Thrombectomy systems and related methods

Abstract

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

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Application No. 63 / 269,380, filed March 15, 2022, which is incorporated by reference in its entirety herein. 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.

[0002]

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

[0003]

[0004] Thrombotic material can lead to blockage of fluid flow within the mammalian vascular system. Such blockages can occur in various areas within the body, such as the pulmonary system, peripheral vasculature, deep vasculature, or within the brain. Pulmonary embolism typically occurs when a blood clot originating from another part of the body (e.g., the veins of the pelvis or legs) breaks off and travels to the lungs. Anticoagulation therapy is the current standard of care for treating pulmonary embolism, but may be ineffective in some patients. In addition, conventional devices for removing thrombotic material may not be able to navigate the pulmonary vascular anatomy, may be ineffective in removing thrombotic material, and / or may lack the ability to provide sensor data or other feedback to clinicians during a thrombectomy procedure. [Means for solving the problem]

[0004]

[0005] 1. A thrombus removal device comprising: an elongated catheter having an aspiration lumen configured to be coupled to a suction source; an expandable funnel coupled to the aspiration lumen and the elongated catheter, the expandable funnel including a proximal flaring portion near the aspiration lumen and a distal flaring portion near a distal end of the expandable funnel; and one or more fluid ports disposed near or within the expandable funnel that define a fluid region.

[0005]

[0006] In some embodiments, the device may further include a suction source and / or a fluid source.

[0007] In some embodiments, a first diameter of the expandable funnel at the proximal flaring portion is within 10% of a second diameter of the expandable funnel at the distal flaring portion.

[0006]

[0008] In one embodiment, a first diameter of the expandable funnel at the proximal flaring portion is within 20% of a second diameter of the expandable funnel at the distal flaring portion.

[0009] In other aspects, the proximal flaring portion is configured to facilitate advancement of the clot into the fluid region.

[0007]

[0010] In some variations, the distal end of the expandable funnel is directed radially outward.

[0011] In some variations, the distal end of the expandable funnel curves back proximally towards the distal flaring portion.

[0008]

[0012] In one aspect, the distal end is not joined to the distal overhanging portion.

[0013] In some embodiments, the distal end is joined to a distal overhanging portion.

[0014] In some embodiments, the expandable funnel further comprises a funnel rim.

[0009]

[0015] In one aspect, the funnel rim comprises a shape memory material.

[0016] In some embodiments, the infundibulum frame includes a plurality of axially extending spines and one or more layers of radially and / or circumferentially extending struts between adjacent spines.

[0010]

[0017] In a further aspect, the proximal overhang is formed as a result of bending in each of the plurality of axially extending barbs.

[0018] In one aspect, the distal overhanging portion is formed as a result of bending in each of a plurality of radially and / or circumferentially extending struts.

[0011]

[0019] In one embodiment, the device further includes at least one hinge on each of the plurality of radially and / or circumferentially extending struts.

[0020] In some embodiments, the first hinge is disposed at a distal-most portion of each of the plurality of radially and / or circumferentially extending struts.

[0012]

[0021] In other aspects, the second hinge is disposed at a junction between one of the plurality of radially and / or circumferentially extending struts and one of the plurality of axially extending barbs.

[0013]

[0022] In some embodiments, the at least one hinge is configured to reduce the covering force of the expandable infundibulum.

[0023] In one embodiment, at least one hinge is integral with a plurality of radially and / or circumferentially extending struts.

[0014]

[0024] In one aspect, the plurality of axially extending barbs are stiffer than the plurality of radially and / or circumferentially extending struts.

[0025] In other aspects, the plurality of axially extending barbs have a thickness greater than a thickness of the plurality of radially and / or circumferentially extending struts.

[0015]

[0026] In some embodiments, the funnel frame includes two layers of radially and / or circumferentially extending struts.

[0027] In one aspect, the plurality of axially extending spines and the plurality of radially and / or circumferentially extending struts collectively form a plurality of petals (i.e., petal-like portions) in each of one or more layers.

[0016]

[0028] In other embodiments, the petals on the proximal layer of the infundibulum casing are smaller than the petals on the distal layer of the infundibulum casing.

[0029] In some embodiments, the device comprises at least six petals in each of the one or more layers.

[0017]

[0030] In one aspect, the device includes a compliant material attached to a funnel frame.

[0031] In another embodiment, the distal most portion of the expandable infundibulum comprises only flexible material without an infundibulum rim.

[0018]

[0032] In one aspect, the distal-most extent of the infundibulum frame is proximal to the distal-most portion of the expandable infundibulum.

[0033] A catheter device is provided that includes an elongated catheter having a lumen therethrough, and an expandable funnel having a distal end coupled to the elongated catheter, the expandable funnel including a funnel frame including a plurality of axially extending spines, one or more layers of radially and / or circumferentially extending struts between adjacent spines, and one or more hinges disposed on or within the plurality of radially extending struts, the one or more hinges adapted to flex circumferentially and / or radially to change a shape of the expandable funnel.

[0019]

[0034] In some embodiments, the expandable funnel further comprises a proximal flaring portion near the elongate catheter and a distal flaring portion near a distal end of the expandable funnel.

[0035] In another embodiment, the first diameter of the expandable funnel at the proximal flaring portion is within 10% of the second diameter of the expandable funnel at the distal flaring portion.

[0020]

[0036] In one embodiment, a first diameter of the expandable funnel at the proximal flaring portion is within 20% of a second diameter of the expandable funnel at the distal flaring portion.

[0037] In another aspect, the device includes a plurality of jets disposed near or within the expandable funnel, and a fluid source coupled to the plurality of jets and configured to generate a plurality of fluid streams within or near the expandable funnel.

[0021]

[0038] In one aspect, the distal end of the expandable funnel is directed radially outward.

[0039] In one aspect, the distal end of the expandable funnel curves back towards the proximal expandable funnel.

[0022]

[0040] In another embodiment, the distal end is not joined to the distal overhang.

[0041] In some embodiments, the distal end is joined to a distal overhanging portion.

[0042] In some embodiments, the infundibulum rim comprises a shape memory material.

[0023]

[0043] In one aspect, the proximal overhang is formed as a result of bending each of the plurality of axially extending barbs.

[0044] In some aspects, the distal overhang is formed as a result of bending each of the plurality of radially extending struts.

[0024]

[0045] In one aspect, the first hinge is disposed at a distal-most portion of each of the plurality of radially extending struts.

[0046] In other aspects, the second hinge is disposed at a junction between one of the plurality of radially extending struts and one of the plurality of axially extending barbs.

[0025]

[0047] In some embodiments, the one or more hinges are integral with a plurality of radially extending struts.

[0048] In one aspect, the plurality of axially extending barbs are stiffer than the plurality of radially extending struts.

[0026]

[0049] In some aspects, the plurality of axially extending barbs have a thickness greater than a thickness of the plurality of radially extending struts.

[0050] In some embodiments, the infundibulum frame includes two layers of radially extending struts.

[0027]

[0051] In one aspect, the plurality of axially extending spines and the plurality of radially extending struts collectively form a plurality of petals in each of one or more layers.

[0052] In some embodiments, the petals on the proximal layer of the infundibulum rim are smaller than the petals on the distal layer of the infundibulum rim.

[0028]

[0053] In some embodiments, the one or more layers further comprise at least six petals each.

[0054] In another embodiment, a flexible material is attached to the funnel frame.

[0029]

[0055] In one aspect, the distal most portion of the expandable funnel comprises only flexible material without a funnel rim.

[0056] In another embodiment, the flexible material includes a first layer of flexible material inside the expandable funnel and a second layer of flexible material outside the expandable funnel.

[0030]

[0057] In other embodiments, the first flexible material layer has lubricious properties.

[0058] In some embodiments, the first flexible material layer comprises PTFE or ePTFE.

[0059] In another aspect, the delivery sheath is configured to move axially over the elongate catheter and the expandable infundibulum.

[0031]

[0060] In one aspect, advancing the delivery sheath over the infundibulum causes the radially extending struts to bend or break at multiple hinges.

[0061] In another aspect, advancing the delivery sheath over the infundibulum causes the distal end of the infundibulum rim to move inwardly without expanding radially outwardly.

[0032]

[0062] A thrombus removal device is provided and includes an elongated catheter having an aspiration lumen, an aspiration source coupled to the aspiration lumen, and an expandable funnel coupled to the aspiration lumen and to the elongated catheter, the expandable funnel having a distal end that is flared radially outward relative to a proximal portion.

[0033]

[0063] In some aspects, the expandable funnel includes a compound curvature along the axial dimension of the expandable funnel.

[0064] In another embodiment, the compound curvature includes a reversal of the curvature.

[0034]

[0065] In some embodiments, the distal end includes a reversal of the curvature.

[0066] In one embodiment, the expandable funnel further comprises a frame.

[0067] In some embodiments, the distal extent of the frame is proximal to the distal end of the expandable infundibulum.

[0035]

[0068] In one aspect, the distal end of the expandable funnel is relatively more flexible than the remainder of the expandable funnel.

[0069] A thrombus removal device is provided that includes an elongate catheter having an aspiration lumen, an aspiration source coupled to the aspiration lumen, and an expandable funnel coupled to the aspiration lumen and the elongate catheter, the expandable funnel including an aspiration element disposed at a distal portion, the aspiration element adapted to increase suction in a region of the expandable funnel adjacent the aspiration element.

[0036]

[0070] In some embodiments, the suction element includes a skirt portion (or apron portion) attached at one end to an expandable funnel portion, the skirt including a surface configured to move freely.

[0037]

[0071] In some aspects, the surface is adapted to be moved proximally.

[0072] In other embodiments, the surface is adapted to contact a blood clot.

[0073] In one aspect, the suction element includes a protrusion (rib) that extends radially inward from and at least partially around the inner circumference of the expandable funnel.

[0038]

[0074] In some embodiments, the projection extends completely around the inner circumference of the expandable infundibulum.

[0075] In one aspect, the projection is disposed at an axial position of the expandable funnel.

[0076] A method is provided for removing a thrombus from a patient's blood vessel using a thrombus removal device, the method including introducing a distal portion of an elongated catheter having an expandable funnel into the blood vessel to a target site proximate the thrombus, everting a distal end of the expandable funnel, operating an aspiration source on the elongated catheter, and removing the thrombus from the patient with the aspiration source through the thrombus removal device.

[0039]

[0077] In some embodiments, the methods include macerating the thrombus within the infundibulum and / or within the distal portion of the elongate catheter.

[0078] In one aspect, everting includes approaching the thrombus with an actuating element to enhance maceration.

[0040]

[0079] In another embodiment, the macerating comprises irrigating the thrombus with one or more fluid streams.

[0080] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings. [Brief description of the drawings]

[0041] [Figure 1]

[0081] 1 illustrates 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. [Figure 1A] 2 illustrates the above portion of the thrombus removal system. [Figure 1B] 2 illustrates the above portion of the thrombus removal system. [Figure 1C] 2 illustrates the above portion of the thrombus removal system. [Figure 1D] 2 illustrates the above portion of the thrombus removal system. [Figure 1E] 2 illustrates the above portion of the thrombus removal system. [Figure 1F] 2 illustrates the above portion of the thrombus removal system. [Figure 1G] 2 illustrates the above portion of the thrombus removal system. [Figure 1H] 2 illustrates the above portion of the thrombus removal system. [Figure 1I] 2 illustrates the above portion of the thrombus removal system. [Figure 1J] 2 illustrates the above portion of the thrombus removal system. [Figure 1K] 2 illustrates the above portion of the thrombus removal system. [Figure 1L] 2 illustrates the above portion of the thrombus removal system. [Figure 2A]

[0082] FIG. 2A is a plan view illustrating an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Figure 2B]FIG. 2B is a plan view illustrating the above configuration. [Figure 2C] FIG. 2C is a plan view illustrating the above configuration. [Figure 2D] FIG. 2D is a plan view illustrating the above configuration. [Figure 2E] FIG. 2E is a plan view illustrating the above configuration. [Diagram 3]

[0083] FIG. 3A is an elevational view of an irrigation port configuration of a thrombus removal system in accordance with an embodiment of the present technology; FIG. 3B is an elevational view of another configuration of the irrigation port; FIG. 3C is an elevational view of another configuration of the irrigation port; FIG. 3D is an elevational view of another configuration of the irrigation port; FIG. 3E is an elevational view of another configuration of the irrigation port; FIG. 3F is an elevational view of another configuration of the irrigation port; FIG. 3G is an elevational view of another configuration of the irrigation port; and FIG. 3H is an elevational view of another configuration of the irrigation port. [Figure 4]

[0084] FIG. 4A is an elevational view of an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology; FIG. 4B is an elevational view of another configuration of the irrigation ports and fluid flows; FIG. 4C is an elevational view of another configuration of the irrigation ports and fluid flows; FIG. 4D is an elevational view of another configuration of the irrigation ports and fluid flows; FIG. 4E is an elevational view of another configuration of the irrigation ports and fluid flows; FIG. 4F is an elevational view of another configuration of the irrigation ports and fluid flows; FIG. 4G is an elevational view of another configuration of the irrigation ports and fluid flows; and FIG. 4H is an elevational view of another configuration of the irrigation ports and fluid flows. [Diagram 5]

[0085] FIG. 5A illustrates a configuration of an irrigation port of a thrombus removal system in accordance with an embodiment of the present technology; FIG. 5B illustrates an alternative configuration of the irrigation port; FIG. 5C illustrates an alternative configuration of the irrigation port; FIG. 5D illustrates an alternative configuration of the irrigation port; FIG. 5E illustrates an alternative configuration of the irrigation port; FIG. 5F illustrates an alternative configuration of the irrigation port; and FIG. 5G illustrates an alternative configuration of the irrigation port. [Figure 6A]

[0086] FIG. 6A illustrates an embodiment of a thrombus removal system that includes a saline source, an aspiration system, and one or more controls for controlling irrigation and / or aspiration of the system. [Figure 6B] FIG. 6B illustrates another embodiment of the thrombus removal system. [Figure 6C] FIG. 6C illustrates another embodiment of the thrombus removal system. [Figure 7A]

[0087] FIG. 7A illustrates that the funnel portion of the thrombectomy catheter can include a shape that promotes clot capture during aspiration. [Figure 7B] FIG. 7B shows a portion of the funnel. [Figure 7C] FIG. 7C shows a portion of the funnel. [Figure 7D] FIG. 7D shows a portion of the funnel. [Figure 7E] FIG. 7E shows a portion of the funnel. [Figure 8]

[0088] 8A, 8B, and 8C are diagrams illustrating an embodiment of a funnel distal tip, another embodiment of the funnel distal tip, and another embodiment of the funnel distal tip, respectively. [Figure 9A]

[0089] FIG. 9A shows an example of a funnel moving into an everted configuration. [Figure 9B] FIG. 9B is a diagram showing the above example. [Figure 9C] FIG. 9C shows the above example. [Figure 10A]

[0090] FIG. 10A illustrates an embodiment of a funnel and a funnel frame. [Figure 10B] FIG. 10B illustrates another embodiment of the funnel and funnel frame. [Figure 10C]

[0091] FIG. 10C is a diagram illustrating the covering of the funnel portion of FIGS. 10A and 10B. [Figure 10D]FIG. 10D illustrates the covering of the infundibulum. [Figure 10E] FIG. 10E illustrates the covering of the infundibulum. [Figure 10F] FIG. 10F illustrates the covering of the infundibulum. [Figure 11]

[0092] FIG. 10C illustrates the covering power required for the infundibulum of FIGS. 10A and 10B. [Figure 12]

[0093] 12A, 12B, 12C, and 12D are diagrams illustrating an aspiration element adapted to increase the suction force inside a thrombectomy catheter. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0042]

[0094] This application is related to the disclosures in International Application No. PCT / US2021 / 020915, filed March 4, 2021, the disclosure of which is incorporated herein by reference for all purposes.

[0043]

[0095] The present technology is generally directed to clot removal systems and associated methods. A system configured according to an embodiment of the present technology can include, for example, an elongate catheter having a distal portion configured to be positioned within a patient's blood vessel, a proximal portion configured to be external to the patient, a fluid delivery mechanism configured to fragment the clot with pressurized fluid, an aspiration mechanism configured to aspirate the clot fragments, and one or more lumens extending at least partially from the proximal portion to the distal portion.

[0044]

[0096] The terms used in the description presented below are intended to be interpreted in the broadest possible manner, even when used in conjunction with a detailed description of certain specific embodiments of the present technology. Although certain terms may be emphasized below, any terms intended to be interpreted in some limited manner are clearly and specifically defined in the Detailed Description section of this invention. In addition, the present technology can include other embodiments that are within the scope of the examples but are not described in detail in connection with the figures.

[0045]

[0097] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the technology. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0046]

[0098] Throughout this specification, references to relative terms such as, for example, "substantially," "approximately," and "about" are used herein to mean plus or minus 10% of the stated value.

[0047]

[0099] Although some embodiments herein are described in the context of thrombus removal, it is recognized that the technology can be used and / or modified to remove other types of emboli that may occlude blood vessels, such as fat, tissue, or foreign bodies. In addition, while some embodiments herein are described in the context of thrombus removal from the pulmonary artery (e.g., pulmonary embolectomy), the technology may be applied to the removal of thrombi and / or emboli from other parts of the vasculature (e.g., neurovascular, coronary, or peripheral applications). Also, while some embodiments are discussed in the context of macerating the thrombus with a fluid, the technology can be adapted to be used with other techniques (e.g., ultrasound, mechanical, enzymatic, etc.) for fragmenting the thrombus into smaller fragments or particles.

[0048]

[0100] The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed technology. System for thrombus removal

[0101] As presented above, the present technology is generally directed to a clot removal system. Such a system includes an elongated catheter having a distal portion positionable within a patient's blood vessel (e.g., an artery or vein), a proximal portion positionable outside the patient's body, a fluid delivery mechanism configured to fragment the clot with pressurized fluid, an aspiration mechanism configured to aspirate the clot fragments, and one or more lumens extending at least partially from the proximal portion to the distal portion. In some embodiments, the system herein is configured to engage a clot within a patient's blood vessel, fragment the clot into small fragments, and aspirate the fragments out of the patient's body. The pressurized fluid stream (e.g., jet) functions to cut or macerate the clot before, during, and / or after at least a portion of the clot enters the aspiration lumen or funnel of the system. Fragmentation helps prevent clogging of the aspiration lumen, and fragmentation allows the clot removal system to macerate large, hard clots that could not otherwise be aspirated. As used herein, "thrombus" and "embolism" are used somewhat interchangeably in various respects. It should be recognized that while descriptions may refer to the removal of a "thrombus," this should be understood to encompass the removal of thrombus fragments and other emboli as provided herein.

[0049]

[0102] According to embodiments of the present technology, a fluid delivery mechanism can provide multiple fluid streams (e.g., jets) to the fluid openings of the thrombus removal system to macerate, cut, fragment, pulverize and / or urge the thrombus to be removed from the proximal portion of the thrombus removal system. The thrombus removal system can include an aspiration lumen that extends at least partially from the proximal portion to the distal portion of the thrombus removal system that is adapted for fluid communication with an aspiration pump (e.g., a vacuum source). In operation, the aspiration pump can generate a volume of lower pressure in the aspiration lumen near the proximal portion of the thrombus removal system to encourage aspiration of the thrombus from the distal portion.

[0050]

[0103] FIG. 1 illustrates a distal portion 10 of a thrombus removal system according to an embodiment of the present technology. Section AA of FIG. 1A illustrates an elevational cross-sectional view of the distal portion. The exemplary section AA of FIG. 1A depicts a funnel 20 positioned at the distal end of the distal portion 10, the funnel adapted to engage a thrombus and / or a tissue (e.g., blood vessel) wall to aid in fragmenting and / or removing the thrombus. The funnel can be formed by any of the configurations described herein. The exemplary section AA of FIG. 1A 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 substantially annular volume forms at least one fluid lumen 45 between the outer wall 40 and the inner wall 50. The fluid lumen 45 is adapted for fluid communication with a fluid delivery mechanism. One or more openings (e.g., nozzles, orifices, or ports) 30 are positioned in the thrombus removal system such that they are in fluid communication with the fluid lumen 45 and the irrigation manifold 25. In operation, the ports 30 are adapted to direct (e.g., be pressurized) fluid toward a thrombus engaged with the distal portion 10 of the thrombus removal system.

[0051]

[0104] In various embodiments, the system can have an average flow velocity in the fluid lumen of at least 20 m / s to achieve consistent and successful aspiration of the clot. In some embodiments, the fluid source itself can deliver fluid to the jet in a pre-programmed sequence, including a pulsed sequence or some combination of pulsatile and constant flow. In these embodiments, the average pulsed fluid velocity can be at least 20 m / s, but during the pulsation of the fluid source, the peak fluid velocity can be up to 30 m / s or more. In some embodiments, the jet or opening is 0.0100 inches or larger, or at least 0.008 inches, to avoid undesirable spraying of the fluid. In some embodiments, the system has a minimum vacuum or aspiration pressure of 15 inHg, so that it can achieve the desired performance required to remove the target clot after it has been macerated or comminuted with the jets described above.

[0052]

[0105] The thrombus removal system can be sized and configured to access and remove thrombus in various locations or vessels within a patient's body. The dimensions of the system may vary depending on the target location, but it should be understood that generally the same features and components described herein are implemented in the thrombus removal system regardless of the application. For example, a thrombus removal system configured to remove a pulmonary embolism (PE) from a patient may have an outer wall / tube sized approximately 3.7-4.3 mm (11-13 Fr), or preferably 4.0 mm (12 Fr), and an inner wall / tube sized approximately 2.3-3.0 mm (7-9 Fr), or preferably 2.7 mm (8 Fr). Meanwhile, deep vein thrombosis (DVT) devices may have an outer wall / tube size of approximately 3.0-3.7 mm (9-11 Fr), or preferably 3.3 mm (10 Fr), and an inner wall / tube size of 2.0-3.0 mm (6-9 Fr), or preferably 2.5 mm (7.5 Fr). Further applications are provided for ischemic stroke and peripheral embolism applications.

[0053]

[0106] Section BB in FIG. 1B illustrates in plan view a portion of the thrombus removal system proximal to the infundibulum and irrigation manifold. Section BB depicts outer wall 140, inner wall 150, aspiration lumen 155, and fluid lumen 145. In some embodiments, in cross section, aspiration lumen 155 is substantially circular and fluid lumen 145 is substantially toroidal shaped (e.g., cross section 70). It will be appreciated that alternative constructions and / or arrangements of inner wall 150 and outer wall 140 will produce variations in the cross-sectional shapes of aspiration lumen 155 and fluid lumen 145. For example, inner wall 150 can be shaped to form aspiration lumen 155 that is substantially elliptical, circular, rectilinear, rectangular, pentagonal, or hexagonal in cross section. Inner wall 150 and outer wall 140 can be shaped and arranged to form fluid lumen 145 that is generally crescent-shaped, diamond-shaped, or irregular in cross section. For example, with reference to cross-section BB in Figure 1C, the region between inner wall 150 and outer wall 140 can include one or more wall structures 165 (e.g., as in cross-section 80) that form respective fluid lumens 145. Wall structures 165 can be formed by lamination between outer wall 140 and inner wall 150, or by extrusion of multiple lumens forming multiple wall structures.

[0054]

[0107] Sections BB in Figures 1D-1H show additional examples of portions of the thrombus removal system that are proximal to the infundibulum and irrigation manifold. Similar to the embodiments described above, the portions in these examples can include an outer wall 140, an inner wall 150, and an aspiration lumen 155. In addition, the illustrated portions of the thrombus removal system can include an intermediate wall 170 disposed between the outer wall 140 and the inner wall 150. The intermediate wall 170 allows for the annular space between the inner and outer walls to be further divided into multiple different fluid lumens and / or auxiliary lumens. For example, referring to Figure 1D, the intermediate wall can be substantially hexagonal in shape, and the annular space can include multiple fluid lumens 145a-141 and multiple auxiliary lumens 175a-175f. As shown in Figure 1D, the fluid lumens can be formed by any combination of the outer wall 140 and the intermediate wall 170, or between the intermediate wall 170, the inner wall 150, and two auxiliary lumens. For example, fluid lumen 145a is formed in the space between outer wall 140 and intermediate wall 170. However, fluid lumen 145g is formed in the space between intermediate wall 170, inner wall 150, auxiliary lumen 175a, and auxiliary lumen 175b. In general, 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 / openings / orifices of the system. The auxiliary lumens can be configured for multiple functions. In some embodiments, the auxiliary lumens can be coupled to a fluid / saline source and an opening used as an additional fluid lumen. In other embodiments, the auxiliary lumens can be configured as steering ports and can include guidewires or steering wires within the lumen for steering 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 to provide feedback to the system during therapy (e.g., sensors can be used to detect clogs and initiate a clog removal protocol, or determine the appropriate therapy mode based on sensor feedback, such as sequence of injection pulses, sequence of suction, etc.).Thus, the auxiliary port can be used to connect to sensors, for example, via electrical, optical, mechanical / wire, and / or fluid connections. It is also envisioned that the fluid and auxiliary lumens can be configured to carry and deliver other fluids, such as thrombolytic drugs or radiopaque contrast injections, to the target tissue site during treatment.

[0055]

[0108] It should be understood that in some embodiments, all fluid lumens are fluidly connected to all of the jets or openings of the thrombus removal device. Thus, when a flow of fluid is delivered from the fluid lumen(s) to the jets, all of the jets are actuated at once with a fluid jet. However, it should also be understood that in some embodiments, the fluid lumens are separate or different, and these different fluid lumens may be fluidly coupled to one or more jets, but not to all of the 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 the subset of jets. This allows for additional functionality of the device where designated jets can be actuated in a user-defined or pre-determined order.

[0056]

[0109] Section BB of FIG. 1E illustrates another embodiment of the portion of the thrombus removal system that is proximal to the infundibulum and irrigation manifold. Similar to the embodiment of FIG. 1D, this embodiment also includes an intermediate wall 170. However, the intermediate wall in this example is substantially rectangular, facilitating the formation of fluid lumens 145a-145k and auxiliary lumens 175a-175d. The example shown in section BB of FIG. 1F is similar to the example of the embodiment of FIG. 1E, but this embodiment includes only fluid lumens 145a-145d. Fluid lumens 145e-145k from the embodiment of FIG. 1E are not used as fluid lumens in this embodiment. They can be lumens that are, for example, empty, evacuated, filled with insulating material, and / or filled with radiopaque material or any other material that may be useful for visualizing the thrombus removal system during therapy. Embodiment 1F includes the same four auxiliary ports as illustrated and described in the embodiment of FIG. 1E.

[0057]

[0110] Section BB of FIG. 1G illustrates another example of a portion of the thrombus removal system that is proximal to the infundibulum and irrigation manifold. As with the embodiment described above, the illustrated portion of the thrombus removal system can include an intermediate wall 170 disposed between the outer wall 140 and the inner wall 150. However, this embodiment includes four distinct fluid lumens 145a-d formed by a wall structure 165. As with the embodiment of FIG. 1C, the wall structure 165 can be formed by lamination between the outer wall 140 and the inner wall 150 or by extrusion of multiple lumens forming multiple wall structures. As shown, this embodiment can include a pair of auxiliary lumens 175a and 175b, which can be used, for example, for steering or sensor connection as described above.

[0058]

[0111] Section BB in FIG. 1H is another similar embodiment in which a middle wall and an outer wall can be used to form fluid lumens 145a and 145b. Auxiliary lumens 175a and 175b can be formed in the space between the 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, it should be understood that in other embodiments, the middle wall may not contact the outer wall, which would facilitate a single annular fluid lumen as shown by fluid lumen 145 in section BB in FIG. 1I. In another embodiment, as shown in section BB in FIG. 1J, inner wall 150 and outer wall 140 may not be concentric, which would facilitate the formation of a thicker or wider annular space and / or fluid lumen 145 on one side of the device relative to the other side. As shown in FIG. 1J, the distance between the outer wall 140 and the inner wall at the top (eg, 12 o'clock) portion of the device is greater than the distance between the outer wall and the inner wall at the bottom (eg, 6 o'clock) portion of the device.

[0059]

[0112] 1K illustrates in plan view a portion of the thrombus removal system including the irrigation manifold 225. View CC depicts an outer wall 240, an inner wall 250, a fluid lumen 245, an aspiration lumen 255, and ports 230 for directing the respective fluid flows 210.

[0060]

[0113] Detail view 101 of FIG. 1L illustrates an elevational cross-sectional view of a portion of irrigation manifold 25 including a plurality of ports 230 formed in inner wall 250. In some embodiments, the thickness of one or more walls of the thrombus removal system may vary along its axial length and / or its circumference. As shown in detail view 101, inner wall 250 has a first thickness 265 in a region 250 that is proximal to irrigation manifold 25 and a second thickness 270 in a region 235 that includes ports 230. In some embodiments, second thickness 270 is greater than first thickness 265. First thickness 265 can correspond to the overall wall thickness of inner wall 50 and / or outer wall 40, which can be about 0.10 mm to about 0.60 mm, or any value within the aforementioned range. The second thickness 270 can be about 0.20 mm to about 0.70 mm, about 0.70 mm to about 0.90 mm, or about 0.90 mm to about 1.20 mm. The second thickness 270 can be any value within the aforementioned ranges. The dimensions of the second thickness 270 can be selected to provide a fluid path through the port 230 that generates a substantially laminar flow for the fluid flow directed therethrough when the fluid delivery mechanism delivers fluid through the fluid lumen 245 at a typical operating pressure. Such operating pressures can be about 10 psi to about 60 psi, about 60 psi to about 100 psi, or about 100 psi to about 150 psi. The operating pressure of the fluid delivery mechanism can be any value within the aforementioned ranges of values. In some embodiments, the fluid delivery mechanism operates in a high pressure mode having a pressure of about 150 psi to about 250 psi, about 250 psi to about 350 psi, about 350 psi to about 425 psi, or about 425 psi to about 500 psi. The operating pressure of the fluid delivery mechanism in the high pressure mode can be any value within the aforementioned range of values.In general, the length of the opening or hole through the wall used to form the port 230 should have a diameter sufficient to prevent the formation of spray or mist and a length sufficient to create a laminar flow as the fluid exits the port. Instead, a focused jet or focused flow is desired. Considering the above parameters, the length of the opening through the wall used to form the port should be at least 0.25 mm long, optionally up to 0.4 mm or up to 1 mm long or longer. Lengths shorter than that length may undesirably cause the ejection of mist or spray from the port and will not effectively fragment or macerate the target clot.

[0061]

[0114] In some embodiments, the profile (cross-sectional dimension) of port 230 varies along its length (e.g., is non-cylindrical). Variation in the cross-sectional dimension of the port can modify and / or adjust the characteristics of the fluid flow along port 230. For example, a reduction in the cross-sectional dimension can accelerate the fluid flow through port 230 (for a given volume of fluid). In some embodiments, port 230 can be conical (e.g., tapered) along its length such that its smallest dimension is located at the distal end of port 230, distal relative to the direction of fluid flow.

[0062]

[0115] In some embodiments, the ports 230 are formed to direct the fluid flow along a selected path. Figures 2A-2E illustrate various embodiments of arrangements of the ports 230 to direct the respective fluid streams 210. In some embodiments, such as those shown in Figures 2A and 2B, at least two ports 230 are arranged to generate (e.g., respective) fluid streams 210 that intersect at an intersection region 237 of the clot removal system. The intersection region 237 can be a region of increased fluid momentum and / or energy transfer, where these increases are relative to individual fluid streams that are not directed to combine at the intersection. The increased fluid momentum and / or energy transfer at the intersection can advantageously fragment the clot more efficiently and / or quickly. In some embodiments, the 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. The intersection region can be substantially near (e.g., 237) or away from (e.g., 238 and 239 in the embodiment of FIG. 2D) the central axis 290 of the thrombus removal system. In some embodiments, at least two intersection regions (e.g., 238 and 239) are formed. In some embodiments, one or more ports 230 are positioned to direct the fluid stream 210 along an oblique angle relative to the central axis of the thrombus removal system. The operating pressure of the fluid delivery mechanism may be selected to approach a target fluid velocity for the fluid stream 210 delivered from the port 230. The target fluid velocity of the 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. The target fluid velocity of the fluid stream 210 can be any value within the range of values ​​mentioned above. In some embodiments, at least two ports 230 are adapted to deliver the respective fluid streams at different fluid velocities for a given pressure of the fluid delivery mechanism. In some embodiments, the at least two ports 230 are adapted to deliver respective fluid streams at substantially the same fluid velocity for a given pressure of the fluid delivery mechanism.In some embodiments, angular momentum is imparted to the thrombus by application of a) at least one fluid stream 210 directed at an oblique angle from the port 230, and / or b) at least two fluid streams 210 having different fluid velocities. Advantageously, the angular momentum created on the thrombus can impart forces (e.g., centrifugal forces) that aid in fragmenting and removing the thrombus. Advantageously, the increased cross-sectional area of ​​the fluid lumen 145 reduces the required operating pressure of the fluid delivery mechanism to achieve a target fluid velocity of the fluid stream.

[0063]

[0116] 3A-3H, the ports 330 can be positioned along various axial locations of the thrombus removal system. The thrombus removal system can include a flow axis 305 aligned with a general direction of flow of fluid aspirated therein (e.g., distal to proximal). In some embodiments, the location of the ports 330 includes being a) near the base, b) at the middle, c) at the distal, or d) proximal of the funnel portion 320 of the thrombus removal system. In some embodiments, at least two ports 330 are aligned along the flow axis 305. In some embodiments, at least two ports 330 are positioned at different axial locations along the flow axis 305. In some embodiments, at least two ports 330 are positioned along a given axial location of the flow axis 305 (e.g., along the circumference of the thrombus removal system).

[0064]

[0117] 4A-H depict various configurations of fluid streams 410 directed from respective ports 430. The fluid streams 410 can be directed along paths that are substantially orthogonal, proximal, and / or distal to a flow axis 405 (similar to flow axis 305). In some embodiments, at least two fluid streams are directed in different directions relative to the flow axis 405. In some embodiments, at least two fluid streams are directed in the same direction (e.g., proximal) relative to the flow axis 405. In some embodiments, at least a first fluid stream is directed orthogonally, at least a second fluid stream is directed proximally, and at least a third fluid stream is directed distally relative to the flow axis 405. Angle α may characterize the angle at which the fluid streams 410 are directed relative to an axis orthogonal to the flow axis 405 (e.g., as shown in cross sections DD of FIGS. 4G and 4H ). The fluid flow intersection region can be within an interior portion of the thrombus removal system and / or external (e.g., distal) to the thrombus removal system. In some embodiments, the fluid flow that is directed in a nominal direction (e.g., distal) by the port 430 is deflected along an altered path (e.g., proximally) by the (e.g., suction) pressure generated by the suction mechanism during operation.

[0065]

[0118] 5A-5G illustrate various outlet opening shapes in which the port 530 may be configured in accordance with embodiments of the present technology. The opening shapes may include oval, circular, cross ("x" shape), "t" shape, rectangular, or square shapes. The fluid flow delivered from the port 530 may include substantially laminar flow (e.g., at the opening), or turbulent flow (e.g., fan-like or outward).

[0066]

[0119] 6A-6C illustrate various configurations of a clot removal system 600 including a clot removal device 602, a vacuum source and canister 604, and a fluid source 606. In some embodiments, the vacuum source and canister and the fluid source are housed in a console unit that is removably connected to the clot removal device. A fluid pump can be housed in the console or 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 clot removal device 602 can include a funnel 608, a flexible shaft 610, a handle 612, and one or more controllers 614 and 616. For example, in the embodiment shown in FIG. 6A, the device can include a finger switch or trigger 614 and a foot pedal or switch 616, which can be used to control aspiration and irrigation, respectively. Alternatively, as shown in the embodiment of FIG. 6B, the device can include only a foot switch 616 that can be used to control both functions, or in FIG. 6C, the device can include only a footstool 616 that is also used to control both functions. It is also envisioned that embodiments can include only a finger switch for controlling both the aspiration and irrigation functions. As shown in FIG. 6A, a vacuum source can be coupled to the aspiration lumen of the device with a vacuum line 618. Any blood clots or other debris removed from the patient during therapy can be stored in a vacuum canister 604. Similarly, a fluid source (e.g., a saline bag) can be coupled to the fluid lumen of the device with a fluid line 620.

[0067]

[0120] Still referring to FIG. 6A, electronics lines 622 can couple any electronics / sensors etc. from the device to the system console / controller. The system console including the CPUs / electronic controllers can be configured to monitor fluid and pressure levels and adjust automatically or in real time as needed. In some embodiments, the CPUs / electronic controllers are configured to control vacuum and irrigation as well as electromechanically stop and start both systems in response to sensor data such as pressure data, flow data etc.

[0068]

[0121] As mentioned above, suction occurs down a central lumen of the device and is provided by a vacuum pump in the console, which may include a container to collect any clots or debris that is removed from the patient. Funnel design

[0122] Various funnel shapes and design configurations are provided herein. Any of the funnels depicted in this disclosure may be used or included in a thrombus removal catheter that includes any of the other features described herein and includes one or more jets and / or fluid streams configured to break up or macerate the clot, and / or an aspiration lumen fluidly coupled to the funnel for aspirating the clot from the patient. In some embodiments, any of the funnels described herein may include a jet or fluid stream inside the funnel. In some embodiments, the jet or fluid stream may originate from the funnel itself. In other embodiments, the jet or fluid stream may be inside the aspiration lumen or at the distal end of the aspiration lumen. Additionally, any of the funnels disclosed or described herein may include a mechanical manipulation or gripping element as described in PCT Application No. PCT / US2023 / 062002, filed February 2, 2023.

[0069]

[0123] 7A-7B show side and top views of the funnel 20 of a thrombus removal catheter, which may include a shape that promotes clot capture during aspiration. The funnel 20 may include an expandable and collapsible frame 724 and a flexible membrane 726. The frame 724 is configured to assume a folded configuration (e.g., inside a delivery sheath or inside a catheter) to reduce the diameter of the funnel during delivery and manipulation to the target thrombus site. Once the delivery sheath or catheter is removed from the funnel, the frame 724 is configured to self-expand to assume an deployed configuration.

[0070]

[0124] The infundibulum frame 724 may comprise a shape memory material such as Nitinol. The frame may comprise a complex structure including multiple axially extending barbs 728, with adjacent barbs 728 connected to radially extending struts 730. The frame may further comprise a collar 729 configured to attach the infundibulum frame to the shaft of the thrombectomy catheter. In some embodiments, the barbs, struts, and collar are integral with one another (e.g., laser cut from a single sheet of material). In other embodiments, the barbs, struts, and collar are separate components that are welded, glued, or attached together as known in the art.

[0071]

[0125] The catheter may further include a fluid stream or jet that cuts, breaks up, or macerates the clot(s) that are drawn into one or more fluid faces or regions (e.g., fluid face 727). Not all embodiments of the thrombus removal catheters provided herein require a jet / fluid stream, but fluid face 727 is shown as an exemplary reference for those embodiments that include a jet / fluid stream. Fluid face 727 may also refer to a plane on which a jet or fluid port is located. In embodiments without a jet or fluid stream, reference number 727 may refer to a narrow region inside the funnel adjacent to or within the aspiration lumen. In FIG. 7A, fluid face 727 is generally shown at a collar 729 adjacent to or near the aspiration lumen. It should be understood that in other embodiments, the fluid region and / or jet may be located elsewhere. For example, the funnel itself may include a jet, which may move the fluid region into the funnel. In other embodiments, the fluid face may be within the aspiration lumen. In some embodiments, there may be multiple fluid planes located through the funnel, collar, and / or aspiration lumen. Alternatively, the fluid planes need not be perpendicular to the longitudinal axis, but may instead be angled depending on whether the jet is directed proximally, distally, or perpendicular to the longitudinal axis of the catheter.

[0072]

[0126] As shown in FIGS. 7A-7B, each pair of adjacent barbs 728 can be attached or connected to one or more sets (e.g., layers) of radially and / or circumferentially extending struts 730. In some embodiments, the barbs 728 have a larger width or cross-section than the struts 730. Similarly, the barbs 728 are stiffer or more resistant to bending than the struts 730. In the embodiment of FIGS. 7A-7B, the frame includes two layers of radially extending struts 730 that connect adjacent barbs 728. Each layer of radially extending struts can be axially displaced along the funnel from another layer. It can be seen how the combination of the axially extending barbs 728 and the radially extending struts 730 form petals 732 (similar to a chevron pattern). In the illustrated embodiment, the frame includes two layers of petals, with six petals in each layer. It should be understood that other embodiments may include more or fewer layers of petals (e.g., up to 5 layers) and may include more or fewer petals per layer (e.g., up to 4 petals per layer, up to 8 petals per layer, up to 10 petals per layer). The petals in the first layer (e.g., proximal to the infundibulum) may be smaller than the petals in the second layer (e.g., distal to the infundibulum).

[0073]

[0127] Still referring to Figures 7A-7B, the radially extending struts 730 may include one or more deflection points or hinges that reduce sheathing forces and facilitate more uniform and controllable folding from the expanded configuration to the folded configuration. A first deflection point or hinge 738 is shown at the distal-most region of the struts (e.g., at the distal tip of each petal 732). As shown in Figure 7A, each radially extending strut connects radially between adjacent spines, but also extends axially slightly distally along the infundibulum. The distal-most portion of each radially extending strut includes a hinge or deflection point 738. The frame structure does not include radially or circumferentially extending struts that do not have a hinge or deflection point at the distal-most axial position of the radially extending strut. Also note that the centrally located hinge or deflection point 738 in each strut at the strut's most distal axial position is also pointed or oriented distally. The orientation of the hinge 738 prevents the strut / hinge from catching and jamming when sheathing the catheter during re-sheathing. A second deflection point or hinge 740 is shown at each attachment or connection between the strut and the barb. To reduce the sheathing force required to collapse the infundibulum and to prevent or reduce distal spreading of the infundibulum frame during sheathing, the struts can be configured to bend or break at the hinges 738 and 740 when sheathing or folding the infundibulum. In some embodiments, the hinges 738 of the extending struts 730 can hinge in different planes. For example, hinges 740 where extending struts 730 connect or attach to barbed portions 728 allow the struts 730 to bend in a radial plane or radially, and hinges 738 at the distal most portions of struts 730 allow the struts 730 to bend in a circumferential direction. This combination of axial struts and radial and circumferential bending hinges allows the funnel to maintain its structural integrity and preferred shape during the wrapping process while reducing wrapping forces (compared to a frame structure without the hinge arrangement described).

[0074]

[0128] Referring again to FIG. 7A, the funnel 20 can include a distal inversion of the curvature and / or a distal flaring portion 734 near the distal end of the funnel, and a proximal inversion of the curvature and / or a proximal flaring portion 736 near the proximal end of the funnel. Collectively, the distal flaring portion 734 and the proximal flaring portion 736 cause the funnel to assume a "bell" shape when in the expanded configuration. The curvature and / or distal flaring portion of the funnel can reduce the incidence (e.g., rate) of the clot "hanging" at the distal end of the funnel, thereby preventing the clot from entering the funnel and / or causing clot fragments to remain outside the funnel. For example, without the distal flaring portion, the clot can wrap around or extend over the edge of the funnel, and when suction is activated, a portion of the clot is pulled down along the outer surface of the funnel. The distal flared portion 734 of the illustrated funnel provides a rolling surface that encourages the entirety of the clot to be directed toward the interior of the funnel. The curvature and / or proximal flaring of the funnel increases the inner diameter of the funnel near the jet / fluid flow and near the aspiration lumen. Thus, the proximal flaring of the funnel is configured to facilitate engagement and movement of the clot(s) deeper into the funnel to allow for interaction between the clot and the jet / aspiration lumen. The proximal flaring allows the funnel to fold proximally when the clot engages the funnel, thereby bringing a portion of the clot to or across the fluid surface 727.

[0075]

[0129] Additionally, the distal end of the infundibulum, particularly the distal flared portion, is very soft and flexible, allowing the user to advance the thrombectomy device while the infundibulum is in an expanded configuration without undue risk of damaging the vessel wall. The most distal portion of the infundibulum is sufficiently flexible and atraumatic that the device can be advanced in an expanded state. This allows for easier "capture" of the clot, where the position of the infundibulum relative to the clot can be fine-tuned without the need to recoat the infundibulum.

[0076]

[0130] As shown in FIGS. 7A-7B, a proximal flaring portion 736 can be formed as a result of bending or reversing a curve in the barbed portion 728, and a distal flaring portion 734 can be formed as a result of bending or reversing a curve in the struts 730, particularly the most distal layer of the struts 730. Although the distal flaring portion 734 is formed as a result of spreading or curving the struts 730, it should be noted that the very distal most portion 742 of the infundibulum 20 does not include any rigid framework. This allows the most distal portion of the infundibulum to be very flexible relative to the rest of the infundibulum. This flexibility of the distal flaring portion of the infundibulum allows the distal end of the infundibulum to conform to the clot(s) entering the infundibulum, thereby improving engagement with the clot(s) and limiting the amount of blood aspirated into the catheter while the clot(s) are engaged.

[0077]

[0131] 7C-7D illustrate deformation of the flexible distal end 735 that may occur when the funnel 20 engages one or more clots. As discussed above, the distal end 735 of the funnel may include a flexible or flexible portion of the funnel that does not include any supporting framework structure at least in an axial portion of the distal end. When the funnel engages a clot under suction, the flexible distal end is configured to bend radially inward to conform against the clot, sealing or partially sealing the funnel against the clot. This may result in portions of the distal end conforming, bending, or moving radially inward, as shown by the arrows in FIG. 7C. Typically, such bending or conforming occurs in the area between the hinges 738, and the framework does not advance axially distally. However, it should be understood that such bending or conforming may be non-uniform and may occur even in portions where the hinges 738 are present. FIG. 7D is a photograph of the thrombectomy device engaged and sealed / partially sealed with a clot, with the flexible distal end of the infundibulum shown bent or curved inward to accommodate the clot.

[0078]

[0132] FIG. 7E shows another view of the funnel 20, including a fluid surface 727, a proximal flared portion characterized by an inversion of the funnel's curvature (e.g., at 736), a distal flared portion characterized by yet another inversion of the funnel's curvature (e.g., at 734), and a distal end 735. Point 739 indicates a location along the funnel just distal to the proximal flared portion, and point 741 indicates a location along the funnel just proximal to the distal flared portion. The resulting cross-sectional shape of the funnel can include a hyperbolic parabola with at least two inversions of curvature along its axial length, as shown. The funnel can optionally include a cross section between points 741 and 734 that has a constant diameter (e.g., a relatively straight or uniform cross section of the funnel). As described above, the funnel can have an axial length L1 between the distal end 735 and the fluid surface 727. Axial length L2 defines the distance between fluid surface 727 and proximal flared inverted portion 736, length L3 defines the distance between fluid surface 727 and point 739, length L4 defines the distance between fluid surface 727 and point 741, and length L5 defines the distance between fluid surface 727 and distal flared inverted portion 734. The proximal and distal flared portions each result in a funnel having a varying inner diameter. For example, the funnel can have a first diameter d1 at the fluid surface, which may be located near or adjacent where the funnel is coupled to the aspiration lumen of the thrombus removal catheter. In some embodiments, this diameter d1 is the narrowest cross-section of the funnel. In some embodiments, the proximal-most diameter of the funnel is equal to the diameter of the aspiration lumen. Distal to this proximal-most cross-section of the funnel, the diameter increases slightly and the funnel inverts its curvature at proximal flared inverted portion 736 to flare radially outward. The funnel diameter d2 at the proximal flaring portion can be larger than the diameter d1 at the fluid plane. As discussed above, increasing the funnel diameter very close to the aspiration lumen of the proximal flaring portion can facilitate driving the clot toward the injection and / or aspiration lumen of the device. At the cross section of the funnel between the proximal and distal flaring portions, the funnel diameter can increase slightly to diameter d3 at point 739 and diameter d4 at point 741.In some embodiments, the diameter of the funnel at location 739, just distal to the proximal flaring portion, is similar to or substantially equal to the diameter d5 of the funnel at the distal flaring portion. Alternatively, the diameter d4 at point 741 is similar to or substantially equal to the diameter d5 of the funnel at the distal flaring portion. The maximum diameter d6 of the funnel is shown at the distal end of the funnel. The distal flaring portion 734 is another inversion of the curvature of the funnel, resulting in the distal tip or end 735 of the funnel pointing radially outward as shown and described herein.

[0079]

[0133] With respect to the axial length of the infundibulum, the length L2 between the fluid surface and the proximal flaring portion can be in the range of 15-25 percent of the infundibulum length L1. The length L3 between the fluid surface and point 739 (just distal to the proximal flaring portion) can be in the range of 30-40 percent of the infundibulum length L1. The length L5 between the fluid surface and the distal flaring portion can be in the range of 60-80 percent of the infundibulum length L1.

[0080]

[0134] Still referring to FIG. 7E, in some embodiments, the diameter d1 of the funnel at the distal flaring portion 734 is approximately equal to the diameter of the funnel at a point 739 immediately distal to the proximal flaring portion 736. In other embodiments, the diameter of the funnel at point 739 is within 10%, or optionally within 20%, of the diameter of the funnel at the distal flaring portion. In one particular example, the diameter d1 of the funnel at the fluid level may range from 2 to 4 mm, while the diameter d6 at the distal tip 735 of the funnel may range from 10 to 14 mm. Similarly, the diameter d5 at the distal flaring portion may range from 7 to 9 mm, and the diameter d2 at the proximal flaring portion 736 may range from 4 to 8 mm. Additionally, the proximal flaring portion may begin approximately 0.5 to 1.5 mm away from the fluid level or aspiration lumen of the device. The resulting funnel therefore includes a very wide diameter cross-section beginning at the proximal flaring portion that is positioned very close to the aspiration lumen, advantageously displacing clots, including large clots, into the cutting plane of the jet of the thrombectomy catheter.

[0081]

[0135] As discussed above, the funnel can include a flexible material 726 disposed on or over the frame 724. The flexible material can include a resilient material such as a polycarbonate-based urethane, e.g., Chronoflex, or other similar material. In some embodiments, the flexible material includes one or more layers. For example, the funnel can include a first layer of flexible material on the inside of the funnel and a second layer of flexible material on the outside of the funnel. Alternatively, when spraying the flexible material onto the frame, the funnel can include more layers of flexible material in the "windows" between the frame structures than the amount of layers bonded to the frame structure itself. In some embodiments, two or more layers can "sandwich" the funnel frame 724. In another embodiment, an inner layer of flexible material can be used on the inside of the frame 724 and an outer layer can be spray coated on the outside of the frame to attach the inner layer to the frame. In some embodiments, the inner layer of flexible material can include a different material than the outer layer of flexible material. For example, the inner layer of soft material can include a low-tack or lubricious material configured to encourage the clot to slide or glide within the infundibulum rather than stick or adhere to the infundibulum. The low-tack or lubricious material can encourage the clot to move within the infundibulum toward the injection and / or aspiration lumen. In some embodiments, a lubricious material such as polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE) can be used on the inner surface of the infundibulum.

[0082]

[0136] 8A-8C illustrate cross-sectional views of the infundibulum 20 with various distal infundibulum edge variations. For example, the distal flaring portion 834 shown in the embodiment of FIG. 8A may be similar to the distal flaring portion 734 described above in FIGS. 7A-7B. In this example, the distal flaring portion includes a reversal of curvature at the infundibulum where the distal edge 842a of the infundibulum faces radially outward (e.g., toward the vessel wall as the infundibulum is expanded). The embodiment of FIG. 8A further illustrates a cross-section 835 of the infundibulum that includes an axial cross-section of the infundibulum extending between the proximal flaring portion 836 and the distal flaring portion 834. It can be seen from FIG. 8A that the diameter of the infundibulum increases between the proximal and distal flaring portions, but this increase is less than the overall increase in diameter of the proximal and distal flaring portions.

[0083]

[0137] In contrast, the embodiment of Figure 8B shows a distal overhang 834 in which the distal edge 842b of the infundibulum is rolled or curved back inwardly toward the distal overhang (e.g., resembling a ram's horn). Note that in this embodiment, the distal edge is curved or folded back inwardly toward the infundibulum and does not itself seal against the infundibulum, but instead forms an open lip or annulus around the distal tip of the infundibulum.

[0084]

[0138] In the embodiment of Figure 8C, the distal edge 842c of the infundibulum is curved or folded back and sealed or joined to the infundibulum to form a beaded or folded edge. Any deformations in the distal overhang and distal edge of the infundibulum are designed and configured to prevent the clot from getting caught or hanging on the distal edge of the infundibulum and to encourage the clot(s) to enter the interior of the infundibulum.

[0085]

[0139] Alternatively or additionally, the curvature of the funnel and / or the distal flaring portion can facilitate a shape change of the funnel under suction or during advancement of the funnel within a vessel. FIGS. 9A-9B illustrate two configurations of the funnel to illustrate how the funnel can accommodate a dead end or advance directly into a rigid structure such as a vessel wall. In FIG. 9A, the funnel is shown in an expanded or deployed configuration prior to engaging a wall. Length L1 represents the axial distance between the fluid face 727 and the distal end 735 of the funnel. Length L2 represents the axial distance between the fluid face 727 and the proximal flaring portion 736. FIG. 9B shows the funnel in an expanded or deployed configuration after reaching a dead end or being forced into a wall or other rigid structure. The distal end 735 of the funnel has the softness and flexibility to bend and fold, resulting in the funnel being axially shortened. In FIG. 9B, the distance between the distal end 735 and the fluid surface is shortened to a length L1', and the distance between the proximal overhang 736 and the fluid surface 727 is shortened to a length L2'. Note that as such shortening occurs, the diameter of the funnel at the proximal overhang 736 also changes (e.g., increases) as the funnel rim in this cross section bows (e.g., outward) to account for the axial shortening. Further advancement of the catheter may continue to change the shape of the funnel, for example, everting (or everting) the distal portion of the funnel, as shown in FIG. 9C. Even in the everted configuration as shown in FIG. 9C, the combination of jet and suction may still remove the clot. However, the funnel may not form an ideal or partial seal with the clot in this configuration, and the resulting process may cause the clot to "bounce" back against the distal end of the device as it engages the aspiration lumen and is partially cut or macerated with the jet.

[0086]

[0140] 10A-10B illustrate additional views of funnels 20a / 20b including a funnel frame. Funnel 20a of FIG. 10A can include the funnel frame of FIG. 7A-7B, with radially extending struts 1030 including a deflection point or hinge 1038 along the length of each radially extending strut (e.g., at the distal-most portion of each strut). Typically, this hinge or deflection point is at the central portion of the strut. Radially extending struts 1030 can also include a deflection point or hinge 1040 at the location where the strut attaches or connects to axially extending barbs 1028, as previously described. In contrast, funnel 20b of FIG. 10B includes struts 1030 that do not have hinges or deflection points, but instead include a smooth curve 1044 along the span between adjacent barbs 1029. As a result, the infundibulum 20b is more resistant to sheathing and requires additional sheathing force to collapse the infundibulum. Additionally, the embodiment of Figure 10B is prone to radial expansion during sheathing, especially at the distal portion of the infundibulum.

[0087]

[0141] 10C-10F illustrate the covering of infundibulum 20a and 20b (superimposed one on the other for ease of illustration) with a delivery sheath or catheter 1046. It should be understood that infundibulum 20a and 20b are illustrated together to show the difference in covering between these infundibulum. FIG. 10C shows both infundibulum 20a and 20b in a fully expanded or deployed configuration, with the delivery sheath or catheter 1046 withdrawn proximally from the infundibulum casing. In FIG. 10D, the delivery sheath or catheter 1046 is advanced distally in direction 1048 over the proximal portion of the infundibulum casing, contacting the casing and / or infundibulum membrane (not shown), initiating the covering process. In FIG. 10E, the delivery sheath or catheter 1046 is advanced further in direction 1048 to continue covering infundibulum 20a and 20b. Here, the difference in coverage between infundibulum 20a and infundibulum 20b becomes more apparent. Because the radially extending struts of infundibulum 20a include hinges or deflection points as described above, coverage of the infundibulum causes the struts to fold or break along the hinges or deflection points, resulting in the distal tip of infundibulum 20a moving inward in direction 1050. In contrast, the distal tip of infundibulum 20b begins to flare outward while also moving proximally as indicated by arrows 1052, because the struts do not have features configured to encourage bending or hinging action. Although infundibulum 20b increases in axial cross-sectional dimension upon coverage compared to infundibulum 20a, infundibulum 20b also requires a greater covering force from the delivery sheath or catheter 1046. FIG. 10F illustrates further advancement of the delivery sheath or catheter 1046 in direction 1048. In this view, the radial expansion of funnel 20b is very pronounced compared to the smooth inward folding of funnel 20a.

[0088]

[0142] FIG. 11 illustrates the coverage required for funnel portion 20b compared to that required for funnel portion 20a. The top of the diagram illustrates the various degrees of funnel coverage as described above in FIG. 10C and FIG. 10F. Line 1101 corresponds to the coverage of funnel portions 20a and 20b as illustrated in FIG. 10C, and line 1102 corresponds to the coverage of funnel portions 20a and 20b as illustrated in FIG. 10F. As shown, the coverage required for funnel portion 20a is significantly lower than that required for funnel portion 20b, especially early in the coverage. Funnel portion 20a requires approximately 20% to 80% less coverage, depending on the level of coverage. The reduced coverage is a direct result of the deflection points or hinges of the struts, both within each radially extending strut and at the attachment or connection points between the axially extending barbs and the radially extending struts.

[0089]

[0143] 12A-12D, some embodiments of the funnel 20 can include suction elements adapted to increase suction within the thrombus removal catheter and / or the funnel. FIG. 12A depicts a "hard" clot that may be lodged in the distal region (e.g., the funnel) of the thrombus removal catheter. FIG. 12B depicts a thrombus removal catheter having one or more suction elements 1254 disposed on or within the funnel, which are adapted to enhance clot capture. As shown in FIG. 12C, the suction elements 1254 can include protrusions (e.g., ribs) positioned near the distal end of the funnel. The protrusions can be formed in the funnel (e.g., a soft material) or can be individually bonded or glued to the interior of the funnel. The protrusions can be present at least a portion (e.g., the entirety) of the periphery (e.g., inside) of the funnel. The suction elements can locally reduce pressure within the funnel to accelerate flow. As shown in Figure 12D, the suction element can include a flexible member (e.g., a skirt). The flexible skirt can (e.g., passively) conform in shape when a clot is adjacent to the skirt. The change in shape can alter the area and / or volume over which suction is applied, increasing the suction force applied to the clot.

[0090]

[0144] Although the embodiments herein have been described as intended to remove blood clots from a patient's vasculature, other applications of this technology are provided. For example, the devices described herein can be used to break up and remove hardened stool from a patient's digestive tract, such as the patient's intestines or colon. In one embodiment, the device can be inserted into the patient's colon or intestines (such as through the anus) and advanced to the site of the hardened stool. The suction system can then be activated to engage the hardened stool with an engagement member (e.g., the infundibulum) of the device. Finally, the jet or irrigation can be activated to break off the pieces of hardened stool and aspirate them into the system. Any of the techniques described above for controlling the system or removing blood clots can be applied to removing hardened stool.

[0091]

[0145] As one skilled in the art will appreciate from the disclosure herein, various components of the thrombus removal system described above may be omitted without departing from the scope of the present technology. As previously discussed, for example, the present technology may be used and / or modified to remove other types of emboli that may occlude blood vessels, such as fat, tissue, or foreign bodies. Additionally, although some embodiments herein are described in the context of thrombus removal from the pulmonary artery, the disclosed technology may be applied to the removal of thrombi and / or emboli from other parts of the vasculature (e.g., in neurovascular, coronary, or peripheral applications). Similarly, additional components not expressly described above may be added to the thrombus removal system without departing from the scope of the present technology. Thus, the systems described herein are not limited to those configurations expressly identified, but rather encompass variations and modifications of the described systems. conclusion

[0146] The above detailed description of the embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the exact form disclosed above. Specific embodiments of the present technology, and examples thereof, are described above for illustrative purposes, but as those skilled in the art will recognize, various equivalent modifications are possible within the scope of the present technology. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. Various embodiments described herein may be combined to provide further embodiments.

[0092]

[0147] From the above, it will be understood that, although specific embodiments of the present technology have been described herein for illustrative purposes, well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where the context permits, singular or plural terms may also include plural or singular terms, respectively.

[0093]

[0148] Unless the context clearly dictates otherwise, throughout the description and examples, the words "comprises," "comprising," and the like, should be construed in an inclusive sense, i.e., "including, but not limited to," and not in an exclusive or exhaustive sense. As used herein, the terms "connected," "coupled," or any variation thereof, refer to any direct or indirect connection or coupling between two or more elements, and the coupling between the elements may be physical, logical, or a combination thereof. In addition, the words "herein," "above," "below," and words of similar import, when used in this application, refer to this application as a whole, and not to any particular portions of this application. Where the context permits, words in the above detailed description using the singular or plural may each be in the plural or singular. As used herein, the term "and / or," such as "A and / or B," refers to A only, B only, and A and B. In addition, the term "comprising" is used throughout to mean including at least the recited feature(s), but not to the exclusion of any more of the same features and / or other features of additional types. Although specific embodiments have been described herein for purposes of illustration, it will also be understood that various modifications may be made without departing from the technology. Furthermore, while advantages associated with some embodiments of the technology have been described in the context of these embodiments, other embodiments may also exhibit such advantages, but not all embodiments necessarily exhibit such advantages to fall within the scope of the technology. Thus, the present disclosure and related technology may include other embodiments not expressly shown or described herein.

Claims

1. A slender catheter having a suction lumen configured to be connected to a suction source, and defining a longitudinal axis, An expandable funnel portion coupled to the suction lumen and the elongated catheter, the expandable funnel portion including a proximal projection near the suction lumen and a distal projection near the distal end of the expandable funnel portion, A thrombectomy device comprising one or more fluid ports disposed near or inside the expandable funnel portion that defines a fluid region.

2. The thrombectomy device according to claim 1, wherein the first diameter of the expandable funnel portion in the proximal projection is within 10% of the second diameter of the expandable funnel portion in the distal projection.

3. The thrombectomy device according to claim 1, wherein the first diameter of the expandable funnel portion in the proximal projection is within 20% of the second diameter of the expandable funnel portion in the distal projection.

4. The thrombectomy device according to claim 1, wherein the proximal protrusion is configured to facilitate the advancement of the blood clot into the fluid region.

5. The thrombectomy device according to claim 1, wherein the distal end of the expandable funnel portion is directed radially outward.

6. The thrombectomy device according to claim 1, wherein the distal end of the expandable funnel portion curves back proximally toward the distal widening portion.

7. The thrombectomy device according to claim 6, wherein the distal end is not joined to the distal protruding portion.

8. The thrombectomy device according to claim 6, wherein the distal end is joined to the distal protruding portion.

9. The thrombectomy device according to claim 1, wherein the expandable funnel further includes a funnel frame.

10. The thrombus removal device according to claim 9, wherein the funnel frame includes a shape memory material.

11. The thrombectomy device according to claim 1, wherein the funnel frame includes a plurality of axially extending spine-like portions and one or more layers of radially and / or circumferentially extending supports between adjacent spine-like portions.

12. The thrombectomy device according to claim 1, wherein the proximal projection is formed as a result of bending in each of the plurality of axially extending spine-like portions.

13. The thrombectomy device according to claim 1, wherein the distal protruding portion is formed as a result of bending in each of the plurality of radially and / or circumferentially extending supports.

14. The thrombectomy device according to claim 11, further comprising at least one hinge on each of the plurality of radially and / or circumferentially extending support columns.

15. The thrombectomy device according to claim 14, wherein the first hinge is disposed at the most distal portion of each of the plurality of radially and / or circumferentially extending supports.

16. The thrombectomy device according to claim 15, wherein a second hinge is disposed at the joint between one of the plurality of radially extending support columns and one of the plurality of axially extending spine-like portions.

17. The thrombectomy device according to claim 14, wherein the at least one hinge is configured to reduce the covering force of the expandable funnel portion.

18. The thrombectomy device according to claim 14, wherein the at least one hinge is integral with the plurality of radially and / or circumferentially extending supports.

19. The thrombectomy device according to claim 11, wherein the plurality of axially extending spine-like portions have higher rigidity than the plurality of radially and / or circumferentially extending supports.

20. The thrombectomy device according to claim 11, wherein the plurality of axially extending spine-like portions have a thickness greater than the thickness of the plurality of radially and / or circumferentially extending supports.

21. The thrombectomy device according to claim 11, wherein the funnel frame includes two layers of radially extending support columns.

22. The thrombectomy device according to claim 11, wherein the plurality of axially extending spine-like portions and the plurality of radially extending supports collectively form a plurality of petals in each of the one or more layers.

23. The thrombectomy device according to claim 22, wherein the petal in the proximal layer of the funnel frame is smaller than the petal in the distal layer of the funnel frame.

24. The thrombectomy device according to claim 22, further comprising at least six petals on each of the one or more layers.

25. The thrombus removal device according to claim 9, further comprising a flexible material attached to the funnel frame.

26. The thrombectomy device according to claim 24, wherein the distal portion of the expandable funnel comprises only a flexible material without a funnel frame.

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