Catheter CLOG & vessel wall detection in thrombectomy systems

Abstract

A thrombectomy system is configurable to: (i) access a first set of pressure values obtained via a first pressure sensor associated with a first part of an aspiration path; (ii) access a second set of pressure values obtained via a second pressure sensor associated with a second part of the aspiration path, wherein the first set of pressure values and the second set of pressure values are captured over a common time period; (iii) determine whether the first set of pressure values and the second set of pressure values satisfy one or more conditions, wherein satisfaction of the one or more conditions indicates that the aspiration catheter is (a) engaged with a vessel wall of the vasculature of the subject or (b) clogged with pieces of blood clot.

Description

CATHETER CLOG & VESSEL WALL DETECTION IN THROMBECTOMY SYSTEMSCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims priority to and the benefit of United States Provisional Patent Application No. 63 / 755,039, filed on February 6, 2025, and entitled CATHETER CLOG & VESSEL WALL DETECTION 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 tipto be placed nearthe clot priorto activation to drawthe clot into a collection chamber, where it is trapped and removed). As yet another example, rotational thrombectomy- Page 1 - Docket No. 22935.54A / Abbott No. 16028WOO1devices 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.

[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 nearthe distal tip) and can utilize saline solution, ora mixture of saline and the patient's own blood, to create high-velocity jets for direction 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 ofclot fragments as the jetted saline macerates the clot (e.g., thrombus and / or soft emboli).

[0008] Catheter-based thrombectomy devices sometimes experience catheter clogging during clot removal operations. Catheter clogging can result from attempting to aspirate large or tough clots that can be resistant to fragmentation (e.g., due to calcification or fibrin richness). Catheter clogging during clot removal operations can often go undetected (e.g., unlessthe clinician pays close attention to canister blood flow). When the catheter is clogged, suction at the distal tip of the catheter can be lost, and fluid can be sprayed out from the distal tip of the catheter (when a saline jet is present). Fluid released from the distal tip of the catheter can cause cell lysis and / or displacement of blood cells. Additionally, fluid released from the distal tip of the catheter can cause clot material to be pushed away from or spin about the distal tip of the catheter, which can further complicate and / or prolong a clot removal procedure.

[0009] Catheter-based thrombectomy devices can also inadvertently engage with vessel walls of a patient's vasculature during clot removal operations. Such engagement can increase the risk of mechanical injury to patients, such as endothelial damage or even vessel dissection or perforation, which can cause internal bleeding and / or other dangers and complications. Catheter engagement with vessel walls can often go undetected- Page 2 - Docket No. 22935.54A / Abbott No. 16028WOO1during clot removal operations, as such engagements do not always produce immediate or obvious changes in operational parameters or guidance imaging.

[0010] 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

[0011] In some aspects, the techniques described herein relate to a thrombectomy system, including: an aspiration catheter configured for advancement through vasculature of a subject to facilitate clot removal from the vasculature of the subject; 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 a first set of pressure values obtained via a first pressure sensor associated with a first part of an aspiration path of the thrombectomy system, the first set of pressure values indicating vacuum pressure within the first part of the aspiration path over a time period; access a second set of pressure values obtained via a second pressure sensor associated with a second part of the aspiration path, the second set of pressure values indicating vacuum pressure within the second part of the aspiration path over the time period, wherein the first set of pressure values and the second set of pressure values are captured over a common time period; determine whether the first set of pressure values and the second set of pressure values satisfy one or more conditions, wherein satisfaction of the one or more conditions indicates that the aspiration catheter is engaged with a vessel wall of the vasculature of the subject; and after determining that the first set of pressure values and the second set of pressure values satisfy the one or more conditions, perform one or more of: (i) selectively modify an operational state of the thrombectomy system or (ii) selectively present an alert on a user interface of the thrombectomy system.

[0012] In some aspects, the techniques described herein relate to a thrombectomy system, including: an aspiration catheter configured for advancement through vasculature of a subject to facilitate clot removal from the vasculature of the subject; 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- Page 3 - Docket No. 22935.54A / Abbott No. 16028WOO1thrombectomy system to: after operation of the thrombectomy system in a clot removal state or a clot hunting state, access a first set of pressure values obtained via a first pressure sensor associated with a first part of an aspiration path of the thrombectomy system, the first set of pressure values indicating vacuum pressure within the first part of the aspiration path over a time period following deactivation of the clot removal state or the clot hunting state; determine whether the first set of pressure values satisfies one or more conditions, wherein satisfaction of the one or more conditions indicates that the aspiration catheter is at least partially clogged; and after determining that the first set of pressure values satisfies the one or more conditions, perform one or more of: (i) selectively disable activation of an operational state of the thrombectomy system, (ii) selectively present an alert on a user interface of the thrombectomy system, or (iii) trigger one or more pressure cycles for the thrombectomy system.

[0013] In some aspects, the techniques described herein relate to a thrombectomy system, including: an aspiration catheter configured for advancement through vasculature of a subject to facilitate clot removal from the vasculature of the subject; 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: after operation of the thrombectomy system in a clot removal state or a clot hunting state: access a first set of pressure values obtained via a first pressure sensor associated with a first part of an aspiration path of the thrombectomy system, the first set of pressure values indicating vacuum pressure within the first part of the aspiration path over a time period following deactivation of the clot removal state or the clot hunting state; and access a second set of pressure values obtained via a second pressure sensor associated with a second part of the aspiration path, the second set of pressure values indicating vacuum pressure within the second part of the aspiration path over the time period following the deactivation of the clot removal state or the clot hunting state, wherein the first set of pressure values and the second set of pressure values are captured over a common time period; determine whether the first set of pressure values and the second set of pressure values satisfy one or more conditions, wherein satisfaction of the one or more conditions indicates that the aspiration catheter is at least partially clogged; and after determining that the first set of pressure values and the second set of pressure values satisfy the one or more conditions, perform one or- Page 4 - Docket No. 22935.54A / Abbott No. 16028WOO1more of: (i) selectively disable activation of an operational state of the thrombectomy system, (ii) selectively present an alert on a user interface of the thrombectomy system, or (iii) trigger one or more pressure cycles for the thrombectomy system.

[0014] 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

[0015] 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:

[0016] Figure 1 illustrates a perspective view of an example aspiration catheter.

[0017] Figure 2 illustrates a plan view of example disposable components of a system for aspirating thrombus according to an embodiment of the present disclosure.

[0018] Figure 3 illustrates a sectional view of an example distal end of the aspiration catheter of the system for aspirating thrombus of Figure 1.

[0019] Figure 4 illustrates a detail view of an example y-connector of the aspiration catheter of the system for aspirating thrombus of Figure 1.

[0020] Figure 5 illustrates a plan view of example disposable components of a system for aspirating thrombus according to an embodiment of the present disclosure.

[0021] Figure 6 illustrates a perspective view of an example system for aspirating thrombus of Figure 5.

[0022] Figure 7 illustrates a conceptual representation of detecting vessel wall engagement during operation of a thrombectomy system.

[0023] Figure 8 illustrates an example graph showing pressure values associated with operation of a thrombectomy system in which no vessel wall engagement occurs.

[0024] Figures 9 and 10 illustrate example graphs showing pressure values associated with operation of a thrombectomy system in which vessel wall engagement occurs.- Page 5 - Docket No. 22935.54A / Abbott No. 16028WOO1

[0025] Figure 11 illustrates a conceptual representation of detecting catheter clogging during operation of a thrombectomy system.

[0026] Figure 12 illustrates an example graph showing pressure values associated with operation of a thrombectomy system in which no catheter clogging occurs.

[0027] Figures 13 through 16 illustrate example graphs showing pressure values associated with operation of a thrombectomy system in which catheter clogging occurs.

[0028] Figure 17 illustrates a conceptual representation of detecting catheter clogging during operation of a thrombectomy system.DETAILED DESCRIPTION

[0029] As indicated hereinabove, catheter clogging and / or vessel wall engagement incidents in catheter-based thrombectomy systems can often go undetected. For example, many aspiration catheters lack a mechanism to determine whether a catheter of a thrombectomy system is clogged or engaged with a vessel wall during clot removal operations. To detect catheter clogging and / or vessel wall engagement during clot removal operations, users often rely on careful observation of canister blood flow, tactile feedback, and / or imaging feedback, which can detract from the user's attention to other aspects of a clot removal operation. Failure to detect a clogged catheter or vessel wall engagement during a clot removal operation can result in blood lysis, displacement of blood cells, clot displacement, vessel damage, dissection, or perforation, internal bleeding, and / or other negative outcomes for patients.

[0030] The present disclosure pertains to systems, devices, and techniques for detecting catheter clogging and / or vessel wall engagement in thrombectomy systems. According to some disclosed embodiments, a thrombectomy system may include pressure sensors adapted to detect pressure values associated with different parts of an aspiration path of the thrombectomy system. In one example, a first pressure sensor detects pressure values at or near the aspiration catheter, whereas a second pressure sensor detects pressure values at or nearthe aspiration canister. During operation of the thrombectomy system in a clot removal state (or another aspiration state in which negative pressure is applied to the aspiration catheter, such as a clot hunting state or low-level aspiration state), the pressure values obtained by the different pressure sensors may be acquired and analyzed to determine whether engagement between the distal tip of the aspiration catheter and a vessel wall of a subject is likely occurring. In some- Page 6 - Docket No. 22935.54A / Abbott No. 16028WOO1instances, the pressure values obtained by the different pressure sensors being within a threshold similarity to one another (e.g., within 0.5 inHg to one another) for a sufficient amount of time (e.g., about 3 seconds) is indicative of vessel wall engagement. When such a condition is determined to be present based on the acquired pressure data from the pressure sensors, the thrombectomy system may be configured to carry out certain actions to mitigate the vessel wall engagement, such as presenting an alert / warning and / or deactivating aspiration at the aspiration catheter.

[0031] To facilitate catheter clog detection, the thrombectomy system may be configured to analyze the pressure values acquired by the different sensors to determine whether different conditions are satisfied. For example, the ratio of the first pressure values (e.g., acquired by the pressure sensor near the aspiration catheter) to the second pressure values (e.g., acquired by the pressure sensor near the canister) following deactivation of an aspiration state for the catheter can indicate whether a catheter clog is present. For instance, the ratio failing to fall below a certain level (e.g., 0.5) within a certain time period (e.g., about 3 seconds) following deactivation of the aspiration state can indicate that a clog is present in the catheter. Other conditions may additionally or alternatively be assessed to determine whether a catheter clog is present, such as the rate of change of the above-noted ratio. In some implementations, the first pressure values are assessed to determine whether a catheter clog is present (e.g., without regard to the second pressure values). For instance, the first pressure values failing to reach a certain level (e.g., less than 5 inHg) or fall at a certain rate following the deactivation of the aspiration state can indicate catheter clogging. When such conditions are satisfied, the thrombectomy system may be configured to carry out various actions to mitigate the catheter clogging, such as triggering pressure cycling of the thrombectomy system (e.g., to loosen the clog), presenting an alert, and / or disabling re-activation of the aspiration state of the thrombectomy system.

[0032] The techniques described herein can be implemented with minimal (or no) hardware modifications to existing aspiration-based thrombectomy systems (e.g., by adding one or more pressure sensors to the aspiration path, or leveraging existing pressure sensors). In some instances, implementing a catheter clog and / or vessel wall engagement detection system on a thrombectomy device, as described herein, may provide various advantages, such as reducing the duration of thrombectomy operations,- Page 7 - Docket No. 22935.54A / Abbott No. 16028WOO1reducing clot movement / displacement during thrombectomy operations, decreasing patient risks such as blood lysis, vessel damage, internal bleeding, and / or others. Such advantages can beneficially facilitate improved patient outcomes.

[0033] Although examples discussed herein focus, in at least some respects, on implementing a clog detection system on an aspiration catheter that includes a fluid jet at the distal region, the techniques and / or components discussed herein may be implemented on aspiration catheters that omit fluid jets, and / or on other types of catheter-based devices, even outside of the domain of thrombectomy.Example Thrombectomy Device

[0034] The following discussion relatesto 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.

[0035] 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).

[0036] 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- Page 8 - Docket No. 22935.54A / Abbott No. 16028WOO1strain relief 112. In other embodiments, the catheter shaft 111 may be attached to the y-connector 110 with a luer fitting. They-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.

[0037] 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.

[0038] 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 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. 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.- Page 9 - Docket No. 22935.54A / Abbott No. 16028WOO1

[0039] 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.

[0040] 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 144 thus 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- Page 10 - Docket No. 22935.54A / Abbott No. 16028WOO1that 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 userto control the entire operation orthe 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.

[0041] 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 144. 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.

[0042] 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. 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,- Page 11 - Docket No. 22935.54A / Abbott No. 16028WOO1in 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 flowthrough 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., ofthrombus / saline) over its external surface, such thatthe 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).

[0043] A system 200 for aspirating thrombus is illustrated in Figures 5-6. 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 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 nearthe 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- Page 12 - Docket No. 22935.54A / Abbott No. 16028WOO1proximal 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.

[0044] Although examples provided herein focus, in at least some respects, on an aspiration catheter 102 that includes a single orifice 194, an aspiration catheter of a system (e.g., 100 or 200) can include any quantity of orifices through which fluid may pass to form any quantity of fluid jets. For example, a system 100 or 200 for aspirating thrombus can include a quantity of orifices (for forming fluid jets) within a range of 1 to 10, or within a range of 2 to 8, or within a range of 3 to 6.

[0045] Although Figure 3 illustrates the orifice 194 formed in the wall 196 of the supply tube 186, an orifice for forming a fluid jet for an aspiration catheter of a system (e.g., 100 or 200) can be positioned on one or more additional components that are in fluid communication with the supply tube 186. By way of illustrative example, one or more orifices may be formed on a ring (or annulus) that is connected to the catheter shaft 111 (e.g., coaxially connected to the catheter shaft 111 at or near the open distal end 107). The ring can include an internal cavity in fluid communication with the supply tube 186, allowing fluid to travel through the supply tube 186 and the internal cavity of the ring for jetting through the orifice(s) of the ring.

[0046] Furthermore, Figure 3 illustrates the orifice 194 formed as a radial opening in the wall 196 of the supply tube 186, with the orifice wall(s) that forms the orifice 194 between inner and outer surfaces of the supply tube 186 being perpendicular to the tangential axis of the wall 196. In some embodiments, an orifice for forming a fluid jet for an aspiration catheter of a system (e.g., 100 or 200) may be formed as an angled opening, where the orifice wall(s) that forms the orifice (between inner and outer surfaces of a material) has an acute or obtuse angle relative to the tangential axis of the material on which the orifice is formed (e.g., material of a supply tube or an additional component connected to the supply tube). For example, the angle between the orifice wall(s) and the tangential axis of the material on which the orifice is formed can be within a range of 20° to 70°, or 30° to 60°, or 40° to 50° (or within their complementary ranges).

[0047] The orifice(s) of an aspiration catheter 102 of a system (e.g., 100 or 200) for providing fluid jets (i.e., "jet-forming" orifices) may be implemented with various sizes or shapes in different embodiments. In one example, an orifice may comprise a circular hole with a diameter between 0.03 mm (0.001 inches) and 0.15 mm (0.006 inches), or- Page 13 - Docket No. 22935.54A / Abbott No. 16028WOO1between about 0.0508 mm (0.002 inches) and about 0.1016 mm (0.004 inches), or about 0.0787 mm (0.0031 inches). The diameter of the supply lumen 114 may be between about 0.3048 mm (0.012 inches) and about 0.4826 mm (0.019 inches), or between about 0.3556 mm (0.014 inches and about 0.4318 mm (0.017 inches), or about 0.3937 mm (0.0155 inches). As another example, an orifice may comprise a rectangular hole with each side thereof having a length between 0.02 mm (0.0008 inches) and 0.20 mm (0.008 inches). In some implementations, the total cross-sectional area of all jet -forming orifices of an aspiration catheter of a system is between 0.002 mmA2 and 0.02 mmA2, or between 0.003 mmA2 and 0.015 mmA2, or between 0.005 mmA2 and 0.01 mmA2. In some embodiments, pressure measured at the deliver location of each jet-forming orifice during operation of the system (e.g., 100 or 200) is between 400 psi (2.6 MPa) and 2,000 psi (13.8 MPa), or between 500 psi (3.4 MPa) and 2,000 psi (13.8 MPa), or between 600 psi (4.1 MPa) and 1,750 psi (12.1 MPa).

[0048] In some implementations, the diameter of the aspiration lumen 106 is within a range of 2 mm (0.08 inches) to 4 mm (0.16 inches). The orifice 194 may be set proximally of the open distal end 107 by a set amount. For example, orifice 194 can be set proximally of the open distal end 107 by about 0.040" (inches), and in one configuration by 0.051" +- 0.003" or by another desired amount. For example, orifice 42 can be set proximally of the open distal end 107 by approximately 0.035", 0.036", 0.037", 0.038", 0.039", 0.040", 0.041", 0.042", 0.043", 0.044", 0.045", 0.046", 0.047", 0.048", 0.049", 0.050", 0.051", 0.052", 0.053", 0.054", 0.055", 0.056", 0.057", 0.058", 0.059", 0.060", or a range defined by any two of the foregoing. In still other configurations, the open distal end 107 can be set proximally of the open distal end 107 by about 0.01" to about 50".

[0049] In still another configuration a diameter of the aspiration lumen 106 is about 0.075" (inches) to about 0.177" (inches), the orifice 194 (and so a distal end of the supply tube 186) can be set proximally of open distal end 107 about 12" (inches). In still another configuration a diameter of the aspiration lumen 106 is about 0.075" (inches), the orifice 194 (and so a distal end of the supply tube 186) can be set proximally of open distal end 107 about 0.035" (inches) to about 0.060" (inches). In still another configuration, the orifice 194 (and so a distal end of the supply tube 186) can be set proximally of open distal end 107 about 0.010" (inches) to about 50" (inches) where the catheter 102 has a catheter size ranging from about 3 Fr to about 50 Fr. In still another configuration, the- Page 14 - Docket No. 22935.54A / Abbott No. 16028WOO1orifice 194 (and so a distal end of the supply tube 186) can be set proximally of open distal end 107 about 0.010" (inches) to about 0.200" (inches), from about 0.010" (inches) to about 2" (inches), 0.010" (inches) to about 40" (inches), 0.010" (inches) to about 50" (inches), or a range defined by any two of the foregoing. In still other configurations, the orifice 194 (and so a distal end of the supply tube 186) can be set proximally of open distal end 107 based upon Table 1:" "" "" "" "

[0050] In another configuration, the orifice 194 (and so a distal end of the supply tube 186) can be set proximally of open distal end 107 about 0.010" (inches) to about 0.200" (inches) for a catheter having a catheter size ranging from about 3 Fr to about 8 F. In another configuration, the orifice 194 (and so a distal end of the supply tube 186) can be set proximally of open distal end 107 about 0.010" (inches) to about 2" (inches) for a catheter having a catheter size ranging from about 9 Fr to about 11 Fr. In another configuration, the orifice 194 (and so a distal end of the supply tube 186) can be set- Page 15 - Docket No. 22935.54A / Abbott No. 16028WOO1proximally of open distal end 107 about 0.010" (inches) to about 40" (inches) for a catheter having a catheter size ranging from about 12 Fr to about 16 F. In another configuration, the orifice 194 (and so a distal end of the supply tube 186) can be set proximally of open distal end 107 about 0.010" (inches) to about 50" (inches) for a catheter having a catheter size ranging from about 17 Fr to about 26 F. In other configurations, the ranges can include any combination of a range defined by any two of the foregoing proximal location of the orifice 194 with a range defined by any two of the foregoing catheter sizes.

[0051] 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.

[0052] 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 IV pole I 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. 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- Page 16 - Docket No. 22935.54A / Abbott No. 16028WOO1is / 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 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).

[0053] In the example of Figures 5 and 6, 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 1 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.

[0054] In use, a user connects a first connector 256 at a first end 258 of the non-sterile suction tubing 217 to a 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 ports 268. 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. 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 / or additional cables or wires. Alternatively, the connector 236 may couple to the mating receptacle 237 by clipping, friction fitting, vacuum fitting, or other means.- Page 17 - Docket No. 22935.54A / Abbott No. 16028WOO1

[0055] 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 all 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.Vessel Wall Engagement Detection in Thrombectomy Systems

[0056] Figure 7 illustrates a conceptual representation of a process for detecting vessel wall engagement during operation of 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., correspondingto vacuum pump 266), an aspiration canister 706 (e.g., corresponding to canister 218), aspiration tubing 708A and 708B, and an aspiration catheter 710 (e.g., correspondin to aspiration catheter 202). 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- Page 18 - Docket No. 22935.54A / Abbott No. 16028WOO1port 274 and luer 271 as described above). The aspiration canister 706, the aspiration tubing 708A and 708B, and the aspiration catheter 710 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 vacuum or negative pressure at the open distal end 107 of the aspiration catheter 710). The aspiration catheter 710 may be advanced through vasculature of a subject / patient to facilitate clot removal from the subject's vasculature.

[0057] Figure 7 depicts an instance where, at least initially, an aspiration state of the thrombectomy system 702 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 704 of the thrombectomy system 702 may generate negative pressure or vacuum pressure so as to aspirate material positioned at the distal end 107 of the aspiration catheter 710 (e.g., to remove clot material when in a clot removal state, or to draw clot material toward the aspiration catheter 710 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.

[0058] Figure 7 illustrates that the thrombectomy system 702 may further include pressure sensors 712 and 714. The pressure sensors 712 and 714 may take on various forms (e.g., capacitive pressure sensors, piezoelectric pressure sensors, strain gauge pressure sensors, optical pressure sensors, and / or others). In the example shown in Figure 7, the pressure sensors 712 and 714 are connected to aspiration tubing 708B, with pressure sensor 714 being arranged proximate to the aspiration canister 706, and with pressure sensor 712 being arranged proximate to the aspiration catheter 710 (or proximate to a handpiece to which the aspiration catheter 710 is connected). For instance, pressure sensor 714 may be connected to the aspiration tubing 708B less than 2 feet or less than 1 foot from the aspiration canister 706 (e.g., along the length of the aspiration tubing 708B from its connection to the aspiration canister 706), whereas pressure sensor 712 may be connected to the aspiration tubing 708B less than 2 feet or less than 1 foot from the aspiration catheter 710 (e.g., along the length of the aspiration tubing 708B from its connection to the aspiration catheter 710 or an intervening handpiece). In one example embodiment, the aspiration catheter 710 as a length of- Page 19 - Docket No. 22935.54A / Abbott No. 16028WOO1about 43 inches (e.g., from its distal end to its proximal end), and pressure sensor 712 is positioned along the aspiration tubing 708B about 5 inches from the proximal end of the aspiration catheter 710, while pressure sensor 714 is positioned along the aspiration tubing 708B about 6.5 inches from where the aspiration tubing 708B connects to the aspiration canister 706 (e.g., on the cover of the aspiration canister 706) (e.g., or about 78 inches from the proximal end of the aspiration catheter 710). The length of aspiration tubing 708B can be about 84.5 inches, while the length of aspiration tubing 708A can be within a range of about 19.5 inches to about 41 inches. A handpiece or device action switch of the thrombectomy system 702 may be positioned along aspiration tubing 708B about 11.25 inches to about 14.75 inches from the proximal end of the aspiration catheter 710. This particular configuration is provided by way of example only, and other arrangements are within the scope of the present disclosure. For instance, one or more of the pressure sensors may be positioned on the distal tip or portion of the aspiration catheter 710, on the proximal tip or portion of the aspiration catheter 710 (e.g., at or near the connection between the aspiration catheter 710 and the aspiration tubing 708B), on the handpiece connecting the aspiration tubing 708Bto the aspiration catheter 710, on aspiration tubing 708A, on or within the aspiration canister 706, on a console or control box of the thrombectomy system 702, and / or on other locations.

[0059] Figure 7 conceptually depicts data acquired via the pressure sensors 712 and 714. In particular, Figure 7 illustrates pressure value(s) 716 acquired by pressure sensor 712 and pressure value(s) 718 acquired by pressure sensor 714. The pressure value(s) 716 can indicate the current vacuum pressure within the part of the aspiration path to which the pressure sensor 712 is connected (e.g., the part of the aspiration tubing 708B proximate to the aspiration catheter 710). Similarly, the pressure value(s) 718 can indicate the current vacuum pressure within the part of the aspiration path to which the pressure sensor 714 is connected (e.g., the part of the aspiration tubing 708B proximate to the aspiration canister 706). The pressure value(s) 716 and 718 (and any other sensor 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) 716 and 718 (and any other pressure values described herein) can be represented in any suitable form, such as inches of- Page 20 - Docket No. 22935.54A / Abbott No. 16028WOO1mercury (inHg), pascals, atmospheres, bars, torr, pounds per square inch, millimeters of mercury, etc.

[0060] In some embodiments, the pressure value(s) 716 and 718 provide a basis 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 (e.g., a clot removal state or a clot hunting state). Based on the pressure value(s) 716 and 718, the thrombectomy system 702 may selectively maintain or change the aspiration state, and / or take other actions.

[0061] For instance, Figure 7 conceptually depicts that the thrombectomy system 702 may determine whether the pressure value(s) 716 and 718 satisfy one or more conditions (indicated by the arrow extending from the pressure value(s) 716 and the pressure value(s) 718 to the decision block 720). Satisfaction of the condition(s) may indicate that the aspiration catheter 710 is engaged, at its distal tip, with a vessel wall of the vasculature of the subject (e.g., applying suction to the vessel wall). An example condition may comprise the pressure value(s) 716 and the pressure value(s) 718 being within a similarity threshold to one another over a predetermined time period. For example, where p1represents vacuum pressure values from pressure value(s) 716 (measured by pressure sensor 712) and p2represents temporally correlated vacuum pressure values from pressure value(s) 718 (measured by pressure sensor 714, captured at the same timestamps as or at similar timestamps to those of p , an example condition may comprise the following logic holding true for a predetermined time period:|Pi - p2| < Tswhere Tsrepresents a similarity threshold (e.g., a value less than 1 inHg, such as about 0.5 inHg or about 0.2 inHg or another pressure value). In some instances, the time period comprises a temporal window of less than 10 seconds or less than 5 seconds (e.g., about 3 seconds). Temporally contiguous pressure values from the different sets of pressure values 716 and 718 may be included in the tested time period to determine whetherthe above-noted condition is satisfied (though one or more outlier pressure values may be excluded in some cases). Other conditions for indicating whetherthe aspiration catheter 710 is engaged with a vessel wall are possible.

[0062] When the thrombectomy system 702 determines that the pressure value(s) 716 and pressure value(s) 718 fail to satisfy the condition(s) (e.g., via one or more- Page 21 - Docket No. 22935.54A / Abbott No. 16028WOO1processors or logic units), the thrombectomy system 702 may selectively maintain its operational state (indicated in Figure 7 by the arrow labeled "No" extending from decision block 720 to action block 722). 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 different sets of pressure values 716 and 718 are determined to not be sufficiently similar to one another (e.g., within 0.5 inHg of one another) over a sufficient time period (e.g., about 3 seconds). 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 different sets of pressure values 716 and 718 are determined to not be sufficiently similar to one another (e.g., within 0.5 inHg of one another) over a sufficient time period (e.g., about 3 seconds).

[0063] When the thrombectomy system 702 determines that the pressure value(s) 716 and pressure value(s) 718 satisfy the condition(s) (e.g., via one or more processors or logic units), the thrombectomy system 702 may selectively modify its operational state (indicated in Figure 7 by the arrow labeled "Yes" extending from decision block 720 to action block 724). 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 different sets of pressure values 716 and 718 are determined to be sufficiently similar to one another (e.g., within 0.5 inHg of one another) over a sufficient time period (e.g., about 3 seconds). 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 different sets of pressure values 716 and 718 are determined to be sufficiently similarto one another (e.g., within 0.5 inHg of one another) over a sufficient time period (e.g., about 3 seconds).

[0064] Enabling selective, automatic modification of the operational state of the thrombectomy system 702 based on characteristics of the pressure value(s) 716 and 718 can mitigate the incidence of excessive vessel damage to patients.

[0065] In some implementations, when the thrombectomy system 702 determines that the different sets of pressure values 716 and 718 satisfy the condition(s), the- Page 22 - Docket No. 22935.54A / Abbott No. 16028WOO1thrombectomy system 702 may selectively present an alert on a user interface (indicated in Figure 7 by the arrow labeled "Yes" extending from decision block 720 to action block 726). 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 can communicate to a medical professional operating the thrombectomy system 702 that the aspiration catheter 710 is likely engaged with a vessel wall (e.g., at least partially withdrawing or maneuvering the aspiration catheter 710).

[0066] Figure 8 illustrates an example graph 800 showing pressure values obtained under test conditions and associated with operation of a thrombectomy system in which no vessel wall engagement occurs. The vertical axis of graph 800 shows vacuum or negative pressure values measured in inHg, whereas the horizontal axis of graph 800 shows time measured in seconds. Vacuum pressure values measured by a pressure sensor proximate to the aspiration catheter (e.g., corresponding to pressure value(s) 716) are indicated in graph 800 with circles (labeled Pl), whereas vacuum pressure values measured by a pressure sensor proximate to the aspiration canister (e.g., corresponding to pressure value(s) 718) are indicated in graph 800 with diamonds (labeled P2). Marker 802 in graph 800 indicates the approximate time at which a clot removal state is activated for the thrombectomy system, and marker 804 in graph 800 indicates the approximate time at which the clot removal state is deactivated. As is evident in Figure 8, the different pressure values Pl and P2 fail to satisfy the similarity test noted above (e.g., they are not within 0.5 inHg or 0.2 inHg of one another for a sufficiently long period of time, such as about 3 seconds) and are therefore not indicative of vessel wall engagement by the aspiration catheter.

[0067] Figure 9 illustrates an example graph 900 showing test pressure values obtained under test conditions and associated with operation of a thrombectomy system in which (synthetic) vessel wall engagement occurs. The vertical axis of graph 900 shows vacuum or negative pressure values measured in inHg, whereas the horizontal axis of graph 900 shows time measured in seconds. Vacuum pressure values measured by a pressure sensor proximate to the aspiration catheter (e.g., corresponding to pressure value(s) 716) are indicated in graph 900 with circles (labeled Pl), whereas vacuum pressure values measured by a pressure sensor proximate to the aspiration canister (e.g., corresponding to pressure value(s) 718) are indicated in graph 900 with diamonds- Page 23 - Docket No. 22935.54A / Abbott No. 16028WOO1(labeled P2). Marker 902 in graph 900 indicates the approximate time at which a clot removal state is activated for the thrombectomy system, and marker 904 in graph 900 indicates the approximate time at which the clot removal state is deactivated. As is evident in Figure 9, the different pressure values Pl and P2 satisfy the similarity test noted above (e.g., they are within 0.5 inHg or 0.2 inHg of one another for a sufficiently long period of time, such as from 12 seconds to 17 seconds) and are therefore indicative of vessel wall engagement by the aspiration catheter. Figure 9 illustrates the Pl and P2 pressure values diverging from one another following the time period in which they satisfy the similarity test, which can indicate vessel wall damage.

[0068] Figure 10 illustrates graph 1000, which also shows pressure values obtained under test conditions and associated with operation of a thrombectomy system in which (synthetic) vessel wall engagement occurs. The vertical axis of graph 1000 shows vacuum or negative pressure values measured in inHg, whereas the horizontal axis of graph 1000 shows time measured in seconds. Vacuum pressure values measured by a pressure sensor proximate to the aspiration catheter (e.g., corresponding to pressure value(s) 716) are indicated in graph 1000 with a solid line, whereas vacuum pressure values measured by a pressure sensor proximate to the aspiration canister (e.g., corresponding to pressure value(s) 718) are indicated in graph 1000 with a dotted line. Marker 1002 in graph 1000 indicates the approximate time at which a clot removal state is activated for the thrombectomy system, and marker 1004 in graph 1000 indicates the approximate time at which the clot removal state is deactivated. As is evident in Figure 10, the different pressure values satisfy the similarity test noted above (e.g., they are within 0.5 inHg or 0.2 inHg of one another for a sufficiently long period of time, such as from 6 seconds to 15 seconds) and are therefore indicative of vessel wall engagement by the aspiration catheter.Catheter Clog Detection in Thrombectomy Systems

[0069] Figure 11 illustrates a conceptual representation of a process for detecting catheter clogging during operation of a thrombectomy system, according to implementations of the present disclosure. In particular, Figure 11 conceptually depicts components, operations, and data objects associated with a thrombectomy system 1102. The thrombectomy system 1102 includes components similar to the thrombectomy system 1102 described hereinabove. For instance, the thrombectomy system 1102- Page 24 - Docket No. 22935.54A / Abbott No. 16028WOO1includes a vacuum pump 1104, an aspiration canister 1106, aspiration tubing 1108A and 1108B, and an aspiration catheter 1110. The aspiration canister 1106, the aspiration tubing 1108A and 1108B, and the aspiration catheter 1110 can form an aspiration path through which material may be aspirated from a subject or patient (e.g., by operation of the vacuum pump 1104 to cause vacuum or negative pressure at the open distal end 107 of the aspiration catheter 1110). The aspiration catheter 1110 may be advanced through vasculature of a subject / patient to facilitate clot removal from the subject's vasculature.

[0070] The thrombectomy system 1102 shown in Figure 11 also includes pressure sensors 1112 and 1114 connected to aspiration tubing 1108B, with pressure sensors 1112 being proximate to the aspiration catheter 1110 and with pressure sensors 1114 being proximate to the aspiration canister 1106 (similar to pressure sensors 712 and 714 connected to aspiration tubing 708B of thrombectomy system 702). As indicated above, other positionings of the pressure sensors 1112 and 1114 are within the scope of the present disclosure.

[0071] Figure 11 conceptually depicts data acquired via the pressure sensors 1112 and 1114, including pressure value(s) 1116 acquired by pressure sensor 1112 and pressure value(s) 1118 acquired by pressure sensor 1114. In the example shown in Figure 11, the pressure value(s) 1116 indicate the current vacuum pressure within the part of the aspiration path proximate to the aspiration catheter 1110 (e.g., the part of the aspiration tubing 1108B to which the pressure sensor 1112 is connected). Similarly, the pressure value(s) 1118 indicate the current vacuum pressure within the part of the aspiration path proximate to the aspiration canister 1106 (e.g., the part of the aspiration tubing 1108B to which the pressure sensors 1114 is connected).

[0072] Figure 11 depicts an instance where, at least initially, an aspiration state for the thrombectomy system 1102 has been deactivated after operation of the thrombectomy system 1102 in the aspiration state (e.g., a clot removal or clot hunting state). Accordingly, the pressure value(s) 1116 and 1118 may represent vacuum pressure within their respective parts of the aspiration path following deactivation of the aspiration state. In some implementations, the deactivation of the aspiration state is manually triggered by user input. In some instances, the deactivation of the aspiration state is automatically triggered by the thrombectomy system 1102. For example, the thrombectomy system 1102 may obtain other sensor data suggestive of potential- Page 25 - Docket No. 22935.54A / Abbott No. 16028WOO1catheter clogging and use this as a basis to trigger deactivation of the aspiration state to obtain a pressure-based determination of whether a catheter clog is present. In the example shown in Figure 11, the thrombectomy system 1102 includes a flow sensor 1113 connected to aspiration tubing 1108B (though the flow sensor 1113 may be positioned on other portions of the thrombectomy system 1102). The flow sensor 1113 may be implemented in various forms (e.g., a mass flow sensor, an ultrasonic flow sensor, a turbine-based flow sensor, a rotary piston flow meter, and / or others). Figure 11 further illustrates flow data 1115 acquired via the flow sensor 1113, which may indicate a flow rate of liquid through part of the aspiration path (e.g., at the part of the aspiration tubing 1108B to which the flow sensor 1113 is connected). In some implementations, when the flow data 1115 indicates that the flow of liquid through the aspiration path (or at least part of the aspiration path) has dropped below a threshold level, the thrombectomy system 1102 may trigger deactivation of the aspiration state to facilitate pressure-based determination of whether catheter clogging is present (described in more detail below).

[0073] As noted previously, Figure 11 provides an example in which, at least initially, an aspiration state for the thrombectomy system 1102 has been deactivated after operation of the thrombectomy system 1102 in the aspiration state. Based on the pressure value(s) 1116 and 1118 representing vacuum pressure within parts of the aspiration path following deactivation of the aspiration state, the thrombectomy system 1102 may selectively perform pressure cycling, may selectively disable re-activation of the aspiration state (e.g., for a time), and / or may take other actions.

[0074] For instance, Figure 11 conceptually depicts that the thrombectomy system 1102 may determine whether the pressure value(s) 1116 and 1118 satisfy one or more conditions (indicated by the arrow extending from the pressure value(s) 1116 and the pressure value(s) 1118 to the decision block 1120). Satisfaction of the condition(s) may indicate that the aspiration catheter 1110 is at least partially clogged (e.g., with clot material). An example condition may be based on whether a ratio of the pressure value(s) 1116 to the pressure value(s) 1118 reaches a threshold ratio within a predetermined time period following the deactivation of the aspiration state of the thrombectomy system 1102. For instance, where prrepresents vacuum pressure values from pressure value(s) 1116 (measured by pressure sensor 1112) and p2represents temporally correlated vacuum pressure valuesfrom pressure value(s) 1118 (measured by pressure sensor 1114,- Page 26 - Docket No. 22935.54A / Abbott No. 16028WOO1captured at the same timestamps as or at similartimestamps to those of p , an example condition may comprise the following logic failing to betrue within a predetermined time period following the deactivation of the aspiration state of the thrombectomy system 1102:Pi< TP2 ~rwhere Trrepresents a threshold ratio (e.g., a value less than 0.7, such as about 0.3 or another ratio). In some instances, the time period comprises a temporal window of less than 10 seconds or less than 5 seconds (e.g., about 3 seconds). Temporally contiguous pressure valuesfrom the different sets of pressure values 1116 and 1118 may be included in the tested time period to determine whether the above-noted condition is satisfied (though one or more outlier pressure values may be excluded in some cases). Other conditions for indicating whether the aspiration catheter 1110 is clogged are possible.

[0075] When the thrombectomy system 1102 determines that the pressure value(s) 1116 and pressure value(s) 1118 fail to satisfy the condition(s) (e.g., via one or more processors or logic units), the thrombectomy system 1102 may selectively maintain its operability (indicated in Figure 11 by the arrow labeled "No" extending from decision block 1120 to action block 1122). For example, after deactivation of the aspiration state ofthe thrombectomy system 1102 and determining that the ratio of the pressure value(s) 1116 to the pressure value(s) 1118 satisfies the threshold ratio (e.g., being equal to or below 0.3, where 0.3 is the threshold ratio) within the predetermined time period (e.g., about 3 seconds), the thrombectomy system 1102 may refrain from (i) disabling activation or re-activation of the aspiration state for the thrombectomy system 1102 and / or (ii) triggering one or more pressure cycles for the thrombectomy system 1102. The aspiration state may thus be re-activated (e.g., automatically or by manual reactivation by the user) to permit continuation of the clot removal or clot hunting operation.

[0076] When the thrombectomy system 1102 determines that the pressure value(s) 1116 and pressure value(s) 1118 satisfy the condition(s) (e.g., via one or more processors or logic units), the thrombectomy system 1102 may trigger pressure cycles for the thrombectomy system 1102 (indicated in Figure 11 by the arrow labeled "Yes" extending from decision block 1120 to action block 1124). The pressure cycles can include cycling- Page 1 - Docket No. 22935.54A / Abbott No. 16028WOO1through negative pressure states in the aspiration catheter 1110 (and / or aspiration tubing 708B) by activating and deactivating the aspiration state for the thrombectomy system 1102 (e.g., in one or more iterations). For example, after deactivation of the aspiration state of the thrombectomy system 1102 and determining that the ratio of the pressure value(s) 1116 to the pressure value(s) 1118 fails to satisfy the threshold ratio (e.g., being equal to or below 0.3, where 0.3 is the threshold ratio) within the predetermined time period (e.g., about 3 seconds), the thrombectomy system 1102 may re-activate the aspiration state and subsequently deactivate the aspiration state one or more times, which may introduce changing vacuum pressure conditions that can loosen or dislodge material clogging the aspiration catheter 1110. In some implementations, with each deactivation of the aspiration state associated with the pressure cycling, pressure values obtained by the pressure sensors 1112 and 1114 may be assessed for satisfaction of the condition(s) noted above (e.g., the ratio of the pressure values satisfying a threshold ratio), which may indicate whether a catheter clog persists through pressure cycling iterations. In some instances, the thrombectomy system 1102 can be configured to continue performing pressure cycles of the aspiration catheter 1110 while the pressure data obtained via the pressure sensors 1112 and 1114 indicates that a catheter clog persists (e.g., or until a stop condition is satisfied, such as performance of a predetermined number of pressure cycles).

[0077] Enabling automated pressure cycling upon detection of a catheter clog can contribute to expedited resolution of a catheter clog, which can reduce clot removal failures and / or operating times, or otherwise improve patient outcomes.

[0078] When the thrombectomy system 1102 determines that the pressure value(s) 1116 and pressure value(s) 1118 satisfy the condition(s) (e.g., via one or more processors or logic units), the thrombectomy system 1102 may disable activation of one or more operational states for the thrombectomy system 1102 (indicated in Figure 11 by the arrow labeled "Yes" extending from decision block 1120 to action block 1126). Disabling activation of the operational state(s) can include preventing the thrombectomy system 1102 (e.g., in software) from re-entering the clot removal state and / or the clot hunting state following deactivation of one of these states to obtain the pressure value(s) 1116 and 1118 to determine whether a catheter clog was present. For example, after deactivation of an aspiration state of the thrombectomy system 1102 and determining- Page 28 - Docket No. 22935.54A / Abbott No. 16028WOO1that the ratio of the pressure value(s) 1116 to the pressure value(s) 1118 fails to satisfy the threshold ratio (e.g., being equal to or below 0.3, where 0.3 is the threshold ratio) within the predetermined time period (e.g., about 3 seconds), the thrombectomy system 1102 may selectively disable re-activation of the aspiration state for a predetermined amount of time, or until confirmatory user input is received from the user (e.g., user input confirming that one or more clog clearing measures have been taken, such as advancing a separator element / wire into the aspiration catheter 1110), or until another condition is satisfied (e.g., powering off of the system). In some implementations, selective disablement of reactivation of the aspiration state(s) of a thrombectomy system is performed following performance of one or more pressure cycles for the thrombectomy system 1102, as described above.

[0079] In some implementations, When the thrombectomy system 1102 determines that the pressure value(s) 1116 and pressure value(s) 1118 satisfy the condition(s) (e.g., via one or more processors or logic units), the thrombectomy system 1102 may selectively present an alert on a user interface (indicated in Figure 11 by the arrow labeled "Yes" extending from decision block 1120 to action block 1128). 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 can communicate to a medical professional operating the thrombectomy system 1102 that the aspiration catheter 1110 is likely clogged, which can prompt the medical professional to take actions to address the clog (e.g., replacing the aspiration catheter 1110 with an unclogged aspiration catheter, advancing a separator element / wire into the aspiration catheter 1110, etc.).

[0080] Figure 12 illustrates an example graph 1200 showing pressure values obtained under test conditions and associated with operation of a thrombectomy system in which no catheter clogging occurs. The vertical axis of graph 1200 shows vacuum or negative pressure values measured in inHg, whereas the horizontal axis of graph 1200 shows time measured in seconds. Vacuum pressure values measured by a pressure sensor proximate to the aspiration catheter (e.g., corresponding to pressure value(s) 1116) are indicated in graph 1200 with a solid line, whereas vacuum pressure values measured by a pressure sensor proximate to the aspiration canister (e.g., corresponding to pressure value(s) 1118) are indicated in graph 1200 with a dotted line. Marker 1202 in graph 1200 indicates- Page 29 - Docket No. 22935.54A / Abbott No. 16028WOO1the approximate time at which a clot removal state is activated for the thrombectomy system, and marker 1204 in graph 1200 indicates the approximate time at which the clot removal state is deactivated. As is evident in Figure 12, the different pressure values fail to satisfy the ratio test noted above (e.g., the ratio of the sold line pressure values to the dotted line pressure values falls to far below a threshold ratio of about 0.7 or 0.3 within far less than 3 seconds following deactivation of the clot removal state) and are therefore not indicative of catheter clogging.

[0081] Figure 13 illustrates graph 1300, which also shows pressure values obtained under test conditions and associated with operation of a thrombectomy system in which (synthetic) catheter clogging occurs. The vertical axis of graph 1300 shows vacuum or negative pressure values measured in inHg, whereas the horizontal axis of graph 1300 shows time measured in seconds. Vacuum pressure values measured by a pressure sensor proximate to the aspiration catheter (e.g., corresponding to pressure value(s) 1116) are indicated in graph 1300 with a solid line, whereas vacuum pressure values measured by a pressure sensor proximate to the aspiration canister (e.g., corresponding to pressure value(s) 1118) are indicated in graph 1300 with a dotted line. Marker 1302 in graph 1300 indicates the approximate time at which a clot removal state is activated for the thrombectomy system, and marker 1304 in graph 1300 indicates the approximate time at which the clot removal state is deactivated. As is evident in Figure 13, the different pressure values satisfy the ratio test noted above (e.g., the ratio of the solid line pressure values to the dotted line pressure values fails to fa II to or below a threshold ratio of about 0.3 within 3 seconds following deactivation of the clot removal state) and are therefore indicative of catheter clogging.

[0082] Figures 14, 15, and 16 illustrates graphs 1400, 1500, and 1600, respectively, which also show pressure values obtained under test conditions and associated with operation of a thrombectomy system in which (synthetic) catheter clogging occurs. In each of these Figures, the ratio of the pressure values measured by a pressure sensor proximate to the aspiration catheter (indicated with solid lines) to the pressure values measured by a pressure sensor proximate to the aspiration canister (indicated with dotted lines) failsto satisfy a threshold ratio (e.g., about 0.3) within a predetermined time period (e.g., about 3 seconds) following deactivation of the clot removal state (indicated by marker 1404, 1504, and 1604 in Figures 14, 15, and 16, respectively).- Page 30 - Docket No. 22935.54A / Abbott No. 16028WOO1

[0083] In some implementations vacuum pressure data associated with a single pressure sensor can indicate whether an aspiration catheter of a thrombectomy system is clogged. For instance, Figure 17 illustrates the thrombectomy system 1102 from Figure 11, including the vacuum pump 1104, aspiration canister 1106, aspiration tubing 1108A and 1108B, aspiration catheter 1110, pressure sensors 1112, pressure sensors 1114, and pressure value(s) 1116 and 1118. Figure 17 conceptually depicts the pressure value(s) 1116 (obtained via pressure sensor 1112 arranged proximate to aspiration catheter 1110) being used to determine whether one or more conditions are satisfied that are indicative ofcatheter clogging (indicated in Figure 17 by the arrow extending from pressure value(s) 1116 to decision block 1720). In the example shown in Figure 17, the pressure value(s) 1118 are not used in determining whetherthe condition(s) indicative of catheter clogging are satisfied. An example condition may be based on whetherthe pressure value(s) 1116 reach a reference pressure value within a predetermined time period following the deactivation of the aspiration state of the thrombectomy system 1102. For instance,represents vacuum pressure values from pressure value(s) 1116 (measured by pressure sensor 1112), an example condition may comprise the following logic failing to be true within a predetermined time period following the deactivation of the aspiration state of the thrombectomy system 1102:Pi < Trefwhere Tref represents a reference pressure value. In some examples, the reference pressure value may be less than about 10 inHg, or less than about 5 inHg, or another pressure value. In some implementations, the reference pressure value is (or is determined based on) a pressure value detected by the pressure sensor 1112 prior to activation of the aspiration state (i.e., the aspiration state that becomes deactivated to obtain the pressure value(s) 1116). In some instances, the time period comprises a temporal window of less than 10 seconds or less than 5 seconds (e.g., about 3 seconds). Temporally contiguous pressure values from the set of pressure values 1116 may be included in the tested time period to determine whether the above-noted condition is satisfied (though one or more outlier pressure values may be excluded in some cases).

[0084] Another example condition may be based on whether a rate of change of pressure values of the set of pressure value(s) 1116 reaches a threshold rate of change within a predetermined time period following the deactivation of the aspiration state of- Page 31 - Docket No. 22935.54A / Abbott No. 16028WOO1the thrombectomy system 1102. In some implementations, the threshold rate of change is about (or less than) 50 inHg / s, or about (or less than) 24 inHg / s, or another rate of vacuum pressure change.

[0085] Figure 17 indicates that the thrombectomy system 1102 may carry out similar actions to those described above with reference to Figure 11 based on whether the condition(s) associated with the pressure value(s) 1116 (ignoring the value(s) 1118) indicate catheter clogging. For instance, when the pressure value(s) 1116 fail to satisfy a reference pressure value, or when a rate of change represented in the pressure value(s) 1116 fails to satisfy a threshold rate of change, the thrombectomy system 1102 may maintain its operability as described above with reference to action block 1122 of Figure 11 (as indicated in Figure 17 by the arrow labeled "No" extending from decision block 1720 to action block 1722). When the pressure value(s) 1116 satisfy a reference pressure value, or when a rate of change represented in the pressure value(s) 1116 satisfies a threshold rate of change, the thrombectomy system 1102 may (i) perform pressure cycling as described above with reference to action block 1124 of Figure 11 (as indicated in Figure 17 by the arrow labeled "Yes" extending from decision block 1720 to action block 1724), (ii) disable one or more operational states of the thrombectomy system 1102 as described above with reference to action block 1126 of Figure 11 (as indicated in Figure 17 by the arrow labeled "Yes" extending from decision block 1720 to action block 1726), and / or (iii) present one or more alerts as described above with reference to action block 1128 of Figure 11 (as indicated in Figure 17 by the arrow labeled "Yes" extending from decision block 1720 to action block 1728).

[0086] The pressure data represented in graphs 1200, 1300, 1400, 1500, and 1600 indicate that the conditions described above with reference to Figure 17 may be used to determine catheter clogging in thrombectomy systems.Example Embodiments

[0087] Embodiments disclosed herein can include those in the following numbered clauses:

[0088] Clause 1. The subject matter shown and / or described herein.

[0089] Clause 2. A thrombectomy system, comprising: an aspiration catheter configured for advancement through vasculature of a subject to facilitate clot removal from the vasculature of the subject; one or more processors; and one or more computer-- Page 32 - Docket No. 22935.54A / Abbott No. 16028WOO1readable recording media that store instructions that are executable by the one or more processors to configure the thrombectomy system to: access a first set of pressure values obtained via a first pressure sensor associated with a first part of an aspiration path of the thrombectomy system, the first set of pressure values indicating vacuum pressure within the first part of the aspiration path over a time period; access a second set of pressure values obtained via a second pressure sensor associated with a second part of the aspiration path, the second set of pressure values indicating vacuum pressure within the second part of the aspiration path over the time period, wherein the first set of pressure values and the second set of pressure values are captured over a common time period; determine whether the first set of pressure values and the second set of pressure values satisfy one or more conditions, wherein satisfaction of the one or more conditions indicates that the aspiration catheter is engaged with a vessel wall of the vasculature of the subject; and after determining that the first set of pressure values and the second set of pressure values satisfy the one or more conditions, perform one or more of: (i) selectively modify an operational state of the thrombectomy system or (ii) selectively present an alert on a user interface of the thrombectomy system.

[0090] Clause 3. The thrombectomy system of clause 2, wherein the aspiration path is defined by the aspiration catheter, an aspiration canister, and aspiration tubing.

[0091] Clause 4. The thrombectomy system of clause 3, wherein the first pressure sensor is connected to the aspiration tubing proximate to the aspiration catheter.

[0092] Clause 5. The thrombectomy system of clause 3, wherein the second pressure sensor is connected to the aspiration tubing proximate to the aspiration canister.

[0093] Clause 6. The thrombectomy system of clause 2, wherein the one or more conditions comprise pressure values of the first set of pressure values and the second set of pressure values being within a similarity threshold to one another for a duration of the time period.

[0094] Clause 7. The thrombectomy system of clause 6, wherein the similarity threshold comprises less than 1 inHg.

[0095] Clause 8. The thrombectomy system of clause 7, wherein the similarity threshold comprises about 0.5 inHg or about 0.2 inHg.

[0096] Clause 9. The thrombectomy system of clause 6, wherein the time period comprises less than 10 seconds.- Page 33 - Docket No. 22935.54A / Abbott No. 16028WOO1

[0097] Clause 10. The thrombectomy system of clause 9, wherein the time period comprises about 3 seconds.

[0098] Clause 11. The thrombectomy system of clause 2, wherein selectively modifying the operational state of the thrombectomy system comprises deactivating a clot removal state or a clot hunting state of the thrombectomy system.

[0099] Clause 12. The thrombectomy system of clause 2, wherein the instructions are executable by the one or more processors to configure the thrombectomy system to, after determining that the first set of pressure values and the second set of pressure values fail to satisfy the one or more conditions, selectively maintain the operational state of the thrombectomy system.

[0100] Clause 13. The thrombectomy system of clause 2, wherein the first pressure sensor or the second pressure sensor is positioned at a distal tip of the aspiration catheter, a proximal opening of the aspiration catheter, a device activating switch of the thrombectomy system, an aspiration canister, or an aspiration pump of the thrombectomy system.

[0101] Clause 14. A thrombectomy system, comprising: an aspiration catheter configured for advancement through vasculature of a subject to facilitate clot removal from the vasculature of the subject; 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: after operation of the thrombectomy system in a clot removal state or a clot hunting state, access a first set of pressure values obtained via a first pressure sensor associated with a first part of an aspiration path of the thrombectomy system, the first set of pressure values indicating vacuum pressure within the first part of the aspiration path over a time period following deactivation of the clot removal state or the clot hunting state; determine whether the first set of pressure values satisfies one or more conditions, wherein satisfaction of the one or more conditions indicates that the aspiration catheter is at least partially clogged; and after determining that the first set of pressure values satisfies the one or more conditions, perform one or more of: (i) selectively disable activation of an operational state of the thrombectomy system, (ii) selectively present an alert on a user interface of the thrombectomy system, or (iii) trigger one or more pressure cycles for the thrombectomy system.- Page 34 - Docket No. 22935.54A / Abbott No. 16028WOO1

[0102] Clause 15. The thrombectomy system of clause 14, wherein the aspiration path is defined by the aspiration catheter, an aspiration canister, and aspiration tubing.

[0103] Clause 16. The thrombectomy system of clause 15, wherein the first pressure sensor is connected to the aspiration tubing proximate to the aspiration catheter.

[0104] Clause 17. The thrombectomy system of clause 15, wherein the first pressure sensor is connected to the aspiration tubing proximate to the aspiration canister.

[0105] Clause 18. The thrombectomy system of clause 14, wherein the deactivation of the clot removal state or the clot hunting state is automatically triggered based on flow data associated with the aspiration path.

[0106] Clause 19. The thrombectomy system of clause 14, wherein the one or more conditions comprise a rate of change of pressure values ofthe first set of pressure values failing to satisfy a threshold rate of change within the time period.

[0107] Clause 20. The thrombectomy system of clause 19, wherein the threshold rate of change is less than about 50 inHg / s.

[0108] Clause 21. The thrombectomy system of clause 20, wherein the threshold rate of change is less than about 24 inHg / s.

[0109] Clause 22. The thrombectomy system of clause 14, wherein the one or more conditions comprise pressure values of the first set of pressure values failing to reach a reference pressure value within the time period.

[0110] Clause 23. The thrombectomy system of clause 22, wherein the reference pressure value comprises or is determined based on one or more pressure values detected via the first pressure sensor prior to operation of thrombectomy system in the clot removal state or the clot hunting state.

[0111] Clause 24. The thrombectomy system of clause 22, wherein the reference pressure value is less than about 10 inHg.

[0112] Clause 25. The thrombectomy system of clause 24, wherein the reference pressure value is less than about 5 inHg.

[0113] Clause 26. The thrombectomy system of clause 14, wherein the time period comprises less than 10 seconds.

[0114] Clause 27. The thrombectomy system of clause 26, wherein the time period comprises about 3 seconds.- Page 35 - Docket No. 22935.54A / Abbott No. 16028WOO1

[0115] Clause 28. The thrombectomy system of clause 14, wherein selectively disabling activation of an operational state of the thrombectomy system comprises selectively disabling re-activation of the clot removal state or the clot hunting state followingthe deactivation of the clot removal state orthe clot hunting state.

[0116] Clause 29. The thrombectomy system of clause 14, wherein the one or more pressure cycles for the thrombectomy system comprise re-activation and subsequent deactivation of the clot removal state orthe clot hunting state.

[0117] Clause 30. The thrombectomy system of clause 28, wherein the instructions are executable by the one or more processors to configure the thrombectomy system to, after determining that the first set of pressure values fails to satisfy the one or more conditions, refrain from disabling activation of the operational state of the thrombectomy system.

[0118] Clause 31. The thrombectomy system of clause 14, wherein the first pressure sensor is positioned at a distal tip of the aspiration catheter, a proximal opening of the aspiration catheter, a device activating switch of the thrombectomy system, an aspiration canister, or an aspiration pump of the thrombectomy system.

[0119] Clause 32. A thrombectomy system, comprising: an aspiration catheter configured for advancement through vasculature of a subject to facilitate clot removal from the vasculature of the subject; 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: after operation of the thrombectomy system in a clot removal state or a clot hunting state: access a first set of pressure values obtained via a first pressure sensor associated with a first part of an aspiration path of the thrombectomy system, the first set of pressure values indicating vacuum pressure within the first part of the aspiration path over a time period following deactivation of the clot removal state orthe clot hunting state; and access a second set of pressure values obtained via a second pressure sensor associated with a second part of the aspiration path, the second set of pressure values indicating vacuum pressure within the second part of the aspiration path over the time period following the deactivation of the clot removal state or the clot hunting state, wherein the first set of pressure values and the second set of pressure values are captured over a common time period; determine whether the first set of pressure values and the second set of pressure- Page 36 - Docket No. 22935.54A / Abbott No. 16028WOO1values satisfy one or more conditions, wherein satisfaction of the one or more conditions indicates that the aspiration catheter is at least partially clogged; and after determining that the first set of pressure values and the second set of pressure values satisfy the one or more conditions, perform one or more of: (i) selectively disable activation of an operational state of the thrombectomy system, (ii) selectively present an alert on a user interface of the thrombectomy system, or (iii) trigger one or more pressure cycles forthe thrombectomy system.

[0120] Clause 33. The thrombectomy system of clause 32, wherein the aspiration path is defined by the aspiration catheter, an aspiration canister, and aspiration tubing.

[0121] Clause 34. The thrombectomy system of clause 33, wherein the first pressure sensor is connected to the aspiration tubing proximate to the aspiration catheter.

[0122] Clause 35. The thrombectomy system of clause 33, wherein the second pressure sensor is connected to the aspiration tubing proximate to the aspiration canister.

[0123] Clause 36. The thrombectomy system of clause 32, wherein the deactivation of the clot removal state or the clot hunting state is automatically triggered based on flow data associated with the aspiration path.

[0124] Clause 37. The thrombectomy system of clause 32, wherein the one or more conditions comprise a ratio of pressure values of the first set of pressure values to pressure values of the second set of pressure values failing to reach a threshold ratio within the time period.

[0125] Clause 38. The thrombectomy system of clause 37, wherein the threshold ratio comprises less than 0.7.

[0126] Clause 39. The thrombectomy system of clause 37, wherein the threshold ratio comprises less than 0.3.

[0127] Clause 40. The thrombectomy system of clause 32, wherein the time period comprises less than 10 seconds.

[0128] Clause 41. The thrombectomy system of clause 40, wherein the time period comprises about 3 seconds.

[0129] Clause 42. The thrombectomy system of clause 32, wherein selectively disabling activation of an operational state of the thrombectomy system comprises- Page 37 - Docket No. 22935.54A / Abbott No. 16028WOO1selectively disabling re-activation of the clot removal state or the clot hunting state followingthe deactivation of the clot removal state orthe clot hunting state.

[0130] Clause 43. The thrombectomy system of clause 32, wherein the one or more pressure cycles for the thrombectomy system comprise re-activation and subsequent deactivation of the clot removal state orthe clot hunting state.

[0131] Clause 44. The thrombectomy system of clause 32, wherein the instructions are executable by the one or more processors to configure the thrombectomy system to, after determining that the first set of pressure values fails to satisfy the one or more conditions, refrain from disabling activation of the operational state of the thrombectomy system.

[0132] Clause 45. The thrombectomy system of clause 32, wherein the first pressure sensor or the second pressure sensor is positioned at a distal tip of the aspiration catheter, a proximal opening of the aspiration catheter, a device activating switch of the thrombectomy system, an aspiration canister, or an aspiration pump of the thrombectomy system.Additional Details Related to Implementing the Disclosed Embodiments

[0133] 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.

[0134] 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.

[0135] 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- Page 38 - Docket No. 22935.54A / Abbott No. 16028WOO1storage 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.

[0136] 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.

[0137] 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 or hardware 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- Page 39 - Docket No. 22935.54A / Abbott No. 16028WOO1suitable communication channel(s), such as, by way of non-limiting example, Bluetooth, ultra-wideband, WLAN, infrared communication, and / or others.

[0138] 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, pressure sensors, microphones, thermometers, barometers, magnetometers, accelerometers, gyroscopes, and / or others.

[0139] 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).

[0140] 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 can comprise at least two distinctly different kinds of computer-readable media: computer storage media and transmission media.

[0141] 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- Page 40 - Docket No. 22935.54A / Abbott No. 16028WOO1program 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.

[0142] 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, ora 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.

[0143] 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.

[0144] 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. 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- Page 41 - Docket No. 22935.54A / Abbott No. 16028WOO1above. Rather, the described features and acts are disclosed as example forms of implementingthe claims.

[0145] 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.).

[0146] 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.

[0147] 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.

[0148] 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).- Page 42 - Docket No. 22935.54A / Abbott No. 16028WOO1

[0149] 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 embodimentscan 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.

[0150] 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 includesthe 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.

[0151] 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- Page 43 - Docket No. 22935.54A / Abbott No. 16028WOO1involving 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.- Page 44 - Docket No. 22935.54A / Abbott No. 16028WOO1

Claims

CLAIMSWe Claim:

1. A thrombectomy system, comprising:an aspiration catheter configured for advancement through vasculature of a subject to facilitate clot removal from the vasculature of the subjec - one or more processors; andone 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 a first set of pressure values obtained via a first pressure sensor associated with a first part of an aspiration path of the thrombectomy system, the first set of pressure values indicating vacuum pressure within the first part of the aspiration path over a time period;access a second set of pressure values obtained via a second pressure sensor associated with a second part of the aspiration path, the second set of pressure values indicating vacuum pressure within the second part of the aspiration path over the time period, wherein the first set of pressure values and the second set of pressure values are captured over a common time period;determine whether the first set of pressure values and the second set of pressure values satisfy one or more conditions, wherein satisfaction of the one or more conditions indicates that the aspiration catheter is engaged with a vessel wall of the vasculature of the subject; and after determining that the first set of pressure values and the second set of pressure values satisfy the one or more conditions, perform one or more of: (i) selectively modify an operational state of the thrombectomy system or (ii) selectively present an alert on a user interface of the thrombectomy system.

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

3. The thrombectomy system of claim 2, wherein the first pressure sensor is connected to the aspiration tubing proximate to the aspiration catheter, and wherein- Page 45 - Docket No. 22935.54A / Abbott No. 16028WOO1the second pressure sensor is connected to the aspiration tubing proximate to the aspiration canister.

4. The thrombectomy system of claim 1, wherein the one or more conditions comprise pressure values of the first set of pressure values and the second set of pressure values being within a similarity threshold to one another for a duration of the time period.

5. The thrombectomy system of claim 4, wherein the similarity threshold comprises less than 1 inHg.

6. The thrombectomy system of claim 4, wherein the time period comprises less than 10 seconds.

7. The thrombectomy system of claim 1, wherein selectively modifying the operational state of the thrombectomy system comprises deactivating a clot removal state or a clot hunting state of the thrombectomy system.

8. The thrombectomy system of claim 1, wherein the instructions are executable by the one or more processors to configure the thrombectomy system to, after determining that the first set of pressure values and the second set of pressure values fail to satisfy the one or more conditions, selectively maintain the operational state of the thrombectomy system.

9. A thrombectomy system, comprising:an aspiration catheter configured for advancement through vasculature of a subject to facilitate clot removal from the vasculature of the subject;one or more processors; andone or more computer-readable recording media that store instructions that are executable by the one or more processors to configure the thrombectomy system to:after operation of the thrombectomy system in a clot removal state or a clot hunting state, access a first set of pressure values obtained via a first pressure sensor associated with a first part of an aspiration path of the thrombectomy system, the first set of pressure values indicating vacuum pressure within the first part of the aspiration path over a time period following deactivation of the clot removal state orthe clot hunting state;- Page 46 - Docket No. 22935.54A / Abbott No. 16028WOO1determine whether the first set of pressure values satisfies one or more conditions, wherein satisfaction of the one or more conditions indicates that the aspiration catheter is at least partially clogged; and after determining that the first set of pressure values satisfies the one or more conditions, perform one or more of: (i) selectively disable activation of an operational state of the thrombectomy system, (ii) selectively present an alert on a user interface of the thrombectomy system, or (iii) trigger one or more pressure cycles for the thrombectomy system.

10. The thrombectomy system of claim 9, wherein the aspiration path is defined by the aspiration catheter, an aspiration canister, and aspiration tubing.

11. The thrombectomy system of claim 10, wherein the first pressure sensor is connected to the aspiration tubing proximate to the aspiration catheter, and wherein the first pressure sensor is connected to the aspiration tubing proximate to the aspiration canister.

12. The thrombectomy system of claim 9, wherein the deactivation of the clot removal state or the clot hunting state is automatically triggered based on flow data associated with the aspiration path.

13. The thrombectomy system of claim 9, wherein the one or more conditions comprise a rate of change of pressure values of the first set of pressure values failing to satisfy a threshold rate of change within the time period.

14. The thrombectomy system of claim 13, wherein the threshold rate of change is less than about 50 inHg / s.

15. The thrombectomy system of claim 9, wherein the one or more conditions comprise pressure values ofthe first set of pressure values failingto reach a reference pressure value within the time period.

16. The thrombectomy system of claim 15, wherein the reference pressure value comprises or is determined based on one or more pressure values detected via the first pressure sensor prior to operation of thrombectomy system in the clot removal state or the clot hunting state.

17. The thrombectomy system of claim 15, wherein the reference pressure value is less than about 10 inHg.- Page 47 - Docket No. 22935.54A / Abbott No. 16028WOO118. The thrombectomy system of claim 9, wherein selectively disabling activation of an operational state of the thrombectomy system comprises selectively disabling reactivation of the clot removal state or the clot hunting state following the deactivation of the clot removal state or the clot hunting state.

19. The thrombectomy system of claim 9, wherein the one or more pressure cycles forthe thrombectomy system comprise re-activation and subsequent deactivation of the clot removal state or the clot hunting state.

20. A thrombectomy system, comprising:an aspiration catheter configured for advancement through vasculature of a subject to facilitate clot removal from the vasculature of the subject- one or more processors; andone or more computer-readable recording media that store instructions that are executable by the one or more processors to configure the thrombectomy system to:after operation of the thrombectomy system in a clot removal state or a clot hunting state:access a first set of pressure values obtained via a first pressure sensor associated with a first part of an aspiration path of the thrombectomy system, the first set of pressure values indicating vacuum pressure within the first part of the aspiration path over a time period following deactivation of the clot removal state or the clot hunting state; andaccess a second set of pressure values obtained via a second pressure sensor associated with a second part of the aspiration path, the second set of pressure values indicating vacuum pressure within the second part of the aspiration path overthe time period followingthe deactivation of the clot removal state or the clot hunting state, wherein the first set of pressure values and the second set of pressure values are captured over a common time period;determine whether the first set of pressure values and the second set of pressure values satisfy one or more conditions, wherein satisfaction- Page 48 - Docket No. 22935.54A / Abbott No. 16028WOO1of the one or more conditions indicates that the aspiration catheter is at least partially clogged; andafter determining that the first set of pressure values and the second set of pressure values satisfy the one or more conditions, perform one or more of: (i) selectively disable activation of an operational state of the thrombectomy system, (ii) selectively present an alert on a user interface of the thrombectomy system, or (iii) trigger one or more pressure cycles for the thrombectomy system.- Page 49 - Docket No. 22935.54A / Abbott No. 16028WOO1

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