Thrombus removal systems and associated methods

Abstract

The present technology relates to systems and methods for removing a thrombus from a blood vessel of a patient. In some embodiments, the present technology is directed to systems including an elongated catheter having a distal portion configured to be positioned within the blood vessel of the patient, 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 with a fluid lumen and configured to apply fluid to at least partially fragment the thrombus.

Description

THROMBUS REMOVAL SYSTEMS AND ASSOCIATED METHODSPRIORITY CLAIM

[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 698,993, titled “THROMBUS REMOVAL SYSTEMS AND ASSOCIATED METHODS,” and filed on September 25, 2024, which is herein 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 generally relates to medical devices and, in particular, to systems including aspiration and fluid delivery mechanisms and associated methods for removing a thrombus from a mammalian blood vessel.BACKGROUND

[0004] Thrombotic material may lead to a blockage in fluid flow within the vasculature of a mammal. Such blockages may occur in varied regions within the body, such as within the pulmonary system, peripheral vasculature, deep vasculature, or brain. Pulmonary embolisms typically arise when a thrombus originating from another part of the body (e.g., a vein in the pelvis or leg) becomes dislodged and travels to the lungs.

[0005] Anti coagulation therapy is the current standard of care for treating pulmonary embolisms, but may not be effective in some patients. Additionally, conventional devices for removing thrombotic material may not be capable of navigating the tortuous vascular anatomy, may not be effective in removing thrombotic material, and / or may lack the ability to provide sensor data or other feedback to the clinician during the thrombectomy procedure.

[0006] Existing thrombectomy devices operate based on simple aspiration which works sufficiently for certain clots but is largely ineffective for difficult, organized clots. Many patients presenting with deep vein thrombus (DVT) are left untreated as long as the risk of limb ischemia is low. In more urgent cases, they are treated with catheter-directed thrombolysis or lytic therapy to break up a clot over the course of many hours or days. More recently other tools like clot retrievers have been developed to treat DVT and pulmonary- 1 -SG Docket No.: 10844-737.668embolism (PE), but these tools are not being widely adopted because of their limited effectiveness and additional costs versus aspiration or the standard of case.

[0007] Blood loss is an undesirable result of thrombectomy. If the end of the catheter is not in contact with the clot when aspirating, blood is aspirated rather than clot. Positioning the distal end of the catheter adjacent to the clot is difficult. Fluoroscopy is used to help navigate the catheter to the clot. The clot is not easily distinguished from the surrounding anatomy. Contrast agent can be injected upstream of the clot to identify the margins of the clot. Patients can tolerate a limited amount of contrast agent. Other ways to determine whether the catheter is adjacent to clot are needed to help reduce blood loss.SUMMARY OF THE DISCLOSURE

[0008] A system for removing thrombus from a patient, the system comprising: an elongate catheter having a distal end and an aspiration lumen disposed therein; a vacuum source fluidly coupled to the aspiration lumen and configured to reduce pressure in the aspiration lumen to engage thrombus with the distal end; one or more fluid ports disposed near the distal end; a fluid lumen disposed in the elongate catheter and in fluid communication with the one or more fluid ports, the fluid lumen configured to provide a flow of fluid to the one or more fluid ports to deliver one or more jetted fluid streams configured to break up the thrombus; at least one conduit fluidly coupled to the aspiration lumen; and at least one valve operatively coupled to the conduit, the at least one valve being controllable to direct aspirated material from the elongate catheter into a first collection container when jetted fluid streams are being delivered and to direct aspirated material from the elongate catheter into a second collection container when jetted fluid streams are not being delivered.

[0009] In some aspects, the at least one conduit comprises a first conduit extending from the aspiration lumen to the at least one valve, a second conduit extending from the at least one valve to the first collection container, and a third conduit extending from the at least one valve to the second collection container.

[0010] In one aspect, the at least one valve comprises a single valve.

[0011] In another aspect, the single valve is configured to close the second fluid conduit to direct aspirated material to the second collection container and is configured to close the third fluid conduit to direct aspirated material to the first collection container.

[0012] In some aspects, the at least valve comprises at least two valves.

[0013] In one aspect, the first collection container is disposed within the second collection container.- 2 -SG Docket No.: 10844-737.668

[0014] In some aspects, the system further comprises a venting conduit coupled between the first collection container and the second collection container.

[0015] In some aspects, the system further comprises comprising at least one filter disposed along the at least one conduit between the aspiration lumen and the first collection container.

[0016] In other aspects, the system further comprises at least one filter disposed along the at least one conduit between the aspiration lumen and the first collection container.

[0017] In another aspect, the system further comprises a first filter disposed along the second conduit and a second filter disposed along the third conduit.

[0018] In some aspects, the system further comprises a console, the vacuum source and at least one valve being disposed on or in the console.

[0019] In one aspect, the at least one conduit passes through a cassette assembly, the cassette assembly being mountable onto the console to place the at least one conduit into operative coupling with the at least one valve.

[0020] In some aspects, the at least one valve comprises a pinch valve.

[0021] In one aspect, the pinch valve comprises a cam subassembly disposed on a stepper motor.

[0022] In some aspects, the system further comprises a syringe assembly fluidly coupled to the first collection container, the syringe assembly being configured to pull aspirated material from the first collection container for return to the patient.

[0023] A system for removing thrombus is provided, the system comprising: an elongate catheter having a distal end and an aspiration lumen disposed therein; a vacuum source fluidly coupled to the aspiration lumen and configured to reduce pressure in the aspiration lumen to engage thrombus with the distal end; at least one conduit fluidly coupled to the aspiration lumen; and at least one valve operatively coupled to the at least one conduit, the at least one valve being controllable to selectively direct aspirated material from the elongate catheter into a first collection container or into a second collection container.

[0024] In some aspects, the at least one valve is configured to selectively direct the aspirated material based on a system state of the elongate catheter.

[0025] In some aspects, the system further comprises at least one pressure sensor disposed in the at least one fluid conduit or the aspiration lumen, wherein the at least one valve is configured to selectively direct the aspirated material based on a measured pressure.

[0026] In one aspect, the elongate catheter is further configured to deliver a plurality of jetted fluid streams from the distal end, wherein the at least one valve is configured to- 3 -SG Docket No.: 10844-737.668selectively direct the aspirated material based on if the plurality of jetted fluid streams are being delivered.

[0027] In some aspects, the at least one conduit comprises a first conduit extending from the aspiration lumen to the at least one valve, a second conduit extending from the at least one valve to the first collection container, and a third conduit extending from the at least one valve to the second collection container.

[0028] In some aspects, the at least one valve comprises a single valve.

[0029] In one aspect, the single valve is configured to close the second fluid conduit to direct aspirated material to the second collection container and is configured to close the third fluid conduit to direct aspirated material to the first collection container.

[0030] In some aspects, the at least valve comprises at least two valves.

[0031] In one aspect, the first collection container is disposed within the second collection container.

[0032] In some aspects, the system further comprises a venting conduit coupled between the first collection container and the second collection container.

[0033] In some aspects, the system further comprises at least one filter disposed along the at least one conduit between the aspiration lumen and the first collection container.

[0034] In other aspects, the system further comprises at least one filter disposed along the at least one conduit between the aspiration lumen and the first collection container.

[0035] In additional aspects, the system further comprises a first filter disposed along the second conduit and a second filter disposed along the third conduit.

[0036] In some aspects, the system further comprises a console, the vacuum source and at least one valve being disposed on or in the console.

[0037] In one aspect, the at least one conduit passes through a cassette assembly, the cassette assembly being mountable onto the console to place the at least one conduit into operative coupling with the at least one valve.

[0038] In some aspects, the at least one valve comprises a pinch valve.

[0039] In some aspects, the pinch valve comprises a cam subassembly disposed on a stepper motor.

[0040] In one aspect, the system includes a syringe assembly fluidly coupled to the first collection container, the syringe assembly being configured to pull aspirated material from the first collection container for return to the patient.

[0041] A system for removing thrombus is provided, the system comprising: an elongate catheter having a distal end and an aspiration lumen disposed therein; a vacuum source fluidly coupled to the aspiration lumen and configured to reduce pressure in the aspiration - 4 -SG Docket No.: 10844-737.668lumen to engage thrombus with the distal end; at least one conduit fluidly coupled to the aspiration lumen; at least one valve operatively coupled to the at least one conduit; and an electronic controller configured to determine a system state of the elongate catheter and to selectively control the at least one valve to direct aspirated material from the elongate catheter into a first collection container or a second collection container based on the system state.

[0042] A system for removing thrombus is also provided, the system comprising: an elongated catheter having at least one aspiration lumen configured to remove thrombus material; an aspiration mechanism fluidly coupled to the aspiration lumen and configured to reduce pressure in the aspiration lumen; a pressure sensor configured to monitor a pressure inside the aspiration lumen; at least one valve disposed between the pressure sensor and the aspiration mechanism; and an electronic controller operatively coupled to the pressure sensor and the at least one valve, the electronic controller being configured to control the at least one valve and the aspiration mechanism to selectively direct aspirated material into a first reservoir or a second reservoir based on the monitored pressure.

[0043] In some aspects, the system further comprises a port fluidly coupling the first reservoir to a blood return syringe to extract blood from the first reservoir for blood return.

[0044] A thrombectomy system is provided, comprising an elongate catheter having a distal end and an aspiration lumen and fluid lumen disposed therein, the elongate catheter also having one or more fluid ports disposed near the distal end and in fluid communication with the fluid lumen, the one or more fluid ports being configured to deliver jetted fluid streams towards a thrombus; a console having a vacuum source, a fluid source, at least one valve, a first collection container, and a second collection container; a disposable tubing set removably coupled to the console and the elongate catheter, the disposable tubing set being configured to fluidly couple the aspiration lumen to the vacuum source and the fluid lumen to the fluid source, the disposable tubing set including a cassette assembly that interfaces one or more conduits of the disposable tubing set with the at least one valve; wherein the at least one valve is controllable to direct aspirated material from the elongate catheter into the first collection container when jetted fluid streams are being delivered and to direct aspirated material from the elongate catheter into the second collection container when jetted fluid streams are not being delivered.

[0045] A thrombectomy method is provided, comprising: inserting a thrombectomy catheter into a patient’s vasculature; operating the thrombectomy catheter in a first operating mode in which fluid is jetted from the thrombectomy catheter into the patient while material is aspirated from the patient; operating the thrombectomy catheter in a second operating- 5 -SG Docket No.: 10844-737.668mode in which fluid is not jetted from the thrombectomy catheter while material is aspirated from the patient; and directing the aspirated material into a first collection container in the first operating mode and a second collection container in the second operating mode.

[0046] In some aspects, the method includes returning the material in the second collection container to the patient.

[0047] A method for removing thrombus is provided, comprising: introducing a distal portion of an elongated catheter into the body of a patient, the catheter including an aspiration lumen in fluid communication with the distal end for removal of thrombus; positioning a distal end of the catheter in the region of a target thrombus; initiating a clot hunting mode in which blood is extracted from the patient into a first reservoir; detecting when a clot is engaged with the distal portion; and when the clot is engaged, initiating a clot extraction mode in which blood and clot is extracted from the patient into a second reservoir.

[0048] In some aspects, the method includes returning blood from the first reservoir to the patient.BRIEF DESCRIPTION OF THE DRAWINGS

[0049] The novel features of the invention are set forth with particularity in the claims that follow. 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 of which:

[0050] FIGS. 1-1L illustrate various views of a portion of a thrombus removal system including a distal portion of an elongated catheter configured in accordance with an embodiment of the present technology.

[0051] FIGS. 2A-2E illustrate plan views of various configurations of irrigation ports and fluid streams of a thrombus removal system according to embodiments of the present technology.

[0052] FIGS. 3A-3H illustrate an elevation view of various configurations of irrigation ports of a thrombus removal system according to embodiments of the present technology.

[0053] FIGS. 4A-4E illustrate an elevation view of various configurations of irrigation ports and fluid streams of a thrombus removal system according to embodiments of the present technology.

[0054] FIG. 5 is a thrombectomy system.

[0055] FIG. 6 is a schematic diagram of a thrombectomy system having separate reservoirs for collecting blood to be returned and for collecting removed clot.- 6 -SG Docket No.: 10844-737.668

[0056] FIG. 7 is a schematic diagram of another thrombectomy system having separate reservoirs for collecting blood to be returned and for collecting removed clot.

[0057] FIGS. 8A-8C are an example of a tubing set and a cassette assembly for coupling the tubing set to a thrombectomy console.

[0058] FIGS. 9A-9B illustrate embodiments of a collection cannister that includes separate reservoirs for collecting blood to be returned and for collecting removed clot.

[0059] FIGS. 10A-10D illustrate a thrombectomy console that includes a user-interface that provides intraoperative guidance and information on the thrombectomy procedure.DETAILED DESCRIPTION

[0060] This application is related to disclosure in International Application No. PCT / US2021 / 020915, filed March 4, 2021 (the ‘915 application), the disclosure of which is incorporated by reference herein for all purposes. The ‘915 application describes general mechanisms for capturing and removing a clot. By example, the catheter may include a capture element such as an auger to break up and draw in a clot material into an aspiration lumen. In another example, multiple fluid streams are directed toward the clot to fragment the material.

[0061] The present technology is generally directed to thrombus removal systems and associated methods. A system configured in accordance with an embodiment of the present technology can include, for example, an elongated catheter having a distal portion configured to be positioned within a blood vessel of the patient, a proximal portion configured to be external to the patient, a fluid delivery mechanism configured to fragment the thrombus with pressurized fluid, an aspiration mechanism configured to aspirate the fragments of the thrombus, and one or more lumens extending at least partially from the proximal portion to the distal portion..

[0062] The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the examples but are not described in detail with respect to the figures.

[0063] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the- 7 -SG Docket No.: 10844-737.668embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0064] Reference throughout this specification to relative terms such as, for example, "generally," "approximately," and "about" are used herein to mean the stated value plus or minus 10%.

[0065] Although some embodiments herein are described in terms of thrombus removal, it will be appreciated that the present technology can be used and / or modified to remove other types of emboli that may occlude a blood vessel, such as fat, tissue, or a foreign substance. Additionally, although some embodiments herein are described in the context of thrombus removal from a pulmonary artery (e.g., pulmonary embolectomy), the technology may be applied to removal of thrombi and / or emboli from other portions of the vasculature (e.g., in neurovascular, coronary, or peripheral applications). Moreover, although some embodiments are discussed in terms of maceration of a thrombus with a fluid, the present technology can be adapted for use with other techniques for breaking up a thrombus into smaller fragments or particles (e.g., ultrasonic, mechanical, enzymatic, etc.).

[0066] The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed present technology.Systems for Thrombus Removal

[0067] As provided above, the present technology is generally directed to thrombus removal systems. Such systems include an elongated catheter having a distal portion positionable within a blood vessel of the patient (e.g., an artery or vein), a proximal portion positionable outside the patient's body, a fluid delivery mechanism configured to fragment the thrombus with pressurized fluid, an aspiration mechanism configured to aspirate the fragments of the thrombus, 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 in a patient's blood vessel, break the thrombus into small fragments, and aspirate the fragments out of the patient's body. The pressurized fluid streams (e.g., jets) function to cut or macerate thrombus, before, during, and / or after at least a portion of the thrombus has entered the aspiration lumen or a funnel of the system. Fragmentation helps to prevent clogging of the aspiration lumen and allows the thrombus removal system to macerate large, firm clots that otherwise could not be aspirated. As used herein, “thrombus” and “embolism” are used somewhat interchangeably in various respects. It should be- 8 -SG Docket No.: 10844-737.668appreciated that while the description may refer to removal of “thrombus,” this should be understood to encompass removal of thrombus fragments and other emboli as provided herein.

[0068] According to embodiments of the present technology, a fluid delivery mechanism can provide a plurality of fluid streams (e.g., jets) to fluid apertures of the thrombus removal system for macerating, cutting, fragmenting, pulverizing and / or urging thrombus to be removed from a proximal portion of the thrombus removal system. The thrombus removal system can include an aspiration lumen extending at least partially from the proximal portion to the distal portion of the thrombus removal system that is adapted for fluid communication with an aspiration pump (e.g., vacuum source). In operation, the aspiration pump may generate a volume of lower pressure within the aspiration lumen near the proximal portion of the thrombus removal system, urging aspiration of thrombus from the distal portion.

[0069] FIG. 1 illustrates a distal portion 10 of a thrombus removal system according to an embodiment of the present technology. FIG. 1 A Section A-A illustrates an elevation sectional view of the distal portion. The example section A-A in FIG. 1 A depicts a funnel 20 that is positioned at the distal end of the distal portion 10, the funnel adapted to engage with thrombus and / or a tissue (e.g., vessel) wall to aid in thrombus fragmentation and / or removal. The funnel can have a variety of shapes and constructions as would be understood by one of skill from the description herein. The example section A-A in FIG. 1 A depicts a double walled thrombus removal device construction having an outer wall / tube 40 and an inner wall / tube 50. An aspiration lumen 55 is formed by the inner wall 50 and is centrally located. A generally 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 the fluid delivery mechanism. One or more apertures (e.g., nozzles, orifices, or ports) 30 are positioned in the thrombus removal system to be in fluid communication with the fluid lumen 45 and an irrigation manifold 25. In operation, the ports 30 are adapted to direct (e.g., pressurized) fluid toward thrombus that is engaged with the distal portion 10 of the thrombus removal system.

[0070] 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 clots. In some embodiments, the fluid source itself can be delivered in a pulsed sequence or a preprogrammed sequence that includes some combination of pulsatile flow and constant flow to deliver fluid to the jets. In these embodiments, while the average pulsed fluid velocity may be up to 20 m / s, the peak fluid velocity in the lumen may be up to 30 m / s or more during the pulsing of the fluid source. In some embodiments, the jets or apertures are no smaller than - 9 -SG Docket No.: 10844-737.6680.0100” or even as small as 0.008” to avoid undesirable spraying of fluid. In some embodiments, the system can have a minimum vacuum or aspiration pressure of 15 inHg, to remove target clots after they have been macerated or broken up with the jets described above.

[0071] The thrombus removal system can be sized and configured to access and remove thrombi in various locations or vessels within a patient’s body. It should be understood that while the dimensions of the system may vary depending on the target location, 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 pulmonary embolism (PE) from a patient may have an outer wall / tube with a size of approximately 11-13 Fr, or preferably 12 Fr, and an inner wall / tube with a size of 7-9 Fr, or preferably 8 Fr. A deep vein thrombosis (DVT) device, on the other hand, may have an outer wall / tube with a size of approximately 9-11 Fr, or preferably 10 Fr, and an inner wall / tube with a size of 6-9 Fr, or preferably 7.5 Fr. Applications are further provided for ischemic stroke and peripheral embolism applications.

[0072] Section B-B of FIG. IB illustrates in plan view a portion of the thrombus removal system that is proximal to the funnel and irrigation manifold. Section B-B depicts an outer wall 140, an inner wall 150, an aspiration lumen 155 and a fluid lumen 145. In some embodiments, in cross-section the aspiration lumen 155 is generally circular and the fluid lumen 145 is generally annular in shape (e.g., cross-section 70). It will be appreciated that alternative constructions and / or arrangements of the inner wall 150 and the outer wall 140 produce variations in cross-sectional shape of the aspiration and fluid lumens 155 and 145. For example, the inner wall 150 can be shaped to form an aspiration lumen 155 that, in crosssection, is generally oval, circular, rectilinear, square, pentagonal, or hexagonal. The inner and outer walls 150 and 140 can be shaped and arranged to form a fluid lumen 145 that, in cross-section, is generally crescent-shaped, diamond shaped, or irregularly shaped. For example, referring to FIG. 1C Section B-B, the region between the inner wall 150 and the outer wall 140 can include one or more wall structures 165 that form respective fluid lumens 145 (e.g., as in cross-section 80). The wall structures 165 can be formed by lamination between the outer and inner walls 140 and 150, or by a multi -lumen extrusion that forms a plurality of the wall structures.

[0073] Section B-B of FIGS. 1D-1H illustrate additional examples of a portion of the thrombus removal system that is proximal to the funnel and irrigation manifold. Similar to the embodiments described above, the portion in these examples can include an outer wall 140, an inner wall 150, and an aspiration lumen 155. Additionally, the illustrated portion of- 10 -SG Docket No.: 10844-737.668the thrombus removal system can include a middle wall 170 disposed between the outer wall 140 and the inner wall 150. The middle wall 170 enables further segmentation of the annular space between the inner wall and outer wall into a plurality of distinct fluid lumens and / or auxiliary lumens. For example, referring to FIG. ID, the middle wall can be generally hexagon shaped, and the annular space can include a plurality of fluid lumens 145a- 141 and a plurality of auxiliary lumens 175a-175f. As shown in FIG. ID, the fluid lumens can be formed by some combination of the outer wall 140 and the middle wall 170, or between the middle wall 170, the inner wall 150, and two of the auxiliary lumens. For example, fluid lumen 145a is formed in the space between outer wall 140 and middle wall 170. However, fluid lumen 145g is formed in the space between middle wall 170, inner wall 150, auxiliary lumen 175a, and auxiliary lumen 175b. Generally, the fluid lumens are configured to carry a flow of fluid such as saline from a saline source of the system to one or more ports / apertures / orifices of the system. The auxiliary lumens can be configured for a number of functions. In some embodiments, the auxiliary lumens can be coupled to the fluid / saline source and to the apertures to be used as additional fluid lumens. In other embodiments, the auxiliary lumens can be configured as steering ports and can include a guide wire or steering wire within the lumen for steering of the thrombus removal system. Additionally, in other embodiments, the auxiliary lumens can be configured to carry electrical, mechanical, or fluid connections to one or more sensors. For example, the system may include one or more electrical, optical, or fluid based sensors disposed along any length of the system. The sensors can be used during therapy to provide feedback for the system (e.g., sensors can be used to detect clogs to initiate a clog removal protocol, or to determine the proper therapy mode based on sensor feedback such as jet pulse sequences, aspiration sequences, etc.). The auxiliary ports can therefore be used to connect to the sensors, e.g., by electrical connection, optical connection, mechanical / wire connection, and / or fluid connection. It is also contemplated that the fluid and auxiliary lumens can be configured to carry and deliver other fluids, such as thrombolytics or radio-opaque contrast injections to the target tissue site during treatment.

[0074] It should be understood that in some embodiments, all the fluid lumens are fluidly connected to all of the jets or apertures of the thrombus removal device. Therefore, when a flow of fluid is delivered from the fluid lumen(s) to the jets, all jets are activated with a jet of fluid at once. However, it should also be understood that in some embodiments, the fluid lumens are separate or distinct, and these distinct fluid lumens may be fluidly coupled to one or more jets but not to all jets of 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.- 11 -SG Docket No.: 10844-737.668This enables additional functionality in the device, in which specific jets can be activated in a user defined or predetermined order.

[0075] In various embodiments, the fluid pressure is generated at the pump (in the console or handle). The fluid is accelerated as it exits the ports at the distal end and is directed to the target clot. In this way a wider variety of cost-effective components can be used to form the catheter while still maintaining a highly-effective device for clot removal. Additional details are provided below.

[0076] Section B-B of FIG. IE illustrates another embodiment of the portion of the thrombus removal system that is proximal to the funnel and irrigation manifold. Similar to the embodiment of FIG. ID, this embodiment also includes a middle wall 170. However, the middle wall in this example is generally square shaped, facilitating the formation of fluid lumens 145a-145k and auxiliary lumens 175a-175d. The example illustrated in section B-B of FIG. IF is similar to that of the embodiment of FIG. IE, however this embodiment includes only fluid lumens 145a-145d. The fluid lumens 145e-145k from the embodiment of FIG. IE are not used as fluid lumens in this embodiment. They can be, for example, empty lumens, vacuum, filled with an insulative material, and / or filled with a radio-opaque material or any other material that may help visualize the thrombus removal system during therapy. The embodiment IF includes the same four auxiliary reports as illustrated and described in the embodiment of FIG. IE.

[0077] Section B-B of FIG. 1G illustrates another example of a portion of the thrombus removal system that is proximal to the funnel and irrigation manifold. Similar to the embodiments described above, the illustrated portion of the thrombus removal system can include a middle 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 wall structures 165. As with the embodiment of FIG. 1C, the wall structures 165 can be formed by lamination between the outer and inner walls 140 and 150, or by a multi-lumen extrusion that forms a plurality of the 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 for sensor connections as described above.

[0078] Section B-B of FIG. 1H is another similar embodiment in which the middle wall and 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 middle wall and the inner wall. It should be understood that the middle wall can contact the outer wall to create independent fluid lumens 145a and 145b. However, in other embodiments, it should be understood that the middle wall may not contact the outer wall, which would facilitate a single annular fluid lumen, such as is - 12 -SG Docket No.: 10844-737.668shown by fluid lumen 145 in Section B-B of FIG. II. In another embodiment, as shown in Section B-B of FIG. 1 J, the inner wall 150 and the outer wall 140 may not be concentric, which facilitates formation of an annular space and / or fluid lumen 145 that is thicker or wider on one side of the device relative to the other side. As shown in FIG. 1 J, a distance between the exemplary outer wall 140 and inner wall at the top (e.g., 12 o’clock) portion of the device is larger than a distance between the outer wall and inner wall at the bottom (e.g., 6 o’clock) portion of the device.

[0079] Section C-C of FIG. IK illustrates in plan view a portion of the thrombus removal system comprising an irrigation manifold 225. Section C-C depicts an outer wall 240, an inner wall 250, a fluid lumen 245, an aspiration lumen 255, and ports 230 for directing respective fluid streams 210.

[0080] Detail View 101 of FIG. IL illustrates a section view in elevation of a portion of the irrigation manifold 25 that includes a plurality of ports 230 that are formed within an inner wall 250. In some embodiments, a thickness of one or more walls of the thrombus removal system may be varied along its axial length and / or its circumference. As shown in Detail View 101, inner wall 250 has a first thickness 265 in a region 250 that is proximal to the irrigation manifold 25, and a second thickness 270 in a region 235 that includes the ports 230. In some embodiments, the second thickness 270 is greater than the first thickness 265. The first thickness 265 can correspond to a general wall thickness of the inner wall 50 and / or of the outer wall 40, which can be from about 0.10 mm to about 0.60 mm, or any value within the aforementioned range. The second thickness 270 can be from about 0.20 mm to about 0.70 mm, from about 0.70 mm to about 0.90 mm, or from about 0.90 mm to about 1.20 mm. The second thickness 270 can be any value within the aforementioned range. The dimension of the second thickness 270 can be selected to provide a fluid path through the ports 230 that produces a generally laminar flow for a fluid stream that is directed therethrough, when the fluid delivery mechanism supplies fluid via the fluid lumen 245 at a typical operating pressure. Such operating pressure can be from about 10 psi to about 60 psi, from about 60 psi to about 100 psi, or from about 100 psi to about 150 psi. The operating pressure of the fluid delivery mechanism can be any value within the aforementioned range of values. In some embodiments, the fluid delivery mechanism is operated in a high pressure mode, having a pressure from about 150 psi to about 250 psi, from about 250 psi to about 350 psi, from about 350 psi to about 425 psi, or from 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 range of values.- 13 -SG Docket No.: 10844-737.668

[0081] The manifold is configured to increase a fluid pressure and / or flow rate of the fluid. When fluid is provided by the fluid delivery mechanism to the fluid lumen(s) 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 is configured to increase the flow rate of the fluid to a second flow rate. The second pressure and / or second fluid rate can be higher than the first pressure and / or first flow rate. As a result, the manifold can be configured to increase the relatively low operating pressures and / or flow rates generated by the fluid delivery mechanism to the relatively high pressures and / or high flow rates generated by the ports / fluid streams.

[0082] In some embodiments, a profile (cross-sectional dimension) of a port 230 varies along its length (e.g., is non-cylindrical). A variation in the cross-sectional dimension of the port may alter and / or adjust a characteristic of fluid flow along the port 230. For example, a reduction in cross-sectional dimension may accelerate a flow of fluid through the port 230 (for a given volume of fluid). In some embodiments, a port 230 may be conical along its length (e.g., tapered), such that its smallest dimension is positioned at the distal end of the port 230, where distal is with respect to a direction of fluid flow.

[0083] In some embodiments, the port 230 is formed to direct the fluid flow along a selected path. FIGS. 2A-2E illustrate various embodiments of arrangements of ports 230 for directing respective fluid streams 210. In some embodiments, such as those shown in FIGS. 2A and 2B, at least two ports 230 are arranged to produce (e.g., respective) fluid streams 210 that intersect at an intersection region 237 of the thrombus removal system. An intersection region 237 can be a region of increased fluid momentum and / or energy transfer, which multiply with respect to individual fluid streams that are not directed to combine at the intersection. The increased fluid momentum and / or energy transfer at an intersection may advantageously fragment thrombus more efficiently and / or quickly. As described above, the fluid streams can be configured to accelerate and cause cavitation and / or other effects to further add to breaking up of the target clot. In some embodiments, an intersection region can be formed from at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, at least 9, or at least 10 fluid streams 210. An intersection region can be generally near a central axis 290 of the thrombus removal system (e.g., 237), or away from the central axis (e.g., 238 and 239 in the embodiment of FIG. 2D). In some embodiments, at least two intersection regions (e.g., 238 and 239) are formed. In some embodiments, one or more ports 230 are arranged to direct a fluid stream 210 along an oblique angle with respect to the central axis of the thrombus removal system. An operating pressure of the fluid delivery mechanism may be selected to approach a minimum targeted fluid velocity for a fluid stream 210 that is- 14 -SG Docket No.: 10844-737.668delivered from a port 230. The targeted fluid velocity for a fluid stream 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 targeted fluid velocities in some embodiments can be in the range above 15m / s to up tol50 m / s. At these higher velocities (e.g. above 15m / s, or alternatively above 20m / s), the fluid streams may be configured to generate cavitation in a target thrombus or tissue. It has been found that with fluid exiting from the ports to these flow rates a cavitation effect can be created in the focal area of the intersecting or colliding fluid streams, or additionally at a boundary of one or more of the fluid streams. While the exact specifications may change based on the catheter size, in general, at least one of the fluid streams should be accelerated to such a high velocity to create cavitation as described in detail below. The targeted fluid velocity for fluid stream 210 can be any value within the range of aforementioned values. 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 the substantially the same fluid velocities, for a given pressure of the fluid delivery mechanism. In some embodiments, one port is adapted to deliver fluid at high velocity and the respective one or more other ports is adapted to deliver fluid at relatively lower velocities. Advantageously, an increased cross-sectional area of the fluid lumen 145 reduces a required operating pressure of the fluid delivery mechanism to achieve a targeted fluid velocity of the fluid streams.

[0084] In some embodiments, the fluid streams are configured to create angular momentum that is imparted to a thrombus. In some examples, angular momentum is imparted on the thrombus by application of a) at least one fluid stream 210 that is directed at an oblique angle from a port 230, and / or b) at least two fluid streams 210 that have different fluid velocities. For example, fluid streams that cross near each other but do not necessarily intersect may create a “swirl” or rotational energy on the clot material. Advantageously, angular momentum produced in a thrombus may impart a (e.g., centrifugal) force that assists in fragmentation and removal of the thrombus. Rotating of the clot may enhance delivery of the clot material to the jets. By example, with a large, amorphous clot the soft material may be easily aspirated or broken up by the fluid streams whereas tough fibrin may be positioned away from the fluid streams. Rotating or swirling of the clot moves the material around so the harder clot material is presented to the jets. The swirling may also further break up the clot as it is banged inside the funnel.

[0085] Referring to FIGS. 3A-3H, ports 330 can be arranged along various axial positions of the thrombus removal system. The thrombus removal system can include a flow axis 305- 15 -SG Docket No.: 10844-737.668that is aligned with a general direction (e.g., distal-to-proximal) of flow for fluid that is aspirated therein. In some embodiments, a position of a port 330 comprises a) near a base of, b) in a middle portion of, c) in a distal portion of, or d) proximal to, a funnel portion 320 of the thrombus removal system. In some embodiments, at least two ports 330 are aligned along flow axis 305. In some embodiments, at least two ports 330 are arranged at a different axial and / or angular positions along the flow axis 305. In some embodiments, at least two ports 330 are arranged (e.g., along a perimeter of the thrombus removal system) along a given axial position of the flow axis 305.

[0086] FIGS. 4A-4E illustrate various configurations of a thrombus removal system 400, including a thrombus removal device, 402, a vacuum source and cannister 404, and a fluid source 406. In some embodiments, the vacuum source and cannister and the fluid source are housed in a console unit that is detachably connected to the thrombus removal device. A fluid pump can be housed in the console, or alternatively, in the handle of the device. The console can include one or more CPUs, electronic controllers, or microcontrollers configured to control all functions of the system. The thrombus removal device 402 can include a funnel 408, a flexible shaft 410, a handle 412, and one or more controls 414 and 416. For example, in the embodiment shown in FIG. 4 A, the device can include a finger switch or trigger 414 and a foot pedal or switch 416. These 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 414, which can be used to control both functions, or in FIG. 4C, the device can include only an overpedal 416, also used to control both functions. It is also contemplated that an embodiment could include only a finger switch to control both aspiration and irrigation functions. As shown in FIG. 4A, the vacuum source can be coupled to the aspiration lumen of the device with a vacuum line 418. Any clots or other debris removed from a patient during therapy can be stored in the vacuum cannister 404. Similarly, the fluid source (e.g., a saline bag) can be coupled to the fluid lumens of the device with a fluid line 420.

[0087] Still referring to FIG. 4A, electronics line 422 can couple any electronics / sensors, etc. from the device to the console / controllers of the system. The system console including the CPUs / electronic controllers can be configured to monitor fluid and pressure levels and adjust them automatically or in real-time as needed. In some embodiments, the CPUs / electronic controllers are configured to control the vacuum and irrigation as well as electromechanically stop and start both systems in response to sensor data, such as pressure data, flow data, etc.- 16 -SG Docket No.: 10844-737.668

[0088] In FIG. 4D, a system assembly is shown including a funnel 408 and a flexible shaft 410 of a thrombus removal device inserted into a steerable introducer catheter 31. A hub assembly such as a Touhy Borst is shown which can provide access for a medical device into the steerable introducer catheter and include an injection port for fluidic connection to the contrast injector 424. In this embodiment, injection of contrast from the injector 424 into the hub assembly provides the contrast agent into the annular space between the introducer catheter 31 and the thrombus removal device (e.g., the shaft of the thrombus removal device).

[0089] FIG. 4E shows the funnel 408 of the thrombus removal device axially disposed out of a distal end of the introducer catheter 31. In this example, contrast delivered by the injector 424 into the annular space can still be delivered into the patient, even when the funnel is in a deployed configuration. In some examples, the funnel can disperse the contrast agent as it is delivered past the funnel from the annular space.

[0090] As is described above, aspiration occurs down the central lumen of the device and is provided by a vacuum pump in the console. The vacuum pump can include a container that collects any thrombus or debris removed from the patient.

[0091] FIG. 5 is another example of a thrombectomy system 500 that can include a thrombectomy catheter 501 and a thrombectomy console 502. The catheter 501 can include a catheter shaft, an optional expandable funnel at a distal end of the shaft, and a handle with an aspiration line 504 coupled to an aspiration lumen in the catheter and an irrigation line 506 coupled to a fluid line or lumen for delivery of fluid to one or more jets or irrigation ports at a distal end of the catheter. The handle can further include a guidewire or auxiliary port 508 for gaining access to the aspiration lumen of the device, such as for introducing a guidewire into the catheter and / or introducing other fluids into the aspiration lumen.

[0092] The catheter can be introduced into the patient with an introducer sheath 503 which can include a handle and a sheath shaft. The introducer sheath can include a pressure sensor for measuring pressure in the patient and a flush line for introducing fluid into the annular space between the introducer sheath and the thrombectomy catheter (e.g., saline, contrast, etc.). A dilator 505 can be introduced into the introducer sheath to assist in gaining access to the patient anatomy.

[0093] The console 502 can include a display 509 for providing information to a user on a given procedure, a saline or fluid source 510 coupled to the irrigation line of the catheter, and a source of vacuum 511 (e.g., within the console) coupled to the aspiration line of the catheter. The vacuum source can be fluidly coupled to a collection cannister 512 and clot trap or filter 513 for capturing removed clot and / or separating blood from removed clot. The- 17 -SG Docket No.: 10844-737.668console can also include one or more electrical connections to a switch or electronics line of the catheter.Blood and Clot Collection and Return

[0094] FIG. 6 is a schematic diagram of a thrombectomy system 600 that includes a thrombectomy catheter 602, a vacuum pump 604, a saline pump 606, and a vacuum cannister 608. The vacuum cannister can include a first reservoir or first collection container 610 and a second reservoir or second collection container 612. In the illustrated embodiment, the first reservoir and the second reservoir are disposed within the vacuum cannister. At least one valve, such as valves 616 and 622, can be selectively controlled to direct material aspirated from a patient with the catheter into one or both of the first and second reservoirs. The valves can be controlled based on a system state, a measured pressure or parameter, or an operating mode of the catheter.

[0095] For example, in some aspects, the catheter may include a clot hunting or clot searching mode and a clot clearing or clot extraction mode. Various features or parameters of the system may be activated or deactivated based on the operating mode.

[0096] During a clot searching mode of the system, jet valve 614 can be closed (to turn off or prevent jetting or prevent delivery of jetted fluid streams from the catheter into the patient) and search valve 616 can be opened, or be periodically opened and closed, to selectively couple the vacuum pump 604 to the catheter 602. During this clot searching mode, a small volume of blood or biological material is removed from the patient and collected in first reservoir 610 within vacuum cannister 608. This blood can be removed via syringe 618 through filter 620 at any time during or after the procedure for return of blood to the patient.

[0097] It is noted that in this clot searching mode, there is no jetted fluid or jetted fluid streams delivered into the patient. Jetted fluid streams, for the purposes of this disclosure, can be high velocity or high pressure fluid streams designed and configured to interact with and break up clot material. Jetted fluid streams are distinguished from lower flow, or lower velocity / pressure irrigation streams. In the context of a thrombectomy procedure, a jetted fluid stream may introduce the risk of hemolysis into the patient’s blood. Therefore, it is desirable to avoid returning blood to a patient which may have interacted with jetted fluid streams. However, blood may be returned if irrigation fluid is introduced to the blood (not jetted fluid). Therefore, for purposes of this disclosure, in the clot searching mode there is no jetted fluid introduced into the patient, but an irrigation fluid is acceptable.

[0098] Once clot has been engaged, a clot extraction mode is initiated, either automatically or by the user, in which search valve 616 can be closed, and extract valve 622- 18 -SG Docket No.: 10844-737.668can be opened. Jet valve 614 can also be opened to activate the jets and introduce jetted fluid streams into the patient to break up the clot. The vacuum pump aspirates biological material from the patient, which can include clot and blood, into the catheter, through clot catcher or filter 624 and into second reservoir 612. Clot can remain within the clot catcher, and blood removed during clot extraction is stored within the second reservoir. This blood is not suitable to be returned to the patient (e.g., because of the risk of hemolysis introduced by the jetting), therefore the syringe 618 does not have access to this second reservoir. Rinse valve 626 can periodically be actuated to flush saline from the saline pump through the clot catcher and into the second reservoir. This function can rinse blood out of the clot catcher to provide better visibility to the removed clot within clot catcher 624.

[0099] In some aspects, the valves 616 and 622 are controlled simply based on whether jetted fluid streams are being introduced into the patient or not. For example, if jetting is activated, then valve 616 can be closed and valve 622 can be opened, to direct aspirated material form the catheter into reservoir 612. If jetting is not activated (e.g., only aspiration is activated, or aspiration is activated with fluid irrigation), then then valve 616 can be opened and valve 622 can be closed, to direct aspirated material form the catheter into reservoir 610. As discussed above, the blood within reservoir 610 can be returned to the patient via syringe 618.

[0100] In other aspects, the system can continuously monitor the pressure or other parameters within the aspiration lumen or the catheter during the clot hunting procedure, and periodically actuate search valve 616 between the vacuum pump and the distal end of the catheter to selectively couple the distal end to the vacuum pump. When the search valve is closed or clamped off, the pressure within the aspiration lumen can be monitored. If the pressure within the aspiration lumen quickly rebounds back towards atmospheric + blood pressure (e.g., 15 psi), then the system is likely not engaged with clot. However, if the pressure within the aspiration lumen does not rebound, then the system is likely engaged with clot. The system monitors to see if the vacuum remains stable or more quickly returns to atmospheric. Based on the rate of pressure change (aka rebound) and / or pressure in the lumen with successive cycles the system detects clot engagement. The system can then control valves 616 and 622 based on whether or not there is clot engagement. If a clot is engaged, then aspirated material can be directed to reservoir 612. If no clot is engaged, then the aspirated material can be directed to reservoir 610.

[0101] FIG. 7 is another example of a thrombectomy system 700, which can include similar functionality to that of thrombectomy system 600 discussed above. Thrombectomy system 700 includes a thrombectomy catheter 702, a vacuum pump 704, a saline pump 706,- 19 -SG Docket No.: 10844-737.668and a vacuum cannister 708. The vacuum cannister can include a first reservoir or first collection container 710 and a second reservoir or second collection container 712. In the illustrated embodiment, the first reservoir is disposed within the second reservoir, and the second reservoir is the vacuum cannister. At least one valve 715 is selectively coupled to one or more conduits leading from the aspiration catheter to the first and second reservoirs. The valve can be controlled to direct material aspirated from the patient with the catheter into one or both of the first and second reservoirs. The valve can be controlled based on a system state, a measured pressure or parameter, or an operating mode of the catheter.

[0102] The system 700 can further include optional filters or clot catchers 724 to collect thrombus prior to the first and second reservoirs. The system can also include a venting conduit or line from the first reservoir into the second reservoir. In some examples, the first reservoir comprises a blood collection bag disposed within the vacuum cannister. Without the venting line, since the vacuum cannister can be under vacuum, overfilling of the first reservoir can lead to the first reservoir “popping” or bursting. The venting conduit can prevent this from occurring, and can allow excess material to flow from the first reservoir to the second reservoir.

[0103] System 700 can also include a blood return syringe 718 connectable to the first reservoir for blood return to the patient. A filter 720 and stopcock 721 can be disposed in the fluid conduit or line between the syringe and the first reservoir to filter the blood and fluidly decouple the syringe when blood return is not required.

[0104] The at least one valve of the embodiment of FIG. 7 can be controlled in a similar manner to as described above. In some aspects, the valve is controlled to selectively direct aspirated material from the catheter into either the first reservoir or the second reservoir. In some examples, aspirated material can be directed into the first reservoir 710 when jetting or jetted fluid streams are turned off, or not delivered into the patient. However, when jetting is turned on or activated, the aspirated material can be directed into second reservoir 712 by the at least one valve 715.

[0105] The embodiments of FIGS. 6 and 7 show the clot catcher separate from the vacuum cannister / second reservoir. In additional embodiments, the clot catcher can be disposed within the vacuum cannister and / or within the second reservoir.

[0106] In the embodiment of FIG. 7, the at least one valve comprises a single valve configured to selectively occlude or open a first conduit leading to the first reservoir or a second conduit leading to the second reservoir. The valve can comprise, for example, a cam subassembly disposed on a stepper motor. The valve can be disposed on the console of the system, and be configured to engage with a tubing set of the catheter. In some examples, the - 20 -SG Docket No.: 10844-737.668tubing set can be routed into a cassette assembly 800, shown in FIG. 8A. In this example, a first fluid conduit is directed into an inlet 825 of the cassette assembly. A second fluid conduit 826 extends from the cassette assembly to the first reservoir discussed above, and a third fluid conduit 827 extends from the cassette assembly to the second reservoir discussed above. The cassette can be configured to be mounted onto the thrombectomy console, such that the valve 815 of the console is placed into communication with the second and third conduits. The valve can then be controlled to occlude either the second conduit, the third conduit, or both, to direct aspirated fluid to the desired reservoir as previously discussed.

[0107] FIG. 8B show additional details of the cassette which can include a cam subassembly 828 configured to interact with the fluid conduits within the cassette to selectively occlude the conduits. Rotation of the cam assembly, such as with a stepper motor on the console, can cause arms 829 and 830 to move to occlude the appropriate conduit, depending on the rotation of the cam assembly. It should be understood that while the cam assembly and cam arms are shown as being integrated into the cassette, in other embodiments they can be integrated directly into or onto the console, simplifying the connection. FIG. 8C is a view of the cassette mounted onto the console, placing the fluid conduits into communication with the valve.

[0108] FIGS. 9A-9B illustrate two embodiments of a vacuum cannister, such as the vacuum cannister described above. In FIG. 9A, a clot catcher 924 is disposed within the vacuum cannister, to allow for collection and presentation of clot within the cannister. FIG. 9B shows a vacuum cannister that can be used with the schematic of FIG. 7 and includes a clot catcher 924 included in the cannister along with a first reservoir 910 inside the cannister. The cannister itself can act as the second reservoir 912 for collecting blood during the clot extraction or jetting mode. Connections to the various other components of the system are shown, including ports for the vacuum pump, the inlet from the catheter, the outlet to the blood return syringe, and a venting port.

[0109] FIG. 10A is an example of a thrombectomy console, with a graphical user interface (GUI) presenting intraoperative guidance and information, including but not limited to pre and post treatment pressure waveform measured by the system within the body (e.g., within the pulmonary artery, left pulmonary artery, right pulmonary artery), the amount of blood removed from the patient, the current vacuum pressure at the distal end of the catheter. The GUI can also display the elapsed time of the procedure, and can include an indicator showing the current system state (e.g., standby, clot hunting, clot extraction, etc.).

[0110] In FIG. 10B, the GUI is shown overlaid with a procedure when the system is in standby or clot hunting mode. The pressure waveform is shown, and the system is not yet - 21 -SG Docket No.: 10844-737.668engaged with clot. If blood is removed at this point, it is monitored and tracked on the console GUI.[OHl] FIG. 10C shows the system engaged with clot, and the GUI indicates the clot engagement (in the clot engagement icon) and switches to a jetting mode in which fluid jets are delivered into the clot. The system displays the pressure on the console and also the volume of blood / clot removed, along with the pressure in the aspiration lumen.

[0112] FIG. 10D shows the GUI after the first clot has been removed, when the system is no longer engaged with clot and has returned to a standby or clot hunting mode. The total volume of blood / clot is still displayed, along with the pressure waveform within the PA, LPA, RPA, and the pressure in the aspiration lumen.Conclusion

[0113] The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0114] From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.

[0115] Unless the context clearly requires otherwise, throughout the description and the examples, the words "comprise," "comprising," and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to." As used herein, the terms "connected," "coupled," or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words "herein," "above," "below," and words of similar import, when used in this application, shall 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 number may also include the plural or singular number respectively. As used herein, the phrase "and / or" as in "A and / or B" refers to- 22 -SG Docket No.: 10844-737.668A alone, B alone, and A and B. Additionally, the term "comprising" is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.- 23 -SG Docket No.: 10844-737.668

Claims

CLAIMS:What is claimed is:

1. A system for removing thrombus from a patient, the system comprising: an elongate catheter having a distal end and an aspiration lumen disposed therein; a vacuum source fluidly coupled to the aspiration lumen and configured to reduce pressure in the aspiration lumen to engage thrombus with the distal end; one or more fluid ports disposed near the distal end; a fluid lumen disposed in the elongate catheter and in fluid communication with the one or more fluid ports, the fluid lumen configured to provide a flow of fluid to the one or more fluid ports to deliver one or more jetted fluid streams configured to break up the thrombus; at least one conduit fluidly coupled to the aspiration lumen; and at least one valve operatively coupled to the conduit, the at least one valve being controllable to direct aspirated material from the elongate catheter into a first collection container when jetted fluid streams are being delivered and to direct aspirated material from the elongate catheter into a second collection container when jetted fluid streams are not being delivered.

2. The system of claim 1, wherein the at least one conduit comprises a first conduit extending from the aspiration lumen to the at least one valve, a second conduit extending from the at least one valve to the first collection container, and a third conduit extending from the at least one valve to the second collection container.

3. The system of claim 2, wherein the at least one valve comprises a single valve.

4. The system of claim 3, wherein the single valve is configured to close the second fluid conduit to direct aspirated material to the second collection container and is configured to close the third fluid conduit to direct aspirated material to the first collection container.

5. The system of claim 2, wherein the at least valve comprises at least two valves.

6. The system of claim 1, wherein the first collection container is disposed within the second collection container.- 24 -SG Docket No.: 10844-737.6687. The system of claim 6, further comprising a venting conduit coupled between the first collection container and the second collection container.

8. The system of claim 1, further comprising at least one filter disposed along the at least one conduit between the aspiration lumen and the first collection container.

9. The system of claim 1, further comprising at least one filter disposed along the at least one conduit between the aspiration lumen and the first collection container.

10. The system of claim 2, further comprising a first filter disposed along the second conduit and a second filter disposed along the third conduit.

11. The system of claim 1, further comprising a console, the vacuum source and at least one valve being disposed on or in the console.

12. The system of claim 11, wherein the at least one conduit passes through a cassette assembly, the cassette assembly being mountable onto the console to place the at least one conduit into operative coupling with the at least one valve.

13. The system of claim 12, wherein the at least one valve comprises a pinch valve.

14. The system of claim 13, wherein the pinch valve comprises a cam subassembly disposed on a stepper motor.

15. The system of claim 1, further comprising a syringe assembly fluidly coupled to the first collection container, the syringe assembly being configured to pull aspirated material from the first collection container for return to the patient.

16. A system for removing thrombus, the system comprising: an elongate catheter having a distal end and an aspiration lumen disposed therein; a vacuum source fluidly coupled to the aspiration lumen and configured to reduce pressure in the aspiration lumen to engage thrombus with the distal end; at least one conduit fluidly coupled to the aspiration lumen; and- 25 -SG Docket No.: 10844-737.668at least one valve operatively coupled to the at least one conduit, the at least one valve being controllable to selectively direct aspirated material from the elongate catheter into a first collection container or into a second collection container.

17. The system of claim 16, wherein the at least one valve is configured to selectively direct the aspirated material based on a system state of the elongate catheter.

18. The system of claim 16, further comprising at least one pressure sensor disposed in the at least one fluid conduit or the aspiration lumen, wherein the at least one valve is configured to selectively direct the aspirated material based on a measured pressure.

19. The system of claim 16, wherein the elongate catheter is further configured to deliver a plurality of jetted fluid streams from the distal end, wherein the at least one valve is configured to selectively direct the aspirated material based on if the plurality of jetted fluid streams are being delivered.

20. The system of claim 16, wherein the at least one conduit comprises a first conduit extending from the aspiration lumen to the at least one valve, a second conduit extending from the at least one valve to the first collection container, and a third conduit extending from the at least one valve to the second collection container.

21. The system of claim 20, wherein the at least one valve comprises a single valve.

22. The system of claim 21, wherein the single valve is configured to close the second fluid conduit to direct aspirated material to the second collection container and is configured to close the third fluid conduit to direct aspirated material to the first collection container.

23. The system of claim 20, wherein the at least valve comprises at least two valves.

24. The system of claim 16, wherein the first collection container is disposed within the second collection container.

25. The system of claim 24, further comprising a venting conduit coupled between the first collection container and the second collection container.- 26 -SG Docket No.: 10844-737.66826. The system of claim 16, further comprising at least one filter disposed along the at least one conduit between the aspiration lumen and the first collection container.

27. The system of claim 16, further comprising at least one filter disposed along the at least one conduit between the aspiration lumen and the first collection container.

28. The system of claim 20, further comprising a first filter disposed along the second conduit and a second filter disposed along the third conduit.

29. The system of claim 16, further comprising a console, the vacuum source and at least one valve being disposed on or in the console.

30. The system of claim 29, wherein the at least one conduit passes through a cassette assembly, the cassette assembly being mountable onto the console to place the at least one conduit into operative coupling with the at least one valve.

31. The system of claim 30, wherein the at least one valve comprises a pinch valve.

32. The system of claim 31, wherein the pinch valve comprises a cam subassembly disposed on a stepper motor.

33. The system of claim 16, further comprising a syringe assembly fluidly coupled to the first collection container, the syringe assembly being configured to pull aspirated material from the first collection container for return to the patient.

34. A system for removing thrombus, the system comprising: an elongate catheter having a distal end and an aspiration lumen disposed therein; a vacuum source fluidly coupled to the aspiration lumen and configured to reduce pressure in the aspiration lumen to engage thrombus with the distal end; at least one conduit fluidly coupled to the aspiration lumen; at least one valve operatively coupled to the at least one conduit; and an electronic controller configured to determine a system state of the elongate catheter and to selectively control the at least one valve to direct aspirated material from the elongate catheter into a first collection container or a second collection container based on the system state.- 27 -SG Docket No.: 10844-737.66835. A system for removing thrombus, the system comprising: an elongated catheter having at least one aspiration lumen configured to remove thrombus material; an aspiration mechanism fluidly coupled to the aspiration lumen and configured to reduce pressure in the aspiration lumen; a pressure sensor configured to monitor a pressure inside the aspiration lumen; at least one valve disposed between the pressure sensor and the aspiration mechanism; and an electronic controller operatively coupled to the pressure sensor and the at least one valve, the electronic controller being configured to control the at least one valve and the aspiration mechanism to selectively direct aspirated material into a first reservoir or a second reservoir based on the monitored pressure.

36. The system of claim 35, further comprising a port fluidly coupling the first reservoir to a blood return syringe to extract blood from the first reservoir for blood return.

37. A thrombectomy system, comprising: an elongate catheter having a distal end and an aspiration lumen and fluid lumen disposed therein, the elongate catheter also having one or more fluid ports disposed near the distal end and in fluid communication with the fluid lumen, the one or more fluid ports being configured to deliver jetted fluid streams towards a thrombus; a console having a vacuum source, a fluid source, at least one valve, a first collection container, and a second collection container; a disposable tubing set removably coupled to the console and the elongate catheter, the disposable tubing set being configured to fluidly couple the aspiration lumen to the vacuum source and the fluid lumen to the fluid source, the disposable tubing set including a cassette assembly that interfaces one or more conduits of the disposable tubing set with the at least one valve; wherein the at least one valve is controllable to direct aspirated material from the elongate catheter into the first collection container when jetted fluid streams are being delivered and to direct aspirated material from the elongate catheter into the second collection container when jetted fluid streams are not being delivered.

38. A thrombectomy method, comprising: inserting a thrombectomy catheter into a patient’s vasculature;- 28 -SG Docket No.: 10844-737.668operating the thrombectomy catheter in a first operating mode in which fluid is jetted from the thrombectomy catheter into the patient while material is aspirated from the patient; operating the thrombectomy catheter in a second operating mode in which fluid is not jetted from the thrombectomy catheter while material is aspirated from the patient; and directing the aspirated material into a first collection container in the first operating mode and a second collection container in the second operating mode.

39. The method of claim 38, further comprising returning the material in the second collection container to the patient.

40. A method for removing thrombus, comprising: introducing a distal portion of an elongated catheter into the body of a patient, the catheter including an aspiration lumen in fluid communication with the distal end for removal of thrombus; positioning a distal end of the catheter in the region of a target thrombus; initiating a clot hunting mode in which blood is extracted from the patient into a first reservoir; detecting when a clot is engaged with the distal portion; and when the clot is engaged, initiating a clot extraction mode in which blood and clot is extracted from the patient into a second reservoir.

41. The method of claim 40, further comprising returning blood from the first reservoir to the patient.- 29 -SG Docket No.: 10844-737.668

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