Systems and related devices and methods for treating embolisms

Abstract

The present disclosure relates to systems and methods for intravascular treatment of intravascular clots in a human patient. A method according to an embodiment of the present technology may include, for example, positioning a distal portion of a catheter near an intravascular clot. The method may further include coupling a pressure source to the catheter via a conduit subsystem that includes a valve or other fluid control device, and activating the pressure source to charge a vacuum while the valve is closed. The valve may then be opened to apply the vacuum to the catheter, thereby sucking at least a portion of the clot into the catheter from the blood vessel.

Description

Technical Field

[0001] The present technology generally relates to systems, methods, and devices for endovascular embolization and / or endovascular treatment of thrombi in human patients. In particular, some embodiments of the present technology relate to systems for releasing stored vacuum pressure to aspirate clot material from blood vessels. Background Art

[0002] Thromboembolic events are characterized by occlusion of blood vessels. Thromboembolic diseases (such as stroke, pulmonary embolism, heart attack, peripheral thrombosis, atherosclerosis, etc.) affect many people. These diseases are major causes of morbidity and mortality.

[0003] When an artery is occluded by a clot, tissue ischemia occurs. If the occlusion persists, the ischemia will progress to tissue infarction. However, if blood flow is rapidly restored, infarction will not occur or will be greatly limited. Failure to restore blood flow can correspondingly result in limb defects, angina, myocardial infarction, stroke, or even death.

[0004] In the venous circulation, occlusions can also cause serious harm. Blood clots can form in the large veins of the legs and pelvis, a condition commonly known as deep vein thrombosis (DVT). DVT typically occurs where there is a tendency for blood stasis (e.g., long - haul air travel, immobility, etc.) and coagulation (e.g., cancer, recent surgery such as orthopedic surgery, etc.). DVT can block the drainage of venous blood in the legs, resulting in swelling, ulcers, pain, and infection. DVT can also create a reservoir where blood clots can accumulate and then travel to other parts of the body, including the heart, lungs, brain (stroke), abdominal organs, and / or limbs.

[0005] In the pulmonary circulation, unwanted substances can cause harm by blocking the pulmonary artery (a condition called pulmonary embolism). If the blockage is upstream of the main or large pulmonary artery branches, it will severely impair the total blood flow in the lungs and thus severely impair the entire body. This can lead to hypotension and shock. If the blockage is downstream of the large - to - medium pulmonary artery branches, it can prevent a significant portion of the lungs from participating in gas exchange with the blood, resulting in low blood oxygen and an accumulation of carbon dioxide in the blood.

[0006] There are many existing techniques for restoring blood flow through occluded blood vessels. For example, embolectomies are a surgical technique that involves cutting into a blood vessel and placing a balloon-tipped device (such as a Fogarty catheter) at the occluded location. The balloon is then inflated beyond the clot and the balloon is used to withdraw the obstruction to the incision point. The obstruction is then removed by the surgeon. While this surgical technique is useful, subjecting a patient to surgery can be traumatic and is preferably avoided when possible. Additionally, the use of a Fogarty catheter can be problematic due to the risk of damaging the blood vessel lining when withdrawing the catheter.

[0007] Percutaneous methods are also used to restore blood flow. A common percutaneous technique is known as balloon angioplasty, where a balloon-tipped catheter is introduced into the blood vessel (e.g., typically through a guiding catheter). The balloon-tipped catheter is then advanced to the occlusion point and inflated to dilate the stenosis. Balloon angioplasty is suitable for treating vascular stenosis, but is generally ineffective for treating acute thromboembolism because no occlusive material is removed and restenosis often occurs after dilation. Another percutaneous technique involves placing a catheter near the clot and infusing streptokinase, urokinase, or other thrombolytic agents to dissolve the clot. Unfortunately, thrombolysis typically takes hours to days to be successful. Additionally, thrombolytic agents can cause bleeding, and in many patients thrombolytic agents cannot be used at all.

[0008] There are a variety of devices for performing thrombectomy or removing other foreign bodies. However, such devices have been found to have highly complex structures, be traumatic to the treated blood vessels, or lack the ability to be properly secured to the blood vessel. Additionally, many devices have highly complex structures that result in difficulties in manufacturing and quality control as well as delivery problems when passed through curved or small-diameter catheters. Less complex devices may allow the user to pull on the clot, especially for inexperienced users, and such devices may not completely capture and / or collect all of the clot material.

[0009] Accordingly, there is a need for improved systems and methods for embolism extraction. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly illustrating the principles of the disclosure.

[0011] Figure 1 is a partial schematic side view of a clot removal system configured in accordance with the present technology.

[0012] Figure 2Is a side view of a locking syringe configured according to the present technology.

[0013] Figure 3A Is a side view of a locking syringe configured according to the present technology.

[0014] Figure 3B Is a locking syringe configured according to the present technology for attaching Figure 3A to Figure 1 a clot removal system. Side view of the adapter.

[0015] Figure 3C Is a side view of an adapter coupled to Figure 3A a locking syringe. Figure 3B Side view of the adapter.

[0016] Figure 3D Is a locking syringe coupled via Figure 3B an adapter to Figure 1 a clot removal system. Figure 3A Side view of the locking syringe.

[0017] Figure 4A Is a perspective side view of another pressure source configured according to the present technology, Figure 4B and 4C is Figure 4A an enlarged schematic side view of the pressure source during operation.

[0018] Figure 5 Is a cross-sectional side view of an auto-release syringe configured according to the present technology.

[0019] Figure 6 Is a perspective top view of a syringe configured according to the present technology.

[0020] Figure 7 Is a side view of an over-wire locking syringe configured according to the present technology.

[0021] Figure 8 Is a flowchart of a process or method for operating a clot removal system according to the present technology.

[0022] Figures 9A - 9C Is a side view of the proximal portion of a clot removal system during a clot removal procedure using the locking syringe of FIG. 3 according to the present technology. Figure 1 Side view.

[0023] Figure 10A and 10B Is a schematic view of the distal portion of a clot removal system during a clot removal procedure according to the present technology. Figure 1 Side view.

[0024] Figure 11Partial schematic side view of another clot removal system configured according to the present technology.

[0025] Figure 12 Flowchart of another process or method for operating a clot removal system according to the present technology.

[0026] Figures 13A - 14C During a clot removal procedure according to the present technology Figure 11 Schematic of the distal portion of a clot removal system.

[0027] Figure 15 Flowchart of another process or method for operating a clot removal system according to the present technology.

[0028] Figures 16A - 16E During a clot removal procedure according to the present technology Figure 11 Schematic of the distal portion of a clot removal system.

[0029] Figure 17 Partial schematic side view of another clot removal system configured according to the present technology.

[0030] Figures 18A - 18H During a clot removal procedure according to the present technology, Figure 17 Side view of the distal portion of the clot removal system shown.

[0031] Figure 19 Stereo side view of a pressure source configured according to the present technology for filtering blood from aspirated clot material during a clot removal procedure.

[0032] Figure 20A Partial exploded side view of a filter device and a pressure source configured according to the present technology.

[0033] Figure 20B Is coupled to Figure 20A Of the filter device Figure 20A Stereo side view of a syringe.

[0034] Figure 20C Is coupled to Figure 1 Of the clot removal system Figure 20B Side view of the filter device and the syringe.

[0035] Figure 20D And 20E Is coupled to Figure 1 Of the clot removal system to reintroduce blood to a patient Figure 20A Side view of the syringe in.

[0036] Figure 21A Partial exploded side view of a filter device, a pressure source, and a reinfusion syringe configured according to the present technology.

[0037] Figure 21B is coupled to Figure 21A a pressure source and a reinfusion syringe Figure 21A A perspective side view of a filter device of

[0038] Figure 22 A partially exploded side view of a filter device configured according to the present technology.

[0039] Figure 23 A partially exploded side view of a filter device configured according to the present technology.

[0040] Figure 24 is configured according to the present technology Figure 1 An enlarged isometric view of a clot removal system.

[0041] Figure 25 is configured according to the present technology Figure 1 An enlarged isometric view of a clot removal system. Specific embodiments

[0042] The present technology is generally directed to methods and systems for removing clot material from the blood vessels of a human patient. In some embodiments, a catheter can be positioned within a blood vessel such that a distal portion of the catheter (e.g., a distal opening) is located near a clot within the blood vessel. The catheter can be fluidly coupled to a pressure source via a valve or other fluid control device located outside the patient. With the valve closed, the pressure source can be activated to charge a vacuum chamber of the pressure source with a vacuum. The valve can then be opened to apply the vacuum to the catheter, thereby sucking at least a portion of the clot from the blood vessel into the catheter. In some embodiments, an intervention device can be delivered through the catheter and used to engage the clot before and / or after applying the vacuum to the catheter.

[0043] In one aspect of the present technology, the pressure source is configured to generate and store a vacuum before fluidly connecting the pressure source to the catheter. Thus, opening the fluid control device can instantaneously or almost instantaneously apply the stored vacuum pressure to the catheter, thereby creating suction throughout the catheter. In particular, the suction is applied to the distal portion of the catheter near the clot. Compared to, for example, simply activating the pressure source and fluidly connecting it to the catheter, pre-charging or storing a vacuum before applying the vacuum to the catheter can create a greater suction force (and corresponding fluid flow rate) at and / or near the distal portion of the catheter. The greater suction force generated by applying the stored vacuum can be used to suck or remove a clot from within a blood vessel of a human patient.

[0044] Although many embodiments of devices, systems, and methods for treating pulmonary embolism are described hereinafter, additional to those described herein, other applications and other embodiments are also within the scope of the present technology (e.g., intravascular procedures other than embolization therapy, intravascular procedures for treating cerebral embolism, intravascular procedures for treating deep vein thrombosis (DVT), etc.). Additionally, several other embodiments of the present technology may have configurations, states, components, or procedures different from those described herein. Further, it should be understood that specific elements, substructures, advantages, uses, and / or other features of the embodiments referred to Figures 1 - 25 may be suitably interchanged, substituted, or configured with additional embodiments according to the present technology. Additionally, suitable elements of the embodiments referred to Figures 1 - 25 may be used as standalone and / or self - contained devices. Accordingly, one of ordinary skill in the art will understand that the present technology may have other embodiments that include additional elements, or the present technology may have other embodiments that do not have several features shown and described hereinafter with reference to Figures 1 - 25 Accordingly, one of ordinary skill in the art will understand that the present technology may have other embodiments that include additional elements, or the present technology may have other embodiments that do not have several features shown and described hereinafter with reference to

[0045] Regarding the terms "distal" and "proximal" in this specification, unless otherwise specified, these terms may refer to the relative position of a portion of a catheter subsystem with respect to the operator and / or its position in the vasculature. Moreover, as used herein, designations such as "backward", "forward", "upward", "downward", etc. do not imply a limitation on the use of the referenced component in a particular direction. It should be understood that such designations refer to the orientation of the referenced component as shown in the figures; the systems of the present technology may be used in any orientation suitable for the user.

[0046] The headings provided herein are for convenience only and should not be construed as limiting the disclosed subject matter.

[0047] One, Selected embodiments of the clot removal system

[0048] Figure 1 is a partial schematic side view of a clot treatment or clot removal system configured according to an embodiment of the present technology and including a suction assembly 10 ("assembly 10"). In the illustrated embodiment, assembly 10 includes a catheter subsystem 100, a conduit subsystem 120, and a pressure source 140. Catheter subsystem 100 includes a catheter 102 (e.g., a suction catheter), and catheter 102 includes an elongate shaft that defines a lumen 104 and has a distal portion 103a and a proximal portion 103b. Catheter subsystem 100 also includes a valve 106 that may be integrated or coupled to the proximal portion 103b of catheter 102.

[0049] In the illustrated embodiment, valve 106 includes a distal portion 107a, a proximal portion 107b, and a lumen 109 extending from the distal portion 107a to the proximal portion 107b. Valve 106 also includes a flow controller within lumen 109 ( Figure 1 obscured in). In some embodiments, the valve is a hemostatic valve configured to maintain hemostasis during a clot removal procedure by preventing fluid from flowing in the proximal direction through valve 106 when various components such as a delivery sheath, pull member, guide wire, intervention device, other aspiration catheters (e.g., as described in detail with reference to Figures 11 - 16E ) are inserted through valve 106 and delivered through catheter 102 to a treatment site in a blood vessel. Valve 106 also includes a branch or side port 108 that is located distal to the flow controller within lumen 109 and is configured to fluidly couple lumen 104 of catheter 102 to tubing subsystem 120. In the illustrated embodiment, valve 106 includes a button 101 that can be actuated (e.g., pressed) to open the tube within lumen 109. In some embodiments, valve 106 can be of the type disclosed in U.S. Patent Application No. 16 / 117,519, filed Aug. 30, 2018, titled “Hemostatic Valve and Method of Use,” which is incorporated herein by reference in its entirety. In some embodiments, the proximal portion 107b of valve 106 is also configured to be removably (e.g., via a snap-fit arrangement) coupled to a retraction / aspiration device for aspirating lumen 104 of catheter 102 and / or for retracting an intervention device, catheter, delivery sheath, catheter, etc. located within lumen 104. Specific details of such retraction / aspiration devices and related methods are disclosed in U.S. Patent Application No. 9,526,864, filed Jun. 9, 2015, titled “Retraction and Aspiration Devices and Related Systems and Methods for Treating Embolisms,” which is incorporated herein by reference in its entirety.

[0050] Tubing subsystem 120 fluidly couples catheter subsystem 100 to pressure source 140. More specifically, tubing subsystem 120 can include one or more tubing segments 124 (labeled first tubing segment 124a and second tubing segment 124b, respectively), at least one fluid control device 126 (e.g., a valve), at least one connector 128 for fluidly coupling tubing subsystem 120 to pressure source 140, and / or other suitable components. More specifically, in the illustrated embodiment, fluid control device 126 is a stopcock that is (i) fluidly coupled to side port 108 of valve 106 via first tubing segment 124a and (ii) fluidly coupled to connector 128 via second tubing segment 124b. In some embodiments, fluid control device 126 can define a lumen having a diameter (or cross-sectional dimension) that is greater than or equal to the diameter of lumen 104 of catheter 102, the diameter of first tubing segment 124a, and / or the diameter of second tubing segment 124b.

[0051] The fluid control device 126 can be operated externally by a user to regulate the fluid flowing therethrough, specifically, the fluid from the lumen 104 of the conduit 102 to the pressure source 140. In other embodiments, the fluid control device 126 can be a clamp that can be actuated (e.g., pressed or squeezed by the user's hand) to partially or completely restrict the fluid flowing through the pipe segment 124a and / or the pipe segment 124b. In yet another other embodiment, the fluid control device 126 can be omitted and its function incorporated into the pressure source 140 (e.g., as described in detail below with reference to Figure 5 ). In some embodiments, the fluid control device 126 can include a quick-release mechanism (e.g., a spring-loaded device) for quickly opening, releasing, etc., the fluid control device 126 to fluidly connect the pressure source 140 to the conduit 102 (e.g., instantaneously or almost instantaneously). In some embodiments, the fluid control device 126 can be automatically opened / closed (e.g., by a motor, switch, etc.). When the pressure source 140 is pre-charged with a vacuum, as described in detail below, such a quick-release fluid control device 126 can reduce the time required for the pressure in the assembly 10 to reach equilibrium after the fluid control device 126 is opened, and can thereby increase the suction force generated at the distal portion 103a of the conduit 102.

[0052] In some embodiments, the connector 128 is a quick-release connector (e.g., a quick-disconnect fitting) that enables the conduit 102 and the fluid control device 126 to be quickly coupled / decoupled to the pressure source 140. In other embodiments, the pipe subsystem 120 can have more or fewer pipe segments, connectors, and / or fluid control devices, and can have other suitable configurations. In some embodiments, one or more components can be permanently connected and / or integrally formed.

[0053] The pressure source 140 is configured to generate (e.g., form, create, charge, establish, etc.) a vacuum (e.g., a negative relative pressure) and store the vacuum for subsequent application to the conduit subsystem 100. Below with reference to Figures 2 - 7More details of suitable pressure sources are described in detail. During operation of the assembly 10, the user can first close the fluid control device 126 before activating the pressure source 140 to accumulate a vacuum pressure within the pressure source 140 (e.g., the vacuum chamber of the pressure source 140). In some embodiments, the user can control or select the volume of the vacuum generated. In this way, the vacuum is charged into the pressure source 140 before fluidly connecting the pressure source 140 to the conduit subsystem 100. To aspirate the lumen 104 of the conduit 102, the user can open the fluid control device 126 to fluidly connect the pressure source 140 to the conduit subsystem 100, thereby applying or releasing the vacuum stored in the pressure source 140 to the lumen 104 of the conduit 102. The opening of the fluid control device 126 instantaneously or almost instantaneously applies the stored vacuum pressure to the conduit subsystem 120 and the conduit 102, thereby creating an aspiration throughout the conduit 102. In particular, aspiration is applied at the distal portion 103a of the conduit 102. In one aspect of the present technology, pre-charging or storing a vacuum before applying the vacuum to the lumen 104 of the conduit 102 is expected to generate a greater suction force (and corresponding fluid flow rate) at and / or near the distal portion 103a of the conduit 102 compared to simply activating the pressure source 140 and fluidly connecting it to the conduit. As described in detail below, the suction force generated by applying the stored vacuum can be used to aspirate or remove clotting substances from within the blood vessels of a human patient. Second, For use in a clot removal system Selected embodiments of the pressure source

[0054] As referred to above Figure 1 As described in detail, the assembly 10 of the present technology includes a pressure source (e.g., a vacuum source, a negative pressure source, etc.) configured to be charged with a vacuum, which can be applied to the conduit subsystem 100 to generate a suction force to aspirate clotting substances from within the blood vessels. Generally speaking, the pressure source can be any suitable source or combination of sources for generating and / or storing negative pressure. In some embodiments, the pressure source can be a pump (e.g., an electric pump coupled to a vacuum chamber), while in other embodiments, the pressure source can include one or more syringes that can be actuated or activated by a user of the assembly 10 to generate and store a vacuum therein.

[0055] Figure 2 is a side view of a pressure source 240 including a vacuum pressure locking syringe (“syringe 240”) configured according to the present technology. In some embodiments, the syringe 240 can be of the type sold by Merit Medical Systems, Inc. under the trademark “VacLok”. In the illustrated embodiment, the syringe 240 includes a plunger 242 that is slidably and rotatably located within a chamber or barrel 244. For clarity, Figure 2The middle barrel 244 is shown as transparent. The plunger 242 includes a seal 243 and a plurality of indexing members 246 that define slots 248 between adjacent pairs. The tab member 245 projects inwardly from the inner surface of the barrel 244 and is configured to removably seat within the slot 248 to lock the plunger 242 in position relative to the barrel 244. In some embodiments, the barrel 244 may be made of a transparent material that permits a user to view the material (e.g., clot) within the barrel 244 and to view the relative position between the slot 248 and the tab member 245 to lock the syringe 240.

[0056] Referring together Figure 1 and Figure 2 , the syringe 240 also includes a tip 247 for coupling the syringe 240 to the tubing subsystem 120. In the illustrated embodiment, the tip 247 is a standard luer connector that may be coupled to the connector 128 via one or more suitable adapters. The tip 247 also defines a lumen or bore 249 having an inner diameter D1. In some embodiments, the diameter D1 is about 0.103", or about 0.080" to about 0.200", or about 0.100" to about 0.150", or about 0.100" to about 0.110". In some embodiments, the inner diameter D1 is about 14 French.

[0057] During operation of the assembly 10, a user may first close the fluid control device 126 and then grasp the plunger 242 and / or the barrel 244 and withdraw (e.g., retract) the plunger 242 at least partially from the barrel 244 to create a vacuum within the barrel 244. Once the user has withdrawn the plunger 242 to a sufficient or desired volume, the user may lock the plunger 242 by rotating the plunger 242 relative to the barrel 244 such that the tab member 245 seats within a corresponding one of the slots 248. In other embodiments, the syringe 240 may not be a locking syringe, and instead the user may hold the plunger 242 in position relative to the barrel 244. Moreover, the user may control the volume of the vacuum by withdrawing the plunger 242 more or less to provide a desired amount or level of aspiration / suction when the fluid control device 126 is opened. In some embodiments, the volume of the syringe is about 60 cc or less than about 60 cc.

[0058] Figure 3A is a side view of a pressure source 340 that includes a vacuum pressure locking syringe ("syringe 340") configured in accordance with the present technology. The syringe 340 may have some features that are generally similar to those described above with reference to Figure 2Features of the syringe 240 described. For example, syringe 340 includes a plunger 342 that is slidably and rotatably located within a barrel 344, and the plunger 342 includes a plurality of indexing members 346 that define slots 348 between adjacent pairs thereof. For clarity, Figure 3A (and Figure 3C ) show the barrel 344 as transparent. When withdrawing the plunger 342, the user can lock the plunger 342 at a specified volume by rotating the plunger 342 relative to the barrel 344 such that a tab member 345 on the inner surface of the barrel 344 is located within a corresponding one of the slots 348. In some embodiments, the maximum volume of syringe 340 is about 60 cc or greater than 60 cc.

[0059] In the illustrated embodiment, syringe 340 includes a large-bore tip 347 that defines a cavity or bore 349, such as a Toomey tip. In some embodiments, the inner diameter D2 of bore 349 can be greater than or equal to the maximum inner diameter of assembly 10 (e.g., catheter 102 and tubing subsystem 120). In certain embodiments, tip 347 can be about 26 French or greater. Thus, referring together Figure 2 and 3A , diameter D2 can be greater than dimension D1. For example, dimension D2 can be about two times, three times, four times, or more times diameter Dl.

[0060] Figure 3B is a side view of an adapter 350 configured according to the present technique for connecting syringe 340 to tubing subsystem 100. Figure 3C is a side view of adapter 350 coupled to syringe 340, Figure 3D is a side view of syringe 340 coupled to tubing subsystem 120 via adapter 350. For ease of illustration, adapter 350 is shown as partially transparent in Figure 3C . Referring to Figure 3B , adapter 350 includes (i) a first portion 351 that defines a first cavity or bore 352 having an inner diameter of D3, (ii) a second portion 353 that defines a second cavity or bore 354, and (iii) a stepped surface or interface 355 between the first and second portions 351, 353. The first portion 351 can also include a seal 357, such as an O-ring around its outer surface.

[0061] Referring together Figures 3A - 3D, the second hole 354 of the adapter 350 is configured to removably receive the tip 347 of the syringe 340 therein. In some embodiments, the tip 347 can be snugly received in the second hole 354 by an interference fit. In some embodiments, a seal (e.g., an O-ring) can be located between the outer surface of the tip 347 and the inner surface of the second hole 354. In other embodiments, the syringe 340 can be permanently coupled to or integrally formed with the adapter 350. The first portion 351 of the adapter 350 is configured to removably be located within the connector 128 of the conduit subsystem 120 to fluidly couple the syringe 340 to the conduit subsystem 120. In some embodiments, the first portion 351 of the adapter 350 can be pushed into the connector 128 until the interface 355 abuts the connector 128. When the first portion 351 of the adapter 350 is located within the connector 128, the seal 357 seals the interface between the connector 128 and the adapter 350.

[0062] The diameter D3 of the first hole 352 of the adapter 350 can be selected to be approximately equal to or greater than the maximum inner diameter of the assembly 10 (e.g., the catheter 102 and the conduit subsystem 120). For example, the catheter 102 can be about 9 French or larger, and the diameter D3 can be selected to be greater than the size of the catheter 102. Thus, when the fluid control device 126 is opened, the continuous lumen between the catheter 102 and the syringe 340 can have a generally constant diameter and / or not include any constriction at the interface between the syringe 340 and the conduit subsystem 120. That is, the adapter 350 can connect the syringe 340 and the conduit subsystem 120 without restricting or constricting the fluid path. In contrast, a standard Luer connector (e.g., the syringe 240) can only provide a continuous lumen for a catheter of about 8 French or smaller. Any constriction of the fluid path between the catheter 102 and the syringe 340 can reduce the volumetric flow rate (e.g., suction and flow rate) that can be generated when the vacuum stored in the syringe 340 is applied to the catheter 102.

[0063] Generally, the syringe 340 and the adapter 350 can reduce the fluid resistance in the assembly 10, thus facilitating a faster pressure equilibrium in the assembly 10 when the fluid control device 126 is opened to apply the charged vacuum to the catheter 102. In some embodiments, for example, when the syringe 240 ( Figure 2)When 60 cc of vacuum is filled and the fluid control device 126 is open, it may take about 1 - 2 seconds for the pressure in the assembly 10 to equalize. In contrast, when the syringe 340 is filled with 60 cc of vacuum and the fluid control device 126 is open, it may take less than about 1 second (e.g., about 0.5 seconds) for the pressure in the assembly 10 to equalize. More specifically, Table 1 shows representative pressure equalization times and associated flow rates when the syringe 240 is coupled to a 20 French catheter (i.e., catheter 102). Table 2 shows representative pressure equalization times and associated flow rates when the syringe 340 and adapter 350 are coupled to a 20 French catheter (i.e., catheter 102).

[0064] Table 1

[0065]

[0066]

[0067] Table 2

[0068] <![CDATA Pressure equalization time (seconds) > <![CDATA Flow rate (cc / second) > 0.9 66.7 0.8 75.0 0.7 85.7 0.6 100.0 0.5 120.0 0.4 150.0 0.3 200.0 0.2 300.0 0.1 600.0

[0069] In each case, the syringe 340 provides a relatively faster equalization time and a correspondingly greater flow rate. It is expected that the faster pressure equalization and flow rate provided by the syringe 340 will correspondingly provide a greater suction force at the distal portion 103a of the catheter 102. That is, generally speaking, increasing the aperture of the syringe used to provide the vacuum pressure is expected to provide a greater suction force (e.g., will provide a greater vacuum impulse) in a smaller time period. In some embodiments, the greater suction force may facilitate the removal of clot material from the patient's blood vessel, even in cases where the clot is tightly lodged or adhered within the blood vessel (e.g., a chronic clot).

[0070] In addition, as Figure 3D shown, the adapter 350 can couple the syringe 340 to the connector 128 without any intermediate pipe segments or additional adapters. Such an arrangement can minimize the total length, volume, etc. of the components fluidly connecting the catheter 102 to the syringe 340. It is expected that the magnitude of the suction force generated at the distal portion 103a of the catheter 102 (e.g., when the vacuum filled in the syringe 340 is applied to the catheter 102 by opening the fluid control device 126) is proportional to the length of the fluid path between the pressure source 340 and the catheter 102. Therefore, it is expected that the operation of the assembly 10 with the syringe 340 and adapter 350 will increase the suction force generated at the distal portion 103a of the catheter 102. In some embodiments, the greater suction force may facilitate the removal of clot material from the patient's blood vessel, even in cases where the clot is tightly lodged or adhered within the blood vessel (e.g., a chronic clot).

[0071] Figure 4A is a side perspective view of a pressure source 400 configured according to the present technology and including Figures 3A - 3D the syringe 340 (“main syringe 340”) and the secondary syringe 460 shown. The secondary syringe 460 may include a plunger 462 slidably disposed within a chamber or barrel 464. The main and secondary syringes 340, 460 may have the same volume or different volumes. In the illustrated embodiment, the tip 463 of the secondary syringe 460 is coupled via a coupling member 465, such as a tube, to a first one-way valve (e.g., check valve) 470. The first one-way valve 470 is configured to fluidly connect the secondary syringe 460 to the surrounding environment or to another device coupled to the first one-way valve 470. A second one-way valve (e.g., check valve) 472 spans between the main syringe 340 and the secondary syringe 460 and is configured to fluidly connect the main syringe 340 and the secondary syringe 460. More specifically, in the illustrated embodiment, the second one-way valve 472 is connected between a first portion 351 of the adapter 350 and the coupling member 465. In other embodiments, the second one-way valve 472 may couple the main and secondary syringes 340, 460 in a different manner. For example, the second one-way valve 472 may span and directly connect the barrels 344, 464. The main and secondary syringes 340, 460 may be coupled or fastened together via one or more connectors 474 that secure the barrels 344, 464 relative to each other.

[0072] In some embodiments, the second one-way valve 472 is a normally open check valve that is configured to (i) allow fluid (e.g., air) to flow from the main syringe 340 and the adapter 350 to the secondary syringe 460, and (ii) prevent fluid from flowing back from the secondary syringe 460 into the main syringe 340. In some embodiments, the second one-way valve 472 has an opening (e.g., opening) pressure of approximately 0 psi. In one aspect of the present technology, such an arrangement maximizes the amount of vacuum that can be charged within the main syringe 340. That is, the opening pressure of the second one-way valve 472 does not reduce the effective vacuum within the main syringe 340. In other embodiments, a normally closed or other type of valve may be used for the second one-way valve 472. However, in such embodiments, the vacuum efficiency of the pressure source 400 would be reduced by the opening pressure of the second one-way valve 472. Similarly, the first one-way valve 470 may be a check valve that is configured to (i) allow fluid to flow from the secondary syringe 460 to the surrounding environment (or other device) and (ii) prevent fluid from flowing back from the surrounding environment into the secondary syringe 460.

[0073] Figure 4B and 4C is an enlarged schematic side view of the pressure source 400 during operation. More specifically, Figure 4B and 4CRespectively show the fluid flow paths through the first and second one-way valves 470, 472 during the retraction and advancement of the plunger 462 through the barrel 464 of the secondary syringe 460. First, referring together to Figure 4A and 4B , during the retraction / withdrawal of the plunger 462, (i) the first one-way valve 470 closes to prevent fluid from flowing into the secondary syringe 460, while (ii) the second one-way valve 472 opens to allow fluid to flow into the secondary syringe 460 from the main syringe 340, the conduit subsystem 100 ( Figure 1 ), and / or the tubing subsystem 120 ( Figure 1 ). This flow path is indicated by the arrow R in Figure 4B . Referring together to Figure 4A and 4C , during the advancement of the plunger 462, (i) the first one-way valve 470 opens to allow fluid (e.g., drainage fluid) to flow from the secondary syringe 460 to the surrounding environment (or other device), while (ii) the second one-way valve 472 closes to prevent fluid from flowing from the secondary syringe 460 into (e.g., back into) the main syringe 360, the conduit subsystem 100, and / or the tubing subsystem 120. This flow path is indicated by the arrow A in Figure 4C .

[0074] Referring together to Figure 1 and 3A -4C, the pressure source 400 can be coupled to the tubing subsystem 120 by coupling the main syringe 340 to the connector 128 (e.g., as shown in Figure 3DAs shown). When the pressure source is coupled to the conduit subsystem 120, the retraction of the plunger 462 of the secondary syringe 460 evacuates the evacuable volume of the assembly 10. For example, when the fluid control device 126 is closed, the retraction of the plunger 462 of the secondary syringe 460 evacuates fluid from (i) the primary syringe 340 (e.g., from the barrel 344, tip 347, and / or adapter 350) and (ii) a portion of the conduit subsystem 120 between the fluid control device 126 and the primary syringe 340 through the second one-way valve 472. This can enable the generation of more charging / storing vacuum for subsequent application to the catheter subsystem 100 to aspirate clot material. In some embodiments, before withdrawing the plunger 342 of the primary syringe 340, the plunger 462 of the secondary syringe 460 can be withdrawn / advanced (e.g., "cycled") one or more times to evacuate air from (i) the tip 347 of the primary syringe 340 and / or (ii) a portion of the conduit subsystem 120 between the fluid control device 126 and the tip 347. In other embodiments, after withdrawing the plunger 342 of the primary syringe 340, the plunger 462 of the secondary syringe 460 can alternatively or additionally be withdrawn to further evacuate the barrel 344 of the primary syringe 340. In some embodiments, for example, the plunger 462 can be cycled when the fluid control device 126 is open to remove clot material that is stuck or blocked within the catheter subsystem 100. That is, cycling the secondary syringe 460 when the fluid control device 126 is open can create a vacuum pressure and suction within the conduit 102 to assist in aspirating / removing clot material.

[0075] In some embodiments, the volumes of the primary and secondary syringes 340, 460 can be selected based on one or more desired characteristics of the clot removal procedure using the pressure source 400. For example, the secondary syringe 460 can have a larger volume than the primary syringe 340 to allow for the charging of a high vacuum within the primary syringe 340 while limiting patient blood loss.

[0076] In one aspect of the present technique, the pressure source 340 allows for the generation of more vacuum without increasing the volume of the primary syringe 340. For example, the vacuum generated solely by the primary syringe 340 is proportional to the volume of the primary syringe 340. Thus, in order to generate more vacuum using only the primary syringe 340, the volume of the primary syringe 340 must be increased. In contrast, the configuration including the secondary syringe 460 and the first and second one-way valves 470, 472 in the pressure source 400 allows (e.g., maximizes) the generated vacuum to be independent of the volume of the primary syringe 340. Thus, for example, when applying a vacuum to the catheter subsystem 100, the generated vacuum can be increased without correspondingly increasing the volume of blood withdrawn from the patient.

[0077] In some embodiments (e.g., as described below with reference to Figure 19(Further described in detail), the main syringe 340 of the pressure source 400 can be replaced with a simple pressure vessel or other volume (e.g., tank, cylinder, tube, etc.). In these embodiments, simply cycling the secondary syringe 460 one or more times can create a vacuum in the tank. In some embodiments, the secondary syringe 460 can include a pump or vacuum source other than a syringe. Similarly, the secondary syringe 460 or other vacuum source can be fluidly coupled to the main syringe 340 in other ways (e.g., through a different check valve arrangement) to create the same or similar flow patterns as Figure 4B and 4C shown. Moreover, in some embodiments, the first and second one-way valves 470, 472 can be other types of flow control devices that are mechanically activated / deactivated (e.g., opened and closed) via the pressure differential within the pressure source 400 rather than being passive. For example, the flow control devices 470, 472 can be mechanically coupled to the plunger 462 of the secondary syringe 460 such that cycling the plunger 462 activates / deactivates the flow control devices 470, 472 to operate the pressure source 400 in the manner Figure 4B and 4C shown.

[0078] Figure 5 is a side cross-sectional view of a pressure source 540 including an automatic release syringe ("syringe 540") configured according to the present technology. Generally, the syringe 540 is configured to automatically apply a selected volume of charging vacuum to the conduit subsystem 100 without the need to actuate an intermediate fluid control device (e.g., Figure 1 the fluid control device 126 shown). The syringe 540 can have some features that are generally similar to the features of the syringes 240, 340 described in detail above with reference to Figure 2 and 3A -3D. For example, the syringe 540 includes a first plunger 542 that is slidably located within a chamber or barrel 544. The first plunger 542 also includes a first seal 543 that mates with the inner surface of the barrel 544 such that when the first plunger 542 is withdrawn through the barrel 544, a vacuum is created within the barrel 544. Similarly, referring together to Figure 1 and Figure 5 , the syringe 540 includes a tip 547 (e.g., a Tommy tip) to couple the syringe 540 (e.g., via a Tommy tip adapter) to the conduit subsystem 120 and define an aperture 549. In some embodiments, the aperture 549 has a relatively large diameter, and the selected diameter is used to provide rapid pressure equilibration in the assembly 10 after releasing the vacuum stored in the syringe 540.

[0079] The first plunger 542 may further include (i) a gripping portion 541 configured to be engaged by a user to retract the first plunger 542 and (ii) a cavity 581 extending longitudinally therein. In the illustrated embodiment, a plunger assembly 582 is slidably located within and extends through the cavity 581 of the first plunger 542. The plunger assembly 582 includes (i) a second plunger 583 and (ii) a release member 584 slidably and / or rotatably located within a cavity 585 of the second plunger 583. The release member 584 includes an engagement member 586 configured to engage the gripping portion 541 of the first plunger 542 when the first plunger 542 is withdrawn from the barrel 544. The second plunger 583 includes a second seal 587 configured to engage and seal an inner surface of the aperture 549 of the syringe 540 such that a vacuum can be formed in the barrel 544 when the first plunger 542 is withdrawn through the barrel 544. That is, the second seal 587 may seal (e.g., fluidly disconnect) the syringe barrel 544 from the tubing subsystem 120 and the catheter subsystem 100. In some embodiments, the syringe 540 may further include an O-ring 579 or other suitable component for sealing the interface between the first and second plungers 542, 582 to maintain the vacuum formed within the barrel 544 while also allowing the first plunger 542 to move (e.g., translate) relative to the second plunger 583.

[0080] The plunger assembly 582 further includes a locking mechanism (not shown) configured to allow / prevent longitudinal movement of the release member 584 relative to the second plunger 583. In some embodiments, for example, rotation of the release member 584 relative to the second plunger 583 in a first direction may lock the two components in place, while rotation of the release member 584 relative to the second plunger 583 in a second direction may unlock the two components such that the release member 584 can be withdrawn or pushed into the cavity 585 of the second plunger 583. In other embodiments, the release member 584 and the second plunger 583 may be integrally formed or permanently locked together.

[0081] The plunger assembly 582 enables (i) a user of the syringe 540 to select the volume of vacuum desired to be formed in the syringe 540, and (ii) the automatic release or application of the generated vacuum via the opening of the aperture 549 (e.g., pulling out). Specifically, during operation of the syringe 540, the user may first unlock the release member 584 and slide the release member 584 to a position corresponding to the desired vacuum volume. For example, the release member 584 may have scale lines 588 or other markings along its length corresponding to the volume of the syringe 540 (e.g., the vacuum chamber volume). After selecting the desired volume, the user may lock the release member 584 relative to the second plunger 583 (e.g., by rotating the release member 584) to prevent relative movement of the two components. After locking the release member 584, the user may grasp the gripping portion 541 to retract the first plunger 542 relative to the barrel 544 and the plunger assembly 582, thereby creating a vacuum within the barrel 544 between the first and second seals 543, 587. When the first plunger 542 has been retracted to the desired volume, the gripping portion 541 mates with the mating member 586 of the release member 584 such that further retraction of the first plunger 542 simultaneously retracts the plunger assembly 582. When the plunger assembly 582 is retracted, the second seal 587 of the second plunger 583 is pulled out of the aperture 549, thereby releasing the vacuum stored within the barrel 544. In this manner, the syringe 540 provides for the automatic release of the charged vacuum pressure at a specified volume and with a single retraction of the first plunger 542. In other words, the syringe 540 has a built-in fluid control device and thus does not require a separate fluid control device 126 and / or an additional step for opening the fluid control device 126.

[0082] Figure 6 is a top view of a pressure source 640 including a syringe (“syringe 640”) configured according to the present technology. The syringe 640 may include some features that are generally similar to the features of the syringes 240, 340, and 540 described above with reference to Figures 2 - 3D and 5. For example, the syringe 640 includes a plunger 642 slidably disposed within a barrel 644, and a tip 647 (e.g., a large bore tip). In the illustrated embodiment, the syringe 640 also includes a lever or handle 690 operatively coupled to the plunger 642. The handle 690 provides a mechanical lever for withdrawing the plunger 642 to create a vacuum within the barrel 644. More specifically, the handle 690 may be coupled to a crossbar 691 that rotates relative to the plunger 642 via actuation (e.g., rotation) of the handle 690. The crossbar 691 may be coupled to a gear ( Figure 6(shielded in the middle), the gear is configured to cooperate with the track 692 on the plunger 642. Thus, rotation of the handle 690 in the first direction retracts the plunger 642 relative to the barrel 644 to create a vacuum in the barrel 644. Also, rotation of the handle 690 in the second (e.g., opposite) direction pushes the plunger 642 into the barrel 644 to, for example, expel fluid, substance, etc. from the barrel 644.

[0083] In one aspect of the present technology, the handle 690 provides additional mechanical leverage relative to a standard syringe, and thus the force (e.g., strain, energy, etc.) required by a user of the syringe 640 to create a vacuum in the syringe 640 can be reduced. Thus, using the syringe 640 can reduce the time required to remove a clot with the assembly 10. In some embodiments, the volume of the syringe 640 can be greater than 60 cc (e.g., greater than 80 cc, greater than 100 cc, greater than 120 cc, greater than 140 cc, etc.). In a particular embodiment, for example, the syringe 640 can have a volume of about 140 cc. For such a large volume, without the additional mechanical leverage provided by the handle 690, some users may have difficulty manually retracting the plunger 642. Thus, the syringe 640 is capable of using a larger volume syringe, which can correspondingly generate greater suction in the catheter subsystem 100.

[0084] Referring again to Figure 1 , when the stored vacuum pressure is applied to the catheter subsystem 100, a less tortuous (e.g., more linear) fluid path between the pressure source 140 and the catheter subsystem 100 is expected to generate greater suction and a corresponding flow rate at the distal portion 103a of the catheter 102. Thus, in some embodiments, the side port 108 of the valve 106 can be formed to have an angle A of less than about 90°, less than about 75°, less than about 60°, less than about 45°, less than about 30°, less than about 15°, etc. Reducing the relative angle between the side port 108 and the chamber 109 of the valve 106 (and thus the chamber 104 of the catheter 102) reduces the curvature of the fluid path between the pressure source 140 and the catheter 102. Additionally, in some embodiments, the pressure source 140 can be coupled to the proximal portion 107b of the valve 106 rather than the side port 108 or additionally coupled to the side port 108 to provide a more linear fluid path between the pressure source 140 and the catheter 102. For example, Figure 24 is an enlarged isometric view of the assembly 10 showing the pressure source 340 directly coupled to the proximal portion 107b of the valve rather than to the connector 128 of the conduit subsystem 120 and the side port 108 of the valve 106. Although the pressure source 340 is shown in Figure 24 , but as referred to above in Figures 2 - 6Any of the pressure sources described in detail can be configured to be coupled to the proximal portion 107b of valve 106 rather than the side port 108. In other embodiments, the side port 108 can be omitted, and valve 106 and plumbing subsystem 120 can be coupled to conduit 102 via a Y connector. For example, Figure 25 is an enlarged isometric view of assembly 10, showing valve 106 and plumbing subsystem 120 connected to conduit 102 via Y connector 2590. In yet another other embodiment, plumbing system 120 is linearly coupled to conduit 102, and valve 106 projects at an angle from conduit 102.

[0085] However, in some embodiments, a guidewire or other component is located within valve 106 during a clot removal procedure (e.g., to deliver an intervention device to a treatment site within a patient). Thus, in some embodiments, to facilitate coupling of pressure source 140 to the proximal portion 107b of valve 106 even when a guidewire is inserted therein, pressure source 140 can be a syringe configured for wire delivery. For example, Figure 7 is a side view of a pressure source 740 including a vacuum pressure locking syringe (“syringe 740”) configured for guidewire 794 delivery and operation in accordance with the present technique. Syringe 740 can have some features that are generally similar to the features of syringe 340 described in detail above with reference to FIG. 3. For example, syringe 740 includes a plunger 742 that is slidably and rotatably located within barrel 744. For clarity, Figure 7 barrel 744 in is shown as transparent. In the illustrated embodiment, plunger 742 includes a cavity 796 (shown in dashed lines) that extends longitudinally therethrough. Guidewire 794 can be inserted through cavity 796 of plunger 742 such that syringe 740 can be advanced over guidewire 794 to attach to the proximal portion 107b of valve 106. Syringe 740 can also include one or more sealing components (e.g., valves, O-rings, etc.; not shown) for maintaining a seal between guidewire 794 and plunger 742 to allow a vacuum to be established and stored in barrel 744.

[0086] Generally, those skilled in the art will understand that various embodiments of the pressure sources disclosed herein can be combined, e.g., to include multiple pressure sources or a pressure source having different components or combinations of components. For example, in some embodiments, secondary syringe 460 ( Figures 4A - 4C ) can be coupled to syringes 240, 540, 640, or 740 via one or more one-way valves (referenced respectively Figure 2 and 5-7) to create additional vacuum. In some embodiments, multiple pressure sources may be coupled to the conduit 102 via the pipe subsystem 120 and / or via the valve 106. Additionally, each pressure source may be the same or different and may be coupled to the conduit subsystem 100 via a single fluid control device (e.g., fluid control device 126), or may be coupled to the conduit subsystem 100 via separate fluid control devices. Thus, the profile of the vacuum applied to the conduit 102 can be selected or adjusted by using multiple different pressure sources. For example, a particular vacuum profile may depend at least on (i) the respective characteristics of the multiple pressure sources (e.g., volume, aperture size, etc.), (ii) the manner in which the pressure sources are coupled to the conduit subsystem 100 (e.g., via separate valves, via the same valve, etc.), and (iii) the time at which the vacuum of each pressure source is applied or released to the conduit subsystem 100 (e.g., staggered release, simultaneous release, etc.). As an example, in some embodiments, the syringe 240 ( Figure 2 ) and the syringe 340 (Figure 3) can both be coupled to the pipe subsystem 120 via, for example, a Y connector. After filling both the syringes 240, 340 with vacuum pressure, opening the fluid control device 126 can apply a combined vacuum to the conduit 102 simultaneously. The syringe 340 with a larger aperture size can provide a short and powerful vacuum pressure impulse, while the syringe 240 with a smaller aperture size can provide a longer and more sustained vacuum pull. This combination can apply a large, fast-acting suction force to remove and capture the clot in the conduit 102, while applying a more sustained suction force to capture more clots.

[0087] III, Selected embodiments of the clot removal method

[0088] Figure 8 is a flowchart of a process or method 800 for operating a clot removal system including the component 10 according to the present technology to remove clots from within a blood vessel (e.g., a pulmonary blood vessel) of a human patient. Figures 9A - 9C is a side view of the proximal portion of the component 10, Figure 10A and 10B is a schematic view of the distal portion of the component 10 during a clot removal procedure according to an embodiment of the present technology. In particular, Figures 9A - 9C is a side view of the component 10 including the syringe 340 and the adapter 350 ( Figures 3A - 3D ), Figure 10A and 10B is a side view of the conduit 102, where the distal portion 103a of the conduit 102 is located near an embolism or clot PE within a blood vessel BV (e.g., a pulmonary blood vessel). Although for illustrative purposes, in Figure 1, in the context of the embodiments shown in FIGS. 3A - 3D, and 9A - 10B, some features of method 800 are described, but those skilled in the art will readily understand that other suitable systems and / or devices described herein can be used to perform method 800. In particular, although described in the context of syringe 340, method 800 can be performed using any one or combination of the pressure sources described in detail above with reference to Figures 2 - 7 At block 802, method 800 includes positioning the distal portion 103a of catheter 102 near a clot within a blood vessel of a human patient (e.g., at the treatment site). For example, in

[0089] the embodiment shown, the distal end of the distal portion 103a of catheter 102 is located near the proximal portion of clot PE. When fluid control device 126 is open, reducing the distance between the distal end of catheter 102 and the proximal portion of clot PE without contacting clot PE with catheter 102 is expected to maximize the suction force on clot PE. Reducing the distance (such as the gap) between the inner diameter of blood vessel BV and the outer diameter of the catheter is also expected to maximize the suction force on clot PE. However, in other embodiments, the distal end of catheter 102 can be at least partially within clot PE, or the distal end of catheter 102 can be distal to clot PE. Figure 10A

[0090] Figure 10A The pulmonary vasculature can be accessed through the patient's vasculature, for example, via the femoral vein. In some embodiments, catheter subsystem 100 can include an introducer (e.g., a Y - connector with a hemostatic valve; not shown) that can be partially inserted into the femoral vein. A guide wire (not shown) can be introduced through the introducer into the femoral vein and navigated through the right atrium, tricuspid valve, right ventricle, pulmonary valve, and into the main pulmonary artery. Depending on the location of the embolism, the guide wire can be directed to one or more branches of the right pulmonary artery and / or left pulmonary artery. In some embodiments, the guide wire can extend all or part of the way through clot PE. In other embodiments, the guide wire can extend to a position just proximal to clot PE. After positioning the guide wire, catheter 102 can be placed on the guide wire and advanced (as shown by arrow A1) to a position near clot PE, as shown.

[0091] ​In some embodiments, to confirm the position of the distal portion 103a of the catheter 102, a contrast agent can be injected through the catheter 102 and viewed using fluorescence imaging techniques known in the art. In some embodiments, the valve 106 can be opened to determine the position of the distal portion 103a of the catheter 102 relative to the clot PE. For example, the activation button 101 can be pressed to open the lumen 109 of the valve 106. If there is substantially no back-bleeding through the valve 106, the operator can determine that the distal portion 103a of the catheter 102 is fully engaged with the clot PE. In contrast, if there is some back-bleeding through the valve 106, the operator can determine that the distal portion 103a of the catheter is not fully engaged with the clot PE. Thus, to position the distal portion 103a of the catheter 102 just proximal to the clot PE, the operator can (i) first determine that the distal portion 103a of the catheter is fully engaged with the clot PE by activating the valve 106 and detecting no back-bleeding, and (ii) then (e.g., by withdrawing the catheter 102 proximally) reposition the catheter 102 and activate the valve 106 until back-bleeding is detected, thereby confirming that the distal portion 103a of the catheter 102 is located proximal to the clot PE. In some embodiments, the valve 106 can be opened during retraction of the catheter 102 until back-bleeding is detected. In other embodiments, during retraction of the catheter 102, the valve 106 can be closed, and the catheter 106 can be retracted a set (e.g., predetermined) distance before the valve 106 is opened again. In one aspect of the present technique, when it is difficult to determine the position of the catheter 102 via radiographic techniques, the activation via the valve 106 can be used to determine the position of the distal portion 103a of the catheter 102. In contrast, many conventional hemostatic valves cannot be activated in this manner.

[0092] In some embodiments, the guidewire can then be withdrawn, while in other embodiments, the guidewire can be retained and can be used to guide other catheters (e.g., delivery catheters, additional aspiration catheters, etc.), interventional devices, etc. to the treatment site. However, it should be understood that other access locations into the patient's venous circulatory system are possible and consistent with the present technique. For example, the user can access through the jugular vein, subclavian vein, brachial vein, or any other vein that connects to or ultimately leads to the superior vena cava. Using other blood vessels that are closer to the right atrium of the patient's heart may also be advantageous as it reduces the length of the instrument required to reach the pulmonary embolism.

[0093] At block 804, method 800 includes coupling a pressure source (e.g., syringe 340) to the catheter 102 via the fluid control device 126. For example, in Figure 9A the illustrated embodiment, the tip 347 of the syringe 340 ( Figure 3A and 3C as shown, butFigure 9A (which is shielded in [the relevant context]) can be coupled to the connector 128 via the adapter 350. Once the syringe 340 is coupled to the catheter 102, (i) the fluid control device 126 is opened to fluidly connect the syringe 340 to the lumen 104 of the catheter 102, and (ii) the fluid control device 126 is closed to fluidly disconnect the syringe 340 from the lumen 104 of the catheter 102. The fluid control device 126 is in Figure 9A the open position in [the relevant context].

[0094] At block 806, the method 800 includes activating the syringe 340 to generate a vacuum while the fluid control device 126 is closed. For example, as Figure 9B shown, the user can first actuate the fluid control device 126 to close the fluid control device 126, and then retract the plunger 342 to generate a vacuum in the barrel 344 of the syringe 340. As described in detail above, the user can then lock the plunger 342 relative to the barrel 344 to store or maintain a known volume of vacuum in the syringe 340. In this way, the syringe 340 can be pre-charged with vacuum before applying the vacuum to the catheter 102. In contrast, many conventional aspiration techniques involve activating a negative pressure source (e.g., a pump, a syringe, etc.) while the pressure source is fluidly connected to the lumen to be aspirated. In some embodiments, when the pressure source 400 ([[]]END]] Figures 4A - 4C ) with the secondary syringe 460 is used together with the primary syringe 340, the secondary syringe 460 can be cycled one or more times before or after retracting the plunger 342 to increase the vacuum pressure.

[0095] At block 808, the method 800 includes opening the fluid control device 126 to apply the vacuum to the lumen 104 of the catheter 102. For example, referring to Figure 9C , the user can actuate the fluid control device 126 (e.g., twist the handle of the fluid control device 126) to open the fluid control device 126 and apply the vacuum stored in the syringe 340 to the catheter subsystem 100. As Figure 10BAs shown, applying a vacuum at the distal tip 103a of the catheter 102 causes suction (e.g., as shown by arrow A2), which withdraws at least a portion of the clot PE from the blood vessel BV and into the lumen 104 of the catheter 102. In some embodiments, the fluid control device 126 is opened instantaneously or almost instantaneously to create suction at the distal portion 103a of the catheter 102. In certain embodiments, applying a vacuum can create suction for less than about 1 second (e.g., about 0.5 second), substantially less than about 1 second (e.g., about 0.3 second, about 0.1 second, etc.), less than about 2 seconds, or greater than about 2 seconds until pressure equilibrium in the assembly 10. In some embodiments, depending on the volume of the vacuum chamber formed in the syringe 340 and the dimensions of the catheter subsystem 100 and the tubing subsystem 120 (e.g., where the volume of the syringe 340 is greater than or approximately equal to the volume of the catheter subsystem 100), at least some of the clot PE can be drawn entirely through the lumen 104 of the catheter 102 into the barrel 344 of the syringe 340. In some such embodiments, the user can determine whether subsequent steps for treating the clot PE are necessary or desirable by observing the amount of clot collected in the syringe 340. For example, Figure 9C Shown is the syringe 340 and the tubing subsystem 120 after the fluid control device 126 has been opened to apply the vacuum stored in the syringe 340 to the catheter 102. In the illustrated embodiment, some of the clot PE can be seen in the syringe 340.

[0096] In some embodiments, the fluid control device 126 or another fluid control device can operate intermittently to provide discrete bursts of suction. For example, the fluid control device 126 can be rapidly opened and closed to provide a first burst of suction (e.g., vacuum release) without fully equilibrating the pressure in the assembly 10. The fluid control device 126 can then be opened again to provide a second burst of suction, or repeatedly opened and closed to provide a desired suction pattern. In some embodiments, the assembly 10 can be specifically configured to facilitate applying multiple bursts of suction. For example, (i) the fluid control device 126 can be spring-loaded, electronically controlled, etc., to rapidly open and close the valve, and / or (ii) the pressure source 140 can have a large vacuum chamber and / or a small aperture to increase the time required for pressure equilibrium in the assembly 10 (e.g., increase the discharge time of the pressure source 140).

[0097] Sometimes, as Figure 10BAs shown, the vacuum stored in the discharge pressure source may not be able to remove all the clotting substances PE (or the required amount of clotting substances PE) from the blood vessel BV through the lumen 104 of the aspiration catheter 102. That is, a single aspiration may not be able to fully remove the clotting substances PE from the blood vessel BV. In this case, the user of the assembly 10 may wish to apply the vacuum pressure again (perform a "pass") to remove all or part of the remaining clotting substances PE in the blood vessel BV. In this case, before the method 800 returns to block 802, the pressure source can be disconnected from the pipeline subsystem 120 and emptied (for example, the aspirated removed clots are removed). For example, the adapter 350 and the syringe 340 can be decoupled from the connector 128, and the plunger 342 can be pushed into the barrel 344 to discharge the clotting substances PE and the associated fluid from the barrel 344 via the tip 347. When the distal portion of the catheter 102 is near the remaining clotting substances PE (for example, not moved relative to the previous aspiration pass), the pressure source can then be re-coupled to the connector 128 (block 804), recharged (block 806), and the vacuum pressure can be released (block 808) to aspirate all or part of the remaining clotting substances PE.

[0098] Blocks 802-808 can be repeated until the required amount of clotting substances is removed from the patient or until the catheter 102 becomes blocked. In some embodiments, to check whether the catheter 102 is blocked, the fluid control device 126 and / or the valve 106 can be opened to check for back bleeding. The absence of back bleeding may indicate that the catheter 102 may be blocked. Similarly, if the barrel 344 of the syringe 340 mainly contains air and relatively little blood and clotting substances (for example, less than 5-10 cc) after aspirating the catheter 102 (block 808), it may indicate that the catheter 102 may be blocked. When the catheter 102 is blocked or a sufficient amount of clotting substances PE has been removed from the patient, the method 800 can proceed to block 810 and the catheter 102 can be removed from the patient. When the catheter 102 is blocked, the catheter 102 can be flushed and cleaned before re-entering the patient (block 802). In other embodiments, a different (for example, new, unused, etc.) catheter can be inserted into the patient and positioned to remove the remaining clotting substances PE from the patient.

[0099] In some embodiments, if the catheter 102 becomes blocked, the syringe 340 can be refilled and used to apply one or more subsequent vacuum pulses to the catheter 102 rather than removing the catheter 102 from the patient. More specifically, the fluid control device 126 can be closed, and the syringe 340 can be removed from the connector 128 and emptied to remove clots and blood therefrom. Then, blocks 804 - 808 can be repeated to apply another vacuum pulse to the catheter 102. That is, rather than removing the catheter 102 after detecting a blockage, the syringe 340 can be "cycled" until the vacuum force applied to the clot PE overcomes the force between the clot PE and the catheter 102 and draws the clot PE into the syringe 340. In some embodiments, when a pressure source 400 ( Figures 4A - 4C ) with a secondary syringe 460 is used in conjunction with the primary syringe 340, the secondary syringe 460 can be cycled one or more times to increase the vacuum in the assembly 10 (e.g., in the catheter 102), thereby increasing the suction force applied to the clot PE. That is, rather than removing the catheter 102 after detecting a blockage, the secondary syringe 460 can be cycled until the vacuum force applied to the clot PE overcomes the force between the clot PE and the catheter 102 and draws the clot PE into the syringe 340. In some embodiments, as described in detail below with reference to Figures 15 - 16E , a second clot removal assembly can telescope through the first assembly 10 to facilitate removal of the blocked clot PE.

[0100] In some embodiments, an interventional device, such as a clot removal and / or clot treatment device, can be delivered through the catheter 102 to the treatment site to cooperate with and facilitate clot removal before and / or after applying a stored vacuum to the catheter 102. Suitable interventional devices and related methods are disclosed in U.S. Patent Application No. 9,526,864, titled "Retraction and Aspiration Devices for Treating Embolisms and Related Systems and Methods," filed on June 9, 2015, and U.S. Patent Application No. 8,784,434, titled "Methods and Apparatus for Treating Embolisms," filed on March 15, 2013, which are hereby incorporated by reference in their entireties. In some embodiments, for example, a user can first advance the interventional device to the treatment site and at least partially cooperate the clot PE with the interventional device to dislodge (e.g., flush) the clot PE. Such dislodging of the clot PE can facilitate removal of the clot PE during a subsequent aspiration pass. Similarly, in some embodiments, a user can use the interventional device to cooperate with residual clot PE after a first aspiration pass ( Figure 10B ).

[0101] Four, Selected embodiments of the telescopic clot removal system and related clot removal method

[0102] Figure 11is a partial schematic side view of another clot treatment or clot removal system configured according to the present technology. In the illustrated embodiment, the clot removal system includes a first aspiration assembly 20 and a second aspiration assembly 30. The first and second aspiration assemblies 20, 30 (“assemblies 20, 30”) may include features that are generally similar to the features of the aspiration assembly 10 described in detail above with reference to Figures 1 - 10B For example, the first aspiration assembly 20 includes (i) a first catheter subsystem 1000 having a first catheter 1002 and a first valve 1006, (ii) a first conduit subsystem 1020 having a first fluid control device 1026 (e.g., a stopcock), and (iii) a first pressure source 1040 that can be fluidly coupled to the first catheter subsystem 1000 via the first conduit subsystem 1020. Similarly, the second aspiration assembly 30 includes (i) a second catheter subsystem 1100 having a second catheter 1102 and a second valve 1106, (ii) a second conduit subsystem 1120 having a second fluid control device 1126 (e.g., a stopcock), and (iii) a second pressure source 1140 that can be fluidly coupled to the second catheter subsystem 1100 via the second conduit subsystem 1120.

[0103] The first and second catheters 1002, 1102 each respectively include a lumen 1004, 1104 defined therein and an elongate shaft having distal portions 1003a, 1103a. The first and second valves 1006, 1106 each respectively include (i) distal portions 1007a, 1107a, (ii) proximal portions 1007b, 1107b, (iii) lumens 1009, 1109 extending therethrough, and (iv) flow controllers (obscured in FIG. 10) within the lumens 1009, 1109. The first fluid control device 1026 is operable to regulate or control (e.g., fluidly connect or disconnect) fluid flow between the first pressure source 1040 and the first catheter subsystem 1000. The second fluid control device 1126 is operable to regulate or control (e.g., fluidly connect or disconnect) fluid flow between the second pressure source 1140 and the second catheter subsystem 1100.

[0104] In the illustrated embodiment, the cross-sectional dimensions (e.g., diameter) of the second catheter 1102 are less than those of the first catheter 1002 such that the second catheter 1102 can be inserted through the first valve 1006 and into the lumen 1004 of the first catheter 1002. In some embodiments, the second catheter 1102 is telescopically insertable through the lumen 1004 of the first catheter 1002 until the distal portion 1103a of the second catheter 1102 extends beyond the distal end of the first catheter 1002. Thus, the second catheter 1102 can be longer than the first catheter 1002. In some embodiments, the second catheter 1102 can have a size of 16 French or less, and the first catheter 1002 can have a size of 20 French or greater. When the second catheter 1102 is located within the first catheter 1002, the first valve 1006 can provide a hemostatic seal that prevents fluid flow (e.g., blood flow) through the first valve 1006 and from the first catheter subsystem 1000. In some embodiments (e.g., as described in detail below with reference to Figures 14A - 14C ), a sealing member 1499 can be located between the first catheter 1002 and the second catheter 1102 to seal the lumen 1004 of the first catheter 1002 when the second catheter 1102 is advanced distally beyond the sealing member.

[0105] In some embodiments, the first and second pressure sources 1040, 1140 (“pressure sources 1040, 1140”) are separate sources, each configured to generate and store a vacuum for subsequent application to the first and second catheter subsystems 1000, 1100, respectively, as described in detail above with reference to Figures 1 - 10B . In other embodiments, one or both of the pressure sources 1040, 1140 can be configured to provide a continuous negative pressure rather than a charge or burst of stored vacuum pressure. In yet other embodiments, one of the pressure sources 1040, 1140 can be omitted, or the pressure sources 1040, 1140 can be fluidly coupled and / or integrally formed.

[0106] Figure 12 is a flowchart of a process or method 1280 according to the present technique for operating a clot removal system including components 20 and 30 to remove clot material from within a blood vessel (e.g., a pulmonary blood vessel) of a human patient. Figures 13A - 13C is a schematic view of the distal portions of components 20, 30 during a clot removal procedure according to the present technique. Figures 14A - 14C is a schematic side view of the distal portions of components 20, 30 during a clot removal procedure according to the present technique and including an optional sealing member. Although for illustrative purposes in Figure 11 and 13ASome features of method 1280 are described in the context of the embodiment shown in -14C, but those skilled in the art will readily understand that other suitable systems and / or devices may be used to perform method 1280.

[0107] At block 1282, method 1280 includes endovascularly positioning the first catheter 1002 within a human patient. For example, Figure 13A The first catheter 1002 is shown after being advanced (e.g., as represented by arrow A1) into a position within a blood vessel BV (e.g., a pulmonary blood vessel). More specifically, the first catheter 1002 may be advanced within the blood vessel BV until the distal portion 1003a of the first catheter 1002 is proximal to a clotting substance PE within the blood vessel BV. In some embodiments, the position of the distal portion 1003a of the first catheter 1002 relative to the clotting substance PE may be determined by activating the first valve 1006 and determining whether there is back bleeding through the first valve 1006, as described in detail above. In the illustrated embodiment, the clotting substance PE is located within a branch (e.g., a reduced diameter portion) of the blood vessel BV. In some embodiments, as referenced above Figure 8 In detail, an introducer and a guide wire may be used to achieve entry into the blood vessel BV.

[0108] At block 1284, method 1280 includes advancing a second catheter 1102 through the first catheter 1002 until the distal portion 1103a of the second catheter 1102 is near the clotting substance PE within the blood vessel BV (e.g., at the treatment site). To advance the second catheter 1102 through the first catheter 1002, the user may first insert the distal portion 1103a of the second catheter 1102 through the first valve 1006 before advancing the second catheter 1102 (e.g., as represented by arrow A1) through the lumen 1004 of the first catheter 1002. In some embodiments, the first valve 1006 may be actuated (e.g., by pressing one or more buttons) to open the lumen 1009 of the first valve 1006 so that the second catheter 1102 may be inserted therein. In some embodiments, the position of the distal portion 1103a of the second catheter 1102 relative to the clotting substance PE may be determined by activating the second valve 1106 and determining whether there is back bleeding through the second valve 1106, as described in detail above. In other embodiments, the position of the (smaller) second catheter 1102 may be endovascularly positioned near the clotting substance PE before the position of the (larger) first catheter 1002 is endovascularly positioned. In such embodiments, the second catheter 1102 may be used as a guide or track to guide the advancement of the first catheter 1002 to the treatment site.

[0109] Figure 13AThe second catheter 1102 is shown after having advanced the second catheter 1102 through the first catheter 1002 and beyond the distal end of the first catheter 1002 to position the distal end of the second catheter 1102 near the proximal portion of the clot PE. In other embodiments, the distal end of the second catheter 1102 may be at least partially within the clot PE, or the distal end of the second catheter 1102 may be distal to the clot PE. In one aspect of the present technique, because the second catheter 1102 has a smaller cross-sectional size than the first catheter 1002, the second catheter 1102 can be advanced to a narrower (e.g., more distal) treatment site within the blood vessel BV. In Figure 13A the illustrated embodiment, for example, the first catheter 1002 may be too large to be located within a branch of the blood vessel BV, while the second catheter 1102 can be located within the branch near or within the clot PE.

[0110] At block 1286, method 1280 includes coupling a second pressure source 1140 to the second catheter 1102 via a second fluid control device 1126. For example, any one or combination of the pressure sources described in detail above Figures 2 - 7 can be coupled to the second catheter 1102 via the second plumbing subsystem 1120. Once the second pressure source 1140 is coupled to the second catheter 1102, (i) opening the second fluid control device 1126 fluidly connects the second pressure source 1140 to the lumen 1104 of the second catheter 1102, and (ii) closing the second fluid control device 1126 fluidly disconnects the second pressure source 1140 from the lumen 1104 of the second catheter 1102. In some embodiments, method 1280 may further include coupling a first pressure source 1040 to the first catheter 1002 (e.g., via the first plumbing subsystem 1020).

[0111] At block 1288, method 1280 includes activating the second pressure source 1140 to generate a vacuum while the second fluid control device 1126 is closed. In particular, the second pressure source 1140 can be activated to accumulate or pre-charge a vacuum for subsequent application to the second catheter 1102. In some embodiments, the first pressure source 1040 can also be activated to generate and store a vacuum for subsequent application to the first catheter 1002.

[0112] At block 1290, method 1280 includes opening the second fluid control device 1126 to apply the vacuum stored in the second pressure source 1140 to the lumen 1104 of the second catheter 1102. As Figure 13BAs shown, applying a vacuum causes suction (e.g., as represented by arrow A2), which suctions at least a portion of the clot PE from the blood vessel BV and into the lumen 1104 of the second catheter 1102. In some embodiments, the second fluid control device 1126 is opened instantaneously or almost instantaneously to create suction at the distal portion 1103a of the second catheter 1102. In one aspect of the present technique, pre-charging or storing a vacuum prior to applying the vacuum to the lumen 1104 of the second catheter 1102 is expected to create a greater suction force (and corresponding fluid flow rate) at and / or near the distal portion 1103a of the second catheter 1102 as compared to simply activating the second pressure source 1140 when the second pressure source 1140 is fluidly connected to the second catheter 1102.

[0113] In some embodiments, where the first pressure source 1040 is also activated to generate and store a vacuum (e.g., at block 1288), the method 1280 may further include opening the first fluid control device 1026 to create suction at the distal portion 1003a of the first catheter 1002. Those skilled in the art will understand that the suction profile in the blood vessel BV can be selected or modified based on the characteristics of the pressure sources 1040, 1140 (e.g., volume, aperture, etc.) and the opening times of the first and second fluid control devices 1026, 1126. For example, the first fluid control device 1026 can be opened simultaneously with the second fluid control device 1126 to create a combined and relatively large suction force in the blood vessel BV. In other embodiments, the first fluid control device 1026 can be opened after the second fluid control device 1126 to create a staggered or stepped suction force in the blood vessel BV. For example, the first fluid control device 1026 can be opened after the second fluid control device 1126 to (i) suction any remaining clot PE in the blood vessel BV after the suction of the second catheter 1102, and / or (ii) suction any clot PE adhering to or extending from the second catheter 1102. In other embodiments, the first pressure source 1040 can be a pump or other source for providing a continuous negative pressure rather than accumulating a charged negative pressure, and thus can create a continuous (e.g., constant) suction at the distal portion 1003a of the first catheter 1002. In some such embodiments, the first fluid control device 1026 can remain open during the clot removal procedure to provide continuous suction throughout the procedure.

[0114] In some embodiments, an intervention device may be delivered through the second catheter 1102 and used to engage a clot PE before and / or after a vacuum is applied to the second catheter 1102. Specific details of suitable intervention devices and related methods of use are disclosed in, for example, U.S. Provisional Patent Application No. 16 / 258,344, filed January 25, 2019, titled "Single-Insertion Delivery System for Treating Embolisms and Related Systems and Methods", which is incorporated herein by reference in its entirety.

[0115] At block 1292, method 1280 includes retracting the second catheter 1102 proximally through the first catheter 1002. In some embodiments, multiple aspiration passes may be performed using the second catheter 1102 before retracting the second catheter 1102. In some embodiments, as Figure 13C shown, the first pressure source 1040 or another pressure source coupled to the first catheter 1002 may be activated to create aspiration (e.g., as represented by arrow A3) at the distal portion 1003a of the first catheter 1002 during retraction of the second catheter 1102. The aspiration may be constant or provided in one or more bursts, as described in detail above. In some embodiments, the second catheter 1102 may be withdrawn completely from the patient and disposed of or cleaned (e.g., flushed with a sterile liquid) for reuse.

[0116] Sometimes, when a vacuum is applied to the second catheter 1102 (block 1290), the clot PE is not completely drawn into the second catheter 1102 and may thus adhere or hang on the distal portion 1103a of the second catheter 1102. For example, Figure 14A is Figure 13C an enlarged view of the distal portion of the assemblies 20, 30 shown and shows a portion of the clot PE adhering or hanging on the distal portion 1103a of the second catheter 1102. In the embodiment shown, an optional seal 1499 is disposed between the first and second catheters 1002, 1102 to facilitate removal of such hanging clot PE. More specifically, the seal 1499 (shown in cross-section) may be disposed between the outer surface of the second catheter 1102 and the inner surface of the first catheter 1002. The seal 1499 may be an O-ring, grommet, or other suitable component that fluidly disconnects the lumen 1004 of the first catheter 1002 from the blood vessel BV when the second catheter 1102 is located therethrough (e.g., when the distal end of the second catheter 1102 is distal to the seal 1499).

[0117] Figure 14B and 14Cis an enlarged view of the distal portions of components 20, 30 and shows second catheter 1102 (and suspended clot PE) further retracted into lumen 1004 of first catheter 1002. In some embodiments, first pressure source 1040 may be activated to fill lumen 1004 of first catheter 1002 with a vacuum. For example, after advancing second catheter 1102 through first catheter 1002 and past seal 1499 (e.g., block 1284) to seal lumen 1004 of first catheter 1002, an operator may open first fluid control device 1026 and activate first pressure source 1040 to accumulate a vacuum in lumen 1004 of first catheter 1002. Refer Figure 14C , when the distal end of second catheter 1102 is retracted proximally past seal 1499, lumen 1004 of first catheter 1002 becomes fluidly connected to blood vessel BV and instantaneously or almost instantaneously releases the vacuum to create suction (e.g., as represented by arrow A4). In the illustrated embodiment, the suction acts to separate or remove clot PE from second catheter 1102 and pull clot PE proximally through lumen 1004 of first catheter 1002. In this manner, a second suction burst is automatically applied via first catheter 1002 during retraction of second catheter 1102. In one aspect of the present technique, the user does not need to take any additional steps to release the vacuum stored in first catheter 1002 because the release is automatically triggered by the retraction of second catheter 1102.

[0118] At block 1294, the user may determine whether it is necessary or desirable to redeploy second catheter 1102 or another catheter through first catheter 1002 to remove any residual clot PE that was not removed during the first suction pass and / or any clot located elsewhere in blood vessel BV (e.g., to initiate a second suction pass). In some embodiments, the operator may observe the amount of clot PE collected in first pressure source 1040 and / or second pressure source 1140 to at least partially determine whether another suction pass is needed. In other embodiments, the operator may rely on imaging of blood vessel BV (e.g., fluorescence imaging) or other techniques known in the art to determine whether an additional suction pass is needed or desirable.

[0119] If another pass is not required (e.g., the clot PE has been sufficiently removed), the user may choose to completely withdraw the components 20, 30 from the patient at block 1296. If clot PE remains in the blood vessel, the method may return to block 1284. In particular, the same second catheter 1102 may be cleaned (e.g., flushed with saline) and advanced again through the first catheter 1002 until the distal portion 1103a of the second catheter 1102 is near the remaining clot PE within the blood vessel BV. In some embodiments, a new second catheter 1102 may be used for each pass to reduce the likelihood of contamination (e.g., re-introducing clot PE). In some embodiments, the first catheter 1002 may be aspirated (e.g., via the first pressure source 1040) before redeploying the second catheter 1102 to, for example, remove any clot PE that may be present in the first catheter 1002 and prevent it from being re-introduced into the blood vessel BV when the second catheter 1102 is advanced therethrough during another pass. Once the desired amount of clot PE has been removed from the patient, the components 20, 30 may be completely withdrawn from the patient (block 1294).

[0120] In one aspect of the present technique, the method 1280 provides a suction catheter that can be deployed multiple times without removing the first catheter 1002 after each deployment. Thus, the present technique allows for only a single insertion of the guiding catheter to remove clots during a procedure that includes multiple passes, improving the speed of the procedure and reducing trauma to the patient since the guiding catheter does not need to be re-introduced (e.g., advanced through the vasculature and past the heart) before each pass. Additionally, in certain embodiments, the present technique may enable the position of the first catheter 1002 to be re-set at an alternative treatment site within the patient without removing the first catheter 1002 from the patient and thus without re-introducing the first catheter 1002 through the heart. For example, the position of the first catheter 1002 may be re-set at another treatment site within the lung, including a treatment site in the contralateral lung. More specifically, (i) a dilator may be re-introduced into the first catheter 1002, (ii) the first catheter 1002 may be withdrawn into the main pulmonary artery, (iii) the guide wire may be redirected to the new treatment site, (iv) the first catheter 1002 may be advanced over the guide wire to the new treatment site, and (v) the dilator may be removed.

[0121] Figure 15 is another process or method 1580 for operating a clot removal system including components 20, 30 ( Figure 1 ) to remove a clot from within a blood vessel (e.g., a pulmonary blood vessel) of a human patient. Figure 16A is an enlarged side view of the distal portion of the first component 20, Figures 16B - 16Eis a side view of the distal portions of components 20, 30 during a clot removal procedure in which a clot blocks a first component 20 according to the present technique. Although some features of method 1580 are described in the context of the embodiments shown in Figure 11 and 16A -16E, those skilled in the art will readily understand that other suitable systems and / or devices may be used to perform method 1580.

[0122] Some features of method 1580 are generally similar, respectively, to the features of methods 880 and / or 1280 described above with reference to Figure 8 and 12 For example, at block 1582, the method includes positioning a first catheter 1002 of a first component 20 endovascularly within a human patient. At block 1584, method 1580 includes coupling a first pressure source 1040 to the first catheter 1002 via a first fluid control device 1026. For example, any one or combination of the pressure sources described in detail above with reference to Figures 2 - 7 may be coupled to the second catheter 1002 via a first plumbing subsystem 1020. At block 1586, method 1580 includes activating the first pressure source 1040 to create a vacuum while the first fluid control device 1026 is closed. In particular, the first pressure source 1040 may be activated to accumulate or pre-charge a vacuum for subsequent application to the first catheter 1002. At block 1588, method 1580 includes opening the first fluid control device 1026 to apply the vacuum stored in the first pressure source 1040 to the lumen 1004 of the first catheter 1002. As described in detail above, opening the first fluid control device 1026 creates suction instantaneously or almost instantaneously at the distal portion 1003a of the first catheter 1002.

[0123] However, when a vacuum is applied to the first catheter 1002 (block 1588), sometimes the clot is not completely drawn into the first catheter 1002 and / or blocks the first catheter 1002. For example, Figure 16Ais an enlarged view of the distal portion of the first component 20, showing a portion of the clot PE that extends from the distal portion 1003a of the first catheter 1002 and occludes / clogs the lumen 1004 of the first catheter 1002. Thus, a portion of the clot PE is not within the first catheter 1002. Accordingly, at block 1590, method 1580 may include determining whether the first catheter 1002 is blocked. In some embodiments, the operator may determine that the first catheter 1002 is blocked based on the vacuum chamber of the first pressure source 1040 that contains little or no clot PE and blood. For example, since the clot PE blocks the first catheter 1002, the vacuum chamber of the first pressure source 1040 cavitates when the first fluid control device 1026 is opened. If the first catheter 1002 is not blocked, method 1580 may proceed to block 1598, and the first catheter 1002 may be withdrawn from the patient, or the operator may perform another aspiration pass (e.g., as detailed in blocks 808 and 810 of method 800 as referenced above Figure 8 shown).

[0124] If the first catheter 1002 is blocked, method 1580 may proceed to block 1592, which includes advancing a second catheter 1102 through the first catheter 1002 until the distal portion 1103a of the second catheter 1102 is located in or near the occluding clot PE. For example, Figure 16B shows the second catheter 1102 after it has been advanced into the first catheter 1002, where the distal end of the second catheter 1102 is at or near the occluding clot PE. To advance the second catheter 1102 through the first catheter 1002, the user may first insert the distal portion 1103a of the second catheter 1102 through the first valve 1006 ( Figure 11 ).

[0125] At block 1594, method 1580 includes activating a second pressure source 1140 coupled to the second catheter 1102 ( Figure 11 ). More specifically, the second pressure source 1140 (e.g., any one or combination of the pressure sources detailed above as referenced Figures 2 - 7 ) may be coupled to the second catheter 1102 via a second fluid control device 1126 ( Figure 11) and when the second fluid control device 1126 is closed, the second pressure source 1140 can be activated to accumulate or pre - charge a vacuum. Then, the second fluid control device 1126 can be actuated to apply the vacuum stored in the second pressure source 1140 to the lumen 1104 of the second conduit 1102. In other embodiments, the second pressure source 1140 can simply provide a continuous vacuum rather than an instantaneous vacuum release. That is, in some embodiments, the second pressure source 1140 does not pre - charge a vacuum.

[0126] Applying a vacuum to the second conduit 1102 can draw at least a portion of the occluding clot PE into the second conduit 1102 and / or aspirate the clot PE adjacent to the distal end of the second conduit 1102. For example, Figure 16C shows a portion of the clot PE adhering to or extending from the distal portion 1103a of the second conduit 1102 after aspiration of the second conduit 1102. In Figure 16C the illustrated embodiment, the increased vacuum pressure generated through the second conduit 1102 is still not sufficient to break up the clot PE such that it can be fully aspirated through the first and / or second conduits 1002, 1102. That is, the clot PE occludes the lumen 1004 of the first conduit 1002. In other embodiments, the increased vacuum pressure from the second pressure source 1140 is sufficient to break up the clot PE such that it is aspirated into, for example, the vacuum chambers of the first and / or second pressure sources 1040, 1140.

[0127] At block 1596, the method can include retracting the second conduit 1102 and the clot PE through the lumen 1004 of the first conduit 1002. For example, Figure 16D shows retracting the second conduit 1102 through the lumen 1004 of the first conduit 1002, which in turn retracts the attached clot PE. In some embodiments, the second conduit 1102 and the clot PE can be fully withdrawn through the first conduit 1002. In other embodiments, retracting the clot PE through the first conduit 1002 causes the clot PE to break up and be aspirated into the vacuum chambers of the first and / or second pressure sources 1040, 1140. For example, Figure 16E shows the clot PE disintegrating when the vacuum of the first and / or second pressure sources 1040, 1140 is released instantaneously or almost instantaneously to aspirate the clot PE proximally (e.g., as indicated by arrow A5).

[0128] At block 1598, the first and second conduits 1002, 1102 can be withdrawn from the patient, or the operator can perform another aspiration pass using one or both of the first and second conduits 1002, 1102.

[0129] In one aspect of the present technology, even if the first aspiration blocks the first catheter 1002, the method 1580 removes the clot. More specifically, the second catheter 1102 can be used to remove the blocked clot PE without withdrawing the first catheter 1002 and the blocked clot PE through the blood vessel BV. Five, Clot removal system and Phase Additional selected embodiments of the related clot removal method Reality Embodiments

[0130] In summary, it can be understood that, for purposes of illustration, specific embodiments of the present technology have been described herein, but various modifications can be made without departing from the scope of the present technology. For example, in many of the embodiments described above, the stored vacuum pressure can be used to aspirate or draw in clotting substances from the blood vessel and into the catheter without engaging the intervention device with the clotting substances. However, those skilled in the art will understand that the aspiration devices and techniques disclosed herein can be used with any suitable intervention device and / or during a clot removal procedure using an intervention device. In some embodiments, for example, the clot removal system can be configured to apply the stored vacuum pressure to a guiding catheter to create an aspiration burst when the intervention device is retracted into and / or retracted through the guiding catheter.

[0131] For example, Figure 17 is a partial schematic view of a clot removal system 1700 (“system 1700”) configured according to the present technology. Some features of system 1700 are generally similar to the features of the clot removal systems described in detail above with reference to Figure 1 For example, system 1700 includes a catheter or sheath 1702 that includes an elongate shaft, and a valve 1706 coupled to the proximal portion of the sheath 1702. The valve 1706 has a side port 1708 that fluidly couples the lumen of the sheath 1702 to a tubing subsystem 1720 and a pressure source 1740 (schematically shown). A fluid control device 1726 (e.g., a stopcock or clamp; schematically shown) is operable to fluidly disconnect or connect the pressure source 1740 from the lumen of the sheath 1702. The pressure source 1740 can be any suitable pressure source for generating and storing a vacuum pressure, as described in detail above.

[0132] In the illustrated embodiment, system 1700 also includes (i) a self-expanding (e.g., mesh) funnel 1780 coupled to the proximal portion of the sheath 1702 and (ii) an intervention device (e.g., a thrombectomy device) 1790. In the illustrated embodiment, the intervention device 1790 includes an expandable coring element (e.g., a first portion) 1792 coupled to an expandable cylindrical element (e.g., a second portion) 1794. In some embodiments, the intervention device 1790 is configured to self-expand from a compressed delivery state to an expanded deployed state. The intervention device 1790 is as Figure 17is shown in the deployed state. The elongate shaft 1782 and / or one or more shafts located within the elongate shaft 1782 (e.g., the intermediate shaft 1884 and inner shaft 1886 as shown respectively in Figure 18E and 18F ) are coupled to the access device 1790 and are configured to retract, advance, and / or manipulate (e.g., move between a delivery and deployed state) the access device 1790. In some embodiments, the system 1700 may generally be the same as or similar to any clot removal system disclosed in U.S. Patent Application Publication No. 2018 / 0193043, titled "Devices and Methods for Treating Vascular Occlusions," filed on April 26, 2017, which is incorporated herein by reference in its entirety.

[0133] In the illustrated embodiment, the system 1700 is shown positioned within the blood vessel BV of a human patient and adjacent to a clotting substance DV (e.g., deep vein thrombosis) within the blood vessel BV. Specifically, Figure 17 the system 1700 is shown after the following steps: (i) advancing the sheath 1702 to a position near the proximal portion 1785b of the clot DV, (ii) deploying the funnel 1780, (iii) deploying the access device 1790 from the sheath 1702 (e.g., by advancing the access device 1790 through the valve 1706 and the sheath 1702 to a distal position distal to the distal portion 1785a of the clot DV), and (iv) after expanding the access device 1790 from a compressed delivery state to a deployed state.

[0134] Figures 18A - 18H is an enlarged view of the distal portion of the system 1700 during a clot removal procedure in accordance with the present technique. Generally, Figures 18A - 18H is shown the access device 1790 retracting proximally through the clot DV to capture at least a portion of the clot DV, and subsequently the access device 1790 and the captured clot DV being retracted together into the funnel 1780 and the sheath 1702. In one aspect of the present technique, a charged vacuum pressure generated in the vacuum source 1740 may be applied to the sheath 1702 one or more times during the illustrated process to create suction to aspirate the captured clot DV through the sheath 1702 and / or prevent blockage of the sheath 1702.

[0135] Referring first to Figure 18A , retracting the access device 1790 proximally causes the nucleating element 1792 to separate and / or core the distal end portion 1785a of the clot DV from the wall W of the blood vessel BV. As Figure 18B shown, continuing to retract the access device 1790 proximally through the clot DV causes the cylindrical element 1794 to capture the distal end portion 1785a of the clot therein. Figures 18C - 18EShows further proximal retraction of the interventional device 1790, which results in further separation, nucleation, and / or capture of the clot DV. As Figure 18E shown, when the interventional device 1790 is retracted proximally toward the funnel 1780 and the sheath 1702, the proximal end portion 1785b of the clot DV is nucleated and captured. As Figure 18E further shown therein, a first radiopaque marker 1887a may be located on the distal end portion of the inner shaft 1884, and a second radiopaque marker 1887b may be located on the distal end portion of the sheath 1702.

[0136] In some embodiments, as Figure 18F shown, the interventional device 1790 may be retracted proximally until a portion of the nucleation element 1792 is contained (e.g., located) within the funnel 1780. More specifically, the interventional device 1790 may be retracted proximally until the mouth 1895 of the nucleation element 1792 is contained within the funnel 1780. In some embodiments, the accommodation of the mouth 1895 within the funnel 1780 may be verified by observing the radiopaque marker 1887 ( Figure 18E ) under fluoroscopy. In some embodiments, for example, via fluorescence monitoring, based on the alignment of the distal end portion of the inner shaft 1884 (e.g., the first radiopaque marker 1885a) relative to the distal end portion of the sheath 1702 (e.g., the second radiopaque marker 1885b), it can be determined that the mouth 1895 is fully contained within the funnel 1780. In some embodiments, when the mouth 1895 of the nucleation element 1792 is located within the funnel 1780, the interventional device 1790 may be moved or transitioned from an expanded deployed state to a compressed delivery state to compress and fix the clot DV captured by the interventional device 1790. In some embodiments, for example, the intermediate shaft 1884 may be unlocked and / or decoupled from the inner shaft 1886 (e.g., via user actuation of a plunger or other device) such that the inner shaft 1886 can be advanced distally relative to the intermediate shaft 1884 to fold or compress the interventional device 1790.

[0137] As Figure 18G shown, after the interventional device 1790 is folded, the interventional device 1790 may be retracted proximally through the funnel 1780 and into the sheath 1702. As Figure 18H shown, the interventional device 1790 may be continuously retracted proximally until the interventional device 1790 and the captured clot DV are fully contained within the sheath 1702. In some embodiments, the interventional device 1790 and the captured clot DV may then be passed through the sheath 1702 and the valve 1706 ( Figure 17 ) and withdrawn from the patient's body.

[0138] In some embodiments, folding the intervention device 1790 and / or retracting the intervention device 1790 into the funnel 1780 and / or the sheath 1702 may cause one or more portions of the clot DV to disengage from the clot DV contained in the intervention device 1790. For example, when the intervention device 1790 is folded, all or part of the captured clot DV may be extruded through the pores of the cylindrical element 1794 (e.g., a mesh). In some embodiments, any such clot may be captured by the funnel 1780. Refer to Figure 17 , in some embodiments, the pressure source 1740 may be activated to charge a vacuum, and then the fluid control device 1726 may be opened to apply the charged vacuum to the sheath 1702 (as described in detail above). The vacuum may be applied to the sheath 1702 at any point during the retraction of the intervention device 1790. As Figure 18G and 18H shown, applying the vacuum may create an instantaneous or near-instantaneous suction (e.g., as indicated by arrow A6) at the distal end portion of the sheath 1702, which may suction the extruded portion and / or other portions of the clot DV into and / or through the sheath 1702. In particular, the suction created may suction some or all of the clot DV captured by the funnel 1780. Additionally, in some embodiments, applying a vacuum from the pressure source 1740 may facilitate the smooth retraction of the captured clot DV through the sheath 1702. For example, the suction burst created by applying the vacuum may help prevent clogging of the sheath 1702, and / or may help resolve (e.g., break up) a clog formed in the sheath 1702 during retraction.

[0139] Six, Selected embodiments of the clot removal system with a filter and related clot removal method The systems and methods for clot removal described herein may include applying a pre-charged vacuum to create suction to suction and remove clots from a patient's blood vessel. In one aspect of the technology, suctioning the clot also suctions blood from the patient. It may be advantageous to reintroduce the suctioned blood into the patient to reduce trauma to the patient, particularly in cases where the removal procedure may include multiple suction passes that can withdraw a large amount of blood together. However, the suctioned blood tends to be mixed with the clot, making it unsuitable for reintroduction into the patient. Figures 19 - 20E Various devices for filtering the suctioned blood from the removed clot are shown so that the suctioned blood can be reintroduced into the patient without reintroducing a large amount of clotting substances.

[0140] For example, Figure 19 is a perspective side view of a pressure source 1900 configured according to the present technology for filtering blood from the suctioned clot during a clot removal procedure. The pressure source 1900 is generally similar to that referenced above Figures 4A - 4CThe pressure source 400 described in detail. For example, the pressure source 1900 includes a secondary syringe 460 ("syringe 460") and first and second one-way valves 470 and 472. However, the secondary syringe 460 is coupled to the canister 1940 rather than the main syringe 340( Figures 4A - 4C ). The canister 1940 includes a tip (obscured) coupled to the adapter 350 and is configured to removably reside within the connector 128 of the conduit subsystem 120( Figure 1 ) to fluidly couple the canister 1940 to the conduit subsystem 120. Since the canister 1940 does not include a plunger or other component for changing its volume, the syringe 460 is the only vacuum source for evacuating the canister 1940 (e.g., via repeated cycling of the secondary syringe 460).

[0141] In the illustrated embodiment, the canister 1940 also includes a filter 1942. For clarity, the canister 1940 is shown as transparent in Figure 19 . The filter 1942 is coupled to and / or covers a removable end cap 1944 having a blood separation port 1946. In operation, when blood and clots are drawn into the canister 1940 (e.g., via any of the methods described in detail above), the filter 1942 separates the blood from the clots within the canister 1940. The filtered blood can be removed via the blood separation port 1946. For example, a syringe (not shown) or other device can be fluidly coupled to the blood separation port 1946 and used to draw the blood out of the canister 1940 through the filter 1942. The filtered blood can then be reintroduced into the patient via, for example, the fluid control device 126 and / or the connector 128 of the conduit subsystem 120. Once the blood is removed from the canister 1940, the end cap 1944 can be removed from the canister 1940 (e.g., by unscrewing the end cap 1944 from the body of the canister 1940) to remove the captured clots. In some embodiments, the filter 1942 is attached to the end cap 1944 such that removal of the end cap 1944 removes the filter 1942 and allows the clots to be dumped, scooped, or removed from the canister 1940.

[0142] Figures 20A - 20E A filter device 2050 configured according to the present technology for filtering blood from aspirated clots during a clot removal procedure is shown. The filter device 2050 is configured to be, for example, an in-line filter for one or more of the pressure sources described in detail above with reference to Figures 2 - 7 . For example, Figure 20A is the filter device 2050 and the pressure source 340( Figures 3A - 3D)Partial exploded side view. In the illustrated embodiment, the filter device 2050 includes a filter portion 2060 that is removably locatable within a barrel portion 2070. In the illustrated embodiment, the barrel portion 2070 includes a barrel 2072 that defines a chamber 2074, and a large bore tip 2076 (e.g., as shown in Figure 20C ) configured to fluidly couple the chamber 2074 to an external component (such as the pipe subsystem 120). The filter portion 2060 includes a seal 2062 configured to (i) mate with the inner surface of the barrel 2072 when the filter portion 2060 is located within the chamber 2074 of the barrel portion 2070, and (ii) mate with the outer surface of the syringe 340 (e.g., the outer surface of the barrel 344) when the syringe 340 is inserted into the filter device 2050. In other embodiments, the filter portion 2060 may be permanently attached to or integrally formed with the barrel portion 2070. The filter portion 2060 also includes a filter (e.g., a mesh) 2064 configured (e.g., sized and shaped) to prevent clots from passing therethrough. In some embodiments, the filter 2064 may be configured to prevent clots greater than about 100 μm (e.g., greater than about 110 μm) from passing therethrough.

[0143] Figure 20B Is a three-dimensional side view of the syringe 340 coupled to the filter device 2050. For clarity, the barrel 2072 of the barrel portion 2070 is shown as transparent in Figure 20B (and Figures 20C - 20E ). In the illustrated embodiment, the seal 2062 is located between the outer surface of the barrel 344 of the syringe 340 and the inner surface of the barrel 2072 of the barrel portion 2070. The filter 2064 is located around (e.g., covers) the tip 347 of the syringe 340 to prevent clots from entering the barrel 344 of the syringe 340 during operation.

[0144] Figure 20C Is a side view of the filter device 2050 and the syringe 340 coupled to the pipe subsystem 120 of the assembly 10. More specifically, as described in detail above, the tip 2076 can be inserted into the connector 128 of the pipe subsystem 120. When the filter device 2050 and the syringe 340 are coupled to the pipe subsystem 120, the position of the filter device 2050 is set to be in-line (e.g., in series) with the syringe 340. In Figure 20CIn the illustrated embodiment, the plunger 342 of syringe 340 has been withdrawn to create a negative pressure in the combined volume of barrels 2072 and 344. As described in detail above, opening the fluid control device 126 almost instantaneously applies a negative pressure to catheter 102 to create suction therein. As clots and blood are aspirated through catheter 102 and tubing subsystem 120, filter section 2060 prevents the clots from entering barrel 344 of syringe 340. Thus, the aspirated blood is collected in barrel 344 of syringe 340, while the aspirated clots are collected in barrel 2072 of barrel portion 2070 of filter device 2050. In this way, clots and blood can be separated during aspiration.

[0145] In one aspect of the present technique, separating the blood from the clot allows the blood to be within syringe 340 in a manner that permits the blood to be readily reintroduced into the patient. For example, Figure 20D and 20E is a side view of syringe 340 that is coupled to tubing subsystem 120 of assembly 10 to reintroduce the blood into the patient. In some embodiments, as Figure 20D illustrated, syringe 340 can be decoupled from filter device 2050 and directly coupled to connector 128. With the fluid control device 126 in the open position, by depressing the plunger 342 of syringe 340, the blood can then be reintroduced into the patient through assembly 10. In some embodiments, as Figure 20E illustrated, syringe 340 can be decoupled from filter device 2050 and directly coupled to a port on fluid control device 126. With the fluid control device 126 in the closed position, by depressing the plunger 342 of syringe 340, the blood can then be reintroduced into the patient through assembly 10. Referring together to Figures 20A - 20E , after or before reintroducing the filtered blood into the patient, the filter section 2060 of filter device 2050 can be removed from barrel portion 2070 so that the collected clots can be removed and filter device 2050 can be cleaned. In some embodiments, filter device 2050 and the coupled pressure source can be used to filter blood from the clot after aspiration rather than during. For example, filter device 2050 and the coupled pressure source can be used to withdraw blood and clots collected in canister 1940 of pressure source 1900 (e.g., where canister 1940 does not include filter 1942).

[0146] Figure 21A and 21B illustrate a filter device 2150 configured in accordance with the present technique for filtering blood from aspirated clots during a clot removal procedure. Filter device 2150 is configured to be used with, for example, one or more of the pressure sources described in detail above with reference to Figures 2 - 7 . For example, Figure 21Ais a partially exploded side view of filter device 2150 and pressure source 340( Figures 3A - 3D ). In the illustrated embodiment, filter device 2150 includes a housing 2152 that defines a chamber 2154, a filter 2156 configured to be located within housing 2152, and a cap assembly 2160 configured to be releasably (e.g., via a threaded connection, snap connection, etc.) coupled to housing 2152. In some embodiments, filter 2156 may have a porosity between about 50 - 200 microns.

[0147] Housing 2152 may include a port 2153 that is configured to be removably fluidly coupled to pressure source 340 via a plumbing subsystem 2120. In the illustrated embodiment, plumbing subsystem 2120 includes plumbing segments 2124 (labeled as first plumbing segment 2124a and second plumbing segment 2124b, respectively), a fluid control device 2126 (e.g., a valve, a cock, a clamp, etc.), and a connector 2128 (e.g., a large-bore connector) for fluidly coupling plumbing subsystem 2120 to pressure source 340. In the illustrated embodiment, cap assembly 2160 includes a fluid connector 2162 (e.g., a standard Luer or large-bore connector) that is configured to be connected to a receiving / reinfusion syringe 2170 via, e.g., a plumbing segment 2164. In some embodiments, cap assembly 2160 may include a valve (e.g., a one-way valve, a check valve, etc.) that provides a one-way fluid flow through filter assembly 2150.

[0148] In operation, during a clot removal procedure, pressure source 340 may be decoupled from connector 128( Figure 1 ) after aspiration and when pressure source 340 is filled with blood and clot material. After connecting filter device 2150 to the receiving syringe 2170, pressure source 340 may be coupled to filter device 2150. For example, Figure 21B is a perspective side view of filter device 2150 that is (i) coupled to pressure source 340 via plumbing subsystem 2120 and (ii) coupled to reinfusion syringe 2170 via plumbing segment 2164. More specifically, with reference to Figure 21A and 21B , the tip 347 of pressure source 340 may be coupled to connector 2128 of plumbing subsystem 2120, and the tip 2172 of reinfusion syringe 2170 may be coupled to plumbing segment 2164. In other embodiments, filter device 2150 may be coupled to pressure source 340 and / or reinfusion syringe 2170 in other ways (e.g., directly such that all or part of plumbing subsystem 120 is omitted). Alternatively, filter device 2150 may be directly attached to side port 108( Figure 1), a line IV (not shown), or another suitable connection point for reintroducing blood into the patient.

[0149] After coupling the pressure source 340 to the filter device 2150, the fluid control device 2128 can be opened to fluidly connect the pressure source 340 to the filter device 2150. Then, the operator can depress the plunger 342 of the pressure source 340 to drive blood and clot material from the pressure source 340 into and / or through the filter device 2150. The filter 2156 of the filter device 2150 filters the blood from the clot material such that the blood flows into the reinfusion syringe 2170 and the clot material remains in the chamber 2154 of the filter device 2150. For example, as Figure 21B shown, the blood B fills the reinfusion syringe 2170, and after depressing the plunger 342 of the pressure source 340 in the direction indicated by the arrow H, the clot material PE remains within the chamber 2154 of the filter device 2150.

[0150] Next, the reinfusion syringe 2170 can be decoupled from the filter device 2150 so that the blood B can be reintroduced into the patient. For example, the reinfusion syringe 2170 can be directly coupled to a port on the fluid control device 126 ( Figure 1 ). The cap assembly 2160 can be decoupled from the housing 2152 of the filter device 2150 to, for example, allow the operator to remove the clot material PE collected in the housing 2152, thereby cleaning and preparing the filter device 2150 for another use.

[0151] Figure 22 is a partially exploded side view of a filter device 2250 configured according to the present technology for filtering blood from aspirated clot material during a clot removal procedure. The filter device 2250 is configured to be used with, for example, one or more of the pressure sources described in detail above with reference to Figures 2 - 7 . Generally, the filter device 2250 is generally similar to the filter device 2150 described in detail with reference to Figure 21A and 21B . For example, the filter device 2250 includes a housing 2252 that defines a chamber 2254, a filter 2256 configured to be located within the housing 2252, and a cap assembly 2260 configured to be releasably coupled to the housing 2252. However, in the illustrated embodiment, the filter device 2250 includes a port 2253 that is directly connected to a pressure source configured to be coupled to (e.g., Figures 3A - 3DConnector 2228 of the pressure source 340 shown in []. The cap assembly 2260 includes a fluid connector 2162 (e.g., a standard Luer or large-bore connector) configured to connect to a reinfusion syringe, sheath, IV line, etc. (not shown). In some embodiments, the fluid connector 2262 is angled relative to the filter 2260 and / or the housing 2252. For example, in Figure 22 it, the fluid connector 2262 is formed to have an approximate right angle. In one aspect of the present technology, this arrangement makes the filter device more ergonomic during use.

[0152] Figure 23 is a partially exploded side view of a filter device 2350 configured according to the present technology for filtering blood from aspirated clot material during a clot removal procedure. The filter device 2350 is configured to be used with, for example, one or more of the pressure sources described in detail above with reference to Figures 2 - 7 The filter device 2350 is generally the same as the filter device 2250 described in detail with reference to Figure 22 e.g., including a housing 2252 (“first housing 2252”), a filter 2256 (“first filter 2256”), and a cap assembly 2260 including a fluid connector 2262 (“first fluid connector 2262”). However, in the illustrated embodiment, a second housing 2382 and a second filter 2386 are fluidly connected to the fluid connector 2262. The second housing 2382 includes a second fluid connector 2384, which can be fluidly connected to a reinfusion syringe, sheath, IV line, etc. (not shown). The second filter 2386 is configured to provide a second stage of filtration. For example, in some embodiments, the first filter 2256 has a greater porosity than the second filter 2386. For example, the first filter 2256 can have a porosity between about 50 - 200 microns and the second filter 2386 can have a porosity between about 50 - 170 microns.

[0153] Generally, those skilled in the art will understand that various embodiments of the filter devices disclosed herein can have different components or combinations of components. For example, the filter devices 2050, 2150, 2250, and / or 2350 (“filter devices”) can be used with any one of several different pressure sources different from the syringe 340 (e.g., Figure 2 and those shown in 4 - 7). In some embodiments, the filter device can be formed as a component of a pipe subsystem 120 ( Figure 1 ). Additionally, the filter device can include any number of filters and / or housings to provide any number of filtration stages.

[0154] Seven, Example

[0155] The following examples illustrate several aspects of the present technology:

[0156] [Added after the claims were finalized]

[0157] Summary

[0158] The detailed description of the embodiments of the present technology above is not intended to be exhaustive or to limit the present technology to the precise forms disclosed above. Although specific embodiments and examples of the present technology have been described above for illustrative purposes, those skilled in the relevant art will recognize that various equivalent modifications are possible within the scope of the present technology. For example, although the steps are presented in a given order, alternative embodiments may execute the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0159] In summary, it should be understood that, for illustrative purposes, specific embodiments of the present technology have been described herein, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. If the context permits, singular or plural terms may also respectively include plural or singular terms.

[0160] In addition, unless the word "or" is explicitly defined 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 shall be interpreted to include (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, the term "comprising" throughout refers to including at least one or more of the recited features, such that any additional number of the same features and / or other types of features are not excluded. It will also be understood that, for illustrative purposes, specific embodiments have been described herein, but various modifications can be made without departing from the present technology. Furthermore, although the advantages associated with some embodiments of the present technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need to exhibit such advantages to fall within the scope of the present technology. Thus, the present disclosure and related technologies may include other embodiments not explicitly shown or described herein.

Claims

1. An intravascular treatment system for a clot within a blood vessel of a human patient, comprising: a catheter having a distal portion positioned near the clot within the blood vessel; a pressure source; and a fluid control device fluidly coupled to the pressure source, wherein the fluid control device is configured to move between an open position and a closed position, wherein in the open position the fluid control device fluidly connects the pressure source to the catheter, and wherein in the closed position the fluid control device fluidly disconnects the pressure source from the catheter; wherein, when the fluid control device is in the closed position, the pressure source is activatable to create a vacuum; and after creating the vacuum, moving the fluid control device from the closed position to the open position to apply the vacuum to the catheter, thereby sucking at least a portion of the clot into the catheter, wherein the catheter is a first catheter and further includes a second catheter, wherein the first catheter is configured to be advanced and / or retracted through the second catheter, wherein the pressure source is a first pressure source, wherein the fluid control device is a first fluid control device, and further includes a second pressure source configured to be fluidly connected to the second catheter via a second fluid control device, wherein the second fluid control device is configured to move between an open position and a closed position, wherein in the open position the second fluid control device fluidly connects the second pressure source to the second catheter, and wherein in the closed position the second fluid control device fluidly disconnects the second pressure source from the second catheter, wherein, when the second fluid control device is in the closed position, the second pressure source is activatable to create a vacuum; and wherein, after creating the vacuum, moving the second fluid control device from the closed position to the open position to apply the vacuum to the second catheter, thereby creating suction at the distal portion of the second catheter.

2. The system according to claim 1, wherein the first catheter defines a lumen having a first diameter, wherein the first pressure source includes a syringe having a tip, and wherein the tip defines an aperture having a second diameter greater than the first diameter.

3. The system according to claim 2, wherein the syringe is a vacuum pressure lock syringe.

4. The system according to claim 1, wherein, after creating the vacuum, moving the first fluid control device from the closed position to the open position to create suction at the distal portion of the first catheter for less than about 1 second.

5. The system according to claim 1, wherein the first pressure source includes a pressure vessel and a syringe fluidly coupled to the pressure vessel via a one-way valve, wherein the pressure vessel is fluidly coupled to the first fluid control device, and wherein, The syringe is actuatable to evacuate the pressure vessel.

6. The system according to claim 5, wherein the syringe is a first syringe and the pressure vessel is a second syringe.

7. The system according to claim 1, wherein the first pressure source includes a syringe having a first plunger and a second plunger, wherein retraction of the first plunger is configured to create the vacuum, and wherein retraction of the second plunger is configured to release the vacuum.

8. The system according to claim 7, wherein, After the first plunger is retracted a first distance, the first plunger is arranged to cooperate with the second plunger such that further retraction of the first plunger retracts the second plunger simultaneously.

9. The system according to claim 1, wherein the first pressure source is a syringe having a volume greater than about 60 cc, wherein the first pressure source includes a handle and a plunger, and wherein, The handle is rotatable to retract the plunger to create the vacuum.

10. The system according to claim 1, wherein after creating the vacuum, the first fluid control device is moved from the closed position to the open position to provide near-instantaneous suction at a distal portion of the first conduit.

11. The system according to claim 1, wherein the position of the distal portion of the first conduit is arranged proximal to the clot.

12. The system according to claim 1, wherein the position of the distal portion of the first conduit is at least partially arranged within the clot.

13. The system according to claim 1, further comprising a filter fluidly coupled between the first pressure source and the first conduit and arranged to filter the clot from the blood.

14. The system according to claim 13, wherein the filter is located within the first pressure source.

15. The system according to claim 1, wherein the second conduit defines a lumen and further comprises a seal within the lumen, wherein the seal fluidly disconnects the lumen of the second conduit from the blood vessel.

16. The system according to claim 1, wherein the position of the distal portion of the second conduit is arranged near a treatment site within the blood vessel.

17. The system according to claim 16, wherein the second conduit is arranged to advance over the first conduit.

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