Aspirated material volume determination in thrombectomy systems

The thrombectomy system uses pressure and flow sensors to estimate aspirated material volume, addressing the challenge of incorrect catheter placement and blood loss by optimizing operational states and providing alerts, enhancing clot removal efficiency.

WO2026020088A1PCT designated stage Publication Date: 2026-01-22WALK VASCULAR LLC
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Patent Information

Application Number
PCT/US2025/038211
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-07-19
Filing Date
2025-07-18
Publication Date
2026-01-22

AI Technical Summary

Technical Problem

Conventional catheter-based thrombectomy devices face challenges in accurately determining whether the catheter is engaged with clot material, leading to excessive patient blood loss and inefficiencies in clot removal due to incorrect catheter placement or intermittent displacement.

Method used

Implementing a thrombectomy system with pressure and flow sensors to estimate the aspirated material volume by analyzing pressure and air amount values within the aspiration path, allowing for selective maintenance or modification of the operational state and providing alerts on a user interface.

Benefits of technology

Minimizes excessive patient blood loss and improves clot removal efficiency by ensuring accurate catheter engagement and optimizing the thrombectomy process.

✦ Generated by Eureka AI based on patent content.

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Abstract

A thrombectomy system may be configurable to: (i) access one or more pressure values obtained via a pressure sensor associated with an aspiration path of the thrombectomy system and indicating a current pressure within the aspiration path; (ii) access one or more air amount values obtained via a flow sensor associated with the aspiration path and indicating a current amount of air within the aspiration path; (iii) utilize the one or more pressure values and the one or more air amount values to provide input to a volume module to generate an estimated material volume indicating an estimated volume of material aspirated from a subject via the thrombectomy system; and (iv) based on the estimated material volume, (a) selectively maintain an operational state of the thrombectomy system, (b) selectively modify the operational state of the thrombectomy system, and / or (c) selectively present an alert on a user interface.
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Description

ASPIRATED MATERIAL VOLUME DETERMINATION IN THROMBECTOMY SYSTEMS CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of United States Provisional Patent Application No. 63 / 673,616, filed on July 19, 2024, and entitled ASPIRATED MATERIAL VOLUME DETERMINATION IN THROMBECTOMY SYSTEMS, the entirety of which is incorporated herein by reference for all purposes.BACKGROUNDTechnical Field

[0002] The present disclosure pertains generally to medical devices and methods of their use. More particularly, the present invention pertains to aspiration and thrombectomy devices and methods of use thereof.Description of the Related Technologies

[0003] Blood clots (thrombi) can form in various parts of the body and can pose a serious health risk. For instance, blood clots can block blood flow and / or lead to tissue damage, organ dysfunction, or life-threatening conditions like stroke or heart attack. Thrombectomy is a medical procedure used to remove blood clots from blood vessels to restore blood flow and prevent further complications.

[0004] Various types of catheter-based thrombectomy devices have been developed to aid in the removal of thrombotic material. Such devices are typically inserted into the affected blood vessel through a small incision or artery access point. Catheter-based thrombectomy devices include mechanical thrombectomy devices, rheolytic thrombectomy devices, and others (e.g., ultrasound-assisted devices).

[0005] Mechanical thrombectomy devices can implement various types of mechanical components to engage with and remove thrombotic material. For instance, stent retrievers and clot retriever baskets are designed for navigation through vasculature to the site of a clot, deployment at the clot site to cause the stent retriever or clot retriever basket to entrap the clot, and withdrawal through the vasculature to facilitate clot removal. As another example, suction-based thrombectomy devices use negative pressure to aspirate clots from blood vessels (e.g., via a catheter with a distal tip to be placed near the clot prior to activation to draw the clot into a collection chamber, where it is trapped and removed). As yet another example, rotational thrombectomy devices employ rotational mechanisms to fragment and remove clots (e.g., a rotatingwire or catheter tip for creating shear forces that break down clots), allowing the fragments to be cleared by the body or using aspiration or other techniques.

[0006] Rheolytic thrombectomy devices employ mechanisms that rely on high- velocity jets to break down and remove thrombotic material. Rheolytic thrombectomy mechanisms may be positioned on catheters (e.g., at or near the distal tip) and can utilize saline solution, or a mixture of saline and the patient's own blood, to create high-velocity jets directed toward clots to generate shear forces that disrupt the clot's structure. The jetted fluid can cause fragmentation of the clot, and the fragments may then be cleared naturally from the body or by aspiration techniques.

[0007] Some thrombectomy devices employ aspects of suction-based thrombectomy devices and rheolytic thrombectomy devices. For instance, some thrombectomy devices utilize a saline jet positioned at or near a distal tip of an aspiration catheter, allowing for aspiration of clotfragments as the jetted saline macerates the clot (e.g., thrombus and / or soft emboli).

[0008] To facilitate clot removal, catheter-based thrombectomy devices are typically navigated toward a clot site within patient vasculature. However, users (e.g., healthcare practitioners) often experience difficulty in determining whether a catheter of a thrombectomy device has reached clot material before activating clot aspiration / removal functions. Consequently, suction can inadvertently be applied when the catheter is not engaged with clot material, resulting in patient blood loss. Furthermore, while suction is being applied, the catheter can repeatedly come into and out of engagement with clot material, which can also result in patient blood loss. Excessive patient blood loss during clot aspiration operations (e.g., greater than 0.5 to 1.0 liters) can present patient safety concerns, result in failed clot removal, increase treatment times, and / or cause other negative outcomes.

[0009] The subject matter disclosed herein is not limited to embodiments that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some embodiments described herein may be practiced.SUMMARY

[0010] In some aspects, the techniques described herein relate to a thrombectomy system, including: one or more processors; and one or more computer-readable recording media that store instructions that are executable by the one or more processors to configure the thrombectomy system to: access one or more pressure values obtained via a pressure sensor associated with an aspiration path of the thrombectomy system, the one or more pressure values indicating a current pressure within the aspiration path; access one or more air amount values obtained via a flow sensor associated with the aspiration path, the one or more air amount values indicating a current amount of air within the aspiration path; utilize the one or more pressure values and the one or more air amount values to provide input to a volume module to generate an estimated material volume, the estimated material volume indicating an estimated volume of material aspirated from a subject via the thrombectomy system; and based on the estimated material volume, (i) selectively maintain an operational state of the thrombectomy system, (ii) selectively modify the operational state of the thrombectomy system, and / or (iii) selectively present an alert on a user interface.

[0011] In some aspects, the techniques described herein relate to a method, including: accessing one or more pressure values obtained via a pressure sensor associated with an aspiration path of a thrombectomy system, the one or more pressure values indicating a current pressure within the aspiration path; accessing one or more air amount values obtained via a flow sensor associated with the aspiration path, the one or more air amount values indicating a current amount of air within the aspiration path; utilizing the one or more pressure values and the one or more air amount values as input to a volume module to generate an estimated material volume, the estimated material volume indicating an estimated volume of material aspirated from a subject via the thrombectomy system; and based on the estimated material volume, (i) selectively maintaining an operational state of the thrombectomy system, (ii) selectively modifying the operational state of the thrombectomy system, and / or (iii) selectively presenting an alert on a user interface.

[0012] In some aspects, the techniques described herein relate to one or more computer-readable recording media that store instructions that are executable by one or more processors of a thrombectomy system to configure the thrombectomy system to:access one or more pressure values obtained via a pressure sensor associated with an aspiration path of the thrombectomy system, the one or more pressure values indicating a current pressure within the aspiration path; access one or more air amount values obtained via a flow sensor associated with the aspiration path, the one or more air amount values indicating a current amount of air within the aspiration path; utilize the one or more pressure values and the one or more air amount values as input to a volume module to generate an estimated material volume, the estimated material volume indicating an estimated volume of material aspirated from a subject via the thrombectomy system; and. based on the estimated material volume, (i) selectively maintain an operational state of the thrombectomy system, (ii) selectively modify the operational state of the thrombectomy system, and / or (iii) selectively present an alert on a user interface.

[0013] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an indication of the scope of the claimed subject matter.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Various objects, features, characteristics, and advantages of the invention will become apparent and more readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings and the appended claims, all of which form a part of this specification. In the Drawings, like reference numerals may be utilized to designate corresponding or similar parts in the various Figures, and the various elements depicted are not necessarily drawn to scale, wherein:

[0015] Figure 1 illustrates a perspective view of an example aspiration catheter.

[0016] Figure 2 illustrates a plan view of example disposable components of a system for aspirating thrombus according to an embodiment of the present disclosure.

[0017] Figure 3 illustrates a sectional view of an example distal end of the aspiration catheter of the system for aspirating thrombus of Figure 1.

[0018] Figure 4 illustrates a detail view of an example y-connector of the aspiration catheter of the system for aspirating thrombus of Figure 1.

[0019] Figure 5 illustrates a plan view of example disposable components of a system for aspirating thrombus according to an embodiment of the present disclosure.

[0020] Figure 6A illustrates a perspective view of an example system for aspirating thrombus of Figure 4.

[0021] Figure 6B illustrates a schematic representation of the aspiration system according to an implementation of the present disclosure.

[0022] Figure 7 illustrates a conceptual representation of determining the volume of material aspirated from a subject by a thrombectomy system, according to implementations of the present disclosure.

[0023] Figure 8 illustrates an example flow diagram depicting acts associated with determining the volume of material aspirated from a subject by a thrombectomy system, in accordance with implementations of the present disclosure.DETAILED DESCRIPTION

[0024] As indicated hereinabove, clot removal operations performed using conventional catheter-based thrombectomy devices can result in patient blood loss due to incorrect catheter placement or intermittent displacement of the catheter. Excessive patient blood loss during clot removal can present patient safety and / or other concerns.

[0025] The present disclosure pertains to systems, devices, and techniques for determining the volume of aspirated material in thrombectomy systems.

[0026] For example, to determine the volume of aspirated material, a thrombectomy system may implement a pressure sensor and a flow sensor along the aspiration path for aspirating material from patients / subjects. The aspiration path can be defined by the aspiration catheter, tubing, and canister of the thrombectomy system. The thrombectomy system may access pressure values obtained via the pressure sensorthat indicate the current pressure within the aspiration path. The thrombectomy system may further access air amount values obtained via the flow sensor indicating the current amount of air within the aspiration path. The pressure values and the air amount values may be used to provide input to a volume module to obtain an estimated material volume indicating the estimated volume of material aspirated from the subject. Based on the estimated material volume, the thrombectomy system can (i) selectively maintain its clot removal / aspiration state (e.g., when the estimated material volume is sufficiently low) or (ii) selectively modify its operational state and / or present an alert on a user interface (e.g., when the estimated material volume is sufficiently high).

[0027] In some implementations, the estimated material volume may be determined based on a difference between an initial air volume of the aspiration path (or total volume of the aspiration path) and current estimated air volume values of air within the aspiration path. The current estimated air volume values may be determined based on the air amount values and the pressure values noted above, as well as initial values related to the thrombectomy system (e.g., priorto activating the suction / aspiration state or clot removal state of the thrombectomy system). The initial values can comprise initial pressure values, initial air amounts, and initial air volumes. The current estimated air volume can be based on a product of (i) a ratio of the one or more air amount values and the one or more initial air amount values, (ii) a ratio of the one or more initial pressure values and the one or more pressure values, and / or (iii) the one or more initial air volume values.

[0028] In some instances, determining the volume of material aspirated by a thrombectomy system and triggering actions based on the determined volume, as described herein, may provide various advantages, such as minimizing the incidence of excessive patient blood loss, which can beneficially facilitate improved patient outcomes.

[0029] Although examples discussed herein focus, in at least some respects, on determining the volume of aspirated material and triggering actions for a thrombectomy device, the techniques and / or components discussed herein may be implemented on other types of catheter-based devices, even outside of the domain of thrombectomy.Example Thrombectomy Device

[0030] The following discussion relates to an example catheter-based thrombectomy device that implements aspiration aspects and rheolytic aspects, and that may comprise or be used to implement at least some disclosed embodiments. As noted above, the principles disclosed herein may be implemented in conjunction with other types of catheter-based thrombectomy systems.

[0031] A system 100 for aspirating thrombus is illustrated in Figure 1, illustrating primarily a distal end 105 of an aspiration catheter 102. Figures 2-4 illustrate the system 100 in greater detail. The system 100 for aspirating thrombus includes three major components: a pump 101, an aspiration catheter 102, and a tubing set 103. The aspiration catheter 102 and the tubing set 103 may comprise disposable components. The pump 101 and the pump's associated pump base may comprise reusablecomponents. In some implementations, it is not necessary to sterilize the pump 101, as it may be kept in a non-sterile field or area during use. The aspiration catheter 102 and the tubing set 103 may each be supplied sterile, after sterilization by ethylene oxide gas, electron beam, gamma, or other sterilization methods. The aspiration catheter 102 may be packaged and supplied separately from the tubing set 103, or the aspiration catheter 102 and the tubing set 103 may be packaged together and supplied together. Alternatively, the aspiration catheter 102 and tubing set 103 may be packaged separately, but supplied together (i.e., bundled).

[0032] As shown in Figures 2-4, the aspiration catheter 102 has a distal end 105 and includes an over-the-wire guidewire lumen / aspiration lumen 106 extending between an open distal end 107, and a proximal end comprising a y-connector 110. The catheter shaft 111 of the aspiration catheter 102 is connected to the y-connector 110 via a protective strain relief 112. In other embodiments, the catheter shaft 111 may be attached to the y-connector 110 with a luer fitting. The y-connector 110 comprises a first female luer 113 which communicates with a catheter supply lumen 114 (Figure 3), and a second female luer 115 which communicates with the guidewire lumen / aspiration lumen 106.

[0033] A spike 116 for coupling to a fluid source (e.g., saline bag, saline bottle) allows fluid to enter through an extension tubing 118 and flow into a supply tube 119. An optional injection port allows injection of materials or removal of air. A cassette 121 having a moveable piston 122 is used in conjunction with a mechanical actuator 123 of the pump 101. Fluid is pumped into an injection tube 124 from action of the cassette 121 as applied by the actuator 123 of the pump 101. A male luer 126, hydraulically communicating with the catheter supply lumen 114, via the injection tube 124, is configured to attach to the female luer 113 of the y-connector 110.

[0034] Accessories are illustrated that are intended for applying a vacuum source, such as a syringe 130 having a plunger 132 and a barrel 134, to the aspiration lumen 106 of the catheter 102. The syringe 130 is attached to a vacuum line 136 via the luer 140 of the syringe 130. A stopcock 138 may be used on the luer 140 to maintain the vacuum, or alternatively, the plunger 132 may be a locking variety of plunger that is configured to be locked in the retracted (vacuum) position. A male luer 142 at the end of the vacuum line 136 may be detachably secured to the female luer 115 of the y-connector 110 of the aspiration catheter 102. As shown in more detail in Figure 4, a pressure sensor ortransducer 144 is secured inside an internal cavity 146 of the y-connector 110 proximal to the female luer 113 and the female luer 115. A valve 150, for example a Touhy-Borst, at the proximal end of the y-connector 110 allows hemostasis of the guidewire lumen / aspiration lumen 106 around a guidewire 148. In other embodiments, the valve 150 may comprise a longitudinally spring-loaded seal. The guidewire 148 may be inserted entirely through the guidewire lumen / aspiration lumen 106. Signals output from the pressure sensor 144 are carried through a cable 152 to a connector 154. The connector 154 is plugged into a socket 156 of the pump 101. Pressure related signals may be processed by a circuit board 158 of the pump 101. The pressure transducer 144 may be powered from the pump 101, via the cable 152. The accessories may also be supplied sterile to the user.

[0035] A foot pedal 160 is configured to operate a pinch valve 162 for occluding or opening the vacuum line 136. The foot pedal 160 comprises a base 164 and a pedal 166 and is configured to be placed in a non-sterile area, such as on the floor, under the procedure table / bed. The user steps on the pedal 166, causing a signal to be sent along a cable 168 which is connected via a plug 170 to an input jack 172 in the pump 101. The vacuum line 136 extends through a portion of the pump 101. The circuit board 158 of the pump may include a controller 174 configured to receive one or more signals indicating on or off from the foot pedal 160. The controller 174 of the circuit board 158 may be configured to cause an actuator 176 carried by the pump 101 to move longitudinally to compress and occlude the vacuum line 136 between an actuator head 178 attached to the actuator 176 and an anvil 180, also carried by the pump 101. By stepping on the pedal 166, the user is able to thus occlude the vacuum line 136, stopping the application of a negative pressure. In some embodiments, as the pedal 166 of the foot pedal 160 is depressed, the controller may be configured to open the pinch valve 162.

[0036] The pressure transducer 144 thus senses a negative pressure and sends a signal, causing the controller to start the motor of the pump 101. As the effect via the electronics is substantially immediate, the motor starts pumping almost immediately after the pedal 166 is depressed. As the pedal 166 of the foot pedal 160 is released, the controller 174 then causes the pinch valve 162 to close. The pressure transducer 144thus senses that no negative pressure is present and the controller 174 causes the motor of the pump 101 to shut off. Again, the effect via the electronics is substantially immediate,and thus the motor stops pumping almost immediately after the pedal 166 is depressed. During sterile procedures, the main interventionalist is usually "scrubbed" such that the hands only touch items in the sterile field. However, the feet / shoes / shoe covers are not in the sterile field. Thus again, a single user may operate a switch (via the pedal 166) while also manipulating the catheter 102 and guidewire 148. However, this time, it is the sterile field hands and non-sterile field feet that are used. Alternatively, the foot pedal 160 may comprise two pedals, one for occlude and one for open. In an alternative foot pedal embodiment, the pedal 166 may operate a pneumatic line to cause a pressure activated valve or a cuff to occlude and open the vacuum line 136, for example, by forcing the actuator head 178 to move. In another alternative embodiment, the pedal 166 may turn, slide, or otherwise move a mechanical element, such as a flexible pull cable or push rod that is coupled to the actuator 176, to move the actuator head 178. The cable 168 may be supplied sterile and connected to the base 164 prior to a procedure. The occlusion and opening of the vacuum line 136 thus acts as an on and off switch for the pump 101 (via the pressure sensor 144). The on / off function may thus be performed by a user whose hands can focus on manipulating sterile catheters, guidewires, and accessories, and whose foot can turn the pump on and off in a non-sterile environment. This allows a single user to control the entire operation or the majority of operation of the system 100 for aspirating thrombus. This can be an advantage in terms of a rapid, synchronized procedure, but is also helpful in laboratories where additional assistants are not available. The actuator 176 and anvil 180 may be controlled to compress the vacuum line 136 with a particular force, and the actuator 176 may be controlled to move at a particular speed, either when compressing or when removing compression. Speed and force control allows appropriate response time, but may also be able to add durability to the vacuum line 136, for example, by not over-compressing. The foot pedal 160 may communicate with the pinch valve 162 via a wired connection through the pump 101 or may communicate with the pinch valve 162 wirelessly. Additionally, or alternatively, the pump may be controlled by buttons 184 or other user interfaces.

[0037] It should be noted that in certain embodiments, the pinch valve 162 and the foot pedal 160 may be incorporated for on / off operation of the pinch valve 162 on the vacuum line 136, without utilizingthe pressure sensor l44. In fact, in some embodiments,the pressure sensor 144 may even be absent from the system 100 for aspirating thrombus, the foot pedal 160 being used as a predominant control means.

[0038] Turning to Figure 3, a supply tube 186, which contains the catheter supply lumen 114, freely and coaxially extends within the over-the-wire guidewire lumen / aspiration lumen 106. At least a distal end 188 of the supply tube 186 is secured to an interior wall 190 of the guidewire lumen / aspiration lumen 106 of the catheter shaft 111 by adhesive, epoxy, hot melt, thermal bonding, or other securement modalities. A plug 192 is secured within the catheter supply lumen 114 at the distal end 188 of the supply tube 186. The plug 192 blocks the exit of pressurized fluid, and thus the pressurized fluid is forced to exit through an orifice 194 in the wall 196 of the supply tube 186 (forming a fluid jet, such as a saline jet). The free, coaxial relationship between the supply tube 186 and the catheter shaft 111 along their respective lengths allows for improved flexibility. In some embodiments, in which a stiffer proximal end of the aspiration catheter 102 is desired (e.g., for pushability or even torquability), the supply tube 186 may be secured to the interior wall 190 of the guidewire lumen / aspiration lumen 106 of the catheter shaft 111 along a proximal portion of the aspiration catheter 102, but not along a distal portion. This may be appropriate if, for example, the proximal portion of the aspiration catheter 102 is not required to track through tortuous vasculature, but the distal portion is required to track through tortuous vasculature. The free, substantially unconnected, coaxial relationship between the supply tube 186 and the catheter shaft 111 along their respective lengths, may also be utilized to optimize flow through the guidewire lumen / aspiration lumen 106, as the supply tube 186 is capable of moving out of the way due to the forces of flow (e.g., of thrombus / saline) over its external surface, such that the remaining inner luminal space of the guidewire lumen / aspiration lumen 106 self-optimizes, moving toward the lowest energy condition (least fluid resistance) or toward the largest cross-sectional space condition (e.g., for accommodating and passing pieces of thrombus).

[0039] A system 200 for aspirating thrombus is illustrated in Figures 5 and 6A. Figure 6B is schematically illustrated with functional blocks associated with the functions of structures described herein. An aspiration catheter 202 is similar to the aspiration catheter 102 of Figures 1-4. The aspiration catheter 202 is configured for aspirating thrombus from peripheral vessels, but may also be configured with a size for treatingcoronary, cerebral, pulmonary or other arteries, or veins. The aspiration catheter 202 / system 200 may be used in interventional procedures, but may also be used in surgical procedures. The aspiration catheter 202 / system 200 may be used in vascular procedures, or non-vascular procedures (other body lumens, ducts, or cavities). The catheter 202 comprises an elongate shaft 204 configured for placement within a blood vessel of a subject. The catheter 202 may also comprise a catheter supply lumen 114 (Figure 3) and a guidewire / aspiration lumen 106, each extending along the shaft. The supply lumen 114 may have a proximal end 147 and a distal end 185, and the aspiration lumen 106 may have a proximal end 145 (Figure 4) and an open distal end 107 (Figure 3). An orifice or opening 194 may exist at or nearthe distal end 185 of the supply lumen 114. The orifice or opening 194 may be configured to allow the injection of pressurized fluid into the aspiration lumen 106 at or near the distal end 107 of the aspiration lumen 106 when the pressurized fluid is pumped through the supply lumen 114. In some embodiments, the orifice or opening 194 may be located proximal to the distal end 185 of the supply lumen 114. In some embodiments, the distal end 185 of the supply lumen 114 may comprise a plug 192.

[0040] A pump set 210 (e.g., tubing set) is configured to hydraulically couple the supply lumen 114 to a pump within a saline drive unit (SDU) 212, for injecting pressurized fluid (e.g., saline, heparinized saline) through the supply lumen 114. Suction tubing 214, comprising sterile suction tubing 216 and non-sterile suction tubing 217, is configured to hydraulically couple a vacuum canister 218 to the aspiration lumen 106. A filter 220 may be carried in-line on the suction tubing 214, for example, connected between the sterile suction tubing 216 and the non-sterile suction tubing 217, or on the non-sterile suction tubing 217. The filter 220 is configured to capture large elements such as large pieces of thrombus or emboli.

[0041] The pump set 210 includes a saline spike 221 for connection to a port 222 of a saline bag 224, and an inline drip chamber 226 for visually assessing the movement of saline, as well as keeping air out of the fluid being injected. The saline bag 224 may be hung on an intravenous (IV) pole 227 on one or more hooks 228. A pressure sensor 230, such as a vacuum sensor, may be used within any lumen of the pump set 210, the suction tubing 214, the supply lumen 114 or aspiration lumen 106 of the catheter 202, or any other component which may see fluid flow. Additional or alternative pressure sensorsmay be implemented to measure pressure associated with the vacuum canister 218. The pressure sensor 230 is shown in Figure 5 within a lumen at a junction between a first aspiration tube 232 and a control 233. The control 233 can include an operable valve 239 (see Figure 6B) through which fluid flows to the supply lumen 114. A cable 234 carries signals output from the pressure sensor 230 to a controller 235 in the SDU 212. A connector 236, electrically connected to the cable 234, is configured to be detachably coupled to a mating receptacle 237 (e.g., input jack) in the SDU 212. The SDU 212 also may have a display 238, including an LCD screen or alternative screen or monitor, in order to visually monitor parameters and status of a procedure. In some instances, one or more fluid flow sensors is / are utilized in addition to or as an alternative to the pressure sensor 230. In some embodiments, the fluid flow sensor is a Doppler flow velocity sensor, or other type of flow sensor. In one example, a flow sensor 223 is positioned along tubing between the aspiration catheter 202 and the vacuum canister 218 (see Figure 6B). In some instances, flow metrics may be inferred or characterized by implementing multiple pressure sensors (e.g., (i) a pressure sensor on the pump set 210, suction tubing 214, or aspiration lumen 106, and (ii) a pressure sensor on the vacuum canister 218).

[0042] In the example of Figures 5 and 6A, the SDU 212 is held on a mount 240 by four locking knobs 242. The mount 240 is secured to a telescoping rod 244 that is adjustable from a cart base 245 via a cart height adjustment knob or other element 246. The mount 240 and a handle 247 are secured to the rod 244 via an inner post 248 that is insertable and securable within an inner cavity in the rod 244. The IV pole 227 secures to the mount 240 via a connector 250. The base 245 may include legs 252 having wheels 253 (e.g., three or more wheels or four or more wheels) and may be movable via the handle 247. The system 200 may also carry a basket 254 for placement of components, products, documentation, or other items.

[0043] In use, a user connects a first connector 256 at a first end 258 of the non- sterile suction tubing 217 to a second port 259 on the lid 260 of the canister 218, and connects a second connector 261 at a second end 262 of the non-sterile suction tubing 217 to a vacuum pump input 264 in the SDU 212. A vacuum pump 266 may be carried within the SDU 212 in order to maintain a vacuum / negative pressure within the canister 218. Alternatively, the vacuum inside the canister 218 may be maintained manually, without a vacuum pump, by evacuating the canister 218 via one or more additional ports268. The vacuum pump 266 communicates with atmosphere through a manifold and / or filter 269 (see Figure 6B). In some instances, the SDU 212 internally carries a solenoid 298 that is configured to interface with the interior of the vacuum canister 218 (e.g., via the suction tubing 214 or additional tubing) (see Figure 6B). The solenoid can vent the negative pressure inside the canister by opening a valve 299 coupled to the solenoid (mechanically or electromagnetically) that opens the interior of the canister 218 to ambient pressure (see Figure 6B). The venting allows any foaming of blood or fluid, such as any aspirated liquid, within the canister 218 to be reduced. Foaming can occur during a thrombolysis procedure due to cavitation, as air bubbles are formed. The solenoid 298 is then configured to close the valve 299, to allow negative pressure to again be built up within the interior of the canister 218. The controller 235 is configured to automatically energize the solenoid 298, in order to allow for the degassing / defoaming. For example, the controller 235 may send a signal to energize the solenoid 298 based on the measurement of a targeted negative pressure and / or a targeted time of aspiration cycle. In other cases, the controller 235 can send a signal to energize the solenoid 298 every minute, every five minutes, every ten minutes, etc. Additionally, a user can operate the controller 235, and more generally the controller 174, of the system 200 through the interface panel 290 to initiate degassing / defoaming of the interior of the canister 218. The venting may also be able to remove air bubbles inside the other lumens of the catheter and tubing sets. In some embodiments, the controller 235 can output or send a signal to energize the solenoid 298 to open the valve 299, in order to stop any aspiration, while still allowing the SDU 212 to deliver saline, medication, or saline combined with medication (e.g., thrombolytic drugs), so that the fluids can be delivered out of the open distal end 107 (instead of being aspirated through the aspiration lumen 106).

[0044] In another configuration, a vacuum regulator 267 is disposed between the vacuum pump 266 and the canister 218, optionally in-line between the canister 218 and the SDU 212, to adjust or reduce the vacuum level generated by the vacuum pump 266 (see Figure 6B) (a tank or accumulator can optionally be included along with the vacuum regulator 267 between the vacuum pump 266 and the canister 218). The vacuum regulator 267 can comprise an electro-pneumatic vacuum regulator, electronic vacuum regulator, or other type. For instance, while the vacuum pump 266 can generate in excess of -29.5 inHg (expressed as gauge pressure readings relative to atmospheric pressure (notabsolute values)) vacuum at sea level and -24.5 inHg (expressed as gauge pressure readings relative to atmospheric pressure (not absolute values)) at about 5280 feet elevation, for certain procedures, such as in the pulmonary anatomy, it may be beneficial to have the SDU 212 generate a different vacuum level, such as approximately -18 inHg in one situation. To reduce the vacuum level, the vacuum regulator 267 can be incorporated into the system to control and stabilize the vacuum supplied to the canister 218 and optionally accommodate for variations in elevation where the system is being operated. The vacuum regulator 267 can be a manually-adjustable unit that uses a spring force balanced against an internal diaphragm valve to compensate for fluctuations in downstream flow. The diaphragm has atmospheric pressure on one side and the regulated vacuum on the other side, resulting in the regulated vacuum level is compensated for changes in elevation (i.e., the canister vacuum, if set to -20 inHg at sea level, would still contain -20 inHg at 5280 feet elevation). More generally, the vacuum regulator 267 allows adjustment of a canister vacuum level, as measured by a canister vacuum sensor 219 that communicates with the controller 235, from the maximum attainable (described above) down to zero (atmospheric pressure).

[0045] The vacuum regulator 267 can be adjusted to a nominal -18 inHg setpoint during the manufacturing process, after which the setpoint can be mechanically locked, such as by a fastener, cable tie, etc., or locked using other techniques, to prevent inadvertent change or adjustment. The vacuum regulator 267 can be installed internally within the SDU 212, with the SDU case 284 preventing unauthorized access to the vacuum regulator 267 using tamper-evident seals or other security mechanisms or structures. Alternatively, the vacuum regulator 267 can be disposed externally to the SDU case 284 and can optionally remain unlocked.

[0046] With continued reference to use of the system 200, a user connects a first connector 270 of the sterile suction tubing 216 to an aspiration luer 271 of the aspiration catheter 202 (similar to luer 115), and connects the second connector 272 of the sterile suction tubing 216 to port 274 in the lid 260 of the canister 218. Connector 236 is then coupled to the mating receptacle 237 in the SDU 212 for communication with the control 233 and / orthe pressure sensor 230. For instance, the connector 236 can be snapped into mating receptacle 237 in the SDU 212 for communication with elements of the control 233 and / or for communication with the pressure sensor 230, either via cable 234, and / oradditional cables or wires. Alternatively, the connector 236 may couple to the mating receptacle 237 by clipping, friction fitting, vacuum fitting, or other means.

[0047] After allowing saline to purge through the supply tube 276, cassette 278, and injection tube 279 of the pump set 210, the user connects the luer connector 280 of the pump set 210 to a luer 282 of the aspiration catheter 202 (similar to luer 113). The cassette 278 (similar to cassette 121) is then attached to a saddle 283 in the SDU 212. The saddle 283 is configured to reciprocate a piston to inject the saline from the IV bag 224 at high pressure, after the cassette 278 is snapped in place, keeping the internal contents (e.g., saline) sterile. Systems configured for performing this type of sterile injection of high-pressure saline are described in U.S. Pat. No. 9,883,877, issued February 6. 2018, and entitled, "Systems and Methods for Removal of Blood and Thrombotic Material", which is incorporated by reference in its entirety for a II purposes. The SDU 212 is enclosed within a case 284 and a case lid 285. The controller 235 may reside on a circuit board 286. Noise from a motor 287 controlling the saddle 283 and from the vacuum pump 266 may be abated by internal foam sections 288, 289. The saddle 283 may be moved directly by the motor 287, or may be moved with pneumatics, using a cycled pressurization. An interface panel 290 provides one or more switches 297 and the display 238. Alternatively, the cassette 121 may couple to the saddle 283 by clipping, friction fitting, vacuum fitting, or other means.

[0048] The controller 235 operates the motor 287 to control movement of the saddle 283 and so move the piston 122 (Figure 2) within the cassette 278 to pressurize fluid and deliver it to the aspiration catheter 202. The jet pressure from the opening 194 (Figure 3) is proportional to the speed at which the motor 287 is driven and in one configuration the controller 235 can operate the motor 287 to operate in a range from about 280 rotations per minute (RPM) to about 340 RPM, resulting an jet pressures ranging from about 410 pounds per square inch (PSI) to about 707 PSI. Depending upon the particular implementation in which the system 200 is used, the motor 287 can be operated at different speeds. For instance, for pulmonary anatomy, a desired jet pressure can be achieved by running the motor 287 at a reduced speed of 310 RPM. The controller 235 can be operated through the one or more switches 297 to vary a speed of the motor 287 based upon the particular patient anatomy, such as varying the speed of the motor 287 between about 280 RPM and 410 RPM. Additionally, or as an alternate to the switches,the controller 235 can adjust the motor speed using a proportional-integral-derivative (PI D) speed control algorithm or feedback loop to monitor and correct a speed of the motor 287 for any changes in load conditions.

[0049] In addition to the above, the controller 235 more generally control the operation and functionality of the SDU 212 and the system 200 as a whole. An operation of the vacuum pump 266, such as operating speed, etc., can be controlled by the controller 235 and associated or operatively connected hardware, firmware, etc. While reference is made to noise from the motor 287 controlling the saddle 283 is abated by internal foam sections 288, 289, where a lower audible noise of the vacuum pump 266 might be more desirable for a user, the controller 235 can vary the operating speed of the vacuum pump 266 to reduce the audible noise of the system 200, and more particularly noise from the vacuum pump 266. For instance, the controller 235 can operate the vacuum pump 266 at a reduced speed, such as approximately 60% of maximum speed, during start-up and then reduce the speed to about 30% of maximum when a desired vacuum is achieved, such as -27.5 inHg. The controller 235, and associated printed circuit board and other hardware, firmware, etc., controls the vacuum pump speed at a fixed setpoint. A voltage divider circuit on the board produces a speed input signal to the vacuum pump 266 (such as a vacuum pump motor controller), which sets the pump speed based upon the speed input signal, such as to approximately 60% of maximum in this particular configuration. Other start-up speeds can be achieved with other speed input signals.

[0050] In still another configuration, control of the vacuum pump 266 can be achieved through the one or more switches 297 in combination with the controller 235. For instance, one of the switches 297 is a manually operated potentiometerthat can vary the speed of the vacuum pump 266 from about 0% to about 100% of maximum speed. The speed setting from the potentiometer can be monitored to measure the feedback voltage, and optionally present speed and potentiometer information to the user through the display 238.

[0051] Additionally, the controller 235 controls the information presented on the display 238 or through the SDU 212, such as alarms, warnings, pressure and flow information, or any other information, warnings, etc. related to the operation of the system 200. For instance, the controller 235 can include hardware, firmware, etc. thatprovides through the display, etc. notification of various alarms or other information, such as (i) a "No Suction" alarm notifying a user of vacuum leaks in the system, (ii) a "Terminal Vacuum Fault" alarm indicating a vacuum level that is too high or different from a predetermined threshold which occurs when the vacuum regulator 267 has failed, such as when the canister vacuum is lower than -20 inHg, lower than -18 in Hg or some other predetermined threshold, (iii) "Terminal Motor Fault" alarm indicating a problem with operation of the cassette 278, and (iv) a splash screen, which displays for a few seconds upon power-up of the system 200, providing version information or other relevant information related to any of the hardware, firmware, etc. of the controller 235 or another component of the SDU 212.Aspirated Material Volume Determination in Thrombectomy Devices

[0052] Figure 7 illustrates a conceptual representation of a process for determining the volume of material aspirated from a subject by a thrombectomy system, according to implementations of the present disclosure. In particular, Figure 7 conceptually depicts components, operations, and data objects associated with a thrombectomy system 702. The thrombectomy system 702 can correspond to and / or include components of the thrombectomy system 100 described hereinabove. For instance, the thrombectomy system 702 can comprise a vacuum pump 704 (e.g., corresponding to vacuum pump 266), an aspiration canister 706 (e.g., corresponding to canister 218), and aspiration tubing 708A and 708B. Aspiration tubing 708A can correspond to non-sterile suction tubing 217 (e.g., being connectable to the vacuum pump 704 and the aspiration canister 706 via one or more connection points, such as vacuum pump input 264 and second port 259 as described above), and aspiration tubing 708B can correspond to sterile suction tubing 216 (e.g., being connectable to the vacuum pump 704 and an aspiration catheter 202, such as via port 274 and luer 271 as described above). The aspiration canister 706, the aspiration tubing 708A and 708B, and the aspiration catheter 202 can form an aspiration path through which material may be aspirated from a subject or patient (e.g., by operation of the vacuum pump 704 to cause suction at the open distal end 107 of the aspiration catheter 202).

[0053] Figure 7 depicts an instance where, at least initially, an aspiration state is active. The aspiration state involves operation of components of the thrombectomy system 702 to facilitate clot removal or clot hunting. For instance, the vacuum pump 704of the thrombectomy system 702 may generate negative pressure or aspiration pressure so as to aspirate material positioned at the distal end 107 of the aspiration catheter 202 (e.g., to remove clot material when in a clot removal state, or to draw clot material toward the aspiration catheter 202 when in a clot hunting or low-level aspiration state). Thrombotic or embolic material may be macerated via a high-pressure saline jet formed via an SDU 212 and supply tube 119. Aspirated material may be drawn from the subject through aspiration tubing 708B into the aspiration canister 706.

[0054] Figure 7 illustrates that the thrombectomy system 702 may further include a flow sensor 710 and a pressure sensor 712. In the example shown in Figure 7, the flow sensor 710 and the pressure sensor 712 are connected to aspiration tubing 708A, with the flow sensor 710 being positioned proximal to the pressure sensor 712 along the aspiration tubing 708A. This particular configuration is provided by way of example only, and other arrangements are within the scope of the present disclosure. For instance, the pressure sensor 712 may be arranged proximal to the flow sensor 710, or the flow sensor 710 and / or the pressure sensor 712 may be arranged on a different portion of the aspiration path (e.g., on aspiration tubing 708B, on the aspiration catheter 202, etc.). In some implementations, the flow sensor 710 is implemented as a mass air flow sensor, though other forms are possible (e.g., ultrasonic flow sensors, turbine-based flow sensors, rotary piston flow meters, and / or others). Similarly, the pressure sensor 712 may take on various forms (e.g., capacitive pressure sensors, piezoelectric pressure sensors, strain gauge pressure sensors, optical pressure sensors, and / or others).

[0055] Figure 7 conceptually depicts data acquired via the flow sensor 710 and the pressure sensor 712. In particular, Figure 7 illustrates pressure value(s) 714 and removed air amount value(s) 716. The pressure value(s) 714 can indicate the current pressure within the aspiration path. The removed air amount value(s) 716 can indicate the current amount of air that has flown through the flow sensor 710 and, hence, the amount of air that has been removed from the aspiration path via the vacuum pump 704. The pressure value(s) 714 and the removed air amount value(s) 716 (and any other value(s) or data described herein) can comprise raw measurements (e.g., analog data), processed measurements (e.g., digital data), and / or information based on raw or processed measurements. The pressure value(s) 714 (and any other pressure values described herein) can be represented in any suitable form, such as pascals, atmospheres, bars, torr,pounds per square inch, millimeters of mercury, etc. Similarly, the removed air amount value(s) 716 (and any other matter amount values described herein) can be represented in any suitable form, such as moles, grams, kilograms, pounds, number of particles, standard cubic feet, standard liters, etc.

[0056] The removed air amount value(s) 716 can indicate the current amount of air present in the aspiration path (defined by the aspiration canister 706, aspiration tubing 708A and 708B, and the aspiration catheter 202). The current amount of air present in the aspiration path is represented in Figure 7 by the air amount value(s) 718. The air amount value(s) 718 may be calculated based on the removed air amount value(s) 716 and initial air amount value(s) 720 (indicated in Figure 7 by the arrows extending from the removed air amount value(s) 716 and the initial air amount value(s) 720 to the air amount value(s) 718). In some implementations, the air amount value(s) 718 comprise(s) or is / are determined based on the difference between the initial air amount value(s) 720 and the removed air amount value(s) 716 (measured via the flow sensor 710).

[0057] The initial air amount value(s) 720 can indicate the initial amount of air within the aspiration path (e.g., prior to activation of the aspiration state, or at any timepoint prior to the current timepoint). The initial air amount value(s) 720 can be affected by altitude, ambient pressure, temperature, etc. In some instances, the initial air amount value(s) 720 is / are determined based on initial pressure value(s) 722 and initial air volume(s) 724 (indicated in Figure 7 by the arrows extending from the initial pressure value(s) 722 and the initial air volume(s) 724 to the initial air amount value(s) 720). By way of illustrative example, using the ideal gas equation, the initial air amount value(s) 720 may be approximated via:where nrrepresents the initial air amount value(s) 720, represents the initial pressure value(s) 722, 1 represents the initial air volume(s) 724, R is the ideal gas constant, and T±represents initial temperature.

[0058] The initial pressure value(s) 722 can indicate the initial pressure within the aspiration path, which may be obtained via the pressure sensor 712 (or another pressure sensor or measurement method) prior to the current timepoint (e.g., prior to the thrombectomy system 702 entering an aspiration state / mode). The initial air volume(s)724 can indicate the initial volume of air within the aspiration path, which may be obtained based on known characteristics of the aspiration path (e.g., known volumes of the aspiration canister 706, the aspiration catheter 202, and the aspiration tubing 708A and 708B).

[0059] Figure 7 furthermore conceptually depicts the pressure value(s) 714, the air amount value(s) 718, the initial air amount value(s) 720, the initial pressure value(s) 722, and the initial air volume(s) 724 being utilized to determine estimated air volume(s) 726 (indicated in Figure 7 by the arrows extending from the pressure value(s) 714, the air amount value(s) 718, the initial air amount value(s) 720, the initial pressure value(s) 722, and the initial air volume(s) to the estimated air volume(s) 726). The estimated air volume(s) 726 can indicate the current volume of air within the aspiration path (e.g., at the current timepoint after activation of an aspiration state). In some implementations, the estimated air volume(s) 726 may be determined based on a product of (i) a ratio of the air amount value(s) 718 and the initial air amount value(s) 720, (ii) a ratio of the initial pressure value(s) 722 and the pressure value(s) 714, and (iii) the initial air volume(s) 724. By way of illustrative example, beginning with the ratio form of the ideal gas equation (with temperature and the ideal gas constant assumed to remain constant for simplicity), the estimated air volume(s) 726 can be estimated as follows:where p2represents the pressure value(s) 714, V2represents the estimated airvolume(s) 726, n2represents the air amount value(s) 718, p^ represents the initial pressure value(s) 722, Vrrepresents the initial air volume(s) 724, and n represents the initial air amount value(s) 720. Solving for V2provides:

[0060] Figure 7 also conceptually depicts the estimated air volume(s) 726 and the initial air volume(s) 724 being utilized as input to volume module(s) 728 to determine estimated material volume(s) 730. The estimated material volume(s) 730 indicates the estimated volume of material aspirated from a patient / subject (e.g., within which the aspiration catheter 202 is positioned) via the thrombectomy system 702. In some implementations, the estimated material volume(s) 730 may be determined based on adifference between the initial air volume(s) 724 (orthe volume of the aspiration path, in some instances) and the estimated air volume(s) 726. By way of illustrative example, the estimated material volume(s) 730 may be estimated via:Vest= Vi ~ V2(4) where Vestrepresents the estimated material volume(s) 730, represents the initial air volume(s) 724, and V2represents the estimated airvolume(s) 726. In some instances, the estimated material volume(s) 730 may be estimated via: st=Vpath ~ ^ 2 (5) where Vestrepresents the estimated material volume(s) 730,represents the total volume of the aspiration path (defined by the internal volumes of the aspiration catheter 202, the aspiration canister 706, and the aspiration tubing 708A and 708B), and2represents the estimated air volume(s) 726.

[0061] In some embodiments, the estimated material volume(s) 730 may be used to trigger various actions for the thrombectomy system 702. As noted previously, Figure 7 provides an example in which, at least initially, the thrombectomy system 702 is in an aspiration state. Based on the estimated material volume(s) 730, the thrombectomy system 702 may selectively maintain or change the aspiration state, and / or take other actions.

[0062] For instance, Figure 7 conceptually depicts that the thrombectomy system 702 may determine whether the estimated material volume(s) 730 satisfy one or more conditions (indicated by the arrow extending from the estimated material volume(s) 730 to decision block 732). An example condition may comprise whether the estimated material volume(s) 730 satisfies one or more thresholds, such as a volume within a range of 0.5 to 1.0 liters, or another volume threshold (e.g., a volume determined based on patient characteristics and / or medical history / conditions, a volume entered by a medical professional, etc.). Another example condition may comprise whetherthe rate of change of the estimated material volume(s) 730 (e.g., how quickly the thrombectomy system 702 is aspirating material from the patient / subject) satisfies one or more thresholds (e.g., the rate of change of the estimated material volume(s) 730 can be expected to be higher for blood rather than clot material). Other conditions are possible.

[0063] When the thrombectomy system 702 determines that the estimated material volume(s) 730 fails to satisfy the condition(s), the thrombectomy system 702 mayselectively maintain its operational state (indicated in Figure 7 by the arrow labeled "No" extending from decision block 732 to action block 734). For example, if the thrombectomy system 702 is in a low-level aspiration state or clot hunting state, the thrombectomy system 702 may selectively remain in the low-level aspiration state or clot hunting state when the estimated material volume(s) 730 is determined to not exceed one or more threshold values. As another example, if the thrombectomy system 702 is in a full aspiration state or clot removal state, the thrombectomy system 702 may selectively remain in the full aspiration state or clot removal state when the estimated material volume(s) 730 is determined to not exceed one or more threshold values.

[0064] When the thrombectomy system 702 determines that the estimated material volume(s) 730 satisfies the condition(s), the thrombectomy system 702 may selectively modify its operational state (indicated in Figure 7 by the arrow labeled "Yes" extending from decision block 732 to action block 736). For example, if the thrombectomy system 702 is in a low-level aspiration state or clot hunting state, the thrombectomy system 702 may selectively deactivate the low-level aspiration state or clot hunting state when the estimated material volume(s) 730 is determined to exceed one or more threshold values. As another example, if the thrombectomy system 702 is in a full aspiration state or clot removal state, the thrombectomy system 702 may (i) selectively deactivate the full aspiration state or clot removal state or (ii) selectively enterthe low-level aspiration state or clot hunting state when the estimated material volume(s) 730 is determined to exceed one or more threshold values.

[0065] Enabling selective, automatic modification of the operational state of the thrombectomy system 702 based on characteristics of the estimated material volume(s) 730 can mitigate the incidence of excessive patient blood loss. Such benefits can be advantageously achieved without requiring clinicians to closely monitor the contents of the aspiration canister 706 or other readings / aspects of the thrombectomy system 702.

[0066] In some implementations, when the thrombectomy system 702 determines that the estimated material volume(s) 730 satisfies the condition(s), the thrombectomy system 702 may selectively present an alert on a user interface (indicated in Figure 7 by the arrow labeled "Yes" extendingfrom decision block 732 to action block 738). The alert can take on various forms, such as a visual element shown on a display, an audible alert, a tactile alert (e.g., vibration), combinations of these, and / or others. The alert cancommunicate to a medical professional operating the thrombectomy system 702 that the estimated material volume within the canister 706 has reached a potentially dangerous level, which can prompt the medical professional to take actions to prevent damage to the patient.

[0067] In some instances, multiple estimated material volumes 730 of material aspirated by a thrombectomy system 702 are determined / generated over a temporal window (e.g., over consecutive timepoints while an aspiration state is active). Where multiple estimated material volumes 730 are determined, the thrombectomy system 702 may determine estimated flow rate(s) 740 that indicate the rate at which the thrombectomy system 702 has aspirated or is aspirating material from the subject (indicated in Figure 7 by the arrow extending from the estimated material volume(s) 730 to the estimated flow rate(s) 740. In some examples, the estimated flow rate(s) 740 may be determined based on changes among the multiple estimated material volumes 730 over time (e.g., the rate of change, which can be obtained by calculating the first derivative). As noted above, estimated flow rate(s) 740 may be used to selectively modify or maintain operational states of the thrombectomy system 702 (and / or to trigger alerts).

[0068] Figure 7 further conceptually depicts that the estimated flow rate(s) 740 may be used to determine estimated composition(s) 742 (indicated by the arrow extending from the estimated flow rate(s) 740 to the estimated composition(s) 742). For example, the thrombectomy system 702 can compare the estimated flow rate(s) 740 to reference flow rates or reference flow profiles associated with different materials. The reference flow rates may comprise reference flow profiles / data associated with aspiration of blood, aspiration of clot material, catheter / line occlusions, etc. Reference flow rates for aspiration of blood can be expected to be higher than reference flow rates for aspiration of clot material. Based on the com arison to the reference flow rates, temporal segments of an estimated flow rate(s) 740 dataset or signal may be classified or labeled to correspond to aspiration of blood, aspiration of clot material, occlusion, etc. For each labeled temporal segment, the estimated flow rate(s) 740 may be used in conjunction with the temporal length of the temporal segment to calculate the estimated volume of applicable material (e.g., blood vs clot material) aspirated during the temporal segment, thereby providing estimated composition(s) 742 of the material aspirated from thesubject by the thrombectomy system 702 (e.g., indicating a composition of the estimated material volume(s0 730).

[0069] In some implementations, estimated composition(s) 742 can be used to influence whether to modify the operating state of the thrombectomy system 702 (e.g., only triggering a modification to operational state when the estimated volume of aspirated blood satisfies one or more conditions). In some instances, rather than comparing to reference flow rates, the thrombectomy system 702 may employ one or more machine learning, statistical, rule-based, or other models to classify or label temporal segments of estimated flow rate(s) 740 to determine the estimated composition(s) 742.Example Methods

[0070] The following discussion now refers to a number of methods and method acts that may be performed in accordance with the present disclosure. Although the method acts are discussed in a certain order and illustrated in a flow chart as occurring in a particular order, no particular ordering is required unless specifically stated, or required because an act is dependent on another act being completed prior to the act being performed. One will appreciate that certain embodiments of the present disclosure may omit one or more of the acts described herein.

[0071] Figure 8 illustrates an example flow diagram 800 depicting acts associated with determining the volume of material aspirated from a subject by a thrombectomy system, in accordance with implementations of the present disclosure.

[0072] Act 802 of flow diagram 800 includes accessing one or more pressure values obtained via a pressure sensor associated with an aspiration path of a thrombectomy system, the one or more pressure values indicating a current pressure within the aspiration path. In some instances, the aspiration path is defined by an aspiration catheter, an aspiration canister, and aspiration tubing. In some implementations, the pressure sensor or the flow sensor is arranged on the aspiration tubing.

[0073] Act 804 of flow diagram 800 includes accessing one or more air amount values obtained via a flow sensor associated with the aspiration path, the one or more air amount values indicating a current amount of air within the aspiration path. In some examples, the flow sensor comprises a mass air flow sensor.

[0074] Act 806 of flow diagram 800 includes utilizing the one or more pressure values and the one or more air amount values as input to a volume module to generate an estimated material volume, the estimated material volume indicating an estimated volume of material aspirated from a subject via the thrombectomy system. In some instances, the volume module is configured to determine the estimated material volume based on one or more initial air volume values indicating an initial volume of air within the aspiration path, one or more initial air amount values indicating an initial amount of air within the aspiration path, and one or more initial pressure values indicating an initial pressure within the aspiration path. In some implementations, the one or more initial pressure values are obtained via the pressure sensor. In some examples, the one or more initial air amount values are determined based on the one or more initial pressure values and the one or more initial air volume values. In some instances, the one or more air amount values (referenced in association with act 804) are based on a difference between the one or more initial air amount values and one or more removed air amount values determined via the flow sensor. In some implementations, the estimated material volume is based on a difference between the one or more initial air volume values or a total volume of the aspiration path and one or more estimated air volume values. The one or more estimated air volume values may indicate a current volume of air within the aspiration path. In some examples, the one or more estimated air volume values are based on a product of (i) a ratio of the one or more air amount values and the one or more initial air amount values, (ii) a ratio of the one or more initial pressure values and the one or more pressure values, and / or (iii) the one or more initial air volume values.

[0075] Act 808 of flow diagram 800 includes, based on the estimated material volume, (i) selectively maintaining an operational state of the thrombectomy system, (ii) selectively modifying the operational state of the thrombectomy system, and / or (iii) selectively presenting an alert on a user interface.

[0076] Act 810 of flow diagram 800 includes generating a plurality of estimated material volumes over a temporal window.

[0077] Act 812 of flow diagram 800 includes determining one or more estimated flow rates of material aspirated from the subject over the temporal window based on the plurality of estimated material volumes.

[0078] Act 814 of flow diagram 800 includes determining an estimated composition of material aspirated from the subject by comparing the one or more estimated flow rates to one or more reference flow rates.Example Embodiments

[0079] Disclosed embodiments include at least those represented in the following numbered clauses:

[0080] Clause 1. A thrombectomy system, comprising: one or more processors; and one or more computer-readable recording media that store instructions that are executable by the one or more processors to configure the thrombectomy system to: access one or more pressure values obtained via a pressure sensor associated with an aspiration path of the thrombectomy system, the one or more pressure values indicating a current pressure within the aspiration path; access one or more air amount values obtained via a flow sensor associated with the aspiration path, the one or more air amount values indicating a current amount of air within the aspiration path; utilize the one or more pressure values and the one or more air amount values to provide input to a volume module to generate an estimated material volume, the estimated material volume indicating an estimated volume of material aspirated from a subject via the thrombectomy system; and based on the estimated material volume, perform one or more of: (i) selectively maintain an operational state of the thrombectomy system, (ii) selectively modify the operational state of the thrombectomy system, and / or (iii) selectively present an alert on a user interface.

[0081] Clause 2. The thrombectomy system of clause 1, wherein the aspiration path is defined by an aspiration catheter, an aspiration canister, and aspiration tubing.

[0082] Clause 3. The thrombectomy system of clause 2, wherein the pressure sensor or the flow sensor is arranged on the aspiration tubing.

[0083] Clause 4. The thrombectomy system of any one of clauses 1-3, wherein the flow sensor comprises a mass air flow sensor.

[0084] Clause 5. The thrombectomy system of any one of clauses 1-4, wherein the volume module is configured to determine the estimated material volume based on one or more initial air volume values indicating an initial volume of air within the aspiration path, one or more initial air amount values indicating an initial amount of air within theaspiration path, and one or more initial pressure values indicating an initial pressure within the aspiration path.

[0085] Clause 6. The thrombectomy system of clause 5, wherein the one or more initial pressure values are obtained via the pressure sensor.

[0086] Clause 7. The thrombectomy system of clause 5 or clause 6, wherein the one or more initial air amount values are determined based on the one or more initial pressure values and the one or more initial air volume values.

[0087] Clause 8. The thrombectomy system of any one of clauses 5-7, wherein the one or more air amount values are based on a difference between the one or more initial air amount values and one or more removed air amount values determined via the flow sensor.

[0088] Clause 9. The thrombectomy system of any one of clauses 5-8, wherein the estimated material volume is based on a difference between the one or more initial air volume values or a total volume of the aspiration path and one or more estimated air volume values, the one or more estimated air volume values indicating a current volume of air within the aspiration path.

[0089] Clause 10. The thrombectomy system of clause 9, wherein the one or more estimated air volume values are based on a product of one or more of: (i) a ratio of the one or more air amount values and the one or more initial air amount values, (ii) a ratio of the one or more initial pressure values and the one or more pressure values, and / or (iii) the one or more initial air volume values.

[0090] Clause 11. The thrombectomy system of any one of clauses 1-10, wherein the instructions are executable by the one or more processors to configure the thrombectomy system to: generate a plurality of estimated material volumes over a temporal window; and determine one or more estimated flow rates of material aspirated from the subject over the temporal window based on the plurality of estimated material volumes.

[0091] Clause 12. The thrombectomy system of clause 11, wherein the instructions are executable by the one or more processors to configure the thrombectomy system to determine an estimated composition of material aspirated from the subject by comparing the one or more estimated flow rates to one or more reference flow rates.

[0092] Clause 13. A method, comprising: accessing one or more pressure values obtained via a pressure sensor associated with an aspiration path of a thrombectomy system, the one or more pressure values indicating a current pressure within the aspiration path; accessing one or more air amount values obtained via a flow sensor associated with the aspiration path, the one or more air amount values indicating a current amount of air within the aspiration path; utilizing the one or more pressure values and the one or more air amount values as input to a volume module to generate an estimated material volume, the estimated material volume indicating an estimated volume of material aspirated from a subject via the thrombectomy system; and based on the estimated material volume, performing one or more of (i) selectively maintaining an operational state of the thrombectomy system, (ii) selectively modifying the operational state of the thrombectomy system, and / or (iii) selectively presenting an alert on a user interface.

[0093] Clause 14. The method of clause 13, wherein the aspiration path is defined by an aspiration catheter, an aspiration canister, and aspiration tubing.

[0094] Clause 15. The method of clause 14, wherein the pressure sensor or the flow sensor is arranged on the aspiration tubing.

[0095] Clause 16. The method of any one of clauses 13-15, wherein the volume module is configured to determine the estimated material volume based on one or more initial air volume values indicating an initial volume of air within the aspiration path, one or more initial air amount values indicating an initial amount of air within the aspiration path, and one or more initial pressure values indicating an initial pressure within the aspiration path.

[0096] Clause 17. The method of clause 16, wherein the estimated material volume is based on a difference between the one or more initial air volume values or a total volume of the aspiration path and one or more estimated air volume values, the one or more estimated air volume values indicating a current volume of air within the aspiration path, and wherein the one or more estimated air volume values are based on a product of (i) a ratio of the one or more air amount values and the one or more initial air amount values, (ii) a ratio of the one or more initial pressure values and the one or more pressure values, and (iii) the one or more initial air volume values.

[0097] Clause 18. The method of any one of clauses 13-17, further comprising: generating a plurality of estimated material volumes over a temporal window; and determining one or more estimated flow rates of material aspirated from the subject over the temporal window based on the plurality of estimated material volumes.

[0098] Clause 19. The method of clause 18, further comprising determining an estimated composition of the estimated volume of material aspirated from the subject by comparing the one or more estimated flow rates to one or more reference flow rates.

[0099] Clause 20. One or more computer-readable recording media that store instructions that are executable by one or more processors of a thrombectomy system to configure the thrombectomy system to: access one or more pressure values obtained via a pressure sensor associated with an aspiration path of the thrombectomy system, the one or more pressure values indicating a current pressure within the aspiration path; access one or more air amount values obtained via a flow sensor associated with the aspiration path, the one or more air amount values indicating a current amount of air within the aspiration path; utilize the one or more pressure values and the one or more air amount values as input to a volume module to generate an estimated material volume, the estimated material volume indicating an estimated volume of material aspirated from a subject via the thrombectomy system; and based on the estimated material volume, perform one or more of (i) selectively maintain an operational state of the thrombectomy system, (ii) selectively modify the operational state of the thrombectomy system, and / or (iii) selectively present an alert on a user interface.Additional Details Related to Implementing the Disclosed Embodiments

[0100] The principles disclosed herein may be implemented in various formats. For example, at least some techniques discussed herein may be performed as a method that includes various acts for achieving particular results or benefits. In some instances, the techniques discussed herein are represented in computer-executable instructions that may be stored on one or more hardware storage devices. The computer-executable instructions may be executable by one or more processors to carry out (orto configure a system to carry out) the disclosed techniques. In some embodiments, a system may be configured to send the computer-executable instructions to a remote device to configure the remote device for carrying out the disclosed techniques.

[0101] Systems for implementing the disclosed embodiments may include various components, such as, by way of non-limiting example, processor(s), storage, sensor(s), I / O system(s), communication system(s), etc.

[0102] The processor(s) may comprise one or more sets of electronic circuitries that include any number of logic units, registers, and / or control units to facilitate the execution of computer-readable instructions (e.g., instructions that form a computer program). Such computer-readable instructions may be stored within storage. The storage may comprise physical system memory and may be volatile, non-volatile, or some combination thereof. Furthermore, storage may comprise local storage, remote storage (e.g., accessible via communication system(s) or otherwise), or some combination thereof.

[0103] In some implementations, the processor(s) may comprise or be configurable to execute any combination of software and / or hardware components that are operable to facilitate processing using machine learning models or other artificial intelligencebased structures / architectures. Artificial intelligence-based structures / architectures may take on any suitable form, such as by comprising or utilizing hardware components and / or computer-executable instructions operable to carry out function blocks and / or processing layers configured in the form of, by way of non-limiting example, single-layer neural networks, feed forward neural networks, radial basis function networks, deep feed-forward networks, recurrent neural networks, long-short term memory (LSTM) networks, gated recurrent units, autoencoder neural networks, variational autoencoders, denoising autoencoders, sparse autoencoders, Markov chains, Hopfield neural networks, Boltzmann machine networks, restricted Boltzmann machine networks, deep belief networks, deep convolutional networks (or convolutional neural networks), deconvolutional neural networks, deep convolutional inverse graphics networks, generative adversarial networks, liquid state machines, extreme learning machines, echo state networks, deep residual networks, Kohonen networks, support vector machines, neural Turing machines, and / or others.

[0104] In some instances, actions performable by a system may rely at least in part on communication system(s) for receiving information from remote system(s), which may include, for example, separate systems or computing devices, sensors, and / or others. The communications system(s) may comprise any combination of software orhardware components that are operable to facilitate communication between on-system components / devices and / or with off-system components / devices. For example, the communications system(s) may comprise ports, buses, or other physical connection apparatuses for communicating with other devices / components. Additionally, or alternatively, the communications system(s) may comprise systems / components operable to communicate wirelessly with external systems and / or devices through any suitable communication channel(s), such as, by way of non-limiting example, Bluetooth, ultra-wideband, WLAN, infrared communication, and / or others.

[0105] A system may comprise or be in communication with sensor(s). Sensor(s) may comprise any device for capturing or measuring data representative of perceivable phenomenon. By way of non-limiting example, the sensor(s) may comprise one or more image sensors, microphones, thermometers, barometers, magnetometers, accelerometers, gyroscopes, and / or others.

[0106] Furthermore, a system may comprise or be in communication with I / O system(s). I / O system(s) may include any type of input or output device such as, by way of non-limiting example, a touch screen, a mouse, a keyboard, a controller, and / or others, without limitation. For example, the I / O system(s) may include a display system that may comprise any number of display panels, optics, laser scanning display assemblies, and / or other components. One will appreciate, in view of the present disclosure, that the sensor(s) may, in some instances, be utilized as I / O system(s).

[0107] Disclosed embodiments may comprise or utilize a special purpose or general- purpose computer including computer hardware, as discussed in greater detail below. Disclosed embodiments also include physical and other computer-readable media for carrying or storing computer-executable instructions and / or data structures. Such computer-readable media can be any available media that can be accessed by a general- purpose or special-purpose computer system. Computer-readable media that store computer-executable instructions in the form of data are one or more "computer- readable recording media," "physical computer storage media," or "hardware storage device(s)." Computer-readable media that merely carry computer-executable instructions without storing the computer-executable instructions are "transmission media." Thus, by way of example and not limitation, the current embodiments cancomprise at least two distinctly different kinds of computer-readable media: computer storage media and transmission media.

[0108] Computer storage media (aka "hardware storage device") are computer- readable hardware storage devices, such as RAM, ROM, EEPROM, CD-ROM, solid state drives ("SSD") that are based on RAM, Flash memory, phase-change memory ("PCM"), or other types of memory, or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store desired program code means in hardware in the form of computer-executable instructions, data, or data structures and that can be accessed by a general-purpose or special-purpose computer.

[0109] A "network" may comprise one or more data links that enable the transport of electronic data between computer systems and / or modules and / or other electronic devices. When information is transferred or provided over a network or another communications connection (either hardwired, wireless, or a combination of hardwired or wireless) to a computer, the computer properly views the connection as a transmission medium. Transmission media can include a network and / or data links which can be used to carry program code in the form of computer-executable instructions or data structures and which can be accessed by a general purpose or special purpose computer. Combinations of the above are also included within the scope of computer-readable media.

[0110] Further, upon reaching various computer system components, program code means in the form of computer-executable instructions or data structures can be transferred automatically from transmission computer-readable media to physical computer-readable storage media (or vice versa). For example, computer-executable instructions or data structures received over a network or data link can be buffered in RAM within a network interface module (e.g., a "NIC"), and then eventually transferred to computer system RAM and / or to less volatile computer-readable physical storage media at a computer system. Thus, computer-readable physical storage media can be included in computer system components that also (or even primarily) utilize transmission media.

[0111] Computer-executable instructions comprise, for example, instructions and data which cause a general-purpose computer, special purpose computer, or specialpurpose processing device to perform a certain function or group of functions. The computer-executable instructions may be, for example, binaries, intermediate format instructions such as assembly language, or even source code. Although the subject matter has been described in language specific to structural features and / or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the described features or acts described above. Rather, the described features and acts are disclosed as example forms of implementing the claims.

[0112] Disclosed embodiments may comprise or utilize cloud computing. A cloud model can be composed of various characteristics (e.g., on-demand self-service, broad network access, resource pooling, rapid elasticity, measured service, etc.), service models (e.g., Software as a Service ("SaaS"), Platform as a Service ("PaaS”), Infrastructure as a Service ("laaS"), and deployment models (e.g., private cloud, community cloud, public cloud, hybrid cloud, etc.).

[0113] Those skilled in the art will appreciate that the invention may be practiced in network computing environments with many types of computer system configurations, including, personal computers, desktop computers, laptop computers, message processors, hand-held devices, multi-processor systems, microprocessor-based or programmable consumer electronics, network PCs, minicomputers, mainframe computers, mobile telephones, PDAs, pagers, routers, switches, wearable devices, and the like. The invention may also be practiced in distributed system environments where multiple computer systems (e.g., local and remote systems), which are linked through a network (either by hardwired data links, wireless data links, or by a combination of hardwired and wireless data links), perform tasks. In a distributed system environment, program modules may be located in local and / or remote memory storage devices.

[0114] Alternatively, or in addition, the functionality described herein can be performed, at least in part, by one or more hardware logic components. For example, and without limitation, illustrative types of hardware logic components that can be used include Field-programmable Gate Arrays (FPGAs), Program-specific Integrated Circuits (ASICs), Application-specific Standard Products (ASSPs), System-on-a-chip systems (SOCs), Complex Programmable Logic Devices (CPLDs), central processing units (CPUs), graphics processing units (GPUs), and / or others.

[0115] As used herein, the terms "executable module," "executable component," "component," "module," or "engine" can refer to hardware processing units or to software objects, routines, or methods that may be executed on one or more computer systems. The different components, modules, engines, and services described herein may be implemented as objects or processors that execute on one or more computer systems (e.g., as separate threads).

[0116] It is contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments disclosed above may be made and still fall within one or more of the embodiments. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with an embodiment can be used in all other embodiments set forth herein. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed embodiments. Thus, it is intended that the scope of the present disclosure herein disclosed should not be limited by the particular disclosed embodiments described above. Moreover, while the present disclosure is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the present disclosure is not to be limited to the particular forms or methods disclosed, but to the contrary, the present disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims.

[0117] The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as "up to," "at least," "greater than," "less than," "between," and the like includes the number recited. Numbers preceded by a term such as "approximately", "about", and "substantially" as used herein include the recited numbers (e.g., about 10%=10%), and also represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms "approximately", "about", and "substantially" may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.

[0118] For purposes of the present disclosure and appended claims, the conjunction "or" is to be construed inclusively (e.g., "an apple or an orange" would be interpreted as "an apple, or an orange, or both"; e.g., "an apple, an orange, or an avocado" would be interpreted as "an apple, or an orange, or an avocado, or any two, or all three”), unless: (i) it is explicitly stated otherwise, e.g., by use of "either...or," "only one of," or similar language; or (ii) two or more of the listed alternatives are mutually exclusive within the particular context, in which case "or" would encompass only those combinations involving non-mutually-exclusive alternatives. For purposes of the present disclosure and appended claims, the words "comprising," "including," "having," and variants thereof, wherever they appear, shall be construed as open-ended terminology, with the same meaning as if the phrase "at least" were appended after each instance thereof.

Claims

CLAIMSWe Claim:

1. A thrombectomy system, comprising:□re or more processors; and one or more computer-readable recording media that store instructions that are executable by the one or more processors to configure the thrombectomy system to: access one or more pressure values obtained via a pressure sensor associated with an aspiration path of the thrombectomy system, the one or more pressure values indicating a current pressure within the aspiration path; access one or more air amount values obtained via a flow sensor associated with the aspiration path, the one or more air amount values indicating a current amount of air within the aspiration path; utilize the one or more pressure values and the one or more air amount values to provide input to a volume module to generate an estimated material volume, the estimated material volume indicating an estimated volume of material aspirated from a subject via the thrombectomy system; and based on the estimated material volume, perform one or more of:(i) selectively maintain an operational state of the thrombectomy system,(ii) selectively modify the operational state of the thrombectomy system, and / or (iii) selectively present an alert on a user interface.

2. The thrombectomy system of claim 1, wherein the aspiration path is defined by an aspiration catheter, an aspiration canister, and aspiration tubing.

3. The thrombectomy system of claim 2, wherein the pressure sensor or the flow sensor is arranged on the aspiration tubing.

4. The thrombectomy system of claim 1, wherein the flow sensor comprises a mass air flow sensor.

5. The thrombectomy system of claim 1, wherein the volume module is configured to determine the estimated material volume based on one or more initial air volume values indicating an initial volume of air within the aspiration path, one or more initial air amount values indicating an initial amount of air within the aspiration path, and one or more initial pressure values indicating an initial pressure within the aspiration path.

6. The thrombectomy system of claim 5, wherein the one or more initial pressure values are obtained via the pressure sensor.

7. The thrombectomy system of claim 5, wherein the one or more initial air amount values are determined based on the one or more initial pressure values and the one or more initial air volume values.

8. The thrombectomy system of claim 5, wherein the one or more air amount values are based on a difference between the one or more initial air amount values and one or more removed air amount values determined via the flow sensor.

9. The thrombectomy system of claim 5, wherein the estimated material volume is based on a difference between the one or more initial air volume values or a total volume of the aspiration path and one or more estimated air volume values, the one or more estimated air volume values indicating a current volume of air within the aspiration path.

10. The thrombectomy system of claim 9, wherein the one or more estimated air volume values are based on a product of one or more of: (i) a ratio of the one or more air amount values and the one or more initial air amount values, (ii) a ratio of the one or more initial pressure values and the one or more pressure values, and / or (iii) the one or more initial air volume values.

11. The thrombectomy system of claim 1, wherein the instructions are executable by the one or more processors to configure the thrombectomy system to:generate a plurality of estimated material volumes over a temporal window; and determine one or more estimated flow rates of material aspirated from the subject over the temporal window based on the plurality of estimated material volumes.

12. The thrombectomy system of claim 11, wherein the instructions are executable by the one or more processors to configure the thrombectomy system to determine an estimated composition of material aspirated from the subject by comparing the one or more estimated flow rates to one or more reference flow rates.

13. A method, comprising: accessing one or more pressure values obtained via a pressure sensor associated with an aspiration path of a thrombectomy system, the one or more pressure values indicating a current pressure within the aspiration path; accessing one or more air amount values obtained via a flow sensor associated with the aspiration path, the one or more air amount values indicating a current amount of air within the aspiration path; utilizing the one or more pressure values and the one or more air amount values as input to a volume module to generate an estimated material volume, the estimated material volume indicating an estimated volume of material aspirated from a subject via the thrombectomy system; and based on the estimated material volume, performing one or more of (i) selectively maintaining an operational state of the thrombectomy system, (ii) selectively modifying the operational state of the thrombectomy system, and / or (iii) selectively presenting an alert on a user interface.

14. The method of claim 13, wherein the aspiration path is defined by an aspiration catheter, an aspiration canister, and aspiration tubing.

15. The method of claim 14, wherein the pressure sensor or the flow sensor is arranged on the aspiration tubing.

16. The method of claim 13, wherein the volume module is configured to determine the estimated material volume based on one or more initial air volume values indicating an initial volume of air within the aspiration path, one or more initial air amount values indicating an initial amount of air within the aspiration path, and one or more initial pressure values indicating an initial pressure within the aspiration path.

17. The method of claim 16, wherein the estimated material volume is based on a difference between the one or more initial air volume values or a total volume of the aspiration path and one or more estimated air volume values, the one or more estimated air volume values indicating a current volume of air within the aspiration path, and wherein the one or more estimated air volume values are based on a product of (i) a ratio of the one or more air amount values and the one or more initial air amount values, (ii) a ratio ofthe one or more initial pressure values and the one or more pressure values, and (iii) the one or more initial air volume values.

18. The method of claim 13, further comprising: generating a plurality of estimated material volumes over a temporal window; and determining one or more estimated flow rates of material aspirated from the subject over the temporal window based on the plurality of estimated material volumes.

19. The method of claim 18, further comprising determining an estimated composition of the estimated volume of material aspirated from the subject by comparing the one or more estimated flow rates to one or more reference flow rates.

20. One or more computer-readable recording media that store instructions that are executable by one or more processors of a thrombectomy system to configure the thrombectomy system to:access one or more pressure values obtained via a pressure sensor associated with an aspiration path of the thrombectomy system, the one or more pressure values indicating a current pressure within the aspiration path; access one or more air amount values obtained via a flow sensor associated with the aspiration path, the one or more air amount values indicating a current amount of air within the aspiration path; utilize the one or more pressure values and the one or more air amount values as input to a volume module to generate an estimated material volume, the estimated material volume indicating an estimated volume of material aspirated from a subject via the thrombectomy system; and based on the estimated material volume, perform one or more of (i) selectively maintain an operational state of the thrombectomy system, (ii) selectively modify the operational state of the thrombectomy system, and / or (iii) selectively present an alert on a user interface.

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