Torque limiting actuator for Torque Cars in elongated medical devices

Abstract

This relates to the field of robotic medical treatment systems, specifically to the Torker, a long, slender medical device. [Solution] A device for operating an elongated medical device (EMD) is provided, which includes a torque limiting actuator that releasably secures the elongated medical device and limits the torque applied to the torquer.

Description

Technical Field

[0001] [Cross - reference to Related Patent Applications] This application claims the priority of U.S. Provisional Application No. 63 / 476,397, filed on December 21, 2022. The entire disclosure of this application is incorporated herein by reference.

[0002] Broadly speaking, the present invention relates to the field of robotic medical treatment systems, and more specifically to the torque of elongated medical devices.

Background Art

[0003] Catheters and other elongated medical devices (EMDs) are used in minimally invasive medical procedures for the diagnosis and treatment of various vascular diseases, including neurovascular interventions (NVI), percutaneous coronary interventions (PCI), and peripheral vascular interventions (PVI), also known as nerve intervention surgeries. These procedures typically involve navigating a guidewire through the vascular system and using this guidewire to advance a catheter and perform the treatment. Catheterization begins with obtaining access to the appropriate vessel, such as an artery or vein, using an introducer sheath via a standard percutaneous technique. Through the introducer sheath, the sheath or guidecatheter is then advanced through a diagnostic guidewire to a primary location, such as the internal carotid artery in the case of NVI, the coronary orifice in the case of PCI, or the superficial femoral artery in the case of PVI. Subsequently, a guidewire appropriate for the vascular system is navigated through the sheath or guidecatheter to the target location within the vascular system. In certain situations, such as tortuous anatomical structures, a support catheter or microcatheter is inserted through the guidewire to assist in the navigation of the guidewire. The physician or operator can use an imaging system (e.g., a fluoroscopy device) to acquire cine images from contrast agent injection and select a fixed frame to use as a roadmap for navigating the guidewire or catheter to a target location, such as a lesion. Contrast images are also acquired as the physician is advancing the guidewire or catheter, allowing the physician to confirm that the device is moving along the correct path to the target location. While observing the anatomical structure using fluoroscopy, the physician manipulates the proximal end of the guidewire or catheter to direct its distal tip to the appropriate vessel leading to the anatomical location of the lesion or target, avoiding entry into side branches.

[0004] Robot-assisted catheter-based treatment systems have been developed that can be used to assist physicians performing catheter-based procedures such as NVI, PCI, and PVI. Examples of NVI procedures include coil embolization of aneurysms, fluid embolization of arteriovenous malformations, and mechanical thrombectomy of large vessel occlusion in acute ischemic stroke. In NVI procedures, physicians use a robotic system to gain access to the target lesion and restore normal blood flow by controlling the manipulation of a neurovascular guidewire and microcatheter. Target access is made possible by a sheath or guide catheter, but an intermediate catheter may be required for more distal areas or to provide proper support for the microcatheter and guidewire. The distal tip of the guidewire is navigated into or beyond the lesion, depending on the type of lesion and treatment. When treating an aneurysm, the microcatheter is advanced into the lesion, the guidewire is removed, and several embolic coils are placed in the aneurysm through the microcatheter to block blood flow into the aneurysm. When treating arteriovenous malformations, a fluid embolization is injected into the malformation via a microcatheter. Mechanical thrombectomy to treat vascular occlusion can be achieved by aspiration, the use of a stent retriever, or both. Depending on the location of the thrombus, aspiration is performed via an aspiration catheter or, in the case of small arteries, via a microcatheter. Once the aspiration catheter enters the lesion, negative pressure is applied to push the catheter through and remove the thrombus. Alternatively, the thrombus can be removed by deploying a stent retriever through a microcatheter. Once the stent retriever has entangled the thrombus, it is retrieved by drawing the stent retriever and microcatheter (or intermediate catheter) into a guide catheter.

[0005] In PCI, physicians use a robotic system to gain access to the lesion by manipulating a coronary artery guidewire, perform treatment, and restore normal blood flow. Access is achieved by seating the guide catheter at the coronary artery ostium. The distal end of the guidewire is navigated beyond the lesion, and in the case of complex anatomical structures, a microcatheter can be used to properly support the guidewire. Blood flow is restored by introducing and deploying a stent or balloon into the lesion. In some cases, preparation of the lesion may be required before stent placement, in which case a balloon is introduced for pre-dilation of the lesion, or an atherectomy is performed, for example, using a laser or a rotational atherectomy catheter and balloon via the guidewire. Imaging and physiological measurements may also be performed using imaging catheters or fractional flow reserve (FFR) measurements to determine the appropriate treatment.

[0006] In PVI, physicians use a robotic system to perform the treatment and restore blood flow using techniques similar to NVI. The distal end of the guidewire is navigated to the area beyond the lesion, and a microcatheter may be used to properly support the guidewire in cases of complex anatomical structures. Blood flow is restored by introducing and deploying a stent or balloon into the lesion. As with PCI, lesion preparation and imaging may be used in a similar manner.

[0007] Over-the-wire (OTW) catheters or coaxial systems are used when support at the distal end of a catheter or guidewire is required, for example, to navigate a tortuous or calcified vascular system, to reach distal anatomical sites, or to cross a hard lesion. OTW catheters have a lumen for the guidewire that extends along the entire length of the catheter. This provides a relatively stable system as the guidewire is supported along its entire length. However, this system has several drawbacks compared to rapid-exchange catheters (described later), including high friction and a longer overall length. Typically, to remove or replace an OTW catheter while maintaining the position of the indwelling guidewire, the exposed length of the guidewire (outside the patient) must be longer than that of the OTW catheter. A 300 cm guidewire is generally sufficient for this purpose and is often called a replacement-length guidewire. Due to this guidewire length, two operators are required to remove or replace an OTW catheter. This becomes even more difficult when using a triple coaxial system, known in the art as a triaxial system (quadruple coaxial catheters are also known to be used). However, given its stability, the OTW system is frequently used in NVI and PVI procedures. On the other hand, rapid exchange (or monorail) catheters are often used in PCI procedures. In rapid exchange catheters, the guidewire lumen only passes through the distal portion of the catheter called the monorail or rapid exchange (RX) section. In the RX system, the operator manipulates the interventional devices parallel to each other (in contrast to the OTW system where the devices are manipulated in a tandem configuration), and the exposed length of the guidewire only needs to be slightly longer than the RX section of the catheter. The guidewire for rapid exchange is typically 180-200 cm long. Given the short guidewire and monorail, the RX catheter can be changed by a single operator. However, the RX catheter is often unsuitable when more distal support is required. [Overview of the project]

[0008] In one embodiment, a device for operating an elongated medical device (EMD) includes a torque limiting actuator that releasably secures the elongated medical device and limits the torque applied to the torquer.

[0009] In one embodiment, the torque limiting actuator limits the torque applied to the torquer to a predetermined torque.

[0010] In one embodiment, the torque limiting actuator includes a manual operator and a clutch that prevents torque exceeding a predetermined torque from being applied to the torquer.

[0011] In one embodiment, the torque limiting actuator includes a knob that is manually rotatable around the longitudinal axis (longitudinal axis / vertical axis) of the torquer, and a biasing member between a portion of the knob and a first clutch member. The first clutch member applies torque to the second clutch member until a predetermined torque is reached between the first clutch member and the second clutch member.

[0012] In one embodiment, the torque limiting actuator limits the torque applied to the actuator in a first direction, but does not limit the torque applied to the actuator in a second, opposite direction.

[0013] In one embodiment, the torquer comprises a torquer body and a pusher (pressure device) movable within the torquer body, and moves at least a first pad in a direction intersecting the longitudinal axis of the torquer to pinch (grasp) the EMD.

[0014] In one embodiment, the pinch force between the torquer and the EMD, in a direction intersecting the longitudinal axis of the torquer, is a function of the torque applied to the torquer by the torque limiting actuator.

[0015] In one embodiment, the clutch is a spring-driven first gear that engages with a second gear.

[0016] In one embodiment, when the torque between the first gear and the second gear exceeds a predetermined torque, the first gear slips relative to the second gear.

[0017] In one embodiment, the torquer includes a second pad that is separated from the first pad and movable in a direction toward and away from the first pad in order to pinch the EMD in a releasable manner.

[0018] In one embodiment, the biasing member includes a pair of arms that are separated from each other and away from the longitudinal axis of the torquer.

[0019] In one embodiment, the torque limiting actuator includes a shaft having a portion that is screwed into the body of the torquer and a distal portion that is operable to actuate a pad to contact the EMD when the shaft rotates relative to the body of the torquer.

[0020] In one embodiment, the torque limiting actuator includes a drive gear and a biasing member that biases the drive gear and engages it with a driven gear fixed to a shaft.

[0021] In one embodiment, the torque limiting actuator includes a knob that is manually rotatable relative to the body of the torquer. This knob is connected to a shaft in such a way that it can be released by applying a predetermined torque.

[0022] In one embodiment, the torque limiting actuator notifies the user when sufficient torque is applied to the torquer, for example, through an audible click and / or tactile feedback in the form of knob vibration.

[0023] In one aspect, a torquer for an elongate medical device includes a body having a cavity defining a path, a first pad movable within the cavity, a biasing member separate from the first pad that biases the first pad relative to the body, an actuator movable relative to the body that operates the first pad to pinch (grip) and unpinch (release) the elongate medical device by the first pad within the path, and a knob releasably connected to the actuator that releases when a predetermined torque greater than a predetermined value is applied.

[0024] In one aspect, an EMD drive includes a robotic drive having a robotic drive longitudinal axis, a device module movable along the robotic drive longitudinal axis, and a drive train connecting a motor to a driven member configured to rotate a torquer that pinches an elongate medical device (EMD) about the EMD longitudinal axis, the torquer including a torque limiting actuator manually accessible by a user when the torquer is in a use position within the device module.

[0025] In one aspect, the torquer can be moved from a first device module to a second device module.

[0026] In one aspect, the torquer includes a torque limiting actuator that limits torque applied to the drive train beyond a predetermined torque. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] [Figure 1] It is a schematic diagram illustrating a catheter treatment system. [Figure 2] It is a schematic block diagram illustrating a catheter treatment system. [Figure 3] It is an exploded view of a cassette assembly, a robotic drive, and a drive module of a catheter treatment system. [Figure 4] It is a perspective view of a torquer actuator. [Figure 5] It is an exploded view of the torquer actuator of FIG. 4. [Figure 6] Figure 4 is a plan view of the torquer actuator as seen from the side. [Figure 7] Figure 6 is a cross-sectional view of the torquer actuator. [Figure 8] Figure 4 is an exploded view of the torque limiting knob assembly of the torquer actuator. [Figure 8A] This is a magnified view of the torque limiting assembly. [Figure 8B] This is a perspective view of the knob on the torque limiting assembly. [Figure 9] Figure 4 is a perspective view of the pad and biasing member of the torquer actuator. [Figure 10] This is a perspective view of the Torque actuator located inside the cassette of a catheter treatment system. [Figure 11] This is a cross-sectional view of the torquer actuator illustrating each stopping function. [Modes for carrying out the invention]

[0028] Figure 1 is a perspective view illustrating a catheter-based treatment system 10 according to an embodiment. The catheter-based treatment system 10 may be used to perform catheter-based medical procedures, such as percutaneous coronary intervention (PCI) (e.g., to treat STEMI), neurovascular intervention (NVI) (e.g., to treat acute great vessel occlusion (ELVO)), and peripheral vascular intervention (PVI) (e.g., for critical limb ischemia (CLI)). Catheter-based medical procedures may include diagnostic catheter procedures, in which one or more catheters or other elongated medical devices (EMDs) are used to assist in the diagnosis of a patient's disease. For example, in one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected into one or more arteries through a catheter to take images of the patient's vascular system. Catheter-based medical procedures also include catheter-based therapeutic procedures (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, thrombectomy, treatment of arteriovenous malformations, treatment of aneurysms, etc.), in which a catheter (or other EMD) is used to treat a disease. Treatment procedures can be enhanced by including auxiliary devices 54 (shown in Figure 2), such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and fractional flow reserve (FFR). However, for those with common knowledge in this field, it is obvious that specific dedicated percutaneous intervention devices or components (e.g., guidewire type, catheter type, etc.) can be selected based on the type of procedure being performed. The catheter-based procedure system 10 can accommodate the dedicated percutaneous intervention devices used in the procedure with minimal adjustment and can perform any catheter-based medical procedure.

[0029] The catheter-based treatment system 10 includes, among many other elements, a bedside unit 20 and a control station (not shown). The bedside unit 20 comprises a robotic drive unit 24 and a positioning system 22 positioned adjacent to the patient 12. The patient 12 is placed 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, an articulated arm, or a holder. The positioning system 22 can be attached at one end to, for example, a patient table 18 (shown in Figure 1), a base, or a cart. The robotic drive unit 24 is attached to the other end of the positioning system 22. The positioning system 22 can be retracted (together with the robotic drive unit 24) so ​​that the patient 12 can be placed on the patient table 18. After the patient 12 is on the patient table 18, the positioning system 22 can be used to set or position the robotic drive unit 24 relative to the patient 12 for treatment. The arrangement of the robotic drive unit in a position for treatment is referred to here as the robotic drive unit's operating position. In one embodiment, the patient table 18 is supported and operable by a pedestal 17 fixed to the floor and / or ground. The patient table 18 can move with multiple degrees of freedom relative to the pedestal 17, for example, in roll, pitch, and yaw. The bedside unit 20 may also include a controller and display 46 (shown in Figure 2). For example, the controller and display may be housed in the housing of the robotic drive unit 24.

[0030] Typically, the robotic drive unit 24 is equipped with appropriate percutaneous interventional devices and accessories 48 (shown in Figure 2) (e.g., guidewires, various types of catheters including balloon catheters (but not limited to), stent delivery systems, stent retrievers, embolization coils, fluid embolization, suction pumps, devices for injecting contrast agents or drugs, hemostatic valve adapters, syringes, stopcocks, inflation devices, etc.) that enable a user or operator to perform catheter-based medical procedures via the robotic system by operating various controllers, such as control and input devices, located in a control station. The bedside unit 20, specifically the robotic drive unit 24, may include numerous components and / or combinations thereof to impart the functionality described herein to the bedside unit 20. The robotic drive unit 24 includes a plurality of device modules 32a-d mounted on rails or linear members. Each of the device modules 32a-d can be used to drive EMDs such as catheters and guidewires. For example, the robotic drive unit 24 can be used to automatically feed guidewires into a diagnostic catheter and into a guide catheter in the artery of the patient 12. One or more devices, such as an EMD, enter the patient's body (e.g., a blood vessel) at insertion point 16, for example, via an introducer sheath. Each device module 32a-d includes a drive module and a cassette detachably attached to the drive module. Each drive module is movable along a robotic drive longitudinal axis with a bracket or stage. Figure 1 illustrates four device modules, but one or more device modules are expected.

[0031] The bedside unit 20 communicates with a control station (not shown) and transmits signals generated by the user input device of the control station to the bedside unit 20 wirelessly or via a wire, enabling control of various functions of the bedside unit 20. As described later, the control station 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., load, speed, operating conditions, warning signals, error codes, etc.) to the control station or the control computing system 34 (shown in Figure 2) or both. Communication between the control computing system 34 and each component of the catheter-based treatment system 10 may be provided via a wireless connection, a wired connection, or a communication link, which is other means that enables communication between components. The control station or other similar control system is located either at a local site (e.g., a local control station 38 shown in Figure 2) or at a remote site (e.g., a remote control station and computing system 42 shown in Figure 2). The catheterization system 10 can be operated by a control station at a local site, a control station at a remote site, or simultaneously by both a local and a remote control station. At the local site, the user or operator and the control station are in the same room as the patient 12 and the bedside unit 20, or in an adjacent room. In this context, the local site is the location of the bedside unit 20 and the patient 12 or subject (e.g., an animal or cadaver), and the remote site is the location of the control station used to remotely control the user or operator and the bedside unit 20. The control station (and control computing system) at the remote site and the bedside unit 20 and / or control computing system at the local site communicate using a communication system and services 36 (shown in Figure 2), for example, via the Internet.In one embodiment, the remote site and the local (patient) site are located far apart from each other, for example, in separate rooms within the same building, in separate buildings within the same city, in different municipalities, or in other separate locations where the remote site does not have physical access to the bedside unit 20 and / or patient 12 of the local site.

[0032] The control station typically includes one or more input modules 28 configured to receive user input to operate various components or systems of the catheter-based treatment system 10. In the embodiments shown herein, the control station enables a user or operator to control the bedside unit 20 to perform catheter-based medical procedures. For example, the input modules 28 can be configured to cause the bedside unit 20 to perform various tasks using a percutaneous interventional device (e.g., EMD) in conjunction with a robotic drive unit 24 (e.g., advancing, reversing, or rotating a guidewire; advancing, reversing, or rotating a catheter; inflating or deflating a balloon positioned in the catheter; positioning and / or deploying a stent; positioning and / or deploying a stent retriever; positioning and / or deploying a coil; catheterizing contrast agent; catheterizing a fluid embolization; catheterizing a drug solution or saline solution; catheter aspiration; or performing other functions that may be performed as part of a catheter-based medical procedure). The robotic drive unit 24 includes various drive mechanisms for operating components of the bedside unit 20, including percutaneous interventional devices (e.g., axial and rotational movements).

[0033] In one embodiment, the input module 28 may include one or more touchscreens, joysticks, scroll wheels, and / or buttons. In addition to the input module 28, the control station 26 may also use additional user control devices 44 (shown in Figure 2), such as a foot switch or a microphone for voice commands. The input module 28 may be configured to move each component and percutaneous interventional device, such as a guidewire and one or more catheters or microcatheters, forward, backward, or rotate. Buttons may include, for example, an emergency stop button, a magnification button, a device selection button, and an auto-act button. When the emergency stop button is pressed, power (e.g., electricity) is cut off or removed from the bedside unit 20. In speed control mode, the magnification button acts to increase or decrease the operating speed of the associated component that operates in response to the operation of the input module 28. In position control mode, the magnification button changes the mapping between the input distance and the output command distance. A device selection button allows the user or operator to select which of the percutaneous interventional devices loaded in the robotic drive unit 24 will be controlled by the input module 28. An auto-act button is used to enable the catheter-based treatment system 10 to act by algorithms that can be executed on the percutaneous interventional devices without direct command from the user or operator. In one embodiment, the input module 28 includes one or more control units or icons (not shown) displayed on a touchscreen (which may or may not be part of a display) that, when selected, activate components of the catheter-based treatment system 10. The input module 28 may also include a balloon or stent controller configured to inflate or deflate a balloon and / or deploy a stent. Each of the input modules 28 may include one or more buttons, scroll wheels, joysticks, touchscreens, etc., which can be used to control one or more specific components that are controlled exclusively.Furthermore, one or more touchscreens can display one or more icons (not shown) associated with each part of the input module 28 or each component of the catheter-based treatment system 10.

[0034] The catheter-based treatment system 10 also includes an imaging system 14. The imaging system 14 is, for example, a medical imaging system (e.g., non-digital X-ray, digital X-ray, CT, MRI, ultrasound, etc.) 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. In one embodiment, the imaging system 14 may include a C-arm (shown in Figure 1) that allows the imaging system 14 to partially or completely rotate around the patient 12 to obtain images (e.g., sagittal, caudal, anterior-posterior, etc.) at various angular positions relative to the patient 12. 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.

[0035] 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 a catheter-based medical procedure to assist the user or operator of the control station 26 in properly positioning the guidewire, guidecatheter, microcatheter, stent retriever, coil, stent, balloon, etc., during the procedure. One or more images may be displayed on the display 30. For example, images may be displayed on the display to assist the user or operator in accurately moving the guidecatheter or guidewire to the appropriate position.

[0036] To clarify the direction, a Cartesian coordinate system was introduced with X, Y, and Z axes. The positive X-axis is in the longitudinal (axial) distal direction, that is, from the proximal end to the distal end, or in other words, from proximal to distal. The Y and Z axes lie within the cross-section relative 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. When used here, the X-axis extends along the longitudinal axis of the robot drive unit 24. Since the robot housing may be inclined with respect to a horizontal plane perpendicular to the direction of gravity at the point of use, the X, Y, and Z axes are defined by the robot drive unit 24. Referring to Figure 1, the robot drive unit 24 includes a housing having an upper surface or first member 24a parallel to the XY plane, a lower surface or second member parallel to and spaced apart from the first member 24a, and a front surface or third member 24c extending substantially perpendicularly between the first member 24a and the second member. The third member 24c faces the user when the robot drive unit 24 is in the usage position or direction shown in Figure 1. A fourth member is spaced apart from the third member 24c, substantially parallel to the third member 24c, and perpendicular to the first member 24a and the second member 24b. It is assumed that other shapes may also be used for the robot drive unit housing. In this case, the first member 24a is the upper member, the second member is the lower or bottom member, the front or third member 24c is the part that faces the user in the position of use during surgical procedures, and the fourth member is the part that faces away from the user in the position of use during surgical procedures. The robot drive unit 24 further includes a distal region 24e and a proximal region 24f. In this case, the distal region 24e is close to the insertion point of the patient into which the EMD is introduced, and the proximal region 24f is furthest from the insertion point of the patient into which the EMD is introduced.

[0037] Figure 2 is a block diagram of a catheter-based treatment system 10 according to an embodiment. The catheter-based treatment system 10 may include a control computing system 34. The control computing system 34 may be physically part of, for example, a control station. The control computing system 34 is typically an electronic control unit suitable for providing the functions described herein to the catheter-based treatment system 10. 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, communication systems and services 36 (e.g., the internet, firewall, cloud services, session manager, hospital network, etc.), a local control station 38, additional communication systems 40 (e.g., a telepresence system), a remote control station and computing system 42, and patient sensors 56 (e.g., an electrocardiogram (ECG) device, an electroencephalogram (EEG) device, a blood pressure monitor, a body temperature monitor, a heart rate monitor, a respiratory monitor, etc.). The control computing system 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 and a positioning system 22, and optionally includes additional controllers and displays 46. As described above, the additional controllers and displays may be located in the housing of the robotic drive unit 24. Intervention devices and accessories 48 (e.g., guidewires, catheters, etc.) work in conjunction with the bedside unit 20. In one embodiment, the intervention devices and accessories 48 include dedicated devices (e.g., IVUS catheters, OCT catheters, FFR wires, contrast-enhanced diagnostic catheters, etc.), which work in conjunction with their respective auxiliary devices 54, i.e., IVUS systems, OCT systems, and FFR systems, etc.

[0038] In one embodiment, the control computing system 34 is configured to generate control signals based on user interaction with input modules 28 (of control stations such as a local control station 38 or a remote control station 42) and / or based on information accessible to the computing system 34, so that medical procedures can be performed using the catheter-based procedure system 10. The local control station 38 includes one or more displays 30, one or more input modules 28, and additional user control devices 44. The remote control station and computing system 42 may include components similar to those of the local control station 38. The remote control station 42 and the local control station 38 may be configured separately, each based on the required functions. The additional user control devices 44 may include, for example, one or more foot input controllers. The foot input controllers may be configured to allow the user to select functions of the imaging system 14, such as turning X-rays on / off or scrolling through multiple saved images. In one embodiment, the foot input device may be configured to allow the user to select a device that is mapped (assigned) to a scroll wheel included in the input module 28. Additional communication systems 40 (e.g., audio conferencing, video conferencing, telepresence, etc.) may be employed to assist, for example, the operator in interacting with the patient, medical staff (e.g., angiography staff), and / or equipment near the bedside.

[0039] The catheter-based treatment system 10 may be connected to or configured to include other systems and / or devices not explicitly mentioned. 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 injection system, a drug tracking and / or logging system, a user log, an encryption system, a system to restrict access to or use of the catheter-based treatment system 10, and the like.

[0040] As described above, the control computing system 34 communicates with a bedside unit 20 which includes a robot drive unit 24 and a positioning system 22 and may include additional control equipment and a display 46, and provides control signals to the bedside unit 20 to control the operation of motors and to drive mechanisms used to drive percutaneous interventional devices (e.g., guidewires, catheters, etc.). Various drive mechanisms are provided as part of the robot drive unit 24.

[0041] Referring to Figure 3, device module 32a includes a first drive module 60 and a first cassette 68. Device module 32b includes a second drive module 62 and a second cassette 70. Device module 32c includes a third drive module 64 and a third cassette 72. Device module 32d includes a fourth drive module 66 and a fourth cassette 74. In one embodiment, the first cassette 68, the second cassette 70, the third cassette 72, and the fourth cassette 74 are shipped together as a multi-unit cassette assembly. In one embodiment, the multi-unit cassette assembly 76 allows each cassette to be slidably connected to each other while being detachably connected to each drive module. In one embodiment, each of the multiple device modules 32a-d can operate independently and move linearly along a linear member within the robot drive unit 24. Each device module 32a-d can move independently of each other and relative to the linear member within the robot drive unit. The drive mechanism operates each device module along the longitudinal axis 78 of the robot drive unit 24, which is also referred to here as the robot drive longitudinal axis 78. The robot drive longitudinal axis 78 extends in the direction of a linear member, such as a lead screw drive, along which the device module moves, or is defined along another axis parallel to the linear member along which the device module moves. Referring to Figure 3, each cassette 68-74 is typically oriented vertically in the XZ plane. Each cassette 68-74 has a length along the X axis or parallel to the longitudinal axis 78 that is greater than the width of each cassette along the Y axis or intersects the Y axis. International Publication WO2021 / 011533, whose entire contents are incorporated herein by reference, discloses cassettes positioned approximately horizontally in the XY plane. The distinction between vertical (up / down) and horizontal (left / right) orientations of the cassettes is described in International Publication WO2021 / 011554, whose entire contents are incorporated herein by reference.

[0042] Referring to International Publication WO2021 / 011554, in one embodiment, the drive mechanism includes independent stage translation motors connected to each of the device modules, and a stage drive mechanism such as a lead screw utilizing a rotating nut, a rack and pinion, a belt via a pinion or pulley, or a chain via a sprocket, or the stage translation motors 64a-d are linear motors themselves. The drive mechanism provides forward and reverse movement of the device modules. An example of such a drive mechanism is described in International Publication WO2021 / 011533.

[0043] To prevent contamination of the patient with pathogens, medical staff use 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. Aseptic techniques consist of using sterile barriers, sterile instruments, proper patient preparation, environmental control, and contact guidelines. Accordingly, all EMDs and interventional accessories are sterilized and permitted to come into contact only with either sterile barriers or sterile instruments. In one embodiment, a non-sterile robotic drive unit 24 is covered with a sterile drape (not shown). Each cassette 68-74 is sterilized and acts as a sterile interface between the draped robotic drive unit 24 and at least one EMD. Each cassette 68-74 is designed to be sterilized for single use only, or is designed to be re-sterilized whole or partially so that the cassette 68-74 or its components can be used in multiple procedures.

[0044] Distal and Proximal: “Distal” and “proximal” define the relative positions of two different parts. In the case of a robotic drive system, “distal” and “proximal” are defined by the position of the robotic drive system relative to the patient in its application. When used to define relative position, the distal part is the part of the robotic drive system that is closer to the patient than the proximal part when the robotic drive system is in its application position. Within the patient, vascular landmarks that are further along the pathway from the access point are considered distal to landmarks closer to the access point. The access point is the point where the EMD enters the patient. Similarly, the proximal part is the part of the robotic drive system that is further from the patient than the distal part when the robotic drive system is in its application position. When used to define direction, the distal direction is the path that something is moving or intending to move, or is aiming for or facing, from the proximal part toward the distal part and / or toward the patient when the robotic drive system is in its application position. The proximal direction is the opposite direction of the distal direction. In the example shown in Figure 1, the robotic drive unit is shown from the perspective of the operator facing the patient. In this configuration, the distal direction is along the positive X-axis, and the proximal direction is along the negative X-axis.

[0045] Longitudinal axis (vertical axis / longitudinal direction axis): The "longitudinal 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, passing through the center of the component's cross-section in the direction from the proximal part of the component to the distal part of the component. For example, the longitudinal axis of a guidewire is the central axis in the direction from the proximal part of the guidewire to the distal part of the guidewire, even if the guidewire is nonlinear in the relevant part.

[0046] Axial motion (axial movement): The "axial motion" of a component refers to the translation (parallel movement) of the component along its longitudinal axis. When the distal end of an EMD is moved axially distally along its longitudinal axis, toward or further into the patient, the EMD is advancing. When the distal end of an EMD is moved axially proximal along its longitudinal axis, toward or further away from the patient, the EMD is withdrawing.

[0047] Rotational motion: The "rotational motion" of a component refers to a change in the angular direction of the component around its local longitudinal axis. 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.

[0048] Axial insertion and lateral insertion: "Axial insertion" refers to inserting the first component into the second component along its longitudinal axis. An EMD loaded axially into a collet is inserted axially into the collet. An example of axial insertion is posterior loading of a catheter into the proximal end of a guidewire. "Lateral insertion" refers to inserting the first component into the second component along a direction in a plane intersecting the longitudinal axis of the second component. This can also be called radial loading or lateral loading. In other words, lateral insertion refers to inserting the first component into the second component along a direction parallel to the radial direction of the second component and perpendicular to its longitudinal axis.

[0049] Up / Down, Front / Back, Inside / Outside: "Top, upper side, upward, upward" refers to the general direction opposite to the direction of gravity, while "Bottom, lower side, downward, downward" refers to the general direction in the direction of gravity. "Front (front)" refers to the side of the robot drive unit facing the user at the bedside and opposite the positioning system such as the articulated arm. "Back (rear)" refers to the side of the robot drive unit closer to the positioning system such as the articulated arm. "Inside" means the inside of the part. "Outside" means the outside of the part.

[0050] Stage: "Stage" refers to a component, part, or device used to connect a device module to a robotic drive system. For example, a stage may be used to connect a device module to a rail or linear member of a robotic drive system.

[0051] Drive Module: A "drive module" generally refers to a part of a robot drive system (e.g., a main component) that typically includes one or more motors along with a drive coupler that works in conjunction with a cassette.

[0052] Device module: A "device module" refers to a combination of a drive module and a cassette.

[0053] Cassette: "Cassette" generally refers to a part of a robotic drive system (non-principal, consumable, or sterilizable unit) that is typically a (direct) or (indirect) sterilization interface between the drive module and at least one EMD, via a device adapter.

[0054] Distal shaft drive: "Distal shaft drive" refers to holding and operating the EMD along its shaft. In one embodiment, the on-device adapter is typically located immediately proximal to the hub or Y-connector into which the device is inserted. When the on-device adapter is located near the entry point (body or other catheter or valve), shaft drive typically does not require buckling prevention. (It may include buckling prevention to improve drive capability.)

[0055] Collet: A "collet" refers to a device that can releasably fix a portion of an EMD. Here, "fixed" means that there is no intentional relative movement between the collet and the EMD during operation. In one embodiment, the collet includes at least two members which rotate relative to each other to releasably fix the EMD to at least one of the two members. In one embodiment, the collet includes at least two members which move axially (along the longitudinal axis) relative to each other to releasably fix the EMD to at least one of the two members. In one embodiment, the collet includes at least two members which can rotate relative to each other and move axially to releasably fix the EMD to at least one of the two members.

[0056] Fixed: "Fixed" means that the first member does not move relative to the second member during operation.

[0057] Pinch / Unpinch: "Pinch" refers to fixing the EMD to a component in a way that allows it to be released so that the EMD moves together with the component when the component moves. "Unpinch" refers to releasing the EMD from the component so that the EMD, freed from its attachment to the component, can operate independently of the component.

[0058] On-device adapter: An "on-device adapter (device-mounted adapter)" refers to a sterilization device that can pinch an EMD in a releasable manner to provide a drive interface. On-device adapters are also known as end effectors or EMD capture devices. In one embodiment, not limited to, the on-device adapter is a robot-controlled collet that rotates the EMD around its longitudinal axis, pinches and / or unpinches the EMD with the collet, and / or translates the EMD along its longitudinal axis. In one embodiment, the on-device adapter is a hub drive mechanism such as a gear located at the hub of the EMD.

[0059] EMD: “Elongated medical device (EMD)” refers, in a non-restrictive sense, to medical devices consisting of catheters (e.g., guide catheters, microcatheters, balloon / stent catheters), wire-based devices (e.g., guidewires, embolization coils, stent retrievers, etc.), and any combination thereof. In one embodiment, a wire-based EMD, in a non-restrictive sense, includes guidewires, microwires, proximal pushers for embolization coils, stent retrievers, self-expanding stents, and flow diverters. Typically, a wire-based EMD does not have a hub or handle at its proximal end. In one embodiment, the EMD is a catheter having a hub at its proximal end and a flexible shaft extending distally from the hub, the shaft being more flexible than the hub. In one embodiment, the catheter includes an intermediate section as a transition between the hub and the shaft, which has intermediate flexibility that is softer than the hub and stiffer than the shaft. In one embodiment, the intermediate section is a strain relief.

[0060] Hub (Proximal) Drive: "Hub drive" or "proximal drive" refers to holding and operating the EMD at a proximal position (e.g., a geared adapter of the catheter hub). In one embodiment, hub drive refers to applying force or torque to the catheter hub to translate and / or rotate the catheter. Hub drive can cause the EMD to buckle, and therefore, hub drive often requires an anti-buckling function. In the case of a device without a hub or other interface (e.g., a guidewire), a device adapter can be added to the device to act as an interface to the device module. In one embodiment, the EMD does not include a mechanism to manipulate parts inside the catheter, such as a wire extending from the handle to the distal end of the catheter to bend the distal end of the catheter.

[0061] Sterilizable Units: "Sterilizable units" refer to devices that can be sterilized (i.e., free from pathogenic microorganisms). This includes, in a limited sense, cassettes, consumable units, drapes, device adapters, and sterilizable drive modules / units (which may include electromechanical components). Sterilizable units may come into contact with patients, other sterilization devices, or other objects placed within the sterile field of a medical procedure.

[0062] Sterilization Interface: A "sterilization interface" refers to the interface or boundary between a sterilization unit and a non-sterilization unit. For example, a cassette is a sterilization interface between a robotic drive unit and at least one EMD.

[0063] Consumables: "Consumables" refer to sterilizable units that are typically used only once in a medical procedure. These units may also be considered consumables that have been reusable through a re-sterilization process for use in another medical procedure.

[0064] Gears: "Gears" refers to internal gears such as bevel gears, helical bevel gears, spur gears, miter gears, worm gears, helical gears, rack and pin-on gears, screw gears, sun gears, involute spline shafts and bushings, or other types of gears well known in the art.

[0065] Referring to Figure 4, the torquer actuator 100 includes a torquer 102 and a torque limiting actuator 104. The torquer actuator 100 includes a housing 106 formed from a proximal housing member 108 which is connected to and operable with a distal housing member 110. A pusher 112 is operably housed within the housing 106 along the torquer longitudinal axis 114 between the proximal end 116 and the distal end 118 of the housing 106. A first pad 120 and a second pad 122 act toward and away from the torquer longitudinal axis 114 so as to pinch the shaft of an elongated medical device (EMD) in a releaseable manner. A biasing member 124 biases the first pad 120 and the second pad 122 toward each other. As the pusher 112 moves from the proximal end 116 to the distal end 118, it applies a force toward the first pad 120 and the second pad 122, providing a force sufficient to exceed the biasing force of the biasing member 124. As the pusher 112 moves from the distal end 118 to the proximal end 116, the biasing member 124 is allowed to bias the first pad 120 and the second pad 122 toward each other and toward the torquer longitudinal axis 114.

[0066] In one embodiment, the first pad 120 includes a first portion 128 and a second portion 130 that contacts the EMD at the contact position. The first portion 128 of the first pad 120 includes an outer surface having a proximal ramp 132 and a distal ramp 134. Similarly, the second pad 122 includes a first portion 129 and a second portion 131 that contacts the EMD at the contact position. The first portion 129 includes a proximal ramp 138 and a distal ramp 140.

[0067] The distal housing member 110 includes a first ramp 142 and a second ramp 144. The pusher 112 includes a first ramp 146 and a second ramp 148. As the pusher 112 moves from the proximal position to the distal position, the first ramp 146 and the second ramp 148 of the pusher 112 contact the proximal ramp 132 of the first pad 120 and the proximal ramp 138 of the second pad 122, respectively. Meanwhile, the distal ramp 134 and the distal ramp 140 contact the first ramp 142 and the second ramp 144 of the distal housing member 110, respectively. The contact of each ramp portion pushes the first pad 120 and the second pad 122 toward each other in a direction substantially perpendicular to the torquer longitudinal axis 114, pinching the EMD between the pads. The operation of the Torquer, an elongated medical device, is described in International Publication WO2022 / 154977: "Torquer For An Elongated Medical Device," the full contents of which are incorporated herein by reference.

[0068] The pusher 112 moves distally within the distal housing member 110 by the operation of the torque limiting actuator 104. Referring to Figures 7 and 8, the torque limiting actuator 104 includes a shaft 150 that screws into the proximal housing member 108. The distal end of the shaft 150 is connected to the pusher 112 and acts so that when the shaft 150 moves distally, the pusher 112 moves distally, and when the shaft 150 moves proximal, the pusher 112 moves proximal. The shaft 150 has a distal end 152 that pushes the proximal end 158 of the pusher 112 distally. The pusher 112 includes a pair of arms 156 that engage with the distal hub 154 of the shaft 150 so that when the shaft 150 moves proximal, the pusher 112 also moves proximal.

[0069] The torque limiting actuator 104 includes a knob 160 fixed to the shaft 150 by a fastener 162. Referring to Figure 8B, the knob 160 includes an outer surface 164 operated by an operator and an inner cavity 166 defined by a cavity wall 168. In one embodiment, the cavity wall includes a contour defined by a number of spaced ribs 170, the ribs 170 of which engage tightly with the contour of a drive gear 172. The drive gear 172 is located within the cavity 166 and rotates with the knob 160. The shaft 150 includes a driven gear 174 that meshes with the drive gear 172. When the knob 160 rotates in a first direction, the drive gear 172 rotates, and this rotation causes the driven gear 174 and the shaft 150 to rotate in the first direction. As the knob 160 rotates in the first direction, the shaft 150 moves distally within the threaded region 176 of the proximal housing member 108. This distal movement causes the pusher 112 to move distally, causing the first pad 120 and the second pad 122 to move toward each other to pinch the EMD. In one embodiment, the contour of the cavity wall is a plurality of splines that engage with a mating spline of the housing supporting the drive gear 172. The mating spline prohibits rotational movement between the knob 160 and the drive gear 172, but allows axial movement between the knob 160 and the drive gear 172 along the torquer longitudinal axis 114.

[0070] A biasing member 178 is positioned in the cavity 166 of the knob 160 and biases the drive gear 172 to engage with the driven gear 174. Referring to Figure 8A, the driven gear 174 and the drive gear 172 are face gears that face each other and rotate around a common axis, and in this example, the drive gear 172 and the driven gear 174 rotate around the torquer longitudinal axis 114. The drive gear 172 includes a number of gear teeth 180 having a first face 182 and a second face 184, the inclination of the first face 182 being smaller than the inclination of the second face 184. In one embodiment, the inclination of the first face 182 is greater than or equal to the inclination of the second face 184. Similarly, the driven gear 174 includes a number of gear teeth 186 having a first surface 188 and a second surface 190, which mesh with the first surface 182 and the second surface 184 of the gear teeth 180.

[0071] The drive gear 172 and the driven gear 174 function as a clutch, with the drive gear 172 being the first clutch plate and the driven gear 174 being the second clutch plate. When the torque exceeds a predetermined value, the first surface 182 of the gear tooth 180 passes over the corresponding first surface 188 of the gear tooth 186, resulting in the drive gear 172 slipping relative to the driven gear 174. In other words, "slip" here refers to the situation where a gear tooth passes over its mating gear when a predetermined torque is applied and engagement cannot be maintained.

[0072] As the knob 160 is rotated in the first direction, the shaft 150 continues to move the first pad 120 and the second pad 122 toward each other, pinching the EMD, until the torque required to keep the first pad 120 and the second pad 122 moving toward each other exceeds a predetermined force. Once the predetermined force is reached, the biasing force of the biasing member 178 becomes insufficient thereafter to maintain the drive of the gear teeth 186 by the gear teeth 180. As the knob 160 is rotated with the predetermined force in the first direction, the gear teeth 180 begin to slide toward the gear teeth 186, and each time the first surface 182 of the gear teeth 180 crosses over the first surface 188 of the gear teeth 186, the user is provided with tactile feedback and an audible click sound. In this way, the torque limiting actuator 104 functions as a clutch that limits the magnitude of the force and torque that can be applied to the EMD pinched by the first pad 120 and the second pad 122, even if the operator continues to turn the knob 160 in the first direction after reaching a predetermined force.

[0073] As previously described, the inclination of the second surface 184 of gear tooth 180 and the second surface 190 of gear tooth 186 is steeper than the inclination of the first surface 182 of gear tooth 180 and the first surface 188 of gear tooth 186, respectively. In one embodiment, the inclination of the second surface 184 and the second surface 190 is less than or equal to the inclination of the first surface 182 and the first surface 188. This inclination is sufficient to prevent the second surface 184 of gear tooth 180 from going over the second surface 190 of gear tooth 186 when the knob 160 rotates in a second direction opposite to the first direction. In one embodiment, the rotation in the first direction is clockwise (CW), which is the general direction for tightening / engaging the torquer to the EMD, and the rotation in the second direction is counterclockwise (CCW), which is the general direction for loosening / disengaging the torquer from the EMD. In other words, the pad opens by rotating it counterclockwise. Tightening and loosening the torquer occurs in two main situations: in free space while held in the operator's hand, and while mounted inside a disposable cassette with the cover closed.

[0074] The housing 106 includes a gear 126 fixed to and operable within the housing 106. The gear 126 is driven by an actuator and, after the EMD 220 is fixed to the torquer 102, rotates the torquer actuator 100 together with the EMD 220.

[0075] Referring to Figure 9, the biasing member 124 includes a base 190 having an opening 194 for receiving a portion of the shaft 150. The shaft 150 and the biasing member 124 move independently of each other and freely along the torquer longitudinal axis 114. The biasing member 124 includes a first arm 196 and a second arm 198, which are separated from each other and also separated from the torquer longitudinal axis 114. The first arm 196 and the second arm 198 extend along the outside of the pusher 112. The first arm 196 includes a first branch 200 and a second branch 202, which engage with portions of the first sides of the first pad 120 and the second pad 122, respectively. Similarly, the second arm 198 includes a first branch 204 and a second branch 206, which engage with portions of the second sides of the first pad 120 and the second pad 122. The first and second sides of the first pad 120 and the second pad 122 are spaced apart and located in opposite directions to the torquer longitudinal axis 114. The branches 200, 202, 204, and 206 are preloaded such that the first pad 120 and the second pad 122 are biased away from each other in both the engaged position where they pinch the EMD and the released position where they do not engage with or pinch the EMD. In one embodiment, only one arm 196 is present, and the second arm 198 is absent. In another embodiment, more than two arms are used. Branches 200 and 202 bias pads 120 and pad 122 to push them apart from each other.

[0076] Referring to Figure 10, the torquer actuator 100 is positioned inside the cassette 70 such that the knob 160 extends to the outside of the cassette 70, allowing the user to operate the knob 160 to rotate it in both a first clockwise direction and a second counterclockwise direction. The torquer actuator 100 also includes a guide tube 208 that extends from the distal end of the distal housing member 110 and guides the EMD through the cassette 70.

[0077] Referring to Figure 11, the stopping member is used in conjunction with the torque limiting actuator 104, or separately from the torque limiting actuator 104, to restrict the distal movement of the pusher 112, thereby limiting the magnitude of the force that can be applied between the first pad 120 and the second pad 122. The pusher stopping member 210 is positioned either on the distal portion of the pusher 112 or on the distal housing member 110, and by contacting the stopping member 210, prevents the pusher 112 from moving distally. The first stopping member 210 restricts the movement of the pusher 112 that would otherwise attempt to exceed a specific distal point, thereby limiting the magnitude of the force applied to the EMD 220.

[0078] In one implementation, the second pad stopping member 212 is positioned on the inner part of the distal housing member 110 and contacts one or both of the first pad 120 and the second pad 122 to prevent the pads from moving distally, thereby limiting the movement of the pads as they approach each other and limiting the force applied to the EMD 220.

[0079] In one embodiment, the actuator 214 that drives the gear 126 incorporates a torque limiting mechanism, which is either mechanical or electromechanical and controlled by a controller.

[0080] In one embodiment, the knob stop 216 is positioned on either the knob 160 or the proximal housing member 108 to limit the distance of the shaft 150 entering the housing 106, thereby limiting the distal movement of the pusher 112, the first pad 120, and the second pad 122, and consequently limiting the movement of the first pad 120 and the second pad 122 toward each other, and as a result limiting the pinching force applied from the pads to the EMD.

[0081] In one embodiment, the cover 218 is configured to automatically move from the closed operating position to the open position when a torque exceeding a predetermined torque is applied to the torquer actuator 100. This visually indicates that the torque has exceeded the predetermined force. The opening of the cover 218, along with audible and tactile feedback, provides visual feedback that the predetermined torque has been reached.

[0082] The device described herein offers several features. The first torque limiting actuator 104 provides the user with audible and / or tactile feedback that sufficient torque has been applied to the torquer, ensuring that sufficient torque and force are applied to the inserted elongated transcutaneous device (EMD). When a predetermined torque is reached, the user is warned via audible and tactile feedback as the first gear slips over the second gear. This eliminates cases where insufficient torque results in the EMD slipping within the torquer as the torquer rotates, leading to insufficient performance.

[0083] The torque limiting actuator 104 limits the torque that can be applied to the torquer 102. This allows the use of lightweight and low-cost materials / processes, such as injection-molded plastics, in the design. The torque limiting knob 160 provides a sufficiently large diameter so that a user with less strength can apply the required knob torque, while preventing a strong user from breaking the torque device. If the second part 130 is an elastomer contact pad, damage to the coated EMD used in the procedure can be avoided by limiting the torque applied to the torquer, and therefore the force applied to the EMD by the pad. This type of design requires high force and low contact friction between sliding elements. By limiting the applied torque, the coating of the EMD can be protected and prevented from being damaged.

[0084] The torquer actuator 100 acts to protect the components of the robot drive unit 24 from high torque. The torquer actuator 100 is fixed in place within a disposable cassette mounted on the system robot. High torque can damage the robot drive unit and prevent the system from being used. The torque limiting actuator 104 limits the torque applied to the torquer actuator 100 and, therefore, also limits the torque applied to the components of the robot drive unit 24.

[0085] In one embodiment, the torquer 102 for the elongated medical device 220 includes a body having a cavity defining a path. In one embodiment, the body includes a proximal housing member 108 and a distal housing member 110, each having a cavity therein. Referring to Figures 5 and 11, the EMD 220 extends through a path defined by an opening or channel passing through a fastener 162, a knob 160, a biasing member 178, a drive gear 172, a shaft 150, the proximal housing member 108, a biasing member 124, a pusher 112, the distal housing member 110, and a guide tube 208. A first pad 120 is movable within the cavity. A biasing member 124, separate from the first pad 120, biases the first pad 120 relative to the body. An actuator is movable relative to the body and operates the first pad to pinch and unpinch the elongated medical device by the first pad within the path. The knob is connected to an actuator in a way that allows it to be released when a predetermined torque exceeding a predetermined value is applied.

[0086] While this disclosure has been described based on examples, it is understood that modifications to the form and specific examples may be made without deviating from the idea and scope of the defined subject matter. For example, while several examples are described as containing one or more features that provide one or more advantages, it is also envisioned that the described features may be interchangeable or combined with each other in the described examples or in other alternative examples. The disclosure described is explicitly intended to be as broad as possible. For example, unless otherwise specified, a definition describing one particular element also encompasses multiple such particular elements.

Claims

1. A device for operating long, slender medical devices, Torker for removably securing elongated medical devices (EMDs), A device comprising a torque limiting actuator that limits the torque applied to the torquer.

2. The device according to claim 1, wherein the torque limiting actuator limits the torque applied to the torquer to a predetermined torque.

3. The device according to claim 1, wherein the torque limiting actuator includes a manual actuator and a clutch, the clutch prevents a torque exceeding a predetermined torque from being applied to the torquer.

4. The torque limiting actuator includes a knob that can be manually rotated around the longitudinal axis of the torquer, and a biasing member between a portion of the knob and a first clutch member. The device according to claim 1, wherein the first clutch member applies torque to the second clutch member until a predetermined torque is reached between the first clutch member and the second clutch member.

5. The device according to claim 1, wherein the torque limiting actuator limits the torque applied to the actuator in a first direction, but does not limit the torque applied to the actuator in a second direction opposite to the first direction.

6. The device according to claim 1, wherein the torquer comprises a torquer body and a pusher movable within the torquer body, and at least a first pad is moved in a direction intersecting the longitudinal axis of the torquer to pinch the EMD.

7. The device according to claim 1, wherein the pinch force between the torquer and the EMD in a direction intersecting the longitudinal axis of the torquer is a function of the torque applied to the torquer by the torque limiting actuator.

8. The device according to claim 3, wherein the clutch is a spring-biased first gear that engages with a second gear.

9. The device according to claim 8, wherein when the torque between the first gear and the second gear exceeds a predetermined torque, the first gear slips relative to the second gear.

10. The device according to claim 6, wherein the torquer includes a second pad that is separated from the first pad and movable toward and toward the first pad in order to pinch the EMD in a releasable manner.

11. The device according to claim 10, further comprising a biasing member having a pair of arms that are separated from each other and separated from the longitudinal axis of the torquer.

12. The device according to claim 1, wherein the torque limiting actuator includes a shaft having a portion that is screwed into the body of the torquer, the shaft having a distal portion that is operable to actuate a pad to contact the EMD when the shaft rotates relative to the body.

13. The device according to claim 12, wherein the torque limiting actuator includes a drive gear and a biasing member that biases the drive gear and engages it with a driven gear fixed to the shaft.

14. The device according to claim 13, wherein the torque limiting actuator includes a knob that is manually rotatable relative to the body, and the knob is connected to the shaft in such a way that it can be released by applying a predetermined torque.

15. The device according to claim 1, wherein the torque limiting actuator provides the user with an indication that sufficient torque has been applied to the torquer.

16. Torca is a long, slender medical device. A body having a cavity that defines the path, A first pad that is movable within the cavity, A biasing member, separate from the first pad, biases the first pad relative to the body, An actuator is provided which is movable relative to the body and which operates the first pad to pinch and unpinch the elongated medical device within the path using the first pad, A torquer, comprising a knob connected to the actuator and made releasable when a predetermined torque exceeding a predetermined value is applied.

17. A drive system for EMDs (elongated medical devices), A robot drive device having a longitudinal axis for robot drive, A device module that is movable along the longitudinal axis of the robot drive, The drive train includes a motor connected to a driven member configured to rotate a torquer that pinches the EMD around the longitudinal axis of the EMD, The torquer is part of a drive system that includes a torque limiting actuator that can be manually accessed by a user when the torquer is in a working position within the device module.

18. The drive system according to claim 17, wherein the torque limiting actuator limits the torque applied to the torquer to a predetermined torque.

19. The drive system according to claim 17, wherein the torque limiting actuator includes a manual operator and a clutch, the clutch prevents a torque exceeding a predetermined torque from being applied to the torquer.

20. The torque limiting actuator includes a knob that can be manually rotated around the longitudinal axis of the torquer, and a biasing member between a portion of the knob and a first clutch member. The drive system according to claim 17, wherein the first clutch member applies torque to the second clutch member until a predetermined torque is reached between the first clutch member and the second clutch member.

21. The drive system according to claim 17, wherein the torquer can be moved from the first device module to the second device module.

22. The drive system according to claim 17, wherein the torquer includes a torque limiting actuator that limits the torque applied to the drive train beyond a predetermined torque.

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