Thrombectomy System and Method

Abstract

To provide systems capable of improving the efficiency, efficacy and / or safety of mechanical thrombectomy using robotic catheter-based procedure systems.SOLUTION: Systems 400 and methods include: positioning a catheter lumen in a first position with respect to a thrombus 420, the catheter lumen defined by a catheter 440; initiating evacuation of a lumen of tubing 460a, b, where the tubing lumen is not in fluid communication with the catheter lumen; determining that a pressure within the tubing lumen is equal to or less than a target aspiration pressure; and, in response to the determination that the pressure within the tubing lumen is equal to or less than the target aspiration pressure, automatically establishing fluid communication between the tubing lumen and the catheter lumen.SELECTED DRAWING: Figure 4

Description

Background Art

[0001] As used herein, the "elongated medical device (EMD)" refers to a medical device including, but not limited to, catheters (e.g., guide catheters, microcatheters, aspiration catheters, balloon / stent catheters), wire-based devices (e.g., guide wires, micro wires, embolization coils, stent retrievers, etc.), and combinations thereof. Generally, EMDs can be used in many minimally invasive medical procedures. Such procedures can facilitate the diagnosis and treatment of various vascular diseases and include neurovascular intervention (NVI) (or nerve intervention) surgery, percutaneous coronary intervention (PCI), and peripheral vascular intervention (PVI). Usually, these procedures involve navigating a guide wire through the patient's vascular system and advancing a working catheter through the guide wire to perform the treatment.

[0002] Catheter procedures begin with obtaining access by inserting a sheath into a suitable blood vessel such as an artery or vein. Next, for example, a diagnostic guide wire is passed through the sheath and advanced to a primary location such as the internal carotid artery (in the case of NVI), the coronary ostium (in the case of PCI), or the superficial femoral artery (in the case of PVI). Thereafter, a guide catheter is advanced to the primary location through the diagnostic guide wire. The diagnostic guide wire is removed, and a guide wire suitable for navigating the target vascular system is pushed through the guide catheter to a target location (e.g., lesion, thrombus) within the vascular system. In certain situations, such as in the case of tortuous anatomical structures, a support catheter or microcatheter is inserted through the guide wire to assist in the navigation of the guide wire passing through it.

[0003] To navigate a guidewire or guidewire / microcatheter towards a target location, a physician manipulates the proximal end to advance the guidewire or guidewire / microcatheter while avoiding entering other branch vessels, directing the distal tip towards an appropriate branch vessel along the path to the target location. Prior to the procedure, the physician can use an imaging system (e.g., a fluoroscope) to obtain sequential contrast images of the patient's vasculature and can select one of the images to use as a roadmap for navigating the guidewire or guidewire / microcatheter to the target location. The physician can also obtain contrast images while navigating the guidewire or guidewire / microcatheter and can confirm that the device is moving along the correct path to the target location.

[0004] A robotic catheter treatment system facilitates the above process by supporting each of the guidewire and catheter and physically manipulating each of the guidewire and catheter as desired by the physician. For example, a robotic catheter treatment system includes mechanical components for holding the guidewire and advancing, retracting, and rotating the guidewire in response to commands from the physician. The physician can provide such commands via an input device (e.g., a joystick, buttons, scroll wheel, touch screen) mounted on a control console. The input device allows the physician to select one or more guidewires and / or catheters to control at that time. Thereby, the robotic catheter treatment system can provide superior controllability and accuracy compared to a completely manual catheter treatment. In addition, the control console, and thus the physician, is protected from the X-rays emitted by the imaging system used to track the position of the guidewire and / or catheter during the procedure.

[0005] A robotic catheter-based treatment system is used to assist a physician in performing catheter treatments such as NVI, PCI, and PVI. Examples of robotic-assisted NVI treatments include coil embolization of aneurysms, liquid embolization of arteriovenous malformations, mechanical thrombectomy for large vessel occlusion in cases of acute ischemic stroke, etc. In such NVI treatments, the physician uses the robotic system to manipulate a neurovascular guidewire and a microcatheter to gain access to the lesion and perform a treatment to restore normal blood flow. Access is provided using a sheath or a guiding catheter as described above, but an intermediate catheter may be required to provide access to more distal regions and / or to provide sufficient support to the microcatheter and the guidewire. The distal tip of the guidewire is navigated into or beyond the lesion depending on the type of lesion and treatment. When treating an aneurysm, the microcatheter is advanced into the lesion, the guidewire is removed, and several coils are placed into the aneurysm through the microcatheter. Then, the aneurysm is embolized using the coils. In the case of treating an arteriovenous malformation, a liquid embolization is injected into the malformation through the microcatheter.

[0006] In conventional mechanical thrombectomy, suction may be used to treat vascular occlusion. Suction may be performed directly through the above-described microcatheter or using a larger-diameter suction catheter. After navigating the microcatheter or the suction catheter to the occluding thrombus, the suction pump connected thereto is activated to generate negative pressure and draw the thrombus into the catheter. In conventional suction systems, it may take a significant amount of time to completely remove the thrombus from the blood vessel. In addition, conventional systems generate and apply negative pressure for a longer time than necessary to remove the thrombus. Any of these drawbacks increases the risk of damage to the vasculature and / or the suction pump. A system that can improve the efficiency, effectiveness, and / or safety of mechanical thrombectomy using a robotic catheter-based treatment system is desired.

Brief Description of the Drawings

[0007]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12a

Figure 12b

Figure 13a

Figure 13b

[0008] The following description is provided to enable a person having ordinary skill in the art to make and use the described embodiments. Of course, various modifications will be apparent to those having ordinary skill in the art.

[0009] According to one embodiment, aspiration of the thrombus is initiated only after it is determined that the aspiration (i.e., vacuum) source has reached a threshold negative pressure. Such an initiation procedure increases the removal effect and results in rapid removal of the thrombus in many cases.

[0010] In one embodiment, a suction catheter lumen defined in a suction catheter is positioned at a first position relative to a thrombus. Then, evacuation of a tube lumen not in fluid communication with the suction catheter lumen is initiated. After a predetermined time, it is determined that the pressure in the tube lumen is below a target suction pressure. In response to this determination that the pressure in the tube lumen is below the target suction pressure, fluid communication is automatically established between the tube lumen and the suction catheter lumen (e.g., by opening a valve, releasing a clamp, etc.). Such a process contributes to removing the thrombus more rapidly compared to the case where this is not done. In one example, the operator is notified that the pressure in the tube lumen is below the target suction pressure, and the operator sends a command to automatically establish fluid communication between the tube lumen and the suction catheter lumen.

[0011] According to one embodiment, further, it is determined whether the pressure in the tube lumen is greater than a second pressure, and if it is determined that the pressure in the tube lumen is greater than the second pressure, fluid communication between the tube lumen and the suction catheter lumen is automatically terminated (e.g., by closing a valve, tightening a clamp, etc.). According to these examples, the suction time can be minimized as much as possible to the time truly necessary to remove the thrombus.

[0012] Similarly, according to one embodiment, a notification can be given to inform the operator that the pressure in the tube lumen has become greater than the second pressure. After this notification, and while the pressure in the tube lumen exceeds the second pressure, fluid communication between the tube lumen and the suction catheter lumen is automatically terminated in response to receipt of a command from the operator.

[0013] According to one embodiment, it also includes repositioning the aspiration catheter as needed during the procedure to maintain an appropriate position at the tip of the aspiration catheter facing the thrombus. For example, after automatically establishing fluid communication between the tube lumen and the aspiration catheter, before determining whether the pressure in the tube lumen is greater than a second pressure, it is determined whether the pressure in the tube lumen is within a predefined range. If it is determined that the pressure in the tube lumen is within the predefined range, the position of the aspiration catheter lumen is automatically adjusted until the pressure in the tube lumen becomes less than the threshold aspiration pressure.

[0014] FIG. 1 according to one embodiment is a perspective view of a catheter-based treatment system 10. The catheter-based medical treatment system 10 can be used to perform catheter-based medical treatments, such as PCI (e.g., treatment of STEMI), NVI (e.g., treatment of acute major artery occlusion (ELVO)), and PVI (e.g., for severe lower limb ischemia (CLI)). Catheter-based medical treatments include diagnostic catheter procedures that use one or more catheters or other EMDs to assist in diagnosing a patient's disease. In one embodiment, a contrast agent is injected into one or more arteries through a catheter, and an image of the patient's vasculature is acquired while the contrast agent is therein.

[0015] Catheter-based medical treatments also include catheter-based treatment procedures (e.g., angioplasty, stent placement, treatment of peripheral vascular diseases, thrombus removal, treatment of arteriovenous malformations, treatment of aneurysms), in which case the disease is treated using a catheter (or other EMD). The specific type or nature of the EMD used in catheter-based medical treatments is selected based on the type of procedure to be performed. The catheter-based treatment system 10 can perform various catheter-based medical treatments with the adjustments necessary to accommodate the specific EMD used in the procedure.

[0016] The catheter treatment system 10 includes, among other elements, a bedside unit 20 and a control station 26. The bedside unit 20 includes a robot drive device 24 and a positioning system 22 disposed beside the patient 12. The patient 12 is lying on a patient table 18. The positioning system 22 is used for positioning and supporting the robot drive device 24. The positioning system 22 is, for example, a robotic arm, an articulated arm, a holder, or the like. The positioning system 22 is attached at one end to, for example, a rail, a base, or a cart of the patient table 18. The robot drive device 24 is attached to the other end of the positioning system 22. The positioning system 22 can be retracted (together with the robot drive device 24) when the patient 12 is placed on the patient table 18.

[0017] After the patient 12 is placed on the patient table 18, the positioning system 22 can be used to fix or position the robot drive device 24 relative to the patient 12 for treatment. In one embodiment, the patient table 18 is supported and operated by a pedestal 17 installed on the floor and / or the ground. The patient table 18 can move relative to the pedestal 17 with multiple degrees of freedom, for example, roll, pitch, and yaw. The bedside unit 20 can also include operator control devices and a display (not shown). For example, these control devices and the display can be arranged on the housing of the robot drive device 24.

[0018] "Front / near" here refers to the side of the robot drive device 24 facing the patient 12 and far from the positioning system 22, while "rear / far" refers to the side of the robot drive device 24 close to the positioning system 22. "Up / above / upper" refers to the general direction opposite to the direction of gravity, and "down / below / lower" refers to the general direction of the direction of gravity.

[0019] The robot drive device 24 typically includes appropriate EMDs and related accessories (e.g., plug coils, liquid plugs, suction pumps, contrast agent injection systems, drugs, hemostatic valve adapters, syringes, stopcocks, inflation devices, etc.), enabling the operator 11 to perform catheter-based medical procedures by operating various control devices of the control system, such as the control devices and input devices at the control station 26. The bedside unit 20, particularly the robot drive device 24, includes any component and / or combination of components for imparting the functions described herein to the bedside unit 20.

[0020] The robot drive device 24 includes a plurality of device modules 32, each of which is controlled to drive its respective EMD. Further, each of the device modules 32 is controllable to move linearly towards and away from the patient 12. In one embodiment, the robot drive device 24 can control one or more of the device modules 32 to insert a guide wire into a diagnostic catheter and into a guide catheter within the artery of the patient 12. The EMD enters the body (e.g., blood vessel) of the patient 12 at the insertion point 16, for example, via an introducer sheath.

[0021] The bedside unit 20 communicates with the control station 26, and the control station 26 wirelessly or wiredly transmits signals generated by the control devices of the control station 26 to the bedside unit 20, enabling it to control various functions of the bedside unit 20, including the functions of the robot drive device 24. As will be described later, the control station 26 includes a control computing system 34 (shown in FIG. 2) or is connected to the bedside unit 20 via the control computing system 34. The bedside unit 20 can also provide feedback signals (such as load, speed, operating conditions, warning signals, error codes, etc.) to the control station 26 or the control computing system 34, or both. The communication between the control computing system 34 and each component of the catheter treatment system 10 is provided via a communication link using a wireless connection, a cable connection, or any other means that enables communication between components. The control station 26 or other similar control systems can be located on-site or remotely with respect to the robot drive device 24.

[0022] "Local" is used to refer to the site of the patient 12 and the bedside unit 20. "Remote" is used to refer to a location that does not provide substantial direct physical access to the bedside unit 20 and / or the patient 12. The catheter treatment system 10 can be operated by the control station 26 at the local site, the control station 26 at the remote site, or simultaneously by both the local control station 26 and the remote control station 26. When at the local site, the operator 11 and the control station 26 are arranged in the same room or an adjacent room as the patient 12 and the bedside unit 20.

[0023] The control station 26 of the remote site (and the control computing system) can communicate with the bedside unit 20 and / or the control computing system of the local site using communication systems and services, such as via the Internet for example. In one embodiment, the remote site and the local site are in separate rooms of the same building, separate buildings in the same city, separate municipalities, or other separate locations where the remote site does not provide substantial direct physical access to the bedside unit 20 and / or the patient 12.

[0024] The control station 26 typically includes one or more input systems 28, which include control devices configured to receive user operations for controlling various other components or systems of the robot drive device 24 and / or the catheter treatment system 10. In the illustrated embodiment, the control station 26 enables the operator 11 to control the bedside unit 20 to perform a catheter medical treatment. For example, the input system 28 can be configured to cause the bedside unit 20 to perform various diagnostic or intervention procedures using the EMD controlled by the drive mechanism of the robot drive device 24 (e.g., advancing, retracting, or rotating a guide wire, advancing, retracting, or rotating a catheter, inflating or deflating a balloon located on the catheter, deploying and / or expanding a stent, deploying and / or expanding a stent retriever, deploying and / or expanding a coil, injecting a contrast agent into the catheter, injecting a liquid plug into the catheter, injecting a drug or saline into the catheter, suctioning with the catheter).

[0025] One or more input systems 28 may include one or more touchscreens, joysticks, scroll wheels, and / or buttons. In addition to the input system 28, the control station 26 can use additional user control devices 44 such as foot switches and microphones for voice commands. The input system 28 is configured to instruct the forward, reverse, and / or rotation of the EMD and to be able to instruct the activation or deactivation of various components including pumps, valves, switches, clamps, and the like.

[0026] One or more input systems 28 may include device selection buttons, enabling the operator 11 to select which of the EMDs loaded in the robotic drive 24 to control through user operation of the input control devices of the one or more input systems 28. It is also possible to select an automation routine button, in which case algorithmic operation of the EMD is possible without individual direct commands from the operator 11. In one embodiment, the input system 28 includes one or more control means or icons (not shown) displayed on a touchscreen (e.g., display 30), which, when activated, operate the components of the catheter treatment system 10.

[0027] The display 30 can be configured to display information or patient-specific data to the operator 11 at the control station 26. In one embodiment, the control station 26 may include two or more displays 30. For example, the display 30 can 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 history information (e.g., medical history, age, weight), lesion or treatment evaluation data (e.g., intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR)). Further, the display 30 can be configured to display information specific to the procedure (e.g., procedure checklist, advisories, duration of the procedure, position of the catheter or guidewire, suction vacuum level, volume of drug or contrast agent administered). Additionally, the display 30 may be configured to display information providing functions related to the control computing system, as described later. The display 30 can include a touch screen, i.e., an input device of the system 10.

[0028] The catheter-based treatment system 10 also includes an imaging system 14. The imaging system 14 can be any medical imaging system that can be used in combination with a catheter-based medical treatment (e.g., non-digital X-ray, digital X-ray, CT, MRI, ultrasound). In one embodiment, the imaging system 14 is a digital X-ray imaging device that communicates with the control station 26. The imaging system 14 can include a C-arm that allows the imaging system 14 to rotate partially or completely around the patient 12 in order to obtain images at various angular positions with respect to the patient 12 (e.g., sagittal images, caudal images, anteroposterior images). In one embodiment, the imaging system 14 is a fluoroscopy system that includes a C-arm having an X-ray source 13 and a detector 15, also known as an image intensifier.

[0029] The imaging system 14 can be configured to acquire X-ray images of an appropriate region of the patient 12 during the procedure. For example, the imaging system 14 can be configured to acquire one or more X-ray images of the head to diagnose the neurovascular condition. The imaging system 14 can also be configured to acquire one or more X-ray images (e.g., real-time images) during a catheter-based procedure to assist the operator 11 in properly positioning a guide wire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, etc. during the procedure. The one or more images collected are displayed on the display 30. For example, the images are displayed on the display 30 to enable the operator 11 to accurately move the tip of the aspiration catheter to a position adjacent to the thrombus.

[0030] Here, an orthogonal coordinate system including the X, Y, and Z axes is introduced. The positive X axis points in the distal direction in the longitudinal (axial) direction, i.e., the direction from the proximal end to the distal end. The Y and Z axes are in the cross-section with respect to the X axis, the positive Z axis points upward, i.e., in the direction opposite to gravity, and the direction based on the right-hand rule following this is the Y axis.

[0031] FIG. 2 according to one embodiment is a block diagram of a catheter treatment system 10. The catheter treatment system 10 includes a control computing system 34. The control computing system 34 may physically be, for example, part of the control station 26. The control computing system 34 typically comprises a computer processing unit suitable for controlling the catheter treatment system 10 described herein. For example, the control computing system 34 may be an embedded system, a dedicated circuit, a general-purpose processor that executes program code, etc. The control computing system 34 communicates with the bedside unit 20, the communication system and service 36 (e.g., Internet, firewall, cloud service, session manager, hospital network), the local control station 38, the additional communication system 40 (e.g., telepresence system), the remote control station and computing system 42, and the patient sensor 56 (e.g., electrocardiogram (ECG) device, electroencephalogram (EEG) device, blood pressure monitor, temperature monitor, heart rate monitor, respiratory monitor). The control computing system 34 also communicates with the imaging system 14, the patient table 18, the additional medical system 50, the contrast agent injection system 52, and the auxiliary device 54 (e.g., IVUS, OCT, FFR).

[0032] As described above, the bedside unit 20 includes a robot drive device 24, a positioning system 22, and additional control equipment and a display 46. The additional control equipment and the display 46 can be arranged in the housing of the robot drive device 24. The intervention device and the attached equipment 48 (e.g., guide wire, catheter) are connected to the bedside system 20. In one embodiment, the intervention device and the attached equipment 48 include dedicated devices (e.g., IVUS catheter, OCT catheter, FFR wire, diagnostic catheter for contrast imaging) that connect to their respective auxiliary devices 54 (e.g., IVUS system, OCT system, FFR system).

[0033] In one embodiment, the control computing system 34 is configured to receive and generate control signals based on user operations of control devices 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 those of the local control station 38. The remote control station 42 and the local control station 38 can be separately assembled based on their required functions. The additional user control device 44 may include, for example, one or more foot input controllers. The foot input controller can be configured to enable an operator to select functions of the imaging system 14, such as turning the X-ray source on / off or scrolling through a plurality of stored images. In another embodiment, the foot input controller can be configured to enable an operator to select an EMD mapped to the control device of the input system 28. An additional communication system 40 (e.g., voice conferencing, video conferencing, telepresence) can be employed to assist the operator in interacting with the patient, medical staff (e.g., angio-suite staff), and / or devices in the vicinity of the bedside.

[0034] The control computing system 34 also communicates with both the pump 58 and the vacuum controller 59. The pump 58 comprises some source for generating a vacuum suitable for thrombus aspiration. In one embodiment, the controller 59 can selectively fluidly couple the lumen of the aspiration catheter of the intervention device and accessory 48 with the pump 58.

[0035] According to one embodiment, the operator 11 operates the input system of the remote control station 42 to control the robot drive device 24 and place the aspiration catheter at a first position relative to the thrombus in the patient's blood vessel. A specific example of such positioning, which includes operating a plurality of EMDs in a predetermined sequence, will be described herein. The aspiration catheter is connected to a vacuum controller 59, and this vacuum controller 59 is connected to a pump 58 via a tube. The vacuum controller 59 prevents fluid communication between the lumen of the aspiration catheter and the lumen of the tube. The vacuum controller 59 may include a clamp, a valve, or some other one or more suitable devices.

[0036] The control computing system 34 controls the pump 58 to start evacuating the lumen of the tube connected to the vacuum controller 59. In one embodiment, the control computing system 34 determines that the pressure in the tube lumen has dropped below a target aspiration pressure. In response to this determination, the control computing system 34 controls the vacuum controller 59 to establish fluid communication between the tube lumen and the aspiration catheter lumen (e.g., by opening the valve, clamp, or other device of the controller 59). This operation contributes to drawing (suctioning) the thrombus into the aspiration catheter.

[0037] In one embodiment, the control computing system 34 determines whether the pressure in the tube lumen is greater than a second pressure (e.g., via communication with the pump 58), and in response, controls the vacuum controller 59 to end the fluid communication between the tube lumen and the aspiration catheter lumen. This operation avoids unnecessary aspiration that is not required to remove the thrombus.

[0038] Alternatively, the control computing system 34 instructs the local control station 38 or the remote control station 42 that the pressure in the tube lumen is below the target suction pressure, and this information is presented to the operator 11 via, for example, the display 30. Then, the operator 11 sends a command to the control computing system 34 (e.g., using one or more input systems 28) to automatically establish fluid communication between the tube lumen and the suction catheter lumen. Similarly, the operator 11 is shown that the pressure in the tube lumen is greater than a second pressure, and in response, the operator 11 sends a command to the control computing system 34 to end the fluid communication between the tube lumen and the suction catheter.

[0039] According to another embodiment, after automatically establishing fluid communication between the tube lumen and the suction catheter, before determining whether the pressure in the tube lumen is greater than a second pressure, the control computing system 34 determines whether the pressure in the tube lumen is within a predefined range. If it is determined that the pressure in the tube lumen is within the predefined range, the control computing system 34 instructs the robot drive device 24 to adjust the position of the suction catheter lumen until the pressure in the tube lumen is less than the threshold suction pressure (e.g., by a pre-programmed sequence of operations with or without considering intermediate pressure changes).

[0040] The catheter treatment system 10 can be connected or configured to include various other systems and / or devices not explicitly shown. For example, the catheter treatment system 10 can include an image processing engine, a data storage and archival system, an automatic balloon and / or stent inflation system, a drug infusion system, a drug tracking and / or logging system, a user log, an encryption system, or a system that restricts access to or use of the catheter treatment system 10. It should be noted that any of the determinations related to the control computing system 34 here can also be executed by any appropriate component of the system 10 or any appropriate component connected to the system 10.

[0041] As described above, the control computing system 34 communicates with the bedside unit 20 that includes the robot drive device 24, the positioning system 22, and optionally additional control equipment and a display 46. The control computing system 34 receives signals from the remote control station 42 based on user operations of the control equipment of the input system of the remote control station 42, and provides corresponding control signals to the bedside unit 20 to control the operation of the motors and drive mechanisms used to drive the corresponding EMDs in various degrees of freedom. Various drive mechanisms are provided as part of the robot drive device 24.

[0042] FIG. 3 according to one embodiment is a perspective view of the robotic drive 24 of the catheter treatment system 10. The embodiment is not limited to the robotic drive 24 of FIG. 3. The robotic drive 24 of FIG. 3 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 respective stages 62a-d movably attached to the linear member 60. Each individual device module 32a-d can be coupled to the stages 62a-d using connectors such as offset brackets 78a-d. In another embodiment, the device modules 32a-d are directly attached to the stages 62a-d. Each stage 62a-d can be individually actuated to move linearly along the linear member 60. Thus, each stage 62a-d (and the corresponding device module 32a-d coupled to the stage 62a-d) can operate independently of each other and with respect to the linear member 60.

[0043] A drive mechanism is used to actuate each stage 62a-d. In the embodiment shown in FIG. 3, the drive mechanism includes individual stage translation motors 64a-d coupled to respective ones of the stages 62a-d and a stage drive mechanism 76, and the stage drive mechanism 76 is, for example, a lead screw utilizing a rotating nut, a rack utilizing a pinion, a belt utilizing a pinion or pulley, or a chain utilizing a sprocket. Alternatively, the stage translation motors 64a-d may themselves be linear motors. In one embodiment, the stage drive mechanism 76 is a combination of these mechanisms, for example, each stage 62a-d employs a different type of stage drive mechanism. In the case of an embodiment where the stage drive mechanism is a lead screw and a rotating nut, the lead screw is rotated and each of the stages 62a-d is engaged or disengaged with the lead screw to move, such as advancing or retracting. In the embodiment illustrated in FIG. 3, the stages 62a-d and the device modules 32a-d are in a tandem drive configuration.

[0044] Each device module 32a-d includes device modules 68a-d and cassettes 66a-d mounted and connected to the device modules 68a-d. In the illustrated embodiment of FIG. 3, each cassette 66a-d is mounted to the device modules 68a-d in the vertical direction. In other embodiments, each cassette 66a-d is mounted to the device modules 68a-d in a different mounting direction. Each cassette 66a-d is configured to connect to and support the proximal portion of an EMD (not shown). Also, each cassette 66a-d can include elements that provide one or more degrees of freedom in addition to the linear motion provided by the operation of corresponding stages 62a-d that move linearly along the linear member 60. For example, the cassette 66a-d can include elements used to rotate an EMD supported within the cassette when the cassette is connected to the device modules 68a-d. Each device module 68a-d includes at least one coupler to provide a drive interface to the mechanisms within each cassette 66a-d to provide additional degrees of freedom. Each cassette 66a-d also includes a channel in which device supports 79a-d are located, and each device support 79a-d is used to prevent buckling of the EMD.

[0045] Support arms 77a, 77b, 77c are attached to each of the device modules 32a, 32b, 32c, providing fixed points that support the proximal ends of the device supports 79b, 79c, 79d, respectively. The robot drive 24 also includes a device support connection 72 connected to the device support 79, a distal support arm 70, and a support arm 77o. The support arm 77o is used to provide a fixed point that supports the proximal end of the most distal device support 79a housed in the most distal device module 32a. The introducer interface support (redirector) 74 can be connected to the device support connection 72 and an EMD (e.g., an introducer sheath). Such a configuration of the robot drive 24 has the advantage of reducing the size and weight of the robot drive 24 by using an actuator with a single linear member.

[0046] To prevent contamination of patients by pathogens, healthcare staff use aseptic techniques in the room where the bedside unit 20 and the patient 12 are housed. The room housing the bedside unit 20 and the patient 12 is, for example, a catheter lab or an angiography suite. The aseptic technique consists of using sterile barriers, sterile instruments, appropriate patient preparation, environmental management, and contact guidelines. That is, all EMDs and intervention accessories are sterilized, and only contact with either a sterile barrier or a sterile instrument is permitted. In one embodiment, a sterile drape (not shown) is placed over the non-sterile robotic drive device 24. Each cassette 66a-d is sterilized and acts as a sterile interface between the draped robotic drive device 24 and at least one EMD. Each cassette 66a-d is designed to be sterilized for single use or is designed such that all or part of the cassette 66a-d or its components can be resterilized for use in multiple procedures.

[0047] As used herein, "cassette" broadly refers to a component of a robotic drive system that includes components for supporting and operating (e.g., rotating and / or translating) at least one EMD. "Device module" broadly refers to a component of a robotic drive system that includes one or more motors with drive couplers that connect to the EMD actuating elements of the cassette. The cassette provides a sterile interface between at least one EMD and the device module, either directly or via a device adapter. "Drive module" refers to the combination of the device module and the cassette.

[0048] In one embodiment, the EMD is a catheter having a hub at its proximal end and a flexible shaft extending from the hub towards the distal end of the catheter, with the shaft being softer than the hub. In one embodiment, the catheter includes an intermediate portion that is the transition portion between the hub and the shaft, and the intermediate portion has intermediate flexibility that is softer than the hub and harder than the shaft. In one embodiment, the intermediate portion is a strain relief.

[0049] The longitudinal axis (vertical axis) of a member (e.g., the EMD or other element of a catheter-based treatment system) is the lengthwise line or axis of the member that passes through the center of the member's cross-section in the direction from the proximal portion of the member to the distal portion of the member. For example, the longitudinal axis of a guidewire is the central axis in the direction from the proximal portion of the guidewire to the distal portion of the guidewire, even if the guidewire is not straight at that portion.

[0050] Axial movement of a member means translation (parallel movement) of the member along its longitudinal axis. For example, when the distal end of the EMD is axially moved distally along its longitudinal axis into or further into the patient, the EMD is being advanced. When the distal end of the EMD is axially moved proximally along its longitudinal axis out of or further out of the patient, the EMD is being withdrawn.

[0051] In this context, axial insertion means inserting a first member into a second member along the longitudinal axis of the second member. For example, an EMD axially loaded into a collet is axially inserted into the collet. An example of axial insertion is rear-loading a catheter onto the proximal end of a guidewire. Lateral insertion means inserting a first member into a second member in a direction within a plane that intersects the longitudinal axis of the second member. Lateral insertion is also referred to as radial loading or side loading.

[0052] The rotational movement of a member refers to the angular change of the member around the longitudinal axis of a local part of the member. For example, the rotational movement of the EMD corresponds to the rotation of the EMD clockwise or counterclockwise around its longitudinal axis by an applied torque. Continuous operation refers to an operation that does not require resetting and has no interruption, and discrete operation refers to an operation that requires resetting and is interrupted.

[0053] "Distal" and "proximal" define the relative positions of two different parts. In the case of a robotic drive device, "distal" and "proximal" are defined by the position of the robotic drive device relative to the patient according to the purpose of use.

[0054] When used to define relative positions, the distal portion is the part of the robotic drive that is closer to the patient than the proximal portion when the robotic drive is in the intended use position. In the context of the patient's body, a vascular landmark that is further along the path from the access point is considered to be distal to a landmark closer to the access point. The access point is the point where the EMD enters the patient. Similarly, the proximal portion is the part of the robotic drive that is further from the patient than the distal portion when the robotic drive is in the intended use position.

[0055] When used to define directions, the distal direction refers to the path along which something is moving or attempting to move, or the path along which something is aimed or directed from the proximal portion towards the distal portion and / or towards the patient, when the robotic drive is in the intended use position. The proximal direction is the opposite of the distal direction. For example, referring to FIG. 1, the robotic drive is shown from the perspective of the operator facing the patient. In this configuration, the distal direction is the direction of the positive X-axis coordinate, and the proximal direction is the direction of the negative X-axis coordinate.

[0056] Referring to FIG. 3 with respect to the operation of the module, the EMD moves in the distal direction in the path towards the patient through the introducer interface support 74 that defines the distal end of the robotic drive 24. The proximal end of the robotic drive 24 is the point that is furthest from the distal end in the direction of the negative X-axis.

[0057] Referring to FIG. 3 also with respect to the positions of the individual modules, the most distal device module is the device module 32a that is closest to the distal end of the robotic drive 24. The most proximal device module is the device module 32d that is disposed furthest from the distal end of the robotic drive 24 in the direction of the negative X-axis. The relative positions of the device modules are determined by their relative arrangements with respect to the distal end of the robotic drive. For example, the device module 32b is distal to the device module 32c.

[0058] With respect to the distal / proximal portions, sections (sites), or ends of the EMD or the robotic drive device, the portions of the cassette 66a and the device module 68a are defined by their arrangement relative to the distal end of the robotic drive device. For example, when the cassette 66a is in the use position of the device module 68a, the distal end of the cassette 66a is the portion of the cassette closest to the distal end of the robotic drive device, and the proximal end of the cassette 66a is the portion of the cassette farthest from the distal end of the robotic drive device in the negative X-axis direction. In other words, the distal end of the cassette 66a is the portion of the cassette through which the EMD closest to the path to the patient in the use position passes.

[0059] As described above, embodiments of a control station, such as the control station 26, can include various input systems for controlling the bedside unit 20. The input system can include various input control devices (e.g., buttons, scroll wheels, joysticks, touchscreens) that a user can operate to control (or direct) the operation of the robotic drive device 24. Such input control devices can be arranged in various layouts and patterns in the input system to perform desired tasks that require the individual (and sometimes simultaneous) operation of multiple EMDs, facilitating the desired functions and their coordinated ranking.

[0060] Furthermore, embodiments of the input system can be configured to operate in various control modes. The functions assigned to one or more control devices of the input system in a first control mode can be different from the functions assigned to those one or more control devices in a second control mode, and the control mode can be selected based on the procedure being performed, one or more devices being controlled, the operator's preferences, or some other factor. The input system can be configured to switch between multiple control modes in response to an input from the operator or an input from the control computing system 34.

[0061] The input system described herein can be fixed, integrated, or simply placed on the surface of the control station 26. The input system described herein has either a single integrated housing or multiple housings that can be individually moved.

[0062] FIG. 4 according to one embodiment is a schematic diagram of a thrombus removal system. Each component of the system 400 can be implemented by one or more devices consisting of an appropriate combination of hardware and / or software, and two or more of the illustrated components can also be implemented on the same device.

[0063] FIG. 4 shows a blood vessel 410 that is either a vein or an artery within a patient's body. The blood vessel 410 can be located at any position within the patient's body. A thrombus 420 is within the blood vessel 410. The embodiments are not limited to the thrombus and blood vessel of the relative sizes and shapes shown in FIG. 4 and subsequent figures. The embodiments are also not limited to a single substantially continuous thrombus.

[0064] The catheter controller 430 is operative to navigate the catheter 440 to the thrombus 420 within the blood vessel 410. As shown, the catheter controller 430 has reached a position adjacent to the thrombus 420 within the blood vessel 410 with the tip 440a of the catheter 440. The catheter 440 can be an EMD that defines a lumen for generating a negative pressure. The catheter 440 can be composed of a suction catheter designed to suit the purpose that defines a catheter lumen.

[0065] As described below, the catheter controller 430 can operate (i.e., advance / retreat / rotate) one or more guide wires and catheters (not shown) to navigate the catheter 440 to the illustrated position. Such navigation can be facilitated (but not limited to) using a robotic drive device such as the robotic drive device 24. That is, in one embodiment, the catheter controller 430 can be included in the catheter-based treatment system 10.

[0066] The vacuum source 450 includes a pump and other devices suitable for generating negative pressure in the intervention chamber. According to the system 400, the vacuum source 450 is connected to a tube (pipe) 460a that is connected to the valve / clamp 470. The valve / clamp 470 is connected to a tube 460b that is connected to the catheter 440 via the catheter controller 430. The tubes 460a and 460b are made of tubes suitable for thrombus aspiration as described herein and together include a tube lumen.

[0067] When the valve / clamp 470 is closed, the negative pressure generated by the vacuum source 450 appears in the lumen of the tube 460a but does not appear in the lumen of the tube 460b (and thus not in the catheter 440 either). When the valve / clamp 470 is open, the vacuum source 450, the lumen of the tube 460a, the lumen of the tube 460b, and the lumen of the catheter 440 are all in fluid communication with each other. Accordingly, the negative pressure generated by the vacuum source 450 appears at the tip 440a of the catheter 440.

[0068] According to the system 400, the pressure sensor 480 is connected to or integrated with the vacuum source 450. The pressure sensor 480 measures the pressure generated by the vacuum source 450, for example, the pressure that occurs in the tube 460a when the valve / clamp 470 is closed. The valve / clamp 470 can monitor this pressure through communication with the pressure sensor 480 and determine its opening and closing based on this.

[0069] For example, in one embodiment, the catheter controller 430 operates a series of EMDs under the control of an operator to position the tip 440a of the catheter 440 in proximity to the thrombus 420. Next, the tube 460b is connected to the catheter 440 either manually or via the mechanism of the catheter controller 430, and the tube 460b and the catheter 440 are in fluid communication with each other. The vacuum source 450 is activated to start generating negative pressure in the tube 460a (e.g., by a command from the catheter controller 430 or the operator).

[0070] The valve / clamp 470 monitors the pressure measured by the pressure sensor 480 until it is determined that the pressure in the tube 460a is below the target suction pressure. Alternatively, after it is determined by the pressure sensor 480 that the pressure in the tube 460a is below the target suction pressure, a signal is transmitted from the pressure sensor 480 to the valve / clamp 470. In either case, in response to that determination, the valve / clamp 470 opens and fluid communication between the tube 460a, the tube 460b, and the catheter 440 is automatically established. As a result, the thrombus 420 is forcibly removed from the blood vessel 410 and sucked into the catheter 440.

[0071] After the valve / clamp 470 opens, the valve / clamp 470 determines, in accordance with the pressure sensor 480, that the pressure in the lumen of the tube 460a is greater than a second pressure, and in response, the valve / clamp 470 closes, automatically ending the fluid communication between the lumen of the tube 460a and the catheter 440. This procedure serves to detect the completion of the removal of the thrombus 420 and to end the suction in response to the completion.

[0072] In one embodiment, after the valve / clamp 470 opens and before the pressure in the lumen of the tube 460a becomes greater than the second pressure and the valve / clamp 470 closes, the valve / clamp 470 determines, by the pressure sensor 480, that the pressure in the lumen of the tube 460a is within a predefined range. The predefined range is higher than a first pressure and lower than the second pressure and is intended to indicate the presence of some resistance to the suction into the catheter 440, but not to the extent expected when the tip 440a is positioned against the thrombus 420. If it is determined that the pressure in the lumen of the tube 460a is within the predefined range, the valve / clamp 470 (or, for example, the pressure sensor 480) communicates with the catheter controller 430 and changes (e.g., rotates) the position of the catheter 440 until the pressure in the lumen of the tube 460a is below a predetermined pressure.

[0073] In one embodiment, the valve / clamp 470 is a catheter Controller 430is a component. In this case, a single-section tube extends from the vacuum source 450 to the valve / clamp 470 and is directly connected to the catheter 440 by the catheter controller 430.

[0074] FIG. 5 according to one embodiment is a schematic diagram of a thrombus removal system. For system 500, a blood vessel 510 and a thrombus 520 within the blood vessel 510 as described above are shown. The catheter controller 530 operates to navigate the catheter 540 to the thrombus 520 as described with respect to the catheter controller 430 and the catheter 440.

[0075] The vacuum source 550, the tube 560a, the tube 560b, the valve / clamp 570, and the pressure sensor 580 are configured as described above with respect to the similarly named elements of system 400. System 500 also includes a pressure controller 590 disposed between the pressure sensor 580 and the valve / clamp 570. The pressure controller 590 performs the determination and control of the valve / clamp 570 as described above with respect to the valve / clamp 470. Generally, the pressure controller 590 communicates with the pressure sensor 580 to monitor the pressure in the lumen of the tube 560a and based on this, issues an opening / closing instruction to the valve / clamp 570. In one embodiment, the pressure controller 590 is a component of the catheter controller 530. For this example, the pressure controller 590 may be constituted by the control computing system 34 of system 10.

[0076] The pressure controller 590 activates the vacuum source 550 and starts negative pressure generation in the tube 560a. The pressure controller 590 monitors the pressure measured by the pressure sensor 580 until the pressure in the tube 560a falls below the target suction pressure. In response to this determination, the pressure controller 590 issues an opening instruction to the valve / clamp 570, automatically establishing fluid communication between the tube 560a, the tube 560b, and the catheter 540.

[0077] Following the opening of this valve / clamp 570, the pressure controller 590 further monitors the pressure measured by the pressure sensor 580 until the pressure in the tube 560a becomes greater than the second pressure. In response, the pressure controller 590 instructs the valve / clamp 570 to close, automatically terminating the fluid communication between the lumen of the tube 560a and the catheter 540. Further, if the pressure controller 590 determines that the pressure in the lumen of the tube 560a is within a predefined range that is higher than the first pressure and lower than the second pressure, the pressure controller 590 communicates with the catheter controller 530 and changes (e.g., rotates) the position of the catheter 540 until the pressure in the lumen of the tube 560a becomes less than or equal to the first pressure.

[0078] FIG. 6 according to one embodiment is a schematic diagram of a thrombus removal system. The system 600 is similar to the system 500 of FIG. 5, except that the above-described functions of the pressure sensor 580 and the pressure controller 590 are incorporated into the pressure sensor and controller 690. The vacuum source 680, the tube 660a, the tube 660b, the valve / clamp 670, and the catheter controller 630 are configured as described above with respect to the similarly named elements of the system 500.

[0079] The pressure sensor and controller 690 communicates with the vacuum source 680, monitors the pressure in the lumen of the tube 660a, and accordingly gives instructions to open and close the valve / clamp 670. As described above with respect to the pressure controller 590 of the system 500, in one embodiment, the pressure sensor and controller 690 is a component of the catheter controller 630. For example, the pressure sensor and controller 690 may be configured by the control computing system 34 of the system 10.

[0080] The pressure sensor and controller 690 activates the vacuum source 680 and starts generating negative pressure in the tube 660a. The pressure sensor and controller 690 monitors the pressure generated by the vacuum source 680 (e.g., communicates with the vacuum source 680 including a pressure sensor or by optical detection of the tube 660a) until it is determined that the pressure in the tube 60a is below the target suction pressure. In response to this determination, the pressure sensor and controller 690 instructs the valve / clamp 670 to open, automatically establishing fluid communication between the tube 660a, the tube 660b, and the catheter 640.

[0081] Next, the pressure sensor and controller 690 determines that the pressure in the tube 660a has become greater than a second pressure, and in response, instructs the valve / clamp 670 to close, automatically terminating the fluid communication between the lumen of the tube 660a and the catheter 640. As described above, if the pressure sensor and controller 690 determines that the pressure in the lumen of the tube 660a is within a predefined range that is higher than a first pressure and lower than a second pressure while the valve / clamp 670 is open and then closed, the pressure sensor and controller 690 communicates with the catheter controller 630 and changes (e.g., rotates) the position of the catheter 640 until the pressure in the lumen of the tube 660a is below the first pressure.

[0082] FIG. 7 according to one embodiment is a schematic diagram of a thrombus removal system. The system 700 includes the display of an indicator based on the pressure on the operator and subsequent operator control of the system 700. The system 700 is illustrated in two alternative configurations. In the first configuration, the pressure sensor 770a is connected to or integrated with the vacuum source 740. In the second configuration, the pressure sensor 770b is separate from the vacuum source 740. The pressure sensor 770b determines the pressure in the tube 750a by optical means, a sensor element in the tube 750a, or other suitable techniques.

[0083] Regardless of the implementation of the pressure sensor (e.g., pressure sensor 770a or pressure sensor 770b), system 700 includes displaying an indication of the pressure in tube 750a to operator 775 via display 780. Although FIG. 7 shows a direct communication link between pressure sensor 770a / pressure sensor 770b and display 780, the pressure value can be transmitted to display 780 from pressure sensor 770a / pressure sensor 770b via various intermediate components such as, for example, control computing system 34.

[0084] During the procedure, operator 775 operates catheter controller 730 (e.g., of a catheter-based robotic treatment system such as system 10) to position catheter 740 relative to thrombus 720 within blood vessel 710. Once operator 775 determines a satisfactory position, operator 775 activates vacuum source 740 to initiate generation of negative pressure within tube 750a.

[0085] Display 780 displays an indication of the negative pressure to operator 775. This indication can include the pressure value and / or a presentation that the pressure in tube 750a is below a target suction pressure. The indication may simply be a notification informing that the pressure in tube 750a is below the target suction pressure and the system is ready for suction. After receiving the indication, operator 775 operates operator controller 790 to instruct valve / clamp 760 to open, automatically establishing fluid communication between tube 750a, tube 750b, and catheter 740. Operator controller 790 is configured by any of the input systems described herein and includes, for example, a touch screen (e.g., such that display 780 also constitutes operator controller 790), console buttons, foot switches, and joysticks (among others).

[0086] After the valve / clamp 760 is opened, the display 780 further displays an indication that the pressure in the tube 750a has become greater than the second pressure. This indication can include a notification to end suction. In response to the indication, the operator 775 operates the operator controller 790 to close the valve / clamp 760 and end the fluid communication between the tube 750a and the catheter 740. In one embodiment of the system 700, when the pressure in the tube 750a is monitored and it is determined that the pressure in the tube 750a has become greater than the second pressure, the valve / clamp 760 is instructed to automatically close without the intervention of the operator 775.

[0087] During the period from the opening to the closing of the valve / clamp 760 described above, the display 780 may display an indication that the pressure in the lumen of the tube 750a is within a predefined range that is higher than the first pressure and lower than the second pressure. The indication includes, for example, a pressure value and / or a notification to reposition the catheter 740 relative to the thrombus 720. Based on the indication, the operator 775 instructs the operation of the catheter controller 730 to reposition the catheter 740. The repositioning operation consists of a set of pre-programmed operations and / or individual operations instructed by the operator 775. In one embodiment, the display 780 displays an indication when the pressure in the lumen of the tube 750a decreases below the first pressure, at which point the operator 775 can stop the instruction to the catheter controller 730.

[0088] FIG. 8 according to one embodiment is a schematic diagram of a thrombus removal system. The system 800 is a specific example of the system 700. In particular, the valve 840 is a specific example of the valve / clamp 760. As described with respect to the system 700, the operator 875 can operate the catheter controller 820 to position the catheter 810 relative to a thrombus in a blood vessel. Once the placement is satisfactory, the vacuum source 830 is operated to initiate the generation of a negative pressure in the tube 850a.

[0089] The display 870 displays an indicator of negative pressure to the operator 875. After receiving the indicator, the operator 875 can directly operate and open the valve 840 840 , and accordingly, fluid communication is automatically established between the tube 850a, the tube 850b, and the catheter 810. In the illustrated embodiment, the valve 840 is a flow control valve and includes a slider switch 845 that can be operated with one hand to open or close the valve 840. In one embodiment, various suitable devices for establishing and terminating fluid communication between two lumens can also be employed.

[0090] The display 780 can further display an indicator that the pressure in the tube 750a has become greater than a second pressure. This indicator can include a notification for terminating suction. In response to the indicator, the operator 775 operates the operator controller 790 to close the valve / clamp 760 and terminate the fluid communication between the tube 750a and the catheter 740. In one embodiment of the system 700, the pressure in the tube 750a is monitored, and if it is determined that the pressure in the tube 750a has become greater than the second pressure, the valve / clamp 760 is automatically instructed to close without the intervention of the operator 775.

[0091] During the period from opening to closing of the valve / clamp 760 described above, the display 780 can display an indicator that the pressure in the lumen of the tube 750a is higher than a first pressure and within a predefined range greater than a second pressure. This indicator can include, for example, a pressure value and / or a notification to reposition the catheter 740 with respect to the thrombus 720. Based on the indicator, the operator 775 can instruct the operation of the catheter controller 730 to reposition the catheter 740. The repositioning operation consists of a set of pre-programmed operations and / or individual operations instructed by the operator 775. In one embodiment, the display 780 displays an indicator when the pressure in the lumen of the tube 750a decreases below the first pressure, at which point the operator 775 can stop the instruction to the catheter controller 730.

[0092] FIG. 9 according to one embodiment is a flowchart of a process 900 for aspirating a thrombus. The process 900 and other processes described herein can be executed using any suitable combination of hardware and software. The software program code for implementing these processes can be stored by a non-transitory tangible medium including a fixed disk, volatile or non-volatile random access memory, DVD, flash drive, and magnetic tape, and is executed by a suitable processing unit including (but not limited to) one or more microprocessors, microcontrollers, processing cores, and processor threads. The embodiments are not limited to the examples described below.

[0093] First, at S910, an aspiration catheter defining an aspiration catheter lumen is placed in a first position relative to the thrombus. For example, the operator controls a robotic drive device to manipulate a defined sequence of a series of EMDs at S910 to position the tip of the aspiration catheter relative to the thrombus. According to an example of such a defined sequence, an introducer sheath is inserted into an access site such as (but not limited to) the radial artery or femoral artery. Next, a diagnostic guidewire is inserted into the sheath and advanced to the base of the skull by a robotic drive device responsive to the operator's commands. Thereafter, the guide catheter and the base catheter are advanced to the base of the skull through the diagnostic guidewire (simultaneously or sequentially). Then, the diagnostic guidewire and the guide catheter are removed, leaving the base catheter.

[0094] Subsequently, a coaxial "stack" consisting of a micro-wire wrapped in a micro-catheter wrapped in an aspiration catheter is inserted into the base catheter. Led by the micro-wire, the stack passes through the base of the skull (i.e., where the base catheter ends) and navigates the vasculature until the micro-wire reaches the thrombus. Thereafter, the aspiration catheter is advanced either with or without the micro-catheter (for structural support) until the lumen of the aspiration catheter contacts the thrombus. The above process is assisted by simultaneously acquired contrast X-ray images.

[0095] Figure 10 shows blood vessel 1000 containing base catheter 1010. A stack consisting of micro wire 1020, micro catheter 1030, and aspiration catheter 1040 is on the path to thrombus 1050 through base catheter 1010. Micro wire 1020 has reached thrombus 1050, and micro catheter 1030 is being advanced through micro wire 1020 towards thrombus 1050. Next, aspiration catheter 1040 is advanced through micro catheter 1030 (and micro wire 1020) until it reaches thrombus 1050. Micro wire 1020 and micro catheter 1030 are then removed from within aspiration catheter 1040.

[0096] Returning to process 900, at S920, evacuation of the lumen of the tube is initiated to generate negative pressure within the lumen. The lumen of the tube is connected to a pump or other vacuum source as described above. Also, as previously described, the lumen of the tube is not in fluid communication with the aspiration catheter. According to one embodiment, the operator operates an input controller provided in the robotic catheter treatment system to instruct the activation of the vacuum source at S920.

[0097] The flow waits at S930 until the pressure in the lumen of the tube equals (or falls below) the target pressure. The target pressure is predetermined and / or set by the operator and is determined based on the size and / or shape of the thrombus, the nature of the blood vessel in which the thrombus is located (e.g., vulnerable, tortuous, damaged), or other factors. If it is determined that the pressure in the lumen of the tube equals (or has fallen below) the target pressure, the flow proceeds to S940.

[0098] With S940, a fluid communication is automatically established between the lumen of the tube and the lumen of the aspiration catheter. Some examples of S940 will be described here. In one example, the tube and the aspiration catheter are connected to one end and the other end of a closed valve prior to S940, and S940 includes opening this valve. The valve can be opened by an electromechanical actuator or manually by an operator. Specific examples of S940 are not limited to the examples described here.

[0099] S1110 - S1140 of process 1100 shown in FIG. 11 proceed in the same manner as S910 - S940 of process 900. After S1140, at S1150, the flow waits until it is determined that the pressure in the lumen of the tube exceeds (or is equal to) a second target pressure. As described above, the second (target) pressure is the pressure expected when a thrombus is discharged from the blood vessel (and the aspiration catheter).

[0100] When the second target pressure is reached, the flow proceeds to S1160. At S1160, the fluid communication between the lumen of the tube and the lumen of the aspiration catheter is terminated. Continuing with the above example, S1160 includes electromechanically closing or manually closing a valve disposed between the lumen of the tube and the lumen of the aspiration catheter.

[0101] Referring to FIGS. 12a - b, S1205, S1210, and S1215 of process 1200 proceed in the same manner as S910, S920, and S930 of process 900, respectively. At S1220, an indicator indicating that the pressure in the lumen of the tube (i.e., the pressure appearing in the lumen of the aspiration catheter) has reached the target pressure is displayed to the operator. As described above, the indicator is displayed by a display on the operator console, communicated from a vacuum source or a separate pressure sensor to a control computing system, and the control computing system instructs the display of the indicator.

[0102] At S1225, the flow waits until a command is received from the operator. While waiting at S1225, the target pressure is maintained. When the flow proceeds to S1230, the operator accordingly operates the input controller of the control console and instructs the system to perform suction.

[0103] At S1230, fluid communication is automatically established between the lumen of the tube and the lumen of the suction catheter. Then, the flow waits at S1235 until it is determined that the pressure in the lumen of the tube exceeds (or is equal to) the second target pressure. At S1240, another indicator is displayed to the operator, and this indicator indicates that the pressure in the lumen of the tube (and in the lumen of the suction catheter) has reached the second target pressure. The flow waits at S1245 until the next command is received from the operator.

[0104] At S1245, the operator operates the input controller of the control console and instructs the system to end suction. Accordingly, at S1250, the liquid communication between the lumen of the tube and the lumen of the suction catheter is terminated. For example, at S1250, the valve disposed between the lumen of the tube and the lumen of the suction catheter is closed.

[0105] FIGs. 13a - b according to an embodiment are flowcharts of process 1300. S1310 - S1340 of process 1300 proceed in the same manner as S910 - S940 of process 900. After fluid communication is established between the lumen of the tube and the suction catheter at S1340, the flow proceeds to S1350.

[0106] At S1350, it is determined whether the pressure in the lumen of the tube is within a predefined range. As described above, the predefined range is a predefined pressure range indicating that the suction catheter is not engaged with the thrombus in a manner that can appropriately aspirate the thrombus. If the pressure in the lumen of the tube is not within the predefined range, the flow proceeds to S1370.

[0107] In S1350, when it is determined that the pressure in the lumen of the tube is within a predefined range, in S1360, the position of the lumen of the aspiration catheter is automatically adjusted until the pressure in the lumen of the tube falls below the threshold suction pressure. This adjustment can be automatically performed without operator intervention using one or more sets of catheter operations aimed at improving the position of the catheter. In one embodiment, the adjustment is performed, in part or in whole, under the control of the operator.

[0108] In S1370, it is determined whether the pressure in the lumen of the tube exceeds a second pressure. If it does not exceed, the flow returns to S1350 and the above steps are continued. If it exceeds, in S1380, the fluid communication between the lumen of the tube and the lumen of the aspiration catheter is automatically terminated using the systems described herein or known systems.

[0109] Those of ordinary skill in the art will naturally understand that various modifications and corrections of the above-described embodiments can be made without departing from the scope of the claims. Therefore, it is natural that the idea according to the claims can be implemented other than specifically described herein.

Claims

1. A method for controlling the intraluminal pressure of a catheter, comprising: the catheter is configured to be in fluid communication with a tube via a vacuum controller, the tube extends from the vacuum controller to a vacuum source to connect the vacuum controller to the vacuum source; in response to a first command, disposing the lumen of the catheter against a thrombus; after this disposition, with the fluid communication between the lumen of the tube and the lumen of the catheter blocked by the vacuum controller, in response to a second command, starting to evacuate the lumen of the tube by the vacuum source; determining that the pressure in the lumen of the tube becomes below a target suction pressure due to this evacuation; in response to the determination that the pressure in the lumen of the tube has become below the target suction pressure, automatically establishing fluid communication between the lumen of the tube and the lumen of the catheter by the vacuum controller.

2. After automatically establishing fluid communication between the lumen of the tube and the lumen of the catheter, determining whether the pressure in the lumen of the tube is greater than a second pressure; when it is determined that the pressure in the lumen of the tube is greater than the second pressure, automatically terminating the fluid communication between the lumen of the tube and the lumen of the catheter by the vacuum controller. The method according to claim 1, further comprising this.

3. After automatically establishing fluid communication between the lumen of the tube and the lumen of the catheter and before determining whether the pressure in the lumen of the tube is greater than the second pressure, determining whether the pressure in the lumen of the tube is within a predefined range; when it is determined that the pressure in the lumen of the tube is within the predefined range, automatically adjusting the position of the lumen of the catheter until the pressure in the lumen of the tube becomes lower than a threshold suction pressure. The method according to claim 2, further comprising this.

4. After automatically establishing fluid communication between the lumen of the tube and the lumen of the catheter, determining whether the pressure in the lumen of the tube is within a predefined range; when it is determined that the pressure in the lumen of the tube is within the predefined range, automatically adjusting the position of the lumen of the catheter until the pressure in the lumen of the tube becomes lower than a threshold suction pressure. The method according to claim 1, further comprising this.

5. After automatically establishing fluid communication between the inner cavity of the tube and the inner cavity of the catheter, it is determined whether the pressure in the inner cavity of the tube is greater than a second pressure. When it is determined that the pressure in the inner cavity of the tube is greater than the second pressure, an indicator is displayed to the operator. After displaying the indicator, while the pressure in the inner cavity of the tube is greater than the second pressure, a command is received from the operator. In response to receiving the command, the vacuum controller automatically terminates the fluid communication between the inner cavity of the tube and the inner cavity of the catheter. The method according to claim 1 further includes this.

6. After automatically establishing fluid communication between the inner cavity of the tube and the inner cavity of the catheter and before determining whether the pressure in the inner cavity of the tube is greater than the second pressure, it is determined whether the pressure in the inner cavity of the tube is within a predefined range. When it is determined that the pressure in the inner cavity of the tube is within the predefined range, the position of the inner cavity of the catheter is automatically adjusted until the pressure in the inner cavity of the tube is lower than a threshold suction pressure. The method according to claim 5 further includes this.

7. A method for controlling the pressure in the inner cavity of a catheter, wherein the catheter is configured to be in fluid communication with a tube via a vacuum controller, and the tube extends from the vacuum controller to a vacuum source to connect the vacuum controller to the vacuum source. In response to a first command, the inner cavity of the catheter is placed against a thrombus. After this placement, with the fluid communication between the inner cavity of the tube and the inner cavity of the catheter blocked by the vacuum controller, in response to a second command, the evacuation of the inner cavity of the tube is started by the vacuum source. It is determined that the pressure in the inner cavity of the tube becomes below a target suction pressure due to this evacuation. In response to the determination that the pressure in the inner cavity of the tube has become below the target suction pressure, a first indicator is displayed to the operator. After displaying the first indicator, while the pressure in the inner cavity of the tube is below the target suction pressure, a third command for establishing fluid communication between the inner cavity of the tube and the inner cavity of the catheter is received from the operator. In response to receiving the third command, the vacuum controller automatically establishes fluid communication between the inner cavity of the tube and the inner cavity of the catheter. A method including this.

8. After automatically establishing fluid communication between the inner lumen of the tube and the inner lumen of the catheter, determine whether the pressure in the inner lumen of the tube is greater than a second pressure. When it is determined that the pressure in the inner lumen of the tube is greater than the second pressure, display a second indicator to the operator. After displaying the second indicator, receive a fourth command from the operator while the pressure in the inner lumen of the tube is greater than the second pressure. In response to receiving the fourth command, automatically terminate the fluid communication between the inner lumen of the tube and the inner lumen of the catheter by the vacuum controller. The method according to claim 7 further includes this.

9. After automatically establishing fluid communication between the inner lumen of the tube and the inner lumen of the catheter and before determining whether the pressure in the inner lumen of the tube is greater than the second pressure, determine whether the pressure in the inner lumen of the tube is within a predefined range. When it is determined that the pressure in the inner lumen of the tube is within the predefined range, automatically adjust the position of the inner lumen of the catheter until the pressure in the inner lumen of the tube is lower than a threshold suction pressure. The method according to claim 8 further includes this.

10. After automatically establishing fluid communication between the inner lumen of the tube and the inner lumen of the catheter and before determining whether the pressure in the inner lumen of the tube is greater than the second pressure, determine whether the pressure in the inner lumen of the tube is within a predefined range. When it is determined that the pressure in the inner lumen of the tube is within the predefined range, display a third indicator to the operator to adjust the position of the inner lumen of the catheter until the pressure in the inner lumen of the tube is lower than a threshold suction pressure. The method according to claim 8 further includes this.

11. After automatically establishing fluid communication between the inner lumen of the tube and the inner lumen of the catheter, determine whether the pressure in the inner lumen of the tube is within a predefined range. When it is determined that the pressure in the inner lumen of the tube is within the predefined range, automatically adjust the position of the inner lumen of the catheter until the pressure in the inner lumen of the tube is lower than a threshold suction pressure. The method according to claim 7 further includes this.

12. After automatically establishing fluid communication between the lumen of the tube and the lumen of the catheter, it is determined whether the pressure in the lumen of the tube is within a predefined range. When it is determined that the pressure in the lumen of the tube is within the predefined range, a third indicator is displayed to the operator to adjust the position of the lumen of the catheter until the pressure in the lumen of the tube becomes lower than the threshold suction pressure. The method according to claim 7 further includes this.

13. A catheter defining a lumen, A vacuum source, A tube defining a lumen, wherein a first end of the lumen of the tube is in fluid communication with the vacuum source. A vacuum controller for controlling fluid communication between a second end of the lumen of the tube and a first end of the lumen of the catheter. A pressure sensor for measuring the pressure in the lumen of the tube extending from the vacuum controller to the vacuum source. A system including a control unit, The control unit, After the catheter is disposed against a thrombus, the vacuum controller is controlled so as to cut off fluid communication between the lumen of the tube and the lumen of the catheter. In this fluid communication cut-off state, the pressure measured from the pressure sensor is received, and it is determined that the pressure in the lumen of the tube becomes equal to or lower than the target suction pressure. In response to the determination that the pressure in the lumen of the tube becomes equal to or lower than the target suction pressure, the vacuum controller is automatically controlled to establish fluid communication between the lumen of the tube and the lumen of the catheter. A system configured as such.

14. The control unit, Determines whether the pressure in the lumen of the tube is greater than a second pressure. When it is determined that the pressure in the lumen of the tube is greater than the second pressure, the system according to claim 13 is further configured to automatically control the vacuum controller to end fluid communication between the lumen of the tube and the lumen of the catheter.

15. Further includes a catheter controller for controlling the operation of the catheter. The control unit, Determines whether the pressure in the lumen of the tube is within a predefined range. The system according to claim 14, further configured to automatically control the catheter controller to operate the catheter until the pressure in the lumen of the tube becomes lower than the suction pressure of a threshold value when it is determined that the pressure in the lumen of the tube is within the predefined range. **Claim 16** further comprising a catheter controller configured to control the operation of the catheter, wherein the control unit determines whether the pressure in the lumen of the tube is within a predefined range, The system according to claim 13, further configured to automatically control the catheter controller to operate the catheter until the pressure in the lumen of the tube becomes lower than the suction pressure of a threshold value when it is determined that the pressure in the lumen of the tube is within the predefined range.

Images