Thrombectomy system, blood return method, and method for reconstituting removed blood clot

Abstract

The present technology relates to systems and methods for removing a thrombus from a patient's blood vessel. In some embodiments, the present technology is directed to a system including an elongate catheter having a distal portion configured to be positioned within the patient's blood vessel, a proximal portion configured to be external to the patient, and a lumen extending therebetween. The system can also include a fluid delivery mechanism coupled to the fluid lumen and configured to apply fluid to at least partially fragment the thrombus.

Description

[Technical Field]

[0001] Priority claim

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 380,779, filed October 25, 2022, entitled "THROMBUS REMOVAL SYSTEMS AND ASSOCIATED METHODS," U.S. Provisional Patent Application No. 63 / 380,876, filed October 25, 2022, entitled "CLOT CATCHER AND BLOOD RETURN SYSTEMS AND METHODS FOR THROMBUS REMOVAL DEVICE," and U.S. Provisional Patent Application No. 63 / 502,040, filed May 12, 2023, entitled "THROMBUS REMOVAL SYSTEMS AND METHODS FOR RECONSTITUTING REMOVED BLOOD CLOTS," each of which is incorporated by reference in its entirety. Incorporation by Reference

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Field

[0003] The present technology relates generally to medical devices, and more particularly to systems including aspiration and fluid delivery mechanisms for removing thrombi from mammalian blood vessels, and related methods. Summary of the Invention [Problem to be solved by the invention]

[0002]

[0004] Thrombotic material can lead to blockage of fluid flow within the mammalian vascular system. Such blockages can occur in various areas of the body, such as the pulmonary system, peripheral vasculature, deep vasculature, or brain. Pulmonary embolism typically occurs when a blood clot originating in another part of the body (e.g., a pelvic or leg vein) dislodges and travels to the lungs. Anticoagulation therapy is the current standard of care for treating pulmonary embolism, but it can be ineffective in some patients. Additionally, conventional devices for removing thrombotic material may be unable to navigate tortuous vascular anatomy, may be ineffective at removing thrombotic material, and / or may lack the ability to provide sensor data or other feedback to clinicians during the thrombectomy procedure. Existing thrombectomy devices operate based on simple suction, which works well for certain clots but is largely ineffective against difficult, organized clots. Many patients with deep vein thrombus (DVT) remain untreated unless they are at low risk for limb ischemia. More urgent cases are treated with catheter-directed thrombolysis or dissolution therapy, which can take hours or even days to break up the clot. Recently, other devices, such as clot retrievers, have been developed to treat DVT and pulmonary embolism (PE), but these devices have not been widely adopted due to their limited effectiveness and additional cost relative to aspiration or standard of care. Other recent developments focus on slicing or macerating the clot, but these mechanisms are designed to reduce the risk of catheter clogging and do not address the issues of hard, large, or organized clots. There remains a need for devices that address these and other problems with existing intravenous thrombectomy techniques, including, but not limited to, rapid, easy-to-use, and effective devices for removing various clot morphologies. [Means for solving the problem]

[0003]

[0021] A thrombus removal device is provided that includes an elongate shaft having a working end, at least one fluid lumen in the elongate shaft, and two or more openings disposed at or near the working end, the two or more openings being in fluid communication with the at least one fluid lumen, and configured to generate two or more fluid streams for mechanically fractionating a target thrombus.

[0004]

[0022] A clot removal system is provided that includes an elongate shaft, an aspiration lumen extending along the elongate shaft, a vacuum source fluidly coupled to the aspiration lumen, a blood clot filter disposed along the aspiration lumen, and a blood collection canister disposed along the aspiration lumen proximally from the blood clot filter, the blood collection canister including a movable separator that divides the blood collection canister into a first chamber and a second chamber, wherein operation of the vacuum source causes blood clots removed from a patient to be collected in the blood clot filter and blood removed from the patient to be collected in the first chamber.

[0005]

[0023] In some embodiments, operation of the vacuum source also causes saline to flow into the second chamber and into the vacuum canister.

[0024] In some embodiments, the filter has a pore size of up to 40 microns.

[0006]

[0025] In one aspect, the clot filter is configured to allow blood to pass through but not allow clots to pass through.

[0026] In some embodiments, the clot filter is positively charged.

[0007]

[0027] In one aspect, the separator comprises a plunger.

[0028] In some embodiments, the separator comprises a diaphragm.

[0029] In other embodiments, the system includes at least one saline source fluidly coupled to the second chamber.

[0008]

[0030] In some embodiments, the at least one saline source is removable from the blood collection canister.

[0031] In one embodiment, the system includes a blood return line fluidly coupled to the first chamber.

[0009]

[0032] In another embodiment, the thrombus filter comprises a honeycomb structure.

[0033] In some embodiments, the honeycomb structure includes a plurality of openings interspersed between closed sections.

[0010]

[0034] In some embodiments, the system includes an electrical system configured to apply a positive charge to the closed segment.

[0035] A thrombus removal system is provided that includes an elongate shaft, an aspiration lumen extending along the elongate shaft, a vacuum source fluidly coupled to the aspiration lumen, and a blood collection canister coupled to the aspiration lumen, the blood collection canister including a sieve channel having an opening sized and configured to allow blood to flow from the sieve channel into the blood collection canister while containing thrombus material within the sieve channel.

[0011]

[0036] In some embodiments, the sieve channels have a pore size of up to 40 microns.

[0037] In another embodiment, the sieve channels are positively charged.

[0038] In some embodiments, the system includes a blood return line fluidly coupled to the blood collection canister.

[0012]

[0039] In one embodiment, the sieve channels comprise a honeycomb structure.

[0040] In some embodiments, the honeycomb structure includes a plurality of openings interspersed between closed sections.

[0013]

[0041] In some embodiments, the system includes an electrical system configured to apply a positive charge to the closed segment.

[0042] In one embodiment, the sieve path is spiral.

[0014]

[0043] In other aspects, the sieve pathway forms a tortuous path through the blood collection canister.

[0044] A thrombus removal system is provided that includes an elongate shaft, an aspiration lumen extending proximally from the elongate shaft to a vacuum source, and a blood collection canister disposed between the aspiration lumen and the vacuum source, the blood collection canister including a positively charged transport belt configured to attract thrombus material from fluid within the blood collection canister and a scraper configured to remove thrombus material from the transport belt.

[0015]

[0045] In some embodiments, the scraper comprises a vacuum nozzle.

[0046] A method is provided that includes the steps of removing thrombus material and blood from a patient, applying a positive charge to a thrombus separation device, attracting the thrombus material to the thrombus separation device, and causing the blood to flow into a blood collection canister.

[0016]

[0047] In some embodiments, the clot separation device includes a clot filter.

[0048] In another aspect, the clot detachment device includes a conveyor belt.

[0049] In some embodiments, the clot detachment device includes a sieve channel.

[0017]

[0050] A thrombus removal system is provided that includes an elongate shaft, an aspiration lumen extending proximally in the elongate shaft to a vacuum source, a fluid lumen extending distally to the shaft from a pressurized fluid source, a thrombus detector operable to detect a thrombus between the aspiration lumen and the vacuum source, and a controller operable to adjust fluid flow through the fluid lumen and / or the aspiration lumen when a thrombus is detected by the thrombus detector.

[0018]

[0051] In some embodiments, the system includes a funnel disposed at or near the distal end of the elongate shaft.

[0052] A thrombus removal system is provided that includes an elongate shaft, an aspiration lumen extending proximally from a funnel portion of the elongate shaft to a vacuum source, a fluid lumen extending distally to the shaft from a pressurized fluid source, a thrombus filter disposed between the vacuum source and the aspiration lumen, and one or more blood collection bags disposed between the thrombus filter and the vacuum source.

[0019]

[0053] In some embodiments, the system includes a funnel disposed at or near the distal end of the elongate shaft.

[0054] A method is provided that includes the steps of initiating a thrombectomy procedure in a patient with a thrombectomy device, identifying a system state of the thrombectomy device, determining based on the system state whether fluid aspirated by the thrombectomy device should be returned to the patient or whether the fluid is waste, and directing the fluid into a selected receptacle.

[0020]

[0055] In some embodiments, the first system state is when suction of the thrombectomy device is activated and jet or fluid delivery of the thrombectomy device is stopped.

[0056] In another aspect, the method includes determining that fluid aspirated by the thrombectomy device should be returned to the patient in a first system state.

[0021]

[0057] In some embodiments, the second system state is when the suction of the thrombectomy device is activated and the jet or fluid delivery of the thrombectomy device is activated.

[0058] In one aspect, the method includes determining that fluid aspirated by the thrombus removal device is waste in a second system state.

[0022]

[0059] In some embodiments, directing the fluid into the selected receptacle includes automatically controlling one or more valves to direct the fluid into the selected receptacle.

[0023]

[0060] A thrombectomy method is provided that includes engaging a clot with a thrombectomy device, directing two or more fluid streams into the clot with the thrombectomy device to macerate the clot, and sorting the macerated portion of the clot into a clot collection canister of the thrombectomy device based on parameters of the macerated portion.

[0024]

[0061] In some embodiments, the parameter includes the size of the macerated portion.

[0062] In another aspect, the parameter includes the morphology of the macerated portion.

[0063] In some embodiments, the parameter includes hardness of the macerated portion.

[0025]

[0064] In some aspects, the method includes indicating the volume of the macerated portion to a user.

[0065] In one aspect, indicating to the user includes indicating the volume to the user with one or more measurement markers on the clot collection canister.

[0026]

[0066] In another embodiment, the macerated portions are sorted by differential momentum.

[0067] In some embodiments, sorting the macerated portion further comprises applying one or more electrical charges to an element within the clot collection canister to attract selected macerated portions.

[0027] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings. [Brief explanation of the drawings]

[0028] [Figure 1]

[0006] FIG. 1 illustrates a portion of a thrombus removal system including a distal portion of an elongate catheter configured in accordance with an embodiment of the present technology. [Figure 1A] 1 illustrates the portions of the thrombus removal system. [Figure 1B] 1 illustrates the portions of the thrombus removal system. [Figure 1C] 1 illustrates the portions of the thrombus removal system. [Figure 1D] 1 illustrates the portions of the thrombus removal system. [Figure 1E] 1 illustrates the portions of the thrombus removal system. [Figure 1F] 1 illustrates the portions of the thrombus removal system. [Figure 1G] 1 illustrates the portions of the thrombus removal system. [Figure 1H] 1 illustrates the portions of the thrombus removal system. [Figure 1I] 1 illustrates the portions of the thrombus removal system. [Figure 1J] 1 illustrates the portions of the thrombus removal system. [Figure 1K] 1 illustrates the portions of the thrombus removal system. [Figure 1L] 1 illustrates the portions of the thrombus removal system. [Figure 2A] FIG. 2A is a plan view illustrating an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Figure 2B] FIG. 2B is a plan view illustrating the above configuration. [Figure 2C] FIG. 2C is a plan view illustrating the above configuration. [Figure 2D] FIG. 2D is a plan view illustrating the above configuration. [Figure 2E] FIG. 2E is a plan view illustrating the above configuration. [Figure 3]

[0008] Figure 3A is an elevation view illustrating an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. Figure 3B is an elevation view illustrating the configuration. Figure 3C is an elevation view illustrating the configuration. Figure 3D is an elevation view illustrating the configuration. Figure 3E is an elevation view illustrating the configuration. Figure 3F is an elevation view illustrating the configuration. Figure 3G is an elevation view illustrating the configuration. Figure 3H is an elevation view illustrating the configuration. [Figure 4A]

[0009] FIG. 1 illustrates an embodiment of a thrombus removal system that includes a saline source, an aspiration system, and one or more controllers that control irrigation and / or aspiration of the system. [Figure 4B] FIG. 2 illustrates an embodiment of the system. [Figure 4C] FIG. 2 illustrates an embodiment of the system. [Figure 5]

[0010] FIG. 1 illustrates an embodiment of a thrombus removal system that reduces blood loss. [Figure 6]

[0011] FIG. 1 illustrates another embodiment of a thrombus removal system that reduces blood loss. [Figure 7A]

[0012] FIG. 1 illustrates a thrombus removal system including a thrombus filter and a blood collection bag. [Figure 7B]

[0013] FIG. 1 illustrates a thrombus removal system including a thrombus filter, a vacuum chamber, and a blood collection bag. [Figure 7C] 1 is a flowchart illustrating a method for determining whether aspirated fluid should be returned to the patient. [Figure 8A]

[0015] FIG. 1 illustrates a thrombus removal system including a thrombus filter and a blood collection canister. [Figure 8B] 1 illustrates a thrombus removal system including a thrombus filter and a blood collection canister. [Figure 8C] 1 illustrates a thrombus removal system including a thrombus filter and a blood collection canister. [Figure 8D]1 illustrates a thrombus removal system including a thrombus filter and a blood collection canister. [Figure 8E]

[0016] Figure 1 illustrates a variation of a filter or clot trap for separating clots from the blood after removal by a clot removal device. [Figure 8F] 10A-10C illustrate variations of filters or clot traps for separating clots from the blood after removal by the clot removal device. [Figure 8G] 10A-10C illustrate variations of filters or clot traps for separating clots from the blood after removal by the clot removal device. [Figure 9A]

[0017] FIG. 1 illustrates a thrombus removal system including a thrombus filter and a blood collection canister. [Figure 9B] 1 illustrates a thrombus removal system including a thrombus filter and a blood collection canister. [Figure 9C] 1 illustrates a thrombus removal system including a thrombus filter and a blood collection canister. [Figure 9D] 1 illustrates a thrombus removal system including a thrombus filter and a blood collection canister. [Figure 10]

[0018] Figure 10A illustrates another embodiment of a blood collection canister. Figure 10B illustrates another embodiment of a blood collection canister. Figure 10C illustrates another embodiment of a blood collection canister. Figure 10D illustrates another embodiment of a blood collection canister. [Figure 11A]

[0019] Figure 1 illustrates a structure that can be used in a blood clot filter or blood collection canister. [Figure 11B] 10A-10C illustrate structures that can be used in a clot filter or blood collection canister. [Figure 11C] 10A-10C illustrate structures that can be used in a clot filter or blood collection canister. [Figure 12A]FIG. 10 illustrates another embodiment of a blood collection canister. [Figure 12B] FIG. 10 shows another embodiment of the blood collection canister. [Figure 12C] FIG. 10 shows another embodiment of the blood collection canister. DETAILED DESCRIPTION OF THE INVENTION

[0029]

[0068] This application is related to the disclosures in International Application No. PCT / US2021 / 020915, filed March 4, 2021 (the '915 application), and International Application No. PCT / US2022 / 033024, filed June 10, 2022 (the '024 application), the disclosures of which are incorporated herein by reference for all purposes. The '915 and '024 applications describe general mechanisms for capturing and removing blood clots. For example, multiple fluid streams are directed toward the clot to fragment the material.

[0030]

[0069] The present technology is generally directed to thrombus removal systems and associated methods. Systems configured in accordance with embodiments of the present technology can include, for example, an elongate catheter having a distal portion configured to be positioned within a patient's blood vessel, a proximal portion configured to be external to the patient, a fluid delivery mechanism configured to fragment the thrombus with pressurized fluid, a suction mechanism configured to aspirate the thrombus fragments, and one or more lumens extending at least partially from the proximal portion to the distal portion.

[0031]

[0070] An object of the present disclosure is to provide thrombectomy systems and methods configured to separate clots from aspirated blood, including systems and methods for presentation / measurement of removed clots. In some implementations, the clot removed from the patient can be separated and visually presented to a user of the system, for example, in a clot catcher, filter, or waste container of the system. In other examples, the clot can be presented on a screen (e.g., a photograph, video, or digital representation of the clot).

[0032]

[0071] Another object of the present disclosure is to prepare blood for reuse and / or redelivery to the patient. This may include separating the removed blood from clots (i.e., filtering) and automatically or manually infusing or delivering the blood back to the patient. Blood return may include systems and techniques that minimize contact with air or replace air with CO2, He, or other gases.

[0033]

[0072] The systems and methods provided herein may include various techniques for separating clots from blood, which may include size exclusion / trapping (e.g., with traditional filters such as membranes), depth filtration (e.g., narrow pores or tortuous paths that can further exploit the viscosity of blood against clots), size separation such as delta flow, flow in a velocity field gradient (e.g., using cyclone filters, inertial particle motion, or Couette flow rotating plates or filters), or affinity (e.g., charge, antibody, or collision).

[0034]

[0073] The terms used in the description provided below are intended to be interpreted in the broadest reasonable manner, even when used in conjunction with detailed descriptions of certain specific embodiments of the present technology. Although certain terms may be emphasized below, any terms intended to be interpreted in some restrictive manner are clearly and specifically defined in the Detailed Description section of this invention. In addition, the present technology can include other embodiments that are within the scope of the examples but are not described in detail in connection with the figures.

[0035]

[0074] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the technology. Thus, the appearances of the phrase "in one embodiment" or "in an embodiment" in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0036]

[0075] Throughout this specification, references to relative terms such as, for example, "substantially," "approximately," and "about" are used herein to mean plus or minus 10% of the stated value.

[0037]

[0076] Although some embodiments herein are described in the context of thrombus removal, it is recognized that the technology can be used and / or modified to remove other types of emboli that may occlude blood vessels, such as fat, tissue, or foreign bodies. Additionally, while some embodiments herein are described in the context of thrombus removal from the pulmonary artery (e.g., pulmonary embolectomy), the technology may be applied to the removal of thrombi and / or emboli from other portions of the vasculature (e.g., neurovascular, coronary, or peripheral applications). Also, while some embodiments are discussed in the context of macerating a thrombus with a fluid, the technology can be adapted for use with other techniques (e.g., ultrasound, mechanical, enzymatic, etc.) for fragmenting a thrombus into small fragments or particles.

[0038]

[0077] The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed technology. System for thrombus removal

[0078] As presented above, the present technology is generally directed to thrombus removal systems. Such systems include an elongated catheter having a distal portion positionable within a patient's blood vessel (e.g., an artery or vein), a proximal portion positionable outside the patient's body, a fluid delivery mechanism configured to impart structure and / or consistency to the clot (e.g., fragment the clot with pressurized fluid) so that the clot is more easily transported through an aspiration system, an aspiration mechanism configured to aspirate the clot fragments, and one or more lumens extending at least partially from the proximal portion to the distal portion. In some embodiments, the systems herein are configured to engage a thrombus within a patient's blood vessel, fragment the thrombus into small fragments, and aspirate the fragments out of the patient's body. The pressurized fluid stream (e.g., a jet) functions to cut or macerate the thrombus before, during, and / or after at least a portion of the thrombus enters the aspiration lumen or funnel of the system. Fragmentation helps prevent clogging of the aspiration lumen and allows the thrombus removal system to macerate large, hard clots that could not otherwise be aspirated. As used herein, "thrombus" and "embolism" are used somewhat interchangeably in various respects. It should be recognized that while descriptions may refer to the removal of a "thrombus," this should be understood to encompass the removal of thrombus fragments and other emboli as provided herein.

[0039]

[0079] According to embodiments of the present technology, a fluid delivery mechanism can supply multiple fluid streams (e.g., jets) to the fluid opening of the thrombus removal system to macerate, cut, fragment, pulverize, and / or urge the thrombus for removal from the proximal portion of the thrombus removal system. The thrombus removal system can include an aspiration lumen that extends at least partially from the proximal portion to the distal portion of the thrombus removal system and is adapted for fluid communication with an aspiration pump (e.g., a vacuum source). In operation, in addition to or instead of high-pressure fluid, the aspiration pump can provide low-pressure fluid within the aspiration lumen near the proximal portion of the thrombus removal system to urge aspiration of the thrombus from the distal portion.

[0040]

[0080] FIG. 1 illustrates a distal portion 10 of a thrombus removal system in accordance with an embodiment of the present technology. Section AA of FIG. 1A illustrates an elevational cross-sectional view of the distal portion. The exemplary section AA of FIG. 1A depicts a funnel 20 positioned at the distal end of the distal portion 10, adapted to engage thrombus within the wall of a blood vessel and / or tissue (e.g., a duct) to aid in fragmenting and / or removing the thrombus. The funnel can have a variety of shapes and configurations, as one of ordinary skill in the art would understand from the description herein. The thrombus removal system can be delivered to a thrombus site within a blood vessel through a sheath with the funnel 20 in a compressed configuration. The funnel 20 may self-expand when advanced out of the sheath and / or when the sheath is retracted from the funnel.

[0041]

[0081] 1A depicts a dual-walled thrombectomy device construction including a catheter 22 extending proximally from an infundibulum 20 having an outer wall / tube 40 and an inner wall / tube 50. A centrally located aspiration lumen 55 is formed by the inner wall 50. The aspiration lumen 55 is in communication with a vacuum source, as described below. A substantially annular volume forms at least one fluid lumen 45 between the outer wall 40 and the inner wall 50. The fluid lumen 45 is adapted for fluid communication with a fluid delivery mechanism, as described below. One or more openings (e.g., nozzles, orifices, or ports) 30 are positioned in the thrombectomy system at the base of the infundibulum 20 or within the infundibulum to fluidly communicate with the fluid lumen 45 and the irrigation manifold 25. In operation, port 30 is adapted to direct (e.g., pressurized) fluid toward thrombus material engaging distal portion 10 of the thrombus removal system to macerate, fragment, or cut the thrombus material. Aspiration lumen 55 draws the thrombus material proximally along with fluid from port 30 and blood from the blood vessel to a receiver outside the patient, as described below.

[0042]

[0082] In various embodiments, the system can have an average flow velocity within the fluid lumen of up to 20 m / s to achieve consistent and successful aspiration of the clot. In some embodiments, the fluid source itself can deliver fluid to the jet in a preprogrammed sequence, including a pulsed sequence or some combination of pulsatile and constant flow. In these embodiments, the average pulsed fluid velocity can be up to 20 m / s, but the peak fluid velocity within the lumen can be up to 30 m / s or greater during the pulsation of the fluid source. In some embodiments, the jet or opening is 0.025 cm (0.0100 inches) or larger, or as small as 0.020 cm (0.008 inches), to avoid undesirable spraying of fluid. In some embodiments, the system can have a minimum aspiration absolute pressure of 1 or 2 inHg to remove the target clot after it has been macerated or comminuted by the jet.

[0043]

[0083] The thrombus removal system can be sized and configured to access and remove thrombi in various locations or vessels within a patient's body. While the dimensions of the system may vary depending on the target location, it should be understood that generally similar features and components described herein may be implemented in the thrombus removal system regardless of the application. For example, a thrombus removal system configured to remove a pulmonary embolism (PE) from a patient may have an outer wall / tube measuring approximately 3.7-4.3 mm (11-13 Fr), or preferably 4.0 mm (12 Fr), and an inner wall / tube measuring 2.3-3.0 mm (7-9 Fr), or preferably 2.7 mm (8 Fr). Meanwhile, deep vein thrombosis (DVT) devices may have an outer wall / tube size of approximately 3.0-3.7 mm (9-11 Fr), or preferably 3.3 mm (10 Fr), and an inner wall / tube size of 2.0-3.0 mm (6-9 Fr), or preferably 2.5 mm (7.5 Fr). Further applications are provided for ischemic stroke and peripheral embolism.

[0044]

[0084] Section BB in FIG. 1B illustrates a portion of the thrombus removal system in a plan view proximal to the funnel and irrigation manifold. Section BB depicts outer wall 140, inner wall 150, aspiration lumen 155, and fluid lumen 145. In some embodiments, in cross-section, aspiration lumen 155 is substantially circular and fluid lumen 145 is substantially toroidal (e.g., cross-section 70). It will be appreciated that alternative constructions and / or arrangements of inner wall 150 and outer wall 140 will produce variations in the cross-sectional shapes of aspiration lumen 155 and fluid lumen 145. For example, inner wall 150 can be shaped to form aspiration lumen 155 that is substantially elliptical, circular, linear, rectangular, pentagonal, or hexagonal in cross-section. Inner wall 150 and outer wall 140 can be shaped and arranged to form fluid lumen 145 that is generally crescent-shaped, diamond-shaped, or irregular in cross-section. For example, referring to cross section BB in Figure 1C, the region between inner wall 150 and outer wall 140 can include one or more wall structures 165 (e.g., as in cross section 80) that form respective fluid lumens 145. Wall structures 165 can be formed by lamination between outer wall 140 and inner wall 150 or by extrusion of multiple lumens that form multiple wall structures.

[0045]

[0085] Cross sections BB in Figures 1D-1H show additional examples of portions of the thrombus removal system proximal to the funnel and irrigation manifold. Similar to the embodiments described above, the portions in these examples can include an outer wall 140, an inner wall 150, and an aspiration lumen 155. Additionally, the illustrated portion of the thrombus removal system can include an intermediate wall 170 disposed between the outer wall 140 and the inner wall 150. The intermediate wall 170 allows for the annular space between the inner and outer walls to be further divided into multiple distinct fluid lumens and / or auxiliary lumens. For example, referring to Figure 1D, the intermediate wall can be substantially hexagonal in shape, and the annular space can include multiple fluid lumens 145a-141 and multiple auxiliary lumens 175a-175f. As shown in Figure 1D, a fluid lumen can be formed by any combination of the outer wall 140 and the intermediate wall 170, or between the intermediate wall 170, the inner wall 150, and two auxiliary lumens. For example, fluid lumen 145a is formed in the space between outer wall 140 and intermediate wall 170. However, fluid lumen 145g is formed in the space between intermediate wall 170, inner wall 150, and auxiliary lumens 175a and 175b. Generally, the fluid lumens are configured to carry a flow of fluid, such as saline, from a saline source in the system to one or more ports / openings / orifices in the system. The auxiliary lumens can be configured for multiple functions. In some embodiments, the auxiliary lumens can be coupled to a fluid / saline source and an opening used as an additional fluid lumen. In other embodiments, the auxiliary lumens can be configured as steering ports and can contain guidewires or steering wires within the lumens for steering the thrombus removal system. Additionally, in other embodiments, the auxiliary lumens can be configured to carry electrical, mechanical, or fluidic connections to one or more sensors. For example, the system can include one or more electrical, optical, or fluid-based sensors disposed along any length of the system. The sensors can be used to provide feedback to the system during therapy (e.g., sensors can be used to detect clogs and initiate clog removal protocols, or determine the appropriate therapy mode based on sensor feedback such as the order of injection pulses, the order of suction, etc.).Thus, the auxiliary port can be used to connect to a sensor, for example, by an electrical connection, an optical connection, a mechanical / wire connection, and / or a fluid connection. It is also envisioned that the fluid and auxiliary lumens can be configured to carry and deliver other fluids, such as thrombolytic drugs or radiopaque contrast injections, to a target tissue site during treatment.

[0046]

[0086] It should be understood that in some embodiments, all fluid lumens are fluidly connected to all of the jets or openings of the clot removal device. Thus, when a fluid flow is delivered from one or more fluid lumens to the jets, all of the jets are activated at once with a fluid jet. However, it should also be understood that in some embodiments, the fluid lumens are separate or different, and these different fluid lumens may be fluidly coupled to one or more jets, but not all of the jets on the device. In these embodiments, a subset of the jets can be controlled by delivering fluid only to the fluid lumens that are coupled to that subset of jets. This allows for additional functionality of the device, where designated jets can be activated in a user-defined or predetermined sequence.

[0047]

[0087] In various embodiments, fluid pressure is generated by a pump (either in the console or handle). The fluid is accelerated as it exits a port at the distal end and is directed toward the target clot. In this manner, a wider variety of cost-effective components can be used to form the catheter while still maintaining a highly effective device for clot removal, as described in more detail below.

[0048]

[0088] Section BB of FIG. 1E illustrates another embodiment of the portion of the thrombus removal system proximal to the funnel and irrigation manifold. Like the embodiment of FIG. 1D, this embodiment also includes an intermediate wall 170. However, the intermediate wall in this example is substantially rectangular, facilitating the formation of fluid lumens 145a-145k and auxiliary lumens 175a-175d. The example shown in section BB of FIG. 1F is similar to the example embodiment of FIG. 1E, but this embodiment includes only fluid lumens 145a-145d. Fluid lumens 145e-145k from the embodiment of FIG. 1E are not used as fluid lumens in this embodiment. They can be, for example, empty, evacuated, filled with insulating material, and / or filled with radiopaque material or any other material that may be useful for visualizing the thrombus removal system during therapy. Embodiment 1F includes the same four auxiliary ports as illustrated and described in the embodiment of FIG. 1E.

[0049]

[0089] Section BB of FIG. 1G shows another example of a portion of the thrombus removal system proximal to the funnel and irrigation manifold. Similar to the previously described embodiment, the illustrated portion of the thrombus removal system can include an intermediate wall 170 disposed between the outer wall 140 and the inner wall 150. However, this embodiment includes four distinct fluid lumens 145a-145d formed by a wall structure 165. Similar to the embodiment of FIG. 1C, the wall structure 165 can be formed by lamination between the outer wall 140 and the inner wall 150 or by extrusion of multiple lumens to form multiple wall structures. As shown, this embodiment can include a pair of auxiliary lumens 175a and 175b, which can be used, for example, for steering or sensor connection as described above.

[0050]

[0090] Cross section BB of FIG. 1H is another similar embodiment in which an intermediate wall and an outer wall can be used to form fluid lumens 145a and 145b. Auxiliary lumens 175a and 175b can be formed in the space between the intermediate wall and the inner wall. It should be understood that the intermediate wall can contact the outer wall to create independent fluid lumens 145a and 145b. However, it should be understood that in other embodiments, the intermediate wall may not contact the outer wall, which would facilitate a single annular fluid lumen, as shown by fluid lumen 145 in cross section BB of FIG. 1I. In another embodiment, as shown in cross section BB of FIG. 1J, inner wall 150 and outer wall 140 may not be concentric, which facilitates the formation of a thicker or wider annular space and / or fluid lumen 145 on one side of the device relative to the other. As shown in FIG. 1J, the distance between the exemplary outer wall 140 and the inner wall at the top (e.g., 12 o'clock) portion of the device is greater than the distance between the outer wall and the inner wall at the bottom (e.g., 6 o'clock) portion of the device.

[0051]

[0091] 1K illustrates in plan view a portion of the thrombus removal system including the irrigation manifold 225. View CC depicts the outer wall 240, the inner wall 250, the fluid lumen 245, the aspiration lumen 255, and the ports 230 for directing the respective fluid flows 210.

[0052]

[0092] Detail 101 of FIG. 1L illustrates an elevational cross-sectional view of a portion of irrigation manifold 25 at the base of the infundibulum, including multiple ports 230 formed in inner wall 250. In some embodiments, the thickness of one or more walls of the thrombus removal system may vary along its axial length and / or its circumference. As shown in detail 101, inner wall 250 has a first thickness 265 in region 250 proximal to irrigation manifold 25 and a second thickness 270 in region 235 including ports 230. In some embodiments, second thickness 270 is greater than first thickness 265. First thickness 265 can correspond to the overall wall thickness of inner wall 50 and / or outer wall 40, which can be between about 0.10 mm and about 0.60 mm, or any value within the aforementioned range. The second thickness 270 can be about 0.20 mm to about 0.70 mm, about 0.70 mm to about 0.90 mm, or about 0.90 mm to about 1.20 mm. The second thickness 270 can be any value within the aforementioned ranges. The dimensions of the second thickness 270 can be selected to provide a fluid path through the port 230 that generates a substantially laminar flow for the fluid flow directed therethrough when the fluid delivery mechanism delivers fluid through the fluid lumen 245 at typical operating pressures. Such operating pressures can be about 10 psi to about 60 psi (about 68.95 kPa to about 413.7 kPa), about 60 psi to about 100 psi (about 413.7 kPa to about 689.5 kPa), or about 100 psi to about 150 psi (about 689.5 kPa to about 1034.25 kPa). The operating pressure of the fluid delivery mechanism can be any value within the aforementioned ranges. In some embodiments, the fluid delivery mechanism operates in a high pressure mode having a pressure of about 150 psi to about 250 psi, about 250 psi to about 350 psi, about 350 psi to about 425 psi, or about 425 psi to about 500 psi. The operating pressure of the fluid delivery mechanism in the high pressure mode can be any value within the aforementioned ranges.

[0053]

[0093] The manifold is configured to increase the fluid pressure and / or flow rate of the fluid. When fluid is supplied to the fluid lumen(s) by the fluid delivery mechanism at a first pressure and / or a first flow rate, the manifold is configured to increase the pressure of the fluid to a second pressure and / or increase the flow rate of the fluid to a second flow rate. The second pressure and / or second flow rate can be higher than the first pressure and / or first flow rate. As a result, the manifold can be configured to increase a relatively low operating pressure and / or flow rate generated by the fluid delivery mechanism to a relatively high pressure and / or high flow rate generated by the ports / fluid flow.

[0054]

[0094] In some embodiments, the profile (cross-sectional dimension) of port 230 varies along its length (e.g., is non-cylindrical). Varying the cross-sectional dimension of the port can alter and / or adjust the characteristics of fluid flow along port 230. For example, a reduction in the cross-sectional dimension can accelerate fluid flow through port 230 (for a given volume of fluid). In some embodiments, port 230 can be conical (e.g., tapered) along its length so that its smallest dimension is located at the distal end of port 230, where distal is relative to the direction of fluid flow.

[0055]

[0095] In some embodiments, the ports 230 are configured to direct the fluid flow along a selected path. Figures 2A-2E illustrate various embodiments of arrangements of ports 230 for directing the respective fluid streams 210. In some embodiments, such as those shown in Figures 2A and 2B, at least two ports 230 are arranged to generate (e.g., respective) fluid streams 210 that intersect at an intersection region 237 of the clot removal system. The intersection region 237 can be a region of increased fluid momentum and / or energy transfer relative to individual fluid streams that are not directed to combine at the intersection. Increased fluid momentum and / or energy transfer at the intersection can advantageously fragment the clot more efficiently and / or quickly. As described above, in some embodiments, the fluid streams can be configured to accelerate, induce cavitation and / or other effects to further promote fragmentation of the targeted clot. In some embodiments, an intersection region can be formed from at least two, at least three, at least four, at least five, at least six, at least seven, at least eight, at least nine, or at least ten fluid streams 210. The intersection region can be substantially near (e.g., 237) or away from (e.g., 238 and 239 in the embodiment of FIG. 2D) the central axis 290 of the thrombus removal system. In some embodiments, at least two intersection regions (e.g., 238 and 239) are formed. In some embodiments, one or more ports 230 are positioned to direct the fluid streams 210 along an oblique angle relative to the central axis of the thrombus removal system. The operating pressure of the fluid delivery mechanism can be selected to approach a minimum target fluid velocity for the fluid streams 210 delivered from the ports 230. The target fluid velocity for the fluid streams 210 can be about 5 meters / second (m / s), about 8 m / s, about 10 m / s, about 12 m / s, or about 15 m / s. Additionally, the target fluid velocity in some embodiments can range from greater than 15 m / s up to 150 m / s. At these higher velocities (e.g., greater than about 15 m / s, or greater than 20 m / s), the fluid stream may be configured to generate cavitation in the targeted thrombus or tissue.It has been found that when fluid exits the ports at these flow rates, it can produce a cavitation effect at the focal area of ​​the intersecting or impinging fluid streams, or at the boundary of one or more of the fluid streams. While the exact specifications may vary based on the size of the catheter, in general, at least one of the fluid streams should be accelerated to such a high velocity to produce cavitation, as described in detail below. The target fluid velocity of fluid stream 210 can be any value within the range of values ​​described above. In some embodiments, at least two ports 230 are adapted to deliver respective fluid streams at different fluid velocities (i.e., speed and direction) for a given pressure of the fluid delivery mechanism. In some embodiments, at least two ports 230 are adapted to deliver respective fluid streams at substantially the same fluid velocity for a given pressure of the fluid delivery mechanism. In some embodiments, one port is adapted to deliver fluid at a high velocity, and each of one or more other ports is adapted to deliver fluid at a relatively low velocity. Advantageously, the increased cross-sectional area of ​​the fluid lumen 145 reduces the required operating pressure of the fluid delivery mechanism to achieve a target fluid velocity of the fluid flow.

[0056]

[0096] In some embodiments, the fluid stream is configured to create angular momentum that is imparted to the thrombus. In some instances, angular momentum is imparted to the thrombus by the application of a) at least one fluid stream 210 directed at an oblique angle from the port 230 and / or b) at least two fluid streams 210 having different fluid velocities. For example, fluid streams that pass close to, but do not necessarily intersect with, each other can create "swirl" or rotational energy in the clot material. Advantageously, the angular momentum created in the thrombus can impart forces (e.g., centrifugal force) that aid in the fragmentation and removal of the clot. Rotating the clot can facilitate delivery of clot material to the jet. For example, in a large, irregular clot, soft material may be easily sucked or fragmented by the fluid stream, while hard material may be located away from the fluid stream. Rotating or swirling the clot moves material around, sending the harder clot material toward the jet. Swirling can also slam the clot against the inside of the funnel, further fragmenting it.

[0057]

[0097] 3A-3H depict various configurations of fluid streams 410 directed from each port 430. The fluid streams 410 can be directed along paths that are substantially perpendicular, proximal, and / or distal to the flow axis 405 (similar to flow axis 305). In some embodiments, at least two fluid streams are directed in different directions relative to the flow axis 405. In some embodiments, at least two fluid streams are directed in the same direction (e.g., proximal) relative to the flow axis 405. In some embodiments, at least a first fluid stream is directed orthogonally, at least a second fluid stream is directed proximally, and at least a third fluid stream is directed distally relative to the flow axis 405. Angle α may characterize the angle at which the fluid streams 410 are directed relative to an axis perpendicular to the flow axis 405 (e.g., as shown in cross sections DD of FIGS. 3G and 3H ). The fluid flow intersection region can be within an interior portion of the thrombus removal system and / or external (e.g., distal) to the thrombus removal system. In some embodiments, the fluid flow, directed in a nominal direction (e.g., distal) by port 430, is deflected along an altered path (e.g., proximally) by the (e.g., suction) pressure generated by the suction mechanism during operation.

[0058]

[0098] 4A-4C illustrate various configurations of a clot removal system 400, including a clot removal device 402, a vacuum source and canister 404, a fluid source 406, and a pump 407. In some embodiments, the vacuum source and canister and fluid source are housed in a console unit that is detachably connected to the clot removal device. A fluid pump can be housed in the console or in the device's handle. The console can include one or more CPUs, electronic controllers, or microcontrollers configured to control all functions of the system. The clot removal device 402 can include a funnel 408, a flexible shaft 410, a handle 412, and one or more controllers 414 and 416. For example, in the embodiment shown in FIG. 4A, the device can include a finger switch or trigger 414 and a foot pedal or switch 416, which can be used to control aspiration and irrigation, respectively. Alternatively, as shown in the embodiment of FIG. 4B, the device can include only a foot switch 416 that can be used to control both functions, or in FIG. 4C, the device can include only a foot platform 416 that can also be used to control both functions. It is also envisioned that embodiments can include only a finger switch for controlling both the aspiration and irrigation functions. As shown in FIG. 4A, a vacuum source and canister 404 can be coupled to the aspiration lumen of the device with a vacuum line 418. Any clots or other debris removed from the patient during treatment can be received by and stored in the vacuum canister 404 for later disposal. Similarly, a fluid source 406 (e.g., a saline bag) can be coupled to the fluid lumen of the device with a fluid line 420 for delivering a high-pressure, high-velocity fluid stream or jet at the base of the funnel 408 to fragment thrombus material engaged by the funnel 408, as described above.

[0059]

[0099] 4A, electronics lines 422 can couple any electronics / sensors, etc. from the device to the system console / controller. The system console, including the CPUs / electronic controllers, can be configured to monitor fluid and pressure levels and adjust automatically or in real time as needed. In some embodiments, the CPUs / electronic controllers are configured to control vacuum and irrigation, as well as electromechanically stop and start both systems in response to sensor data such as pressure data, flow data, etc.

[0060]

[0100] 1A and 4A-4C, prior to introducing the thrombectomy device into a patient's blood vessel, the system is primed to remove air by pumping fluid through fluid lumen 45, manifold 25, port 30, aspiration lumen 55, and vacuum line 418. During the thrombectomy procedure, the thrombectomy device is advanced into the patient's blood vessel, and the infundibulum is expanded to engage the thrombus. Pressurized fluid is delivered from fluid source 406 and pump 407 through fluid line 420 and fluid lumen 45 to manifold 25 and port 30. Simultaneously, a vacuum is applied to aspiration lumen 55 by vacuum source and canister 404. Once the clot is engaged, material flowing proximally through aspiration lumen 55 to the vacuum source and canister is primarily fluid combined with any blood delivered via port 30 that may bypass the engaged thrombus. As the fluid jet begins to fragment the clot, the clot material, along with the injected fluid and any blood that may have entered the infundibulum around the clot, is drawn proximally through the aspiration lumen 55. After the clot has been sufficiently fragmented and released from the vessel, the remaining clot material moves proximally toward the vacuum source and canister 404.

[0061]

[0101] In some embodiments, the controller can reduce the strength of the vacuum applied to the aspiration lumen after a clot is detected at the vacuum line so that blood loss is minimized.

[0102] As mentioned above, suction occurs down the central lumen of the device and is provided by a vacuum pump within the console, which may include a container to collect any blood clots or debris that is removed from the patient.

[0062]

[0103] Once the clot has been fragmented and removed, blood flow within the vessel is restored and further application of vacuum will aspirate the patient's blood along with the fluid provided through port 30. After removing the clot, it may be desirable to determine or visualize the volume of the clot that was removed and / or to capture and return blood to the patient in a manner that minimizes loss without returning any part of the clot.

[0063]

[0104] A sensor may be used to detect the movement of a thrombus into canister 404 so that aspiration of the patient's blood can be minimized. For example, a camera may be used to detect the passage of a thrombus through aspiration lumen 55 (e.g., as aspiration lumen 55 passes through catheter handle 412), through vacuum line 418, or at the vacuum source and canister 404. Alternatively, a pressure sensor in communication with aspiration lumen 55 and / or vacuum line 418 may detect the removal of a thrombus, as pressure in aspiration lumen 55 and vacuum line 418 increases as the thrombus dislodges and is drawn proximally. Additional details regarding the use of sensor sensing to detect the removal of a thrombus can be found in International Patent Application No. PCT / US2022 / 033024, filed June 10, 2022, which is incorporated herein by reference.

[0064]

[0105] The pressure sensor may be disposed, for example, in the handle of the catheter (so as to communicate with the portion of the aspiration lumen just distal to catheter 20) or in the canister of the vacuum source. The system may then reduce or stop the fluid supplied to port 30 of funnel 408 and the suction back into aspiration lumen 55 through funnel 408 to reduce the aspiration of blood, for example, by stopping the vacuum source and canister 404 and pump 407.

[0065]

[0106] The system may detect the dislodged thrombus before it reaches the vacuum canister 404. Suction must still be applied to move the thrombus proximally the remaining distance to the vacuum canister (as shown), while any suction applied to the infundibulum in the vessel continues to draw in the patient's blood.

[0066]

[0107] Alternatively, as shown in FIG. 5, when a clot 500 is detected at vacuum line 518, additional fluid from a fluid source and pump (not shown, but which could be, for example, fluid source 406 in FIG. 4A ) may be supplied via Y-junction 502 to catheter 520 distal to vacuum line 518. Some of the additional fluid is drawn proximally into vacuum line 518 (as indicated by arrow 504) to help move the clot further proximally into vacuum canister 524. Any additional fluid added in this manner reduces the amount of blood aspirated from the patient. An additional fluid flow rate equal to the aspiration flow rate stops the removal of the patient's blood. If the additional fluid flow rate is greater than the aspiration rate, some of the additional fluid flows distally (as indicated by arrow 506) through the aspiration lumen of catheter 520, returning any blood in the aspiration lumen to the patient. Additionally or alternatively, additional fluid from the fluid source and pump may be added through port 510 to the distal portion of vacuum line 518 (as indicated by arrow 508) to help move the clot further proximally within the vacuum line while simultaneously reducing the amount of fluid (e.g., the patient's blood) drawn proximally through the aspiration lumen. The funnel at the distal end of catheter 520 may be re-sheathed after a clot is detected at aspiration line 518 to reduce proximal blood flow to catheter 520.

[0067]

[0108] FIG. 6 is an alternative embodiment of the system of FIG. 5, showing an optional valve 612 (e.g., a flap valve) in the Y-junction 602 that may be operated to control the ratio of fluid flowing distally into the catheter 620 to the amount of fluid flowing proximally into the vacuum line 618.

[0068]

[0109] Once the clot has been fragmented and removed, blood flow within the vessel is restored and further application of vacuum will draw the patient's blood along with the fluid delivered through port 30. After removing the clot, it may be desirable to capture and return the blood to the patient to minimize loss without returning any part of the clot.

[0069]

[0110] 7A shows features that allow for separation of thrombus material from the removed blood and capture of the filtered blood for return to the patient. The proximal flow of suction fluid in vacuum line 718 passes through thrombus filter 720, which removes thrombus material 722 from the flowing fluid (i.e., thrombus, blood, and suction fluid from the fluid jet). Once filter 720 becomes loaded with thrombus material, it may be removed and replaced, for example, using coupling 726.

[0070]

[0111] After leaving the filter 720, the filtered fluid (e.g., blood) returns to the vacuum line 718 and flows proximally into one or more sterile, folded collection bags 724 arranged in series along the line 718. Dividers within the bags 724 or their connections 728 can direct the flowing fluid into and out of the bags. As each bag 724 fills, the filtered fluid begins to fill the next bag. The collection bags 724 may be removed via the connections 728 so that the collected blood can be returned to the patient.

[0071]

[0112] In some embodiments, coupling 728 may include a controllable valve (e.g., an electronically actuated valve) to selectively control which of the collection bags open to receive fluid flowing from the vacuum line. Valve control can be based, for example, on the system state of the thrombectomy device (e.g., suction on / off and / or jet on / off, or any combination thereof). For example, during an operating period when only suction is activated and jet is deactivated, only filtered blood passes through filter 720 into the selected collection bag. However, when both suction and jet are activated, the fluid flowing into the controlled bag includes a combination of jet fluid (e.g., saline) and filtered blood. It may be desirable to avoid returning blood that may have been dissolved by the jet / saline back to the patient.

[0072]

[0113] In some embodiments, control of the valve in the coupling 728 can be performed according to a system state. The system state can be associated with the type of fluid being aspirated and whether the fluid should be returned to the patient. In one implementation, the clot removal device can include two different system states for blood collection / return purposes: 1) aspiration on, injection / fluid delivery off, and 2) aspiration on, injection / fluid delivery on. In the first system state, injection / fluid delivery is stopped, so any fluid collected in the aspiration lumen of the device can be assumed to contain either blood or blood from which clots have been removed / macerated. Once the clots have been filtered from the fluid, the fluid entering the collection bag 724 can be assumed to be filtered blood suitable for return to the patient. By controlling the valves or couplings 728 of one or more collection bags 724 to open, this filtered blood can be collected for possible return to the patient. In the second system state described above, the fluid passing through the filter can be assumed to be a combination of blood and injection / irrigation fluid, such as saline, with clots filtered out by the filter 720. In some circumstances, a physician or system may determine that it is acceptable to return the filtered blood / saline to the patient. In other circumstances, a physician or system may determine that returning the blood / saline to the patient poses too great a risk of lysing the blood. In some aspects, valves or connections on one or more collection bags may be controlled to separate this blood / saline into collection bags marked or tagged as containing a combination of blood and saline. In yet additional embodiments, one or more of the collection bags may be identified as a “blood return” bag and one or more of the collection bags may be identified as a “waste” bag. The connections / valves may be automatically controlled based on the system states described above. If only suction is activated and injection is stopped, the valve associated with the “blood return” bag may be opened and the valve associated with the “waste” bag may be closed. Similarly, if both suction and injection are activated, the valve associated with the “blood return” bag may be opened and the valve associated with the “waste” bag may be closed.

[0073]

[0114] 7C is a flowchart illustrating the above-described method. In step 701 of the flowchart, the method may include identifying a system state of the thrombectomy device. As described above, key operating parameters are used to determine the system state: whether suction is activated or deactivated, and whether jetting / fluid delivery is activated or deactivated. In one implementation, two system states are possible: 1) suction on, jetting / fluid delivery off, and 2) suction on, jetting / fluid delivery on.

[0074]

[0115] In step 703 of the flowchart, the method may include determining whether the fluid aspirated by the clot removal device can be returned to the patient or whether the fluid aspirated by the clot removal device is waste. This determination may be based on the system state identified from step 701. For example, in some implementations, it is safe to return the aspirated fluid to the patient when suction is on and jetting is off. In some embodiments, aspirated fluid is safe to return when suction is on and jetting is on. However, in other embodiments, it is not safe to return the aspirated fluid when suction is on and jetting is on due to the risk of jetting / fluid delivery lysing the blood. In some embodiments, a user or physician can determine whether each system state is associated with fluid that is safe to return or fluid that is waste.

[0075]

[0116] In step 705, the method may further include directing (i.e., directing) the aspirated fluid to an appropriate receptacle of the clot removal device. This can be based on whether the fluid is safe to return or is waste. In some embodiments, if it is safe to return the fluid, the fluid can be directed to a blood return container or receptacle (e.g., by controlling one or more valves) to divert the aspirated fluid into a blood return receptacle. In some embodiments, if the fluid is waste, the fluid can be directed to a waste container or receptacle (e.g., by controlling one or more valves) to divert the aspirated fluid into a waste receptacle. In some embodiments, this valve control can be controlled automatically. In some aspects, the timing of controlling the valves can affect the volume of fluid contained between the distal tip of the clot removal device and the appropriate receptacle. For example, after aspirating with the jet turned off, if the jet is suddenly activated, the aspiration lumen may fill with returnable blood. The timing of the valves can be gated or synchronized to direct this returnable blood into the appropriate container before switching the valves to direct the blood / saline combination to, for example, a waste container.

[0076]

[0117] 7B, another embodiment similar to that of FIG. 7A is provided, except that in this embodiment, the collection bag 724 is placed within a vacuum chamber 730. In some embodiments, the vacuum chamber 730 can be connected to a suction source of the clot removal device. In other embodiments, the vacuum chamber may have a separate vacuum source (not shown). In this example, a vacuum is applied to the vacuum chamber, which "inflates" the bag with blood as blood and clots are aspirated from the patient.

[0077]

[0118] In some embodiments, the vacuum chamber 730 can be detachable from the thrombectomy device and pre-loaded with a collection bag. Once the bag is filled with blood, the vacuum chamber can be replaced with a new vacuum chamber with a new, empty collection bag. Alternatively, the collection bags may be sequentially engaged within the vacuum chamber and replaced individually as they are filled.

[0078]

[0119] In some embodiments, the controller can reduce the strength of the vacuum applied to the aspiration lumen after a clot is detected at the vacuum line so that blood loss is minimized.

[0120] 8A-8C, 9A-9B, 10A-10C, 11A-11C, and 12A-12B illustrate features that allow for separation of thrombus material from the removed or aspirated blood and capture of the filtered blood for return to the patient. In some embodiments, the separated thrombus material can be easily identified by the physician and provides a real-time indication of the amount / size / volume of thrombus material removed from the patient during the procedure.

[0079]

[0121] 8A-8B, a clot removal system may include the previously described components, including a clot removal device 802, a vacuum source and canister 804, a fluid source 806, and one or more pumps (not shown). The clot removal system may further include a funnel 808, a flexible elongated shaft 810, and a handle 812. The clot removal system may further include a clot filter 824 and a blood collection canister 826 fluidly coupled to a vacuum line 818. The blood collection canister 826 may further include one or more syringes 828 (or other transfer devices) and a separator 830 configured to fluidly separate the blood collection canister into two separate chambers. The syringes may be optionally removable from the blood collection canister. In some embodiments, the syringes are located on the blood side of the canister, the saline side of the canister, or both. For example, syringes on the blood side of the canister can be used to return blood to the patient (e.g., by removing the syringes from the canister and injecting them back into the patient) or to a line connected to the patient. Syringes on the saline side can be used to optionally draw saline to inject into the patient or to increase or decrease the amount of saline in the blood collection canister. The separator may include, for example, a plunger, a diaphragm, a fluid-impermeable membrane, etc. Generally, the separator is configured to separate the blood / saline removed from the patient from the saline or other fluid inside the blood collection canister during operation of the vacuum source.

[0080]

[0122] It should be understood that many of the components described above can be incorporated into a separate console, such as the vacuum source and canister, blood collection canister, etc. In some embodiments, the thrombus removal device 802 can be positioned within the sterile field, with the console and / or other components positioned outside the sterile field. However, in some embodiments, it may be desirable to position certain components, such as the thrombus filter 824, within the sterile field so that a device user, e.g., a physician, can easily verify the amount of thrombus removed in real time during the procedure.

[0081]

[0123] When the vacuum source is activated and the clot engages the funnel, blood and / or thrombus material flows from the funnel 808 into the suction lumen of the shaft 810, into the vacuum line 818, and then through the clot filter 824. In some embodiments, the clot filter can be a simple size exclusion filter with an effective pore size configured to remove thrombus material 825 from the flowing fluid while allowing blood and / or saline to pass through the filter. For example, the filter may have a pore size of 40 microns (or less), corresponding to many conventional or traditional filters for red blood cells. Red blood cells typically range in diameter from 7.5 to 8.7 μm and in thickness from 1.7 to 2.2 μm. Other suitable pore sizes that allow blood / saline to pass through the filter while minimizing or eliminating the passage of thrombus material are within the scope of this disclosure. The separated thrombus material 825 can be collected in the filter 824.

[0082]

[0124] In some embodiments, the filter 824 can include a clot-adherent material (e.g., polyester) configured to grab (i.e., capture) or adhere to passing clots. Portions of the filter may further include a clot-repellent material (e.g., ePTFE) to selectively allow clots to pass through specific areas or portions of the filter.

[0083]

[0125] Referring to FIG. 8E, the clot filter 824 can be housed within a transparent container or include a transparent window 823, which can include one or more spring-loaded channels 831, so that the clot is pressed against the inner surface of the container or transparent window, allowing visualization of the removed clot. In some aspects, the window or transparent housing can include markers 831 configured to indicate to the user the unit of measure of the captured clot. For example, the markers 831 can be graduated or spaced by known volumetric units (e.g., every 5 ml of clot removed), allowing the user to quickly estimate the amount of clot removed during the procedure. In other embodiments, a weight scale can be used within the clot collection canister to indicate the weight of the removed clot. In some aspects, the weight can be converted to an estimated volume of the removed clot. The filter 824 and blood collection canister can be fully fluidized, preventing clotting during the thrombectomy procedure.

[0084]

[0126] In another embodiment, referring to FIG. 8F , filter 824 may comprise a filter that uses gravity to separate clots from blood after removal by the thrombectomy device. As shown in FIG. 8F , blood and clots can enter filter 824 through an inlet. Membrane or filter 833 may comprise a coarse filter with a pore size that allows blood to flow while preventing clots or thrombus material from passing through. In some aspects, the filter or membrane may be weighted. In other embodiments, a weighted bar may be attached or coupled to the membrane to compress collected clots at the bottom of the filter. In some embodiments, filter 824 may optionally include a spring-loaded mechanism 835 that can apply a force against filter or membrane 833. In some aspects, the optional spring-loaded membrane or weighted bar may keep removed clots trapped in a specific area of ​​the filter (e.g., within a transparent window) and provide an indication to the user as to how much clot has been collected. For example, as shown, markers or hash marks 831 along the edge of the filter 824 can estimate or provide an indication of the amount, size, or volume of the clot removed. In other embodiments, a weight scale can be used within the clot collection canister to indicate the weight of the clot removed. In some aspects, the weight can be converted to an estimated volume of the clot removed.

[0085]

[0127] In another embodiment, referring to FIG. 8G , filter 824 may separate or organize clots by size into various partitions 837 by utilizing differences in momentum of the blood / clots entering the filter. The momentum of larger or heavier clots sorts them into partitions 837 more distal to the inlet, while smaller clots sort into more proximal partitions. Thus, this arrangement allows for automatic sorting of clots into the filter by size, volume, or weight during a thrombectomy procedure. As mentioned above, the filter may be transparent or have a transparent window for visualization of removed clots. Additionally, filter 824 may include a membrane or filter 833 that allows blood to flow through the membrane to an outlet of filter 824 while keeping removed clots separated from the blood.

[0086]

[0128] Actuation of the vacuum source and canister 804 also draws fluid, such as saline, from the blood collection canister 826 into the vacuum canister 804. This causes a separator 830 to expand or move within the blood collection canister, drawing filtered blood / saline 827 into the blood collection canister and / or a syringe on the blood side of the canister. FIG. 8B shows the movement of the separator 830, indicated by the arrow, through the blood collection canister (in this embodiment, the plunger), resulting in blood 827 on a first side of the separator (e.g., the clot removal device side) and saline 829 on a second side of the separator (e.g., the vacuum source and canister side). As the blood collection canister fills with blood, the vacuum canister can be seen filling with saline. In some embodiments, as shown in FIG. 8B, a blood return line 832 can optionally be connected to the patient to return the blood 827 in the blood collection canister to the patient. A syringe can be added to the blood line to aid in the return of blood, which can be closed, for example, with pinch valves or clamps (not shown) on either side of the syringe to facilitate the return of blood to the patient, if desired.

[0087]

[0129] In some embodiments, referring to FIG. 8C, blood collection canister 826 may include multiple syringes, such as syringes 828a, 828b, and 828c. Adding multiple syringes in series with the blood collection canister can increase the amount of blood / clot that can be removed and / or returned from the patient before the blood collection canister needs to be emptied and / or the blood returned to the patient. However, the volume of blood returned to the patient can still be monitored (e.g., 150-300 ml per syringe) depending on the number of syringes emptied during the procedure. As with the above embodiment, the syringes can be removably attached to the blood collection canister.

[0088]

[0130] Figure 8D is a variation of the embodiment of Figure 8B. The embodiment of Figure 8D may include an additional fluid line 851 fluidly coupling the saline side of blood collection canister 826 to saline source 806. In addition, the system may include controllable valves 853a and 853b (e.g., any controllable three-way valve, such as a three-way stopcock) at the connection between line 851 and saline source 806 and at the junction between blood collection canister 826 and the blood return line. During a thrombectomy procedure, valve 853a can be controlled to create a flow of saline from saline source 806 into the thrombectomy catheter, such as a fluid jet or irrigation.

[0089]

[0131] Valve 853b can be controlled by suction source 804, which moves separator 830 in the direction shown by the arrow, to allow blood removed from the patient to flow into blood collection canister 826. After the thrombectomy procedure is complete, valve 853a can be controlled to divert saline from saline source 806 into line 851 toward the saline side of blood collection canister 826, and valve 853b can be controlled to divert blood from the blood collection canister into blood return line 832. In this blood return mode, the saline source fills the saline side of the blood collection canister with saline, driving separator 830 in the opposite direction of the arrow to push blood into blood return line 832. Blood already filtered once by filter 824 can be further filtered by a second filter 855 before being returned to the patient. In some embodiments, blood return line 832 directs the (twice) filtered blood into the introducer sheath of the thrombectomy system for return to the patient. The embodiment of FIG. 8D can provide graded filtration with two different filter pore sizes (e.g., first filter 824 can have a first (coarser) filter size and second filter 855 can have a second (finer) filter size). During a thrombectomy procedure, suction of blood and clots into filter 824 can occur at a first pressure level. During blood return, blood can be filtered through filter 855, and the finer filter has a lower throughput (i.e., flow rate), allowing the blood to be returned to the patient at a second, higher pressure level.

[0090]

[0132] 9A-9B show an embodiment similar to the clot removal system of FIGS. 8A-8B. However, in this embodiment, the blood collection canister 926 includes a deformable diaphragm 930 instead of the plunger illustrated in FIGS. 8A-8B. However, the concept of operation is similar. The blood collection canister 926 can be pre-filled with saline or other fluid. When the vacuum source and canister 904 are activated, fluid is drawn from the blood collection canister 926 into the vacuum canister 904, displacing the diaphragm 930 within the blood collection canister, as shown by the arrows. This draws blood / saline 927 removed from the patient into the blood collection canister on the other side of the diaphragm, as shown in FIG. 9B. The vacuum canister 904 can be filled with saline as the saline in the blood collection canister is displaced by the blood / saline 927 removed from the patient. Similar to the embodiment described above in FIGS. 8A-8B, thrombotic material or clots 925 can collect on thrombus filter 924.

[0091]

[0133] 9C-9D show another embodiment of a clot removal system similar to the system described above in FIGS. 9A-9B. In FIG. 9C, a blood collection canister 926 may include the diaphragm 930 described above. One or more syringes 928 may be disposed on the blood side of the blood collection canister 926 to collect blood for return / re-delivery to the patient. On the saline side of the blood collection canister, a pump 932, such as a single piston pump, may be configured to draw saline from the saline side of the blood collection canister and pump the saline into the vacuum canister 904b. One-way check valves positioned on either side of the pump 932 may prevent the passage of saline into the blood collection canister. In other embodiments, the check valves may be actively actuated to coincide with the operation of the pump. In some examples, as the pump drives or pushes saline into the vacuum canister 904b, negative pressure on the inlet side can be maintained with an optional capacitive device, such as a spring-loaded syringe or diaphragm 934. As the pressure on the saline side decreases, the plunger is pulled down against the spring.

[0092]

[0134] FIG. 9D shows an embodiment similar to that shown in FIG. 9C. However, instead of a single piston pump as in the embodiment of FIG. 9C, this embodiment may include a pump system 936 including two pumps or syringes 938a / 938b with a common drive shaft or piston 940. In this embodiment, pump 938a of the pump system pushes saline into vacuum canister 904b, while pump 938b of the pump system draws saline from the saline side of the blood collection canister. Valves 942, such as one-way check valves or actively controlled valves, on the inlet and outlet sides of the upper and lower pumps can prevent saline from flowing back into the blood collection canister. The spring-loaded syringe or diaphragm 934 of the embodiment of FIG. 9C can optionally be employed in this embodiment, as can a method of controlling volume within the system.

[0093]

[0135] In some embodiments, the clot filter 924 or 924 is removable from the system. After a thrombectomy procedure, the filter can be removed and flared, pushed out, or washed to separate the removed clot / thrombus material from the filter. For example, as shown in Figures 9C-9D, a flushing (i.e., washing) system can be connected to the filter to wash the filter after or during the procedure to flush away blood for better observation of the collected clot material. The removed clot / thrombus material can be measured, weighed, and / or stored for further diagnosis.

[0094]

[0136] In further embodiments, an electrical charge can be applied to the clot filter or other aspects of the system, such as clot filter 824 in FIGS. 8A-8B or clot filter 924 in FIGS. 9A-9D. Because blood is negatively charged, a positive charge can be applied to the clot filter to attract clots or thrombus material to the clot filter while still allowing blood to pass through the pores / openings of the filter. For example, electrical leads can be attached to the filter and connected to a power source to apply a positive charge to the filter. In another embodiment, the polarity of the charge can be reversed, and a negative charge can be applied to the filter to help release collected thrombus material / clots after the procedure. In some embodiments, portions of the filter can be preferentially charged, thereby preferentially loading portions of the filter to prevent filter blockage. Additionally, captured clots can be sorted, for example, by clot morphology (e.g., soft, medium, and hard types). Compartmentalization may be achieved by adjusting the applied charge and / or positioning of elements (eg, plates, protrusions, etc.) in the blood collection canister.

[0095]

[0137] 10A-10D illustrate alternative embodiments of a blood collection canister 1026. In the example of FIG. 10A, the blood collection canister 1026 may include a sieve pathway 1034. The sieve pathway 1034 may comprise a spiral or serpentine pathway from the top to the bottom of the canister, as shown in FIG. 10A. In another example, the sieve pathway 1034 may comprise a back-and-forth pathway, as shown in FIG. 10C. FIG. 10B is an enlarged view of the sieve pathway. The pathway may comprise a lumen, tube, channel, etc., with multiple openings or pores sized and configured to contain clots or thrombotic material 1025 within the sieve pathway but allow blood / saline 1027 to fall or filter out of the pathway by gravity or an external vacuum source. Similar to the clot filters described above, the sieve pathway may include pore sizes on the order of 40 microns to allow blood to pass but not clots or thrombotic material. The pathway also includes hash marks or other units of measurement so that the amount of clot captured / removed within the pathway can be estimated. In operation, a vacuum applied to the blood collection canister and thrombectomy device forces blood / saline / clot from the patient, through the thrombectomy device, and into the sieve pathway of the blood collection canister. The filter or pore size of the sieve pathway allows blood to flow from the sieve pathway into the blood collection canister, but contains the clot or thrombus material within the sieve pathway.

[0096]

[0138] In some embodiments, an electrical charge can be applied to the sieving channel. Because blood is negatively charged, a positive charge can be applied to the sieving channel to attract clots or thrombus material to the sieving channel, while still allowing blood to pass through the pores / openings in the sieving channel and be collected in a blood collection canister. For example, an electrical lead can be attached to the sieving channel and connected to a power source to apply a positive charge to the sieving channel. In another embodiment, the polarity of the charge can be reversed, and a negative charge can be applied to the sieving channel to help release collected thrombus material / clots after the procedure.

[0097]

[0139] FIG. 10D illustrates another embodiment of a blood collection canister 1026 that may include multiple charged protrusions 1044a-1044c configured to capture clots and, for example, separate clots by clot morphology (e.g., soft, medium, hard, etc.). The protrusions can be individually tuned with desired or selected charges to attract desired clot morphologies. For example, a first protrusion 1044a may be charged with a first charge configured to attract a first type of clot or clot morphology, a second protrusion 1044b may be charged with a second charge configured to attract a second type of clot or clot morphology, and a third protrusion 1044c may be charged with a third charge configured to attract the first type of clot or clot morphology. In some embodiments, one or more protrusions may be tuned with the same or similar charges, such that a majority of the clots to be removed are attracted to that particular charge configuration. Although the canister in FIG. 10D shows three protrusions, it should be understood that the canister may include fewer or more protrusions depending on the application.

[0098]

[0140] 11A-11C illustrate another embodiment of a structure that may be incorporated into the clot filter and / or blood collection canister of a clot removal system. In FIG. 11A, a honeycomb structure 1136 is shown that may include a plurality of openings 1138 (shown in white) interspersed with closing sections 1140 (shown in gray shading). The openings, as described above, may have pore sizes configured to allow blood / fluid to pass but not clot or thrombus material. In some embodiments, the closing sections 1140 may include a positive charge, shown as (+), to attract clot or thrombus material while still allowing blood and / or fluid removed from the patient to pass through the openings 1138.

[0099]

[0141] In FIG. 11B, one or more layers 1142 of a honeycomb structure can be implemented within the blood collection canister 1126 as shown. Gravity or vacuum can draw blood, saline, and / or removed clot / thrombus material into the blood collection canister 1126, where it can be filtered through the layers 1142. Clots or thrombus material can collect in the closed sections of each layer, while blood can flow down through the openings and collect within the canister. Similar to the embodiment of FIG. 11A, the layers can include a positive charge, particularly in the closed sections, to further attract clots or thrombus material. While the illustrated embodiment shows alternating positive and negative charges, it should be understood that the various layers 1142 can be individually controlled with a desired charge (e.g., all positive charges or all negative charges, or some combination thereof). Additionally, the layers 1142 can be individually tailored to attract or sort different types or morphologies of clots. For example, the charge level of the first layer may be adjusted to attract or classify soft clots, the second layer may be adjusted to attract or classify medium clots, the third layer may be adjusted to attract or classify hard clots, etc. A syringe may optionally be coupled to the bottom of the canister for collection of blood and return of the blood to the patient. Optionally, canister 1126 may be coupled to a separate blood collection canister (not shown) so that all blood is collected separately.

[0100]

[0142] In FIG. 11C, the same concept can be applied to clot filters 1124a, 1124b, or 1124c, which can be the clot filters from the embodiments of FIGS. 8A-8B and 9A-9B. In this example, the clot filter can include a closed section (optionally charged) designed and configured to collect removed / bound clot material, while the openings allow blood and other fluids to pass through the filter (e.g., into the blood collection canister described above). Filter 1124b can include a honeycomb structure with multiple open lumens, but its surface can be electrically charged. A positively charged filter has a high affinity for clots, so blood flows through the lumens, but clots are trapped on the surface, preventing their passage. Filter 1124c can further include rods in the lumens. If the rods are negatively charged (-) and the surface of the honeycomb structure's lumen is positively charged (+), clots can be attracted to the honeycomb structure. These lumens can be made wider or longer to provide a longer path for blood and clots to flow, thereby increasing the surface area available for clot collection.

[0101]

[0143] FIGS. 12A-12C illustrate another embodiment of a blood collection canister 1226. The blood collection canister 1226 can replace any of the other blood collection canisters described herein. The blood collection canister 1226 can include a conveyor belt 1244 with two or more pulleys and a scraper 1246. The conveyor belt 1244 can be positively charged. FIG. 12A illustrates an embodiment in which the conveyor belt is positioned vertically within the blood collection canister, and FIG. 12B illustrates an embodiment in which the conveyor belt is positioned horizontally within the blood collection canister. As blood, fluid, and thrombus material are removed from the patient into the blood collection canister 1226, the positively charged conveyor belt can operate to attract thrombus material from below the fluid level and be pulled onto the conveyor belt. The scraper 1246 (FIGS. 12A and 12B) can contact or nearly contact the conveyor belt to grab or remove thrombus material from the conveyor belt. In some embodiments, the conveyor belt can be selectively controlled to operate only at designated times, such as after a procedure is completed. The conveyor belt and / or scraper can be lifted off the canister to remove the separated thrombus material from the blood collection canister, resulting in only blood / saline remaining in the canister.

[0102]

[0144] It should be understood that the honeycomb structure of FIG. 12A is also applicable to the sieve filters of FIGS. 11A-11B.

[0145] In an alternative embodiment, a vacuum nozzle may be used instead of a scraper to remove the separated thrombus material directly from the conveyor belt, as shown in Figure 12C. In some instances, this aspirated thrombus material can be stored in a separate thrombus canister. Figure 12B shows an embodiment with both a scraper and a vacuum nozzle.

[0103]

[0146] In some embodiments, the positive charge on the transport belt can be stopped or counteracted near the scraper / vacuum nozzle. In another embodiment, the scraper and / or vacuum nozzle can have a negative charge to counteract the positive charge on the transport belt, which can facilitate the removal / scraping of the removed thrombus material from the transport belt. In some instances, alternating negative and positive charges can dissolve the clot. The present disclosure typically avoids clot dissolution potentially until after the procedure and after the clinician has verified the amount of clot removed.

[0104]

[0147] While the embodiments herein have been described as intended for removing blood clots from a patient's vasculature, other applications of this technology are provided. For example, the devices described herein can be used to break up and remove hardened stool from a patient's digestive tract, such as the patient's intestines or colon. In one embodiment, the device can be inserted into the patient's colon or intestines (such as through the anus) and advanced to the site of the hardened stool. The suction system can then be activated to engage the hardened stool with an engagement member (e.g., a funnel) of the device. Finally, a jet or irrigation can be activated to detach the hardened stool fragments and aspirate them into the system. Any of the techniques described above for controlling the system or removing blood clots can be applied to removing hardened stool.

[0105]

[0148] As those skilled in the art will appreciate from the disclosure herein, various components of the thrombus removal system described above can be omitted without departing from the scope of the present technology. As previously discussed, for example, the present technology can be used and / or modified to remove other types of emboli that may occlude blood vessels, such as fat, tissue, or foreign bodies. Furthermore, although some embodiments herein are described in the context of thrombus removal from a pulmonary artery, the disclosed technology may be applied to the removal of thrombi and / or emboli from other portions of the vasculature (e.g., in neurovascular, coronary, or peripheral applications). Similarly, additional components not explicitly described above may be added to the thrombus removal system without departing from the scope of the present technology. Accordingly, the systems described herein are not limited to those explicitly identified configurations, but rather encompass variations and modifications of the described systems. conclusion

[0149] The above detailed description of embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. Specific embodiments of the present technology, and examples thereof, are described above for illustrative purposes; however, those skilled in the art will recognize that various equivalent modifications are possible within the scope of the present technology. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may be combined to provide further embodiments.

[0106]

[0150] From the above, it will be understood that, although specific embodiments of the present technology have been described herein for illustrative purposes, well-known structures and functions have not been shown or described in detail in order to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where the context permits, singular or plural terms may also include plural or singular terms, respectively.

[0107]

[0151] Unless the context clearly dictates otherwise, throughout the description and examples, words like "comprises," "comprising," and the like should be construed in an inclusive sense, i.e., meaning "including, but not limited to," rather than an exclusive or exhaustive sense. As used herein, the terms "connected," "coupled," or any variation thereof, mean any direct or indirect connection or coupling between two or more elements, and the coupling between elements may be physical, logical, or a combination thereof. In addition, the words "herein," "above," "below," and words of similar import, when used in this application, refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above detailed description using the singular or plural may each be in the plural or singular. As used herein, the term "and / or," such as "A and / or B," refers to A only, B only, and A and B. Additionally, the term "comprising" is used throughout to mean the inclusion of at least the recited feature(s), but not the exclusion of any more of the same features and / or other features of additional types. Specific embodiments have been described herein for purposes of illustration, but it will also be understood 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 these embodiments, other embodiments may also exhibit such advantages, although not all embodiments necessarily exhibit such advantages to fall within the scope of the present technology. Thus, the present disclosure and related technology may include other embodiments not explicitly shown or described herein.

Claims

1. A long, slender shaft and a suction lumen extending along the elongate shaft; a vacuum source fluidly coupled to the aspiration lumen; a blood clot filter disposed along the aspiration lumen; a blood collection canister disposed proximally from the blood clot filter along the suction lumen, the blood collection canister including a movable separator dividing the blood collection canister into a first chamber and a second chamber, wherein operation of the vacuum source causes blood clots removed from the patient to collect in the blood clot filter and blood removed from the patient to collect in the first chamber.

2. The system of claim 1 , wherein operation of the vacuum source further causes saline to flow into the second chamber and vacuum canister.

3. The system of claim 1 , wherein the filter has a pore size of up to 40 microns.

4. The system of claim 1 , wherein the clot filter is configured to allow blood to pass but not allow clots to pass.

5. The system of claim 1 , wherein the clot filter is positively charged.

6. The system of claim 1 , wherein the separating portion comprises a plunger.

7. The system of claim 1 , wherein the isolation portion comprises a diaphragm.

8. The system of claim 1 , further comprising at least one saline source fluidly coupled to the second chamber.

9. The system of claim 8 , wherein the at least one saline source is removable from the blood collection canister.

10. The system of claim 1 , further comprising a blood return line fluidly coupled to the first chamber.

11. The system of claim 1 , wherein the blood clot filter comprises a honeycomb structure.

12. The system of claim 1 , wherein the honeycomb structure comprises a plurality of openings interspersed between closed sections.

13. The system of claim 12 , further comprising an electrical system configured to apply a positive charge to the closed section.

14. A long, slender shaft and a suction lumen extending along the elongate shaft; a vacuum source fluidly coupled to the aspiration lumen; a blood collection canister coupled to the aspiration lumen, the blood collection canister including a sieve channel having an opening sized and configured to allow blood to flow from the sieve channel into the blood collection canister while containing thrombus material within the sieve channel.

15. 15. The system of claim 14, wherein the sieve channels have a pore size of up to 40 microns.

16. The system of claim 14 , wherein the sieve channel is positively charged.

17. The system of claim 14 , further comprising a blood return line fluidly coupled to the blood collection canister.

18. The system of claim 14 , wherein the sieve channels comprise a honeycomb structure.

19. 20. The system of claim 18, wherein the honeycomb structure comprises a plurality of openings interspersed between closed sections.

20. 20. The system of claim 19, further comprising an electrical system configured to apply a positive charge to the closed section.

21. The system of claim 14 , wherein the sieve path is spiral.

22. The system of claim 14 , wherein the sieve path forms a tortuous path through the blood collection canister.

23. A long, slender shaft and an aspiration lumen extending proximally from the elongate shaft to a vacuum source; a blood collection canister disposed between the suction lumen and the vacuum source, the blood collection canister including a positively charged transport belt configured to attract thrombus material from fluid in the blood collection canister and a scraper configured to remove the thrombus material from the transport belt.

24. 24. The system of claim 23, wherein the scraper comprises a vacuum nozzle.

25. removing thrombotic material and blood from the patient; applying a positive charge to the clot detachment device; attracting thrombus material to the thrombus detachment device; and causing the blood to flow into a blood collection canister.

26. 26. The method of claim 25, wherein the clot separation device comprises a clot filter.

27. 26. The method of claim 25, wherein the clot detachment device comprises a conveyor belt.

28. 26. The method of claim 25, wherein the clot detachment device comprises a sieve channel.

29. A long, slender shaft and a suction lumen extending in the elongate shaft proximally to a vacuum source; a fluid lumen extending distally from a source of pressurized fluid to the shaft; a thrombus detector operable to detect a thrombus between the aspiration lumen and the vacuum source; a controller operable to regulate fluid flow through the fluid lumen and / or the aspiration lumen when a thrombus is detected by the thrombus detector.

30. 30. The system of claim 29, further comprising a funnel disposed at or near a distal end of the elongate shaft.

31. A long, slender shaft and a suction lumen extending proximally from the funnel portion of the elongate shaft to a vacuum source; a fluid lumen extending distally from a source of pressurized fluid to the shaft; a thrombus filter disposed between the vacuum source and the aspiration lumen; one or more blood collection bags disposed between the blood clot filter and the vacuum source.

32. 32. The system of claim 31, further comprising a funnel disposed at or near a distal end of the elongate shaft.

33. initiating a thrombectomy procedure in the patient with the thrombectomy device; identifying a system status of the thrombectomy device; determining whether fluid aspirated by the thrombectomy device should be returned to the patient or whether the fluid is waste based on the system status; and directing the fluid into a selected receptacle.

34. 34. The method of claim 33, wherein a first system state is when suction of the thrombectomy device is activated and jet or fluid delivery of the thrombectomy device is stopped.

35. 35. The method of claim 34, further comprising determining that the fluid aspirated by the thrombectomy device should be returned to the patient in the first system state.

36. 34. The method of claim 33, wherein the second system state is when the suction of the thrombus removal device is activated and the jet or fluid delivery of the thrombus removal device is activated.

37. 37. The method of claim 36, further comprising determining that the fluid aspirated by the thrombus removal device is waste in the second system state.

38. 34. The method of claim 33, wherein directing the fluid into the selected receptacle comprises automatically controlling one or more valves to direct the fluid into the selected receptacle.

39. engaging the clot with a thrombectomy device; directing two or more fluid streams with the thrombectomy device into the clot to macerate the clot; and sorting the macerated portion of the clot into a clot collection canister of the thrombectomy device based on a parameter of the macerated portion.

40. 40. The method of claim 39, wherein the parameters include the size of the macerated portion.

41. 40. The method of claim 39, wherein the parameters include the morphology of the macerated portion.

42. 40. The method of claim 39, wherein the parameter comprises a hardness of the macerated portion.

43. 40. The method of claim 39, further comprising indicating the volume of the macerated portion to a user.

44. 44. The method of claim 43, wherein indicating to the user comprises indicating the volume to the user with one or more measurement markers on the clot collection canister.

45. 40. The method of claim 39, wherein the macerated portions are sorted by differential momentum.

46. 40. The method of claim 39, wherein sorting the macerated portions further comprises applying one or more electrical charges to elements within the clot collection canister to attract selected macerated portions.

Images