Control computing system and system for thrombus aspiration

Abstract

A control computing system and a system for thrombus aspiration. A system for thrombus aspiration includes positioning a catheter lumen in a first position relative to a thrombus, the catheter lumen defined by a catheter, initiating evacuation of the lumen, where the lumen is not in fluid communication with the catheter lumen, determining that a pressure within the lumen is equal to or less than a target aspiration pressure, and in response to determining that the pressure within the lumen is equal to or less than the target aspiration pressure, automatically establishing fluid communication between the lumen and the catheter lumen.

Description

[0001] This is a divisional application. The parent application is entitled "System and Method for Thrombus Aspiration", filed on September 8, 2023, with application number 202322450197.6. Technical Field

[0002] This utility model relates to a control computing system and a system for thrombus aspiration. Background Technology

[0003] As used herein, the term elongated medical device (EMD) refers to, but is not limited to, catheters (e.g., guide catheters, microcatheters, aspiration catheters, balloon / stent catheters), wire-based devices (e.g., guidewires, microwires, embolization coils, stent retrieval devices, etc.), and medical devices comprising any combination of the foregoing. Generally, EMDs can be used in many minimally invasive medical procedures. Such procedures facilitate the diagnosis and treatment of a wide range of vascular system diseases and include neurovascular interventional (NVI) procedures, percutaneous coronary intervention (PCI), and peripheral vascular intervention (PVI). Generally, these procedures involve navigating a guidewire through the patient's vascular system and advancing a working catheter via the guidewire to deliver therapy.

[0004] The catheter insertion procedure begins by gaining access to the appropriate vessel (such as an artery or vein) through the insertion of a sheath. Next, for example, a diagnostic guidewire is advanced within the sheath to a primary location, such as the internal carotid artery (in NVI), the coronary ostium (in PCI), or the superficial femoral artery (in PVI). A guiding catheter is then advanced over the diagnostic guidewire to the primary location. The diagnostic guidewire is removed, and a guidewire suitable for navigation through the target vascular system is then advanced through the guiding catheter to the target location within the vascular system (e.g., a lesion, thrombus). In some cases, such as in the presence of tortuous anatomy, a support catheter or microcatheter is inserted over the guidewire to assist in guiding its passage.

[0005] To navigate a guidewire or guidewire / microcatheter towards a target location, the physician advances the guidewire or guidewire / microcatheter while manipulating its proximal end, guiding the distal end along the path to the target location into the appropriate vascular branch while avoiding advancement into other vascular branches. Prior to this procedure, the physician can use an imaging system (e.g., a fluorescein microscope) to obtain successive contrast-enhanced images of the patient's vascular system and can select one of these images as a route map to navigate the guidewire or guidewire / microcatheter to the target location. Contrast-enhanced images are also obtained while the physician is navigating the guidewire or guidewire / microcatheter, allowing the physician to verify that the device is moving along the correct path to the target location.

[0006] Catheter-based robotic procedure systems facilitate this process by supporting and physically manipulating each guidewire and catheter as desired by the physician. For example, a catheter-based robotic procedure system can hold the guidewire and includes mechanical components to advance, retract, and rotate it in response to physician commands. Physicians can provide such commands via input devices mounted to the console (e.g., joysticks, buttons, wheels, touchscreens). These input devices can allow physicians to select one or more guidewires and / or catheters to be controlled at a given time. Thus, catheter-based robotic procedure systems can provide better control and accuracy than purely manual catheter insertion procedures. Furthermore, the console, and therefore the physician, is protected from X-rays emitted by an imaging system used to track the position of the guidewire and / or catheter during the procedure.

[0007] Catheter-based robotic procedural systems can be used to assist physicians in performing catheter insertion procedures such as NVI, PCI, and PVI. Examples of robot-assisted NVI procedures include coil embolization of aneurysms, fluid embolization of arteriovenous malformations, and mechanical thrombectomy for large vessel occlusion in cases of acute ischemic stroke. In such NVI procedures, the physician uses a robotic system to gain access to the lesion by manipulating a neurovascular guidewire and a microcatheter to deliver a therapy that restores normal blood flow. Sheaths or guide catheters, as described above, are used to provide access, but intermediate catheters may also be needed to provide additional distal areas and / or adequate support for the microcatheter and guidewire. Depending on the type of lesion and the treatment, the distal end of the guidewire is navigated into or across the lesion. To treat an aneurysm, a microcatheter is advanced into the lesion, the guidewire is removed, and several coils are deployed into the aneurysm via the microcatheter. The aneurysm is then embolized using the coils. To treat an arteriovenous malformation, a fluid embolization is injected into the malformation via the microcatheter.

[0008] In conventional mechanical thrombectomy, aspiration can be used to treat vascular occlusion. Aspiration can be performed directly through the aforementioned microcatheter or using a larger diameter aspiration catheter. Once the microcatheter or aspiration catheter has been guided to the occluded thrombus, the aspiration pump connected to it is activated to generate negative pressure, which draws the thrombus into the catheter. Conventional aspiration systems can take a significant amount of time to completely remove the thrombus from the vessel. Furthermore, the time it takes for a conventional system to generate and apply negative pressure may be longer than the time required to remove the thrombus. Any of these drawbacks increases the risk of injury to the vascular system and / or the aspiration pump. It is desirable to use catheter-based robotic procedures to improve the efficiency, effectiveness, and / or safety of mechanical thrombectomy. Utility Model Content

[0009] According to a first aspect, a control calculation system is provided for controlling pressure within a catheter lumen of a catheter-based robotic programming system, wherein the control calculation system comprises: a control calculation system configured to: provide a first command to a robot actuator to position the catheter lumen relative to a thrombus, the catheter lumen being defined by the catheter; provide a second command to initiate the emptying of the lumen, wherein the lumen is in fluid communication with the catheter lumen without the aid of a vacuum control; determine that the pressure within the lumen is equal to or less than a target aspiration pressure; and, in response to determining that the pressure within the lumen is equal to or less than the target aspiration pressure, establish fluid communication between the lumen and the catheter lumen via a vacuum control.

[0010] According to a second aspect, a system for thrombus aspiration is provided, wherein the system includes: a vacuum source; a conduit defining a lumen, the lumen being in fluid communication with the vacuum source and the catheter via a valve, wherein the valve is configured to open and close, wherein the conduit defines a catheter lumen; a pressure sensor configured to determine pressure within the lumen; and a catheter control configured to navigate the catheter within a blood vessel and reach the thrombus.

[0011] According to a third aspect, a system is provided, comprising: a conduit defining a lumen, a first end of which is in fluid communication with a vacuum source; a vacuum control in fluid communication with a second end of the lumen and the first end of the conduit defining the lumen; a pressure sensor for determining a pressure within the lumen; and a control unit configured to: control the vacuum control such that the lumen is not in fluid communication with the conduit lumen; receive the determined pressure from the pressure sensor and determine that the pressure within the lumen is equal to or less than a target suction pressure; and automatically control the vacuum control to establish fluid communication between the lumen and the conduit lumen in response to determining that the pressure within the lumen is equal to or less than the target suction pressure. Attached Figure Description

[0012] Figure 1 This is a perspective view of a duct-based robotic programming system according to some embodiments.

[0013] Figure 2 This is a schematic block diagram of a duct-based robotic programming system according to some embodiments.

[0014] Figure 3 This is a perspective view of a robot actuator of a conduit-based robot program system according to an embodiment.

[0015] Figure 4 This is a schematic diagram of a thrombectomy system according to some embodiments.

[0016] Figure 5 This is a schematic diagram of a thrombectomy system according to some embodiments.

[0017] Figure 6This is a schematic diagram of a thrombectomy system according to some embodiments.

[0018] Figure 7 This is a schematic diagram of a thrombectomy system according to some embodiments.

[0019] Figure 8 This is a schematic diagram of a thrombectomy system according to some embodiments.

[0020] Figure 9 This is a flowchart of a thrombectomy procedure according to some embodiments.

[0021] Figure 10 This is a cross-sectional view of a vessel exposing stacked EMDs during a thrombectomy procedure, according to some embodiments.

[0022] Figure 11 This is a flowchart of a thrombectomy procedure according to some embodiments.

[0023] Figure 12a and 12b Includes flowcharts of thrombectomy procedures according to some embodiments.

[0024] Figure 13a and 13b Includes flowcharts of thrombectomy procedures according to some embodiments. Detailed Implementation

[0025] The following description is provided to enable any person skilled in the art to make and use the described embodiments. Various modifications will still be apparent to those skilled in the art.

[0026] In some embodiments, thrombus aspiration is initiated only after it has been determined that the aspiration (i.e., vacuum) source has reached a threshold negative pressure. Such initiation increases removal efficiency and results in faster thrombus removal in many instances.

[0027] In one example, the lumen of the aspiration catheter, defined by the aspiration catheter, is positioned relative to a first location of the thrombus. Drainage of the lumen, which is not in fluid communication with the aspiration catheter lumen, is then initiated. After a period of time, it is determined that the pressure within the lumen is equal to or less than the target aspiration pressure. In response to determining that the pressure within the lumen is equal to or less than the target aspiration pressure, fluid communication is automatically established between the lumen and the aspiration catheter lumen (e.g., by opening a valve, by releasing a clamp). Such a process can be used to drain the thrombus faster than in other ways. In some aspects, the operator is notified that the pressure within the lumen is equal to or less than the target aspiration pressure, and the operator transmits a command to automatically establish fluid communication between the lumen and the aspiration catheter lumen.

[0028] The embodiment can further determine whether the pressure within the lumen is greater than a second pressure, and if it is determined that the pressure within the lumen is greater than the second pressure, automatically terminate (e.g., by closing a valve, by engaging a clamp) the fluid communication between the lumen and the aspiration catheter lumen. These aspects can minimize the aspiration time to the actual time required to remove the thrombus.

[0029] Similarly, some aspects include presenting the operator with an indication that the pressure inside the lumen is greater than a second pressure. After the indication is presented, and when the pressure inside the lumen is greater than the second pressure, in response to a command received from the operator, the fluid communication between the lumen and the aspiration catheter lumen is automatically terminated.

[0030] The embodiment may also include repositioning the aspiration catheter during the procedure if necessary to maintain the proper position of the aspiration catheter tip relative to the thrombus surface. For example, after automatically establishing fluid communication between the lumen and the aspiration catheter, and before determining whether the pressure within the lumen is greater than a second pressure, it is determined whether the pressure within the lumen is within a predefined range. If the pressure within the lumen is determined to be within the predefined range, the position of the aspiration catheter lumen is automatically adjusted until the pressure within the lumen is less than a threshold aspiration pressure.

[0031] Figure 1 This is a perspective view of a catheter-based procedural system 10 according to some embodiments. The catheter-based procedural system 10 can be used to perform catheter-based medical procedures, such as percutaneous interventional procedures, such as PCI (e.g., treatment of STEMI), NVI (e.g., treatment of emergency large vessel occlusion (ELVO)), and PVI (e.g., for severe limb ischemia (CLI)). Catheter-based medical procedures may include diagnostic catheter insertion procedures during which one or more catheters or other EMDs are used to aid in the diagnosis of a patient's condition. In one example, a contrast agent may be injected into one or more arteries via a catheter, and images of the patient's vascular system may be acquired while the contrast agent resides therein.

[0032] Catheter-based medical procedures may also include catheter-based therapeutic procedures (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, thrombus removal, treatment of arteriovenous malformations, aneurysm treatment), wherein a catheter (or other EMD) is used to treat the disease. The specific type or nature of the EMD used in a catheter-based medical procedure is selected based on the type of procedure to be performed. The catheter-based procedure system 10 can be adapted to perform any number of catheter-based medical procedures to suit the specific EMD to be used in the procedure, using necessary adjustments.

[0033] The catheter-based procedure system 10 includes, among other components, a bedside unit 20 and a control station 26. The bedside unit 20 includes a robot actuator 24 and a positioning system 22 located adjacent to the patient 12. The patient 12 is supported on a patient table 18. The positioning system 22 is used to position and support the robot actuator 24. The positioning system 22 can be, for example, a robotic arm, an articulated arm, a retainer, etc. The positioning system 22 can be attached at one end to, for example, a rail, base, or trolley on the patient table 18. The other end of the positioning system 22 is attached to the robot actuator 24. The positioning system 22 can be removed (along with the robot actuator 24) to allow the patient 12 to be placed on the patient table 18.

[0034] Once the patient 12 is positioned on the patient table 18, the positioning system 22 can be used to position or position the robot actuator 24 relative to the patient 12 for procedure. In some embodiments, the patient table 18 is operatively supported by a base 17 fixed to the floor and / or ground. The patient table 18 is capable of movement relative to the base 17 in multiple degrees of freedom, such as roll, pitch, and yaw. The bedside unit 20 may also include operator controls and a display (not shown). For example, such controls and a display may be located on the housing of the robot actuator 24.

[0035] The term "front" in this document refers to the side of the robot actuator 24 facing the patient 12 and away from the positioning system 22, while the term "rear" refers to the side of the robot actuator 24 closest to the positioning system 22. The terms "top," "upper," and "upper" refer to the approximate direction away from the direction of gravity, while the terms "bottom," "lower," and "lower" refer to the approximate direction of gravity.

[0036] Generally, the robot actuator 24 may be equipped with appropriate EMDs and associated accessories (e.g., embolization coils, fluid embolization devices, aspiration pumps, contrast agent injection systems, medications, hemostatic valve adapters, syringes, stopcocks, inflation devices, etc.) to allow the operator 11 to perform catheter-based medical procedures via various controls of the operating control system, such as controls and inputs located at control station 26. The bedside unit 20, and particularly the robot actuator 24, may include any number of components and / or combinations of components to provide the functionality described herein to the bedside unit 20.

[0037] The robotic actuator 24 includes multiple device modules 32, each of which can be controlled to drive its corresponding EMD. Furthermore, each device module 32 can be controlled to move linearly toward and away from the patient 12. In some embodiments, the robotic actuator 24 can control one or more device modules 32 to feed a guidewire into a diagnostic catheter and a guide catheter in an artery of the patient 12. The EMD enters the patient 12's body (e.g., a blood vessel) at insertion point 16 via, for example, a guide sheath.

[0038] Bedside unit 20 communicates with control station 26, allowing signals generated by controls on control station 26 to be transmitted wirelessly or via hardwired to bedside unit 20 to control various functions of bedside unit 20, including the functions of robot actuator 24. As discussed below, control station 26 may include control computing system 34 ( Figure 2 (as shown in the diagram), or coupled to the bedside unit 20 via the control computing system 34. The bedside unit 20 can also provide feedback signals (e.g., load, speed, operating conditions, warning signals, error codes, etc.) to the control station 26, the control computing system 34, or both. Communication between the control computing system 34 and the various components of the catheter-based program system 10 can be provided via a communication link, which can be a wireless connection, a cable connection, or any other component that allows communication between components. The control station 26 or other similar control system can be located locally on or away from the robot driver 24.

[0039] The term "local" refers to the location of patient 12 and bedside unit 20. The term "remote" refers to a location where physical access to bedside unit 20 and / or patient 12 is not readily available. The catheterization procedure system 10 can be operated by a control station 26 at a local site, a control station 26 at a remote site, or both simultaneously. At the local site, the operator 11 and control station 26 are located in the same room as patient 12 and bedside unit 20, or in an adjacent room.

[0040] The control station 26 (and control computing system) at the remote site can communicate with the bedside unit 20 and / or control computing system at the local site using communication systems and services, such as via the Internet. In some embodiments, the remote site and the local site are in different rooms of the same building, different buildings in the same city, different cities, or other different locations, wherein the remote site does not provide substantially immediate physical access to the bedside unit 20 and / or the patient 12.

[0041] Control station 26 generally includes one or more input systems 28, which include controls configured to receive user manipulations for controlling robot actuator 24 and / or various other components or systems of catheter-based procedure system 10. In the illustrated embodiment, control station 26 allows operator 11 to control bedside unit 20 to perform catheter-based medical procedures. For example, input system 28 may be configured to cause bedside unit 20 to perform various diagnostic or interventional procedures using an EMD controlled by the drive mechanism of robot actuator 24 (e.g., advancing, retracting, or rotating guidewires; advancing, retracting, or rotating catheters; inflating or deflating balloons located on catheters; positioning and / or deploying stents; positioning and / or deploying stent retrieval devices; positioning and / or deploying coils; injecting contrast agents into catheters; injecting fluid embolisms into catheters; injecting medications or saline into catheters; aspiration on catheters).

[0042] One or more input systems 28 may include one or more touchscreens, joysticks, scroll wheels, and / or buttons. In addition to input systems 28, control station 26 may use additional user controls 44, such as foot switches and microphones for voice commands. Input systems 28 may be configured to instruct the advance, retraction, and / or rotation of the EMD, as well as the activation or deactivation of various components, including pumps, valves, switches, clamps, etc.

[0043] One or more input systems 28 may include device selection buttons to allow operator 11 to select which EMDs loaded into robot drive 24 are controlled via user manipulation of input controls from one or more input systems 28. An automatic routine button may be selected to implement algorithmic movement of the EMDs without requiring separate direct commands from operator 11. In some embodiments, input system 28 may include one or more controls or icons (not shown) displayed on a touchscreen (e.g., display 30) that, when activated, cause operation of components of the conduit-based program system 10.

[0044] Display 30 can be configured to display information or patient-specific data to operator 11 located at control station 26. In some embodiments, control station 26 may include two or more displays 30. For example, displays 30 may be configured to display image data (e.g., X-ray images, MRI images, CT images, ultrasound images), hemodynamic data (e.g., blood pressure, heart rate), patient record information (e.g., medical history, age, weight), lesion or treatment assessment data (e.g., intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR)). Furthermore, displays 30 may be configured to display procedure-specific information (e.g., procedure list, recommendations, procedure duration, catheter or guidewire position, aspiration vacuum level, volume of delivered medication or contrast agent). Additionally, displays 30 may be configured to display information to provide functionality associated with the control computing system, as described below. Display 30 may include a touchscreen and therefore may include an input device for system 10.

[0045] The catheter-based procedure system 10 also includes an imaging system 14. The imaging system 14 can be any medical imaging system that can be used in conjunction with catheter-based medical procedures (e.g., non-digital X-ray, digital X-ray, CT, MRI, ultrasound). In some embodiments, the imaging system 14 is a digital X-ray imaging device that communicates with a control station 26. The imaging system 14 may include a C-arm that allows the imaging system 14 to rotate partially or completely around the patient 12 to obtain images (e.g., sagittal view, tail view, anterior-posterior view) at different angular positions relative to the patient 12. In some embodiments, the imaging system 14 is a fluoroscopic system including a C-arm with an X-ray source 13 and a detector 15, also referred to as an image intensifier.

[0046] Imaging system 14 can be configured to acquire X-ray images of appropriate areas of the patient 12 during procedures. For example, imaging system 14 can be configured to acquire one or more X-ray images of the head to diagnose neurovascular conditions. Imaging system 14 can also be configured to acquire one or more X-ray images (e.g., real-time images) during catheter-based procedures to assist operator 11 in correctly positioning guidewires, guiding catheters, microcatheters, stent retrieval devices, coils, stents, balloons, etc., during procedures. The acquired images(s) can be displayed on display 30. For example, images can be displayed on display 30 to allow operator 11 to accurately move the tip of the aspiration catheter to a location adjacent to a thrombus.

[0047] This leads to the introduction of a Cartesian coordinate system, comprising the X, Y, and Z axes. The positive X-axis is oriented longitudinally (axially) in the distal direction, i.e., from the proximal end to the distal end. The Y and Z axes lie in the transverse plane of the X-axis, with the positive Z-axis oriented upwards, i.e., in the direction opposite to gravity, and the Y-axis oriented accordingly based on the right-hand rule.

[0048] Figure 2 This is a block diagram of a catheter-based programming system 10 according to an exemplary embodiment. The catheter-based programming system 10 may include a control computing system 34. The control computing system 34 may physically be, for example, part of a control station 26. The control computing system 34 generally includes a computer processing unit adapted to control the catheter-based programming system 10 as described herein. For example, the control computing system 34 may be an embedded system, a dedicated circuit, a general-purpose processor executing program code, etc. The control computing system 34 communicates with the bedside unit 20, communication systems and services 36 (e.g., the Internet, firewall, cloud services, session manager, hospital network), local control station 38, additional communication systems 40 (e.g., telepresence system), remote control station and computing system 42, and patient sensors 56 (e.g., electrocardiogram (ECG) device, electroencephalogram (EEG) device, blood pressure monitor, temperature monitor, heart rate monitor, respiratory monitor). The control computing system 34 can also communicate with the imaging system 14, the patient table 18, the additional medical system 50, the contrast agent injection system 52, and the auxiliary equipment 54 (e.g., IVUS, OCT, FFR).

[0049] As described above, the bedside unit 20 includes a robot actuator 24, a positioning system 22, and additional controls and a display 46. The additional controls and display 46 may be located on the housing of the robot actuator 24. Interventional devices and accessories 48 (e.g., guidewires, catheters) are connected to the bedside system 20. In some embodiments, the interventional devices and accessories 48 may include specialized devices (e.g., IVUS catheters, OCT catheters, FFR lines, diagnostic catheters for comparison) that are connected to their respective accessory devices 54 (e.g., IVUS systems, OCT systems, FFR systems).

[0050] In various embodiments, the control computing system 34 is configured to receive and generate control signals based on user control manipulation of one or more input systems 28 of the local control station 38. The remote control station and computing system 42 may include components similar to the local control station 38. The remote control station 42 and the local control station 38 may be different and customized based on their required functionality. Additional user controls 44 may include, for example, one or more foot pedal input controls. The foot pedal input controls may be configured to allow the operator to select functions of the imaging system 14, such as turning the X-ray source on and off and scrolling through different stored images. In another embodiment, the foot pedal input may be configured to allow the operator to select which EMDs are mapped to which controls of the input system 28. Additional communication systems 40 (e.g., audio conferencing, video conferencing, telepresence) may be employed to assist the operator in interacting with patients, medical personnel (e.g., vascular kit personnel), and / or bedside equipment.

[0051] The control computing system 34 also communicates with pump 58 and vacuum control 59. Pump 58 may include any source for generating a vacuum suitable for thrombus aspiration. In some embodiments, control 59 may be operable to selectively place pump 58 in fluid communication with the lumen of the aspiration catheter of the interventional device and accessory 48.

[0052] According to some embodiments, operator 11 operates the input system of remote control station 42 to control robot actuator 24 to position the aspiration catheter at a first location relative to the patient's intravascular thrombus. Specific examples of such positioning will be described herein, including manipulating multiple EMDs in a prescribed sequence. The aspiration catheter is coupled to vacuum control 59, which is in turn coupled to pump 58 via tubing. Vacuum control 59 prevents fluid communication between the lumen and the tubing of the aspiration catheter. Vacuum control 59 may include clamps, valves, or any other suitable device.

[0053] The control computing system 34 controls the pump 58 to initiate evacuation of the lumen coupled to the vacuum control 59. In some embodiments, the control computing system 34 determines that the pressure within the lumen is equal to or less than a target aspiration pressure. In response to this determination, the control computing system 34 controls the vacuum control 59 to establish fluid communication between the lumen and the aspiration catheter lumen (e.g., by opening a valve, clamp, or other device of control 59). This action can be used to draw (i.e., aspirate) the thrombus into the aspiration catheter.

[0054] In another embodiment, the control computing system 34 (e.g., via communication with the pump 58) determines that the pressure within the lumen is greater than a second pressure, and in response, controls the vacuum control 59 to terminate the fluid communication between the lumen and the aspiration catheter lumen. This action avoids additional aspiration that is not necessary to remove the thrombus.

[0055] Alternatively, the control computing system 34 instructs the local control station 38 or the remote control station 40 that the pressure within the lumen is equal to or less than the target suction pressure, and this information is presented to the operator 11 via, for example, a display 30. The operator 11 can then (e.g., using one or more input systems 28) transmit commands to control the computing system 34 to automatically establish fluid communication between the lumen and the suction catheter lumen. Similarly, an indication that the pressure within the lumen is greater than a second pressure can be presented to the operator 11, and in response, the operator 11 can transmit a command to the control computing system 34 to terminate the fluid communication between the lumen and the suction catheter.

[0056] According to another embodiment, after automatically establishing fluid communication between the lumen and the aspiration catheter, and before determining whether the pressure within the lumen is greater than a second pressure, the control calculation system 34 can determine that the pressure within the lumen is within a predefined range. If the pressure within the lumen is determined to be within the predefined range, the control calculation system 34 can instruct the robot driver 24 to adjust the position of the aspiration catheter lumen (e.g., according to a pre-programmed movement sequence, which may or may not consider intermediate pressure changes) until the pressure within the lumen is less than a threshold aspiration pressure.

[0057] The catheter-based procedure system 10 may be connected to or configured to include any other systems and / or devices not explicitly shown. For example, the catheter-based procedure system 10 may include an image processing engine, a data storage and archiving system, an automated balloon and / or stent inflation system, a drug injection system, a drug tracking and / or recording system, a user log, an encryption system, or a system that restricts access to or use of the catheter-based procedure system 10. It should be noted that any determination attributed herein to the control computing system 34 may be performed by any suitable component of system 10 or any suitable component connected to system 10.

[0058] As mentioned, the control computing system 34 communicates with the bedside unit 20, which includes a robot actuator 24, a positioning system 22, and may include additional controls and a display 46. The control computing system 34 can receive signals from the remote control station 42 based on user manipulation via the input system of the remote control station 42, and can provide corresponding control signals to the bedside unit 20 to control the operation of the motors and drive mechanisms used to drive the corresponding EMD in various degrees of freedom. These drive mechanisms may be provided as part of the robot actuator 24.

[0059] Figure 3 This is a perspective view of a robot actuator 24 of a conduit-based program system 10 according to some embodiments. The embodiments are not limited to... Figure 3 Robot driver 24. Figure 3The robot actuator 24 includes a plurality of device modules 32a-d coupled to a linear member 60. Each device module 32a-d is coupled to the linear member 60 via a corresponding stage 62a-d movably mounted to the linear member 60. The device modules 32a-d can be connected to the stages 62a-d using connectors such as offset brackets 78a-d. In another embodiment, the device modules 32a-d are mounted directly to the stages 62a-d. Each stage 62a-d can be independently actuated to move linearly along the linear member 60. Therefore, each stage 62a-d (and its corresponding device module 32a-d coupled to it) can move independently relative to each other and to the linear member 60.

[0060] The drive mechanism is used to actuate each stage 62a-d. Figure 3 In the illustrated embodiments, the drive mechanism includes independent stage translation motors 64a-d coupled to each stage 62a-d and the stage drive mechanism 76. These motors may be, for example, leadscrews via rotating nuts, racks via pinions, belts via pinions or pulleys, chains via sprockets, or the stage translation motors 64a-d themselves may be linear motors. In some embodiments, the stage drive mechanism 76 may be a combination of these mechanisms; for example, each stage 62a-d may employ a different type of stage drive mechanism. In some embodiments where the stage drive mechanism is a leadscrew and rotating nut, the leadscrew is rotatable, and each stage 62a-d can engage and disengage with the leadscrew to allow it to move, for example, advance or retract. Figure 3 In the embodiment shown, the stage 62a-d and the device module 32a-d are in a serial drive configuration.

[0061] Each device module 32a-d includes a device module 68a-d and a box 66a-d mounted on and coupled to the device module 68a-d. Figure 3In the illustrated embodiment, each box 66a-d is mounted to device module 68a-d in a vertical orientation. In other embodiments, each box 66a-d may be mounted to device module 68a-d in other mounting orientations. Each box 66a-d is configured to abut and support a proximal portion of an EMD (not shown). Furthermore, each box 66a-d may include elements to provide one or more degrees of freedom, in addition to the linear motion provided by actuation of the corresponding stage 62a-d, for linear movement along linear member 60. For example, box 66a-d may include elements that can be used to rotate the EMD supported therein when the box is coupled to device module 68a-d. Each device module 68a-d includes at least one coupler to provide a drive interface to mechanisms in each box 66a-d, thereby providing additional degrees of freedom. Each box 66a-d also includes a channel in which device supports 79a-d are positioned, and each device support 79a-d serves to prevent bending of the EMD.

[0062] Support arms 77a, 77b, and 77c are attached to each device module 32a, 32b, and 32c, respectively, to provide anchor points for the proximal ends of device supports 79b, 79c, and 79d. The robot actuator 24 may also include a device support connector 72 connected to the device support 79, the distal support arm 70, and the support arm 770. The support arm 770 provides anchor points for support of the proximal end of the distal support arm 79a housed in the distal device module 32a. Furthermore, a guide interface support (steering mechanism) 74 may be connected to the device support connector 72 and the EMD (e.g., a guide sheath). This configuration of the robot actuator 24 has the advantage of reducing the size and weight of the robot actuator 24 by using an actuator on a single linear member.

[0063] To prevent pathogen contamination of patients, healthcare professionals use aseptic techniques in the room housing the bedside unit 20 and patient 12. The room housing the bedside unit 20 and patient 12 can be, for example, a catheterization lab or vascular suite. Aseptic techniques include the use of sterile barriers, sterile equipment, proper patient preparation, environmental controls, and contact guidelines. Therefore, all EMDs and interventional accessories can be sterilized and allowed to come into contact with sterile barriers or sterile equipment. In some embodiments, a sterile sterile drape (not shown) is placed over a non-sterile robotic actuator 24. Each cartridge 66a-d is sterilized and serves as a sterile interface between the robotic actuator 24 covered by the sterile drape and at least one EMD. Each cartridge 66a-d can be designed for single-use sterility or can be resterilized, either wholly or partially, so that cartridges 66a-d or components thereof can be used in multiple procedures.

[0064] As used herein, the term "box" generally refers to a component of a robot drive system, including components that support and move (e.g., rotate and / or translate) at least one EMD. A device module generally refers to a component of a robot drive system that includes one or more motors with drive couplers that interface with the moving elements of the box's EMD. The box may provide a sterile interface between at least one EMD and the device module, either directly or via a device adapter. The term "drive module" refers to a combination of the device module and the box.

[0065] In some embodiments, the EMD is a conduit having a hub at its proximal end and a flexible shaft extending from the hub toward the distal end of the conduit, wherein the shaft is more flexible than the hub. In one embodiment, the conduit includes an intermediate portion transitioning between the hub and the shaft, the intermediate portion comprising intermediate flexibility less rigid than the hub but more rigid than the shaft. In some embodiments, the intermediate portion is a strain relief element.

[0066] The longitudinal axis of a component (e.g., an EMD or other element in a catheter-based procedure system) is a line or axis along the length of the component that passes through the center of the component's cross-section in a direction from the proximal portion to the distal portion. For example, the longitudinal axis of a guidewire is a central axis in a direction from the proximal portion of the guidewire toward the distal portion, even if the guidewire may be non-linear in the relevant portion.

[0067] Axial movement of a component refers to translation of the component along its longitudinal axis. For example, the EMD is being advanced when its distal end moves axially into or further into the patient in a distal direction along its longitudinal axis. The EMD is being withdrawn when its distal end moves axially out of or further out of the patient in a proximal direction along its longitudinal axis.

[0068] In this regard, axial insertion refers to inserting the first member into the second member along the longitudinal axis of the second member. For example, axial loading in an EMD axial insertion chuck. An example of axial insertion can be described as reverse loading of the catheter to the proximal end of the guidewire. Lateral insertion refers to inserting the first member into the second member along a plane perpendicular to the longitudinal axis of the second member. Lateral insertion can also be referred to as radial loading or lateral loading.

[0069] Rotational movement of a component refers to a change in the angular orientation of the component about its local longitudinal axis. For example, due to the applied torque, the rotational movement of an EMD corresponds to the EMD rotating clockwise or counterclockwise about its longitudinal axis. Continuous motion refers to motion that does not require resetting and is uninterrupted, while discrete motion refers to motion that requires resetting and is interrupted.

[0070] The terms “distal” and “proximal” define the relative positions of two different features. In the context of robotic actuators, the terms “distal” and “proximal” are defined by the position of the robotic actuator relative to the patient in its intended use.

[0071] When used to define relative position, distal features are those of the robot actuator that are closer to the patient than proximal features when the robot actuator is in its intended use position. Within the patient's body, any vascular system landmarks along the path farther from the access point are considered farther than landmarks closer to the access point, where the access point is the point where the EMD enters the patient. Similarly, when the robot actuator is in its intended use position, proximal features are those farther from the patient than distal features.

[0072] When used to define orientation, distal orientation refers to the path that something is moving or intended to move when the robot actuator is in its intended position of use, or the path that something takes from a proximal feature toward or toward a distal feature and / or the patient. Proximal orientation is the opposite of distal orientation. For example, refer to Figure 1 The robotic device is shown from the perspective of an operator facing the patient. In this arrangement, the distal direction is along the positive X-axis, and the proximal direction is along the negative X-axis.

[0073] Regarding the movement of modules, and refer to Figure 3 The EMD moves distally along a path toward the patient, via the guide interface support 74, which defines the distal end of the robot actuator 24. The proximal end of the robot actuator 24 is the point furthest from the distal end along the negative X-axis.

[0074] Regarding the location of individual modules, and also referencing Figure 3 The farthest device module is device module 32a, which is closest to the far end of robot driver 24. The closest device module is device module 32d, which is located furthest from the far end of robot driver 24 along the negative X-axis. The relative positions of the device modules are determined by their positions relative to the far end of robot driver 24. For example, device module 32b is far from device module 32c.

[0075] Regarding the distal / proximal portions, sections, or ends of the EMD or robot actuator, portions of box 66a and device module 68a are defined by their relative positions to the distal end of the robot actuator. For example, when the box is in the use position on device module 68a, the distal end of box 66a is the portion of the box closest to the distal end of the robot actuator, and the proximal end of box 66a is the portion of the box furthest from the distal end of the robot actuator along the negative X-axis. In other words, the distal end of box 66a is a portion of the box through which the EMD most closely follows the path to the patient in the use position.

[0076] As previously discussed, embodiments of the control station (such as control station 26) may include various input systems for controlling the bedside unit 20. These input systems may include various input controls (e.g., buttons, wheels, joysticks, touchscreens) that a user can manipulate to control (or instruct) the operation of the robot actuator 24. These input controls may be arranged in different layouts or patterns on the input system to facilitate desired functions and their cooperative sequencing, thereby performing desired tasks requiring the independent (and sometimes simultaneous) movement of multiple EMDs.

[0077] Furthermore, embodiments of the input system can be configured to operate in various different control modes. The functionality of one or more controls assigned to the input system in a first control mode may differ from the functionality assigned to one or more controls in a second control mode, and the control mode can be selected based on the executing program, one or more devices to be controlled, operator preferences, or any other factors. The input system can be configured to switch between different control modes in response to input from the operator or from the control computing system 34.

[0078] The input system described herein can be fixed, integrated, or simply placed on the surface of control station 26. As described herein, the input system may include a single integrated housing or multiple independently movable housings.

[0079] Figure 4 This is a schematic diagram of a thrombectomy system according to some embodiments. Each component of system 400 may be implemented by one or more devices including any suitable combination of hardware and / or software, and two or more of the illustrated components may be implemented by one or more of the same devices.

[0080] Figure 4 A blood vessel 410 is shown, which may include a vein or artery within the patient's body. The blood vessel 420 can be located anywhere within the patient's body. A thrombus 420 is disposed within the blood vessel 410. Embodiments are not limited to this. Figure 4 Or any thrombus and vessel of relative size and shape shown in the figures described below. Examples are also not limited to a single, generally continuous thrombus.

[0081] The catheter control 430 is operated to navigate the catheter 440 to the thrombus 420 within the vessel 410. As shown, the catheter control 430 has manipulated the tip 440a of the catheter 440 to the location of the thrombus 420 adjacent to the vessel 410. The catheter 440 may include any EMD defining a lumen in which negative pressure can be generated. The catheter 440 may include a specially designed aspiration catheter defining a catheter lumen.

[0082] As described below, catheter control 430 can manipulate (i.e., advance / retract / rotate) one or more guidewires and catheters (not shown) to navigate catheter 440 to the illustrated location. Such navigation can be facilitated using a robot actuator, such as, but not limited to, robot actuator 24. Thus, in some embodiments, catheter control 430 includes a catheter-based programming system 10.

[0083] Vacuum source 450 may include a pump or other device suitable for generating negative pressure in an interventional operating room. According to system 400, vacuum source 450 is coupled to conduit 460a, which is coupled to valve / clamp 470. Valve / clamp 470 is coupled to conduit 460b, which is coupled to catheter 440 via catheter control 430. Conduits 460a and 460b may include any conduits suitable for thrombus aspiration as described herein, and together include a lumen.

[0084] When valve / clamp 470 is closed, the negative pressure generated by vacuum source 450 exists within the cavity of pipe 460a, but not within the cavity of pipe 460b (and therefore not within conduit 440). When valve / clamp 470 is open, vacuum source 450, the cavities of pipe 460a, pipe 460b, and conduit 440 are all in fluid communication with each other. Therefore, any negative pressure generated by vacuum source 450 is experienced at the tip 440a of conduit 440.

[0085] According to system 400, pressure sensor 480 is coupled to or integrated with vacuum source 450. Pressure sensor 480 can determine the pressure generated by vacuum source 450, such as the pressure generated in pipe 460a when valve / clamp 470 is closed. Valve / clamp 470 can monitor this pressure via communication with pressure sensor 480 and determine whether to open or close itself based on this pressure.

[0086] For example, in some embodiments, the catheter control 430, under operator control, manipulates a series of EMDs to position the tip 440a of the catheter 440 adjacent to the thrombus 420. Next, the conduit 460b is coupled to the catheter 440 manually or via a mechanism of the catheter control 430, such that the conduit 460b and the catheter 440 are in fluid communication with each other. A vacuum source 450 is operated (e.g., via a command from the catheter control 430 or the operator) to initiate the generation of negative pressure within the conduit 460a.

[0087] Valve / clamp 470 monitors the pressure determined by pressure sensor 480 until it determines that the pressure within conduit 460a is equal to or less than the target aspiration pressure. Alternatively, once pressure sensor 480 determines that the pressure within conduit 460a is equal to or less than the target aspiration pressure, pressure sensor 480 may signal valve / clamp 470. In either case, in response to this determination, valve / clamp 470 is opened to automatically establish fluid communication between conduit 460a, conduit 460b, and catheter 440. Thus, thrombus 420 can be forcibly removed from blood vessel 410 and aspirated into catheter 440.

[0088] After opening valve / clamp 470, valve / clamp 470 can further determine, based on pressure sensor 480, that the pressure within lumen 460a is greater than a second pressure, and close itself in response to automatically terminate the fluid communication between lumen 460a and catheter 440. This procedure can be used to detect the completion of thrombus 420 removal and terminate aspiration accordingly.

[0089] In a further embodiment, because the pressure within lumen 460a is greater than a second pressure, after opening valve / clamp 470 but before closing it, valve / clamp 470 determines, based on pressure sensor 480, that the pressure within lumen 460a is within a predefined range. This predefined range is higher than a first pressure and lower than a second pressure, and is intended to indicate some resistance to suction in catheter 440, but not to the extent expected if tip 440a were positioned against thrombus 420. If the pressure within lumen 460a is determined to be within the predefined range, valve / clamp 470 (or, for example, pressure sensor 480) can communicate with catheter control 430 to change (e.g., rotate) the position of catheter 440 until the pressure within lumen 460a is equal to or less than the desired pressure.

[0090] In some embodiments, the valve / clamp 470 is an assembly of the conduit control 430. Thus, a single section of the conduit can extend from the vacuum source 450 to such a valve / clamp 470, which is then directly coupled to the conduit 440 via the conduit control 430.

[0091] Figure 5 This is a schematic diagram of a thrombectomy system according to some embodiments. System 500 includes a blood vessel 510 as described above and a thrombus 520 disposed within the blood vessel 510. As described with respect to catheter control 430 and catheter 440, catheter control 530 is operated to navigate catheter 540 to thrombus 520.

[0092] Vacuum source 550, conduit 560a, conduit 560b, valve / clamp 570, and pressure sensor 580 can be configured as described above with respect to similarly named elements of system 400. System 500 also includes a pressure control 590 disposed between pressure sensor 580 and valve / clamp 570. Pressure control 590 can perform the determination and control of valve / clamp 570, which is attributed above to valve / clamp 470. Generally, pressure control 590 can monitor the pressure within lumen 560a via communication with pressure sensor 580 and instruct valve / clamp 570 to open or close based on this. In some embodiments, pressure control 590 is a component of conduit control 530. In this respect, pressure control 590 may include control computing system 34 of system 10.

[0093] Pressure control 590 can activate vacuum source 550 to begin generating negative pressure within pipe 560a. Pressure control 590 monitors the pressure determined by pressure sensor 580 until the pressure within pipe 560a is equal to or less than the target suction pressure. In response to this determination, pressure control 590 instructs valve / clamp 570 to open, automatically establishing fluid communication between pipe 560a, pipe 560b, and conduit 540.

[0094] After the valve / clamp 570 is opened, the pressure control 590 can further monitor the pressure determined by the pressure sensor 580 until the pressure in the pipe 560a is greater than the second pressure, and in response, instruct the valve / clamp 570 to close itself to automatically terminate the fluid communication between the lumen 560a and the conduit 540. Furthermore, if the pressure control 590 determines that the pressure in the lumen 560a is within a predefined range higher than the first pressure and lower than the second pressure, the pressure control 590 can communicate with the conduit control 530 to change (e.g., rotate) the position of the conduit 540 until the pressure in the lumen 560a is equal to or less than the first pressure.

[0095] Figure 6 This is a schematic diagram of a thrombectomy system according to some embodiments. System 600 is similar to... Figure 5 System 500, except that the functions of pressure sensor 580 and pressure control 590 are combined within pressure sensor and control 690. Vacuum source 680, pipe 660a, pipe 660b, valve / clamp 670 and conduit control 630 can be configured as described above with respect to similarly named components of system 500.

[0096] The pressure sensor and control 690 can monitor the pressure within the lumen 660a via communication with the vacuum source 680, and based on this, instruct the valve / clamp 670 to open or close. As mentioned with respect to the pressure control 590 of system 500, in some embodiments, the pressure sensor and control 690 is a component of the conduit control 630. For example, the pressure sensor and control 690 may include the control computing system 34 of system 10.

[0097] Pressure sensor and control 690 can initiate the operation of vacuum source 680 to begin generating negative pressure within pipe 660a. Pressure sensor and control 690 monitors the pressure generated by vacuum source 680 (e.g., by optically sensing pipe 660a through communication with vacuum source 680, which includes a pressure sensor) until it is determined that the pressure within pipe 660a is equal to or less than the target suction pressure. In response to this determination, pressure sensor and control 690 instructs valve / clamp 670 to open, automatically establishing fluid communication between pipe 660a, pipe 560b, and conduit 640.

[0098] Next, the pressure sensor and control 690 can determine that the pressure within pipe 660a has become greater than the second pressure, and in response, instruct valve / clamp 670 to close itself to automatically terminate the fluid communication between lumen 660a and conduit 640. If, between the opening and closing of valve / clamp 670 as described above, the pressure sensor and control 690 determines that the pressure within lumen 660a is within a predefined range higher than the first pressure and lower than the second pressure, then the pressure sensor and control 690 can communicate with conduit control 630 to change (e.g., rotate) the position of conduit 640 until the pressure within lumen 660a is equal to or less than the first pressure.

[0099] Figure 7 This is a schematic diagram of a thrombectomy system according to some embodiments. System 700 includes presenting pressure-based instructions to an operator, and subsequent operator control of system 700. System 700 is presented in two alternative arrangements: in a first arrangement, pressure sensor 770a is coupled to or integrated with vacuum source 740; and in a second arrangement, pressure sensor 770b is decoupled from vacuum source 740. Pressure sensor 770b can determine the pressure within conduit 750a via optical components, a sensor element within conduit 750a, or any other suitable technology.

[0100] Regardless of the implementation of the pressure sensor (e.g., pressure sensor 770a or pressure sensor 770b), system 700 includes presenting a pressure indication within pipe 750a to operator 775 via display 780. Although Figure 7A direct communication link between pressure sensor 770a / 770b and display 780 is shown, but pressure can be transmitted from pressure sensor 770a / 770b to display 780 via any number of intermediate components (such as, for example, control computing system 34).

[0101] During operation, operator 775 manipulates catheter control 730 (e.g., catheter control of a catheter-based robotic system such as system 10) to position catheter 740 relative to thrombus 720 within blood vessel 710. Once the position is satisfactory to operator 775, operator 775 initiates operation of vacuum source 740 to begin generating negative pressure within conduit 750a.

[0102] Display 780 presents a negative pressure indication to operator 775. This indication may include a pressure value and / or a statement that the pressure within conduit 750a is equal to or less than the target suction pressure. The indication may simply include a notification that the system is ready to suction once the pressure within conduit 750a is equal to or less than the target suction pressure. Upon receiving the indication, operator 775 may manipulate operator control 790 to command valve / clamp 760 to open, thereby automatically establishing fluid communication between conduits 750a, 750b, and conduit 740. Operator control 790 may include any input system described herein, including but not limited to touchscreens (e.g., display 780 may also include operator control 790), console buttons, foot switches, and joysticks.

[0103] After valve / clamp 760 is opened, display 780 may further indicate that the pressure within conduit 750a has become greater than a second pressure. This indication may include a notification to terminate suction. In response to this indication, operator 775 may manipulate operator control 790 to close valve / clamp 760 to terminate fluid communication between conduit 750a and conduit 740. In some embodiments of system 700, the pressure within conduit 750a is monitored, and once it is determined that the pressure within conduit 750a has become greater than a second pressure, valve / clamp 760 is automatically commanded to close without operator 775 intervention.

[0104] Between the opening and closing of valve / clamp 760, display 780 may present and indicate that the pressure within lumen 750a is within a predefined range above a first pressure and below a second pressure. This indication may include a pressure value and / or notification of repositioning catheter 740 relative to thrombus 720. Based on this indication, operator 775 may instruct catheter control 730 to reposition catheter 740. Repositioning may include a set of pre-programmed movements and / or individual movements instructed by operator 775. In some embodiments, once the pressure within lumen 750a has decreased to equal to or less than the first pressure, display 780 presents an indication at which point operator 775 may cease instructing catheter control 730.

[0105] Figure 8 This is a schematic diagram of a thrombectomy system according to some embodiments. System 800 may include an implementation of system 700. In particular, valve 840 includes an implementation of valve / clamp 760. Similar to the description of system 700, an operator 875 may operate catheter control 820 to position the thrombus relative to the intravascular thrombus positioning catheter 810. Once the positioning is satisfactory, vacuum source 830 is operated to initiate the generation of negative pressure within conduit 850a.

[0106] Display 870 presents a negative pressure indication to operator 875. Upon receiving the indication, operator 875 can directly operate valve 740 to open, thereby automatically establishing fluid communication between pipes 850a, 850b, and conduit 810. In the illustrated embodiment, valve 840 includes a flow control valve comprising a slide switch 845, which can be operated with one hand to selectively open or close valve 840. The embodiment can employ any suitable device for establishing and terminating fluid communication between the two chambers.

[0107] Display 780 may further present an indication that the pressure within conduit 750a has become greater than a second pressure. This indication may include a notification to terminate suction. In response to this indication, operator 775 may manipulate operator control 790 to close valve / clamp 760 to terminate fluid communication between conduit 750a and conduit 740. In some embodiments of system 700, the pressure within conduit 750a is monitored, and once it is determined that the pressure within conduit 750a has become greater than a second pressure, valve / clamp 760 is automatically commanded to close without operator 775 intervention.

[0108] Between the opening and closing of valve / clamp 760, display 780 may present and indicate that the pressure within lumen 750a is within a predefined range above a first pressure and below a second pressure. This indication may include a pressure value and / or notification of repositioning catheter 740 relative to thrombus 720. Based on this indication, operator 775 may instruct catheter control 730 to reposition catheter 740. Repositioning may include a set of pre-programmed movements and / or individual movements instructed by operator 775. In some embodiments, once the pressure within lumen 750a has decreased to equal to or less than the first pressure, display 780 presents an indication at which point operator 775 may cease instructing catheter control 730.

[0109] Figure 9 This includes a flowchart of a process 900 for aspirating blood clots according to some embodiments. Process 900 and other processes described herein can be performed using any suitable combination of hardware and software. The software program code embodying these processes can be stored by any non-transitory tangible medium, including hard disks, volatile or non-volatile random access memory, DVDs, flash drives, and magnetic tapes, and executed by any suitable processing unit, including but not limited to one or more microprocessors, microcontrollers, processing cores, and processor threads. Embodiments are not limited to the examples described below.

[0110] Initially, at S910, the aspiration catheter, defining the lumen of the aspiration catheter, is positioned at a first location relative to the thrombus. For example, at S910, the operator can control the robotic actuator to manipulate a series of EMDs in a prescribed sequence to position the tip of the aspiration catheter against the thrombus. Following such a prescribed sequence, the guide sheath is inserted into the access site, such as, but not limited to, the radial or femoral artery. Next, a diagnostic guidewire is inserted into the sheath and advanced by the robotic actuator in response to operator commands to the base of the skull. The guide catheter and the base catheter are then advanced (simultaneously or sequentially) over the diagnostic guidewire to the base of the skull. The diagnostic guidewire and guide catheter are then removed, leaving the base catheter in place.

[0111] A coaxial "stack" of microfilaments is then inserted into a base catheter, which is surrounded by a microcatheter, which in turn is surrounded by an aspiration catheter. Guided by the microfilaments, the stack passes under the skull (i.e., where the base catheter terminates) and navigates the vascular system until the microfilaments reach the thrombus. The aspiration catheter is then advanced, with or without the microcatheter (i.e., for structural support), until its lumen contacts the thrombus. The entire process is aided by simultaneously acquired and contrast-enhanced X-ray images.

[0112] Figure 10The illustration shows the vessel 1000 in which the base catheter 1010 is lodged. A stack consisting of a microfilament 1020, a microcatheter 1030, and an aspiration catheter 1040 has passed through the base catheter 1010 on its way to the thrombus 1050. The microfilament 1020 has reached the thrombus 1050, and the microcatheter 1030 is being advanced over the microfilament 1020 toward the thrombus 1050. Next, the aspiration catheter 1040 will be advanced over the microcatheter 1030 (and the microfilament 1020) until the aspiration catheter 1040 reaches the thrombus 1050. The microfilament 1020 and the microcatheter 1030 can then be removed from within the aspiration catheter 1040.

[0113] Returning to process 900, at S920, purging of the lumen is initiated to generate a negative pressure therein. As noted above, the lumen may be coupled to a pump or other vacuum source. It is also noted that the lumen is not in fluid communication with the suction conduit. According to some embodiments, at S920, the operator operates input controls associated with a conduit-based robotic program system to instruct the operation of the vacuum source.

[0114] At S930, the procedure is paused until the pressure within the lumen is equal to (or less than) the target pressure. The target pressure can be predefined and / or set by the operator and can be determined based on the size and / or shape of the thrombus, the nature of the vessel in which the thrombus resides (e.g., fragile, tortuous, damaged), or any other factor. Once it is determined that the pressure within the lumen is equal to (or less than) the target pressure, the procedure proceeds to S940.

[0115] At S940, fluid communication is automatically established between the tubing and the suction conduit lumen. Several examples of S940 are described herein. In one example, prior to S940, both the tubing and the suction conduit are coupled to either end of a closed valve, and S940 includes opening the valve. This valve can be opened via an electromechanical actuator or manually by an operator. Implementations of S940 are not limited to those described herein.

[0116] Figure 11 Processes S1110 to S1140 of procedure 1100 can be performed similarly to S910 to S940 of procedure 900. After S1140, at S1150, the process is paused until the pressure within the lumen is determined to be greater than (or equal to) a second target pressure. As described above, the second target pressure can be the pressure anticipated after the thrombus has been emptied from the blood vessel (and aspiration catheter).

[0117] Once the second target pressure is reached, the process proceeds to S1160. At S1160, fluid communication between the lumen and the suction conduit lumen is terminated. Continuing the example above, S1160 may include the electromechanical or manual closure of a valve located between the lumen and the suction conduit lumen.

[0118] Referring to Figure 12, steps S1205, S1210, and S1215 of process 1200 can be performed similarly to the corresponding steps in steps S910, S920, and S930 of process 900. At S1220, an indication is presented to the operator that the pressure within the lumen (i.e., the pressure experienced by the suction catheter lumen) has reached the target pressure. As described above, this indication can be presented via a display on the operator's console and can be transmitted from a vacuum source or a separate pressure sensor to a control computing system, which then instructs the presentation of the indication.

[0119] The process pauses at S1225 until a command is received from the operator. The target pressure can be maintained during the pause at S1225. The operator can use the input controls on the console to instruct the system to perform suction; in response, the process proceeds to S1230.

[0120] At S1230, fluid communication is automatically established between the lumen and the aspiration tubing lumen. The process then pauses at S1235 until the pressure within the lumen is determined to be greater than (or equal to) the second target pressure. At S1240, another indication is presented to the operator that the pressure within the lumen (and the aspiration tubing lumen) has reached the second target pressure. The process pauses at S1245 until the next command is received from the operator.

[0121] The operator can operate the input control of the console at S1245 to instruct the system to terminate suction. In response, at S1250, the fluid communication between the tubing lumen and the suction guide lumen is terminated. For example, a valve located between the tubing lumen and the suction guide lumen can be closed at S1250.

[0122] Figure 13 is a flowchart of process 1300 according to some embodiments. S1310 to S1340 of process 1300 can be performed similarly to S910 to S940 of process 900. After fluid communication between the lumen and the aspiration catheter is established at S1340, the process proceeds to S1350.

[0123] At S1350, it is determined whether the pressure within the lumen is within a predefined range. As described above, the predefined range may include a pressure range indicating that the aspiration catheter is not engaging the thrombus in a manner that provides appropriate suction to the thrombus. If the pressure within the lumen is not within the predefined range, the procedure proceeds to S1370.

[0124] If the pressure within the lumen is determined to be within a predefined range at S1350, the position of the aspiration catheter lumen is automatically adjusted at S1360 until the pressure within the lumen is less than a threshold aspiration pressure. This adjustment can be performed automatically without operator intervention using one or more catheter movements intended to better position the catheter. In some embodiments, the adjustment is performed under partial or full operator control.

[0125] At S1370, it is determined whether the pressure within the lumen is greater than the second pressure. If not, the process returns to S1350 and continues as described above. If so, at S1380, the fluid communication between the lumen and the aspiration catheter lumen is automatically terminated using any system described herein or known to the public.

[0126] Those skilled in the art will appreciate that various adaptations and modifications can be configured to fit the above embodiments without departing from the claims. Therefore, it should be understood that the claims can be practiced in ways other than those specifically described herein.

Claims

1. A control computing system for controlling a pressure within a catheter lumen of a catheter-based robotic procedure system, wherein the control computing system comprises: a control computing system configured to: provide a first command to a robotic drive to position a catheter lumen at a position relative to a thrombus, the catheter lumen defined by a catheter; provide a second command to initiate evacuation of a tube lumen, wherein the tube lumen is not in fluid communication with the catheter lumen by way of a vacuum control; determine that a pressure within the tube lumen is equal to or less than a target aspiration pressure; and in response to determining that the pressure within the tube lumen is equal to or less than the target aspiration pressure, establish fluid communication between the tube lumen and the catheter lumen via the vacuum control.

2. The control computing system of claim 1, wherein the control computing system is configured to: after automatically establishing fluid communication between the tube and the catheter, determine, via the control computing system, whether the pressure within the tube lumen is greater than a second pressure; and if it is determined that the pressure within the tube lumen is greater than the second pressure, automatically terminate fluid communication between the tube lumen and the catheter lumen via the vacuum control.

3. The control computing system of claim 2, wherein the control computing system is configured to: after automatically establishing fluid communication between the tube and the catheter, and prior to determining whether the pressure within the tube lumen is greater than the second pressure, determine, via the control computing system, whether the pressure within the tube lumen is within a predefined range; and if it is determined that the pressure within the tube lumen is within the predefined range, automatically adjust, via the robotic drive, the position of the catheter lumen until the pressure within the tube lumen is less than a threshold aspiration pressure.

4. The control computing system of claim 1, wherein the control computing system is configured to: after automatically establishing fluid communication between the tube lumen and the catheter lumen, determine, via the control computing system, whether the pressure within the tube lumen is within a predefined range; and if it is determined that the pressure within the tube lumen is within the predefined range, automatically adjust, via the robotic drive, the position of the catheter lumen until the pressure within the tube lumen is less than a threshold aspiration pressure.

5. The control computing system of claim 1, wherein the control computing system is configured to: and after automatically establishing fluid communication between the lumen and the catheter lumen, determining, via the control computing system, whether the pressure within the lumen is greater than a second pressure; if it is determined that the pressure within the tube lumen is greater than the second pressure, present an indication to an operator via a display; after presenting the indication, and while the pressure within the tube lumen is greater than the second pressure, receive a command from the operator via a control; and in response to receipt of the command, automatically terminate fluid communication between the tube lumen and the catheter lumen via a valve or a clamp.

6. The control computing system of claim 5, wherein the control computing system further comprises: after automatically establishing fluid communication between the tube lumen and the catheter lumen, and prior to determining that the pressure within the tube lumen is greater than the second pressure, determine, via the control computing system, whether the pressure within the tube lumen is within a predefined range; and if it is determined that the pressure within the tube lumen is within the predefined range, automatically adjust, via the robotic drive, the position of the catheter lumen until the pressure within the tube lumen is less than a threshold aspiration pressure.

7. A system for thrombus aspiration, wherein the system comprises: a vacuum source; ​ a conduit defining a lumen, the lumen being in fluid communication with a vacuum source and a catheter via a valve, wherein the valve is configured to open and close, wherein the catheter defines a catheter lumen; a pressure sensor configured to determine a pressure within the lumen; and a catheter control configured to navigate the catheter within a blood vessel and to reach a thrombus.

8. The system of claim 7, wherein the valve is disposed between the lumen and the catheter.

9. The system of claim 7, wherein, the vacuum source generates a negative pressure in the lumen when the valve is closed.

10. The system of claim 7, wherein the pressure sensor is in communication with the vacuum source.

11. The system of claim 7, wherein the pressure sensor is configured to provide a signal to the valve to open when the pressure sensor determines that the pressure within the conduit is equal to or less than a target aspiration pressure.

12. The system of claim 7, wherein the lumen has at least a first portion and a second portion defined by a position of the valve.

13. The system of claim 12, wherein the pressure sensor is configured to provide a signal to the valve to close when the pressure sensor determines that the pressure within the first portion of the conduit is greater than a second pressure.

14. The system of claim 12, wherein the system further comprises a pressure control disposed between the pressure sensor and the valve.

15. The system of claim 14, wherein the pressure control is configured to monitor the pressure within the first portion of the lumen via communication with the pressure sensor and instruct the valve to open or close based thereon.

16. The system of claim 7, wherein the catheter control is configured to manipulate a series of elongated medical devices (EMDs) under control of an operator to position a tip of the catheter proximate to the thrombus.

17. The system of claim 7, wherein the catheter control is disposed between the valve and the catheter.

18. The system of claim 12, wherein, the vacuum source generates a negative pressure in the first portion of the lumen but not in the second portion when the valve is closed.

19. A system for thrombus aspiration, wherein the system comprises: a conduit defining a lumen, a first end of the lumen being in fluid communication with a vacuum source; a vacuum control in fluid communication with a second end of the lumen and a first end of a catheter defining a lumen; a pressure sensor to determine a pressure within the lumen; and a control unit configured to: control the vacuum control such that the lumen is not in fluid communication with the catheter lumen; receive the determined pressure from the pressure sensor and determine that the pressure within the lumen is equal to or less than a target aspiration pressure; and in response to determining that the pressure within the lumen is equal to or less than the target aspiration pressure, automatically control the vacuum control to establish fluid communication between the lumen and the catheter lumen.

20. The system of claim 19, wherein the control unit is further configured to: determine whether the pressure within the lumen is greater than a second pressure; and if it is determined that the pressure within the lumen is greater than the second pressure, automatically control the vacuum control to terminate the fluid communication between the lumen and the catheter lumen.

21. The system of claim 20, wherein the system further comprises a catheter control to control movement of the catheter, the control unit is further configured to: determine whether the pressure within the lumen is within a predefined range; and if it is determined that the pressure within the lumen is not within the predefined range, automatically control the catheter control to move the catheter. If it is determined that the pressure within the lumen is within the predefined range, then the catheter control is automatically controlled to move the catheter until the pressure within the lumen is less than the threshold suction pressure.

22. The system of claim 19, wherein the system further comprises a catheter control for controlling catheter movement, the control unit is further configured to: determine whether the pressure within the lumen is within a predefined range; and if it is determined that the pressure within the lumen is within the predefined range, then the catheter control is automatically controlled to move the catheter until the pressure within the lumen is less than the threshold suction pressure.

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