WO2025054612A1 - Thrombus removal systems and associated methods - Google Patents

Abstract

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

Description

THROMBUS REMOVAL SYSTEMS AND ASSOCIATED METHODS

CLAIM OF PRIORITY

[0001] This application claims priority to U.S. Provisional Patent Application No. 63/581,157, titled “THROMBUS REMOVAL SYSTEMS AND ASSOCIATED METHODS,” and filed September 7, 2023, which is herein incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

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

FIELD

[0003] The present technology generally relates to medical devices and, in particular, to systems including aspiration and fluid delivery mechanisms and associated methods for removing a thrombus from a mammalian blood vessel.

BACKGROUND

[0004] Thrombotic material may lead to a blockage in fluid flow within the vasculature of a mammal. Such blockages may occur in varied regions within the body, such as within the pulmonary system, peripheral vasculature, deep vasculature, or brain. Pulmonary embolisms typically arise when a thrombus originating from another part of the body (e.g., a vein in the pelvis or leg) becomes dislodged and travels to the lungs. Anti coagulation therapy is the current standard of care for treating pulmonary embolisms, but may not be effective in some patients.

[0005] Additionally, conventional devices for removing thrombotic material may not be capable of navigating the tortuous vascular anatomy, may not be effective in removing thrombotic material, and/or may lack the ability to provide sensor data or other feedback to the clinician during the thrombectomy procedure. Existing thrombectomy devices operate based on simple aspiration which works sufficiently for certain clots but is largely ineffective for difficult, organized clots. Many patients presenting with deep clots in difficult to reach anatomical locations and/or deep vein thrombus (DVT) or PE are left untreated as long as the risk of limb ischemia is low. [0006] In more urgent cases, they are treated with catheter-directed thrombolysis or lytic therapy to break up a clot over the course of many hours or days.

[0007] More recently other tools like clot retrievers have been developed to treat DVT and pulmonary embolism (PE). Clot retrievers typically include a structure that is deployed from a distal end of the catheter within the vessel to capture thrombus and then withdrawn back into the distal end of the catheter for thrombus removal. The structure can include stentlike structures, expandable capture baskets, or capture structures that include passive capture features like rakes, barbs, or prongs to engage the clot. These tools are not being widely adopted because of their limited effectiveness, high mortality rates, and additional costs versus aspiration or the standard of care. Additionally, advancing the capture structure distally from the end of the catheter poses additional challenges including limited visualization of the clot relative to the capture device and the risk of damaging vessel walls with the passive capture structures. Other recent developments focus on slicing or macerating the clot, but these mechanisms are designed to reduce the risk of the catheter clogging and do not address the problem of tough, large, organized clots. There remains the need for a device to address these and other problems with existing venous thrombectomy including, but not limited to, a fast, easy-to-use, and effective device for removing a variety of clot morphologies in difficult to reach anatomical locations.

SUMMARY OF THE DISCLOSURE

[0008] In general, there is provided a thrombus removal device, comprising an elongate catheter having an aspiration lumen; an expandable funnel coupled to a distal tip of the elongate catheter; at least one mechanical engagement feature disposed within the distal tip; a first fluid lumen in elongate catheter fluidly coupled to a second fluid lumen in the distal tip, wherein a flow of fluid from the first fluid lumen into the second fluid lumen may be configured to deploy the at least one mechanical engagement feature within the expandable funnel.

[0009] In some examples, the at least one mechanical engagement feature may be configured to be deployed the expandable funnel towards a central axis of the aspiration lumen. The at least one mechanical engagement feature may be configured to be deployed generally radially within the expandable funnel across at least a portion of the expandable funnel. The at least one mechanical engagement feature comprises a cutting portion. The at least one mechanical engagement feature comprises a blunted tip.

[0010] In some examples, a thrombus removal device described herein may further comprise a fluid source in fluid communication with the first fluid lumen of the elongate catheter. A thrombus removal device may also comprise a jet orifice positioned within the distal tip and being fluidly coupled with the first fluid lumen, the jet orifice being configured to provide a fluid stream within the aspiration lumen or within the expandable funnel. A thrombus removal device described herein may further comprise an aspiration source in fluid communication with the aspiration lumen. The at least one mechanical engagement feature may further comprise a third fluid lumen extending therethrough.

[0011] During operation, the at least one mechanical engagement feature may be configured to direct a flow of fluid from the second fluid lumen through the third fluid lumen to provide a stream of fluid within the expandable funnel.

[0012] In some examples, the expandable funnel comprises a funnel frame configured to self-expand the expandable funnel to a fully expanded configuration. The expandable funnel further comprises a compliant material disposed over at least a portion of the funnel frame. The at least one mechanical engagement feature includes a pair of mechanical engagement features configured to collide at a pinch point when actuated.

[0013] In some examples, the at least one mechanical engagement feature includes a pair of mechanical engagement features configured to create a shearing action when actuated. The at least one mechanical engagement feature comprises a plurality of mechanical engagement features that may be collectively actuated as a group. The at least one mechanical engagement feature comprises a plurality of mechanical engagement features that may be individually and independently actuated. The at least one mechanical engagement feature comprises a plurality of mechanical engagement features configured to move towards a central point within the expandable funnel.

[0014] In general, there is provided a thrombus removal system, comprising: an elongate catheter having an aspiration lumen and a fluid lumen and terminating at a distal tip; an aspiration source coupled to the aspiration lumen; an expandable funnel coupled to the distal tip; a plurality of fluid ports disposed within the distal tip; at least one mechanical engagement feature disposed within the distal tip; and a fluid source coupled to the fluid lumen, wherein a flow of fluid from the fluid source through the fluid lumen is configured to deploy the at least one mechanical engagement feature into the expandable funnel and provide a plurality of fluid streams from the plurality of fluid ports into the aspiration lumen and/or the expandable funnel.

[0015] The at least one mechanical engagement feature may extend distally from a spring in the distal tip, wherein the spring may be hydraulically actuatable to deploy the at least one mechanical engagement feature. [0016] In some examples, the at least one mechanical engagement feature comprises at least one jet orifice in fluid communication with the fluid lumen and configured to provide additional fluid streams from the at least one mechanical engagement feature. The spring may be disposed within an actuation fluid channel of the distal tip, wherein the flow of fluid from the fluid source into the fluid lumen may be configured to flow into the actuation fluid channel to actuate the spring. The spring may be disposed within an actuation fluid channel of the distal tip, wherein the flow of fluid from the fluid source into the fluid lumen may be configured to flow into the actuation fluid channel to actuate the spring. The spring may be configured to be actuated by a first fluid pressure, and wherein the mechanical engagement feature may be configured to provide the fluid stream based on a second fluid pressure.

[0017] In general, there is provided a method of removing thrombus from a patient, comprising: inserting a thrombectomy catheter into the patient; expanding a distal expandable member of the catheter adjacent to a target thrombus; aspirating the target thrombus into the distal expandable member; generating a flow of fluid within the thrombectomy catheter to produce at least one fluid stream within the distal expandable member and to also deploy at least one mechanical engagement element into the distal expandable member; and aspirating the target thrombus out of the thrombectomy catheter.

[0018] The step of engaging the target thrombus with at least one mechanical engagement features may comprise selecting at least one of a) actuating at least one mechanical engagement feature within the distal expandable member to contact the target thrombus, and b) delivering a fluid stream from the at least one mechanical engagement feature towards the thrombus.

[0019] In some examples, the methods described herein may further comprise directing the at least one fluid stream and the at least one mechanical engagement feature to contact the target thrombus.

[0020] In general, there is provided a method, comprising: inserting a thrombectomy catheter into a patient; expanding a distal expandable member of the catheter adjacent to a target thrombus; aspirating the target thrombus into the distal expandable member delivering fluid into a fluid lumen of the thrombectomy catheter to deploy at least one mechanical engagement features within the distal expandable member to contact the target thrombus; delivering a fluid stream within the expandable member towards the target thrombus; and aspirating the target thrombus out of the thrombectomy catheter.

[0021] In some examples, the fluid stream may be delivered to the target thrombus through the at least one mechanical engagement feature. The step of delivering fluid into the fluid lumen of the thrombectomy catheter to deploy at least one mechanical engagement features comprises contacting a spring with the fluid, wherein the spring in operable communication with the proximal end of the at least one mechanical engagement feature, and wherein the fluid is configured to deploy the at least one mechanical engagement feature by contacting the spring.

[0022] In some examples, the methods described herein may further comprise adjusting a pressure of the fluid stream between one or more fluid pressures delivered towards the target thrombus.

[0023] In general, there is provided a thrombus removal device, comprising: an elongate catheter having an aspiration lumen and a first fluid lumen; a distal tip coupled to the elongate catheter, the distal tip comprising at least one thrombus engagement feature within a second fluid lumen and at least one fluid port in a third fluid lumen; an expandable funnel coupled to the distal tip; wherein a flow of fluid from the first fluid lumen to the second fluid lumen and the third fluid lumen is configured to move the at least one thrombus engagement feature into the expandable funnel and provide at least one fluid stream into the expandable funnel.

[0024] In some examples, the at least one thrombus engagement feature may be actuatable to move the at least one thrombus engagement within the expandable funnel towards a central axis of the aspiration lumen. The at least one thrombus engagement feature may be actuatable to move the at least one mechanical engagement feature generally radially within the expandable funnel across at least a portion of the expandable funnel. The at least one mechanical engagement feature comprises a cutting portion. The at least one mechanical engagement feature comprises a blunted tip.

[0025] The at least one thrombus engagement feature may be in operable communication with a spring, and wherein the second fluid lumen may be configured to deliver fluid to the spring to actuate the at least one thrombus engagement feature.

[0026] In general, there is provided a thrombus removal device is provided, comprising: an elongate catheter having an aspiration lumen; an aspiration source coupled to the aspiration lumen; an expandable funnel coupled to the aspiration lumen and the elongate catheter; at least one mechanical engagement feature disposed within the expandable funnel, wherein the at least one mechanical engagement feature is actuatable to move the at least one mechanical engagement feature within the expandable funnel. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0028] FIGS. 1-1L illustrate various views of a portion of a thrombus removal system including a distal portion of an elongated catheter configured in accordance with an embodiment of the present technology.

[0029] FIGS. 2A-2E illustrate plan views of various configurations of irrigation ports and fluid streams of a thrombus removal system according to embodiments of the present technology.

[0030] FIGS. 3A-3K illustrate an elevation view of various configurations of irrigation ports and fluid streams of a thrombus removal system according to embodiments of the present technology.

[0031] FIGS. 4A-4D illustrate various embodiments of a thrombus removal system including a saline source, an aspiration system, and one or more controls for controlling irrigation and/or aspiration of the system.

[0032] FIGS. 5A and 5B illustrate one embodiment of a distal of an elongate medical device.

[0033] FIGS. 6A-6E illustrate another embodiment of a distal of an elongate medical device.

[0034] FIGS. 7A-7E illustrate another embodiment of a distal of an elongate medical device.

[0035] FIGS. 8A-8C illustrate one embodiment of a distal of an elongate medical device.

[0036] FIGS. 9A and 9B illustrate another embodiment of a distal of an elongate medical device.

[0037] FIGS. 10A and 10B illustrate one embodiment of a distal end of an elongate medical device with mechanical engagement features configured to function as a cutter. [0038] FIGS. 11 A-l ID illustrate variations of mechanical engagement features that are disposed to be radially inward-facing, and actuated via a hinge or pivot region to move in a proximal direction.

[0039] FIG. 12 illustrates one embodiment of a nested frame approach for a funnel and mechanical engagement features of a thrombus removal device. [0040] FIGS. 13A-13F illustrate examples of array articulation with various examples of mechanical engagement features layer arrangements as described herein.

[0041] FIGS. 14A and 14B illustrate exemplary orientations and arrangements of mechanical engagement features arrays having one or more layers as described herein.

[0042] FIGS. 15A and 15B illustrate another embodiment of a thrombus removal device that includes mechanical engagement features that are deployed when fluid is delivered into fluid lumens of the mechanical engagement features.

[0043] FIGS. 16A and 16B illustrate an embodiment of a thrombus removal device that includes mechanical engagement features that are deployed when fluid is delivered into one or more inflatable elements.

[0044] FIGS. 17A and 17B illustrate another embodiment of a thrombus removal device that includes mechanical engagement features that are deployed when fluid is delivered into one or more inflatable elements.

[0045] FIGS. 18A and 18B illustrate one embodiment of a thrombus removal system.

[0046] FIGS. 19A and 19B illustrate fluid channels having tapered and square ridges between them, respectively.

[0047] FIG. 20 illustrates an example of a tip for a thrombus removal system from a proximal perspective.

[0048] FIGS. 21A and 21B illustrate additional details of the tip from FIG. 20 including a perspective view from the distal end in FIG. 21 A and a cross section of a side elevation view in FIG. 2 IB.

[0049] FIG. 22 illustrates an alternative example of deployment mechanisms for a tip, such as the tip illustrated in FIG. 20.

[0050] FIGS. 23 A and 23B show another example of a tip for a thrombus removal system from a proximal perspective in FIG. 23 A and a distal perspective in FIG. 23B.

[0051] FIG. 24 illustrates an exploded perspective view of the tip illustrated in FIGS.

23A and 23B.

[0052] FIG. 25 illustrates a detailed view of the hydraulic deployment and jet features of the distal tip shown in FIGS. 23A and 23B.

[0053] FIGS. 26 A and 26B illustrate examples of fang deployments for the tip illustrated in FIG 23 A and 23B.

[0054] FIGS. 27 A and 27B illustrate additional examples of fang deployment including the tip illustrated in FIG. 23 A and 23B.

[0055] FIGS. 28A-28D illustrate additional examples of hydraulic fang deployment. DETAILED DESCRIPTION

[0056] This application is related to disclosure 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 by reference herein for all purposes. The ‘915 and ‘024 applications describes general mechanisms for capturing and removing a clot. By example, multiple fluid streams are directed toward the clot to fragment the material.

[0057] The present technology is generally directed to thrombus removal systems and associated methods. A system configured in accordance with an embodiment of the present technology can include, for example, an elongated catheter having a distal portion configured to be positioned within a blood vessel of the patient, a proximal portion configured to be external to the patient, a fluid delivery mechanism configured to fragment the thrombus with pressurized fluid, an aspiration mechanism configured to aspirate the fragments of the thrombus, and one or more lumens extending at least partially from the proximal portion to the distal portion.

[0058] The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the examples but are not described in detail with respect to the figures.

[0059] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0060] Reference throughout this specification to relative terms such as, for example, "generally," "approximately," and "about" are used herein to mean the stated value plus or minus 10%.

[0061] Although some embodiments herein are described in terms of thrombus removal, it will be appreciated that the present technology can be used and/or modified to remove other types of emboli that may occlude a blood vessel, such as fat, tissue, or a foreign substance. Additionally, although some embodiments herein are described in the context of thrombus removal from a pulmonary artery (e.g., pulmonary embolectomy), the technology may be applied to removal of thrombi and/or emboli from other portions of the vasculature (e.g., in neurovascular, coronary, within chambers of the heart, or peripheral applications). Moreover, although some embodiments are discussed in terms of maceration of a thrombus with a fluid, the present technology can be adapted for use with other techniques for breaking up a thrombus into smaller fragments or particles (e.g., ultrasonic, mechanical, enzymatic, etc.).

[0062] The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed present technology.

Systems for Thrombus Removal

[0063] As provided above, the present technology is generally directed to thrombus removal systems. Such systems include an elongated catheter having a distal portion positionable within a blood vessel of the patient (e.g., an artery or vein), a proximal portion positionable outside the patient's body, a fluid delivery mechanism configured to fragment the thrombus with pressurized fluid, an aspiration mechanism configured to aspirate the fragments of the thrombus, and one or more lumens extending at least partially from the proximal portion to the distal portion. In some embodiments, the systems herein are configured to engage a thrombus in a patient's blood vessel, break the thrombus into small fragments, and aspirate the fragments out of the patient's body. The pressurized fluid streams (e.g., jets) function to cut or macerate thrombus, before, during, and/or after at least a portion of the thrombus has entered the aspiration lumen or a funnel of the system. Fragmentation helps to prevent clogging of the aspiration lumen and allows the thrombus removal system to macerate large, firm clots that otherwise could not be aspirated. As used herein, “thrombus” and “embolism” are used somewhat interchangeably in various respects. Typically a thrombus is a portion of clotted blood that has stopped moving through the vasculature and is lodged or stuck and the emboli is a portion of clotted blood that is moving in the vasculature that can eventually become a thrombus and additionally seed a larger thrombus either by collecting other emboli or blood clotting on the thrombus.

[0064] It should be appreciated that while the description may refer to removal of “thrombus,” this should be understood to encompass removal of thrombus fragments and other emboli as provided herein.

[0065] According to embodiments of the present technology, a fluid delivery mechanism can provide a plurality of fluid streams (e.g., jets) to fluid apertures of the thrombus removal system for macerating, cutting, fragmenting, pulverizing and/or urging thrombus to be removed from a proximal portion of the thrombus removal system. The thrombus removal system can include an aspiration lumen extending at least partially from the proximal portion to the distal portion of the thrombus removal system that is adapted for fluid communication with an aspiration pump (e.g., vacuum source). In operation, the aspiration pump may generate a volume of lower pressure within the aspiration lumen near the proximal portion of the thrombus removal system, urging aspiration of thrombus from the distal portion to the proximal portion.

[0066] FIG. 1 illustrates a distal portion 10 of a thrombus removal system according to an embodiment of the present technology. FIG. 1 A Section A-A illustrates an elevation sectional view of the distal portion. The example section A-A in FIG. 1 A depicts a funnel 20 that is positioned at the distal end of the distal portion 10, the funnel adapted to engage with thrombus and/or a tissue (e.g., vessel) wall to aid in thrombus collection, fragmentation, and/or removal. The funnel can have a variety of shapes and constructions as would be understood by one of skill from the description herein. The example section A-A in FIG. 1 A depicts a double walled thrombus removal device construction having an outer wall/tube 40 and an inner wall/tube 50. An aspiration lumen 55 is formed by the inner wall 50 and is centrally located. A generally annular volume forms at least one fluid lumen 45 between the outer wall 40 and the inner wall 50. The fluid lumen 45 is adapted for fluid communication with the fluid delivery mechanism. One or more apertures (e.g., nozzles, orifices, or ports) 30 are positioned in the thrombus removal system to be in fluid communication with the fluid lumen 45 and an irrigation manifold 25. In operation, the ports 30 are adapted to direct (e.g., pressurized) fluid toward thrombus that is engaged with the distal portion 10 of the thrombus removal system.

[0067] In various embodiments, the system can have an average flow velocity within the fluid lumen of up to 20 m/s to achieve consistent and successful aspiration of clots. In some embodiments, the fluid source itself can be delivered in a pulsed sequence or a preprogrammed sequence that includes some combination of pulsatile flow and constant flow to deliver fluid to the jets. In these embodiments, while the average pulsed fluid velocity may be up to 20 m/s, the peak fluid velocity in the lumen may be up to 30 m/s or more during the pulsing of the fluid source. In some embodiments, the jets or apertures have an aperture size ranging between 0.005” to 0.020” to avoid undesirable spraying of fluid. In some embodiments, the system can have a minimum vacuum or aspiration pressure of 15 inHg, to remove target clots after they have been macerated or broken up with the jets described above. [0068] The thrombus removal system can be sized and configured to access and remove thrombi in various locations or vessels within a patient’s body. It should be understood that while the dimensions of the system may vary depending on the target location, generally similar features and components described herein may be implemented in the thrombus removal system regardless of the application. For example, a thrombus removal system configured to remove pulmonary embolism (PE) from a patient may have an outer wall/tube with a size of approximately 11-13 Fr, or preferably 12 Fr, and an inner wall/tube with a size of 7-9 Fr, or preferably 8 Fr. A deep vein thrombosis (DVT) device, on the other hand, may have an outer wall/tube with a size of approximately 9-11 Fr, or preferably 10 Fr, and an inner wall/tube with a size of 6-9 Fr, or preferably 7.5 Fr. Applications are further provided for ischemic stroke and peripheral embolism applications.

[0069] Section B-B of FIG. IB illustrates in plan view a portion of the thrombus removal system that is proximal to the funnel and irrigation manifold. Section B-B depicts an outer wall 140, an inner wall 150, an aspiration lumen 155 and a fluid lumen 145. In some embodiments, in cross-section the aspiration lumen 155 is generally circular and the fluid lumen 145 is generally annular in shape (e.g., cross-section 70). It will be appreciated that alternative constructions and/or arrangements of the inner wall 150 and the outer wall 140 produce variations in cross-sectional shape of the aspiration and fluid lumens 155 and 145. For example, the inner wall 150 can be shaped to form an aspiration lumen 155 that, in crosssection, is generally oval, circular, rectilinear, square, pentagonal, or hexagonal. The inner and outer walls 150 and 140 can be shaped and arranged to form a fluid lumen 145 that, in cross-section, is generally crescent-shaped, diamond shaped, or irregularly shaped. For example, referring to FIG. 1C Section B-B, the region between the inner wall 150 and the outer wall 140 can include one or more wall structures 165 that form respective fluid lumens 145 (e.g., as in cross-section 80). The wall structures 165 can be formed by lamination between the outer and inner walls 140 and 150, or by a multi -lumen extrusion that forms a plurality of the wall structures.

[0070] Section B-B of FIGS. 1D-1H illustrate additional examples of a portion of the thrombus removal system that is proximal to the funnel and irrigation manifold. Similar to the embodiments described above, the portion in these examples can include an outer wall 140, an inner wall 150, and an aspiration lumen 155. Additionally, the illustrated portion of the thrombus removal system can include a middle wall 170 disposed between the outer wall 140 and the inner wall 150. The middle wall 170 enables further segmentation of the annular space between the inner wall and outer wall into a plurality of distinct fluid lumens and/or auxiliary lumens. For example, referring to FIG. ID, the middle wall can be generally hexagon shaped, and the annular space can include a plurality of fluid lumens 145a- 141 and a plurality of auxiliary lumens 175a-175f. As shown in FIG. ID, the fluid lumens can be formed by some combination of the outer wall 140 and the middle wall 170, or between the middle wall 170, the inner wall 150, and two of the auxiliary lumens. For example, fluid lumen 145a is formed in the space between outer wall 140 and middle wall 170. However, fluid lumen 145g is formed in the space between middle wall 170, inner wall 150, auxiliary lumen 175a, and auxiliary lumen 175b. Generally, the fluid lumens are configured to carry a flow of fluid such as saline from a saline source of the system to one or more ports/apertures/orifices of the system. The auxiliary lumens can be configured for a number of functions. In some embodiments, the auxiliary lumens can be coupled to the fluid/saline source and to the apertures to be used as additional fluid lumens. In other embodiments, the auxiliary lumens can be configured as steering ports and can include a guide wire or steering wire within the lumen for steering of the thrombus removal system. Additionally, in other embodiments, the auxiliary lumens can be configured to carry electrical, mechanical, or fluid connections to one or more sensors. For example, the system may include one or more electrical, optical, or fluid based sensors disposed along any length of the system. The sensors can be used during therapy to provide feedback for the system (e.g., sensors can be used to detect clogs to initiate a clog removal protocol, or to determine the proper therapy mode based on sensor feedback such as jet pulse sequences, aspiration sequences, and or proper functioning of the system, etc.). The auxiliary ports can therefore be used to connect to the sensors, e.g., by electrical connection, optical connection, mechanical/wire connection, and/or fluid connection. It is also contemplated that the fluid and auxiliary lumens can be configured to carry and deliver other fluids, such as thrombolytics or radio-opaque contrast injections to the target tissue site during treatment.

[0071] It should be understood that in some embodiments, all the fluid lumens are fluidly connected to all of the jets or apertures of the thrombus removal device. Therefore, when a flow of fluid is delivered from the fluid lumen(s) to the jets, all jets are activated with a jet of fluid at once. However, it should also be understood that in some embodiments, the fluid lumens are separate or distinct, and these distinct fluid lumens may be fluidly coupled to one or more jets but not to all jets of the device. In these embodiments, a subset of the jets can be controlled by delivering fluid only to the fluid lumens that are coupled to that subset of jets. This enables additional functionality in the device, in which specific jets can be activated in a user defined or predetermined order.

[0072] In various embodiments, the fluid pressure is generated at the pump (at the console or handle). The fluid is accelerated as it exits through the ports at the distal end and is directed to the target clot. In this way a wider variety of cost-effective components can be used to form the catheter while still maintaining a highly-effective device for clot removal. Additional details are provided below.

[0073] Section B-B of FIG. IE illustrates another embodiment of the portion of the thrombus removal system that is proximal to the funnel and irrigation manifold. Similar to the embodiment of FIG. ID, this embodiment also includes a middle wall 170. However, the middle wall in this example is generally square shaped, facilitating the formation of fluid lumens 145a-145k and auxiliary lumens 175a-175d. The example illustrated in section B-B of FIG. IF is similar to that of the embodiment of FIG. IE, however this embodiment includes only fluid lumens 145a-145d. The fluid lumens 145e-145k from the embodiment of FIG. IE are not used as fluid lumens in this embodiment. They can be, for example, empty lumens, vacuum, filled with an insulative material, and/or filled with a radio-opaque material or any other material that may help visualize the thrombus removal system during therapy. The embodiment IF includes the same four auxiliary reports as illustrated and described in the embodiment of FIG. IE.

[0074] Section B-B of FIG. 1G illustrates another example of a portion of the thrombus removal system that is proximal to the funnel and irrigation manifold. Similar to the embodiments described above, the illustrated portion of the thrombus removal system can include a middle wall 170 disposed between the outer wall 140 and the inner wall 150. However, this embodiment includes four distinct fluid lumens 145a-145d formed by wall structures 165. As with the embodiment of FIG. 1C, the wall structures 165 can be formed by lamination between the outer and inner walls 140 and 150, or by a multi-lumen extrusion that forms a plurality of the wall structures. As shown, this embodiment can include a pair of auxiliary lumens 175a and 175b, which can be used, for example, for steering or for sensor connections as described above.

[0075] Section B-B of FIG. 1H is another similar embodiment in which the middle wall and outer wall can be used to form fluid lumens 145a and 145b. Auxiliary lumens 175a and 175b can be formed in the space between the middle wall and the inner wall. It should be understood that the middle wall can contact the outer wall to create independent fluid lumens 145a and 145b. However, in other embodiments, it should be understood that the middle wall may not contact the outer wall, which would facilitate a single annular fluid lumen, such as is shown by fluid lumen 145 in Section B-B of FIG. II. In another embodiment, as shown in Section B-B of FIG. 1 J, the inner wall 150 and the outer wall 140 may not be concentric, which facilitates formation of an annular space and/or fluid lumen 145 that is thicker or wider on one side of the device relative to the other side. As shown in FIG. 1 J, a distance between the exemplary outer wall 140 and inner wall at the top (e.g., 12 o’clock) portion of the device is larger than a distance between the outer wall and inner wall at the bottom (e.g., 6 o’clock) portion of the device.

[0076] Section C-C of FIG. IK illustrates in plan view a portion of the thrombus removal system comprising an irrigation manifold 225. Section C-C depicts an outer wall 240, an inner wall 250, a fluid lumen 245, an aspiration lumen 255, and ports 230 for directing respective fluid streams 210.

[0077] Detail View 101 of FIG. IL illustrates a section view in elevation of a portion of the irrigation manifold 25 that includes a plurality of ports 230 that are formed within an inner wall 250. In some embodiments, a thickness of one or more walls of the thrombus removal system may be varied along its axial length and/or its circumference. As shown in Detail View 101, inner wall 250 has a first thickness 265 in a region 250 that is proximal to the irrigation manifold 25, and a second thickness 270 in a region 235 that includes the ports 230. In some embodiments, the second thickness 270 is greater than the first thickness 265. The first thickness 265 can correspond to a general wall thickness of the inner wall 50 and/or of the outer wall 40, which can be from about 0.10 mm to about 0.60 mm, or any value within the aforementioned range. The second thickness 270 can be from about 0.20 mm to about 0.70 mm, from about 0.70 mm to about 0.90 mm, or from about 0.90 mm to about 1.20 mm. The second thickness 270 can be any value within the aforementioned range. The dimension of the second thickness 270 can be selected to provide a fluid path through the ports 230 that produces a generally laminar flow for a fluid stream that is directed therethrough, when the fluid delivery mechanism supplies fluid via the fluid lumen 245 at a typical operating pressure. Such operating pressure can be from about 10 psi to about 60 psi, from about 60 psi to about 100 psi, or from about 100 psi to about 150 psi. The operating pressure of the fluid delivery mechanism can be any value within the aforementioned range of values. In some embodiments, the fluid delivery mechanism is operated in a high pressure mode, having a pressure from about 150 psi to about 250 psi, from about 250 psi to about 350 psi, from about 350 psi to about 425 psi, or from about 425 psi to about 500 psi, or up to 1,000 psi. The operating pressure of the fluid delivery mechanism in the high pressure mode can be any value within the aforementioned range of values.

[0078] The manifold is configured to increase a fluid pressure and/or flow rate of the fluid. When fluid is provided by the fluid delivery mechanism to the fluid lumen(s) at a first pressure and/or a first flow rate, the manifold is configured to increase the pressure of the fluid to a second pressure and/or is configured to increase the flow rate of the fluid to a second flow rate. The second pressure and/or second fluid rate can be higher than the first pressure and/or first flow rate. As a result, the manifold can be configured to increase the relatively low operating pressures and/or flow rates generated by the fluid delivery mechanism to the relatively high pressures and/or high flow rates generated by the ports/fluid streams.

[0079] In some embodiments, a profile (cross-sectional dimension) of a port 230 varies along its length (e.g., is non-cylindrical). A variation in the cross-sectional dimension of the port may alter and/or adjust a characteristic of fluid flow along the port 230. For example, a reduction in cross-sectional dimension may accelerate a flow of fluid through the port 230 (for a given volume of fluid). In some embodiments, a port 230 may be conical along its length (e.g., tapered), such that its smallest dimension is positioned at the distal end of the port 230, where distal is with respect to a direction of fluid flow.

[0080] In some embodiments, the port 230 is formed to direct the fluid flow along a selected path. FIGS. 2A-2E illustrate various embodiments of arrangements of ports 230 for directing respective fluid streams 210. In some embodiments, such as those shown in FIGS. 2A and 2B, at least two ports 230 are arranged to produce (e.g., respective) fluid streams 210 that intersect at an intersection region 237 of the thrombus removal system. An intersection region 237 can be a region of increased fluid momentum, turbulence, shear, and/or energy transfer, which multiply with respect to individual fluid streams that are not directed to combine at the intersection. The increased fluid momentum and/or energy transfer at an intersection may advantageously fragment thrombus more efficiently and/or quickly. As described above, the fluid streams can be configured to accelerate and cause cavitation and/or other effects to further add to breaking up of the target clot. In some embodiments, an intersection region can be formed from at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, at least 9, or at least 10 fluid streams 210. An intersection region can be generally near a central axis 290 of the thrombus removal system (e.g., 237), or away from the central axis (e.g., 238 and 239 in the embodiment of FIG. 2D). In some embodiments, at least two intersection regions (e.g., 238 and 239) are formed. In some embodiments, one or more ports 230 are arranged to direct a fluid stream 210 along an oblique angle with respect to the central axis of the thrombus removal system. An operating pressure of the fluid delivery mechanism may be selected to approach a minimum targeted fluid velocity for a fluid stream 210 that is delivered from a port 230. The targeted fluid velocity for a fluid stream 210 can be about 5 meters/second (m/s), about 8 m/s, about 10 m/s, about 12 m/s, or about 15 m/s. Additionally, the targeted fluid velocities in some embodiments can be in the range above 15m/s to up tol50 m/s. At these higher velocities (e.g. above 15m/s, or alternatively above 20m/s), the fluid streams may be configured to generate cavitation in a target thrombus or tissue. It has been found that with fluid exiting from the ports to these flow rates a cavitation effect can be created in the focal area of the intersecting or colliding fluid streams, or additionally at a boundary of one or more of the fluid streams. While the exact specifications may change based on the catheter size, in general, at least one of the fluid streams should be accelerated to such a high velocity to create cavitation as described in detail below. The targeted fluid velocity for fluid stream 210 can be any value within the range of aforementioned values. In some embodiments, at least two ports 230 are adapted to deliver respective fluid streams at different fluid velocities (i.e. speed and direction), for a given pressure of the fluid delivery mechanism. In some embodiments, at least two ports 230 are adapted to deliver respective fluid streams at the substantially the same fluid velocities, for a given pressure of the fluid delivery mechanism. In some embodiments, one port is adapted to deliver fluid at high velocity and the respective one or more other ports is adapted to deliver fluid at relatively lower velocities. Advantageously, an increased cross-sectional area of the fluid lumen 145 reduces a required operating pressure of the fluid delivery mechanism to achieve a targeted fluid velocity of the fluid streams.

[0081] In some embodiments, the fluid streams are configured to create angular momentum that is imparted to a thrombus. In some examples, angular momentum is imparted on the thrombus by application of a) at least one fluid stream 210 that is directed at an oblique angle from a port 230, and/or b) at least two fluid streams 210 that have different fluid velocities. For example, fluid streams that cross near each other but do not necessarily intersect may create a “swirl” or rotational energy on the clot material. Advantageously, angular momentum produced in a thrombus may impart a (e.g., centrifugal) force that assists in fragmentation and removal of the thrombus. Rotating of the clot may enhance delivery of the clot material to the jets. By example, with a large, amorphous clot the soft material may be easily aspirated or broken up by the fluid streams whereas tough fibrin may be positioned away from the fluid streams. Rotating or swirling of the clot moves the material around so the harder clot material is presented to the jets. The swirling may also further break up the clot as it is banged inside the funnel.

[0082] FIGS. 3A-3H depict various configurations of fluid streams 410 that are directed from respective ports 430. A fluid stream 410 can be directed along a path that is substantially orthogonal, proximal, and/or distal to the flow axis 405 (which is like to flow axis 305). In some embodiments, at least two fluid streams are directed in different directions with respect to the flow axis 405. In some embodiments, at least two fluid streams are directed in a same direction (e.g., proximally) with respect 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 with respect to the flow axis 405. An angle a may characterize an angle that a fluid stream 410 is directed with respect to an axis that is orthogonal to the flow axis 405 (e.g., as shown in section D-D of FIGS. 3G and 3H). An intersection region of fluid streams can be within an interior portion of the thrombus removal system, and/or exterior (e.g., distal) to the thrombus removal system. In some embodiments, a fluid stream that is directed by a port 430 in a nominal direction (e.g., distally) is deflected along an altered path (e.g., proximally) by (e.g., suction) pressure generated by the aspiration mechanism during operation.

[0083] FIGS. 31 to 3K add additional depiction of various configurations for fluid streams 411 similar to FIGS. 3A to 3H relating to in an embodiment where the thrombus removal system comprises mechanical engagement features 450. In some embodiments, the mechanical engagement features can be actuatable to mechanically move from a first (nonengaged or extended) configuration to a second (engaged) configuration. In FIG. 31 and 3 J the thrombus removal system is shown from a side view with mechanical engagement features 450 visible through the funnel. Fluid streams 411 are provided from the mechanical engagement features via jet ports 415. The jet ports are in fluid communication with the fluid lumen(s) of the system and direct the fluid streams 411 according to the position of the mechanical engagement feature 450. In FIG. 3K. the thrombus removal system is shown from the distal end with the mechanical engagement features 450 in an engaged configuration. [0084] The fluid streams illustrated in FIG. 31 are shown from the jet ports 415 at an angle towards an interior of the funnel. In this configuration, the mechanical engagement features 450 are generally flared outward similar to a plane of the funnel to allow for a thrombus to be positioned inside of the funnel and mechanical engagement features 450. The angle of the fluid stream may support engagement (e.g., retention, separation, maceration, etc.) of the thrombus material inside the funnel. For example, the mechanical engagement features 450 can remain in an extended configuration while the fluid streams 411 contact the thrombus. In some examples, the mechanical engagement features 450 are articulated or actuated, whereby the distal end of a mechanical engagement feature can transition from the extended configuration to the engagement configuration as illustrated in FIG. 3K. The transition to the engagement configuration can cause the mechanical engagement features 450 to move towards an aspiration lumen or base of the funnel. From the view in 3K, the mechanical engagement features 450 are visible with the distal ends of each mechanical engagement feature 450 positioned in the center of the funnel. In this configuration, the jets 415 can direct the fluid streams towards the interior (e.g., center) of the funnel. As illustrated in FIGS. 31 and 3J, the fluid stream is directed at an angle, relative to the mechanical engagement feature, towards the center of the funnel. This fluid stream angle (e.g., angle between the fluid stream and the mechanical engagement feature) may be an acute angle as illustrated in FIGS. 31 and 3K. In some examples, the fluid stream angle may be different from one fluid opening or jet to another. In some examples, the fluid stream angle may be an obtuse angle. In some examples, the fluid stream angle may be orthogonal and directed towards a central axis of the funnel. In some examples, the fluid stream angle may be configured to direct the fluid stream towards the central axis of the funnel. In some examples, the jets or fluid openings of the mechanical engagement features may be positioned such that the fluid is directed tangentially relative to the central axis of the funnel. In some examples, the mechanical engagement features may comprise one or more jets or fluid openings configured to direct the flow of fluid therefrom at different angles relative to other jets or fluid openings.

[0085] Although FIG. 31 illustrates mechanical engagement elements 450, each with a single jet 415, the arrangement and orientation of the jets may comprise multiple jets on a single engagement feature as illustrated in FIG. 3 J. Here, each mechanical engagement feature 450 has two or more jets (e.g., 415a and 415b) with jet 415a distal to jet 415b on the mechanical engagement feature 415b. Although not illustrated, additional configurations and positioning of the jets can be appreciated to include variations in the number of jets, position of the jets, orientation of the jet and fluid stream angle, jets included on all or less than all mechanical engagement features, etc. or combinations thereof.

[0086] FIGS. 4A-4D illustrate various configurations of a thrombus removal system 600, including a thrombus removal device, 602, a vacuum source and cannister 604, and a fluid source 606. In some embodiments, the vacuum source and cannister and the fluid source are housed in a console unit that is detachably connected to the thrombus removal device. A fluid pump can be housed in the console, or alternatively, in the handle of the device. The console can include one or more CPUs, electronic controllers, or microcontrollers configured to control all functions of the system. The thrombus removal device 602 can include a funnel 608, a flexible shaft 610, a handle 612, and one or more controls 614 and 616. For example, in the embodiment shown in FIG. 4 A, the device can include a finger switch or trigger 614 and a foot pedal or switch 616. These can be used to control aspiration and irrigation, respectively. Alternatively, as shown in the embodiment of FIG. 4B, the device can include only a foot switch 614, which can be used to control both functions, or in FIG. 4C, the device can include only an overpedal 616, also used to control both functions. It is also contemplated that an embodiment could include only a finger switch to control both aspiration and irrigation functions. As shown in FIG. 4A, the vacuum source can be coupled to the aspiration lumen of the device with a vacuum line 618. Any clots or other debris removed from a patient during therapy can be stored in the vacuum cannister 604. Similarly, the fluid source (e.g., a saline bag) can be coupled to the fluid lumens of the device with a fluid line 620.

[0087] Still referring to FIG. 4A, electronics line 622 can couple any electronics/sensors, etc. from the device to the console/controllers of the system. The system console including the CPUs/electronic controllers can be configured to monitor fluid and pressure levels and adjust them automatically or in real-time as needed. In some embodiments, the CPUs/electronic controllers are configured to control the vacuum and irrigation as well as electromechanically stop and start both systems in response to sensor data, such as pressure data, flow data, etc.

[0088] As is described above, aspiration occurs down the central lumen of the device and is provided by a vacuum pump in the console. The vacuum pump can include a container that collects any thrombus or debris removed from the patient.

[0089] FIG. 4D is a close-up view of the console of the thrombus removal system, which can include the vacuum source and cannister 604 and the fluid source 606. In some embodiments, the cannister 604 and/or the fluid source 606 can include features designed and configured to assist in determining or estimating therapy progress, including determining or estimating the amount (e.g., volume) or percentage of clot removed. Additionally, the cannister 604 and/or the fluid source 606 can include features designed and configured to assist in determining the amount of fluid (e.g., jets) delivered into the patient and/or the amount of blood removed or aspirated from the patient.

[0090] In FIG. 4D, cannister 604 can include sensor 607. In one embodiment, sensor 607 can comprise one or more weight scales configured to measure or sense the weight of fluids and biological materials inside the cannister. The weight scale(s) can be zeroed prior to therapy, and can provide real time weight measurement of the amount of fluid and/or biological materials removed or aspirated from the patient during a clot removal procedure. [0091] In some embodiments, the cannister itself can include a drain with a drain size or filter configured to allow drainage of fluids from the cannister (such as blood and/or saline) while preventing clot material or other biological tissues from draining from the cannister. In this manner, the cannister and weight scale(s) are able to measure only the weight of the clot removed, and not blood and/or saline. Optionally, the blood and other fluids such as saline can be drained into a separate cannister (not shown), which can then be used to determine the amount of blood removed from the patient in addition to the amount of clot removed. In one implementation, fluid source 606 can also include sensor 609, which can be used to track the amount of fluid or saline delivered to the patient through jetting. The sensor 609 can comprise, for example, additional weight scales, or optionally, any other sensor configured to measure the flow of fluid such as a flow sensor. The fluid delivered by the fluid source 606 can be measured by sensor 609 and subtracted from the fluid drained into the separate (not shown) cannister. Therefore, the amount of clot can be determined with weight scales 607 in the cannister 604, and the amount of blood can be calculated in the separate container by subtracting the collected volume from the amount of saline delivered.

[0092] In another embodiment, the sensor 607 on or in the cannister 604 can comprise a camera. In some embodiments, the camera can comprise a miniature or fiber optic camera. In some implementations, the camera can be configured to provide real-time imaging of the cannister to provide a visual guide to the user regarding what is being aspirated from the patient. For example, the user can visualize the amount and/or size of clot being removed. The images from the camera can be displayed for the user, such as on a display that provides additional information about the status of the system, device, and procedure.

[0093] In other embodiments, the sensor 607 on or in the cannister 604 can comprise other types of sensors, such as optical sensors, flow sensors, etc. Generally, the sensors can be used to monitor or characterize the amount and/or type of material or fluid that enters the cannister to provide the user with additional information regarding the status of the therapy. Mechanical Manipulation Features for Engagement with Tissue or Material at Distal end of Device (e.g„ Grabber Arms)

[0094] Some embodiments of a thrombus removal device can include features enabling mechanical manipulation or engagement with tissue or material at a distal end of the device. These features can be referred to herein as mechanical engagement features, grabber arms, fangs, actuation elements, actuating elements, mechanical manipulation arms, mechanical cutting arms, or the like. In some examples, the mechanical engagement feature may be a fluid stream. For example, fluid may be directed from a fluid lumen to a jet or fluid opening and directed towards a thrombus such that the fluid stream becomes a mechanical engagement feature. The grabber arms are generally designed and configured to engage and pull clots into the distal end of the device (e.g., the funnel and/or aspiration lumen). In various implementations, the mechanical engagement features disclosed herein are configured to achieve some combination of pulling thrombus into the funnel, pulling thrombus into the jet plane, pulling thrombus into the aspiration lumen, and/or breaking off or cutting pieces of the thrombus into pieces sufficiently small to be aspirated through the aspiration lumen. While the thrombus removal systems described herein generally include an aspiration lumen and one or more fluid streams or jets, it should be understood that the grabber arms may be implemented in devices without aspiration lumens or without one or more fluid streams or jets. Additionally, the devices described herein generally include an expandable funnel on the distal end of the device. However it should be understood that some embodiments with mechanical engagement features may not include an expandable funnel, but instead some other structure on or near the distal end of the device.

[0095] Mechanical engagement features can comprise an arrangement of fangs, arms, or actuatable members positionable at a distal end of a device, such as a thrombus removal device. In some embodiments, the mechanical engagement features are positioned within a distal end of the device (e.g., within a funnel of the device), however other embodiments contemplate positioning the mechanical engagement features outside of the distal end (e.g., funnel), or alternatively, inside an aspiration lumen of the device.

[0096] The mechanical engagement features described herein do not include any components that extend distally beyond the distal end of the expandable member or funnel. In general, all actuation or movement of the mechanical engagement features is provided within the confines of the expandable member or funnel. In some embodiments, the mechanical engagement features can include cutting or serrated edges, sharp points, or shearing/pinching mechanisms of action against a targeted clot or tissue. Maintaining the entirety of the mechanical engagement features within the funnel or expandable member increases patient safety and prevents accidentally damaging, cutting, or piercing sensitive tissues such as vessel walls.

[0097] The mechanical engagement features described herein can generally include an at- rest state in which the mechanical engagement features are generally not obstructing a central or aspiration lumen of the device (e.g., resting near, adjacent to, or against an inner wall of the expandable member or funnel). The mechanical engagement features can also include an actuated or closed state in which the mechanical engagement features are manipulated to move, either axially and/or radially, towards the central or aspiration lumen of the device. However, in some embodiments, the at rest state includes engagement members that extend into the expandable member or funnel, and an actuated state in which the engagement members are near, rest against, or contact the funnel or expandable member. In some embodiments, this manipulation causes the mechanical engagement features to move axially towards the central or aspiration lumen, and in other embodiments, the manipulation causes the mechanical engagement features to move radially across the expandable member or funnel towards or across a central axis of the opening.

[0098] Generally, actuation or manipulation of the mechanical engagement features results in movement along a pivot within the expandable member or funnel. The pivot provides an inflection point between the mechanical engagement feature and the actuating member (e.g., a pull wire, an outer sheath, etc.). While this disclosure discussed movement of the mechanical engagement features as either being axially (e.g., distal to proximal) or radially (e.g., across the funnel or expandable member) it should be understood that since the mechanical engagement features of this disclosure typically move along a pivot, the movement characteristics may be more complex (e.g., a mechanical engagement feature may first swing radially towards a center of the expandable member or funnel before then swinging more axially towards the opening or aspiration lumen of the device).

[0099] The mechanical engagement features described herein typically also are directed or face inwards towards a central axis of the device (as opposed to facing outwards towards a vessel wall.

[0100] FIGS. 5A-5B illustrate a top-down view and a side-view, respectively, of one embodiment of a distal end 21 of a device which can include additional functionality for delivery and therapy. In the illustrated embodiment, the distal end 21 can include a frame 2200 comprising a plurality of petals that can include an outer frame 2202 and an inner frame 2204. In the illustrated embodiment, the distal end frame is shown having a total of 6 petals, but it should be understood that in other embodiments any number of petals can be implemented, including 2, 3, 4, 5, 6, 7, 8, 9, 10 or more petals. Also, while the petals and petal features are described independently herein, it should be understood that in some embodiments, the frame is a unitary design in which the entire structure, including the plurality of petals, is typically a unitary structure and is manufactured from a single piece of metal (e.g., the entire pattern is laser cut from a piece of nitinol or other appropriate metal or material). The structure of the distal end frame after cutting and shaping can be a single piece of material (e.g., nitinol).

[0101] Referring still to FIGS. 5A-5B, the frame can additionally include one or more mechanical engagement features 2206 arranged near or adjacent to an opening 2208 in the distal end. The mechanical engagement features can be generally inwards facing (e.g., facing inwards towards a central axis of the device). In some embodiments of the device (e.g., when the device is a thrombectomy removal device), the opening 2208 can coincide with an aspiration lumen of the device. As will be described in more detail below, the mechanical engagement features can be manipulated or actuated so as to cause distal tips 2210 of the mechanical engagement features 2206 to move or pivot axially towards or away from the opening 2208. The mechanical engagement features 2206 can optionally be coupled to or include fluid lumens and fluid ports 515, and can be configured to produce jets or fluid streams 511 which can be directed towards an interior of the funnel or distal end 21. In some embodiments, portions of the mechanical engagement features 2206 comprise a hollow frame with fluid lumens that can be fluidically coupled to fluid lumens of the catheter or shaft of the device, described above. In other embodiments, compliant fluid lumens or tubing can be coupled to or carried by the mechanical engagement features 2206 to provide fluid to the fluid ports 515. The fluid streams or jets are shown in FIGS. 5A-5B as being directed from the distal ends of the mechanical engagement features 2206. However, it should be understood that the fluid ports 515 can be positioned on any portion or surface of the mechanical engagement features, such that fluid streams can be directed in any direction with respect to the direction of the mechanical engagement features.

[0102] In some implementations, the mechanical engagement features of FIGS. 5A-5B can be manipulated or actuated manually by a user of the device, such as by engaging with pull wires or sliding/rotating an outer sheath over the device. In other embodiments, the actuation or manipulation can be automated such as by coupling the engagement features to motors configured to actuate pull wires or translate/rotate an outer sheath. The motors can be controlled by the user, such as by interacting with a user input device on the device handle or console (e.g., buttons, levers, switches, triggers, etc.).

[0103] FIGS. 6A-6E illustrate the relative motion of distal tips 2210 of mechanical engagement features 2206 as they pivot towards opening 2208. Referring to FIG. 6 A, the funnel or expandable member is fully expanded and, in this configuration, the mechanical engagement features 2206 are extended fully away from the opening 2208 in the axial direction. In this configuration, the delivery sleeve 2212 is pulled proximally away from the distal end such that it does not provide any forward/distal pressure against the distal end, to allow the distal end to fully expand. Alternatively, the distal end can be pushed out of the delivery sheath. It should be understood that as the distal tips of the mechanical engagement features pivot towards opening 2208, any fluid ports disposed on the mechanical engagement features will also pivot, causing fluid streams delivered by the fluid ports of the mechanical engagement features to change direction within the funnel.

[0104] Referring to FIG. 6B, the delivery sleeve 2212 can be advanced slightly so as to apply pressure or contact to a portion of the distal end, including to a portion of the outer frame (2202 in FIG. 5 A) and/or inner frame (2204 in FIG. 5A). In some embodiments, the delivery sleeve can be manipulated or advanced manually, such as by a user of the device. In other embodiments, the delivery sleeve can be actuated or manipulated automatically, such as with a motor or other mechanical device. In additional embodiments, the delivery sleeve can be actuated rapidly back and forth along the shaft of the device. Relative movement of the delivery sheath in the distal direction (e.g., against the expanded funnel) causes the inner frame and mechanical engagement feature and distal tip (and any fluid ports or fluid streams) to move or pivot generally proximally in direction towards the opening or aspiration lumen of the device. It should be noted that in this embodiment, the mechanical engagement features 2206 have an at rest state in which they are extended outwards and into the funnel or expandable device. Actuating these mechanical engagement features causes them to move proximally towards the opening but also causes them to approach or contact the interior wall of the funnel or expandable member thereby opening or unobstructing the funnel. It is noted that other embodiments described herein include an opposite configuration (i.e., the at rest state leaves the mechanical engagement features 2206 out of the way of the funnel, and the actuated state causes the mechanical engagement features to extend into the funnel or expandable member).

[0105] Each subsequent drawing, FIG. 6C, 6D, and 6E, shows the delivery sleeve 2212 being advanced slightly more distally over the distal end, causing the distal tip, mechanical engagement features 2206, and fluid ports or fluid streams of the distal end to move or pivot proximally towards the opening 2208 and/or aspiration lumen of the device. It should be understood that the distal tip design, including the inner and outer frames, allows the mechanical engagement features 2206 to be manipulated with the delivery sleeve while maintaining full expansion (or nearly full expansion) of the distal end/funnel. For example, the inner frames can be coupled to the mechanical engagement features, and when the delivery sleeve is advanced over the funnel, the inner frames can be designed to be contacted by the sleeve to move the mechanical engagement features 2206 while still allowing the outer frames to maintain full expansion of the device, and therefore full contact with the lumen or vessel. It is noted that the mechanical engagement features of FIGS. 6A-6E do not extend past the distal end of the expandable member or funnel (e.g., past outer frame 2202). The outer frame or funnel/expandable member therefore protects exterior tissues (e.g., vessel walls) from the movement/pivoting and actuation of the mechanical engagement features, allowing them to interact only with the target clot captured by the funnel/expandable member.

[0106] FIGS. 7A-7E illustrate the concept of actuating or manipulating the mechanical engagement features by contacting selected portions of the distal end/funnel/frame with the delivery sleeve. Referring to FIG. 7A, a single petal 2200 is shown in which the distal end is not contacted by the delivery sleeve. In this example, the distal end is allowed to be in its fully expanded configuration, causing the mechanical engagement feature 2206 to move fully axially away from (or distal from) the opening or aspiration lumen of the device (not shown). In embodiments where the mechanical engagement feature includes one or more fluid ports 715, the angle/direction of the fluid stream 711 ejected from the fluid port 715 is shown. Referring to FIG. 7B, the delivery sheath (not shown for purposes of description) is advanced distally over the device so as to contact the distal end at location 2214a. In one embodiment, the sheath is configured to contact only the inner frame 2204 of the distal end, thereby causing the mechanical engagement feature 2206 to move or pivot towards the opening or aspiration lumen (or proximally relative to the position of the mechanical engagement feature in FIG. 7A). In embodiments where the mechanical engagement feature includes one or more fluid ports 715, the angle/direction of the fluid stream 711 ejected from the fluid port 715 is shown. FIG. 7C shows the delivery sheath being advanced even further distally to location 2214b, causing the mechanical engagement feature to move or pivot even closer to the opening (e.g., axially in the proximal direction relative to the device). In embodiments where the mechanical engagement feature includes one or more fluid ports 715, the angle/direction of the fluid stream 711 ejected from the fluid port 715 is shown. Similarly, in FIGS. 7D and 7E, the sheath is further advanced to locations 2214c and 2214d, respectively, causing further pivoting/deflection/movement of the mechanical engagement features. This arises in part from the interaction with inner frame 2204. It can be seen in the embodiment of FIG. 7E that the delivery sheath can begin to contact the outer frame, which can cause some contraction or collapse of the distal end. In this embodiment, it may be possible that the distal end collapses enough so as to not fully contact the vessel wall. Typically it is desirable to not collapse the funnel, so care can be taken by the user or system to not advance the sheath to the point where the outer frame is contacted or compressed. In some embodiments, the device can include a stop limiter that is configured to prevent the sheath from collapsing or compressing the expandable member or funnel.

[0107] The ability to manipulate the mechanical engagement features and eject fluid streams from the mechanical engagement features provides additional functionality to a medical device such as a thrombectomy removal device during therapy. For example, in some embodiments, the mechanical engagement feature(s) can be designed and configured to engage with a clot that is in the funnel, either mechanically or with the fluid streams. In some embodiments, this physical or mechanical interaction with the clot can be leveraged so as to physically pull or move the clot into contact with the device. Depending on the configuration of the device (e.g., funnel, aspiration lumen, one or more jets, etc.), the mechanical engagement features can be used to 1) pull the clot into contact with additional jets or into a plane of the jets of the funnel, to thereby break up the clot and aspirate the clot, 2) pull the clot into or towards the aspiration lumen, and/or 3) prevent the clot from exiting the distal end or funnel of the device. The combination of the mechanical engagement features, the jets, and aspiration allow for clot removal capabilities not previously enabled by other devices. The combination can also cut or help cut the clot while pushing it into the aspiration lumen or jet plane.

[0108] FIGS. 8A-8C illustrate another embodiment of a distal end 21. This distal end frame design can still include a petal shaped frame 2200 including outer frames 2202, and inner frames 2204. The embodiment of FIGS. 8A-8C can optionally include jets or fluid ports integrated into the mechanical engagement features themselves, as described above. While this embodiment is illustrated without the previously described mechanical engagement features, it should be understood that variants can include one or more mechanical engagement features. However, referring to FIGS. 8B and 8C, alternating frame petals of the distal end can include varying side profiles to customize the way in which the funnel interacts with a delivery sheath. For example, referring to FIG. 8B, it can be seen that the outermost side profile of the outer frame and inner frame, represented by reference number 2216, shows a generally linear or straight profile. In contrast, the outermost side profile of the outer frame and inner frame in FIG. 8C, represented by reference number 2218, includes a slightly curved or bowed-out profile. For purposes of illustration, referring back to FIG. 8A, petal or frame edges having the flat profile shown in FIG. 8B can be represented by the (-) symbol, and petal edges having the curved or bowed-out profile shown in FIG. 8C can be represented by the (+) symbol. It can be seen in FIG. 8A that alternating petal edges can have alternating (+) and (-) side profiles. In doing so, the work required to advance the delivery sheath over the funnel can be reduced. More specifically, if half the petal edges have the (+) profile and half the petal edges have the (-) profile, advancement of the delivery sheath will only create contact with the (+) profile edges, thereby reducing friction between the funnel and sheath (e.g., contact with only 3 petal edges instead of 6). Additionally, the (-) profile petal edges can still be designed and configured to absorb some of the deformation caused by advancement of the sheath, further reducing the forces required.

[0109] The distal end embodiment of FIGS. 9A-9B can include similar structure to that as described above. However, in this embodiment the distal end, including the inner and outer frames, can include a membrane 917 or other covering such as an elastomer covering (e.g., a thermoplastic urethane, or silicone) or other membrane material as known in the art. In some embodiments, the membrane 917 can fill in the interior portions of the frame, including those surrounded by the inner and outer frames. In other embodiments, the membrane can cover the entirety of the frame. When the funnel and mechanical engagement features include fluid ports configured to produce fluid streams directly from the mechanical engagement features, the membrane 917 can include openings around the fluid ports to accommodate the fluid streams.

[0110] Referring to FIGS. 10A-10B, various alternative embodiments of mechanical engagement features 2506 that may be actuated manually or automatically (e.g., with a motor or other automated actuation source) are depicted. As shown in FIGS. 10A-10B, the mechanical engagement feature 2506 includes a distal portion 2508, a proximal portion 2510, and a hinge 2512 adapted to rotate and/or pivot the distal portion 2508 from a first, at-rest position to a second, actuated position. The feature 2506 can further include one or more fluid ports configured to produce or eject fluid streams 2511 into the funnel or aspiration lumen, as previously described. The actuation of the mechanical engagement feature can be generally in a radial direction, that is, within a given axial position within the distal end and/or catheter body (e.g., FIG. 10B). In some embodiments the mechanical engagement feature, when actuated, functions as a cutter (e.g., blade or knife), cutting into portions of any captured clot. In some embodiments, the distal portion 2508 may be sharp or serrated to improve cutting ability. Actuation of the mechanical engagement feature can be made by advancement or rotation of an outer catheter sheath, a pull wire, or any other actuation approaches described herein. It is also noted that while the features shown in the embodiment of FIGS. 10A-10B include a proximal portion that is actuated with an external sheath, other embodiments are contemplated in which there is no proximal portion, only the inward-facing distal portion 2508, and actuation can be with other mechanisms including, for example, pull wires.

[0111] Referring to FIGS. 11 A-l ID, variations of the mechanical engagement features of FIGS. 10A-10B, but with elements that are disposed to be radially inward-facing, and actuated via a hinge or pivot region to move in a proximal or distal direction. Additionally, as described above, the mechanical engagement features can include fluid lumens and fluid ports configured to directly deliver fluid streams 2611, as shown. As shown, actuation of the mechanical engagement feature(s) 2606 can be accomplished with a pull-wire 2618. In another embodiment, actuation can include advancement of an outer catheter over an external portion of the actuation element (as in the embodiment of FIGS. 10A-10D), causing the hinge to pivot the internal region in the proximal direction. In the embodiment of FIGS. 11 A-l IB, the mechanical engagement member can have an at rest configuration as shown in FIG. 11 A, with the mechanical engagement member resting against the distal end, frame, or funnel distally to the pivot 2612. Actuation then causes the mechanical engagement feature to swing down or proximally towards the lumen or aspiration lumen of the device, as indicated by the arrow. Alternatively, in the embodiment of FIGS. 11C-1 ID, the mechanical engagement member 2606 can have an at rest configuration in which the mechanical engagement member is proximal to the pivot 2612, this time within the lumen or aspiration lumen of the device. Actuation then causes the mechanical engagement feature to swing up or distally towards the distal end or funnel of the device, as indicated by the arrow. As with the embodiments described above, the mechanical engagement members can be actuated to pivot either manually or automatically, such as by manipulating an external sheath, manipulating pull wires, or using a motor or other automated feature to manipulate the sheath or pull wires. [0112] FIG. 12 illustrates one embodiment of a nested frame approach for a funnel or distal end 2700 and mechanical engagement feature array with mechanical engagement features 2710 of a medical device. As shown in FIG. 12, the funnel 2700 can include a funnel frame structure that is distally disposed relative to the mechanical engagement features frame structure 2705. In some embodiments, the funnel frame structure 2715 is independent from or decoupled from the mechanical engagement features frame structure 2710. The funnel frame structure 2715 can provide radial stiffness and support for the funnel 2700. In some embodiments, the funnel frame structure 2715 can comprise a shape memory material (e.g., Nitinol) to facilitate automatic expansion of the funnel (e.g., when a sheath or covering of the funnel is removed). The engagement feature frame structure can be configured to actuate the mechanical engagement feature array to cause individual engagement features to grab or engage clots and pull those clots proximally into the funnel and/or towards the aspiration lumen and/or jets of the device. In one embodiment, a sheath (not shown, but previously described in other embodiments) of the device is configured to be moved distally over the shaft of the medical device to engage the mechanical engagement feature frame structure without engaging the funnel frame structure 2715, causing one or more mechanical engagement features 2710 of the mechanical engagement feature array to pivot or move about an axis within the expandable member or funnel. The nested frame structure that positions the engagement feature frame structure proximally relative to the funnel frame structure allows for actuation and movement of the mechanical engagement features without collapsing the funnel or distal end.

[0113] The mechanical engagement feature array illustrated in FIG. 12 shows an example of an array having a plurality of mechanical engagement features 2710 arranged circumferentially around or within the distal end of the medical device. Actuation of the mechanical engagement features 2710 can advance the distal tips of each mechanical engagement feature within the array towards a central axis of the medical device to grab, manipulate, cut, macerate, or otherwise physically engage the thrombus material. In some embodiments, the mechanical engagement features can be configured to contact, pinch, or shear past another in the central axis of the device, and in other embodiments the mechanical engagement features are short enough to leave an open aperture in the central axis of the device even when actuated or closed. Although a single layer array is illustrated in FIG. 12, other embodiments can include a mechanical engagement feature array comprising one or more levels or layers of mechanical engagement features. Each layer of mechanical engagement features may be selectively actuatable independent from other layers to enable selectively engaging the thrombus material depending on the thrombus location within the funnel or distal end.

[0114] In FIG. 12, the mechanical engagement features (e.g., arms 2710) are shown with fluid aperture openings 2720 positioned near the distal end of each mechanical engagement feature 2710. In this example, each mechanical engagement feature is shown with three fluid openings 2720 arranged on a side of the mechanical engagement feature such that a fluid stream directed from the fluid lumen through the mechanical engagement feature can be directed out of the fluid opening 2720 based on the position of the mechanical engagement feature 2710. Specifically, in this view, each mechanical engagement feature 2710 is articulated such that the distal ends are biased towards the center of the funnel. Accordingly, the fluid openings are configured to direct fluid streams towards the center of the funnel.

[0115] Although the fluid openings are illustrated on the sides of mechanical engagement features in FIG. 12, the arrangement and orientation of each fluid opening may be on an exterior surface, interior surface, side surface, or a combination thereof. In some examples, jets, as described herein, may be substituted for fluid openings. In some examples, the mechanical engagement features may comprise one or more jets and one or more fluid openings.

[0116] FIGS. 13A-13F illustrate additional examples of mechanical engagement feature arrays from a cross sectional view showing examples of different mechanical engagement feature layers and various examples of engagement configurations. The mechanical engagement features of FIGS. 13A-13F are shown in isolation for purposes of illustration, but it should be understood that they can be disposed entirely within an expandable member or funnel (not shown) as with previously described embodiments. Additionally, these mechanical engagement features can include actuation mechanisms coupled to the engagement features (e.g., pull wires, external sheaths, motors, etc.) to cause the mechanical engagement members to pivot or move within the expandable member/funnel during actuation. Any of the mechanical engagement feature arrays in FIGS. 13A-13F can include jet or fluid ports disposed on or along the mechanical engagement features to produce one or more jets or fluid streams. The fluid ports can be on distal ends of the mechanical engagement features, or along top, bottom, or side surfaces of the features.

[0117] Referring to FIG. 13 A, a mechanical engagement feature array is shown comprising three layers of mechanical engagement feature 2800a, 2800b, 2800c axially displaced from another. Mechanical engagement feature 2800c may be a distal layer of mechanical engagement features that can be actuated towards one another and a central point (e.g., pinch point) to grab, cut or otherwise engage thrombus material. Mechanical engagement features 2800b and 2800a may be actuated in combination with mechanical engagement features 2800c, independent of 2800c, or a combination where one or more mechanical engagement features of each layer 2800c, 2800b, and 2800a are actuatable. The different layers of mechanical engagement features may be configured to interact with the thrombus material in different ways. In some examples, some mechanical engagement features or layers may be configured to retain thrombus material within the medical device (e.g., the funnel or distal end) while other mechanical engagement features or layers are configured to cut, pinch, pull, twist, or rotate thrombus or tissue material. For example, mechanical engagement features 2800c may be configured to close towards one another to hold the thrombus material or tissue within the funnel, or prevent the thrombus material or tissue from exiting the funnel, while mechanical engagement features 2800b and/or 2800a may be actuated to cut, pinch, pull, twist, or rotate the thrombus material.

[0118] In some examples, one of more layers of mechanical engagement features may be actuated independent of other mechanical engagement features layers. In some examples, one or more layers of mechanical engagement features may be actuated in combination with one or more additional mechanical engagement features layers. For example, referring to FIG.

13 A, one or more mechanical engagement features or mechanical engagement features layers may be actuated independent of one another such as mechanical engagement features 2800a being retracted proximally after engaging thrombus material while mechanical engagement features layers 2800b and 2800c can remain statically engaged to the thrombus material to allow mechanical engagement features layer 2800a to cut, tear, or otherwise separate proximal segments of the thrombus material therein. In some examples, one or more mechanical engagement features layers may work in concert with one another to manipulate the thrombus material.

[0119] Again referring to FIG. 13 A, mechanical engagement features layers 2800a, 2800b, and 2800c may be actuated in series or any other sequence relative to one another. For example, the thrombus removal device may engage thrombus material and one or more mechanical engagement features layers may be actuated to engage the thrombus material. For example, mechanical engagement features layer 2800a may engage the proximal segment of thrombus material, then mechanical engagement features layer 2800b may subsequently engage the thrombus material following by subsequent distal mechanical engagement features layers (e.g., mechanical engagement features layer 2800c). In some examples, the sequence of engagement may be configured to pull or displace the entire thrombus proximally within the thrombus removal device or towards a cutting plane of jets of the device. For example, mechanical engagement features layer 2800a may engage the proximal segment of thrombus material and be retracted proximally while mechanical engagement features layer 2800b is actuated to engage the thrombus material and support a proximal displacement of the thrombus material followed by subsequent distal mechanical engagement features layers engaging the thrombus and retracting proximally to pull the entire thrombus proximally towards the thrombus removal device (e.g., aspiration catheter).

[0120] FIGS. 13A and 13B illustrate examples of how one or more mechanical engagement features layers may engage a thrombus. For example, FIG. 13B illustrates mechanical engagement features 2810a and 2810b (e.g., opposing mechanical engagement features of the same layer) being designed and configured to collide so as to pinch one or more clots within the funnel or distal end. In this example, mechanical engagement features on opposite sides of the funnel are shown, with the distal tips of the mechanical engagement features being designed to contact each other when actuated. In one embodiment, the mechanical engagement features can be arranged so that they first collide and pinch clot material before then pulling the clot in towards the aspiration lumen as actuation of the mechanical engagement features continues. It should be understood that in embodiments where there are more than two mechanical engagement features, not all the mechanical engagement features must be designed to collide and pinch the clot. In some examples, only two of the mechanical engagement features can be arranged in this manner, and the other mechanical engagement features can operate similar to the other mechanical engagement features embodiments described herein. However, in some embodiments, all the mechanical engagement features can be designed and configured to collide at a single point (e.g., at a central point in the funnel or distal end).

[0121] FIG. 13C illustrates another example of how one or more mechanical engagement features layers may engage a thrombus. In this example, the mechanical engagement feature tips of two or more mechanical engagement features can be offset to create a shearing action (e.g., like scissors) when the mechanical engagement features are actuated. In some examples, offset configuration in this way may be configured to shear a segment of the thrombus. In some examples, an offset configuration may be configured to manipulate or displace thrombus material for engagement with one or more mechanical engagement features layers. For example, mechanical engagement features 2820b and 2820a may be configured to engage different areas of a thrombus to increase the engagement and hold the thrombus in a particular orientation while one or more additional mechanical engagement features layers impact the thrombus material proximally or distally from mechanical engagement features layer 2820.

[0122] In some examples, a mechanical engagement features layer may comprise a plurality of offset mechanical engagement features configured to be actuated independent or in combination with one another to engage a thrombus and retain the thrombus material in a static position while one or more mechanical engagement features layers can be actuated to impact the thrombus (e.g., shear, cut, macerate, etc.). In some examples, one or more mechanical engagement features of a layer may be configured to engage a thrombus to rotate the thrombus material. As described herein, the closure of mechanical engagement features within a layer or array may be configured to engage the thrombus material and provide rotational force to the material by closing similar to an iris around an aperture.

[0123] FIG. 13D illustrates a mechanical engagement features array configuration allowing one or more mechanical engagement features or layers to incorporate apertures and fluid lumens to deliver fluid streams from mechanical engagement features 2830a. The fluid delivery mechanism can provide a plurality of fluid streams (e.g., jets) to fluid apertures of the thrombus removal system through one or more apertures within the mechanical engagement features array. For example, one or more fluid streams delivered by the mechanical engagement features may be configured for macerating, cutting, fragmenting, pulverizing and/or urging thrombus to be removed from a proximal portion of the thrombus removal system. Mechanical engagement features 2830b and 2830may be configured to retain, cut, twist, slice, pinch, or rotate thrombus material while the mechanical engagement features 2830a may be configured to provide fluid streams or jets that contact the thrombus material sufficient to break the segment of thrombus at or near the mechanical engagement features 2830a. Resulting proximal segments of thrombus material may be retracted by mechanical engagement features 2830b while layer 2830can retain the proximal segment of thrombus material to prevent or reduce potential distal migration of thrombus material. In some examples, a series of cutting of thrombus material by mechanical engagement features layers may be facilitated by the proximal and distal retention of the thrombus material while one or more medial mechanical engagement features layers impact the thrombus material to shear or otherwise break the thrombus allowing the proximal layers (e.g., 2830b) to retract the proximal thrombus material segment into the thrombus removal device. [0124] Similar to FIG. 13D, FIG. 13E illustrates an example configuration of mechanical engagement features 2840a and 2840b incorporating apertures and fluid streams being offset. As described herein, the jets from mechanical engagement features 2840a and 2840b may be configured to shear or otherwise break apart thrombus material. Distal mechanical engagement features layer 2840c may be configured to retain and enclose the thrombus material within the distal end of the thrombus removal device while the fluid streams from mechanical engagement features 2840a and 2840b impact the thrombus material. For example, distal mechanical engagement features layer 2840c may be configured to reduce thrombus fragments from exiting the array while medial and proximal layers engage and break apart the thrombus material.

[0125] In some examples, one or more mechanical engagement features or layers may comprise different characteristics configured to impact the thrombus material in a variety of ways. For example, some mechanical engagement features may be more stiff than others. Increased stiffness may provide improved cutting, macerating, or engagement with thrombus material. In some examples, mechanical engagement features with increased stiffness may be configured to cut, macerate, or otherwise deform the thrombus material while more flexible mechanical engagement features can be configured to hold, retain, or otherwise manipulate the thrombus material in support of the stiffer cutting members. FIG. 13F illustrates an example where mechanical engagement feature 2850a or any other feature may have increased stiffness, rigidity, or geometry to provide a cutting impact on the thrombus material. Mechanical engagement features 2850b may be sufficiently stiff to retain the thrombus material while mechanical engagement features 2850a can be configured to impact the thrombus material to cut, tear, macerate, or otherwise deform the thrombus material at a proximal end of the array for improved aspiration of pieces of the thrombus material separated by mechanical engagement feature 2850b.

[0126] Additionally, FIG. 13F illustrates an example of increased articulation of mechanical engagement features relative to one another. For example, the space between mechanical engagement features 2850b may illustrate a pinch point generally central or towards a central axis of the thrombus removal device, while the distal layer 2850c is illustrated as overlapping mechanical engagement features that can be configured to engage the thrombus at more than one point or area increasing the engagement with the thrombus material to prevent distal migration or inadvertent separation of a distal segment of thrombus material. Mechanical engagement features 2850a may be a single mechanical engagement feature or a single actuated mechanical engagement feature from a layer that can be actuated to pull against the proximal portion of thrombus material. For example, mechanical engagement features 2850a may be actuated to engage the thrombus at a proximal segment of the thrombus material and the mechanical engagement feature may be retractable while layers 2850b and 2850c maintain a static engagement with the thrombus material thereby allowing mechanical engagement feature 2850a to cut, tear, or otherwise separate thrombus material proximally into the thrombus removal device.

[0127] In some embodiments, the stiffness of the mechanical engagement feature frame structure can be tuned independently of the stiffness of the funnel frame structure. For example, it may be desirable to have a funnel that is as compliant as possible so as to avoid injuring or damaging delicate vessel structures. At the same time, it may also be desirable to have a mechanical engagement feature frame structure and mechanical engagement features that are more stiff than the funnel, to provide improved clot engagement or maceration. Alternatively, it may be desirable to have the mechanical engagement features be more compliant than the funnel itself. Regardless, in some embodiments, the mechanical engagement features frame structure is stiffer than the funnel frame structure, and in other embodiments, the mechanical engagement features frame structure is less stiff than the funnel frame structure. Alternatively, the mechanical engagement features frame structure can have substantially the same stiffness as the funnel frame structure.

[0128] FIGS. 14A to 14B illustrate cross-sectional views of mechanical engagement features arrays disposed within an expandable member or funnel, as viewed from the distal end of the medical device. The layers of mechanical engagement features within an array may be configured to actuate and extend outward, inward, laterally, diagonally, orthogonally, etc. or a combination thereof to engage a thrombus or otherwise impact thrombus material within the distal end of the thrombus removal device. Referring to FIG. 14A, one or more layers may comprise a plurality of mechanical engagement features 2900 configured to actuate and enclose towards or beyond a central point (e.g., a central axis). In some examples, the mechanical engagement features 2900 can be actuated or controlled independently, in groups, all-together, or some combination thereof. The mechanical engagement features 2900 can include fluid or jet ports configured to direct fluid streams 2915 into the device, such as into a funnel or aspiration lumen of the device, as shown.

[0129] In FIG. 14B, another example of a layer of mechanical engagement features 2910a is shown closing in a cyclone or cylindrical manner around a central axis 2910. The mechanical engagement features 2910a may be arranged in a single layer or offset relative to one another. The cylindrical closing of mechanical engagement features 2910a can be similar to an iris closing around a central aperture and may be controllable via mechanical engagement feature articulation to increase or decrease the aperture provided around the central axis 2910. In some examples, the mechanical engagement features may be configured to close entirely to retain or sever thrombus material therein. In some examples, mechanical engagement features 2910a may be configured to close in sequence relative to one another to rotate the thrombus material retained therein. In other examples, the mechanical engagement features 2910a can be actuated or controlled independently, in groups, all-together, or some combination thereof. The mechanical engagement features 2900 can include fluid or jet ports configured to direct fluid streams 2915 into the device, such as into a funnel or aspiration lumen of the device, as shown.

[0130] In some examples, the distal tip geometry of the mechanical engagement features may be configured to engage or otherwise impact thrombus material to provide manipulation or deformation (e.g., shearing, cutting, macerating, etc.) of the thrombus material therein. For example, referring to FIG. 14A, the distal tip geometry is generally a point or piercing tip, while other examples may include a rounded or blunt tip. In some examples, the distal tip may be configured to impact the thrombus material. In some examples, the distal tip geometry can be configured to cut the thrombus material. In some examples, a lateral edge or side of one or more mechanical engagement features may be configured to impact the thrombus material. In some examples, a combination of a tip and lateral edge may be configured to engage or impact the thrombus material. In some examples, a surface (e.g., distal and/or proximal surface) may be configured to impact the thrombus material. For example, a surface of one or more mechanical engagement features may be smooth, or irregular having teeth, knurled surface, or otherwise textured to provide increase engagement and manipulation of the thrombus material.

[0131] As described herein, one or more mechanical engagement features, layers, or arrays of mechanical engagement features may be actuated simultaneously, independently, selectively, etc. or a combination thereof. In some examples, any layer may be actuated based on the actuation or impact of one or more layers. For example, a proximal layer may be actuated, and one or more distal layers may be subsequently actuated once the proximal layer is actuated and engages the thrombus material. Some examples of layer or mechanical engagement feature articulation may include alternating mechanical engagement features (e.g., every-other mechanical engagement features) or any pattern of subsequent actuation. This manner of actuation or articulation of the mechanical engagement features may be configured to grab and/or pull thrombus material. In some examples, the manner of actuation or articulation may be configured to grab and/or pull the thrombus towards the aspiration lumen (e.g., proximally). Some examples of layer or mechanical engagement feature articulation may include sequential actuation of one or more mechanical engagement features or layers (e.g., mechanical engagement feature 1, mechanical engagement feature 2, mechanical engagement feature 3). This manner of actuation may be configured to twist and/or rotate the thrombus material. Some examples of layer or mechanical engagement feature articulation may include varied axial position (e.g., offset or height of mechanical engagement features). This manner of actuation may be configured to retain, grab, pull, etc. the thrombus material. Some examples of layer or mechanical engagement feature articulation may include varied radial overlap of one or more mechanical engagement features of a layer. For example, mechanical engagement features may overlap, scissor, hook, curve, etc. or a combination thereof. This manner of actuation may be configured to pinch, cut, shear, etc. or a combination thereof the thrombus material. Some examples of layer or mechanical engagement features articulation may include iris closure (e.g., cyclonically, tangentially arrayed closure). This manner of actuation may be configured to twist and/or rotate the thrombus material.

[0132] In some implementations, the mechanical engagement features can serve to hold the clot within the distal end of the device, but not cut, macerate, or otherwise disrupt the clot. In one example, one or more mechanical engagement features can be actuated or positioned to hold the clot within the funnel, and the aspiration and/or jets may be oscillated on and off to break up and remote the clot from the patient. In one example, one or more mechanical engagement features can be actuated or positioned to pull the clot proximally independent of additional maceration or impact to the clot material. For example, one or more mechanical engagement features may be configured to loosen the distal end of the clot (e.g., by pulling the clot proximally), independent from/prior to maceration, In some implementations, the jetting or fluid streams can be sequenced with mechanical engagement features actuation. For examplejetting can be turned on when the mechanical engagement features are actuated, and turned off when the mechanical engagement features are not actuated. In some examples, jetting can be turned on only after the mechanical engagement features are fully deployed or actuated, or alternatively, only when the mechanical engagement features are not deployed. Any combination of sequencing jetting and mechanical engagement features actuation is contemplated.

[0133] In some examples, actuation of one or more mechanical engagement features within the array may be based on manipulation or engagement of elongate members in operable communication with the mechanical engagement features. As described above, a sheath may be manipulated either axially or by rotation to actuate the mechanical engagement features. Movement of this sheath may be motorized or automated. In other examples, pull wires may be coupled to the mechanical engagement features and be configured to actuate the mechanical engagement features when the pull wires are engaged by a user or other actuation interface. In some examples, the pull wires can be attached or coupled to a motor configured to mechanically adjust a position of the pull wires to manipulate the mechanical engagement features. In some examples, mechanical engagement features actuation may be provided by a pneumatic system configured to adjust a pressure to the layers or mechanical engagement features for selective articulation of one or more mechanical engagement features, layers, or arrays. In some examples, operation of the mechanical engagement features may be facilitated by a thermal or electrical process. Actuation of the mechanical engagement features can be controlled, for example, with a user interface (e.g., button or GUI on a handle or console of the system). In some examples, a single user interface can be configured to control all mechanical engagement features at once. In other embodiments, multiple user interfaces or buttons can be configured to control the mechanical engagement features independently or in groups. For example, one or more mechanical engagement features may comprise a material or otherwise be configured to react to changes in temperature or electrical impulses transmitted to the mechanical engagement features. In some examples, one or more mechanical engagement features may be configured to automatically be actuated on contact (e.g., sufficient contact) with thrombus material within the distal end of the thrombus removal device. In some examples, actuation and articulation of one or more mechanical engagement features may be provided by engagement with a handle at a proximal end of the thrombus removal device (e.g., outside of a patient when in use). One or more engagement elements may be selectively controlled by a user to engage or otherwise actuate the mechanical engagement features and initiate their associated function. In some examples, one or more mechanical engagement features may be actuated by the sheath or delivery catheter. For example, a sheath may be advanced distally towards the mechanical engagement features causing actuation of the mechanical engagement features by pressure provided by the distal end of the sheath on the mechanical engagement features. In some examples, a proximal layer may be configured to transfer or transmit an actuation force to subsequent (e.g., distal layers).

[0134] In any of the examples provided herein, transition of the mechanical engagement features from the open configuration (e.g., stowed configuration) to the closed or actuated configuration may be facilitated by a pressure of fluid supplied from the fluid lumen(s) to the mechanical engagement features. Referring to FIGS. 15A-15B, mechanical engagement features 3000 may be in fluid communication with one or more fluid lumens 3010 of the device, such as fluid lumens disposed within or formed by the elongate shaft of the device. In FIG. 15 A, the mechanical engagement features 3000 are shown in a deployed configuration within the fluid lumens 3010 of the device. In FIG. 15B, the fluid then may be directed through the fluid lumen to the mechanical engagement feature and through a lumen or interior of the mechanical engagement feature to a jet or fluid opening of the mechanical engagement feature, as described herein. However, in addition to providing a fluid stream 3015 from the mechanical engagement feature, the fluid pressure may be configured to deploy or transition the mechanical engagement features from the stowed position to a deployed position. For example, the pressure of the fluid from the fluid lumen to the mechanical engagement feature may be sufficient to extend a mechanical engagement feature from the stowed position extending the mechanical engagement feature to a deployed configuration ready to directed a flow of fluid or further articulate to engage the thrombus material. In some examples, the mechanical engagement features can include a shape memory material that assumes a pre-determined or pre-biased configuration when the mechanical engagement feature exits the fluid lumen. For example, in FIG. 15B, the mechanical engagement features can be pre-biased or pre-formed to bend inwards towards an aspiration lumen 55 of the device. In some examples, when the fluid is no longer directed into the fluid lumen, the mechanical engagement features can be configured to retract or pull back into the fluid lumens into the stowed configuration.

[0135] In some examples, pressure of fluid passing through the fluid lumens to the mechanical engagement features may be adjustable. For example, a first pressure of the fluid may be sufficient to deploy a mechanical engagement feature. Then a second pressure may be configured to provide a fluid stream flowing out from a jet or fluid opening of the mechanical engagement feature. In some examples, the second pressure may be greater than the first pressure such that the first pressure may be sufficient to deploy the mechanical engagement feature without providing a flow of fluid from the jet or fluid opening, or optionally, providing a flow of fluid sufficient for irrigation within the funnel but not strong enough to form jets or fluid streams that can disrupt the thrombus.

[0136] In some examples, articulation of mechanical engagement features may be based on the pressure of the fluid flowing from the fluid lumen through the mechanical engagement feature. For example, a first pressure may be configured to deploy the mechanical engagement feature, a second pressure may be configured to articulate a distal end of a mechanical engagement feature towards the center of the funnel to engage the thrombus, then a third fluid pressure may be configured to provide the fluid stream from the fluid opening or jet of the mechanical engagement feature. The third pressure may be sufficient to contact and support removal of the thrombus. [0137] The fluid pressure may be adjustable and configured to hydraulically actuate and articulate the mechanical engagement features. For example, the fluid pressure may be configured to articulate the mechanical engagement members to provide repeated articulation such a biting repetition of the mechanical engagement feature to contact the thrombus. For example, pressure may be supplied through the fluid lumen to the mechanical engagement feature to sufficiently actuate the mechanical engagement features (e.g., fangs) to a closed configuration, then pressure may be adjusted (e.g., reduced) allowing the mechanical engagement feature to transition to the open configuration, then the pressure may be adjusted (e.g., increased) to transition back to the closed configuration and the repetitive transitioning between the open configuration and closed configuration can modify the thrombus material in the funnel (e.g., macerate, cut, break, sever, etc.). In some examples, the pressure may be pulsed or otherwise dynamically provided to the mechanical engagement feature and the articulation may be based on the amount and frequency of the pressure supplied.

[0138] In some examples, the mechanical engagement features may be configured with fluid streams at any position on one or more of the mechanical engagement features. Referring to FIG. 16 A, and expanding on examples of fluid streams illustrated in FIGS. 15A and 15B, fluid streams 3020 are illustrated emanating from the distal tip of mechanical engagement features 3025. For example, fluid streams 3020 may be orthogonal or directed generally perpendicular to a central axis.

[0139] Also illustrated in FIG. 16B is an example of retracting the mechanical engagement features back into the fluid lumens after fluid delivery or jetting is turned off. For example, springs 3030 or other mechanical retraction mechanisms can be coupled to the mechanical engagement features 3025 and disposed within the fluid lumen. When jetting is turned on, the force applied by the fluid to the mechanical engagement members is enough to overcome the counterforce applied by springs 3030, allowing the mechanical engagement members to deploy within the funnel. However, when jetting is turned off, the mechanical engagement features may be retracted by one or more springs 3030. For example, the mechanical engagement features may be spring loaded to retract from a deployed position. In some examples, the mechanical engagement features may be spring loaded to deploy, retract, or a combination thereof.

[0140] Additional embodiments are shown in FIGS. 17A and 17B. Here, the device can include one or more inflatable elements 3060a/3060b configured to deploy the mechanical engagement features 3050a/3050b. The inflatable elements 3060a/3060b may be positioned near a base of the funnel adjacent to the mechanical engagement features and can be configured to expand outward from a section, segment, or annularly around the base of the funnel. The inflatable element may be positioned interior to the mechanical engagement features such that when expanded, the inflatable elements 3060a/3060b may provide expansion or rotation of the mechanical engagement features around a pivot 3070. In some examples, the inflatable element may be configured to expand and support the mechanical engagement features.

[0141] FIGS. 17A-17B show two different inflatable element configurations (3060a/3060b) in a single device, for ease of illustration. It should be understood that in some embodiments, the only inflatable element configuration used is that of 3060a for deployment all mechanical engagement features. In other embodiments, the 3060b configuration is used. It should be understood that a combination of inflatable element configurations could also be implemented.

[0142] FIG. 17A shows an example of a device in which the mechanical engagement features 3050 are in a stowed or undeployed configuration. The mechanical engagement features 3050 are shown resting in pockets 3065a/3065b of the device or funnel, such that the mechanical engagement features are not substantially blocking the funnel or aspiration lumen 55 of the device.

[0143] FIG. 17B shows an example of the device in which the mechanical engagement features 3050 are deployed into the funnel and optionally delivering jets or fluid streams into the funnel.

[0144] To deploy mechanical engagement feature 3050a from the stowed configuration (left side of FIG. 17A) to the deployed configuration (left side of FIG. 17B), fluid can be delivered into fluid lumen 3010 and into pocket 3065a. As the pocket fills with fluid, the fluid presses upon mechanical engagement feature 3050a which extends into the funnel around pivot 3070. Compliant material portion 3075 can stretch or expand to allow mechanical engagement feature 3050a to extend into the funnel while maintaining the fluid within pocket 3065. Furthermore, inflation of inflation element 3060a can still allow for fluidic coupling between the mechanical engagement feature 3050a and the fluid lumen 3010, allowing for the delivery of jets or fluid streams from the mechanical engagement feature into the funnel via fluid ports in the mechanical engagement feature.

[0145] To deploy mechanical engagement feature 3050b from the stowed configuration (right side of FIG. 17 A) to the deployed configuration (right side of FIG. 17B), fluid can be delivered into fluid lumen 3010 and into balloon or inflatable 3060b within pocket 3065. As the inflatable element 3060b fills with fluid, the inflatable presses upon mechanical engagement feature 3050b which extends into the funnel around pivot 3070. Inflatable element 3060b can stretch or expand to allow mechanical engagement feature 3050b to extend into the funnel. Furthermore, inflation of inflation element 3060b can still allow for fluidic coupling between the mechanical engagement feature 3050b and the fluid lumen 3010, allowing for the delivery of jets or fluid streams from the mechanical engagement feature into the funnel via fluid ports in the mechanical engagement feature.

[0146] Inflatable elements 3060a/3060b can be inflated or filled with an inflation medium (such as air, saline, gas, etc.), causing the mechanical engagement feature to deploy into the funnel. Inflation can be provided via fluid lumens 3010, as shown, or alternatively separate inflation lumens can be provided, decoupling inflation of the inflatable elements from jetting. In some embodiments, the mechanical engagement features do not include fluid ports for jetting, but instead jetting can be integrated into the funnel itself or into the fluid lumen. In some examples, jetting can be provided from the funnel/fluid lumen in addition to from the mechanical engagement features.

[0147] Additionally, systems configured in accordance with an embodiment of the present technology can include, for example, a thrombus removal device having: an inner catheter shaft; a distal tip coupled to the inner catheter shaft, in which the distal tip includes a plurality of raised portions and at least one port that extends through the distal tip and is position between adjacent raised portions; an expandable member disposed over the plurality of raised portions and extending distally from the distal tip; an outer catheter layer disposed over the inner catheter shaft and the plurality of raised portions to form an annular space between the outer catheter layer and the inner catheter shaft; and a fluid source fluidly coupled to the annular space, the at least one port to produce at least one fluid stream into the expandable member.

[0148] FIG. 18A illustrates a side view of an embodiment of a thrombus removal device 3100. As shown here, distal tip 3102 of the device is coupled to a funnel 3104 that can include a funnel collar 3103 at the base of funnel 3104. The distal tip can comprise a distal portion of an inner catheter shaft, or a separate coupling element attached to the inner catheter shaft. The funnel and funnel collar can comprise a shape memory material such as nitinol. The device 3100 can further include an outer catheter shaft 3101 which may comprise a braided catheter layer. As described herein, spacing can be provided between the inner catheter shaft and the outer catheter shaft 3101 to form an annular space that can be used for a number of purposes in the system. In some embodiments, some or all of the annular space between the inner and outer catheter shafts can be used as a fluid lumen to direct fluid from a proximal end of the system shaft to the distal tip and/or funnel. For example, a fluid lumen 3105 traverses through the annular space between the inner catheter shaft and the outer catheter shaft 3101. The fluid lumen can terminate at one or more fluid ports 3106 in the distal tip, the fluid ports being configured to direct one or more fluid streams into one or more of the funnel or an aspiration lumen 3109 of the device. The outer catheter may abut or be disposed over the funnel/funnel collar to fluidly couple the lumen(s) 3105 to the distal tip and to the fluid ports 3106.

[0149] FIG. 18B is a cross-sectional view of device 3100 including inner catheter shaft 3107 and outer catheter shaft 3101, forming fluid lumen 3105 which traverses the length of the catheter shaft to the distal tip. As shown in FIG. 18B, the catheter shaft can also form an aspiration lumen 3109 in the center of the catheter shaft, which can provide aspiration to the distal tip (e.g., to the funnel 3104). Details on additional catheter lumen designs between an inner and outer catheter shaft, as well as fluid port locations and jet/fluid stream configurations can be found in International Patent Application No. PCT/US2022/033024, which is incorporated herein by reference in its entirety.

[0150] FIGS. 19A-19B illustrate additional embodiments of a distal tip for a thrombus removal device described herein. The distal tip correspond to distal tips described above (e.g., distal tip 10 in FIG. 1). As described herein, the distal tip 3202 can include raised portions 3210 that include tapered ends 3220 in FIG. 19A and square ends 3221. Fluid channels 3231 are formed between adjacent raised portions 3210, as previously described. The fluid channels 3231 can provide a flow of fluid (e.g., saline) towards fluid ports 3206 to produce a plurality of jets or fluid streams near the distal end of the device, such as into a funnel or other expandable element of the device.

[0151] FIG. 19A shows a side view of distal tip 3202 with raised portions 3210 having a tapered end and step-down portions 3299. According to certain embodiments, there is at least one tapered flow end 220 on the raised portions 3210. Adjacent raised portions 3210 form fluid lumens 3231, which are in fluid communication with fluid lumen 3205 of the catheter (e.g., formed between inner and outer catheter shafts). Fluid flow traverses through fluid channel(s) into fluid lumens 3231 of the distal tip and egresses or is ejected at fluid ports 3206, exiting distal tip and entering the space within an expandable element such as a funnel. According to certain embodiments, tapered ends reduce flow circulation in the distal tip 3202.

[0152] FIG. 19B shows a side view of distal tip 3202 with raised portions having a squared end 3221 and step-down portions 3299. According to certain embodiments, there is at least one squared end 3221 on the raised portions 3210. Adjacent raised portions 3210 form fluid lumens 3231, which are in fluid communication with fluid lumen 3205 of the catheter (e.g., formed between inner and outer catheter shafts). Fluid flow traverses through fluid lumen(s) 3205 into fluid lumens 3231 of the distal tip and egresses or is ejected at fluid ports 3206, exiting distal tip and entering the space within an expandable element such as a funnel.

[0153] FIG. 20 shows a distal tip 3300 in a perspective view from the proximal end. The tip body 3305 comprises a proximal tip body 3305a coupled to a distal tip body 3305b. A gasket 3310 is positioned between the proximal tip body 3305a and distal tip body 3305b. Fluid channels 3320 are arranged around a perimeter of the tip body 3305 and are generally formed between raised portions 3321, the tip body 3305a, and a funnel/funnel collar disposed over the distal tip as previously described. The raised portions are configured for separating all or a portion of fluid flowing from lumen 3105 (of FIG. 18B) to each fluid channel 3320. Actuation channels 3322 are similarly positioned around the perimeter of the tip body 3305. Actuation channels 3322 can also be configured to receive fluid from the fluid lumen 3105 (of FIG. 18B) that flows through the actuation channel to a spring segment 3311 of the gasket. The spring segments 3311 can be adapted to respond to the fluid flow or fluid pressure by bending in an opposite direction from a neutral state as illustrated in FIG. 20 to a deployed state whereby actuating elements 3330 extending from the spring segments 3311 are deployed through ports 3325 to extend into or across the tip lumen 3315. Fluid channels 3320 can be adapted to direct the fluid from the fluid lumen to jets or fluid ports 3335 and then through the fluid ports 3335 towards or across the tip lumen 3315.

[0154] According to certain embodiments of the thrombus removal device, the actuating elements 3330 may be coupled the spring segments 3311. In some examples, the actuating elements 3330 may be an extension of the spring segments 3311 and configured to extend towards and through the ports 3325. The spring segments 3311 can be configured to facilitate deployment when they are contacted with fluid flowing in actuation channels 3322. For example, when fluid contacts the spring segment 3311 with sufficient pressure, associated actuating elements will be advanced corresponding to the change in the spring configuration and the distal tip of the actuating elements can be deployed through the port 3325. The example illustrated in FIG. 20, shows the spring segments as leaf springs in a curved configuration across the fang channel 3322. The height of the spring segments 3311 may be configured to segregate a distal segment of the actuation channel 3322 from the fluid thereby concentrating the force of fluid contacting the proximal side of the spring segment 3311 to overcome the spring force and deploy the actuating elements 3330. In some examples, a length of deployment may be based on the curvature of the spring segment 3311. For example, the length and actuating elements 3330 may be deployed may be associated with the depth of curvature of the associated spring segment 3311. In some examples, each spring segment 3311 may have a uniform depth of curvature. In some examples, spring segments 3311 may have different depths of curvature providing different or selectable actuating elements deployment lengths.

[0155] In FIG. 21 A, additional details of the tip distal end interior are shown including the fluid ports 3335 and ports 3325. The arrangement and orientation of the ports 3325 can be configured to support the deployment and deployment configuration of the actuating elements 3330 as they are advanced distally into a deployed state towards or across the lumen 3315. For example, ports 3325 may comprise angled surfaces configured to contact and deflect actuating elements 3330 as they are deployed or extended towards or across the lumen 3315. Continuing this example, an actuating elements 3330 may be deployed when the spring segment is contacted by the fluid, and the distal end or portion of the actuating elements 3330 may contact a distal side of the port 3325 to be deflected at an angle based on contact with the port 3325. In other examples, the actuating elements may have a shape memory and can be adapted to curve or confirm to the shape memory after deployment towards the lumen 3315. Similarly, fluid ports 3335 may be adapted to direct a jet or flow of fluid through the fluid channel 3320 towards or across the lumen 3315. The fluid ports 3335 may be oriented at an angle relative to an interior surface of the lumen 3315 and direct the fluid jet at a predetermined angle towards or across the lumen 3315 and therefore towards thrombus material in, adjacent, or proximal to the lumen 3315 for maceration, and aspiration of thrombus material through the lumen 3315 (e.g., aspiration lumen). In some aspects, the actuating elements and/or the fluid ports may be positioned orthogonally to the aspiration lumen.

[0156] The cross-section view illustrated in FIG. 2 IB highlights exemplary details of the spring segments 3311 and actuating elements 3330 in a retracted position with the actuating elements distal ends 3331 locatable in or adjacent to the ports 3325. This cross section view also shows an example of the fluid port 3335 and an angle of the port 3335 as it extends from an exterior though to an interior of the tip 3300. The aspiration lumen 3315 is clearly shown and can coupled to the aspiration lumen of the catheter assembly, as described herein. In this example, and as shown in FIG. 21 A, the tapered distal end 3345 of the tip 3300 can be configured to support aspiration and funneling of thrombus material into the aspiration lumen during use.

[0157] The spring segments 3311 shown in the cross-section of FIG. 21B are also shown to highlight the example of a concave configuration with the trough of each spring segment concave proximally and associated actuating elements 3330 retracted corresponding to the depth of the spring. It can be understood that the deployed configuration can include a change in the spring segments 3311 from this concave configuration to a convex configuration deploying each actuating elements 3330 a length of change from the concave spring configuration to the convex spring configuration.

[0158] FIG. 22 illustrates an alternative spring-based deployment mechanism of a distal tip, as described herein. The tip 3301 is shown as a single piece body with fluid channels 3327 similar to those described in FIGS. 19A, 19B, and 20 with a fluid port 3328 adapted to direct a jet of fluid through the port 3328 to an interior of the tip (e.g., aspiration lumen). In this example, the springs 3312 are shown as coil springs with a plunger 3313 positioned proximally in the actuation channel 3323 and adapted to receive the fluid pressure from the fluid lumen 3105 to translate the actuating elements 3331 from a retracted configuration, as illustrated, to a deployed configuration through the port 3326 as the fluid pressure overcomes the spring bias of the actuating elements 3331 to a retracted configuration. Similarly to the spring segments in FIG. 20, the coil springs 3312 are adapted to translate the fluid pressure to fang deployment in use to contact thrombus material in the funnel or adjacent to the aspiration lumen, as described herein. In this example, the coil springs 3312 may be expanded against the plunger 3313 and the fluid pressure can be adapted to compress the spring 3312 to deploy actuating elements 3331.

[0159] FIGS. 23A and 23B show another example of a distal tip with variations on the hydraulic deployment mechanisms for the actuating elements. In this example, the tip comprises a two-part body with a proximal body part 3405a coupled to the distal body part 3405b and a gasket positioned between the two tip parts. The gasket, similar to that illustrated in FIG. 20 has spring segments 3411 positioned across actuation channels 3422. The actuation channels 3422 are shown here adjacent to fluid channels 3420 with a raised separator 3425 between the fluid channel 3420 and actuation channel 3422. A plunger 3415 is positioned around the tip body with actuating elements 3430 in fluid communication with plunger openings 3445. Here, the actuating elements 3430 are shown as tubular actuating elements with a lumen extending from the distal end of the actuating elements through the plunger and through the plunger opening 3445. This lumen can be configured to receive fluid flowing from the fluid lumen of a catheter assembly described herein (e.g., fluid lumen 3105 in FIG. 18B). The plunger 3415 provides routing of fluid through the lumen as well as translation of the hydraulic pressure of the fluid contacting the proximal side of the plunger 3415 to displace the plunger distally against the spring segments 3411. In this configuration, the plunger may control actuating elements deployment based on the fluid pressure contacting the proximal side of the plunger 3415, as an alternative to the actuating elements deployment described in FIG. 20 whereby the fluid contacts the spring segments directly to deploy the fangs. Here, the spring segments may be adapted to bias the plunger/ actuating elements assembly to a retracted position when the fluid pressure is not sufficient to overcome the spring bias against the plunger. For example, when fluid is supplied to the proximal side of the plunger, the pressure can be sufficient to overcome the spring bias against the distal side of the plunger and the actuating elements may be distally advanced through the ports 3435. Additionally, a portion of the fluid contacting or directed towards the proximal side of the plunger 3415 can be routed through the lumen and out of the distal end of the actuating elements towards thrombus material or otherwise towards the lumen 3401. [0160] The fluid channels 3410 are shown with the gasket height not exceeding the surface of the tip body. Similarly, the plunger segment extending across the fluid channel 3420 may also be sufficiently low to allow fluid to flow through the fluid channel 3420 to the fluid or jet port 3440 where the fluid may be directed through the jet port to the lumen 3401 (e.g., and any thrombus material positioned in or adjacent to the lumen 3401). At area 3410 the transition of the spring segment height from across the actuation channel to the fluid channel is shown where the raised portion 3425 allows the spring segment height to change (e.g., decrease) to the thickness of the distal tip wall.

[0161] FIG. 23B shows the distal tip 3400 from FIG. 23 A in a distal perspective view with actuating element 3430 in a deployed or partially deployed configuration as the actuating element distal tip 3431 is extending through the port 3435. The distal tip of the actuating element 3431 highlights the lumen extending through the actuating element 3430 from the plunger opening 3445 and how the lumen can be adapted to direct a flow of fluid through the lumen to the tip lumen 3401. Arrow 3450 shows an example of a fluid flow direction against the plunger 3415 and, in this view, the fluid is sufficient to at least partially overcome the bias of spring segment 3411 to allow deployment of the actuating element 3430 into the lumen. The jet ports 3440 are shown in an example of an arrangement around an interior of the tip lumen 3401 and can be directed towards an interior of the lumen, as described herein, to contact and break thrombus material positioned therein for aspiration through the lumen 3401 and aspiration lumen of a catheter assembly coupled to the tip 3400. It is also notable that from this view, the spring segments are shown to facilitate the passage of the actuating element 3430 through the spring segment 3411 to the plunger. Here, the spring segments have a channel to accommodate the actuating elements passing therethrough while still maintaining sufficient contact with the distal side of the plunger 3415.

[0162] FIG. 24 illustrates an exploded view of the distal tip in FIG. 23 A to show the arrangement of the gasket with spring segments 3411 between the distal tip body 3405b and the proximal tip body 3405a. The plunger 3415 is shown proximal to the gasket but may be circumferentially engaged to the tip body (e.g., proximal tip body 3405a). The fang 3430 is shown in line with the plunger opening 3445 as it may be extended through the opening with the lumen created through the fang and the plunger from the fang distal tip proximally to the plunger opening 3445.

[0163] According to certain embodiments of the thrombus removal device, the gasket may be positioned between the tip body segments. In some examples, the gasket may be a continuous annular element with the spring segments positions and configured as described herein. In some examples, the gasket may be a discontinuous annulus whereby the spring segments may be individually provided across the actuation channels, as described herein. [0164] FIG. 25 shows additional detail of the distal tip from FIG. 23 A with a close-up proximal view of the plunger opening 3445 including the actuating element proximal end visible through the opening 3445. In some examples, the actuating elements may be coupled to the distal end of the plunger opening 3445. In other examples, the actuating elements may extend through the plunger to the proximal side of the plunger opening 3445 such that the fang lumen extends through the plunger to receive fluid flowing therethrough. The spring segment 3411 includes is shown with a spring opening 3412 configured to allow the actuating elements 3430 through the opening 3412 in the spring and to the plunger 3415. The port 3435 can be seen with the actuating element 3430 extending at least partially therethrough. In this detailed view, a plunger recess 3426 in the raise portion 3425 can be seen allowing for translation of the plunger 3415 distally and proximally within the plunger recess 3426. For example, the plunger may be circumferentially engaged with the tip body and when fluid pressure is supplied to the proximal face of the plunger 3415, the plunger can travel or be distally advanced by the fluid pressure along the plunger recess.

[0165] FIGS. 26 A to 26B illustrate different examples of deployment configurations including transitions from a retracted state to a deployed state whereby the actuating elements of a distal tip, described herein, may be advanced towards thrombus material or otherwise towards a lumen of the tip during use. Referring to FIG. 26A, a distal tip similar to that illustrated in FIG. 23 A is shown with the actuating element in a retracted state as no pressure has been applied to the plunger 3415. The spring segment 3422 is in the concave configuration and the actuating element 3430 is retracted in the actuation channel with the actuating element distal tip (hidden from view) has yet to be extended or advanced through the port. Once fluid pressure (e.g., from the fluid lumen 105) is supplied, the pressure may be sufficient to overcome the concave spring bias against the plunger 3415 and the plunger may advance distally to change the spring segment 411 from the concave configuration in FIG. 26A to the convex configuration shown in FIG. 26B. The actuating element 3430 in FIG. 26B is now deployed, at least partially through the port 3435 such that the actuating element distal tip 3431 is seen beyond the fang port 3435 into and/or towards the tip lumen. The hydraulic deployment of actuating elements, as described herein, may be based on the fluid pressure supplied to the proximal end of the fang, spring segment, plunger, or other feature at, near, or coupled to the proximal end of an actuating element. In the examples illustrated in FIGS. 26 A to 27B, the actuating elements may be those illustrated in FIG. 23 A with the added function of direct a fluid jet through the fang lumen and out the fang distal end 431 to contact thrombus material. In any example described herein, thrombus material may be contacted by fangs, fluid, or a combination thereof. In some examples, the actuating elements described herein may deploy together (e.g., at the same rate) or sequentially, or consecutively, or in any configuration to promote engagement with and segmentation of a thrombus material for aspiration through the tip lumen (e.g., aspiration lumen).

[0166] Referring to FIGS. 27A and 27B, the fangs 3430 are shown in a similar deployment transition to that illustrated by FIG. 26 A and 26B. Here, and as previously described, the actuating elements 3430 have curved or curled segments 3432 between the proximal end and the distal end 3431 of the actuating element 3430. The curve or arc of the actuating element during deployment may be based on a shape memory of the actuating element material and/or by contact with the opening 3435. For example, the opening 3435 may be adapted to deflect the actuating element 3430 during deployment to modify or bias an angle or direction of deployment of the fang 3430.

[0167] FIGS. 28A-28D illustrate another embodiment of a thrombectomy device distal tip 2802 that includes a plurality of fluidically deployed actuation elements 2804. The actuation elements 2804 can include a lumen disposed therein, and each actuation element can be slideably disposed within a valve 2806. Fluid entering the distal tip can enter fluid lumen 2808, when can push against the actuation element within that valve causing the actuation element to move distally relative to the distal tip and into or across the aspiration lumen of the device. When the actuation element is fully deployed, a port 2810 within the actuation element and in fluid communication with the lumen within the actuation element is exposed by window 2812, which is fluidly coupled to fluid lumens 2814. Continued delivery of fluid into the distal tip allows fluid to enter the actuation element lumen and be delivered as a fluid stream or jet out of a distal end of each actuation element. This embodiment thereby provides a distally deployed jet that is actuated by fluid pressure across the valve and opens at a predetermined pressure. Springs 2816 may be coupled to the actuation elements, to provide a counter force to the fluid stream. When fluid delivery is terminated, the springs can cause the actuation elements to retract back into the distal tip and valve. This arrangement provides a pressure differential applying force to the actuation elements, countered by the springs. A feature of this arrangement is that when the actuating element is deployed, the pressure across it prior to deployment is already very high (pre-determined level), allowing for high pressure fluid stream delivery immediately upon actuation element deployment.

[0168] According to certain embodiments of the thrombus removal device, when the actuating elements are deployed, they may be repeatedly deployed and retracted during use to provide a biting or sequential engagement with thrombus material.

[0169] According to certain embodiments of the thrombus removal device, the fluid pressure supplied to deploy the actuating elements and/or provide a fluid flow through the jet ports of a distal tip may be a continuous fluid pressure or may comprise more than one fluid pressure. For example, a first fluid pressure may be supplied to the spring segments (e.g., as illustrated in FIG. 20) or to the plunger (e.g., as illustrated in FIG. 23 A) to deploy the actuating elements. The same first pressure may be directed through the fluid channels described herein and out of the jet ports to provide a jet of fluid towards the thrombus material at the same time, rate, and pressure as the actuating element deployment, including additional fluid jet flow through the actuation lumens. In some examples, there may be multiple fluid pressures. For example, a first fluid pressure may be supplied to the tip and be sufficient to provide a jet of fluid through the fluid channels and out of the fluid ports described herein. In some examples, a second fluid pressure being greater than the first may be supplied to the tip continuing the flow of fluid jets through the jet ports but also providing sufficient force to overcome the spring bias to deploy the actuating elements. In some examples the second pressure may be sufficient to provide the additional fluid jet through the fang lumen. Additional fluid pressures may be greater or less than the first and second fluid pressure to provide variation in the fluid pressure, fang deployment rate, etc. of the distal tip when in use to engage thrombus material. In any example, the fluid pressures may be varied or dynamically adjustable to deploy fangs and/or fluid jets in a desired configuration.

[0170] According to certain embodiments of the thrombus removal device, the actuating elements are actuated by the pressure generated by the saline in the catheter and not mechanically actuated by advancing/retracting the sheath. This can provide a number of advantages such as not requiring a motorized caddy system for the handles.

[0171] According to certain embodiments of the thrombus removal device, the actuating elements can be controlled by the cyclic change in irrigation pressure in the catheter created by the saline pump.

[0172] According to certain embodiments of the thrombus removal device, the actuating elements can reside inside the tip and not on the outer diameter of a funnel frame. [0173] According to certain embodiments of the thrombus removal device, the tip design now has eight chambers (e.g., channels). For example, four chambers can be dedicated to fluid jetting (e.g., fluid channels) and an additional four chambers that contain the concealed fangs (e.g., fang channels). In some examples, each chamber can have a Nitinol actuator that looks like a leaf spring (e.g., spring segment). This can be one single piece for all four chambers (e.g., gasket).

[0174] According to certain embodiments of the thrombus removal device, the actuation mechanism for advancing/retracting the fangs i can be locatable in each of these fang channels.

[0175] According to certain embodiments of the thrombus removal device, proximal to each leaf spring can be the plunger. This can be also one single piece for all four chambers (e.g., fang channels). In some examples, fangs can be attached to each plunger (bonded, or press fit etc.). The actuating element may pass through a hole in each leaf spring (e.g., spring segment) so that it can reach the distal face of the tip.

[0176] According to certain embodiments of the thrombus removal device, during actuation, a force can be applied to the proximal face of the plunger due to the increase in irrigation pressure (e.g., fluid pressure). As the plunger can be free floating on the tip, this applied force causes the plunger (and the fang) to move forward. In some examples, once the plunger starts moving forward it engages with the leaf spring (in a convex shape). The applied force can cause the leaf spring to snap through and become inverted into a concave shape thereby allowing the plunger to advance further forward and allow the fang to move out into the clot.

[0177] According to certain embodiments of the thrombus removal device, once the stiffness of the spring overcomes the irrigation pressure acting on the face of the plunger, the leaf spring (e.g., spring segment) can snap back to its original configuration and retract the fang into the tip. This can provide the cyclic motion of the fang advancing/retracting into the jet.

[0178] According to certain embodiments of the thrombus removal device, the two parts of the tip (and the housed leaf spring and plunger) can be held together with the cryo-swaged collar of the funnel.

[0179] According to certain embodiments of the thrombus removal device, the fangs can also be shape set. The actuating elements can be shape set in the advanced configuration. Upon retraction they will be straightened out to fit in the tip. The actuating elements can have certain additional features (e.g., saw tooth profile, pinch at different planes etc.) In addition, if the fangs are made from hypotubes and as the plunger has a hole, they can also take in the saline and become additional jets (e.g., as illustrated in FIG. 23 A)

[0180] According to certain embodiments of the thrombus removal device, fangs can be mounted onto two springs that are nested within a cavity in the ribs of the tip. Springs provide the retraction force of the fangs once pressure is relived.

[0181] Fluid chamber size may be configured to fit a sufficiently stiff spring into the cavities in the tip. For example, a 0.003 gauge pin can act as core for the spring and the spring with be 0.002in wire. Fangs can be shapeset in the actuated “hooked” position or configuration.

[0182] According to certain embodiments of the thrombus removal device, the spring segments (e.g., leaf springs) may have a shape such as an “S” bend that can elongate further to extend fang the required distance.

[0183] According to certain embodiments of the thrombus removal device, retraction spring force can be provided by an adjacent spring that is a mirror of the actuating spring (e.g., spring segment). The contact between both actuating fangs can create a spring force between the parts causing a retraction with the pressure is relieved

[0184] According to certain embodiments of the thrombus removal device, an outer tube can be connected to the outer and inner catheter shafts. The inner can be free to slide within the outer during pressurization. Fangs can be attached to the inner tube and will move forward as a result. In some examples, the spring back force can be generated by the shapeset geometry of the fangs and the inner diameter of the outer tube.

[0185] According to certain embodiments of the thrombus removal device, fangs may be positioned on an inner diameter of tip. For example, the configuration may be inverted from the outer diameter of the tip to the inner diameter of the tip (e.g., inside the tip lumen). In some examples, the tip may further comprise an inflatable membrane positioned in a chamber in the tip. In some examples, when the membrane is inflated it can be free to bulge or herniate through to the ID and cause the fangs to radially close inwards.

[0186] According to certain embodiments of the thrombus removal device, the jets and fangs can share the same jetting hole. In some examples, the fluid jets can be actuated first. Once a specific pressure is met, the leaf spring (e.g., spring segments) would actuate causing the fang to move forward. Fang can be inside the jet.

[0187] According to certain embodiments of the thrombus removal device, the expandable member is a funnel.

[0188] According to certain embodiments of the thrombus removal device, a funnel collar is disposed over the plurality of raised portions. [0189] According to certain embodiments of the thrombus removal device, the expandable member is friction fit over the plurality of raised portions.

[0190] According to certain embodiments of the thrombus removal device, the plurality of raised portions has one or more of a tapered shape or a square shape.

[0191] According to certain embodiments of the thrombus removal device, the plurality of raised portions is comprised of a shape memory material that is cryo-swaged.

[0192] According to certain embodiments of the thrombus removal device, the expandable member is disposed over the plurality of raised portions without welding or adhesives.

[0193] According to certain embodiments of the thrombus removal device, the plurality of raised portions have a step-down portion.

[0194] According to certain embodiments of the thrombus removal device, the step-down portion increases engagement between the plurality of raised portions and the expandable member.

[0195] Another system configured in accordance with an embodiment of the present technology can include, for example, a medical device, including: a catheter shaft; a distal shaft portion; and a distal end comprising a shape memory material that is friction fit to the distal shaft portion.

[0196] According to certain embodiments of the medical device, the distal shaft portion is attached to the distal end without adhesive or welding.

[0197] According to certain embodiments of the medical device, the distal shaft portion contains a plurality of raised portions.

[0198] According to certain embodiments of the medical device, the plurality of raised portions have one or more of a tapered shape or a square shape.

[0199] According to certain embodiments of the medical device, the raised portions contain step-down portions.

[0200] According to certain embodiments of the medical device, the step-down portion increases engagement between the plurality of raised portions of the distal shaft portion and the distal end.

[0201] According to certain embodiments of the medical device, the distal shaft portion is attached to the distal end via cryo-swaging.

[0202] The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0203] From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.

[0204] Unless the context clearly requires otherwise, throughout the description and the examples, the words "comprise," "comprising," and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to." As used herein, the terms "connected," "coupled," or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words "herein," "above," "below," and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. As used herein, the phrase "and/or" as in "A and/or B" refers to A alone, B alone, and A and B. Additionally, the term "comprising" is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMS: What is claimed is:

1. A thrombus removal device, comprising: an elongate catheter having an aspiration lumen; an expandable funnel coupled to a distal tip of the elongate catheter; at least one mechanical engagement feature disposed within the distal tip; a first fluid lumen in elongate catheter fluidly coupled to a second fluid lumen in the distal tip, wherein a flow of fluid from the first fluid lumen into the second fluid lumen is configured to deploy the at least one mechanical engagement feature within the expandable funnel.

2. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature is configured to be deployed the expandable funnel towards a central axis of the aspiration lumen.

3. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature is configured to be deployed generally radially within the expandable funnel across at least a portion of the expandable funnel.

4. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature comprises a cutting portion.

5. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature comprises a blunted tip.

6. The thrombus removal device of claim 1, further comprising: a fluid source in fluid communication with the first fluid lumen of the elongate catheter; a jet orifice positioned within the distal tip and being fluidly coupled with the first fluid lumen, the jet orifice being configured to provide a fluid stream within the aspiration lumen or within the expandable funnel.

7 The thrombus removal device of claim 1, further comprising an aspiration source in fluid communication with the aspiration lumen.

8. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature further comprises a third fluid lumen extending therethrough.

9. The thrombus removal device of claim 6, wherein, during operation, the at least one mechanical engagement feature is configured to direct a flow of fluid from the second fluid lumen through the third fluid lumen to provide a stream of fluid within the expandable funnel.

10. The thrombus removal device of claim 1, wherein the expandable funnel comprises a funnel frame configured to self-expand the expandable funnel to a fully expanded configuration.

11. The thrombus removal device of claim 10, wherein the expandable funnel further comprises a compliant material disposed over at least a portion of the funnel frame.

12. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature includes a pair of mechanical engagement features configured to collide at a pinch point when actuated.

13. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature includes a pair of mechanical engagement features configured to create a shearing action when actuated.

14. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature comprises a plurality of mechanical engagement features that are collectively actuated as a group.

15. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature comprises a plurality of mechanical engagement features that are individually and independently actuated.

16. The thrombus removal device of claim 1, wherein the at least one mechanical engagement feature comprises a plurality of mechanical engagement features configured to move towards a central point within the expandable funnel.

17. A thrombus removal system, comprising: an elongate catheter having an aspiration lumen and a fluid lumen and terminating at a distal tip; an aspiration source coupled to the aspiration lumen; an expandable funnel coupled to the distal tip; a plurality of fluid ports disposed within the distal tip; at least one mechanical engagement feature disposed within the distal tip; and a fluid source coupled to the fluid lumen, wherein a flow of fluid from the fluid source through the fluid lumen is configured to deploy the at least one mechanical engagement feature into the expandable funnel and provide a plurality of fluid streams from the plurality of fluid ports into the aspiration lumen and/or the expandable funnel.

18. The thrombus removal system of claim 17, wherein the at least one mechanical engagement feature extends distally from a spring in the distal tip, wherein the spring is hydraulically actuatable to deploy the at least one mechanical engagement feature.

19. The thrombus removal system of claim 17, wherein the at least one mechanical engagement feature comprises at least one jet orifice in fluid communication with the fluid lumen and configured to provide additional fluid streams from the at least one mechanical engagement feature.

20. The thrombus removal system of claim 17, wherein the spring is disposed within an actuation fluid channel of the distal tip, wherein the flow of fluid from the fluid source into the fluid lumen is configured to flow into the actuation fluid channel to actuate the spring.

21. The thrombus removal system of claim 19, wherein the spring is disposed within an actuation fluid channel of the distal tip, wherein the flow of fluid from the fluid source into the fluid lumen is configured to flow into the actuation fluid channel to actuate the spring.

22. The thrombus removal system of claim 21, wherein the spring is configured to be actuated by a first fluid pressure, and wherein the mechanical engagement feature is configured to provide the fluid stream based on a second fluid pressure.

23. A method of removing thrombus from a patient, comprising: inserting a thrombectomy catheter into the patient; expanding a distal expandable member of the catheter adjacent to a target thrombus; aspirating the target thrombus into the distal expandable member; generating a flow of fluid within the thrombectomy catheter to produce at least one fluid stream within the distal expandable member and to also deploy at least one mechanical engagement element into the distal expandable member; and aspirating the target thrombus out of the thrombectomy catheter.

24. The method of claim 23, wherein the step of engaging the target thrombus with at least one mechanical engagement features comprises: selecting at least one of a) actuating at least one mechanical engagement feature within the distal expandable member to contact the target thrombus, and b) delivering a fluid stream from the at least one mechanical engagement feature towards the thrombus.

25. The method of claim 23, further comprising directing the at least one fluid stream and the at least one mechanical engagement feature to contact the target thrombus.

26. A method, comprising: inserting a thrombectomy catheter into a patient; expanding a distal expandable member of the catheter adjacent to a target thrombus; aspirating the target thrombus into the distal expandable member; delivering fluid into a fluid lumen of the thrombectomy catheter to deploy at least one mechanical engagement features within the distal expandable member to contact the target thrombus; delivering a fluid stream within the expandable member towards the target thrombus; and aspirating the target thrombus out of the thrombectomy catheter.

27. The method of claim 26, wherein the fluid stream is delivered to the target thrombus through the at least one mechanical engagement feature.

28. The method of claim 26, wherein the step of delivering fluid into the fluid lumen of the thrombectomy catheter to deploy at least one mechanical engagement features comprises contacting a spring with the fluid, wherein the spring in operable communication with the proximal end of the at least one mechanical engagement feature, and wherein the fluid is configured to deploy the at least one mechanical engagement feature by contacting the spring.

29. The method of claim 26, further comprising adjusting a pressure of the fluid stream between one or more fluid pressures delivered towards the target thrombus.

30. A thrombus removal device, comprising: an elongate catheter having an aspiration lumen and a first fluid lumen; a distal tip coupled to the elongate catheter, the distal tip comprising at least one thrombus engagement feature within a second fluid lumen and at least one fluid port in a third fluid lumen; an expandable funnel coupled to the distal tip; wherein a flow of fluid from the first fluid lumen to the second fluid lumen and the third fluid lumen is configured to move the at least one thrombus engagement feature into the expandable funnel and provide at least one fluid stream into the expandable funnel.

31. The thrombus removal device of claim 30, wherein the at least one thrombus engagement feature is actuatable to move the at least one thrombus engagement within the expandable funnel towards a central axis of the aspiration lumen.

32. The thrombus removal device of claim 30, wherein the at least one thrombus engagement feature is actuatable to move the at least one mechanical engagement feature generally radially within the expandable funnel across at least a portion of the expandable funnel.

33. The thrombus removal device of claim 30, wherein the at least one mechanical engagement feature comprises a cutting portion.

34. The thrombus removal device of claim 30, wherein the at least one mechanical engagement feature comprises a blunted tip.

35. The thrombus removal device of claim 30, wherein the at least one thrombus engagement feature is in operable communication with a spring, and wherein the second fluid lumen is configured to deliver fluid to the spring to actuate the at least one thrombus engagement feature.