Vascular occlusion detection from motorized separator torque measurement signal

Abstract

To provide systems and methods for detecting different engagement conditions of a separator instrument of a system.SOLUTION: Processing circuitry is used to establish a baseline of one or more operational parameters for the separator instrument. At least one deviation from the established one or more baseline operational parameters of the separator instrument is identified using the processing circuitry. The processing circuitry is used to determine that the identified at least one deviation corresponds to at least one engagement condition of the separator instrument. An action is performed based on the determination by the processing circuitry.SELECTED DRAWING: Figure 8

Description

[Technical Field]

[0001] Background of the Invention The present disclosure relates to systems and methods for cutting, collecting, and removing occlusive material from blood vessels and other body cavities, and more particularly to systems and methods for altering the operation of an apparatus for removing occlusive material based on, for example, detection of an engagement between a separator device and the occlusive material.

[0002] summary The unwanted accumulation of obstructive material in the vascular system can be caused by many factors. For example, thrombosis (the formation of blood clots) and atherosclerosis (the buildup of fats, cholesterol, and other substances in blood vessel walls) are common conditions that lead to the accumulation of material that at least partially blocks blood vessels. These deposits restrict blood flow and risk fragmenting and escalating into the bloodstream. If this fragmented material reaches the heart, brain, or lungs, it can be fatal. One example of such a condition is deep vein thrombosis (DVT), in which a blood clot forms in the deep (as opposed to superficial) veins of the body, usually in the legs. DVT is generally characterized by the accumulation of a large amount of strong, chronic blood clots that obstruct venous flow. Therefore, there is a need for effective treatments that not only address the complication but also prevent the spread and recurrence of further associated complications. [Background technology]

[0003] Therapies based on drug administration, filter implants, and catheter-based removal have commonly been used to remove obstructing material from blood vessels and other body cavities. Anticoagulants such as heparin are the most commonly prescribed medications for treating DVT, for example. Anticoagulant administration helps prevent the growth of blood clots and relies on the body's own dissolution process to remove them. This process is expensive, slow-acting, ineffective for large or complete blockages, and carries the risk of residual clots entering the bloodstream and causing venous damage elsewhere.

[0004] The implantation of thrombus filters is used as a preventative measure for individuals at risk of developing blood clots. These filters are typically surgically implanted in the inferior vena cava. The filter functions to capture blood clots and then remove them through the body's dissolving process. While these filters significantly reduce the chance of clot fragments traveling to the heart or lungs, they often require the use of anticoagulants, which entails all of the complications discussed above. Furthermore, filter retrieval rates are low due to low physician follow-up and patient compliance.

[0005] Catheter-based interventions offer an alternative treatment method. Catheters or catheter-based devices are percutaneously inserted into blood vessels and manipulated to directly contact the target material. In the case of newly formed thrombi or small, unattached plaques, the material may be removed from the catheter by aspiration, mechanical capture, or other means. This approach has the advantage of rapidly removing the target material and leaving little residual material behind, which could lead to the recurrence or proliferation of associated disease. However, limitations on the type and amount of occlusive material that can be successfully removed make this an impractical approach for many disease states, such as some DVTs, which can be associated with large and stubborn thrombus burdens.

[0006] Catheter-based devices include rotating blades, high-pressure water jets, laser ablation, or other forceful means to break down target material. Such methods are common in dedicated atherectomy tools, where blockages are formed by plaque attached to the wall. Many such devices may suffer from at least one of two drawbacks. First, methods for removing target material after it has been fragmented may be ineffective or marginal. For example, some devices have small lumens that are prone to clogging, or inefficient pressure gradients that do not allow the detached thrombus or plaque to be drawn into the system. If not removed, the detached thrombus or plaque may be released into downstream vessels, risking further complications. Second, devices that use blades to fragment stubborn thrombus or plaque may result in damage to the vessel wall.

[0007] For the reasons discussed above, there has been an unmet need for methods and devices for quickly and safely removing a wide range of occlusive material, including at least thrombus and atheroma, without damaging the surrounding blood vessel. Accordingly, a significant improvement over the approaches described above would involve detecting various engagement states of devices designed to remove occlusive material and modifying the operation of the device so as not to damage healthy tissue surrounding or intertwined with the occlusive material. Summary of the Invention

[0008] Described herein, in accordance with various embodiments of the present disclosure, is a method for detecting various engagement states of a device (e.g., a separator instrument) configured to remove occlusive material within a blood vessel and performing an action (e.g., modifying operating parameters of the separator instrument to avoid damaging healthy tissue surrounding or intertwined with the occlusive material) based on the determination. A processing circuit is used to establish a baseline of one or more operating parameters of the device, which can be a separator instrument. At least one deviation from the established one or more baseline operating parameters is identified using the processing circuit. Using the processing circuit, it is determined that the identified at least one deviation corresponds to at least one engagement state of the separator instrument. The processing circuit performs the action based on the determination.

[0009] In some embodiments, the device includes a catheter (e.g., a thrombectomy catheter) for use in a subject's vasculature, including a rotatable and / or axially movable cutting instrument. The cutting instrument may be a spiral (e.g., helical) cutting instrument, such as a separator instrument. A rounded, spherical, substantially spherical, or partially spherical element at the distal end of the instrument can be connected to a body having a twisted shape (e.g., spiral and / or helical). The cutting instrument is disposed within the lumen of the catheter and configured for axial and / or rotational movement within the lumen between a proximal-most position and a distal-most position. In some embodiments, the cutting instrument can extend slightly beyond the distal-most position of the lumen of the catheter, such that at least a portion of the cutting instrument extends outside the lumen of the catheter. Additionally or alternatively, the cutting instrument can be flush with or embedded within the catheter. Accordingly, the separator instrument may incorporate a positive displacement pump or other related structure for displacing fluids with a viscosity greater than that of water or other room-temperature liquids. In some examples, the body includes at least one edge configured to encourage movement of the material toward the proximal end of the lumen upon contact with or proximity to the material. When a processing circuit is coupled to the cutting instrument and power (e.g., electrical power) is supplied, the cutting instrument deploys and rotates various elements to cut into the occlusive material. For example, torque values ​​may be measured from the rotating elements to distinguish between freely rotating elements, engaged elements, and elements engaged with material that they should not engage. These torque values ​​(e.g., operating parameters) may be modified based on instructions sent from the processing circuit to avoid the rotating elements damaging healthy tissue.

[0010] In one example, the catheter further includes at least one motor coupled to the separator device, the at least one motor configured to impart rotational and / or axial motion, e.g., reciprocating axial motion, to the cutting device. In another example, the body includes a shaft, e.g., a cylindrical shaft, having a spiral shape surrounding the shaft. In one example, the body includes a central smooth surface configured to propel the cut portion of the target material from the distal end of the body toward the proximal end of the body.

[0011] In some embodiments, establishing a baseline for one or more operating parameters includes processing a selected data set representative of a heterogeneous population. Additionally or alternatively, the at least one deviation from the established baseline operating parameters of the separator device includes at least one of a change in one or more of rotational speed, torque load, or rotational direction. The baseline for the one or more operating parameters may be established by retrieving a data structure from memory corresponding to a stored predefined expected range for the one or more operating parameters. A current operating state of the separator system is identified. Baseline values ​​for the one or more operating parameters are selected based on the identified current operating state from the expected range for the one or more operating parameters. In some embodiments, the at least one deviation includes an interruption or pause in operation of the separator device. The at least one engagement state of the separator device may include engagement of the separator device with one or more of saline, blood solution, valve tissue, at least one thrombus, an abnormal tissue mass, a foreign body, plaque, or a blood vessel.

[0012] In some embodiments, the one or more operating parameters include torque. Additionally or alternatively, establishing a baseline for one or more separator instrument operating parameters includes receiving a signal including torque information for the powered separator and processing the signal to calculate a baseline torque in real time. Identifying at least one deviation from the established one or more baseline separator instrument operating parameters may include determining that values ​​of one or more torque measurements determined from the signal are anomalous relative to the baseline torque. Determining at least one engagement state of the separator instrument includes distinguishing whether the anomalous one or more torque measurements are caused by an occlusion of the blood vessel or a cause other than the occlusion.

[0013] In some embodiments, the signal is received from a sensor coupled to the motor of the motorized separator. Additionally or alternatively, the torque information includes at least one torque measurement measured by the sensor at a sampling rate. The real-time baseline torque can be determined based on one or more of the current torque measurement, a previously calculated baseline torque, or a preclinically derived value. In some embodiments, the system stores, in a memory communicatively coupled to the processing circuit, maximum values ​​corresponding to one or more operating parameters and minimum values ​​corresponding to one or more operating parameters for each manufacturing iteration of the system. The processing circuit can utilize these values ​​for further processing. For example, the baseline of one or more operating parameters is compared to the maximum and minimum values. Based on the comparison, it is determined that the value corresponding to the baseline of the one or more operating parameters exceeds the maximum value or the value is less than the minimum value. In response to the determination, the processing circuit modifies one or more operating parameters or terminates operation of the system without updating the baseline.

[0014] In some embodiments, the current torque measurement and the previously calculated baseline torque are weighted based on a total number of torque measurements received from the signal. In some embodiments, a rate of change of the torque value of the current torque measurement is determined based on a sampling rate. In some embodiments, a rate of change of the torque value of the current torque measurement is determined based on a sampling rate. A maximum calculated baseline torque and a minimum calculated baseline torque are calculated by modifying the previously calculated baseline torque based on the rate of change of the torque value. A range of updated baseline torque values ​​is determined based on a comparison of the maximum calculated baseline torque and the minimum calculated baseline torque to the previously calculated baseline torque.

[0015] In some embodiments, the previously calculated baseline torque is weighted based on a first value calculated based on the adjustment parameter and the total number of torque measurements. The first value is calculated by subtracting 1 from the adjustment parameter divided by the total number of torque measurements, and if the current torque measurement exceeds an amplitude threshold, the real-time baseline torque may not be dynamically updated based on the current torque measurement. The amplitude threshold may be calculated by multiplying the previously calculated baseline torque by a limit adjustment parameter.

[0016] In some embodiments, the method incorporates determining a dynamic threshold based on the calculated baseline torque and a previously calculated baseline torque, and determining that at least one torque measurement is anomalous relative to the baseline torque based on comparing the value of the at least one torque measurement to the dynamic threshold. Additionally or alternatively, the dynamic threshold includes an upper bound and a lower bound. The upper bound is a multiplier of the previously calculated baseline torque, and the lower bound is a multiplier of the previously calculated baseline torque.

[0017] In some embodiments, the method includes determining that at least one torque measurement is anomalous based on whether the value of the at least one torque measurement is greater than an upper dynamic threshold or less than a lower dynamic threshold. For two subsequent measurements (e.g., consecutive or within a specified sampling period) that exceed a dynamic threshold boundary, the number of measurements between them is determined. The number of measurements between them is compared to a threshold. The threshold is determined based on a sampling rate of the signal, and distinguishing the anomalous one or more torque measurements as being caused by an obstruction in the vasculature includes identifying a pattern in the values ​​of the one or more torque measurements that is associated with an obstruction in the vasculature.

[0018] In some embodiments, the non-occlusion causes include one or more of a change in the orientation of the powered separator, wrapping of the vessel, a valve, a vessel wall, fluctuations, noise, or an erroneous reading. Additionally or alternatively, one or more abnormal torque measurements may be determined to be caused by wrapping of the vessel. In response to this determination, operating parameters of the powered separator may be altered.

[0019] In some embodiments, the present disclosure relates to a system for detecting various engagement states of a separator device. The system includes a control circuit communicatively coupled to the separator device, the control circuit configured to send operational instructions to the separator device. Additionally or alternatively, a processing circuit communicatively coupled to the control circuit, the processing circuit configured to cause one or more of the circuits to perform the methods and processes described herein. For example, one or more of the control circuitry or process circuits may be configured to receive and execute instructions determined by processing a non-transitory computer-readable medium having non-transitory computer-readable instructions encoded therein that, when executed by the circuitry, cause the circuitry to perform one or more of the methods or processes of the present disclosure. [Brief explanation of the drawings]

[0020] These and other objects and advantages of the present disclosure will become apparent from the following detailed description considered in conjunction with the accompanying drawings.

[0021] [Figure 1] FIG. 1 is a perspective view of a thrombectomy catheter system according to some embodiments of the present disclosure.

[0022] [Figure 2] FIG. 10 is a side detailed view of a spiral cutting instrument in the distal-most segment of a thrombectomy catheter system, according to some examples of the present disclosure.

[0023] [Figure 3] FIG. 10 is a side transparent detail view of a spiral cutting instrument in operation, according to some examples of the present disclosure.

[0024] [Figure 4] FIG. 10 is a side detail view of another embodiment of a spiral cutting instrument, according to some examples of the present disclosure.

[0025] [Figure 5A] 5 is a side transparent detail view of the spiral cutting instrument of FIG. 4 in operation, according to some examples of the present disclosure.

[0026] [Figure 5B] 5 is a cross-sectional view of the spiral cutting instrument of FIG. 4, according to some examples of the present disclosure.

[0027] [Figure 6] 1 is an exemplary graph of data characterizing an operating parameter compared to a baseline of the operating parameter, according to some examples of the present disclosure.

[0028] [Figure 7] 10 is an exemplary graph of data characterizing operating parameters when an instrument of the present disclosure comes into interface contact with an occlusion, according to some examples of the present disclosure.

[0029] [Figure 8]FIG. 10 is a block diagram of an exemplary process for detecting various engagement conditions, according to some examples of the present disclosure.

[0030] [Figure 9] FIG. 1 is a block diagram of an exemplary process for verifying operating parameters of an apparatus of the present disclosure, according to some examples of the present disclosure.

[0031] [Figure 10] FIG. 10 is a block diagram of an example process for calculating an amplitude threshold, according to some examples of the present disclosure.

[0032] [Figure 11] FIG. 1 is a block diagram of an example process for determining that a measurement of an operating parameter is anomalous compared to a baseline measurement of the operating parameter, according to some examples of the present disclosure.

[0033] [Figure 12] FIG. 10 is a block diagram of an example process for identifying the number of measurements to process using dynamic threshold boundaries, according to some examples of the present disclosure.

[0034] [Figure 13] FIG. 1 is a block diagram of an example process for determining the cause of an abnormal measurement, according to some examples of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0035] Provided herein are methods and systems for modifying the operation of an occlusive material removal device based on, for example, detection of an engagement condition between a separator device and occlusive material.

[0036] Terms of direction or position, such as "upper," "lower," "front," "rear," "leading," and "following," are used in relation to the orientation of the figures being described. Because components in examples of the present invention can be positioned in several different orientations, this terminology is used for illustrative purposes and not as a limitation. Other combinations and / or modifications of the above-described structures, arrangements, applications, proportions, elements, materials, or components used in practicing the subject matter of the present invention, including those not specifically described, can be changed or otherwise specially tailored to particular environments, manufacturing specifications, design parameters, or other operating requirements without departing from the general principles thereof.

[0037] As used herein, the terms "distal" and "proximal" are understood to denote location. Objects, elements, and components are "proximal" or "distal" to one another on the system. "Proximal" refers to a direction along the path of the catheter system toward the system controls and operator, and "distal" refers to a direction along the path of the catheter system away from the system controls and operator, toward or beyond the end of the operating head.

[0038] As used herein, a suction source may refer to any device that provides a negative pressure gradient. The negative pressure source may be a vacuum pump, a peristaltic pump, a progressive cavity pump, a diaphragm pump, a piston pump, a high-speed water jet positioned at an appropriate angle and orientation to create the desired negative pressure gradient, or a simple syringe. All variations are understood to be within the scope and spirit of the present invention.

[0039] The term "occlusion" as used herein refers to both partial and complete vascular occlusion. An example of a partial vascular occlusion is a blood vessel narrowed by hardened material such as plaque. Also, as used herein, "complete" removal of the occlusion is understood as the effective removal of the occlusive material, such as a thrombus. While the occlusive material may escape removal, one skilled in the art can characterize the removal as complete when the device restores vascular patency.

[0040] As used herein, the term "catheter system" refers to a system configured to remove occlusive material from a bodily passageway, such as a blood vessel. In the examples described herein, the catheter system is illustrated as a thrombus removal catheter system. However, for the avoidance of doubt, the examples described herein are not limited to use as a device for removing thrombi from bodily passageways. Indeed, the examples described herein may be used to remove any suitable occlusive material from a bodily passageway, including, but not limited to, thrombi, atheromas, and the like.

[0041] The methods and / or any instructions for carrying out any of the embodiments described herein may be encoded on a computer-readable medium. A computer-readable medium includes any medium capable of storing data. The computer-readable medium may be transitory, including but not limited to, propagating electrical or electromagnetic signals, or non-transitory, including but not limited to, volatile and non-volatile computer memory or storage devices such as hard disks, floppy disks, USB drives, DVDs, CDs, media cards, register memory, processor cache, random access memory (RAM), etc.

[0042] FIG. 1 shows a perspective view of a thrombus removal catheter system 100. The system 100 includes a specialized catheter or sheath catheter 102 attached to a base unit 107, which houses powered components (e.g., a controller, an aspiration pump, a clot collection container, etc.) that are manipulated by a user to activate the internal components (not visible in FIG. 1 ) of the specialized catheter or sheath catheter 102 of the system 100. The distal end 102 a of the sheath catheter 102 is inserted into a vein, artery, or other passageway, advanced to a treatment site, and then deployed to mechanically disrupt, fragment, and aspirate target material from the passageway. A spiral cutting instrument 101 is disposed at the distal end of the sheath catheter 102 and extends axially from an opening 103 at the distal end of the sheath catheter 102. The spiral cutting instrument 101 has a substantially spherical element with a rounded shape at its distal end, which functions as an atraumatic tip (described in more detail below), reducing the risk of damaging a vessel or tissue passageway or surface by advancing the spiral cutting instrument 101 through the opening 103 of the sheath catheter 102. The opening 103 allows material from the patient's body to enter an aspiration lumen formed in the sheath catheter 102. The spiral cutting instrument 101 also extends axially from the opening 103. The proximal end 104 of the sheath catheter 102 is coupled to a motor 105, which provides rotational and / or reciprocating axial motion to the internal components of the sheath catheter 102. The proximal end 104 of the sheath catheter 102 is in fluid communication with a suction source, such as a pump 106, which provides a negative pressure gradient (e.g., vacuum suction) to draw the target material through the opening 103 and into the aspiration lumen of the sheath catheter 102. Other known suction sources may also be used within the scope of this disclosure. The negative pressure gradient and mechanical fragmentation together ensure efficient and effective removal of material from the body.

[0043] In an alternative example, system 100 may include one or more pumps or valves in fluid communication with system 100. Such pumps and valves may provide or remove fluid in a manner that alters the pressure within system 100. System 100 may be controlled by an ergonomically shaped handle (not shown in FIG. 1 ), which houses motor 105 and also houses or is in fluid contact with pump 106. This allows a user to easily control and operate system 100. System 100 also includes processing and control circuitry 108. Processing and control circuitry 108 includes one or more components for receiving, processing, and transmitting data related to controlling and monitoring one or more of motor 105, catheter 102, or sensors (not shown) located throughout system 100, and collects data related to the various components to determine whether modifications to the operation of one or more of motor 105 or catheter 102 are necessary. For example, one type of operational data that may be used by the processing and control circuitry 108 includes torque data, which, when analyzed according to one or more processes and methods of the present disclosure, can be correlated with an engagement or operational state of the catheter 102. Depending on the engagement or operational state determined by the processing and control circuitry 108, the processing and control circuitry 108 may generate one or more instructions that, when executed, modify the operation of the system 100 to change the engagement or operational state.

[0044] FIG. 2 shows a detailed side view of a spiral cutting instrument in the distal-most segment of a thrombectomy catheter system, according to some examples of the present disclosure. The sheath catheter 202 in the distal region 200 is shown transparent (dashed lines) to facilitate understanding of the internal components. The distal region 200 of the sheath catheter has an opening 203 from which the spiral cutting instrument 201 extends axially. The spiral cutting instrument 201 includes a spiral body 214 coupled to a substantially spherical element 216, which functions as an atraumatic tip. The spiral body 214 of the spiral cutting instrument 201 has a corkscrew-like twisted spiral shape surrounding a central cylindrical shaft 208, as shown in FIG. 2. The spiral body 214 includes a pair of edges 210 and 212 in the twisted spiral shape surrounding the central cylindrical shaft 208. In one example, each of the pair of edges 210 and 212 is substantially sharp or configured to advance cutting of the target material upon contact. In another example, one of the edges 210, 212 is substantially sharp, while the other edge 210, 212 remains substantially blunt. In this configuration, as the helical body 214 rotates, the substantially blunt edge is configured to gently pull or draw in the target material, while the substantially sharp edge is configured to slice or cut a small portion of the target material upon contact.

[0045] FIG. 3 shows a side, transparent detail view of the spiral cutting instrument in operation, according to some examples of the present disclosure. As shown in FIG. 3, the distal end of the sheath catheter 202 is positioned proximal to the target material 205. Once the sheath catheter 202 is positioned adjacent to the target material, the motor 106 selectively provides rotational and / or axial motion to the spiral cutting instrument 201, advancing the spiral cutting instrument 201 distally (typically while simultaneously rotating or rotationally oscillating) and extending from the distal end of the sheath catheter 202. The substantially spherical element 216 serves as an atraumatic tip upon initial contact with the target material 205. Specifically, the rounded, atraumatic distal substantially spherical element 216 allows the spiral cutting instrument 201 to be safely advanced through the diseased vessel or target tissue.

[0046] During operation, as the substantially spherical element 216 of the helical cutting instrument 201 passes through the target material 205, the target material 205 comes into contact with the pair of rotating edges 210, 212 of the helical body 214. As described above, in one example, the pair of edges 210 and 212 are each substantially sharp and configured to cut a portion of the target material 205 upon rotational contact. Specifically, the target material 205 is subjected to a shear force by the edges 210, 212 as the helical body 214 rotates or rotationally oscillates to cut or slice the target material 205. In another example, only one of the edges 210, 212 is substantially sharp, while the other edge 210, 212 remains substantially dull. In this configuration, as the helical body 214 rotates, the substantially blunt edge is configured to gently pull or draw in the target material 205, while the substantially sharp edge is configured to slice or cut a small portion 205a of the target material 205 upon contact.

[0047] The resulting fragments are then drawn into the lumen of the Sheath Catheter 202 using multiple mechanisms acting individually and / or in concert. Specifically, as shown in FIG. 2 , as the double helix structure of the helical body 214 rotates, the distal end (i.e., the end connected to the substantially spherical element 216) picks up the cut portion 205a of the target material 205 and moves it along the surface of the helical body 214 toward the proximal end of the helical cutting instrument 201. For example, in one example, the helical surface of the helical body provides a sliding channel for the cut portion 205a of the target material 205 to exit from the distal portion to the proximal portion of the catheter 202. In another example, the helical surface of the helical body may include a grooved portion configured to provide a sliding channel for the cut portion 205a of the target material 205. Additionally, the cut portion 205a of the subject material 205 is further drawn into the lumen of the sheath catheter 202 by a suction source (such as pump 106 of FIG. 1) that provides a negative pressure gradient within the lumen of the sheath catheter 202. The cut portion 205a of the subject material 205 is drawn into the lumen of the sheath catheter and passes to the proximal region of the sheath catheter 202, where it may be removed from the patient's body.

[0048] In this manner, material (e.g., pieces cut from tissue or clots) is fragmented and ingested within the system while suction minimizes residual material escaping evacuation. Once the material of interest 205, or portion 205a thereof, is within the lumen of the Sheath Catheter 202, suction draws the material through the lumen and into a collection chamber (not shown).

[0049] A motor capable of axially advancing and retracting the helical cutting instrument 201 along the lumen of the catheter and simultaneously rotating or rotationally oscillating the helical cutting instrument 201 within the lumen of the catheter is typically attached to the proximal end of the Sheath Catheter, as shown in FIG. 1 , and may be housed in an ergonomically designed handle. An opening may be formed in another structure at the distal end of the Sheath Catheter, such as in a separate housing. For example, the separate housing may be a metal or rigid polymer tube having an opening formed therein. In some examples, the helical cutting instrument 201 is a separate device from the Sheath Catheter, and the helical cutting instrument 201 may be rotated and axially advanced and retracted separately and independently from the Sheath Catheter. The catheter may function as a sheath for the helical cutting instrument 201 in some examples.

[0050] While the example shown in FIG. 3 depicts a spiral cutting instrument 201 having a double-helix-shaped edge, it is understood that the edge may take any suitable shape. Indeed, the cutting instrument 201 may include any suitable number of edges, such as a single edge or any multiple edges, depending on the configuration of the cutting instrument 201 and / or its intended operational purpose. In some examples, the cutting instrument may include at least one edge with a different curvature, e.g., the edge may include at least one straight portion (e.g., an axially aligned portion) and at least one curved portion. In some examples, the edge may be a spiral edge with a constant or varying pitch. In some examples, the radial height of the edge may be constant or may vary along the length of the body 214. In some examples, the edge may extend radially outward, e.g., vertically, from the longitudinal axis of the body 214, e.g., over at least a portion of the edge's length. In some examples, the edge may be angled forward or rearward, e.g., angled toward the longitudinal forward direction of the body 214 or angled toward the longitudinal rearward direction, e.g., over at least a portion of the edge's length. For the avoidance of doubt, the term "helical" as applied to the examples described herein is used for purposes of illustration and not limitation. Indeed, the present disclosure contemplates that the benefits of the cutting instrument described herein may be achieved with any appropriately configured edge or edges of the cutting instrument 201.

[0051] In some embodiments, the helical cutting tool 201 is integrated into or considered part of a progressive cavity pump (hereinafter "PCP") assembly. A PCP is a positive displacement pump that can move fluid as, for example, a rotor rotates. The volumetric flow rate of fluid transport is proportional to the potentially bidirectional rotational speed of the rotor, assuming a low level of rotor-induced shear applied to the fluid pumped through the assembly. The rotor of the PCP can incorporate, for example, a helical cutting instrument 201 to induce bidirectional rotation within the fluid in interface contact with the helical cutting instrument 201. Ideally, the helical cutting instrument 201 is controlled or operated via the controls of the PCP assembly to ensure minimal fluctuation in net fluid flow in a desired direction (e.g., in a direction to draw fluid or other dislodged material from an occluded region of a vascular region).

[0052] FIG. 4 shows a side view of another embodiment of a spiral cutting instrument, according to some examples of the present disclosure. The spiral cutting instrument 401 of FIG. 4 includes a substantially spherical element 416 connected to a spiral body 414. The operation of the spiral body 414 is similar to that of the spiral body 214 described above in connection with FIGS. 2 and 3. The substantially spherical element 416 of the spiral cutting instrument 401 differs from the substantially spherical element 216 of the spiral cutting instrument 201 in that the substantially spherical element 416 includes a gouging portion 420. In one example, the edge of the gouging portion 420 is substantially sharp or configured to facilitate cutting of the target material when the substantially spherical element 416 contacts the target material (while simultaneously rotating or rotating and laterally vibrating). Additionally, as further shown in FIG. 4, the gouging portion 420 is designed to open into the spiral body 414 of the spiral cutting instrument 401. This utilizes the helical shape of the helical body 414 to allow the sliced ​​or cut portion of the subject material to move proximally along the helical body 414 (e.g., via a central channel or surface that may be substantially flat and / or smooth).

[0053] 4, in some examples, the Sheath Catheter 402 includes an opening 403 and an atraumatic distal tip 424, which may be softer / more flexible than the remainder of the Sheath Catheter 402. The soft, atraumatic distal tip 424 allows the device to be safely advanced through the diseased vessel. The substantially sharp edge of the gouging portion 420 is typically serrated or configured to facilitate cutting of the target material as the spiral cutting instrument 401 advances (and optionally rotates and / or rotationally oscillates). The substantially sharp edge of the gouging portion 420 is configured to facilitate shearing the excised portion of the target material from the remaining mass of the target material when the tip engages the target material.

[0054] The opening 403 is typically formed as a "side window" in the distal region of the sheath catheter 402, and the spiral cutting instrument 401 may be advanced and retracted to adjust the size of the gap between the cutting body and the distal end of the window. Suction draws target material, such as thrombus material, into the open window, and the rotating spiral cutting instrument 401 fragments the thrombus as it enters the window. The motor that rotates or rotationally oscillates the spiral cutting instrument 401 is typically attached to the proximal end of the sheath catheter and housed in an ergonomically designed handle, as shown in FIG. 1 . The opening may also be formed in another structure, such as a separate housing, at the distal end of the sheath catheter. For example, the separate housing may be a metal or rigid polymer tube with an opening formed therein. In some examples, both the sheath catheter and the spiral cutting instrument are substantially flexible and pliable.

[0055] Figure 5A shows the system 500 at a fourth time point in the helical cutting instrument rotation configuration. As shown in Figure 5A, rotational shear forces are applied to the target material, causing the target material to separate and slice or shear relatively uniformly. The axial and rotational movement of the helical cutting instrument 501 eventually causes the cutting edges 510, 512 of the gouging portion 520 and the helical body 514 to contact the target material 526, shearing or slicing the target material 526.

[0056] As the spiral cutting instrument 501 moves axially while simultaneously rotating or rotationally oscillating, the target material 526 may be sliced ​​into smaller portions. This slicing produces discrete and relatively uniform fragments that are then partially aspirated by the helical structure of the spiral body 514. As the spiral cutting instrument 501 slices or cuts the target material, the resulting cut portions are aspirated proximally along the spiral body 514 (e.g., through the channel surfaces of the spiral body). The relatively uniform fragments 526a are then further aspirated proximally (indicated by the arrow) within the lumen of the Sheath Catheter. This fragmentation occurs within the lumen of the Sheath Catheter, thereby reducing the risk of dispersing thrombus fragments within the patient's vasculature.

[0057] 5B illustrates a cross-section of the spiral cutting instrument of FIG. 5A taken along line 5-5, according to some examples of the present disclosure. As shown in FIG. 5B, as the spiral cutting instrument 501 rotates or rotationally oscillates within the lumen of the sheath catheter 524, a shear force is applied to the target material 526 by the edges 510, 512 of the spiral cutting instrument 501. The shear force applied by the edges 510, 512 of the spiral cutting instrument 501 slices the target material 526. This slicing produces discrete and relatively uniform fragments 536 that are then sucked proximally along the spiral body of the spiral cutting instrument 501.

[0058] 5B illustrates counterclockwise rotation of the spiral cutting instrument 501, in other examples, the spiral cutting instrument 501 can be rotated clockwise. In one example, edge 510 of spiral cutting instrument 501 is substantially blunt, while edge 512 of spiral cutting instrument 501 is substantially sharp or configured to facilitate cutting of the target material 526. When edge 510 initially contacts the target material 526, instead of cutting or slicing the target material, edge 510 draws a fragment of the target material 526 (e.g., fragment 536) into the lumen of the sheath catheter. As rotation of the spiral cutting instrument 501 continues, substantially sharp edge 512 contacts fragment 536 and cuts or slices the fragment. In this manner, the two distinct edges 510, 512 work together to slice small, discrete portions of the target material 526 while preventing damage to the blood vessel.

[0059] FIG. 6 illustrates a graph 600 of data illustrating a characteristic of an operating parameter compared to a baseline of the operating parameter, according to some examples of the present disclosure. Graph 600 represents data collected regarding torque measurements as a separator device engages one or more occlusive material or other elements within the vasculature. The data in graph 600 may be used, in whole or in part, to perform any or all of process 800 of FIG. 8 , process 900 of FIG. 9 , process 1000 of FIG. 10 , process 1100 of FIG. 11 , process 1200 of FIG. 12 , and process 1300 of FIG. 13 . Graph 600 may be used to illustrate a characteristic of the operation of one or more elements or components shown in or described with reference to FIGS. 1-5B .

[0060] Graph 600 includes a vertical axis 602, a horizontal axis 604, and separator torque data 606. Separator torque data 606 includes normal operation samples 608A and 608B as well as a wrap state operation sample 610. A dynamic threshold 612 provides a baseline for expected operation deviations, and deviations from dynamic threshold 612, as shown in wrap state operation sample 610, correspond to the separator device becoming entangled with tissue of the vasculature being treated.

[0061] As part of executing the process characterized in FIGS. 8-13, data is displayed via graph 600. As illustrated by separator torque data 606, the motor torque of the motor driving the separator generates a peak 614 each time the motor changes direction. While not explicitly indicated by graph 600, separator torque data 606 may contain unwanted noise in the recorded data based on one or more of abrupt changes in treatment speed or separator engagement status. Furthermore, dynamic threshold 612 is expected to vary based on one or more of physiological differences between patients, as well as manufacturing tolerances in the device, and different patients treated using different separators or hardware (e.g., motor and separator combinations). However, dynamic threshold 612 is not affected by wrap status, as changes in the value illustrated in wrap status behavior sample 610 may be based on the device's rotational speed to remove occlusive material. In some embodiments, a wrap condition is detected based on changes in the device's periodic response (e.g., based on periodic changes in direction due to changing device response), and does not affect the baseline in a manner that would cause a different patient or different device to modify the dynamic threshold 612. The calculations for establishing the dynamic threshold 612 are intentionally set so that the baseline is not modified in response to the detection of a wrap condition. Rather, the dynamic threshold 612 is calculated and established to confirm that a wrap condition is occurring, and the dynamic threshold 612 is presented to intelligently account for various device-level changes before a particular device experiences a wrap condition.

[0062] In some embodiments, the system stores, in a memory communicatively coupled to the processing circuit, maximum values ​​corresponding to one or more operating parameters and minimum values ​​corresponding to one or more operating parameters for each manufacturing iteration of the system. The processing circuit may use these values ​​for further processing. For example, a baseline of one or more operating parameters is compared to the maximum and minimum values. Based on the comparison, it is determined that the value corresponding to the baseline of the one or more operating parameters exceeds the maximum value or is less than the minimum value. In response to the determination, the processing circuit either modifies the one or more operating parameters or terminates operation of the system without updating the baseline.

[0063] To obtain a baseline for use in identifying an engagement condition, and to track baselines for different patients that are free from unwanted peaks, noise, and rapping, an algorithm is described herein that quickly learns the patient and device baselines toward the start of an operation cycle and ensures that adjustments or modifications to the device's operation in a particular patient (e.g., as characterized by data in rapping condition operation sample 610) prevent or avoid a rapping condition. Separator torque data 606 is, from a computational perspective,

number

number

number

number

number

number

[0064] As an example of a calculated learning rate for the dynamic threshold 612, the value of the dynamic threshold 612 is expressed as:

number

number

number

number

number

number

[0065] To avoid peaks due to motor direction changes and noise affecting the dynamic threshold, the computer readable instructions may incorporate logic to modify the dynamic threshold function as follows:

number

number

number

number

number

number

number

number

[0066] In some embodiments, torque values ​​below a dynamic threshold are also considered to improve detection of a lap condition. For example, the following relationship may be used to provide insight into when deviations below the threshold should be considered:

number

[0067] FIG. 7 shows a graph 700 of data characterizing operating parameters when a device of the present disclosure comes into interface contact with an occlusion, according to some examples of the present disclosure. Graph 700 represents data collected regarding torque measurements as a separator device engages one or more occlusive material or other elements within the vasculature. The data in graph 700 may be used, in whole or in part, as part of or concurrently with any or all of process 800 of FIG. 8 , process 900 of FIG. 9 , process 1000 of FIG. 10 , process 1100 of FIG. 11 , process 1200 of FIG. 12 , and process 1300 of FIG. 13 . Graph 700 may be used to characterize the operation of one or more elements or components shown in or described with reference to FIGS. 1-5B .

[0068] In contrast to graph 600, graph 700 represents data samples in which a wrap state has not been achieved (e.g., based on adjustments or modifications to operating parameters of the separator device or motor). Data profile 702 represents data samples of motor torque, and data profile 706 represents a step function characterizing the direction of the motor (e.g., to achieve interface contact to remove the obstruction). Dynamic threshold 704 is calculated based on the algorithm described with reference to FIG. 6 and may be updated based on changes in data profile 702 (e.g., if data profile 702 changes from a profile similar to normal operating samples 608A and 608B to a profile similar to wrapped operating sample 610). The presence of obstructive material is detected based on data profile 702. For example, a thrombus is identified based on the presence of a data deviation 708 indicative of an increasing torque over a number of data samples.

[0069] Figure 8 is a block diagram of a process 800 for detecting various engagement conditions, according to some examples of the present disclosure. Process 800 may be performed by processing and control circuitry 108 of Figure 1. Additionally, or alternatively, process 800 may be performed in whole or in part as part of, or simultaneously with, any or all of process 900 of Figure 9, process 1000 of Figure 10, process 1100 of Figure 11, process 1200 of Figure 12, and process 1300 of Figure 13. Data characterized by one or more of graph 600 of Figure 6 or graph 700 of Figure 7 may be used as part of the execution of process 800.

[0070] At process block 802, a baseline is determined for one or more operating parameters of the separator device. The baseline is characterized by a stored, predefined, expected range that characterizes healthy blood free of one or more clots or occlusions. In some embodiments, a selected data set representative of a heterogeneous population is processed, as characterized by callout 802A. At process block 804, at least one deviation from the established one or more baseline operating parameters of the separator device is identified. The deviation from the baseline of the one or more operating parameters includes one or more changes in rotational speed, torque load, or rotational direction, as characterized by callout 804A. Additionally or alternatively, the deviation from the baseline of the one or more operating parameters includes an interruption or suspension of operation of the separator device, as characterized by callout 804B. At process block 806, it is determined that the identified at least one deviation corresponds to at least one engagement state of the separator device. As characterized by callout 806A, the engagement state includes one or more of engagement of the separator device with one or more of saline, blood solution, valve tissue, at least one thrombus, abnormal tissue mass, foreign body, plaque, or blood vessel. At process block 808, action is taken based on the above determination (e.g., modifying the torque or speed of a rotating component engaging the occlusive material or modifying the distance the separator is extended).

[0071] Figure 9 is a block diagram of a process 900 for ascertaining operating parameters of an apparatus of the present disclosure, according to some examples of the present disclosure. Process 900 may be performed by processing and control circuitry 108 of Figure 1. Additionally or alternatively, process 900 may be performed in whole or in part as part of, or concurrently with, any or all of process 800 of Figure 8, process 1000 of Figure 10, process 1100 of Figure 11, process 1200 of Figure 12, and process 1300 of Figure 13. Data characterized by one or more of graphs 600 of Figure 6 or graphs 700 of Figure 7 may be used as part of the execution of process 900.

[0072] At process block 902, the operating parameter includes torque. At process block 904, a signal including torque information for the motorized separator is received. As characterized by callout 904A, the signal may be from a sensor coupled to the motor of the motorized separator. If the torque information is from a sensor, process block 904B is used to determine that the torque information includes a value of at least one torque measurement measured by the sensor at a sampling rate. As characterized by callout 904C, in some embodiments, if the current torque measurement exceeds an amplitude threshold, the real-time baseline torque is not dynamically updated based on the current torque measurement. At process block 906, the signal is processed to calculate a baseline torque in real time. In some embodiments, process block 908 is employed immediately after process block 906. In other embodiments, process blocks 906A-906D may be employed after process block 906 but before process block 908. At process block 906A, a real-time baseline torque is determined based on one or more of a current torque measurement, a previously calculated baseline torque, or a pre-clinically derived value (e.g., stored in memory or communicatively accessible via a server). At process block 906B, the current torque measurement and the previously calculated baseline torque are weighted based on the total number of torque measurements received from the signal. At process block 906C, the previously calculated baseline torque is weighted based on a first value calculated based on an adjustment parameter and the total number of torque measurements. At process block 906D, the first value is calculated by subtracting an integer equal to 1 from the adjustment parameter divided by the total number of torque measurements. At process block 908, one or more torque measurements determined from the signal are determined to be abnormal relative to the baseline torque. At process block 910, the abnormal one or more torque measurements are distinguished as being caused by an occlusion in the blood vessel or a cause other than an occlusion (e.g., a mechanical failure of a portion of the system).

[0073] Figure 10 is a block diagram of a process 1000 for calculating an amplitude threshold, according to some examples of the present disclosure. Process 1000 may be performed by processing and control circuitry 108 of Figure 1. Additionally, or alternatively, process 1000 may be performed in whole or in part as part of, or simultaneously with, any or all of process 800 of Figure 8, process 900 of Figure 9, process 1100 of Figure 11, process 1200 of Figure 12, and process 1300 of Figure 13. Data characterized by one or more of graphs 600 of Figure 6 or graphs 700 of Figure 7 may be utilized as part of the execution of process 1000.

[0074] Decision block 1002 is used to determine whether the real-time baseline torque is dynamically updated based on the current torque measurement when the current torque measurement exceeds the amplitude threshold. If the real-time baseline torque is dynamically updated based on the current torque measurement when the current torque measurement exceeds the amplitude threshold (yes at 1002), process block 908 of process 900 is used for further processing. If the real-time baseline torque is not dynamically updated based on the current torque measurement when the current torque measurement exceeds the amplitude threshold (no at 1002), process block 1004 is used for further processing. In process block 1004, the amplitude threshold is calculated by multiplying the previously calculated baseline torque by a limit adjustment parameter (e.g., a parameter provided, identified, or determined based on one or more of system functionality, system calibration, or coded operating limits).

[0075] FIG. 11 is a block diagram of a process 1100 for determining whether a measurement of an operating parameter is anomalous compared to a baseline measurement of the operating parameter, according to some examples of the present disclosure. Process 1100 may be performed by processing and control circuitry 108 of FIG. 1. Additionally or alternatively, process 1100 may be performed in whole or in part as part of, or concurrently with, any or all of process 800 of FIG. 8, process 900 of FIG. 9, process 1000 of FIG. 10, process 1200 of FIG. 12, and process 1300 of FIG. 13. Data characterized by one or more of graphs 600 of FIG. 6 or graphs 700 of FIG. 7 may be utilized as part of the execution of process 1100.

[0076] Process 1100 is utilized when process 900 proceeds to process block 904 based on one or more conditions described with reference to FIG. 9 . At process block 1102, a dynamic threshold is determined based on the calculated baseline torque and a previously calculated baseline torque. As characterized by callout 1102A, the dynamic threshold may include an upper limit and a lower limit. Callout 1102B clarifies that the upper limit may be a multiplier of the previously calculated baseline torque. Callout 1102C clarifies that the lower limit is a multiplier of the previously calculated baseline torque. At process block 1104, at least one torque measurement is determined to be anomalous relative to the baseline torque based on comparing the value of the at least one torque measurement to the dynamic threshold.

[0077] FIG. 12 is a block diagram of a process 1200 for identifying the number of measurements to process using dynamic threshold boundaries, according to some examples of the present disclosure. Process 1200 may be performed by processing and control circuitry 108 of FIG. 1. Additionally or alternatively, process 1200 may be performed in whole or in part as part of, or concurrently with, any or all of process 800 of FIG. 8, process 900 of FIG. 9, process 1000 of FIG. 10, process 1100 of FIG. 11, and process 1300 of FIG. 13. Data characterized by one or more of graphs 600 of FIG. 6 or graphs 700 of FIG. 7 may be utilized as part of the execution of process 1200.

[0078] At process block 1202, at least one torque measurement is determined to be anomalous based on whether the value of the at least one torque measurement is greater than an upper dynamic threshold bound or less than a lower dynamic threshold bound (e.g., based on the upper and lower bounds characterized by callouts 1102B and 1102C in FIG. 11 ). At process block 1204, for two subsequent measurements that cross a dynamic threshold boundary, the number of measurements is determined, the number of measurements corresponding to the number between the two subsequent measurements. At process block 1206, the number of measurements between is compared to a threshold. As characterized by callout 1206A, the threshold is determined based on the sampling rate of a signal (e.g., a signal conveying torque data measured by a torque sensor in the system).

[0079] Figure 13 is a block diagram of a process 1300 for determining the cause of an anomalous measurement. Process 1300 may be performed by processing and control circuitry 108 of Figure 1. Additionally or alternatively, process 1300 may be performed in whole or in part as part of, or simultaneously with, any or all of process 800 of Figure 8, process 900 of Figure 9, process 1000 of Figure 10, process 1100 of Figure 11, and process 1200 of Figure 12. Data characterized by one or more of graph 600 of Figure 6 or graph 700 of Figure 7 may be utilized as part of the execution of process 1300.

[0080] Process 1300 is utilized when process 900 proceeds to process block 910 based on one or more conditions described with reference to FIG. 9 . As characterized by callout 910A, a pattern of one or more torque measurements associated with an occlusion in a blood vessel is identified and, therefore, used via process block 910 to distinguish the anomalous one or more torque measurements as being caused by the occlusion rather than other causes. Additionally or alternatively, as characterized by callout 910B, other causes than the occlusion are distinguished from the occlusion as including one or more of the following: a change in the direction of the powered separator, wrapping of the blood vessel, a valve, a blood vessel wall, fluctuations, noise, or an erroneous reading via process block 910. Each condition associated with a cause other than the occlusion is based on one or more stored or communicably accessible data ranges or patterns that are characterized so that the system can determine corrective action in response to the particular data ranges or patterns. In process block 1302, it is determined that the anomalous one or more torque measurements are caused by wrapping of the blood vessel. At process block 1304, operating parameters of the powered separator are altered in response to the determination (e.g., modifying the torque or speed of a rotating component that engages the obstructing material, or modifying the distance the separator extends).

[0081] The systems and processes described above are intended to be illustrative, not limiting. Those skilled in the art will understand that operations of the processes described herein may be omitted, modified, combined, and / or rearranged, and that additional operations may be performed without departing from the scope of the present invention. More generally, the above disclosure is intended to be illustrative, not limiting. Only the following claims are intended to set boundaries on what is covered by this disclosure. Furthermore, it should be noted that features and limitations described in any embodiment may be applied to other embodiments herein, and that flow charts or examples associated with one embodiment may be combined with other embodiments, executed in a different order, or executed in parallel in any appropriate manner. Furthermore, the systems and methods described herein may be executed in real time. It should also be noted that the above systems and / or methods may be applied to and used in accordance with other systems and / or methods.

[0082] Although some parts of this disclosure may refer to "practices" or examples, such references are merely to illustrate the context of the disclosure and do not constitute any admission as to what constitutes the state of the art.

Claims

1. 1. A method for detecting various engagement states of a separator device in a system including said separator device, said method comprising: establishing a baseline of one or more operating parameters of the separator system using processing circuitry; using the processing circuitry to identify at least one deviation from the established one or more baseline operating parameters of the separator device; using the processing circuitry to determine that the identified at least one deviation corresponds to at least one engagement state of the separator device; and using the processing circuitry to perform an action based on the determination; A method comprising:

2. establishing the baseline of one or more operating parameters includes processing a selected data set that is representative of a heterogeneous population; 10. The method of claim 1, wherein the baseline is characterized by a stored predefined expected range that characterizes healthy blood free of one or more of a clot or an occlusion.

3. establishing the baseline of one or more operating parameters comprises: retrieving from memory a data structure corresponding to stored predefined expected ranges of the one or more operating parameters, the stored predefined expected ranges characterizing healthy blood free of one or more of a thrombus or an occlusion; identifying a current operating state of the separator system, the current operating state corresponding to an observable change between the collected range of the one or more operating parameters and the stored predefined expected range of the one or more operating parameters; selecting a baseline value for the one or more operating parameters from the expected range for the one or more operating parameters based on the identified current operating condition; and modifying operation of the separator system based on the observable change, the modifying operation comprising: increasing a target operating parameter in response to detecting a blood condition that is asynchronous with a stored predefined expected range characterizing said healthy blood; or decreasing the target operating parameter in response to detecting a blood condition that is out of sync with a stored predefined expected range characterizing the healthy blood; and 10. The method of claim 1, wherein the baseline value is not affected if observable changes exceed a predefined frequency or a predefined range.

4. 10. The method of claim 1, wherein the at least one deviation from the established one or more baseline operating parameters of the separator device includes at least one of: (a) a change in one or more of rotational speed, torque load, or direction of rotation; or (b) an interruption or suspension of operation of the separator device.

5. 10. The method of claim 1, wherein the at least one engagement state of the separator device comprises the separator device engaging one or more of saline, blood solution, valve tissue, at least one thrombus, an abnormal tissue mass, a foreign body, plaque, or a blood vessel.

6. the system stores, for each production iteration of the system in a memory communicatively coupled to the processing circuit, maximum values ​​corresponding to the one or more operating values ​​and minimum values ​​corresponding to the one or more operating parameters; comparing the baseline of the one or more operating parameters to the maximum and minimum values; determining, based on the comparison, whether a value corresponding to the baseline of the one or more operating parameters exceeds the maximum value or whether the value is less than the minimum value; responsive to said determining, using said processing circuitry to one or more of: modifying said one or more operating parameters or terminating operation of said system without updating said baseline; The method of claim 1 further comprising:

7. the one or more operating parameters include torque, and establishing the baseline of the one or more operating parameters of the separator device comprises: receiving a signal containing torque information of the electric separator; and processing the signal to calculate a baseline torque in real time; The method of claim 1 , comprising:

8. identifying the at least one deviation from the established one or more baseline operating parameters of the separator device includes determining that one or more torque measurements determined from the signal are anomalous relative to the baseline torque; and the established one or more baseline operating parameters correspond to healthy blood free of one or more thrombi or occlusions, and an observable change in collected operating data is established in response to engagement between an element of the separator system and an occlusive material. The method of claim 7.

9. 9. The method of claim 8, wherein determining the at least one engagement state of the separator device comprises distinguishing whether the abnormal one or more torque measurements are caused by an obstruction in the vasculature or a cause other than an obstruction.

10. The method of claim 7 , wherein the signal is received from a sensor coupled to one or more of the motorized separator or the separator tool motor.

11. The method of claim 10 , wherein the torque information comprises at least one torque measurement measured by the sensor at a sampling rate. Luk

12. 12. The method of claim 11, wherein the real-time baseline torque is determined based on one or more of a current torque measurement, a previously calculated baseline torque, a pre-clinically derived value, or a value derived from previous clinical use.

13. The method of claim 12 , wherein the current torque measurement and the previously calculated baseline torque are weighted based on a total number of torque measurements received from the signal.

14. determining a rate of change of the torque value of the current torque measurement based on the sampling rate; and calculating a maximum calculated baseline torque and a minimum calculated baseline torque by modifying the previously calculated baseline torque based on the rate of change of torque value over a set period of time; The method of claim 12 further comprising:

15. 15. The method of claim 14, wherein a range of updated baseline torque values ​​is determined based on a comparison of the maximum calculated baseline torque and the minimum calculated baseline torque to the previously calculated baseline torque.

16. 14. The method of claim 13, wherein the previously calculated baseline torque is weighted based on a learning rate calculated based on a time period over which data corresponding to torque measurements are collected and a total number of torque measurements.

17. 17. The method of claim 16, wherein the first value is calculated by subtracting one from the adjustment parameter divided by the total number of torque measurements.

18. The method of claim 12 , wherein the real-time baseline torque is dynamically updated based on a comparison of the current torque measurement to an amplitude threshold.

19. 20. The method of claim 18, wherein the amplitude threshold is calculated by multiplying the previously calculated baseline torque by a noise limit parameter.

20. an upper limit corresponding to the amplitude threshold is modified based on the noise limit parameter; and a lower limit corresponding to the amplitude threshold is modified based on the noise limit parameter; 20. The method of claim 19.

21. 21. The method of claim 20, further comprising updating the baseline of the one or more operating parameters in response to determining that the amplitude threshold is between the upper and lower limits.

22. 21. The method of claim 20, wherein at least one engagement state of the separator is determined based on one or more of: detecting at least one pattern in operational data or lack of detecting at least one pattern in operational data over a predetermined data sampling period; in response to one or more of determining that the baseline has been updated; avoiding a change in an operational parameter or determining that the baseline has not been updated; enabling a more aggressive operational state for removal of occlusive material in response to determining that the baseline of the one or more operational parameters is between the upper and lower limits.

23. the amplitude threshold corresponds to an upper limit of the torque measurement; and The method of claim 18, wherein the real-time baseline torque is not dynamically updated if the current torque measurement exceeds the upper limit.

24. the amplitude threshold corresponds to a lower limit of the torque measurement; and The method of claim 18, wherein the real-time baseline torque is not dynamically updated if the current torque measurement is below the lower limit.

25. determining a dynamic threshold based on the calculated baseline torque and a previously calculated baseline torque; and determining that the at least one torque measurement is anomalous relative to the baseline torque based on comparing a value of the at least one torque measurement to the dynamic threshold; The method of claim 11 further comprising:

26. the dynamic threshold includes an upper bound and a lower bound; the upper bound is a multiplier of the previously calculated baseline torque; and the lower bound is a multiplier of the previously calculated baseline torque.

26. The method of claim 25.

27. determining that the at least one torque measurement is anomalous based on whether a value of the at least one torque measurement is greater than the upper bound of the dynamic threshold or less than the lower bound of the dynamic threshold; determining the number of measurements between two subsequent measurements that cross the dynamic threshold boundary; and comparing the number of measurements between with a specified upper bound; 27. The method of claim 26, further comprising:

28. 28. The method of claim 27, wherein the specified upper limit is determined based on the sampling rate of the signal.

29. distinguishing the abnormal one or more torque measurements as being caused by an obstruction in the vasculature includes identifying a pattern in the one or more torque measurements associated with the obstruction in the vasculature; and 10. The method of claim 9, wherein the pattern of the one or more torque measurements associated with the occlusion of the vasculature is outside one or more upper or lower limits of the established one or more baseline operating parameters.

30. 10. The method of claim 9, wherein the cause other than the occlusion comprises one or more of a change in direction of a powered separator, wrapping of a vessel, a valve, a vessel wall, fluctuations, noise, or an erroneous reading.

31. determining that the one or more abnormal torque measurements are caused by wrapping of a vessel; and changing operating parameters of the electric separator in response to the determination; 31. The method of claim 30, further comprising:

32. 1. A system for detecting various engagement states of a separator device of a system, said system comprising: a control circuit communicatively coupled to the separator device, the control circuit configured to send operating instructions to the separator device; and a processing circuit communicatively coupled to the control circuit, the processing circuit comprising: configured to establish a baseline of one or more operating parameters of the separator device; configured to identify at least one deviation from the established one or more baseline operating parameters of the separator device; configured to determine that the identified at least one deviation corresponds to at least one engagement state of the separator device; and a processing circuit configured to cause an action to be performed based on the determination; Including, the system.

33. the processing circuitry is further configured to process a selected data set that is representative of a heterogeneous population; and the processing circuit establishing the baseline via a stored predefined expected range that characterizes healthy blood free of one or more of a thrombus or an occlusion; 33. The system of claim 32.

34. The processing circuitry further comprises: retrieving from memory a data structure corresponding to stored predefined expected ranges of the one or more operating parameters, the stored predefined expected ranges configured to characterize healthy blood free of one or more of a thrombus or an occlusion; identifying a current operating state of the separator system, the current operating state configured to correspond to an observable change between the collected range of the one or more operating parameters and the stored predefined expected range of the one or more operating parameters; configured to select a baseline value for the one or more operating parameters from the expected range for the one or more operating parameters based on the identified current operating condition; and modifying operation of the separator system based on the observable change, the modifying operation comprising: increasing a target operating parameter in response to detecting a blood condition that is out of sync with a stored predefined expected range characterizing said healthy blood; or decreasing a target operating parameter in response to detecting a blood condition that is out of sync with a stored predefined expected range characterizing said healthy blood; and configured to include one or more of:

33. The system of claim 32, wherein the baseline value is not affected by observable changes at a predefined frequency or beyond a predefined range.

35. 33. The system of claim 32, wherein the at least one deviation from the established one or more baseline operating parameters of the separator device includes at least one of: (a) a change in one or more of rotational speed, torque load, or rotational direction, or (b) an interruption or suspension of operation of the separator device.

36. 33. The system of claim 32, wherein the at least one engagement state of the separator device comprises the separator device engaging one or more of saline, blood solution, valve tissue, at least one thrombus, an abnormal tissue mass, a foreign body, plaque, or a blood vessel.

37. the system stores, for each manufacturing iteration of the system, maximum values ​​corresponding to the one or more operating values ​​and minimum values ​​corresponding to the one or more operating parameters in a memory communicatively coupled to the processing circuitry, and the processing circuitry further configured to compare the baseline of the one or more operating parameters to the maximum and minimum values; configured to determine, based on the comparison, whether a value corresponding to the baseline of the one or more operating parameters exceeds the maximum value or whether the value is less than the minimum value; and configured, in response to the determination, to use the processing circuitry to one or more of: modify the one or more operating parameters or terminate operation of the system without updating the baseline.

33. The system of claim 32.

38. the one or more operating parameters include torque, and the processing circuit configured to establish the baseline of the one or more operating parameters of the separator device further comprises: configured to receive a signal containing torque information of the electric separator; and 33. The system of claim 32, configured to process the signal to calculate a baseline torque in real time.

39. the processing circuitry configured to identify the at least one deviation from the established one or more baseline operating parameters of the separator device is further configured to determine that one or more torque measurements determined from the signal are anomalous with respect to the baseline torque; and 33. The system of claim 32, wherein the established one or more baseline operating parameters correspond to healthy blood free of one or more thrombi or occlusions, and an observable change in collected operating data is established in response to engagement between an element of the separator system and occlusive material.

40. 40. The system of claim 39, wherein the processing circuit configured to determine the at least one engagement state of the separator device is further configured to distinguish whether the abnormal one or more torque measurements are caused by an obstruction in the vasculature or a cause other than an obstruction.

41. 39. The system of claim 38, wherein the signal is received by the processing circuit from a sensor communicatively coupled to a motor of the electrically driven separator and to the processing circuit.

42. 42. The system of claim 41, wherein the torque information comprises at least one torque measurement measured by the sensor at a sampling rate.

43. 43. The system of claim 42, wherein the real-time baseline torque is determined by the processing circuitry based on one or more of a current torque measurement, a previously calculated baseline torque, a pre-clinically derived value, or a value derived from previous clinical use.

44. 44. The system of claim 43, wherein the current torque measurement and the previously calculated baseline torque are weighted by the processing circuitry based on a total number of torque measurements received from the signal.

45. The processing circuitry further comprises: configured to determine a rate of change of the torque value of the current torque measurement based on the sampling rate; and and calculating a maximum calculated baseline torque and a minimum calculated baseline torque by modifying a previously calculated baseline torque based on a rate of change of the torque value over a set period of time.

44. The system of claim 43.

46. 46. ​​The system of claim 45, wherein the processing circuitry is configured to determine a range of updated baseline torque values ​​based on a comparison of the maximum and minimum calculated baseline torques to the previously calculated baseline torques.

47. 47. The system of claim 46, wherein the previously calculated baseline torque is weighted by the processing circuitry based on a learning rate calculated based on a period of time over which data corresponding to torque measurements is collected and the total number of torque measurements.

48. 48. The system of claim 47, wherein the first value is calculated by the processing circuitry by subtracting one from the adjustment parameter divided by the total number of torque measurements.

49. 44. The system of claim 43, wherein the real-time baseline torque is dynamically updated using the processing circuitry based on a comparison of the current torque measurement to an amplitude threshold.

50. 50. The system of claim 49, wherein the amplitude threshold is calculated using the processing circuitry based on the previously calculated baseline torque multiplied by a noise limit parameter.

51. the processing circuitry modifies an upper limit corresponding to the amplitude threshold based on the noise limit parameter; and 51. The system of claim 50, wherein the processing circuitry modifies a lower limit corresponding to the amplitude threshold based on the noise limit parameter.

52. 52. The system of claim 51 , wherein the processing circuitry updates the baseline of the one or more operating parameters using the amplitude threshold in response to determining that the baseline of the one or more operating parameters is between the upper limit and the lower limit.

53. 52. The system of claim 51, wherein the processing circuit determines the at least one engagement state of the separator based on one or more of: detecting at least one pattern in operational data over a predetermined data sampling period, or not detecting the at least one pattern in operational data, in response to one or more of: determining that the baseline has been updated; avoiding changing an operating parameter or determining that the baseline has not been updated; enabling a more aggressive operating state for removal of occlusive material in response to determining that the baseline of the one or more operating parameters is between the upper and lower limits.

54. the amplitude threshold corresponds to an upper limit of the torque measurement; and 50. The system of claim 49, wherein the processing circuitry does not dynamically update the real-time baseline torque if the current torque measurement exceeds the upper limit.

55. the amplitude threshold corresponds to a lower limit of the torque measurement; and 50. The system of claim 49, wherein the processing circuitry does not dynamically update the real-time baseline torque if the current torque measurement is below the lower limit.

56. The processing circuitry further comprises: configured to determine a dynamic threshold based on the calculated baseline torque and a previously calculated baseline torque; and the at least one torque measurement is configured to be determined to be anomalous relative to the baseline torque based on comparing a value of the at least one torque measurement to the dynamic threshold.

43. The system of claim 42.

57. the dynamic threshold includes an upper bound and a lower bound; the upper bound is a multiplier of the previously calculated baseline torque; and the lower bound is a multiplier of the previously calculated baseline torque.

57. The system of claim 56.

58. The processing circuitry further comprises: determining that the at least one torque measurement is abnormal based on whether a value of the at least one torque measurement is greater than the upper bound of the dynamic threshold or less than the lower bound of the dynamic threshold; configured to determine the number of measurements between two consecutive measurements that cross the dynamic threshold boundary; and configured to compare the number of measurements therebetween to a specified upper limit; 58. The system of claim 57.

59. 59. The system of claim 58, wherein the specified upper limit is determined by the processing circuitry based on the sampling rate of the signal.

60. the processing circuitry configured to distinguish the anomalous one or more torque measurements as being caused by the occlusion of the vasculature is further configured to identify a pattern in the one or more torque measurements associated with the occlusion of the vasculature; and the processing circuitry is configured to determine that the pattern of the one or more torque measurements associated with the occlusion in the vasculature falls outside one or more of upper or lower limits of the established one or more baseline operating parameters.

41. The system of claim 40.

61. 41. The system of claim 40, wherein the cause other than the occlusion comprises one or more of a change in orientation of the powered separator, a wrapping of a vessel, a valve, a vessel wall, fluctuations, noise, or an erroneous reading.

62. the processing circuitry further configured to determine that the one or more abnormal torque measurements are caused by wrapping of a vessel; and and changing an operating parameter of the electric separator in response to the determination.

62. The system of claim 61.

63. A non-transitory computer-readable medium having non-transitory computer-readable instructions encoded thereon that, when executed by control circuitry, cause the control circuitry to: establishing a baseline of one or more operating parameters of the separator device; identifying at least one deviation from the established one or more baseline operating parameters of the separator device; determining that the identified at least one deviation corresponds to at least one engagement state of the separator device; and performing an action based on said determination. A non-transitory computer-readable medium for causing

64. The instructions to the control circuitry further include: Processing a selection dataset that is representative of a heterogeneous population; and Establishing said baseline via stored predefined expected ranges that characterize healthy blood free of one or more of a clot or an occlusion.

64. The non-transitory computer-readable medium of claim 63,

65. The instructions to the control circuitry further include: retrieving from memory a data structure corresponding to the stored predefined expected ranges of the one or more operating parameters; identifying a current operating state of the separator system, the current operating state corresponding to an observable change between the collected range of the one or more operating parameters and the stored predefined expected range of the one or more operating parameters; selecting a baseline value for the one or more operating parameters from the expected range for the one or more operating parameters based on the identified current operating condition; and modifying operation of the separator system based on the observable change, the modifying operation comprising: increasing a target operating parameter in response to detecting a blood condition that is out of sync with a stored predefined expected range characterizing said healthy blood; or decreasing a target operating parameter in response to detecting a blood condition that is out of sync with a stored predefined expected range characterizing said healthy blood; Modifying, including one or more of Let them do this, 64. The non-transitory computer-readable medium of claim 63, wherein the baseline value is not affected by observable changes that exceed a predefined frequency or a predefined range.

66. 64. The non-transitory computer-readable medium of claim 63, wherein the at least one deviation from the established one or more baseline operating parameters of the separator device includes at least one of: (a) a change in one or more of rotational speed, torque load, or rotational direction; or (b) an interruption or suspension of operation of the separator device.

67. 64. The non-transitory computer-readable medium of claim 63, wherein at least one engagement state of the separator device comprises engagement of the separator device with one or more of saline, blood solution, valve tissue, at least one thrombus, abnormal tissue mass, foreign body, plaque, or blood vessel.

68. the instructions cause a system communicatively coupled to the control circuit to store in a memory, for each production iteration of the system, maximum values ​​corresponding to the one or more operating values ​​and minimum values ​​corresponding to the one or more operating parameters, and the instructions further cause the control circuit to: comparing the baseline of the one or more operating parameters to the maximum and minimum values; determining, based on the comparison, whether a value corresponding to the baseline of the one or more operating parameters exceeds the maximum value or whether the value is less than the minimum value; in response to the determination, causing one or more of modifying the one or more operating parameters or terminating operation of the system without updating the baseline; 64. The non-transitory computer-readable medium of claim 63,

69. the one or more operating parameters include torque, the instructions being sent to the control circuit, and receiving a signal containing torque information of the electric separator; processing said signal to calculate a baseline torque in real time; 64. The non-transitory computer-readable medium of claim 63,

70. The instructions to the control circuitry further include: identifying the at least one deviation from the established one or more baseline operating parameters of the separator device further configured to determine that one or more torque measurements determined from the signal are anomalous relative to the baseline torque; and obtaining the established one or more baseline operating parameters, the established one or more baseline operating parameters corresponding to healthy blood free of one or more of a thrombus or an occlusion, and an observable change in collected operating data being established in response to engagement between an element of the separator system and an occlusion material; 70. The non-transitory computer-readable medium of claim 69,

71. 71. The non-transitory computer-readable medium of claim 70, wherein the instructions further cause the control circuitry to distinguish whether the abnormal one or more torque measurements are caused by an obstruction in the vasculature or by a cause other than an obstruction.

72. 70. The non-transitory computer-readable medium of claim 69, wherein the instructions cause the signal to be received by the control circuit from a sensor communicatively coupled to a motor of the electrically driven separator and the control circuit.

73. 73. The non-transitory computer-readable medium of claim 72, wherein the torque information comprises at least one torque measurement measured by the sensor at a sampling rate.

74. 74. The non-transitory computer-readable medium of claim 73, wherein the instructions cause the control circuitry to determine the real-time baseline torque based on one or more of a current torque measurement, a previously calculated baseline torque, a pre-clinically derived value, or a value derived from previous clinical use.

75. 75. The non-transitory computer-readable medium of claim 74, wherein the instructions cause the control circuitry to weight the current torque measurement and the previously calculated baseline torque based on a total number of torque measurements received from the signal.

76. The instructions cause the control circuit to: determining a rate of change of the torque value of the current torque measurement based on the sampling rate; and calculating a maximum calculated baseline torque and a minimum calculated baseline torque by modifying the previously calculated baseline torque based on the rate of change of torque value over a set period of time; 75. The non-transitory computer-readable medium of claim 74.

77. 77. The non-transitory computer-readable medium of claim 76, wherein the instructions cause the control circuitry to determine a range of updated baseline torque values ​​based on a comparison of the maximum calculated baseline torque and the minimum calculated baseline torque to the previously calculated baseline torque.

78. 78. The non-transitory computer-readable medium of claim 77, wherein the instructions cause the control circuitry to apply a weight to a previously calculated baseline torque based on a first value calculated based on an adjustment parameter and the total number of torque measurements.

79. 79. The non-transitory computer-readable medium of claim 78, wherein the instructions cause the control circuit to calculate a first value by subtracting one from the adjustment parameter divided by the total number of torque measurements.

80. 75. The non-transitory computer-readable medium of claim 74, wherein the instructions prevent the control circuit from dynamically updating the real-time baseline torque based on the current torque measurement if the current torque measurement exceeds an amplitude threshold.

81. 81. The non-transitory computer-readable medium of claim 80, wherein the instructions cause the control circuitry to calculate the amplitude threshold based on the previously calculated baseline torque multiplied by a noise limit parameter.

82. The instructions cause the control circuit to: modifying an upper limit value corresponding to the amplitude threshold based on the noise limit parameter; and modifying a lower limit value corresponding to the amplitude threshold based on the noise limit parameter; 82. The non-transitory computer-readable medium of claim 81,

83. 83. The non-transitory computer-readable medium of claim 82, wherein the instructions cause the control circuitry to further update the baseline of the one or more operating parameters utilizing the amplitude threshold in response to determining that the baseline of the one or more operating parameters is between the upper limit and the lower limit.

84. 83. The non-transitory computer-readable medium of claim 82, wherein the instructions cause the control circuitry to determine the at least one engagement state of the separator based on one or more of: detecting at least one pattern in operational data over a predetermined data sampling period or not detecting the at least one pattern in operational data in response to one or more of: determining that the baseline has been updated; avoiding changing an operating parameter or determining that the baseline has not been updated; enabling a more aggressive operating state for occlusion material removal in response to determining that the baseline of the one or more operating parameters is between the upper and lower limits.

85. the amplitude threshold corresponds to an upper limit of the torque measurement; and 81. The non-transitory computer-readable medium of claim 80, wherein the instructions cause the control circuitry not to dynamically update the real-time baseline torque if the current torque measurement exceeds the upper limit.

86. the amplitude threshold corresponds to a lower limit of the torque measurement; and 81. The non-transitory computer-readable medium of claim 80, wherein the instructions cause the control circuitry not to dynamically update the real-time baseline torque if the current torque measurement is below the lower limit.

87. The instructions to the control circuitry further include: determining a dynamic threshold based on the calculated baseline torque and a previously calculated baseline torque; and 74. The non-transitory computer-readable medium of claim 73, wherein the at least one torque measurement is determined to be anomalous relative to the baseline torque based on comparing the at least one torque measurement to the dynamic threshold.

88. the dynamic threshold includes an upper bound and a lower bound; the upper bound is a multiplier of the previously calculated baseline torque; and the lower bound being a multiplier of the previously calculated baseline torque; 88. The non-transitory computer-readable medium of claim 87.

89. The instructions to the control circuitry further include: determining that the at least one torque measurement is abnormal based on whether a value of the at least one torque measurement is greater than the upper bound of the dynamic threshold or less than the lower bound of the dynamic threshold; determining the number of measurements between two subsequent measurements that cross the dynamic threshold boundary; and comparing the number of measurements between them to a threshold value; 90. The non-transitory computer-readable medium of claim 88, further comprising:

90. 90. The non-transitory computer-readable medium of claim 89, wherein the instructions cause the control circuitry to further determine the threshold value based on the sampling rate of the signal.

91. The instructions to the control circuitry further include: identifying a pattern in the one or more torque measurements associated with the occlusion of the vasculature; and determining that the pattern of the one or more torque measurements associated with the occlusion of the vasculature is outside one or more upper or lower limits of the established one or more baseline operating parameters; 72. The non-transitory computer-readable medium of claim 71,

92. 72. The non-transitory computer readable medium of claim 71, wherein the cause other than the occlusion comprises one or more of a change in direction of the powered separator, wrapping of a vessel, a valve, a vessel wall, fluctuations, noise, or an erroneous reading.

93. The instructions to the control circuitry further include: determining that the abnormal one or more torque measurements are caused by wrapping of a vessel; and changing operating parameters of the electric separator in response to the determination; 93. The non-transitory computer-readable medium of claim 92,

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