Systems and related devices and methods for treating embolism

Abstract

Disclosed herein are systems and methods for endovascular treatment of clots within the blood vessel of 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 also include coupling a pressure source to the conduit via a conduit subsystem including a valve or other fluid control device, and activating the pressure source to charge a vacuum when the valve is closed. The valve may then be opened to apply a vacuum to the catheter to draw at least a portion of the clot from the blood vessel into the catheter.

Description

[0001] This application is a divisional application of the Chinese invention patent application (application number: 201980067623.1, application date: August 8, 2019, invention name: System for treating embolism and related devices and methods). Technical Field

[0002] The present technology generally relates to systems, methods, and devices for the intravascular treatment of emboli and / or thrombi in human patients. In particular, some embodiments of the present technology relate to systems for releasing stored vacuum pressure to aspirate clotted material from a blood vessel. Background Art

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

[0004] When an artery is occluded by a clot, tissue ischemia occurs. If the occlusion persists, the ischemia progresses to tissue infarction. However, if blood flow is quickly restored, infarction may not occur or be greatly limited. Failure to restore blood flow can, in turn, lead to limb loss, angina, myocardial infarction, stroke, or even death.

[0005] In the venous circulation, blockages 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 in areas prone to blood stagnation (e.g., long-distance air travel, immobility, etc.) and clotting (e.g., cancer, recent surgery (such as orthopedic surgery), etc.). DVT can block blood drainage from the leg veins, leading to swelling, ulcers, pain, and infection. DVT can also create reservoirs 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.

[0006] In the pulmonary circulation, unwanted substances can cause harm by blocking a pulmonary artery (a condition called pulmonary embolism). If the blockage is upstream of a major or large pulmonary artery branch, it can severely impair total blood flow to the lungs and, therefore, the entire body. This can lead to low blood pressure and shock. If the blockage is downstream of a large or medium-sized pulmonary artery branch, it can prevent a significant portion of the lung from participating in gas exchange with the blood, resulting in low blood oxygen levels and a buildup of carbon dioxide in the blood.

[0007] There are many existing techniques for restoring blood flow through blocked blood vessels. For example, embolectomy is a surgical technique that involves cutting open a blood vessel and placing a balloon-tipped device (such as a Fogarty catheter) at the site of the occlusion. The balloon is then inflated beyond the point of the clot and used to withdraw the obstruction to the incision site. The surgeon then removes the obstruction. While this surgical technique is useful, subjecting the patient to surgery can be invasive and is best avoided whenever possible. Furthermore, the use of a Fogarty catheter can be problematic due to the risk of damaging the vessel lining when withdrawing the catheter.

[0008] Percutaneous methods are also used to restore blood flow. A common percutaneous technique is called balloon angioplasty, in which a balloon-tipped catheter is introduced into the blood vessel (e.g., typically via an introductory catheter). The balloon-tipped catheter is then advanced to the site of the occlusion and inflated to dilate the stenosis. Balloon angioplasty is suitable for treating vascular stenosis but is generally ineffective for treating acute thromboembolism because no occlusion 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 often takes several hours to days to be successful. In addition, thrombolytic agents can cause bleeding and, in many patients, cannot be used at all.

[0009] A variety of devices exist for performing thrombectomy or removing other foreign matter. However, such devices have been found to have highly complex structures, cause trauma to the treated vessel, or lack the ability to be properly secured to the vessel. Furthermore, many devices have highly complex structures, which lead to manufacturing and quality control difficulties, as well as delivery issues when passing through curved or small-diameter catheters. Less complex devices may allow the user to pull the clot, which can be particularly challenging for inexperienced users, and such devices may not fully capture and / or collect all of the clotted material.

[0010] Therefore, a need exists for improved systems and methods for embolic retrieval. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Many aspects of the present technology may be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed upon clearly illustrating the principles of the present disclosure.

[0012] Figure 1 is a partially schematic side view of a clot removal system configured in accordance with the present technology.

[0013] Figure 2is a side view of a locking syringe configured in accordance with the present technology.

[0014] Figure 3A is a side view of a locking syringe configured in accordance with the present technology.

[0015] Figure 3B is a side view of an adapter for connecting a locking syringe of Figure 3A to a clot removal system of Figure 1 .

[0016] Figure 3C is a side view of an adapter of Figure 3A coupled to a locking syringe of Figure 3B .

[0017] Figure 3D is a side view of a locking syringe of Figure 3B coupled to a clot removal system of Figure 1 via an adapter of Figure 3A .

[0018] Figure 4A is a perspective side view of another pressure source configured in accordance with the present technology, Figure 4B and 4C is an enlarged schematic side view of a pressure source of Figure 4A during operation.

[0019] Figure 5 is a cross-sectional side view of an automatic release syringe configured in accordance with the present technology.

[0020] Figure 6 is a perspective top view of a syringe configured in accordance with the present technology.

[0021] Figure 7 is a side view of an over-wire locking syringe configured in accordance with the present technology.

[0022] Figure 8 is a flowchart of a process or method of operating a clot removal system in accordance with the present technology.

[0023] Figures 9A-9C is a side view of a proximal portion of a clot removal system of Figure 1 during a clot removal procedure using the locking syringe of Figure 3 in accordance with the present technology.

[0024] Figure 10A and 10B are schematic views of a distal portion of a clot removal system of Figure 1 during a clot removal procedure in accordance with the present technology.

[0025] Figure 11is a partially schematic side view of another clot removal system configured in accordance with the present technology.

[0026] Figure 12 is a flow chart of another process or method of operating a clot removal system in accordance with the present technology.

[0027] Figures 13A-14C During the clot removal procedure according to this technique Figure 11 Schematic diagram of the distal portion of the clot removal system.

[0028] Figure 15 is a flow chart of another process or method of operating a clot removal system in accordance with the present technology.

[0029] Figures 16A-16E During the clot removal procedure according to this technology Figure 11 Schematic diagram of the distal portion of the clot removal system.

[0030] Figure 17 is a partially schematic side view of another clot removal system configured in accordance with the present technology.

[0031] Figures 18A-18H During the clot removal procedure according to this technique, Figure 17 A side view of the distal portion of a clot removal system is shown.

[0032] Figure 19 is a perspective side view of a pressure source configured in accordance with the present technology for filtering blood from aspirated clotted material during a clot removal procedure.

[0033] Figure 20A is a partially exploded side view of a filter assembly and pressure source configured in accordance with the present technology.

[0034] Figure 20B is coupled to Figure 20A The filter device Figure 20A A stereoscopic side view of a syringe.

[0035] Figure 20C is coupled to Figure 1 The clot removal system Figure 20B Side view of the filter assembly and syringe.

[0036] Figure 20D and 20E is coupled to Figure 1 clot removal system to reintroduce blood into the patient Figure 20A Side view of the syringe.

[0037] Figure 21A is a partially exploded side view of a filter assembly, pressure source, and re-infusion syringe configured in accordance with the present technology.

[0038] Figure 21B is coupled to Figure 21A Pressure source and refill syringe Figure 21A A three-dimensional side view of a filter device.

[0039] Figure 22 is a partially exploded side view of a filter apparatus configured in accordance with the present technology.

[0040] Figure 23 is a partially exploded side view of a filter apparatus configured in accordance with the present technology.

[0041] Figure 24 It is configured according to this technology Figure 1 Magnified isometric view of the clot removal system.

[0042] Figure 25 It is configured according to this technology Figure 1 Magnified isometric view of the clot removal system. Specific embodiments

[0043] The present technology is generally directed to methods and systems for removing clotted material from a blood vessel of a human patient. In some embodiments, a catheter can be positioned intravascularly within the blood vessel such that a distal portion (e.g., a distal opening) of the catheter is located proximate to the clotted material 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's body. With the valve closed, the pressure source can be activated to apply a vacuum to a vacuum chamber of the pressure source. The valve can then be opened and a vacuum applied to the catheter, thereby drawing at least a portion of the clotted material from the blood vessel into the catheter. In some embodiments, an interventional device can be delivered through the catheter and used to engage the clotted material before and / or after the vacuum is applied to the catheter.

[0044] In one aspect of the present technology, a pressure source is configured to generate and store a vacuum before the pressure source is fluidically connected to the catheter. Thus, opening the fluid control device can instantaneously or nearly instantaneously apply the stored vacuum pressure to the catheter, thereby generating suction throughout the catheter. In particular, the suction is applied to the distal portion of the catheter near the clot. Precharging or storing the vacuum before applying the vacuum to the catheter can generate greater suction (and corresponding fluid flow rate) at and / or near the distal portion of the catheter compared to, for example, simply activating the pressure source and fluidically connecting it to the catheter. The greater suction generated by applying the stored vacuum can be used to aspirate or remove clots from within a blood vessel of a human patient.

[0045] Although many embodiments are described below for devices, systems, and methods for treating pulmonary embolism, other applications and other embodiments in addition to those described herein are also within the scope of the present technology (e.g., endovascular procedures other than embolization, endovascular procedures for treating cerebral embolism, endovascular procedures for treating deep vein thrombosis (DVT), etc.). In addition, several other embodiments of the present technology may have different configurations, states, components, or procedures than those described herein. Furthermore, it should be understood that reference to Figure 1-25 The specific elements, substructures, advantages, uses, and / or other features of the described embodiments may be interchanged, substituted, or configured as appropriate with additional embodiments according to the present technology. Figure 1-25 Suitable elements of the described embodiments may be used as independent and / or self-contained devices. Therefore, those skilled in the art will accordingly understand that the present technology may have other embodiments including additional elements, or the present technology may have other embodiments without the following references. Figure 1-25 Other embodiments of the several features shown and described.

[0046] With respect to 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 relative to an operator and / or a location in the vasculature. Furthermore, as used herein, designations such as "rearward," "forward," "upward," "downward," etc., are not intended to limit the referenced components to use in a particular orientation. It should be understood that such designations refer to the orientation of the referenced components as shown in the figures; the systems of the present technology may be used in any orientation suitable for the user.

[0047] The headings provided herein are for convenience only and should not be construed as limiting the disclosed subject matter.

[0048] Selected Embodiments of Clot Removal Systems

[0049] Figure 1 is a partially schematic side view of a clot treatment or clot removal system including an aspiration assembly 10 ("assembly 10") configured in accordance with an embodiment of the present technology. In the illustrated embodiment, assembly 10 includes a catheter subsystem 100, a tubing subsystem 120, and a pressure source 140. Catheter subsystem 100 includes a catheter 102 (e.g., an aspiration catheter) including an elongated shaft defining a lumen 104 and having a distal portion 103a and a proximal portion 103b. Catheter subsystem 100 also includes a valve 106 that can be integrated with or coupled to the proximal portion 103b of catheter 102.

[0050] In the illustrated embodiment, the valve 106 includes a distal portion 107a, a proximal portion 107b, and a cavity 109 extending from the distal portion 107a to the proximal portion 107b. The valve 106 also includes a flow controller ( Figure 1 In some embodiments, the valve is a hemostatic valve configured to be removed when attached to a device such as a delivery sheath, a pulling member, a guidewire, an interventional device, or other aspiration catheter (e.g., as described in reference Figure 11-16E Detailed description of the invention is provided in detail. The invention relates to a device for maintaining hemostasis during a clot removal procedure by preventing fluid from flowing in a proximal direction through the valve 106 when various components (such as a valve or a control valve) are inserted through the valve 106 and delivered to a treatment site in a blood vessel through the catheter 102. The valve 106 also includes a branch or side port 108, which is located distal to the flow controller in the lumen 109 and is configured to fluidically couple the lumen 104 of the catheter 102 to the tubing subsystem 120. In the illustrated embodiment, the valve 106 includes a button 101 that can be actuated (e.g., pressed) to open the tube within the lumen 109. In some embodiments, the valve 106 can be of the type disclosed in U.S. Patent Application No. 16 / 117,519, filed on August 30, 2018, entitled "Hemostasis Valve and Method of Use," which is incorporated herein by reference in its entirety. In some embodiments, the proximal portion 107 b of the valve 106 is further configured to be removably coupled (e.g., via a snap-fit ​​arrangement) to a retraction / aspiration device for aspirating the lumen 104 of the catheter 102 and / or for retracting an interventional device, catheter, delivery sheath, catheter, etc. located within the lumen 104. Specific details of such a retraction / aspiration device and related methods are disclosed in U.S. Patent Application No. 9,526,864, filed on June 9, 2015, entitled “Retraction and Aspiration Device and Related Systems and Methods for Treating Embolism,” which is incorporated herein by reference in its entirety.

[0051] The tubing subsystem 120 fluidly couples the catheter subsystem 100 to a pressure source 140. More specifically, the tubing subsystem 120 may include one or more tubing segments 124 (labeled as a first tubing segment 124a and a second tubing segment 124b, respectively), at least one fluid control device 126 (e.g., a valve), at least one connector 128 for fluidly coupling the tubing subsystem 120 to the pressure source 140, and / or other suitable components. More specifically, in the illustrated embodiment, the fluid control device 126 is a stopcock that is (i) fluidly coupled to the side port 108 of the valve 106 via the first tubing segment 124a, and (ii) fluidly coupled to the connector 128 via the second tubing segment 124b. In some embodiments, the fluid control device 126 may define a lumen having a diameter (or cross-sectional dimension) that is greater than or equal to the diameter of the lumen 104 of the catheter 102, the diameter of the first tubing segment 124a, and / or the diameter of the second tubing segment 124b.

[0052] The fluid control device 126 can be externally operated by a user to regulate the flow of fluid therethrough, specifically, the flow from the lumen 104 of the catheter 102 to the pressure source 140. In other embodiments, the fluid control device 126 can be a clamp that can be actuated (e.g., depressed or squeezed by a user's hand) to partially or completely restrict the flow of fluid through the tubing segment 124a and / or tubing segment 124b. In still other embodiments, the fluid control device 126 can be omitted and its functionality incorporated into the pressure source 140 (e.g., as described below with reference to FIG. Figure 5 (described in detail below). In some embodiments, fluid control device 126 can include a quick-release mechanism (e.g., a spring-loaded device) for quickly opening, releasing, etc., fluid control device 126 to (e.g., instantaneously or nearly instantaneously) fluidically connect pressure source 140 to catheter 102. In some embodiments, fluid control device 126 can be opened / closed automatically (e.g., by a motor, switch, etc.). When 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 pressure in assembly 10 to reach equilibrium after fluid control device 126 is opened, and can thereby increase the suction force generated at distal portion 103a of catheter 102.

[0053] In some embodiments, connector 128 is a quick-release connector (e.g., a quick-disconnect fitting) that enables quick coupling / decoupling of conduit 102 and fluid control device 126 to pressure source 140. In other embodiments, tubing subsystem 120 may have more or fewer tubing segments, connectors, and / or fluid control devices, and may have other suitable configurations. In some embodiments, one or more components may be permanently connected and / or integrally formed.

[0054] The pressure source 140 is configured to generate (eg, form, create, fill, establish, etc.) a vacuum (eg, a negative relative pressure) and store the vacuum for subsequent application to the catheter subsystem 100. Figure 2-7More details of a suitable pressure source are described in detail. During operation of assembly 10, a user can first close fluid control device 126 to build up vacuum pressure within pressure source 140 (e.g., a vacuum chamber of pressure source 140) before activating pressure source 140. In some embodiments, the user can control or select the volume of vacuum generated. In this manner, a vacuum is charged within pressure source 140 before fluidly connecting pressure source 140 to catheter subsystem 100. To aspirate lumen 104 of catheter 102, the user can open fluid control device 126 to fluidly connect pressure source 140 to catheter subsystem 100, thereby applying or releasing the vacuum stored in pressure source 140 to lumen 104 of catheter 102. The opening of fluid control device 126 instantaneously or nearly instantaneously applies the stored vacuum pressure to catheter subsystem 120 and catheter 102, thereby creating an aspiration throughout catheter 102. In particular, aspiration is applied at distal portion 103a of catheter 102. In one aspect of the technology, pre-charging or storing a vacuum before applying the vacuum to lumen 104 of catheter 102 to fluidly connect pressure source 140 to catheter 102 is expected to create a greater suction force (and corresponding fluid flow rate) at and / or near distal portion 103a of catheter 102 than simply activating pressure source 140. As described in detail below, the suction force created by applying the stored vacuum can be used to aspirate or remove clot material from within a blood vessel of a human patient.

[0055] Two, Selected embodiments of pressure sources for use with clot removal systems

[0056] As described in detail above with reference to Figure 1 As described in detail above, assembly 10 of the technology includes a pressure source (e.g., a vacuum source, negative pressure source, etc.) configured to charge a vacuum that can be applied to catheter subsystem 100 to create a suction force to aspirate clot material from within a blood vessel. Generally, 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 assembly 10 to generate and store a vacuum therein.

[0057] Figure 2 is a side view of a pressure source 240 including a vacuum pressure-locked syringe (“syringe 240”) configured in accordance with the technology. In some embodiments, syringe 240 can be a type of syringe sold by Merit Medical Systems, Inc. under the trademark “VacLok.” In the illustrated embodiment, 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 grooves 248 between adjacent pairs. Tab members 245 protrude inwardly from the inner surface of the barrel 244 and are configured to be removably seated in the grooves 248 to lock the plunger 242 in position relative to the barrel 244. In some embodiments, the barrel 244 can be made of a transparent material that allows the user to observe the contents of the barrel 244 (e.g., clotted material) and observe the relative position between the grooves 248 and the tab members 245 to lock the syringe 240.

[0058] Reference 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 can be coupled to the connector 128 via one or more suitable adapters. The tip 247 also defines a cavity or hole 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.

[0059] During operation of assembly 10, a user can first close fluid control device 126, then grasp plunger 242 and / or barrel 244, withdrawing (e.g., retracting) plunger 242 at least partially from barrel 244, thereby creating a vacuum in barrel 244. Once the user has withdrawn plunger 242 to a sufficient or desired volume, the user can lock plunger 242 by rotating it relative to barrel 244 so that tab member 245 is positioned within a corresponding one of slots 248. In other embodiments, rather than locking the syringe 240, the user can maintain the position of plunger 242 relative to barrel 244. Furthermore, the user can control the volume of the vacuum by withdrawing plunger 242 more or less to provide a desired amount or level of aspiration / suction when fluid control device 126 is opened. In some embodiments, the volume of the syringe is approximately 60 cc or less.

[0060] Figure 3A is a side view of a pressure source 340 including a vacuum pressure lock syringe ("syringe 340") configured in accordance with the present technology. Syringe 340 may have features generally similar to those described above with reference to Figure 2Features of the syringe 240 are described. For example, the syringe 340 includes a plunger 342 that is slidably and rotatably positioned 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 ) shows barrel 344 as transparent. When withdrawing plunger 342, the user can lock plunger 342 at a specified volume by rotating plunger 342 relative to barrel 344 so that tab member 345 on the inner surface of barrel 344 is located within a corresponding one of grooves 348. In some embodiments, the maximum volume of syringe 340 is approximately 60 cc or greater.

[0061] In the illustrated embodiment, the syringe 340 includes a large bore tip 347, such as a Toomey tip, defining a cavity or hole 349. In some embodiments, the inner diameter D2 of the hole 349 can be greater than or equal to the maximum inner diameter of the assembly 10 (e.g., the catheter 102 and the tubing subsystem 120). In certain embodiments, the tip 347 can be approximately 26 French or larger. Figure 2 and 3A , diameter D2 can be greater than dimension D1. For example, dimension D2 can be approximately two times, three times, four times, or more times the diameter D1.

[0062] Figure 3B is a side view of an adapter 350 for connecting a syringe 340 to a catheter subsystem 100 configured in accordance with the present technology. Figure 3C is a side view of an adapter 350 coupled to a syringe 340, Figure 3D is a side view of a syringe 340 coupled to the tubing subsystem 120 via an adapter 350. For ease of illustration, the adapter 350 is Figure 3C Displayed as partially transparent. Figure 3B , adapter 350 includes (i) a first portion 351 defining a first cavity or bore 352 having an inner diameter D3, (ii) a second portion 353 defining 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 may also include a seal 357, such as an O-ring, around its outer surface.

[0063] Reference together Figures 3A-3DThe second bore 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 bore 354 by an interference fit. In some embodiments, a seal (e.g., an O-ring) can be located between an outer surface of the tip 347 and an inner surface of the second bore 354. In other embodiments, the syringe 340 can be permanently coupled or integrally formed with the adapter 350. The first portion 351 of the adapter 350 is configured to be removably located within the connector 128 of the tubing subsystem 120 to fluidly couple the syringe 340 to the tubing 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.

[0064] The diameter D3 of the first bore 352 of the adapter 350 can be selected to be about equal to or greater than the maximum inner diameter of the assembly 10 (e.g., the catheter 102 and the tubing subsystem 120). For example, the catheter 102 can be about 9 French or greater, 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 open, the continuous lumen between the catheter 102 and the syringe 340 can have a substantially constant diameter and / or not contain any constriction at the interface between the syringe 340 and the tubing subsystem 120. That is, the adapter 350 can connect the syringe 340 and the tubing subsystem 120 without limiting 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 that is about 8 French or less. Any constriction of the fluid path between the catheter 102 and the syringe 340 can reduce the volumetric flow rate (e.g., the suction force and the flow rate) that can be generated when the vacuum stored in the syringe 340 is applied to the catheter 102.

[0065] Generally, the syringe 340 and the adapter 350 can reduce fluidic resistance in the assembly 10, thereby facilitating faster pressure equalization 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 (e.g., a standard luer connector) is used in place of the syringe 340, the fluidic resistance in the assembly 10 can be increased, which can slow down the pressure equalization in the assembly 10 when the fluid control device 126 is opened. Figure 2) is filled with 60 cc of vacuum and the fluid control device 126 is open, the pressure in the assembly 10 may require approximately 1-2 seconds to equilibrate. In contrast, when the syringe 340 is filled with 60 cc of vacuum and the fluid control device 126 is open, the pressure in the assembly 10 may require less than approximately 1 second (e.g., approximately 0.5 seconds) to equilibrate. More specifically, Table 1 shows representative pressure equilibration times and associated flow rates when the syringe 240 is coupled to a 20 French tube (i.e., tube 102). Table 2 shows representative pressure equilibration times and associated flow rates when the syringe 340 and adapter 350 are coupled to a 20 French tube (i.e., tube 102).

[0066] Table 1

[0067]

[0068] Table 2

[0069]

[0070] In each case, syringe 340 provides a relatively faster equilibration time and a correspondingly greater flow rate. It is expected that the faster pressure equilibration and flow rate provided by syringe 340 will correspondingly provide greater suction at distal portion 103a of catheter 102. That is, generally speaking, increasing the bore diameter of the syringe used to provide vacuum pressure is expected to provide greater suction in a shorter period of time (e.g., provide a greater vacuum impulse). In some embodiments, greater suction can facilitate removal of clotted material from a patient's blood vessel, even in cases where the clot is firmly lodged or adhered within the vessel (e.g., chronic clots).

[0071] In addition, if Figure 3D As shown, adapter 350 can couple syringe 340 to connector 128 without requiring any intermediate tubing segments or additional adapters. This arrangement can minimize the overall length, volume, and other components of the components fluidically connecting catheter 102 to syringe 340. It is expected that the amount of suction generated at distal portion 103a of catheter 102 (e.g., when vacuum from syringe 340 is applied to catheter 102 by opening fluid control device 126) is proportional to the length of the fluid path between pressure source 340 and catheter 102. Therefore, operation of assembly 10 with syringe 340 and adapter 350 is expected to increase the suction generated at distal portion 103a of catheter 102. In some embodiments, this increased suction can facilitate the removal of clots from a patient's blood vessels, even in cases where the clots are tightly lodged or adhered within the vessel (e.g., chronic clots).

[0072] Figure 4Ais configured in accordance with the present technology to include Figures 3A-3D A side perspective view of pressure source 400 including primary syringe 340 ("primary syringe 340") and secondary syringe 460 is shown. Secondary syringe 460 can include a plunger 462 that is slidably located within a chamber or barrel 464. Primary and secondary syringes 340, 460 can have the same volume or different volumes. In the illustrated embodiment, a tip 463 of secondary syringe 460 is coupled to a first one-way valve (e.g., check valve) 470 via a coupling member 465 such as a tube. First one-way valve 470 is configured to fluidly connect secondary syringe 460 to the ambient environment or another device coupled to first one-way valve 470. A second one-way valve (e.g., check valve) 472 spans between and is configured to fluidly connect primary syringe 340 and secondary syringe 460. More specifically, in the illustrated embodiment, second one-way valve 472 is connected between first portion 351 of adapter 350 and coupling member 465. In other embodiments, second one-way valve 472 can couple primary and secondary syringes 340, 460 in different ways. For example, second one-way valve 472 can span and directly connect barrels 344, 464. Primary and secondary syringes 340, 460 can be coupled or fastened together via one or more connectors 474 that secure the position of barrels 344, 464 relative to each other.

[0073] In some embodiments, second one-way valve 472 is a normally open check valve that is configured to (i) allow fluid (e.g., air) to flow from primary syringe 340 and adapter 350 to secondary syringe 460 and (ii) prevent fluid from flowing in reverse from secondary syringe 460 into primary syringe 340. In some embodiments, second one-way valve 472 has an opening (e.g., opening) pressure of about 0 psi. In one aspect of the present technology, such an arrangement maximizes the amount of vacuum that can be charged within primary syringe 340. That is, the opening pressure of second one-way valve 472 does not reduce the effective vacuum within primary syringe 340. In other embodiments, a normally closed or other type of valve can be used for second one-way valve 472. However, in such embodiments, the vacuum efficiency of pressure source 400 will be reduced by the opening pressure of second one-way valve 472. Similarly, first one-way valve 470 can be a check valve that is configured to (i) allow fluid to flow from secondary syringe 460 to the ambient environment (or other device) and (ii) prevent fluid from flowing in reverse from the ambient environment into secondary syringe 460.

[0074] Figure 4B and 4C is a magnified schematic side view of pressure source 400 during operation. More specifically, Figure 4B and 4CThe fluid flow paths through the first and second one-way valves 470, 472 during retraction and advancement of the plunger 462 through the barrel 464 of the secondary syringe 460 are shown, respectively. Figure 4A and 4B During 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 from the primary syringe 340, the catheter subsystem 100 ( Figure 1 ), and / or piping subsystem 120 ( Figure 1 ) flows into the secondary syringe 460. The flow path is composed of Figure 4B The arrow R in the figure indicates that Figure 4A and 4C During advancement of the plunger 462, (i) the first one-way valve 470 opens to allow fluid (e.g., drainage) 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 primary syringe 360, the catheter subsystem 100, and / or the tubing subsystem 120. The flow path is defined by Figure 4C Indicated by arrow A in .

[0075] Reference together Figure 1 and 3A -4C, the pressure source 400 may be coupled to the tubing subsystem 120 (e.g., as shown) by coupling the primary syringe 340 to the connector 128. Figure 3D). When a pressure source is coupled to the tubing subsystem 120, 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, retraction of the plunger 462 of the secondary syringe 460, through the second one-way valve 472, evacuates fluid from (i) the primary syringe 340 (e.g., from the barrel 344, the tip 347, and / or the adapter 350) and (ii) the portion of the tubing subsystem 120 between the fluid control device 126 and the primary syringe 340. This can enable the generation of more filling / storage vacuum for subsequent application to the catheter subsystem 100 to aspirate clotted material. In some embodiments, prior to withdrawing the plunger 342 of the primary syringe 340, the plunger 462 of the secondary syringe 460 may 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) the portion of the tubing 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 may alternatively or additionally be withdrawn to further evacuate the barrel 344 of the primary syringe 340. In some embodiments, for example, the plunger 462 may be cycled while the fluid control device 126 is open to dislodge clotted material that is stuck or blocked within the catheter subsystem 100. That is, cycling the secondary syringe 460 while the fluid control device 126 is open may generate vacuum pressure and suction within the catheter 102 to aid in aspiration / removal of clotted material.

[0076] In some embodiments, the volumes of the primary and secondary syringes 340, 460 can be selected based on one or more desired characteristics of a 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 a high vacuum to be created within the primary syringe 340 while limiting blood loss to the patient.

[0077] In one aspect of the present technology, 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 by the primary syringe 340 alone is proportional to the volume of the primary syringe 340. Therefore, in order to generate more vacuum using the primary syringe 340 alone, the volume of the primary syringe 340 must be increased. In contrast, the configuration of the pressure source 400, which includes the secondary syringe 460 and the first and second one-way valves 470, 472, allows (e.g., maximizes) the generated vacuum to be independent of the volume of the primary syringe 340. Thus, for example, when a vacuum is applied to the catheter subsystem 100, the generated vacuum can be increased without a corresponding increase in the volume of blood withdrawn from the patient.

[0078] In some embodiments (e.g., as described below with reference to Figure 19As further described in detail, the primary syringe 340 of the pressure source 400 can be replaced with a simple pressure vessel or other volume (e.g., a canister, cylinder, tube, etc.). In these embodiments, the secondary syringe 460 can be simply cycled one or more times to create a vacuum in the canister. 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 primary syringe 340 in other ways (e.g., through a different check valve arrangement) to create a vacuum such as Figure 4B and 4C Furthermore, in some embodiments, the first and second one-way valves 470, 472 may be other types of flow control devices that are mechanically activated / deactivated (e.g., opened and closed) by a pressure differential within the pressure source 400 rather than passively operated. For example, the flow control devices 470, 472 may be mechanically coupled to the plunger 462 of the secondary syringe 460 such that the circulating plunger 462 activates / deactivates the flow control devices 470, 472 to Figure 4B and 4C The pressure source 400 operates in the manner shown.

[0079] Figure 5 is a side cross-sectional view of a pressure source 540 including an automatic release syringe ("syringe 540") configured in accordance with the present technology. Generally, syringe 540 is configured to release the fluid without requiring actuation of an intermediate fluid control device (e.g., Figure 1 In the case of a fluid control device 126 as shown, a selected volume of filling vacuum is automatically applied to the catheter subsystem 100. The syringe 540 can have some features that are generally similar to those described above with reference to Figure 2 and 3A -3D details the features of the syringes 240, 340. For example, the syringe 540 includes a first plunger 542 slidably positioned within a chamber or barrel 544. The first plunger 542 also includes a first seal 543 that cooperates with the inner surface of the barrel 544 so that when the first plunger 542 is withdrawn through the barrel 544, a vacuum is formed within the barrel 544. Similarly, reference is made to Figure 1 and Figure 5 , syringe 540 includes a tip 547 (e.g., a Tommy tip) for coupling syringe 540 (e.g., via a Tommy tip adapter) to tubing subsystem 120 and defines a bore 549. In some embodiments, bore 549 has a relatively large diameter selected to provide rapid pressure equalization in assembly 10 after releasing the vacuum stored in syringe 540.

[0080] The first plunger 542 may also include (i) a grip 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, the plunger assembly 582 is slidably positioned 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 positioned within the cavity 585 of the second plunger 583. The release member 584 includes an engagement member 586 configured to engage with the grip 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 against the inner surface of the bore 549 of the syringe 540 to enable a vacuum to be formed in the barrel 544 when the first plunger 542 is withdrawn through the barrel 544. That is, the second seal 587 can seal (e.g., fluidically disconnect) the barrel 544 of the syringe from the tubing subsystem 120 and the catheter subsystem 100. In some embodiments, the syringe 540 can 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.

[0081] The plunger assembly 582 also 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 can lock the two components in place, while rotation of the release member 584 relative to the second plunger 583 in a second direction can unlock the two components, allowing the release member 584 to be withdrawn from or pushed into the cavity 585 of the second plunger 583. In other embodiments, the release member 584 and the second plunger 583 can be integrally formed or permanently locked together.

[0082] The plunger assembly 582 enables (i) the user of the syringe 540 to select the desired volume of vacuum to be created within the syringe 540, and (ii) automatically release or apply the created vacuum via opening (e.g., extraction) of the aperture 549. Specifically, during operation of the syringe 540, the user may first unlock the release member 584 and slide it to a position corresponding to the desired vacuum volume. For example, the release member 584 may have graduated 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 grip 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 a desired volume, the gripping portion 541 engages the engaging member 586 of the release member 584, so that further retraction of the first plunger 542 simultaneously retracts the plunger assembly 582. As 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 in the barrel 544. In this manner, the syringe 540 provides automatic release of the charge 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, thereby eliminating the need for a separate fluid control device 126 and / or additional steps for opening the fluid control device 126.

[0083] Figure 6 is a top view of a pressure source 640 including a syringe ("syringe 640") configured in accordance with the present technology. Syringe 640 may include features generally similar to those described above with reference to Figure 2-3D and 5 . For example, the syringe 640 includes a plunger 642 slidably positioned within a barrel 644, and a tip 647 (e.g., a wide bore tip). In the illustrated embodiment, the syringe 640 also includes a lever or handle 690 operably 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 can 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 can be coupled to a gear ( Figure 6(hidden in FIG. 1 ), the gear is configured to mate with a track 692 on the plunger 642. Thus, rotation of the handle 690 in a first direction retracts the plunger 642 relative to the barrel 644 to apply a vacuum to the barrel 644. Also, rotation of the handle 690 in a second (e.g., opposite) direction advances the plunger 642 into the barrel 644 to, for example, expel fluid, substance, etc. from the barrel 644.

[0084] In one aspect of the present technology, handle 690 provides additional mechanical leverage relative to a standard syringe, thereby reducing the force (e.g., strain, energy, etc.) required by a user of syringe 640 to create a vacuum within syringe 640. Consequently, using syringe 640 can reduce the time required to remove clotted material using assembly 10. In some embodiments, syringe 640 can have a volume greater than 60 cc (e.g., greater than 80 cc, greater than 100 cc, greater than 120 cc, greater than 140 cc, etc.). In certain embodiments, for example, syringe 640 can have a volume of approximately 140 cc. With such a large volume, some users may have difficulty manually retracting plunger 642 without the additional mechanical leverage provided by handle 690. Consequently, syringe 640 enables the use of larger syringes, which can correspondingly generate greater suction within catheter subsystem 100.

[0085] Reference again Figure 1 , when 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 produce greater suction and corresponding flow rate at the distal portion 103a of the catheter 102. Accordingly, in some embodiments, the side port 108 of the valve 106 can be formed to have an angle A that is 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 lumen 109 of the valve 106 (and thus the lumen 104 of the catheter 102) reduces the tortuosity of the fluid path between the pressure source 140 and the catheter 102. Furthermore, in some embodiments, the pressure source 140 can be coupled to the proximal portion 107b of the valve 106 instead of or in addition 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 coupled directly to the proximal portion 107b of the valve, rather than to the connector 128 of the tubing subsystem 120 and the side port 108 of the valve 106. Figure 24 The pressure source 340 is shown in FIG, but the above reference Figure 2-6Any of the pressure sources described in detail can be configured to be coupled to the proximal portion 107b of the valve 106 instead of the side port 108. In other embodiments, the side port 108 can be omitted, and the valve 106 and tubing subsystem 120 can be coupled to the catheter 102 via a Y-connector. For example, Figure 25 is an enlarged isometric view of the assembly 10 showing the valve 106 and tubing subsystem 120 connected to the catheter 102 via a Y-connector 2590. In yet other embodiments, the tubing system 120 is linearly coupled to the catheter 102, and the valve 106 protrudes at an angle from the catheter 102.

[0086] However, in some embodiments, a guidewire or other component is located within the valve 106 during the duration of a clot removal procedure (e.g., to deliver an interventional device to a treatment site within a patient). Accordingly, in some embodiments, to facilitate coupling of the pressure source 140 to the proximal portion 107b of the valve 106 even when a guidewire is inserted therein, the pressure source 140 can be a syringe configured for over-the-wire delivery. For example, Figure 7 is a side view of a pressure source 740 including a vacuum pressure-locked syringe (“syringe 740”) configured for over-the-wire 794 delivery and operation in accordance with the present technology. The syringe 740 can have some features that are generally similar to those of the syringe 340 described in detail above with reference to FIG. 3. For example, the syringe 740 includes a plunger 742 slidably and rotatably located within a barrel 744. For the sake of clarity, Figure 7 the barrel 744 in is shown as transparent. In the illustrated embodiment, the plunger 742 includes a lumen 796 (shown in dashed lines) extending longitudinally therethrough. The guidewire 794 is insertable through the lumen 796 of the plunger 742 such that the syringe 740 is advanceable over the guidewire 794 to attach to the proximal portion 107b of the valve 106. The syringe 740 can also include one or more sealing components (e.g., valves, O-rings, etc.; not shown) for maintaining a seal between the guidewire 794 and the plunger 742 to allow a vacuum to be established and stored in the barrel 744.

[0087] In general, those of skill in the art will appreciate that various embodiments of the pressure sources disclosed herein can be combined, e.g., to include multiple pressure sources or pressure sources having different components or combinations of components. For example, in some embodiments, the secondary syringe 460 ( Figures 4A-4C ) can be coupled to the syringe 240, 540, 640, or 740 (referenced in Figure 2 and 5-7) to generate additional vacuum. In some embodiments, multiple pressure sources may be coupled to the catheter 102 via the tubing subsystem 120 and / or via the valve 106. Furthermore, the individual pressure sources may be the same or different and may be coupled to the catheter subsystem 100 via a single fluid control device (e.g., fluid control device 126) or may be coupled to the catheter subsystem 100 via separate fluid control devices. Thus, the profile of the vacuum applied to the catheter 102 may be selected or adjusted by using multiple different pressure sources. For example, a particular vacuum profile may depend on at least (i) the respective characteristics of the multiple pressure sources (e.g., volume, aperture, etc.), (ii) the manner in which the pressure sources are coupled to the catheter subsystem 100 (e.g., via separate valves, via the same valve, etc.), and (iii) the timing of applying or releasing the vacuum of each pressure source to the catheter subsystem 100 (e.g., staggered release, simultaneous release, etc.). As an example, in some embodiments, the syringe 240 ( Figure 2 ) and syringe 340 ( FIG. 3 ) can both be coupled to tubing subsystem 120 via, for example, a Y-connector. After both syringes 240 and 340 are charged with vacuum pressure, opening fluid control device 126 simultaneously applies a combined vacuum to catheter 102. The larger-bore syringe 340 provides a short, powerful pulse of vacuum pressure, while the smaller-bore syringe 240 provides a longer, more sustained vacuum pull. This combination allows for the application of high, fast-acting suction to remove and capture clotted material in catheter 102, while also applying a more sustained suction to capture larger amounts of clotted material.

[0088] three, Selected Embodiments of Clot Removal Methods

[0089] Figure 8 is a flow chart of a process or method 800 for operating a clot removal system including assembly 10 to remove clotted material from a blood vessel (eg, a pulmonary vessel) of a human patient in accordance with the present technology. Figures 9A-9C is a side view of the proximal portion of the assembly 10, Figure 10A and 10B is a schematic diagram of the distal portion of assembly 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 assembly 10 including the syringe 340 and the adapter 350 ( Figures 3A-3D ), Figure 10A and 10B is a side view of the catheter 102, wherein the distal portion 103a of the catheter 102 is positioned near an embolic or clotted object PE within a blood vessel BV (eg, a pulmonary vessel). Figure 1, 3A-3D, and 9A-10B, but those skilled in the art will readily appreciate that other suitable systems and / or devices described herein may be used to perform method 800. In particular, although described in the context of syringe 340, method 800 may be implemented using the syringe 340 described above. Figure 2-7 Detailed description of any one or combination of stressors is performed.

[0090] At block 802, method 800 includes positioning the distal portion 103a of the catheter 102 proximate to a clot within a blood vessel of a human patient (eg, at a treatment site). Figure 10A In the illustrated embodiment, the distal tip of the distal portion 103a of the catheter 102 is positioned adjacent to the proximal portion of the clot PE. When the fluid control device 126 is open, reducing the distance between the distal tip of the catheter 102 and the proximal portion of the clot PE without bringing the clot PE into contact with the catheter 102 is expected to maximize the suction force on the clot PE. Reducing the distance (e.g., the gap) between the inner diameter of the blood vessel BV and the outer diameter of the catheter is also expected to maximize the suction force on the clot PE. However, in other embodiments, the distal tip of the catheter 102 can be at least partially within the clot PE, or the distal tip of the catheter 102 can be distal to the clot PE.

[0091] The pulmonary vasculature may be accessed through the patient's vasculature, for example, via the femoral vein. In some embodiments, the catheter subsystem 100 may include an introducer (e.g., a Y-connector with a hemostatic valve; not shown) that may be partially inserted into the femoral vein. A guidewire (not shown) may be introduced into the femoral vein via the introducer and navigated through the right atrium, the tricuspid valve, the right ventricle, the pulmonary valve, and into the main pulmonary artery. Depending on the location of the embolism, the guidewire may be directed to one or more branches of the right pulmonary artery and / or the left pulmonary artery. In some embodiments, the guidewire may extend fully or partially through the clot PE. In other embodiments, the guidewire may extend to a position just proximal to the clot PE. After the guidewire is positioned, the catheter 102 may be placed over the guidewire and advanced (as indicated by arrow A1) to a position proximal to the clot PE, as shown in FIG. Figure 10A shown.

[0092] 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 fluorescent 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 102 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 confirm 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 reposition the catheter 102 (e.g., by proximally withdrawing 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 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, the valve 106 can be closed during retraction of the catheter 102 and can be retracted a set (e.g., a predetermined) distance before the valve 106 is reopened. In one aspect of the present technology, determining the position of the distal portion 103a of the catheter 102 via activation of the valve 106 can be used when determining the position of the catheter 102 via radiographic techniques is difficult. In contrast, many conventional hemostatic valves cannot be activated in this manner.

[0093] In some embodiments, the guidewire can then be withdrawn, while in other embodiments, the guidewire can remain and can be used to guide other catheters (e.g., a delivery catheter, an additional aspiration catheter, etc.), interventional devices, etc. to the treatment site. However, it should be understood that other entry points into the patient's venous circulatory system are possible and consistent with the present technology. For example, a 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 because it reduces the length of the instrumentation required to reach the pulmonary embolism.

[0094] At block 804, method 800 includes coupling a pressure source (eg, syringe 340) to catheter 102 via fluid control device 126. For example, Figure 9A In the embodiment shown, the tip 347 ( Figure 3A and 3C shown, but Figure 9A 104 ) 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 fluidically connect the syringe 340 to the lumen 104 of the catheter 102, and (ii) the fluid control device 126 is closed to fluidically disconnect the syringe 340 from the lumen 104 of the catheter 102. Figure 9A is in the open position.

[0095] At block 806, the method 800 includes activating the injector 340 to generate a vacuum when the fluid control device 126 is closed. Figure 9B As 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 create 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 connected to the fluid of the cavity to be aspirated. In some embodiments, when the pressure source 400 ( Figure 4A -4C) When used with the primary syringe 340, the secondary syringe 460 may be cycled one or more times to increase vacuum pressure before or after retracting the plunger 342.

[0096] At block 808, the method 800 includes opening the fluid control device 126 to apply a 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. Figure 10BAs shown, applying a vacuum causes suction (e.g., as indicated by arrow A2) at the distal tip 103a of the catheter 102, which draws at least a portion of the clotted material PE from the blood vessel BV and into the lumen 104 of the catheter 102. In some embodiments, instantaneous or nearly instantaneous opening of the fluid control device 126 creates suction at the distal portion 103a of the catheter 102. In certain embodiments, applying the vacuum can create suction for less than about 1 second (e.g., about 0.5 seconds), substantially less than about 1 second (e.g., about 0.3 seconds, about 0.1 seconds, etc.), less than about 2 seconds, or greater than about 2 seconds, until pressure in the assembly 10 equilibrates. 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 clotted material PE can be completely drawn through the lumen 104 of the catheter 102 and into the barrel 344 of the syringe 340. In some such embodiments, the user can determine whether subsequent steps to treat the clot PE are necessary or advisable by observing the amount of clot collected in syringe 340. For example, Figure 9C The syringe 340 and tubing subsystem 120 are shown after the fluid control device 126 has been opened to apply the vacuum stored in the syringe 340 to the catheter 102. In the embodiment shown, some clotted material PE is visible in the syringe 340.

[0097] In some embodiments, fluid control device 126 or another fluid control device can be operated intermittently to provide discrete bursts of suction. For example, fluid control device 126 can be rapidly opened and closed to provide a first burst of suction (e.g., a vacuum release) without fully equalizing the pressure in assembly 10. Fluid control device 126 can then be opened again to provide a second burst of suction, or repeatedly opened and closed to provide the desired suction pattern. In some embodiments, assembly 10 can be specifically configured to facilitate the application of multiple bursts of suction. For example, (i) fluid control device 126 can be spring-loaded, electronically controlled, etc., to rapidly open and close the valve, and / or (ii) pressure source 140 can have a large vacuum chamber and / or a small orifice to increase the time required for pressure in assembly 10 to equalize (e.g., increase the venting time of pressure source 140).

[0098] Sometimes, such as Figure 10BAs shown, venting the stored vacuum in the pressure source to aspirate the lumen 104 of the catheter 102 may not remove all of the clotted material PE (or the desired amount of clotted material PE) from the blood vessel BV. That is, a single aspiration may not adequately remove the clotted material PE from the blood vessel BV. In this case, the user of the assembly 10 may wish to apply vacuum pressure again (perform a "suction pass") to remove all or a portion of the remaining clotted material PE in the blood vessel BV. In this case, the pressure source may be disconnected from the tubing subsystem 120 and evacuated (e.g., to remove the aspirated clot) before the method 800 returns to block 802. For example, the adapter 350 and syringe 340 may be decoupled from the connector 128, and the plunger 342 may be pushed into the barrel 344 to discharge the clotted material PE and associated fluid from the barrel 344 via the tip 347. When the distal portion of the catheter 102 is located near the remaining clotted material PE (e.g., has not moved relative to the last aspiration pass), the pressure source can then be recoupled to the connector 128 (box 804), re-inflated (box 806), and the vacuum pressure released (box 808) to aspirate all or a portion of the remaining clotted material PE.

[0099] Blocks 802-808 may be repeated until the desired amount of clotted material is removed from the patient, or until catheter 102 becomes obstructed. In some embodiments, to check for obstruction in catheter 102, fluid control device 126 and / or valve 106 may be opened to check for back bleeding. The absence of back bleeding may indicate a possible obstruction in catheter 102. Similarly, if barrel 344 of syringe 340 contains primarily air and relatively little blood and clotted material (e.g., less than 5-10 cc) after aspirating catheter 102 (block 808), this may indicate a possible obstruction in catheter 102. When catheter 102 becomes obstructed or a sufficient amount of clotted material PE has been removed from the patient, method 800 may proceed to block 810 and catheter 102 may be removed from the patient. If catheter 102 becomes obstructed, it may be flushed and cleaned before re-entering the patient (block 802). In other embodiments, a different catheter (e.g., a new, unused, etc.) may be inserted into the patient and positioned to remove the remaining clotted material PE from the patient.

[0100] In some embodiments, if the catheter 102 becomes clogged, the syringe 340 may 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 may be turned off, and the syringe 340 may be removed from the connector 128 and evacuated to remove the clot and blood therein. Blocks 804–808 may then be repeated to apply another vacuum pulse to the catheter 102. That is, rather than removing the catheter 102 after a clog is detected, the syringe 340 may 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 the pressure source 400 ( Figure 4A -4C) When used 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 clotted material PE. That is, instead of removing the catheter 102 after a blockage is detected, the secondary syringe 460 can be cycled until the vacuum force applied to the clotted material PE overcomes the force between the clotted material PE and the catheter 102 and draws the clotted material PE into the syringe 340. In some embodiments, as described below with reference to Figure 15-16E As described in detail, the second clot removal assembly can be extended and retracted through the first assembly 10 to facilitate the removal of the blocked clot PE.

[0101] In some embodiments, an interventional device, such as a clot removal and / or clot treatment device, can be delivered to the treatment site via catheter 102 to facilitate and promote clot removal before and / or after a stored vacuum is applied to catheter 102. Suitable interventional devices and related methods are disclosed in U.S. Patent Application No. 9,526,864, filed on June 9, 2015, entitled "Retraction and Aspiration Device and Related Systems and Methods for Treating Embolism," and U.S. Patent Application No. 8,784,434, filed on March 15, 2013, entitled "Methods and Devices for Treating Embolism," both of which are incorporated herein by reference in their entirety. In some embodiments, for example, a user can first advance an interventional device to the treatment site and at least partially engage the interventional device to loosen (e.g., flush) the clot PE. Such loosening of the clot PE can facilitate removal of the clot PE during a subsequent aspiration pass. Similarly, in some embodiments, the user may use the interventional device to engage the residual clot PE after the first aspiration pass ( Figure 10B ).

[0102] Four, Selected embodiments of telescopic clot removal systems and related clot removal methods

[0103] Figure 11is a partially schematic side view of another clot treatment or clot removal system configured in accordance with the present technology. In the illustrated embodiment, the clot removal system includes a first suction assembly 20 and a second suction assembly 30. The first and second suction assemblies 20, 30 ("assemblies 20, 30") may include features that are generally similar to those described above with reference to Figure 1-10B Detailed description of features of the aspiration assembly 10. For example, the first aspiration assembly 20 includes (i) a first conduit subsystem 1000 having a first conduit 1002 and a first valve 1006, (ii) a first tubing subsystem 1020 having a first fluid control device 1026 (e.g., a stopcock), and (iii) a first pressure source 1040 fluidly coupled to the first conduit subsystem 1000 via the first conduit subsystem 1020. Similarly, the second aspiration assembly 30 includes (i) a second conduit subsystem 1100 having a second conduit 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 fluidly coupled to the second conduit subsystem 1100 via the second conduit subsystem 1120.

[0104] Each of the first and second catheters 1002, 1102 includes an elongated shaft defining a lumen 1004, 1104 and having a distal portion 1003a, 1103a. Each of the first and second valves 1006, 1106 includes (i) a distal portion 1007a, 1107a, (ii) a proximal portion 1007b, 1107b, (iii) a lumen 1009, 1109 extending therethrough, and (iv) a flow controller (obscured in FIG. 10 ) within the lumen 1009, 1109. A first fluid control device 1026 is operable to regulate or control (e.g., fluidically connect or disconnect) fluid flow between a first pressure source 1040 and the first catheter subsystem 1000. A second fluid control device 1126 is operable to regulate or control (e.g., fluidically connect or disconnect) fluid flow between a second pressure source 1140 and the second catheter subsystem 1100.

[0105] In the illustrated embodiment, the second catheter 1102 has a smaller cross-sectional dimension (e.g., diameter) than the first catheter 1002 so 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 can be telescopically extended through the lumen 1004 of the first catheter 1002 until the distal portion 1103a of the second catheter 1102 extends beyond the distal tip 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 more. When the second catheter 1102 is positioned 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 below with reference to Figures 14A-14C ), the sealing member 1499 can be positioned 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.

[0106] 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 conduit subsystems 1000, 1100, respectively, as described above with reference to Figure 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 still 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.

[0107] Figure 12 is a flow chart of a process or method 1280 for operating a clot removal system including components 20 and 30 to remove clotted material from a blood vessel (eg, a pulmonary vessel) of a human patient in accordance with the present technology. Figures 13A-13C is a schematic illustration of the distal portion of assemblies 20, 30 during a clot removal procedure in accordance with the present technology. Figures 14A-14C is a schematic side view of a distal portion of an assembly 20, 30 during a clot removal procedure and including an optional sealing member according to the present technology. Figure 11 and 13ASome features of method 1280 are described in the context of the embodiment shown in FIG. 14C , but those skilled in the art will readily appreciate that other suitable systems and / or devices may be used to perform method 1280 .

[0108] At block 1282, method 1280 includes positioning first catheter 1002 intravascularly within a human patient. For example, Figure 13A The first catheter 1002 is shown after being advanced (e.g., as indicated by arrow A1) to a position within a blood vessel BV (e.g., a pulmonary vessel). More specifically, the first catheter 1002 can be advanced within the blood vessel BV until the distal portion 1003a of the first catheter 1002 is located proximal to the clot material PE within the blood vessel BV. In some embodiments, the position of the distal portion 1003a of the first catheter 1002 relative to the clot material PE can 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 embodiment shown, the clot material PE is located within a branch (e.g., a reduced diameter portion) of the blood vessel BV. In some embodiments, as described above with reference to Figure 8 As described in detail, access to the blood vessel BV may be achieved using an introducer and a guidewire.

[0109] At block 1284, method 1280 includes advancing second catheter 1102 through first catheter 1002 until distal portion 1103a of second catheter 1102 is positioned proximate to clot PE within blood vessel BV (e.g., at the treatment site). To advance second catheter 1102 through first catheter 1002, the user may first insert distal portion 1103a of second catheter 1102 through first valve 1006 before advancing second catheter 1102 (e.g., as indicated by arrow A1) through lumen 1004 of first catheter 1002. In some embodiments, first valve 1006 may be actuated (e.g., by depressing one or more buttons) to open lumen 1009 of first valve 1006 to allow insertion of second catheter 1102. In some embodiments, the position of distal portion 1103a of second catheter 1102 relative to clot PE may be determined by activating second valve 1106 and determining whether back bleeding has occurred past second valve 1106, as described in detail above. In other embodiments, the (smaller) second catheter 1102 may be positioned intravascularly near the clot PE prior to positioning the (larger) first catheter 1002. In such embodiments, the second catheter 1102 may serve as a guide or track for advancing the first catheter 1002 to the treatment site.

[0110] Figure 13AThe second catheter 1102 is shown after it has been advanced 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 a proximal portion of the clot PE. In other embodiments, the distal end of the second catheter 1102 can be at least partially within the clot PE, or the distal end of the second catheter 1102 can be distal to the clot PE. In one aspect of the present technology, because the second catheter 1102 has a smaller cross-sectional dimension 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. Figure 13A In the illustrated embodiment, for example, the first catheter 1002 may be too large to be positioned within a branch of the blood vessel BV, while the second catheter 1102 may be positioned within the branch near or within the clot PE.

[0111] At block 1286, the method 1280 includes coupling the second pressure source 1140 to the second conduit 1102 via the second fluid control device 1126. For example, as described above with reference to Figure 2-7 Any one or combination of the pressure sources described in detail may be coupled to the second conduit 1102 via the second piping subsystem 1120. Once the second pressure source 1140 is coupled to the second conduit 1102, (i) opening of the second fluid control device 1126 fluidly connects the second pressure source 1140 to the lumen 1104 of the second conduit 1102, and (ii) closing of the second fluid control device 1126 fluidly disconnects the second pressure source 1140 from the lumen 1104 of the second conduit 1102. In some embodiments, the method 1280 may further include coupling the first pressure source 1040 to the first conduit 1002 (e.g., via the first piping subsystem 1020).

[0112] At block 1288, the 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 conduit 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 conduit 1002.

[0113] At block 1290, the 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 conduit 1102. Figure 13BAs shown, applying the vacuum causes suction (e.g., as represented by arrow A2), which draws at least a portion of the clotted material PE from the blood vessel BV and into the lumen 1104 of the second conduit 1102. In some embodiments, instantaneously or nearly instantaneously opening the second fluid control device 1126 creates suction at the distal portion 1103a of the second conduit 1102. In one aspect of the present technology, pre-charging or storing the vacuum prior to applying the vacuum to the lumen 1104 of the second conduit 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 conduit 1102 than simply activating the second pressure source 1140 when the second pressure source 1140 is fluidly connected to the second conduit 1102.

[0114] In some embodiments, after 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 generate suction at the distal portion 1003a of the first catheter 1002. Those skilled in the art will appreciate that the suction profile within 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 timing of the opening of the first and second fluid control devices 1026, 1126. For example, the first fluid control device 1026 may be opened simultaneously with the second fluid control device 1126 to generate a combined and relatively large suction within the blood vessel BV. In other embodiments, the first fluid control device 1026 may be opened after the second fluid control device 1126 to generate a staggered or stepped suction within the blood vessel BV. For example, the first fluid control device 1026 can be opened after the second fluid control device 1126 to (i) aspirate any clot material PE remaining in the blood vessel BV after aspiration of the second catheter 1102, and / or (ii) aspirate any clot material 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 continuous negative pressure, rather than accumulated negative pressure, thereby generating 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.

[0115] In some embodiments, an interventional device can be delivered through the second catheter 1102 and used to engage the clot PE before and / or after vacuum is applied to the second catheter 1102. Specific details of suitable interventional devices and related methods of use are disclosed, for example, in provisional U.S. patent application No. 16 / 258,344, filed on January 25, 2019, entitled "Single Insert Delivery System and Related Systems and Methods for Treating Embolism," which is incorporated herein by reference in its entirety.

[0116] At block 1292, method 1280 includes proximally retracting second catheter 1102 through first catheter 1002. In some embodiments, multiple aspiration passes can be performed using second catheter 1102 before retracting second catheter 1102. In some embodiments, as Figure 13C As shown, first pressure source 1040 or another pressure source coupled to first catheter 1002 can be activated to generate suction at distal portion 1003a of first catheter 1002 during retraction of second catheter 1102 (e.g., as indicated by arrow A3). Suction can be constant or provided in one or more bursts, as described in detail above. In some embodiments, second catheter 1102 can be completely withdrawn from the patient and placed or cleaned (e.g., flushed with a sterile fluid) for reuse.

[0117] Sometimes, when vacuum is applied to the second conduit 1102 (block 1290), the clotted material PE is not completely drawn into the second conduit 1102 and may adhere to or hang on the distal portion 1103a of the second conduit 1102. For example, Figure 14A yes Figure 13C An enlarged view of the distal portion of the assembly 20, 30 is shown, illustrating a portion of clotted material PE adhered to or suspended from the distal portion 1103a of the second catheter 1102. In the illustrated embodiment, an optional seal 1499 is positioned between the first and second catheters 1002, 1102 to facilitate removal of such suspended clotted material PE. More specifically, the seal 1499 (shown in cross-section) can be positioned between the outer surface of the second catheter 1102 and the inner surface of the first catheter 1002. The seal 1499 can be an O-ring, a grommet, or other suitable component that fluidically disconnects the lumen 1004 of the first catheter 1002 from the blood vessel BV when the second catheter 1102 is positioned therethrough (e.g., when the distal tip of the second catheter 1102 is distal to the seal 1499).

[0118] Figure 14B and 14C1004 is an enlarged view of the distal portion of the assembly 20, 30 and shows the second catheter 1102 (and the suspended clotted material PE) being further retracted into the lumen 1004 of the first catheter 1002. In some embodiments, the first pressure source 1040 can be activated to create a vacuum in the lumen 1004 of the first catheter 1002. For example, after advancing the second catheter 1102 through the first catheter 1002 and past the seal 1499 (e.g., block 1284) thereby sealing the lumen 1004 of the first catheter 1002, the operator can open the first fluid control device 1026 and activate the first pressure source 1040 to build up a vacuum in the lumen 1004 of the first catheter 1002. Figure 14C When the distal tip of the second catheter 1102 is proximally retracted beyond the seal 1499, the lumen 1004 of the first catheter 1002 becomes fluidically connected to the blood vessel BV and the vacuum is instantaneously or nearly instantaneously released to generate suction (e.g., as indicated by arrow A4). In the illustrated embodiment, the suction acts to separate or remove the clotted material PE from the second catheter 1102 and pull the clotted material PE proximally through the lumen 1004 of the first catheter 1002. In this manner, a second burst of suction is automatically applied via the first catheter 1002 during retraction of the second catheter 1102. In one aspect of the present technology, the user does not need to take any additional steps to release the vacuum stored in the first catheter 1002, as the release is automatically triggered by the retraction of the second catheter 1102.

[0119] At block 1294, the user can determine whether it is necessary or desirable to redeploy the second catheter 1102 or another catheter through the first catheter 1002 to remove any residual clot material PE that was not removed in the first aspiration pass and / or any clot material located elsewhere in the blood vessel BV (e.g., to initiate a second aspiration pass). In some embodiments, the operator can observe the amount of clot material PE collected in the first pressure source 1040 and / or the second pressure source 1140 to at least partially determine whether another aspiration pass is necessary. In other embodiments, the operator can rely on imaging of the blood vessel BV (e.g., fluoroscopic imaging) or other techniques known in the art to determine whether an additional aspiration pass is necessary or desirable.

[0120] If another pass is not required (e.g., clot material PE is sufficiently removed), the user may elect to completely withdraw the assembly 20, 30 from the patient at block 1296. If clot material PE still remains within the blood vessel, the method may return to block 1284. Specifically, 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 positioned adjacent to the remaining clot material 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., reintroduction of clot material PE). In some embodiments, the first catheter 1002 may be aspirated (e.g., via the first pressure source 1040) prior to redeploying the second catheter 1102 to, for example, dislodge any clot material PE that may be present in the first catheter 1002 to prevent reintroduction of the clot material PE into the blood vessel BV as the second catheter 1102 is advanced therethrough during another pass. Once the desired amount of clotted material PE has been removed from the patient, the assemblies 20 , 30 may be fully withdrawn from the patient (block 1294 ).

[0121] In one aspect of the present technology, method 1280 provides a multi-deployable aspiration catheter without removing the first catheter 1002 after each deployment. Thus, the present technology allows for a single insertion of a guide catheter to remove clotted material during a procedure that includes multiple passes, which increases the speed of the procedure and reduces trauma to the patient because the guide catheter does not need to be reintroduced (e.g., advanced through the vasculature and past the heart) before each pass. Furthermore, in certain embodiments, the present technology can enable the repositioning of the first catheter 1002 to an alternate treatment site within the patient without removing the first catheter 1002 from the patient, thereby eliminating the need to reintroduce the first catheter 1002 past the heart. For example, the first catheter 1002 can be repositioned to another treatment site within the lung, including a treatment site in the contralateral lung. More specifically, (i) the dilator can be reintroduced into the first catheter 1002, (ii) the first catheter 1002 can be withdrawn into the main pulmonary artery, (iii) the guidewire can be redirected to a new treatment site, (iv) the first catheter 1002 can be advanced over the guidewire to the new treatment site, and (v) the dilator can be removed.

[0122] Figure 15 The present technology is used to operate the components 20, 30 ( Figure 1 ) is a flow chart of another process or method 1580 for removing a clot from a blood vessel (e.g., a pulmonary vessel) of a human patient. Figure 16A is an enlarged side view of the distal portion of the first assembly 20, Figures 16B-16Eis a side view of the distal portion of the assemblies 20, 30 during a clot removal procedure in which a clot obstructs the first assembly 20 according to the present technology. Figure 11 and 16A While some features of method 1580 are described in the context of the embodiment shown in FIG. 16E , those skilled in the art will readily appreciate that other suitable systems and / or devices may be used to perform method 1580 .

[0123] Some features of method 1580 are generally similar to those of the above reference Figure 8 and 12 The features of methods 880 and / or 1280 are described in detail. For example, at block 1582, the method includes positioning the first conduit 1002 of the first assembly 20 intravascularly within a human patient. At block 1584, the method 1580 includes coupling the first pressure source 1040 to the first conduit 1002 via the first fluid control device 1026. For example, as described above with reference to Figure 2-7 Any one or combination of the pressure sources described in detail can be coupled to the second conduit 1002 via the first tubing subsystem 1020. At block 1586, the method 1580 includes activating the first pressure source 1040 to generate a vacuum while the first fluid control device 1026 is closed. In particular, the first pressure source 1040 can be activated to accumulate or pre-charge a vacuum for subsequent application to the first conduit 1002. At block 1588, the 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 conduit 1002. As described in detail above, opening the first fluid control device 1026 instantaneously or nearly instantaneously generates suction at the distal portion 1003a of the first conduit 1002.

[0124] However, when a vacuum is applied to the first conduit 1002 (block 1588), sometimes the clot is not completely drawn into the first conduit 1002 and / or blocks the first conduit 1002. For example, Figure 16Ais an enlarged view of the distal portion of the first assembly 20, illustrating a portion of the clot PE extending from the distal portion 1003a of the first catheter 1002 and blocking / occluding the lumen 1004 of the first catheter 1002. As such, a portion of the clot PE is not within the first catheter 1002. Therefore, at block 1590, the 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 containing little or no clot PE and blood. For example, because the clot PE is blocking 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, the method 1580 may proceed to block 1598, and the first catheter 1002 may be withdrawn from the patient, or the operator may perform another suction pass (e.g., as described above with reference to FIG. 1590). Figure 8 8 and 810 of the illustrated method 800).

[0125] If the first catheter 1002 is blocked, the method 1580 may proceed to block 1592, which includes advancing the second catheter 1102 through the first catheter 1002 until the distal portion 1103a of the second catheter 1102 is positioned in or near the blocked clot PE. For example, Figure 16B The second catheter 1102 is shown after it has been advanced into position within the first catheter 1002, with the distal tip of the second catheter 1102 at or near the obstructing 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 ).

[0126] At block 1594, the method 1580 includes activating the second pressure source 1140 coupled to the second conduit 1102 ( Figure 11 More specifically, the second pressure source 1140 (eg, as described above with reference to Figure 2-7 Any one or combination of pressure sources described in detail) may be coupled to the second conduit 1102 ( 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. The second fluid control device 1126 can then 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 momentarily releasing the vacuum. That is, in some embodiments, the second pressure source 1140 is not pre-charged with a vacuum.

[0127] Applying a vacuum to the second conduit 1102 can draw at least a portion of the blocked clotted material PE into the second conduit 1102 and / or draw the clotted material PE proximate to the distal end of the second conduit 1102. For example, Figure 16C FIG. 1 shows a portion of the clotted material PE adhered to or extending from the distal portion 1103a of the second catheter 1102 after aspiration of the second catheter 1102. Figure 16C In the illustrated embodiment, the increased vacuum pressure generated by the second conduit 1102 is still insufficient to disrupt the clot PE so that it can be completely aspirated through the first and / or second conduits 1002, 1102. In other words, the clot PE blocks the lumen 1004 of the first conduit 1002. In other embodiments, the increased vacuum pressure from the second pressure source 1140 is sufficient to disrupt the clot PE so that it can be aspirated, for example, into the vacuum chamber of the first and / or second pressure sources 1040, 1140.

[0128] At block 1596, the method may include retracting the second catheter 1102 and the clotted material PE through the lumen 1004 of the first catheter 1002. For example, Figure 16D The second conduit 1102 is shown retracted 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 completely withdrawn through the first conduit 1002. In other embodiments, retracting the clot PE through the first conduit 1002 causes the clot PE to break apart and be drawn into the vacuum chamber of the first and / or second pressure sources 1040, 1140. For example, Figure 16E The clot PE is shown breaking up when the vacuum of the first and / or second pressure sources 1040 , 1140 is instantaneously or nearly instantaneously released to draw the clot PE proximally (eg, as represented by arrow A5 ).

[0129] At block 1598 , the first and second catheters 1002 , 1102 may be withdrawn from the patient, or the operator may perform another aspiration pass using one or both of the first and second catheters 1002 , 1102 .

[0130] In one aspect of the present technology, method 1580 removes the clot even if the first suction is through an obstructed first catheter 1002. More specifically, second catheter 1102 can be used to remove the obstructing clot PE without withdrawing first catheter 1002 and the obstructing clot PE through vessel BV.

[0131] five, Additional Selected Embodiments of Clot Removal Systems and Related Clot Removal Methods

[0132] In summary, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but that various modifications may be made without departing from the scope of the technology. For example, in many of the embodiments described above, stored vacuum pressure may be used to aspirate or draw coagulation material from a blood vessel and into a catheter without engaging an interventional device with the coagulation material. However, those skilled in the art will appreciate that the suction devices and techniques disclosed herein may be used with any suitable interventional device and / or during a clot removal procedure using an interventional device. In some embodiments, for example, the clot removal system may be configured to apply stored vacuum pressure to a guide catheter to generate a burst of suction as the interventional device is retracted into and / or through the guide catheter.

[0133] For example, Figure 17 is a partial schematic diagram of a clot removal system 1700 ("system 1700") configured in accordance with the present technology. Some features of system 1700 are generally similar to those described above with reference to Figure 1 Features of a clot removal system are described in detail. For example, system 1700 includes a catheter or sheath 1702 including an elongated shaft, and a valve 1706 coupled to a proximal portion of sheath 1702. Valve 1706 has a side port 1708 that fluidly couples the lumen of sheath 1702 to a tubing subsystem 1720 and a pressure source 1740 (shown schematically). A fluid control device 1726 (e.g., a stopcock or clamp; shown schematically) is operable to fluidly disconnect or connect pressure source 1740 to the lumen of sheath 1702. Pressure source 1740 can be any suitable pressure source for generating and storing vacuum pressure, as described in detail above.

[0134] In the illustrated embodiment, the system 1700 further comprises (i) a self-expanding (e.g., mesh) funnel 1780 coupled to a proximal portion of the sheath 1702 and (ii) an interventional device (e.g., a thrombus retrieval device) 1790. In the illustrated embodiment, the interventional device 1790 comprises 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 interventional device 1790 is configured to self-expand from a compressed delivery state to an expanded deployed state. The interventional device 1790 is as shown. Figure 17The elongated shaft 1782 and / or one or more shafts located within the elongated shaft 1782 (e.g., Figure 18E and 18F The intermediate shaft 1884 and inner shaft 1886 are shown coupled to the interventional device 1790 and are configured to retract, advance, and / or manipulate (e.g., move between a delivery state and a deployed state) the interventional device 1790. In some embodiments, the system 1700 can be generally the same as or similar to any of the clot removal systems disclosed in U.S. Patent Application Publication No. 2018 / 0193043, filed April 26, 2017, entitled “Device and Method for Treating Vascular Occlusion,” which is incorporated herein by reference in its entirety.

[0135] In the illustrated embodiment, the system 1700 is shown as being positioned intravascularly within a blood vessel BV of a human patient and adjacent to a blood clot (e.g., a deep vein thrombosis) within the blood vessel BV. Figure 17 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 interventional device 1790 from the sheath 1702 (e.g., by advancing the interventional device 1790 through the valve 1706 and the sheath 1702 to a position distal to the distal portion 1785a of the clot DV), and (iv) expanding the interventional device 1790 from a compressed delivery state to a deployed state.

[0136] Figures 18A-18H is an enlarged view of a distal portion of system 1700 during a clot removal procedure in accordance with the present technology. Figures 18A-18H The interventional device 1790 is shown being retracted proximally through the clot DV to capture at least a portion of the clot DV, and subsequently the interventional device 1790 and the captured clot DV are retracted together into the funnel 1780 and the sheath 1702. In one aspect of the present technology, an inflated vacuum pressure generated in the vacuum source 1740 may be applied to the sheath 1702 one or more times during the illustrated procedure to create suction to draw the captured clot DV through the sheath 1702 and / or to prevent clogging of the sheath 1702.

[0137] First reference Figure 18A , the interventional device 1790 is retracted proximally causing the core removal 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. Figure 18B As shown, continued proximal retraction of the interventional device 1790 through the clot DV causes the distal end portion 1785a of the cylindrical member 1794 to capture the clot therein. Figures 18C-18EFurther proximal retraction of the interventional device 1790 is shown, which results in further separation, nucleation, and / or capture of the clot material DV. Figure 18E As 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 cored and captured. Figure 18E As further shown in FIG, a first radiopaque marker 1887a can be located on a distal end portion of the inner shaft 1884 and a second radiopaque marker 1887b can be located on a distal end portion of the sheath 1702.

[0138] In some embodiments, as Figure 18F As shown, the interventional device 1790 can be retracted proximally until a portion of the nucleus retrieval element 1792 is contained (e.g., located) within the funnel 1780. More specifically, the interventional device 1790 can be retracted proximally until the port 1895 of the nucleus retrieval element 1792 is contained within the funnel 1780. In some embodiments, the nucleus retrieval element 1792 can be viewed by observing the radiopaque marker 1887 ( Figure 18E ) to verify the containment of the port 1895 within the funnel 1780 under fluoroscopy. In some embodiments, for example, via fluoroscopic monitoring, the port 1895 can be determined to be fully contained within the funnel 1780 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). In some embodiments, when the port 1895 of the nucleation element 1792 is positioned within the funnel 1780, the interventional device 1790 can be moved or transitioned from an expanded, deployed state to a compressed, delivery state to compress and secure clot material DV captured by the interventional device 1790. In some embodiments, for example, the intermediate shaft 1884 can 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 collapse or compress the interventional device 1790.

[0139] like Figure 18G As shown, after the interventional device 1790 is folded, the interventional device 1790 can be retracted proximally through the funnel 1780 and into the sheath 1702. Figure 18H As shown, the interventional device 1790 can continue to be retracted proximally until the interventional device 1790 and the captured clot DV are completely contained within the sheath 1702. In some embodiments, the interventional device 1790 and the captured clot DV can then be withdrawn through the sheath 1702 and valve 1706 ( Figure 17 ) and withdrawn from the patient.

[0140] In some embodiments, folding the interventional device 1790 and / or retracting the interventional device 1790 into the funnel 1780 and / or sheath 1702 can cause one or more portions of the clot DV to break away from the clot DV contained within the interventional device 1790. For example, when the interventional device 1790 is folded, all or a portion of the captured clot DV can be squeezed through the pores of the (e.g., mesh) cylindrical element 1794. In some embodiments, any such clot can be captured by the funnel 1780. Figure 17 In some embodiments, the pressure source 1740 can be activated to apply a vacuum, and then the fluid control device 1726 can be opened to apply the applied vacuum to the sheath 1702 (as described in detail above). The vacuum can be applied to the sheath 1702 at any point during the retraction of the interventional device 1790. Figure 18G and 18H As shown, applying a vacuum can generate instantaneous or nearly instantaneous suction (e.g., as indicated by arrow A6) at the distal end portion of the sheath 1702, which can draw an extruded portion and / or other portions of the clotted material DV into and / or through the sheath 1702. In particular, the suction generated can draw some or all of the clotted material DV captured by the funnel 1780. Furthermore, in some embodiments, applying a vacuum from the pressure source 1740 can facilitate smooth retraction of the captured clotted material DV through the sheath 1702. For example, the burst of suction generated by applying a vacuum can help prevent blockage of the sheath 1702 and / or help resolve (e.g., break up) a blockage that forms in the sheath 1702 during retraction.

[0141] six, Selected embodiments of a clot removal system with a filter and associated clot removal methods

[0142] The systems and methods described herein for clot removal may include applying a pre-charged vacuum to generate suction to remove the clot from a patient's blood vessel. In one aspect of the present technology, aspirating the clot also aspirates blood from the patient. Reintroducing the aspirated blood into the patient to reduce trauma to the patient may be advantageous, particularly where the removal procedure may include multiple aspiration passes that may withdraw a large amount of blood. However, the aspirated blood often mixes with the clot, making it unsuitable for reintroduction into the patient. Figure 19-20E Various devices are shown for filtering aspirated blood from the removed clotted material so that the aspirated blood can be reintroduced into the patient without reintroducing significant amounts of clotted material.

[0143] For example, Figure 19 is a perspective side view of a pressure source 1900 configured in accordance with the present technology for filtering blood from aspirated clotted material during a clot removal procedure. The pressure source 1900 is generally similar to the pressure source 1900 described above with reference to FIG. Figures 4A-4CThe pressure source 400 is 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 tank 1940 instead of the primary syringe 340 ( Figures 4A-4C The canister 1940 includes a tip (shielded) coupled to the adapter 350 and is configured to be removably located on the connector 128 of the piping subsystem 120. Figure 1 ) to fluidly couple the tank 1940 to the tubing subsystem 120. Because the tank 1940 does not include a plunger or other components for changing its volume, the syringe 460 is the only vacuum source for evacuating the tank 1940 (e.g., via repeated cycles of the secondary syringe 460).

[0144] In the embodiment shown, the tank 1940 also includes a filter 1942. For clarity, the tank 1940 is Figure 19 Filter 1942 is coupled to and / or covers a removable end cap 1944 having a blood separation port 1946. In operation, when blood and clotted material are drawn into canister 1940 (e.g., via any of the methods described in detail above), filter 1942 separates the blood from the clotted material within canister 1940. The filtered blood can be removed via blood separation port 1946. For example, a syringe (not shown) or other device can be fluidically coupled to blood separation port 1946 and used to withdraw blood from canister 1940 through filter 1942. The filtered blood can then be reintroduced into the patient via, for example, fluid control device 126 and / or connector 128 of tubing subsystem 120. Once the blood is removed from canister 1940, end cap 1944 can be removed from canister 1940 (e.g., by unscrewing end cap 1944 from the body of canister 1940) to remove the captured clotted material. In some embodiments, the filter 1942 is attached to the end cap 1944 such that removing the end cap 1944 removes the filter 1942 and allows the curd to be poured, scooped, or otherwise removed from the jar 1940 .

[0145] Figures 20A-20E A filter device 2050 configured in accordance with the present technology for filtering blood from aspirated clot material during a clot removal procedure is shown. The filter device 2050 is configured for use, for example, with the above reference Figure 2-7 An in-line filter for one or more pressure sources as described in detail. For example, Figure 20A is the filter device 2050 and the pressure source 340 ( Figures 3A-3D). In the illustrated embodiment, the filter device 2050 includes a filter portion 2060 that is removably positionable within a cartridge portion 2070. In the illustrated embodiment, the cartridge portion 2070 includes a cartridge 2072 defining a chamber 2074, and a wide-bore tip 2076 (e.g., such as a nozzle) configured to fluidly couple the chamber 2074 to an external component (e.g., the tubing subsystem 120). Figure 20C ). Filter portion 2060 includes a seal 2062 configured to (i) mate with the inner surface of barrel 2072 when filter portion 2060 is located within chamber 2074 of barrel portion 2070, and (ii) mate with the outer surface of syringe 340 (e.g., the outer surface of barrel 344) when syringe 340 is inserted into filter device 2050. In other embodiments, filter portion 2060 may be permanently attached to barrel portion 2070 or integrally formed therewith. Filter portion 2060 also includes a filter (e.g., a mesh) 2064 configured (e.g., sized and shaped) to prevent clotted material from passing therethrough. In some embodiments, filter 2064 may be configured to prevent clots larger than approximately 100 μm (e.g., larger than approximately 110 μm) from passing therethrough.

[0146] Figure 20B is a perspective side view of the syringe 340 coupled to the filter device 2050. For clarity, the barrel 2072 of the barrel portion 2070 is shown in FIG. Figure 20B (and Figures 20C-20E ) is shown as transparent in FIG. In the illustrated embodiment, seal 2062 is located between the outer surface of barrel 344 of syringe 340 and the inner surface of barrel 2072 of barrel portion 2070. Filter 2064 is located around (e.g., covers) tip 347 of syringe 340 to prevent clotted material from entering barrel 344 of syringe 340 during operation.

[0147] Figure 20C is a side view of the filter device 2050 and syringe 340 coupled to the tubing 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 tubing subsystem 120. When the filter device 2050 and syringe 340 are coupled to the tubing subsystem 120, the filter device 2050 is positioned in a straight-through manner (e.g., in series) with the syringe 340. Figure 20CIn the illustrated embodiment, the plunger 342 of the syringe 340 has been withdrawn to create negative pressure in the combined volume of the barrels 2072 and 344. As described in detail above, opening the fluid control device 126 almost instantaneously applies negative pressure to the catheter 102 to create suction therein. As clot material and blood are aspirated through the catheter 102 and the tubing subsystem 120, the filter portion 2060 prevents the clot material from entering the barrel 344 of the syringe 340. Thus, the aspirated blood is collected in the barrel 344 of the syringe 340, while the aspirated clot material is collected in the barrel 2072 of the barrel portion 2070 of the filter device 2050. In this manner, the clot material and blood can be separated during aspiration.

[0148] In one aspect of the technology, separating the blood from the clot material enables the blood to be easily reintroduced into the patient within the syringe 340. For example, Figure 20D and 20E is a side view of the syringe 340 coupled to the tubing subsystem 120 of the assembly 10 to reintroduce the blood into the patient. In some embodiments, as illustrated in Figure 20D the syringe 340 can be decoupled from the filter device 2050 and directly coupled to the connector 128. With the fluid control device 126 in the open position, the blood can then be reintroduced into the patient through the assembly 10 by depressing the plunger 342 of the syringe 340. In some embodiments, as illustrated in Figure 20E the syringe 340 can be decoupled from the filter device 2050 and directly coupled to the port on the fluid control device 126. With the fluid control device 126 in the closed position, the blood can then be reintroduced into the patient through the assembly 10 by depressing the plunger 342 of the syringe 340. Referring to Figures 20A-20E , after or before reintroducing the filtered blood into the patient, the filter portion 2060 of the filter device 2050 can be removed from the barrel portion 2070 so that the collected clot material can be removed and the filter device 2050 can be cleaned. In some embodiments, the filter device 2050 and coupled pressure source can be used to filter blood from clot material after, but not during, aspiration. For example, the filter device 2050 and coupled pressure source can be used to withdraw blood and clot material collected in the canister 1940 of the pressure source 1900 (e.g., where the canister 1940 does not include a filter 1942).

[0149] Figure 21A and 21B is shown a filter device 2150 configured in accordance with the technology for filtering blood from aspirated clot material during a clot removal procedure. The filter device 2150 is configured for use with, for example, one or more pressure sources described in detail above with reference to Figure 2-7 . For example, Figure 21Ais the filter device 2150 and the pressure source 340 ( Figures 3A-3D ). In the illustrated embodiment, filter device 2150 includes a housing 2152 defining a chamber 2154, a filter 2156 configured to be positioned within housing 2152, and a cap assembly 2160 configured to be releasably coupled to housing 2152 (e.g., via a threaded connection, a snap-fit ​​connection, etc.). In some embodiments, filter 2156 may have a porosity between approximately 50-200 microns.

[0150] Housing 2152 may include a port 2153 configured to be removably fluidically coupled to pressure source 340 via tubing subsystem 2120. In the illustrated embodiment, tubing subsystem 2120 includes tubing segments 2124 (labeled as first tubing segment 2124a and second tubing segment 2124b, respectively), a fluid control device 2126 (e.g., a valve, stopcock, clamp, etc.), and a connector 2128 (e.g., a large-bore connector) for fluidically coupling tubing 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) configured to connect to a receiving / reinfusion syringe 2170 via, for example, tubing segment 2164. In some embodiments, cap assembly 2160 may include a valve (e.g., a one-way valve, a check valve, etc.) that provides one-way fluid flow through filter assembly 2150.

[0151] In operation, during a clot removal procedure, after aspiration has passed and when the pressure source 340 is filled with blood and clot material, the pressure source 340 may be connected to the connector 128 ( Figure 1 ) decoupled. After the filter device 2150 is connected to the receiving syringe 2170, the pressure source 340 can be coupled to the filter device 2150. For example, Figure 21B is a perspective side view of a filter device 2150 (i) coupled to a pressure source 340 via a tubing subsystem 2120 and (ii) coupled to a re-infusion syringe 2170 via a tubing segment 2164. More specifically, referring to Figure 21A and 21B , the tip 347 of the pressure source 340 can be coupled to the connector 2128 of the tubing subsystem 2120, and the tip 2172 of the re-infusion syringe 2170 can be coupled to the tubing segment 2164. In other embodiments, the filter device 2150 can be coupled to the pressure source 340 and / or the re-infusion syringe 2170 in other ways (e.g., directly such that all or part of the tubing subsystem 120 is omitted). Alternatively, the filter device 2150 can be attached directly to the side port 108 ( Figure 1), an IV line (not shown), or another suitable connection point for reintroducing blood into the patient.

[0152] 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. The operator can then depress the plunger 342 of the pressure source 340 to drive blood and clotted 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 clotted material so that the blood flows into the re-infusion syringe 2170 and the clotted material is retained in the chamber 2154 of the filter device 2150. For example, Figure 21B As shown, blood B fills the reinfusion syringe 2170 and after the plunger 342 of the pressure source 340 is depressed in the direction indicated by arrow H, clotted material PE remains within the chamber 2154 of the filter device 2150.

[0153] 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 ( Figure 1 ). The cap assembly 2160 can be decoupled from the housing 2152 of the filter device 2150 to, for example, allow an operator to remove the clotted material PE collected in the housing 2152, thereby cleaning and preparing the filter device 2150 for another use.

[0154] Figure 22 is a partially exploded side view of a filter device 2250 configured in accordance with the present technology for filtering blood from aspirated clotted material during a clot removal procedure. The filter device 2250 is configured to be used with, for example, the filter device 2250 described above with reference to FIG. Figure 2-7 In general, the filter device 2250 is substantially similar to the filter device 2250 of the reference Figure 21A and 21B Detailed description of the filter device 2150 is provided. For example, the filter device 2250 includes a housing 2252 defining a chamber 2254, a filter 2256 configured to be positioned 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 filter configured to be coupled to a pressure source (e.g., Figures 3A-3D2260) is connected to the pressure source 340 shown in FIG. The cap assembly 2260 includes a fluid connector 2162 (e.g., a standard Luer or large bore connector) configured to connect to a re-infusion 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 In one embodiment, the fluid connector 2262 is formed to have an approximately right angle. In one aspect of the present technology, this arrangement makes the filter device more ergonomic during use.

[0155] Figure 23 is a partially exploded side view of a filter device 2350 configured in accordance with the present technology for filtering blood from aspirated clotted material during a clot removal procedure. The filter device 2350 is configured to be used with, for example, the filter device 2350 described above with reference to FIG. Figure 2-7 The filter device 2350 is generally similar to the one or more pressure sources described in detail. Figure 22 The filter device 2250 described in detail is identical, for example, 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 fluidically connected to the fluid connector 2262. The second housing 2382 includes a second fluid connector 2384, which can be fluidically connected to a re-infusion syringe, sheath, IV line, etc. (not shown). The second filter 2386 is configured to provide a second level 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 may have a porosity between approximately 50-200 microns, and the second filter 2386 may have a porosity between approximately 50-170 microns.

[0156] In general, one skilled in the art will appreciate that the various embodiments of the filter devices disclosed herein may have different components or combinations of components. For example, the filter devices 2050, 2150, 2250, and / or 2350 ("filter devices") may be used with different syringes than the syringe 340 (e.g., Figure 2 4-7). In some embodiments, the filter device can be formed as a pipe subsystem 120 ( Figure 1 ) components. In addition, the filter device can include any number of filters and / or housings to provide any number of filtration stages.

[0157] Summarize

[0158] The above detailed description of the embodiments of the present technology is not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments and examples of the present technology are described above for illustrative purposes, 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 perform 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 are described herein, but well-known structures and functions are not 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 include plural or singular terms, respectively.

[0160] Furthermore, unless the word "or" is expressly limited to referring only to a single item in a list of two or more items that does not include other items, the use of "or" in such a list should be interpreted 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" is used throughout to mean including at least one or more of the features recited, such that any greater number of the same features and / or additional types of other features are not excluded. It will also be understood that specific embodiments are described herein for illustrative purposes, but that various modifications may be made without departing from the present technology. Furthermore, while 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. Accordingly, the present disclosure and related technology may include other embodiments not explicitly shown or described herein.

Claims

1. A blood filtration system comprising: container, wherein— In a first state of the container, the container is attached to the aspiration catheter assembly, fluidly coupled to the aspiration catheter of the aspiration catheter assembly, and configured to receive blood and clotted material aspirated from the patient's vasculature through the aspiration catheter, and In a second state of the container, the container is separated from the aspiration catheter assembly and is fluidly isolated from the aspiration catheter; Filter device, comprising: - a housing defining a chamber; - an inlet, wherein in a third state of the container, the container is attached to and fluidly coupled to the inlet to provide blood and clotted material to the inlet; - exit; - a fluid path extending from the inlet, through the chamber and to the outlet; and - a filter positioned in the chamber along the fluid path and configured to (a) permit blood to flow along the fluid path from the inlet to the outlet and (b) inhibit clotted material from flowing along the fluid path from the inlet to the outlet; and Syringes, of which— In a first state of the syringe, the syringe is attached to the outlet, is fluidically coupled to the outlet, and can be actuated to draw filtered blood through the outlet. In the second state of the syringe, the syringe is separated from the outlet and is fluidically isolated from the outlet.

2. The blood filtration system of claim 1, wherein the syringe is a first syringe, and wherein the container is a second syringe.

3. The blood filtration system according to claim 1, wherein: The container is a vacuum pressure lock syringe.

4. The blood filtration system of claim 1 , wherein the filter is a first filter, and wherein the filter device further comprises a second filter configured to (a) further permit blood to flow along the fluid path from the inlet to the outlet, and (b) further inhibit clotted material from flowing along the fluid path from the inlet to the outlet.

5. The blood filtration system according to claim 4, wherein: The second filter is located in the chamber between the first filter and the outlet, wherein the first filter has a first porosity, and wherein the second filter has a second porosity less than the first porosity.

6. The blood filtration system of claim 1, wherein the inlet has an inlet inner diameter, and wherein the outlet has an outlet inner diameter that is smaller than the inlet inner diameter.

7. The blood filtration system according to claim 1, wherein: The filter device also includes a cover coupled to the housing, wherein the outlet is coupled to the cover, and wherein the cover is removable from the housing to provide access to the filter.

8. The blood filtration system according to claim 1, wherein: The inlet includes at least one tube and a fluid control device, wherein the fluid control device is movable between (a) a first position in which the inlet is in fluid communication with the chamber and (b) a second position in which the inlet is fluidly disconnected from the chamber.

9. The blood filtration system according to claim 1, wherein: In a third state of the syringe, the syringe is attached to a reinfusion catheter assembly including a reinfusion catheter and is fluidly coupled with the reinfusion catheter to reinfuse filtered blood into the patient's vasculature.

10. The blood filtration system according to claim 1, wherein: The volume of the container is 60 cubic centimeters or greater.

11. A system for treating a clot in a patient's vasculature, the system comprising: an aspiration catheter assembly comprising an aspiration catheter configured to be positioned intravascularly in the vasculature of a patient such that a distal portion of the aspiration catheter is positioned proximate to a clotted material; A first container, wherein— In a first state of the first container, the first container is attached to the aspiration catheter assembly and fluidly coupled to the aspiration catheter to receive blood and clotted material aspirated from the patient's vasculature through the aspiration catheter, and In a second state of the first container, the first container is separated from the aspiration catheter assembly and is fluidly isolated from the aspiration catheter; Filter device, comprising: - a housing defining a chamber; - an inlet, wherein in a third state of the first container, the first container is attached to and fluidly coupled to the inlet to provide blood and clotted material to the inlet; - exit; - a fluid path extending from the inlet, through the chamber and to the outlet; and - a filter positioned in the chamber along the fluid path and configured to (a) permit blood to flow along the fluid path from the inlet to the outlet and (b) inhibit clotted material from flowing along the fluid path from the inlet to the outlet; and a reinfusion catheter assembly comprising a reinfusion catheter configured to be positioned intravascularly in the vasculature of a patient; and A second container, wherein— In a first state of the second container, the second container is attached to the outlet and fluidly coupled to the outlet to receive filtered blood from the outlet, In a second state of the second container, the second container is separated from the outlet and is fluidically isolated from the outlet, In a third state of the second container, the second container is attached to the re-infusion catheter assembly and fluidly coupled to the re-infusion catheter to re-infuse filtered blood into the patient's vasculature, and The second container is configured to be in only a single state at a time, among the first state, the second state, or the third state.

12. The system according to claim 11, wherein The aspiration catheter and the re-infusion catheter comprise the same catheter.

13. The system according to claim 11, wherein: The second container is a syringe, and wherein the syringe is actuatable to drive filtered blood through the reinfusion catheter when the syringe is in the third state of the syringe.

14. The system according to claim 11, wherein: The second container is a syringe, and wherein, when the syringe is in the first state of the syringe, the syringe is actuatable to withdraw filtered blood through the outlet of the filter device.

15. The system of claim 11, wherein the re-infusion catheter is separate from the aspiration catheter.

16. A system for treating a clot in a patient's vasculature, the system comprising: a catheter having a distal portion and a proximal portion, wherein the catheter is configured to be advanced intravascularly through the vasculature of a patient such that the distal portion of the catheter is positioned proximate to a clot, and wherein the catheter has a size of 16 French or greater; and a hemostasis valve coupled to the proximal portion of the catheter and configured to selectively provide fluid access to the catheter; fluidly coupled to a side port of the catheter distal to the hemostasis valve; A syringe comprising a barrel and a tip, wherein the tip has a size of 16 French or larger, wherein the syringe is configured to be fluidly coupled to a catheter via the side port to define a fluid path extending through the catheter, through the side port, through the tip of the syringe, and into the barrel of the syringe, and wherein a diameter of the fluid path remains constant or widens from a distal portion of the catheter to the barrel of the syringe.

17. The system of claim 16, further comprising a tubing assembly fluidly coupled to the side port, wherein: The syringe is configured to be fluidly coupled to a catheter via the tubing assembly and the side port, The fluid path further extends through the conduit assembly, and The diameter of the fluid path remains constant or widens from the distal portion of the catheter, through the tubing assembly, to the barrel of the syringe.

18. The system of claim 16, further comprising a valve fluidly coupled to the side port, wherein: The syringe is configured to be fluidly coupled to the catheter via the valve and the side port, The fluid path further extends through the valve, The valve is movable between (a) a first position that prevents fluid flow along the fluid path from the catheter to the syringe and (b) a second position that allows fluid flow along the fluid path from the catheter to the syringe, and When the valve is in the second position, the diameter of the fluid path from the distal portion of the catheter, through the valve, to the barrel of the syringe remains constant or widens.

19. The system of claim 16, wherein: The barrel of the syringe has a volume of 60 cubic centimeters or greater, The syringe also includes a plunger slidably positioned within the barrel and a locking mechanism, The plunger is slidable through the barrel from a first position to a second position to create a vacuum pressure within the barrel, and The locking mechanism is configured to engage the plunger in the second position to lock the plunger in the second position.

20. The system of claim 16, wherein: The catheter has a size of 16 French or greater and a corresponding catheter inner diameter; The side port has a side port inner diameter; The tip has a size of 16 French or greater and a corresponding tip inner diameter; and The tip inner diameter is equal to or greater than the catheter inner diameter and the side port inner diameter.

21. The system of claim 20, further comprising a tubing assembly fluidly coupled to the side port, wherein: The syringe is configured to be fluidly coupled to the catheter via the tubing assembly and the side port, The fluid path further extends through the conduit assembly, and The tubing assembly has an inner diameter of the tubing assembly that is equal to or greater than the inner diameter of the catheter so that the diameter of the fluid path remains constant or widens from the distal portion of the catheter, through the side port, through the tubing assembly, and to the barrel of the syringe.

22. The system of claim 20, further comprising a valve fluidly coupled to the side port, wherein: The syringe is configured to be fluidly coupled to the catheter via the valve and the side port, The fluid path further extends through the valve, The valve is movable between (a) a first position that prevents fluid flow along the fluid path from the catheter to the syringe and (b) a second position that allows fluid flow along the fluid path from the catheter to the syringe, and the valve having an inner diameter that is equal to or greater than an inner diameter of the catheter, such that when the valve is in the second position, the diameter of the fluid path from the distal portion of the catheter, through the side port, through the valve, to the barrel of the syringe remains constant or widens, The syringe is configured to store vacuum pressure when the valve is in the first position, and The valve is movable from a first position in which vacuum pressure is stored in the syringe to a second position, thereby applying vacuum pressure to the catheter such that at least a portion of the clotted material is drawn into the catheter.

23. The system of claim 20, wherein the catheter is between 16 French and 24 French in size, and wherein the tip of the syringe is 24 French or larger in size.

24. The system of claim 20, wherein the clot comprises a pulmonary embolism or a deep vein thrombosis, and wherein the distal portion of the catheter is configured to be advanced intravascularly through the patient's vasculature such that the distal portion of the catheter is positioned proximate to the pulmonary embolism or deep vein thrombosis.

25. The system of claim 20, wherein: The barrel of the syringe has a volume of 60 cubic centimeters or greater.

26. The system of claim 20, wherein: The syringe also includes a plunger slidably positioned within the barrel and a locking mechanism, The plunger is slidable through the barrel from a first position to a second position to create a vacuum pressure within the barrel, and The locking mechanism is configured to engage the plunger in the second position to lock the plunger in the second position.

27. A system for treating pulmonary embolism in the vasculature of a patient, the system comprising: a catheter defining a lumen and having a distal portion, wherein the catheter is configured to be advanced intravascularly through the vasculature of a patient such that the distal portion of the catheter is positioned proximate to the pulmonary embolism; Suction container; a valve between the suction container and the catheter; and a fluid path extending through the lumen of the catheter, through the valve, and to the aspiration vessel, wherein— The valve is movable between (a) a first position that prevents fluid flow along the fluid path from the lumen of the catheter to the aspiration container and (b) a second position that allows fluid flow along the fluid path from the lumen of the catheter to the aspiration container, The suction reservoir is configured to store vacuum pressure when the valve is in a first position, and The valve is movable from a first position in which vacuum pressure is stored in the suction reservoir to a second position, thereby: applying vacuum pressure to the lumen of the catheter to produce a flow rate greater than 40 cubic centimeters per second within the lumen of the catheter and to cause at least a portion of the pulmonary embolus to be aspirated into the lumen of the catheter, and The pressure within the aspiration container and the pressure within the conduit are substantially equalized in less than two seconds, thereby producing a flow rate greater than 40 cubic centimeters per second in less than two seconds.

28. The system of claim 27, wherein the catheter has a size of 16 French or larger.

29. The system of claim 27, wherein the catheter has a size of 20 French or larger.

30. The system of claim 27, wherein the suction vessel has a volume of 60 cubic centimeters or less.

31. The system of claim 27, wherein the suction vessel has a volume of 60 cubic centimeters or greater.

32. The system of claim 27, wherein: The flow rate is greater than 45 cubic centimeters per second.

33. The system of claim 27, wherein: The flow rate is greater than 60 cubic centimeters per second.

34. The system of claim 27, wherein: The flow rate is greater than 70 cubic centimeters per second.

35. The system of claim 27, wherein: The valve is actuatable by a user to move to a first position and a second position.

36. The system of claim 27, wherein: The valve is capable of moving from a first position in which vacuum pressure is stored in the suction reservoir to a second position, thereby equalizing the pressure in the suction reservoir and the pressure in the conduit in less than about one second, thereby generating a flow rate greater than 40 cubic centimeters per second in less than about one second.

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