Robot-assisted movement of long, thin medical devices

Abstract

To provide a robot system and method to automatically move medical devices such as a guide wire and / or a catheter.SOLUTION: In one exemplary embodiment, a system 700 includes: 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 determine a magnitude and a direction of linear translation of the first elongated medical device and responsive to the determined translation of the first elongated medical device, cause a linear translation of the second elongated medical device, the linear translation of the second elongated device having a substantially equal magnitude to the linear translation of the first elongated medical device and being in a direction opposite the direction of translation of the first elongated medical device. The controller is further configured to modify at least one parameter of the linear translation of either (a) the first elongated medical device or (b) the second elongated medical device in response to the determined translation of the first elongated device.SELECTED DRAWING: Figure 7

Description

[Technical Field]

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

[0002] [Technical field] The present invention relates generally 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 technology]

[0003] Catheters (and other elongated medical devices) can be used in many minimally invasive medical procedures for the diagnosis and treatment of various vascular disorders, including neurovascular intervention (NVI), also known as neurointerventional 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 over the guidewire to perform the treatment. A catheterization procedure begins with gaining access to an appropriate vessel, such as an artery or vein, with a sheath or guide catheter using standard percutaneous techniques. The sheath or guide catheter is then advanced over the diagnostic guidewire to a key location, such as the internal carotid artery for NVI, the coronary ostia for PCI, or the superficial femoral artery for PVI. A guidewire appropriate for the vascular system is then navigated through the sheath or guide catheter to the target location within the vascular system. In certain situations, such as tortuous anatomy, a support catheter or microcatheter is inserted over the guidewire to aid in guidewire navigation. A physician (operator) can use an imaging system (e.g., a fluoroscope) to acquire images with contrast 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 the anatomy using fluoroscopy, the physician can manipulate the proximal end of the guidewire or catheter to direct the distal tip into the appropriate vessel and prevent it from advancing into a side branch.

[0004] Robotic catheterization systems have been developed to assist physicians in performing catheterization procedures, such as neurovascular intervention (NVI), PCI, and PVI. Examples of neurovascular intervention (NVI) catheterization procedures include coil embolization of aneurysms, liquid embolization of arteriovenous malformations, and mechanical thrombectomy of large vessel occlusions in the setting of acute ischemic stroke. In NVI, physicians use a robotic system to manipulate neurovascular guidewires and microcatheters to gain access to the lesion and perform treatments to restore normal blood flow. Access is provided by a sheath or guide catheter, but intermediate catheters may be required for more distal areas or to provide adequate support for the microcatheter and guidewire. The distal tip of the guidewire is navigated into or beyond the lesion, depending on the type and treatment of the lesion. In the treatment of aneurysms, a microcatheter is advanced into the lesion, the guidewire is removed, and several coils are deployed through the microcatheter into the aneurysm for embolization. In the treatment of arteriovenous malformations, a liquid embolic agent is injected into the malformation using a microcatheter. Mechanical thrombectomy to treat vascular occlusions is performed either through aspiration or the use of a stent retriever. Aspiration can be performed directly through a microcatheter or by using a larger-bore aspiration catheter. Once the aspiration catheter reaches the lesion, negative pressure is applied through the catheter to remove the thrombus. Alternatively, the thrombus can be removed by placing a stent retriever through the microcatheter. The thrombus is retrieved by capturing it in the stent retriever and retracting the stent retriever and microcatheter into the guide catheter.

[0005] During PCI, physicians use a robotic system to manipulate a cardiac guidewire to gain access to the lesion, perform treatment, and restore normal blood flow. An access pathway is established by placing a guide catheter at the coronary artery ostium. The distal tip of the guidewire is navigated past the lesion, and in complex anatomies, a microcatheter is used to properly support the guidewire. Blood flow is restored by delivering and deploying a stent or balloon at the lesion. The lesion may require preparation before stent placement by delivering a balloon for pre-dilatation of the lesion or by performing atherectomy, for example, using a laser or rotational atherectomy catheter and a balloon over the guidewire. Imaging and physiological measurements may be performed to determine the appropriate treatment using an imaging catheter or FFR measurements.

[0006] With PVI, physicians use a robotic system to perform the procedure and restore blood flow using techniques similar to NVI. The distal tip of a guidewire is navigated past the lesion, and a microcatheter can be used to provide adequate support for the guidewire through the complex anatomy. 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. Summary of the Invention

[0007] According to one aspect, a system includes an apparatus having a first elongate medical device and a second elongate medical device, and a controller coupled to the apparatus. The controller is configured to determine an amount and direction of linear displacement of the first elongate medical device and to linearly displace the second elongate medical device in response to the determined displacement of the first elongate medical device, the linear displacement of the second elongate medical device being substantially equal to and opposite to the linear displacement of the first elongate medical device. The controller is further configured to modify at least one parameter of the linear displacement of either (a) the first elongate medical device or (b) the second elongate medical device.

[0008] In one example, altering the at least one parameter includes limiting an amount of displacement of the second elongate medical device. The controller alters the at least one parameter in response to identifying a loss of traction related to the linear displacement of the second elongate medical device.

[0009] In one example, the at least one parameter includes an amount or rate of displacement of the first elongate medical device. In one aspect, the first elongate medical device is a catheter and the second elongate medical device is a guidewire.

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

[0011] In one example, the controller identifies unexpected operation of the second elongated medical device, in which case the controller discontinues altering at least one parameter of the first elongated medical device or the second elongated medical device upon identifying the unexpected operation of the second elongated medical device.

[0012] In one example, the controller detects the presence or absence of the second elongated medical device based on detecting movement of the second elongated medical device via input from the sensor, and upon detecting the absence of the second elongated medical device, the controller discontinues altering at least one parameter of the first elongated medical device or the second elongated medical device.

[0013] In one example, the controller terminates the linear displacement of the second elongated medical device when the linear displacement of the second elongated medical device does not exceed a first threshold of the determined displacement of the first elongated medical device, and 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 of the determined displacement of the first elongated medical device, the second threshold being greater than the first threshold.

[0014] In one example, the system further includes one or more other elongated medical devices that are similarly restricted in behavior as the second elongated medical device.

[0015] In one embodiment, the system includes an elongate medical device device having at least one elongate medical device and a control station connected to the elongate medical device device. The control station includes a control module that executes a predetermined pattern of motion of a proximal portion of the elongate medical device in response to user commands. The predetermined pattern of motion is oscillation of the elongate medical device about a longitudinal axis of the elongate medical device. Auxiliary commands vary the amplitude of the oscillation.

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

[0017] In one example, the auxiliary command changes the amplitude of the vibration by biasing the amplitude, where generating the bias includes moving the center position of the vibration.

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

[0019] In one example, the vibration of the elongated medical device has a first amplitude as it advances through the blood vessel and a second amplitude as it passes over the obstacle.

[0020] In one example, the predetermined motion pattern is activated only during linear motion of the elongated medical instrument, and the control module ceases vibration of the elongated medical instrument when the linear motion is stopped, reversed, or pushed (poked).

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

[0022] In one embodiment, the system includes an elongate medical device apparatus having at least one elongate medical device and a control station. The control station includes a control module for executing a motion pattern of a proximal portion of the elongate medical device in response to a user command related to linear displacement of the elongate medical device. The motion pattern is a linear displacement involving continuous rotation of the elongate medical device in one direction about a longitudinal axis of the elongate medical device. The motion pattern is initiated by a forward linear displacement and terminated by a reverse linear displacement.

[0023] In one example, the auxiliary command can change the rotational speed of the motion pattern.

[0024] In one embodiment, the system includes an elongate medical device apparatus having at least one elongate medical device and a control station. The control station includes a control module that executes a predetermined motion pattern of a proximal portion of the elongate medical device in response to user commands. The predetermined motion pattern is a linear oscillation of the elongate medical device, the linear oscillation including alternating forward and backward (reciprocating) linear movement of the elongate medical device. The motion pattern is initiated by the forward linear displacement and terminated by the backward linear displacement.

[0025] A system according to one aspect includes an apparatus having a first elongate medical device and a second elongate medical device, and a controller coupled to the apparatus, the controller configured to receive commands related to operation of the first elongate medical device, actuate the first elongate medical device, detect the movement of the first elongate medical device, and synchronize the movement of the second elongate medical device with the movement of the first elongate medical device in response to the detected linear displacement of the elongate medical device.

[0026] In one example, the movement of the first elongate medical instrument and the synchronized movement of the second elongate medical instrument include alternating small forward and backward linear motions with resulting forward linear displacements. [Brief explanation of the drawings]

[0027] The present invention will be more fully understood from the following detailed description taken in conjunction with the following drawings, in which like parts are numbered and in which: [Figure 1] FIG. 1 is a perspective view illustrating a catheter-based treatment system according to one embodiment. [Figure 2] 1 is a schematic block diagram illustrating a catheter-based treatment system according to one embodiment. [Figure 3] FIG. 2 is a perspective view of a robot driving device of a catheter-based treatment system according to one embodiment. [Figure 4A] ~ [Figure 4B] FIG. 1 illustrates an exemplary mode of robotic movement of an elongated medical device (EMD) in a catheter-based treatment system, referred to herein as wiggle. [Figure 5] 1 illustrates an exemplary mode of robotic operation of an EMD in a catheter-based treatment system, referred to herein as drilling. [Figure 6] FIG. 1 illustrates the phases of an exemplary mode of robotic operation of an EMD in a catheter-based treatment system, referred to herein as jackhammer. [Figure 7] 1 illustrates an exemplary mode of robotic movement of an EMD in a catheter-based treatment system, referred to herein as active device fixation (ADF). [Figure 8] 8 is a flowchart illustrating a method of closed-loop operation associated with the example mode of FIG. 7. [Figure 9] FIG. 1 illustrates an example mode of synchronized robotic operation of two or more EMDs in a catheter-based treatment system. [Figure 10] FIG. 4C is a state machine command diagram associated with the example modes of FIGS. 4A and 4B. [Figure 11] FIG. 4C is a state machine command diagram associated with the example modes of FIGS. 4A and 4B. [Figure 12] FIG. 6 is a state machine command diagram associated with the example mode of FIG. 5. [Figure 13] FIG. 7 is a state machine command diagram associated with the example mode of FIG. 6. [Figure 14]FIG. 7 is a state machine command diagram associated with the example mode of FIG. 6. [Figure 15] FIG. 9 is a state machine command diagram associated with the example modes of FIGS. 7 and 8. [Figure 16A] ~ [Figure 16D] 10 is an example of an algorithm diagram for active device fixation. [Figure 17] FIG. 10 is a diagram illustrating an example of a graphical user interface. DETAILED DESCRIPTION OF THE INVENTION

[0028] FIG. 1 is a perspective view illustrating a catheter-based treatment system according to one embodiment. The catheter-based treatment system 10 shown in FIG. 1 is used to perform catheter-based medical procedures, such as percutaneous interventional procedures, such as percutaneous coronary intervention (PCI) for STEMI, neurovascular intervention (NVI) (e.g., treatment of acute major artery occlusion (ELVO)), and peripheral vascular intervention (PVI) for critical limb ischemia (CLI). Catheter-based medical procedures include diagnostic catheterization procedures, in which one or more catheters (or other elongated medical devices (EMDs)) are used to assist in diagnosing a patient's condition. For example, in one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected through a catheter into one or more arteries to obtain images of the patient's vascular system. Catheter-based medical procedures also include catheter-based therapeutic procedures (e.g., angioplasty, stent placement, peripheral vascular disease treatment, clot removal, arteriovenous malformation treatment, aneurysm treatment, etc.), in which a catheter (or other elongated medical device) is used to treat a condition. Therapeutic procedures may be enhanced with accessory devices 54 (shown in FIG. 2 ), such as, for example, intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. However, those skilled in the art will appreciate that a given percutaneous interventional device or component (e.g., various guidewires, various catheters, etc.) may be selected according to the type of procedure to be performed. The catheter-based treatment system 10 may perform any number of catheter-based medical procedures, with minor adjustments to accommodate the given percutaneous interventional device used in the procedure.

[0029] The catheter-based procedure system 10 includes, among other things, a bedside unit 20 and a control station 26. An overview of the major building blocks of the catheter-based procedure system 10 is shown in FIG. 2 and described in detail below. The bedside unit 20 includes a robotic drive 24 and a positioning system 22 (e.g., robotic arm, articulated arm, holder, etc.) that are positioned adjacent to the patient. The bedside unit 20 also includes a control and display unit 46 (shown in FIG. 2). The control and display unit may be mounted, for example, on the housing of the robotic drive 24. The patient 12 is supported on a table 18. Typically, the robotic drive 24 includes appropriate percutaneous interventional equipment or other accessories 48 (shown in FIG. 2) (e.g., guidewires, various catheters, balloon catheters, stent deployment systems, stent retrievers, embolic coils, liquid emboli, aspiration pumps, contrast agents, medications, etc.) that allow a user to perform a catheter-based medical procedure with the robotic system by manipulating various controls, such as those at the control station 26. Bedside unit 20, and in particular robotic drive 24, may include any number and / or combination of components to provide bedside unit 20 with the functionality described herein. Robotic drive 24 includes multiple instrument modules 32 mounted on rails 60 (shown in FIG. 3). Each of instrument modules 32 is used to drive an elongated medical device, such as a catheter or guidewire. For example, robotic drive 24 may be used to automatically feed a guidewire into a diagnostic catheter and into a guide catheter positioned within an artery of patient 12. One or more instruments, such as an EMD, are advanced into the patient's body (e.g., a blood vessel) at insertion location 16, for example, using an introducer and introducer sheath.

[0030] The bedside unit 20 is in communication with a control station 26, and signals generated by user inputs at the control station 26 are sent to the bedside unit 20 to control various functions of the bedside unit 20. As described below with reference to FIG. 2, the control station 26 includes or is connected to the bedside unit 20 via a control computing system 34 (shown in FIG. 2). The bedside unit 20 also provides feedback signals (load, speed, operating conditions, warning signals, error codes, etc.) to the control station 26, the control computing system 34 (shown in FIG. 2), or both. Communication between the control computing system and the various components of the catheter-based treatment system 10 is provided via communication links, which may be wireless, wired, or any other means that enable communication between the components. The control station 26 or other similar control system may be located at either a local site (e.g., a local control station 38 shown in FIG. 2) or a remote site (e.g., a remote control station and computing system 42 shown in FIG. 2). The catheter-based treatment system 10 may be operated by a control station at a local site, by a control station at a remote site, or by both a local control station and a remote control station simultaneously. At a local site, the operator and control station 26 are located in the same room as or adjacent to the patient 12 and bedside unit 20. As used herein, the local site is the location of the bedside system 20 and patient 12 (subject), and the remote site is the location of the operator (e.g., physician) and the control station 26 used to remotely control the bedside system 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 communications systems and services 36 (shown in FIG. 2), for example, over the Internet. In one embodiment, the remote site and the local (patient) site are separate from one another, for example, multiple rooms in the same building, multiple buildings in the same city, multiple buildings in multiple cities, or another 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 catheter-based procedure system 10. In the illustrated embodiment, the control station 26 allows a user to control the bedside unit 20 to perform a catheter-based medical procedure. For example, the input module 28 is 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 24 (e.g., advance, retract, or rotate a guidewire; advance, retract, or rotate a catheter; inflate or deflate a balloon located on a catheter; position and / or deploy a stent; position and / or deploy a stent retriever; position and / or deploy a coil; inject contrast into a catheter; inject a liquid embolus into a catheter; inject medication or saline into a catheter; perform aspiration through a catheter; or perform any other function that may be performed as part of a catheter-based medical procedure). The robotic drive system 24 includes various drive mechanisms for producing movement (eg, axial and rotational movement) of the components of the bedside unit 20, including the percutaneous interventional equipment.

[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 controls 44 (shown in FIG. 2), such as a footswitch or microphone for voice commands. The input module 28 is configured to advance, reverse, or rotate various components and percutaneous interventional devices, such as a guidewire and one or more catheters or microcatheters. The buttons include, for example, an emergency stop button, a magnification button, an equipment selection button, and an automatic operation button. Pressing the emergency stop button triggers a relay, cutting off power to the bedside unit 20. In speed control mode, the magnification button acts to increase or decrease the speed of movement of the associated component in response to manipulation of the input module 28. In position control mode, the magnification button changes the mapping between input distance and output command distance. The equipment selection button allows the user to select which percutaneous interventional device loaded into the robotic drive 24 is to be controlled by the input module 28. The automatic operation button is used to enable the catheter-based treatment system 10 to perform algorithmic operations on the percutaneous interventional device without direct commands from the user. In one embodiment, the input module 28 includes one or more controls or icons (not shown) displayed on a touchscreen, the activation of which operates components of the catheter-based treatment system 10. The input module 28 also includes balloon or stent controls configured to inflate or deflate a balloon and / or deploy a stent. Each of the modules includes one or more buttons, scroll wheels, joysticks, touchscreens, etc., suitable for controlling the particular component with its dedicated control. Additionally, the touchscreen may display one or more icons (not shown) associated with each component of the input module 28 or associated with each component of the catheter-based treatment system 10.

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

[0034] The catheter-based procedure system 10 also includes an imaging system 14. The imaging system 14 is a medical imaging system (e.g., non-digital x-ray, digital x-ray, CT, MRI, ultrasound, etc.) used in conjunction with a catheter-based medical procedure. In one embodiment, the imaging system 14 is a digital x-ray imager in communication with a control station 26. In one embodiment, the imaging system 14 includes a C-arm (as shown in FIG. 1 ) that 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, caudal, anterior-posterior, etc.).

[0035] The imaging system 14 may be configured to take X-ray images of appropriate regions of the patient 12 during a given 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 to assist a user at the control station 26 in properly positioning a guidewire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, or the like during the procedure. One or more images may be displayed on the display 30. Specifically, the images may be displayed on the display 30 to assist a user in accurately moving, for example, a guide catheter or guidewire to the appropriate position.

[0036] Referring to FIG. 2, a block diagram of one embodiment of a catheter-based treatment system 10 is shown. The catheter-based treatment system 10 includes a control computing system 34. The control computing system 34 may physically be part of, for example, the control station 26 (shown in FIG. 1). The control computing system 34 is typically an electronic control unit suitable for providing the catheter-based treatment system 10 with the various functions described herein. By way of example, the control computing system 34 may be an embedded system, a dedicated circuit, or a general-purpose system programmed with the functions described herein. The control computing system 34 communicates with the bedside unit 20, communication systems and services 36 (e.g., the Internet, firewalls, cloud services, session managers, hospital networks, etc.), a local control station 38, another communication system 40 (e.g., a telepresence system), a remote control station and computing system 42, and patient sensors 56 (e.g., an electrocardiogram (ECG) device, an electroencephalogram (EEG) device, a blood pressure monitor, a temperature monitor, a heart rate monitor, a respiratory monitor, etc.). The control computing system 34 also communicates with the imaging system 14, the patient table 18, other medical systems 50, a contrast injection system 52, and accessory devices 54 (e.g., IVTJS, OCT, FFR, etc.). The bedside unit 20 includes a robotic drive 24, a positioning system 22 (e.g., a robotic arm, an articulated arm, a holder, etc.), and may also include a separate control and display unit 46. As described above, the control and display unit 46 may be located on the housing of the robotic drive 24. Interventional equipment and accessories 48 (e.g., guidewires, catheters, etc.) connect to the bedside unit 20. In one embodiment, the interventional equipment and accessories 48 include specialized devices (e.g., IVTJS catheters, OCT catheters, FFR wires, diagnostic catheters for contrast, etc.) that connect to accessory devices 54, i.e., IVTJS systems, OCT systems, FFR systems, 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 (e.g., a control station 26 (shown in FIG. 1 ), such as a local control station 38 or a remote control station 42) and / or based on information available to the control computing system 34 so that a medical procedure can be performed using the catheter-based procedure system 10. The local control station 38 includes one or more display units 30, one or more input modules 28, and a separate user control unit 44. The remote control station and computing system 42 include similar components to the local control station 38. The remote 42 and local 38 control stations can be customized for different functions depending on the functionality required. The separate user control unit 44 can include one or more foot input devices. The foot input devices are configured to allow a user to select functions of the imaging system 14, such as turning x-rays on or off, scrolling through various stored images, etc. In another embodiment, the foot input devices are configured to allow a user to select which device to map to a scroll wheel included in the input module 28. Other communication systems 40 (audio conferencing, video conferencing, telepresence, etc.) may be employed to assist the operator in interacting with the patient, the 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 equipment not explicitly shown, such as an image processing engine, a data storage and archiving system, an automated balloon and / or stent inflation system, a medication injection system, a medication tracking and / or logging system, a user log, an encryption system, a system for restricting access to or use of the catheter-based treatment system 10, etc.

[0039] As described, the control computing system 34 communicates with the bedside unit 20, which includes the robotic drive 24, the positioning system 22, and a separate control and display unit 44, and provides control signals to the bedside unit 20 to control the operation of the motors and drive mechanisms used to drive the percutaneous interventional devices (e.g., guidewires, catheters, etc.). The various drive mechanisms are provided as part of the robotic drive 24 (shown in FIGS. 1 and 2). FIG. 3 is a perspective view of the robotic drive of a catheterization system according to one embodiment. In FIG. 3, the robotic drive 24 includes multiple instrument modules 32 coupled to a linear rail 60. Each instrument module 32 is coupled to the rail 60 via a stage 62 slidably mounted on the rail 60. The instrument modules 32 are connected to the stage 62 using a connector, such as an offset bracket 78. In another embodiment, the device modules 32 are mounted directly to the stage 62. Each stage 62 can be independently actuated to move linearly along the rail 60. Thus, each stage 62 (and the corresponding equipment module 32 coupled to the stage 62) moves individually relative to each other and relative to the rails 60. A drive mechanism is used to actuate each stage 62. In the embodiment shown in Figure 3, the drive mechanism includes an independent stage displacement motor 64 coupled to each of the stages 62 and a stage drive mechanism 76, e.g., a lead screw. In Figure 3, the stages 62 and equipment modules 32 are in a serial drive configuration.

[0040] Each instrument module 32 includes a drive module 68 and a cassette 66 mounted and coupled to the drive module 68. In FIG. 3, each cassette 66 is shown mounted vertically to the drive module 68. In other embodiments, the cassette 66 is mounted to the drive module 68 in other ways. The cassette 66 is sterile and configured to receive and support an elongated medical instrument (not shown). Additionally, the cassette 66 coupled to the drive module 68 includes a mechanism that provides at least one additional degree of freedom, such as rotation, to the elongated medical instrument. The drive module 68 includes at least one coupler to provide a power interface to the mechanism of the cassette 66 that provides the additional degree of freedom. Each cassette 66 also contains an instrument support 79 that prevents buckling of the elongated medical instrument. The robotic drive 24 includes an instrument support connection 72 connected to the device support 79, a distal restraint arm 70, and a support arm 77. Additionally, an introducer interface support (redirector) 74 may be connected to the instrument support connection 72 and to the elongated medical instrument (e.g., introducer sheath). This configuration of the robotic drive 24 has the advantage of reducing the size and weight of the robotic drive 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 vasculature, in which one or more catheters are used to aid in diagnosing a patient's condition. For example, in one example, 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 vasculature (e.g., angioplasty, stent placement, peripheral vascular lesion treatment, clot removal, arteriovenous malformation treatment, aneurysm treatment, etc.). Those skilled in the art will appreciate that certain percutaneous interventional devices or components (e.g., various guidewires, various catheters, etc.) may be selected according to the type of procedure to be performed.

[0042] As used herein, a distal direction is toward the patient, and a proximal direction is away from the patient. For example, the distal end of an elongated medical device (EMD), such as a guide catheter, refers to the end that is inserted into the patient, and the proximal end of the EMD refers to the end that is coupled to the bedside unit 20 described above. The words above and up refer approximately to directions away from the direction of gravity, and the words below and down refer approximately to the direction of gravity. The word before refers to the side of the robotic mechanism that faces the user and is away from the articulated arm. The word after refers to the side of the robotic mechanism that is closer to the articulated arm. The word inward refers to the interior portion of the mechanism. The word outward refers to the exterior portion of the mechanism.

[0043] To perform a procedure, an elongated medical device, such as a guide catheter, a guidewire, and / or a working catheter, is inserted into a patient. In one example of an interventional procedure, a guide catheter is inserted into the patient's femoral artery through an introducer and positioned adjacent to a coronary ostium in the patient's heart. The guide catheter maintains a linear position along its longitudinal axis within the instrument module 32. In medical procedures such as percutaneous coronary intervention (PCI), a guide catheter is used to pass guidewires and other elongated medical devices, such as balloon stent catheters, into the patient, for example, to perform diagnostic exploration or to treat stenoses in the patient's vasculature. The distal end of the guide catheter is positioned within the ostium of the patient's heart. The robotic drive 24 drives the guidewire and / or working catheter, such as the balloon stent catheter, in and out of 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] Linear motion of a percutaneous device, also referred to herein as an elongated medical device (EMD), is motion along the longitudinal axis of the EMD. The longitudinal axis of the EMD is defined as a path extending from the proximal end of the EMD to the distal end of the EMD. If the EMD were more rigid, the entire EMD would be oriented such that the proximal end of the EMD, the distal end of the EMD, and the entire EMD between them lie on a straight line. In this case, the longitudinal axis of the EMD may be defined by a straight line. However, if the EMD is flexible and moves either within a robotic drive mechanism or through a non-linear vasculature pathway, some portion of the EMD will not lie along the straight line defined by the proximal end of the EMD and the distal end of the EMD. However, the central portion of the EMD traveling through a robotic drive mechanism or a non-linear portion of the vasculature would still be said to lie on the longitudinal axis of the EMD. That is, linear motion is motion of the EMD along the longitudinal axis of the EMD. Movement of the EMD away from the proximal end, in a direction into the patient, is forward or forward linear movement, and movement of the EMD away from the distal end, out of the patient, is backward or rearward linear movement.

[0045] The rotational motion of the EMD is defined as the rotation of the EMD about its longitudinal axis. The clockwise rotational motion of the EMD is the clockwise rotation of the EMD about its longitudinal axis at the location of the drive mechanism.

[0046] In one example, a primary user controller or user input provides commands to move the EMD. In one embodiment, the primary or primary user controller is a joystick that provides commands for multiple motion magnitudes. In one embodiment, the joystick is pivotable forward or backward from a central neutral position to provide commands to move the EMD to a forward or backward position, respectively. In one embodiment, a linear deadband is defined as a joystick position where no forward or reverse command is provided. In one example, moving the joystick 3° forward or backward results in no movement of the EMD. In one embodiment, rotation of the joystick about its longitudinal axis provides a rotation command to the EMD. Rotating the joystick clockwise results in clockwise rotation of the EMD, and rotating the joystick counterclockwise results in counterclockwise rotation of the EMD. However, a command to rotate the EMD occurs only if the joystick is rotated beyond the 3° rotation deadband in either direction, in one embodiment. Of course, the rotation deadband may be less than 3°. In one embodiment, the rotational deadband is 2 degrees, and in another embodiment, the rotational deadband is greater than 3 degrees.

[0047] An operator utilizes the robotic system described herein to drive the EMD for several separate vascular procedures, including lesion crossing, vessel navigation, lesion measurement, lesion assessment, lesion preparation, self-expanding stent deployment, and device stabilization during guide catheter manipulation, among others.

[0048] Various user input devices allow an operator to control the operation of one, several, or all of the EMDs in the system 10. For example, an 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 treatment system, various examples described herein allow an operator to select one or more modes of robotic motion to assist during a procedure. The modes of robotic motion can execute patterns of motion, including predetermined repetitive movements, with or without separate operator input to the robotic drive. As used herein, "pattern" refers to a sequence, e.g., a sequence of movements or a sequence of commands. Movements can, in some examples, be enabled with predetermined default values ​​that can be changed with further operator input. Various movements are described below with reference to FIGS. 4-9. Some movements apply to any or all of the EMDs used in a particular procedure, while other movements are only useful for certain types of EMDs.

[0049] In the figures described below, various motion patterns are illustrated at the distal end of the EMD, or the end of the EMD that is inserted into a patient. In various examples, the desired motion pattern is implemented at the proximal portion of the EMD through 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 portion of the EMD is transmitted to the distal end of the EMD. The exact motion at the distal end may or may not match the motion at the proximal portion depending on various factors, such as compliance of the EMD, friction against the vessel wall, tortuosity of the vasculature, or resistance encountered at the lesion. Some robotic motions can compensate for misalignment and input or adjust motion at the proximal portion to more precisely achieve the desired motion at the distal end. For example, the amount of desired motion at the distal end can be adjusted (scaled) by a factor applied to the motion performed at the proximal end. This factor can be determined based on real-time imaging, experimentation, or historical data according to the procedure, device characteristics, specific vasculature, or other parameters. The coefficients or adjustments are applied by an operator or a control computing system.

[0050] Referring to FIGS. 4A and 4B, a mode of robotic operation in an EMD system is illustrated. FIGS. 4A and 4B illustrate an EMD device 100 used in the exemplary system described above with reference to FIGS. 1-3. The EMD device 100 according to this embodiment includes a first EMD 110 and a second EMD 120. FIGS. 4A and 4B show the distal portions of the EMDs 110 and 120. The two EMDs are coaxially arranged, with the second EMD 120 disposed within the first EMD 110. In this example, the first EMD 110 has an internal lumen that accommodates the second EMD 120 and allows the second EMD 120 to move (e.g., rotate and / or translate) relative to the first EMD 110. Those skilled in the art will appreciate that more than two EMDs may be provided and arranged coaxially, with more than one EMD accommodated within the internal lumen of another EMD.

[0051] Once a mode is selected by the operator, the robot drive 24 causes one or more EMDs 110, 120 to enter a predetermined motion pattern. In the example shown in FIGS. 4A and 4B, one EMD (e.g., a guidewire) 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 mode of robot motion shown in FIGS. 4A and 4B is referred to herein as a wiggle mode. Wiggle mode is characterized by an oscillatory rotation of the EMD about its longitudinal axis. In one example, when wiggle mode is activated, the EMD (the second EMD 120 in the example shown in FIGS. 4A and 4B) enters a rotational oscillation about its longitudinal axis 125. In another example, the EMD 120 rotationally oscillates only when the user commands the EMD 120 to proceed in a forward linear displacement. The EMD 120, depicted in this example as a guidewire, rotates alternately clockwise and counterclockwise, as shown in cross-section AA of FIG. 4A. The vibration of the EMD is characterized by various parameters, such as amplitude and / or frequency. As illustrated in Figure 4A, the amplitude is indicated by the range of rotation 140 relative to a central position represented by a reference plane 130 in Figure 4A. In various examples, an operator can set vibration parameters such as amplitude, rotation speed, frequency, or cycle time.

[0052] Various vibration parameters can be set in a predetermined pattern to achieve a desired result or for a predetermined purpose. For example, the vibration amplitude 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 required to complete one vibration) or vibration frequency can also be set in a predetermined pattern to achieve a desired result. In one example, the EMD is vibrated at a rotational speed of 900 degrees per second.

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

[0054] As shown in Figures 4A and 4B, auxiliary commands can be used to modify certain characteristics of the vibration of the EMD. In the example shown in Figures 4A and 4B, the auxiliary commands are received from a user input device such as a joystick 150. Figure 4A illustrates the vibration relative to a plane 130, which represents the center position of the vibration in the absence of 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 in Figure 4A by the arrow on the joystick and arrow 170 beside the EMD 120. The vibration can be modified through commands from the joystick 150.

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

[0056] As described above, other parameters of the vibration, such as amplitude, frequency, rotation speed, or cycle time, can be changed by an operator. For example, the amplitude of the vibration can be changed by user input using a joystick or another input device, such as a graphical user interface. In the case of a joystick, the amplitude can be increased by rotating the joystick clockwise and 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 decreases the amplitude to a lower value, such as 90°.

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

[0058] As described above, a predetermined motion pattern in wiggle mode may be performed for navigation purposes. In this example, the predetermined motion involves forward linear motion of the EMD (e.g., a guidewire). That is, vibration is activated only when the EMD is in forward linear motion while the mode is active. In one example, when the forward linear motion stops for a predetermined period of time (e.g., 1 second), the rotational vibration is discontinued. Rotational vibration is not activated during non-forward linear motion. That is, rotational vibration may be discontinued if the linear motion is reversed or pushed. In this context, "pushing" refers to a separate (discrete) 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 an 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 first EMD 110 and a second EMD 120 arranged coaxially, as illustrated in cross-section view AA.

[0060] FIG. 5 illustrates a predetermined motion pattern associated with what will be referred to herein as the drill mode. When the drill mode is selected by the operator, the robotic drive system 24 places one or more EMDs 110, 120 in a predetermined motion pattern characterized by continuous unidirectional rotation of at least one EMD about its longitudinal axis 125, as indicated by arrow 160, combined with forward linear motion of the EMDs, as indicated by arrow 170. In this example, the EMD (e.g., the second EMD 120 or the guidewire) spins 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 the predetermined motion pattern. For example, the rotational speed can be set between about 1 and about 10 revolutions per second, preferably about 2.5 revolutions per second. In one example, the operator can set the rotational speed by inputting a separate value.

[0061] As mentioned above, different robotic operations are performed on different EMDs. The drill mode shown in Figure 5 can be performed on a guidewire to overcome an obstacle such as a lesion.

[0062] Similar to the wiggle mode described above with reference to FIGS. 4A and 4B, when the drill mode of FIG. 5 is enabled, continuous unidirectional rotation is aborted when forward linear motion ceases for a predetermined period of time. That is, rotation is stopped while the EMD is not in forward linear motion while the drill mode is active. A similar abort of unidirectional rotation occurs if the linear motion is reversed or jerked. In one example, an auxiliary input can be used to increase or decrease the rotation rate in drill mode. For example, the operator moves the joystick forward to increase the rotation rate and backward to decrease the rotation rate.

[0063] Referring to Figure 6, various phases of another mode of robot operation in an 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 illustrates a predetermined motion pattern associated with what will be referred to herein as the jackhammer mode. When the jackhammer mode is selected by the operator, the robotic drive 24 places one or more EMDs 110, 120 in a predetermined motion pattern characterized by linear oscillation of the EMDs 110, 120. In the example shown in Figure 6, the second EMD 120 (e.g., a guidewire) is shown oscillating linearly. The jackhammer mode is used by the operator to facilitate the guidewire overcoming obstacles, such as lesions.

[0065] As illustrated in Figure 6, the linear oscillation involves alternating forward and backward linear motion of the elongated medical device. Figure 6 shows forward linear motion of the EMD 120 from position (a) to position (b), followed by backward linear motion of the EMD 120 from position (b) to position (c). This motion pattern continues in a repeating cycle with motion of the EMD 120 from position (c) to position (d).

[0066] The jackhammer mode shown in FIG. 6 performs alternating forward and backward linear motion of the elongated medical device, resulting in forward linear motion of the EMD 120, which, for example, allows the EMD 120 to pass or overcome a lesion. In this example, the alternating forward linear motion is at least slightly greater than the alternating backward linear motion. Thus, as shown in FIG. 6, at the start of an oscillation cycle, the EMD 120 is at position (a), and at the completion of the oscillation cycle (and the start of the next oscillation cycle), the EMD 120 is at position (c), which is forward of position (a). That is, the cumulative forward linear motion allows the EMD 120 to, for example, pass or overcome a lesion.

[0067] As discussed above and shown in the example of Figure 6, the jackhammer mode is used with the second EMD 120, i.e., the guidewire. In other examples, a similar motion pattern is used with other EMDs, such as the microcatheter (or first EMD 110).

[0068] Similar to the wiggle and drill modes described above with reference to Figures 4A, 4B, and 5, when the input of forward linear motion is stopped while the jackhammer mode of Figure 6 is active, the alternating forward and backward linear motion that characterizes the jackhammer mode is discontinued. In one example, the jackhammer mode is discontinued when the input of forward linear motion is stopped for a predetermined period of time. That is, when the jackhammer mode is activated, the linear vibration is discontinued while the EMD is not performing forward linear motion. Similar discontinuation can be performed if the linear vibration is reversed or rocked.

[0069] Referring to Figure 7, another mode of robotic operation in an EMD system is illustrated. The mode shown in Figure 7 is referred to as active device fixation (ADF). ADF is activated in systems where at least two EMDs are used in a procedure, such as robotic system 700, in which an instrument module of an EMD 720 is coupled to an instrument module 740 of another EMD 710. In the example of Figure 7, robotic system 700 is used to perform a procedure on a patient 702 by inserting an EMD into the vasculature 704 of the patient 702.

[0070] The robotic system 700 of 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 guide catheter 730, is positioned therethrough through which the microcatheter 710 and guidewire 720 are displaced. The microcatheter 710 is linearly displaced through corresponding linear displacement of an instrument module 740, which includes an instrument support or support track 750 through which the EMDs 710, 720 are coaxially fed to the next instrument module.

[0071] In the apparatus shown in FIG. 7, the instrument module is linearly displaced and drives the linear displacement of the microcatheter 710. Displacement of the instrument module 740 also drives the linear displacement of the guidewire 720. The guide catheter 730 can be linearly displaced by another corresponding device module (not shown in FIG. 7). The microcatheter 710, guidewire 720, and guide catheter 730 are in a coaxial arrangement. That is, as illustrated in FIG. 7, within the patient 702, the three EMDs 710, 720, and 730 are coaxially positioned through a passageway, such as the carotid artery.

[0072] The operator may wish to reposition one EMD while leaving other EMDs stationary within the patient 702. For example, the operator may wish 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 the EMDs 710, 720, and 730. Those skilled in the art will understand that, as discussed above, it is the proximal ends of the EMDs that are controlled.

[0073] When ADF mode is enabled, the operator can linearly displace the microcatheter 710 by displacing the instrument module 740 forward a distance Δd, as illustrated in FIG. 7B. In one example, encoder measurements of motion are used to determine the amount and direction. The ADF mode causes a corresponding movement of the guidewire 720 in the opposite direction, such that the position of the proximal end of the guidewire 720 remains substantially stationary relative to the patient 702, as illustrated in FIG.

[0074] Movement of the guidewire 720 relative to the instrument module 740 is accomplished using a drive tire 742, and the linear movement of the guidewire 720 can be measured using a corresponding encoder connected to an auxiliary encoder tire 744. As shown in FIG. 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 (rearward), 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 controller, such as the control computing system 34 described above with reference to FIG. 2.

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

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

[0077] Based on the determination 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 accomplished by, for example, driving the guidewire 720 with the drive tire 742 (block 810). The movement of the guidewire 720 is detected by, for example, an encoder coupled to the auxiliary encoder tire 744 or other sensor provided within the system 700 (block 812).

[0078] In the example of Figure 8, various safe features are provided to provide safeguards in closed-loop operation to prevent over- or mis-correction due to failure or defects in the 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 in response to movement of the microcatheter 710) is complete, as indicated by the guidewire 720 reaching its intended 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 substantially equals 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 value (e.g., 0.5 mm), the process is considered complete, and returns to block 802 for a new commanded movement of the first EMD 710. In one example, the error determined in block 816 is added to the previous error, and the error compared to the threshold is the cumulative threshold.

[0080] If the position of the guidewire 720 is within a first error threshold in block 818, it can be determined that the compensation operation of the guidewire 720 is complete. The first threshold is the difference between the position change of the microcatheter 710 and the equal and opposite position change of the guidewire 720. For example, if the differences between the operations are within 0.5 mm of each other, the operation can be considered complete. Without this first threshold, the guidewire 720 may continue to operate and vibrate to correct the position error. An operator may find this vibration undesirable when positioning the EMD in the patient's anatomy. Optionally, the compensation operation of the guidewire 720 can be re-executed if the position error exceeds a second threshold greater than the first threshold. For example, the compensation operation will not be re-executed unless the position error exceeds a second threshold of 1.0 mm. In another example, the compensation operation may be re-executed by a further command input (e.g., from a user actuating a joystick).

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

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

[0083] 7 and 8, the linear motion of the first EMD 710 and the second EMD 720 occurs substantially simultaneously, although one skilled in the art will appreciate that processor timing or measurement frequency may result in a minimal offset in the timing of the operations.

[0084] In one example, data from the encoders may indicate unexpected movement of the EMDs 710, 720. The movement is determined to be unintended, for example, if it exceeds a predetermined rate or threshold or does not correspond to the commanded movement. In this case, the movement can be recognized as unexpected, and the reference positions of the EMDs 710, 720 can be adjusted without making any change to the rate or amount of commanded displacement of either EMD.

[0085] Data from an encoder connected to the auxiliary encoder tire 744 can be used to detect the presence or absence of the second EMD 720. For example, when movement of the guidewire 720 is commanded through movement of the drive tire 742, a signal from the auxiliary encoder tire 744 is used to indicate the presence or absence of the guidewire. If the auxiliary encoder tire 744 indicates movement of the guidewire 720 above a predetermined threshold (e.g., 0.1 mm) corresponding to the commanded movement, the presence of the guidewire 720 can be confirmed. On the other hand, if movement in response to the commanded movement of the drive tire 742 is not detected by the auxiliary encoder tire 744, the absence of the guidewire 720 can be detected or identified. In another example, the second EMD 720 can be assumed not to be present by the control computing system until its presence is first detected.

[0086] Those skilled in the art will appreciate that the number of EMDs may be greater than two. For example, in the example described above, one or more other EMDs (in addition to the guidewire 720) may be displaced in response to the movement of the microcatheter. For example, EMDs displaced in response to the movement of the microcatheter include a guidewire, a balloon or stent catheter, and other available EMDs. In one example, one or more other EMDs are included, each constrained in the same manner as a second EMD. For example, when the guide catheter is moved, multiple EMDs move in an equal and opposite direction to the movement of the guide catheter. In one system, the guide catheter, guidewire, and third EMD are disposed on a common base that moves 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 an opposite direction to the movement of the base, equal and opposite to the movement of the guide catheter. When multiple EMD devices are present, the device not maintained in an opposite direction relative to the guide catheter is the EMD that constrains the movement of the guide catheter. Alternatively, the guide catheter is constrained (slowed or stopped) by an EMD that slows most of the other EMDs. The other EMDs continue to track the movement of the guide catheter, so that all EMDs move a distance substantially equal and opposite to that moved by the guide catheter.

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

[0088] As illustrated in FIG. 9, the linear vibration associated with the jackhammer mode involves alternating forward and backward linear motion of the two EMDs 110, 120. FIG. 9 shows the forward linear motion of the EMDs 110, 120 from position (a) to position (b), each by an amount Δd1, followed by the backward linear motion of the EMDs 110, 120 from position (b) to position (c), each by an amount Δd2. As noted above, the amount of forward linear motion (Δd1) is greater than the amount of backward linear motion (Δd2). The motion pattern continues in a repeating cycle, beginning with motion of the EMDs 110, 120 from position (c) to position (d), each by Δd1.

[0089] Synchronization of the motion 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 determine the motion 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 FIG. 7, can be used to measure the motion of the first EMD 110. In response to the measured motion of the first EMD 110, the controller drives the second EMD 120 to displace the same amount and in the same direction as the first EMD 110.

[0090] Referring to FIG. 10, a state machine diagram corresponding to an example of the wiggle mode, referred to as spin mode as described above with reference to FIGS. 4A and 4B, is shown. The example in FIG. 10 illustrates how commands are provided to the primary user input and the linear and rotary drives of the guidewire device. When spin mode is selected, the rotary drive mechanism provides rotational oscillation of the guidewire while the guidewire is driven forward. Referring to FIG. 10, when spin mode is selected as an example selection, there are four separate command states. First, in the No GWL COMMAND (GWL: guidewire linear) state, where there is no command from the primary user input, the controller does not provide an automatic command to the rotary drive mechanism or linear drive mechanism to provide rotational or linear motion to the guidewire. In this state, the operator can provide rotational motion to the guidewire (GW) through user-input rotational motion. Second, in the GW FORWARD MOTOR COMMAND state, when the operator provides a command via the primary user interface to move the guidewire in a linear forward direction, the rotary drive automatically provides rotational oscillation motion to the guidewire. Also, in the GW FORWARD MOTOR COMMAND state, any rotational input to the primary user input will be ignored, and no additional rotational motion will be imparted to the guidewire by the rotary drive. In this GW FORWARD MOTOR COMMAND state, where the primary user interface is a joystick, when the operator rotates the joystick, this will provide clockwise (CW) and counterclockwise (CCW) rotation commands to the rotary drive mechanism, but this joystick rotation will not result in a command from the controller to the rotary drive mechanism to rotate the guidewire in addition to automatic guidewire oscillation. In a third command state, where the user provides a linear reverse command to the GW reverse motor via the primary user input, the guidewire rotary drive will not impart any rotational motion to the guidewire unless the user provides a further command to rotate the guidewire.When the primary user input is a backward joystick movement of the joystick, it commands the linear drive to move the guidewire in a reverse or withdrawal direction toward the patient, but does not provide a command to the rotary drive to impart a rotational oscillatory motion to the guidewire. However, in this third state, either a clockwise or counterclockwise joystick rotation causes the controller to command the rotary drive to rotate the guidewire in either a clockwise or counterclockwise direction. Another way of looking at this third state is that the primary input reverse motion behaves the same as the base operating state. When the operator provides a linear advance command through the primary user input mechanism, the position in the oscillation cycle is saved, and if operator manipulation of the primary user input in the linear advance direction continues again, the cycle will resume from where it stopped. In one embodiment, the position in the cycle is not saved, but starts anew each time the operator stops and initiates linear advance motion via the primary user input.

[0091] In one example, the automatic rotational oscillations occurring as described above in various states include, in each cycle, first a 360° CW rotation at 900° / sec and a 360° CCW rotation at 900° / sec, after which the cycle is repeated with no pause between direction changes other than that required by the physical limitations of the electromechanical rotary drive mechanism. Of course, other speeds and rotation amounts are contemplated. In one example, the speed is between less than 900° / sec and greater than 900° / sec.

[0092] In the fourth GW FORWARD MOTOR COMMAND (DISCRETE) state, a separate operating mode is now selected by selecting the jog button for discrete forward motion, but no spin operation instructions are provided to the spin drive mechanism. When the user deselects the spin operation algorithm via the secondary user interface, the primary user input operation reverts to the basic standard command without automatic alternating spin operation.

[0093] If the primary user input is a joystick and the controller and spin motion technique is selected with a secondary user input, the rotational drive mechanism provides a continuous rotational oscillation of the GW during forward motion of the EMD using the primary controller. However, if the operator intends to rotate the primary user input (such as a joystick) while the GW is forward, the system does not provide any additional rotation beyond the rotational oscillation. In one embodiment, the oscillation rate is degrees of rotation per unit of axial motion movement, or some other non-linear relationship between oscillation rate and linear velocity.

[0094] In one example, the linear deadband of the primary user input is not subject to oscillatory rotational motion. That is, if the linear deadband is a 2°-3° movement of the primary user input, automatic rotational oscillation will not occur until the primary user input is moved beyond the linear deadband. In one example, rotation of the primary user input without other linear motion commands of the linear deadband will cause the rotary drive to impart rotational motion to the guidewire.

[0095] Referring to FIG. 11, a state machine diagram corresponding to another example of the wiggle mode described above with reference to FIGS. 4A and 4B is provided. The example shown in FIG. 11 has the same functionality as the example of FIG. 10 for the four identified states, except that rotational input from the primary user input during rotational oscillation results in greater rotational motion in one direction than the other. By way of example, the primary user input is a joystick, with the user providing both: moving the joystick generally away from the user to provide a linear advance command to the linear drive mechanism; simultaneously rotating the joystick clockwise causes the rotary drive mechanism to alternately rotate the guidewire in 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 joystick's neutral position, the ratio of CW to CCW rotation increases. Similarly, as the operator rotates the joystick CCW while also moving the joystick forward, the rotary drive rotates the guidewire in a net CCW direction as described above.

[0096] Referring to FIG. 12, a state machine diagram is provided corresponding to an example of the drill mode described above with reference to FIG. 5. When drill mode is selected, there are four distinct command states. First, in the No GWL COMMAND (GWL) state, where there are no guidewire linear commands from the primary user interface, conventional CW and CCW rotation commands can be provided by CW and CCW manipulation or movement of the primary user interface, such as a joystick. That is, commands from the primary user interface for CW or CCW rotation of the guidewire are issued via the controller to the rotary drive mechanism to rotate the guidewire in the CW or CCW direction. Second, in the GW FORWARD MOTOR COMMAND state, when the operator issues a command via the primary user interface to move the guidewire in a linear forward direction, the rotary drive automatically imparts a CW rotational motion to the guidewire. Also, in the GW FORWARD MOTOR COMMAND state, any rotational input to the primary user input is ignored, and no additional rotational motion is imparted to the guidewire by the rotary drive. If the primary user interface is a joystick and the operator intends to rotate the joystick, this will provide CW and CCW rotation commands to the rotary drive mechanism in the second GW FORWARD MOTOR COMMAND state, but the joystick rotation will not provide a command from the controller to the rotary drive mechanism to rotate the guidewire in addition to the automatic CW rotation of the guidewire. In the third GW REVERSE MOTOR COMMAND state, where the user provides a linear reverse motion command via the primary user input, the guidewire rotary drive will not provide automatic rotational motion to the guidewire. However, in this state, if the user also provides a command to rotate the guidewire by manipulating the primary user input, the GW will be rotated as in the basic normal operating state.If the primary user input is a backward joystick movement of the joystick, it commands the linear drive to move the guidewire away from the patient or in a withdrawal direction without commanding the rotary drive to impart a rotational motion to the guidewire. However, in this third state, rotation of the joystick in either a CW or CCW movement will result in the controller commanding the rotary drive to rotate the guidewire in either a CW or CCW direction. Stated another way in this third state, a backward movement of the primary input will produce the same behavior as in the base actuation state.

[0097] In one example, the autorotation motion that occurs as described above in various states is a 900° / sec CW rotation. Of course, other speeds and rotation rates are contemplated. In one embodiment, the speed is greater than 900° / sec, and in one embodiment, the speed is less than 900° / sec but greater than zero° / sec.

[0098] In the fourth GW FORWARD MOTOR COMMAND (DISCRETE) state, where discrete operation mode is selected by selecting the separate forward jog buttons, no rotary motion commands are provided to the rotary drive mechanism. When the user deselects drill mode, the primary user input operation reverts to the basic standard commands with no automatic rotary motion.

[0099] In one embodiment, the rate of rotation is degrees of rotation per unit of axial motion movement, or some other non-linear relationship between rotational rate and linear velocity.

[0100] In one example, while in drill mode, the linear deadband of the primary user input does not provide CW rotational motion. That is, if the linear deadband is 2°-3° of motion of the primary user input, automatic CW rotation will not occur until the primary user input moves beyond the linear deadband. In one embodiment, excluding the linear deadband, rotation of the primary user input without a linear motion command will cause the rotary drive to impart rotational motion to the guidewire.

[0101] Referring to FIG. 13, a state machine diagram corresponding to the Jackhammer mode example described above with reference to FIG. 6 is shown. In the example of FIG. 13, Jackhammer mode is applied to a guidewire. When Jackhammer mode for a guidewire (GW) is selected, there are a number of states that affect the operation of the GW. In the NO GWL COMMAND state (no guidewire linear motion command), user input provides normal rotational operation. This means that the operator rotates the GW CW or CCW by manipulating the user input. In the GW FORWARD MOTOR COMMAND (JOYSTICK) state, the GW linear drive mechanism automatically cycles the GW in forward and reverse directions, with forward motion greater than reverse motion. In this state, the operator can also impart CW or CCW direction to the GW by manipulating the user interface (by rotating the joystick in 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 to give the GW a reverse motion, but there is no automatic cyclic linear motion (forward and reverse) of the GW. In the GW FORWARD MOTOR COMMAND state, based on a shake or individual motion button or input, the GW linear drive mechanism does not give the GW an automatic cyclic linear motion. In one embodiment, the automatic cyclic motion is 1.5 mm forward at 12 mm / s and 1 mm reverse at 12 mm / s, and the pause between the forward and reverse motion is the dwell period required for the GW linear drive mechanism to switch direction. In one embodiment, the dwell period is not discernible to the operator. Of course, other distances and speeds are also possible, such as greater than 0 mm and less than 1.5 mm and 1 mm, respectively, or greater than or equal to 1.5 mm and 1 mm, respectively. Similarly, the speed may be greater than zero and less than 12 mm / s, or greater than or equal to 12 mm / s. Jackhammer motion techniques are described in U.S. Patent No. 9,220,568, which is incorporated herein by reference. In one embodiment, the reverse motion is greater than the forward motion.

[0102] Referring to FIG. 14, a state machine diagram corresponding to another example of the jackhammer mode described above with reference to FIG. 6 is illustrated. In the example of FIG. 14, the jackhammer mode is applied to a balloon or stent catheter, also referred to herein as a dot shot. When the example mode of FIG. 14 is selected, there are a number of conditions that affect the operation of the balloon catheter or stent catheter (individually and collectively referred to herein as a "BSC"). The BSC may also include other elongated medical devices. The mode shown in FIG. 14 is similar to the mode of FIG. 13, however, the rotational aspect is not relevant since there is no rotational drive for the BSC.

[0103] Referring to FIG. 15, a state machine diagram corresponding to an example of the ADF mode described above with reference to FIGS. 7 and 8 is shown. In one example of the ADF mode, coordinated control of one or two linear drives is provided. These linear drives are on the same platform and move linearly with the GC when the platform moves in a linear direction. The ADF mode allows the linear drives of the guidewire and / or BSC to move the GC relative to the ground or patient while maintaining a fixed position of the GW and BSC relative to the ground or patient. In one embodiment, when the ADF operation algorithm is selected and enabled, the system detects whether the guidewire and catheter are loaded by automatically moving the guidewire and catheter forward and backward a fixed distance and checking via position sensors whether the guidewire and catheter are loaded in their respective linear drives. In one embodiment, this forward and backward movement is called a perturbation, and involves advancing the guidewire 0.1 mm and then retracting the guidewire the same distance. However, other distances greater or less than 0.1 mm, such as 1 mm or 0.01 mm, are also contemplated. The distance is selected to minimize the impact on the procedural risk profile while still being detected by the sensor. In one embodiment, the device detection system is an active device detector, such as an optical sensor, a mechanical sensor, or a magnetic sensor. In the first GW AND BSC NOT LOADED state, which is a state in which no command is given from the operator via user input to move the guide catheter forward or backward along its longitudinal axis, and no GC linear command is given, the GW and BSC linear drive mechanisms move the GW and BSC, respectively, in equal and opposite directions relative to the movement of the guide catheter. As an example, moving the guide catheter forward 1 cm causes the guidewire and BSC drive mechanisms to move the guidewire and BSC backward 1 cm. This is done even if the GW and BSC are not detected within their respective linear drive mechanisms. This device detection function allows the ADF to be used successfully when two or more fixed devices are loaded, but only one of them is loaded.If closed-loop control were always enabled for all locked instrument drive modules, the system could prevent all instrument operation when no instrument was loaded, due to the inability to lock an unloaded instrument. Additionally, the instrument detection function also provides a fail-safe mechanism if the sensors do not detect the presence of a guidewire and BSC. In one embodiment of this mode, the GW and BSC tow notification is suppressed. The tow notification provides a warning if the sensors do not detect the GW and BSC operating at the speed intended by the controller.

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

[0105] In the GW LOADED state, where the guidewire is detected as loaded and the BSC is detected as unloaded, neither the guidewire nor the BSC moves unless there is a command to linearly move the guide catheter. However, when the GC user input is activated or actuated to linearly move the guide catheter, a command is automatically given to the guidewire linear drive mechanism to move in the opposite direction by an amount equal to maintain the guidewire position in a fixed position, even if the amount of movement required by the guidewire linear drive mechanism to maintain a fixed position differs from the amount of movement given to the guide catheter linear drive mechanism. 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 the movement provided by the guide catheter linear drive.

[0106] In the GW AND BSC LOADED state, both the guidewire linear drive mechanism and the BSC linear drive mechanism move the guidewire and BSC, respectively, in the opposite direction to the movement of the guide catheter, with the amount of movement set so that the GW and BSC remain in fixed positions relative to the patient and / or the ground, thus providing closed-loop control for both the GW and BSC.

[0107] In one embodiment, a closed-loop system for operating the GW and BSC uses sensors, such as encoders coupled to the tires, to determine whether the positions of the GW and BSC have properly moved in an equal and opposite direction to the GC's movement. If the encoder provides feedback that the GW and / or BSC are in a position that is less than the proper equal and opposite change in GC position, 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 proper equal and opposite relative position. As an example, if a guide catheter user input commands the guide catheter to move 10 units forward and the encoder indicates that the GW has moved in the opposite direction but only moved a distance of 8 units, the GC linear drive mechanism is automatically decelerated until the GW and / or BSC move in sync the equal and opposite distance of the GC. Once the GW and / or BSC are synchronized, the GC linear drive is accelerated 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 GW and / or BSC linear motion until the GW and / or BSC are synchronized with the GC. In one embodiment, the GC is decelerated and, if necessary, the GW and / or BSC are simultaneously accelerated. Synchronization is when the GW and BSC remain in a fixed position relative to the ground and / or patient while the GC moves.

[0108] In one embodiment, the GW and / or BSC operate at a rate that is different from the rate of the GC, rather than at a fixed equal and opposite amount.

[0109] In one embodiment, an auxiliary encoder is used to provide a closed loop control system for locking the GW and / or BSC equipment in the ADF motion technique.

[0110] In one embodiment, the ADF operation technique stops the operation of the GC if spatial fixation 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 on the GW linear drive and / or BSC linear drive by detecting auxiliary encoder operation. If no operation is detected, it is assumed that no equipment is loaded. In this embodiment, no determination is made as to whether there is equipment loaded on the linear drive; it is checked only on the first command for equipment or equipment operation. If no equipment is detected as loaded, open-loop control is used to lock out, protecting against a simple auxiliary encoder failure fault.

[0112] In one embodiment, a user can provide manual adjustments in the ADF operation technique by manually manipulating user inputs for the GW and / or BSC. User commands to linearly operate the GW and / or BSC complement the automatic operation. In one embodiment, an operator command to linearly operate the GW and BSC in the ADF operation technique temporarily suspends the ADF operation technique until the user ceases to provide independent GW or BSC linear operation commands.

[0113] Referring to Figures 16A-16D, in one embodiment, active device fixation (ADF) operation consists of fixing the device position relative to the ground or patient, or the device inertial position. The inertial position of each device is assumed to displace in the same direction as the GC displaces. Therefore, to maintain the device position, when ADF is enabled, its position must move in the opposite direction to the GC direction. The GC position xGC(t) (denoted x_GC_t) is the integral of the command velocity vGC(t) (denoted v_GC_t). This relationship is captured by the GC integrator model. JPEG0007815338000001.jpg33129

[0114] The GW position xGW(t) (denoted as x_GW_t) is the integral of the scaled (scaled) GW command velocity vGW(t) (denoted as v_GW_t), scaled by the real number kGW (denoted as k_GW). JPEG0007815338000002.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. JPEG0007815338000003.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 corrective 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 a 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) that include a 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 limited BSC joystick speed and the sum of 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 limited GW joystick speed and the sum of the ADF feedback term dx_GC(t).

[0119] In one embodiment of the ADF technique, users can operate the GW and BSC independently of the GC motion by including a reference term that is the integral of the GW and BSC's respective velocity commands. The GC forward and reverse motion decreases as the feedback error increases due to the GW and BSC equipment slip (function y=fcn(e_GW_t, e_BSC_t)).

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

[0121] Active device immobilization can be achieved in another embodiment where the GW and BSC are secured relative to the ground and / or patient using mechanical clamping devices. The clamping devices selectively secure the devices during GC operation. In one embodiment, the GW and BSC are secured relative to the ground with dynamic devices, such as robotic arms, that operate to maintain their relative positions during GC operation. In one embodiment, GC operation is automatically stopped if movement of the GW or BSC is detected, such as by sensors and / or imaging systems.

[0122] Referring to Figure 16, the system, denoted as max{0,1-|e_device|_inf / e_max}, limits the command rate to GC upon feedback error of GW or BSC as follows: JPEG0007815338000004.jpg25131where, e deviceis an upper bound on the error of either GW or BSC. The final GC speed is reduced to ensure that the GC motion is bounded due to machine slip. vGC-SET(t) represents the user GC joystick (user input) speed set point. e max is the maximum allowable tracking error between the GC and GW or BSC positions.

[0123] The computer-executable instructions for the steps of exemplary methods 300 and 400 are stored in the form of computer-readable media. Computer-readable media includes volatile and nonvolatile, removable and non-removable media implemented in any manner or technology for storage of information such as computer-readable instructions, data structures, program modules, or other data. Computer-readable media includes, but is not limited to, random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory, or other memory technology, compact disc ROM (CD-ROM), digital versatile disc (DVD), or other optical storage, magnetic cassette, magnetic tape, magnetic disk storage, or other magnetic storage device, or any other medium that can be used to store desired instructions and that can be accessed by system 10 (shown in FIG. 1), including the Internet or other computer network type access.

[0124] Referring to FIG. 17, a constant speed pullback motion technique is selected for the GW. In one embodiment, the constant speed value is selected from a number of options, or a specific speed is entered via a user device such as a keyboard. Upon such backward movement of the primary user interface by the operator, the GW is pulled out at a constant speed. In one embodiment, the constant speed motion technique only works in the backward direction, i.e., the backward movement is at a constant speed regardless of the range of movement position of the primary user interface in the backward direction. Forward movement of the primary user interface is proportional to or follows the range of movement of the primary interface.

[0125] In one embodiment, the constant speed operation technique also allows for constant speed of the GW in the forward direction. In one embodiment, a turbo input button allows for the constant speed to be increased to a higher speed. In one embodiment, the increased constant speed only lasts while the user holds the turbo button. In one embodiment, the constant speed increase takes effect and remains in effect when the turbo button is pressed, and will remain in effect until the turbo button is turned off. In one embodiment, the increased constant speed remains in effect for a predetermined time and / or a predetermined distance of linear movement of the GW.

[0126] Although not shown, a pushability override input allows increased pushability only if the initial pushability limit is reached during instrument advancement. In this mode, the motor current increases the torque of the advancement motion until it stalls (exceeds the predetermined limit). In one embodiment, the force is increased for the entire procedure, or the force can be increased for a limited time after the initial force limit is reached. In one embodiment, the user can return to a lower predetermined or selected force limit by deselecting the pushability override function.

[0127] In one embodiment, techniques (ADF, Wiggle, Jackhammer) can be independently selected for each EMD in a catheter-based treatment system. For example, ADF can be selected for a guide catheter, Wiggle for a guidewire, and Dot Shot for a 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 other patient data, such as, but not limited to, image and / or hemodynamic data. In one embodiment, certain techniques are automatically highlighted and recommended upon selection based on processing of image data.

[0128] The written description uses examples to disclose the invention, including the best mode, and to enable any person skilled in the art to make and use the invention. The scope of the invention is defined by the claims, and includes other examples that may occur to those skilled in the art. Such other examples are intended to be within the scope of the claims even if they have structural elements that do not differ from the literal recitation of the claims, or have structural elements that differ from the literal recitation of the claims, or have equivalent structural elements that do not differ significantly from the literal recitation of the claims. The order and sequence of any process or method steps may be changed or rearranged according to alternative embodiments.

[0129] Many other changes and modifications can be made to the present invention without departing from the spirit thereof, the scope of these and other modifications being apparent from the appended claims.

Claims

1. 1. A system comprising an elongated medical device apparatus configured to operate at least one interventional device for movement through a vascular system, the system comprising: a control module that executes a predetermined pattern of motion of a proximal portion of the interventional device navigating through a blood vessel in response to a user command of linear displacement of the interventional device; the proximal portion of the interventional instrument is held and manipulated within the elongated medical device apparatus; the predetermined motion pattern is a linear displacement involving continuous unidirectional rotation of the interventional device about a longitudinal axis of the interventional device; The system wherein the predetermined motion pattern is activated when the linear displacement is a forward linear displacement and is discontinued when the linear displacement is a reverse linear displacement.

2. The system of claim 1 , wherein an auxiliary command can change the rotational speed of the predetermined motion pattern.

3. 2. The system of claim 1, wherein the predetermined motion pattern is executed when the user command is an instruction to move the interventional device in a distal direction toward a patient and is not executed when the user command is an instruction to move the interventional device in a proximal direction away from the patient.

4. 10. The system of claim 1, wherein the unidirectional rotation of the interventional device has a first velocity as the interventional device advances through a vessel and a second velocity as the interventional device passes through an obstacle.

5. 1. A system comprising: an elongated medical device apparatus configured to operate at least one interventional device for movement through a vascular system; and a control station, the control station includes a control module that, in response to user commands, executes a predetermined pattern of motion of a proximal portion of the interventional device navigating through a blood vessel; the proximal portion of the interventional instrument is held and manipulated within the elongated medical device apparatus; the predetermined motion pattern is a linear oscillation of the interventional device, the linear oscillation consisting of alternating forward and backward linear motion of the interventional device; The system, wherein the predetermined motion pattern is initiated by a forward linear displacement in which the interventional device advances through the blood vessel, and terminated by a backward linear displacement in which the interventional device moves in a direction opposite to the forward linear displacement.

6. The system of claim 5 , wherein the control module is configured to change an amplitude of the linear oscillation of the interventional device in response to a second user command.

7. 6. The system of claim 5, wherein the predetermined motion pattern is executed when the user command is an instruction to move the interventional device in a distal direction toward a patient and is not executed when the user command is an instruction to move the interventional device in a proximal direction away from the patient.

8. 6. The system of claim 5, wherein the linear vibration of the interventional device has a first amplitude as the interventional device advances through a vessel and a second amplitude as the interventional device passes through an obstacle.

Images