Robot-assisted operation of slender medical devices

Abstract

The present invention provides a robotic system and method for automatically operating elongated medical devices such as guidewires and / or catheters. [Solution] The system includes a device having a first elongated medical device and a second elongated medical device, and a controller connected to the device. The controller identifies the amount and direction of linear displacement of the first elongated medical device, and linearly displaces the second elongated medical device in accordance with the identified displacement of the first elongated medical device, wherein the linear displacement of the second elongated medical device is substantially equal to the linear displacement of the first elongated medical device and is in the opposite direction to the direction of displacement of the first elongated medical device. The controller is configured to change at least one parameter of the linear displacement of either (a) the first elongated medical device or (b) the second elongated medical device in accordance with the identified displacement of the first elongated medical device.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the priority and benefit of U.S. Provisional Application No. 62 / 733,429, filed on September 19, 2018, entitled "ROBOTIC ASSISTED MOVEMENTS OF PERCUTANEOUS DEVICES", and U.S. Provisional Application No. 62 / 803,899, filed on February 11, 2019, entitled "PROXIMAL DEVICE FIXATION WITH SINGLE FAULT", and all of these applications are incorporated herein by reference.

[0002] [Technical Field] The present invention generally relates to the field of catheter treatment systems, and more particularly to robotic systems and methods for automatically operating elongated medical devices such as guidewires and / or catheters.

Background Art

[0003] Catheters (and other slender medical devices) can be used in many minimally invasive medical procedures for the diagnosis and treatment of various vascular diseases, including neurovascular interventions (NVI), also known as nerve intervention surgery, percutaneous coronary intervention (PCI), and peripheral vascular intervention (PVI). These procedures typically involve navigating a guidewire through the vascular system and advancing a working catheter through the guidewire to perform the treatment. Catheterization procedures begin with obtaining a pathway to the appropriate vessel, such as an artery or vein, using a standard percutaneous technique with a sheath or guide catheter. The sheath or guide catheter is then advanced through a diagnostic guidewire to a key location, such as the internal carotid artery in NVI, the coronary orifice in PCI, or the superficial femoral artery in PVI. Subsequently, a guidewire appropriate for the vascular system is navigated through the sheath or guide catheter to the target location within the vascular system. In certain situations, such as with winding anatomical structures, a support catheter or microcatheter is inserted through the guidewire to assist in guidewire navigation. The physician (operator) can use an imaging system (e.g., a fluoroscopy) to acquire images with contrast agent injection and select a fixed frame to use as a roadmap to navigate the guidewire or catheter to a target location such as a lesion. Contrast-enhanced images are also obtained while the physician delivers the guidewire or catheter device, allowing the physician to confirm that the device is moving along the correct path to the target location. While observing anatomical structures using fluoroscopy, the physician manipulates the proximal end of the guidewire or catheter to direct the distal tip towards the appropriate vessel and prevent it from advancing into a side branch.

[0004] Robotic catheterization systems have been developed that can be used to assist physicians during catheterization procedures such as NVI, PCI, and PVI. Examples of neurovascular interventional (NVI) catheterization procedures include coil embolization of aneurysms, fluid embolization of arteriovenous malformations, and mechanical thrombectomy of large vessel occlusion in acute ischemic stroke. In NVI, physicians use a robotic system to manipulate a neurovascular guidewire and microcatheter to gain contact with the lesion and restore normal blood flow. The access route is created by a sheath or guide catheter, but an intermediate catheter may be required for more distal areas or to provide proper support for the microcatheter and guidewire. The distal tip of the guidewire is navigated either into or beyond the lesion, depending on the type of lesion and the treatment. In aneurysm treatment, the microcatheter is advanced into the lesion, the guidewire is withdrawn, and several coils are deployed into the aneurysm through the microcatheter for embolization. In arteriovenous malformation treatment, fluid embolization is injected into the malformation using a microcatheter. Mechanical thrombectomy to treat vascular occlusion is performed either by aspiration or by using a stent retriever. Aspiration is performed directly through a microcatheter or using a larger diameter aspiration catheter. Once the aspiration catheter reaches the lesion, negative pressure is applied to push the catheter through and remove the thrombus. Alternatively, the thrombus can be removed by positioning a stent retriever through a microcatheter. The thrombus is taken into the stent retriever, and the stent retriever and microcatheter are drawn into a guide catheter to retrieve it.

[0005] In PCI, physicians use a robotic system to manipulate a cardiac guidewire to gain contact with the lesion, perform treatment, and restore normal blood flow. The access route is created by positioning a guide catheter at the coronary artery orifice. The distal end of the guidewire is navigated to the lesion, and in the case of complex anatomical structures, a microcatheter is used to properly support the guidewire. Blood flow is restored by delivering and deploying a stent or balloon to the lesion. The lesion may require preparation before stent placement, either by delivering a balloon for pre-dilation of the lesion or by performing an atherectomy using, for example, a laser or a rotational atherectomy catheter and a balloon through the guidewire. Imaging and physiological measurements may be performed using imaging catheters or FFR measurements to determine the appropriate treatment.

[0006] In PVI, the physician uses a robotic system to perform the treatment and restore blood flow using techniques similar to NVI. The distal tip of the guidewire can be navigated to the area beyond the lesion, and a microcatheter can be used to provide appropriate support for the guidewire against complex anatomical structures. Blood flow is restored by delivering and deploying a stent or balloon to the lesion. As with PCI, lesion preparation and imaging can also be used. [Overview of the Initiative]

[0007] A system according to one embodiment comprises an apparatus having a first elongated medical device and a second elongated medical device, and a controller connected to the apparatus. The controller is configured to specify the amount and direction of linear displacement of the first elongated medical device and to linearly displace the second elongated medical device in accordance with the specified displacement of the first elongated medical device. The linear displacement of the second elongated medical device is substantially equal to the linear displacement of the first elongated medical device and is in the opposite direction to the direction of displacement of the first elongated medical device. The controller is further configured to change at least one parameter of the linear displacement of either (a) the first elongated medical device or (b) the second elongated medical device.

[0008] In one example, changing at least one parameter includes limiting the amount of displacement of a second elongated medical device. The controller changes at least one parameter in response to the identification of a loss of traction related to the linear displacement of the second elongated medical device.

[0009] In one example, at least one parameter includes the amount or velocity of displacement of the first elongated medical device. In one embodiment, the first elongated medical device is a catheter, and the second elongated medical device is a guidewire.

[0010] In one example, the linear motion of the first elongated medical device and the linear motion of the second elongated medical device occur substantially simultaneously.

[0011] In one example, the controller identifies an unexpected operation of the second elongated medical device, and in this case, upon identifying the unexpected operation of the second elongated medical device, the controller stops changing at least one parameter of the first or second elongated medical device.

[0012] In one example, the controller detects the presence or absence of a second elongated medical device based on the detection of its operation via input from a sensor. When the controller detects the absence of the second elongated medical device, it stops changing at least one parameter of either the first or second elongated medical device.

[0013] In one example, the controller terminates the linear displacement of the second elongated medical device if the linear displacement of the second elongated medical device does not exceed a first threshold for the specified displacement of the first elongated medical device. The controller resumes the linear displacement of the second elongated medical device when the linear displacement of the second elongated medical device exceeds a second threshold for the specified displacement of the first elongated medical device. The second threshold is greater than the first threshold.

[0014] In one example, the system further includes one or more other elongated medical devices whose behavior is restricted in the same way as the second elongated medical device.

[0015] A system according to one embodiment comprises an elongated medical device apparatus having at least one elongated medical device, and a control station connected to the elongated medical device apparatus. The control station includes a control module that performs a predetermined operating pattern of the proximal portion of the elongated medical device in response to a user command. The predetermined operating pattern is the vibration of the elongated medical device around its longitudinal axis. An auxiliary command changes the amplitude of the vibration.

[0016] In one example, an auxiliary command changes the amplitude of the vibration by decreasing or increasing the amplitude.

[0017] In one example, an auxiliary command modifies the amplitude of an oscillation by biasing its amplitude. Generating this bias involves moving the center of the oscillation.

[0018] In one example, auxiliary commands are received from either a control module or an operator input device.

[0019] In one example, the vibration of a long, slender medical device has a first amplitude as it moves forward through a blood vessel and a second amplitude as it passes over an obstacle.

[0020] In one example, a predetermined operating pattern is activated only when the elongated medical device is moving linearly. The control module stops the vibration of the elongated medical device when the linear movement is stopped, reversed, or pushed (poked).

[0021] In one example, at least one parameter of the vibration is configurable, and this parameter is frequency, amplitude, or rotational speed.

[0022] A system according to one aspect includes an elongated medical device apparatus having at least one elongated medical device and a control station. The control station includes a control module for executing an operation pattern of a proximal portion of the elongated medical device in response to a user command regarding linear displacement of the elongated medical device. The operation pattern is a linear displacement involving continuous rotation of the elongated medical device in one direction about the longitudinal axis of the elongated medical device. The operation pattern is initiated by a forward linear displacement and terminated by a reverse linear displacement.

[0023] In one example, the rotation speed of the operation pattern can be changed with an auxiliary command.

[0024] A system according to one aspect includes an elongated medical device apparatus having at least one elongated medical device and a control station. The control station includes a control module for executing a predetermined operation pattern of a proximal portion of the elongated medical device in response to a user command. The predetermined operation pattern is a linear vibration of the elongated medical device, and this linear vibration includes alternating forward and backward (reciprocating) linear movement of the elongated medical device. The operation pattern is initiated by a forward linear displacement and terminated by a reverse linear displacement.

[0025] A system according to one aspect includes a device having a first elongated medical device and a second elongated medical device, and a controller connected to the device. The controller is configured to receive a command regarding the operation of the first elongated medical device, operate the first elongated medical device, detect the operation of the first elongated medical device, and synchronize the operation of the second elongated medical device with the operation of the first elongated medical device according to the detected linear displacement of the elongated medical device.

[0026] In one example, the operation of the first elongated medical device and the synchronized operation of the second elongated medical device result in a fine alternating forward and backward linear movement with a forward linear displacement. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings in which like reference numerals refer to like parts. [Figure 1] Perspective view illustrating a catheter-based treatment system according to an embodiment. [Figure 2] Schematic block diagram illustrating a catheter-based treatment system according to an embodiment. [Figure 3] Perspective view of a robotic drive device of a catheter-based treatment system according to an embodiment. [Figure 4A] ~ [Figure 4B] Diagram illustrating an exemplary mode, herein referred to as wiggle (fine movement), regarding the robotic operation of an elongate medical device (EMD) in a catheter-based treatment system. [Figure 5] Diagram illustrating an exemplary mode, herein referred to as drill (perforation operation), regarding the robotic operation of an EMD in a catheter-based treatment system. [Figure 6] Diagram illustrating each phase of an exemplary mode, herein referred to as jackhammer (rock drilling operation), regarding the robotic operation of an EMD in a catheter-based treatment system. [Figure 7] Diagram illustrating an exemplary mode, herein referred to as active device fixation (ADF), regarding the robotic operation of an EMD in a catheter-based treatment system. [Figure 8] Flowchart illustrating a method of closed-loop operation related to the exemplary mode of FIG. 7. [Figure 9] Diagram illustrating an exemplary mode regarding the synchronized robotic operation of two or more EMDs in a catheter-based treatment system. [Figure 10] State machine command diagram related to the exemplary modes of FIGS. 4A and 4B. [Figure 11] State machine command diagram related to the exemplary modes of FIGS. 4A and 4B. [Figure 12] State machine command diagram related to the exemplary mode of FIG. 5. [Figure 13] State machine command diagram related to the exemplary mode of FIG. 6. [Figure 14]A diagram of state machine commands related to the example mode in Figure 6. [Figure 15] State machine command diagrams related to the exemplary modes in Figures 7 and 8. [Figure 16A] ~ [Figure 16D] An example of an algorithm diagram for fixing the active device. [Figure 17] A diagram illustrating a graphical user interface. [Modes for carrying out the invention]

[0028] Figure 1 is a perspective view illustrating a catheter-based treatment system according to one embodiment. The catheter-based treatment system 10 shown in Figure 1 is used to perform catheter-based medical procedures, such as percutaneous interventional procedures including percutaneous coronary intervention (PCI) such as STEMI, neurovascular intervention (NVI) (such as treatment for acute major cerebral artery occlusion (ELVO)), and peripheral vascular intervention (PVI) such as critical limb ischemia (CLI). Catheter-based medical procedures include diagnostic catheter procedures, in which one or more catheters (or other elongated medical devices (EMDs)) are used to assist in the diagnosis of a patient's disease. For example, in one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected into one or more arteries through a catheter to image the patient's vascular system. Catheter-based medical procedures also include catheter-based therapeutic procedures (such as angioplasty, stent placement, treatment of peripheral vascular disease, blood clot removal, treatment of arteriovenous malformations, and treatment of aneurysms), in which a catheter (or other elongated medical device) is used to treat a disease. Treatment procedures can be enhanced using auxiliary equipment 54 (shown in Figure 2), such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and fractional flow reserve (FFR). However, it will be obvious to those skilled in the art that a predetermined percutaneous interventional device or component (various guidewires, various catheters, etc.) can be selected according to the type of procedure to be performed. The catheter-based treatment system 10 can perform any number of catheter-based medical procedures with some adjustments to accommodate the predetermined percutaneous interventional device used for the procedure.

[0029] The catheter-based treatment system 10 includes, in particular, a bedside unit 20 and a control station 26. Figure 2 shows an overview of the main building blocks of the catheter-based treatment system 10, which are described in detail below. The bedside unit 20 has a robotic drive unit 24 and a positioning system 22 (robot arm, articulated arm, holder, etc.) placed adjacent to the patient. The bedside unit 20 also has a control unit and a display unit 46 (shown in Figure 2). The control unit and display unit can be installed, for example, in the housing of the robotic drive unit 24. The patient 12 is supported on a table 18. Typically, the robotic drive unit 24 is equipped with appropriate percutaneous interventional equipment or other accessories 48 (shown in Figure 2) (e.g., guidewires, various catheters, balloon catheters, stent placement systems, stent retrievers, embolization coils, fluid embolization, suction pumps, contrast agents, pharmaceuticals, etc.), and enables the user to perform catheter-based medical procedures using the robotic system by operating various control units, such as the control unit in the control station 26. The bedside unit 20, and in particular the robotic drive unit 24, may include any number and / or combination of components to provide the bedside unit 20 with the functions described herein. The robotic drive unit 24 includes a plurality of instrument modules 32 mounted on a rail 60 (shown in Figure 3). Each of the instrument modules 32 is used to drive elongated medical devices such as catheters and guidewires. For example, the robotic drive unit 24 is used to automatically feed a guidewire into a diagnostic catheter and a guide catheter placed in the artery of the patient 12. One or more devices, such as an EMD, enter the patient's body (e.g., a blood vessel) at insertion position 16 using, for example, an introducer and introducer sheath.

[0030] The bedside unit 20 communicates with the control station 26, and signals generated by user input to the control station 26 are transmitted to the bedside unit 20 to control various functions of the bedside unit 20. As will be described later with reference to Figure 2, the control station 26 includes a control computing system 34 (shown in Figure 2) or is connected to the bedside unit 20 via the control computing system 34. The bedside unit 20 also provides feedback signals (loading, speed, operating conditions, warning signals, error codes, etc.) to the control station 26 or the control computing system 34 (shown in Figure 2), or both. Communication between the control computing system and the various components of the catheterization system 10 is provided via a communication link that may be wireless, wired, or any other means that enables communication between components. The control station 26 or other similar control system is located either at a local site (e.g., the local control station 38 shown in Figure 2) or a remote site (e.g., the remote control station and computing system 42 shown in Figure 2). The catheter-based treatment system 10 is operated by a control station at a local site, by a control station at a remote site, or simultaneously by both a local and a remote control station. At the local site, the operator and the control station 26 are in the same room as the patient 12 and the bedside unit 20, or in an adjacent room. In this case, the local site is the location of the bedside unit 20 and the patient 12 (subject), and the remote site is the location of the operator (e.g., a doctor) and the control station 26 used to remotely control the bedside unit 20.The control station 26 (and control computing system) at the remote site and the bedside unit 20 and / or control computing system at the local site communicate using a communication system and services 36 (shown in Figure 2), for example, via the Internet. In one embodiment, the remote site and the local (patient) site are geographically separated, for example, multiple rooms in the same building, multiple buildings in the same city, multiple buildings in multiple cities, or a different location where the remote site does not have physical contact with the bedside unit 20 or patient 12 at the local site.

[0031] The control station 26 typically includes one or more input modules 28 configured to receive user inputs for operating various components or systems of the catheterization procedure system 10. In the illustrated embodiment, the control station 26 enables the user to control the bedside unit 20 to perform catheterization medical procedures. For example, the input modules 28 are configured to cause the bedside unit 20 to perform various tasks using various percutaneous interventional devices (e.g., elongated medical devices) connected to the robotic drive unit 24 (e.g., advancing, retracting, or rotating a guidewire; advancing, retracting, or rotating a catheter; inflating or deflating a balloon positioned in a catheter; positioning and / or deploying a stent; positioning and / or deploying a stent retriever; positioning and / or deploying a coil; injecting contrast agent into a catheter; injecting liquid embolization into a catheter; injecting medicine or saline solution into a catheter; aspirating with a catheter; performing any other functions that may be performed as part of a catheterization medical procedure, etc.). The robot drive unit 24 includes various drive mechanisms for causing the movement (e.g., axial and rotational movement) of the components of the bedside unit 20, including the transcutaneous interventional device.

[0032] In one embodiment, the input module 28 includes a touchscreen, one or more joysticks, a scroll wheel, and / or buttons. In addition to the input module 28, the control station 26 may also use other user control units 44 (shown in Figure 2), such as a foot switch or microphone for voice commands. The input module 28 is configured to move various components and percutaneous interventional devices, such as guidewires and one or more catheters or microcatheters, forward, backward, or rotate. The buttons include, for example, an emergency stop button, a magnification button, an equipment selection button, and an auto-operation button. When the emergency stop button is pressed, a relay is triggered, cutting off the power supply to the bedside unit 20. In speed control mode, the magnification button acts to increase or decrease the speed of movement of the relevant component in response to the operation of the input module 28. In position control mode, the magnification button changes the mapping between the input distance and the output command distance. The equipment selection button allows the user to select which of the percutaneous interventional devices loaded in the robotic drive unit 24 will be controlled by the input module 28. The automatic operation button is used to enable algorithmic actions that the catheter treatment system 10 performs on percutaneous interventional devices without direct commands from the user. In one embodiment, the input module 28 includes one or more control units or icons (not shown) displayed on a touchscreen, the activation of which activates components of the catheter treatment system 10. The input module 28 also includes a balloon or stent control unit configured to inflate or deflate a balloon and / or deploy a stent. Each module includes one or more buttons, scroll wheels, joysticks, touchscreens, etc., suitable for controlling a particular component for which there is a dedicated control unit. Furthermore, the touchscreen may display one or more icons (not shown) related to each component of the input module 28 or related to each component of the catheter treatment system 10.

[0033] The control station 26 includes a display unit 30. In another embodiment, the control station 26 includes two or more display units 30. The display units 30 are configured to display information or patient-specific data to a user at the control station 26. The display units 30 are configured to display, for example, image data (X-ray images, MRI images, CT images, ultrasound images, etc.), hemodynamic data (blood pressure, heart rate, etc.), patient record information (medical history, age, weight, etc.), lesion or treatment evaluation data (IVUS, OCT, FFR, etc.). The display units 30 may also be configured to display procedure-specific information (procedure checklist, recommendations, time required for the procedure, catheter position or guidewire position, volume of medication or contrast agent to be delivered, etc.). Furthermore, the display units 30 are configured to display information to provide functionality in cooperation with the control computing system 34 (shown in Figure 2). The display units 30 include touchscreen functionality to provide some of the system's user input functions.

[0034] The catheter-based treatment system 10 also includes an imaging system 14. The imaging system 14 is a medical imaging system (such as non-digital X-ray, digital X-ray, CT, MRI, or ultrasound) used in conjunction with the catheter-based medical treatment. In one embodiment, the imaging system 14 is a digital X-ray imaging device that communicates with a control station 26. In one embodiment, the imaging system 14 includes a C-arm (as shown in Figure 1) which allows the imaging system 14 to rotate partially or completely around the patient 12 to obtain images at various angular positions relative to the patient 12 (e.g., sagittal view, caudal view, anterior-posterior view, etc.).

[0035] The imaging system 14 may be configured to take X-ray images of appropriate areas of the patient 12 during a predetermined procedure. For example, the imaging system 14 may be configured to take one or more X-ray images of the head to diagnose a neurovascular condition. The imaging system 14 may also be configured to take one or more X-ray images (e.g., real-time images) during a catheter-based medical procedure and assist the user of the control station 26 in properly positioning guidewires, guide catheters, microcatheters, stent retrievers, coils, stents, balloons, etc., during the procedure. One or more images are displayed on the display unit 30. Specifically, images are displayed on the display unit 30 so that the user can accurately move, for example, a guide catheter or guidewire to the appropriate position.

[0036] Referring to Figure 2, a block diagram of a catheter-based treatment system 10 according to one embodiment is shown. The catheter-based treatment system 10 includes a control computing system 34. Physically, the control computing system 34 may be, for example, part of a control station 26 (shown in Figure 1). The control computing system 34 is typically an electronically controlled unit suitable for providing the catheter-based treatment system 10 with the various functions described herein. Examples of the control computing system 34 include an embedded system, a dedicated circuit, or a general-purpose system programmed with the functions described herein. The control computing system 34 communicates with a bedside unit 20, communication systems and services 36 (such as the Internet, firewall, cloud services, session manager, and hospital network), a local control station 38, another communication system 40 (such as a telepresence system), a remote control station and computing system 42, and patient sensors 56 (such as an electrocardiogram (ECG) device, an electroencephalogram (EEG) device, a blood pressure monitor, a temperature monitor, a heart rate monitor, and a respiratory monitor). Furthermore, the control computing system 34 communicates with the imaging system 14, the patient table 18, another medical system 50, the contrast agent injection system 52, and auxiliary equipment 54 (IVTJS, OCT, FFR, etc.). The bedside unit 20 includes a robotic drive unit 24, a positioning system 22 (robot arm, articulated arm, holder, etc.), and may also include a separate control unit and display unit 46. As described above, the control unit and display unit 46 can be located in the housing of the robotic drive unit 24. Interventional equipment and accessories 48 (guide wires, catheters, etc.) are connected to the bedside unit 20. In one embodiment, the interventional equipment and accessories 48 include special devices (IVTJS catheter, OCT catheter, FFR wire, contrast agent diagnostic catheter, etc.) that connect to auxiliary equipment 54, i.e., IVTJS system, OCT system, FFR system, etc.

[0037] In one embodiment, the control computing system 34 is configured to generate control signals based on user interaction with an input module 28 (such as a control station 26 (shown in Figure 1), including a local control station 38 or a remote control station 42) and / or based on available information in the control computing system 34, so that a medical procedure can be performed using the catheter-type procedure system 10. The local control station 38 includes one or more display units 30, one or more input modules 28, and another user control unit 44. The remote control station and computing system 42 include components similar to those of the local control station 38. The remote 42 and local 38 control stations may be specially tailored as different depending on the required functions. The other user control unit 44 may include one or more foot input devices. The foot input devices are configured to allow the user to select functions of the imaging system 14. These functions include turning X-rays on / off and scrolling through various stored images. In another embodiment, the foot input devices are configured to allow the user to select which devices to map to the scroll wheels included in the input modules 28. A separate communication system 40 (such as audio conferencing, video conferencing, or telepresence) can be used to assist the operator when interacting with the patient, angiography staff, or equipment near the bedside.

[0038] The catheter-based treatment system 10 may be connected to or configured to include any other systems and / or devices not explicitly shown. For example, the catheter-based treatment system 10 may include an image processing engine, a data storage and archiving system, an automated balloon and / or stent inflation system, a drug infusion system, a drug tracking and / or logging system, a user log, an encryption system, a system that restricts access to or use of the catheter-based treatment system 10, and so on.

[0039] As described, the control computing system 34 communicates with a bedside unit 20 which includes a robot drive unit 24, a positioning system 22, and another control unit and display unit 44, and provides control signals to the bedside unit 20 to control the operation of motors and drive mechanisms used to drive percutaneous interventional devices (guidewires, catheters, etc.). Various drive mechanisms are provided as part of the robot drive unit 24 (shown in Figures 1 and 2). Figure 3 is a perspective view of the robot drive unit of a catheter treatment system according to one embodiment. In Figure 3, the robot drive unit 24 includes a plurality of device modules 32 connected to a linear rail 60. Each device module 32 is connected to the rail 60 via a stage 62 which is slidably mounted on the rail 60. The device modules 32 are connected to the stage 62 using connectors such as offset brackets 78. In a different embodiment, the device modules 32 are directly mounted to the stage 62. Each stage 62 can be operated independently to move linearly along the rail 60. Therefore, each stage 62 (and the corresponding equipment module 32 connected to the stage 62) operates individually relative to each other and to the rail 60. A drive mechanism is used to operate each stage 62. In the embodiment shown in Figure 3, the drive mechanism includes independent stage displacement motors 64 connected to each of the stages 62 and a stage drive mechanism 76, for example, a lead screw. In Figure 3, the stages 62 and the equipment module 32 are in a series drive configuration.

[0040] Each device module 32 includes a drive module 68 and a cassette 66 mounted on and connected to the drive module 68. In Figure 3, each cassette 66 is shown mounted vertically on the drive module 68. In other embodiments, the cassette 66 is mounted on the drive module 68 in a different manner. The cassette 66 is sterile and configured to house and support an elongated medical device (not shown). Furthermore, the cassette 66 connected to the drive module 68 includes a mechanism that provides the elongated medical device with at least one additional degree of freedom, such as rotation. The drive module 68 includes at least one coupler to provide a power interface to the mechanism of the cassette 66 that provides its additional degree of freedom. Each cassette 66 also houses a device support 79 that prevents buckling of the elongated medical device. The robotic drive unit 24 includes a device support connector 72 connected to the device support 79, a distal restraint arm 70, and a support arm 77. In addition, the introducer interface support (redirector) 74 may be connected to the equipment support connection part 72 and the elongated medical device (e.g., introducer sheath). This structure of the robot drive unit 24 has the advantage of reducing the size and weight of the robot drive unit 24 by combining the actuators on a single rail.

[0041] Catheter-based medical procedures include diagnostic catheterization procedures performed in the heart, brain, or peripheral vascular system, in which one or more catheters are used to assist in the diagnosis of a patient's disease. For example, in one case, a contrast agent is injected through a catheter into one or more coronary arteries to obtain images of the patient's heart. Catheter-based medical procedures include catheter-based therapeutic procedures performed in the heart, brain, or peripheral vascular system (such as angioplasty, stent placement, treatment of peripheral vascular lesions, blood clot removal, treatment of arteriovenous malformations, and treatment of aneurysms). It will be understood by those skilled in the art that a specific percutaneous intervention device or component (such as various guidewires and various catheters) can be selected according to the type of procedure to be performed.

[0042] In this context, the distal direction is toward the patient, and the proximal direction is toward the patient. For example, the distal end of an elongated medical device (EMD), such as a guide catheter, refers to the end inserted into the patient, and the proximal end of the EMD refers to the end connected to the bedside unit 20 described above. The upper and upper sides of a word refer to an approximate direction away from the direction of gravity, and the lower and lower sides of a word refer to an approximate direction of gravity. The front of a word refers to the side of the robot mechanism that faces the user and is away from the articulated arm. The back of a word refers to the side of the robot mechanism that is closer to the articulated arm. The inward direction of a word refers to the inner part of the mechanism. The outward direction of a word refers to the outer part of the mechanism.

[0043] During the procedure, elongated medical devices such as guide catheters, guidewires, and / or working catheters are inserted into the patient. In one example of an interventional procedure, a guide catheter is inserted into the patient's femoral artery through an introduction device and positioned close to the coronary artery opening of the patient's heart. The guide catheter maintains a linear position along its longitudinal axis within the device module 32. In medical procedures such as percutaneous coronary intervention (PCI), the guide catheter is used to insert other elongated medical devices such as guidewires and balloon stent catheters into the patient, for example, to perform exploratory diagnostics or to treat stenosis in the patient's vascular system. The distal end of the guide catheter is positioned within the hilum of the patient's heart. The robotic drive unit 24 drives the guidewire and / or working catheter, such as a balloon stent catheter, inside and outside the patient. The guidewire and working catheter are driven within the guide catheter between the distal end of the robotic mechanism and the patient.

[0044] Here, the linear motion of a transdermal device, also called an elongated medical device (EMD), is the motion along the longitudinal axis of the EMD. The longitudinal axis of the EMD is defined as the path extending from the proximal end to the distal end of the EMD. If the EMD is more rigid, the entire EMD is positioned such that the proximal end, the distal end, and the entire EMD in between are on a straight line. In this case, the longitudinal axis of the EMD can be defined by a straight line. However, if the EMD is flexible and moves through either a robotic drive mechanism or a non-linear vascular pathway, then a portion of the EMD will not be along the straight line defined by the proximal and distal ends of the EMD. However, the central portion of the EMD moving through the robotic drive mechanism or the non-linear portion of the vascular system can still be said to be on the longitudinal axis of the EMD. That is, linear motion is the motion of the EMD along its longitudinal axis. EMD movements away from the proximal end in an intrapatient direction are forward or linear movements, while EMD movements away from the distal end out of the patient are backward or linear movements.

[0045] The rotational motion of the EMD is defined as the rotation of the EMD around its vertical axis. The clockwise rotational motion of the EMD is the clockwise rotation of the EMD around its vertical axis at the position of the drive mechanism.

[0046] In one example, a first user controller or user input provides commands to operate the EMD. In one embodiment, the first or primary user controller is a joystick that provides commands of multiple magnitudes of movement. In one embodiment, commands to move the EMD to a forward or backward position are provided by being movable along a pivot axis from a central neutral position. In one embodiment, a linear dead zone is defined as a joystick position where no forward or backward commands are provided. In one example, moving the joystick 3° forward or backward does not cause any movement of the EMD. In one embodiment, rotation of the joystick around a vertical axis provides rotation commands to the EMD. Clockwise rotation of the joystick results in clockwise rotation of the EMD, and counterclockwise rotation of the joystick results in counterclockwise rotation of the EMD. However, in one embodiment, commands providing rotation of the EMD occur only when the joystick is rotated beyond a 3° rotation dead zone in either direction. The rotation dead zone may, of course, be less than 3°. In one embodiment, the rotational dead zone is 2°, while in another embodiment, the rotational dead zone exceeds 3°.

[0047] The operator drives the EMD using the robotic system described herein for several separate vascular procedures. These vascular procedures include, in particular, lesion crossing, vascular navigation, lesion measurement, lesion assessment, lesion preparation, self-expanding stent deployment, and instrument stabilization during guide catheter manipulation.

[0048] Various user input devices enable the operator to control the operation of one, more, or all EMDs in system 10. For example, the operator can control the operation of a guide catheter, microcatheter, guidewire, or other EMDs individually or together. To facilitate the effectiveness of procedures using the exemplary catheter-based procedure system, the various examples described herein allow the operator to select one or more modes of robotic operation for assistance during the procedure. These modes of robotic operation can execute a pattern of motion including predetermined repetitive movements, with or without separate operator input to the robotic drive unit. The term "pattern" as used herein refers to a sequence, such as a sequence of movements or a sequence of commands. In some examples, the movements can be enabled with predetermined default values, which can be changed by further operator input. Various movements are described below with reference to Figures 4 to 9. Some movements apply to any or all of the EMDs used in a particular procedure, while others are useful only for certain types of EMDs.

[0049] In the diagrams described below, various motion patterns are illustrated at the distal end of the EMD, or at the end of the EMD inserted into the patient. In various examples, the desired motion pattern is performed at the proximal end of the EMD via an actuator (e.g., a drive motor or drive wheel). In other words, when the drive motor is activated, the desired motion at the proximal end of the EMD is transmitted to the distal end. The precise motion at the distal end may or may not match the motion at the proximal end due to various factors such as the obedience of the EMD, friction against the vessel wall, tortuosity of the vascular system, or resistance facing the lesion. Some robotic motions can compensate for this mismatch and input or adjust the motion at the proximal end to more accurately achieve the desired motion at the distal end. For example, the amount of the desired motion at the distal end can be adjusted (expanded / reduced) by a coefficient applied to the motion performed at the proximal end. This coefficient can be determined based on the procedure, instrument characteristics, real-time imaging, experiments, or historical data according to a specific vascular system or other parameters. The coefficient or adjustment is applied by the operator or the control computing system.

[0050] Referring to Figures 4A and 4B, modes of robot operation in the EMD system are illustrated. Figures 4A and 4B illustrate an EMD apparatus 100 used in the exemplary system described above with reference to Figures 1 to 3. The EMD apparatus 100 according to this embodiment includes a first EMD 110 and a second EMD 120. Figures 4A and 4B show the distal portions of the EMDs 110 and 120. The two EMDs are arranged coaxially, with the second EMD 120 housed within the first EMD 110. In this example, the first EMD 110 has a lumen that accommodates the second EMD 120 and allows the second EMD 120 to operate (e.g., rotate and / or displace) relative to the first EMD 110. Those skilled in the art will of course understand that there are also examples in which more than two EMDs are provided and arranged coaxially, with more than one EMD housed within the lumen of the other EMDs.

[0051] When a mode is selected by the operator, the robot drive unit 24 causes one or more EMDs 110, 120 to enter a predetermined motion pattern. In the example shown in Figures 4A and 4B, one EMD (e.g., a guide wire) enters the predetermined motion pattern. In another example, multiple EMDs enter the motion pattern at different times (e.g., one EMD at a time). The robot motion modes shown in Figures 4A and 4B are referred to here as wiggle modes. Wiggle modes are characterized by the oscillating rotation of the EMDs around the longitudinal axis. In one example, when wiggle mode is activated, the EMD (the second EMD 120 in the example shown in Figures 4A and 4B) enters rotational oscillation around the longitudinal axis 125. In another example, the EMD 120 rotates only when the user commands it to move with a forward linear displacement. In this example, the EMD 120, depicted as a guide wire, rotates alternately clockwise and counterclockwise, as shown in cross-sectional view AA of Figure 4A. The vibration of the EMD is characterized by various parameters such as amplitude and / or frequency. As shown in Figure 4A, the amplitude is indicated by the range of rotation 140 with respect to the center position represented by the reference plane 130 in Figure 4A. In various examples, the operator can set vibration parameters such as amplitude, rotational speed, frequency, or cycle time.

[0052] To achieve a desired result or for a predetermined purpose, various parameters of the vibration can be set to a predetermined pattern. For example, the amplitude of the vibration is set to about 60° to about 180°, preferably about 90° to about 150°, and more preferably about 125°. The cycle time (e.g., the time to complete one vibration) or vibration frequency is similarly set to a predetermined pattern to achieve the desired result. In one example, the vibration of the EMD is performed at a rotational speed of 900 degrees per second.

[0053] As described above, various robotic movements are performed on various EMDs. The wiggle mode described above can be performed with respect to a guidewire, for example, for navigation or to advance through a blood vessel. The wiggle mode can be performed with respect to a guidewire with multiple parameters for the purpose of overcoming obstacles such as lesions. In this example, the amplitude of the vibration is set to a larger level. For example, the amplitude of the vibration for the purpose of crossing a lesion can be set to about 180° to about 900°, preferably about 360° to about 720°. A mode with these parameters can be called a "spin" mode and can be selected by the operator.

[0054] As shown in Figures 4A and 4B, auxiliary commands can be used to change predetermined characteristics of the EMD's vibration. In the examples shown in Figures 4A and 4B, auxiliary commands are received from a user input device such as a joystick 150. Figure 4A illustrates the vibration relative to a plane 130 representing the center position of the vibration when there is no rotational input from the joystick 150. The joystick in Figure 4A is shown with a forward input that causes a forward linear displacement of the EMD 120, as indicated by the arrow on the joystick and the arrow 170 next to the EMD 120 in Figure 4A. The vibration can be changed through commands from the joystick 150.

[0055] In this regard, input from the joystick 150 can tilt or change the orientation of the vibration center position. For example, as shown in Figure 4B, the vibration center position can be moved by rotating the joystick. Rotating the joystick clockwise moves the center position 130 to a new center position 130' clockwise, as illustrated in Figure 4B.

[0056] As described above, other parameters of vibration, such as amplitude, frequency, rotational speed, or cycle time, can be changed by the operator. For example, the amplitude of vibration can be changed by user input using another input device such as a joystick or a graphical user interface. In the case of a joystick, the amplitude can be increased by rotating the joystick clockwise or decreased by rotating the joystick counterclockwise. In this example, if the amplitude is set to 125° in a predetermined mode, rotating the joystick clockwise can increase the amplitude to a higher value, such as 150°. Similarly, rotating the joystick counterclockwise will decrease the amplitude to a lower value, such as 90°.

[0057] Figures 4A and 4B show auxiliary commands received from an operator input device such as a joystick 150. In other examples, auxiliary commands are received from a controller or control module, such as the control computing system 34 described above with reference to Figure 2. The control module can generate auxiliary commands in response to other user input or to detected parameters, such as the operation of the EMD or resistance to the operation of the distal part of the EMD.

[0058] As described above, the predetermined motion patterns of the wiggle mode may be performed for navigation purposes. In this example, the predetermined motion involves forward linear motion of the EMD (e.g., guide wire). That is, vibration is activated only when the EMD is in forward linear motion while the mode is active. In one example, if the forward linear motion stops for a predetermined time (e.g., 1 second), the rotational vibration is stopped. Rotational vibration is not activated when there is no forward linear motion. That is, if the linear motion is reversed or pushed, the rotational vibration may be stopped. In this context, "pushing" refers to a separate (independent) motion (rotational or linear) of the EMD performed in response to input from the operator.

[0059] Referring to Figure 5, another mode of robot operation in the EMD system is illustrated. Figure 5 shows an example of the EMD apparatus 100 described above with reference to Figures 4A and 4B. The EMD apparatus 100 according to this embodiment includes a coaxially arranged first EMD 110 and a second EMD 120, as illustrated in cross-sectional view AA.

[0060] Figure 5 shows a predetermined motion pattern associated with a mode, which we refer to here as the drill mode. When the drill mode is selected by the operator, the robot drive unit 24 puts one or more EMDs 110, 120 into a predetermined motion pattern characterized by continuous unidirectional rotation of at least one EMD around its longitudinal axis 125, as indicated by arrow 160, in combination with the forward linear motion of the EMDs indicated by arrow 170. In this example, the EMDs (e.g., a second EMD 120 or guide wire) spin in one direction. The direction of rotation can be clockwise or counterclockwise. The unidirectional rotation 160 of the EMD 120 can be characterized by a rotational speed. The rotational speed can be set as part of a predetermined motion pattern. For example, the rotational speed is set to about 1 to 10 revolutions per second, preferably about 2.5 revolutions per second. In one example, the operator can set the rotational speed by inputting a different value.

[0061] As described above, various robotic movements are performed on various EMDs. The drill mode shown in Figure 5 can be performed with respect to a guide wire to overcome obstacles such as lesions.

[0062] Similar to the wiggle mode described above with reference to Figures 4A and 4B, when the drill mode shown in Figure 5 is enabled and the forward linear motion is stopped for a predetermined time, continuous unidirectional rotation is stopped. That is, rotation is stopped while the EMD is not in forward linear motion during the activation of drill mode. If the linear motion is reversed or shaken, a similar stoppage of unidirectional rotation is performed. In one example, auxiliary inputs can be used to increase or decrease the rotation speed in drill mode. For example, the operator moves the joystick forward to increase the rotation speed and backward to decrease the rotation speed.

[0063] Referring to Figure 6, various phases of different modes of robot operation in the EMD system are illustrated. Figure 6 shows an example of the EMD apparatus 100 described above with reference to Figures 4A, 4B and 5. The EMD apparatus 100 according to one embodiment includes a first EMD 110 and a second EMD 120 arranged coaxially.

[0064] Figure 6 shows a predetermined operating pattern associated with a mode, which we refer to here as the jackhammer mode. When the jackhammer mode is selected by the operator, the robot drive unit 24 places one or more EMDs 110, 120 into a predetermined operating pattern characterized by linear vibrations of the EMDs 110, 120. The example shown in Figure 6 shows a second EMD 120 (e.g., a guidewire) exhibiting linear vibrations. The jackhammer mode is used by the operator to facilitate the guidewire overcoming obstacles such as lesions.

[0065] As illustrated in Figure 6, linear vibration includes alternating forward and backward linear motion of the elongated medical device. Figure 6 shows the forward linear motion of the EMD120 from position (a) to position (b), followed by the backward linear motion of the EMD120 from position (b) to position (c). This motion pattern continues in a repeating cycle, along with the motion of the EMD120 from position (c) to position (d).

[0066] The jackhammer mode shown in Figure 6 performs alternating forward and backward linear motion of the elongated medical device, resulting in forward linear motion of the EMD120. This allows, for example, the EMD120 to pass over or go over a lesion. In this example, the alternating forward linear motions are at least slightly larger than the alternating backward linear motions. Therefore, as shown in Figure 6, at the start of the vibration cycle, the EMD120 is in position (a), and at the completion of the vibration cycle (and at the start of the next vibration cycle), the EMD120 is in position (c), which is forward of position (a). That is, the cumulative forward linear motion allows the EMD120 to pass over or go over a lesion, for example.

[0067] As described above and shown in the example in Figure 6, the jackhammer mode is used with the second EMD120, i.e., the guidewire. In other examples, a similar operating pattern is used with other EMDs, such as a microcatheter (or the first EMD110).

[0068] Similar to the wiggle mode and drill mode described above with reference to Figures 4A, 4B, and 5, when the jackhammer mode in Figure 6 is enabled, the alternating forward and backward linear motion characteristic of the jackhammer mode is stopped when the input for forward linear motion is stopped. In one example, the jackhammer mode is stopped when the input for forward linear motion is stopped for a predetermined time. That is, when the jackhammer mode is activated, linear vibration is stopped as long as the EMD is not performing forward linear motion. A similar stop can be performed if the linear vibration is reversed or shaken.

[0069] Referring to Figure 7, another mode of robotic operation in an EMD system is illustrated. The mode shown in Figure 7 is called Active Device Fixation (ADF). ADF is activated in a system in which at least two EMDs are used for a procedure, such as in a robotic system 700 in which the instrument module of EMD 720 is coupled to the instrument module 740 of another EMD 710. In the example in Figure 7, the robotic system 700 is used to perform a procedure on patient 702 by inserting the EMD into the patient's vascular system 704.

[0070] The robotic system 700 in Figure 7 includes a first EMD, such as a microcatheter 710, and a second EMD, which is a guidewire 720. A third EMD, such as a guidecatheter 730, is installed through which the microcatheter 710 and guidewire 720 are displaced. The microcatheter 710 is linearly displaced through a corresponding linear displacement of an instrument module 740, which includes an instrument support or support track 750 through which the EMDs 710 and 720 are coaxially supplied to the next instrument module.

[0071] In the apparatus shown in Figure 7, the device module is linearly displaced, driving the linear displacement of the microcatheter 710. The displacement of the device module 740 also drives the linear displacement of the guidewire 720. The guidecatheter 730 can be linearly displaced by another corresponding device module (not shown in Figure 7). The microcatheter 710, guidewire 720, and guidecatheter 730 are coaxially arranged. That is, as shown in Figure 7, within the patient 702, the three EMDs 710, 720, and 730 are arranged coaxially through a passage such as the carotid artery.

[0072] The operator may want to reposition one EMD while leaving other EMDs stationary within patient 702. For example, the operator may want to linearly displace the microcatheter 710 to the position shown in Figure 7B while maintaining the position of the guidewire 720. Figure 7 shows the positions of the distal portions of EMDs 710, 720, and 730. Those skilled in the art will understand, as stated above, that it is the proximal end of the EMD that is controlled.

[0073] When ADF mode is enabled, the operator can linearly displace the microcatheter 710 by displacing the instrument module 740 forward by a distance Δd, as illustrated in Figure 7B. In one example, measurement of the movement by an encoder is used to determine the amount and direction. ADF mode causes a corresponding movement of the guidewire 720 in the opposite direction, resulting in the proximal end of the guidewire 720 remaining substantially stationary relative to the patient 702, as shown in Figure 7.

[0074] The movement of the guidewire 720 relative to the instrument module 740 is performed using the drive tire 742, and the linear movement of the guidewire 720 can be measured using the corresponding encoder connected to the auxiliary encoder tire 744. As shown in Figure 7B, the drive tire 742 causes a rearward displacement of the guidewire 720 relative to the instrument module 740. Conversely, when the microcatheter is retracted (reverse), the drive tire 742 causes a forward displacement of the guidewire 720 relative to the instrument module 740. The rotation of the auxiliary encoder tire 744 due to the movement of the guidewire 720 is provided to a central control unit, such as the control computing system 34 described above with reference to Figure 2.

[0075] In response to the identified displacement of the first EMD710, with the ADF mode enabled, the control computing system 34 causes a linear displacement of the guidewire 720 by an amount substantially equal to the linear displacement of the microcatheter 710 (Δd in the example of Figure 7) and in the opposite direction to the direction of the displacement of the microcatheter 710 relative to the instrument module 740.

[0076] Referring to Figure 8, a flowchart illustrates method 800 for performing ADF mode using closed-loop operation. According to the example in Figure 8, the process begins with the operation of a first EMD (e.g., a microcatheter 710) in accordance with a command from the operator (block 802). In response to this command, the microcatheter 710 is driven by the instrument module 740 (block 804). The operation of the microcatheter 710 is detected (or determined), for example, based on an instruction from an encoder that tracks the position of the microcatheter 710 (block 806).

[0077] Based on the identification of the movement of the microcatheter 710, a corresponding movement of a second EMD (e.g., guidewire 720) in the opposite direction is commanded (block 808). The commanded movement of the second EMD 720 is performed, for example, by driving the guidewire 720 with a drive tire 742 (block 810). The movement of the guidewire 720 is detected, for example, by an encoder coupled to an auxiliary encoder tire 744 or other sensors provided within the system 700 (block 812).

[0078] In the example shown in Figure 8, various safety features are provided to offer safeguards during closed-loop operation. The safeguards prevent overcompensation or inaccuracy caused by failure or defect of a sensor (e.g., encoder) or drive tire 742.

[0079] In this regard, in block 814, the control computing system determines whether the desired movement of the guidewire 720 (e.g., movement corresponding to the movement of the microcatheter 710) has been completed, which is indicated by the guidewire 720 reaching the planned target position. In this example, the control computing system uses the amount of movement measured by the associated encoder 742. If the amount of movement measured by the associated encoder is substantially equal to the desired amount of movement of the guidewire 720, the movement is considered complete in block 814, and the process moves to block 816. In block 816, the difference between the measured movement of the microcatheter 710 (block 802) and the measured movement of the guidewire 720 by the encoder is calculated as an error. If the error is below a threshold (e.g., 0.5 mm), the process is considered complete, and the process returns to block 802 for a new commanded movement of the first EMD 710. In one example, the error identified in block 816 is added to the previous error, and the error compared to the threshold is the cumulative threshold.

[0080] In block 818, if the position of the guidewire 720 is within a first error threshold, it can be determined that the compensatory action of the guidewire 720 is complete. The first threshold is the difference between the positional change of the microcatheter 710 and the equally opposite positional change of the guidewire 720. For example, if the difference in their movements is within 0.5 mm, the action can be considered complete. Without this first threshold, the guidewire 720 may continue to move and vibrate to correct the positional error. The operator may find this vibration undesirable when positioning the EMD to the patient's anatomical structure. In some cases, the compensatory action of the guidewire 720 may be re-executed if the positional error exceeds a second threshold greater than the first threshold. For example, the compensatory action will not be re-executed unless the positional error exceeds a second threshold of 1.0 mm. In another example, the compensatory action may be re-executed by further command input (e.g., from a user operating a joystick).

[0081] Returning to block 814, if the movement of the guidewire 720 has not completed the movement commanded in response to the movement of the microcatheter 710, the process determines whether the detected movement of the guidewire 720 is inconsistent with the amount of movement commanded by the guidewire 720 tire. This occurs when the amount of commanded movement of the drive tire does not match the detected movement of the encoder tire. In this case, the ADF mode limits the amount of drive by the drive tire to prevent excessive displacement of the guidewire 720, if the inconsistency is due to a sensor (encoder tire) failure.

[0082] In another example, the input from encoder 734 may indicate that the movement of the guidewire 720 is unable to keep up with the movement of the microcatheter 710 as a result of slippage or loss of traction between the drive tire 742 and the guidewire 720. When the movement of the guidewire 720 falls behind that of the microcatheter 710, the movement of the microcatheter 710 may be slowed down or stopped to maintain the proximal position of the guidewire.

[0083] In the examples shown in Figures 7 and 8, the linear motion of the first EMD710 and the second EMD720 occurs substantially simultaneously. However, a person skilled in the art will understand that the timing of the processor or the frequency of measurement may result in a minimal offset in the timing of the operation.

[0084] In one example, data from the encoder may indicate unexpected operation of the EMD710,720. Operation is considered unintended if, for example, it exceeds a predetermined speed or threshold, or does not correspond to the commanded operation. In this case, the operation can be recognized as unexpected, and the reference position of the EMD710,720 can be adjusted without changing the commanded displacement speed or amount of either EMD.

[0085] The presence or absence of a second EMD 720 can be detected using data from an encoder connected to the auxiliary encoder tire 744. For example, if the movement of a guide wire 720 is commanded through the movement of the drive tire 742, the presence or absence of the guide wire is indicated using a signal from the auxiliary encoder tire 744. If the auxiliary encoder tire 744 indicates movement of the guide wire 720 that exceeds a predetermined threshold (e.g., 0.1 mm) corresponding to the commanded movement, the presence of the guide wire 720 can be confirmed. On the other hand, if the auxiliary encoder tire 744 does not detect movement of the drive tire 742 corresponding to the commanded movement, the absence of the guide wire 720 can be detected or identified. In another example, the control computing system may assume that the second EMD 720 does not exist until its presence is first detected.

[0086] Those skilled in the art will understand that the number of EMDs may be more than two. For example, in the above example, one or more additional EMDs (in addition to the guidewire 720) can be displaced in response to the movement of the microcatheter. For example, EMDs displaced in response to the movement of the microcatheter include the guidewire, balloon or stent catheter, and any other available EMDs. In one example, one or more additional EMDs are included, and the behavior of each is constrained in the same way as the second EMD. For example, when operating the guide catheter, multiple EMDs move in the same direction as and opposite to the movement of the guide catheter. In one system, the guide catheter, guidewire and third EMD are placed on a common base that operates all three devices together. To maintain the position of the guidewire and third EMD relative to the patient, the guidewire and third EMD move in the same direction as and opposite to the movement of the guide catheter, and opposite to the movement of the base. If multiple EMD devices are present, the device that is not maintained in the opposite direction to the guide catheter is the EMD that constrains the movement of the guide catheter. In another method, the guide catheter is constrained (decelerated or stopped) by an EMD that slows down most of the other EMDs. The other EMDs continue to track the movement of the guide catheter. As a result, all EMDs will move a distance that is substantially equal to or opposite to the distance moved by the guide catheter.

[0087] Referring to Figure 9, another mode for robot operation in the EMD system is illustrated. To synchronize the operation of two or more EMDs when at least two EMDs are driven by separate drive modules, the closed-loop operation described above can be used with reference to Figures 7 and 8. In the example shown in Figure 9, EMDs 110 and 120 operate synchronously in the jackhammer mode described above with reference to Figure 6.

[0088] As illustrated in Figure 9, the linear oscillation associated with the jackhammer mode involves alternating forward and backward linear motion of the two EMD110 and 120 units. Figure 9 shows the forward linear motion of EMD110 and 120 from position (a) to position (b) by an amount of Δd1, followed by the backward linear motion of EMD110 and 120 from position (b) to position (c) by an amount of Δd2. As mentioned above, the amount of forward linear motion (Δd1) is greater than the amount of backward linear motion (Δd2). The motion pattern begins with the motion of EMD110 and 120 from position (c) to position (d) by an amount of Δd1 each, and continues in a repeating cycle.

[0089] Synchronization of the operation of the first EMD 110 and the second EMD 120 is achieved by a closed-loop system that uses input from a sensor, such as an encoder, to detect or identify the operation of one EMD, and uses the information from the sensor to drive the other EMD. For example, a command causes the first EMD 110 to be driven. The command is received from a controller or operator input. An encoder tire, such as the auxiliary encoder tire 744 described above with reference to Figure 7, can be used to measure the operation of the first EMD 110. Depending on the measured operation of the first EMD 110, the controller drives the second EMD 120 to be displaced by the same amount and in the same direction as the first EMD 110.

[0090] Referring to Figure 10, a state machine diagram corresponding to an example of the wiggle mode, called the spin mode, as described above with reference to Figures 4A and 4B, is shown. The example in Figure 10 shows how commands are provided to the main user input and the linear and rotary drive mechanisms of the guidewire equipment. When the spin mode is selected, the rotary drive mechanism provides rotational vibration to the guidewire while the guidewire is being driven forward. Referring to Figure 10, there are four separate command states when the spin mode is selected as an example. Firstly, in the No GWL COMMAND (GWL: Guidewire Linear) state, where there are no commands from the main user input, the controller does not give automatic commands to the rotary or linear drive mechanism that provides rotational or linear motion to the guidewire. In this state, the operator can provide rotational motion to the guidewire (GW) by a rotational motion input from the user. Secondly, in the GW FORWARD MOTOR COMMAND state, when the operator gives a command via the main user interface to move the guidewire in the linear forward direction, the rotary drive mechanism automatically provides rotational vibration motion to the guidewire. Furthermore, in the GW FORWARD MOTOR COMMAND state, all rotational inputs to the main user input are ignored, and no further rotational motion is imparted to the guide wire from the rotary drive unit. In this GW FORWARD MOTOR COMMAND state, where the main user interface is a joystick, when the operator rotates the joystick, this provides the rotary drive unit with clockwise (CW) and counterclockwise (CCW) rotation commands, but this rotation of the joystick does not result in any commands from the controller to the rotary drive unit to rotate the guide wire other than automatic vibration of the guide wire. In a third command state, where the user gives a linear reverse command to the GW reverse motor via the main user input, the guide wire rotary drive unit does not impart any rotational motion to the guide wire unless the user further commands the guide wire to rotate.When the primary user input is a joystick movement backward, the linear drive unit is instructed to move the guidewire in the opposite direction to the patient or in the withdrawal direction, but no command is provided to the rotary drive unit to impart rotational vibration to the guidewire. However, in this third state, rotation of the joystick in either CW or CCW direction instructs the rotary drive unit to rotate the guidewire in either the CW or CCW direction. In this third state, another way to describe it is that the primary input backward movement behaves the same as in the basic operating state. When the operator provides a linear forward command through the primary user input mechanism, the position during the vibration cycle is saved, and if the operator operation of the primary user input in the linear forward direction continues again, the cycle restarts from where it stopped. In one embodiment, the position in the cycle is not saved, and it starts anew each time the operator stops and initiates linear forward movement via the primary user input.

[0091] In one example, the automatic rotational vibrations that occur as described above in various conditions each cycle first include 360° CW rotation at 900° / sec and 360° CCW rotation at 900° / sec, after which the cycle is repeated without pauses between directional changes other than those required by the physical limitations of the electromechanical rotational drive mechanism. Of course, other speeds and rotational amounts are also possible. In one example, the speed is between less than 900° / sec and greater than 900 deg / sec.

[0092] In the fourth state, GW FORWARD MOTOR COMMAND (DISCRETE), separate operating modes are selected by selecting the jog button for individual (separated) forward movement, but no rotational movement instruction is provided to the rotational drive mechanism. If the user deselects the spin operation algorithm via the second user interface, the operation of the main user input reverts to the basic standard command without automatic alternating rotation movement.

[0093] When the primary user input is a joystick and the controller and spin motion technique are selected as a second user input, the rotational drive mechanism provides rotational oscillation of the GW that continues during the forward movement of the EMD using the primary controller. However, if the operator intends to rotate the primary user input (e.g., a joystick) while the GW is moving forward, the system does not provide any rotation other than rotational oscillation. In one embodiment, the oscillation velocity is the degree of rotation per unit of movement in the axial motion, or some other nonlinear relationship between the oscillation velocity and the linear velocity.

[0094] In one example, no vibration-rotation motion is assigned to the linear dead zone of the main user input. That is, if the linear dead zone is a 2° to 3° movement of the main user input, automatic rotational vibration will not occur until the main user input moves beyond the linear dead zone. In one example, the rotation of the main user input without any other linear motion commands in the linear dead zone causes the rotary drive device to produce rotational motion in the guide wire.

[0095] Referring to Figure 11, a state machine diagram corresponding to another example of the wiggle mode described above is provided with reference to Figures 4A and 4B. The example shown in Figure 11 has the same function as the example in Figure 10 for the four specified states, except that the rotational input from the main user input during rotational oscillation results in a greater rotational movement in one direction than the others. As an example, the main user input is a joystick, and the user provides both: a linear forward command to the linear drive mechanism by moving the joystick roughly away from the user, and simultaneously rotating the joystick clockwise, causing the rotary drive mechanism to rotate the guide wire alternately in the CW and CCW directions, with the degree of CW rotation being greater than the degree of CCW rotation during each cycle. As the operator rotates the joystick further away from the neutral position, the ratio of CW to CCW rotations increases. Similarly, if the operator rotates the joystick in the CCW direction while also moving the joystick forward, the rotary drive rotates the guide wire net in the CCW direction as described above.

[0096] Referring to Figure 12, a state machine diagram is provided corresponding to the example of drill mode described above with reference to Figure 5. When drill mode is selected, there are four separate command states. Firstly, in the No GWL COMMAND (GWL: Guidewire Linear) state, where there are no guidewire linear commands from the main user interface, normal CW and CCW rotation commands can be provided by CW and CCW operations or movements of the main user interface, such as a joystick. That is, commands from the main user interface regarding the CW or CCW rotation of the guidewire give commands to the rotation drive mechanism that rotates the guidewire in the CW or CCW direction via the controller. Secondly, in the GW FORWARD MOTOR COMMAND state, when the operator gives a command via the main user interface to move the guidewire in the linear forward direction, the rotation drive device automatically imparts CW rotational motion to the guidewire. Also, in the GW FORWARD MOTOR COMMAND state, all rotational inputs to the main user input are ignored, and no other rotational motion is imparted to the guidewire by the rotation drive device. If the primary user interface is a joystick and the operator intends to rotate the joystick, this will give CW and CCW rotation commands to the rotary drive mechanism in the second GW FORWARD MOTOR COMMAND state, but the rotation of the joystick will not give the rotary drive mechanism any command to rotate the guide wire in addition to the automatic CW rotation of the guide wire. In the third GW REVERSE MOTOR COMMAND state, where the user gives a linear reverse operation command via primary user input, the guide wire rotary drive does not give the guide wire an automatic rotation operation. However, in this state, if the user also gives a command to rotate the guide wire by operating the primary user input, the GW will rotate as in the basic normal operating state.If the primary user input is a backward joystick movement, the controller does not give a command to the rotary drive unit to impart rotational motion to the guidewire, but rather a command to move the guidewire in the opposite direction to the patient or in the direction of withdrawal. However, in this third state, either a CW or CCW rotation of the joystick results in the controller commanding the rotary drive unit to rotate the guidewire in the CW or CCW direction. In other words, in this third state, the primary input of a backward movement produces the same behavior as in the basic operating state.

[0097] In one example, the automatic rotational operation that occurs as described above in various conditions is 900° / second CW rotation. Of course, other speeds and rotational speeds are also possible. In one embodiment, the speed is greater than 900° / second, and in another embodiment, the speed is less than 900° / second but greater than zero° / second.

[0098] In the fourth GW FORWARD MOTOR COMMAND (DISCRETE) state, where individual operating modes are selected by selecting separate forward jog buttons, no rotational operation commands are provided to the rotary drive mechanism. When the user deselects drill mode, the primary user input reverts to basic standard commands without automatic rotational operation.

[0099] In one embodiment, the rotational speed is the degree of rotation per unit of movement in the axial direction, or some other nonlinear relationship between the rotational speed and the linear speed.

[0100] In one example, while in drill mode, CW rotation is not provided in the linear dead zone of the main user input. That is, if the linear dead zone is a 2° to 3° movement of the main user input, automatic CW rotation will not occur until the main user input moves beyond the linear dead zone. In one embodiment, rotation of the main user input without a linear movement command, excluding the linear dead zone, will cause the rotary drive to produce rotational motion in the guide wire.

[0101] Referring to Figure 13, a state machine diagram corresponding to the jackhammer mode example described above with reference to Figure 6 is illustrated. In the example in Figure 13, the jackhammer mode is applied to the guide wire. When the jackhammer mode for the guide wire (GW) is selected, there are several states that affect the operation of the GW. In the NO GWL COMMAND state (no guide wire linear motion command), user input provides normal rotational operation. This is where the operator rotates the GW in CW or CCW direction by operating the user input. In the GW FORWARD MOTOR COMMAND (JOYSTICK) state, the GW linear drive mechanism automatically operates the GW in a forward-reverse cycle, with the forward motion being greater than the reverse motion. In this state, the operator can also give the GW a CW or CCW direction by operating the user interface (by joystick rotation in the CW or CCW direction if the user interface is a joystick). In the GW REVERSE MOTOR COMMAND state, the operator operates the user interface to pull out the GW or give the GW a reverse movement, but there is no automatic periodic linear movement (forward and reverse) of the GW. In the GW FORWARD MOTOR COMMAND state, based on shaking or individual operation buttons or inputs, the GW linear drive mechanism does not give the GW automatic periodic linear movement. In one embodiment, the automatic periodic movement is 1.5 mm forward at 12 mm / s and 1 mm backward at 12 mm / s, with a pause between forward and reverse movements being the dwell time required for the GW linear drive mechanism to switch direction. In one embodiment, the dwell time is not perceptible to the operator. Of course, other distances and speeds are also possible, and can be greater than 0 mm and less than 1.5 mm and 1 mm, respectively, or 1.5 mm and 1 mm or more, respectively. Similarly, the speed may be greater than zero and less than 12 mm / s, or 12 mm / s or more. The jackhammer motion technique is described in U.S. Patent 9,220,568, which is incorporated herein by reference. In one embodiment, the reverse motion is greater than the forward motion.

[0102] Referring to Figure 14, a state machine diagram corresponding to another example of the jackhammer mode described above with reference to Figure 6 is illustrated. In the example in Figure 14, the jackhammer mode is applied to a balloon or stent catheter, also referred to here as dotting. When the exemplary mode in Figure 14 is selected, there are many states that affect the operation of the balloon catheter or stent catheter (referred to here individually or collectively as "BSC"). BSC may also include other elongated medical devices. The mode shown in Figure 14 is similar to the mode in Figure 13, but the mode of rotation is irrelevant because there is no rotational drive mechanism for the BSC.

[0103] Referring to Figure 15, a state machine diagram corresponding to an example of the ADF mode described above is shown with reference to Figures 7 and 8. In an example of the ADF mode, coordinated control of one or two linear drive mechanisms is provided. These linear drive mechanisms are on a similar base and move linearly with the GC when the base moves linearly. In the ADF mode, the linear drive mechanisms of the guidewire and / or BSC maintain the fixed positions of the GW and BSC relative to the ground or patient while moving the GC relative to the ground or patient. In one embodiment, once the ADF motion algorithm is selected and enabled, the system detects whether the guidewire and catheter are loaded by automatically moving them forward and backward by a certain distance, and checks via position sensors whether the guidewire and catheter are loaded in their respective linear drive mechanisms. In one embodiment, this forward and backward movement is called a perturbation, which moves the guidewire forward by 0.1 mm and then backward by the same distance. However, other distances greater than or less than 0.1 mm, such as 1 mm or 0.01 mm, are also possible. The distance is selected to minimize the impact on the treatment risk profile while also allowing detection by the sensor. In one embodiment, the device detection system is an active device detector such as an optical sensor, a mechanical sensor, and a magnetic sensor. In the first GW AND BSC NOT LOADED state, this state is one in which no GC linear command is given, meaning there is no command given by the operator via user input to move the guide catheter forward or backward along the longitudinal axis of the guide catheter, but the GW and BSC linear drive mechanisms move the GW and BSC, respectively, equally in opposite directions to the movement of the guide catheter. For example, if the guide catheter is moved 1 cm forward, the guidewire and BSC drive mechanisms move the guidewire and BSC 1 cm backward. This is done even if the GW and BSC are not detected within their respective linear drive mechanisms. This device detection function allows for the effective use of the ADF when only one of two or more fixed devices is loaded.If closed-loop control is always enabled for all fixed equipment drive modules, when equipment is not loaded, the system may prevent all operation of all equipment because it cannot secure the unloaded equipment. In addition, the equipment detection function also provides a fail-safe mechanism if the sensor does not detect the presence of guidewires and BSCs. In one embodiment of this mode, GW and BSC towing notifications are suppressed. Towing notifications provide a warning if the sensor does not detect GW and BSC operating at the speed intended by the controller.

[0104] When a user provides input to linearly move the guide catheter by operating the entire substrate, and therefore the linear drive mechanism of the BSC and the linear drive mechanism of the guidewire, either through a primary user input or a specific guide catheter user input, the linear drive mechanism of the guidewire and the linear drive mechanism of the BSC are automatically given a command to linearly move the guidewire and catheter in the opposite direction by a distance equal to the movement of the guide catheter. In one embodiment, the movement of the guide catheter in a first direction occurs simultaneously with the movement of the guidewire and BSC in the opposite direction to the first direction. In one embodiment, the command to provide the guidewire and BSC to move in the opposite direction when the user input provides the movement command for the guide catheter is generated only when the user input for the guide catheter exceeds a dead zone.

[0105] In the GW LOADED state, where the guidewire is detected as loaded and the BSC is detected as not loaded, neither the guidewire nor the BSC will move unless there is a command to linearly move the guidecatheter. However, if a GC user input is activated to linearly move the guidecatheter, a command is automatically given to the guidewire linear drive mechanism, and even if the amount of movement required by the guidewire linear drive mechanism to maintain the fixed position differs from the amount of movement given to the guidecatheter linear drive mechanism, it will move in the opposite direction by an amount equal to that required to maintain the fixed position of the guidewire. In this way, closed-loop control is provided. In contrast, in this command state, the BSC linear drive mechanism moves in the opposite direction by an amount equal to that provided by the guidecatheter linear drive mechanism.

[0106] In the GW AND BSC LOADED state, both the guidewire linear drive mechanism and the BSC linear drive mechanism are set to move the guidewire and BSC, respectively, in the opposite direction to the movement of the guide catheter, so that the GW and BSC remain in a fixed position relative to the patient and / or the ground. In this way, closed-loop control is provided for both the GW and BSC.

[0107] In one embodiment, a closed-loop system operating the GW and BSC uses sensors, such as encoders connected to the tires, to determine whether the positions of the GW and BSC have moved appropriately in the same direction as the GC's movement and in the opposite direction. If the encoder provides feedback that the GW and / or BSC are in a position appropriately equal to and less than the GC's position change in the opposite direction, a command is automatically sent to the GC linear drive mechanism to decelerate the GC's movement until the GW and BSC return to the appropriate relative positions in the same direction and in the opposite direction. For example, if guide catheter user input commands the guide catheter to move forward by 10 units, and the encoder indicates that the GW has moved in the opposite direction but only by a distance of 8 units, the GC linear drive mechanism is automatically decelerated until the GW and / or BSC move synchronously with the GC for the same distance in the same direction and in the opposite direction. Once the GW and / or BSC are synchronized, the GC linear drive mechanism accelerates back to its originally intended operating speed. In one embodiment, when slippage is detected in the GW and / or BSC, the GW and / or BSC drive mechanism increases the speed of the linear motion of the GW and BSC until the GW and / or BSC become synchronized with the GC. In one embodiment, the GC is decelerated, and the GW and / or BSC are accelerated simultaneously as needed. Synchronization is when the GW and BSC remain in a fixed position relative to the ground and / or patient while the GC is moving.

[0108] In one embodiment, the operation of GW and / or BSC is not a fixed, equally opposite amount, but a different rate from the rate of GC.

[0109] In one embodiment, an auxiliary encoder is used to provide a closed-loop control system for fixing GW and / or BSC equipment in ADF operation technology.

[0110] In one embodiment, the ADF operation technique stops the operation of the GC if spatial fixing of the GW and / or BSC is not possible according to the control law.

[0111] In one embodiment, the auxiliary encoder detects whether equipment is loaded into the GW linear drive and / or BSC linear drive by detecting the operation of the auxiliary encoder. If no operation is detected, the equipment is assumed not to be loaded. In this embodiment, no determination is made as to whether or not there is equipment loaded into the linear drive mechanism, but this is checked only by the first command relating to the equipment or the operation of the equipment. If no equipment is detected as loaded, open-loop control is used for fixation to protect against simple defects of auxiliary encoder failure.

[0112] In one embodiment, the user can provide manual adjustments to the ADF operation technique by manually manipulating user input with respect to the GW and / or BSC. User commands to linearly operate the GW and / or BSC complement the automatic operation. In one embodiment, operator commands to linearly operate the GW and BSC with the ADF operation technique temporarily suspend the ADF operation technique until the user stops providing independent GW or BSC linear operation commands.

[0113] Referring to Figures 16A to 16D, in one embodiment, the Active Device Fixation (ADF) operation consists of fixing the device position relative to the ground or patient, and the device inertial position. It is assumed that the inertial position of each device is displaced in the same direction as the GC is displaced. Therefore, in order to maintain the position of the device, when the ADF is activated, its position must move in the opposite direction to the direction of the GC. The position of the GC xGC(t) (denoted as x_GC_t) is the integral of the command velocity vGC(t) (denoted as v_GC_t). This relationship can be captured in the GC integrator model. JPEG2026108850000002.jpg33129

[0114] The position of the gate wave (GW) xGW(t) (denoted as x_GW_t) is the integral of the adjusted (scaled / reduced) gate wave command velocity vGW(t) (denoted as v_GW_t), and is adjusted by a real number kGW (denoted as k_GW). JPEG2026108850000003.jpg36165

[0115] Therefore, this physical model with 0 < kGW < 1 can capture the slip. When kGW is zero, complete GW slip occurs. As a result, the inertial position of GW, denoted as xGWt (x_GWi(t)), is the sum of xCM / (t) and the GC position xGC(t). Similarly, the physical model of BSC is as follows. JPEG2026108850000004.jpg34158

[0116] The command speed vBSC to BSC is denoted as v_BSC(t), and the corresponding position xBSC is denoted as x_BSC(t). As a result, the inertial position of BSC, denoted as xBSa (x_BSCi(t)), is the sum of xBSc(J) and the GC position xGC(t).

[0117] In one embodiment of the ADF operation technique, it acts to fix the inertial positions of GW and BSC, enabling the user to operate GW and BSC independently from the GC movement with a joystick (JS) command, and reducing the forward (FWD) and reverse (REV) movements of GC when the slip of GW is excessive and a correction movement needs to catch up.

[0118] In one embodiment, the inertial positions of GW and BSC are supplied to GW and BSC respectively along with the negative command speed of GC, and the speeds of GW and BSC are adjusted in proportion to their corresponding feedback terms (e_BSC_t, e_GW_t) including the negative change in the position of GC (dx_GC_t). Here, e_BSC_t is equal to (r_BSC_t - x_BSC_t), and r_BSC_t is the integral of the product of the sum of the limited BSC joystick speed and the ADF feedback term dx_GC(t). dx_GC(t) is equal to the initial GC position x_GC(0) minus the current GC position x_GC(t). ***Here, e_GW_t is equal to (r_GW_t - x_GW_t), and r_GW_t is the integral of the product of the sum of the limited GW joystick speed and the ADF feedback term dx_GC(t).

[0119] In one embodiment of ADF technology, the user can operate the GW and BSC independently of the GC motion by including a reference term, which is the integral of the velocity commands of the GW and BSC, respectively. The forward and reverse motion of the GC decreases as the feedback error increases due to slip in the GW and BSC instruments (function y=fcn(e_GW_t, e_BSC_t)).

[0120] Referring to Figure 16, the terms .9 and .95 in the GW and BSC control section represent the slip of the GW and BSC in a single simulation. In other words, .9 represents a 10 percent slip of the GW, and .95 represents a 5 percent slip of the BSC. .9 and .95 are supplied to the control system from encoders that detect the slip of the GW and BSC, respectively. The actual slip rates of the GW and BSC are determined using encoders or other sensors during the operation of the ADF technology.

[0121] Active device fixation can be achieved in another embodiment in which the GW and BSC are fixed to the ground and / or the patient using mechanical clamping equipment. The clamping equipment selectively fixes the equipment during GC operation. In one embodiment, the GW and BSC are fixed to the ground by dynamic equipment such as a robotic arm that operates to maintain relative position during GC operation. In one embodiment, if the movement of the GW or BSC is detected by a sensor and / or imaging system, the GC operation is automatically stopped.

[0122] Referring to Figure 16, the system represented as max{0,1-|e_device|_inf / e_max} limits the command rate to GC in the event of a GW or BSC feedback error as follows: JPEG2026108850000005.jpg25131 Here, e deviceThis is the upper limit of the error for either GW or BSC. The final GC speed is reduced to ensure that the GC motion is bounded due to equipment slip. vGC-SET(t) represents the user GC joystick (user input) speed setting point. max This is the maximum allowable tracking error between the GC and GW or BSC positions.

[0123] The computer-executable instructions in the steps of the exemplary methods 300 and 400 are stored in the form of computer-readable media. Computer-readable media include volatile and non-volatile, removable and non-removable media, which are implemented by any method or technique as storage of information such as computer-readable instructions, data structures, program modules, or other data. Computer-readable media include, but are not limited to, random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory, or other memory technologies, compact disk ROM (CD-ROM), digital versatile disk (DVD), or other optical storage, magnetic cassettes, magnetic tapes, magnetic disk storage, or other magnetic storage devices, or any other media that can be used to store desired instructions and can be accessed by System 10 (shown in Figure 1), including access via the Internet or other computer network formats.

[0124] Referring to Figure 17, a constant-speed pullback motion technique is selected for the gatewheel (GW). In one embodiment, the constant speed value is selected from a number of options, or a specific speed is input via a user device such as a keyboard. In such a reverse movement by the operator of the main user interface, the GW is pulled out at a constant speed. In one embodiment, the constant-speed motion technique acts only in the reverse direction, i.e., the reverse speed is constant regardless of the range of the main user interface's operating position in the reverse direction. The forward movement of the main user interface is proportional to, or follows, the range of the main interface's operation.

[0125] In one embodiment, the constant-speed operation technology also enables a constant speed of the GW in the forward direction. In one embodiment, a turbo input button allows the constant speed to be increased to a faster speed. In one embodiment, the increased constant speed is only active while the user holds down the turbo button. In one embodiment, the increase in constant speed is activated and maintained when the turbo button is pressed and remains active until the turbo button is turned off. In one embodiment, the increased constant speed maintains its effect for a predetermined time and / or a predetermined distance of linear movement of the GW.

[0126] Although not illustrated, the push-in override input allows for increased push force only when the initial push-in force limit is reached during the forward movement of the equipment. In this mode, the motor current increases the torque of the forward movement until it reaches a deadlock (exceeds a predetermined limit). In one embodiment, the force can be increased over the entire procedure or during a limited time after the initial force limit has been reached. In one embodiment, the user can revert to a lower predetermined or selected force limit by not selecting the push-in override function.

[0127] In one embodiment, techniques (ADF, wiggle, jackhammer) can be selected independently for each EMD in a catheter-based treatment system. For example, ADF can be selected for the guide catheter, wiggle for the guidewire, and dotting for the BSC. In one embodiment, multiple techniques can be used simultaneously. In one embodiment, once a particular technique is selected, all other incompatible techniques are no longer available for selection. In one embodiment, the available techniques for selection are based on, but are not limited to, other patient data such as images and / or hemodynamic data. In one embodiment, when selecting based on image data processing, a particular technique is automatically highlighted and recommended.

[0128] The description herein uses examples to disclose the invention, including in its best mode, and to enable those skilled in the art to make and use the invention. The scope of the present invention is defined by the claims and includes other examples that are conceivable to those skilled in the art. Such other examples are intended to be included in the claims if they have structural elements that are identical to, or different from, or equivalent structural elements that are not significantly different from, the literal description of the claims. The order and arrangement of steps in any process or method may be modified or rearranged according to alternative embodiments.

[0129] Many other changes and modifications can be made to the present invention without departing from the spirit of the invention. The scope of these and other changes will become apparent from the claims.

Claims

1. A system comprising a device having a first elongated medical device and a second elongated medical device, and a controller connected to the device, The aforementioned controller, The amount and direction of linear displacement of the first elongated medical device are identified, The system is configured such that, in response to the specified displacement of the first elongated medical device, the second elongated medical device is linearly displaced, and the linear displacement of the second elongated medical device is substantially equal in amount to the linear displacement of the first elongated medical device and is in the opposite direction to the direction of the displacement of the first elongated medical device. The system further comprises a controller configured to change at least one parameter of the linear displacement of either (a) the first elongated medical device or (b) the second elongated medical device.

2. The system according to claim 1, wherein the modification of at least one parameter includes limiting the amount of displacement of the second elongated medical device.

3. The system according to claim 2, wherein the controller modifies the at least one parameter in response to the identification of a loss of traction force in the linear displacement of the second elongated medical device.

4. The system according to claim 1, wherein the at least one parameter includes the amount or velocity of the displacement of the first elongated medical device.

5. The system according to claim 1, wherein the first elongated medical device is a catheter and the second elongated medical device is a guidewire.

6. The system according to claim 1, wherein the linear displacement of the first elongated medical device and the linear displacement of the second elongated medical device are substantially simultaneous.

7. The controller identifies the unexpected operation of the second elongated medical device, The system according to claim 1, wherein the controller, upon identifying the unexpected operation of the second elongated medical device, ceases changing the at least one parameter of the first elongated medical device or the second elongated medical device.

8. The system according to claim 1, wherein the controller detects the presence or absence of the second elongated medical device based on the detection of the operation of the second elongated medical device by input from the sensor.

9. The system according to claim 8, wherein the controller stops changing the at least one parameter of the first or second elongated medical device when it detects the absence of the second elongated medical device.

10. The system according to claim 1, wherein the controller terminates the linear displacement of the second elongated medical device when the linear displacement of the second elongated medical device is within a first threshold of the specified displacement of the first elongated medical device.

11. The system according to claim 10, wherein the controller restarts the linear displacement of the second elongated medical device when the linear displacement of the second elongated medical device is greater than a second threshold of the determined displacement of the first elongated medical device, and the second threshold is greater than the first threshold.

12. The system according to claim 1, further comprising one or more other elongated medical devices, wherein the behavior of the other elongated medical devices is constrained in the same manner as that of the second elongated medical device.

13. A system comprising an elongated medical device apparatus having at least one elongated medical device, and a control station connected to the elongated medical device apparatus, The control station includes a control module that, in response to a user command, executes a predetermined operating pattern of the proximal portion of the elongated medical device. The predetermined operating pattern is the vibration of the elongated medical device centered on the vertical axis of the elongated medical device. The auxiliary command changes the amplitude of the vibration, system

14. The system according to claim 13, wherein the auxiliary command changes the amplitude of the vibration by decreasing or increasing the amplitude.

15. The system according to claim 13, wherein the auxiliary command changes the amplitude of the vibration by biasing the amplitude.

16. The system according to claim 15, further comprising moving the center position of the vibration when the bias is applied.

17. The system according to claim 13, wherein the auxiliary command is received from either the control module or the operator input device.

18. The system according to claim 13, wherein the vibration of the elongated medical device has a first amplitude when it is moving forward through a blood vessel and a second amplitude when it is passing over an obstacle.

19. The system according to claim 13, wherein the predetermined operation pattern is activated only when the elongated medical device undergoes linear displacement.

20. The system according to claim 19, wherein the control module stops the vibration of the elongated medical device when the linear displacement is stopped, reversed, or pushed.

21. The system according to claim 13, wherein at least one parameter of the vibration is configurable, the parameter being frequency, amplitude, or rotational speed.

22. A system comprising an elongated medical device apparatus having at least one elongated medical device, and a control station, The control station includes a control module that executes a motion pattern of the proximal portion of the elongated medical device in response to a user command for linear displacement of the elongated medical device. The aforementioned motion pattern is a linear displacement accompanied by continuous unidirectional rotation of the elongated medical device around its vertical axis. The aforementioned operating pattern is initiated by a forward linear displacement and terminated by a backward linear displacement.

23. The system according to claim 22, wherein the rotation speed of the operation pattern can be changed by an auxiliary command.

24. A system comprising an elongated medical device apparatus having at least one elongated medical device, and a control station, The control station includes a control module that, in response to a user command, executes a predetermined operating pattern of the proximal portion of the elongated medical device. The predetermined motion pattern is a linear vibration of the elongated medical device, and the linear vibration includes alternating forward and backward linear motion of the elongated medical device. The aforementioned operating pattern is initiated by a forward linear displacement and terminated by a backward linear displacement.

25. A system comprising a device having a first elongated medical device and a second elongated medical device, and a controller connected to the device, The aforementioned controller, Upon receiving a command for the operation of the first elongated medical device, The first elongated medical device is activated, The operation of the first elongated medical device is detected, A system configured to synchronize the operation of a second elongated medical device with the operation of the first elongated medical device in accordance with the detected linear displacement of the first elongated medical device.

26. The system according to claim 25, wherein the operation of the first elongated medical device and the synchronized operation of the second elongated medical device include small, alternating forward and backward linear movements that result in forward linear displacement.

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