Contrast injection and visualization system and method for thrombectomy devices

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 / 373,430, filed August 24, 2022, entitled "THROMBUS REMOVAL SYSTEMS AND ASSOCIATED METHODS," and U.S. Provisional Patent Application No. 63 / 380,984, filed October 26, 2022, entitled "CONTRAST INJECTION AND VISUALIZATION SYSTEMS AND METHODS FOR THROMBUS REMOVAL DEVICE," each of which is incorporated by reference in its entirety into this specification. 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. [Background technology]

[0002]

[0004] Thrombotic material can lead to blockage of fluid flow within the vascular system of mammals. Such blockages can occur in various areas of the body, such as the pulmonary system, peripheral vasculature, deep vasculature, or within the brain. Pulmonary embolism typically occurs when a blood clot originating in another part of the body (e.g., a vein in the pelvis or leg) breaks off and travels to the lungs.

[0003]

[0005] 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.

[0004]

[0006] Existing thrombectomy devices operate based on simple suction, which works well against certain clots but is largely ineffective against difficult, organized clots. Many patients presenting 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 lysis therapy, which can take hours or days to break up the clot.

[0005]

[0007] Visualization of the clot and the position of the thrombectomy device relative to the clot is also problematic. While positioning the thrombectomy catheter near the clot is fairly routine, properly positioning the thrombectomy catheter locally at the clot is particularly difficult. The further the catheter is from the clot before activating suction, the more blood may be unnecessarily aspirated.

[0006]

[0008] More 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 limited effectiveness and additional cost relative to aspiration or standard of care.

[0007]

[0009] Other recent developments have focused on slicing or macerating the clot, but these mechanisms are designed to reduce the risk of catheter clogging and do not address the problem of hard, large, organized clots. Summary of the Invention [Problem to be solved by the invention]

[0008]

[0010] There remains a need for devices that address these and other problems with existing venous thrombectomy techniques, including, but not limited to, fast, easy-to-use, and effective devices for removing various clot forms. [Means for solving the problem]

[0009]

[0020] 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.

[0010]

[0021] A method for visualizing a thrombectomy procedure is provided, comprising the steps of advancing a thrombectomy device to a target thrombus location, injecting a predetermined volume of contrast agent through one or more fluid lumens and one or more fluid ports of the thrombectomy device near the target thrombus location, visualizing the volume of contrast agent to identify the thrombus, capturing the thrombus in a funnel of the thrombectomy device, and delivering a fluid jet from a fluid source into the one or more fluid lumens to generate one or more jets from the one or more fluid ports to sever the thrombus.

[0011]

[0022] In one aspect, injecting the volume of contrast agent further comprises injecting the volume of contrast agent with a contrast agent injector of the thrombectomy device.

[0023] In one aspect, the volume of contrast agent enters one or more fluid lumens distal to the fluid source.

[0012]

[0024] In one aspect, the volume of contrast agent enters one or more fluid lumens that are proximal to the fluid source.

[0025] In some embodiments, the volume of contrast agent enters one or more fluid lumens at the fluid source.

[0013]

[0026] In one embodiment, the volume of contrast agent is less than 5 ml.

[0027] In one embodiment, the volume of contrast agent is less than 10 ml.

[0028] In one embodiment, the volume of contrast agent is less than 20 ml.

[0014]

[0029] In some aspects, the method includes periodically repeating the injecting and visualizing steps.

[0030] In one aspect, the method includes repeating the injecting and visualizing steps every 1 to 3 seconds.

[0015]

[0031] In other embodiments, the method includes repeating the injecting and visualizing steps every 3 to 5 seconds.

[0032] In one aspect, the method includes adjusting the concentration of the contrast agent in the jet fluid.

[0016]

[0033] In some embodiments, the method includes delivering two or more concentration densities of contrast agent to a target thrombus location to generate a gradient image of the thrombus.

[0034] In another aspect, the method includes repositioning the thrombus removal device adjacent to the thrombus based on the visualizing step.

[0017]

[0035] In one embodiment, the target thrombus location is located in the pulmonary artery.

[0036] 1. A method for visualizing a thrombectomy procedure, comprising: advancing a thrombectomy device to a target thrombus location; injecting a predetermined volume of contrast agent through one or more contrast lumens and one or more contrast ports of the thrombectomy device near the target thrombus location; visualizing the volume of contrast agent to identify the thrombus; capturing the thrombus in a funnel of the thrombectomy device; and delivering a fluid jet from a fluid source into one or more fluid lumens to generate one or more jets from the one or more fluid ports to sever the thrombus.

[0018]

[0037] In some embodiments, injecting the volume of contrast agent further comprises injecting a single dose of contrast agent with a contrast agent injector of the thrombectomy device.

[0038] In one embodiment, the volume of contrast agent is less than 5 ml.

[0019]

[0039] In one embodiment, the volume of contrast agent is less than 10 ml.

[0040] In another embodiment, the volume of contrast agent is less than 20 ml.

[0041] In some aspects, the method includes periodically repeating the injecting and visualizing steps.

[0020]

[0042] In some embodiments, the method includes repeating the injecting and visualizing steps every 1 to 3 seconds.

[0043] In some embodiments, the method includes repeating the injecting and visualizing steps every 3-5 seconds.

[0021]

[0044] In one embodiment, the one or more contrast lumens and one or more contrast ports are different from the one or more fluid lumens and one or more fluid ports.

[0045] In some embodiments, the method includes delivering two or more concentration densities of contrast agent to a target thrombus location to generate a gradient image of the thrombus.

[0022]

[0046] In another aspect, the method includes repositioning the thrombus removal device adjacent to the thrombus based on the visualizing step.

[0047] In one embodiment, the target thrombus location is located in the pulmonary artery.

[0023]

[0048] 1. A method for visualizing a thrombectomy procedure, comprising: advancing an introducer sheath and a dilator to a target thrombus location; delivering a predetermined volume of contrast agent between the introducer sheath and the dilator near the target thrombus location; visualizing the volume of contrast agent to identify the thrombus; removing the dilator from the introducer sheath; introducing a thrombectomy device into the introducer sheath; advancing the thrombectomy device through a distal opening of the introducer sheath to deploy a funnel portion of the thrombectomy device; capturing the thrombus in the funnel portion; and delivering a fluid jet from a fluid source into one or more fluid lumens and one or more jet ports of the thrombectomy device to generate one or more jets to sever the thrombus.

[0024]

[0049] In one aspect, the method includes aspirating the thrombus with a thrombectomy device.

[0050] In one aspect, the target thrombus location is in the subject's pulmonary artery.

[0051] In another embodiment, the contrast agent is delivered through grooves or slits in the dilator.

[0025]

[0052] In one aspect, the method includes delivering a predetermined volume of contrast agent from the introducer sheath to near the target thrombus location when the funnel portion of the thrombectomy device is deployed.

[0053] In some aspects, delivering the volume of contrast agent further comprises injecting the volume of contrast agent with a contrast agent injector of the thrombectomy device.

[0026]

[0054] In one embodiment, the volume of contrast agent is less than 5 ml.

[0055] In one embodiment, the volume of contrast agent is less than 10 ml.

[0056] In one embodiment, the volume of contrast agent is less than 20 ml.

[0027]

[0057] In another aspect, the method includes periodically repeating the delivering and visualizing steps.

[0058] In another aspect, the method includes repeating the delivering and visualizing steps every 1 to 3 seconds.

[0028]

[0059] In another aspect, the method includes repeating the delivering and visualizing steps every 3 to 5 seconds.

[0060] In another aspect, the method includes delivering two or more concentration densities of contrast agent to a target thrombus location to generate a gradient image of the thrombus.

[0029]

[0061] In another aspect, the method includes repositioning the thrombus removal device adjacent to the thrombus based on the visualizing step.

[0062] A thrombus removal catheter device is provided that includes an elongate catheter shaft, a funnel disposed on or near a distal end of the shaft, an aspiration lumen in the shaft, at least one fluid lumen coupled to a fluid source, at least one port disposed near the distal end of the at least one fluid lumen, the at least one port configured to generate a fluid jet to macerate or cut a target thrombus, and a contrast injector fluidically coupled to the shaft, the contrast injector configured to deliver a dose of contrast from the shaft to a target thrombus location.

[0030]

[0063] In some embodiments, the contrast injector is fluidly coupled to at least one fluid lumen distal to the fluid source.

[0064] In one aspect, the contrast injector is fluidly coupled to at least one fluid lumen that is proximal to the fluid source.

[0031]

[0065] In one aspect, the contrast injector is fluidly coupled to at least one fluid lumen in the fluid source.

[0066] In one aspect, the system includes one or more valves that are selectively controllable to allow contrast from the injector to enter the shaft of the thrombectomy device.

[0032]

[0067] In one aspect, one or more valves and / or injectors are configured to deliver a selected volume of contrast agent into the shaft at a selected time interval.

[0068] A contrast agent delivery system is provided that includes an elongated, steerable shaft, a lumen disposed within the shaft, a dilator assembly removably disposed within the shaft, and a contrast agent source in fluid communication with the lumen, the contrast agent source configured to deliver a predetermined volume of contrast agent to a target thrombus location between the dilator assembly and the shaft.

[0033]

[0069] In one embodiment, the dilator assembly includes one or more grooves where it interfaces with the shaft.

[0070] In one embodiment, the dilator assembly includes one or more slits where it interfaces with the shaft.

[0034]

[0071] In another embodiment, the dilator assembly includes one or more ports configured to deliver the volume of contrast agent.

[0072] In one aspect, the contrast source includes a contrast injector.

[0035]

[0073] In some embodiments, the contrast injector is configured to deliver a single dose of contrast agent that is less than 5 ml in volume.

[0074] In one embodiment, the contrast injector is configured to deliver a single dose of contrast agent having a volume of less than 10 ml.

[0036]

[0075] In one embodiment, the contrast injector is configured to deliver a single dose of contrast agent having a volume of less than 20 ml.

[0076] In another aspect, the contrast injector is configured to periodically deliver the volume of contrast agent.

[0037]

[0077] A medical device loading tool is provided that includes a funnel introducer including a distal opening and a proximal opening, and an introducer shuttle including an elongated shaft adapted to be inserted into the proximal opening, wherein a thrombus removal catheter having an expandable and collapsible funnel is configured to be loaded into the introducer funnel in a delivery configuration by pulling the thrombus removal catheter and funnel proximally through the funnel introducer and into the introducer shuttle.

[0038]

[0078] In one aspect, the infundibulum introducer is configured to reduce the loading force required to seat the infundibulum into the introducer shuttle.

[0079] In another aspect, the infundibulum introducer includes a chamfered edge on the inside of the distal opening configured to provide a smooth lead-in from the infundibulum introducer into the introducer shuttle.

[0039] 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]

[0040] [Figure 1]

[0012] 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]

[0014] 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]

[0015] 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 4D] FIG. 2 illustrates an embodiment of the system. [Figure 4E] FIG. 2 illustrates an embodiment of the system. [Figure 4F] FIG. 2 illustrates an embodiment of the system. [Figure 4G] FIG. 2 illustrates an embodiment of the system. [Figure 4H] FIG. 2 illustrates an embodiment of the system. [Figure 5A]

[0016] FIG. 1 illustrates one embodiment of a thrombus removal device. [Figure 5B] FIG. 1 is a diagram illustrating the embodiment. [Figure 5C] FIG. 1 is a diagram illustrating the embodiment. [Figure 5D] FIG. 1 is a diagram illustrating the embodiment. [Figure 5E] FIG. 1 is a diagram illustrating the embodiment. [Figure 6A]

[0017] FIG. 1 illustrates the sequence for advancing a delivery catheter and expander to a target thrombus location within a patient. [Figure 6B] FIG. 10 is a diagram illustrating the above sequence. [Figure 6C] FIG. 10 is a diagram illustrating the above sequence. [Figure 6D] FIG. 10 is a diagram illustrating the above sequence. [Figure 6E] FIG. 10 is a diagram illustrating the above sequence. [Figure 6F] FIG. 10 is a diagram illustrating the above sequence. [Figure 6G] FIG. 10 is a diagram illustrating the above sequence. [Figure 6H] FIG. 10 is a diagram illustrating the above sequence. [Figure 6I] FIG. 10 is a diagram illustrating the above sequence. [Figure 6J] FIG. 10 is a diagram illustrating the above sequence. [Figure 7]

[0018] FIG. 1 illustrates an example of an introducer catheter and a dilator having grooves configured to deliver contrast media to a target location, such as the pulmonary artery. [Figure 8] 1 is a flowchart illustrating a method for visualizing a thrombectomy procedure. DETAILED DESCRIPTION OF THE INVENTION

[0041]

[0080] 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.

[0042]

[0081] 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.

[0043]

[0082] 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.

[0044]

[0083] 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.

[0045]

[0084] 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.

[0046]

[0085] 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.

[0047]

[0086] The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed technology. System for thrombus removal

[0087] As presented above, the present technology is generally directed to a thrombus removal system. Such a system includes 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 fragment the thrombus with pressurized fluid, an aspiration mechanism configured to aspirate the thrombus 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.

[0048]

[0088] According to embodiments of the present technology, a fluid delivery mechanism can supply multiple fluid streams (e.g., jets) to a 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, the aspiration pump can generate a volume of lower pressure within the aspiration lumen near the proximal portion of the thrombus removal system to urge aspiration of the thrombus from the distal portion.

[0049]

[0089] Alternatively, according to further embodiments of the present technology, the fluid delivery mechanism can supply multiple contrast-containing fluid streams (e.g., contrast jets) to the fluid opening of the thrombectomy system for the introduction of contrast or dye through the fluid opening of the thrombectomy system into the patient. In some embodiments, the contrast-containing fluid streams or contrast jets can be supplied at a pressure or velocity sufficient to macerate, cut, fragment, pulverize, and / or encourage the thrombus to be removed from the proximal portion of the thrombectomy system. The contrast-containing fluid streams can serve the dual purpose of breaking up the thrombus into small pieces and visualizing the thrombectomy procedure and clot (e.g., in real time during the procedure). For example, the contrast-containing fluid streams can include a concentration of a radiopaque material.

[0050]

[0090] 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 a thrombus and / or tissue (e.g., blood vessel) wall 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 exemplary section AA of FIG. 1A depicts a dual-walled thrombus removal device configuration having an outer wall / tube 40 and an inner wall / tube 50. A suction lumen 55 is formed by the inner wall 50 and is centrally located. 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. One or more openings (e.g., nozzles, orifices, or ports) 30 are positioned in the thrombus removal system so as to be in fluid communication with the fluid lumen 45 and the irrigation manifold 25. In operation, the ports 30 are adapted to direct (e.g., be pressurized) fluid toward a thrombus engaged in the distal portion 10 of the thrombus removal system.

[0051]

[0091] 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 unwanted spraying of the fluid. In some embodiments, the system can have a minimum vacuum or aspiration pressure of 50.796 kPa (15 inHg) to remove the target clot after it has been macerated or comminuted by the jet.

[0052]

[0092] 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.

[0053]

[0093] 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.

[0054]

[0094] 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.

[0055]

[0095] 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.

[0056]

[0096] 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.

[0057]

[0097] 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.

[0058]

[0098] 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.

[0059]

[0099] 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.

[0060]

[0100] 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.

[0061]

[0101] Detail 101 of FIG. 1L illustrates an elevational cross-sectional view of a portion of irrigation manifold 25 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.

[0062]

[0102] 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.

[0063]

[0103] 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.

[0064]

[0104] 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, the fluid streams can be configured to accelerate, induce cavitation and / or other effects to further promote fragmentation of the target 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.

[0065]

[0105] 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.

[0066]

[0106] 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. Cavitation occurrence

[0107] The exemplary system includes fluid jet ports configured in a specific manner to enhance clot removal. Bench studies have shown that the exemplary fluid streams or jets dramatically improve clot removal through various mechanisms of action, optionally including, but not limited to, cavitation and water shear. In contrast to conventional fluid mechanisms for thrombectomy, in some embodiments herein, the fluid streams from each port are delivered at a flow rate (and pattern) sufficient to create cavitation and / or other preferential effects to improve clot removal. In certain instances, the cavitation effect is created by a large pressure drop and deceleration at the focal point and / or intersection of at least two fluid streams. Cavitation can provide a source of turbulent kinetic energy that can be used to mechanically fragment and / or liquefy a clot or other target tissue structure. When fluid velocity is sufficiently high, materials accumulate impact energy, which can cause deformation and fragmentation. This can also modify the surface properties of the clot to allow materials to penetrate, enabling cavitation within the clot. The impact or interaction of high-velocity jets causes hydrodynamic cavitation, whereby a pressure drop below the vapor pressure of the liquid creates bubbles that eventually collapse with significant mechanical energy within the cavitation field, causing a type of rupture in the clot material. Furthermore, when multiple jets are directed toward a focal point or close enough to each other, the closure velocity of the fluid particles is significantly higher (up to twice as fast) than a single jet. This forces fluid and / or particles out of the space between the fluid jets at high velocity. The velocity of the fluid jets is high enough to create a pressure drop below the vapor pressure, causing the fluid to evaporate. When the pressure rises again, the bubbles collapse, causing cavitation. The forces and cavitation effects of the exemplary system have been found to significantly exceed those of conventional fluid jets and mechanical tools such as rotating screws. In some instances, the collapse of the bubbles generates heat in or around the target tissue, which can further promote clot fragmentation. In bench studies, systems according to various embodiments have been able to remove certain clot material that could not be removed by simple suction or water jets.In other studies, the exemplary system was able to remove clot material in a fraction of the time of conventional systems.

[0067]

[0108] 4A-4H illustrate various configurations of a clot removal system 600, including a clot removal device 602, a vacuum source and canister 604, a fluid source 606, and a pump 607. 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. The fluid pump 607 can be housed in the console as shown 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 602 can include a funnel 608, a flexible shaft 610, a handle 612, and one or more controllers 614 and 616. For example, in the embodiment shown in FIG. 4A, the device can include a finger switch or trigger 614 and a foot pedal or switch 616, 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 616 that can be used to control both functions, or in FIG. 4C, the device can include only a foot platform 616 that is also used to control both functions. It is also envisioned that embodiments can include only a finger switch for controlling both the suction and irrigation functions. As shown in FIG. 4A, a vacuum source can be coupled to the suction lumen of the device with vacuum line 618. Any blood clots or other debris removed from the patient during therapy can be stored in vacuum canister 604. Similarly, a fluid source (e.g., a saline bag) can be coupled to the fluid lumen of the device with fluid line 620.

[0068]

[0109] 4A, electronics lines 622 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.

[0069]

[0110] 4D-4H illustrate embodiments of the thrombectomy system 600 that can additionally include a contrast agent injector 624 fluidly coupled to the fluid line 620 distal to the fluid source 606 (FIG. 4D) or proximal to the fluid source 606 (FIG. 4E), or to a fluid line or auxiliary lumen within another or different thrombectomy device from the fluid line and jet / port (FIG. 4F). In various embodiments, the contrast agent injector can be automatically controlled. The contrast agent injector can be configured to direct, apply, or inject a predetermined volume of contrast agent into the subject's bloodstream for purposes of visualizing one or more clots in the subject and / or the relative position of the thrombectomy device with respect to one or more clots. Controlled herein can include any of pressure, velocity, or volume, or any combination thereof. The contrast agent can be used, for example, to aid in positioning the thrombectomy device and / or to provide the user with information regarding hemodynamic status, vascular anatomy, and / or treatment progress / completion.

[0070]

[0111] In some embodiments, the imaging agent can be immunologically tagged with a specific marker or designed to be attracted to or accumulate on or within a target thrombus. For example, immunologically tagging a thrombus with an imaging agent involves attaching a molecule that can specifically bind to a component of the thrombus, thereby improving visualization of the clot during a medical imaging procedure. This technique can be used in medical imaging modalities such as computed tomography (CT), magnetic resonance imaging (MRI), and ultrasound, where the imaging agent helps to highlight specific structures within the clot.

[0071]

[0112] In some embodiments, molecules uniquely present on or near a thrombus can be identified. These molecules may be absent or minimally present in healthy tissue to ensure the specificity of the tagging process. Common targets include fibrin, the protein that forms the structural backbone of a thrombus, and other clot-specific proteins or receptors. Contrast agents can be designed to carry immunological tags. Contrast agents can be small molecules, nanoparticles, or specially designed biomolecules. The immunological tag, often an antibody or a small antibody fragment called a Fab fragment, can then be chemically attached to the contrast agent. This attachment can be achieved through various chemical conjugation techniques, such as biotin-streptavidin interactions, covalent bonds, or other specific binding mechanisms. According to embodiments of the present disclosure, the immunologically tagged contrast agent can be administered to a subject using the contrast agent injector described above. Depending on the imaging modality, the tagged agent may be injected into the bloodstream (e.g., using a contrast agent injector), ingested, or introduced through other appropriate routes. The contrast agent is configured to bind to or near the thrombus upon circulating through the vasculature due to a specific interaction between the tag and the target molecule. The tagged clot can be seen under normal medical imaging (e.g., CT, MRI, ultrasound). The tagged contrast agent is configured to localize to the thrombus area but enhance the visibility of the clot on the resulting image. This enhanced contrast makes the thrombus stand out against the surrounding tissue, aiding in accurate diagnosis and assessment of the size, shape, and location of the clot. In some aspects, the contrast agent may be injected directly into the clot. In some embodiments, the contrast agent may be delivered as part of a thrombolysis pretreatment procedure.

[0072]

[0113] The contrast injector 624 can be configured to automatically inject or deliver a selected volume or dose of any contrast agent into the thrombectomy system to aid in imaging of the thrombectomy device and / or the targeted thrombus. In some embodiments, the volume and timing of the contrast agent delivered by the injector are selected by the user or preselected, but the injector can be configured to automatically and / or continuously deliver the contrast agent at a selected volume and frequency. In the illustrated embodiment, the contrast injector may include a cradle assembly configured to receive one or more contrast injection syringes. The cradle assembly may include an automatic pusher or other mechanism configured to engage the syringes to inject contrast agent into the fluid lines of the thrombectomy system. As illustrated, the contrast injector is fluidly coupled to the fluid flow / injection components of the thrombectomy system. Thus, the contrast agent delivered to the thrombectomy system in these embodiments can then be delivered to the patient through the fluid / injection ports described above.

[0073]

[0114] Valve 626 can be controlled by a system processor or controller, for example, to facilitate the injection of contrast into the fluid stream. When valve 626 is in a closed state, fluid can pass from fluid source 606 through fluid line 620 into the aforementioned fluid lumen of the thrombectomy device and then through an injection orifice or port to facilitate cutting or maceration of clots trapped in the funnel of the device. However, when valve 626 is in an open state, contrast from a contrast injector can enter the fluid lumen of the thrombectomy device (e.g., fluid line 620) for delivery or injection into the patient at the funnel location (e.g., through the injection port).

[0074]

[0115] In the embodiment of FIG. 4D , fluid delivery from the fluid source 606 can be paused while contrast is being injected into the system, and only a fixed concentration of contrast can be delivered to the patient from the contrast injector. In other embodiments, a selected amount or volume of fluid from the fluid source can be blended or mixed with contrast from the contrast injector and delivered to the target location. The amount of fluid mixed with the contrast can be controlled to provide a desired or appropriate concentration of contrast for imaging. In some embodiments, fluid from the fluid source can be selectively mixed or blended with contrast from the contrast injector to provide different concentrations of contrast depending on the particular density or type of clot being imaged. For example, a high concentration of contrast may allow for better visualization of very solid or rigid portions of the clot (e.g., the leading edge of the clot), while a low concentration of contrast is sufficient to allow visualization of softer or more flexible portions of the clot. Thus, if the concentration of contrast agent injected does not achieve adequate visualization, the concentration can be adjusted and a bolus injection of another contrast agent can provide good visualization of the clot.

[0075]

[0116] However, in the embodiment of Figure 4E, the contrast injector delivers the contrast agent proximal to the fluid source 606, so that any contrast agent injected into the system is blended or mixed with the fluid in the fluid source. While the embodiment of Figure 4E does not have the ability to deliver contrast agent to a target location at an injection port independent of injection or fluid delivery, it is still able to produce a known concentration of contrast agent in the fluid source (e.g., knowing the volume of fluid in the fluid source and the amount of contrast agent injected into the fluid line by the contrast injector).

[0076]

[0117] While Figures 4D and 4E show delivery of contrast agent into the fluid line distal and proximal to the fluid source, respectively, it should be understood that in other embodiments, the contrast agent can be injected directly into the fluid source.

[0077]

[0118] Alternatively, in FIG. 4F , the contrast injector 624 can be fluidly coupled to a fluid line or auxiliary lumen within the thrombectomy device that is separate or distinct from the fluid lines and jet orifices / ports. For example, FIGS. 1B-1K above illustrate several embodiments in which the shaft of the thrombectomy device can include one or more fluid lumens fluidly coupled to the jet port, and further illustrate some embodiments that include additional auxiliary lumens not used for jetting or fluid delivery. Thus, the embodiment of FIG. 4F illustrates that fluid can be delivered through the fluid lumens and jet orifices to fragment or macerate a clot, and further provides a separate lumen within the shaft for contrast delivery separate from fluid delivery or jetting. As with other embodiments, the valve 626 can be controlled to enable delivery of contrast from the contrast injector 624 into the device (e.g., into an auxiliary lumen or contrast delivery lumen of the device). In this example, the auxiliary lumen can be fluidly coupled to a contrast delivery port or opening near the distal end of the device (e.g., near the distal end of the shaft or in the infundibulum itself).

[0078]

[0119] In another embodiment, instead of delivering contrast media into the auxiliary lumen of the thrombectomy device, as shown in Figures 4G-4H, the contrast media can be delivered to the annular space between the shaft of the thrombectomy device and an introducer sheath or catheter used to deliver and advance the thrombectomy device to the target clot location. Further details regarding the introducer sheath are described below and shown in particular in Figures 5A-5D, 6A-6E, and 7A-7C.

[0079]

[0120] FIG. 4G shows a system assembly including a thrombectomy device funnel 608 and flexible shaft 610 inserted into a steerable introducer catheter 31. A hub assembly, such as a Touhy Borst, is shown that allows medical device access into the steerable introducer catheter and can include an injection port for fluid connection to a contrast injector 624. In this embodiment, injection of contrast from the injector 624 into the hub assembly provides contrast into the annular space between the introducer catheter 31 and the thrombectomy device (e.g., the shaft of the thrombectomy device). FIG. 4H shows the thrombectomy device funnel 608 disposed axially from the distal end of the introducer catheter 31. In this example, contrast delivered by the injector 624 into the annular space can still be delivered to the patient even when the funnel is in the deployed configuration. In some instances, the funnel can disperse contrast as the contrast is delivered from the annular space through the funnel. While the embodiment of Figures 4G-4H shows the thrombectomy device inserted into an introducer catheter 31, it should be understood that any elongated or catheter-based medical device can be inserted into an introducer catheter and used with a contrast injector 624. Contrast can be deployed in the annular space between the medical device and the introducer catheter, as described above. The medical device may include an expandable element (such as, but not limited to, a funnel) that can be compressed or folded within the introducer catheter. Alternatively, a dilator device can be inserted into the introducer catheter, as described below.

[0080]

[0121] The contrast injector 624 of Figures 4D-4H can employ a control algorithm or protocol to provide consistent or controlled injection of contrast near the distal end of the thrombectomy device. In some embodiments, the contrast injector can be configured to inject a predetermined or preselected bolus or volume of contrast into the patient at the target thrombus location. For example, the contrast injector can be configured to deliver a bolus of contrast (e.g., a 5 ml bolus or "shot" of contrast) at a predetermined time interval (e.g., every 3-5 seconds). In some embodiments, the amount and frequency of the delivered bolus of contrast is determined by the system state of the thrombectomy device. Thus, the delivery of the contrast at the above amount and frequency can be tied to or triggered by a sensed state of the device or system during the clot removal procedure. For example, if the thrombectomy device is in a "clot-hunting" state where the clot is not engaged with the infundibulum, jetting is not activated or at a minimum, and suction is not activated or at a minimum, the contrast injector may be configured to deliver larger doses of contrast less frequently (e.g., 10 ml doses or "shots" of contrast every 5-10 seconds). Alternatively, if the system detects that a clot is engaged with the infundibulum and increases suction and jetting to remove the clot, the contrast injector may be configured to deliver smaller doses of contrast more frequently (e.g., 5 ml doses or "shots" every 1-3 seconds). Once the system determines that the clot has been removed, the contrast injector may again reduce the pace and volume of contrast delivery, or may stop contrast delivery entirely.

[0081]

[0122] While the above embodiments describe a fluid connection between a contrast injector and a thrombectomy device, it should be understood that some embodiments can include more than one fluid connection between the injector and the device. For example, a series of valves and fluid lines can be used to connect the contrast injector to two or more points along the fluid path of the device. For example, the fluid lines can include connections to the system proximal to the fluid source, distal to the fluid source, and can also include connections to non-fluid lumen connections, such as to an auxiliary lumen or to the annular space between the introducer catheter and the shaft of the thrombectomy system. One or more electronic valves can then be controlled by the system to determine where the contrast enters the system. For example, a valve between the injector and a fluid line distal to the fluid source can be opened to deliver a dose of contrast directly into the fluid line, which is then injected into the patient at the injection port. Alternatively, a valve between the injector and an auxiliary lumen can be opened to deliver a dose of contrast into the auxiliary lumen, facilitating delivery of the contrast independently of injection. Additionally, prior to treatment, a valve between the injector and the annular space between the introducer and shaft can be opened to allow contrast injection through the dilator / introducer prior to deployment of the thrombectomy device.

[0082]

[0123] 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 clots or debris that is removed from the patient.

[0083]

[0124] 5A-5D illustrate one embodiment of a medical device loading tool 500 configured to load a medical device, such as a thrombectomy catheter, into an introducer sheath. As described herein, the thrombectomy catheter may include a funnel at the distal end of the elongate shaft. The medical device loading tool 500 may be configured to collapse the funnel of the thrombectomy device for insertion into the introducer sheath and delivery into a subject.

[0084]

[0125] FIG. 5A is an exploded view of a medical device loading tool 500. The loading tool may include a funnel introducer 24 and an introducer shuttle 28. The funnel introducer may include a distal opening 36 and a proximal opening configured to receive the introducer shuttle. The inner diameter of the funnel introducer proximal opening can be configured to receive the outer diameter of the introducer shuttle. Together, the funnel introducer 24 and the introducer shuttle 28 can be configured to load a thrombectomy device as discussed herein into an introducer sheath or catheter. The funnel introducer and the introducer shuttle can be configured to compress the distal expandable portion (e.g., the funnel) of the thrombectomy catheter from an expanded / deployed configuration to a collapsed / delivery configuration. The medical device loading tool can further include an O-ring or seal 29 and a seal cap 32 configured to attach to the proximal end of the introducer shuttle. The medical device loading tool advantageously reduces the loading force required to seat the infundibulum 20 within the introducer shuttle 28 .

[0085]

[0126] FIG. 5B illustrates a medical device loading tool 500 with the distal tip of the introducer shuttle 28 inserted into the proximal portion of the infundibulum introducer 24. The infundibulum introducer may include a distal opening 36 generally shaped and configured to receive the funnel of the medical device. In some embodiments, the shape of the distal opening may correspond to or resemble the shape of a funnel. In some aspects, the shape of the distal opening may be a slightly narrowed or folded version of the shape of a funnel. The distal opening may be configured to reduce the loading force of the funnel into the introducer shuttle. In some embodiments, the proximal portion of the infundibulum introducer 24 may include a chamfered edge 34, which may provide a smooth lead-in from the infundibulum introducer into the introducer shuttle. When a medical device (such as a thrombectomy device) is inserted into the medical device loading tool and drawn proximally into the tool, the distal opening 36 of the infundibulum introducer 24 first engages the funnel or expandable element of the medical device, folding or partially folding the funnel or expandable element, and then continued proximal drawing of the medical device into the tool completely collapses or loads the funnel or expandable element into the introducer shuttle. When the funnel or expandable element is in the introducer shuttle, the funnel or expandable element may be considered to be in a folded or delivery configuration.

[0086]

[0127] 5C is a proximal view of introducer shuttle 28, showing O-ring or seal 29 and seal cap 32. As shown, the proximal end may be filleted or atraumatic to avoid hard edges that could damage the medical device as it is pulled through the loading tool and introducer shuttle.

[0087]

[0128] FIG. 5D shows a medical device loaded into a medical device loading tool 500. The medical device may include, for example, a thrombectomy device having an expandable element 508, such as an expandable funnel. As shown, the proximal end of a medical device catheter shaft 510 may be inserted into the opening 36 of the funnel introducer 24 and extend through the proximal end of the introducer shuttle 28. In some embodiments, the medical device may also be primed before being loaded into the loading tool. To prime the device, the device may be submerged in a water or fluid bath and the jet or irrigation port of the device may be activated to force water through the jet / irrigation port and into the water bath. A suction source may then be activated to draw water from the aspiration lumen of the device. Referring to FIG. 5E, a waste container 26 is shown that may be fluidly coupled to the aspiration lumen of the device. In some embodiments, the user may monitor the waste container during the priming process. The thrombectomy device is primed when no air bubbles are present in the lines leading to the waste container or in the container itself. In other embodiments, this process can be automated, for example, by running a priming sequence for a set period of time, or by attaching a sensor (such as an optical sensor) to the line leading to the waste container or to the container itself to monitor for the presence of air bubbles. When air is no longer detected by the sensor, the system can automatically stop the priming sequence.

[0088]

[0129] Returning to FIG. 5D , a medical device can be pulled proximally into the medical device loading tool 500. First, the funnel introducer 24 collapses or partially collapses the funnel or expandable element 508 of the medical device. Next, the medical device is pulled further proximally (indicated by arrow 38) into the introducer shuttle 28, placing the funnel or expandable element 508 in a delivery or collapsed configuration within the introducer shuttle. Once the funnel of the medical device is seated within the introducer shuttle, the funnel shuttle may be removed or split from the introducer shuttle. The primed and collapsed medical device can then be inserted into the introducer sheath with the introducer shuttle. In some embodiments, the primed and collapsed medical device can be inserted into a Touhy Borst, as in FIG. 4B , to load the medical device into the introducer sheath. Once the device is loaded into the sheath, the introducer shuttle engages the Touhy Borst and can remain in place or can be removed (e.g., torn) from the medical device. At this stage, the medical device (e.g., thrombectomy device) is primed, funneled, and ready for insertion into the patient.

[0089]

[0130] 6A-6E illustrate a sequence for advancing a delivery catheter and dilator to a target thrombus location within a patient. In the illustrated example, the one or more thrombi include one or more pulmonary embolisms (PEs) located in the patient's pulmonary arteries (PAs).

[0090]

[0131] 6A, a guidewire 624 can be inserted into the patient's vasculature and advanced toward the patient's target thrombus location. For example, the guidewire can be inserted into the patient's femoral vein and routed through the right atrium (RA) and right ventricle (RV) into the pulmonary artery. In some examples, the guidewire 624 passes through one or more thrombi in the pulmonary artery.

[0091]

[0132] 6B, the dilator 628 and introducer catheter 626 can be advanced over the guidewire into the patient. In FIG. 6B, the dilator 628 is shown in the RV before being advanced into the PA.

[0092]

[0133] FIG. 6C shows the dilator 628 and introducer catheter 626 further advanced over the guidewire into the pulmonary circulation, such as the pulmonary artery (PA). Once the dilator and introducer catheter are in the pulmonary artery, as shown, a contrast medium or agent can be delivered into the pulmonary artery. The contrast medium can be, for example, a “puff” or single dose of contrast medium that disperses within the pulmonary artery to image any nearby thrombi. In another embodiment, the contrast medium can be delivered continuously or in a “stream” that characterizes blood flow as opposed to highlighting clots. In one embodiment, the contrast medium can be injected directly by the introducer catheter 626 through one or more spaces between the dilator 628 and the introducer catheter. As described above, a contrast injector can be fluidly coupled or connected to the annular space between the thrombectomy device shaft and the introducer catheter or sheath. The contrast injector can be configured to automatically and / or continuously deliver a selected volume of contrast medium into this annular space and through the dilator. 7, in one implementation, the dilator 728 can include a groove 732, slit, port, or opening in fluid communication with a source of contrast agent to facilitate contrast agent injection from the introducer catheter 726 when the dilator is in place. For example, contrast agent can be delivered through the introducer catheter and between the dilator and the introducer catheter.

[0093]

[0134] In FIG. 6D , the dilator can be removed from the introducer catheter, leaving only the introducer catheter 626 positioned proximal to one or more target thrombi within the PA. In some embodiments, the introducer catheter can include one or more pressure sensors 630 positioned near the distal end of the introducer catheter. The pressure sensor 630 can be configured to continuously or periodically obtain pressure measurements from within the vasculature, such as within the PA. In some embodiments, the pressure sensor can provide a baseline pulmonary artery pressure before removing the thrombus. The pressure sensor may comprise, for example, a fiber optic pressure sensor. Other pressure sensor types, including fluid column sensors, are contemplated. In some embodiments, the pressure sensor can be configured to continuously monitor the PA pressure. During clot removal, the pressure sensor can provide useful information regarding the status of the procedure. For example, during removal, the pressure sensor can be used to monitor blood pressure within the vessel to characterize how effectively the thrombus removal system is removing the clot. Typically, the baseline pressure when a clot is present is elevated because blood cannot pass through the clot. During clot removal, the pressure can be continuously monitored, and a drop in pressure indicates to the user that the device has removed some or all of the clot.

[0094]

[0135] In FIG. 6E, the thrombectomy device 602 can be advanced within the sheath and passed through the distal opening of the introducer catheter 626. By advancing the thrombectomy device from the introducer catheter, the expandable funnel 608 of the thrombectomy device can be deployed or expanded within the PA. The thrombectomy device and introducer catheter can be further advanced and steered toward the thrombus or clot, as shown in FIG. 6F. At this stage of the procedure, the user can optionally inject an additional “puff” or dose of contrast agent into the vessel near the target thrombus location to visualize the clot and / or introducer catheter. The contrast agent can be delivered to the annular space between the thrombectomy device catheter and the introducer catheter. When the thrombectomy device funnel or expandable element 608 is deployed, the funnel can act to distribute the contrast agent near the thrombus. Note that pressure measurements can be taken continuously or periodically within the PA during this and all other steps of the procedure.

[0095]

[0136] In Figures 6G and 6H, a clot removal device can engage one or more clots within the PA to remove the clots. As described above, the clots can be removed with a combination of suction and a jet / fluid stream delivered into the clot to fragment or macerate it. The progress of the treatment can be monitored with on-demand "puffs" or single doses of contrast agent as needed. Additionally, as described above, pressure measurements can be obtained periodically or continuously with pressure sensor 630.

[0096]

[0137] In Figure 6I, with the clot removed, the thrombectomy device and introducer catheter can be retracted proximally within the patient. Another optional "puff" or dose of contrast agent can be delivered to the PA and previous clot location to confirm that the targeted clot has been removed. Pressure measurements can be taken with pressure sensor 630, if desired. In Figure 6J, the thrombectomy device and funnel can be retracted into the introducer catheter, and the entire system, including the introducer catheter, can be removed from the patient.

[0097]

[0138] In some embodiments, the thrombectomy device can be configured to deliver a single dose of contrast agent with a predetermined or user-selected contrast agent density to a target clot location. The ability to adjust the density or concentration of the delivered contrast agent can be used to refine or enhance visualization of clots, particularly complex clots with cross-sections or portions of varying density and stiffness. Injecting contrast agents of varying or different concentrations into a target clot location can achieve clot localization and also provide information about the clot density profile. In one implementation, multiple single doses or "shots" of contrast agent with varying contrast agent concentrations can be delivered to the clot location. An image gradient can then be formed from the sequential injections of varying contrast agent densities. For example, a first dose (e.g., 5 ml) of contrast agent with a first contrast agent density can be injected into the target clot location. A first image of the clot can be captured, highlighting cross-sections or portions of the clot that are well-suited or adapted to absorb or react to the first contrast agent density. Next, a second bolus (e.g., 5 ml) of contrast agent having a second contrast agent density can be injected into the target clot location. The second image of the clot highlights or images a different cross-section or portion of the clot compared to the first image. This can be repeated until the entire clot is imaged. In some instances, the various images of the clot at different contrast agent densities can be combined with image processing techniques to form a complete image of the clot based on the different contrast agent densities.

[0098]

[0139] 8 is a flowchart illustrating a method for visualizing a thrombectomy procedure. Referring to step 802, the method can include advancing a thrombectomy device to a target thrombus location. In some examples, the thrombectomy device is delivered to the target location with an introducer catheter. In other embodiments, the introducer catheter retrieves the thrombectomy device near the target thrombus location, and then the thrombectomy device is advanced from the introducer catheter.

[0099]

[0140] At step 804, the method can include injecting a single dose of contrast agent at the target thrombus location with the thrombectomy device. In some examples, the contrast agent can be injected through one or more fluid lumens and fluid ports of the thrombectomy device. In other embodiments, the contrast agent can be injected or delivered through another auxiliary lumen or contrast agent lumen and associated port of the thrombectomy device (e.g., injection separate from contrast agent delivery). Additionally, in another embodiment, the contrast agent can be delivered from the annular space between the introducer catheter and the thrombectomy device (or between the introducer and the dilator).

[0100]

[0141] In step 806, the method may include visualizing the dose of contrast agent to identify the thrombus. The imaging may be any medical imaging configured to image the contrast agent, including but not limited to ultrasound imaging, CT, MRI, X-ray, etc.

[0101]

[0142] In step 808, the method can include capturing the thrombus in a funnel of the thrombectomy device. For example, suction can be activated in the thrombectomy device to draw the thrombus into the funnel of the thrombectomy device. In some embodiments, additional contrast can be delivered to confirm placement of the thrombus within the device.

[0102]

[0143] In step 810, the method may include delivering a fluid jet from a fluid source into one or more fluid lumens to generate one or more jets from one or more fluid ports to cut, macerate, or fragment the thrombus. In some examples, suction may be used to draw or remove the thrombus fragments from the patient.

[0103]

[0144] 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.

[0104]

[0145] 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

[0146] 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.

[0105]

[0147] 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.

[0106]

[0148] 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. 1. A method of visualizing a thrombectomy procedure, comprising: advancing the thrombectomy device to the target thrombus location; injecting a predetermined volume of contrast agent through one or more fluid lumens and one or more fluid ports of the thrombus removal device near the target thrombus location; visualizing the volume of contrast agent to identify the thrombus; capturing the thrombus in a funnel of the thrombectomy device; delivering a fluid jet from a fluid source into the one or more fluid lumens to generate one or more jets from the one or more fluid ports to cut the thrombus.

2. The method of claim 1 , wherein injecting the volume of contrast agent further comprises injecting the volume of contrast agent with a contrast agent injector of the thrombectomy device.

3. The method of claim 1 , wherein the volume of contrast agent enters the one or more fluid lumens distal to the fluid source.

4. The method of claim 1 , wherein the volume of contrast agent enters the one or more fluid lumens that are proximal to the fluid source.

5. The method of claim 1 , wherein the volume of contrast agent enters the one or more fluid lumens at the fluid source.

6. The method of claim 1 , wherein the volume of contrast agent is less than 5 ml.

7. The method of claim 1 , wherein the volume of contrast agent is less than 10 ml.

8. The method of claim 1 , wherein the volume of contrast agent is less than 20 ml.

9. 10. The method of claim 1, further comprising periodically repeating the injecting and visualizing steps.

10. 10. The method of claim 9, further comprising repeating the injecting and visualizing steps every 1 to 3 seconds.

11. 10. The method of claim 9, further comprising repeating the injecting and visualizing steps every 3 to 5 seconds.

12. The method of claim 1 , further comprising adjusting the concentration of the contrast agent in the jet fluid.

13. The method of claim 1 , further comprising delivering two or more concentration densities of contrast agent to the target thrombus location to generate gradient images of the thrombus.

14. The method of claim 1 , further comprising the step of repositioning the thrombus removal device adjacent the thrombus based on the visualizing step.

15. The method of claim 1 , wherein the target thrombus location is located in a pulmonary artery.

16. 1. A method of visualizing a thrombectomy procedure, comprising: advancing the thrombectomy device to the target thrombus location; injecting a predetermined volume of contrast agent through one or more contrast lumens and one or more contrast ports of the thrombectomy device near the target thrombus location; visualizing the volume of contrast agent to identify the thrombus; capturing the thrombus in a funnel of the thrombectomy device; delivering a fluid jet from a fluid source into one or more fluid lumens to generate one or more jets from one or more fluid ports to cut the thrombus.

17. 17. The method of claim 16, wherein injecting the volume of contrast agent further comprises injecting a single dose of contrast agent with a contrast agent injector of the thrombectomy device.

18. 17. The method of claim 16, wherein the volume of contrast agent is less than 5 ml.

19. 17. The method of claim 16, wherein the volume of contrast agent is less than 10 ml.

20. 17. The method of claim 16, wherein the volume of contrast agent is less than 20 ml.

21. 17. The method of claim 16, further comprising periodically repeating the injecting and visualizing steps.

22. 22. The method of claim 21, further comprising repeating the injecting and visualizing steps every 1 to 3 seconds.

23. 22. The method of claim 21, further comprising repeating the injecting and visualizing steps every 3 to 5 seconds.

24. The method of claim 16 , wherein the one or more contrast lumens and the one or more contrast ports are different from the one or more fluid lumens and the one or more fluid ports.

25. 17. The method of claim 16, further comprising delivering two or more concentration densities of contrast agent to the target thrombus location to generate gradient images of the thrombus.

26. 17. The method of claim 16, further comprising the step of repositioning the thrombus removal device adjacent the thrombus based on the visualizing step.

27. 17. The method of claim 16, wherein the target thrombus location is located in a pulmonary artery.

28. 1. A method of visualizing a thrombectomy procedure, comprising: advancing the introducer sheath and dilator to the target thrombus location; delivering a volume of contrast agent between the introducer sheath and the dilator proximate the target thrombus location; visualizing the volume of contrast agent to identify the thrombus; removing the dilator from the introducer sheath; introducing a thrombectomy device into the introducer sheath; advancing the thrombectomy device through a distal opening of the introducer sheath to deploy a funnel portion of the thrombectomy device; capturing the thrombus in the infundibulum; and delivering a fluid jet from a fluid source into one or more fluid lumens and one or more jet ports of the thrombus removal device to generate one or more jets to cut the thrombus.

29. 30. The method of claim 28, further comprising aspirating the thrombus with the thrombus removal device.

30. 29. The method of claim 28, wherein the target thrombus location is in a pulmonary artery of the subject.

31. 29. The method of claim 28, wherein the contrast agent is delivered through grooves or slits in the dilator.

32. 30. The method of claim 28, further comprising delivering a volume of contrast agent from the introducer sheath to near the target thrombus location when the funnel portion of the thrombectomy device is deployed.

33. 30. The method of claim 28, wherein delivering the volume of contrast agent further comprises injecting the volume of contrast agent with a contrast agent injector of the thrombectomy device.

34. 29. The method of claim 28, wherein the volume of contrast agent is less than 5 ml.

35. 29. The method of claim 28, wherein the volume of contrast agent is less than 10 ml.

36. 29. The method of claim 28, wherein the volume of contrast agent is less than 20 ml.

37. 30. The method of claim 28, further comprising periodically repeating the delivering and visualizing steps.

38. 38. The method of claim 37, further comprising repeating the delivering and visualizing steps every 1 to 3 seconds.

39. 38. The method of claim 37, further comprising repeating the delivering and visualizing steps every 3 to 5 seconds.

40. 30. The method of claim 28, further comprising delivering two or more concentration densities of contrast agent to the target thrombus location to generate gradient images of the thrombus.

41. 30. The method of claim 28, further comprising repositioning the thrombus removal device adjacent the thrombus based on the visualizing step.

42. an elongated catheter shaft; a funnel disposed on or near the distal end of the shaft; a suction lumen in the shaft; at least one fluid lumen coupled to a fluid source; at least one port disposed near a distal end of the at least one fluid lumen, the at least one port configured to generate a fluid jet to macerate or cut a target thrombus; a contrast agent injector fluidly coupled to the shaft, the contrast agent injector configured to deliver a dose of contrast agent from the shaft to a target thrombus location.

43. 43. The apparatus of claim 42, wherein the contrast injector is fluidly coupled to the at least one fluid lumen distal to the fluid source.

44. 43. The apparatus of claim 42, wherein the contrast injector is fluidly coupled to the at least one fluid lumen proximal to the fluid source.

45. 43. The apparatus of claim 42, wherein the contrast injector is fluidly coupled to the at least one fluid lumen in the fluid source.

46. 43. The apparatus of claim 42, further comprising one or more valves selectively controllable to allow contrast agent from the injector to enter the shaft of the thrombectomy device.

47. 43. The apparatus of claim 42, wherein the one or more valves and / or the injector are configured to deliver a selected volume of contrast agent into the shaft at a selected time interval.

48. an elongated steerable shaft; a lumen disposed within the shaft; a dilator assembly removably disposed within the shaft; a contrast agent source in fluid communication with the lumen, the contrast agent source configured to deliver a predetermined volume of contrast agent to a target thrombus location between the dilator assembly and the shaft.

49. 49. The system of claim 48, wherein the dilator assembly includes one or more grooves that couple it to the shaft.

50. 49. The system of claim 48, wherein the dilator assembly includes one or more slits where it interfaces with the shaft.

51. 49. The system of claim 48, wherein the expander assembly includes one or more ports configured to deliver the volume of contrast agent.

52. 49. The system of claim 48, wherein the contrast source comprises a contrast injector.

53. 53. The system of claim 52, wherein the contrast injector is configured to deliver a single dose of contrast agent having a volume of less than 5 ml.

54. 53. The system of claim 52, wherein the contrast injector is configured to deliver a single dose of contrast agent having a volume of less than 10 ml.

55. 53. The system of claim 52, wherein the contrast injector is configured to deliver a single dose of contrast agent having a volume of less than 20 ml.

56. 53. The system of claim 52, wherein the contrast injector is configured to deliver the volume of contrast periodically.

57. an infundibular introducer including a distal opening and a proximal opening; an introducer shuttle including an elongate shaft adapted to be inserted into the proximal opening, wherein a thrombus removal catheter having an expandable and collapsible funnel is configured to be loaded into the introducer funnel in a delivery configuration by pulling the thrombus removal catheter and the funnel proximally through the funnel introducer and into the introducer shuttle.

58. 58. The tool of claim 57, wherein the infundibulum introducer is configured to reduce the loading force required to seat the infundibulum into the introducer shuttle.

59. 48. The tool of claim 47, wherein the infundibulum introducer includes a chamfered edge on the inside of the distal opening configured to provide a smooth lead-in from the infundibulum introducer into the introducer shuttle.

Images