Systems, devices, and methods for treating vascular occlusion

Abstract

To provide suitable systems, devices, and methods for treating suitable vascular occlusions. [Solution] A system and method for intravascular processing of blood clots in the blood vessels of human patients are disclosed herein. A device according to an embodiment of the art may include, for example, a plurality of interconnected struts forming a single 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 is pulled toward the blood clot in the blood vessel to engage with, break, and / or capture the blood clot.

Description

Technical Field

[0001] Cross - reference to Related Applications 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.

[0002] The present technology generally relates to systems, devices, and methods for the endovascular treatment of thrombotic material (e.g., emboli 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 thrombotic material.

Background Art

[0003] Thromboembolic events are characterized by the occlusion of blood vessels. Thromboembolic disorders such as stroke, pulmonary embolism, heart attack, peripheral thrombosis, and atherosclerosis affect many people. These disorders are a major cause of morbidity and mortality.

[0004] When an artery is occluded by a blood clot, tissue ischemia occurs. If the occlusion persists, the ischemia progresses to tissue infarction. However, if blood flow is rapidly restored, infarction does not occur or is significantly limited. Therefore, if blood flow cannot be restored, there is a risk of limb loss, angina, myocardial infarction, stroke, and even death.

[0005] In venous circulation, occlusive substances can also cause serious harm. Blood clots can form in the large veins of the lower extremities and pelvis, a common condition known as deep vein thrombosis (DVT). DVT generally occurs when there is a tendency for blood to stagnate (e.g., long-distance air travel, immobility) or clot (e.g., recent surgery such as cancer or orthopedic surgery). DVT can obstruct the drainage of venous blood from the lower extremities, leading to swelling, ulcers, pain, and infection. DVT can also create reservoirs where blood clots can collect and then travel to other parts of the body, such as the heart, lungs, brain (stroke), abdominal organs, and / or limbs.

[0006] In the pulmonary circulation, undesirable substances can cause harm by obstructing the pulmonary arteries, a condition known as pulmonary embolism. If the obstruction is upstream, in the main pulmonary artery or major branches, it can severely impair total blood flow in the lungs and thus the entire body. This can lead to hypotension and shock. If the obstruction is downstream, in major to moderate branches of the pulmonary arteries, it can prevent a significant portion of the lungs from participating in gas exchange with the blood, leading to low blood oxygen levels and carbon dioxide buildup.

[0007] There are many existing techniques to restore blood flow through blocked vessels. For example, embolization is a surgical procedure that involves cutting the vessel and placing a balloon-tipped device (such as a Fogarty catheter) at the site of the blockage. The balloon is then inflated beyond the blood clot and used to pull the occluding material back to the incision. The occluding material is then removed by the surgeon. While such surgical procedures have been useful, exposing patients to surgery can be traumatic and should be avoided whenever possible. Furthermore, the use of Fogarty catheters can be problematic because there is a risk of damaging the inner lining of the vessel when the catheter is withdrawn.

[0008] Percutaneous methods are also used to restore blood flow. A common percutaneous technique is called balloon angioplasty, in which a catheter with a balloon tip is introduced into the blood vessel (for example, typically via an introduction catheter). The catheter with the balloon tip is then advanced to the occlusion and inflated to dilate the stenosis. While balloon angioplasty is suitable for treating vascular stenosis, it is generally not effective for treating acute thromboembolism because the occlusive material is not completely removed and restenosis regularly occurs after dilation. Another percutaneous technique involves placing a catheter near the blood clot and injecting streptokinase, urokinase, or other thrombolytic agents to dissolve the clot. Unfortunately, thrombolysis typically takes several hours to several days to be successful. Furthermore, thrombolytic agents can cause bleeding, and in many patients, thrombolytic agents cannot be used at all.

[0009] Various devices exist for performing thrombectomy or removing other foreign bodies. However, such devices have been found to be either extremely complex, cause trauma to the vessel being treated, or lack the ability to be properly fixed to the vessel. Furthermore, the complex structure of many devices poses manufacturing and quality control problems, as well as delivery problems when passing through curved or small-diameter catheters. Less complex devices may allow users, especially inexperienced users, to pass through the blood clot, and such devices may not be able to capture and / or collect all of the blood clot material.

[0010] Therefore, there is a need for improved systems and methods for embolus extraction. [Overview of the Initiative] [Means for solving the problem]

[0011] This technology generally relates to systems, devices, and methods for removing blood clot material from the blood vessels of human patients. In some embodiments, the clot removal system may include a delivery catheter and a clot processing device. The clot processing device may include a plurality of interconnected struts that form a single structure movable between a compression configuration and an expansion configuration. In the expansion configuration, the single structure may include (i) a proximal connecting region, (ii) a proximal conical region extending from the proximal connecting region, (iii) a cylindrical region extending from the proximal conical region, (iv) a distal conical region extending from the cylindrical region, and (v) a distal connecting region extending from the distal conical region. In some embodiments, a first portion of the struts forms a first cell in the proximal conical region, and a second portion of the struts forms a second cell smaller than the first cell in the distal conical region.

[0012] In some embodiments, the system further includes a handle configured to be grasped by an operator, and a first shaft coupled between the handle and the proximal connection region of the clot-forming device. The clot-forming device can be maintained in a compressed configuration within the lumen of the delivery catheter and near the distal end of the delivery catheter. To move the clot-forming device to an expanded configuration, the operator can move the handle to advance the first shaft, thereby advancing the clot-forming device beyond the distal end and out of the lumen of the delivery catheter. When the clot-forming device is no longer constrained by the delivery catheter, the clot-forming device can expand (e.g., self-expand) to an expanded configuration. In some embodiments, the system further includes a second shaft extending at least partially through the first shaft and coupled to the distal connection region of the clot-forming device. Relative movement between the first and second shafts can allow the clot-forming device to be extended / shortened and, accordingly, radially expanded / compressed.

[0013] During a procedure to remove blood clot material from a human patient's blood vessel, a clot-removing device can be expanded distal to the blood clot material within the vessel and then retracted proximally into the blood clot material to capture / disrupt the clot material. In one aspect of the art, a larger first cell of the clot-removing device is configured to receive the blood clot material through it when the clot-removing device is pulled toward the blood clot material, and a smaller second cell of the clot-removing device is configured to hold the blood clot material within the clot-removing device. In another aspect of the art, the clot-removing device has sufficient radial stiffness (e.g., cylindrical region) to prevent the clot-removing device from sliding (e.g., not engaging) the blood clot material when the clot-removing device is pulled toward the blood clot material. Thus, the clot-removing device can be used to capture / disrupt adhered, organized, and / or chronic blood clots that are otherwise difficult to remove.

[0014] Many aspects of this technology can be better understood by referring to the following drawings. The components in the drawings are not necessarily to scale. Instead, the emphasis is on clearly illustrating the principles of this disclosure. The present invention provides, for example, the following: (Item 1) It is a blood clot processing system, An external catheter to define the lumen, An inner catheter, which is at least partially disposed within the lumen of the outer catheter, A blood clot processing device comprising a plurality of interconnected supports that form a single structure movable between a compression configuration and an expansion configuration, In the aforementioned extended configuration, the single structure is The proximal connection region connected to the aforementioned external catheter, A proximal cone region extending from the proximal connection region, wherein the first portion of the support forms a first cell in the proximal cone region, A cylindrical region extending from the aforementioned proximal conical region, A distal conical region extending from the cylindrical region, wherein the second portion of the support forms a second cell in the distal conical region, and the second cell is smaller than the first cell, A blood clot processing system comprising: a distal connecting region extending from the distal conical region and coupled to the internal catheter. (Item 2) The blood clot processing system according to item 1, wherein the inner catheter has (a) a distal end portion coupled to the distal connection region of the blood clot processing device, and (b) a proximal end portion configured to float in the lumen of the outer catheter. (Item 3) The blood clot processing system according to item 1, wherein the inner catheter and the outer catheter are configured to receive a guidewire passing through them. (Item 4) The blood clot processing system according to item 1, further comprising a handle coupled to the proximal end of the outer catheter, the handle comprising an operating mechanism coupled to the proximal end of the inner catheter, wherein the operation of the operating mechanism is configured to move the inner catheter parallel to the outer catheter, thereby compressing or extending the blood clot processing device in the longitudinal direction. (Item 5) A delivery catheter for defining the lumen, The present invention further includes a handle, which is coupled to the proximal end portion of the outer catheter and is movable between a first position and a second position relative to the delivery catheter, In the first position, the blood clot processing device is confined within the lumen of the delivery catheter having the compression configuration. The blood clot processing system according to item 1, wherein, in the second position, the blood clot processing device is located distal to the lumen of the extended configuration. (Item 6) The blood clot processing system according to item 5, further comprising a hub coupled to the proximal end portion of the delivery catheter, wherein the handle includes a locking mechanism configured to secure the handle to the hub in the second position. (Item 7) The blood clot treatment system according to item 5, wherein the handle, the delivery catheter, the outer catheter, and the inner catheter are configured to receive a guide wire passing therethrough. (Item 8) The blood clot treatment system according to item 1, wherein in the expanded configuration, the cylindrical region has a diameter of about 0.71 inches to about 1.34 inches. (Item 9) The blood clot treatment system according to item 1, wherein the struts of the blood clot treatment device are configured to self-expand from the compressed configuration to the expanded configuration when unrestrained. (Item 10) The blood clot treatment system according to item 1, wherein the struts of the blood clot treatment device comprise a shape memory material. (Item 11) The blood clot treatment system according to item 1, wherein the single structure comprises (a) a first number of the struts within the proximal conical region and (b) a second number of the struts within the distal conical region that is greater than the first number of the struts. (Item 12) A method for removing a blood clot, the method comprising: placing a distal portion of a guide catheter proximate to a blood clot substance within a blood vessel of a human patient; advancing a blood clot treatment device through the guide catheter to be proximate to the blood clot substance; expanding the blood clot treatment within the blood vessel distal to the blood clot substance, the blood clot treatment device comprising interconnected struts forming a single structure having a proximal portion and a distal portion, the struts forming a plurality of first cells in the proximal portion and a plurality of second cells in the distal portion, the first cells being larger than the second cells; generating suction at the distal portion of the guide catheter; retracting the blood clot treatment device proximally through the blood clot material. (Item 13) The method according to item 12, wherein advancing the thrombus treatment device through the guide catheter includes advancing the thrombus treatment device on a guide wire. (Item 14) The method according to item 12, wherein the proximal portion of the single structure is coupled to an outer catheter that at least partially extends through the guide catheter, and the distal portion of the single structure is coupled to an inner catheter that at least partially extends through the outer catheter. (Item 15) The method according to item 14, wherein advancing the thrombus treatment device through the guide catheter includes advancing the thrombus treatment device on a guide wire through the guide catheter, the outer catheter, and the inner catheter. (Item 16) The method according to item 12, wherein generating the suction at the distal portion of the guide catheter includes generating the suction to suck a first portion of the thrombus material into the guide catheter before retracting the thrombus treatment device proximally. (Item 17) The method according to item 16, wherein retracting the thrombus treatment device proximally includes retracting the thrombus treatment device proximally through a second portion of the thrombus material remaining in the blood vessel to capture the second portion of the thrombus material. (Item 18) The method according to item 12, wherein retracting the thrombus treatment device proximally through the thrombus material includes capturing at least a portion of the thrombus material, and the method further includes retracting the thrombus treatment device and the captured thrombus material into the guide catheter. (Item 19) A thrombus treatment system, An outer shaft defining a lumen, An inner shaft at least partially disposed within the lumen of the outer shaft, A blood clot processing system comprising: a plurality of interconnected struts forming a single structure having a proximal portion and a distal portion, wherein the proximal portion is connected to the outer shaft and the distal portion is connected to the inner shaft, and the struts form a plurality of first cells in the proximal portion and a plurality of second cells in the distal portion, the first cells being larger than the second cells. (Item 20) The blood clot processing system according to item 12, wherein the outer shaft and the inner shaft are configured to receive a guide wire passing through them. [Brief explanation of the drawing]

[0015] [Figure 1A] This is a side view of the blood clot processing system in its pre-deployment configuration, as configured according to an embodiment of this technology. [Figure 1B] This is a side view of a blood clot processing system in a deployed configuration, configured according to an embodiment of this technology. [Figure 1C] Figure 1B is an extended perspective view of the distal portion of the blood clot processing system shown in Figure 1B, configured according to an embodiment of this technology. [Figure 2A] Figures 1A to 1C are side views of the blood clot processing device in the blood clot processing system configured according to an embodiment of this technology. [Figure 2B] Figures 1A to 1C show a proximal perspective view of the blood clot processing device in a blood clot processing system configured according to an embodiment of this technology. [Figure 2C] Figures 1A to 1C show distal perspective views of the blood clot processing device in the blood clot processing system configured according to an embodiment of this technology. [Figure 3] This is a flowchart of a process or method for operating a blood clot processing system to remove blood clot material from within the blood vessels of a human patient, according to an embodiment of this technology. [Figure 4A] This is a schematic diagram of the distal portion of the blood clot processing system during the procedure for removing blood clot material from the blood vessels of a human patient, according to an embodiment of this technology. [Figure 4B]This is a schematic diagram of the distal portion of the blood clot processing system during the procedure for removing blood clot material from the blood vessels of a human patient, according to an embodiment of this technology. [Figure 4C] This is a schematic diagram of the distal portion of the blood clot processing system during the procedure for removing blood clot material from the blood vessels of a human patient, according to an embodiment of this technology. [Figure 4D] This is a schematic diagram of the distal portion of the blood clot processing system during the procedure for removing blood clot material from the blood vessels of a human patient, according to an embodiment of this technology. [Figure 4E] This is a schematic diagram of the distal portion of the blood clot processing system during the procedure for removing blood clot material from the blood vessels of a human patient, according to an embodiment of this technology. [Figure 4F] This is a schematic diagram of the distal portion of the blood clot processing system during the procedure for removing blood clot material from the blood vessels of a human patient, according to an embodiment of this technology. [Modes for carrying out the invention]

[0016] Many embodiments of systems, devices, and methods for treating pulmonary embolism are described below, but other uses and embodiments beyond those described herein are within the scope of this technology (e.g., endovascular procedures other than those for treating embolism, endovascular procedures for treating cerebral embolism, endovascular procedures for treating deep vein thrombosis (DVT), etc.). Furthermore, some other embodiments of this technology may have different configurations, states, components, and / or procedures than those described herein. Moreover, it will be understood that certain elements, substructures, advantages, uses, and / or other features of the embodiments described with reference to Figures 1-4F may be appropriately interchangeable, replaced, or otherwise comprised of each other according to additional embodiments of this technology. Furthermore, suitable elements of the embodiments described with reference to Figures 1-4F can be used as standalone and / or self-contained devices. Therefore, those skilled in the art will understand accordingly that the technology may have other embodiments with additional elements, or that the technology may have other embodiments without some of the features shown and described below with reference to Figures 1-4F.

[0017] With regard to the terms “distal” and “proximal” in this description, unless otherwise specified, these terms may refer to the relative position of a part of the catheter subsystem with respect to the operator and / or a location within the vascular system. Furthermore, as used herein, indications such as “posterior,” “anterior,” “superior,” and “inferior” do not imply that the referred components must be used in a particular orientation. Such indications will be understood to refer to the orientation of the referred components, as shown in the figures. The systems and devices of this technology can be used in any orientation suitable for the user.

[0018] Figures 1A and 1B are side views of a blood clot processing or blood clot removal system 100 ("System 100") configured according to embodiments of the present technology. In Figure 1A, System 100 is in a constrained / pre-deployment configuration, and in Figure 1B, System 100 is in an extended / deployed configuration. Referring together to Figures 1A and 1B, in the illustrated embodiment, System 100 includes a delivery catheter 102 (e.g., a tube, shaft, etc.; also referred to herein as an outer shaft) 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 connected to a port assembly 112 via the hub 110.

[0019] In the illustrated embodiment, the port assembly 112 includes a fluid control device 114 fluidly connected between (i) a port connector 116 (e.g., a Luer connector / fitting) and (ii) a tubular section 118 coupled to a hub 110 (e.g., to a branch or lateral port of the hub 110). The fluid control device 114 is operable 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, and in other embodiments, the fluid control device 114 may be a clamp, a valve, and / or other suitable fluid control device. During a blood clot removal procedure using the system 100, various components (e.g., syringes, vacuum sources, etc.) can be coupled to the port connector 116 to remove fluid from the lumen of the delivery catheter 102 and / or inject fluid therein. For example, in some embodiments, a syringe or other pressure source can be coupled to the port connector 116 and used to draw in a vacuum while the fluid control device 114 is closed, and then the fluid control device 114 can be opened instantaneously or nearly instantaneously to apply a vacuum to the lumen of the delivery catheter 102 (e.g., to generate suction at the distal portion 103b to remove blood clot material). In other embodiments, a constant vacuum source (e.g., a pump) can be coupled to the port assembly 112 to provide continuous suction to the lumen of the delivery catheter 102. In some embodiments, a flushing fluid (e.g., saline solution) can be injected through the port assembly 112 to flush the lumen of the delivery catheter 102.

[0020] In the illustrated embodiment, system 100 further includes an intermediate shaft 104 (e.g., a catheter, tube, etc.) that extends at least partially through the lumen of the delivery catheter 102 and defines the lumen, and an inner shaft 106 (e.g., a catheter, tube, etc.) that extends at least partially through the lumen of the intermediate shaft 104. Thus, in some embodiments, the delivery catheter 102, the intermediate shaft 104, and the inner shaft 106 are coaxially aligned / arranged. System 100 further includes a clot removal device 130 coupled to the intermediate shaft 104 and the inner shaft 106. The delivery catheter 102, the intermediate shaft 104, the inner shaft 106, and the clot removal device 130 can collectively be referred to as the processing portion 111 (e.g., the insertion portion) of system 100. As will be described in more detail below with reference to Figures 3-4F, the processing portion 111 is configured to be inserted through a guide catheter to position the clot removal device 130 at the treatment site during a clot removal procedure.

[0021] As will be described in more detail below with reference to Figures 2A-2C, the blood clot processing device 130 may be a self-expanding single structure comprising multiple interconnected struts. In the pre-deployment configuration shown in Figure 1A, the blood clot processing device 130 is confined within the delivery catheter 102 and therefore concealed. In the deployed configuration shown in Figure 1B, the blood clot processing device 130 extends beyond the distal end portion 103b of the delivery catheter 102 (e.g., the distal end of the delivery catheter 102) and expands radially.

[0022] Figure 1C is an extended perspective view of the distal portion of the system 100 shown in Figure 1B, configured according to an embodiment of the present technology. In the illustrated embodiment, the intermediate shaft 104 includes a distal end portion 105b coupled to the proximal portion 131a of the blood clot processing device 130. In some embodiments, the proximal portion 131a of the blood clot processing device 130 includes a plurality of struts that are assembled together and fixed to the distal end portion 105b of the intermediate shaft 104. For example, the struts of the proximal portion 131a of the blood clot processing device 130 can be fixed to the outer surface of the intermediate shaft 104 via adhesive, fasteners, hubs or other devices. The inner shaft 106 includes a distal end portion 107 coupled to the distal portion 131b of the blood clot processing device 130. In some embodiments, the distal portion 131b of the blood clot processing device 130 includes a plurality of struts that are assembled together and fixed to the distal end portion 107 of the inner shaft 106 via friction fitting, press-fitting, or the like between the inner shaft 106 and the distal tip 108 (e.g., non-traumatic tip). In other embodiments, the struts of the distal portion 131b of the blood clot processing device 130 can be fixed to the outer surface of the inner shaft 106 via adhesive, fasteners, hubs, or other devices.

[0023] Referring again to Figures 1A and 1B, the intermediate shaft 104 includes a proximal end portion 105a coupled to the handle 120 (e.g., to the distal portion of the handle 120) in order to operably couple the handle 120 to the blood clot processing device 130. Thus, the intermediate shaft 104 extends between the handle 120 and the blood clot processing device 130 and is operably coupled. In some embodiments, the proximal end portion of the inner shaft 106 (hidden in Figures 1A and 1B) is not coupled to any part of the system 100 and floats within the lumen of the intermediate shaft 104. In one aspect of the art, this arrangement allows the inner shaft 106 to move relative to the intermediate shaft 104 in response to an external force acting on the blood clot processing device 130, thereby allowing the blood clot processing device 130 to extend / shorten longitudinally and compress / expand radially accordingly. In other embodiments, the proximal end portion of the inner shaft 106 can be coupled to an actuation mechanism 122 of the handle 120 (shown by dashed lines in Figures 1A and 1B). The actuation mechanism 122 can be configured to drive the inner shaft 106 proximal and / or distal to shorten and / or extend the blood clot processing device 130, respectively. More specifically, in some embodiments, distal movement of the actuation mechanism 122 relative to the handle 120 can move the inner shaft 106 distal to the intermediate shaft 104, thereby extending and radially compressing the blood clot processing device 130, while proximal movement of the actuation mechanism 122 relative to the handle 120 can move the inner shaft 106 proximal to the intermediate shaft 104, thereby shortening and radially expanding the blood clot processing device 130.

[0024] In the illustrated embodiment, the handle 120 further includes a proximal hub 124, such as a Luer hub, configured to receive a guidewire (not shown) through it. The handle 120, the inner shaft 106, and the tip 108 together can define a lumen for receiving the guidewire through it. In some embodiments, the guidewire 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 further includes a locking function 126, such as a spin lock or a push-in and turn lock. The locking function 126 is configured to selectively engage (e.g., lock engage) with a mating function 115 of the hub 110. By locking the handle 120 to the hub 110 via the locking function 126 and the mating function 115, the position of the intermediate shaft 104 relative to the delivery catheter 102 is fixed. In the illustrated embodiment, the intermediate shaft 104 is longer than the delivery catheter 102 such that when the handle 120 is locked engaged with the hub 110, a portion of the intermediate shaft 104 and the blood clot processing device 130 extends distally from the distal end portion 103b of the delivery catheter 102.

[0025] To deploy the blood clot processing device 130 from its pre-deployment configuration (Figure 1A) to its deployed configuration (Figure 1B), the operator can move the handle 120 distally toward the hub 110 and / or move the hub 110 toward the handle 120. This movement advances the intermediate shaft 104 distally through the delivery catheter 102, pushing the blood clot processing device 130 distally away from the delivery catheter 102. The blood clot processing device 130 can self-expand when released from the lumen of the delivery catheter 102. When the handle 120 is adjacent to the hub 110, the operator can activate the locking function 126 to fix the position of the intermediate shaft 104 relative to the delivery catheter 102, for example, to maintain the blood clot processing device 130 in the deployed configuration.

[0026] In some embodiments, proximal movement of the handle 120 and / or distal movement of the hub 110 (e.g., from the position shown in Figure 1B to the position shown in Figure 1A) can pull the clot-forming device 130 back into the delivery catheter 102. That is, in some embodiments, the clot-forming device 130 can be resheathed within the delivery catheter 102. In such embodiments, the clot-forming device 130 can be repeatedly expanded and then contracted and compressed within the delivery catheter 102. In some embodiments, the tip 108 is configured (e.g., sized and shaped such that) in the pre-deployment configuration (Figure 1A) to be adjacent to the distal end portion 103b of the delivery catheter 102. This can prevent or restrict the clot-forming 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 tip 108 is sized and shaped such that the tip 108, and therefore the entire clot-forming device 130, can be retracted through the delivery catheter 102.

[0027] Figures 2A-2C are a side view, a proximal perspective view, and a distal perspective view, respectively, of an extended configuration blood clot processing device 130 configured according to an embodiment of the present art. Referring together to Figures 2A-2C, the blood clot processing device 130 comprises a plurality of struts 240 that define together a plurality of first cells 250 (e.g., gaps, pores, openings, etc.) and a plurality of second cells 252. The struts 240 can have various shapes and sizes, and in some embodiments, the struts 240 can have thicknesses and / or diameters of about 0.0125-0.150 inches, about 0.075-0.125 inches, about 0.090-0.150 inches, and / or other dimensions. Generally, the struts 240 together form a single structure configured to engage with, capture, break up, and / or separate a portion of the blood vessel containing the thrombus (e.g., a vascular thrombus) from the blood vessel containing the thrombus.

[0028] In the illustrated embodiment, (i) the first cell 250 is generally proximal and the second cell 252 is generally distal, and (ii) the first cell 250 is larger than the second cell 252. As is best seen in Figure 2A, the blood clot processing device 130 includes (i) a first region 242 containing 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 containing a distal portion 131b. In the illustrated embodiment, the struts 240 are brought together in a first region 242 and a fifth region 246 (e.g., positioned close to each other) to facilitate their connection to the intermediate shaft 104 and the inner shaft 106, respectively, as shown in Figure 1C. The second region 243 may have a conical shape that generally tapers proximally (e.g., narrows radially). Similarly, the fourth region 245 may have a conical shape that generally tapers distally. The third region 244 generally has a tubular / cylindrical shape, for example, including a generally flat outer strut surface / boundary 248. Furthermore, 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. 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 smaller second cells 252. The third region 244 may be a transitional region in which the number of struts 240 increases proximal (for example, toward the fourth region 245), and as a result, some of the first cells 250 are adjacent to some of the second cells 252 in the third region 244. In other embodiments, the first cell 250 may be formed only in the second region 243, may occupy the entire third region 244, may extend into the fourth region 245, and so on.

[0029] In some embodiments, the blood clot processing device 130 is made from a shape memory material such as a shape memory alloy and / or a shape memory polymer. For example, the blood clot processing device 130 may include nitinol and / or a nitinol alloy. Similarly, the blood clot processing device 130 can be made using a variety of techniques, including welding, laser welding, cutting, laser cutting, and expansion. For example, in some embodiments, the blood clot processing device 130 can first be laser cut from a piece of nitinol (e.g., a nitinol tube) and then further shaped using a heat-setting process so that the blood clot processing device 130 has the shape shown in the expanded configuration. For example, as is known in the field of heat-set nitinol structures, the blood clot processing device 130 can be held in its desired configuration using a fixture, mandrel, or mold, and then the blood clot processing device 130 can be subjected to appropriate heat treatment so that the support 240 of the blood clot processing device 130 takes the shape of the outer contour of the mandrel or mold, or otherwise sets the shape. The heat-setting process can be carried out in an oven or a fluidized bed, as is well known. Thus, the heat-setting process can result in a desired shape, geometric shape, bend, curve, sawtooth, scallop, void, hole, etc., in a superelastic and / or shape-memory material or multiple material used to form the blood clot processing device 130. Thus, the blood clot processing device 130 can be radially constrained without plastic deformation and self-expand when the radial constraint is released.

[0030] Generally, the size of the blood clot preparation device 130 can be selected based on the size (e.g., diameter) of the blood vessel from which the thrombus is extracted. In some embodiments, in a fully expanded configuration not confined within a blood vessel, the blood clot preparation device 130 may have a length L (Figure 2A) such as approximately 0.025 to 1.50 inches, or approximately 0.70 to 1.15 inches. In some embodiments, in a fully expanded position not confined within a blood vessel, the blood clot preparation device 130 may have a maximum diameter D (Figure 2A; e.g., third region 244) such as approximately 0.025 to 1.5 inches, or approximately 0.71 to 1.34 inches.

[0031] The clot processing device 130 is configured to engage, break, and / or capture (e.g., shape, size, angle, form, etc.) the clot material from within the blood vessel when the clot processing device 130 is retracted through / towards the clot material in an extended configuration. For example, as will be described in more detail below with reference to Figures 3-4F, the clot processing device 130 can be retracted proximal to / towards the clot material. In one aspect of the present technology, a larger first cell 250 is configured to receive the clot material through it when the clot processing device 130 is retracted towards the clot material, and a smaller second cell 252 (and connecting strut 240) is configured to hold the clot material within the clot processing device 130. In another aspect of this technology, the blood clot processing device 130 has sufficient radial rigidity (e.g., a third region 244) to prevent the blood clot processing device 130 from sliding (e.g., failing to engage) with the blood clot material when the blood clot processing device 130 is pulled against the blood clot material. Thus, attached, organized, and / or chronic blood clots can be captured / broken using the blood clot processing device 130. In some embodiments, a portion of the support column 240 (e.g., a second region 243) can be sharpened and / or include a cutting element (e.g., a knife or knife edge) attached thereto or otherwise integrated therewith to further facilitate the breakdown / cutting of the blood clot material.

[0032] Figure 3 is a flowchart of a process or method 360 for operating system 100 to remove blood clot material from a patient's (e.g., human patient's) blood vessel (e.g., pulmonary blood vessel) according to an embodiment of the present technology. Figures 4A–4F are schematic diagrams of the distal portion of system 100 inserted through guide catheter 470 during a procedure to remove blood clot material PE from a patient's blood vessel BV according to an embodiment of the present technology. While some features of method 360 are described in the context of the embodiments shown in Figures 4A–4F for illustrative purposes, those skilled in the art will readily understand that method 360 can be performed using other suitable systems and / or devices described herein.

[0033] Referring to Figures 3 and 4A, in block 361, method 360 may include positioning the distal portion 471 of the guide catheter 470 in close proximity to the blood clot PE within the vascular BV (e.g., at the treatment site). In the illustrated embodiment, the distal end of the guide catheter 470 is positioned in close proximity to the proximal portion of the blood clot PE. However, in other embodiments, the distal end of the guide catheter 470 may be positioned at least partially within the blood clot PE, or the distal end of the guide catheter 470 may be positioned distal to the blood clot PE. Access to the vascular BV can be achieved, for example, via the patient's vascular system, for example, via the femoral vein. In some embodiments, such as when the vascular BV is a pulmonary vessel, an introducer (e.g., a Y-connector with a hemostatic valve; not shown) may be connected to the guide catheter 470 and partially inserted into the femoral vein. The guidewire 472 may be guided into the femoral vein via the introducer and navigated through the right atrium, tricuspid valve, right ventricle, and pulmonary artery to the main pulmonary artery. Depending on the location of the blood clot PE, the guidewire 472 can be guided to one or more branches of the right and / or left pulmonary arteries. In some embodiments, the guidewire 472 can be extended completely or partially through the blood clot PE. In other embodiments, the guidewire 472 can be extended to a position immediately proximal to the blood clot PE. As shown in Figure 4A, after positioning the guidewire 472, the guide catheter 470 can be positioned on the guidewire 472 and advanced to a position close to the blood clot PE.

[0034] In some embodiments, a pressure source can be coupled to the guide catheter 470 and used to draw in the lumen of the guide catheter 470 to generate suction (for example, as indicated by arrow A) to draw in all or part of the blood clot material PE into the guide catheter 470. In some embodiments, for example, a vacuum can be pre-filled (for example, in a syringe fluid-connected to the lumen of the guide catheter 470) and applied to the lumen of the guide catheter 470 to generate instantaneous or near-instantaneous suction at the distal portion 471 of the guide catheter 470 (for example, to generate an suction pulse at the distal portion 471 of the guide catheter 470). Specific details of such methods and associated devices are disclosed in U.S. Patent Application No. 16 / 536,185, filed on August 8, 2019, entitled “SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED DEVICES AND METHODS,” which is incorporated herein by reference in its entirety.

[0035] However, even when aspiration is applied to remove / dislodge blood clot material PE from the blood vessel BV, aspiration may not be sufficient to remove / dislodge all blood clot material PE. For example, many chronic (e.g., organized) blood clots can adhere strongly to the walls of the blood vessel BV, making them difficult to remove. In one aspect of this technology, system 100 can be inserted through a guide catheter 470 before, during, and / or after aspiration is applied via the guide catheter 470, and can engage, dislodge, and / or capture blood clot material PE even if it is strongly adhered within the blood vessel BV.

[0036] For example, referring to Figures 3 and 4B, in block 362, method 360 may include advancing a blood clot processing device 130 (compressed within the delivery catheter 102 and therefore concealed in Figure 4B) through a guide catheter 470 to bring it into contact with the blood clot material PE. More specifically, the processing portion 111 of system 100 can advance through the guide catheter 470 in a compressed pre-deployed configuration until its tip 108 is positioned (i) distal to the distal portion 471 of the guide catheter 470 and (ii) distal to the blood clot material PE in the blood vessel BV. In other embodiments, the tip 108 may be positioned within the blood clot material PE. In some embodiments, the processing portion 111 can advance on a guidewire 472, while in other embodiments, the guidewire 472 may be omitted.

[0037] Referring to Figures 3 and 4C, in block 363, method 360 may include moving the clot preparation device 130 from a compressed pre-deployment configuration to an expanded deployed configuration so that the clot preparation device 130 expands distally to and / or partially within the clot material PE. For example, as described in detail above with reference to Figures 1A and 1B, the operator of system 100 moves the intermediate shaft 104 relative to the delivery catheter 102 by advancing the handle 120 distally toward the hub 110 and / or retracting the hub 110 toward the handle 120, thereby advancing the clot preparation device 130 out of the delivery catheter 102, thereby expanding (e.g., self-expanding) the clot preparation device 130 into the vascular BV. In the illustrated embodiment, the clot preparation device 130 (e.g., the outer support surface 248 of the third region 244) comes into contact with (e.g., engages with, adheres to, etc.) the wall of the vascular BV. In some embodiments, the blood clot formation device 130 is larger than the blood vessel BV so that the blood clot formation device 130 exerts a radially outward force on the wall of the blood vessel BV. In other embodiments, the blood clot formation device 130 can be sized so that it does not come into contact with the wall of the blood vessel BV.

[0038] Referring to Figures 3 and 4D, in block 364, method 360 may include retracting the clot processing device 130 proximal (e.g., in the direction of arrow B) into / towards the clot material PE. More specifically, referring to Figures 1A and 1B, the operator may retract the processing portion 111 through the lumen of the guide catheter 470 by pulling the entire system 100 proximal (e.g., by grasping the hub 110). Once the clot processing device 130 is retracted, it engages with the clot material PE to capture / break up the clot material PE. For example, the clot material PE may enter through the first cell 250 (Figures 2A-2C) and be held within the clot processing device 130 by the smaller second cell 252 (Figures 2A-2C). In one aspect of this technology, the blood clot processing device 130 can shear the blood clot material PE from the wall of the blood vessel BV even when the blood clot material PE is strongly attached to the wall of the blood vessel BV.

[0039] In some embodiments, when the inner shaft 106 is floating in the lumen of the intermediate shaft 104, the length L (Figure 2A) of the clot-forming device 130 may increase as the clot-forming device 130 is pulled toward / towards the clot material PE, and as the intermediate shaft 104 moves proximal to the inner shaft 106. In other embodiments, if the system 100 includes an actuation mechanism 122, the operator can increase the longitudinal and / or radial stiffness of the clot-forming device 130 by acting on the actuation mechanism 122 to lock or substantially lock the relative positions of the intermediate shaft 104 and the inner shaft 106.

[0040] Referring to Figures 3 and 4E, in block 365, method 360 may include retracting the clot preparation device 130 so that the captured clot material PE can be captured into the lumen of the guide catheter 470. In some embodiments, the clot preparation device 130 can be completely removed from the guide catheter 470. In some embodiments, if any of the clot material PE remains in the blood vessel BV, the clot preparation device 130 can be washed, and blocks 362-365 can be repeated to capture the remaining clot material PE. Alternatively, a new clot preparation device 130 can be reinserted through the guide catheter 470 to capture the remaining clot material PE. In some embodiments, the clot preparation device 130 may be able to decompose the clot material PE without necessarily capturing it, and after or during the retraction of the clot preparation device 130, suction can be applied to the guide catheter 470 to aspirate the remaining clot material PE into the guide catheter 470. Finally, referring to Figures 3 and 4F, in block 366, method 360 may include removing the blood vessel BV and the guide catheter 470 from the patient after a sufficient portion of the blood clot material has been removed from the patient.

[0041] Some aspects of this technology are shown in the following additional examples. 1. A blood clot processing system, An external catheter to define the lumen, An inner catheter, which is at least partially disposed within the lumen of the outer catheter, A blood clot processing device comprising a plurality of interconnected supports forming a single structure movable between a compression configuration and an expansion configuration, wherein in the expansion configuration, the single structure is The proximal connection region connected to the aforementioned external catheter, A proximal cone region extending from the proximal connection region, wherein the first portion of the support forms a first cell in the proximal cone region, A cylindrical region extending from the aforementioned proximal conical region, A distal conical region extending from the cylindrical region, wherein the second portion of the support forms a second cell in the distal conical region, and the second cell is smaller than the first cell, A blood clot processing system comprising: a distal connecting region extending from the distal conical region and coupled to the internal catheter. 2. The blood clot processing system according to Example 1, wherein the inner catheter has (a) a distal end portion coupled to the distal connection region of the blood clot processing device, and (b) a proximal end portion configured to float in the lumen of the outer catheter. 3. The blood clot processing system according to Example 1 or Example 2, wherein the inner catheter and the outer catheter are configured to receive a guidewire passing through them. 4. A blood clot processing system according to any one of Examples 1 to 3, further comprising a handle coupled to the proximal end of the outer catheter, the handle comprising an operating mechanism coupled to the proximal end of the inner catheter, wherein the operation of the operating mechanism is configured to move the inner catheter parallel to the outer catheter, thereby compressing or extending the blood clot processing device in the longitudinal direction. 5. A delivery catheter for defining the lumen, The present invention further includes a handle, which is coupled to the proximal end portion of the outer catheter and is movable between a first position and a second position relative to the delivery catheter, In the first position, the blood clot processing device is confined within the lumen of the delivery catheter having the compression configuration. The blood clot processing system according to any one of Examples 1 to 4, wherein, in the second position, the blood clot processing device is located distal to the lumen of the extended configuration. 6. The blood clot processing system according to Embodiment 5, further comprising a hub coupled to the proximal end portion of the delivery catheter, wherein the handle includes a locking mechanism configured to secure the handle to the hub in the second position. 7. The blood clot processing 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 guidewire through them. 8. The blood clot processing system according to any one of Examples 1 to 7, wherein the extended configuration has a diameter of approximately 0.71 inches to approximately 1.34 inches. 9. The blood clot processing system according to any one of Examples 1 to 8, wherein the support column of the blood clot processing device is configured to self-expand from the compression configuration to the expansion configuration when not constrained. 10. The blood clot processing system according to any one of Examples 1 to 9, wherein the support column of the blood clot processing device includes a shape memory material. 11. The blood clot processing system according to any one of Examples 1 to 10, wherein the single structure includes (a) a first number of the struts in the proximal conical region and (b) a second number of the struts in the distal conical region that is greater than the first number of struts. 12. A method for removing a blood clot, wherein the method is The distal portion of the guide catheter is positioned in close proximity to the blood clot material within the blood vessels of a human patient, The blood clot processing device is advanced through the guide catheter to bring it into close proximity to the blood clot material. The method involves expanding the clot formation process within a distal blood vessel of the blood clot material, wherein the clot formation device includes a plurality of interconnected struts forming a single structure having a proximal portion and a distal portion, the struts forming a plurality of first cells in the proximal portion and a plurality of second cells in the distal portion, the first cells being larger than the second cells, The guide catheter generates suction at the distal portion, A method comprising retracting the blood clot processing device proximal to the blood clot material. 13. The method according to Example 12, wherein advancing the blood clot processing device through the guide catheter includes advancing the blood clot processing device on a guide wire. 14. The method according to Example 12 or Example 13, wherein the proximal portion of the single structure is coupled to an outer catheter that extends at least partially through the guide catheter, and the distal portion of the single structure is coupled to an inner catheter that extends at least partially through the outer catheter. 15. The method according to Example 14, wherein advancing the blood clot processing device through the guide catheter includes advancing the blood clot processing device on a guide wire through the guide catheter, the outer catheter, and the inner catheter. 16. The method according to any one of Examples 12 to 15, wherein generating the aspiration at the distal portion of the guide catheter is to generate aspiration to draw a first portion of the blood clot material into the guide catheter before retracting the blood clot processing device proximal. 17. The method according to Example 16, wherein retracting the blood clot processing device proximal to the blood clot processing device through the second portion of the blood clot material remaining in the blood vessel, thereby capturing the second portion of the blood clot material. 18. The method according to any one of Examples 12 to 17, wherein the method comprises retracting the clot processing device proximal to the clot material, thereby capturing at least a portion of the clot material, and further comprising retracting the clot processing device and the captured clot material into the guide catheter. 19. A blood clot processing system, The outer shaft defines the lumen, An inner shaft, at least partially disposed within the lumen of the outer shaft, A blood clot processing system comprising: a plurality of interconnected struts forming a single structure having a proximal portion and a distal portion, wherein the proximal portion is connected to the outer shaft and the distal portion is connected to the inner shaft, and the struts form a plurality of first cells in the proximal portion and a plurality of second cells in the distal portion, the first cells being larger than the second cells. 20. The blood clot processing system according to Example 12, wherein the outer shaft and the inner shaft are configured to receive a guide wire passing through them. 21. A blood clot processing device, It includes a plurality of interconnected supports that form a single structure movable between a compressed configuration and an extended configuration, wherein in the extended configuration, the single structure is Proximal connection region and A proximal cone region extending from the proximal connection region, wherein the first portion of the support forms a first cell in the proximal cone region, A cylindrical region extending from the aforementioned proximal conical region, A distal conical region extending from the cylindrical region, wherein the second portion of the support forms a second cell in the distal conical region, the second cell being smaller than the first cell, A blood clot processing device comprising a distal connecting region extending from the distal conical region. 22. A first shaft connected to the proximal connection region and defining the lumen The blood clot processing device according to Example 21, further comprising a second shaft coupled to the distal connection region and extending at least partially through the lumen of the first shaft. 23. The blood clot processing device according to Example 21 or Example 22, wherein the second shaft has (a) a distal end portion coupled to the distal connection region, and (b) a proximal end portion configured to float in the lumen of the first shaft. 24. The blood clot processing device according to any one of Examples 21 to 23, wherein the support column is configured to self-expand from the compression configuration to the expansion configuration when not restrained. 25. The blood clot processing device according to any one of Examples 21 to 24, wherein the support column is made of a shape memory material. 26. A blood clot processing device, A blood clot processing device comprising a plurality of interconnected struts forming a single 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, the first cells being larger than the second cells.

[0042] The above detailed description of embodiments of the Art is not intended to be exhaustive or to limit the Art to the exact forms disclosed above. Specific embodiments and examples of the Art are described above for illustrative purposes, but various equivalent modifications are possible within the scope of the Art, as will be recognized by those skilled in the art. For example, while the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may be combined to provide further embodiments.

[0043] From the foregoing, it will be understood that while specific embodiments of the present technology are described herein for illustrative purposes, well-known structures and functions are not illustrated or described in detail in order to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where the context permits, singular or plural terms may each include plural or singular terms.

[0044] Furthermore, unless the word “or” is explicitly limited to referring to a list of two or more items and meaning only a single item that is exclusive to the 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. Furthermore, the term “including” is used throughout to mean including at least the enumerated features(s). While certain embodiments are described herein for illustrative purposes, it will be understood that various modifications can be made without departing from the Art. Furthermore, while advantages related to some embodiments of the Art have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments are necessarily required to exhibit advantages that fall within the scope of the Art. Thus, this disclosure and related art may encompass other embodiments not expressly shown or described herein.

Claims

[Claim 1] Treatment of vascular occlusion, etc.

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