WO2026059631A1 - Surveillance de pression saline basée sur la détection de courant de moteur dans des systèmes de thrombectomie - Google Patents

Surveillance de pression saline basée sur la détection de courant de moteur dans des systèmes de thrombectomie

Info

Publication number
WO2026059631A1
WO2026059631A1 PCT/US2025/035503 US2025035503W WO2026059631A1 WO 2026059631 A1 WO2026059631 A1 WO 2026059631A1 US 2025035503 W US2025035503 W US 2025035503W WO 2026059631 A1 WO2026059631 A1 WO 2026059631A1
Authority
WO
WIPO (PCT)
Prior art keywords
peak
thrombectomy system
state
fluid pressure
thrombectomy
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/035503
Other languages
English (en)
Inventor
Matthew Wayne Tilstra
Gregory Brian INGERSOLL
Joseph Higgins
Benjamin Daniel HASELMAN
Grant Alan ADAMS
Brian Peter SCHMALZ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Walk Vascular LLC
Original Assignee
Walk Vascular LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Walk Vascular LLC filed Critical Walk Vascular LLC
Publication of WO2026059631A1 publication Critical patent/WO2026059631A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system

Definitions

  • 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.
  • Blood clots 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.
  • 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).
  • Mechanical thrombectomy devices can implement various types of mechanical components to engage with and remove thrombotic material.
  • 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.
  • suction-based thrombectomy devices use negative pressure to aspirate clots from blood vessels (e.g., via a catheter with a distal
  • rotational thrombectomy devices employ rotational mechanisms to fragment and remove clots (e.g., a rotating wire 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.
  • 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 nearthe 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.
  • Some thrombectomy devices employ aspects of suction-based thrombectomy devices and rheolytic thrombectomy devices.
  • some thrombectomy devices utilize a saline jet positioned at or near a distal tip of an aspiration catheter, allowing for aspiration of clot fragments as the jetted saline macerates the clot (e.g., thrombus and/or soft emboli).
  • 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 sensor data obtained via a current sensor associated with a fluid drive unit of the thrombectomy system, wherein the sensor data captures motor current overtime for the fluid drive unit; determine one or more peak-to-peak current values or profiles over one or more temporal windows represented in the sensor data; utilize the one or more peak-to-peak current values or profiles as input to a fluid pressure module to generate a fluid pressure state associated
  • the techniques described herein relate to a method, including: accessing sensor data obtained via a current sensor associated with a fluid drive unit of a thrombectomy system, wherein the sensor data captures motor current over time or position for the fluid drive unit; determining one or more peak-to-peak current values over one or more temporal windows represented in the sensor data; utilizing the one or more peak-to-peak current values as input to a fluid pressure module to generate a fluid pressure state associated with a catheter connected to the fluid drive unit of the thrombectomy system; and based on the fluid pressure state, perform one or more of: (i) selectively maintaining an operational state of the thrombectomy system, (ii) selectively modifying the operational state of the thrombectomy system, or (iii) selectively presenting an alert on a user interface.
  • 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 sensor data obtained via a current sensor associated with a fluid drive unit of the thrombectomy system, wherein the sensor data captures motor current over time for the fluid drive unit; determine one or more peak-to-peak current values over one or more temporal windows represented in the sensor data; utilize the one or more peak-to-peak current values as input to a fluid pressure module to generate a fluid pressure state associated with a catheter connected to the fluid drive unit of the thrombectomy system; and based on the fluid pressure state, 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, or (iii) selectively present an alert on a user interface.
  • Figure 2 illustrates a plan view of example disposable components of a system for aspirating thrombus according to an embodiment of the present disclosure.
  • Figure 3 illustrates a sectional view of an example distal end of the aspiration catheter of the system for aspirating thrombus of Figure 1.
  • Figure 4 illustrates a detail view of an example y-connector of the aspiration catheter of the system for aspirating thrombus of Figure 1.
  • Figure 5 illustrates a plan view of example disposable components of a system for aspirating thrombus according to an embodiment of the present disclosure.
  • Figure 6A illustrates a perspective view of an example system for aspirating thrombus of Figure 4.
  • Figure 6B illustrates a schematic representation of the aspiration system according to an implementation of the present disclosure.
  • Figure 7 illustrates a conceptual representation of a process for monitoring fluid pressure states based on motor current detection in thrombectomy systems, according to implementations of the present disclosure.
  • Figures 8, 9, 10, 11, and 12 illustrate example graphs depicting motor current profiles for a fluid drive unit of a thrombectomy system under various operational conditions, according to implementations of the present disclosure.
  • Figure 13 illustrates an example flow diagram depicting acts associated with monitoring fluid pressure states based on motor current detection in thrombectomy systems, in accordance with implementations of the present disclosure.
  • some thrombectomy devices utilize a saline jet positioned at or near a distal tip of an aspiration catheter, allowing for aspiration of clot fragments as the jetted saline macerates the clot material.
  • fluctuations in the pressure of saline pumped toward the distal region of the aspiration catheter can fluctuate for various reasons, such as occlusions in the saline delivery line, exhaustion of saline for delivery, disconnection of one or more fittings/connectors, and/or other reasons.
  • Monitoring saline pressure during operation can thus allow for detection and/or mitigation of potential problems that may arise during use of a thrombectomy system, which can improve patient outcomes.
  • the present disclosure pertains to systems, devices, and techniques for determining the fluid pressure state of a thrombectomy system based on the motor current of the fluid drive system.
  • At least some disclosed embodiments are directed to a thrombectomy system that is configured to access sensor data that captures motor current over time for a fluid drive unit of the thrombectomy system.
  • the thrombectomy system analyzes the sensor data to determine a peak-to-peak current profile or value(s) over a temporal window represented in the sensor data.
  • the thrombectomy system utilizes the peak-to-peak current profile or value(s) as input to a fluid pressure module to determine a fluid pressure state associated with a catheter connected to the fluid drive unit of the thrombectomy system.
  • the thrombectomy system can perform various actions, such as selectively maintaining an operational state of the thrombectomy system (e.g., when the fluid pressure state indicates normal operation) or selectively modifying the operational state and/or presenting an alert on a user interface (e.g., when the fluid pressure state indicates abnormal operation).
  • monitoring fluid pressure state of a thrombectomy system based on motor current of the fluid drive unit to trigger actions may provide various advantages, such as minimizing the incidence and/or severity of operational errors and/or malfunctions (e.g., fluid exhaustion, disconnection of components, occlusions), which can beneficially facilitate improved patient outcomes.
  • operational errors and/or malfunctions e.g., fluid exhaustion, disconnection of components, occlusions
  • 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.
  • the principles disclosed herein may be implemented in conjunction with other types of catheter-based thrombectomy systems.
  • 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 reusable components. 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).
  • 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.
  • 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.
  • a spike 116 for coupling to a fluid source 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.
  • a vacuum source such as a syringe 130 having a plunger 132 and a barrel 134
  • 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.
  • a pressure sensor or transducer 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.
  • 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.
  • 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 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.
  • the controller may be configured to open the pinch valve 162.
  • the pressure transducer 144 thus senses a negative pressure and sends a signal, causing the controller to start the motor of the pump 101.
  • the motor starts pumping almost immediately after the pedal 166 is depressed.
  • the controller 174 causes the pinch valve 162 to close.
  • the pressure transducer 144 thus senses that no negative pressure is present and the controller 174 causes the motor of the pump 101 to shut off.
  • the effect via the electronics is substantially immediate, and thus the motor stops pumping almost immediately after the pedal 166 is depressed.
  • the main interventionalist is usually "scrubbed" such that the hands only touch items in the sterile field.
  • the feet/shoes/shoe covers are not in the sterile field.
  • a single user may operate a switch (via the pedal 166) while also manipulating the catheter 102 and guidewire 148.
  • the foot pedal 160 may comprise two pedals, one for occlude and one for open.
  • 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.
  • 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,
  • 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.
  • 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.
  • 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 144.
  • 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.
  • 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).
  • 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.
  • 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
  • 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).
  • the lowest energy condition least fluid resistance
  • the largest cross-sectional space condition e.g., for accommodating and passing pieces of thrombus
  • 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 treating coronary, 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 near the 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.
  • the orifice or opening 194 may be located proximal to the distal end 185 of the supply lumen 114.
  • the distal end 185 of the supply lumen 114 may comprise a plug 192.
  • 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.
  • SDU saline drive unit
  • 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.
  • 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 sensors may 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.
  • one or more fluid flow sensors is/are utilized in addition to or as an alternative to the pressure sensor 230.
  • the fluid flow sensor is a Doppler flow velocity sensor, or other type of flow sensor.
  • a flow sensor 223 is positioned along tubing between the aspiration catheter 202 and the vacuum canister 218 (see Figure 6B).
  • 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).
  • 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.
  • 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.
  • the vacuum inside the canister 218 may be maintained manually, without a vacuum pump, by evacuating the canister 218 via one or more additional ports 268.
  • the vacuum pump 266 communicates with atmosphere through a manifold and/or filter 269 (see Figure 6B).
  • 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.
  • 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
  • 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).
  • medication e.g., thrombolytic drugs
  • 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 othertype.
  • the vacuum pump 266 can generate in excess of -29.5 inHg (expressed as gauge pressure readings relative to atmospheric pressure (not absolute 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.
  • 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).
  • 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).
  • 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.
  • the vacuum regulator 267 can be disposed externally to the SDU case 284 and can optionally remain unlocked.
  • 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/or the pressure sensor 230.
  • 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/or additional cables or wires.
  • the connector 236 may couple to the mating receptacle 237 by clipping, friction fitting, vacuum fitting, or other means.
  • the user 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.
  • 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
  • An interface panel 290 provides one or more switches 297 and the display 238.
  • the cassette 121 may couple to the saddle 283 by clipping, friction fitting, vacuum fitting, or other means.
  • the controller 235 operates the motor 287 to control movement of the saddle 283 and to 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 jet pressures ranging from about 410 pounds per square inch (PSI) to about 707 PSI.
  • the motor 287 can be operated at different speeds.
  • 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 (PID) speed control algorithm or feedback loop to monitor and correct a speed of the motor 287 for any changes in load conditions.
  • PID proportional-integral-derivative
  • 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.
  • 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
  • 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.
  • the vacuum pump 266 such as a vacuum pump motor controller
  • control of the vacuum pump 266 can be achieved through the one or more switches 297 in combination with the controller 235.
  • 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.
  • 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.
  • the controller 235 can include hardware, firmware, etc. that provides through the display, etc.
  • a "No Suction” alarm notifying a user of vacuum leaks in the system (i) 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 inHg 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.
  • Figure 7 illustrates a conceptual representation of a process for monitoring fluid pressure states based on motor current detection in thrombectomy systems, according to implementations of the present disclosure.
  • Figure 7 conceptually depicts components, operations, and data objects associated with a thrombectomy system 702.
  • the thrombectomy system 702 can correspond to and/or
  • the thrombectomy system 702 can comprise a fluid drive unit 704 (e.g., corresponding to SDU 212) that includes a motor 706 (e.g., corresponding to motor 287).
  • the motor 706 can be configured to actuate one or more components of a saddle 708 (e.g., corresponding to saddle 283).
  • a cassette 710 (e.g., corresponding to cassette 278) may be selectively connected to the saddle 708 such that actuation of the components of the saddle 708 can cause reciprocation of a piston (e.g., corresponding to piston 122) within the cassette 710.
  • Reciprocation of the piston of the cassette 710 may cause saline (or another fluid) to be drawn from a saline bag 712 (e.g., corresponding to saline bag 712) via a supply tube 714 (e.g., corresponding to supply tube 714) and injected through an injection tube 716 (e.g., corresponding to injection tube 279, 124) at high pressure.
  • the injection tube 716 may be connected (e.g., via a luer connector 280 and luer 282, 113) to a supply lumen (e.g., corresponding to supply lumen 114) of an aspiration catheter 718 (e.g., corresponding to aspiration catheter 202).
  • the supply lumen of the aspiration catheter 718 may comprise an opening or orifice (e.g., corresponding to orifice 194) near its distal end for providing a high-pressure saline jet for macerating clot material during thrombectomy operations.
  • Figure 7 depicts an instance where, at least initially, a fluid injection state is active.
  • the fluid injection state can involve operation of components of the thrombectomy system 702 to provide a high-pressure fluid jet at the distal region of the aspiration catheter 718.
  • the motor 706 may drive the saddle 708 (and consequently the piston of the cassette 710) inject saline from the saline bag 712 to form a high-pressure saline jet at the distal region of the aspiration catheter 718.
  • the high-pressure saline jet may macerate clot material to assist in thrombectomy operations.
  • Figure 7 illustrates that the thrombectomy system may further include a current sensor 719.
  • the current sensor 719 may be part of otherwise in communication with the motor 706 (indicated in Figure 7 by the current sensor 719 being adjacent to the motor 706).
  • the current sensor 719 can facilitate acquisition of motor current data 720 associated with operation of the motor 706 (indicated in Figure 7 by the arrow extending from the sensor 719 to the motor current data 720).
  • the current sensor 719 can be embodied in various ways. By way of non-limiting example, the current sensor 719 can
  • the motor current data 720 indicates the motor current of the motor 706 over time.
  • the motor current data 720 can comprise raw measurement data (e.g., analog measurements), processed measurement data (e.g., digital measurements), and/or information based on raw or processed measurement data.
  • the thrombectomy system 702 can determine peak-to-peak current 722 based on the motor current data 720 (indicated in Figure 7 by the arrow extending from the motor current data 720 to the peak-to-peak current 722).
  • the peak-to-peak current 722 can comprise the difference between the maximum current and the minimum current over a temporal window (e.g., one or more pulsatile patterns) represented in the motor current data 720.
  • Figure 8 provides an example graph 802 of motor current overtime (e.g., corresponding to motor current data 720).
  • the graph 802 captures motor current values for a motor 706 of a fluid drive unit 704 through startup and running of a fluid injection state with the cassette 710 installed and with the aspiration catheter 718 connected.
  • the motor current is illustrated in graph 802 with a solid line ("Actual Current Averaged") and shows a pulsatile pattern due to the pumping action of the saline pump.
  • the peak-to-peak motor current (e.g., represented in graph 802 as the difference between current values 804 and 806, corresponding to peak-to-peak current 722) shows the work being done from the saline pumping action.
  • the work to pump saline varies with saline pressure (e.g., via a positive relationship), enabling the peak-to-peak current 722 to indicate the fluid pressure state associated with the thrombectomy system 702.
  • the work to pump saline is one of many components that can affect or be represented in the motor current of a motor 706 of a fluid drive unit 704.
  • Other nonpumping components of the motor current can include the no-load motor current, the work needed to drive the gear box, cam assembly, linear bearings, the saline pump cassette, and/or others.
  • Such non-pumping components of motor current can change overtime and can be affected by variables such as temperature (e.g., resulting in thermal expansion or contraction of components, changes in viscosity, etc.), altitude, positioning of components (e.g., movement of the aspiration catheter 718 or tubing, mechanical shifts in alignment), and/or others. Changes in non-pumping components can result in a
  • Figure 9 illustrates an example graph 902 of motor current over time for a motor 706 of a fluid drive unit 704, showing the startup and running of a fluid injection state with no cassette 710 installed.
  • Graph 902 shows the motor current (represented in graph 902 with a solid line, labeled "Actual Current Averaged") decreasing over time as the motor and gearbox warm up (e.g., warming of the lubrication in the gears and bearings can decrease the contribution of the motor and gearbox to the motor current).
  • the overall decrease in the motor current is depicted in graph 902 by trend line 904, which shows a decrease in overall or average motor current despite there not being a corresponding decrease in saline pressure (e.g., because the cassette 710 is not installed in the example described with reference to Figure 9, no change in saline pressure is occurring).
  • trend line 904 shows a decrease in overall or average motor current despite there not being a corresponding decrease in saline pressure (e.g., because the cassette 710 is not installed in the example described with reference to Figure 9, no change in saline pressure is occurring).
  • the initial motor current of a motor 706 of a fluid drive unit 704 can be affected by the initial temperature of the motor, which can cause a motor that has been recently used to present with a lower initial motor current.
  • peak-to-peak motor current can provide a basis for determining fluid pressure state, notwithstanding changes in nonpumping loads.
  • graph 802 illustrates an upward shift in overall motor current due to non-pumping motor current components (indicated in Figure 8 by reference label 808).
  • the peak-to-peak motor current e.g., represented in graph 802 as the difference between current values 810 and 812 is substantially unaffected by the upward shift in overall motor current brought about by the non-pumping components.
  • the peak-to-peak current 722 can be used to estimate the fluid pressure state associated with the thrombectomy system 702.
  • Figure 7 conceptually depicts the peak-to-peak current 722 being utilized as input to a fluid pressure module 724 (as indicated by the arrow extending from the peak-to-peak current 722 to the fluid pressure module 724).
  • the fluid pressure module 724 may process the peak-to-peak current 722 (or the motor current data 720 and/or other information based thereon) to determine a fluid pressure state 732 for the thrombectomy system 702 and/or components thereof (e.g., the aspiration catheter 718).
  • the fluid pressure module 724 may comprise any combination of software or hardware objects and may determine fluid pressure status based on motor current data in various ways. In some instances, the fluid pressure module 724 is configured to compare the peak-to-peak current 722 to reference peak-to-peak current 726 information to determine the fluid pressure state 732. The peak-to-peak current 722 and the reference fluid pressure module 724 selected for comparison may be based on one or more time thresholds (e.g., a set amount of time following startup) and/or other rules. [0061] The reference peak-to-peak current 726 can comprise peak-to-peak current values or profiles associated with different fluid pressure states.
  • graph 802 of Figure 8 depicts running of a fluid injection state (with the cassette 710 installed and with the aspiration catheter 718 connected) in an in-range pressure state (e.g., within a pressure range associated with normal conditions or associated with the absence of any occlusions, component disconnections, leaks, saline exhaustion, etc.).
  • peak-to-peak current data of graph 802 may represent a reference peak-to-peak current 726, which may be used by the fluid pressure module 724 to determine whether the input peak-to-peak current 722 indicates that the thrombectomy system 702 is running in an in-range pressure state.
  • the fluid pressure module 724 may determine similarity (e.g., a similarity score) between the input peak- to-peak current 722 and the reference peak-to-peak current 726. Based on the determined similarity (e.g., if the similarity score satisfies one or more thresholds or other
  • the fluid pressure module 724 may determine whether to assign the in-range pressure state label for the thrombectomy system 702.
  • graph 902 of Figure 9 depicts running of a fluid injection state of a thrombectomy system 702 with the cassette 710 disconnected, resulting in a low-pressure state (or low backpressure state).
  • graph 1002 of Figure 10 depicts startup and running of a fluid injection state of a thrombectomy system 702 with the cassette 710 connected but with the aspiration catheter 718 disconnected, resulting in a low-pressure state (or low backpressure state).
  • the low-pressure state can be associated with lower peak-to-peak motor current values (e.g., relative to peak-to-peak current values associated with normal operation or an inrange pressure state).
  • Peak-to-peak currents of graphs 902 and 1002 may represent reference peak-to-peak currents 726 against which the input peak-to-peak current 722 may be compared by the fluid pressure module 724 to determine whether the thrombectomy system 702 is running in a low-pressure state (e.g., whether to assign a low-pressure state label for the thrombectomy system 702 based on the input peak-to- peak current 722).
  • graph 1102 of Figure 11 depicts startup and running of a fluid injection state of a thrombectomy system 702 with an in-range pressure state (indicated by reference label 1104) followed by an upstream occlusion state (indicated by reference label 1106).
  • An upstream occlusion state can be caused by exhaustion of saline from the saline bag 712, occlusion or pinching/kinking of the supply tube 714, etc.
  • the upstream occlusion state can be associated with a nearly flat motor current (e.g., relative to peak-to-peak current values associated with normal operation or an in-range pressure state).
  • Peak-to-peak currents of graph 1102 may represent a reference peak-to-peak current 726 against which the input peak-to-peak current 722 may be compared by the fluid pressure module 724 to determine whether the thrombectomy system 702 is running in an upstream occlusion state.
  • graph 1202 of Figure 12 depicts startup and running of a fluid injection state of a thrombectomy system 702 with an in-range pressure state (indicated by reference label 1204), followed by a downstream occlusion state (indicated by reference label 1206), followed again by an in-range pressure state (indicated by reference label 1204)
  • a downstream occlusion state can be caused by occlusion or pinching/kinking of the injection tube 716 or the supply lumen within the aspiration catheter 718, etc. As is evident from graph 1202, the downstream occlusion state can be associated with an increased peak-to-peak motor current (e.g., relative to peak-to-peak current values associated with normal operation or an in-range pressure state).
  • Peak-to- peak currents of graph 1202 may represent a reference peak-to-peak current 726 against which the input peak-to- peak current 722 may be compared by the fluid pressure module 724 to determine whether the thrombectomy system 702 is running in a downstream occlusion state.
  • Graph 1202 of Figure 12 also illustrates the similarity of the amplitude of the peak-to-peak motor current before introduction of the downstream occlusion (at the region associated with reference label 1204) and after clearing of the downstream occlusion (at the region associated with reference label 1208), which can illustrate the robustness of peak-to-peak current as a basis for estimating fluid pressure state despite variations in overall or average motor current caused by non-pumping loads (e.g., caused in the example shown in Figure 12 by movement/manipulation of the saline line).
  • Reference peak-to-peak current 726 information can comprise motor current profiles, peak-to-peak values, or other information based on reference motor current data.
  • the reference peak-to-peak current 726 information can include reference profiles, values, or other information associated with fluid pressure states other than those illustrated by example above.
  • the reference peak-to-peak current 726 information can include information associated with a high-pressure state, an upstream leak state (resulting in a flattening of peak-to-peak current), a downstream leak state (resulting in a drop in back pressure and peak-to-peak current, which can result from the catheter becoming disconnected), and/or others.
  • Peak-to-peak current 722 and reference peak-to-peak current 726 may be determined in any suitable manner, such as, by way of non-limiting example, profile/waveform comparison methods, correlation coefficients, Euclidean distance (or other distance metrics), dynamic time warping, kernel methods, curve
  • similarity is determined based on extraction and analysis/comparison of key features/metrics of the input peak- to-peak current 722 and the reference peak-to-peak current 726, such as peaks (e.g., maxima), valleys (e.g., minima), slopes, inflection points, and/or other distinctive characteristics.
  • the reference peak-to-peak current 726 information includes different sets of reference peak-to-peak current 726 data for different operational variables 728 associated with the thrombectomy system 702.
  • the fluid pressure module 724 may select a set of reference peak-to-peak current 726 data for comparison with input peak-to-peak current 722 to determine the fluid pressure state 732 based on operational variables 728 of the thrombectomy system 702 (as indicated in Figure 7 by the arrow extending from the operational variables 728 to the fluid pressure module 724).
  • Operational variables 728 of a thrombectomy system 702 or fluid drive unit 704 can include, by way of non-limiting example, operational mode/state (e.g., low-level aspiration, full aspiration, low-level fluid injection, full fluid injection, user-selected target fluid pressure settings, etc.), catheter state/characteristics (e.g., catheter type, catheter positioning), operational altitude, ambient temperature, motor speed (e.g., stroke speed), motor position, stroke volume (e.g., upstroke volume, downstroke volume, upstroke/downstroke ratio), linear bearing position, fluid pressure generating mechanism position, pump flow ratio, and/or others.
  • operational mode/state e.g., low-level aspiration, full aspiration, low-level fluid injection, full fluid injection, user-selected target fluid pressure settings, etc.
  • catheter state/characteristics e.g., catheter type, catheter positioning
  • operational altitude ambient temperature
  • motor speed e.g., stroke speed
  • motor position e.g., stroke
  • the fluid pressure module 724 can be configured to utilize additional types of motor current data to determine the fluid pressure state 732, such as average current 730 that is temporally correlated with the peak-to-peak current 722 (e.g., average current 730 for the same temporal window as the peak-to-peak current 722).
  • additional types of motor current data such as average current 730 that is temporally correlated with the peak-to-peak current 722 (e.g., average current 730 for the same temporal window as the peak-to-peak current 722).
  • the fluid pressure module 724 utilizes one or more Al modules to determine similarity as discussed above and/or to infer or label the fluid pressure state 732 based on the peak-to-peak current 722 (and/or operational variables 728 or other information based on the motor current data 720).
  • the Al module(s) are trained on training data comprising peak-to-peak current (and/or operational variables or other information based on motor current data)
  • the fluid pressure state 732 can take on various forms, such as a classification or label (e.g., "in-range pressure”, “high pressure”, “low pressure”, “upstream occlusion”, “downstream occlusion”, “upstream leak”, “downstream leak”, and/or others), an estimated fluid pressure value or range of values, etc.
  • a classification or label e.g., "in-range pressure”, “high pressure”, “low pressure”, “upstream occlusion”, “downstream occlusion”, “upstream leak”, “downstream leak”, and/or others
  • an indication of the fluid pressure state 732 may, in some instances, be presented on a display 742 of the thrombectomy system 702.
  • Such functionality can enable users to monitor the fluid pressure state during thrombectomy operations and take corrective action if needed, which can improve thrombectomy success rates and/or patient outcomes.
  • the fluid pressure state 732 may be used to trigger various actions for the thrombectomy system 702.
  • Figure 7 provides an example in which, at least initially, the thrombectomy system 702 is in a fluid injection state. Based on the fluid pressure state 732, the thrombectomy system 702 may selectively maintain or change its operational state, and/or take other actions.
  • Figure 7 conceptually depicts that the thrombectomy system 702 may determine whether the fluid pressure state 732 satisfies one or more conditions (indicated by the arrow extending from the fluid pressure state 732 to decision block 734).
  • An example condition may comprise whether the fluid pressure state 732 satisfies one or more thresholds (e.g., pressure value or range thresholds), corresponds to or matches one or more target classifications/labels (e.g., in-range pressure state), and/or others.
  • Another example condition may comprise whether the rate of change of the peak-to-peak current 722 satisfies one or more thresholds (which can imply fluid pressure or operational states/conditions of the thrombectomy system 702). Other conditions are possible.
  • the thrombectomy system 702 may selectively maintain its operational state (indicated in Figure 7 by the arrow labeled
  • the thrombectomy system 702 may selectively remain in the fluid injection state when the fluid pressure state 732 is determined to correspond to a target classification/la bel associated with normal or safe operation (e.g., in-range pressure state) or is determined to be within one or more target or threshold ranges of values.
  • a target classification/la bel associated with normal or safe operation (e.g., in-range pressure state) or is determined to be within one or more target or threshold ranges of values.
  • the thrombectomy system 702 may selectively modify its operational state (indicated in Figure 7 by the arrow labeled "No" extending from decision block 734 to action block 738).
  • the thrombectomy system 702 may selectively deactivate the fluid injection state when the fluid pressure state 732 is determined to fail to correspond to a target classification/label associated with normal or safe operation (e.g., where the fluid pressure state 732 corresponds to a high-pressure state, low-pressure state, upstream occlusion state, downstream occlusion state, upstream leak state, or downstream leak state) or is determined to be outside of one or more target threshold ranges of values.
  • Other modifications may be performed based on the fluid pressure state 732 failing to satisfy one or more conditions, such as increasing or decreasing the motor speed or other operational characteristics of the motor (or other thrombectomy components, such as aspiration components including a vacuum pump).
  • Enabling selective, automatic modification of the operational state of the thrombectomy system 702 based on characteristics of the fluid pressure state 732 can mitigate the incidence of clinical failures associated with thrombectomy operations (e.g., due to saline exhaustion, leaks, disconnections, occlusions, etc.). Such benefits can be advantageously achieved without requiring clinicians to closely monitor audible and or tactile characteristics (e.g., vibrations) of the motor 706 to estimate whether normal operation is occurring.
  • the thrombectomy system 702 may selectively present an alert on a user interface (indicated in Figure 7 by the arrow labeled "No" extending from decision block 734 to action block 740).
  • 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
  • the alert can communicate to a medical professional operating the thrombectomy system 702 that the fluid pressure state is outside of an expected range, which can prompt the medical professional to take corrective actions to safeguard the operation.
  • multiple peak-to-peak current 722 values or profiles may be determined over consecutive temporal windows.
  • the thrombectomy system 702 may determine a rate of change 744 that indicates the rate at which the thrombectomy system 702 is changing over time (indicated in Figure 7 by the arrow extending from the fluid pressure state 732 to the rate of change 744.
  • rate of change 744 may be used to selectively modify or maintain operational states of the thrombectomy system 702 (and/or to trigger alerts).
  • Figure 7 further conceptually depicts that the rate of change 744 may be used to determine or estimate a system state 746 (indicated by the arrow extending from the rate of change 744 to the system state 746).
  • the thrombectomy system 702 can compare the rate of change 744 to reference rates of change values or profiles associated with different system states, such as a wear state of one or more components of the thrombectomy system 702 (e.g., the motor 706 or saddle 708), an amount of compliance associated with the component(s) of the thrombectomy system 702 (e.g., which can result from bulging or wear of tubing of the thrombectomy system 702), an estimated location of an occlusion or leak (e.g., how far upstream or downstream from the cassette 710 the occlusion or leak is, which can affect how quickly the peak-to-peak current changes in response to the occlusion or leak), and/or other system states.
  • Estimated system states 746 can be presented and/or
  • estimated system states 746 can be used to determine which reference peak-to-peak current 726 information to use for comparison with input peak-to-peak current 722 to determine fluid pressure state 732 (or which Al module(s) to use to estimate the fluid pressure state 732).
  • the thrombectomy system 702 may employ one or more machine learning, statistical, rule-based, or other models to predict or estimate system states 746 based on the rate of change 744.
  • Figure 13 illustrates an example flow diagram depicting acts associated with monitoring fluid pressure states based on motor current detection in thrombectomy systems, in accordance with implementations of the present disclosure.
  • Act 1302 of flow diagram 1300 includes accessing sensor data obtained via a current sensor associated with a fluid drive unit of a thrombectomy system, wherein the sensor data captures motor current over time or position for the fluid drive unit.
  • Act 1304 of flow diagram 1300 includes determining one or more peak-to- peak current values over one or more temporal windows represented in the sensor data.
  • Act 1306 of flow diagram 1300 includes utilizing the one or more peak-to-peak current values as input to a fluid pressure module to generate a fluid pressure state associated with a catheter connected to the fluid drive unit of the thrombectomy system.
  • the fluid pressure module is configured to compare the one or more peak-to-peak current values or profiles to one or more reference peak-to-peak current values or profiles to determine the fluid pressure state.
  • the one or more reference peak-to-peak current values are determined based on one or more operational variables associated with thrombectomy system.
  • the one or more operational variables comprise one or more of: motor speed, motor position, stroke volume, linear bearing position, fluid pressure generating mechanism position, or pump flow ratio associated with the fluid drive unit.
  • the fluid pressure state comprises one or more of: a high pressure state, a low pressure state, an in-range pressure state, an upstream occlusion state, a downstream occlusion state, an upstream leak state, or a downstream leak state.
  • the fluid pressure module is configured to utilize one or more average current values for the one or more temporal windows to generate the fluid pressure state.
  • Act 1308 of flow diagram 1300 includes, based on the fluid pressure state, 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, or (iii) selectively presenting an alert on a user interface.
  • Act 1310 of flow diagram 1300 includes presenting an indication of the fluid pressure state on the user interface.
  • Act 1312 of flow diagram 1300 includes determining one or more rates of change of the one or more peak-to-peak current values over time.
  • Act 1314 of flow diagram 1300 includes determining, based on the one or more rates of change, one or more of: a wear state of one or more components of the thrombectomy system, an amount of compliance associated with one or more components of the thrombectomy system, or an estimated location of an occlusion or a leak.
  • 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: capture sensor data via a current sensor associated with a fluid drive unit of the thrombectomy system, wherein the sensor data captures motor current over time for the fluid drive unit; determine one or more peak-to-peak current values or profiles over one or more temporal windows represented in the sensor data; utilize the one or more peak-to-peak current values or profiles as input to a fluid pressure module to generate a fluid pressure state associated with a catheter connected to the fluid drive unit of the thrombectomy system; and based on the fluid pressure state, 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, or (iii) selectively present an alert on a user interface.
  • Clause 6 The thrombectomy system of clause 1, wherein the fluid pressure state comprises one or more of: a high pressure state, a low pressure state, an in-range pressure state, an upstream occlusion state, a downstream occlusion state, an upstream leak state, or a downstream leak state.
  • a method comprising: capturing sensor data via a current sensor associated with a fluid drive unit of a thrombectomy system, wherein the sensor data captures motor current over time or position for the fluid drive unit; determining one or more peak-to-peak current values over one or more temporal windows represented in the sensor data; utilizing the one or more peak-to-peak current values as input to a fluid pressure module to generate a fluid pressure state associated with a catheter connected to the fluid drive unit of the thrombectomy system; and based on the fluid pressure state, 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, or (iii) selectively presenting an alert on a user interface.
  • Clause 12 The method of clause 11, wherein the fluid pressure module is configured to compare the one or more peak-to-peak current values to one or more reference peak-to-peak current values to determine the fluid pressure state.
  • Clause 14 The method of clause 13, wherein the one or more operational variables comprise one or more of: motor speed, motor position, stroke volume, linear bearing position, or pump flow ratio associated with the fluid drive unit.
  • Clause 16 The method of clause 11, wherein the fluid pressure state comprises one or more of: a high pressure state, a low pressure state, an in-range pressure state, an upstream occlusion state, a downstream occlusion state, an upstream leak state, or a downstream leak state.
  • Clause 17 The method of clause 16, further comprising presenting an indication of the fluid pressure state on the user interface.
  • Clause 18 The method of clause 11, wherein the fluid pressure module is configured to utilize one or more average current values for the one or more temporal windows to generate the fluid pressure state.
  • Clause 19 The method of clause 11, further comprising: determining one or more rates of change of the one or more peak-to-peak current values over time; and determining, based on the one or more rates of change, one or more of: a wear state of one or more components of the thrombectomy system, an amount of compliance associated with one or more components of the thrombectomy system, or an estimated location of an occlusion or a leak.
  • 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: capture sensor data via a current sensor associated with a fluid drive unit of the thrombectomy system, wherein the sensor data captures motor current over time for the fluid drive unit; determine one or more peak- to-peak current values over one or more temporal windows represented in the sensor data; utilize the one or more peak-to-peak current values as input to a fluid pressure module to generate a fluid pressure state associated with a catheter connected to the fluid drive unit of the thrombectomy system; and based on the fluid pressure state, 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, or (iii) selectively present an alert on a user interface.
  • 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 (or to 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.
  • 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.
  • 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.
  • storage may comprise local storage, remote storage (e.g., accessible via communication system(s) or otherwise), or some combination thereof.
  • 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 adversari
  • 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 or hardware components that are operable to facilitate communication between on-system components/devices and/or with off-system components/devices.
  • the communications system(s) may comprise ports, buses, or other physical connection
  • 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.
  • 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.
  • the sensor(s) may comprise one or more image sensors, microphones, thermometers, barometers, magnetometers, accelerometers, gyroscopes, and/or others.
  • 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.
  • 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.
  • the sensor(s) may, in some instances, be utilized as I/O system(s).
  • 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.”
  • the current embodiments can comprise at least two distinctly different kinds of computer-readable media: computer storage media and transmission media.
  • Computer storage media are computer- readable hardware storage devices, such as RAM, ROM, EEPROM, CD-ROM, solid state
  • SSD Page 33 - Docket No. 22935.37A/Abbott No. 15658WOO1 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.
  • 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.
  • 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.
  • 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).
  • program code means in the form of 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.
  • NIC network interface module
  • computer-readable physical storage media can be included in computer system components that also (or even primarily) utilize transmission media.
  • Computer-executable instructions comprise, for example, instructions and data which cause a general-purpose computer, special purpose computer, or special purpose 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.
  • 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.).
  • SaaS Software as a Service
  • PaaS Platform as a Service
  • laaS Infrastructure as a Service
  • deployment models e.g., private cloud, community cloud, public cloud, hybrid cloud, etc.
  • 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.
  • program modules may be located in local and/or remote memory storage devices.
  • the functionality described herein can be performed, at least in part, by one or more hardware logic components.
  • illustrative types of hardware logic components 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.
  • executable module can refer to hardware processing units or to software objects, routines, or methods that may be executed on one or more computer systems.
  • executable component can refer to hardware processing units or to software objects, routines, or methods that may be executed on one or more computer systems.
  • 15658WOO1 may be implemented as objects or processors that execute on one or more computer systems (e.g., as separate threads).
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgical Instruments (AREA)

Abstract

Un système de thrombectomie peut être configuré pour : (i) accéder aux données de capteur obtenues par l'intermédiaire d'un capteur de courant associé à une unité d'entraînement de fluide du système de thrombectomie, les données de capteur capturant un courant de moteur au cours du temps pour l'unité d'entraînement de fluide ; (ii) déterminer une ou plusieurs valeurs ou un ou plusieurs profils de courant de crête à crête sur une ou plusieurs fenêtres temporelles représentées dans les données de capteur ; (iii) utiliser la ou les valeurs ou le ou les profils de courant de crête à crête en tant qu'entrée dans un module de pression de fluide pour générer un état de pression de fluide associé à un cathéter relié à l'unité d'entraînement de fluide du système de thrombectomie ; et (iv) sur la base de l'état de pression de fluide, effectuer une ou plusieurs opérations parmi : (a) maintenir de manière sélective un état opérationnel du système de thrombectomie, (b) modifier de manière sélective l'état opérationnel du système de thrombectomie, ou (c) présenter de manière sélective une alerte sur une interface utilisateur.
PCT/US2025/035503 2024-09-16 2025-06-26 Surveillance de pression saline basée sur la détection de courant de moteur dans des systèmes de thrombectomie Pending WO2026059631A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463695180P 2024-09-16 2024-09-16
US63/695,180 2024-09-16

Publications (1)

Publication Number Publication Date
WO2026059631A1 true WO2026059631A1 (fr) 2026-03-19

Family

ID=96736611

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/035503 Pending WO2026059631A1 (fr) 2024-09-16 2025-06-26 Surveillance de pression saline basée sur la détection de courant de moteur dans des systèmes de thrombectomie

Country Status (1)

Country Link
WO (1) WO2026059631A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150327875A1 (en) * 2014-05-19 2015-11-19 Walk Vascular, Llc Systems and methods for removal of blood and thrombotic material
US20230149033A1 (en) * 2021-11-16 2023-05-18 Eximo Medical Ltd. Smart aspiration system

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150327875A1 (en) * 2014-05-19 2015-11-19 Walk Vascular, Llc Systems and methods for removal of blood and thrombotic material
US9883877B2 (en) 2014-05-19 2018-02-06 Walk Vascular, Llc Systems and methods for removal of blood and thrombotic material
US20230149033A1 (en) * 2021-11-16 2023-05-18 Eximo Medical Ltd. Smart aspiration system

Similar Documents

Publication Publication Date Title
US12318098B2 (en) Aspiration systems, devices and methods for treating ischemic stroke
US12144515B2 (en) Aspiration systems, devices and methods for treating ischemic stroke
US20220387052A1 (en) Systems and methods for removal of blood and thrombotic material
US20220168002A1 (en) Aspiration systems, devices and methods for treating ischemic stroke
US20220323096A1 (en) Aspiration systems, devices and methods for treating ischemic stroke
US10716880B2 (en) Systems and methods for aspiration and monitoring
JP2021532851A (ja) 吸引カテーテルを用いた血栓除去のための吸引式血栓除去システムおよび方法
US20220257268A1 (en) Systems and methods for removal of blood and thrombotic material
US12171444B2 (en) Systems and methods for removal of blood and thrombotic material
US20230047991A1 (en) Isovolumetric pump and systems and methods thereof
US20240148958A1 (en) Aspiration systems, devices and methods for treating ischemic stroke
WO2026059631A1 (fr) Surveillance de pression saline basée sur la détection de courant de moteur dans des systèmes de thrombectomie
US20250186068A1 (en) Signal-based clot engagement detection in thrombectomy devices
US20250186069A1 (en) Adaptive aspiration based on clot detection in thrombectomy devices
US20250195093A1 (en) Methods, systems, and devices for centering an aspiration catheter within a body lumen
US20250195089A1 (en) Blood loss systems, methods, and devices
WO2025122769A1 (fr) Détection de mise en prise de caillot basée sur un signal dans des dispositifs de thrombectomie
WO2026020088A1 (fr) Détermination de volume de matériau aspiré dans des systèmes de thrombectomie
WO2025122829A1 (fr) Aspiration adaptative basée sur la détection de caillot dans des dispositifs de thrombectomie
WO2026019482A1 (fr) Systèmes de réduction de perte de sang pour dispositifs de thrombectomie
US20250186070A1 (en) Clot engagement detection in thrombectomy systems
US20250186071A1 (en) Thrombectomy catheter system and methods of use
US20250195090A1 (en) Catheter clog detection in thrombectomy systems
WO2025128417A1 (fr) Détection d'obstruction de cathéter dans des systèmes de thrombectomie
US20250352225A1 (en) Aspiration systems, devices and methods for treating ischemic stroke