Robot control of slender medical devices

Abstract

A system including an EMD coupled to a robotic drive. The EMD includes an outer member defining a lumen, an inner member disposed in the lumen and coupled to a distal portion of the outer member, and a linearly and rotationally actuable element coupled to the outer member. The robotic drive includes a plurality of device modules, each of the plurality of device modules being individually linearly movable by the robotic drive. A first cassette is coupled to a first device module of the plurality of device modules and coupled to the linearly and rotationally actuable element of the outer member. A second cassette is coupled to a second device module of the plurality of device modules and coupled to the inner member.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the priority of U.S. Provisional Application No. 63 / 262,108, filed on October 5, 2021. The content of this application is incorporated herein by reference for all purposes.

[0002] Embodiments generally relate to the technical field of robotic medical treatment systems, and more specifically, to systems, devices, and methods for robotically controlling the movement of one or more elongated medical devices (EMDs) in robotic intervention medical treatments.

Background Art

[0003] Catheters and other EMDs are used in medical procedures for the diagnosis and / or treatment of various vascular diseases, including neurovascular intervention (NVI), percutaneous coronary intervention (PCI), and peripheral vascular intervention (PVI). These procedures typically involve navigating a guidewire through the patient's vascular system and using the guidewire to advance catheters, valves, stents, etc. for treatment.

[0004] A physician can use an imaging system to obtain contrast images for use in diagnosis, lesion identification, and determination of the path to advance a guidewire or catheter to the target (e.g., lesion) site. The contrast images are also acquired while the physician is operating the proximal end of the guidewire or catheter, guiding the distal tip of the guidewire or catheter to a blood vessel in the path to the target site, monitoring for complications such as perforation or incision, and avoiding entry into collateral branches of the vascular system.

[0005] Flexibility is desirable in catheters and other medical devices to allow them to navigate the vascular system. The distal end of the device should be more bendable than other parts, but the device also needs to be able to apply torque to its tip. Some conventional "maneuverable" catheters include multiple wires (sometimes called push / pull wires) integrated into the catheter wall. By applying tension to these wires at the proximal end of such a catheter, the distal end of the catheter can be bent in various directions, assisting vascular navigation as the catheter is advanced.

[0006] Some EMDs include an outer member and an inner member connected to the distal portion of the outer member. The distal end bends or deforms by moving the outer and inner members relative to each other. These EMDs have the advantage of having a smaller cross-section than the cable-operated EMDs described above.

[0007] Controlling the distal tip requires manipulating the handheld portion to manually rotate the outer member relative to the inner member and / or manually retract the inner member relative to the outer member for insertion. An improved system for controlling such EMDs is desired, which would improve the control of the distal tip or other operable devices connected to the distal tip by improving the precision and accuracy of the relative movement between the outer and inner members. This improvement could lead to increased procedure speed and improved safety. [Brief explanation of the drawing]

[0008] The embodiments can be further understood by the following detailed description with reference to the drawings. In the drawings, reference numerals are used for similar parts. [Figure 1] Perspective view of a catheter-type treatment system according to one embodiment. [Figure 2] A schematic block diagram of a catheter-type treatment system according to one embodiment. [Figure 3]A perspective view of the robotic drive device of a catheter-type treatment system according to one embodiment. [Figure 4] An oblique view of the EMD. [Figure 5] A perspective view of an EMD configured for robot control according to one embodiment. [Figure 6] A diagram illustrating the robot operation of an EMD according to one embodiment. [Figure 7] A diagram illustrating the robot operation of an EMD according to one embodiment. [Figure 8] A diagram illustrating the robot operation of an EMD according to one embodiment. [Figure 9] A diagram illustrating the robot operation of an EMD according to one embodiment. [Figure 10] A diagram illustrating the robot operation of an EMD according to one embodiment. [Figure 11] A schematic diagram showing the complete insertion position of the EMD during robot operation according to one embodiment. [Figure 12] A schematic diagram showing an EMD equipped with an operable element according to one embodiment, with the operable element in a first selective arrangement. [Figure 13] A schematic diagram showing an EMD equipped with an operable element according to one embodiment, with a second selective arrangement of the operable element. [Figure 14] A perspective view of an operable element that is connected to a drive member and also rotatably connects a hemostatic valve to a Luer connector connected to an inner member. [Figure 15] Figure 14 shows an exploded view of the internal component, Luer connector, operable element, and hemostatic valve. Detailed description of the invention

[0009] The following description is provided so that a person with ordinary skill in the art may carry out and use the embodiments described. However, it is understood that a person with ordinary skill in the art may make various modifications.

[0010] As used herein, "EMD" refers to (but is not limited to) medical devices including catheters (e.g., guide catheters, microcatheters, balloon / stent catheters), wire-type devices (e.g., guidewires, microwires, proximal pushers for embolization coils, stent retrievers, self-expanding stents, flow diverters, etc.), and any combination thereof.

[0011] In one embodiment, the operation of an EMD (Electromagnetic Modulation Device) including an inner member located within a lumen of an outer member defined by the outer member is facilitated in a robotic system, and the relative movement between these inner and outer members results in movement of the distal portion of the EMD. In one embodiment, the lumen of the outer member does not need to extend along the entire length of the outer member. The outer member consists of a tube (however, the embodiment is not limited thereto). Either or both of the inner and outer members may include multiple components.

[0012] Examples of resulting distal end movements include (but are not limited to) bending of the distal portion when the EMD is a guidewire or catheter (e.g., Rapid Medical's Columbus, Bendit's Bendit), diameter expansion or contraction of the distal portion in the case of an adjustable stent retriever (e.g., Rapid Medical's Tigertriever), and control of the distal and proximal elements of a stent retriever (e.g., ThrombX Medical's ThrombX retriever) or an adjustable remodeling device (e.g., Rapid Medical's Comaneci, Perflow Medical's Cascade). The inner and outer members can each constitute a separate EMD. Each of these separate EMDs can be connected at its distal portion and selectively manipulated.

[0013] According to one embodiment, the application of the above-described relative motion between an outer member and an inner member disposed within the outer member becomes easier in a robot system. The inner member is, for example, partially disposed within the outer member, with a portion of the inner member extending from one or both ends of the outer member. The relative motion can be linear, rotational, or both. Relative rotational motion is achieved in one embodiment by rotating the proximal end of the outer member and / or the proximal portion of the inner member in different directions and / or at different speeds. Relative linear motion is achieved by moving the proximal portion of the outer member and / or the inner member forward or backward in different directions and / or at different speeds. To rotate the entire EMD without relative rotational motion, both proximal ends of the outer member and the inner member can be rotated in the same direction (i.e., clockwise or counterclockwise) at the same angular velocity. To move the entire EMD forward or backward without relative linear motion, both proximal ends of the outer member and the inner member can be moved in the same direction at the same speed.

[0014] According to one embodiment, relative rotational motion can be easily achieved by providing a rotatable element, such as a gear (but not limited to gears), on the outer surface of one or both of the outer and inner members. The rotatable element can be provided on the outer surface in a position where it can engage with the drive mechanism of the cassette in which the outer or inner member is loaded.

[0015] Relative linear motion is easily achieved by providing a positioning function unit having bearing surfaces at the front and rear on one or both of the outer and inner members. The positioning function unit is positioned to engage with a function unit of the cassette in which the outer or inner member is loaded, and this function unit engages with the bearing surface, causing the outer or inner member to move back and forth as a result of the linear movement of the cassette. In one embodiment, the bearing surface is integrated with or connected to a rotatable element.

[0016] According to one embodiment, the length of the inner member that protrudes from the outer member when the inner member is not receiving the tension to move the distal portion of the EMD is different from the length used for hand-held operations. In particular, according to one embodiment, the length of the inner member is determined such that the distance between the proximal end of the inner member and the proximal end of the outer member is at least as long as the minimum operating distance between the respective mounting mechanism portions of the adjacent cassettes in which the outer member and the inner member are loaded.

[0017] By operating the outer and inner members of such an EMD simultaneously at the same or different speeds, the movement of the distal portion (e.g., bending, expansion, contraction) occurs faster than the movement caused by either operating the outer member with the inner member fixed or operating the inner member with the outer member fixed.

[0018] The robotic system is calibrated with respect to an input device in order to accurately control the tip of the EMD. For example, a 60-degree rotation of the knob of the input device can cause a 60-degree bend, or the input device can be moved so as to accurately correspond to the desired radius of curvature of the distal tip of the EMD. A specific radius of curvature is used to match the vascular radius of curvature in order to hold the device in a specific location (e.g., when treating by moving other devices).

[0019] Tracking of the distal portion of the EMD by an imaging system (e.g., a fluoroscopy system) enables the EMD to be advanced automatically and the distal portion to be bent in order to navigate the EMD to the target without human intervention. If the three-dimensional centerline of the desired vascular path to the target is known, the robotic system can bend the distal tip of the EMD according to a program when advancing the EMD along the vascular path to the target.

[0020] Robotic operation of an EMD generally involves coordinating multiple sequential and / or simultaneous insertion, bending, and / or rotational movements to navigate the EMD, select a vessel, advance through tortuous or narrowed vessels, or stay in a desired path (i.e., avoid entering the wrong side branch). Robotic operation according to one embodiment involves causing the distal tip of the EMD to move in a wave-like motion (with or without rotation, reciprocating rotation, or reciprocating advancement) to reduce friction with the vessel wall, thereby facilitating the advance or reverse movement of the EMD and / or another adjacent or coaxial EMD through tortuous or narrowed vessel regions.

[0021] In one embodiment, the robotic operation of the distal tip of the EMD described herein can be coordinated with other EMDs. For example, the EMD is placed in the lumen of a suction catheter and controlled as described herein to assist in advancing the suction catheter towards the thrombus without causing the thrombus to cross the thrombus and resulting in thrombus fragmentation.

[0022] As explained here, bending the distal tip of the EMD is used to avoid damaging blood vessels, such as when bending the distal tip of the guidewire into a J shape. This prevents the advancing tip from entering side branches and penetrating arteries, which may not be visualized by angiography in the case of NVI. The J shape can also be used as a knuckle for subintimal dissection to move beyond CTO (chronic total occlusion) in coronary artery procedures.

[0023] The relative motion facilitated by one embodiment may be restricted mechanically and / or by software to prevent damage to the blood vessel or the EMD itself. In one embodiment, a sensor is installed in the EMD or a rotational and / or linear motion actuator to measure force, and the measured value is used to limit the magnitude of the force applied to the blood vessel or device. The sensor can measure strain using strain gauges or fiber Bragg grids integrated into the EMD or actuator.

[0024] Figure 1, relating to one embodiment, is a perspective view of a catheter-based treatment system 10. The catheter-based treatment system 10 is used to perform catheter-based medical procedures, such as percutaneous interventional procedures like PCI (e.g., to treat STEMI), NVI (e.g., to treat emergency vascular occlusion (ELVO)), and PVI (e.g., for critical limb ischemia (CLI)). Catheter-based medical procedures may include diagnostic catheter procedures that use one or more catheters or other EMDs to assist in the diagnosis of a patient's disease. For example, in one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected into one or more arteries through a catheter to obtain images of the patient's vascular system while the contrast agent is present.

[0025] Catheter-based medical procedures also include catheter-based therapeutic procedures that use catheters (or other EMDs) to treat diseases (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, thrombectomy, treatment of arteriovenous malformations, treatment of aneurysms, etc.). Therapeutic procedures can be enhanced by using auxiliary devices 54 (shown in Figure 2), such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and fractional flow reserve (FFR). However, anyone with common knowledge in this field will understand that specific percutaneous interventional devices or components (e.g., certain guidewires, certain catheters, etc.) are selected based on the type of procedure to be performed. The catheter-based medical procedure system 10 can accommodate the specific percutaneous interventional devices used in the procedure with minimal adjustment and can perform any catheter-based medical procedure.

[0026] The catheter-based treatment system 10 includes, among many other elements, a bedside unit 20 and a control station 26. The bedside unit 20 includes a robotic drive unit 24 and a positioning system 22 located in close proximity to the patient 12. The patient 12 is laid on a patient table 18. The positioning system 22 is used to position and support the robotic drive unit 24. The positioning system 22 is, for example, a robotic arm, articulated arm, or holder. At one end, the positioning system 22 is attached to, for example, a rail, base, or cart of the patient table 18. The robotic drive unit 24 is attached to the other end of the positioning system 22. The positioning system 22 (together with the robotic drive unit 24) can move the patient 12 so that it can be laid on the patient table 18. After the patient 12 is laid on the patient table 18, the positioning system 22 can be used to fix or position the robotic drive unit 24 relative to the patient 12 for treatment. In one embodiment, the patient table 18 is operably supported by a base 17 fixed to the floor and / or ground. The patient table 18 can move with multiple degrees of freedom relative to the base 17, for example, in roll, pitch, and yaw. The bedside unit 20 may also include control equipment and a display 46 (shown in Figure 2). For example, the control equipment and display may be housed in the housing of a robotic drive unit 24.

[0027] "Front / Forward" refers to the side of the robot drive unit 24 that faces the patient 12 and is farther from the positioning system 22, while "back / rear" refers to the side of the robot drive unit 24 that is closer to the positioning system 22. "Up / upper / upper" refers to the general direction opposite to the direction of gravity, while "down / lower / downward" refers to the general direction in the direction of gravity.

[0028] Generally, the robotic drive unit 24 is equipped with appropriate percutaneous interventional devices and accessories 48 (shown in Figure 2) (for example, EMD including the internal and external members described herein, guidewires, various catheters including balloon catheters, stent delivery systems, stent retrievers, embolization coils, fluid embolization, suction pumps, contrast agents, drug delivery devices, hemostatic valve adapters, syringes, stopcocks, inflation devices, etc.), enabling the operator (user) 11 to perform catheter-based medical procedures using the robotic system by operating various controllers of the control system described herein, such as control equipment and input modules located in the control station 26. The bedside unit 20, and in particular the robotic drive unit 24, includes various components and / or combinations of components to provide the bedside unit 20 with the functions described herein. The operator 11 at the control station 26 is referred to herein as the control station user, control station operator, user, or operator. The operator at the bedside unit 20 is referred to as the bedside unit user or bedside unit operator.

[0029] The robotic drive unit 24 includes a plurality of device modules 32a-d mounted on a rail or linear member 60 (shown in Figure 3). The rail or linear member 60 guides and supports the device modules. Each of the device modules 32a-d can be used to drive an EMD such as a catheter or guidewire. For example, the robotic drive unit 24 can be used to automatically insert a guidewire into a diagnostic catheter and then into a guide catheter in an artery of patient 12. One or more devices, such as EMDs, enter the patient's body (e.g., a blood vessel) at insertion point 16, for example, via an introducer sheath.

[0030] The bedside unit 20 communicates with the control station 26, and signals generated by the control equipment of the control station 26 are transmitted to the bedside unit 20 wirelessly or via a wire, enabling control of various functions of the bedside unit 20, including the functions of the robotic drive unit 24. As will be described later, the control station 26 includes a control computing system 34 (shown in Figure 2) or is connected to the bedside unit 20 via the control computing system 34. The bedside unit 20 can also provide feedback signals (e.g., loading, speed, operating conditions, warning signals, error codes, etc.) to the control station 26, the control computing system 34 (shown in Figure 2), or both. Communication between the control computing system 34 and the various components of the catheter-based treatment system 10 is provided via a communication link, which is a wireless connection, a wired connection, or other means that enables communication between components.

[0031] "Local" is used to refer to the location of the patient 12 and the bedside unit 20. The catheterized treatment system 10 can be operated by a control station 26 at a local site, a control station 26 at a remote site, or both a local and a remote control station 26 simultaneously. At the local site, the operator 11 and the control station 26 are located in the same room as the patient 12 and the bedside unit 20, or in an adjacent room. As used here, the local site is the location of the bedside unit 20 and the patient 12 or subject (e.g., animal or cadaver), and the remote site is the location of the control station 26 and the operator 11 used to remotely control the bedside unit 20. "Remote" is used to refer to a location at the local site that does not have physical access to the bedside unit 20 and / or the patient 12.

[0032] In one embodiment, the remote site and the local (patient) site are separate locations, such as different rooms in the same building, different buildings in the same city, different municipalities, or other locations where the remote site does not have physical access to the bedside unit 20 and / or patient 12 of the local site.

[0033] The control station 26 includes an input module 28 containing a controller configured according to one embodiment to receive user input for controlling various other components or systems of the robotic drive unit 24 and / or catheter-based treatment system 10. In the illustrated embodiment, the control station 26 enables an operator 11 to control the bedside unit 20 to perform catheter-based medical procedures. For example, the input module 28 is configured to cause the bedside unit 20 to perform various tasks using a percutaneous interventional device (e.g., EMD) connected to the robotic drive unit 24 (e.g., advancing, reversing or rotating a guidewire, advancing, reversing or rotating a catheter, inflating or deflating a balloon placed in a catheter, positioning and / or deploying a stent, positioning and / or deploying a stent retriever, positioning and / or deploying a coil, injecting contrast agent into a catheter, injecting a liquid embolization into a catheter, injecting a drug or saline solution into a catheter, aspirating with a catheter, or performing other functions that may be performed as part of a catheter-based medical procedure). The robot drive unit 24 includes various drive mechanisms for operating (e.g., linear and rotational motion) components of the bedside unit 20, including a transcutaneous intervention device, in response to user operation of the controller of the input module 28.

[0034] The input module 28 may include a device selection button, described later, to allow the operator 11 to select which of the percutaneous intervention devices loaded in the robot drive unit 24 to control via user operation of the input controller. An automatic operation button can be used to enable the catheter-based treatment system 10 to perform algorithmic operations that can be executed by the percutaneous intervention device without direct commands from the operator 11.

[0035] The input module 28 may also include a balloon or stent controller configured to instruct the inflation or deflation of a balloon and / or the deployment of a stent. The input module 28 may include one or more dedicated buttons, scroll wheels, joysticks, touchscreens, etc., to instruct the control of one or more specific components. In addition, one or more touchscreens may display one or more icons (not shown) that indicate the relative positions of various components of the input module 28 or the catheter-based treatment system 10. Such one or more touchscreens display a user interface to clarify and / or indicate the configuration of the controllers of the input module 28 and one or more functions, including (but not limited to) linear and / or rotational lock functions.

[0036] The control station 26 includes a display 30. In one embodiment, the control station 26 includes two or more displays 30. The displays 30 are configured to display information or patient-specific data to the operator 11 of the control station 26. For example, the displays 30 are configured to display image data (e.g., X-ray images, MRI images, CT images, ultrasound images, etc.), hemodynamic data (e.g., blood pressure, heart rate, etc.), patient record information (e.g., medical history, age, weight, etc.), lesion or treatment evaluation data (e.g., IVUS, OCT, FFR, etc.). Furthermore, the displays 30 are configured to display information specific to a procedure (e.g., a procedure checklist, recommendations, procedure duration, catheter or guidewire position, amount of drug or contrast agent delivered, etc.). The displays 30 are also configured to display information that provides functions related to the control computing system 34 (shown in Figure 2). The displays 30 may include touchscreen functionality to provide some of the system's user input functions.

[0037] The catheter-based treatment system 10 also includes an imaging system 14. The imaging system 14 is one of several medical imaging systems (e.g., non-digital X-ray, digital X-ray, CT, MRI, ultrasound, etc.) that can be used in conjunction with the catheter-based medical treatment. In one embodiment, the imaging system 14 is a digital X-ray imaging device that communicates with a control station 26. In one embodiment, the imaging system 14 includes a C-arm (shown in Figure 1) that allows the imaging system 14 to rotate partially or completely around the patient 12 to obtain images at different angular positions relative to the patient 12 (e.g., sagittal, caudal, anterior-posterior, etc.). In one embodiment, the imaging system 14 is a fluoroscopy system including a C-arm having an X-ray source 13 and a detector 15, also known as an image intensifier.

[0038] The imaging system 14 can be configured to acquire X-ray images of appropriate areas of the patient 12 during the procedure. For example, the imaging system 14 can be configured to acquire one or more X-ray images of the head to diagnose a neurovascular condition. The imaging system 14 can also be configured to acquire one or more X-ray images (e.g., real-time images) during catheter-based medical procedures to assist the operator 11 of the control station 26 in properly positioning the guidewire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, etc. One or more images are displayed on the display 30. For example, images may be displayed on the display 30 so that the operator 11 can accurately move the guide catheter or guidewire to the appropriate position.

[0039] To clarify the direction, a Cartesian coordinate system was introduced with X, Y, and Z axes. The positive X-axis represents the distal direction in the longitudinal direction (axial direction), that is, the direction from the proximal end to the distal end, or in other words, the direction from proximal to distal. The Y and Z axes lie within the intersecting plane with respect to the X-axis, with the positive Z-axis pointing upward, i.e., in the opposite direction to gravity, and the Y-axis being automatically determined by the right-hand rule.

[0040] Figure 2, relating to one embodiment, is a block diagram of a catheter-based treatment system 10. The catheter-based treatment system 10 includes a control computing system 34. The control computing system 34 may be physically part of, for example, a control station 26 (shown in Figure 1). Broadly speaking, the control computing system 34 consists of a computer processing unit suitable for providing a catheter-based treatment system 10 with the various functions described herein. For example, the control computing system 34 may be an implantable system, a dedicated circuit, or a general-purpose system programmed with the functions described herein. The control computing system 34 communicates with a bedside unit 20, a control station 38, an additional communication system 40 (e.g., a telepresence system), 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.).

[0041] The control computing system 34 also communicates with the imaging system 14, the patient table 18, additional medical systems 50, the contrast agent injection system 52, and auxiliary devices 54 (e.g., IVUS, OCT, FFR, etc.). The bedside unit 20 includes a robotic drive unit 24, a positioning system 22, and additional control equipment and displays 46. As described above, the additional control equipment and displays can be located in the housing of the robotic drive unit 24. Interventional devices and accessories 48 (e.g., guidewires, catheters, etc.) are connected to the bedside system 20. In one embodiment, the interventional devices and accessories 48 include specialized devices (e.g., EMD including the internal and external members described herein, IVUS catheters, OCT catheters, FFR wires, contrast-enhanced diagnostic catheters, etc.), and such specialized devices are connected to their respective auxiliary devices 54, i.e., IVUS systems, OCT systems, and FFR systems, etc.

[0042] In one embodiment, the control computing system 34 is configured to receive and generate control signals based on user operations of the controllers of the input module 28 of the control station 26, and / or to receive and generate control signals based on information accessible to the control computing system 34, thereby enabling the execution of medical procedures using the catheter-type treatment system 10.

[0043] The catheter-based treatment system 10 may be connected to or configured to include any other systems and / or devices, although this is not explicitly stated. For example, the catheter-based treatment system 10 may include an image processing engine, a data storage and archiving system, an automated balloon and / or stent inflation system, a drug infusion system, a drug tracking and / or logging system, a user log, an encryption system, and a system that restricts access to or use of the catheter-based treatment system 10.

[0044] Figure 3, relating to one embodiment, is a perspective view of the robot drive unit 24 of the catheter-type treatment system 10. The embodiment is not limited to the robot drive unit 24 of Figure 3. The robot drive unit 24 of Figure 3 includes a plurality of drive modules 32a-d connected to a linear member 60. Each of the drive modules 32a-d is connected to the linear member 60 via a stage 62a-d that is operably mounted to the linear member 60. Each individual drive module 32a-d is connected to the stage 62a-d using a connector such as an offset bracket 78a-d. In another embodiment, the drive modules 32a-d are directly mounted to the stage 62a-d.

[0045] Each stage 62a-d can be operated individually to move linearly along the linear member 60. Thus, each stage 62a-d (and the corresponding drive modules 32a-d connected to the stages 62a-d) can operate individually relative to each other and to the linear member 60. A drive mechanism is used to operate each stage 62a-d. In the embodiment shown in Figure 3, the drive mechanism has individual stage translation motors 64a-d connected to each stage 62a-d and the stage drive mechanism 76, where the stage drive mechanism 76 is, for example, a lead screw via a rotating nut, a rack via a pinion, a belt via a pinion or pulley, or a chain via a sprocket. Alternatively, the stage translation motors 64a-d themselves can be linear motors. In one embodiment, the stage drive mechanism 76 can also be a combination of these mechanisms, for example, different types of stage drive mechanisms can be used for each stage 62a-d. In an embodiment where the stage drive mechanism consists of a lead screw and a rotating nut, the lead screw can be rotated and each stage 62a-d can be engaged or disengaged with the lead screw to move, for example, forward or backward. In the embodiment shown in Figure 3, the stages 62a-d and the drive module 32a-d are configured as a tandem drive.

[0046] Each drive module 32a-d includes a device module 68a-d and a cassette 66a-d mounted on and connected to the device module 68a-d. In the embodiment shown in Figure 3, each cassette 66a-d is mounted on the device module 68a-d in the vertical direction. In other embodiments, each cassette 66a-d may be mounted on the device module 68a-d in a different mounting direction. Each cassette 66a-d is configured to connect to and support the proximal portion of the EMD (not shown). Each cassette 66a-d may also include elements that provide one or more degrees of freedom in addition to the linear motion provided by the operation of the corresponding stage 62a-d to move linearly along the linear member 60. For example, the cassette 66a-d may include elements used to rotate the EMD when the cassette is connected to the device module 68a-d.

[0047] Each device module 68a-d includes at least one coupler to provide a drive interface to the mechanism within each cassette 66a-d to provide further degrees of freedom. Each cassette 66a-d also includes a channel in which device supports 79a-d are arranged, and each device support 79a-d is used to prevent buckling of the EMD. Support arms 77a, 77b, and 77c are attached to each drive module 32a, 32b, and 32c, respectively, providing fixed points to support the proximal ends of the device supports 79b, 79c, and 79d, respectively. The robot drive unit 24 also includes a device support 79, a distal support arm 70, and a device support connector 72 connected to the support arm 77o. The support arm 77o is used to provide a fixed point to support the proximal end of the most distal device support 79a housed in the most distal drive module 32a. Furthermore, the introducer interface support (redirector) 74 can be connected to the device support connection section 72 and the EMD (e.g., introducer sheath). This configuration of the robot drive unit 24 has the advantage of reducing the size and weight of the robot drive unit 24 by using an actuator with a single linear member.

[0048] To prevent contamination of patients with pathogens, healthcare staff employ aseptic techniques in the bedside unit 20 and the room housing the patient 12 or subject (shown in Figure 1). The bedside unit 20 and the room housing the patient 12 are, for example, a catheterization laboratory or angiography suite. The aseptic techniques consist of using sterile barriers, sterile instruments, proper patient preparation, environmental control, and contact guidelines. For this reason, all EMD and interventional equipment are sterilized and permitted to come into contact only with either sterile barriers or sterile instruments. In one embodiment, an unsterilized robotic drive unit 24 is covered with a sterile drape (not shown). Each cassette 66a-d is sterilized and acts as a sterile interface between the draped robotic drive unit 24 and at least one EMD. Each cassette 66a-d may be designed to be sterilized for single use, or it may be designed to be re-sterilized in whole or in part so that the cassette 66a-d or its components can be used in multiple procedures.

[0049] As used herein, "cassette" broadly refers to a component of a robotic drive system that includes components for supporting and operating (e.g., rotation and / or translation) at least one EMD. "Device module" broadly refers to a component of a robotic drive system that includes one or more motors having drive couplers that interface with the EMD actuating elements of the cassette. The cassette provides a sterile interface between at least one EMD and the device module, either directly or via a device adapter. "Drive module" refers to the combination of the device module and the cassette.

[0050] In one embodiment, the EMD is a catheter having a hub at its proximal end and a flexible shaft centrifugal from the hub toward the distal end of the catheter, wherein the shaft is more flexible than the hub. In one embodiment, the catheter includes an intermediate portion connecting the hub and the shaft, and this intermediate portion has intermediate flexibility, being softer than the hub and harder than the shaft. In one embodiment, the intermediate portion is a strain relief.

[0051] The longitudinal axis (vertical axis, longitudinal direction axis) of a component (for example, an EMD or other element in a catheter-based treatment system) is a line or axis along the length of the component that passes through the center of the component's cross-section in the direction from the proximal portion of the component to the distal portion of the component. For example, the longitudinal axis of a guidewire is the central axis in the direction from the proximal portion of the guidewire to the distal portion of the guidewire, even if the guidewire is not a straight line in the relevant portion.

[0052] Linear motion of a component refers to the translation (parallel movement) of the component along its longitudinal axis. For example, when the distal end of an EMD is moved linearly distally along its longitudinal axis into or further into the patient, the EMD is moving forward. When the distal end of an EMD is moved linearly proximal along its longitudinal axis outward from or further outward from the patient, the EMD is being withdrawn.

[0053] In this regard, linear insertion refers to inserting a first component into a second component along its longitudinal axis. For example, an EMD linearly loaded into a collet is linearly inserted into the collet. An example of linear insertion is back-loading a catheter into the proximal end of a guidewire. Lateral insertion means inserting a first component into a second component along a direction in a plane intersecting the longitudinal axis of the second component. Lateral insertion may also be called radial loading or lateral loading.

[0054] Rotational motion of a component refers to a change in the angular direction of the component around its longitudinal axis. For example, the rotational motion of an EMD corresponds to the clockwise or counterclockwise rotation of the EMD around its longitudinal axis due to the applied torque. Continuous motion refers to uninterrupted motion that does not require a reset, while discrete motion refers to interrupted motion that requires a reset.

[0055] "Distal" and "proximal" define the relative positions of two different parts. In the context of robotic drive systems, "distal" and "proximal" are defined by the position of the robotic drive system relative to the patient in its intended use.

[0056] When used to define relative position, the distal portion is the part of the robotic drive that is closer to the patient than the proximal portion when the robotic drive is in its intended position. Within the patient, vascular landmarks that are further away along the path from the access point are distal to landmarks closer to the access point. The access point is the point where the EMD enters the patient. Similarly, the proximal portion is the part of the robotic drive that is further from the patient than the distal portion when the robotic drive is in its intended position.

[0057] When used to define direction, the distal direction refers to the path something is moving or intending to move, or the path something is aiming for or facing, from the proximal part toward the distal part and / or toward the patient, when the robot drive is in the intended position. The proximal direction is the opposite direction of the distal direction. For example, referring to Figure 1, the robot drive is shown from the viewpoint of an operator facing the patient. In this configuration, the distal direction is the direction of the positive X-axis, and the proximal direction is the direction of the negative X-axis.

[0058] Regarding the operation of the module, referring to Figure 3, the EMD moves distally in a path toward the patient through the introducer interface support 74 which defines the distal end of the robot drive unit 24. The proximal end of the robot drive unit 24 is the point furthest from the distal end in the negative X-axis direction.

[0059] Regarding the positions of the individual modules, referring again to Figure 3, the most distal drive module is drive module 32a, which is closest to the distal end of the robot drive unit 24. The most proximal drive module is drive module 32d, which is located furthest from the distal end of the robot drive unit 24 in the negative X-axis direction. The relative positions of the drive modules are determined by their relative positions to the distal end of the robot drive unit. For example, drive module 32b is distal to drive module 32c.

[0060] With respect to the distal / proximal portions, regions, or ends of the EMD or robotic drive unit, the portions of cassette 66a and device module 68a are defined by their relative positions to the distal end of the robotic drive unit. For example, when the cassette is in the use position of device module 68a, the distal end of cassette 66a is the portion of the cassette closest to the distal end of the robotic drive unit, and the proximal end of cassette 66a is the portion of the cassette furthest from the distal end of the robotic drive unit in the negative X-axis direction. In other words, the distal end of cassette 66a is the portion of the cassette closest to the path from the EMD to the patient when in use.

[0061] As previously described, embodiments of the control station 26 may include various different input modules for controlling the bedside unit 20. The input modules may include various input controllers (e.g., buttons, scroll wheels, joysticks, etc.) that a user can operate to control (or direct) the operation of the robot drive unit 24. These input controllers may be arranged in various layouts or patterns within the input module to facilitate the necessary functions and their coordination prioritization to perform desired tasks that require the individual (and sometimes simultaneous) operation of multiple EMDs and / or the individual (and sometimes simultaneous) operation of separate parts of one EMD, as described herein.

[0062] Figures 4A and 4B are perspective views of the EMD400 used in one embodiment. The embodiment is not limited to the EMD400. The EMD400 includes an inner member 410 positioned inside an outer member 420. The distal portion 412 of the inner member 410 is connected to the distal portion 422 of the outer member 420. The “connection” in this case includes, but is not limited to, any attachment method including welding, ultrasonic welding, thermal bonding, adhesive bonding, molding, etc. The “connection” may occur on any surface facing the distal ends of the inner member 410 and the outer member 420. The distal portion 412 of the inner member is shown to be substantially flush with the distal end of the outer member 420, however, in one embodiment, the distal portion of the inner member 410 may extend beyond the distal end of the outer member 420. The proximal portion of the inner member 410 extends beyond the proximal end of the outer member 420 in one embodiment. This portion of the inner member 410 is connected to and operated by an actuated element that extends beyond the proximal end of the outer member 420.

[0063] Each of the inner member 410 and the outer member 420 is linearly movable in the proximal and distal directions and rotatable clockwise and counterclockwise. Linear motion allows for longitudinal relative motion between these members. This relative motion and the connection of the distal portions of these members cause bending of the distal ends, as is well known in the art. In one embodiment, the inner member 410 and the outer member 420 are configured to also be able to rotate relative to each other, or alternatively, to be able to rotate relative to each other. Such rotational motion can cause bending or other deformation of the distal ends of these members.

[0064] As is well known in the art, at least one of the inner member 410 and the outer member 420 can have slots formed to increase flexibility toward the distal end of the member and improve operability. The degree of flexibility is determined by the number of slots, the spacing between slots, the shape of the slots, the angles defined by the slots, the thickness of the material, and other factors. In one embodiment, the desired flexibility is achieved by using a flexible material that acts as a substitute for such slotted portions and a rigid reinforcing material that acts as a substitute for non-slotted portions.

[0065] In one embodiment, the inner member 410 and the outer member 420 are formed from appropriately flexible and suitable biocompatible materials (e.g., stainless steel (e.g., AISI 316), nitinol, cobalt-chromium alloy, nickel-titanium alloy, etc.), plastics (e.g., nylon, polypropylene, and many others), or combinations thereof. The composition of the inner member 410 may be different from that of the outer member 420. Either or both of the inner member 410 and the outer member 420 may comprise machined parts and / or component assemblies.

[0066] In one embodiment, the inner member 410 defines a lumen along its entire length, and this lumen may define a lumen along the entire length of the EMD. During treatment, fluid can be injected into the lumen from the proximal end of the inner member 410. Fluid and material can also be extracted (e.g., aspirated) from the vascular system through the lumen. A connector, such as a Luer connector, may be connected to the proximal end of the inner member 410. Such a connector facilitates a proper fluid-tight connection between the lumen and an injection / aspiration / other system, such as a syringe, hemostatic valve, tubing, or other device (but not limited to these).

[0067] Figure 5, relating to one embodiment, is a perspective view of the EMD500 configured for robot operation. As described with respect to the EMD400, the EMD500 includes an inner member 510 positioned inside an outer member 520, the distal portions of these members being connected so as to bend in response to relative motion. The inner member 510 and outer member 520 of the EMD500 may exhibit any of the characteristics described above with respect to the EMD400 in Figures 4A and 4B.

[0068] The inner member 510 and the outer member 520 are movable relative to each other in the longitudinal direction. In one embodiment, the inner member 510 and the outer member 520 are configured to also be able to rotate relative to each other, or alternatively, to be able to rotate relative to each other. The relative movement and the connection of the distal portions of these members cause bending and / or other deformation of the distal ends.

[0069] The operable elements 515 and 525 are, respectively, Inner member 510 and outer member It is attached to 520. Each of the operable elements 515 and 525 is, in one embodiment, individually drivable and rotates the member / tube on which it is attached. This rotation can result in a relative rotational motion between the inner member 510 and the outer member 520.

[0070] Advantageously, rotating the inner member 510 and the outer member 520 in opposite directions can cause a relative rotation of a certain magnitude faster than rotating only one of the inner member 510 or the outer member 520, assuming the same rotational speed. Nevertheless, as described below, in one embodiment, it is possible to rotate either the inner member 510 or the outer member 520, in which case the other is fixed to prevent its own rotation. In such an embodiment, the actuation element for rotational movement can be omitted from the inner / outer member whose rotation is fixed relative to the other.

[0071] The rotatable portions of the actuable elements 515, 525 are illustrated as gear teeth, but the embodiments are not limited thereto. In one embodiment, one or both of the actuable elements 515, 525 consist of a pulley or O-ring with a surface that frictionally engages with a drive device, such as a belt. In one embodiment, the rotatable element is not connected to the inner member 510 and the outer member 520, and the drive element is used to impart rotation to the inner member 510 and / or the outer member 520 by contacting the surface of the inner member 510 and / or the outer member 520. The embodiments are not limited to one rotatable element per member / tube.

[0072] Each of the actuated elements 515, 525 includes linear actuated portions 516, 517 and 526, 527 for linearly moving the corresponding inner member 510 and outer member 520. For example, if the portion of the cassette in which the inner member 510 is loaded can engage with portion 516 when the cassette moves proximal, and as a result the longitudinal position of the outer member 520 remains fixed, the inner member 510 is pulled out from the outer member 520. Conversely, if the portion of the cassette in which the inner member 510 is loaded can engage with portion 517 when the cassette moves distal, and as again assumed that the longitudinal position of the outer member 520 remains fixed, the inner member 510 moves forward into the outer member 520.

[0073] The portion of the cassette in which the outer member 520 is loaded can engage with portion 526 when the cassette moves proximally, resulting in proximal movement of the inner member 510, while the portion of the cassette can engage with portion 527 when the cassette moves distally, resulting in distal movement of the outer member 520. Using either of these linear movements, the relative longitudinal relationship between the inner member 510 and the outer member 520 can be changed.

[0074] In one embodiment, a guide wire torquer (pin vise) or collet mounted on the inner member 510 is used as a linearly and / or rotatably movable element to facilitate the linear and / or rotational movement of the inner member 510. In one embodiment, the linearly and / or rotatably movable element is connected to the guide wire torquer (pin vise) or collet mounted on the inner member 510.

[0075] The embodiments are not limited to a single actuated element that includes a portion providing rotational and linear motion. Nor are the embodiments limited to rotational and linear motion of both the inner member 510 and the outer member 520. For example, each of the inner member 510 and the outer member 520 may be coupled to one or more robot-driveable actuated elements to cause its rotation, or not be coupled to one or more robot-driveable actuated elements to cause its linear motion, or not be coupled to one or more robot-driveable actuated elements. As illustrated below, rotational and / or linear actuated elements may be coupled to any suitable location on either the inner member 510 and / or the outer member 520.

[0076] Figure 6, relating to one embodiment, is a schematic diagram of the robot operation of the EMD. The outer member 520 is loaded into the cassette 620 of the robot catheter system, as described above with respect to the cassettes 66a-66d of the robot drive unit 24. As previously described, the mechanism within the cassette 620 is driven by a drive module. The drive of this mechanism drives the operable element 525, which rotates the outer member 520 relative to the inner member 510. In the embodiment of Figure 6, the cassette 620 can move linearly so that the outer member 520 moves linearly relative to the inner member 510.

[0077] Figure 7, relating to one embodiment, is a schematic diagram of the robot operation of the EMD. The inner member 510 is loaded into the cassette 710 of the robot catheter system so that the mechanism of the cassette 710 drives the actuariable element 515 to rotate the inner member 510 relative to the outer member 520. The cassette 710 can move linearly so as to move the inner member 510 linearly relative to the outer member 520.

[0078] Figure 8, relating to one embodiment, is a schematic diagram of the robot operation of the EMD. The outer member 520 is loaded into the cassette 820 of the robot catheter system, and when the mechanism of the cassette 820 is driven, it drives the operable element 525 to rotate the outer member 520 relative to the inner member 510. In the embodiment of Figure 8, the cassette 810 moves linearly, causing the inner member 510 to move linearly relative to the outer member 520.

[0079] The inner member 510 shown in Figure 9 is loaded into the cassette 910 of the robot catheter system so that the mechanism of the cassette 910 can drive the actuariable element 515 to rotate the inner member 510 relative to the outer member 520. The cassette 920 can move linearly so as to move the outer member 520 linearly relative to the inner member 510.

[0080] Figure 10 illustrates the inner member 510 loaded in cassette 1010 and the outer member 520 loaded in cassette 1020. Each of cassettes 1010 and 1020 includes a mechanism for driving their respective actuaries 515 and 525, as described above with respect to Figure 5. Each of cassettes 1010 and 1020 moves linearly in the proximal and distal directions, allowing the inner member 510 and the outer member 520 to move relative to each other. The linear motion described herein is achieved by a portion of the cassette that engages with a corresponding portion of a linearly actuated element connected to each of the inner member 510 or the outer member 520, as described above with respect to Figure 5. In one embodiment, the portion of the cassette includes a portion that holds the inner member 510 or the outer member 520 fixed to the cassette when the cassette moves linearly.

[0081] As described above, the relative linear and / or rotational motion of the inner and outer members of the EMD can produce a desired action at the distal portion of the members. One embodiment receives an operator command and is activated to perform a desired action (e.g., bending the tip by a certain amount, inflating the thrombectomy device), and in response controls motors attached to each of two cassettes that support the inner and outer members, respectively, causing the inner and outer members to move linearly and / or rotationally to produce the necessary relative motion between the inner and outer members to produce the desired action.

[0082] Figure 11 illustrates cassettes 1110 and 1120 of robotic drive units positioned close together, as made possible by the robotic drive unit. Such an arrangement determines the minimum length of the proximal portion of the inner member 510 extending from the outer member 520. This length should be sufficient to allow the inner member to be loaded into cassette 1110. Such a requirement necessitates increasing the length of the inner member 510 with respect to commercially available maneuverable catheters that include an inner member and an outer member.

[0083] Figures 12 and 13, relating to one embodiment, illustrate different examples of the positions in which the rotatable elements 515 and 525 are connected to the inner member 510 and the outer member 520. As described above, none or one or more operable elements can be connected to any location on the inner member 510 and / or the outer member 520. The operable elements are connected in a manner that facilitates engagement with the corresponding drive elements of the cassettes 1210, 1220, 1310, and 1320.

[0084] Figure 14 is a perspective view and Figure 15 is an exploded view showing one embodiment of an operable element assembly 158 connected to an inner member 122 having a lumen. The gear 160 of the operable element assembly 158 engages with the drive member 58 of the cassette, rotatably connecting the assembly 158 to the inner member 122. This configuration forms a liquid-tight rotating seal with the male Luer connector 41 of the rotating element 40, creating a continuous fluid path from the hemostatic valve 176 to the lumen of the inner member 122. If the inner member 122 does not have a lumen, the hemostatic valve 176 and the Luer connector may be omitted.

[0085] The gear 160 of the operable element assembly 150 is driven by the drive gear 58, imparting rotation to the inner member 122, while the body of the hemostatic valve 176 is separated from the rotational movement, preventing the position of the second leg 178 of the hemostatic valve 176 from rotating when the inner member 122 rotates. The bracket 190 interacts with the groove 182 to support the rotating assembly 158 and is fixed to either the base 32 or the wall 74. The hemostatic valve 176 is supported by the bracket 192, which is fixed to either the base 32 or the wall 74. The brackets 190,192 provide stability to the longitudinal axis 50 of the hemostatic valve 176 and also function as a part that causes linear movement of the inner member 122 when the cassette on which the brackets 190,192 are arranged moves linearly.

[0086] Computer-executable program code that controls the catheter-based treatment system or displays the user interface described herein is stored in a non-temporary computer-readable medium. Computer-readable medium includes volatile and non-volatile, removable and non-removable media implemented by any method or technique for storing information such as computer-readable instructions, data structures, program modules, or other data. Computer-readable medium includes, but is not limited to, random access memory (RAM), read-on memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory, or other memory technologies, compact disk ROM (CD-ROM), digital general-purpose disk (DVD), or other optical storage, magnetic cassettes, magnetic tapes, magnetic disk storage, or other magnetic storage devices, or any other medium that can be used to store a given instruction and is accessible by System 10 (shown in Figure 1), including via the Internet or other accessible computer network.

Claims

1. An EMD comprising an outer member defining a lumen and an inner member defining a lumen, wherein the inner member is positioned in the lumen of the outer member and connected to the distal portion of the outer member, and the lumen of the inner member can be used as a fluid passage, A linearly movable element attached to one of the outer member and the inner member, A system comprising: a first cassette into which one of the outer member and the inner member having the linearly operable element can be loaded, and which moves linearly in response to a first command, A system wherein the linear motion of the first cassette engages with one of the linearly operable elements of the loaded outer member and inner member, causing one of the outer member and inner member to move, thereby generating relative linear motion between the outer member and the inner member, and this relative linear motion causes deformation in the connected distal portion of the outer member and the inner member.

2. A second linearly operable element attached to the other of the outer member and the inner member, The present invention further includes a second cassette into which the other of the outer member and the inner member, which have the second linearly operable element, can be loaded, and which moves linearly in response to a second command, The system according to claim 1, wherein the linear motion of the second cassette causes a portion of the second cassette to engage with the second linearly operable element of the other of the loaded outer member and the inner member, thereby moving the other of the outer member and the inner member, and generating a second relative linear motion between the outer member and the inner member, the second relative linear motion causing deformation in the connected distal portion of the outer member and the inner member.

3. The present invention further includes a rotatably operable element attached to one of the outer member and the inner member, The system according to claim 2, wherein the first cassette includes a first drive element that drives one of the rotatably actuated elements of the loaded outer member and the inner member in response to a third command, the driving of the rotatably actuated element by the first drive element causes a relative rotational movement between the outer member and the inner member, and the relative rotational movement causes deformation in the connected distal portions of the outer member and the inner member.

4. The present invention further includes a second rotatably operable element attached to the other of the outer member and the inner member, The system according to claim 3, wherein the second cassette includes a second drive element that drives the other second rotatably actuated element of the loaded outer member and inner member in response to a fourth command, the driving of the second rotatably actuated element by the second drive element causing a second relative rotational movement between the outer member and the inner member, the second relative rotational movement causing deformation in the connected distal portion of the outer member and the inner member.

5. The system according to claim 3, wherein the linearly operable element and the rotationally operable element are composed of a single element including a linearly operable portion and a rotationally operable portion.

6. A rotatably operable element attached to the other of the outer member and the inner member, A second cassette further includes, which is capable of loading the other of the outer member and the inner member having the rotatably operable element, and which has a drive element that drives the rotatably operable element of the loaded outer member and the other of the inner member in response to a second command, thereby causing a relative rotational movement between the outer member and the inner member, by rotating the other of the outer member and the inner member. The system according to claim 1, wherein the relative rotational motion by the second cassette causes deformation in the distal portion where the outer member and the inner member are connected.

7. The present invention further includes a second rotatably operable element attached to one of the outer member and the inner member, The system according to claim 6, wherein the first cassette includes a second drive element that drives one of the second rotatably actuated elements of the loaded outer member and inner member in response to a third command, the driving of the second rotatably actuated element by the second drive element causing a relative rotational movement between the outer member and the inner member, the relative rotational movement causing deformation in the connected distal portions of the outer member and the inner member.

8. The system according to claim 7, wherein the linearly operable element and the second rotationally operable element are composed of a single element including a linearly operable portion and a rotationally operable portion.

9. The EMD receives a command to control the tip portion, which includes an outer member defining the lumen and an inner member defining the lumen. The inner member is positioned within the lumen of the outer member and connected to the distal portion of the outer member, and the lumen of the inner member can be used as a fluid passage. In response to the command, the first device module of the robot drive unit is controlled to move a first cassette containing one of the outer member and the inner member, which is fitted with a linearly movable element, in a linear motion, and the portion of the first cassette is engaged with the linearly movable element attached to one of the outer member and the inner member, thereby moving one of the outer member and the inner member, and thereby generating a relative linear motion between the outer member and the inner member. A method comprising causing deformation in the distal portion of the outer member and the inner member connected by the relative linear motion.

10. In response to the command, the second device module of the robot drive unit is controlled to drive a rotatable element attached to the other of the outer member and the inner member to rotate the other of the outer member and the inner member, thereby causing a relative rotational movement between the outer member and the inner member. The method according to claim 9, further comprising causing deformation in the distal portion of the outer member and the inner member to be connected by the relative rotational motion.

11. In response to the command, the first device module is controlled to drive a rotatably operable element attached to one of the outer member and the inner member to rotate the one of the outer member and the inner member, thereby causing a relative rotational movement between the outer member and the inner member. The method according to claim 9, further comprising causing deformation in the distal portion of the outer member and the inner member to be connected by the relative rotational motion.

12. The method according to claim 11, wherein the linearly operable element and the rotationally operable element are composed of a single element including a linearly operable portion and a rotationally operable portion.

13. In response to the command, the second device module of the robot drive unit is controlled to drive a second rotatably operable element mounted on the other of the outer member and the inner member, thereby causing the other of the outer member and the inner member to rotate, and thereby generating a relative rotational movement between the outer member and the inner member. The method according to claim 11, further comprising causing deformation in the distal portion of the outer member and the inner member to be connected by the relative rotational motion.

14. In response to the command, the second device module is controlled to linearly move the second cassette, which is loaded with the other of the outer member and the inner member, to which the second linearly movable element is attached, and the portion of the second cassette is engaged with the second linearly movable element attached to the other of the outer member and the inner member, thereby moving the other of the outer member and the inner member, and thereby generating relative linear motion between the outer member and the inner member. The method according to claim 13, further comprising causing deformation in the distal portion of the outer member and the inner member connected by the relative linear motion.

15. The linearly operable element and the rotationally operable element are composed of a single first element including a linearly operable portion and a rotationally operable portion. The method according to claim 14, wherein the second linearly operable element and the second rotationally operable element are comprised of a single second element including a second linearly operable portion and a second rotationally operable portion.

16. A system for controlling the tip of an EMD, Including EMD and robot drive unit, The aforementioned EMD is An outer member defining the lumen and an inner member defining the lumen, Includes linear and rotationally operable elements mounted on the inner member, The inner member is positioned in the lumen of the outer member and connected to the distal portion of the outer member, and the lumen of the inner member can be used as a fluid passage. The robot drive device is It includes multiple device modules, a first cassette, and a second cassette. Each of the aforementioned plurality of device modules is capable of linear motion independently by its respective drive module. The first cassette is connected to one of the plurality of device modules, and is capable of loading the inner member having the linear and rotationally operable elements, and is configured to have a portion of the loaded inner member that can engage with the linear and rotationally operable elements, The second cassette is connected to one of the second of the plurality of device modules and is capable of loading the outer member. A system in which the operation of the linear and rotationally operable elements of the inner member according to the portion of the first cassette causes relative linear motion and / or rotational motion between the inner member and the outer member, and this relative linear motion and / or rotational motion can cause deformation in the connected distal portion of the inner member and the outer member.

17. The system according to claim 16, wherein the linearly and rotationally operable elements include a linearly operable portion and a rotationally operable portion.

18. The EMD further includes a second linear and rotationally operable element mounted on the outer member, The second cassette is capable of loading the outer member having the second linear and rotationally operable element, and is configured to have a portion of the loaded outer member that can engage with the second linear and rotationally operable element. The system according to claim 16, wherein the operation of the second linear and rotationally operable element of the outer member according to the portion of the second cassette causes relative linear motion and / or rotational motion between the outer member and the inner member, and the relative linear motion and / or rotational motion can cause deformation in the connected distal portion of the outer member and the inner member.

19. The linearly and rotationally operable element includes a linearly operable portion and a rotationally operable portion, The system according to claim 18, wherein the second linearly and rotationally operable element includes a second linearly operable portion and a second rotationally operable portion.

20. The portion of the first cassette is configured to drive and rotate the linear and rotationally operable elements, The system according to claim 18, wherein the portion of the second cassette is configured to drive the second linear and rotary operable element and to rotate it independently of the rotation of the linear and rotary operable element.

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