Thrombectomy systems and related methods

Abstract

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

Description

[Technical field]

[0001] Related Applications

[0001] This application is related to International Application PCT / US2021 / 020915, filed March 4, 2021, and U.S. patent application Ser. No. 63 / 190,784, filed May 19, 2021, the disclosures of which are incorporated by reference in this specification. Incorporation by Reference

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

[0002]

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

[0003]

[0004] Thrombus material can cause obstruction of fluid flow in the mammalian vasculature. Such obstruction can occur in various areas of the body, such as in the pulmonary system, the peripheral vasculature, the deep vasculature, or in the brain. Pulmonary embolism usually occurs when a clot originating in another part of the body (e.g., the pelvic or leg veins) breaks off and travels to the lungs. Anticoagulation is the current standard of care for treating pulmonary embolism, but may not be effective in some patients. In addition, conventional devices for removing thrombus material may be unable to navigate the pulmonary vasculature, may be ineffective at removing thrombus material, and / or may lack the ability to provide sensor data or other feedback to clinicians during thrombectomy procedures. [Means for solving the problem]

[0004]

[0012] A clot removal system is provided that includes an elongated catheter device, an aspiration mechanism, and a fluid delivery mechanism. The elongated catheter device includes a distal portion configured to be positioned within a patient's blood vessel and including an inner wall and an outer wall forming an aspiration lumen, a manifold formed near a distal end of the fluid lumen, the manifold having at least two fluid ports formed therein, the at least two fluid ports adapted to be fluidly connected to the fluid lumen to direct respective fluid flows from the at least two fluid ports, and a proximal portion configured to be positioned outside the patient, the aspiration lumen extending from the distal portion to the proximal portion. The aspiration mechanism is positioned outside the patient and fluidly coupled to the aspiration lumen and configured to reduce pressure in the distal portion to (a) engage the clot with the distal portion and / or (b) draw the clot and / or clot fragments proximally. The fluid delivery mechanism is configured to supply fluid through the fluid lumen.

[0005]

[0013] In some embodiments, the inner and outer walls are arranged concentrically (ie, coaxially) such that the fluid lumen has a generally annular cross-section.

[0006]

[0014] In one embodiment, the system further includes at least one fluid wall disposed in the space between the inner wall and the outer wall, the at least one fluid wall forming a fluid lumen.

[0007]

[0015] In some embodiments, the irrigation manifold is formed from an inner wall and an outer wall.

[0008]

[0016] In one embodiment, at least two fluid ports are formed in the inner wall of the manifold.

[0009]

[0017] In some embodiments, the inner wall has a first thickness in a first region within the manifold and a second thickness proximal to the first region. In other embodiments, the first thickness is greater than the second thickness. In one embodiment, the first thickness is about twice the second thickness. In some implementations, the first thickness is between 0.10 mm and 0.60 mm and the second thickness is between 0.20 mm and 0.70 mm. In some embodiments, the first thickness is selected to provide a generally laminar flow for each fluid stream.

[0010]

[0018] In one embodiment, the cross-sectional dimension of two or more of the fluid ports varies along their length.

[0011]

[0019] In some implementations, the two or more fluid ports are cone-shaped along their length.

[0012]

[0020] In one embodiment, the smallest dimension of the two or more fluid ports is located at a distal end of the two or more fluid ports.

[0013]

[0021] In some embodiments, the respective fluid flows are configured to intersect near at least one intersection region.

[0014]

[0022] In one embodiment, the at least one intersection region is located proximal to at least one of the at least two fluid ports.

[0015]

[0023] In other embodiments, the at least one intersection region is located distal to at least one of the at least two fluid ports.

[0016]

[0024] In some embodiments, the irrigation manifold is configured to increase the flow rate of fluid in the fluid lumen, hi other embodiments, the irrigation manifold is configured to increase the pressure of fluid in the fluid lumen.

[0017]

[0025] In some embodiments, the system further comprises a funnel positioned at a distal end of the distal portion, the funnel configured to engage the thrombus.

[0018]

[0026] In one embodiment, the irrigation manifold is disposed proximal to the manifold, hi another embodiment, the irrigation manifold is integrated into the funnel.

[0019]

[0027] A method for removing a thrombus from a blood vessel of a patient is provided, the method comprising the steps of: introducing a distal portion of an elongate catheter to a location of the thrombus within the blood vessel; retracting at least a portion of the thrombus into the distal portion; and directing fluid toward the thrombus at between 10-15 m / s from at least two distinct points along respective intersecting fluid paths.

[0020]

[0028] In some embodiments, the retracting step is by suction applied via an aspiration lumen of the elongate catheter.

[0021]

[0029] In another embodiment, the directing step further includes directing one of the respective fluid paths proximally. In some embodiments, the directing step further includes directing one of the respective fluid paths distally. In other embodiments, the directing step further includes directing a first fluid path proximally and a second fluid path distally. In another example, the directing step further includes directing a first fluid path proximally and a second fluid path perpendicular to the aspiration flow axis.

[0022]

[0030] There is also provided a method for removing a thrombus from a patient's blood vessel, the method comprising the steps of: introducing a distal portion of an elongate catheter to a location of the thrombus within the vessel; drawing at least a portion of the thrombus into the distal portion; delivering fluid from a fluid delivery mechanism into a fluid lumen of the elongate catheter; increasing a flow rate of the fluid using an irrigation manifold disposed at a distal end of the fluid lumen; and directing at least two fluid flows using ports disposed in the irrigation manifold.

[0023]

[0031] In some embodiments, the retracting step is by suction applied via an aspiration lumen of the elongate catheter.

[0024]

[0032] In one embodiment, at least two fluid flows are directed proximally using the ports. In other embodiments, at least two fluid flows are directed distally using the ports. In some examples, at least two fluid flows are directed perpendicular to the longitudinal axis of the elongate catheter using the ports. In another embodiment, at least two fluid flows are directed toward an intersection region.

[0025]

[0033] In some embodiments, the flow rate of the at least two fluid streams is comprised between 10 and 15 m / s, while in other embodiments, the flow rate of the at least two fluid streams is comprised between 12 and 15 m / s.

[0026]

[0005] 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 in which: [Brief description of the drawings]

[0027] [Figure 1]

[0006] FIG. 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]1 illustrates a portion of a thrombus removal system including a distal portion of an elongate catheter configured in accordance with an embodiment of the present technology. [Figure 1B] 1 illustrates a portion of a thrombus removal system including a distal portion of an elongate catheter configured in accordance with an embodiment of the present technology. [Figure 1C] 1 illustrates a portion of a thrombus removal system including a distal portion of an elongate catheter configured in accordance with an embodiment of the present technology. [Figure 1D] 1 illustrates a portion of a thrombus removal system including a distal portion of an elongate catheter configured in accordance with an embodiment of the present technology. [Figure 1E] 1 illustrates a portion of a thrombus removal system including a distal portion of an elongate catheter configured in accordance with an embodiment of the present technology. [Figure 2A] FIG. 2A is a top 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 top view showing an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Figure 2C] FIG. 2C is a top view showing an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Figure 2D] FIG. 2D is a top view showing an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Figure 2E] FIG. 2E is a top view showing an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Diagram 3]

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

[0009] FIG. 4A is an elevational view illustrating 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 illustrating an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. FIG. 4C is an elevational view illustrating an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. FIG. 4D is an elevational view illustrating an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. FIG. 4E is an elevational view illustrating an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. FIG. 4F is an elevational view illustrating an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. FIG. 4G is an elevational view illustrating an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. FIG. 4H is an elevational view illustrating an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Figure 5A]

[0010] FIG. 5A illustrates an irrigation port configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Figure 5B] FIG. 5B illustrates an irrigation port configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Figure 5C] FIG. 5C illustrates an irrigation port configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Figure 5D]FIG. 5D illustrates an irrigation port configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Figure 5E] FIG. 5E illustrates an irrigation port configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Figure 5F] FIG. 5F illustrates an irrigation port configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Figure 5G] FIG. 5G illustrates an irrigation port configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Figure 6] FIG. 1 illustrates the relationship between jet flow rate and interaction with one or more blood clots. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028]

[0034] The present technology is generally directed to clot removal systems and associated methods. A system configured in accordance with 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.

[0029]

[0035] The terms used in the description presented below are intended to be interpreted in the broadest reasonable manner, even when used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may be emphasized below, but any terms intended to be interpreted in any limiting manner will be clearly and specifically defined in the Detailed Description section of this invention. In addition, the present technology may include other embodiments that are within the scope of the examples but are not described in detail in connection with the figures.

[0030]

[0036] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or property described in connection with the 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 properties may be combined in any suitable manner in one or more embodiments.

[0031]

[0037] Throughout this specification, references to relative terms such as, for example, "generally," "approximately," and "about" are used herein to mean plus or minus 10% of the stated value.

[0032]

[0038] Although some embodiments herein are described in the context of removing a thrombus, it will be appreciated that the techniques may be used and / or modified to remove other types of emboli that may occlude a blood vessel, such as fat, tissue, or foreign bodies. Additionally, while some embodiments herein are described in the context of removing a thrombus from a pulmonary artery (e.g., pulmonary embolectomy), the techniques may also be applied to remove thrombi and / or emboli from other parts of the vasculature (e.g., neurovascular, coronary, or peripheral applications). Furthermore, while some embodiments are discussed in the context of macerating a thrombus with a fluid, the techniques may be adapted for use with other techniques (e.g., ultrasound, mechanical, enzymes, etc.) to fragment a thrombus into small fragments or particles.

[0033]

[0039] The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed technology. System for thrombus removal

[0040] As presented above, the present technology is generally directed to a thrombus removal system. Such a system includes an elongated catheter having a distal portion that can be positioned within a patient's blood vessel (e.g., an artery or vein), a proximal portion that can be positioned outside the patient's body, a fluid delivery mechanism configured to fragment the thrombus with pressurized fluid, an aspiration mechanism configured to aspirate the thrombus fragments, and one or more lumens extending at least partially from the proximal portion to the distal portion. In some embodiments, the system herein is configured to engage the thrombus within the patient's blood vessel, fragment the thrombus into small fragments, and aspirate the fragments out of the patient's body. A pressurized fluid flow (e.g., a jet) functions to cut or macerate the thrombus before, during, and / or after at least a portion of the thrombus enters the aspiration lumen or funnel of the system. Fragmentation helps prevent the aspiration lumen from clogging and allows the thrombus removal system to macerate large, hard clots that otherwise cannot be aspirated. As used herein, "thrombus" and "embolism" are used somewhat interchangeably in various respects. It should be recognized that while the present description may refer to the removal of a "thrombus," the description should be understood to encompass the removal of thrombus fragments and other emboli as presented herein.

[0034]

[0041] According to embodiments of the present technology, a fluid delivery mechanism can provide multiple fluid streams (e.g., jets) to a fluid aperture of the thrombus removal system for macerating, cutting, fragmenting, pulverizing, and / or facilitating removal of the thrombus from a proximal portion of the thrombus removal system. The suction removal system can include an aspiration lumen adapted to be fluidly connected to an aspiration pump (e.g., a vacuum source) and extending at least partially from the proximal portion to the distal portion of the thrombus removal system. During operation, the aspiration pump can generate a lower pressure volume in the aspiration lumen near the proximal portion of the thrombus removal system, thereby facilitating aspiration of the thrombus from the distal portion.

[0035]

[0042] FIG. 1 illustrates a distal portion 10 of a thrombus removal system according to an embodiment of the present technology. FIG. 1 includes section lines AA, BB, and CC shown in FIG. 1A, FIG. 1B / 1C, and FIG. 1D, respectively. Section AA in FIG. 1A illustrates an elevational cross-sectional view of the distal portion. The exemplary section AA in FIG. 1A illustrates a funnel 20 positioned at a distal end of the distal portion 10, which is adapted to engage a thrombus and / or a tissue wall (e.g., a vessel wall) to assist in thrombus fragmentation and / or removal. The exemplary section AA in FIG. 1A illustrates a dual-walled thrombus removal device configuration having an outer wall / outer tube 40 and an inner wall / inner 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 to be fluidly connected to a fluid delivery mechanism. One or more apertures (e.g., nozzles, orifices, or openings) 30 are positioned within the thrombus removal system such that they are fluidly connected to the fluid lumen 45 and the irrigation manifold 25. During operation, the openings 30 are adapted to direct a fluid (e.g., pressurized fluid) toward a thrombus engaged in the distal portion 10 of the thrombus removal system. In some embodiments, the manifold may be positioned proximal to the infundibulum. In other embodiments, the manifold may be integral to the infundibulum.

[0036]

[0043] The thrombus removal system may be sized and configured to access and remove thrombus in various locations or vessels within a patient's body. It should be understood that the dimensions of the system may vary depending on the target location, but generally the same features and components described herein will be implemented in the thrombus removal system regardless of application. For example, a thrombus removal system configured to remove pulmonary embolism (PE) from a patient may have an outer wall / outer tube having a size of about 11-13 Fr, or preferably 12 Fr, and an inner wall / inner tube having a size of 7-9 Fr, or preferably 8 Fr. On the other hand, a deep vein thrombosis (DVT) device may have an outer wall / outer tube having a size of about 9-11 Fr, or preferably 10 Fr, and an inner wall / inner tube having a size of 6-9 Fr, or preferably 7.5 Fr. Applications for ischemic stroke and peripheral arterial embolism applications are further provided.

[0037]

[0044] Section BB of FIG. 1B illustrates in plan view a portion of the thrombus removal system proximal to the funnel and irrigation manifold. Section BB depicts outer wall 140, inner wall 150, aspiration lumen 155, and fluid lumen 145. As shown, inner wall 150 forms the aspiration lumen, and the inner and outer walls are concentric with one another. Fluid lumen 145 is formed in the space between the inner and outer walls. In some embodiments, in cross section, aspiration lumen 155 is generally circular and fluid lumen 145 is generally annular shaped (e.g., section 70). It will be appreciated that alternative configurations and / or arrangements of inner wall 150 and outer wall 140 create 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 generally elliptical, circular, rectangular, square, pentagonal, or hexagonal in cross section. Inner wall 150 and outer wall 140 may be shaped and arranged to form a fluid lumen 145 that is generally crescent-shaped, diamond-shaped, or irregularly shaped in cross-section. For example, referring to cross-section BB of FIG. 1C, the area between inner wall 150 and outer wall 140 may include one or more wall structures 165 (e.g., as in cross-section 80) that form each fluid lumen 145. Wall structures 165 may be formed by lamination between outer wall 140 and inner wall 150 or by multi-lumen extrusion to form multiple wall structures.

[0038]

[0045] 1D illustrates in plan view a portion of a thrombus removal system including irrigation manifold 225. View CC depicts outer wall 240, inner wall 250, fluid lumen 245, aspiration lumen 255, and openings 230 for directing the respective fluid flows 210.

[0039]

[0046] Detail view 101 of FIG. 1E illustrates in elevational section a portion of irrigation manifold 25 including a plurality of openings 230 formed in inner wall 250. As shown, the manifold may be positioned at or near a distal end of a fluid lumen formed by the inner and outer walls. 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 proximal to irrigation manifold 25 and a second thickness 270 in a region 235 including openings 230. In some embodiments, second thickness 270 is greater than first thickness 265. First thickness 265 may correspond approximately to the wall thickness of inner wall 50 and / or outer wall 40 and may be about 0.10 mm to about 0.60 mm or any value within the ranges mentioned above. 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 ranges mentioned above. The dimensions of the second thickness 270 can be selected to provide a fluid path through the opening 230 that creates a generally laminar flow for fluid flow induced through the fluid path when the fluid delivery mechanism delivers fluid through the fluid lumen 245 at a typical operating pressure. Such operating pressure 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 ranges of values ​​mentioned above. In some embodiments, the fluid delivery mechanism is operated 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 range of values ​​mentioned above.

[0040]

[0047] The manifold is configured to increase the fluid pressure and / or flow rate of the fluid. When a fluid is provided to the fluid lumen by the fluid delivery mechanism at a first pressure and / or a first flow rate, the manifold is configured to increase the pressure of the fluid to a second pressure and / or increase the flow rate of the fluid to a second flow rate. The second pressure and / or second flow rate may be greater than the first pressure and / or first flow rate. As a result, the manifold may be configured to increase a relatively low operating pressure and / or small flow rate generated by the fluid delivery mechanism to a relatively high pressure and / or large flow rate generated by the opening / fluid flow.

[0041]

[0048] In some embodiments, the profile (cross-sectional dimension) of the opening 230 varies along its length (e.g., is non-cylindrical). The variation in the cross-sectional dimension of the opening can change and / or tailor the nature of the fluid flow along the opening 230. For example, reducing the cross-sectional dimension can accelerate the fluid flow through the opening 230 (for a given volume of fluid). In some embodiments, the opening 230 can be conically shaped (e.g., tapered) along its length such that its smallest dimension is located at the distal end of the opening 230, where distal is relative to the direction of fluid flow.

[0042]

[0049] In some embodiments, the openings 230 are configured to direct the fluid flows along a selected path. Figures 2A-2E show various embodiments of the arrangement of the openings 230 to direct the respective fluid flows 210. In some embodiments, such as the embodiment shown in Figures 2A and 2B, at least two openings 230 are configured to create intersecting (e.g., respective) fluid flows 210 at an intersection region 237 of the clot removal system. The intersection region 237 can be an area of ​​increased fluid momentum and / or energy transfer with respect to the individual fluid flows 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 more quickly. In some embodiments, the intersection region can be formed of 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 flows 210. The intersection region may generally be near the 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 openings 230 are configured to direct the fluid flow 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 flow 210 delivered from the openings 230. The target fluid velocity for the fluid flow 210 may be about 5 meters per second (m / s), about 8 m / s, about 10 m / s, about 12 m / s, about 10-15 m / s, or about 12-15 m / s. The target fluid velocity for the fluid flow 210 may be any value within the range of values ​​mentioned above. In some embodiments, the at least two openings 230 are adapted to deliver respective fluid flows at different fluid velocities at a given pressure of the fluid delivery mechanism.In some embodiments, the at least two openings 230 are adapted to deliver respective fluid flows at substantially the same fluid velocity at a given pressure of the fluid delivery mechanism. In some embodiments, angular momentum is imparted to the thrombus by a) application of at least one fluid flow 210 directed at an oblique angle from the openings 230 and / or b) application of at least two fluid flows 210 having varying fluid velocities. Advantageously, the angular momentum created within the thrombus can impart forces (e.g., centrifugal forces) that aid in fragmenting and removing the thrombus. Advantageously, the expanding cross-sectional area of ​​the fluid lumen 145 reduces the required operating pressure of the fluid delivery mechanism to achieve a target fluid velocity of the fluid flow.

[0043]

[0050] 3A-3H, the openings 330 can be arranged 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 (i.e., a primary direction) for fluid to be aspirated therein (e.g., distal to proximal). In some embodiments, the location of the openings 330 includes a) near the base of the funnel portion 320 of the thrombus removal system, b) in a middle portion of the funnel portion 320 of the thrombus removal system, c) in a distal portion of the funnel portion 320 of the thrombus removal system, or d) proximal to the funnel portion 320 of the thrombus removal system. Although the embodiments shown herein show only a single opening 330, it should be understood that any of these embodiments can include multiple openings arranged around the funnel or proximal to the funnel. For example, any of the aperture arrangements shown in Figures 2A-2E may be implemented a) near the base of the funnel portion 320 of the thrombus removal system, b) in a middle portion of the funnel portion 320 of the thrombus removal system, c) in a distal portion of the funnel portion 320 of the thrombus removal system, or d) proximal to the funnel portion 320 of the thrombus removal system.

[0044]

[0051] In some embodiments, the at least two apertures 330 are aligned along the flow axis 305 (e.g., FIG. 3E). In some embodiments, the at least two apertures 330 are arranged at different axial positions along the flow axis 305 (e.g., FIGS. 3F, 3G, 3H). In some embodiments, the at least two apertures 330 are arranged along a given axial position of the flow axis 305 (e.g., along the circumference of the thrombus removal system). As above, any of the aperture arrangements shown in FIGS. 2A-2E may be implemented in the aperture arrangements shown in the embodiments of FIGS. 3F, 3G, and 3H.

[0045]

[0052] 4A-4H depict various configurations of fluid flows 410 directed from each opening 430. The fluid flows 410 may be directed along paths that are substantially perpendicular (e.g., FIG. 4A), proximal (e.g., FIG. 4C), and / or distal (e.g., FIG. 4B) to the flow axis 405 (similar to the flow axis 305). In some embodiments, at least two fluid flows are directed in different directions relative to the flow axis 405 (e.g., FIG. 4E). In some embodiments, at least one fluid flow is directed in the same direction relative to the flow axis 405 (e.g., distal) and at least one other fluid flow is directed in a different direction (e.g., perpendicular or proximal as shown in FIG. 4D). In some embodiments, at least a first fluid flow is directed substantially perpendicular to the flow axis, at least a second fluid flow is directed proximally, and at least a third fluid flow is directed distal to the flow axis 405. Angle α can characterize the angle at which fluid flow 410 is directed relative to an axis that is perpendicular to flow axis 405 (e.g., as shown in cross-sections DD of FIGS. 4G and 4H). The fluid flow crossover region can be within an interior portion of the thrombus removal system and / or can be external to the thrombus removal system (e.g., distal). In some embodiments, the fluid flow directed in a nominal direction (e.g., distal) by opening 430 is deflected along an altered path (e.g., proximal) by pressure (e.g., suction) generated by the suction mechanism during operation.

[0046]

[0053] 5A-5G show various exit aperture (or opening) geometries with which the opening 530 may be configured in accordance with embodiments of the present technology. The aperture geometries may include elliptical, circular, cross-shaped ("x" shaped), "t" shaped, rectangular, or square shapes. The fluid flow delivered from the opening 530 may include substantially laminar flow (e.g., at the aperture) or may include turbulent flow (e.g., fanning out or outward). For example, FIG. 5B shows an "x" shaped exit aperture geometry. FIG. 5C shows a "t" shaped exit aperture geometry. FIG. 5D-5G show variations of the elliptical exit aperture geometry. As shown in FIG. 5D, the fluid flow may be substantially laminar, and in FIG. 5E, the flow may fan outward.

[0047]

[0054] Referring to FIG. 6, a chart is provided showing the relationship between the jet exit velocity or flow rate (average) and the mechanism of action of one or more clots engaged by the clot removal device (i.e., engaged in the funnel or engaged in the aspiration lumen). In general, when the jet flow rate is reduced (e.g., below 10 m / s, depending on various parameters such as clot formation and jet configuration), the jet functions to help purge (in other words, sweep or remove) the clot into the aspiration lumen (especially if the funnel is blocked or partially blocked by a clot). This purging can include the function of pushing the clot into or through the aspiration lumen, as well as providing fluid into the funnel and into the aspiration lumen to help remove the clot. This purging can also help break down soft, loose material on the surface of the clot, but does not allow for the removal of harder material. However, once the jet flow rate begins to exceed the cutting threshold 602, the jet begins to cut the thrombus or thrombus surface, thereby fragmenting the thrombus into smaller pieces that can then be more easily aspirated into the aspiration lumen of the thrombus removal device. Additionally, it has been found that at a high enough velocity, the jet will pierce the clot surface and penetrate to the inner portion of the clot. In some embodiments, the threshold includes a jet flow rate in the range of 10-12 m / s. In other embodiments, the ideal cutting or perforating flow rate of the jet is in the range of 10-15 m / s, or alternatively in the range of 12-15 m / s.

[0048]

[0055] 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. Although specific embodiments of the present technology and examples for the present technology are described above for illustrative purposes, those skilled in the art will recognize that 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. The various embodiments described herein may also be combined to provide further embodiments.

[0049]

[0056] It will be appreciated from the above that, although specific embodiments of the present technology have been described herein for purposes of illustration, 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 the plural or singular terms, respectively.

[0050]

[0057] Throughout this description and examples, unless the context clearly requires otherwise, words such as "comprise" and "comprising" should be construed in an inclusive sense, i.e., "including but not limited to," rather than an exclusive or exhaustive sense. As used herein, the terms "connected," "coupled," or variations 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 similar words, when used in this application, refer to this application as a whole and not to any particular portion of this application. Where the context permits, words in the above detailed description using the singular or plural number can also include the plural or singular number, respectively. As used herein, the phrase "and / or," such as in "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 features, and thus does not exclude a greater number of the same features and / or additional types of other features. Moreover, while certain embodiments have been described herein for purposes of illustration, it will be recognized that various modifications may be made without departing from the technology. Moreover, while advantages associated with some embodiments of the technology are described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily need to exhibit such advantages to be within the scope of the technology. Thus, the present disclosure and related technology may encompass other embodiments not expressly shown or described herein.

Claims

1. 1. A thrombus removal system comprising an elongate catheter device, an aspiration mechanism, and a fluid delivery mechanism, The elongated catheter device comprises: a distal portion configured to be positioned within a patient's blood vessel and comprising an inner wall forming an aspiration lumen, an outer wall, and a fluid lumen formed within a space between the inner wall and the outer wall; a manifold formed near a distal end of the fluid lumen, the manifold having at least two fluid ports formed therein, the at least two fluid ports adapted to be fluidly connected to the fluid lumen to direct respective fluid flows from the at least two fluid ports; a proximal portion configured to be positioned external to the patient, the aspiration lumen extending from the distal portion to the proximal portion; the suction mechanism is positioned external to the patient and fluidly connected to the suction lumen and configured to reduce pressure at the distal portion to (a) engage a thrombus with the distal portion and / or (b) draw the thrombus and / or thrombus fragments proximally; the fluid delivery mechanism is configured to deliver fluid through the fluid lumen. Thrombectomy system.

2. The thrombus removal system of claim 1 , wherein the inner wall and the outer wall are arranged concentrically such that the fluid lumen has a generally annular cross-section.

3. The thrombus removal system of claim 1 , further comprising at least one fluid wall disposed in the space between the inner wall and the outer wall, the at least one fluid wall forming the fluid lumen.

4. The thrombus removal system of claim 1 , wherein the manifold is formed from the inner wall and the outer wall.

5. The thrombus removal system of claim 1 , wherein the at least two fluid ports are formed in the interior wall of the manifold.

6. The thrombus removal system of claim 5 , wherein the inner wall has a first thickness in a first region within the manifold and a second thickness proximal to the first region.

7. The thrombus removal system of claim 6 , wherein the first thickness is greater than the second thickness.

8. The thrombus removal system of claim 7 , wherein the first thickness is approximately twice the second thickness.

9. The thrombus removal system of claim 6, wherein the first thickness is between 0.10 mm and 0.60 mm and the second thickness is between 0.20 mm and 0.70 mm.

10. The thrombus removal system of claim 6 , wherein the first thickness is selected to provide a generally laminar flow for the respective fluid flows.

11. The thrombus removal system of claim 1 , wherein the cross-sectional dimension of the two or more fluid ports varies along its length.

12. The thrombus removal system of claim 11 , wherein the two or more fluid ports are cone-shaped along their length.

13. The thrombus removal system of claim 12 , wherein a minimum dimension of the two or more fluid ports is located at a distal end of the two or more fluid ports.

14. The thrombus removal system of claim 1 , wherein the respective fluid flows are configured to intersect near at least one intersection region.

15. The thrombus removal system of claim 14 , wherein the at least one intersecting region is located proximal to at least one of the at least two fluid ports.

16. The thrombus removal system of claim 14 , wherein the at least one intersecting region is located distal to at least one of the at least two fluid ports.

17. The thrombus removal system of claim 1 , wherein the manifold is configured to increase the flow rate of the fluid within the fluid lumen.

18. The thrombus removal system of claim 1 , wherein the manifold is configured to increase the pressure of the fluid within the fluid lumen.

19. The thrombus removal system of claim 1 , further comprising a funnel positioned at a distal end of the distal portion, the funnel configured to engage the thrombus.

20. The thrombus removal system of claim 19 , wherein the manifold is disposed proximal to the infundibulum.

21. The thrombus removal system of claim 19 , wherein the manifold is integrated into the funnel.

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