Aspiration tubing

Abstract

An example medical aspiration system includes an aspiration tube and a flow control device. The aspiration tube includes a distal portion defining a distal lumen configured to be fluidically coupled to a lumen of an aspiration catheter and a proximal portion defining a proximal lumen configured to be fluidically coupled to an aspiration pump. The proximal lumen is fluidically coupled to the distal lumen, and an inner diameter of the proximal lumen is greater than an inner diameter of the distal lumen. The flow control device includes a housing configured to receive the proximal portion of the aspiration tube, a flow sensor configured to sense fluid flow within the proximal lumen, and a valve configured to modulate fluid flow through the proximal lumen.

Description

ASPIRATION TUBING

[0001] This application claims priority from and the benefit of U.S. Provisional Patent Application No. 63 / 642,446, filed on May 3, 2024, and entitled, “ASPIRATION TUBING,” the entire content of which is incorporated herein by reference.TECHNICAL FIEED

[0002] This disclosure relates to medical aspiration.BACKGROUND

[0003] In some cases, medical aspiration can be used to remove material from a patient. For example, medical aspiration can be used to remove a thrombus, such as a clot or other occlusion, from a blood vessel of a patient.SUMMARY

[0004] This disclosure describes example devices and systems configured to reduce withdrawal of body fluid (e.g., blood) from a patient during a medical aspiration procedure, and related methods. An aspiration catheter can be used to remove a thrombus from a hollow anatomical structure (e.g., a blood vessel) of a patient. For example, a distal opening of the catheter may be positioned in the hollow anatomical structure near a thrombus and an aspiration force can be applied to a lumen of the aspiration catheter in order to draw the thrombus through the catheter lumen and out of the hollow anatomical structure. In some instances, such as with deep vein thrombosis (DVT) and pulmonary embolism (PE) procedures, it may be preferable to use larger aspiration catheters, e.g., 12 French (Fr) or greater, to remove large clot burdens from vessels. As the aspiration catheter lumen diameter increases, the flow through the aspiration catheter increases, shortening the time in which the maximum blood volume that can be extracted from a patient (e.g., approx. 450 milliliters) will be reached more quickly than in a case with a smaller aspiration catheter, and potentially force a premature end to the procedure.

[0005] In examples described herein, a medical aspiration system is configured to monitor blood flow through an aspiration catheter and / or aspiration tubing using a flow sensor and actuate a valve, e.g., a flow control valve, based on the measured flow. The valve may allow unrestricted flow to pass when the distal end of the aspiration catheter encounters a blockage (from thrombus or potentially a vessel wall) but will regulate (e.g., reduce) the flow of blood if the aspiration catheter is in patent blood flow in a vessel. In some examples,the aspiration system may allow a clinician to “search” for thrombus in the vessel using fluoroscopy guidance, while substantially only applying a relatively high aspiration force when the catheter tip is occluded.

[0006] In examples described herein, the medical aspiration system further includes an aspiration tube (including one or more tubes and also referred to as aspiration tubing), and a flow control device including the flow sensor and the valve. The aspiration tube is configured to fluidically couple a proximal end of the aspiration catheter to a suction source, such as an aspiration pump to provide an aspiration force to the lumen of the aspiration catheter, and / or a collection canister. The aspiration tube is compatible with the flow control device, which is configured to control the flow and amount of blood aspirated by the aspiration catheter by monitoring and controlling the flow through the aspiration tube. The flow control device and the aspiration tube may be compatible with several sizes of catheters, e.g., for procedures used in different anatomical structures, such as different sizes of blood vessels of a patient. The aspiration tube may satisfy several design factors, for example, an inner diameter (ID) and length configured to be compatible with several sizes of catheters, and one or more materials having material properties compatible with both the valve (e.g., a pinch valve) and the flow sensor (e.g., ultrasonic or optical flow sensor). For example, the aspiration tube may comprise one or more materials with a hardness (e.g., durometer, also referred to as Shore hardness herein) or resilience to provide adequate flexibility and stiffness to be pinched closed by compression by a pinch valve and to open when released by the pinch valve, a fatigue resistance to withstand a plurality of compressions / decompressions at least over the course of an aspiration procedure, a vacuum resistance, a transparency to ultrasonic signals, an optical transparency, and / or desirable electrical properties (e.g., electrical resistance).

[0007] In examples described herein, an aspiration system includes a “stepped,” or “hybrid,” aspiration tube comprising a proximal portion having a relatively large ID compatible for use with a flow sensor and a valve of a flow control device, and a distal portion having a relatively smaller ID for connecting to an aspiration catheter. The aspiration tube may comprise a distal portion separate from the proximal portion and fluidically coupled to each other by a step connector, where the distal and proximal portions may be made of the same or different materials.

[0008] The devices, systems, and techniques of this disclosure may provide one or more advantages and benefits. For instance, a stepped aspiration tube allows the flow control device to be compatible with a plurality of sizes of aspiration catheters by providing a consistent tube size (proximal portion) and material for consistent flow signals for a flow sensor of a flow control device, as well as a consistent tube for providing a consistentcompression resistance for a valve of the flow control device. The stepped aspiration tube may also provide a distal portion long enough to allow an aspiration catheter to be used in a sterile zone, room, and / or environment and fluidically coupled to a flow control device located outside of the sterile zone. The stepped aspiration tube may also provide a proximal portion compatible with multiple connections to an aspiration pump and catheter, e.g., lateral and / or vertical connections to the collection canister.

[0009] In one example, this disclosure describes a medical aspiration system including: an aspiration tube including: a distal portion defining a distal lumen configured to be fluidically coupled to a lumen of an aspiration catheter; and a proximal portion defining a proximal lumen configured to be fluidically coupled to an aspiration pump, wherein the proximal lumen is fluidically coupled to the distal lumen, and wherein an inner diameter of the proximal lumen is greater than an inner diameter of the distal lumen; and a flow control device including: a housing configured to receive the proximal portion of the aspiration tube; a flow sensor configured to sense fluid flow within the proximal lumen; and a valve configured to modulate fluid flow through the proximal lumen.

[0010] In another example, this disclosure describes an aspiration tube including: a distal portion defining a distal lumen configured to be fluidically coupled to a lumen of an aspiration catheter; and a proximal portion defining a proximal lumen configured to be fluidically coupled to an aspiration pump, wherein an inner diameter of the proximal lumen is greater than an inner diameter of the distal lumen, wherein the proximal portion is configured to be compatible with an ultrasonic flow sensor, and wherein the proximal portion is configured to be compressed by a pinch valve and to resist compression to open the proximal lumen upon release of compression by the pinch valve.

[0011] In another example, this disclosure describes a method of aspirating material from a patient, the method including: connecting an aspiration catheter to an aspiration tube, the aspiration tube including: a distal portion defining a distal lumen configured to be fluidically coupled to a lumen of the aspiration catheter; and a proximal portion defining a proximal lumen configured to be fluidically coupled to an aspiration pump, wherein an inner diameter of the proximal lumen is greater than an inner diameter of the distal lumen; positioning the proximal portion within a housing of a flow control device, the flow control device including: a flow sensor configured to sense fluid flow within the proximal lumen when the proximal portion is within the housing; and a valve configured to modulate fluid flow through the proximal lumen; connecting the proximal portion to the aspiration pump; and aspirating, using the aspiration catheter, material from a patient.

[0012] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. 1 is a schematic diagram illustrating an example aspiration system including an example aspiration tube.

[0014] FIG. 2 is a perspective view of an example flow control device.

[0015] FIG. 3 is a schematic side view of an example aspiration tube.

[0016] FIG. 4 is a perspective view of an example aspiration tube within an example flow control device.

[0017] FIG. 5A is a perspective view of an example step connector.

[0018] FIG. 5B is a cross-sectional view of an example step connector along the line A-A’ shown in FIG. 5C.

[0019] FIG. 5C is a schematic side view of an example step connector along the line B-B’ shown in FIG. 5A.

[0020] FIG. 5D is a cross-sectional view of an example step connector along the line B- B’ shown in FIG. 5 A.

[0021] FIG. 6 is a flow diagram of an example method of aspirating a material from a patient.DETAILED DESCRIPTION

[0022] This disclosure describes devices and systems configured to regulate a flow of a body fluid, such as blood, from a body of a patient during a medical aspiration procedure, as well as aspiration systems including such devices and systems, and corresponding methods. In examples described herein, an aspiration system, such as a thrombectomy system, includes an aspiration pump and an aspiration catheter, which may have a range of sizes (e.g., 6 Fr to 12 Fr) configured to aspirate material, e.g., a thrombus, from a hollow anatomical lumen (e.g., a blood vessel) of a patient, e.g., peripheral, venous, and / or pulmonary vessels. The catheter may be configured to be used in a sterile zone, room, environment, or the like, e.g., and operating room. The catheter may be configured to be connected to an aspiration tube inside a sterile zone, and the aspiration tube may be configured to connect to the aspiration pump and / or a canister (e.g., a discharge reservoir) connected to the pump, outside the sterile zone.

[0023] For example, the aspiration tube may have a length sufficient to connect to the aspiration catheter with a sterile zone and the canister and / or pump located outside of the sterile zone. The aspiration system may also include a flow control device including a valve, such as a pinch valve, and a flow sensor. The flow control device may be configured to monitor the flow of a fluid within the aspiration catheter by monitoring the fluid flow of the aspiration tube connected to the aspiration catheter, e.g., fluidically coupled to the aspiration catheter. A fluid flow rate within a lumen of the aspiration tube is indicative of the fluid flow rate through a lumen of the aspiration catheter. The flow control device may also be configured to control the flow of fluid through the aspiration catheter by controlling the flow of a fluid through the aspiration tube connected to the aspiration catheter, e.g., to minimize blood loss during an aspiration procedure.

[0024] For example, a controller (e.g., processing circuitry, control circuitry, or the like) may be operatively and / or communicatively connected to the aspiration pump, the valve, and / or the flow sensor. The controller may be configured to receive a signal from the flow sensor to monitor the flow of blood through the aspiration tube (and aspiration catheter) and to control the valve to control the flow of blood, and thus control an amount of blood loss by the patient, passing through the aspiration tube (and the aspiration catheter). In some examples, the controller is configured to pulse the valve to open and close a lumen of the aspiration tube, e.g., to open the lumen of the aspiration tube for short amounts of time when the fluid flow rate is high (e.g., patent blood flow) and to open the lumen of the aspiration tube for longer amounts of time when the fluid flow rate is low, e.g., to allow the system to aspirate a thrombus is captured by the aspiration catheter. In some examples, the controller is configured to pulse the valve to open and close, or partially open or partially close, a lumen of the aspiration tube for amounts to time to aspirate a partial blockage of the aspiration catheter and / or the aspiration tubing, e.g., by a thrombus.

[0025] In some examples, during a medical aspiration procedure, a clinician can connect a distal end of the aspiration tube to a proximal end of the aspiration catheter, and connect a proximal end of the aspiration tube to a suction source and / or a collection canister configured to collect aspirated material. The clinician can close a manual pinch clamp, located proximal the distal end of the aspiration tube, to prevent fluid flow through the aspiration tube, and turn on the suction source. The flow control device may be turned on and at least a portion of the aspiration tube may be positioned within a housing of the flow control device, e.g., in a channel of the flow sensor and a channel of the valve. The clinician may the open the manual pinch clamp and the flow control device may automatically regulate the flow of fluid within the aspiration tube, which is driven by the suction force (e.g., vacuum provided by the suctionsource). The flow control device is configured to determine the fluid flow through the aspiration tube via the flow sensor and control the fluid flow through the aspiration tube via the valve. When the aspiration procedure is finished, the clinician may close the manual pinch clamp, turn off the suction source and the flow control device, remove the aspiration tube from the flow control device (e.g., from the flow sensor and valve), disconnect the aspiration tube from the aspiration pump, and dispose of the aspiration catheter and the aspiration tube appropriately.

[0026] Aspiration tube design factors include an inner diameter (ID) and length configured to be compatible with several sizes of catheters, and one or more materials having material properties compatible with both the valve (e.g., a pinch valve) and the flow sensor (e.g., ultrasonic or optical flow sensor). For example, the aspiration tube may comprise one or more materials with a hardness (e.g., durometer) or resilience to provide adequate flexibility and stiffness to be pinched closed by compression by a pinch valve and to open when released by the pinch valve, as well as a fatigue resistance to withstand a plurality of compressions / decompressions at least over the course of an aspiration procedure. The aspiration tube may also comprise one or more materials with a vacuum resistance, a transparency to ultrasonic signals, an optical transparency, and / or desirable electrical properties (e.g., electrical resistance). Additionally, the aspiration tube may have a geometry (e.g., a wall thickness and lumen size, or ID and OD) configured to be compatible with both the valve (e.g., a pinch valve) and the flow sensor (e.g., ultrasonic or optical flow sensor). For example, the aspiration tube may have a wall thickness that, in combination with its materials properties, provides a hardness or resilience to provide adequate flexibility and stiffness to be pinched closed by compression by a pinch valve and to open when released by the pinch valve, a fatigue resistance to withstand a plurality of compressions / decompressions at least over the course of an aspiration procedure, a vacuum resistance, a transparency to ultrasonic signals, an optical transparency, and / or desirable electrical properties (e.g., electrical resistance). In some examples, an ID of the aspiration tube is at least 12 Fr to prevent blockages, and may be 14 Fr, 16 Fr, 18 Fr, or larger in some examples. In addition, the flow sensor that senses fluid flow in the aspiration tube is configured to generate a signal that is indicative of fluid flow of for several sizes of aspiration catheters that may be used with the aspiration tube.

[0027] It can be challenging for an aspiration tube having a single ID size (e.g., lumen size) to meet the requirements of an aspiration system configured for use with multiple sizes of aspiration catheters. For example, aspiration rate through the aspiration tube is proportional to aspiration pressure and the size (e.g., ID) of the aspiration tube. Larger sizedaspiration tubes may result in increased aspiration force (e.g., suction force) at a distal tip of an attached catheter for a given aspiration pressure. An aspiration tube with a smaller ID may improve maintaining an aspiration force (e.g., a suction force), but may result in increased blockages within the aspiration tube. An aspiration tube with a larger ID may increase the aspiration force and increase the amount of blood aspirated for the same aspiration pressure, while reducing blockages.

[0028] In examples described herein, an aspiration system includes a “stepped,” or “hybrid,” aspiration tube comprising a proximal portion having a relatively large ID (e.g., at least 14 Fr) configured for use and compatibility with a flow sensor and a valve of a flow control device, and a distal portion having a relatively smaller ID (e.g., 12 Fr or smaller) for connecting to an aspiration catheter. The proximal portion and the distal portion may be made of the same material or a different material. In some examples, the distal portion and the proximal portion are integrally formed, and may be monolithically formed of the same material, and may have a stepped portion between the distal and proximal portions in which the inner diameter of the aspiration tube changes between the larger inner diameter of the proximal portion and the smaller inner diameter of the distal portion. In other examples, the aspiration tube may comprise a distal portion separate from the proximal portion and mechanically and fluidically coupled to each other by a step connector, where the distal and proximal portions may be made of the same or different materials. In some examples, the step connector is also referred to as a reducer.

[0029] The devices, systems, and techniques of this disclosure may provide one or more advantages and benefits. For instance, a stepped aspiration tube allows the flow control device to be compatible with a plurality of sizes of aspiration catheters by providing a consistent tube size and material for consistent flow signals for the flow sensor, as well as a consistent tube for providing a consistent compression resistance for the valve. The stepped aspiration tube may also provide a distal portion long enough to allow an aspiration catheter to be used in a sterile zone, room, and / or environment and fluidically coupled to a flow control device located outside of the sterile zone by providing an adequate length of at least the distal portion of the aspiration tube. The stepped aspiration tube may also provide a proximal portion compatible with multiple connections to an aspiration pump and canister, e.g., lateral and / or vertical connections to the collection canister.

[0030] FIG. 1 is a schematic diagram illustrating an example medical aspiration system 100 (also referred to herein as “aspiration system 100”) including a suction source 102, a discharge reservoir 104 (also referred to herein as a collection canister), a flow control device 106, an aspiration catheter 108, aspiration tubing 116, e.g., proximal aspiration tube 116a anddistal aspiration tube 116b (collectively, “aspiration tubing 116”), and a controller 118. Medical aspiration system 100 may be used to treat a variety of conditions, including thrombosis. Thrombosis occurs when a thrombus (e.g., a blood clot or other material such as plaques or foreign bodies) forms and obstructs vasculature of a patient. For example, medical aspiration system 100 may be used to treat a pulmonary embolism or deep vein thrombosis, which may occur when a thrombus forms in a deep vein of a patient, such as in a leg of the patient.

[0031] Medical aspiration system 100 is configured to remove a thrombus from a patient. Medical aspiration system 100 may be configured to remove a thrombus via aspiration catheter 108, e.g., to draw the thrombus from the patient using a suction force applied to aspiration catheter 108. Material passing through aspiration catheter 108 is deposited into discharge reservoir 104, via a suction force applied by suction source 102 to aspiration catheter 108 (e.g., to an inner lumen of aspiration catheter 108). Aspiration catheter 108 includes an elongated body defining a catheter lumen and terminating in a distal opening 114.

[0032] To treat a patient with thrombosis, a clinician may position distal opening 114 of aspiration catheter 108 in a blood vessel of the patient near the thrombus or other occlusion and apply, via suction source 102, a suction force (also referred to herein as suction, vacuum force, negative pressure, or aspiration force) to the aspiration catheter 108 (e.g., to one or more lumens of the catheter) to engage the thrombus with suction force at distal opening 114 of aspiration catheter 108. For example, suction source 102 can be configured to create a negative pressure within the inner lumen of aspiration catheter 108 to draw a material from the inside the blood vessel into the catheter lumen via distal opening 114 of aspiration catheter 108. The negative pressure within the inner lumen can create a pressure differential between the inner lumen and the environment external to at least a distal portion of aspiration catheter 108 that causes the material, e.g., a thrombus, fluid (e.g., blood, saline introduced into the patient as part of the aspiration procedure, or the like), and / or other material, to be introduced from the blood vessel into the catheter lumen via catheter distal opening 114. For example, the fluid may flow from patient vasculature, into the catheter lumen via distal opening 114, and subsequently through aspiration tubing 116 into discharge reservoir 104.

[0033] Once distal opening 114 of aspiration catheter 108 has engaged a thrombus that is within a blood vessel, the clinician may remove aspiration catheter 108 with the thrombus held within opening 114 or attached to the distal tip of the elongated body, or suction off pieces of the thrombus (or the thrombus as a whole) until the thrombus is removed from the blood vessel of the patient through a lumen of aspiration catheter 108 itself and / or through the lumen of an outer catheter in which aspiration catheter 108 is at least partially positioned.The outer catheter can be, for example, a guide catheter configured to provide additional structural support to the aspiration catheter. In some cases, aspiration of thrombus can be performed concurrently with use of a thrombectomy device, such as a thrombus removal basket, to facilitate removal of thrombus via mechanical thrombectomy.

[0034] As used herein, “suction force” is intended to include, within its scope, related concepts such as suction pressure, vacuum force, vacuum pressure, negative pressure, and the like. A suction force can be generated by a vacuum, e.g., by creating a partial vacuum within a sealed volume fluidically connected to aspiration catheter 108, or by direct displacement of liquid in aspiration catheter 108 and / or aspiration tubing 116 via (e.g.) a peristaltic pump, or otherwise. Accordingly, suction forces or suction as specified herein can be measured, estimated, computed, etc. without need for direct sensing or measurement of force. A “higher,” “greater,” or “larger” (or “lower,” “lesser,” or “smaller”) suction force described herein may refer to the absolute value of the negative pressure generated by the suction source on a catheter or another component, such as a discharge reservoir 104.

[0035] In some examples, suction source 102 can comprise a pump (also referred to herein as “aspiration pump 102” or “vacuum source 102”). The suction source 102 can include one or more of a positive displacement pump (e.g., a peristaltic pump, a rotary pump, a reciprocating pump, or a linear pump), a direct-displacement pump (e.g., a peristaltic pump, or a lobe, vane, gear, or piston pump, or other suitable pumps of this type), a direct-acting pump (which acts directly on a liquid to be displaced or a tube containing the liquid), an indirect-acting pump (which acts indirectly on the liquid to be displaced), a centrifugal pump, and the like. An indirect-acting pump can comprise a vacuum pump, which displaces a compressible fluid (e.g., a gas such as air) from the evacuation volume (e.g., discharge reservoir 104, which can comprise a canister), generating suction force on the liquid. Accordingly, the evacuation volume (when present) can be considered part of the suction source. In some examples, suction source 102 includes a motor-driven pump, while in other examples, suction source 102 can include a syringe, and mechanical elements such as linear actuators, stepper motors, etc. As further examples, the suction source 102 could comprise a water aspiration venturi or ejector jet.

[0036] Flow control device 106 includes valve 110 and flow sensor 112. In the example shown, flow sensor 112 is positioned upstream, e.g., distal to, valve 110. Valve 110 includes any suitable configuration that enables valve 110 to modulate fluid flow through aspiration tubing 116, such as by mechanically compressing proximal aspiration tube 116a. Modulation of fluid flow through proximal aspiration tube 116a can include full occlusion of the lumen of proximal aspiration tube 116a (in which there is no fluid flow (e.g., no fluid flow or nomeaningful fluid flow) through proximal aspiration tube 116a) or partial occlusion of the lumen of proximal aspiration tube 116a. In some examples, valve 110 includes a pinch valve, such as a solenoid-actuated pinch valve, configured to restrict flow within a lumen of aspiration tube 116a via proximal compressing aspiration tube 116a. For example, valve 110 may include a solenoid-actuated pinch valve 110 including a travel distance (e.g., of the solenoid, pinch head, and / or end connection) substantially similar to or greater than the ID of the lumen of aspiration tube 116a.

[0037] Flow sensor 112 is configured to generate a signal indicative of fluid flow rate through proximal aspiration tube 116a or another tube that is received in fluid control device 106. In some examples, flow sensor 112 includes a non-contact flow sensor. For example, flow sensor 112 may include an ultrasonic flow sensor or an optical flow sensor, or any suitable non-contact flow sensor. In some examples, flow sensor 112 is configured to detect, sense, and / or measure a fluid flow rate of a fluid within proximal aspiration tube 116a externally from proximal aspiration tube 116a, e.g., to keep flow sensor 112 fluidically separate from the fluid, e.g., blood.

[0038] Controller 118 includes control circuitry 120 configured to control a suction force applied by suction source 102 to aspiration catheter 108. For example, control circuitry 120 may be configured to directly control an operation of suction source 102 to vary the suction force applied by suction source 102 to the inner lumen of aspiration catheter 108, e.g. by controlling the motor speed, or stroke length, volume or frequency, or other operating parameters, of suction source 102. As another example, control circuitry 120 may be configured to control one or more functions of flow control device 106, e.g., to control valve 110. Other techniques for modifying a suction force applied by suction source 102 to the inner lumen of aspiration catheter 108 may be used in other examples. Control circuitry 120 may be configured to control flow sensor 112, and / or to receive a signal indicative of a flow within proximal aspiration tube 116a from flow sensor 112.

[0039] Control circuitry 120, as well as other processors, processing circuitry, controllers, control circuitry, and the like, described herein, may include any combination of integrated circuitry, discrete logic circuity, analog circuitry, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), or field- programmable gate arrays (FPGAs). In some examples, control circuitry 120 may include multiple components, such as any combination of one or more microprocessors, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry, and / or analog circuitry. In some examples, control circuitry 120 may further include, additionally or alternatively to electric -based processors, one or more controls thatoperate using fluid motion power (e.g., hydraulic power) in combination with or in addition to electricity. For example, control circuitry 120 may include a fluid circuit comprising a fluid circuit comprising a plurality of fluid passages and switches arranged and configured such that, when a fluid (e.g., liquid or gas) flows through the passages and interacts with the switches, the fluid circuit performs the functionality of control circuitry 120 described herein.

[0040] Memory 122 may store program instructions, such as software, which may include one or more program modules, which are executable by control circuitry 120. When executed by control circuitry 120, such program instructions may cause control circuitry 120 to provide the functionality ascribed to control circuitry 120 herein. The program instructions may be embodied in software and / or firmware. Memory 122, as well as other memories described herein, may include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or any other digital media. Although control circuitry 120 and memory 122 are shown in FIG. 1 as being in a common housing, in other examples, control circuitry 120 and / or memory 122 can be physically separate from each other.

[0041] With some aspiration systems, some amount of a body fluid may be incidentally withdrawn during the aspiration procedure. For instance, while approaching and aspirating a thrombus with a distal opening of the catheter, the clinician may incidentally aspirate and remove a volume of the patient’s blood, e.g., that is not inherently necessary to withdraw as part of the procedure. Flow control device 106 is configured to reduce the incidental withdrawal of the patient’s blood during an aspiration procedure by reducing a flow of fluid through aspiration tubing 116 and through a catheter lumen of aspiration catheter 108.

[0042] Aspiration tubing 116 comprises a “stepped” or “hybrid” aspiration tubing 116. For example, aspiration tubing 116 may comprise a distal aspiration tube 116b portion defining a distal lumen configured to be fluidically coupled to a lumen of aspiration catheter 108 and a proximal aspiration tube 116a portion defining a proximal lumen configured to be fluidically coupled to suction source 102 (e.g., via discharge reservoir 104). In some examples, an inner diameter of the proximal lumen of the proximal portion is greater than an inner diameter of the distal lumen of the distal portion, and at least the proximal portion is configured to be compatible with flow sensor 112 and valve 110 of a flow control device 106. For example, proximal aspiration tube 116a is configured to fit, or be coupled to, flow sensor 112 and valve 110 and may be made of a material compatible with flow sensor 112 and valve

[0043] FIG. 2 is a perspective view of an example flow control device 206, which is an example of flow control device 106 of FIG. 1. FIG. 3 is a conceptual side view of an example aspiration tube 216, which is an example of aspiration tubing 116 of FIG. 1. FIG. 4 is a perspective view of an example aspiration tube 216 positioned within an example flow control device 206. FIGS. 2-4 are described together below. In the examples shown, flow of a fluid (e.g., blood) is generally in the proximal direction, e.g., from a distal end 254 (FIG. 3) of aspiration tube 216 (e.g., configured to be connected to an aspiration catheter via a catheter connector 244) to a proximal end 256 (FIG. 3) of aspiration tube 216 (e.g., configured to be connected to suction source 102 and / or discharge reservoir 104 via an aspiration pump connector 246), as indicated by flow direction indicator 270.

[0044] In the examples shown, flow control device 206 includes housing 202, lid 204, channel 214 (FIG. 2) defined by housing 202, connector attachment 208 (FIG. 2), flow sensor 212, and valve 210. Flow control device 206, flow sensor 212, and valve 210 may be substantially similar to flow control device 106, flow sensor 112, and valve 110, respectively, described above.

[0045] In the examples shown, connector attachment 208 is positioned along channel 214 within housing 202, and channel 214 is configured to be continuous with channels and / or apertures for flow sensor 212 and valve 210, e.g., flow sensor channel 213 and / or valve channel 211. Housing 202 may be formed from any suitable material or combination of materials, including, but not limited to, a metal, such as aluminum, a plastic, a ceramic, or any suitable material for housing components of flow control device 206. In the example shown in FIG. 2, housing 202 is configured to receive at least a part of proximal portion 236 (FIG. 3) of aspiration tube 216. In the example shown in FIG. 2, aspiration tube 216 is not positioned within flow control device 206. In the examples shown in FIGS. 2 and 4, flow control device 206 is illustrated with lid 204 open, or raised, or in an open configuration. In some examples, lid 204 may be closed or in a closed configuration (not shown), e.g., when flow control device is in use.

[0046] In some examples, channel 214 comprises a recess configured to receive at least a part of proximal portion 236 of aspiration tube 216, e.g., to guide and / or support aspiration tube 216 when aspiration tube 216 is received within the channels and / or apertures of flow sensor 212 and valve 210. Connector attachment 208 is configured to engage with (e.g., mate with, interface with) step connector 240 (FIGS. 3, 4) of aspiration tube 216, and / or another transition portion of aspiration tube 216 (not shown). In some examples, step connector 240 is configured to fit within connector attachment 208 relatively easily (e.g., with some relatively movement therebetween). In other examples, connector attachment 208 isconfigured to attach step connector 240 (or a transition portion) to housing 202, such as by an interference / press fit. In some examples, housing 202 includes connector attachment 208, e.g., connector attachment 208 may be integral to housing 202. In the example shown, connector attachment 208 comprises a recess shaped to receive step connector 240 and / or a transition portion of aspiration tube 216. In some examples, step connector 240 and / or connector attachment 208 may be configured to visually indicate a direction of fluid flow, e.g., from distal portion 226 to proximal portion 236.

[0047] In some examples, connector attachment 208 is configured to position step connector 240 within housing 202 at connector attachment 208. In other examples, connector attachment 208 is configured to position step connector 240 within housing 202 at connector attachment 208 without attaching step connector 240 and / or aspiration tube 216 to housing 202, e.g., connector attachment 208 may be recess shaped to receive step connector 240 without press fitting.

[0048] In the example shown, connector attachment 208 is positioned within housing 202 at a distance 260 from valve 210. For example, connector attachment 208 may be configured to position step connector 240 at distance 260 from valve 210, e.g., when step connector 240 is engaged and / or mated with connector attachment 208. Distance 260 is measured along channel 214, e.g. alone a longitudinal axis of channel 214, which can be straight in some examples. In the example shown, flow sensor 212 is positioned between connector attachment 208 and valve 210. Thus, as fluid flows in a direction from aspiration catheter 108 to discharge reservoir 104, the fluid flows to flow sensor 212 before it reaches valve 210. Distance 260 may affect peak flow measurements by flow sensor 212 and / or the accuracy of peak flow measurements. In some examples, distance 260 is a predetermined distance selected to improve monitoring and / or control of flow rates of a fluid within aspiration tube 216, improve monitoring and / or control of pulsing flow rates of a fluid within aspiration tube 216, and / or improve detection and / or monitoring of blockages (e.g., reduced flow) within an aspiration catheter (e.g., aspiration catheter 108) and / or aspiration tube 216, e.g., by improving the accuracy of flow measurements and / or peak flow measurements of a fluid within proximal portion 236 by flow sensor 212. For example, if the distance 260 is too large, then a pulsed aspiration rate (and blood loss) may be higher than desired, and if distance 260 is too short, then “samples” of the flow (e.g., an amount of fluid) may be too small for reliable signal analysis, which may reduce blockage detection time and accuracy. Distance 260 may also be large enough for flow sensor 212 and valve 210 to be accommodated with a sufficient distance between flow sensor 212 and valve 210 so as to reduce and / or prevent the impact of valve 210 (e.g., transient pressure and / or flow differences near valve 210 caused byopening / closing the lumen of aspiration tube 216 by valve 210) from disrupting the flow signal detected by flow sensor 212.

[0049] In some examples, a shorter distance 260 may result in a relatively lower flow rate and slower blockage detection (e.g., a reduced flow rate and / or blockage detection response time) by controlling the pulse volume per valve open time via valve 210 but may increase noise in the flow rate measurements (e.g., when too close to step connector 240). In some examples, a longer distance 260 may result in a higher signal to noise measurement ratio for flow rate and blockage detection, but may increase the measurement time (e.g., decrease the measurement response time) and increase the amount of blood aspirated to detect a flow rate and / or a blockage. In some examples, distance 260 may depend on the ID of aspiration tube 216 downstream from step connector 240, e.g., the ID of proximal portion 236 (FIGS. 3, 4). In some examples, distance 260 is selected based on the ID of aspiration tube 216 upstream from step connector 240, e.g., the ID of distal portion 226 (FIGS. 3, 4), and / or a ratio of the IDs of both proximal portion 236 and distal portion 226. In some examples, distance 260 may be from about 20 times the ID of proximal portion 236 to about 50 times the ID of proximal portion 236.

[0050] Referring to FIG. 3, aspiration tube 216 includes distal portion 226, step connector 240, and proximal portion 236. In some examples, aspiration tube 216 also includes catheter connector 244 configured to connect a distal end of distal portion 226 to a proximal end of an aspiration catheter, manual pinch clamp 242 configured to be manipulated to pinch aspiration tube 216 closed to prevent fluid flow with aspiration tube 216 or opened to allow fluid flow within aspiration tube 216, and / or aspiration pump connector 246 configured to connect a proximal end of proximal portion 236 to suction source 102, e.g., directly or indirectly through a discharge reservoir 104.

[0051] Distal portion 226 defines a lumen (referred to as a distal lumen) configured to be fluidically coupled to a lumen of an aspiration catheter, e.g., aspiration catheter 108 of FIG. 1. For example, a distal end of distal portion 226 may be connected to proximal end of aspiration catheter 108 via catheter connector 244 such that the distal lumen of distal portion 226 is fluidically coupled to a lumen of aspiration catheter 108. Distal portion 226 may be an elongated body defining a tube size, e.g., an outer diameter (OD) and a distal lumen having a distal lumen ID. In some examples, distal portion 226 has an OD from about 1 Fr to about 12 Fr, and may have an ID from about 0.165 millimeters (mm) to about 4 mm. Distal portion 226 may be made of one or more materials. For example, distal portion 226 may be made of plastic, rubber, a polymer, polyvinyl chloride (PVC), a silicone, or the like, and may have a Shore A hardness above about 40A to about 70A. In some examples, distal portion 226 maybe substantially clear or transparent, or translucent. In some examples, distal portion 226 may be a 12 Fr tube having about a 3 mm ID and a Shore A hardness of about 60A.

[0052] Distal portion 226 may have a length 262 configured to improve blood loss performance (e.g., decrease or optimize blood loss), improve blockage detection time (e.g., reduce blockage detection time), improve free flow aspiration rate (e.g., to remove a blockage or thrombus) while being long enough to reach from the flow control device 206 outside of the sterile zone to the aspiration catheter 108 inside of the sterile zone, e.g., to enable the flow control device 206 to be located outside of the sterile zone. In some examples, distal portion 226 has a length 262 of at least 0.25 meters, or at least about 0.5 meters, or at least about 1 meter, or at least about 2 meters, or at least about 3 meters.

[0053] Proximal portion 236 defines a lumen (referred to as a proximal lumen) configured to be fluidically coupled to suction source 102 and / or discharge reservoir 104. For example, a proximal end of proximal portion 236 may be connected to distal end of discharge reservoir 104 via aspiration pump connector 246 such that the proximal lumen of proximal portion 236 is fluidically coupled to discharge reservoir 104. Proximal portion 236 may be configured to be connected to distal portion 226, for example, the proximal lumen may be configured to be fluidically coupled to the distal lumen via step connector 240.

[0054] Proximal portion 236 may be an elongated body defining a tube size, e.g., an OD, and a proximal lumen having a proximal lumen ID. Proximal portion 236 may have an ID that is greater than an ID of distal portion 226, e.g., the ID of the proximal lumen may be greater than or larger than the ID of the distal lumen. In some examples, proximal portion 236 has an OD from about 14 Fr or about 4.7 mm to about 30 Fr or about 10 mm, and has an ID from about 2 millimeters (mm) to about 8 mm, or an ID of about 4.5 mm and an OD of about 8 mm.

[0055] Proximal portion 236 may be made of one or more suitable materials. For example, proximal portion 236 may be made of plastic, rubber, a polymer, polyvinyl chloride (PVC), a silicone, or the like, and may have a Shore A hardness above about 40A to about 70A. In some examples, proximal portion 236 may be an 18 Fr tube having about a 4.8 mm ID and a Shore A hardness of about 56A, or proximal portion 236 may be a 24 Fr tube having about a 4.5 mm ID and a Shore A hardness of about 56A.

[0056] Proximal portion 236 may be configured to be compatible with a flow sensor, e.g., flow sensor 212. For example, flow sensor 212 may be calibrated to a particular tube size, and aspiration tube 216 may enable flow control device 206 to be used with a range of catheter sizes, e.g., because proximal portion 236 may be used with a range of catheter sizes (e.g., proximal portion 236 stays the same and flow sensor 212 may stay the same). Also,proximal portion 236 may enable control circuitry 120 to use the same algorithm for a range of catheter sizes because proximal portion 236 size stays consistent for a range of catheter sizes and / or signals from flow sensor 212 stay consistent.

[0057] Proximal portion 236 may have a size (e.g., and OD) configured to couple with flow sensor 212, and a wall thickness, e.g., (OD - ID) / 2, and material compatible with flow sensor 212. In some examples, flow sensor 212 includes an ultrasonic sensor, and proximal portion 236 is sized to fit within flow sensor 212 and is formed from a material and has a wall thickness and rigidity that enables an ultrasonic transducer of sensor 212 to emit ultrasonic sound waves into the proximal lumen and receive ultrasonic sound waves from the proximal lumen. In some examples, flow sensor 212 includes an optical sensor, and proximal portion 236 is sized to fit within flow sensor 212 and is formed from a material and wall thickness that enables a light source of flow sensor 212 to may emit electromagnetic waves (e.g., light) into the proximal lumen and receive electromagnetic waves from the proximal lumen, e.g., proximal portion 236 may be substantially clear or transparent, or translucent.

[0058] In some examples, valve 210 comprises a solenoid-actuated pinch valve. In the example shown, valve 210 may be normally closed, e.g., in a closed or pinch position when the solenoid is not energized. An example valve is described in commonly-assigned U.S. Patent Application Publication No. 2024 / 0108794. Valve 210 may include a release button 209. For example, a user may depress release button 209 in order to open valve 210, such as to insert or remove aspiration tube 216 within or from flow control device 206 (e.g., insert aspiration tube 216 in or remove aspiration tube 216 from within valve channel 211). In some examples, flow control device 206 includes one or more features configured to aid a user in inserting or removing aspiration tube 216. In the examples shown in FIGS. 2 and 4, housing 202 includes recess 218 configured to provide a surface for a user to grip when depressing release button 209. For example, the user may position the user’s fingers within recess 218 to grip housing 202 in order to depress release button 209, e.g., with the user’s thumb or other fingers. In this way, recess 218 may help a user gain leverage as the user depresses release button 209.

[0059] Proximal portion 236 is also compatible for use with a valve 210 of flow control device 206, e.g., is configured to be opened and closed with a valve, e.g., such that valve 210 may control proximal lumen to fully open (e.g., for patent fluid flow), partially open, partially close, or fully close (e.g., to be fully occluded). For example, valve 210 may be selected and / or configured to work, and / or optimally work, with a particular tube size, e.g., an 18 Fr tube. For example, proximal portion 236 may be configured to be compressed by a pinch valve 210 and to resist compression to open the proximal lumen upon release of compressionby the pinch valve 210. Proximal portion 236 may have a size (e.g., and OD) configured to couple with valve 210, and a wall thickness and material compatible with pinch valve 210, e.g., soft and flexible enough to be compressed by valve 210 to partially or fully occlude the proximal lumen and stiff or hard enough to retain its shape upon partial or full release of compression by valve 210 to partially or fully open the proximal lumen, e.g., having a hardness in a range of about 40Ato about 70A. In some examples, proximal portion 236 may have an OD of less than about 8 mm, e.g., to easily fit into valve 210, be fully compressible (e.g., for with a fully occluded proximal lumen) within 20 milliseconds with a pinch valve spring force (of valve 210) of between 100 Newtons (N) and 140N, provide enough resistance (e.g., having a hardness of between about 55A-65Ato compression to support a solenoid opening force (e.g., of valve 210), and not fatigue (e.g., material fatigue) under vacuum (from suction source 102) and compression (from valve 210) for the duration of a procedure, e.g., up to about 2 hours. In some examples, valve 210 is configured to control the proximal lumen to fully open or fully close, but not partially open or partially close.

[0060] In some examples, proximal portion 236 has a length 264 configured to improve blood loss performance (e.g., decrease or optimize blood loss), improve blockage detection time (e.g., reduce blockage detection time), improve free flow aspiration rate (e.g., to remove a blockage or thrombus), e.g., relative to a long tube, while being long enough to reach from the flow control device 206 to discharge reservoir 104 and / or suction source 102 (FIG. 1). For example, proximal portion 236 may have a length configured to reach discharge reservoir 104 from step connector 240 when step connector 240 is engaged with connector attachment 208 to allow the flow control device 206 to be used and / or located in various positions around suction source 102 and / or discharge reservoir 104 as needed, and to be able to connect to discharge reservoir 104 (or suction source 102) with any suitable connector, e.g., including a vertical connector on the top of discharge reservoir 104. In some examples, proximal portion 236 may have a length of at least 0.1 meters, or at least about 0.25 meters, or at least about 0.5 meters, or at least about 1 meter.

[0061] In some examples, distal portion 226 is physically separate from the proximal portion 236, with step connector 240 configured to mechanically connect distal portion 226 to proximal portion 236 and / or to fluidically couple the distal lumen and the proximal lumen. In other examples, aspiration tube 216 may not include step connector 240, but instead may include a transition portion (not shown) between the IDs of distal portion 226 and proximal portion 236. For example, distal portion 226 and proximal portion 236 may be integrally and / or monolithically formed with each other and with a transition portion between them, thetransition portion including a transition (e.g., step and / or tapered) between the smaller ID of distal portion 226 and the larger ID of proximal portion 236.

[0062] FIGS. 5A-5D are different views of an example step connector 240. FIG. 5A is a perspective view of step connector 240, FIG. 5B is a cross-sectional view of step connector 240 taken along the line A-A’ shown in FIG. 5C, the cross-section being taken in a direction orthogonal to a longitudinal axis of step connector 240, FIG. 5C is a schematic side view of step connector 240, and FIG. 5D is a cross-sectional view of an example step connector, the cross-section being taken along the line B-B’ shown in FIG. 5 A and in a direction parallel to the longitudinal axis of step connector 240. In the examples shown, step connector 240 includes a distal end 326 configured to connect to distal portion 226 and a proximal end 336 configured to connect to proximal portion 236. Step connector 240 includes connector lumen 342, which is configured to fluidically couple the distal lumen of distal portion 226 (FIG. 3) of aspiration tube 216 and the proximal lumen of proximal portion 236 of aspiration tube 216, e.g., thereby fluidically coupling the distal and proximal lumens.

[0063] Step connector 240 is configured to engage with connector attachment 208 of flow control device 206. In some examples, step connector 240 may be configured to visually indicate a direction of fluid flow from distal portion 226 to proximal portion 236. For example, step connector 240 may include flow indicator 344 configured to visually indicate which end is distal end 326, which end is proximal end 336, and a direction of fluid flow from distal portion 226 to proximal portion 236.

[0064] FIG. 4 is a perspective view of aspiration tube 216 positioned within flow control device 206. In the example shown, proximal portion 236 is engaged with, or positioned within, channel 214, valve 210, and flow sensor 212, step connector 240 is engaged with connector attachment 208, and distal portion 226 is connected to proximal portion 236 by step connector 240.

[0065] In the example shown, proximal portion 236 is positioned within flow sensor 212 to enable flow sensor 212 to measure a flow of a fluid (e.g., blood) within proximal portion 236. Valve 210 comprises a pinch valve, and proximal portion 236 is positioned within pinch valve 210 to enable pinch valve 210 to compress proximal portion 236 with a compression force to partially or fully occlude the proximal lumen and / or release proximal portion 236 to allow proximal portion 236 to partially or fully open. In the example shown, step connector 240 is engaged with connector attachment 208 at a distance 260 from valve 210 to enable flow sensor 212 to determine a flow of a fluid between step connector 240 and valve 210 within the proximal lumen, from which control circuitry 120 may determine if aspiration tube216 and / or aspiration catheter 108 is partially or fully blocked or occluded, e.g., by a material, thrombus, or the like.

[0066] FIG. 6 is a flow diagram of an example method of aspirating a material from a patient. The method of FIG. 6 is described with reference to the various aspects of medical aspiration system 100 of FIG. 1 and flow control device 206 and aspiration tube 216 of FIGS. 2-5 for illustrative purposes, however, such descriptions are not intended to be limiting and the method can be used with other example systems including aspiration tubing described herein.

[0067] A user connects aspiration catheter 108 to aspiration tube 216 (600). For example, a clinician may connect aspiration catheter 108 to aspiration tube 216 via catheter connector 244 while within a sterile zone. In some examples, catheter connector 244 is a hemostasis valve, and the clinician connects catheter 108 to aspiration tube 216 via hemostasis valve 244. In some examples, catheter 108 may include an attached hemostasis valve, and the clinician may connect catheter 108 to aspiration tube 216 via the attached hemostasis valve 244.

[0068] The user, or a different user, may position proximal portion 236 of aspiration tube 216 within flow sensor 212 and valve 210 of flow control device 206 (602). For example, the user may position proximal portion 236 within channel 214 and channels of flow sensor 212 and valve 210 located outside of the sterile zone. In some examples, before or after positioning proximal portion 236 within flow control device 206, the user may connect distal portion 226 to proximal portion 236, e.g., using step connector 240 and connecting distal and proximal portions 226, 236 outside of the sterile zone. For example, the user may fluidically couple the distal and proximal lumens of distal portion 226 and proximal portion 236, respective, to connector lumen 342 by connecting a proximal end of distal portion 226 to a distal end 326 of step connector 240 and by connecting a distal end of proximal portion 236 to a proximal end 336 of step connector 240. In some examples, the user may connect the distal portion 226 and the proximal portion 236 may press fitting a portion of the length of distal and proximal portions 226, 236 over or within a portion of the length of distal and proximal ends 326, 336 of step connector 240, respectively.

[0069] The user may then cause step connector 240 to engage with connector attachment 208. Connector attachment 208 may comprise a recess in housing 202 configured to receiver step connector 240, and the user may place and / or press fit step connector within connector attachment 208.

[0070] The user may connect a proximal end of proximal portion 236 to suction source 102 (606). For example, the user may connect proximal portion 236 to discharge reservoir104 using aspiration pump connector 246. The user, e.g., a clinician, may then aspirate material from a patient using aspiration catheter 108 while controlling the flow of blood from the patient using flow control device 206 (608). For example, after aspiration catheter 108 is connected to suction source 102 via aspiration tube 216 and proximal portion 236 and step connector 240 are positioned within flow control device 206, a user (which may be the clinician or a different user) may power on suction source 102 and flow control device 206 to provide suction to aspiration catheter 108 and to control the flow and / or amount of blood aspirated while aspirating material from the patient.

[0071] The techniques described in this disclosure, including those attributed to control circuitry 120, or various constituent components, may be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the techniques may be implemented within one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components, embodied in programmers, such as clinician or patient programmers, medical devices, or other devices. Processing circuitry, control circuitry, and sensing circuitry, as well as other processors and controllers described herein, may be implemented at least in part as, or include, one or more executable applications, application modules, libraries, classes, methods, objects, routines, subroutines, firmware, and / or embedded code, for example. In addition, analog circuits, components and circuit elements may be employed to construct one, some or all of the control circuitry 120, instead of or in addition to the partially or wholly digital hardware and / or software described herein. Accordingly, analog or digital hardware may be employed, or a combination of the two. Whether implemented in digital or analog form, or in a combination of the two, control circuitry 120 can comprise a timing circuit.

[0072] In one or more examples, the functions described in this disclosure may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored on, as one or more instructions or code, a computer- readable medium and executed by a hardware-based processing unit. The computer-readable medium may be an article of manufacture including a non-transitory computer-readable storage medium encoded with instructions. Instructions embedded or encoded in an article of manufacture including a non-transitory computer-readable storage medium encoded, may cause one or more programmable processors, or other processors, to implement one or more of the techniques described herein, such as when instructions included or encoded in the non- transitory computer-readable storage medium are executed by the one or more processors. Example non-transitory computer-readable storage media may include RAM, ROM,programmable ROM (PROM), erasable programmable ROM (EPROM), electronically erasable programmable ROM (EEPROM), flash memory, a hard disk, a compact disc ROM (CD-ROM), a floppy disk, a cassette, magnetic media, optical media, or any other computer readable storage devices or tangible computer readable media.

[0073] In some examples, a computer-readable storage medium comprises non-transitory medium. The term “non-transitory” may indicate that the storage medium is not embodied in a carrier wave or a propagated signal. In certain examples, a non-transitory storage medium may store data that can, over time, change (e.g., in RAM or cache).

[0074] The functionality described herein may be provided within dedicated hardware and / or software modules. Depiction of different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, functionality associated with one or more modules or units may be performed by separate hardware or software components, or integrated within common or separate hardware or software components. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0075] The following clauses provide some examples of the disclosure. The examples described herein may be combined in any permutation or combination.

[0076] Example 1: A medical aspiration system including: an aspiration tube including: a distal portion defining a distal lumen configured to be fluidically coupled to a lumen of an aspiration catheter; and a proximal portion defining a proximal lumen configured to be fluidically coupled to an aspiration pump, wherein the proximal lumen is fluidically coupled to the distal lumen, and wherein an inner diameter of the proximal lumen is greater than an inner diameter of the distal lumen; and a flow control device including: a housing configured to receive the proximal portion of the aspiration tube; a flow sensor configured to sense fluid flow within the proximal lumen; and a valve configured to modulate fluid flow through the proximal lumen.

[0077] Example 2: The medical aspiration system of example 1, wherein the proximal portion is configured to be positioned within the flow sensor and is configured to enable the flow sensor to measure a flow of a fluid within the proximal lumen.

[0078] Example 3 : The medical aspiration system of example 1 or example 2, wherein the flow sensor comprises an ultrasonic flow sensor configured to sense fluid flow in the proximal lumen from a location external to the proximal portion.

[0079] Example 4: The medical aspiration system of any one of examples 1 through 3, wherein the valve comprises a pinch valve configured to compress the proximal portion, and wherein the proximal portion is configured to be positioned within the pinch valve.

[0080] Example 5 : The medical aspiration system of example 4, wherein proximal portion is configured to be compressed by the pinch valve to at least partially occlude the proximal lumen and to resist compression to at least partially open the proximal lumen upon release of compression by the pinch valve.

[0081] Example 6: The medical aspiration system of example 5, wherein the proximal portion comprises a Shore A hardness of about 40Ato about 70A.

[0082] Example 7 : The medical aspiration system of any one of examples 1 through 6, wherein the distal portion is separate from the proximal portion, the system further comprising a step connector configured to mechanically couple the distal portion and the proximal portion and configured to fluidically couple the distal lumen and the proximal lumen.

[0083] Example 8: The medical aspiration system of example 7, wherein the step connector is configured to engage with a recess of the flow control device, wherein the step connector is configured to indicate a direction of fluid flow from the distal portion to the proximal portion.

[0084] Example 9: The medical aspiration system of example 8, wherein the step connector, when engaged with the recess, is positioned at a predetermined distance from the valve, wherein the predetermined distance enables the flow sensor to sense a flow rate of the fluid between the step connector and the valve, and enables the flow control device to determine if the aspiration catheter or the aspiration tube is at least partially blocked based on the flow rate.

[0085] Example 10: The medical aspiration system of any one of examples 7 through 9, wherein a length of the distal portion from the aspiration catheter to the step connector is greater than about 1 meter, wherein a length of the proximal portion from the step connector to an aspiration pump connector is greater than about 0.25 meters.

[0086] Example 11: The medical aspiration system of any one of examples 1 through 10, wherein the inner diameter of the distal lumen is at least 12 French (Fr), wherein the inner diameter of the proximal lumen is at least 14 Fr.

[0087] Example 12: The medical aspiration system of any one of examples 1 through 11, wherein at least one of the distal portion or the proximal portion is substantially transparent or substantially translucent.

[0088] Example 13: An aspiration tube including: a distal portion defining a distal lumen configured to be fluidically coupled to a lumen of an aspiration catheter; and a proximal portion defining a proximal lumen configured to be fluidically coupled to an aspiration pump, wherein an inner diameter of the proximal lumen is greater than an inner diameter of the distal lumen, wherein the proximal portion is configured to be compatible with an ultrasonic flow sensor, and wherein the proximal portion is configured to be compressed by a pinch valve and to resist compression to open the proximal lumen upon release of compression by the pinch valve.

[0089] Example 14: The aspiration tube of example 13, wherein the distal portion is separate from the proximal portion, the aspiration tube further comprising a step connector configured to mechanically couple the proximal portion and the distal portion and configured to fluidically couple the distal lumen and the proximal lumen, and wherein the step connector is configured to engage with a recess of a flow control device including the ultrasonic flow sensor, wherein the step connector is configured to indicate a direction of fluid flow from the distal portion to the proximal portion.

[0090] Example 15: The aspiration tube of example 14, wherein the step connector, when engaged with the recess, is positioned at a predetermined distance from the pinch valve, wherein the predetermined distance enables the ultrasonic flow sensor to sense a flow rate of the fluid between the step connector and the pinch valve, and enables the flow control device to determine if the aspiration catheter or the aspiration tube is at least partially blocked based on the flow rate.

[0091] Example 16: The aspiration tube of any one of examples 13 through 15, wherein the inner diameter of the distal lumen is at least 12 French (Fr), wherein the inner diameter of the proximal lumen is at least 14 Fr.

[0092] Example 17: The aspiration tube of any one of examples 13 through 16, wherein at least one of the distal portion or the proximal portion is substantially transparent or substantially translucent.

[0093] Example 18: The aspiration tube of any one of examples 13 through 17, wherein the proximal portion comprises a Shore durometer of about 40Ato about 70A.

[0094] Example 19: A method of aspirating material from a patient, the method including: connecting an aspiration catheter to an aspiration tube, the aspiration tube includes a distal portion defining a distal lumen configured to be fluidically coupled to a lumen of the aspiration catheter; and a proximal portion defining a proximal lumen configured to be fluidically coupled to an aspiration pump, wherein an inner diameter of the proximal lumen is greater than an inner diameter of the distal lumen; positioning the proximal portion within ahousing of a flow control device, the flow control device including: a flow sensor configured to sense fluid flow within the proximal lumen when the proximal portion is within the housing; and a valve configured to modulate fluid flow through the proximal lumen; connecting the proximal portion to the aspiration pump; and aspirating, using the aspiration catheter, material from a patient.

[0095] Example 20: The method of example 19, wherein at least one of the distal portion or the proximal portion is substantially transparent or substantially translucent.

[0096] Various aspects of the disclosure have been described. These and other aspects are within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1. A medical aspiration system comprising: an aspiration tube comprising: a distal portion defining a distal lumen configured to be fluidically coupled to a lumen of an aspiration catheter; and a proximal portion defining a proximal lumen configured to be fluidically coupled to an aspiration pump, wherein the proximal lumen is fluidically coupled to the distal lumen, and wherein an inner diameter of the proximal lumen is greater than an inner diameter of the distal lumen; and a flow control device comprising: a housing configured to receive the proximal portion of the aspiration tube; a flow sensor configured to sense fluid flow within the proximal lumen; and a valve configured to modulate fluid flow through the proximal lumen.

2. The medical aspiration system of claim 1, wherein the proximal portion is configured to be positioned within the flow sensor and is configured to enable the flow sensor to measure a flow of a fluid within the proximal lumen.

3. The medical aspiration system of claim 1 or claim 2, wherein the flow sensor comprises an ultrasonic flow sensor configured to sense fluid flow in the proximal lumen from a location external to the proximal portion.

4. The medical aspiration system of any one of claims 1 through 3, wherein the valve comprises a pinch valve configured to compress the proximal portion, and wherein the proximal portion is configured to be positioned within the pinch valve.

5. The medical aspiration system of claim 4, wherein proximal portion is configured to be compressed by the pinch valve to at least partially occlude the proximal lumen and to resist compression to at least partially open the proximal lumen upon release of compression by the pinch valve.

6. The medical aspiration system of claim 5, wherein the proximal portion comprises a Shore A hardness of about 40A to about 70A.

7. The medical aspiration system of any one of claims 1 through 6. wherein the distal portion is separate from the proximal portion, the system further comprising a step connector configured to mechanically couple the distal portion and the proximal portion and configured to fluidically couple the distal lumen and the proximal lumen.

8. The medical aspiration system of claim 7, wherein the step connector is configured to engage with a recess of the flow control device, wherein the step connector is configured to indicate a direction of fluid flow from the distal portion to the proximal portion.

9. The medical aspiration system of claim 8, wherein the step connector, when engaged with the recess, is positioned at a predetermined distance from the valve, wherein the predetermined distance enables the flow sensor to sense a flow rate of the fluid between the step connector and the valve, and enables the flow control device to determine if the aspiration catheter or the aspiration tube is at least partially blocked based on the flow rate.

10. The medical aspiration system of any one of claims 7 through 9, wherein a length of the distal portion from the aspiration catheter to the step connector is greater than about 1 meter, wherein a length of the proximal portion from the step connector to an aspiration pump connector is greater than about 0.25 meters.

11. The medical aspiration system of any one of claims 1 through 10, wherein the inner diameter of the distal lumen is at least 12 French (Fr), wherein the inner diameter of the proximal lumen is at least 14 Fr.

12. The medical aspiration system of any one of claims 1 through 11, wherein at least one of the distal portion or the proximal portion is substantially transparent or substantially translucent.

13. An aspiration tube comprising : a distal portion defining a distal lumen configured to be fluidically coupled to a lumen of an aspiration catheter; and a proximal portion defining a proximal lumen configured to be fluidically coupled to an aspiration pump,wherein an inner diameter of the proximal lumen is greater than an inner diameter of the distal lumen, wherein the proximal portion is configured to be compatible with an ultrasonic flow sensor, and wherein the proximal portion is configured to be compressed by a pinch valve and to resist compression to open the proximal lumen upon release of compression by the pinch valve.

14. The aspiration tube of claim 13, wherein the distal portion is separate from the proximal portion, the aspiration tube further comprising a step connector configured to mechanically couple the proximal portion and the distal portion and configured to fluidically couple the distal lumen and the proximal lumen, and wherein the step connector is configured to engage with a recess of a flow control device including the ultrasonic flow sensor, wherein the step connector is configured to indicate a direction of fluid flow from the distal portion to the proximal portion.

15. The aspiration tube of claim 14, wherein the step connector, when engaged with the recess, is positioned at a predetermined distance from the pinch valve, wherein the predetermined distance enables the ultrasonic flow sensor to sense a flow rate of the fluid between the step connector and the pinch valve, and enables the flow control device to determine if the aspiration catheter or the aspiration tube is at least partially blocked based on the flow rate.

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