectively, configured according to an embodiment of the present technology.

[0015] Figure 1C is configured according to an embodiment of the present technology Figure 1B An enlarged perspective view of the distal portion of the clot treatment system shown.

[0016] Figures 2A to 2C are respectively configured according to an embodiment of the present technology Figures 1A to 1C Side view, proximal-facing perspective view, and distal-facing perspective view of the clot treatment device of the clot treatment system.

[0017] Figure 3 is a flowchart of a process or method for operating a clot treatment system to remove clot material from within the blood vessels of a human patient according to an embodiment of the present technology.

[0018] Figures 4A to 4F is a schematic view of the distal portion of a clot treatment system during a procedure to remove clot material from the blood vessels of a human patient according to an embodiment of the present technology. DETAILED DESCRIPTION

[0019] The present technology generally relates to systems, devices, and methods for removing clot material from the blood vessels of a human patient. In some embodiments, the clot removal system may include a delivery catheter and a clot treatment device. The clot treatment device may include a plurality of interconnected struts that form an integral structure that can move between a compressed configuration and an expanded configuration. In the expanded configuration, the integral structure may include (i) a proximal connection region, (ii) a proximal tapered region extending from the proximal connection region, (iii) a cylindrical region extending from the proximal tapered region, (iv) a distal tapered region extending from the cylindrical region, and (v) a distal connection region extending from the distal tapered region. In some embodiments, a first portion of the struts forms a first unit in the proximal tapered region, and a second portion of the struts forms a second unit in the distal tapered region, the second unit being smaller than the first unit.

[0020] In some embodiments, the system further includes a handle configured to be grasped by an operator, and a first cannula coupled between the handle and a proximal connection region of the clot treatment device. The clot treatment device may be maintained in a compressed configuration within the lumen of the delivery catheter and near the distal terminus of the delivery catheter. To move the clot treatment device to an expanded configuration, the operator may move the handle to advance the first cannula, thereby advancing the clot treatment device past the distal terminus and out of the lumen of the delivery catheter. When the clot treatment device is no longer constrained by the delivery catheter, the clot treatment device may expand (e.g., self-expand) to the expanded configuration. In some embodiments, the system further includes a second cannula that at least partially extends through the first cannula and is coupled to a distal connection region of the clot treatment device. Relative movement between the first cannula and the second cannula may allow the clot treatment device to elongate / shorten and correspondingly radially expand / compress.

[0021] During a procedure to remove clot material from a blood vessel of a human patient, the clot treatment device may be expanded distally of the clot material within the blood vessel and then retracted proximally into the clot material to capture / disrupt the clot material. In one aspect of the technology, a larger first unit of the clot treatment device is configured to receive clot material passing therethrough when the clot treatment device is pulled toward the clot material, and a smaller second unit of the clot treatment device is configured to retain the clot material within the clot treatment device. In another aspect of the technology, the clot treatment device has sufficient radial stiffness (e.g., at a cylindrical region) to inhibit the clot treatment device from slipping (e.g., not engaging) the clot material when the clot treatment device is pulled toward the clot material. Thus, the clot treatment device can be used to capture / disrupt adherent, aggregated, and / or chronic clots that would otherwise be difficult to remove.

[0022] Although many embodiments are described below with respect to systems, devices, and methods for treating pulmonary embolism, other applications and other embodiments beyond those applications and other embodiments described herein are also within the scope of the technology (e.g., endovascular procedures other than embolisms, endovascular procedures for treating cerebral embolisms, endovascular procedures for treating deep vein thrombosis (DVT), etc.). Additionally, several other embodiments of the technology may have configurations, states, components, or processes different from those described herein. Further, it should be understood that specific elements, substructures, advantages, uses, and / or other features of the embodiments described with reference to FIGS. 1 to Figure 4F the specific elements, substructures, advantages, uses, and / or other features of the embodiments described with reference to FIGS. 1 to Figure 4F the suitable elements of the embodiments described with reference to FIGS. 1 to may be used as stand-alone and / or self-sufficient devices. Accordingly, those of ordinary skill in the art will understand that the technology may have other embodiments with additional elements, or that the technology may have embodiments without the following reference to FIGS. 1 toFigure 4F Other embodiments of several features shown and described.

[0023] Regarding the terms "distal" and "proximal" in this specification, unless otherwise indicated, these terms may refer to the relative position of the various parts of the catheter subsystem with respect to the operator and / or the position in the vasculature. Additionally, as used herein, terms such as "backward", "forward", "upward", "downward", etc. do not mean to limit the components mentioned to be used in a specific direction. It should be understood that such terms refer to the orientation of the components mentioned as shown in the drawings; the systems and devices of the present technology can be used in any orientation suitable for the user.

[0024] Figure 1A and Figure 1B is a side view of a clot treatment or clot removal system 100 ("system 100") configured according to an embodiment of the present technology. In Figure 1A it is shown that the system 100 is in a constrained / undeployed configuration, and in Figure 1B it is shown that the system 100 is in an expanded / deployed configuration. Referring together to Figure 1A and Figure 1B in the illustrated embodiment, the system 100 includes a delivery catheter 102 (e.g., a tube, cannula, etc.; also referred to herein as an outer cannula) that defines a lumen and has a proximal end portion 103a and a distal end portion 103b. The proximal end portion 103a of the delivery catheter 102 is coupled to a hub 110, such as a sealable hub, valve, etc. The lumen of the delivery catheter 102 can be fluidly coupled to a port assembly 112 via the hub 110.

[0025] In the illustrated embodiment, the port assembly 112 includes a fluid control device 114 that is fluidly coupled between: (i) a port connector 116 (e.g., a Luer connector / fitting), and (ii) a conduit section 118 that is coupled to the hub 110 (e.g., a branch or side port that is coupled to the hub 110). The fluid control device 114 is actuable to fluidly connect the lumen of the delivery catheter 102 to the port connector 116. In the illustrated embodiment, the fluid control device 114 is a stopcock valve, while in other embodiments, the fluid control device 114 can be a clamp, valve, and / or other suitable fluid control device. During a clot removal procedure using the system 100, various components (e.g., a syringe, a vacuum source, etc.) can be coupled to the port connector 116 to remove fluid from the lumen of the delivery catheter 102 and / or inject fluid into the lumen. For example, in some embodiments, a syringe or other pressure source can be coupled to the port connector 116 and used to draw a vacuum when the fluid control device 114 is closed, and the fluid control device 114 can be opened to instantaneously or almost instantaneously apply a vacuum to the lumen of the delivery catheter 102 (e.g., to create suction in the distal portion 103b to remove clot material). In other embodiments, a constant vacuum source (e.g., a pump) can be coupled to the port assembly 112 to provide a constant suction on the lumen of the delivery catheter 102. In some embodiments, a flush fluid (e.g., saline) can be injected through the port assembly 112 to flush the lumen of the delivery catheter 102.

[0026] In the illustrated embodiment, the system 100 also includes an intermediate cannula 104 (e.g., a catheter, a tube, etc.) that at least partially extends through the lumen of the delivery catheter 102 and defines the lumen, and an inner cannula 106 (e.g., a catheter, a tube, etc.) that at least partially extends through the lumen of the intermediate cannula 104. Thus, in some embodiments, the delivery catheter 102, the intermediate cannula 104, and the inner cannula 106 are coaxially aligned and / or arranged. The system 100 also includes a clot treatment device 130 that is coupled to the intermediate cannula 104 and the inner cannula 106. The delivery catheter 102, the intermediate cannula 104, the inner cannula 106, and the clot treatment device 130 can be collectively referred to as the treatment portion 111 (e.g., the insertion portion) of the system 100. As described in more detail below with reference to Figures 3 to 4F the treatment portion 111 is configured to be inserted through a guide catheter to position the clot treatment device 130 at the treatment site during a clot removal procedure.

[0027] As described in more detail below with reference to Figures 2A to 2C the clot treatment device 130 can be a self-expanding monolithic structure that includes a plurality of interconnected struts. In Figure 1A the pre-deployment configuration shown, the clot treatment device 130 is constrained within the delivery catheter 102 and is thus shielded. In Figure 1BIn the deployed configuration shown, the clot treatment device 130 extends through the distal end portion 103b (e.g., the distal terminus) of the delivery catheter 102 and expands radially.

[0028] Figure 1C is configured according to an embodiment of the present technology Figure 1B An enlarged perspective view of the distal portion of the system 100 shown. In the embodiment shown, the intermediate cannula 104 includes a distal end portion 105b that is coupled to the proximal portion 131a of the clot treatment device 130. In some embodiments, the proximal portion 131a of the clot treatment device 130 includes a plurality of struts that are gathered together and secured to the distal end portion 105b of the intermediate cannula 104. For example, the struts at the proximal portion 131a of the clot treatment device 130 may be secured to the outer surface of the intermediate cannula 104 via an adhesive, fastener, hub, or other means. The inner cannula 106 includes a distal end portion 107 that is coupled to the distal portion 131b of the clot treatment device 130. In some embodiments, the distal portion 131b of the clot treatment device 130 includes a plurality of struts that are gathered together and secured to the distal end portion 107 of the inner cannula 106 via a friction fit, press fit, or the like between the inner cannula 106 and the distal tip 108 (e.g., a trauma-preventing tip). In other embodiments, the struts at the distal portion 131b of the clot treatment device 130 may be secured to the outer surface of the inner cannula 106 via an adhesive, fastener, hub, or other means.

[0029] Referring again together Figure 1A and Figure 1B , the intermediate cannula 104 includes a proximal end portion 105a that is coupled to the handle 120 (e.g., coupled to the distal portion of the handle 120) to operably couple the handle 120 to the clot treatment device 130. Thus, the intermediate cannula 104 extends between the handle 120 and the clot treatment device 130 and operably couples the handle and the clot treatment device. In some embodiments, the proximal end portion of the inner cannula 106 (obscured in Figure 1A and Figure 1B ) is not coupled to any part of the system 100 and floats within the lumen of the intermediate cannula 104. In one aspect of the present technology, this arrangement allows the inner cannula 106 to move relative to the intermediate cannula 104 in response to an external force on the clot treatment device 130, thereby allowing the clot treatment device 130 to longitudinally elongate / shorten and correspondingly radially compress / expand. In other embodiments, the proximal end portion of the inner cannula 106 may be coupled to the actuation mechanism 122 of the handle 120 (in Figure 1A and Figure 1Bshown in dashed lines). The actuation mechanism 122 may be configured to drive the inner cannula 106 proximally and / or distally to shorten and / or elongate the clot treatment device 130, respectively. More particularly, in some embodiments, distal movement of the actuation mechanism 122 relative to the handle 120 may cause the inner cannula 106 to move distally relative to the intermediate cannula 104 to elongate and radially compress the clot treatment device 130, while proximal movement of the actuation mechanism 122 relative to the handle 120 may cause the inner cannula 106 to move proximally relative to the intermediate cannula 104 to shorten and radially expand the clot treatment device 130.

[0030] In the illustrated embodiment, the handle 120 also includes a proximal hub 124 configured to receive a guide wire (not shown) therethrough, such as a Luer hub. The handle 120, the inner cannula 106, and the tip 108 may together define a lumen for receiving a guide wire therethrough. In some embodiments, the guide wire may have a diameter of about 0.035 inches, about 0.018 inches, less than about 0.1 inches, less than about 0.05 inches, etc. In some embodiments, the handle 120 also includes a lock feature 126, such as, for example, a spin lock or a push-turn lock. The lock feature 126 is configured to selectively mate (e.g., lockingly mate) with a mating feature 115 of the hub 110. Locking the handle 120 to the hub 110 via the lock feature 126 and the mating feature 115 fixes the position of the intermediate cannula 104 relative to the delivery catheter 102. In the illustrated embodiment, the intermediate cannula 104 is longer than the delivery catheter 102 such that when the handle 120 is lockingly mated with the hub 110, a portion of the intermediate cannula 104 and the clot treatment device 130 extend distally from the distal end portion 103b of the delivery catheter 102.

[0031] To deploy the clot treatment device 130 from a pre-deployment configuration ( Figure 1A ) to a deployed configuration ( Figure 1B ), the operator may move the handle 120 distally toward the hub 110 and / or may move the hub 110 toward the handle 120. This movement causes the intermediate cannula 104 to advance distally through the delivery catheter 102 and pushes the clot treatment device 130 distally out of the delivery catheter 102. The clot treatment device 130 may self-expand when it is released from the lumen of the delivery catheter 102. When the handle 120 abuts the hub 110, the operator may actuate the lock feature 126 to fix the position of the intermediate cannula 104 relative to the delivery catheter 102, for example, to hold the clot treatment device 130 in the deployed configuration.

[0032] In some embodiments, proximal movement of the handle 120 and / or distal movement of the hub 110 (e.g., from Figure 1B the position shown to Figure 1AThe position shown) can retract the clot treatment device 130 into the delivery catheter 102. That is, in some embodiments, the clot treatment device 130 can be re-sleeved into the delivery catheter 102. In such embodiments, the clot treatment device 130 can be repeatedly expanded and then retracted and compressed into the delivery catheter 102. In some embodiments, the distal end 108 is configured (e.g., sized and shaped) to abut the distal end portion 103b of the delivery catheter 102 prior to deployment ( Figure 1A ). This can inhibit or even prevent the clot treatment device 130 from being fully pulled through the delivery catheter 102, and in some embodiments, can substantially seal the lumen of the delivery catheter 102. In other embodiments, the distal end 108 is sized and shaped to allow the distal end 108 and thus the entire clot treatment device 130 to be retracted through the delivery catheter 102.

[0033] Figures 2A to 2C are a side view, a proximal-facing perspective view, and a distal-facing perspective view of an expanded configuration of a clot treatment device 130 configured according to an embodiment of the present technology. Referring together Figures 2A to 2C , the clot treatment device 130 includes a plurality of struts 240 that together define a plurality of first units 250 (e.g., voids, holes, openings, etc.) and a plurality of second units 252. The struts 240 can have various shapes and sizes, and in some embodiments, the struts 240 can have a thickness and / or diameter between about 0.0125 inches and 0.150 inches, between about 0.075 inches and 0.125 inches, between about 0.090 inches and 0.150 inches, and / or other dimensions. Generally, the struts 240 together form an overall structure configured to engage, capture, disrupt, and / or separate a portion of a thrombus (e.g., a vascular thrombus) from the blood vessel containing the thrombus.

[0034] In the illustrated embodiment, (i) the first units 250 generally face proximally, while the second units 252 generally face distally, and (ii) the first units 250 are larger than the second units 252. As Figure 2A best shown, the clot treatment device 130 includes: (i) a first region 242 including a proximal portion 131a, (ii) a second region 243 distal to the first region 242, (iii) a third (e.g., central) region 244 distal to the second region 243, (iv) a fourth region 245 distal to the third region 244, and (v) a fifth region 246 distal to the fourth region 245 and including a distal portion 131b. In the illustrated embodiment, the struts 240 are clustered together (e.g., positioned close to each other) at the first region 242 and the fifth region 246 to facilitate their respective connections to the intermediate sleeve 104 and the inner sleeve 106, as Figure 1CAs shown. The second region 243 may have a generally conical shape that tapers in the proximal direction (e.g., radially narrows). Similarly, the fourth region 245 may have a generally conical shape that tapers in the distal direction. The third region 244 may have a generally tubular / cylindrical shape that includes, for example, a generally flat outer strut surface / boundary 248. Additionally, in the illustrated embodiment, the first region 242 and the second region 243 have fewer struts 240 than the fourth region 245 and the fifth region 246, thereby defining a larger first unit 250. Conversely, the fourth region 245 and the fifth region 246 have more struts 240 than the first region 242 and the second region 243, thereby defining a smaller second unit 252. The third region 244 may be a transition region where the number of struts 240 increases in the proximal direction (e.g., toward the fourth region 245) such that some of the first unit 250 abuts some of the second unit 252 in the third region 244. In other embodiments, the first unit 250 may be formed only in the second region 243, may occupy the entire third region 244, may extend into the fourth region 245, etc.

[0035] In some embodiments, the clot treatment device 130 is made of a shape memory material (such as a shape memory alloy and / or a shape memory polymer). For example, the clot treatment device 130 may include nitinol and / or a nitinol alloy. Similarly, the clot treatment device 130 may be manufactured using a variety of techniques, including welding, laser welding, cutting, laser cutting, expansion, etc. For example, in some embodiments, the clot treatment device 130 may first be laser cut from a piece of nitinol (e.g., a nitinol tube) and then further shaped using a heat setting process such that the clot treatment device 130 has the shape shown in the expanded configuration. For example, as is known in the art of heat setting nitinol structures, a fixture, mandrel, or mold may be used to hold the clot treatment device 130 in its desired configuration, and then the clot treatment device 130 may be subjected to a suitable heat treatment such that the struts 240 of the clot treatment device 130 assume or otherwise conform to the outer contour of the mandrel or mold. As is well known, the heat setting process may be performed in an oven or a fluidized bed. Thus, the heat setting process may impart the desired shape, geometry, bends, curves, serrations, scallops, voids, holes, etc. in one or more superelastic and / or shape memory materials used to form the clot treatment device 130. Thus, the clot treatment device 130 may be radially constrained without plastic deformation and will self-expand upon release of the radial constraint.

[0036] Generally, the size of the clot treatment device 130 can be selected based on the size (e.g., diameter) of the blood vessel from which the thrombus is to be extracted. In some embodiments, in a fully expanded configuration not constrained within a blood vessel, the clot treatment device 130 can have a length L between about 0.025 inches and 1.50 inches, between about 0.70 inches and 1.15 inches, etc.( Figure 2A ). In some embodiments, in a fully expanded position not constrained within a blood vessel, the clot treatment device 130 can have a maximum diameter D between about 0.025 inches and 1.5 inches, between about 0.71 inches and 1.34 inches, etc.( Figure 2A ; e.g., at the third region 244).

[0037] The clot treatment device 130 is configured (e.g., shaped, sized, angled, formed, etc.) to engage, disrupt, and / or capture clot material from within a blood vessel when the clot treatment device 130 is advanced / retracted against the clot material in an expanded configuration. For example, as described in more detail below with reference to Figures 3 to 4F the clot treatment device 130 can be withdrawn proximally through / against the clot material. In one aspect of the present technique, the larger first unit 250 is configured to receive the clot material passing therethrough when the clot treatment device 130 is pulled toward the clot material, and the smaller second unit 252 (and associated struts 240) are configured to retain the clot material within the clot treatment device 130. In another aspect of the present technique, the clot treatment device 130 has sufficient radial stiffness (e.g., at the third region 244) to inhibit the clot treatment device 130 from slipping from the clot material (e.g., not engaging the clot material) when the clot treatment device 130 is pulled toward the clot material. Thus, the clot treatment device 130 can be used to capture / disrupt adherent, aggregated, and / or chronic clots. In some embodiments, portions of the struts 240 (e.g., at the second region 243) can be sharp and / or can include cutting elements (e.g., blades or knife edges) attached to or otherwise integrated with such portions to further facilitate disruption / cutting of the clot material.

[0038] Figure 3 is a flow chart of a process or method 360 for operating the system 100 to remove clot material from within a blood vessel (e.g., a pulmonary blood vessel) of a patient (e.g., a human patient). Figures 4A to 4F is a schematic illustration of a distal portion of the system 100 inserted through a guiding catheter 470 during a procedure to remove clot material PE from a blood vessel BV of a human patient. Although shown for illustrative purposes in Figures 4A to 4FSome features of method 360 are described in the context of the illustrated embodiments, but those skilled in the art will readily understand that method 360 may be performed using other suitable systems and / or devices described herein.

[0039] Referring Figure 3 to Figure 4A and, at block 361, method 360 may include positioning the distal portion 471 of the guide catheter 470 near the clot mass PE within the blood vessel BV (e.g., at the treatment site). In the illustrated embodiment, the position of the distal terminus of the guide catheter 470 is set near the proximal portion of the clot mass PE. However, in other embodiments, the position of the distal terminus of the guide catheter 470 may be set at least partially within the clot mass PE, or the position of the distal terminus of the guide catheter 470 may be set distal to the clot mass PE. Access to the blood vessel BV may be achieved through the patient's vasculature (e.g., via the femoral vein). In some embodiments, such as when the blood vessel BV is a pulmonary blood vessel, a introducer (e.g., a Y-connector with a hemostatic valve; not shown) is connected to the guide catheter 470 and may be partially inserted into the femoral vein. A guide wire 472 may be guided through the introducer into the femoral vein and guided through the right atrium, tricuspid valve, right ventricle, pulmonary valve, and into the main pulmonary artery. Depending on the position of the clot mass PE, the guide wire 472 may be guided to one or more branches of the right pulmonary artery and / or left pulmonary artery. In some embodiments, the guide wire 472 may extend completely or partially through the clot mass PE. In other embodiments, the guide wire 472 may extend to a position just proximal to the clot mass PE. After positioning the guide wire 472, the guide catheter 470 may be placed over the guide wire 472 and advanced to a position near the clot mass PE, as Figure 4A shown.

[0040] In some embodiments, a pressure source may be coupled to the guide catheter 470 and used to aspirate the lumen of the guide catheter 470 to, for example, generate a force (e.g., as indicated by arrow A) to aspirate / pull a whole or a part of the clot mass PE into the guide catheter 470. For example, in some embodiments, a vacuum may be pre-charged (e.g., in a syringe fluidly coupled to the lumen of the guide catheter 470), and the vacuum may be applied to the lumen of the guide catheter 470 to instantaneously or almost instantaneously create a suction force at the distal portion 471 of the guide catheter 470 (e.g., to create a suction pulse at the distal portion 471 of the guide catheter 470). Specific details of such methods and related devices are disclosed in U.S. Patent Application No. 16 / 536,185, filed on August 8, 2019, entitled "Systems and Related Devices and Methods for Treating Embolisms", which is incorporated herein by reference in its entirety.

[0041] However, even when suction is applied to remove / retrieve clot material PE from blood vessel BV, the suction may not be sufficient to retrieve / destroy all of the clot material PE. For example, many chronic (e.g., aggregated) clots may adhere strongly to the wall of blood vessel BV, making it difficult to remove these clots. In one aspect of the present technology, system 100 can be inserted through guide catheter 470 before, during, and / or after applying suction via guide catheter 470 to engage, disrupt, and / or capture clot material PE, even when clot material PE is strongly adhered within blood vessel BV.

[0042] For example, referring Figure 3 and Figure 4B , at block 362, method 360 may include advancing clot treatment device 130 (compressed within delivery catheter 102 and thus shielded within Figure 4B ) through guide catheter 470 to be near clot material PE. More particularly, in a compressed pre-deployment configuration, the treatment portion 111 of system 100 can be advanced through guide catheter 470 until the position of tip 108 is set distally of (i) the distal portion 471 of guide catheter 470 and (ii) distally of clot material PE within blood vessel BV. In other embodiments, the position of tip 108 can be set within clot material PE. In some embodiments, treatment portion 111 can be advanced over guidewire 472, while in other embodiments, guidewire 472 can be omitted.

[0043] Referring Figure 3 and Figure 4C , at block 363, method 360 may include moving clot treatment device 130 from a compressed pre-deployment configuration to an expanded deployment configuration such that clot treatment device 130 expands distally of and / or partially within clot material PE. For example, as described in detail above with reference to Figure 1A and Figure 1B , an operator of system 100 can advance handle 120 distally toward hub 110 and / or retract hub 110 toward handle 120 to move intermediate sleeve 104 relative to delivery catheter 102 to advance clot treatment device 130 out of delivery catheter 102, thereby allowing clot treatment device 130 to expand (e.g., self-expand) within blood vessel BV. In the illustrated embodiment, clot treatment device 130 (e.g., the outer strut surface 248 of the third region 244) contacts (e.g., engages, abuts, etc.) the wall of blood vessel BV. In some embodiments, clot treatment device 130 is oversized relative to blood vessel BV such that clot treatment device 130 applies a radially outward force on the wall of blood vessel BV. In other embodiments, clot treatment device 130 can be sized such that it does not contact the wall of blood vessel BV.

[0044] ReferringFigure 3 and Figure 4D at block 364, method 360 may include retracting the clot treatment device 130 proximally (e.g., in the direction of arrow B) into / toward the clot mass PE. More particularly, referring to Figure 1A and Figure 1B , the operator may, pull the entire system 100 proximally (e.g., by grasping hub 110 and pulling) to retract the treatment portion 111 through the lumen of the guide catheter 470. As the clot treatment device 130 is retracted, the clot treatment device 130 engages the clot mass PE to capture / disrupt the clot mass PE. For example, the clot mass PE may enter through the first unit 250( Figures 2A to 2C )) and be retained within the clot treatment device 130 by the smaller second unit 252( Figures 2A to 2C ). In one aspect of the present technique, the clot treatment device 130 may shear the clot mass PE from the wall of the blood vessel BV, even when the clot mass PE is strongly adhered to the wall of the blood vessel BV.

[0045] In some embodiments, in the case where the inner cannula 106 floats within the lumen of the intermediate cannula 104, the length L of the clot treatment device 130( Figure 2A ) may increase as the clot treatment device 130 is pulled into / toward the clot mass PE and the intermediate cannula 104 moves proximally relative to the inner cannula 106. In other embodiments, in the case where the system 100 includes an actuation mechanism 122, the operator may actuate the actuation mechanism 122 to increase the longitudinal and / or radial stiffness of the clot treatment device 130 by locking or substantially locking the relative positions of the intermediate cannula 104 and the inner cannula 106.

[0046] Referring to Figure 3 and Figure 4E , at block 365, method 360 may include retracting the clot treatment device 130 and the captured clot mass PE into the lumen of the guide catheter 470. In some embodiments, the clot treatment device 130 may be completely removed from the guide catheter 470. In some embodiments, if any clot mass PE remains in the blood vessel BV, the clot treatment device 130 may be cleaned and blocks 362 to 365 may be repeated to capture the remaining clot mass PE. Alternatively, a new clot treatment device 130 may be reinserted through the guide catheter 470 to capture the remaining clot mass PE. In some embodiments, the clot treatment device 130 may disrupt the clot mass PE without having to capture the clot mass PE, and suction may be applied to the guide catheter 470 after or during the retraction of the clot treatment device 130 to aspirate the remaining clot mass PE into the guide catheter 470. Finally, referring to Figure 3 and Figure 4F, at block 366, method 360 may include removing the guide catheter 470 from the blood vessel BV and from the patient after removing a sufficient portion of the clot material from the patient.

[0047] Several aspects of the present technology are set forth in the following additional examples:

[0048] 1. A clot treatment system, comprising:

[0049] An outer catheter that defines a lumen;

[0050] An inner catheter that is positioned at least partially within the lumen of the outer catheter; and

[0051] A clot treatment device that includes a plurality of interconnected struts that form an integral structure movable between a compressed configuration and an expanded configuration, wherein in the expanded configuration, the integral structure includes—

[0052] A proximal connection region that is coupled to the outer catheter;

[0053] A proximal tapered region that extends from the proximal connection region, wherein a first portion of the struts forms a first unit in the proximal tapered region;

[0054] A cylindrical region that extends from the proximal tapered region;

[0055] A distal tapered region that extends from the cylindrical region, wherein a second portion of the struts forms a second unit in the distal tapered region, and wherein the second unit is smaller than the first unit; and

[0056] A distal connection region that extends from the distal tapered region and is coupled to the inner catheter.

[0057] 2. The clot treatment system of example 1, wherein the inner catheter has (a) a distal end portion coupled to the distal connection region of the clot treatment device and (b) a proximal end portion configured to float within the lumen of the outer catheter.

[0058] 3. The clot treatment system of example 1 or example 2, wherein the inner catheter and the outer catheter are configured to receive a guide wire therethrough.

[0059] 4. The clot treatment system according to any one of Examples 1–3 further includes a handle coupled to the proximal end portion of the outer catheter, wherein the handle includes an actuation mechanism coupled to the proximal end portion of the inner catheter, and wherein actuation of the actuation mechanism is configured to translate the inner catheter relative to the outer catheter to longitudinally compress or longitudinally elongate the clot treatment device.

[0060] 5. The clot treatment system according to any one of Examples 1–4 further includes:

[0061] a delivery catheter that defines a lumen; and

[0062] a handle coupled to the proximal end portion of the outer catheter and movable relative to the delivery catheter between a first position and a second position, wherein—

[0063] in the first position, the clot treatment device is constrained in the lumen of the delivery catheter in the compressed configuration, and

[0064] in the second position, the clot treatment device is positioned distal of the lumen in the expanded configuration.

[0065] 6. The clot treatment system according to Example 5 further includes a hub coupled to the proximal end portion of the delivery catheter, wherein the handle includes a locking feature configured to fix the handle to the hub in the second position.

[0066] 7. The clot treatment system according to Example 5 or Example 6, wherein the handle, the delivery catheter, the outer catheter, and the inner catheter are configured to receive a guide wire therethrough.

[0067] 8. The clot treatment system according to any one of Examples 1–7, wherein in the expanded configuration, the cylindrical region has a diameter between about 0.71 inches and about 1.34 inches.

[0068] 9. The clot treatment system according to any one of Examples 1–8, wherein the struts of the clot treatment device are configured to self-expand from the compressed configuration to the expanded configuration when unconstrained.

[0069] 10. The clot treatment system according to any one of Examples 1–9, wherein the struts of the clot treatment device include a shape memory material.

[0070] 11. The clot treatment system according to any one of Examples 1–10, wherein the overall structure includes (a) a first number of the struts in the proximal conical region and (b) a second number of the struts greater than the first number of struts in the distal conical region.

[0071] 12. A method for clot removal, the method comprising:

[0072] Positioning a distal portion of a guiding catheter near a clot mass within a blood vessel of a human patient;

[0073] Advancing a clot treatment device through the guiding catheter to be near the clot mass;

[0074] Expanding the clot treatment within the blood vessel distal to the clot mass, wherein the clot treatment device includes a plurality of interconnected struts forming an integral structure having a proximal portion and a distal portion, wherein the struts form a plurality of first units in the proximal portion and a plurality of second units in the distal portion, and wherein the first units are larger than the second units;

[0075] Creating a suction force at the distal portion of the guiding catheter; and

[0076] Retracting the clot treatment device proximally through the clot mass.

[0077] 13. The method of example 12, wherein advancing the clot treatment device through the guiding catheter includes advancing the clot treatment device over a guide wire.

[0078] 14. The method of example 12 or 13, wherein the proximal portion of the integral structure is coupled to an outer catheter that at least partially extends through the guiding catheter, and wherein the distal portion of the integral structure is coupled to an inner catheter that at least partially extends through the outer catheter.

[0079] 15. The method of example 14, wherein advancing the clot treatment device through the guiding catheter includes advancing the clot treatment device over a guide wire that extends through the guiding catheter, the outer catheter, and the inner catheter.

[0080] 16. The method of any one of examples 12 - 15, wherein creating a suction force at the distal portion of the guiding catheter includes creating the suction force before retracting the clot treatment device proximally to draw a first portion of the clot mass into the guiding catheter.

[0081] 17. The method of example 16, wherein retracting the clot treatment device proximally includes retracting the clot treatment device proximally through a second portion of the clot mass remaining in the blood vessel to capture the second portion of the clot mass.

[0082] 18. The method according to any one of Examples 12–17, wherein retracting the clot treatment device proximally through the clot mass includes capturing at least a portion of the clot mass, and wherein the method further includes retracting the clot treatment device and the captured clot mass into the guide catheter.

[0083] 19. A clot treatment system, comprising:

[0084] An outer sheath defining a lumen;

[0085] An inner sheath at least partially positioned within the lumen of the outer sheath; and

[0086] A plurality of interconnected struts forming an integral structure having a proximal portion and a distal portion, wherein the proximal portion is coupled to the outer sheath, wherein the distal portion is coupled to the inner sheath, and wherein the struts form a plurality of first units in the proximal portion and a plurality of second units in the distal portion, and wherein the first units are larger than the second units.

[0087] 20. The clot treatment system according to Example 12, wherein the outer sheath and the inner sheath are configured to receive a guide wire therethrough.

[0088] 21. A clot treatment device, comprising:

[0089] A plurality of interconnected struts forming an integral structure movable between a compressed configuration and an expanded configuration, wherein in the expanded configuration, the integral structure includes—

[0090] A proximal connection region;

[0091] A proximal tapered region extending from the proximal connection region, wherein a first portion of the struts forms a first unit in the proximal tapered region;

[0092] A cylindrical region extending from the proximal tapered region;

[0093] A distal tapered region extending from the cylindrical region, wherein a second portion of the struts forms a second unit in the distal tapered region, and wherein the second unit is smaller than the first unit; and

[0094] A distal connection region extending from the distal tapered region.

[0095] 22. The clot treatment device according to Example 21, further comprising:

[0096] A first cannula that is coupled to the proximal connection region and defines a lumen; and

[0097] A second cannula that is coupled to the distal connection region and at least partially extends through the lumen of the first cannula.

[0098] 23. The clot treatment device according to example 21 or example 22, wherein the second cannula has (a) a distal end portion coupled to the distal connection region and (b) a proximal end portion configured to float within the lumen of the first cannula.

[0099] 24. The clot treatment device according to any one of examples 21–23, wherein the struts are configured to self-expand from the compressed configuration to the expanded configuration when unconstrained.

[0100] 25. The clot treatment device according to any one of examples 21–24, wherein the struts are made of a shape memory material.

[0101] 26. A clot treatment device comprising:

[0102] A plurality of interconnected struts that form an integral structure having a proximal portion and a distal portion, wherein the struts form a plurality of first units in the proximal portion and a plurality of second units in the distal portion, and wherein the first units are larger than the second units.

[0103] The detailed description above of embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise forms disclosed above. Although specific embodiments and examples of the present technology have been described above for purposes of illustration, as will be recognized by those skilled in the relevant art, various equivalent modifications can be made within the scope of the present technology. For example, although steps are presented in a given order, alternative embodiments can perform the steps in a different order. The various embodiments described herein can also be combined to provide further embodiments.

[0104] It will be understood from the foregoing that specific embodiments of the present technology are described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where circumstances permit, singular or plural terms may also respectively include plural or singular terms.

[0105] In addition, unless the word “or” is expressly limited to mean only a single item in a list of two or more items excluding any other items, the use of “or” in such a list shall be construed to include (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, the term “comprising” throughout means including at least one or more of the stated features, such that the addition of any greater number of the same features and / or additional types of other features is not excluded. It will also be understood that, for purposes of illustration, specific embodiments have been described herein, but that various modifications may be made without departing from the technology. Moreover, while the advantages associated with certain embodiments of the technology have been described in the context of these embodiments, other embodiments may also exhibit these advantages, and not all embodiments need to exhibit these advantages to fall within the scope of the technology. Accordingly, the present disclosure and the related art may include other embodiments not expressly shown or described herein.

Claims

1. A system for treating clot material in a patient's vascular system, the system comprising: A guiding catheter that defines a lumen and has a distal end portion, wherein the catheter is configured to advance within a blood vessel through the patient's vascular system such that the distal end portion of the guiding catheter is positioned proximate to the clot material; A syringe having a barrel, wherein the syringe is actuatable to create a vacuum pressure within the barrel, wherein the barrel is configured to store the vacuum pressure, and wherein the syringe is configured to be fluidly coupled to the lumen of the guiding catheter to apply the vacuum pressure stored within the barrel to the lumen to aspirate at least a first portion of the clot material into the lumen; and A clot treatment device including a delivery catheter, a shaft, and an expandable member having a proximal end portion fixed to the shaft, wherein— The expandable member includes a plurality of interconnected struts that form an integral structure movable between a compressed configuration within the delivery catheter and an expanded configuration outside the delivery catheter, In the expanded configuration, the integral structure includes (a) a proximal conical region extending from the proximal end portion, (b) a cylindrical region extending from the proximal conical region, and (c) a distal conical region extending from the cylindrical region to the distal end portion of the expandable member, The clot treatment device is configured to be inserted through the guiding catheter with the expandable member in the compressed configuration within the delivery catheter, The clot treatment device is configured to be moved to the expanded configuration outside the delivery catheter away from the guiding catheter, and The expandable member is configured to retract proximally in the expanded configuration to capture at least a second portion of the clot material remaining in the blood vessel after aspirating the first portion of the clot material.

2. The system of claim 1, wherein the clot treatment device further includes a distal tip coupled to the distal end portion of the expandable member.

3. The system of claim 2, wherein the distal tip is configured to abut the distal end of the delivery catheter when the expandable member is in the compressed configuration within the delivery catheter.

4. The system of claim 1, wherein the struts of the expandable member form a first unit in the proximal conical region and a second unit in the distal conical region, and wherein the first unit is larger than the second unit.

5. The system of claim 1, wherein the shaft is a first shaft, and wherein the clot treatment device further includes a second shaft that extends through the first shaft and is coupled to the distal end portion of the expandable member.

6. The system of claim 1, wherein the syringe is fluidly coupled to the lumen of the guiding catheter through a valve, wherein the valve is movable between (a) a first position and (b) a second position, the first position preventing fluid from flowing from the lumen of the guiding catheter to the barrel, the second position allowing fluid to flow from the lumen of the guiding catheter to the barrel.

7. The system according to claim 6, wherein the syringe is configured to be actuated to create a vacuum pressure within the barrel when the valve is in the first position, and wherein the vacuum pressure is stored within the barrel while the valve is movable from the first position to the second position, thereby applying the vacuum pressure to the lumen of the guide catheter to aspirate a first portion of the clot material into the lumen.

8. The system according to claim 1, wherein the expandable member is further configured to contract into the lumen of the guide catheter together with a second portion of the captured clot material in the expanded configuration.

9. The system according to claim 1, wherein the struts of the expandable member are configured to self-expand from a compressed configuration to an expanded configuration when the expandable member is outside the delivery catheter.

10. The system according to claim 1, wherein the struts of the clot treatment device comprise a shape memory material.

11. The system according to claim 1, wherein the syringe is a vacuum pressure lock syringe.

12. The system according to claim 1, wherein the clot material comprises a pulmonary embolism.

13. The system according to claim 1, wherein the clot material comprises a deep vein thrombosis.

14. A system for treating clot material in a patient's vascular system, the system comprising: A guide catheter that defines a lumen and has a distal end portion, wherein the catheter is configured to be advanced within a blood vessel through the patient's vascular system such that the distal end portion of the guide catheter is positioned proximate the clot material; A pressure source configured to generate and store a vacuum pressure, wherein the pressure source is configured to be fluidly coupled to the lumen of the guide catheter to apply the stored vacuum pressure therein to the lumen to aspirate at least a first portion of the clot material into the lumen; and A clot treatment device including a delivery catheter, a shaft, and an expandable member having a proximal end portion secured to the shaft, wherein— The expandable member includes a plurality of interconnected struts that form an integral structure movable between a compressed configuration within the delivery catheter and an expanded configuration outside the delivery catheter, In the expanded configuration, the integral structure includes (a) a proximal tapered region extending from the proximal end portion, (b) a cylindrical region extending from the proximal tapered region, and (c) a distal tapered region extending from the cylindrical region to the distal end portion of the expandable member, The clot treatment device is configured to be inserted through the guide catheter with the expandable member in the compressed configuration within the delivery catheter, The clot treatment device is configured to be moved to the expanded configuration outside the delivery catheter away from the guide catheter, and The expandable member is configured to retract proximally in the expanded configuration to capture at least a second portion of the clot material remaining in the blood vessel after aspirating the first portion of the clot material.

15. The system according to claim 14, wherein the clot treatment device further includes a distal tip coupled to the distal end portion of the expandable member, and wherein the distal tip is configured to abut the distal end of the delivery catheter when the expandable member is in the compressed configuration within the delivery catheter.

16. The system according to claim 14, wherein the syringe is fluidly coupled to the lumen of the guide catheter via a valve, wherein the valve is movable between (a) a first position and (b) a second position, the first position preventing fluid from flowing from the lumen of the guide catheter to the barrel, the second position allowing fluid to flow from the lumen of the guide catheter to the barrel, wherein the syringe is configured to be actuated to create a vacuum pressure within the barrel with the valve in the first position, and wherein the vacuum pressure is stored within the barrel while the valve is movable from the first position to the second position, thereby applying the vacuum pressure to the lumen of the guide catheter to aspirate a first portion of the clot material into the lumen.

17. The system according to claim 16, wherein the clot material comprises a pulmonary embolism or a deep vein thrombosis.

18. The system according to claim 14, wherein the expandable member is further configured to contract into the lumen of the guide catheter together with a second portion of the captured clot material in an expanded configuration.

19. The system according to claim 14, wherein the struts of the expandable member are configured to self-expand from a compressed configuration to an expanded configuration when the expandable member is located outside the delivery catheter.

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