CN221844971U - Torque limiting actuator for an elongate medical device torquer - Google Patents

Abstract

A torque device releasably securing an elongate medical device thereto, and including a torque limiting actuator limiting torque applied to the torque device.

Description

Torque-limiting actuator for slim medical device torquers

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No. 63/476,397, filed on December 21, 2022, the disclosure of which is incorporated herein by reference for all purposes.

Technical Field

The utility model generally relates to the field of robotic medical surgery systems, and more particularly to a slender medical device torquer.

Background Art

Catheter and other elongated medical devices (EMD) can be used for minimally invasive medical procedures for diagnosing and treating diseases of various vascular systems, including neurovascular intervention (NVI) (also referred to as neurointerventional surgery), percutaneous coronary intervention (PCI) and peripheral vascular intervention (PVI). These operations generally involve guiding a guide wire through the vascular system, and advancing the catheter via the guide wire to provide treatment. The catheter insertion operation begins by entering a suitable blood vessel (such as an artery or vein) with a guide sheath using standard percutaneous techniques. Then, by the guide sheath, the sheath or guide catheter is advanced to a primary position on the diagnostic guide wire, such as the internal carotid artery for NVI, the coronary artery ostium for PCI or the superficial femoral artery for PVI. The guide wire suitable for the vascular system is then guided to the target position in the vascular system by the sheath or guide catheter. In some cases, such as in a tortuous anatomical structure, a support catheter or microcatheter is inserted on the guide wire to help guide the guide wire. The physician or operator can use an imaging system (e.g., a fluoroscope) to obtain images with contrast injection and select a fixed frame to use as a roadmap to navigate the guidewire or catheter to the target location (e.g., a lesion). As the physician delivers the guidewire or catheter, contrast-enhanced images are also obtained so that the physician can verify that the device is moving along the correct path to the target location. While viewing the anatomy using fluoroscopy, the physician manipulates the proximal end of the guidewire or catheter to guide the distal tip into the appropriate vessel toward the lesion or target anatomical location and avoid advancement into the side branches.

Catheter-based robotic surgery systems have been developed that can be used to assist doctors in performing catheterization procedures, such as NVI, PCI, and PVI. Examples of NVI surgeries include coil embolization of aneurysms, liquid embolization of arteriovenous malformations, and mechanical thrombectomy of large vessel occlusions in the context of acute ischemic stroke. In NVI surgery, doctors use a robotic system to obtain target lesion access by controlling the operation of neurovascular guidewires and microcatheters, thereby providing treatment to restore normal blood flow. Access to the target is enabled by a sheath or guide catheter, but an intermediate catheter may also be required for a more distal area, or sufficient support may be provided for the microcatheter and guidewire. Depending on the type and therapy of the lesion, the distal tip of the guidewire is introduced into or through the lesion. In order to treat an aneurysm, a microcatheter is advanced into the lesion, the guidewire is removed, and several embolic coils are deployed into the aneurysm by the microcatheter and used to block blood flow into the aneurysm. In order to treat an arteriovenous malformation, liquid embolism is injected into the malformation via a microcatheter. Mechanical thrombectomy for treating vascular occlusion can be achieved by suction and/or using a stent retriever. Depending on the location of the clot, aspiration is performed either through an aspiration catheter or, for smaller arteries, through a microcatheter. Once the aspiration catheter is at the lesion, negative pressure is applied to remove the clot through the catheter. Alternatively, a stent retriever can be deployed through the microcatheter to remove the clot. Once the clot has been integrated into the stent retriever, the clot is retrieved by retracting the stent retriever and microcatheter (or intermediate catheter) into the guide catheter.

In PCI, physicians use a robotic system to access the lesion by manipulating a coronary guidewire to deliver treatment and restore normal blood flow. This access is achieved by placing a guide catheter in the coronary ostium. The distal tip of the guide wire is guided through the lesion, and for complex anatomical structures, a microcatheter can be used to provide adequate support for the guidewire. Blood flow is restored by delivering and deploying a stent or balloon at the lesion. The lesion may require preparation before stent implantation, pre-dilation of the lesion by delivering a balloon, or atherectomy by using, for example, a laser atherectomy or rotational atherectomy catheter and a balloon over the guidewire. Diagnostic imaging and physiological measurements can be performed using an imaging catheter or fractional flow reserve (FFR) measurements to determine appropriate treatment.

In PVI, physicians use a robotic system to deliver treatment and restore blood flow using techniques similar to NVI. The distal tip of a guidewire is guided past the lesion, and a microcatheter may be used to provide adequate support for the guidewire for complex anatomy. Blood flow is restored by delivering and deploying a stent or balloon to the lesion. As with PCI, lesion preparation and diagnostic imaging may also be used.

When support is needed at the distal end of the catheter or guidewire, for example, to guide curved or calcified vasculature, reach distal anatomical locations, or pass through hard lesions, an over-the-wire (OTW) catheter or coaxial system is used. The OTW catheter has an inner lumen for a guidewire that extends the entire length of the catheter. This provides a relatively stable system because the guidewire is supported along the entire length. However, the system has some disadvantages, including higher friction and a longer total length compared to a rapid exchange catheter (see below). Typically, in order to remove or exchange an OTW catheter while maintaining the position of the indwelling guidewire, the exposed length of the guidewire (outside the patient's body) must be longer than the OTW catheter. A 300 cm long guidewire is generally sufficient for this purpose and is generally referred to as an exchange length guidewire. Due to the length of the guidewire, two operators are required to remove or exchange the OTW catheter. If a three-coaxial catheter (referred to as a three-axis system in the art) is used, this will become even more challenging (quadruple coaxial catheters are also known to be used). However, due to its stability, the OTW system is often used in NVI and PVI surgery. On the other hand, PCI procedures typically use rapid exchange (or monorail) catheters. The guidewire lumen in a rapid exchange catheter passes only through the distal segment of the catheter, called the monorail or rapid exchange (RX) segment. For RX systems, the operator manipulates the interventional devices parallel to each other (as opposed to OTW systems, in which the devices are manipulated in a series configuration), and the exposed length of the guidewire only needs to be slightly longer than the RX segment of the catheter. Rapid exchange length guidewires are typically 180-200cm long. Given the shorter length of the guidewire and the monorail, RX catheters can be exchanged by a single operator. However, when more distal support is needed, RX catheters are typically not enough.

Utility Model Content

In one embodiment, an apparatus for manipulating an elongated medical device releasably secures an elongated medical device (EMD) thereto and includes a torque limiting actuator that limits torque applied to a torquer.

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

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

In one embodiment, the torque limiting actuator includes a knob that is manually rotated about the longitudinal axis of the torquer, a biasing member between a portion of the knob and a first clutch member, 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.

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

In one embodiment, the torquer includes a torquer body and a pusher movable within the torquer body to move at least a first pad in a direction perpendicular to a longitudinal axis of the torquer to clamp the EMD.

In one embodiment, the clamping force between the torquer and the EMD perpendicular to the longitudinal axis of the torquer is a function of the torque applied to the torquer by the torque limiting actuator.

In one embodiment, the clutch is a spring biased first gear meshing with a second gear.

In one embodiment, once a predetermined torque between the first gear and the second gear is exceeded, the first gear slips relative to the second gear.

In one embodiment, the torquer includes a second liner spaced apart from the first liner and movable toward and away from the first liner to releasably clamp the EMD.

In one embodiment, the biasing member includes a pair of arms spaced apart from each other and from the longitudinal axis of the torquer.

In one embodiment, the torque limiting actuator includes a shaft having a portion threadedly secured to a body of the torquer and a distal portion operable to move a pad into engagement with the EMD upon rotation of the shaft relative to the body.

In one embodiment, a torque limiting actuator includes a drive gear and a biasing member that biases the drive gear into engagement with a driven gear fixed to a shaft, the drive gear.

In one embodiment, the torque limiting actuator includes a knob that is manually rotated relative to the body and is releasably connected to the shaft when a predetermined torque is applied.

In one embodiment, the torque limiting actuator provides an indication to the user once sufficient torque has been applied to the torquer, such as through tactile feedback in the form of an audible click and/or vibration of the knob.

In one embodiment, a torquer for an elongated 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, which biases the first pad relative to the body; an actuator movable relative to the body, which moves the first pad to clamp and/or unclamp the elongated medical device, wherein the first pad is within the path; and a knob releasably connected to the actuator when a predetermined torque exceeding a predetermined value is applied.

In one embodiment, an EMD drive includes: a robotic drive having a robotic drive longitudinal axis; a device module movable along the robotic drive longitudinal axis; a drive train coupling a motor to a driven member, the driven member being configured to rotate a torquer that clamps the EMD around the longitudinal axis of an elongated medical device (EMD), the torquer including a torque limiting actuator that is manually usable by a user when the torquer is in a use position in the drive module.

In one embodiment, the torquer may be moved from a first equipment module to a second equipment module.

In one embodiment, the torque machine includes a torque limiting actuator that limits the torque applied to the driveline to exceed a predetermined torque.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of an exemplary catheter surgery system.

2 is a schematic block diagram of an exemplary catheter surgery system.

3 is an exploded view of the cartridge assembly, robotic drive, and drive module of the catheter surgery system.

FIG. 4 is an isometric view of a torquer actuator.

FIG. 5 is an exploded view of the torquer actuator of FIG. 4 .

6 is a side plan view of the torquer actuator of FIG. 4 .

FIG. 7 is a cross-sectional view of the torquer actuator of FIG. 6 .

8 is an exploded view of the torque limit knob assembly of the torquer actuator of FIG. 4 .

FIG. 8A is a close-up of a portion of the torque limiting assembly.

8B is an isometric view of a knob of the torque limiting assembly.

9 is an isometric view of a pad and biasing member of the torquer actuator of FIG. 4 .

10 is an isometric view of a torquer actuator in a cassette of a catheter surgery system.

11 is a cross-sectional view of a torquer actuator showing various detent features.

DETAILED DESCRIPTION

FIG. 1 is a perspective view of an example catheter-based surgical system 10 according to one embodiment. The catheter-based surgical system 10 can be used to perform catheter-based medical procedures, such as percutaneous interventional procedures, such as percutaneous coronary intervention (PCI) (e.g., to treat STEMI), neurovascular interventional procedures (NVI) (e.g., to treat emergency large vessel occlusion (ELVO)), peripheral vascular interventional procedures (PVI) (e.g., for critical limb ischemia (CLI)), etc.). Catheter-based medical procedures can include diagnostic catheterization procedures, during which one or more catheters or other elongated medical devices (EMDs) are used to help diagnose a patient's disease. For example, during one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected into one or more arteries through a catheter, and an image of the patient's vascular system is taken. Catheter-based medical procedures can also include catheter-based therapeutic procedures (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, clot removal, arteriovenous malformation therapy, aneurysm treatment, etc.), during which a catheter (or other EMD) is used to treat the disease. The therapeutic procedure may be enhanced by including auxiliary devices 54 (shown in FIG. 2 ), such as, for example, intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. However, it should be noted that those skilled in the art will recognize that certain specific percutaneous interventional devices or components (e.g., type of guidewire, type of catheter, etc.) may be selected based on the type of procedure to be performed. The catheter-based surgical system 10 may perform any number of catheter-based medical procedures with minor adjustments to accommodate the specific percutaneous interventional device to be used in the procedure.

The catheter-based surgical system 10 includes, among other elements, a bedside unit 20 and a control station (not shown). The bedside unit 20 includes a robotic drive 24 and a positioning system 22 located near the patient 12. The patient 12 is supported on a patient table 18. The positioning system 22 is used to position and support the robotic drive 24. The positioning system 22 can be, for example, a robotic arm, an articulated arm, a holder, etc. The positioning system 22 can be attached to, for example, a patient table 18 (as shown in FIG. 1 ), a base, or a cart at one end. The other end of the positioning system 22 is attached to the robotic drive 24. The positioning system 22 can be moved away (with the robotic drive 24) to allow the patient 12 to be placed on the patient table 18. Once the patient 12 is positioned on the patient table 18, the positioning system 22 can be used to position or position the robotic drive 24 relative to the patient 12 for the operation. The position of the robotic drive in the position for the operation is referred to herein as the robotic drive use position. In one embodiment, the patient table 18 is operably supported by a base 17 fixed to a floor and/or ground. The patient table 18 is movable relative to the base 17 in multiple degrees of freedom (eg, roll, pitch, and yaw). The bedside unit 20 may also include a control and display 46 (shown in FIG. 2 ). For example, the control and display may be located on the housing of the robotic drive 24 .

Generally, the robot drive 24 can be equipped with appropriate percutaneous interventional devices and accessories 48 (shown in FIG. 2 ) (e.g., guidewires, various types of catheters, including but not limited to balloon catheters, stent delivery systems, stent retrievers, embolic coils, liquid embolic agents, suction pumps, devices for delivering contrast agents, drugs, hemostatic valve adapters, syringes, stopcocks, expansion devices, etc.), to allow a user or operator to perform catheter-based medical procedures via the robot system by operating various controls (such as controls and inputs located at a control station). The bedside unit 20 (and in particular the robot drive 24) can include any number of components and/or combinations of components to provide the bedside unit 20 with the functionality described herein. The robot drive 24 includes a plurality of device modules 32a-d mounted to a track or linear member. Each of the device modules 32a-d can be used to drive an EMD, such as a catheter or a guidewire. For example, the robot drive 24 can be used to automatically feed a guidewire into a diagnostic catheter and a guide catheter in a patient's 12 artery. One or more devices (such as EMD) enter the body (e.g., blood vessel) of the patient 12 via, for example, an introducer sheath at the insertion point 16. Each device module 32a-d includes a drive module and a box removably attached to the drive module. Each drive module can be moved along the robot drive longitudinal axis using a carriage or platform. Although FIG. 1 shows four device modules, it is conceivable that the number of device modules can be one or more.

The bedside unit 20 communicates with a control station (not shown) to allow signals generated by user inputs to the control station to be transmitted wirelessly or via hard wiring to the bedside unit 20 to control various functions of the bedside unit 20. As discussed below, the control station 26 may include a control computing system 34 (shown in FIG. 2 ) or be coupled to the bedside unit 20 via a control computing system 34. The bedside unit 20 may also provide feedback signals (e.g., load, speed, operating conditions, warning signals, error codes, etc.) to the control station, the control computing system 34 (shown in FIG. 2 ), or both. Communication between the control computing system 34 and the various components of the catheter-based surgical system 10 may be provided via a communication link, which may be a wireless connection, a cable connection, or any other means that allows communication between the components. A control station or other similar control system may be located at a local site (e.g., a local control station 38 shown in FIG. 2 ) or a remote site (e.g., a remote control station and computer system 42 shown in FIG. 2 ). The catheter surgery system 10 can be operated by a control station at a local site, by a control station at a remote site, or by both a local control station and a remote control station. At the local site, the user or operator and the control station are located in the same room or an adjacent room as the patient 12 and the bedside unit 20. As used herein, the local site is the location of the bedside unit 20 and the patient 12 or subject (e.g., an animal or a corpse), and the remote site is the location of the user or operator and the control station for remotely controlling the bedside unit 20. The control station (and control computing system) at the remote site and the bedside unit 20 and/or the control computing system at the local site can communicate using a communication system and service 36 (shown in FIG. 2 ), for example, over the Internet. In one embodiment, the remote site and the local (patient) site are far from each other, for example, in different rooms in the same building, in different buildings in the same city, in different cities, or in other different locations where the remote site does not have physical access to the bedside unit 20 and/or the patient 12 at the local site.

The control station typically includes one or more input modules 28 that are configured to receive user input to operate various components or systems of the catheter-based surgical system 10. In the illustrated embodiment, the control station allows a user or operator to control the bedside unit 20 to perform a catheter-based medical procedure. For example, the input module 28 can be configured to cause the bedside unit 20 to perform various tasks (e.g., advance, retract or rotate a guidewire, advance, retract or rotate a catheter, expand or deflate a balloon located on a catheter, position and/or deploy a stent, position and/or deploy a stent retriever, position and/or deploy a coil, inject contrast media into a catheter, inject a liquid embolic agent into a catheter, inject a drug or saline into a catheter, perform suction on a catheter, or perform any other function that can be performed as part of a catheter-based medical procedure) using a percutaneous interventional device (e.g., an EMD) docked with the robotic drive 24. The robotic drive 24 includes various drive mechanisms to cause movement (e.g., axial and rotational movement) of components of the bedside unit 20 including the percutaneous interventional device.

In one embodiment, the input module 28 may include one or more touch screens, joysticks, rollers and/or buttons. In addition to the input module 28, the control station 26 may use additional user controls 44 (shown in FIG. 2 ), such as a foot switch and microphone for voice commands, etc. The input module 28 may be configured to advance, retract or rotate various components and percutaneous interventional devices, such as, for example, guidewires and one or more catheters or microcatheters. The buttons may include, for example, an emergency stop button, a multiplier button, a device selection button, and an automatic movement button. When the emergency stop button is pressed, the power supply (e.g., electricity) to the bedside unit 20 is cut off or removed. When in speed control mode, the multiplier button is used to increase or decrease the speed in response to the manipulation of the input module 28, and the associated components move at this speed. When in position control mode, the multiplier button changes the mapping between the input distance and the output command distance. The device selection button allows the user or operator to select which percutaneous interventional devices loaded into the robot drive 24 are controlled by the input module 28. The automatic movement button is used to implement the algorithmic movement that the catheter-based surgical system 10 can perform on the percutaneous interventional device without direct commands from the user or operator. In one embodiment, the input module 28 may include one or more controls or icons (not shown) displayed on the touch screen (which may or may not be part of the display), which, when activated, cause the operation of the components of the catheter-based surgical system 10. The input module 28 may also include a balloon or stent control, which is configured to expand or contract the balloon and/or deploy the stent. Each input module 28 may include one or more buttons, rollers, joysticks, touch screens, etc., which can be used to control one or more specific components dedicated to the control. In addition, one or more touch screens can display one or more icons (not shown) related to various parts of the input module 28 or various components of the catheter-based surgical system 10.

The catheter-based surgical system 10 also includes an imaging system 14. The imaging system 14 can be any medical imaging system that can be used in conjunction with a catheter-based medical procedure (e.g., non-digital X-ray, digital X-ray, CT, MRI, ultrasound, etc.). In an exemplary 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 can include a C-arm (shown in FIG. 1 ) that allows the imaging system 14 to partially or completely rotate around the patient 12 so as to obtain images at different angular positions relative to the patient 12 (e.g., sagittal views, caudal views, anterior-posterior views, etc.). In one embodiment, the imaging system 14 is a fluoroscopic system that includes a C-arm having an X-ray source 13 and a detector 15, also referred to as an image intensifier.

The imaging system 14 can be configured to take X-ray images of appropriate areas of the patient 12 during surgery. For example, the imaging system 14 can be configured to take one or more X-ray images of the head to diagnose neurovascular conditions. The imaging system 14 can also be configured to take one or more X-ray images (e.g., real-time images) during a catheter-based medical procedure to help a user or operator of the control station 26 properly position a guidewire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, etc. during surgery. One or more images can be displayed on the display 30. For example, an image can be displayed on the display to allow a user or operator to accurately move a guide catheter or guidewire into an appropriate position.

In order to clarify the direction, a rectangular coordinate system with an X-axis, a Y-axis and a Z-axis is introduced. The positive X-axis is oriented in the longitudinal (axial) distal direction, i.e. in the direction from the proximal end to the distal end, in other words, from the proximal side to the distal side. The Y-axis and the Z-axis are in a transverse plane of the X-axis, wherein the positive Z-axis is oriented upward, i.e. in the direction opposite to gravity, and the Y-axis is automatically determined by the right-hand rule. As used herein, the X-axis extends along the longitudinal axis of the robot drive 24. Since in the use position, the robot housing can be at an angle relative to a horizontal plane perpendicular to the direction of gravity, the X-axis, the Y-axis and the Z-axis are defined by the robot drive 24. Referring to FIG. 1 , the robot drive 24 includes a housing having: a top or first member 24a parallel to the X-Y plane; a bottom or second member parallel to and spaced from the first member 24a; a front or third member 24c substantially perpendicular to and extending between the first and second members 24a, the third member facing the user when the robot drive 24 is in the use position or orientation shown in FIG. 1 . The fourth member is spaced apart from and substantially parallel to the third member 24c, and perpendicular to the first and second members 24a, 24b. It is contemplated that other shapes of robot drive housings may be used. In this case, the first member 24a would be the upper member, the second member would be the lower or bottom member, the front or third member 24c would be the portion facing the user in the use position during surgery, and the fourth member would be the portion facing away from the user in the use position during surgery. The robot drive 24 also includes a distal region 24e and a proximal region 24f. Wherein the distal region 24e is closer to the patient entry point through which the EMD will be introduced, and the proximal region 24f is farthest from the patient entry point through which the EMD will be introduced.

FIG. 2 is a block diagram of a catheter-based surgical system 10 according to an example embodiment. The catheter surgical system 10 may include a control computing system 34. The control computing system 34 may be physically part of a control station, for example. The control computing system 34 may generally be an electronic control unit suitable for providing the various functions described herein for the catheter-based surgical system 10. For example, the control computing system 34 may be an embedded system, a dedicated circuit, a general-purpose system programmed with the functions described herein, etc. The control computing system 34 communicates with the bedside unit 20, a communication system and service 36 (e.g., the Internet, a firewall, a cloud service, a session manager, a hospital network, etc.), a local control station 38, an additional communication system 40 (e.g., a telepresence system), a remote control station and computing system 42, and a patient sensor 56 (e.g., an electrocardiogram (ECG) device, an electroencephalogram (EEG) device, a blood pressure monitor, a temperature monitor, a heart rate monitor, a respiratory monitor, etc.). The control computing system also communicates with the imaging system 14, the patient table 18, additional medical systems 50, a contrast injection system 52, and accessory devices 54 (e.g., IVUS, OCT, FFR, etc.). The bedside unit 20 includes a robotic drive 24, a positioning system 22, and may include additional controls and displays 46. As described above, the additional controls and displays may be located on the housing of the robotic drive 24. Interventional devices and accessories 48 (e.g., guidewires, catheters, etc.) are docked to the bedside unit 20. In one embodiment, the interventional devices and accessories 48 may include specialized devices (e.g., IVUS catheters, OCT catheters, FFR guidewires, diagnostic catheters for angiography, etc.) that are docked to their respective accessory devices 54, i.e., IVUS systems, OCT systems, FFR systems, etc.

In various embodiments, the control computing system 34 is configured to generate control signals based on user interaction with the input module 28 (e.g., of a control station (such as a local control station 38 or a remote control station 42)) and/or based on information accessible to the control computing system 34 so that a medical procedure can be performed using the catheter-based surgical system 10. The local control station 38 includes one or more displays 30, one or more input modules 28, and additional user controls 44. The remote control station and computing system 42 may include components similar to the local control station 38. The remote control station 42 and the local control station 38 may be different and customized based on their desired functions. The additional user controls 44 may include, for example, one or more foot input controls. The foot input controls may be configured to allow a user to select functions of the imaging system 14, such as turning X-ray on and off and scrolling through different stored images. In another embodiment, the foot input device may be configured to allow a user to select which devices are mapped to a scroll wheel included in the input module 28. Additional communication systems 40 (eg, audio conferencing, video conferencing, telepresence, etc.) may be employed to assist the operator in interacting with the patient, medical staff (eg, vascular laboratory staff), and/or equipment near the bedside.

The catheter-based surgical system 10 may be connected or configured to include any other systems and/or devices not explicitly shown. For example, the catheter-based surgical system 10 may include an image processing engine, a data storage and archiving system, an automated balloon and/or stent expansion system, a drug injection system, a drug tracking and/or recording system, a user log, an encryption system, a system for limiting access to or use of the catheter-based surgical system 10, and the like.

As described, the control computing system 34 communicates with the bedside unit 20, which includes the robotic drive 24, the positioning system 22, and may include additional controls and a display 46; and may provide control signals to the bedside unit 20 to control the operation of motors and drive mechanisms used to drive percutaneous interventional devices (e.g., guidewires, catheters, etc.). Various drive mechanisms may be provided as part of the robotic drive 24.

Referring to FIG. 3 , the device module 32a includes a first drive module 60 and a first box 68. The device module 32b includes a second drive module 62 and a second box 70. The device module 32c includes a third drive module 64 and a third box 72. The device module 32d includes a fourth drive module 66 and a fourth box 74. In one embodiment, the first box 68, the second box 70, the third box 72, and the fourth box 74 are transported together as a multi-unit box assembly. In one embodiment, the multi-unit box assembly 76 allows each box to be removably connected to their respective drive modules while being slidably connected together. In one embodiment, each of the plurality of device modules 32a-d can be independently actuated to move linearly along a linear member within the robot drive 24. Each device module 32a-d can move independently relative to each other and the linear members in the robot drive. The drive mechanism moves each device module along the longitudinal axis 78 of the robot drive 24, which is also referred to as the robot drive longitudinal axis 78 in this article. The robot drive longitudinal axis 78 can extend along a linear member (such as a screw drive along which the equipment module moves), or can be defined along another axis parallel to the linear member along which the equipment module moves. Referring to Figure 3, each box 68-74 is typically oriented vertically in the XZ plane. The length of each box 68-74 along the X-axis or parallel to the longitudinal axis 78 is greater than the width of each box along the Y-axis or perpendicular to the Y-axis. PCT International Publication No. WO 2021/011533, which is incorporated herein by reference in its entirety, discloses a box positioned in a substantially horizontal position in the XY plane. The distinction between vertical and horizontal of the box is described in PCT International Publication No. WO 2021/011554, and is incorporated herein by reference in its entirety.

Referring to WO 2021/011554, in one embodiment, the drive mechanism includes an independent platform translation motor and a platform drive mechanism (such as a screw via a rotating nut, a rack via a pinion, a belt via a pinion or pulley, a chain via a sprocket) coupled to each equipment module, or the platform translation motor 64a-d itself can be a linear motor. The drive mechanism provides advancement and retraction of the equipment module. An example of such a drive mechanism is described in WO 2021/011533.

To prevent the patient from being contaminated by pathogens, medical staff use aseptic techniques (shown in Figure 1) in the room accommodating bedside unit 20 and patient 12 or experimenter. The room accommodating bedside unit 20 and patient 12 can be, for example, a catheter laboratory or a vascular room. Aseptic techniques consist of using a sterile barrier, sterilizing equipment, appropriate patient preparation, environmental control and contact guidelines. Therefore, all EMDs and interventional accessories are sterilized and can only be contacted with a sterile barrier or sterilizing equipment. In one embodiment, a sterile cover cloth (not shown) is placed on non-sterile robot drive 24. Each box 68-74 is sterilized and serves as a sterilization interface between the robot drive 24 covered and at least one EMD. Each box 68-74 can be designed to be disposable and sterilized, or sterilized again in whole or in part so that box 68-74 or its parts can be used in multiple operations.

Distal and proximal: The terms distal and proximal define the relative position of two different features. With respect to the robotic drive, the terms distal and proximal are defined by the position of the robotic drive relative to the patient in its intended use. When used to define relative positions, a distal feature is a feature of the robotic drive that is closer to the patient than a proximal feature when the robotic drive is in its intended use position. In the patient, any vascular system landmark that is farther away from the access point along the path is considered to be farther away than a landmark that is closer to the access point, where the access point is the point where the EMD enters the patient. Similarly, a proximal feature is a feature that is farther from the patient than a distal feature when the robotic drive is in its intended use position. When used to define a direction, a distal direction refers to a path on which something moves or is intended to move or something points from a proximal feature to or faces a distal feature and/or a patient when the robotic drive is in its intended use position. The proximal direction is the direction opposite to the distal direction. By reference to the example of FIG. 1 , the robotic device is shown from the perspective of an operator facing the patient. In this arrangement, the distal direction is along the positive X-coordinate axis and the proximal direction is along the negative X-coordinate axis.

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

Axial movement: The term axial movement of a member refers to the translation of a member along the longitudinal axis of the member. When the distal end of the EMD moves axially in the distal direction along its longitudinal axis into or further into the patient, the EMD is being advanced. When the distal end of the EMD moves axially in the proximal direction along its longitudinal axis away from or further away from the patient, the EMD is being withdrawn.

Rotational movement: The term rotational movement of a component refers to a change in the angular orientation of a component about the local longitudinal axis of the component. Rotational movement of an EMD corresponds to a clockwise or counterclockwise rotation of the EMD about its longitudinal axis due to an applied torque.

Axial and Lateral Insertion: The term axial insertion refers to the insertion of the first member into the second member along the longitudinal axis of the second member. The EMD loaded axially in the collet is inserted axially into the collet. An example of an axial insertion may refer to backloading a catheter over the proximal end of a guidewire. The term lateral insertion refers to the insertion of the first member into the second member in a direction in a plane perpendicular to the longitudinal axis of the second member. This may also be referred to as radial loading or side loading. In other words, lateral insertion refers to the insertion of the first member into the second member in a direction parallel to the radius and perpendicular to the longitudinal axis of the second member.

Up/Down; Front/Back; Inward/Outward: The terms top, upward, and upper refer to the general direction away from the direction of gravity, and the terms bottom, downward, and lower refer to the general direction in the direction of gravity. The term "front" refers to the side of the robot drive facing the bedside user and away from the positioning system (such as an articulated arm). The term "back" refers to the side of the robot drive closest to the positioning system (such as an articulated arm). The term inward refers to the inner part of the feature. The term outward refers to the outer part of the feature.

Platform: The term platform refers to a member, feature, or device used to couple an equipment module to a robotic drive. For example, the platform can be used to couple an equipment module to a track or linear member of a robotic drive.

Drive module: The term drive module generally refers to a component (eg, a main component) of a robot drive system, which typically includes one or more motors with a drive coupling that is connected to a cartridge.

Equipment module: The term equipment module refers to the combination of a driver module and a cassette.

Cartridge: The term cartridge generally refers to a component (non-primary, consumable or sterilizable unit) of a robotic drive system, which is typically a sterile interface between a drive module and at least one EMD (directly) or through a device adapter (indirectly).

Shaft (distal) drive: The term shaft (distal) drive refers to grasping the EMD and manipulating the EMD along its shaft. In one example, the on-device adapter is typically placed just proximal to the hub or Y-connector into which the device is inserted. If the location of the on-device adapter is near the insertion point (to the body or another catheter or valve), shaft drive typically does not require an anti-buckling feature. (It may include an anti-buckling feature to improve driveability.)

Collet: The term collet refers to a device that releasably secures a portion of an EMD. The term secured herein refers to the absence of intentional relative movement of the collet and the EMD during operation. In one embodiment, the collet includes at least two components that rotate and move relative to each other to releasably secure the EMD to at least one of the two components. In one embodiment, the collet includes at least two components that rotate and move relative to each other axially (along a longitudinal axis) to releasably secure the EMD to at least one of the two components. In one embodiment, the collet includes at least two components that rotate and move axially relative to each other to releasably secure the EMD to at least one of the two components.

Fixed: The term fixed means that during operation, there is no intentional relative movement of a first component with respect to a second component.

Clamp/Unclamp: The term clamp refers to releasably securing the EMD to a component so that when the component moves, the EMD and the component move together. The term unclamp refers to releasing the EMD from the component so that the EMD is no longer secured to the component, but is not secured to the component, and the EMD moves independently of the component.

On-device adapter: The term on-device adapter refers to a sterilization device that is capable of releasably clamping an EMD to provide a drive interface. The on-device adapter is also referred to as an end effector or EMD capture device. In one non-limiting embodiment, the on-device adapter is a chuck that is operably robotically controlled to rotate the EMD about its longitudinal axis, clamp the EMD to the chuck and/or unclamp the EMD from the chuck, and/or translate the EMD along its longitudinal axis. In one embodiment, the on-device adapter is a hub drive mechanism, such as a gear located on the hub of the EMD.

EMD: The term elongated medical device (EMD) refers to, but is not limited to, catheters (e.g., guide catheters, microcatheters, balloon/stent catheters), wire-based devices (e.g., guidewires, embolic coils, stent retrievers, etc.), and medical devices comprising any combination of these. In one example, wire-based EMDs include, but are not limited to, guidewires, microwires, proximal pushers for embolic coils, stent retrievers, self-expanding stents, and shunts. Typically, wire-based EMDs do not have a hub or handle at their proximal terminals. In one embodiment, the EMD is a catheter having a hub at the proximal end of the catheter and a flexible shaft extending from the hub to the distal end of the catheter, wherein the shaft is more flexible than the hub. In one embodiment, the catheter includes an intermediate portion transitioning between the hub and the shaft, the intermediate portion having an intermediate flexibility that is less rigid than the hub and more rigid than the shaft. In one embodiment, the intermediate portion is a strain relief.

Hub (proximal) drive: The term hub drive or proximal drive refers to the grasping and manipulation of the EMD from a proximal location (e.g., a gear adapter on the catheter hub). In one embodiment, hub drive refers to the application of force or torque to the hub of the catheter to translate and/or rotate the catheter. Hub drive may cause the EMD to buckle, and therefore hub drives generally require anti-buckling features. For devices 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 any mechanism for manipulating features within the catheter, such as a wire extending from a handle to the distal end of the catheter to deflect the distal end of the catheter.

Sterilizable Unit: The term sterilizable unit refers to a device that is capable of being sterilized (free of pathogenic microorganisms). This includes, but is not limited to, boxes, consumable units, drapes, device adapters, and sterilizable drive modules/units (which may include electromechanical components). Sterilizable units may come into contact with the patient, other sterile equipment, or anything placed within the sterile area of a medical procedure.

Sterile interface: The term sterile interface refers to the interface or boundary between sterile and non-sterile units. For example, a box can be a sterile interface between a robotic drive and at least one EMD.

Consumable: The term consumable refers to a sterilizable unit that typically has a single use in a medical procedure. The unit may be a reusable consumable that is used in another medical procedure through a resterilization process.

Gear: The term gear may be a bevel gear, spiral bevel gear, spur gear, helical gear, worm gear, spiral gear, rack and pin, screw gear, internal gear (such as sun gear, involute spline shaft, and bushing), or any other type of gear known in the art.

4, the torquer actuator 100 includes a torquer 102 and a torque limiting actuator 104. The torquer actuator 100 includes a housing 106 formed by a proximal housing member 108, which is operably connected to a distal housing member 110. A pusher 112 is movably received within the housing 106 along a torquer longitudinal axis 114 between a proximal end 116 of the housing and a distal end 118 of the housing 106. A first pad 120 and a second pad 122 move toward and away from the torquer longitudinal axis 114 to releasably clamp the shaft of an elongated medical device (EMD). A biasing member 124 biases the first pad 120 and the second pad 122 away from each other. Movement of the pusher 112 from the proximal end 116 to the distal end 118 forces the first pad 120 and the second pad 122 to move toward each other and provide sufficient force to overcome the biasing force of the biasing member 124. Movement of the pusher 112 from the distal end 118 to the proximal end 116 allows the biasing member 124 to bias the first and second pads 120 , 122 away from each other and away from the torquer longitudinal axis 114 .

In one embodiment, the first liner 120 includes a first portion 128 and a second portion 130 that contacts the EMD in the engaged position. The first portion 128 of the first liner 120 includes an outer surface having a proximal bevel 132 and a distal bevel 134. Similarly, the second liner 122 includes a first portion 129 and a second portion 131 that contacts the EMD in the engaged position. The first portion 129 includes a proximal bevel 138 and a distal bevel 140.

The distal shell member 110 includes a first bevel 142 and a second bevel 144. The pusher 112 includes a first bevel 146 and a second bevel 148. As the pusher 112 moves from the proximal position to the distal position, the first bevel 146 and the second bevel 148 of the pusher 112 contact the proximal bevel 132 and the second bevel 148 of the first liner 120 and the second liner 122, respectively. Similarly, the distal bevel 134 and the distal bevel 140 contact the first bevel 142 and the second bevel 144 of the distal shell member 110, respectively. The contact of the bevel portions forces the first liner 120 and the second liner 122 toward each other in a direction substantially perpendicular to the longitudinal axis 114 of the torquer, thereby clamping the EMD between them. The operation of the torquer for an elongated medical device is described in the publication WO 2022/154977 entitled "Torquer For An Elongated Medical Device" and is incorporated herein in its entirety.

By manipulating the torque limiting actuator 104, the pusher 112 is moved distally within the distal housing member 110. Referring to FIGS. 7 and 8, the torque limiting actuator 104 includes a shaft 150 that is threadedly engaged with the proximal housing member 108. The shaft 150 includes a distal end operably connected to the pusher 112, such that movement of the shaft 150 in the distal direction moves the pusher 112 in the distal direction, and movement of the shaft 150 in the proximal direction moves the pusher 112 in the proximal direction. The pusher 112 has a distal end 152 that pushes a proximal end 158 of the pusher 112 in the distal direction. The pusher 112 includes a pair of arms 156 that engage a distal hub 154 of the shaft 150 so that when the shaft 150 moves in the proximal direction, the pusher 112 also moves in the proximal direction.

The torque limiting actuator 104 includes a knob 160 that is secured to the shaft 150 using a fastener 162. Referring to FIG. 8B , the knob 160 includes an outer surface 164 that is manipulated by an operator and an inner cavity 166 defined by a cavity wall 168. In one embodiment, the cavity wall includes a profile defined by a plurality of spaced ribs 170 that actively mesh with a profile on a drive gear 172 that 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. Rotation of the knob 160 in a first direction causes the drive gear 172 to rotate, which in turn rotates the driven gear 174 and the shaft 150 in the first direction. When the knob 160 is rotated in the first direction, the shaft 150 moves in a distal direction within a threaded region 176 of the proximal housing member 108. Then, movement in the distal direction moves the pusher 112 in the distal direction, which causes the first liner 120 and the second liner 122 to move toward each other to clamp the EMD. In one embodiment, the contour of the cavity wall is a plurality of splines that mesh with mating splines of a housing supporting the drive gear 172. The mating splines prevent rotational movement between the knob 160 and the drive gear 172, but allow axial movement between the knob 160 and the drive gear 172 along the torquer longitudinal axis 114.

The biasing member 178 is located within the cavity 166 of the knob 160 and is used to bias the drive gear 172 into engagement with the driven gear 174. Referring to FIG. 8A , the driven gear 174 and the drive gear 172 are face gears in that they face each other and rotate about a common axis, in this case, the drive gears 172 and 174 rotate about the torquer longitudinal axis 114. The drive gear 172 includes a plurality of gear teeth 180 having a first face 182 and a second face 184, wherein the angle of the first face 182 is less than the angle of the second face 184. In one embodiment, the angle of the first face 182 is equal to or greater than the angle of the second face 184. Similarly, the driven gear 174 has a plurality of gear teeth 186 having a first face 188 and a second face 190 that mesh with the first face 182 and the second face 184 of the gear teeth 180.

The driving gear 172 and the driven gear 174 act as a clutch, wherein the driving gear 172 is a first clutch plate and the driven gear 174 is a second clutch plate. When the torque exceeds a predetermined value, the first face 182 of the gear tooth 180 arches upward and passes over the corresponding first face 188 of the gear tooth 186, thereby causing the driving gear 172 to slip relative to the driven gear 174. In other words, the manner in which the gear teeth overlap each other rather than remain in meshing during the application of a predetermined torque is referred to herein as slipping.

As the knob 160 is rotated in the first direction, the shaft 150 will continue to move the first pad 120 and the second pad 122 toward each other to clamp the EMD until the torque required to continue to move the first pad 120 toward the second pad 122 exceeds the predetermined force. Once the predetermined force is reached, the spring force of the biasing member 178 will no longer be sufficient to keep the gear teeth 180 from transmitting movement to the gear teeth 186. The predetermined force rotation of the knob 160 in the first direction will cause the gear teeth 180 to slide over the gear teeth 186, thereby providing an audible click and tactile feedback to the user when the first face 182 of the gear teeth 180 slides upward and slides over the first face 188 of the gear teeth 186. In this way, the torque limiting actuator 104 acts as a clutch that limits the amount of force and torque that can be applied to the EMD when the first pad 120 and the second pad 122 clamp the EMD, even if the operator continues to rotate the knob 160 in the first direction once the predetermined force is reached.

As described, the angles of the second face 184 of the gear teeth 180 and the second face 190 of the gear teeth 186 are greater than the angles of the first face 182 and the first face 188 of the gear teeth 180 and the gear teeth 186, respectively. In one embodiment, the angle of the second face 184 and the second face 190 is less than or equal to the angle of the first face 182 and the first face 188. When the knob 160 is rotated in a second direction opposite to the first direction, the angle is sufficient to prevent the second face 184 of the gear teeth 180 from sliding upward and sliding over the second face 190 of the gear teeth 186. In one embodiment, the rotation in the first direction is a clockwise (CW) direction, which is the convention for tightening/engaging the torquer to the EMD, and the second direction is a counterclockwise (CCW) direction, which is the convention for loosening/disengaging the torquer from the EMD. In other words, rotation in the counterclockwise direction will cause the liner to open. Tightening and loosening of the torque device occurs in two main scenarios: in free space, where the torque device is held in the operator's hand; and installed in a disposable box, where the lid is closed.

The housing 106 includes a gear 126 operably secured to the housing 106 , which is driven by the actuator to rotate the torquer actuator 100 with the EMD 220 once the EMD 220 has been secured to the torquer 102 .

9, the biasing member 124 includes a base portion 190 having a hole 194 that receives a portion of the shaft 150. The shaft 150 and the biasing member 124 are free to move independently of each other along the torquer longitudinal axis 114. The biasing member 124 includes a first arm 196 and a second arm 198 that are spaced apart from each other and 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 that engage a portion on a first side 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 that engage a portion on a second side of the first pad 120 and the second pad 122. The first and second sides of the first and second pads 120 and 122 are spaced apart from the torquer longitudinal axis 114 and in opposite directions of the torquer longitudinal axis 114. The branches 200, 202, 204 and 206 are preloaded to bias the first liner 120 and the second liner 122 away from each other in both an engaged position in which the first liner 120 and the second liner 122 clamp the EMD and a disengaged position in which the first liner 120 and the second liner 122 do not engage with the EMD and clamp the EMD. In one embodiment, there is only one arm 196 and there is no second arm 198. In one embodiment, more than two arms are used. The branches 200 and 202 are biased to push the liner 120 and the liner 122 away from each other.

10 , the torquer actuator 100 is located within the cartridge 70 such that the knob 160 extends outside the cartridge 70 so that a user can manipulate the knob 160 to rotate the knob 160 in both a first CW direction and a second CCW direction. Note that the torquer actuator 100 includes a guide tube 208 extending from the distal end of the distal housing member 110 to guide the EMD through the cartridge 70.

11 , a stop member is used in conjunction with the torque limiting actuator 104, or independently of the torque limiting actuator 104, to limit the movement of the pusher 112 in the distal direction and thereby limit the amount of force that can be applied between the first pad 120 and the second pad 122. A pusher stop member 210 can be placed on a distal portion of the pusher 112 or on a portion of the distal housing member 110 that will prevent the pusher 112 from moving in the distal direction upon contact with the stop member 210. The first stop member 210 will limit the pusher 112 from moving distally beyond a certain point and will therefore limit the amount of force applied to the EMD 220.

In one embodiment, a second pad stop member 212 can be positioned on an interior portion of the distal housing member 110 which will contact one or both of the first pad 120 and the second pad 122 to prevent the pads from moving distally and thereby limit movement of the pads toward each other, thereby limiting the force applied to the EMD 220.

In one embodiment, the actuator 214 of the drive gear 126 may have a built-in torque limiting mechanism that is mechanical or electromechanical and controlled by a controller.

In one embodiment, a knob stop 216 can be placed on the knob 160 or the proximal housing member 108 which will limit the distance the shaft 150 can extend into the housing 106, thereby limiting the distal travel of the pusher 112, the first pad 120 and the second pad 122, thereby limiting the movement of the first pad 120 and the second pad 122 toward each other and thereby limiting the clamping force applied by the pads to the EMD.

In one embodiment, the lid 218 is configured to automatically move from the closed use position to the open position when the torque applied to the torquer actuator 100 exceeds a predetermined torque. This will provide a visual indication that the torque has exceeded the predetermined force. The opening of the lid 218 and the audible and tactile feedback provide visual feedback that the predetermined torque has been reached.

The device described herein has many features. The first torque limiting actuator 104 provides audible and/or tactile feedback to the user that they have applied enough torque to the torquer to ensure that enough torque and force can be applied to the inserted elongated transcutaneous device (EMD). Once the predetermined torque is reached, the user is alerted via audible and tactile feedback of the first gear sliding over the second gear. This eliminates the situation where the torque applied by the EMD slipping within the torquer as the torquer rotates is too small, resulting in poor performance.

The torque limiting actuator 104 limits the torque that can be applied to the torquer 102. This allows lightweight and low-cost materials/processes, such as injection molded plastics, to be used in the design. The torque limiting knob 160 prevents strong users from damaging the torque device while providing a large enough diameter so that weaker users can provide the required knob torque. Wherein the second portion 130 is an elastic contact pad that limits the torque applied to the torquer, and therefore the force applied by the pad and EMD avoids damaging the coated EMD used in the operation. This type of design requires high force and low contact friction between the sliding elements. By limiting the applied torque, the coating of the EMD can be protected and not damaged.

The torquer actuator 100 is used to protect the components of the robot drive 24 from high torque. The torquer actuator 100 is tightened in place in a disposable cartridge mounted on the system robot. High torque may damage the robot drive, thereby preventing the use of the system. 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 24.

In one embodiment, a torquer 102 for an 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 of which has a cavity therein. Referring to FIGS. 5 and 11 , the EMD 220 extends through a path defined by an opening or passage through a fastener 162, a knob 160, a biasing member 178, a drive gear 172, a shaft 150, a proximal housing member 108, a biasing member 124, a pusher 112, a distal housing member 110, and a guide tube 208. The first pad 120 is movable within the cavity. The biasing member 178, which is separate from the first pad 120, biases the first pad 120 relative to the body. The actuator is movable relative to the body, which moves the first pad to clamp and/or unlock the elongated medical device, wherein the first pad is within the path. The knob is releasably connected to the actuator when a predetermined torque exceeding a predetermined value is applied.

Although the present disclosure has been described with reference to example embodiments, those skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the defined subject matter. For example, although different example embodiments may have been described as including one or more features that provide one or more benefits, it is conceivable that the described features may be interchangeable or alternatively combined with each other in the described example embodiments or in other alternative embodiments. The present disclosure described is clearly intended to be as broad as possible. For example, unless otherwise specifically noted, a definition that lists a single specific element also covers a plurality of such specific elements.

Claims (22)

1. An apparatus for manipulating an elongate medical device, comprising:

A torque releasably securing an Elongate Medical Device (EMD) thereto; and

A torque limiting actuator that limits torque applied to the torque converter.

2. The apparatus of claim 1, wherein the torque limiting actuator limits torque applied to the torque converter to a predetermined torque.

3. The apparatus of claim 1, wherein the torque limiting actuator comprises a manual operator and a clutch that prevents torque applied to the torque device from exceeding a predetermined torque.

4. The apparatus of claim 1, wherein the torque limiting actuator comprises a knob that is manually rotated about a longitudinal axis of the torque device, a biasing member between a portion of the knob and a first clutch member, wherein the first clutch member applies torque to a second clutch member until a predetermined torque between the first clutch member and the second clutch member is reached.

5. The apparatus of claim 1, wherein the torque limiting actuator limits torque applied to the actuator in a first direction, but not in a second, opposite direction.

6. The apparatus of claim 1, wherein the torquer comprises a torquer body and a pusher movable within the torquer body to move at least a first pad in a direction perpendicular to a longitudinal axis of a torquer to clamp the EMD.

7. The apparatus of claim 1, wherein a clamping force between the torque device and the EMD perpendicular to a longitudinal axis of the torque device is a function of a torque applied to the torque device by the torque limiting actuator.

8. The apparatus of claim 3, wherein the clutch is a spring biased first gear engaged with a second gear.

9. The apparatus of claim 8, wherein the spring biased first gear slips relative to the second gear once a predetermined torque between the first gear and the second gear is exceeded.

10. The apparatus of claim 6, wherein the torquer comprises a second liner spaced apart from the first liner and movable toward and away from the first liner to releasably clamp the EMD.

11. The apparatus of claim 10, further comprising a biasing member having a pair of arms spaced apart from each other and spaced apart from a longitudinal axis of the torque device.

12. The apparatus of claim 1, wherein the torque limiting actuator comprises a shaft having a portion threadably secured to a body of the torque device and a distal portion operable to move a pad into engagement with the EMD upon rotation of the shaft relative to the body.

13. The apparatus of claim 12, wherein the torque limiting actuator comprises a drive gear and a biasing member that biases the drive gear into engagement with a driven gear fixed to the shaft, the drive gear.

14. The apparatus of claim 13, wherein the torque limiting actuator comprises a knob that is manually rotated relative to the body, the knob being releasably connected to the shaft upon application of a predetermined torque.

15. The apparatus of claim 1, wherein the torque limiting actuator provides an indication to a user once sufficient torque has been applied to the torque converter.

16. A torque machine for an elongate medical device:

A body having a cavity defining a path;

A first liner 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 moves the first pad, wherein movement of the first pad clamps and/or unclamps the elongate medical device having the first pad within the path; and

A knob releasably connected to the actuator when a predetermined torque exceeding a predetermined value is applied.

17. An EMD drive system, comprising:

A robotic drive having a robotic drive longitudinal axis;

An equipment module movable along the robot drive longitudinal axis; and

A drive train coupling a motor to a driven member configured to rotate a torque that clamps an Elongate Medical Device (EMD) about a EMD longitudinal axis, the torque including a torque limiting actuator that is manually user-accessible when the torque is in a use position in a drive module.

18. The EMD drive system of claim 17, wherein the torque limiting actuator limits torque applied to the torque converter to a predetermined torque.

19. The EMD drive system of claim 17, wherein the torque limiting actuator comprises a manual operator and a clutch that prevents torque applied to the torque device from exceeding a predetermined torque.

20. The EMD drive system of claim 17, wherein the torque limiting actuator comprises a knob that is manually rotated about a longitudinal axis of the torque converter, a biasing member between a portion of the knob and a first clutch member, wherein the first clutch member applies torque to a second clutch member until a predetermined torque between the first clutch member and the second clutch member is reached.

21. The EMD drive system of claim 17, wherein the torque device is movable from a first device module to a second device module.

22. The EMD drive system of claim 17, wherein the torque converter comprises a torque limiting actuator that limits torque applied to the driveline beyond a predetermined torque.