Systems, devices, and methods for treating vascular occlusions

Abstract

Disclosed herein are systems and methods for intravascular treatment of clotted material within a blood vessel of a human patient. Devices according to embodiments of the present technology may include, for example, a plurality of interconnected struts forming an integral structure having a proximal portion and a distal portion. The struts 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 clotted material within a blood vessel to engage, disrupt, and / or capture the clotted material.

Description

[0001] Cross-reference to related applications

[0002] 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 OCCLUSIVE”, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present technology generally relates to systems, devices, and methods for intravascular treatment of clotted material (e.g., emboli and / or thrombus) within a human patient's blood vessel. In particular, some embodiments of the present technology relate to expandable devices for engaging and removing clotted material. Background Art

[0004] Thromboembolic events are characterized by the occlusion of a blood vessel. Thromboembolic disorders (such as stroke, pulmonary embolism, heart attack, peripheral thrombosis, atherosclerosis, etc.) affect many people. These disorders are the main causes of morbidity and mortality.

[0005] When an artery is occluded by a clot, tissue ischemia develops. If the occlusion persists, the ischemia will progress to tissue infarction. However, if blood flow is quickly reestablished, infarction will not develop or will be greatly limited. Failure to reestablish blood flow can, in turn, lead to amputation, angina, myocardial infarction, stroke, or even death.

[0006] In the venous circulation, occlusive substances 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 usually occurs in places where blood stagnation (e.g., long-distance flights, immobility, etc.) and agglomeration (e.g., cancer, recent surgical operations, such as plastic surgery, etc.) tend to occur. DVT may hinder the drainage of venous blood from the legs, resulting in swelling, ulcers, pain and infection. DVT may also form a reservoir in which blood clots may gather and then travel to other parts of the body, including the heart, lungs, brain (stroke), abdominal organs, and / or limbs.

[0007] In the pulmonary circulation, undesirable substances can cause harm by blocking a pulmonary artery, a condition known as a pulmonary embolism. If the blockage is upstream in the main pulmonary artery or a large branch pulmonary artery, it can seriously compromise the total blood flow in the lungs, and therefore 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 prevents a large portion of the lung from participating in the exchange of gases to the blood, resulting in low blood oxygen and a buildup of blood carbon dioxide.

[0008] Many existing technologies can reconstruct blood flow through occluded blood vessels. For example, embolectomy is a surgical technique that involves cutting open a blood vessel and placing a device with a balloon at the end (such as a Fogarty catheter) at the location of the occlusion. The balloon is then inflated at a point outside the clot and used to draw the obstructing material back to the incision point. The surgeon then removes the obstructing material. Although this surgical technique is useful, it can be traumatic to subject a patient to surgery and is best avoided as much as possible. Additionally, using a Fogarty catheter can be problematic because there is a risk of damaging the inner wall of the blood vessel when the catheter is withdrawn.

[0009] Percutaneous methods are also used to reconstruct blood flow. Common percutaneous techniques are referred to as balloon angioplasty, in which a catheter with a balloon at the end is introduced into a blood vessel (e.g., usually introduced by an introductory catheter). The catheter with a balloon at the end is then advanced to the point of occlusion and inflated to dilate the stenosis. Balloon angioplasty is suitable for treating vascular stenosis, but it is usually ineffective for treating acute thromboembolism because no occluding material 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 requires hours to days to be successful. Additionally, thrombolytic agents may cause bleeding, and for many patients, thrombolytic agents cannot be used at all.

[0010] There are various devices for performing thrombectomy or removing other foreign matter. However, it has been found that such devices have highly complex structures that are traumatic to the treated vessel, or lack the ability to be properly secured against the vessel. In addition, many devices have highly complex structures that can lead to manufacturing and quality control difficulties and delivery issues 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 completely capture and / or collect all of the clot material.

[0011] Therefore, there is a need for improved systems and methods for embolic retrieval. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Many aspects of the present technology may 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.

[0013] Figure 1A and Figure 1B Side views of a clot handling system in a pre-deployment configuration and a deployed configuration, respectively, configured in accordance with an embodiment of the present technology.

[0014] Figure 1C is configured according to an embodiment of the present technology Figure 1BAn enlarged perspective view of the distal portion of the clot management system is shown.

[0015] FIG. 2A to FIG. 2C are respectively configured according to embodiments of the present technology Figures 1A to 1C A side view, a proximally facing stereoscopic view, and a distally facing stereoscopic view of a clot handling device of a clot handling system.

[0016] Figure 3 is a flow chart of a process or method for operating a clot management system to remove clot material from within a blood vessel of a human patient in accordance with an embodiment of the present technology.

[0017] 4A to 4F is a schematic diagram of a distal portion of a clot management system according to an embodiment of the present technology during a procedure to remove clotted material from a blood vessel of a human patient. DETAILED DESCRIPTION

[0018] The present technology generally relates to systems, devices, and methods for removing clot material from a blood vessel of a human patient. In some embodiments, the clot removal system may include a delivery catheter and a clot handling device. The clot handling 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 strut forms a first unit in the proximal tapered region, and a second portion of the strut forms a second unit in the distal tapered region that is smaller than the first unit.

[0019] In some embodiments, the system further comprises a handle configured to be grasped by an operator, and a first sleeve coupled between the handle and a proximal connection region of the clot handling device. The clot handling device can maintain a compressed configuration within the lumen of the delivery catheter and near the distal terminal of the delivery catheter. In order to move the clot handling device to an expanded configuration, the operator can move the handle to advance the first sleeve, thereby advancing the clot handling device past the distal terminal and leaving the lumen of the delivery catheter. When the clot handling device is no longer constrained by the delivery catheter, the clot handling device can be expanded (e.g., self-expanded) to an expanded configuration. In some embodiments, the system further comprises a second sleeve that at least partially extends through the first sleeve and is coupled to a distal connection region of the clot handling device. The relative movement between the first sleeve and the second sleeve can allow the clot handling device to lengthen / shorten and correspondingly expand / compress radially.

[0020] During surgery to remove clotted material from a blood vessel of a human patient, a clot handling device may be extended distally of the clotted material within the blood vessel and then retracted proximally into the clotted material to capture / destroy the clotted material. In one aspect of the present technology, a larger first unit of the clot handling device is configured to receive clotted material passing therethrough when the clot handling device is pulled toward the clotted material, and a smaller second unit of the clot handling device is configured to retain the clotted material within the clot handling device. In another aspect of the present technology, the clot handling device has sufficient radial stiffness (e.g., at a cylindrical region) to inhibit the clot handling device from sliding away from the clotted material (e.g., not engaging with the clotted material) when the clot handling device is pulled toward the clotted material. Thus, the clot handling device can be used to capture / destroy adherent, aggregated, and / or chronic clots that would otherwise be difficult to remove.

[0021] Although many embodiments are described below with respect to systems, devices, and methods for treating pulmonary embolism, other applications and other embodiments other than those described herein are also within the scope of the present technology (e.g., endovascular procedures other than embolism, endovascular procedures for treating cerebral embolism, endovascular procedures for treating deep vein thrombosis (DVT), etc.). Additionally, several other embodiments of the technology may have configurations, states, components, or processes that are different from those described herein. Furthermore, it should be understood that with reference to FIGS. 1 to 12 , the present invention may be described in detail. Figure 4F The specific elements, substructures, advantages, uses, and / or other features of the described embodiments may be interchanged, replaced, or otherwise configured with one another as appropriate according to additional embodiments of the present technology. Figure 4F Suitable elements of the described embodiments may be used as stand-alone and / or self-contained devices. Therefore, those skilled in the art will accordingly understand that the technology may have other embodiments with additional elements, or the technology may have no embodiments described below with reference to FIGS. Figure 4F Other embodiments of several features are shown and described.

[0022] With respect to 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. In addition, as used herein, the designations "rearward", "forward", "upward", "downward", etc. are not meant to limit the referenced components to use in a particular orientation. It should be understood that such designations refer to the orientation of the referenced components as shown in the accompanying drawings; the systems and devices of the present technology can be used in any orientation suitable for the user.

[0023] Figure 1A and Figure 1Bis a side view of a clot handling or clot removal system 100 ("system 100") configured in accordance with an embodiment of the present technology. Figure 1A In, the system 100 is in a pre-constraint / deployment configuration, and in Figure 1B , the system 100 is in an expanded / deployed configuration. Figure 1A and Figure 1B In the illustrated embodiment, the system 100 includes a delivery catheter 102 (e.g., a tube, cannula, etc.; may also be referred to herein as an outer cannula) defining a lumen and having 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, a valve, etc. The lumen of the delivery catheter 102 may be fluidically coupled to a port assembly 112 via the hub 110.

[0024] In the illustrated embodiment, the port assembly 112 includes a fluid control device 114 that is fluidically coupled between: (i) a port connector 116 (e.g., a Luer connector / fitting), and (ii) a tubing segment 118 coupled to the hub 110 (e.g., coupled to a branch or side port of the hub 110). The fluid control device 114 is actuatable 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, while in other embodiments, the fluid control device 114 can be a clamp, a 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 instantly or nearly instantly apply a vacuum to the lumen of the delivery catheter 102 (e.g., to create suction at the distal portion 103b to remove clotted material). In other embodiments, a constant vacuum source (e.g., a pump) can be coupled to the port assembly 112 to provide constant suction to the lumen of the delivery catheter 102. In some embodiments, a flushing fluid (e.g., saline) can be injected through the port assembly 112 to flush the lumen of the delivery catheter 102.

[0025] In the illustrated embodiment, the system 100 also includes an intermediate sleeve 104 (e.g., a catheter, a tube, etc.) that at least partially extends through the lumen of the delivery catheter 102 and defines a lumen, and an inner sleeve 106 (e.g., a catheter, a tube, etc.) that at least partially extends through the lumen of the intermediate sleeve 104. Therefore, in some embodiments, the delivery catheter 102, the intermediate sleeve 104, and the inner sleeve 106 are coaxially aligned and / or arranged. The system 100 also includes a clot handling device 130 coupled to the intermediate sleeve 104 and the inner sleeve 106. The delivery catheter 102, the intermediate sleeve 104, the inner sleeve 106, and the clot handling device 130 may be collectively referred to as a handling portion 111 (e.g., an insertion portion) of the system 100. As described below with reference to Figures 3 to 4F Described in more detail, the treatment portion 111 is configured to be inserted through a guide catheter to position the clot treatment device 130 at a treatment site during a clot removal procedure.

[0026] As referenced below FIG. 2A to FIG. 2C In more detail, the clot handling device 130 can be a self-expanding unitary structure comprising a plurality of interconnected struts. Figure 1A In the illustrated pre-deployment configuration, the clot management device 130 is constrained within the delivery catheter 102 and is therefore shielded. Figure 1B In the deployed configuration shown, the clot management device 130 extends through the distal end portion 103b of the delivery catheter 102 (eg, the distal terminal end of the delivery catheter 102) and expands radially.

[0027] Figure 1C is configured according to an embodiment of the present technology Figure 1B An enlarged perspective view of a distal portion of the system 100 is shown. In the illustrated embodiment, the intermediate sleeve 104 includes a distal end portion 105b coupled to the proximal portion 131a of the clot handling device 130. In some embodiments, the proximal portion 131a of the clot handling device 130 includes a plurality of struts that are gathered together and secured to the distal end portion 105b of the intermediate sleeve 104. For example, the struts at the proximal portion 131a of the clot handling device 130 can be secured to the outer surface of the intermediate sleeve 104 via an adhesive, fasteners, a hub, or other means. The inner sleeve 106 includes a distal end portion 107 coupled to the distal portion 131b of the clot handling device 130. In some embodiments, the distal portion 131b of the clot handling device 130 includes a plurality of struts that are grouped together and secured to the distal end portion 107 of the inner cannula 106 via a friction fit, a press fit, etc. between the inner cannula 106 and a distal tip 108 (e.g., an atraumatic tip). In other embodiments, the struts at the distal portion 131b of the clot handling device 130 may be secured to the outer surface of the inner cannula 106 via adhesives, fasteners, a hub, or other devices.

[0028] Let’s refer to it again Figure 1A and Figure 1B , the intermediate sleeve 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 handling device 130. Thus, the intermediate sleeve 104 extends between the handle 120 and the clot handling device 130 and operably couples the handle and the clot handling device. In some embodiments, the proximal end portion (at the distal end of the inner sleeve 106) of the inner sleeve 106 is Figure 1A and Figure 1B 106 is not coupled to any portion of the system 100 and floats within the lumen of the intermediate sleeve 104. In one aspect of the present technology, this arrangement allows the inner sleeve 106 to move relative to the intermediate sleeve 104 in response to external forces on the clot handling device 130, thereby allowing the clot handling device 130 to lengthen / shorten longitudinally and correspondingly compress / expand radially. In other embodiments, the proximal end portion of the inner sleeve 106 may be coupled to the actuation mechanism 122 of the handle 120 (in Figure 1A and Figure 1B 104 to shorten and / or extend the clot-handling device 130, respectively. More particularly, in some embodiments, distal movement of the actuation mechanism 122 relative to the handle 120 may cause the inner sleeve 106 to move distally relative to the intermediate sleeve 104 to extend and radially compress the clot-handling device 130, while proximal movement of the actuation mechanism 122 relative to the handle 120 may cause the inner sleeve 106 to move proximally relative to the intermediate sleeve 104 to shorten and radially expand the clot-handling device 130.

[0029] In the illustrated embodiment, the handle 120 also includes a proximal hub 124, such as a Luer hub, configured to receive a guide wire (not shown) therethrough. The handle 120, the inner sleeve 106, and the end 108 can together define a lumen for receiving a guide wire therethrough. In some embodiments, the guide wire can 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, for example, such as a spin lock or a push-in rotation lock. The lock feature 126 is configured to selectively cooperate (e.g., lockably cooperate) with the mating feature 115 of the hub 110. The handle 120 is locked to the hub 110 via the lock feature 126 and the mating feature 115 to fix the position of the intermediate sleeve 104 relative to the delivery catheter 102. In the illustrated embodiment, the intermediate sleeve 104 is longer than the delivery catheter 102 such that when the handle 120 is lockingly engaged with the hub 110 , a portion of the intermediate sleeve 104 and the clot handling device 130 extend distally from the distal end portion 103b of the delivery catheter 102 .

[0030] In order to change the clot treatment device 130 from the pre-deployment configuration ( Figure 1A ) to expand the 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 advances the intermediate sleeve 104 distally through the delivery catheter 102 and pushes the clot handling device 130 distally out of the delivery catheter 102. The clot handling 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 sleeve 104 relative to the delivery catheter 102, for example, to maintain the clot handling device 130 in the deployed configuration.

[0031] In some embodiments, proximal movement of handle 120 and / or distal movement of hub 110 (e.g., from Figure 1B The location shown to Figure 1A In some embodiments, the clot handling device 130 can be retracted into the delivery catheter 102 (e.g., the position shown). That is, in some embodiments, the clot handling device 130 can be reinserted into the delivery catheter 102. In such embodiments, the clot handling device 130 can be repeatedly expanded and then retracted and compressed into the delivery catheter 102. In some embodiments, the tip 108 is configured (e.g., sized and shaped) to be configured (e.g., Figure 1A) abuts the distal end portion 103b of the delivery catheter 102. This can inhibit or even prevent the clot handling device 130 from being completely pulled through the delivery catheter 102, and in some embodiments, can substantially seal the lumen of the delivery catheter 102. In other embodiments, the tip 108 is sized and shaped to allow the tip 108, and therefore the entire clot handling device 130, to be retracted through the delivery catheter 102.

[0032] FIG. 2A to FIG. 2C 1 and 2 are a side view, a proximal-facing perspective view, and a distal-facing perspective view of an expanded configuration of a clot handling device 130 configured according to an embodiment of the present technology. FIG. 2A to FIG. 2C , the clot handling device 130 includes a plurality of struts 240 that collectively define a plurality of first cells 250 (e.g., voids, holes, openings, etc.) and a plurality of second cells 252. The struts 240 can have a variety of 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 sizes. In general, the struts 240 collectively form an integral structure that is configured to engage, capture, disrupt, and / or separate a portion of a thrombus (e.g., a vascular thrombus) from a vessel containing the thrombus.

[0033] In the illustrated embodiment, (i) the first cell 250 is generally proximally oriented and the second cell 252 is generally distally oriented, and (ii) the first cell 250 is larger than the second cell 252. Figure 2A As best shown, the clot management device 130 includes: (i) a first region 242 including the 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 the distal portion 131b. In the illustrated embodiment, the struts 240 are clustered together (e.g., positioned proximate to one another) at the first region 242 and the fifth region 246 to facilitate their connection to the intermediate sleeve 104 and the inner sleeve 106, respectively, as shown. 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 including, for example, a generally flat outer strut surface / border 248. In addition, 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 cell 250. In contrast, 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 cell 252. The third region 244 may be a transition region in which the number of struts 240 increases in the proximal direction (e.g., toward the fourth region 245) such that some of the first cells 250 abut against some of the second cells 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 to the fourth region 245 , and so on.

[0034] In some embodiments, the clot handling 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 handling device 130 may include nitinol and / or a nitinol alloy. Similarly, the clot handling device 130 may be manufactured using a variety of techniques, including welding, laser welding, cutting, laser cutting, expansion, and the like. For example, in some embodiments, the clot handling device 130 may first be laser cut from a piece of nitinol (e.g., a nitinol tube), and then further formed using a heat setting process so that the clot handling 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, a mandrel, or a mold may be used to hold the clot handling device 130 in its desired configuration, and then the clot handling device 130 may be subjected to a suitable heat treatment so that the pillars 240 of the clot handling device 130 present or otherwise shape 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 a desired shape, geometry, bends, curves, serrations, scallops, voids, holes, etc., into one or more superelastic and / or shape memory materials used to form the clot handling device 130. Thus, the clot handling device 130 may be radially constrained without plastic deformation and will self-expand upon release of the radial constraint.

[0035] In general, the size of the clot handling 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 handling device 130 can have a length L ( 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 management device 130 may have a maximum diameter D ( D ) between about 0.025 inches and 1.5 inches, between about 0.71 inches and 1.34 inches, etc. Figure 2A ; for example, in the third region 244).

[0036] The clot handling 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 handling device 130 is retracted through / against the clot material in the expanded configuration. For example, as described below with reference to Figures 3 to 4F Described in more detail, the clot handling device 130 can be withdrawn proximally through / against the clot material. In one aspect of the present technology, the larger first unit 250 is configured to receive clot material passing therethrough when the clot handling 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 handling device 130. In another aspect of the present technology, the clot handling device 130 has sufficient radial stiffness (e.g., at the third region 244) to inhibit the clot handling device 130 from sliding away from the clot material (e.g., not engaging with the clot material) when the clot handling device 130 is pulled toward the clot material. Thus, the clot handling device 130 can be used to capture / destroy adherent, aggregated, and / or chronic clots. In some embodiments, a portion of the strut 240 (e.g., at the second region 243) can be sharp and / or can include a cutting element (e.g., a knife or blade) attached to or otherwise integrated therewith to further facilitate disruption / cutting of the clotted material.

[0037] Figure 3 is a flow chart of a process or method 360 for operating the system 100 to remove clotted material from within a blood vessel (eg, a pulmonary vessel) of a patient (eg, a human patient) in accordance with an embodiment of the present technology. 4A to 4F 4 is a schematic diagram of a distal portion of a system 100 inserted through a guide catheter 470 during a procedure to remove clotted material PE from a blood vessel BV of a human patient in accordance with an embodiment of the present technology. 4A to 4FCertain features of method 360 are described in the context of the illustrated embodiment, but those skilled in the art will readily appreciate that method 360 may be performed using other suitable systems and / or devices as described herein.

[0038] refer to Figure 3 and Figure 4A , at box 361, method 360 may include setting the position of the distal portion 471 of the guide catheter 470 to be near the clot material PE within the blood vessel BV (e.g., at the treatment site). In the illustrated embodiment, the position of the distal terminal of the guide catheter 470 is set to be near the proximal portion of the clot material PE. However, in other embodiments, the position of the distal terminal of the guide catheter 470 may be at least partially set within the clot material PE, or the position of the distal terminal of the guide catheter 470 may be set distal to the clot material PE. Access to the blood vessel BV may be achieved through the patient's vascular system (e.g., via the femoral vein). In some embodiments, such as when the blood vessel BV is a pulmonary vessel, an introducer (e.g., a Y-shaped connector with a hemostatic valve; not shown) is connected to the guide catheter 470 and may be partially inserted into the femoral vein. The guidewire 472 may be guided into the femoral vein through the introducer and guided through the right atrium, the tricuspid valve, the right ventricle, the pulmonary valve, and into the main pulmonary artery. Depending on the location of the clotted material PE, the guide wire 472 may be guided to one or more branches of the right pulmonary artery and / or the left pulmonary artery. In some embodiments, the guide wire 472 may extend completely or partially through the clotted material PE. In other embodiments, the guide wire 472 may extend to a position just proximal to the clotted material PE. After setting the location of the guide wire 472, the guide catheter 470 may be placed over the guide wire 472 and advanced to the vicinity of the location of the clotted material PE, such as Figure 4A shown.

[0039] In some embodiments, a pressure source may be coupled to the guide catheter 470 and used to draw suction from the lumen of the guide catheter 470 to, for example, generate a force (e.g., as indicated by arrow A) to draw / draw all or a portion of the clot material 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 a vacuum may be applied to the lumen of the guide catheter 470 to instantaneously or nearly instantaneously generate suction at the distal portion 471 of the guide catheter 470 (e.g., to generate 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, entitled “Systems and Related Devices and Methods for Treating Embolism,” filed on August 8, 2019, which is incorporated herein by reference in its entirety.

[0040] However, even in the case where suction is applied to remove / take out the clotted material PE from the blood vessel BV, the suction may not be sufficient to remove / destroy all of the clotted material PE. For example, many chronic (e.g., aggregated) clots may be strongly adhered to the wall of the blood vessel BV, making it difficult to remove these clots. In one aspect of the present technology, the system 100 may be inserted through the guide catheter 470 before, during, and / or after applying suction via the guide catheter 470 to engage, destroy, and / or capture the clotted material PE, even in the case where the clotted material PE is strongly adhered within the blood vessel BV.

[0041] For example, refer to Figure 3 and Figure 4B At block 362, method 360 may include causing the clot handling device 130 (compressed within the delivery catheter 102 and thus Figure 4B 470 to be in the vicinity of the clotted material PE. More particularly, in the compressed pre-deployment configuration, the treatment portion 111 of the system 100 can be advanced through the guide catheter 470 until the position of the tip 108 is disposed (i) distal to the distal portion 471 of the guide catheter 470 and (ii) distal to the clotted material PE within the blood vessel BV. In other embodiments, the position of the tip 108 can be disposed within the clotted material PE. In some embodiments, the treatment portion 111 can be advanced over the guide wire 472, while in other embodiments, the guide wire 472 can be omitted.

[0042] refer to Figure 3 and Figure 4C At block 363, the method 360 may include moving the clot handling device 130 from the compressed pre-deployment configuration to the expanded deployed configuration such that the clot handling device 130 is expanded distally of the clot material PE and / or partially expanded within it. For example, as described above with reference to Figure 1A and Figure 1B Described in detail, the operator of the system 100 can advance the handle 120 distally toward the hub 110 and / or retract the hub 110 toward the handle 120 to move the intermediate sleeve 104 relative to the delivery catheter 102 to advance the clot handling device 130 outside the delivery catheter 102, thereby allowing the clot handling device 130 to expand (e.g., self-expand) within the blood vessel BV. In the illustrated embodiment, the clot handling device 130 (e.g., the outer strut surface 248 of the third region 244) contacts (e.g., fits, is juxtaposed, etc.) the wall of the blood vessel BV. In some embodiments, the clot handling device 130 is oversized relative to the blood vessel BV, so that the clot handling device 130 exerts a radially outward force on the wall of the blood vessel BV. In other embodiments, the clot handling device 130 can be sized so that it does not contact the wall of the blood vessel BV.

[0043] refer to Figure 3 and Figure 4D At block 364, the method 360 may include retracting the clot handling device 130 proximally (eg, in the direction of arrow B) toward / from the clot material PE. More particularly, with reference to Figure 1A and Figure 1B , the operator can pull the entire system 100 proximally (e.g., by grasping the hub 110 to pull) to retract the processing portion 111 through the lumen of the guide catheter 470. When the clot handling device 130 is retracted, the clot handling device 130 cooperates with the clot material PE to capture / destroy the clot material PE. For example, the clot material PE can be removed by the first unit 250 ( FIG. 2A to FIG. 2C )) enters and is occupied by the smaller second unit 252 ( FIG. 2A to FIG. 2C ) is retained within the clot handling device 130. In one aspect of the present technology, the clot handling device 130 can shear clot material PE from the wall of the blood vessel BV even when the clot material PE is strongly adhered to the wall of the blood vessel BV.

[0044] In some embodiments, with the inner sleeve 106 floating within the lumen of the intermediate sleeve 104, the length L of the clot handling device 130 ( Figure 2A ) can increase as the clot handling device 130 is pulled into / toward the clot material PE and the intermediate sleeve 104 moves proximally relative to the inner sleeve 106. In other embodiments, where the system 100 includes an actuation mechanism 122, the operator can actuate the actuation mechanism 122 to increase the longitudinal and / or radial stiffness of the clot handling device 130 by locking or substantially locking the relative positions of the intermediate sleeve 104 and the inner sleeve 106.

[0045] refer to Figure 3 and Figure 4E , at frame 365, the method 360 may include retracting the clot handling device 130 and the captured clot material PE into the lumen of the guide catheter 470. In some embodiments, the clot handling device 130 may be completely removed from the guide catheter 470. In some embodiments, if any clot material PE remains in the blood vessel BV, the clot handling device 130 may be cleaned and frames 362 to 365 may be repeated to capture the remaining clot material PE. Alternatively, a new clot handling device 130 may be reinserted through the guide catheter 470 to capture the remaining clot material PE. In some embodiments, the clot handling device 130 may break up the clot material PE without having to capture the clot material PE, and after or during retraction of the clot handling device 130, suction may be applied to the guide catheter 470 to draw the remaining clot material PE into the guide catheter 470. Finally, reference is made to Figure 3 and Figure 4FAt box 366, method 360 may include removing guide catheter 470 from blood vessel BV and from the patient after removing a sufficient portion of the clotted material from the patient.

[0046] Several aspects of the present technology are illustrated in the following additional examples:

[0047] 1. A clot handling system, comprising:

[0048] an outer catheter defining a lumen;

[0049] an inner catheter positioned at least partially within the lumen of the outer catheter; and

[0050] A clot handling device comprising 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 comprises—

[0051] a proximal connection region coupled to the outer catheter;

[0052] a proximal tapered region extending from the proximal connecting region, wherein a first portion of the strut forms a first cell in the proximal tapered region;

[0053] a cylindrical region extending from the proximal tapered region;

[0054] a distal tapered region extending from the cylindrical region, wherein a second portion of the struts forms a second cell in the distal tapered region, and wherein the second cell is smaller than the first cell; and

[0055] A distal connection region extends from the distal tapered region and is coupled to the inner catheter.

[0056] 2. A clot handling system as described in Example 1, wherein the inner catheter has (a) a distal end portion coupled to the distal connection region of the clot handling device and (b) a proximal end portion configured to float within the cavity of the outer catheter.

[0057] 3. The clot management system of Example 1 or Example 2, wherein the inner catheter and the outer catheter are configured to receive a guide wire therethrough.

[0058] 4. The clot handling system as described in any 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 extend the clot handling device.

[0059] 5. The clot handling system of any one of Examples 1-4, further comprising:

[0060] a delivery catheter defining a lumen; and

[0061] 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—

[0062] In the first position, the clot handling device is constrained in the compressed configuration within the lumen of the delivery catheter, and

[0063] In the second position, the clot management device is positioned distally of the lumen in the expanded configuration.

[0064] 6. The clot handling system as described in 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 secure the handle to the hub in the second position.

[0065] 7. A clot management system as described in 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.

[0066] 8. The clot handling system of any 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.

[0067] 9. A clot handling system as described in any of Examples 1-8, wherein the struts of the clot handling device are configured to self-expand from the compressed configuration to the expanded configuration when unconstrained.

[0068] 10. The clot handling system of any of Examples 1-9, wherein the pillars of the clot handling device comprise a shape memory material.

[0069] 11. A clot handling system as described in any of Examples 1-10, wherein the overall structure includes (a) a first number of the struts in the proximal tapered region and (b) a second number of the struts greater than the first number of struts in the distal tapered region.

[0070] 12. A method for clot removal, the method comprising:

[0071] positioning a distal portion of the guide catheter proximate to clotted material within a blood vessel of a human patient;

[0072] advancing a clot management device through the guide catheter to be proximate to the clot material;

[0073] extending the clot management within the blood vessel distal to the clot material, wherein the clot management device comprises a plurality of interconnected struts forming a unitary structure having a proximal portion and a distal portion, wherein the struts form a plurality of first cells in the proximal portion and a plurality of second cells in the distal portion, and wherein the first cells are larger than the second cells;

[0074] generating suction at the distal portion of the guide catheter; and

[0075] The clot management device is retracted proximally through the clotted material.

[0076] 13. The method of Example 12, wherein advancing the clot handling device through the guide catheter comprises advancing the clot handling device over a guidewire.

[0077] 14. A method as described in Example 12 or Example 13, wherein the proximal portion of the integral structure is coupled to an outer catheter that extends at least partially through the guide catheter, and wherein the distal portion of the integral structure is coupled to an inner catheter that extends at least partially through the outer catheter.

[0078] 15. The method of Example 14, wherein advancing the clot handling device through the guide catheter comprises advancing the clot handling device over a guidewire extending through the guide catheter, the outer catheter, and the inner catheter.

[0079] 16. A method as described in any of Examples 12-15, wherein generating suction at the distal portion of the guide catheter includes generating suction before retracting the clot handling device proximally to draw a first portion of the clot material into the guide catheter.

[0080] 17. A method as described in Example 16, wherein retracting the clot handling device proximally includes retracting the clot handling device proximally through a second portion of the clot material remaining in the blood vessel to capture the second portion of the clot material.

[0081] 18. A method as described in any of Examples 12-17, wherein retracting the clot handling device proximally through the clot material includes capturing at least a portion of the clot material, and wherein the method further includes retracting the clot handling device and the captured clot material into the guide catheter.

[0082] 19. A clot handling system comprising:

[0083] an outer sleeve defining a lumen;

[0084] an inner sleeve positioned at least partially within the lumen of the outer sleeve; and

[0085] 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 sleeve, wherein the distal portion is coupled to the inner sleeve, and wherein the struts form a plurality of first cells in the proximal portion and a plurality of second cells in the distal portion, and wherein the first cells are larger than the second cells.

[0086] 20. The clot management system of Example 12, wherein the outer sleeve and the inner sleeve are configured to receive a guide wire therethrough.

[0087] 21. A clot handling device, comprising:

[0088] a plurality of interconnected struts, the 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 comprises—

[0089] proximal connection area;

[0090] a proximal tapered region extending from the proximal connecting region, wherein a first portion of the strut forms a first cell in the proximal tapered region;

[0091] a cylindrical region extending from the proximal tapered region;

[0092] a distal tapered region extending from the cylindrical region, wherein a second portion of the struts forms a second cell in the distal tapered region, and wherein the second cell is smaller than the first cell; and

[0093] A distal connecting region extends from the distal tapered region.

[0094] 22. The clot handling device of example 21, further comprising:

[0095] a first sleeve coupled to the proximal connection region and defining a lumen; and

[0096] A second cannula is coupled to the distal connection region and extends at least partially through the lumen of the first cannula.

[0097] 23. A clot handling device as described in Example 21 or Example 22, wherein the second sleeve has (a) a distal end portion coupled to the distal connection region and (b) a proximal end portion configured to float within the cavity of the first sleeve.

[0098] 24. A clot handling device as described in any of Examples 21-23, wherein the struts are configured to self-expand from the compressed configuration to the expanded configuration when unconstrained.

[0099] 25. A clot handling device as described in any of Examples 21-24, wherein the struts are made of a shape memory material.

[0100] 26. A clot handling device, comprising:

[0101] 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 cells in the proximal portion and a plurality of second cells in the distal portion, and wherein the first cells are larger than the second cells.

[0102] The above detailed description of the embodiments of the present technology is not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments and examples of the present technology are described above for illustrative purposes, as will be appreciated by those skilled in the relevant art, a variety of equivalent modifications may be made within the scope of the present technology. For example, although the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The multiple embodiments described herein may also be combined to provide further embodiments.

[0103] It will be understood from the foregoing that specific embodiments of the present technology are described herein for illustrative purposes, but to avoid unnecessarily obscuring the description of the embodiments of the present technology, well-known structures and functions are not shown or described in detail. Where the context permits, singular or plural terms may also include plural or singular terms, respectively.

[0104] In addition, unless the word "or" is explicitly limited to refer only to a single item in a list of two or more items that does not include other items, the use of "or" in such a list should be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. In addition, the term "comprising" refers throughout to including at least one or more of the described features, so that additional types of any greater number of the same features and / or other features are not excluded. It will also be understood that, for the purpose of illustration, specific embodiments are described herein, but various modifications may be made without departing from the present technology. In addition, although the advantages associated with certain embodiments of the present 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 present technology. Therefore, the present disclosure and related technologies may include other embodiments not explicitly shown or described herein.

Claims

1. A clot handling system, comprising: a delivery catheter having a distal end portion; an outer catheter defining a lumen; an inner catheter positioned at least partially within the lumen of the outer catheter; and A clot handling device comprising a plurality of interconnected struts forming an integral structure movable between a compressed configuration within the delivery catheter and an expanded configuration outside the delivery catheter, wherein in the expanded configuration the integral structure comprises— a proximal connection region coupled to the outer catheter; a proximal tapered region extending from the proximal connecting region, wherein a first portion of the strut forms a first cell in the proximal tapered region; a cylindrical region extending from the proximal tapered region; a distal tapered region extending from the cylindrical region, wherein a second portion of the struts forms a second cell in the distal tapered region, and wherein the second cell is smaller than the first cell; and a distal connection region extending from the distal tapered region and coupled to the inner catheter; and A distal tip coupled to the inner catheter, wherein the distal tip is configured to abut a distal end portion of the delivery catheter when the clot management device is in a compressed configuration within the delivery catheter.

2. A clot handling system as described in claim 1, wherein the inner catheter has (a) a distal end portion coupled to the distal connection area of ​​the clot handling device and (b) a proximal end portion configured to float within the cavity of the outer catheter.

3. The clot management system of claim 1, wherein the inner catheter and the outer catheter are configured to receive a guide wire therethrough.

4. The clot handling system of claim 1, further comprising a handle coupled to the proximal end portion of the outer catheter, wherein the handle comprises 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 extend the clot handling device.

5. The clot handling system of claim 1, further comprising: wherein the clot handling device is movable relative to the delivery catheter between a first position and a second position, wherein— In the first position, the clot handling device is constrained in the compressed configuration within the lumen of the delivery catheter, and In the second position, the clot management device is positioned distally of the lumen of the delivery catheter in the expanded configuration.

6. A clot management system as described in claim 5, wherein the delivery catheter, the outer catheter, and the inner catheter are configured to receive a guide wire therethrough.

7. The clot handling system of claim 1, wherein in the expanded configuration, the cylindrical region has a diameter between 0.71 inches and 1.34 inches.

8. The clot handling system of claim 1, wherein the struts of the clot handling device are configured to self-expand from the compressed configuration to the expanded configuration when unconstrained.

9. The clot handling system of claim 1, wherein the pillars of the clot handling device comprise a shape memory material.

10. A clot handling system as described in claim 1, wherein the overall structure includes (a) a first number of the struts in the proximal tapered region and (b) a second number of the struts greater than the first number of struts in the distal tapered region.

11. A clot handling system, comprising: a delivery catheter having a distal end portion; an outer sleeve defining a lumen; an inner sleeve, the inner sleeve being positioned at least partially within the lumen of the outer sleeve; and a plurality of interconnected struts, the plurality of interconnected struts forming a unitary structure having a proximal portion and a distal portion, wherein the proximal portion is coupled to the outer sleeve, wherein the distal portion is coupled to the inner sleeve, wherein the unitary structure is configured to be positioned within the delivery catheter in a compressed configuration and to be expanded from the delivery catheter to an expanded configuration, and wherein the struts form a plurality of first cells in the proximal portion and a plurality of second cells in the distal portion, and wherein the first cells are larger than the second cells; and A distal tip is coupled to the inner sleeve, wherein the distal tip is configured to abut a distal end portion of the delivery catheter when the overall structure is in a compressed configuration within the delivery catheter.

12. The clot management system of claim 11, wherein the outer sleeve and the inner sleeve are configured to receive a guide wire therethrough.

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