Catheter-based robotic program system and system for thrombus aspiration

Abstract

A catheter-based robotic program 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

Technical Field

[0001] The utility model relates to a robot program system based on a catheter and a system for thrombus aspiration. Background Art

[0002] As used herein, the term elongated medical device (EMD) refers to but is not limited to catheters (e.g., guide catheters, microcatheters, suction catheters, balloon / stent catheters), line-based devices (e.g., guidewires, microwires, embolic coils, stent retrievers, etc.) and medical devices including any combination thereof. Generally speaking, EMDs can be used for many minimally invasive medical procedures. Such procedures can facilitate the diagnosis and treatment of various vascular system diseases, and include neurovascular intervention (NVI) (or neurointervention) surgery, percutaneous coronary intervention (PCI) and peripheral vascular intervention (PVI). Generally speaking, these procedures involve navigating a guidewire through the patient's vascular system, and advancing a working catheter via a guidewire to deliver therapy.

[0003] The catheterization procedure begins with obtaining access to the blood vessel by inserting a sheath in a suitable blood vessel (such as an artery or vein). Next, for example, the diagnostic guide wire is advanced to a primary position in the sheath, such as the internal carotid artery (in NVI), the coronary artery ostium (in PCI) or the superficial femoral artery (in PVI). Then, the guide catheter is advanced to a primary position on the diagnostic guide wire. Remove the diagnostic guide wire, and then the guide wire that is suitable for navigating the target vascular system is pushed to the target position (for example, lesions, thrombus) in the vascular system by the guide catheter. In some cases, such as in the case of a tortuous anatomical structure, a support catheter or a microcatheter is inserted on the guide wire to assist in navigating the guide wire through.

[0004] In order to navigate the guidewire or guidewire / microcatheter toward the target location, the doctor advances the guidewire or guidewire / microcatheter while manipulating the proximal end of the guidewire or guidewire / microcatheter so as to guide the distal end into the appropriate vascular branch along the path to the target location while avoiding advancement into other vascular branches. Prior to the procedure, the doctor can use an imaging system (e.g., a fluoroscope) to obtain continuous contrast-enhanced images of the patient's vascular system, and can select one of these images for use as a roadmap to navigate the guidewire or guidewire / microcatheter to the target location. As the doctor navigates the guidewire or guidewire / microcatheter, contrast-enhanced images are also obtained so that the doctor can verify that the device is moving along the correct path to the target location.

[0005] The robotic procedure system based on catheter promotes the above process by supporting each guide wire and catheter and physically manipulating each guide wire and catheter according to the doctor's expectation. For example, the robotic procedure system based on catheter can hold the guide wire, and includes a mechanical assembly to advance, retract and rotate the guide wire in response to the doctor's command. The doctor can provide such a command via an input device (such as a joystick, button, roller, touch screen) installed to the console. The input device can allow the doctor to select one or more guide wires and / or catheters to be controlled at a given time. Thus, the robotic procedure system based on catheter can provide better control and accuracy than pure manual catheterization procedures. In addition, the console and therefore the doctor can be free from the influence of the x-ray emitted by the imaging system, which is used to track the position of the guide wire and / or catheter during the procedure.

[0006] Catheter-based robotic procedure systems can be used to assist doctors in performing catheterization procedures, such as NVI, PCI, and PVI. Examples of robotic-assisted NVI procedures include coil embolization of aneurysms, liquid embolization of arteriovenous malformations, and mechanical thrombectomy of large vessel occlusions in the case of acute ischemic stroke. In such NVI procedures, doctors use robotic systems to obtain lesion access by manipulating neurovascular guidewires and microcatheters to deliver therapies that restore normal blood flow. Access is provided using a sheath or guide catheter as described above, but an intermediate catheter may also be required to provide additional distal regions and / or provide sufficient support for the microcatheter and guidewire. Depending on the type and treatment of the lesion, the distal end of the guidewire is navigated into or through the lesion. In order to treat an aneurysm, a microcatheter is advanced into the lesion, the guidewire is removed, and several coils are deployed into the aneurysm by the microcatheter. The aneurysm is then embolized with coils. In order to treat an arteriovenous malformation, liquid embolism is injected into the malformation via a microcatheter.

[0007] In conventional mechanical thrombectomy, suction can be used to treat vascular occlusion. Suction can be performed directly through the above-mentioned microcatheter or using a larger caliber suction catheter. Once the microcatheter or suction catheter has been navigated to the occluded thrombus, the suction pump connected to it is activated to generate negative pressure, which causes the thrombus to be sucked into the catheter. Conventional suction systems may require a lot of time to completely remove the thrombus from the blood vessel. In addition, the time that conventional systems can generate and apply negative pressure may be longer than the time required to remove the thrombus. Any of these shortcomings increases the risk of damaging the vascular system and / or the suction pump. It is expected that the system uses a catheter-based robotic program system to improve the efficiency, efficacy and / or safety of mechanical thrombectomy. Utility Model Content

[0008] According to a first aspect, a catheter-based robotic program system is provided, wherein the system includes: a robotic drive; a control computing system configured to: provide a first command to the robotic drive to position a catheter cavity relative to a thrombus, wherein the catheter cavity is defined by the catheter; provide a second command to initiate evacuation of the cavity, wherein the cavity is not fluidically connected to the catheter cavity; determine that the pressure within the cavity is equal to or less than a target aspiration pressure; and in response to determining that the pressure within the cavity is equal to or less than the target aspiration pressure, establish fluid communication between the cavity and the catheter cavity via a vacuum control.

[0009] According to a second aspect, a system for thrombus aspiration is provided, wherein the system comprises: a catheter defining a catheter lumen; a vacuum source; a tubing defining a lumen, the lumen being connected to the vacuum source and the catheter fluid via a valve, wherein the valve is configured to open and close; a pressure sensor configured to determine the pressure within the lumen; and a catheter control configured to navigate the catheter within the blood vessel and reach the thrombus.

[0010] According to a third aspect, a system for thrombus aspiration is provided, wherein the system includes: a catheter defining a catheter lumen; a vacuum source; a tube defining the lumen, one end of the lumen being fluidically connected to the vacuum source; a vacuum control fluidically connected to the other end of the lumen and one end of the catheter lumen; a pressure sensor for determining the pressure within the lumen; and a pressure control for: receiving the determined pressure from the pressure sensor and determining 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 controlling the vacuum control to establish fluid communication between the lumen and the catheter lumen. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 is a perspective view of a catheter-based robotic procedure system, according to some embodiments.

[0012] Figure 2 is a schematic block diagram of a catheter-based robotic procedure system according to some embodiments.

[0013] Figure 3 is a perspective view of a robotic driver of a catheter-based robotic procedure system according to an embodiment.

[0014] Figure 4 is a schematic diagram of a thrombectomy system according to some embodiments.

[0015] Figure 5 is a schematic diagram of a thrombectomy system according to some embodiments.

[0016] Figure 6 is a schematic diagram of a thrombectomy system according to some embodiments.

[0017] Figure 7 is a schematic diagram of a thrombectomy system according to some embodiments.

[0018] Figure 8 is a schematic diagram of a thrombectomy system according to some embodiments.

[0019] Fig. 9 is a flow chart of a thrombectomy procedure according to some embodiments.

[0020] Fig.10 is a cross-sectional view of a blood vessel exposing a stacked EMD during a thrombectomy procedure, according to some embodiments.

[0021] Fig.11 is a flow chart of a thrombectomy procedure according to some embodiments.

[0022] Fig.12a and 12b A flow chart of a thrombectomy procedure according to some embodiments is included.

[0023] Fig.13a and 13b A flow chart of a thrombectomy procedure according to some embodiments is included. DETAILED DESCRIPTION

[0024] 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.

[0025] According to some embodiments, thrombus aspiration is initiated only after it is determined that the suction (ie, vacuum) source has reached a threshold negative pressure. Such activation increases removal efficiency, resulting in faster removal of thrombus in many instances.

[0026] In one example, the suction catheter lumen defined by the suction catheter is positioned relative to the first position of the thrombus. Then the lumen that is not fluidically connected to the suction catheter lumen is emptied. After a period of time, it is determined that the pressure in the lumen is equal to or less than the target suction pressure. In response to determining that the pressure in the lumen is equal to or less than the target suction pressure, fluid communication is automatically established between the lumen and the suction catheter lumen (for example, by opening a valve, by releasing a clamp). Such a process can be used to empty the thrombus faster than otherwise. In some aspects, the operator is notified that the pressure in the lumen is equal to or less than the target suction pressure, and the operator transmits a command to automatically establish fluid communication between the lumen and the suction catheter lumen.

[0027] Embodiments 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 time actually required to remove the thrombus.

[0028] Similarly, some aspects include presenting an indication to the operator that the pressure within the lumen is greater than a second pressure. After presenting the indication, and when the pressure within the lumen is greater than the second pressure, in response to receiving a command from the operator, fluid communication between the lumen and the aspiration catheter lumen is automatically terminated.

[0029] Embodiments may also include repositioning the aspiration catheter as necessary during the procedure to maintain the appropriate 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, determining whether the pressure within the lumen is within a predefined range. If it is determined that the pressure within the lumen is 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.

[0030] Figure 1 is a perspective view of a catheter-based procedure system 10 according to some embodiments. The catheter-based procedure system 10 can be used to perform catheter-based medical procedures, such as percutaneous interventional procedures such as PCI (e.g., to treat STEMI), NVI (e.g., to treat emergency large vessel occlusion (ELVO)), and PVI (e.g., for critical limb ischemia (CLI)). Catheter-based medical procedures can include diagnostic catheterization procedures during which one or more catheters or other EMDs are used to help diagnose a patient's disease. In one example, a contrast agent can be injected into one or more arteries via a catheter and an image of the patient's vasculature is acquired while the contrast agent resides therein.

[0031] Catheter-based medical procedures may also include catheter-based therapy procedures (e.g., angioplasty, stent placement, peripheral vascular disease treatment, thrombus removal, arteriovenous malformation therapy, aneurysm treatment), in which a catheter (or other EMD) is used to treat a disease. The specific type or nature of the EMD used in the catheter-based medical procedure is selected based on the type of procedure to be performed. The catheter-based procedure system 10 can perform any number of catheter-based medical procedures with the necessary adjustments to accommodate the specific EMD to be used in the procedure.

[0032] The catheter-based procedure system 10 includes, among other elements, a bedside unit 20 and a control station 26. The bedside unit 20 includes a robotic drive 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 robotic drive 24. The positioning system 22 can be, for example, a robotic arm, an articulated arm, a holder, etc. The positioning system 22 can be attached at one end to, for example, a track, a base, or a cart on the patient table 18. The other end of the positioning system 22 is attached to the robotic drive 24. The positioning system 22 can be moved away (along with the robotic drive 24) to allow the patient 12 to be placed on the patient table 18.

[0033] Once the patient 12 is positioned on the patient table 18, the positioning system 22 can be used to position or position the robotic drive 24 relative to the patient 12 for the procedure. In some embodiments, the patient table 18 is operably supported by a base 17 fixed to the floor and / or ground. The patient table 18 is capable of moving with multiple degrees of freedom relative to the base 17, 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 displays may be located on the housing of the robotic drive 24.

[0034] The term "front" herein refers to the side of the robotic drive 24 facing the patient 12 and away from the positioning system 22, while the term "rear" refers to the side of the robotic drive 24 closest to the positioning system 22. The terms top, up, and upper refer to a general direction away from the direction of gravity, while the terms bottom, bottom, and lower refer to a general direction toward the direction of gravity.

[0035] In general, the robotic drive 24 may be equipped with appropriate EMDs and associated accessories (e.g., embolic coils, liquid embolics, aspiration pumps, contrast injection systems, medications, hemostatic valve adapters, syringes, stopcocks, inflation devices, etc.) to allow the operator 11 to perform catheter-based medical procedures by operating various controls of the control system, such as the controls and inputs located at the control station 26. The bedside unit 20, and in particular the robotic drive 24, may include any number of components and / or combinations of components to provide the bedside unit 20 with the functionality described herein.

[0036] The robotic drive 24 includes a plurality of device modules 32, each of which can be controlled to drive a corresponding EMD. In addition, each device module 32 can be controlled to move linearly toward and away from the patient 12. In some embodiments, the robotic drive 24 can control one or more device modules 32 to feed a guide wire into a diagnostic catheter and a guide catheter in an artery of the patient 12. The EMD enters the body (e.g., a blood vessel) of the patient 12 at the insertion point 16 via, for example, an introducer sheath.

[0037] The bedside unit 20 is in communication with the control station 26, allowing signals generated by the controls of the control station 26 to be transmitted wirelessly or via hardwiring to the bedside unit 20 to control various functions of the bedside unit 20, including the functions of the robotic drive 24. As discussed below, the control station 26 may include a control computing system 34 ( Figure 2 ), or coupled to the bedside unit 20 via a control computing system 34. The bedside unit 20 may 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 procedure system 10 may be provided via a communication link, which may be a wireless connection, a cable connection, or any other means capable of allowing communication between components. The control station 26 or other similar control system may be located locally to the robotic drive 24 or remotely from the robotic drive 24.

[0038] The term "local" is used to refer to the location of the patient 12 and the bedside unit 20. The term "remote" is used to refer to a location that does not have substantially immediate physical access to the bedside unit 20 and / or the patient 12. The catheter procedure system 10 may be operated by a control station 26 at a local site, a control station 26 at a remote site, or both a local control station 26 and a remote control station 26. At the local site, the operator 11 and the control station 26 are located in the same room as the patient 12 and the bedside unit 20, or in an adjacent room.

[0039] 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 over 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, where the remote site does not provide substantially instant physical access to the bedside unit 20 and / or the patient 12.

[0040] The control station 26 generally includes one or more input systems 28, which include controls configured to receive user manipulations for controlling the robotic drive 24 and / or various other components or systems of the catheter-based procedure system 10. In the illustrated embodiment, the control station 26 allows the operator 11 to control the bedside unit 20 to perform catheter-based medical procedures. For example, the input system 28 can be configured to cause the bedside unit 20 to perform various diagnostic or interventional procedures (e.g., advancing, retracting or rotating a guidewire, advancing, retracting or rotating a catheter, inflating or deflating a balloon located on a catheter, positioning and / or deploying a stent, positioning and / or deploying a stent retriever, positioning and / or deploying a coil, injecting contrast media into a catheter, injecting a liquid embolism into a catheter, injecting a drug or saline into a catheter, performing aspiration on a catheter) using an EMD controlled by the drive mechanism of the robotic drive 24.

[0041] The one or more input systems 28 may include one or more touch screens, joysticks, scroll wheels, and / or buttons. In addition to the input systems 28, the control station 26 may use additional user controls 44, such as a foot switch and microphone for voice commands, etc. The input system 28 may be configured to command advancement, retraction, and / or rotation of the EMD, as well as activation or deactivation of various components including pumps, valves, switches, clamps, etc.

[0042] The one or more input systems 28 may include a device selection button to allow the operator 11 to select which EMDs loaded into the robotic drive 24 to control via user manipulation of the input controls of the one or more input systems 28. An automatic routine button may be selected to implement algorithmic movement of the EMDs without separate direct commands from the operator 11. In some embodiments, the input system 28 may include one or more controls or icons (not shown) displayed on a touch screen (e.g., display 30) that, when activated, cause operation of components of the catheter-based procedure system 10.

[0043] The display 30 may be configured to display information or patient-specific data to the operator 11 located at the control station 26. In some embodiments, the control station 26 may include two or more displays 30. For example, the display 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), blood flow reserve fraction (FFR)). In addition, the display 30 may be configured to display procedure-specific information (e.g., procedure list, recommendation, procedure duration, catheter or guidewire position, aspiration vacuum level, volume of delivered drug or contrast agent). In addition, the display 30 may be configured to display information to provide functions associated with the control computing system, as described below. The display 30 may include a touch screen and may therefore include an input device for the system 10.

[0044] 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 a catheter-based medical procedure (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 the control station 26. The imaging system 14 can include a C-arm that allows the imaging system 14 to be partially or completely rotated around the patient 12 to obtain images at different angular positions relative to the patient 12 (e.g., sagittal views, caudal views, anterior-posterior views). In some embodiments, the imaging system 14 is a fluoroscopic system including a C-arm having an X-ray source 13 and a detector 15, also referred to as an image intensifier.

[0045] The imaging system 14 can be configured to acquire X-ray images of appropriate areas 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 neurovascular conditions. 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 guidewire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, etc. during the procedure. The acquired image(s) can be displayed on the display 30. For example, the image can be displayed on the display 30 to allow the operator 11 to accurately move the tip of the aspiration catheter to a location adjacent to a thrombus.

[0046] A rectangular coordinate system is thus introduced, comprising the X, Y and Z axes. The positive X axis is oriented in the longitudinal (axial) distal direction, i.e. in the direction from the proximal end to the distal end. The Y axis and the Z axis are in a transverse plane to the X axis, wherein the positive Z axis is oriented upwards, i.e. in the opposite direction of gravity, and the Y axis is oriented accordingly based on the right-hand rule.

[0047] Figure 2 is a block diagram of a catheter-based procedure system 10 according to an exemplary embodiment. The catheter-based procedure system 10 may include a control computing system 34. The control computing system 34 may be physically part of, for example, the control station 26. The control computing system 34 may generally include a computer processing unit that is suitable for controlling the catheter-based procedure system 10 as 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, communication systems and services 36 (e.g., the Internet, a firewall, a cloud service, a session manager, a hospital network), a local control station 38, additional communication systems 40 (e.g., a telepresence system), a remote control station and computing system 42, and patient sensors 56 (e.g., an electrocardiogram (ECG) device, an electroencephalogram (EEG) device, a blood pressure monitor, a temperature monitor, a heart rate monitor, a respiratory monitor). The control computing system 34 may also communicate with the imaging system 14 , the patient table 18 , additional medical systems 50 , a contrast media injection system 52 , and ancillary equipment 54 (eg, IVUS, OCT, FFR).

[0048] As described above, the bedside unit 20 includes a robotic drive 24, a positioning system 22, and additional controls and displays 46. The additional controls and displays 46 can be located on the housing of the robotic drive 24. Interventional devices and accessories 48 (e.g., guidewires, catheters) are docked to the bedside system 20. In some embodiments, the interventional devices and accessories 48 can include specialized devices (e.g., IVUS catheters, OCT catheters, FFR wires, diagnostic catheters for contrast) that dock to their respective accessory devices 54 (e.g., IVUS systems, OCT systems, FFR systems).

[0049] In various embodiments, the control computing system 34 is configured to receive and generate control signals based on the user's 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 desired functions. Additional user controls 44 may include, for example, one or more foot input controls. The foot input controls may be configured to allow the operator to select functions of the imaging system 14, such as turning on and off the X-ray source and scrolling through different stored images. In another embodiment, the foot 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 the patient, medical staff (e.g., vascular kit personnel) and / or equipment near the bedside.

[0050] The control computing system 34 is also in communication with a pump 58 and a vacuum control 59. The pump 58 may include any source for generating a vacuum suitable for thrombus aspiration. In some embodiments, the control 59 may be operable to selectively place the pump 58 in fluid communication with the lumen of the aspiration catheter of the interventional device and accessory 48.

[0051] According to some embodiments, the operator 11 operates the input system of the remote control station 42 to control the robot drive 24 to position the aspiration catheter at a first position relative to the thrombus in the patient's blood vessel. Specific examples of such positioning will be described herein, including manipulating multiple EMDs in a specified order. The aspiration catheter is coupled to a vacuum control 59, which is in turn coupled to a pump 58 via a conduit. The vacuum control 59 prevents fluid communication between the lumen and the lumen of the aspiration catheter. The vacuum control 59 may include a clamp, a valve, or any other suitable device or devices.

[0052] 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 the 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 the control 59). This action can be used to pull (i.e., aspirate) the thrombus into the aspiration catheter.

[0053] 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 the second pressure, and in response, controls the vacuum control 59 to terminate fluid communication between the lumen and the aspiration catheter lumen. This action can avoid additional aspiration that is not necessary to remove the thrombus.

[0054] 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 aspiration pressure, and this information is presented to the operator 11 via, for example, the display 30. The operator 11 can then (e.g., using one or more input systems 28) transmit a command to the control computing system 34 to automatically establish fluid communication between the lumen and the aspiration catheter lumen. Similarly, an indication that the pressure within the lumen is greater than the 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 aspiration catheter.

[0055] According to still further embodiments, after automatically establishing fluid communication between the lumen and the aspiration catheter, and before determining whether the pressure within the lumen is greater than the second pressure, the control computing system 34 may determine that the pressure within the lumen is within a predefined range. If it is determined that the pressure within the lumen is within the predefined range, the control computing system 34 may instruct the robotic drive 24 to adjust the position of the aspiration catheter lumen (e.g., in a preprogrammed sequence of moves that may or may not take into account intermediate pressure changes) until the pressure within the lumen is less than the threshold aspiration pressure.

[0056] The catheter-based procedure system 10 may be connected 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 expansion 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 the system 10 or any suitable component connected to the system 10.

[0057] As mentioned, the control computing system 34 communicates with the bedside unit 20, which includes the robotic drive 24, the positioning system 22, and may include additional controls and a display 46. The control computing system 34 may receive signals from the remote control station 42 based on user manipulation of the control of the input system of the remote control station 42, and may provide corresponding control signals to the bedside unit 20 to control the operation of the motors and drive mechanisms for driving the corresponding EMD in various degrees of freedom. The various drive mechanisms may be provided as part of the robotic drive 24.

[0058] Figure 3 is a perspective view of a robotic drive 24 of a catheter-based procedure system 10 according to some embodiments. Figure 3 Robot drive 24. Figure 3The robotic drive 24 includes a plurality of equipment modules 32a-d coupled to the linear member 60. Each equipment module 32a-d is coupled to the linear member 60 via a corresponding stage 62a-d that is movably mounted to the linear member 60. The equipment modules 32a-d can be connected to the stages 62a-d using connectors such as offset brackets 78a-d. In another embodiment, the equipment modules 32a-d are directly mounted 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 the corresponding equipment modules 32a-d coupled to the stages 62a-d) can move independently relative to each other and the linear member 60.

[0059] A drive mechanism is used to actuate each stage 62a-d. Figure 3 In the embodiment shown in , the drive mechanism includes an independent stage translation motor 64a-d coupled to each stage 62a-d and a stage drive mechanism 76, for example, via a lead screw via a rotating nut, a rack via a pinion, a belt via a pinion or pulley, a chain via a sprocket, or the stage translation motor 64a-d itself can be a linear motor. In some embodiments, the stage drive mechanism 76 can be a combination of these mechanisms, for example, each stage 62a-d can adopt a different type of stage drive mechanism. In some embodiments where the stage drive mechanism is a lead screw and a rotating nut, the lead screw can be rotated, and each stage 62a-d can engage and disengage with the lead screw to enable it to move, such as to advance or retract. Figure 3 In the embodiment shown in FIG. 5 , the stages 62 a - d and the equipment modules 32 a - d are in a serial drive configuration.

[0060] Each equipment module 32a-d includes an equipment module 68a-d and a box 66a-d mounted on and coupled to the equipment module 68a-d. Figure 3In the embodiment shown in, each box 66a-d is mounted to the equipment module 68a-d in a vertical orientation. In other embodiments, each box 66a-d can be mounted to the equipment module 68a-d in other mounting orientations. Each box 66a-d is configured to dock with the proximal portion of the EMD (not shown) and support the proximal portion. In addition, each box 66a-d can include elements to provide one or more degrees of freedom in addition to the linear motion provided by the actuation of the corresponding stage 62a-d, to move linearly along the linear member 60. For example, the box 66a-d can include elements that can be used to rotate the EMD supported therein when the box is coupled to the equipment module 68a-d. Each equipment module 68a-d includes at least one coupler to provide a drive interface to the mechanism in each box 66a-d, thereby providing additional degrees of freedom. Each box 66a-d also includes a channel, in which the equipment support 79a-d is positioned, and each equipment support 79a-d is used to prevent the EMD from bending.

[0061] Support arms 77a, 77b and 77c are attached to each device module 32a, 32b and 32c, respectively, to provide a fixing point for the proximal end of device supports 79b, 79c and 79d, respectively. The robot drive 24 can also include an equipment support connector 72 connected to the device support 79, the distal support arm 70 and the support arm 770. The support arm 770 is used to provide a fixing point for the support of the proximal end of the farthest support arm 79a contained in the farthest device module 32a. In addition, the guide interface support (steering gear) 74 can be connected to the device support connector 72 and the EMD (e.g., the guide sheath). The configuration of the robot drive 24 has the benefit of reducing the volume and weight of the robot drive 24 by using an actuator on a single linear member.

[0062] In order to prevent pathogens from contaminating the patient, the medical staff uses aseptic techniques in the room accommodating the bedside unit 20 and the patient 12. The room accommodating the bedside unit 20 and the patient 12 can be, for example, a catheter room or a vascular suite. Aseptic techniques include the use of sterile barriers, sterile equipment, correct patient preparation, environmental control and contact guidelines. Therefore, all EMDs and interventional accessories can be sterilized and allowed to contact with sterile barriers or sterile equipment. In some embodiments, a sterile disinfection drape (not shown) is placed on a non-sterile robot drive 24. Each box 66a-d is sterilized and serves as a sterile interface between the robot drive 24 and at least one EMD covered by the disinfection drape. Each box 66a-d can be designed to be disposable and sterile, or sterilized again in whole or in part, so that the box 66a-d or its components can be used in multiple programs.

[0063] As used herein, the term "box" generally refers to the component of a robot drive system, including a component that supports and moves (e.g., rotates and / or translates) at least one EMD. Equipment module generally refers to the component of a robot drive system, and it includes one or more motors with a drive coupler that docks with the EMD mobile element of the box. Box can provide a sterile interface between at least one EMD and equipment module directly or through an equipment adapter. The term "drive module" refers to the combination of equipment module and box.

[0064] In some embodiments, the EMD is a catheter having a hub at a proximal end of the catheter and a flexible shaft extending from the hub toward a distal end of the catheter, wherein the shaft is more flexible than the hub. In one embodiment, the catheter includes an intermediate portion transitioning between the hub and the shaft, the intermediate portion including an intermediate flexibility that is less rigid than the hub but more rigid than the shaft. In some embodiments, the intermediate portion is a strain relief.

[0065] The longitudinal axis of a member (e.g., an EMD or other element in a catheter-based procedure system) is a line or axis along the length of the member that passes through the center of the member's cross-section in a direction from the member's proximal portion to the member's distal portion. For example, the longitudinal axis of a guidewire is the central axis in a direction from the proximal portion of the guidewire toward the distal portion of the guidewire, even though the guidewire may be nonlinear in the relevant portion.

[0066] Axial movement of a component refers to translation of the component along its longitudinal axis. For example, when the distal end of the EMD moves axially into or further into the patient in the distal direction along its longitudinal axis, the EMD is being advanced. When the distal end of the EMD moves axially out of the patient or further out of the patient in the proximal direction along its longitudinal axis, the EMD is being withdrawn.

[0067] In this regard, axial insertion refers to inserting a first member into a second member along the longitudinal axis of the second member. For example, an EMD loaded axially in a chuck is inserted axially into the chuck. An example of axial insertion may be referred to as reverse loading a catheter to the proximal end of a guidewire. Lateral insertion refers to inserting a first member into a second member in a planar direction perpendicular to the longitudinal axis of the second member. Lateral insertion may also be referred to as radial loading or lateral loading.

[0068] Rotational movement of a component refers to a change in the angular orientation of the component about its local longitudinal axis. For example, rotational movement of an EMD corresponds to a clockwise or counterclockwise rotation of the EMD about its longitudinal axis due to an applied torque. 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.

[0069] The terms "distal" and "proximal" define the relative position of two different features. With respect to the robotic drive, the terms "distal" and "proximal" are defined by the position of the robotic drive in its intended use relative to the patient.

[0070] When used to define relative positions, a distal feature is a feature of the robotic actuator that is closer to the patient than a proximal feature when the robotic actuator is in its intended use position. Within the patient, any vasculature landmark along the path away from an access point, which is the point at which the EMD enters the patient, is considered to be farther away than a landmark closer to the access point. Similarly, a proximal feature is a feature that is farther from the patient than a distal feature when the robotic actuator is in its intended use position.

[0071] When used to define direction, the distal direction refers to the path that something is moving or intended to move when the robotic actuator is in its intended position of use, or the path that something is moving from proximal features toward or towards distal features and / or the patient. The proximal direction is the opposite of the distal direction. 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-coordinate axis and the proximal direction is along the negative X-coordinate axis.

[0072] Regarding the movement of modules, refer to Figure 3 , the EMD moves in a distal direction on a path toward the patient, through the introducer interface support 74, which defines the distal end of the robotic drive 24. The proximal end of the robotic drive 24 is the point farthest from the distal end along the negative X-axis.

[0073] Regarding the location of individual modules, and also refer to Figure 3 , the most distal equipment module is equipment module 32a that is closest to the distal end of the robot drive 24. The most proximal equipment module is equipment module 32d that is located farthest from the distal end of the robot drive 24 along the negative X-axis. The relative positions of the equipment modules are determined by their positions relative to the distal end of the robot drive. For example, equipment module 32b is distal to equipment module 32c.

[0074] Portions of the cassette 66a and device module 68a are defined by their relative position to the distal end of the robotic driver with respect to the distal / proximal portion, section, or end of the EMD or robotic driver. For example, when the cassette is in the in-use position on 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 driver, and the proximal end of the cassette 66a is the portion of the cassette farthest from the distal end of the robotic driver along the negative X-axis. In other words, the distal end of the cassette 66a is the portion of the cassette through which the EMD is closest to the path leading to the patient in the in-use position.

[0075] As previously discussed, embodiments of a control station, such as the control station 26, may include a variety of different input systems for controlling the bedside unit 20. The input system may include a variety of different input controls (e.g., buttons, scroll wheels, joysticks, touch screens) that a user may manipulate to control (or instruct) the operation of the robotic drive 24. These input controls may be arranged in different layouts or patterns on the input system to facilitate the desired functionality and cooperative sequencing thereof to perform desired tasks requiring independent (and sometimes simultaneous) movement of multiple EMDs.

[0076] In addition, embodiments of the input system may be configured to operate in a variety of different control modes. The functionality assigned to one or more controls of the input system in a first control mode may be different from the functionality assigned to one or more controls in a second control mode, and the control mode may be selected based on the program being executed, the one or more devices to be controlled, operator preferences, or any other factors. The input system may be configured to switch between different control modes in response to input from an operator or from the control computing system 34.

[0077] An input system as described herein may be fixed, integrated, or simply placed on a surface of the control station 26. As described herein, an input system may include a single integrated housing or multiple independently movable housings.

[0078] Figure 4 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 the same device(s).

[0079] Figure 4 Blood vessel 410 is shown, which may include a vein or an artery in a patient's body. Blood vessel 420 may be located anywhere in the patient's body. Thrombus 420 is disposed within blood vessel 410. Embodiments are not limited to Figure 4 or any of the thrombi and vessels of relative size and shape shown in the subsequently described figures. Embodiments are also not limited to a single substantially continuous thrombus.

[0080] The catheter control 430 operates to navigate the catheter 440 to the thrombus 420 within the blood vessel 410. As shown, the catheter control 430 has manipulated the tip 440a of the catheter 440 to a position adjacent to the thrombus 420 within the blood vessel 410. The catheter 440 can include any EMD that defines a lumen in which a negative pressure can be generated. The catheter 440 can include a specially designed aspiration catheter that defines a catheter lumen.

[0081] As will be described below, the catheter control 430 can manipulate (i.e., advance / retract / rotate) one or more guidewires and catheters, not shown, to navigate the catheter 440 to the illustrated position. Such navigation can be facilitated using a robotic drive, such as, but not limited to, the robotic drive 24. Thus, in some embodiments, the catheter control 430 comprises the catheter-based procedure system 10.

[0082] 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 conduit 440 via conduit control 430. Conduit 460a and conduit 460b may include any conduit suitable for thrombus aspiration as described herein, and together include a lumen.

[0083] When the valve / clamp 470 is closed, the negative pressure generated by the vacuum source 450 is present within the lumen of the tube 460a, but not within the lumen of the tube 460b (and therefore not within the catheter 440). 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. Therefore, any negative pressure generated by the vacuum source 450 is experienced at the tip 440a of the catheter 440.

[0084] According to the system 400, a pressure sensor 480 is coupled to or integrated with the vacuum source 450. The pressure sensor 480 can determine the pressure generated by the vacuum source 450, such as the pressure generated within the pipe 460a when the valve / clamp 470 is closed. The valve / clamp 470 can monitor the pressure via communication with the pressure sensor 480 and determine whether to open or close itself based on this.

[0085] For example, in some embodiments, catheter control 430 manipulates a series of EMDs under operator control to position tip 440a of catheter 440 adjacent thrombus 420. Next, tubing 460b is coupled to catheter 440, either manually or via a mechanism of catheter control 430, so that tubing 460b and catheter 440 are in fluid communication with each other. Vacuum source 450 is operated (e.g., via a command from catheter control 430 or an operator) to begin generating negative pressure within tubing 460a.

[0086] The valve / clamp 470 monitors the pressure determined by the pressure sensor 480 until it is determined that the pressure within the conduit 460a is equal to or less than the target aspiration pressure. Alternatively, once the pressure sensor 480 determines that the pressure within the conduit 460a is equal to or less than the target aspiration pressure, the pressure sensor 480 may provide a signal to the valve / clamp 470. In either case, in response to the determination, the valve / clamp 470 is opened to automatically establish fluid communication between the conduit 460a, the conduit 460b, and the catheter 440. Thus, the thrombus 420 can be forcibly removed from the blood vessel 410 and sucked into the catheter 440.

[0087] After opening the valve / clamp 470, the valve / clamp 470 can further determine based on the pressure sensor 480 that the pressure within the lumen 460a is greater than the second pressure, and in response close itself to automatically terminate the fluid communication between the lumen 460a and the catheter 440. Such a procedure can be used to detect the completion of the removal of the thrombus 420 and terminate the aspiration accordingly.

[0088] In still further embodiments, because the pressure within lumen 460a is greater than the second pressure, after opening valve / clamp 470, but before closing valve / clamp 470, valve / clamp 470 determines that the pressure within lumen 460a is within a predefined range based on pressure sensor 480. The predefined range is above the first pressure and below the second pressure, and is intended to indicate that there is some resistance to suction in catheter 440, but not to the extent that would be expected if tip 440a were positioned against thrombus 420. If it is determined that the pressure within lumen 460a is within the predefined range, valve / clamp 470 (or, for example, pressure sensor 480) may 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.

[0089] In some embodiments, valve / clamp 470 is a component of catheter control 430. Thus, a single section of tubing can extend from vacuum source 450 to such valve / clamp 470, which is then directly coupled to catheter 440 through catheter control 430.

[0090] Figure 5 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 blood vessel 510. As described with respect to catheter control 430 and catheter 440, catheter control 530 operates to navigate catheter 540 to thrombus 520.

[0091] The vacuum source 550, the conduit 560a, the conduit 560b, the valve / clamp 570, and the pressure sensor 580 can be configured as described above with respect to the similarly named elements of the system 400. The system 500 also includes a pressure control 590 disposed between the pressure sensor 580 and the valve / clamp 570. The pressure control 590 can perform the determination and control of the valve / clamp 570, which is attributed to the valve / clamp 470 above. In general, the pressure control 590 can monitor the pressure within the lumen 560a via communication with the pressure sensor 580, and based on this, instruct the valve / clamp 570 to open or close. In some embodiments, the pressure control 590 is a component of the catheter control 530. In this regard, the pressure control 590 can include the control computing system 34 of the system 10.

[0092] The pressure control 590 can initiate operation of the vacuum source 550 to begin generating negative pressure within the conduit 560a. The pressure control 590 monitors the pressure determined by the pressure sensor 580 until the pressure within the conduit 560a is equal to or less than the target suction pressure. In response to this determination, the pressure control 590 instructs the valve / clamp 570 to open to automatically establish fluid communication between the conduit 560a, the conduit 560b, and the catheter 540.

[0093] Following this opening of the valve / clamp 570, the pressure control 590 may further monitor the pressure determined by the pressure sensor 580 until the pressure within the conduit 560a is greater than the second pressure, and in response, instruct the valve / clamp 570 to close itself to automatically terminate fluid communication between the lumen 560a and the catheter 540. In addition, if the pressure control 590 determines that the pressure within the lumen 560a is within a predefined range that is greater than the first pressure and less than the second pressure, the pressure control 590 may communicate with the catheter control 530 to change (e.g., rotate) the position of the catheter 540 until the pressure within the lumen 560a is equal to or less than the first pressure.

[0094] Figure 6 is a schematic diagram of a thrombectomy system according to some embodiments. System 600 is similar to Figure 5 500, except that the above-described functionality of pressure sensor 580 and pressure control 590 is combined within pressure sensor and control 690. Vacuum source 680, tubing 660a, tubing 660b, valve / clamp 670, and catheter control 630 can be configured as described above with respect to similarly named elements of system 500.

[0095] The pressure sensor and control 690 can monitor the pressure within the lumen 660a via communication with the vacuum source 680 and, based thereon, command the valve / clamp 670 to open or close. As mentioned with respect to the pressure control 590 of the system 500, in some embodiments, the pressure sensor and control 690 is a component of the catheter control 630. For example, the pressure sensor and control 690 can include the control computing system 34 of the system 10.

[0096] The pressure sensor and control 690 can initiate operation of the vacuum source 680 to begin generating negative pressure within the conduit 660a. The pressure sensor and control 690 monitors the pressure generated by the vacuum source 680 (e.g., by communicating with the vacuum source 680 including the pressure sensor, by optically sensing the conduit 660a) until it is determined that the pressure within the conduit 660a is equal to or less than the target suction pressure. In response to this determination, the pressure sensor and control 690 instructs the valve / clamp 670 to open to automatically establish fluid communication between the conduit 660a, the conduit 560b, and the catheter 640.

[0097] Next, the pressure sensor and control 690 can determine that the pressure within the tubing 660a has become greater than the second pressure, and in response, instruct the valve / clamp 670 to close itself to automatically terminate fluid communication between the lumen 660a and the catheter 640. If, between the opening and closing of the valve / clamp 670 as described above, the pressure sensor and control 690 determines that the pressure within the lumen 660a is within a predefined range of above the first pressure and below the second pressure, the pressure sensor and control 690 can communicate with the catheter control 630 to change (e.g., rotate) the position of the catheter 640 until the pressure within the lumen 660a is equal to or less than the first pressure.

[0098] Figure 7 is a schematic diagram of a thrombectomy system according to some embodiments. System 700 includes presentation of a pressure-based indication to an operator, and subsequent operator control of system 700. System 700 is presented in two alternative arrangements, a first arrangement in which pressure sensor 770a is coupled to or integrated with vacuum source 740, and a second arrangement in which pressure sensor 770b is separate from vacuum source 740. Pressure sensor 770b may determine pressure within conduit 750a via optics, a sensor element within conduit 750a, or any other suitable technique.

[0099] Regardless of the implementation of the pressure sensor (eg, pressure sensor 770a or pressure sensor 770b), system 700 includes presenting an indication of the pressure within conduit 750a to operator 775 via display 780. Figure 7A direct communication link between pressure sensor 770a / pressure sensor 770b and display 780 is shown, but pressure may be transmitted from pressure sensor 770a / pressure sensor 770b to display 780 via any number of intermediate components (such as, for example, control computing system 34).

[0100] In operation, operator 775 operates catheter controls 730 (e.g., catheter controls of a catheter-based robotics 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.

[0101] The display 780 presents a negative pressure indication to the operator 775. The indication may include a pressure value and / or an indication that the pressure in the conduit 750a is equal to or less than the target suction pressure. The indication may simply include a notification that once the pressure in the conduit 750a is equal to or less than the target suction pressure, the system is presented to be ready for suction. After receiving the indication, the operator 775 may manipulate the operator control 790 to instruct the valve / clamp 760 to open, thereby automatically establishing fluid communication between the conduit 750a, the conduit 750b, and the conduit 740. The operator control 790 may include any input system described herein, including but not limited to a touch screen (e.g., the display 780 may also include the operator control 790), a console button, a foot switch, and a joystick.

[0102] After opening the valve / clamp 760, the display 780 can further present an indication that the pressure within the conduit 750a has become greater than the second pressure. The indication can include a notification to terminate the suction. In response to the indication, the operator 775 can manipulate the operator control 790 to close the valve / clamp 760 to terminate the fluid communication between the conduit 750a and the catheter 740. In some embodiments of the system 700, the pressure within the conduit 750a is monitored, and once it is determined that the pressure within the conduit 750a has become greater than the second pressure, the valve / clamp 760 is automatically commanded to close without the intervention of the operator 775.

[0103] Between the above-mentioned opening and closing of the valve / clamp 760, the display 780 can present and indicate that the pressure within the lumen 750a is within a predefined range that is higher than the first pressure and lower than the second pressure. The indication can include a pressure value and / or a notification to reposition the catheter 740 relative to the thrombus 720. Based on the indication, the operator 775 can instruct the operation of the catheter control 730 to reposition the catheter 740. Repositioning can include a set of preprogrammed movements and / or individual movements instructed by the operator 775. In some embodiments, once the pressure within the lumen 750a has been reduced to equal to or less than the first pressure, the display 780 presents an indication, at which time the operator 775 can stop the instruction of the catheter control 730.

[0104] Figure 8 8 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, operator 875 may operate catheter control 820 to position catheter 810 relative to a thrombus within a blood vessel. Once the position is satisfactory, vacuum source 830 is operated to begin generating negative pressure within conduit 850a.

[0105] The display 870 presents a negative pressure indication to the operator 875. After receiving the indication, the operator 875 can directly manipulate the valve 740 to open, and thereby automatically establish fluid communication between the pipeline 850a, the pipeline 850b and the catheter 810. In the illustrated embodiment, the valve 840 includes a flow control valve, which includes a slide switch 845, which can be operated with one hand to selectively open or close the valve 840. The embodiment can use any suitable device for establishing and terminating fluid communication between the two chambers.

[0106] The display 780 may further present an indication that the pressure within the conduit 750a has become greater than the second pressure. The indication may include a notification to terminate the suction. In response to the indication, the operator 775 may manipulate the operator control 790 to close the valve / clamp 760 to terminate the fluid communication between the conduit 750a and the catheter 740. In some embodiments of the system 700, the pressure within the conduit 750a is monitored, and once it is determined that the pressure within the conduit 750a has become greater than the second pressure, the valve / clamp 760 is automatically commanded to close without the intervention of the operator 775.

[0107] Between the above-mentioned opening and closing of the valve / clamp 760, the display 780 can present and indicate that the pressure within the lumen 750a is within a predefined range that is higher than the first pressure and lower than the second pressure. The indication can include a pressure value and / or a notification to reposition the catheter 740 relative to the thrombus 720. Based on the indication, the operator 775 can instruct the operation of the catheter control 730 to reposition the catheter 740. Repositioning can include a set of preprogrammed movements and / or individual movements instructed by the operator 775. In some embodiments, once the pressure within the lumen 750a has been reduced to equal to or less than the first pressure, the display 780 presents an indication, at which time the operator 775 can stop the instruction of the catheter control 730.

[0108] Fig. 9 A flow chart of process 900 for aspirating a thrombus according to some embodiments is included. Process 900 and other processes described herein may be performed using any suitable combination of hardware and software. The software program code embodying these processes may be stored by any non-transitory tangible medium, including a hard disk, volatile or non-volatile random access memory, a DVD, a flash drive, and a tape, 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.

[0109] Initially, at S910, the aspiration catheter defining the aspiration catheter lumen is positioned in a first position relative to the thrombus. For example, at S910, the operator can control the robotic driver to manipulate a series of EMDs in a prescribed order to position the tip of the aspiration catheter against the thrombus. According to one such prescribed order, the introducer sheath is inserted into an access site, such as but not limited to the radial artery or the femoral artery. Next, the diagnostic guidewire is inserted into the sheath and is advanced to the base of the skull by the robotic driver in response to operator commands. Then, the guide catheter and the base catheter are advanced (simultaneously or sequentially) to the base of the skull over the diagnostic guidewire. Then, the diagnostic guidewire and the guide catheter are removed, leaving the base catheter.

[0110] The coaxial "stack" consisting of microwires is then inserted into the base catheter, the microwires are surrounded by microcatheters, and the microcatheters are surrounded by a suction catheter. Under microwire guidance, the stack passes through the base of the skull (i.e., where the base catheter terminates) and navigates the vasculature until the microwires reach the thrombus. The suction catheter is then advanced with or without the microcatheter (i.e., for structural support) until the lumen of the suction catheter contacts the thrombus. The foregoing process is aided by simultaneously acquired and contrast-enhanced X-ray images.

[0111] Fig.10The blood vessel 1000 in which the base catheter 1010 resides is illustrated. The stack consisting of the microwire 1020, the microcatheter 1030, and the aspiration catheter 1040 has been passed through the base catheter 1010 on the way to the thrombus 1050. The microwire 1020 has reached the thrombus 1050, and the microcatheter 1030 is being advanced over the microwire 1020 toward the thrombus 1050. Next, the aspiration catheter 1040 will be advanced over the microcatheter 1030 (and the microwire 1020) until the aspiration catheter 1040 reaches the thrombus 1050. The microwire 1020 and the microcatheter 1030 can then be removed from within the aspiration catheter 1040.

[0112] Returning to process 900, at S920, evacuation of the lumen is initiated to generate negative pressure therein. As noted above, the lumen may be coupled to a pump or other vacuum source. As also noted, the lumen is not in fluid communication with the suction catheter. According to some embodiments, at S920, an operator operates an input control associated with a catheter-based robotic programming system to instruct operation of the vacuum source.

[0113] At S930, the process is paused until the pressure in the lumen is equal to (or less than) the target pressure. The target pressure may be predefined and / or set by the operator and may 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 factors. Once it is determined that the pressure in the lumen is equal to (or less than) the target pressure, the process proceeds to S940.

[0114] At S940, fluid communication is automatically established between the lumen and the suction catheter lumen. Several examples of S940 are described herein. In one example, prior to S940, both the conduit and the suction catheter are coupled to either end of a closed valve, and S940 includes opening the valve. The valve can be opened manually via an electromechanical actuator or by an operator. The implementation of S940 is not limited to those described herein.

[0115] Fig.11 S1110 to S1140 of process 1100 may be performed similarly to S910 to S940 of process 900. After S1140, at S1150, the process is paused until it is determined that the pressure in the lumen is greater than (or equal to) the second target pressure. As described above, the second target pressure may be the pressure expected when the thrombus has been evacuated from the blood vessel (and the suction catheter).

[0116] Once the second target pressure is reached, the process proceeds to S1160. At S1160, the fluid communication between the lumen and the aspiration catheter lumen is terminated. Continuing with the above example, S1160 may include an electromechanical or manual closing of a valve disposed between the lumen and the aspiration catheter lumen.

[0117] Turning to FIG. 12 , S1205, S1210, and S1215 of process 1200 may be performed similarly to corresponding steps in S910, S920, and S930 of process 900. At S1220, an indication is presented to the operator indicating that the intraluminal pressure (i.e., the pressure experienced by the suction catheter lumen) has reached the target pressure. As described above, the indication may be presented via a display of the operator console and may be transmitted from a vacuum source or a separate pressure sensor to a control computing system that then instructs the presentation of the indication.

[0118] The process is paused at S1225 until a command from the operator is received. The target pressure can be maintained during the pause at S1225. The operator can operate the input control of the console to instruct the system to perform suction, in response to which the process proceeds to S1230.

[0119] At S1230, fluid communication is automatically established between the lumen and the suction catheter lumen. The process then pauses at S1235 until it is determined that the pressure within the lumen is greater than (or equal to) the second target pressure. Another indication is presented to the operator at S1240 indicating that the pressure within the lumen (and within the suction catheter lumen) has reached the second target pressure. The process pauses at S1245 until the next command from the operator is received.

[0120] The operator can operate the input control of the console at S1245 to instruct the system to terminate the suction. In response, at S1250, the fluid communication between the tubing cavity and the suction catheter cavity is terminated. For example, a valve disposed between the tubing cavity and the suction catheter cavity can be closed at S1250.

[0121] 13 is a flow chart of a process 1300 according to some embodiments. S1310 to S1340 of process 1300 may 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 flow proceeds to S1350.

[0122] 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 predefined range of pressures that indicates that the aspiration catheter is not engaging the thrombus in a manner that provides suitable suction to the thrombus. If the pressure within the lumen is not within the predefined range, the process proceeds to S1370.

[0123] If it is determined at S1350 that the pressure within the lumen is within a predefined range, 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 a set of one or more catheter movements intended to better position the catheter. In some embodiments, the adjustment is performed under partial or full operator control.

[0124] At S1370, determine whether the pressure in the lumen is greater than the second pressure. If not, the process returns to S1350 and continues as described above. If yes, then at S1380, automatically terminate the fluid communication between the lumen and the suction catheter lumen using any system described herein or known.

[0125] Those skilled in the art will appreciate that various adaptations and modifications of the above-described embodiments may be configured without departing from the claims.It is therefore to be understood that the claims may be practiced in ways other than as specifically described herein.

Claims

1. A catheter-based robotic procedure system, wherein the system comprises: Robotic drives; A control computing system is configured to: providing a first command to a robotic actuator to position a catheter lumen at a location relative to the thrombus, the catheter lumen being defined by the catheter; providing a second command to initiate evacuation of a lumen, wherein the lumen is not in fluid communication with the catheter lumen; Determining that the intraluminal pressure is equal to or less than the target aspiration pressure; and In response to determining that the pressure within the lumen is equal to or less than the target aspiration pressure, fluid communication between the lumen and the catheter lumen is established via the vacuum control.

2. The system according to claim 1, wherein the system is configured to: After automatically establishing fluid communication between the lumen and the catheter, determining via the control computing system whether a pressure within the lumen is greater than a second pressure; and If the pressure within the lumen is determined to be greater than the second pressure, fluid communication between the lumen and the catheter lumen is automatically terminated via the vacuum control.

3. The system according to claim 2, wherein the system is configured to: After automatically establishing fluid communication between the lumen and the catheter, and before determining whether the pressure within the lumen is greater than the second pressure, determining via the control computing system whether the pressure within the lumen is within a predefined range; and If the intraluminal pressure is determined to be within the predefined range, the position of the catheter lumen is automatically adjusted via the robotic drive until the intraluminal pressure is less than a threshold aspiration pressure.

4. The system according to claim 1, wherein the system is configured to: After automatically establishing fluid communication between the lumen and the catheter lumen, determining via the control computing system whether a pressure within the lumen is within a predefined range; and If the intraluminal pressure is determined to be within the predefined range, the position of the catheter lumen is automatically adjusted via the robotic drive until the intraluminal pressure is less than a threshold aspiration pressure.

5. The system according to claim 1, wherein the system is configured to: After automatically establishing fluid communication between the lumen and the catheter lumen, determining via the control computing system whether a 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, presenting an indication to the operator via the display; receiving a command from an operator via the control after presenting the indication and when the pressure within the lumen is greater than the second pressure; and In response to receipt of the command, fluid communication between the lumen and the catheter lumen is automatically terminated via the valve or clamp.

6. The system of claim 5, wherein the system further comprises: After automatically establishing fluid communication between the lumen and the catheter lumen, and before determining that the pressure within the lumen is greater than the second pressure, determining via the control computing system whether the pressure within the lumen is within a predefined range; and If the intraluminal pressure is determined to be within the predefined range, the position of the catheter lumen is automatically adjusted via the robotic drive until the intraluminal pressure is less than a threshold aspiration pressure.

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

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

9. The system according to claim 7, wherein: When the valve is closed, the vacuum source creates negative pressure in the lumen.

10. The system of claim 7, wherein the pressure sensor is in communication with a 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 pipeline is equal to or less than the target suction pressure.

12. The system of claim 7, wherein the lumen has at least a first portion and a second portion defined by the location 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 the 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 a pressure sensor and command 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 operator control to position the tip of the catheter adjacent 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: When the valve is closed, the vacuum source generates negative pressure in the first portion of the lumen but not in the second portion.

19. A system for thrombus aspiration, wherein the system comprises: a catheter defining a catheter lumen; Vacuum source; a tube defining a lumen, one end of the lumen being in fluid communication with a vacuum source; a vacuum control in fluid communication with the other end of the lumen and one end of the catheter lumen; a pressure sensor for determining the pressure within the lumen; and Pressure controls for: receiving the determined pressure from the pressure sensor and determining 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, a vacuum control is automatically controlled to establish fluid communication between the lumen and the catheter lumen.

20. The system of claim 19, wherein the pressure control is further configured to: determining whether the pressure within the lumen is greater than a second pressure; and If the pressure within the lumen is determined to be greater than the second pressure, the vacuum control is automatically controlled to terminate fluid communication between the lumen and the catheter lumen.

21. The system of claim 19, wherein the system further comprises a catheter control for controlling movement of the catheter, The pressure control unit is further used for: determining 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, the catheter controls are automatically controlled to move the catheter until the pressure within the lumen is less than a threshold aspiration pressure.

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