Aspiration catheter with a distally directed jet

Abstract

Thrombectomy catheter and high pressure system for preventing clogging thereof. An exemplary thrombectomy catheter may include a catheter body (402) including a catheter lumen extending therethrough. A high-pressure fluid supply tube (412) extends through the catheter lumen from a proximal end region of the catheter body toward a distal end region of the catheter body. The high-pressure fluid supply tube is configured to communicate with a fluid source near the proximal end region of the catheter body. The high-pressure fluid supply tube includes at least one proximally-facing jet (418a-c) for emitting at least one proximally-directed jet in a generally proximal direction from the high-pressure fluid supply tube, and at least one distally-facing jet (418d) for emitting at least one distally-directed jet in a generally distal direction from the high-pressure fluid supply tube. The catheter body further includes an intake inlet disposed along a distal portion of the catheter.

Description

[Technical Field]

[0001] The present disclosure relates to a thrombus removal system. More particularly, the present disclosure relates to an improved aspiration catheter system for thrombus removal. In some examples, the aspiration catheter may include a distally directed jet near the distal end of the aspiration catheter. [Background technology]

[0002] Thrombectomy is a procedure for removing a blood clot from a patient's vasculature. Mechanical and fluid-based systems can be used to remove the blood clot. In fluid-based systems, a catheter can be used to inject fluid into a treatment area of ​​a blood vessel to remove the blood clot. In some instances, effluent (e.g., fluid and / or blood) containing the removed blood clot can be extracted from the blood vessel through the catheter. Of the known blood clot removal systems and methods, there is a continuing need for alternative configurations of blood clot removal catheters and systems, as well as methods of operating such blood clot removal systems. Summary of the Invention

[0003] The present disclosure provides design, material, manufacturing method, and use alternatives for medical devices. In a first example, a thrombus removal catheter may include a catheter body extending from a proximal end region to a distal end region and including a catheter lumen extending between the proximal and distal end regions; a high-pressure fluid supply tube extending through the catheter lumen from the proximal end region of the catheter body toward the distal end region of the catheter body and configured to communicate with a fluid source near the proximal end region of the catheter body; at least one proximally facing jet for emitting at least one proximally directed jet from the high-pressure fluid supply tube within the catheter lumen in a generally proximal direction; at least one distally facing jet for emitting at least one distally directed jet from the high-pressure fluid supply tube within the catheter lumen in a generally distal direction; and a retraction inlet disposed along a distal portion of the catheter.

[0004] Alternatively or additionally to any of the above examples, in another example, the at least one distally facing jet may be distal to the at least one proximally facing jet. Alternatively or additionally to any of the above examples, in another example, the at least one distally directed jet may impinge on an interior surface of the catheter body.

[0005] Alternatively or additionally to any of the above examples, in another example, at least one distally facing jet may extend through a circumferential sidewall of the high pressure fluid supply tube.

[0006] Alternatively or additionally to any of the above examples, in another example, at least one distally facing jet may be axially aligned with at least one proximally facing jet.

[0007] Alternatively or additionally to any of the above examples, in another example, the at least one distally facing jet may be circumferentially offset from the at least one proximally facing jet.

[0008] Alternatively or additionally to any of the above examples, in another example, the at least one distally facing jet may be circumferentially offset from the at least one proximally facing jet by between about 45° and about 135°.

[0009] Alternatively or additionally to any of the above examples, in another example, a sidewall of the at least one distally facing jet extends at an obtuse angle relative to a longitudinal axis of the high pressure fluid supply tube.

[0010] Alternatively or additionally to any of the above examples, in another example, at least one distally facing jet may extend through the distal end of the high pressure fluid supply tube. Alternatively or additionally to any of the above examples, in another example, the at least one distally facing jet may be collinear with the longitudinal axis of the high pressure fluid supply tube.

[0011] Alternatively or additionally to any of the above examples, in another example, the diameter of the at least one distally facing jet may be smaller than the inner diameter of the high pressure fluid supply tube. Alternatively or additionally to any of the above examples, in another example, the diameter of the at least one distally facing jet may be approximately the same as the inner diameter of the high pressure fluid supply tube.

[0012] Alternatively or additionally to any of the above examples, in another example, the sidewall of at least one proximally facing nozzle may extend at an acute angle relative to the longitudinal axis of the high-pressure fluid supply tube.

[0013] Alternatively or additionally to any of the above examples, in another example, the at least one distally facing jet may include two or more distally facing jets. Alternatively or additionally to any of the above examples, in another example, the at least one proximally facing jet may include two or more proximally facing jets.

[0014] In another example, a thrombectomy catheter may include a catheter body extending from a proximal end region to a distal end region and including a catheter lumen extending between the proximal and distal end regions, a high-pressure fluid supply tube extending through the catheter lumen from the proximal end region of the catheter body toward the distal end region of the catheter body and configured to communicate with a fluid source near the proximal end region of the catheter body, at least one proximally facing jet for emitting at least one proximally directed jet in a generally proximal direction from the high-pressure fluid supply tube within the catheter lumen, at least one distally facing jet extending through a circumferential sidewall of the high-pressure fluid supply tube for emitting at least one distally directed jet in a generally distal direction from the high-pressure fluid supply tube within the catheter lumen, and a withdrawal inlet disposed along a distal portion of the catheter, wherein the at least one distally directed jet may be configured to impinge on an interior surface of the catheter body.

[0015] Alternatively or additionally to any of the above examples, in another example, at least one distally facing jet may be axially aligned with at least one proximally facing jet.

[0016] Alternatively or additionally to any of the above examples, in another example, the at least one distally facing jet may be circumferentially offset from the at least one proximally facing jet.

[0017] In another example, a thrombectomy catheter may include a catheter body extending from a proximal end region to a distal end region and including a catheter lumen extending between the proximal and distal end regions, a high-pressure fluid supply tube extending through the catheter lumen from the proximal end region of the catheter body toward the distal end region of the catheter body and configured to communicate with a fluid source near the proximal end region of the catheter body, at least one proximally-facing jet for emitting at least one proximally-directed jet from the high-pressure fluid supply tube within the catheter lumen in a generally proximal direction, at least one distally-facing jet extending through a distal end of the high-pressure fluid supply tube for emitting at least one distally-directed jet from the high-pressure fluid supply tube within the catheter lumen in a generally distal direction, and a withdrawal inlet disposed along a distal portion of the catheter. The at least one distally-facing jet may extend generally perpendicular to a longitudinal axis of the high-pressure supply tube.

[0018] Alternatively or additionally to any of the above examples, in another example, the diameter of the at least one distally facing jet may be smaller than the inner diameter of the high pressure fluid supply tube. The above summary of some exemplary embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. [Brief explanation of the drawings]

[0019] The present disclosure can be more fully understood from the following detailed description of various embodiments considered in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 1 is a perspective view of an exemplary thrombus removal system. [Figure 2] 2 is a partially exploded perspective view of a pump, bubble trap, connecting manifold assembly, and associated fixtures of a pump / catheter assembly for use in the thrombectomy system of FIG. 1. FIG. [Figure 3]3 is a partially exploded side view of a pump, bubble trap, connecting manifold assembly, and associated fixtures of a pump / catheter assembly for use in the thrombectomy system of FIG. 1. FIG. [Figure 4] FIG. 4 is a longitudinal cross-sectional view of the distal end region of an exemplary thrombectomy catheter. [Figure 5] FIG. 5 is a longitudinal cross-sectional view of the distal end region of another exemplary thrombectomy catheter. [Figure 6] FIG. 6 is a longitudinal cross-sectional view of the distal end region of another exemplary thrombectomy catheter. DETAILED DESCRIPTION OF THE INVENTION

[0020] While the present disclosure is amenable to various modifications and alternative forms, details thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the disclosure to the particular embodiments described. On the contrary, the invention covers all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0021] All numerical values ​​herein are assumed to be modified by the term "about," whether explicitly stated or not. The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" can be expressed as including numbers that are rounded to the nearest significant figure.

[0022] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges and / or values ​​for various components, features and / or specifications are disclosed, those skilled in the art inspired by this disclosure will understand that the desired dimensions, ranges and / or values ​​may deviate from those expressly disclosed.

[0023] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0024] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The detailed description and drawings, which are not necessarily to scale, depict example embodiments and are not intended to limit the scope of the present disclosure. The illustrated example embodiments are intended as examples only. Selected features of any example embodiment may be incorporated into additional embodiments, unless expressly stated to the contrary.

[0025] Thrombectomy catheters and systems can be used to remove thrombi, plaque, lesions, clots, etc. from veins or arteries. To prevent shaft damage, some thrombectomy catheters use a jet tube configured so that the jet faces directly backward, i.e., proximally through the catheter (e.g., parallel to the shaft wall). However, this jet tube design can occlude a significant portion of the cross-sectional area of ​​the aspiration lumen, resulting in reduced aspiration rates. Furthermore, this type of jet orientation may require a side window or port, which not only limits the diameter of the vessel the device can reach due to the risk of the vessel wall being drawn into the catheter's side window or port, but can also increase the presence of hemolysis within the target vessel. Other jet aspiration catheters utilize a continuous, high-velocity saline jet to draw fluid or coagulant material into and through the catheter shaft. While a proximally directed jet can macerate any thrombus the jetted fluid may come into contact with and prevent clogging along the length of the catheter shaft, the distal tip of the catheter can still become clogged. The distal tip of the catheter may be at higher risk of clogging during treatment of subacute or chronic thrombi. Disclosed herein are various high-pressure delivery tubes included in thrombectomy catheters that significantly reduce or eliminate the possibility of clogging at the distal tip of the catheter, contributing to more rapid removal of the thrombus.

[0026] FIG. 1 is a perspective view of an exemplary thrombectomy system 10. The thrombectomy system 10 may include a control console or drive unit 12 and a pump / catheter assembly 14. In some examples, the pump / catheter assembly 14 may be a single-use device, such that a new pump / catheter assembly 14 may be used with the drive unit 12 for each medical procedure. Shown on the drive unit 12 are multiple removable panels 16a-16n around and along the drive unit 12 that enclose the internal structure of the drive unit 12. An exemplary drive unit 12 is described in commonly assigned U.S. Patent No. 7,935,077, entitled "THROMBECTOMY CATHETER DEPLOYMENT SYSTEM," the disclosure of which is incorporated herein by reference. Centrally located on the drive unit 12 and aligned with the lower region of panel 16g may be automatically opening doors 18 and 20 that open to expose the interior of the drive unit 12 to provide access to the carriage assembly 22. As discussed further herein, carriage assembly 22, which can house components of pump / catheter assembly 14, is shown accessible by opening closed doors 18 and 20. Drive unit 12 may include a collection basin for collecting fluid leakage from components of pump / catheter assembly 14. For example, removable drip tray 24 is shown positioned on the front of drive unit 12, extending from below carriage assembly 22 toward panel 16a. Other configurations for the collection basin are also contemplated. Drip tray 24 and removable container 26 may collectively support and house an effluent collection bag, such as effluent collection bag 28 of pump / catheter assembly 14. In other examples, drive unit 12 may include a different structure, such as a hook for hanging effluent collection bag 28 or a shelf for placing effluent collection bag 28.If the carriage assembly 22 is movable, a carriage assembly activation switch 30 may be provided on the drive unit 12, such as on panel 16g, to selectively position the carriage assembly 22 inward or outward. A user interface 32 including a memory function may be provided on the drive unit 12, such as on the upper region of the drive unit 12 between the upper regions of the upper side panels 16e and 16f. Saline bag hooks 34 and 36 extend through the panels 16e and 16f, from which saline bags can be hung. The drive unit 12 may include a handle 42, multiple wheels 52a-52n, and a wheel-locking brake pedal 54 to assist medical personnel in operating the drive unit 12.

[0027] Pump / catheter assembly 14, which may be a disposable, single-use device, is shown unattached to drive unit 12. Pump / catheter assembly 14 includes a pump 56 and a thrombectomy catheter 58. During use, a portion of pump / catheter assembly 14 may be secured within a portion of drive unit 12. Other components included in the pump / catheter assembly 14 may include a bubble trap 60 attached to the pump 56, a connection manifold assembly 62 connected to the bubble trap 60, an effluent return tube 66 connected between the connection manifold assembly 62 and the thrombectomy catheter 58, a high-pressure fluid supply tube 64 attached between the output of the pump 56 and the thrombectomy catheter 58 and which may be coaxially disposed inside the effluent return tube 66, a transition fixture 69 between the distal end of the effluent return tube 66 and the proximal end of the thrombectomy catheter 58, an effluent waste tube 68 connecting the effluent collection bag 28 to the connection manifold assembly 62, and a fluid supply tube 70 having a bag spike 71 connecting a fluid supply bag 72 (e.g., a saline bag) to the connection manifold assembly 62. The fluid supply tube 70 is in fluid communication with the interior of the bubble trap 60 and can provide fluid from the fluid supply bag 72 to the pump 56 and then through the high-pressure fluid supply tube 64 to the thrombectomy catheter 58.

[0028] FIG. 2 is a partially exploded perspective view of several components of the pump / catheter assembly 14, generally including the pump 56, the bubble trap 60, the connection manifold assembly 62, and the fixture 140. The pump 56 is centered around a tubular body 112. The components include a base 109 having an upper portion 110 and a lower portion 111 that are disposed around the lower region of the tubular body 112. The top of the upper portion 110 of the base 109 includes an annular surface 117 that closely contacts the capture tab of the carriage assembly 22 to accommodate the pump 56 within the carriage assembly 22. An upper body 114 is disposed around the upper region of the tubular body 112. The base 109 and upper body 114, as well as the connection panel 115, may be molded or constructed in any other suitable manner, for example, to surround most of the tubular body 112. A data plate 113 may be included on the upper body 114 to include a bar code, RFID tag, or other informational indicia for determining the operating parameters of the device.

[0029] The pump 56 may include a hemispherical-shaped pump piston head 116 with a flexible boot 118 connected between and extending between the upper body 114 and the pump piston head 116. In some examples, the geometrically configured lower portion 111 of the base 109 can serve as a mount for one end of the bubble trap 60 (FIG. 3).

[0030] The connection manifold assembly 62 may be secured directly to the other end of the bubble trap 60 and, in some examples, may include a bracket 120 having mounted thereon a vertically oriented tubular manifold 148 having attached thereto or formed thereon a plurality of ports, including a fluid (e.g., saline) inlet port 122, an effluent outlet port 124, a Luer-type effluent return port 126, and / or an auxiliary port 128 and a cap 130. Also shown are connectors 132 and 134 that connect and extend between the connection manifold assembly 62 and the upper portion 110 of the base 109.

[0031] The bubble trap 60 may include two mating halves, one of which, mating half 60a, is shown. A hydrophobic filter 136 may be included in the upper, forward region of bubble trap half 60a. Another hydrophobic filter may be included on a second bubble trap half (not explicitly shown) opposite hydrophobic filter 136 on bubble trap half 60a.

[0032] Fixture 140 and its associated components aid in supporting and connecting effluent return tube 66 to effluent return port 126, and in supporting, passing through, and connecting fluid supply tube 70 to fluid inlet port 122, via connector 142 serially coupled with connecting tube 144. Fixture 140 may include outwardly extending, vertically aligned, opposing tabs 141 a and 141 b that prevent fixture 140 and associated effluent return tube 66, including high-pressure fluid supply tube 64 and fluid supply tube 70, from contacting a roller pump (not explicitly shown) provided with drive unit 12, such as that located within or adjacent to carriage assembly 22.

[0033] 3 is a partially exploded side view of the elements of FIG. 2, showing the relationship of the pump 56, bubble trap 60, connection manifold assembly 62, and fixture 140. Also shown is a vertically oriented tubular manifold 148 secured to bracket 120. The effluent outlet port 124 may be connected to and in fluid communication with the interior of a lower side of tubular manifold 148. The effluent return port 126 may be connected to and in fluid communication with the interior of an upper side of tubular manifold 148. Also connected to tubular manifold 148 are horizontally aligned passage ports 150 and associated connectors 132, each facing the effluent return port 126. The passage port 150 can accommodate the high-pressure fluid supply tube 64, which extends distally through the lumen (not explicitly shown) of the passage port 150, the connector 132, the upper region of the tubular manifold 148, the effluent return port 126, the connector 142, the connecting tube 144, into the effluent return tube 66, and through the return tube 66 to connect to the thrombectomy catheter 58 ( FIG. 1 ). The proximal end of the high-pressure fluid supply tube 64 includes a high-pressure fitting 152 located near the proximal end of the high-pressure fluid supply tube 64 to facilitate connection of the high-pressure fluid supply tube 64 in fluid communication with the interior of the pump 56. The proximal end of the high-pressure fluid supply tube 64, which is the inlet to the high-pressure fluid supply tube 64, may include a plurality of very small holes (not shown) with a filter at its proximal end. A connector 134, which may have internal and / or external threads, is positioned over and around the high-pressure fluid supply tube 64 distal to the high-pressure fitting 152 and may be threaded into a threaded connection port 154 extending horizontally from the upper portion 110 of the base 109 of the pump 56. The connector 134 may be rotated to thread the high-pressure fitting 152 with a corresponding mating threaded structure on the pump 56. The connector 134 may be used to engage the externally threaded end of the connector 134 and secure the connector 134, and thus the pump 56, to the connection manifold assembly 62 and secure the bubble trap 60 to the pump 56.Additionally, direct connection and fluid communication between pump 56 and bubble trap 60 may be provided by a horizontally oriented pump fluid inlet port 156 that engages a corresponding receptor port 158 ​​and seal 159 inside one end of bubble trap 60. Fluid inlet port 122 located on bracket 120 may extend behind tubular manifold 148 to communicate with the interior of bubble trap 60 for debubbling of the fluid (e.g., saline), thereby making unpressurized fluid (e.g., saline) available to pump 56.

[0034] FIG. 4 is a cross-sectional view of a distal end region 404 of an exemplary thrombus removal catheter 400. The thrombus removal catheter 400 may represent an example of the thrombus removal catheter 58 described above. The thrombus removal catheter 400 may include a tubular member or catheter body 402 extending from a proximal end region (not explicitly shown) configured to remain outside the body to a distal end region 404. The catheter body 402 may be an example of the effluent return tube 66 of the thrombus removal catheter 58 described above, or may be in fluid communication with the effluent return tube 66. A lumen 406 may extend from the proximal end region of the catheter body 402 to the distal end region 404. The catheter body 402 may terminate at a distal end of the catheter body 402 with a distal opening 408 facing in a distal direction. In some examples, the distal opening 408 may lie in a plane extending generally perpendicular to the longitudinal axis of the catheter body 402. In other examples, the distal opening 408 may lie in a plane extending generally obliquely relative to the longitudinal axis of the catheter body 402. Generally, the distal opening 408 may be an intake inlet. Although not explicitly shown, the catheter body 402 may include one or more markers (e.g., radiopaque marker bands) disposed along the catheter body 402. Additionally, although not explicitly shown, in some embodiments, the catheter body 402 may include one or more openings extending through its sidewall, if desired.

[0035] The thrombectomy catheter 400 may further include a high-pressure fluid supply tube 410. The high-pressure fluid supply tube 410 may be an example of the high-pressure fluid supply tube 66 of the thrombectomy catheter 58 described above, or may be in fluid communication with the high-pressure fluid supply tube 66. The high-pressure fluid supply tube 410 may be disposed within and extend through the lumen 406 of the catheter body 402. The high-pressure fluid supply tube 410 may include a supply tube wall 412 that defines a lumen or fluid pathway 414 extending therethrough. In at least some examples, the high-pressure fluid supply tube 410 may have a closed distal end 416, allowing fluid to flow distally through the fluid pathway 414 but not exit the distal end. The high pressure fluid supply tube 410 extends along the length of the catheter body 402, and its distal end 416 may be located within the lumen 406 of the catheter body 402, proximal to a distal opening 408 at the distal end of the catheter body 402. The proximal end of the high pressure fluid supply tube 410 may be in fluid communication with a pump 56 described herein to provide high pressure fluid to a fluid path 414 of the high pressure fluid supply tube 410.

[0036] A plurality of jets 418a-d (collectively 418) may be defined along the supply tube wall 412. For example, the supply tube wall 412 may include two, three, four, five, six, or more jets 418. The jets 418 may be spaced along the supply tube wall 412 at any desired interval. For example, each of the jets 418 may be equally spaced from an adjacent jet 418 along the length of the supply tube wall 412. In other examples, the jets 418 may be spaced closer together near the distal end of the supply tube wall 412 than near the proximal end of the supply tube wall 412. For example, the spacing between the jets 418 may gradually increase as one moves proximally along the length of the shaft, or the spacing may be configured to increase in a stepped manner. In some examples, some or all of the jets 418 may be axially aligned along the supply tube wall 412. In other examples, one or more of the jets 418 may be circumferentially offset from one another around the supply tube wall 412. Multiple patterns are contemplated, including a spiral pattern, a pattern in which no two jets 418 are located at the same axial location, a regular pattern with two or more jets 418 located at the same axial location, an irregular pattern (some of the jets 418 may or may not be located at the same axial location), etc.

[0037] The jets 418 can be formed using a suitable method, such as electron discharge machining, etching, cutting (including, for example, laser cutting), etc. In some examples, one or more of the jets 418 can have a substantially round shape. In other examples, one or more of the jets 418 can have a substantially non-circular shape (e.g., elliptical, polygonal, irregular, etc.). In some examples, the jets 418 can be angled or include a beveled surface. It is contemplated that the size and / or shape of the jets 418 can be varied to change the velocity of fluid exiting the jets. For example, decreasing the size of the jets 418 can increase the velocity of fluid exiting the jets 418. In some embodiments, the size of the jets 418 can be varied based on the pressure capabilities of the thrombectomy system, the number of jets, the dimensions (e.g., length, wall thickness, inner diameter, etc.) of the high-pressure fluid supply tube 410, and / or combinations thereof. In some examples, the orifices 418 may have a cross-sectional dimension ranging from about 0.0018 inches (45.72 micrometers) to about 0.0022 inches (55.88 micrometers). However, the orifices 418 may have a cross-sectional dimension less than 0.0018 inches (45.72 micrometers) or greater than 0.0022 inches (55.88 micrometers), if desired.

[0038] Injection of a drive fluid through the lumen 414 of the supply tube wall 412 can eject the fluid through the jets 418, resulting in the generation of a proximally directed suction force. At least some of the jets 418a-c can be angled proximally or otherwise designed to inject a fluid (e.g., a motive fluid, liquid, gas or air, vapor, particle-laden fluid, or the like) generally proximally through the jets 418a-c and into the lumen 406 of the catheter body 402, as depicted by lines 420a-c representing drive jets of fluid ejected generally proximally from the jets 418a-c. For example, each of the jets 418a-c can be positioned at an acute angle relative to the longitudinal axis of the supply tube wall 412 such that the jets 418a-c are angled proximally. In some embodiments, one or more of the jets 418d may be designed to inject a fluid (e.g., drive fluid, liquid, gas or air, vapor, particle-laden fluid, or the like) in a generally distal direction through the jets 418d and into the lumen 406 of the catheter body 402, as depicted by line 420d representing the drive jet fluid being ejected in a generally distal direction from the jets 418d. For example, the jets 418d may be positioned at an oblique angle relative to the longitudinal axis of the delivery tube wall 412 such that the jets 418d are angled distally. It is contemplated that the angle of the jets 418, and therefore the angle of the drive jet 420, may be varied to adjust the velocity of the fluid exiting the jets 418. As further described herein, the supply tube wall 412 may include one or more or more jets 418a, 418b, 418c that are directed or oriented proximally (i.e., jets configured to direct fluid injected through the lumen 414 of the supply tube wall 412 in a proximal direction), and the supply tube wall 412 may include one or more or more jets 418d that are directed or oriented distally (i.e., jets configured to direct fluid injected through the lumen 414 of the supply tube wall 412 in a distal direction).In some examples, the distally facing jet 418d may be axially aligned with one or more of the proximally facing jets 418a-c. In other examples, the distally facing jet 418d may be circumferentially offset from one or more of the proximally facing jets 418a-c. For example, the distally facing jet 418d may be circumferentially offset from one or more of the proximally facing jets 418a-c by an angle ranging from about 10° to about 350°, or from about 45° to about 135°.

[0039] The distally facing jet 418d may be the most distal jet, and the proximally facing jets 418a-c may be located proximal to the distally facing jet 418d. However, this is not required. In some embodiments, the distally facing jet 418d may be located proximal to at least one of the proximally facing jets 418a-c. Although the supply tube wall 412 is illustrated as including only a single distally facing jet 418d, the supply tube wall 412 may include two or more distally facing jets, as desired. If two or more distally facing jets 418d are provided, the distally facing jets may be located at different axial and / or circumferential positions relative to one another, or at similar axial and / or circumferential positions relative to one another, as desired. The distally facing jet 418d can shatter particles as they are drawn into the lumen 406 of the catheter body 402, while the proximally facing jets 418a-c can move particles proximally along the catheter body 402.

[0040] The performance of the thrombus removal catheter 400 and high-pressure fluid delivery tube 410 may be directly related to the velocity of the jetted driving fluid 420 exiting the jet orifice 418 and the shear-induced turbulent flux generated by the jetted driving fluid 420. For example, the more powerful the jetted driving fluid 420, the greater the aspiration velocity. Furthermore, it is contemplated that the performance of the jet-driven aspiration catheter 400 may be directly related to the rate at which thrombus can be drawn into the catheter 400, fragmented, and removed from the body. Any clogs that occur within the catheter body 402 may reduce the amount of thrombus removed or stop its removal entirely. The addition of the distally facing jet orifice 418d may fragment any thrombus that enters the distal opening 408 of the catheter body 402, thus helping to prevent clogging. For example, at the point of impact of the distally directed drive fluid jet 420d, the drive fluid jet 420d may deflect distally and cause a flow out of the tip of the distal opening 408 of the catheter body 402, effectively pulverizing any thrombus that enters the tip of the device and eliminating or reducing the risk of occlusion or clogging of the distal opening 408 of the catheter body 402. It is contemplated that the characteristics of the jets 418 (size, shape, angle, number, spacing, etc.) may be varied to obtain fluid velocities that produce optimal clog removal effects without impeding the proximal flow of thrombus or the rate of thrombus evacuation within the lumen 406 of the catheter body 402.

[0041] The distally facing jets 418d may be spaced a distance proximally from the distal opening 408 of the catheter body 402. It is contemplated that the longitudinal position of the distally facing jets 418d on the supply tube wall 412 relative to the distal opening 408 of the catheter body 402 may be varied based on, for example, the size of the opening of the distally facing jets 418d, the velocity of the fluid within the lumen 414 of the supply tube wall 412, the angle of the distally facing jets 418d, or a combination thereof, to ensure that the distally directed drive jet 420d impacts the interior surface of the catheter body 402. In one example, the distally facing jets 418d may be positioned to cause the distally directed drive jet 420d to impact the interior surface of the catheter body 402 so that the distally directed drive jet 420d does not damage the blood vessel. For example, the distally facing jets 418d may be positioned so that the distally directed drive jet 420d impinges on the interior surface of the catheter body 402 between about 0.070 inches (1.778 mm) and about 0.090 inches (2.286 mm) proximally from the distal end of the catheter body 402. This is by way of example only. The location of impingement of the drive jet 420d of the distally facing jets 418d may be less than 0.070 inches (1.778 mm) or more than 0.090 inches (2.286 mm) proximally from the distal end of the catheter body 402, as desired.

[0042] In some examples, the jets 418 may be oriented at an angle relative to the longitudinal axis of the supply tube wall 412. For example, the proximally facing jets 418a-c may be oriented at an oblique (e.g., acute) angle relative to the longitudinal axis of the supply tube wall 412 and / or may be oriented at an angle greater than 0 degrees and less than 90 degrees relative to the longitudinal axis of the supply tube wall 412. It is contemplated that the distally facing jet 418d may be oriented at an oblique (e.g., obtuse) angle relative to the longitudinal axis of the supply tube wall 412 and / or may be oriented at an angle greater than 90 degrees and less than 180 degrees relative to the longitudinal axis of the supply tube wall 412. In other examples, the jets 418 may be oriented perpendicular to the longitudinal axis of the supply tube wall 412 (e.g., at an angle of about 90 degrees relative to the longitudinal axis of the supply tube wall 412). The angle may or may not be the same for all jets 418.

[0043] In at least some examples, the jets 418 can be understood to be arranged in series. In other words, the jets 418 can be arranged such that adjacent jets 418 are longitudinally spaced apart at various locations along the longitudinal axis of the supply tube wall 412. For example, the jets 418 can be uniformly or non-uniformly spaced apart along the length of the supply tube wall 412. This allows the jets 418 to be positioned at axially spaced apart locations within the catheter body 402 along its length. For example, the jets 418 can be spaced apart along the entire length of the supply tube wall 412 and the corresponding entire length of the catheter body 402, or along a portion thereof, as desired. In some examples, the jets 418 can be spaced apart along the length of the supply tube wall 412 at intervals ranging from every 5 inches (12.7 centimeters (cm)) to 15 inches (38.1 cm), or every 6 inches (15.2 cm) to 12 inches (30.5 cm). In other examples, the spacing between the jets 418 may be less than every 5 inches (12.7 cm) or more than every 15 inches (38.1 cm). Thus, the drive fluid ejects from the jets 418, forming jetted drive fluids 420a-d (collectively 420). In some examples, the jetted drive fluid 420 can reach velocities of 17,150 centimeters per second or more (e.g., more than half the speed of sound). This jetted drive fluid 420 enters the entrained material, where a shear layer between the two causes turbulence, mixing, and momentum transfer. The entrained material can enter the distal opening 408 and then be propelled proximally by the momentum transfer. As the mixture of jetted drive fluid 420 and entrained material moves proximally, the material may sequentially approach multiple jets 418. Upon interaction with the driving fluid 420 ejected from each individual jet 418, momentum in the entrained material mixture increases, allowing the thrombus-forming material to more easily flow proximally through the catheter body 402 and be removed.The increased momentum may allow the catheter body 402 to be used without a second opening or outlet (e.g., located proximal to the distal opening 408). Alternatively, some of the trapped thrombus-forming material can exit the catheter body 402, for example, through a second opening (not shown) in the sidewall of the catheter body 402 located proximal to the distal opening 408, recirculate (e.g., one or more times) to the distal opening 408, and then travel proximally through the lumen 406 of the catheter body 402.

[0044] It is further contemplated that the distally directed drive jet 420d may be partially or completely retracted by the force generated by the proximally directed drive jets 420a-c. When the clot / thrombus reaches the distally directed drive jet 420d, shear stress may pulverize the clot / thrombus. It is contemplated that when the distal opening 408 of the catheter body 402 is blocked by the clot / thrombus, the force generated by the proximally directed drive jets 420a-c may be transmitted proximally to the surface of the clot / thrombus. As a result, the distally directed drive jet 420d is no longer retracted and can transmit a distal force to the surface of the clot / thrombus. Thus, when the distal opening 408 becomes clogged or blocked, the distal and proximal force vectors combine to create an extremely high shear action mechanism that focuses all of the shear stress on the surface of the clot / thrombus, thereby pulverizing the clot / thrombus and unclogging the distal opening 408. It is contemplated that the magnitude of the shear stress on the clot / thrombus can be much greater when the distally directed drive fluid jet 420d is at a smaller angle (e.g., an angle closer to 180 degrees to the longitudinal axis of the supply tube wall 412 than perpendicular to the longitudinal axis of the supply tube wall 412).

[0045] FIG. 5 is a cross-sectional view of a distal end region 504 of another exemplary thrombus removal catheter 500. The thrombus removal catheter 500 may be an example of the thrombus removal catheter 58 described above. The thrombus removal catheter 500 may include a tubular member or catheter body 502 extending from a proximal end region (not explicitly shown) configured to remain outside the body to a distal end region 504. The catheter body 502 may be an example of the effluent return tube 66 of the thrombus removal catheter 58 described above, or may be in fluid communication with the effluent return tube 66. A lumen 506 may extend from the proximal end region of the catheter body 502 to the distal end region 504. The catheter body 502 may terminate in a distally facing distal opening 508 at the distal end of the catheter body 502. In some examples, the distal opening 508 may lie in a plane extending generally perpendicular to the longitudinal axis of the catheter body 502. In other examples, the distal opening 508 may lie in a plane extending generally obliquely relative to the longitudinal axis of the catheter body 502. Generally, the distal opening 508 may be an intake inlet. Although not explicitly shown, the catheter body 502 may include one or more markers (e.g., radiopaque marker bands) disposed along the catheter body 502. Additionally, although not explicitly shown, in some embodiments, the catheter body 502 may include one or more openings extending through its sidewall, if desired.

[0046] The thrombectomy catheter 500 may further include a high-pressure fluid supply tube 510. The high-pressure fluid supply tube 510 may be an example of the high-pressure fluid supply tube 66 of the thrombectomy catheter 58 described above, or may be in fluid communication with the high-pressure fluid supply tube 66. The high-pressure fluid supply tube 510 may be disposed within and extend through the lumen 506 of the catheter body 502. The high-pressure fluid supply tube 510 may include a supply tube wall 512 defining a lumen or fluid pathway 514 extending therethrough. In at least some examples, the high-pressure fluid supply tube 510 may have a partially closed distal end 516. The high-pressure fluid supply tube 510 extends along the length of the catheter body 502, and its distal end 516 may be located within the lumen 506 of the catheter body 502 proximal to a distal opening 508 at the distal end of the catheter body 502. The proximal end of the high pressure fluid supply tube 510 may be in fluid communication with a pump 56 described herein to provide high pressure fluid to a fluid path 514 of the high pressure fluid supply tube 510 .

[0047] A plurality of jets 518a-d (collectively 518) may be defined along the supply tube wall 512. For example, the supply tube wall 512 may include two, three, four, five, six, or more jets 518. The jets 518 may be spaced along the supply tube wall 512 at any desired interval. For example, each of the jets 518 may be equally spaced from an adjacent jet 518 along the length of the supply tube wall 512. In other examples, the jets 518 may be spaced closer together near the distal end of the supply tube wall 512 than near the proximal end of the supply tube wall 512. For example, the spacing between the jets 518 may gradually increase as one moves proximally along the length of the shaft, or the spacing may be configured to increase in a stepped manner. In some examples, some or all of the jets 518 may be axially aligned along the supply tube wall 512. In other examples, one or more of the jets 518 may be circumferentially offset from one another around the supply tube wall 512. Multiple patterns are contemplated, including a spiral pattern, a pattern in which no two jets 518 are located at the same axial position, a regular pattern including two or more jets 518 located at the same axial position, an irregular pattern (some of the jets 518 may or may not be located at the same axial position), etc. The jets 518 may be formed using a suitable method, such as electron discharge machining, etching, cutting (including, e.g., laser cutting), etc. In some examples, one or more of the jets 518 may have a substantially round shape. In other examples, one or more of the jets 518 may have a substantially non-circular shape (e.g., elliptical, polygonal, irregular, etc.). In some examples, the jets 518 may be angled or include an angled surface. It is contemplated that the size and / or shape of the jets 518 may be varied to vary the velocity of the fluid exiting the jets. For example, decreasing the size of the jets 518 can increase the velocity of the fluid exiting the jets 518 .In some embodiments, the size of the jets 518 may be varied based on the pressure capabilities of the thrombectomy system, the number of jets, the dimensions of the high-pressure fluid supply tube 510 (e.g., length, wall thickness, inner diameter, etc.), and / or combinations thereof. In some examples, the jets 518 may have a cross-sectional dimension ranging from about 0.0018 inches (45.72 micrometers) to about 0.0022 inches (55.88 micrometers). However, the jets 518 may have a cross-sectional dimension less than 0.0018 inches (45.72 micrometers) or greater than 0.0022 inches (55.88 micrometers), if desired.

[0048] Injection of drive fluid through the lumen 514 of the supply tube wall 512 can eject the fluid through the jets 518, resulting in the generation of a proximally directed suction force. At least some of the jets 518a-c can extend through a circumferential sidewall of the supply tube wall 512. It is contemplated that at least some of the jets 518a-c can be angled proximally or otherwise designed to inject fluid (e.g., drive fluid, liquid, gas or air, vapor, particle-laden fluid, or the like) generally proximally through the jets 518a-c and into the lumen 506 of the catheter body 502, as depicted by lines 520a-c representing drive jets of fluid ejected generally proximally from the jets 518a-c. For example, each of the jets 518a-c can be positioned at an acute angle relative to the longitudinal axis of the supply tube wall 512 such that the jets 518a-c are angled proximally. In some embodiments, one or more of the jets 518d may be designed to inject a fluid (e.g., a drive fluid, a liquid, a gas or air, a vapor, a particle-laden fluid, or the like) in a generally distal direction through the jets 518d and into the lumen 506 of the catheter body 502, as depicted by line 520d representing the drive jet fluid being ejected in a generally distal direction from the jets 518d. For example, the jets 518d may be aligned collinearly with the longitudinal axis of the supply tube wall 512 such that the jets 518d eject fluid distally in a direction generally parallel to the longitudinal axis of the supply tube wall 512.

[0049] As described further herein, the supply tube wall 512 may include one or more or more jets 518a, 518b, 518c that are directed or oriented proximally (i.e., jets configured to direct fluid injected through the lumen 514 of the supply tube wall 512 in a proximal direction), and the supply tube wall 512 may include one or more or more jets 518d that are directed or oriented distally (i.e., jets configured to direct fluid injected through the lumen 514 of the supply tube wall 512 in a distal direction).

[0050] It is contemplated that the jets 518d may be formed through the distal end 516 of the feeding tube wall 512. The distally facing jets 518d may have a diameter smaller than the inner diameter of the lumen 514 of the feeding tube wall 512. In other examples, the diameter of the distally facing jets 518d may be approximately the same as the inner diameter of the lumen 514 of the feeding tube wall 512. In yet other examples, the circumferential sidewall of the feeding tube wall 512 may be tapered at the distal end 516 such that the diameter of the distally facing jets 518d is larger than the diameter of the lumen 514 of the feeding tube wall 512. It is contemplated that the distal end 516 of the feeding tube wall 512 may be proximal to the distal opening 508 of the catheter body 502 to fully accommodate the distally facing jets 518d.

[0051] The distally facing jet 518d may be the most distal jet, and the proximal facing jets 518a-c may be located proximal to the distally facing jet 518d. Although the supply tube wall 512 is illustrated as including only a single distally facing jet 518d, the supply tube wall 512 may include two or more distally facing jets, as desired. In some cases, two or more distally facing jets 418d may be formed in the distal end 516 of the supply tube wall 512. Alternatively, or additionally, one or more additional distally facing jets 518d may be formed in a circumferential sidewall of the supply tube wall 512. When more than one distally facing jet 518d is provided, one or more of the distally facing jets may extend at different or similar axial and / or circumferential positions through the circumferential sidewall of the delivery tube wall 512, as desired. The distally facing jet 518d may fragment particles as they are drawn into the lumen 506 of the catheter body 502, while the proximally facing jets 518a-c may move particles proximally along the catheter body 502.

[0052] The performance of the thrombus removal catheter 500 and high-pressure fluid delivery tube 510 may be directly related to the velocity of the jetted driving fluid 520 exiting the jet orifice 518 and the shear-induced turbulent flux generated by the jetted driving fluid 520. For example, the more powerful the jetted driving fluid 520, the greater the aspiration velocity. Furthermore, it is contemplated that the performance of the jet-driven aspiration catheter 500 may be directly related to the rate at which thrombus can be drawn into the catheter 500, fragmented, and removed from the body. Any clogging that occurs within the catheter body 502 may reduce the amount of thrombus removed or stop its removal entirely. The addition of the distally facing jet orifice 518d may fragment any thrombus that enters the distal opening 508 of the catheter body 502, thus helping to prevent clogging. For example, at the point of impact of the distally directed drive fluid jet 520d, the drive fluid jet 520d may deflect distally and cause a flow outward from the tip of the distal opening 508 of the catheter body 502, effectively pulverizing any thrombus that enters the distal opening 508 of the catheter body 502 and eliminating or reducing the risk of occlusion or clogging of the distal opening 508 of the catheter body 502. It is contemplated that the characteristics of the jets 518 (e.g., size, shape, angle, number, spacing) may be varied to obtain fluid velocity that produces optimal clog removal without impeding the proximal flow of thrombus or the rate of thrombus evacuation within the lumen 506 of the catheter body 502.

[0053] The distally facing jet 518d may be spaced a distance proximally from the distal opening 508 of the catheter body 502. It is contemplated that the longitudinal position of the distally facing jet 518d on the supply tube wall 512 relative to the distal opening 508 of the catheter body 502 may be varied based on, for example, the size of the opening of the distally facing jet 518d, the velocity of the fluid within the lumen 514 of the supply tube wall 512, the angle of the distally facing jet 518d, or a combination thereof, to ensure that the distally directed drive fluid jet 520d does not impinge on the vessel wall.

[0054] In some examples, the jets 518 may be oriented at an angle relative to the longitudinal axis of the supply tube wall 512. For example, the proximally facing jets 518a-c may be oriented at an oblique (e.g., acute) angle relative to the longitudinal axis of the supply tube wall 512 and / or may be oriented at an angle greater than 0 degrees and less than 90 degrees relative to the longitudinal axis of the supply tube wall 512. It is contemplated that the distally facing jet 518d may be oriented along or parallel to the longitudinal axis of the supply tube wall 512. In other examples, the jets 518 may be oriented perpendicular to the longitudinal axis of the supply tube wall 512 (e.g., at an angle of approximately 90 degrees relative to the longitudinal axis of the supply tube wall 512). The angle may or may not be the same for all jets 518. It is contemplated that the angle of the jet 518, and therefore the angle of the motive fluid jet 520, may be varied to adjust the velocity of the fluid exiting the jet 518.

[0055] In at least some examples, the jets 518 can be understood to be arranged in series. In other words, the jets 518 can be arranged such that adjacent jets 518 are longitudinally spaced apart at various locations along the longitudinal axis of the supply tube wall 512. For example, the jets 518 can be uniformly or non-uniformly spaced apart along the length of the supply tube wall 512. This allows the jets 518 to be positioned at axially spaced apart locations within the catheter body 502 along its length. For example, the jets 518 can be spaced apart along the entire length of the supply tube wall 512 and the corresponding entire length of the catheter body 502, or along a portion thereof, as desired. In some examples, the jets 518 can be spaced apart along the length of the supply tube wall 512 at intervals ranging from every 5 inches (12.7 centimeters (cm)) to 15 inches (38.1 cm), or every 6 inches (15.2 cm) to 12 inches (30.5 cm). In other examples, the spacing between the jets 518 may be less than every 5 inches (12.7 cm) or more than every 15 inches (38.1 cm). Thus, the drive fluid ejects from the jets 518, forming jetted drive fluids 520a-d (collectively 520). In some examples, the jetted drive fluid 520 can reach velocities of 17,150 centimeters per second or more (e.g., more than half the speed of sound). This jetted drive fluid 520 enters the entrained material, where a shear layer between the two causes turbulence, mixing, and momentum transfer. The entrained material enters the distal opening 508 and can then be propelled proximally by the momentum transfer. As the mixture of jetted drive fluid 520 and entrained material moves proximally, the material may sequentially approach multiple jets 518. Upon interaction with the driving fluid 520 ejected from each individual jet 518, momentum in the entrained material mixture increases, allowing the thrombus-forming material to more easily flow proximally through the catheter body 502 and be removed.The increased momentum may allow the catheter body 502 to be used without a second opening or outlet (e.g., located proximal to the distal opening 508). Alternatively, some of the trapped thrombus-forming material can exit the catheter body 502, for example, through a second opening (not shown) in the sidewall of the catheter body 502 located proximal to the distal opening 508, recirculate (e.g., one or more times) to the distal opening 508, and then travel proximally through the lumen 506 of the catheter body 502.

[0056] It is further contemplated that the distally directed drive jet 520d may be partially or completely retracted by the force generated by the proximally directed drive jets 520a-c. When the clot / thrombus reaches the distally directed drive jet 520d, shear stress may pulverize the clot / thrombus. It is contemplated that when the distal opening 508 of the catheter body 502 is blocked by the clot / thrombus, the force generated by the proximally directed drive jets 520a-c may be transmitted proximally to the surface of the clot / thrombus. As a result, the distally directed drive jet 520d is no longer retracted and can transmit a distal force to the surface of the clot / thrombus. Thus, when the distal opening 508 becomes clogged or blocked, the distal and proximal force vectors combine to create an extremely strong shear action mechanism that focuses all of the shear stress on the surface of the clot / thrombus, thereby pulverizing the clot / thrombus and clearing the blockage of the distal opening 508.

[0057] FIG. 6 is a cross-sectional view of a distal end region 604 of another exemplary thrombus removal catheter 600. The thrombus removal catheter 600 may be an example of the thrombus removal catheter 58 described above. The thrombus removal catheter 600 may include a tubular member or catheter body 602 extending from a proximal end region (not explicitly shown) configured to remain outside the body to a distal end region 604. The catheter body 602 may be an example of the effluent return tube 66 of the thrombus removal catheter 58 described above, or may be in fluid communication with the effluent return tube 66. A lumen 606 may extend from the proximal end region of the catheter body 602 to the distal end region 604. The catheter body 602 may terminate in a distally facing distal opening 608 at the distal end of the catheter body 602. In some examples, the distal opening 608 may lie in a plane extending generally perpendicular to the longitudinal axis of the catheter body 602. In other examples, the distal opening 608 may lie in a plane extending generally obliquely relative to the longitudinal axis of the catheter body 602. Generally, the distal opening 608 may be an intake inlet. Although not explicitly shown, the catheter body 602 may include one or more markers (e.g., radiopaque marker bands) disposed along the catheter body 602. Additionally, although not explicitly shown, in some embodiments, the catheter body 602 may include one or more openings extending through its sidewall, if desired.

[0058] The thrombectomy catheter 600 may further include a high-pressure fluid supply tube 610. The high-pressure fluid supply tube 610 may be an example of the high-pressure fluid supply tube 66 of the thrombectomy catheter 58 described above, or may be in fluid communication with the high-pressure fluid supply tube 66. The high-pressure fluid supply tube 610 may be disposed within and extend through the lumen 606 of the catheter body 602. The high-pressure fluid supply tube 610 may include a supply tube wall 612 that defines a lumen or fluid pathway 614 extending therethrough. In at least some examples, the high-pressure fluid supply tube 610 may have a closed distal end 616, allowing fluid to flow through the fluid pathway 614 but not exit the distal end. The high pressure fluid supply tube 610 extends along the length of the catheter body 602, and its distal end 616 may be located within the lumen 606 of the catheter body 602, proximal to a distal opening 608 at the distal end of the catheter body 602. The proximal end of the high pressure fluid supply tube 610 may be in fluid communication with a pump 56 described herein to provide high pressure fluid to a fluid path 614 of the high pressure fluid supply tube 610.

[0059] A plurality of jets 618a-d (collectively 618) may be defined along the supply tube wall 612. For example, the supply tube wall 612 may include two, three, four, five, six, or more jets 618. The jets 618 may be spaced along the supply tube wall 612 at any desired interval. For example, each of the jets 618 may be equally spaced from an adjacent jet 618 along the length of the supply tube wall 612. In other examples, the jets 618 may be spaced closer together near the distal end of the supply tube wall 612 than near the proximal end of the supply tube wall 612. For example, the spacing between the jets 618 may gradually increase as one moves proximally along the length of the shaft, or the spacing may be configured to increase in a stepped manner. In some examples, some or all of the jets 618 may be axially aligned along the supply tube wall 612. In other examples, one or more of the jets 618 may be circumferentially offset from one another around the supply tube wall 612. Multiple patterns are contemplated, including a spiral pattern, a pattern in which no two jets 618 are located at the same axial position, a regular pattern with two or more jets 618 located at the same axial position, an irregular pattern (some of the jets 618 may or may not be located at the same axial position), etc. The jets 618 may be formed using a suitable method, such as electron discharge machining, etching, cutting (including, e.g., laser cutting), etc. In some examples, one or more of the jets 618 may have a substantially round shape. In other examples, one or more of the jets 618 may have a substantially non-circular shape (e.g., elliptical, polygonal, irregular, etc.). In some examples, the jets 618 may be angled or include an angled surface. It is contemplated that the size and / or shape of the jets 618 may be varied to vary the velocity of the fluid exiting the jets. For example, decreasing the size of the jets 618 can increase the velocity of the fluid exiting the jets 618 .In some embodiments, the size of the jets 618 may be varied based on the pressure capabilities of the thrombectomy system, the number of jets, the dimensions of the high-pressure fluid supply tube 610 (e.g., length, wall thickness, inner diameter, etc.), and / or combinations thereof. In some examples, the jets 618 may have a cross-sectional dimension ranging from about 0.0018 inches (45.72 micrometers) to about 0.0022 inches (55.88 micrometers). However, the jets 608 may have a cross-sectional dimension less than 0.0018 inches (45.72 micrometers) or greater than 0.0022 inches (55.88 micrometers), if desired.

[0060] Injection of drive fluid through the lumen 614 of the supply tube wall 612 can eject the fluid through the jets 618, resulting in the generation of a proximally directed suction force. At least some of the jets 618a-c can extend through a circumferential sidewall of the supply tube wall 612. It is contemplated that at least some of the jets 618a-c can be angled proximally or otherwise designed to inject fluid (e.g., drive fluid, liquid, gas or air, vapor, particle-laden fluid, or the like) generally proximally through the jets 618a-c and into the lumen 606 of the catheter body 602, as depicted by lines 620a-c representing drive jets of fluid ejected generally proximally from the jets 618a-c. For example, each of the jets 618a-c can be positioned at an acute angle relative to the longitudinal axis of the supply tube wall 612 such that the jets 618a-c are angled proximally. In some embodiments, one or more of the jets 618d may be designed to inject a fluid (e.g., a drive fluid, a liquid, a gas or air, a vapor, a particle-laden fluid, or the like) in a generally distal direction through the jets 618d and into the lumen 606 of the catheter body 602, as depicted by line 620d representing the drive jet fluid being ejected in a generally distal direction from the jets 618d. For example, the jets 618d may be positioned at an oblique angle relative to the longitudinal axis of the delivery tube wall 612 such that the jets 618d are angled distally.

[0061] As described further herein, the supply tube wall 612 may include one or more or a plurality of jets 618a, 618b, 618c that are directed or oriented proximally (i.e., jets configured to direct fluid injected through the lumen 614 of the supply tube wall 612 in a proximal direction), and the supply tube wall 612 may include one or more or a plurality of jets 618d that are directed or oriented distally (i.e., jets configured to direct fluid injected through the lumen 614 of the supply tube wall 612 in a distal direction).

[0062] In some embodiments, the distally facing jet 618d may be circumferentially offset from the proximally facing jets 618a-d. In the illustrated embodiment, the distally facing jet 618d may be spaced from the proximally facing jets 618a-c by about 45° to about 135°, or by about 90° around the circumference of the delivery tube wall 612. However, other circumferential spacings may be used as desired. For example, the distally facing jet 618d may be spaced from the proximally facing jets 618a-d by about 10° to about 350°, about 45° to about 135°, or about 60° to about 120°. However, it is contemplated that the distally facing jet 618d need not be located adjacent to the catheter body 602. It is contemplated that by positioning the distally facing jet 618d circumferentially offset from the proximally facing jets 618a-c, a spiral effect can be created by the jetted driving fluid 620, thereby improving the fragmentation of thrombus or debris.

[0063] The distally facing jet 618d may be the most distal jet, and the proximally facing jets 618a-c may be located proximal to the distally facing jet 618d. However, this is not required. In some embodiments, the distally facing jet 618d may be located proximal to at least one of the proximally facing jets 618a-c. Although the supply tube wall 612 is illustrated as including only a single distally facing jet 618d, the supply tube wall 612 may include two or more distally facing jets, as desired. If two or more distally facing jets 618d are provided, the distally facing jets may be located at different axial and / or circumferential positions relative to one another, or at similar axial and / or circumferential positions relative to one another, as desired. The distally facing jet 618d can shatter particles as they are drawn into the lumen 606 of the catheter body 602, while the proximally facing jets 618a-c can move particles proximally along the catheter body 602.

[0064] The performance of the thrombus removal catheter 600 and high-pressure fluid delivery tube 610 may be directly related to the velocity of the jetted driving fluid 620 exiting the jet orifice 618 and the shear-induced turbulent flux generated by the jetted driving fluid 620. For example, the more powerful the jetted driving fluid 620, the greater the aspiration velocity. Furthermore, it is contemplated that the performance of the jet-driven aspiration catheter 600 may be directly related to the rate at which thrombi can be drawn into the catheter 600, fragmented, and removed from the body. Any clogging that occurs within the catheter body 602 may reduce the amount of thrombus removed or stop its removal entirely. The addition of the distally facing jet orifice 618d may fragment any thrombi that enter the distal opening 608 of the catheter body 602, thus helping to prevent clogging. For example, at the point of impact of the distally directed drive fluid jet 620d, the drive fluid jet 620d may deflect distally and cause a flow outward from the tip of the distal opening 608 of the catheter body 602, effectively pulverizing any thrombus that enters the distal opening 608 of the catheter body 602 and eliminating or reducing the risk of occlusion or clogging of the distal opening 608 of the catheter body 602. It is contemplated that the characteristics of the jets 618 (e.g., size, shape, angle, number, spacing) may be varied to obtain fluid velocities that produce optimal clog removal effects without impeding the proximal flow of thrombus or the rate of thrombus evacuation within the lumen 606 of the catheter body 602.

[0065] The distally facing jet 618d may be spaced a distance proximally from the distal opening 608 of the catheter body 602. It is contemplated that the longitudinal position of the distally facing jet 618d on the supply tube wall 612 relative to the distal opening 608 of the catheter body 602 may be varied based on, for example, the size of the opening of the distally facing jet 618d, the velocity of the fluid within the lumen 614 of the supply tube wall 612, the angle of the distally facing jet 618d, or a combination thereof, to ensure that the distally directed drive jet 620d impacts the interior surface of the catheter body 602. In one example, the distally facing jet 618d may be positioned to cause the distally directed drive jet 620d to impact the interior surface of the catheter body 602 so that the distally directed drive jet 620d does not damage the blood vessel. For example, the distally facing jets 618d may be positioned so that the distally directed drive jet 620d impinges on the interior surface of the catheter body 602 between about 0.070 inches (1.778 mm) and about 0.090 inches (2.286 mm) proximally from the distal end of the catheter body 602. This is by way of example only. The location of impingement of the drive jet 620d of the distally facing jets 618d may be less than 0.070 inches (1.778 mm) or more than 0.090 inches (2.286 mm) proximally from the distal end of the catheter body 602, as desired.

[0066] In some examples, the jets 618 may be oriented at an angle relative to the longitudinal axis of the supply tube wall 612. For example, the proximally facing sidewalls of the jets 618a-c may be oriented at an oblique (e.g., acute) angle relative to the longitudinal axis of the supply tube wall 612 and / or may be oriented at an angle greater than 0 degrees and less than 90 degrees relative to the longitudinal axis of the supply tube wall 612. It is contemplated that the distally facing sidewall of the jet 618d may be oriented at an oblique (e.g., obtuse) angle relative to the longitudinal axis of the supply tube wall 612 and / or may be oriented at an angle greater than 90 degrees and less than 180 degrees relative to the longitudinal axis of the supply tube wall 612. In other examples, the jets 618 may be oriented perpendicular to the longitudinal axis of the supply tube wall 612 (e.g., at an angle of about 90 degrees relative to the longitudinal axis of the supply tube wall 612). The angle may or may not be the same for all jets 618. It is contemplated that the angle of the jets 618, and therefore the angle of the motive fluid jet 620, may be varied to adjust the velocity of the fluid exiting the jets 618.

[0067] In at least some examples, at least some of the jets 618 can be understood to be arranged in series. In other words, the jets 618 can be arranged such that adjacent jets 618 are longitudinally spaced apart at various locations along the longitudinal axis of the supply tube wall 612. For example, the jets 618 can be evenly or unevenly spaced apart along the length of the supply tube wall 612. This allows the jets 618 to be positioned at axially spaced apart locations within and along the length of the catheter body 602. For example, the jets 618 can be spaced apart along the entire length of the supply tube wall 612 and the corresponding entire length of the catheter body 602, or along a portion thereof, as desired. In some examples, the jets 618 may be spaced apart along the length of the supply tube wall 612 at intervals ranging from every 5 inches (12.7 centimeters (cm)) to every 15 inches (38.1 cm), or every 6 inches (15.2 cm) to every 12 inches (30.5 cm). In other examples, the spacing between the jets 618 may be less than every 5 inches (12.7 cm) or greater than every 15 inches (38.1 cm). Thus, the drive fluid ejects from the jets 618 to form ejected drive fluids 620a-d (collectively 620). In some examples, the ejected drive fluid 620 can reach velocities of 17,150 centimeters per second or greater (e.g., greater than half the speed of sound). This ejected drive fluid 620 enters the entrained material, where shear layers between the two cause turbulence, mixing, and momentum transfer. The drawn-in material may enter the distal opening 608 and then be propelled proximally by momentum transfer. As the mixture of jetted drive fluid 620 and drawn-in material moves proximally, the material may sequentially approach multiple jets 618. Upon interaction with jetted drive fluid 620 from each individual jet 618, momentum in the drawn-in material mixture increases, allowing the thrombus-forming material to more easily flow proximally through the catheter body 602 and be removed.The increased momentum may allow the catheter body 602 to be used without a second opening or outlet (e.g., located proximal to the distal opening 608). Alternatively, some of the trapped thrombus-forming material can exit the catheter body 602, for example, through a second opening (not shown) in the sidewall of the catheter body 602 located proximal to the distal opening 608, recirculate (e.g., one or more times) to the distal opening 608, and then travel proximally through the lumen 606 of the catheter body 602.

[0068] It is further contemplated that the distally directed drive jet 620d may be partially or completely retracted by the force generated by the proximally directed drive jets 620a-c. When the clot / thrombus reaches the distally directed drive jet 620d, shear stress may pulverize the clot / thrombus. It is contemplated that when the distal opening 608 of the catheter body 602 is blocked by the clot / thrombus, the force generated by the proximally directed drive jets 620a-c may be transmitted proximally to the surface of the clot / thrombus. As a result, the distally directed drive jet 620d is no longer retracted and can transmit a distal force to the surface of the clot / thrombus. Thus, when the distal opening 608 becomes clogged or blocked, the distal and proximal force vectors combine to create an extremely strong shear action mechanism that focuses all of the shear stress on the surface of the clot / thrombus, thereby pulverizing the clot / thrombus and clearing the blockage of the distal opening 608.

[0069] Materials that can be used for the various components of the thrombectomy catheters, pump / catheter assemblies, and / or other devices disclosed herein may include those commonly associated with medical devices. For simplicity, the following description will refer to pump / catheter assemblies and their associated components. However, this is not intended to limit the devices and methods described herein, and the description may apply to other similar devices, tubular members, and / or components of tubular members or devices disclosed herein.

[0070] The various components of the devices / systems disclosed herein may comprise metals, metal alloys, polymers (some examples of which are disclosed herein), metal-polymer composites, ceramics, combinations thereof, and the like, or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steel, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic nitinol, other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: N04400 such as MP35-N®, and the like), and the like. R30035 and the like), nickel-molybdenum alloys (e.g., UNS:N10665, such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys and the like, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX® and the like), platinum strengthened stainless steel, titanium, combinations thereof and the like, or any other suitable material.

[0071] Some examples of suitable polymers are polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether-esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and the like. CRISTAMID® available from Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high density polyethylene, MARLEX® low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., available from EMS American GRILAMID® available from Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBSA), polycarbonate, ionomer, polyurethane silicone copolymer (e.g., Elast-Eon® from AorTech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymer, other suitable material, or mixtures, combinations, copolymers, polymer / metal composites, and the like. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0072] In at least some embodiments, some or all of the pump / catheter assembly and its associated components may be doped with, made from, or otherwise include a radiopaque material. A radiopaque material is understood to be a material capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user in locating the pump / catheter assembly and its associated components. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the pump / catheter assembly and its associated components to achieve the same results.

[0073] It should be understood that this disclosure is, in many respects, merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, the use of any of the features of one illustrative embodiment used in other embodiments. The scope of the disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

1. 1. A thrombus removal catheter, comprising: a catheter body extending from a proximal end region to a distal end region and including a catheter lumen extending between the proximal end region and the distal end region; a high-pressure fluid supply tube extending through the catheter lumen from the proximal end region of the catheter body toward the distal end region of the catheter body, the high-pressure fluid supply tube configured to communicate with a fluid source near the proximal end region of the catheter body; at least one proximally facing jet for emitting at least one proximally directed jet in a generally proximal direction from the high pressure fluid delivery tube within the catheter lumen; at least one distally facing jet for emitting at least one distally directed jet in a generally distal direction from the high pressure fluid delivery tube within the catheter lumen; an intake inlet disposed along a distal portion of the catheter; A thrombus removal catheter comprising:

2. The thrombectomy catheter of claim 1 , wherein the at least one distally facing jet is distal to the at least one proximally facing jet.

3. The thrombectomy catheter of claim 1 or 2, wherein the at least one distally directed jet impinges on an interior surface of the catheter body.

4. 3. The thrombectomy catheter of claim 1, wherein the at least one distally facing jet extends through a circumferential sidewall of the high pressure fluid supply tube.

5. The thrombus removal catheter of any one of claims 1 to 4, wherein the at least one distally facing jet is axially aligned with the at least one proximally facing jet.

6. 5. The thrombectomy catheter of claim 1, wherein the at least one distally facing jet is circumferentially offset from the at least one proximally facing jet.

7. 7. The thrombectomy catheter of claim 6, wherein the at least one distally facing jet is circumferentially offset from the at least one proximally facing jet by an angle ranging from about 45 degrees to about 135 degrees.

8. 8. The thrombus removal catheter of claim 1, wherein a sidewall of the at least one distally facing jet extends at an obtuse angle relative to a longitudinal axis of the high-pressure fluid supply tube.

9. The thrombectomy catheter of any one of claims 1 to 3, wherein the at least one distally facing jet extends through a distal end of the high pressure fluid supply tube.

10. 10. The thrombectomy catheter of claim 9, wherein the at least one distally facing jet is collinear with a longitudinal axis of the high pressure fluid delivery tube.

11. 11. The thrombectomy catheter of claim 9 or 10, wherein the diameter of the at least one distally facing jet is smaller than the inner diameter of the high pressure fluid supply tube.

12. 11. The thrombectomy catheter of claim 9 or 10, wherein the diameter of the at least one distally facing jet is approximately the same as the inner diameter of the high pressure fluid supply tube.

13. 13. The thrombus removal catheter of claim 1, wherein a sidewall of the at least one proximally facing jet extends at an acute angle relative to a longitudinal axis of the high-pressure fluid delivery tube.

14. The thrombectomy catheter of any one of claims 1 to 13, wherein the at least one distally facing jet comprises two or more distally facing jets.

15. The thrombus removal catheter of any one of claims 1 to 14, wherein the at least one proximally facing jet comprises two or more proximally facing jets.

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