Torquers for elongated medical devices

Abstract

A torquer for an elongate medical device includes a body having a cavity defining a passageway. A first jaw is movable within the cavity. The first jaw includes a pad having a compliant characteristic. A biasing member separate from the first jaw biases the first jaw against the body. An actuator movable relative to the body actuates the first jaw to pinch and / or unpinch the elongate medical device with the pad within the passageway.

Description

[Background technology]

[0001] 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 intervention (NVI), also known as neurointerventional surgery, percutaneous coronary intervention (PCI), and peripheral vascular intervention (PVI). These procedures typically involve navigating a guidewire through the vascular system and advancing a catheter over the guidewire to perform the treatment. Catheter-based procedures begin with standard percutaneous techniques to access an appropriate vessel, such as an artery or vein, using an introducer sheath. A sheath or guide catheter is then advanced over the introducer sheath to a primary location, such as the internal carotid artery for NVI, the coronary ostium for PCI, or the superficial femoral artery for PVI. A guidewire appropriate for the vascular system is then navigated through the sheath or guide catheter to the target location within the vascular system. In situations such as tortuous anatomy, a support catheter or microcatheter is inserted over the guidewire to aid in the navigation of the guidewire. An operator, such as a physician, can use an imaging system (e.g., fluoroscopy) to obtain contrast injection cines and select a fixed frame to use as a roadmap to navigate the guidewire or catheter to a target location, such as a lesion. Contrast images are also obtained while the operator advances the guidewire or catheter, allowing the operator to verify that the device is moving along the correct path to the target location. While viewing the anatomy using fluoroscopy, the operator manipulates the proximal end of the guidewire or catheter, directing the distal tip into the appropriate vessel and toward the target anatomical location (e.g., a lesion), avoiding entry into side branches.

[0002] Robotic catheter-based treatment systems have been developed that are used to assist physicians in performing catheter-based procedures such as NVI, PCI, and PVI. Examples of NVI procedures include coil embolization of aneurysms, liquid embolization of arteriovenous malformations, and mechanical thrombectomy of large vessel occlusions in the setting of acute ischemic stroke. In NVI procedures, physicians use the robotic system to gain access to the target lesion by controlling the manipulation of a neurovascular guidewire and a microcatheter to administer a treatment that restores normal blood flow. Access to the target is provided by a sheath or guide catheter, but intermediate catheters may be required for more distal regions or to provide adequate support for the microcatheter and guidewire. The distal tip of the guidewire is navigated into or past 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 embolization coils are placed into the aneurysm through the microcatheter and used to block blood flow into the aneurysm. When treating an arteriovenous malformation, a liquid embolus is injected into the malformation via a microcatheter. Mechanical thrombectomy to treat vascular occlusion is accomplished by either or both of aspiration and the use of a stent retriever. 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 is in the lesion, negative pressure is applied through the catheter to remove the thrombus. Alternatively, the thrombus can be removed by placing a stent retriever through the microcatheter. After the thrombus is entangled with the stent retriever, it is retrieved by retracting the stent retriever and the microcatheter (or intermediate catheter) into the guide catheter.

[0003] In PCI, the physician uses a robotic system to manipulate a coronary guidewire to access the lesion, perform treatment, and restore normal blood flow. Access is achieved by seating a guide catheter at the coronary ostium. The distal tip of the guidewire is navigated past the lesion, and for complex anatomy, a microcatheter can be used to properly support the guidewire. Blood flow is restored by delivering and deploying a stent or balloon at the lesion. The lesion may require pretreatment prior to stent placement, and a balloon is delivered to predilatate the lesion, or atherectomy is performed, for example, using a laser or a rotational atherectomy catheter and balloon over the guidewire. Imaging and physiologic measurements can be performed to determine the appropriate treatment using imaging catheters or fractional flow reserve (FFR) measurements.

[0004] In PVI, physicians use a robotic system to perform the procedure and restore blood flow using techniques similar to NVI. The distal tip of a guidewire is navigated to the lesion, and a microcatheter is used to properly support the guidewire in complex anatomical structures. A stent or balloon is delivered to the lesion and deployed to restore blood flow. As with PCI, pre-treatment of the lesion and imaging are also used.

[0005] When support at the distal end of the catheter or guidewire is required, for example, for navigation of tortuous or calcified vasculature, to reach distal anatomical locations, or to cross sclerosing lesions, over-the-wire (OTW) catheters or coaxial systems are used. OTW catheters have a guidewire lumen that runs the entire length of the catheter. This provides support for the guidewire over its entire length, making it a relatively stable system. However, this system has some weaknesses, such as higher friction and a longer overall length, when compared to rapid exchange catheters (described below). Typically, to remove or exchange an OTW catheter while maintaining the position of the indwelling guidewire, the exposed length of the guidewire (out of the patient) must be longer than that of the OTW catheter. A guidewire of 300 cm in length is generally sufficient for this purpose, and is often referred to as an exchange-length guidewire. Due to the length of this guidewire, two operators are required to remove or exchange an OTW catheter. This becomes even more difficult when using triple coaxial systems, known in the art as triaxial systems (quadruplex coaxial catheters have also been known to be used). However, because of their stability, OTW systems are often used in NVI and PVI procedures. Meanwhile, rapid exchange (or monorail) catheters are often used in PCI procedures. The guidewire lumen of a rapid exchange catheter only passes through the distal portion of the catheter, called the monorail or rapid exchange (RX) section. Operators using RX systems manipulate the interventional devices parallel to each other (as opposed to the tandem configuration of the devices in OTW systems), and the exposed length of the guidewire only needs to be slightly longer than the RX section of the catheter. Rapid exchange guidewires are typically 180-200 cm long. Given the short length of the guidewire and monorail, RX catheters can be exchanged by a single operator. However, RX catheters are often inappropriate when more distal support is required.

[0006] During a procedure, various wire-like devices, such as guidewires, stent retrievers, coils, etc., are grasped by their shafts to linearly and / or rotationally manipulate the device within the patient's anatomy. EMDs are typically held in the operator's fingers or by a pin vice-like device commonly known as a torquer.

[0007] The torquer is used by an operator to pinch and unpinch a portion of the EMD, such as a guidewire, during a procedure. The torquer is used to releasably secure a portion of the EMD, allowing the user to manipulate the EMD, such as by rotating and / or translating the EMD.

[0008] The diameter of the devices used in the procedure varies from 0.009-0.038 inch (0.229-0.965 mm) outside diameter (OD). Commercially available torquers are generally designed for a specific OD device. For example, one torquer is used to operate a 0.014 inch (0.356 mm) OD device and another torquer is used to operate a 0.038 inch (0.965 mm) OD device. Summary of the Invention

[0009] A torquer for an elongate medical device includes a body having a cavity defining a passageway within which a first jaw is operable. The first jaw includes a flexible pad. A biasing member separate from the first jaw biases the first jaw against the body. An actuator movable relative to the body actuates the first jaw to pinch and / or unpinch the elongate medical device with the pad within the passageway. In one embodiment, the flexible pad is formed from an elastomeric material. In one embodiment, the actuator is a knob.

[0010] In one aspect, a torquer for releasably gripping an elongate medical device includes a body having a cavity defining a passageway. At least two jaws are operable within the cavity, each of the jaws having a pad base and a pad secured to the pad base. The jaws are unconnected to one another. A biasing member separate from the jaws biases the jaws against the body. A knob movable relative to the body moves the jaws relative to one another to pinch or unpinch the elongate medical device with the pad within the passageway.

[0011] In one aspect, a torquer for releasably gripping an elongate medical device includes a body having a cavity defining a passageway. At least two jaws are operable within the cavity, each of the jaws having an elastomeric pad. The jaws are not connected to one another. A biasing member separate from the jaws biases the jaws against the body. A knob movable relative to the body moves the jaws relative to one another to pinch or unpinch the elongate medical device with the pad within the passageway. Pressure between the elastomeric pad and the elongate medical device is approximately equalized across the elastomeric pad in a fully pinched condition. [Brief description of the drawings]

[0012] [Figure 1] 1 is a schematic diagram of a catheter-based treatment system according to an embodiment. [Diagram 2] 1 is a schematic block diagram of a catheter-based treatment system according to an embodiment. [Diagram 3] 1 is a perspective view of a bedside system of a catheter-based treatment system according to an embodiment. FIG. [Figure 4] FIG. 1 is a perspective view of a passive torquer assembly with pads. [Diagram 5] FIG. 5 is an exploded view of the passive torquer assembly of FIG. [Figure 6] FIG. 5 is an exploded view of the jaws of the passive torquer assembly of FIG. 4 . [Figure 7] 5 is a cross-sectional view taken generally in the XZ plane of FIG. 4 showing the torquer assembly of FIG. 4 with the pad gripping a guidewire (EMD). [Figure 8] 5 is a cross-sectional view (not to scale) taken generally through the XZ plane of FIG. 4 showing the torquer assembly of FIG. 4 with the pads unmated and in the process of releasing the gripped guidewire (EMD). [Figure 9] 5 is a cross-sectional view taken generally in the XZ plane of FIG. 4, showing the torquer assembly of FIG. 4 with the pad in an ungripped state. [Figure 10] FIG. 5 is a cross-sectional view (not to scale) taken generally through the XZ plane of FIG. 4 showing an embodiment of the torquer assembly of FIG. 4 having a single movable jaw in the process of releasing a gripped guidewire (EMD). [Figure 11] FIG. 1 is a perspective view of an active torquer assembly with pads. [Figure 12] FIG. 12 is an exploded view showing some components of the active torquer assembly of FIG. 11 . [Figure 13] FIG. 12 is an exploded view showing the internal components of the active torquer assembly of FIG. 11 . [Figure 14] FIG. 12 is an exploded view of the jaws of the active torquer assembly of FIG. 11 . [Figure 15] 12 is a cross-sectional view taken generally in the XZ plane of FIG. 11 , showing the torquer assembly of FIG. 11 with the knob before it is screwed in and the pad in an ungripped state. [Figure 16] 12 is a cross-sectional view taken generally in the XZ plane of FIG. 11 , showing the torquer assembly of FIG. 11 with the knob screwed in and the pad in an unclamped state. [Figure 17] 12 is a cross-sectional view taken generally along the XZ plane of FIG. 11 , showing the torquer assembly of FIG. 11 with the pad in a gripping state. [Figure 18] 5 is a diagram of the passive torquer assembly of FIG. 4 in a device module. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] [Definition]

[0014] Elongated medical devices (EMDs) refer to devices having, but are not limited to, catheters (e.g., guide catheters, microcatheters, balloon / stent catheters), over-the-wire devices (e.g., guidewires, embolic coils, stent retrievers), and combinations thereof. Over-the-wire EMDs include, but are not limited to, guidewires, microwires, proximal pushers for embolic coils, stent retrievers, self-expanding stents, and flow diverters. Typically, over-the-wire EMDs do not have a hub or handle at their proximal end. (however (Not limited to, in one embodiment, the EMD includes a catheter having a hub at a proximal end of the catheter and a flexible shaft extending from the hub toward the distal end of the catheter, the shaft being more flexible than the hub. In one embodiment, the catheter includes a transition section between the hub and the shaft, the transition section being less flexible than the hub and more flexible than the shaft. In one embodiment, the transition section is a strain relief.

[0015] "Distal" and "proximal" define the relative location of two separate parts. In the context of a robotic drive, "distal" and "proximal" are defined by the intended placement of the robotic drive relative to the patient. When used to define relative location, the distal part is the part of the robotic drive that is closer to the patient than the proximal part when the robotic drive is in the intended placement. Within the patient, vascular landmarks that are further along a path from an access point are considered more distal than landmarks closer to the access point. The access point is the point at which the EMD enters the patient. Similarly, the proximal part is the part of the robotic drive that is further from the patient than the distal part when the robotic drive is in the intended placement. When used to define direction, the distal direction refers to the path that something is moving or moving to, or the path that something is pointing or pointing from the proximal part to the distal part and / or the patient when the robotic drive is in the intended placement. The proximal direction is the opposite direction of the distal direction.

[0016] The longitudinal axis (longitudinal axis, long axis) of a member (EMD or other element of a catheter-based treatment system) is a line or axis that extends the entire length of the member passing through the center of the cross section of the member in a direction from the proximal portion of the member toward 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 toward the distal portion of the guidewire, even if the guidewire is non-linear in the relevant portion.

[0017] "Top, upper / upper, upward" refers to the general direction against the direction of gravity, while "bottom, lower / lower, downward" refers to the general direction in the direction of gravity.

[0018] "Axial movement" of a member means translation (translation) of the member along the longitudinal axis of the member.

[0019] "Rotational movement" of a member means the angular orientation change of the member about the member's local longitudinal axis.

[0020] "Axial insertion" means insertion of a first member into a second member along the longitudinal axis of the second member.

[0021] "Force" means an agent that causes or can cause the movement of an object. A force acting on an object can change the motion of the object, retard the motion of the object, balance forces already acting on the object, and create internal stresses in the object.

[0022] "Torque" means an agent that causes or can cause an object to rotate. A torque acting on an object can change the rotational motion of the object, retard the rotational motion of the object, balance a torque already acting on the object, and cause internal stresses in the object.

[0023] "Fixed" means that there is no intentional relative movement of the first member with respect to the second member during operation.

[0024] "Pinch" means to releasably secure the EMD to the member such that when the member moves, the EMD and member move together. Rotational movement of the member results in rotational movement of the pinched EMD. "Unpinch" means to release the EMD from the member such that when the member moves, the EMD and member move independently. An unpinched EMD can translate / rotate relative to the member.

[0025] "Collet" means a device that can releasably secure a portion of an EMD, where "secure" means that there is no intentional relative movement between the collet and the EMD during operation.

[0026] "Torquer" refers to a device that releasably pinches and unpinches a portion of an EMD, such as a guidewire. "Torquer" is a commonly accepted term used by medical professionals in catheterization procedures to refer to a device used to rotate an EMD and / or translate an EMD. Torquers are also commonly known as collets or pin vices. The torquers disclosed herein are used ex vivo to pinch a portion of an EMD outside of a patient's body.

[0027] [Description of the embodiment]

[0028] FIG. 1 according to an embodiment is a perspective view showing an example of a catheter-based treatment system 10. The catheter-based treatment system 10 is used to perform catheter-based medical procedures, such as percutaneous interventional procedures such as percutaneous coronary intervention (PCI) (e.g., for treating STEMI), neurovascular interventional procedures (NVI) (e.g., for treating emergency large vessel occlusion (ELVO)), peripheral vascular interventional procedures (PVI) (e.g., for critical limb ischemia (CLI)), and the like. Catheter-based medical procedures include diagnostic catheterization procedures that use one or more catheters or other elongated medical devices (EMDs) to assist in diagnosing a patient's disease. For example, in one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected through a catheter into one or more arteries to obtain images of the patient's vascular system. Catheter-based medical procedures also include catheter-based therapeutic procedures that use a catheter (or other EMD) to treat a disease (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, thrombectomy, treatment of arterial venous malformation, treatment of aneurysms, etc.). The therapeutic procedure may be enhanced by the inclusion of auxiliary devices 54 (shown in FIG. 2), such as, for example, intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. However, one of ordinary skill in the art will recognize that the particular percutaneous interventional device or component (e.g., guidewire type, catheter type, etc.) may be selected based on the type of procedure to be performed. The catheter-based treatment system 10 can accommodate, with minor adjustments, the specialized percutaneous interventional device used in the procedure and can perform any catheter-based medical procedure.

[0029] The catheter-based treatment system 10 includes, among other elements, a bedside unit 20 and a control station 26. The bedside unit 20 includes a robotic drive 24 and a positioning system 22 located at the side of the patient 12. The patient 12 is positioned on a patient table 18. The positioning system 22 is used to position and support the robotic drive 24. The positioning system 22 may be, for example, a robotic arm, an articulating arm, a holder, or the like. The positioning system 22 may be mounted at one end, for example, to a rail, base, or cart of the patient table 18. The robotic drive 24 is mounted at the other end of the positioning system 22. The positioning system 22 (together with the robotic drive 24) may be retracted to allow the patient 12 to be positioned on the patient table 18. After the patient 12 is positioned on the patient table 18, the positioning system 22 is used to position (secure) the robotic drive 24 relative to the patient 12 for treatment. In one embodiment, the patient table 18 is supported and actuated on a pedestal 17 that is mounted to the floor and / or ground. The patient table 18 can move with multiple degrees of freedom, e.g., roll, pitch, and yaw, relative to the pedestal 17. The bedside unit 20 can also include a control and display 46 (shown in FIG. 2). For example, the control and display can be located on the housing of the robotic drive 24.

[0030] In general, the robotic drive 24 includes appropriate percutaneous intervention devices and ancillary equipment 48 (shown in FIG. 2 ) (e.g., guidewires, various catheters including balloon catheters, stent delivery systems, stent retrievers, embolization coils, liquid embolization devices, suction pumps, contrast and drug delivery devices, hemostasis valve adapters, syringes, stopcocks, inflation devices, etc.) to allow an operator (user) 11 to utilize the robotic system to perform catheter-based medical procedures by operating various controls, such as controls and input devices, located at the control station 26. The bedside unit 20, and in particular the robotic drive 24, may include any and / or combination of components to provide the bedside unit 20 with the functionality described herein. The operator 11 of the control station 26 is referred to as the control station operator (user), and is referred to herein as the operator (user). The operator (user) of the bedside unit 20 is referred to as the bedside unit operator (user). The robotic drive 24 includes multiple device modules 32a-d mounted on a rail or linear member 60 (shown in FIG. 3 ). The rail or linear member 60 guides and supports the device modules. Each of the device modules 32a-d can be used to drive an EMD, such as a catheter or guidewire. For example, the robotic drive 24 can be used to automatically feed a guidewire into a diagnostic catheter and into a guide catheter in an artery of the patient 12. One or more devices, such as an EMD, enter the body (e.g., a blood vessel) of the patient 12 at an insertion point 16, for example, via an introducer sheath.

[0031] The bedside unit 20 communicates with a control station 26, which transmits signals generated by user inputs of the control station 26 wirelessly or via wires to the bedside unit 20 to allow control of various functions of the bedside unit 20. As described below, the control station 26 includes or is connected to the bedside unit 20 via a control computing system 34 (shown in FIG. 2). The bedside unit 20 may also provide feedback signals (e.g., loading, speed, operating conditions, warning signals, error codes, etc.) to the control station 26 and / or the control computing system 34. Communication between the control computing system 34 and each component of the catheter-based treatment system 10 is provided via a communication link, which may be a wireless connection, a wired connection, or any other means that allows communication between the components. The control station 26 or other similar control system may be located at either a local site (e.g., a local control station 38 in FIG. 2) or a remote site (e.g., a remote control station and computing system 42 in FIG. 2). The catheterization system 10 can be operated by a local site control station or a remote site control station, or both local and remote control stations simultaneously. At a local site, the operator 11 and control station 26 are located in the same room as the patient 12 and bedside unit 20 or in an adjacent room. As used herein, a local site is the location of the bedside unit 20 and the patient 12 or subject (e.g., an animal or cadaver), and a remote site is the location of the operator 11 and control station 26 used to remotely control the bedside unit 20. The control station 26 (and controlling computing system) at the remote site and the bedside unit 20 and / or controlling computing system at the local site communicate over a communications system and services 36 (shown in FIG. 2), e.g., via the Internet.In one embodiment, the remote site and the local (patient) site are separate from one another, for example, in separate rooms in the same building, separate buildings in the same city, separate cities, or other separate locations where the remote site does not have physical access to the bedside unit 20 and / or patient 12 at the local site.

[0032] The control station 26 typically includes one or more input modules 28 configured to receive user inputs for operating each component or system of the catheter-based procedure system 10. In the illustrated embodiment, the control station 26 enables the operator 11 to control the bedside unit 20 to perform a catheter-based medical procedure. For example, the input module 28 is configured to cause the bedside unit 20 to perform various tasks using a percutaneous intervention device (e.g., EMD) in conjunction with the robotic drive 24 (e.g., advance, retract, or rotate a guidewire, advance, retract, or rotate a catheter, inflate or deflate a balloon placed in the catheter, place and / or deploy a stent, place and / or deploy a stent retriever, place and / or deploy a coil, inject contrast into the catheter, inject liquid emboli into the catheter, inject drugs or saline into the catheter, aspirate the catheter, or perform any other function that may be performed as part of a catheter-based medical procedure). The robotic drive 24 includes various drive mechanisms for moving (eg, axial and rotational) the components of the bedside unit 20, including the percutaneous interventional devices.

[0033] In one embodiment, the input module 28 includes one or more touch screens, joysticks, scroll wheels, and / or buttons. In addition to the input module 28, the control station 26 can use additional user controls 44 (shown in FIG. 2), such as a foot switch or a microphone for voice commands. The input module 28 is configured to advance, retract, or rotate various components and various percutaneous intervention devices, such as a guidewire and one or more catheters or microcatheters. The buttons include, for example, an emergency stop button, a magnification button, a device selection button, and an automatic activation button. When the emergency stop button is pressed, power (e.g., electrical power) is cut off or removed to the bedside unit 20. When in a speed control mode, the magnification button acts to increase or decrease the speed at which the associated component moves in response to manipulation of the input module 28. When in a position control mode, the magnification button changes the mapping between an input distance and an output commanded distance. The device selection button allows the operator 11 to select which of the percutaneous intervention devices loaded on the robotic drive 24 is to be controlled by the input module 28. The automatic activation button is used to execute algorithmic operations that the catheter-based treatment system 10 can execute on the percutaneous intervention device without direct command from the operator 11. In one embodiment, the input module 28 includes one or more controllers or icons (not shown) displayed on a touch screen (which may or may not be part of the display 30) that, when activated, activate components of the catheter-based treatment system 10. The input module 28 may also include balloon or stent controls configured to inflate or deflate a balloon and / or deploy a stent. Each of the input modules 28 includes one or more buttons, scroll wheels, joysticks, touch screens, etc., that may be used to dedicatedly control one or more specific components.Additionally, one or more touch screens display one or more icons (not shown) associated with each portion of the input module 28 or each component of the catheter-based treatment system 10 .

[0034] The control station 26 includes a display 30. In one embodiment, the control station 26 may include two or more displays 30. The display 30 is configured to display information or patient-specific data to the operator 11 located at the control station 26. For example, the display 30 may be configured to display image data (e.g., x-ray images, MRI images, CT images, ultrasound images, etc.), hemodynamic data (e.g., blood pressure, heart rate, etc.), patient chart information (e.g., medical history, age, weight, etc.), pathology or treatment evaluation data (e.g., IVUS, OCT, FFR, etc.). Additionally, the display 30 may be configured to display procedure-specific information (e.g., procedure checklists, recommendations, duration of procedure, catheter or guidewire location, amount of drug or contrast delivered, etc.). The display 30 may also be configured to display information to provide functionality associated with the control computing system 34 (shown in FIG. 2). The display 30 may also have touch screen capabilities to provide some of the user input functionality of the system.

[0035] The catheter-based procedure system 10 also includes an imaging system 14. The imaging system 14 may be any medical imaging system (e.g., non-digital x-ray, digital x-ray, CT, MRI, ultrasound, etc.) that may be used in conjunction with a catheter-based medical procedure. In one embodiment, the imaging system 14 is a digital x-ray imager in communication with a control station 26. In one embodiment, the imaging system 14 includes a C-arm (shown in FIG. 1 ) that allows the imaging system 14 to rotate partially or fully around the patient 12 to obtain images of various angular positions relative to the patient 12 (e.g., sagittal, caudal, anterior-posterior, etc.). In one embodiment, the imaging system 14 is a fluoroscopy system that includes a C-arm having an x-ray source 13 and a detector 15, also known as an image intensifier.

[0036] The imaging system 14 is configured to take x-ray images of appropriate regions of the patient 12 during a procedure. For example, the imaging system 14 may be configured to take one or more x-ray images of the head to diagnose a neurovascular condition. The imaging system 14 may also be configured to take one or more x-ray images (e.g., real-time images) during a catheter-based medical procedure to assist the operator 11 at the control station 26 in properly positioning a guidewire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, etc., during a procedure. The one or more images are displayed on the display 30. For example, the images may be displayed on the display 30 to enable the operator 11 to accurately move a guide catheter or guidewire to an appropriate position.

[0037] For directional clarity, a Cartesian coordinate system is presented with X, Y, and Z axes. The positive X axis points in the longitudinal (axial) distal direction, i.e. from the proximal end to the distal end, or in other words from proximal to distal. The Y and Z axes are in the transverse plane to the X axis, with the positive Z axis pointing upwards, i.e. opposite the force of gravity, and the Y axis being automatically determined by the right-hand rule.

[0038] 2 is a block diagram of a catheter-based treatment system 10 according to one embodiment. The catheter-based treatment system 10 includes a control computing system 34. The control computing system 34 may be physically part of, for example, the control station 26 (shown in FIG. 1). The control computing system 34 is typically an electronic control unit suitable for providing the catheter-based treatment system 10 with the functionality described herein. For example, the control computing system 34 may be an embedded system, a dedicated circuit, a general-purpose system programmed with the functionality described herein, etc. The control computing system 34 communicates with the bedside unit 20, communication systems and services 36 (e.g., the Internet, firewalls, cloud services, session managers, hospital networks, etc.), a local control station 38, additional communication systems 40 (e.g., telepresence systems), remote control stations and computing systems 42, and patient sensors 56 (e.g., electrocardiogram (ECG) devices, electroencephalogram (EEG) devices, blood pressure monitors, temperature monitors, heart rate monitors, respiratory monitors, etc.). The control computing system also communicates with the imaging system 14, the patient table 18, the additional medical system 50, the contrast injection system 52, and the auxiliary devices 54 (e.g., IVUS, OCT, FFR, etc.). The bedside unit 20 includes the robotic drive 24 and the positioning system 22, and may also include additional controls and displays 46. As mentioned above, the additional controls and displays may be located on the housing of the robotic drive 24. Interventional devices and auxiliary devices 48 (e.g., guidewires, catheters, etc.) are connected to the bedside system 20. In one embodiment, the interventional devices and auxiliary devices 48 include dedicated devices (e.g., IVUS catheters, OCT catheters, FFR wires, contrast diagnostic catheters, etc.) that connect to the respective auxiliary devices 54, i.e., IVUS system, OCT system, FFR system, etc.

[0039] In one embodiment, the control computing system 34 is configured to generate control signals based on user interactions with an input module 28 (e.g., of a control station 26 (shown in FIG. 1 ), such as a local control station 38 or a remote control station 42) and / or based on information accessible to control the control computing system 34 to perform a medical procedure 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 controls 44. The remote control station and computing system 42 may include similar components as the local control station 38. The remote control station 42 and the local control station 38 may be different, tailored depending on the functionality required for each. The additional user controls 44 may include, for example, one or more foot-input controllers. The foot-input controllers may be configured to allow an operator to select a function of the imaging system 14, such as turning x-rays on and off, scrolling through multiple stored images, etc. In one embodiment, the foot-input device may be configured to allow an operator to select a device that is mapped to a scroll wheel included in the input module 28. Additional communication systems 40 (e.g., voice conversation, video conversation, telepresence, etc.) may be employed to assist the operator in communicating with the patient, medical staff (e.g., angiography suite staff), and / or equipment near the bedside.

[0040] The catheter-based treatment system 10 may be connected or configured to include any other systems and / or devices not expressly 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 expansion system, a drug injection system, a drug tracking and / or logging system, a user log, an encryption system, a system for limiting access or use of the catheter-based treatment system 10, etc.

[0041] As mentioned above, the control computing system 34 communicates with the bedside unit 20, which includes the robotic drive 24 and the positioning system 22, and which may include additional controls and a display 46, and provides control signals to the bedside unit 20 to operate and control motors and drive mechanisms used to drive the percutaneous interventional devices (e.g., guidewires, catheters, etc.). Each drive mechanism may be provided as part of the robotic drive 24.

[0042] FIG. 3 is a perspective view of a robot drive of the catheter treatment system 10 according to an embodiment. In FIG. 3, the robot drive 24 includes a plurality of device modules 32a-d coupled to a linear member 60. Each of the device modules 32a-d is coupled to the linear member 60 via a stage 62a-d movably attached to the linear member 60. Each of the device modules 32a-d is connected to the stage 62a-d using a connector such as an offset bracket 78a-d. In one embodiment, the device modules 32a-d are directly attached to the stage 62a-d. Each of the stages 62a-d can be independently actuated to move linearly along the linear member 60. Thus, each of the stages 62a-d (and the corresponding device modules 32a-d coupled to the stages 62a-d) can be independently actuated relative to each other and relative to the linear member 60. A drive mechanism is used to actuate each of the stages 62a-d. In the embodiment shown in FIG. 3, the drive mechanism can have individual stage translation motors 64a-d and stage drive mechanisms 76 coupled to each stage 62a-d, or the stage translation motors 64a-d themselves can be linear motors. The stage drive mechanisms 76 can be, for example, a lead screw via a rotating nut, a rack via a pinion, a belt via a pinion or pulley, or a chain via a sprocket. In one embodiment, the stage drive mechanisms 76 are a combination of these mechanisms. For example, different types of stage drive mechanisms can be employed for each of the stages 62a-d. In the embodiment shown in FIG. 3, the stage drive mechanisms are a lead screw and a rotating nut, and the lead screw is rotated to engage and disengage each stage 62a-d from the lead screw, thereby moving it, for example, forward or backward. In the embodiment shown in FIG. 3, the stages 62a-d and the device modules 32a-d are in a tandem drive configuration.

[0043] Each device module 32a-d includes a drive module 68a-d and a cassette 66a-d mounted and coupled to the drive module 68a-d. In the embodiment shown in FIG. 3, each of the cassettes 66a-d is mounted to a drive module 68a-d in a vertical orientation.In other embodiments, each cassette 66a-d may be attached to the drive module 68a-d in other mounting orientations. Each cassette 66a-d is configured to connect with and support a proximal portion of an EMD (not shown). Additionally, each cassette 66a-d may include elements that provide one or more degrees of freedom in addition to the linear motion provided by linear movement along the linear member 60 upon actuation of the corresponding stage 62a-d. For example, the cassette 66a-d may include elements that are used to rotate the EMD in the cassette coupled to the drive module 68a-d. Each drive module 68a-d includes at least one coupler to provide a drive interface to mechanisms within each cassette 66a-d to provide an additional degree of freedom. Additionally, each cassette 66a-d includes a channel in which the device support 79a-d is positioned, and each device support 79a-d is used to prevent buckling of the EMD. Support arms 77a, 77b, and 77c are attached to device modules 32a, 32b, and 32c, respectively, to provide fixed points for supporting the proximal ends of device supports 79b, 79c, and 79d, respectively. Robot drive 24 aligns device support 79, distal support arm 70, and support arm 77. 0 The support arm 77 also includes a device support connection 72 connected to the 0 is used to provide a fixed point to support the proximal end of the most distal device support 79a housed in the most distal device module 32a. Additionally, an introducer interface support (redirector) 74 can be connected to the device support connection 72 and to the EMD (e.g., introducer sheath). This configuration of the robot drive 24 has the advantage that the use of actuators on a single linear member can reduce the volume and weight of the robot drive 24.

[0044] To prevent the patient from transmitting pathogens, healthcare staff use aseptic technique in the bedside unit 20 and in the room housing the patient 12 or subject (shown in FIG. 1). The room housing the bedside unit 20 and the patient 12 may be, for example, a catheter lab or an angio suite. Aseptic technique consists of using sterile barriers, sterile instruments, proper patient preparation, environmental control, and contact guidelines. That is, all EMDs and interventional accessories are sterile and are only allowed to come into contact with either the sterile barrier or the sterile instruments. In one embodiment, a sterile drape (not shown) is placed over the non-sterile robotic drive 24. Each cassette 66a-d is sterilized and serves as a sterile interface between the draped robotic drive 24 and at least one EMD. Each cassette 66a-d is designed to be sterilizable for a single use or to be resterilizable in whole or in part so that the cassette 66a-d or its components can be used in multiple procedures.

[0045] 4 and 5, one embodiment of a passive torquer 100 includes an actuator 106, a body 108, a first jaw 110, a second jaw 112, a spring 114, and a spring housing 116. The torquer 100 includes a lumen 118 along a longitudinal centerline that extends throughout the torquer 100. The body 108 includes a cavity 109. The lumen 118 includes: Main unit 108 1 and 2. The actuator 106 extends from the proximal end to the distal end of the housing 109 and is in fluid communication with the cavity 109. The lumen 118 includes a lumen portion that extends through the knob 106 and a lumen portion that extends through the housing 116. The lumen 118 has a diameter greater than a diameter of an EMD (not shown in FIGS. 4 and 5 ) to which the torquer 100 is applied. As described herein, the first jaw 110 and the second jaw 112 are operable within the cavity 109. In one embodiment, the spring 114 has a longitudinal axis that is coaxial with a longitudinal axis of the body 108. In one embodiment, the actuator 106 is a knob that is operable relative to the body 108 to operate the first jaw 110 to grasp and / or release an EMD within the cavity 109. The actuator 106 is configured to operate the first jaw 110 in a manner similar to that described herein. Public awarenessand the terms "actuator" and "knob" are used interchangeably herein. In one embodiment, knob 106 is movable relative to body 108 to operate first jaw 110 and second jaw 112 to grasp and / or release an EMD within cavity 109. Passive torquer 100 is normally in a closed state, in which an EMD is pinched when within torquer 100. An operator or robotic system must manipulate a biasing member to unpinch the EMD.

[0046] With the torquer 100 in an unpinched state, the EMD may be inserted into the lumen 118 in a proximal longitudinal direction 104 at the distal end of the torquer 100 and withdrawn or removed from the lumen 118 in a distal longitudinal direction 102 at the distal end of the torquer 100, or withdrawn or removed from the lumen 118 in a proximal longitudinal direction 104 at the proximal end of the torquer 100. In one embodiment, the EMD may be inserted into the lumen 118 in a distal longitudinal direction 102 at the proximal end of the torquer 100 and withdrawn from the lumen 118 in a proximal longitudinal direction 104 at the proximal end of the torquer 100, or withdrawn from the lumen 118 in a distal longitudinal direction 102 at the distal end of the torquer 100. In the pinched torquer 100, a portion of the EMD (the torquer portion) is fixed relative to the body 108. Specifically, in the pinched state, the first jaw 110 and the second jaw 112 of the torquer 100 pinch a portion of the shaft of the EMD 120 (see FIG. 7 ), so that rotation about the longitudinal axis of the torquer 100 and / or translation along the longitudinal axis of the torquer 100 results in a torque and / or force distributed along the pad that causes the portion of the shaft of the EMD being pinched to undergo the same or substantially the same rotational and / or translational motion. In one embodiment, when a torquer rotation is applied to the EMD with a portion of the EMD pinched across the longitudinal length of the pad, the EMD gradually twists from the proximal end of the torquer to the distal end of the torquer. In one embodiment, the EMD is fixed relative to the proximal end of the pad in the pinched state. The EMD has a degree of rotation across the pads from the proximal end to the distal end of the torquer when torque is applied.

[0047] The knob 106 includes a distal portion 106a and a proximal portion 106b, both of which have longitudinal centerlines aligned with the longitudinal centerline of the torquer 100. In one embodiment, the distal portion 106a of the knob 106 is a support tube having a distally extending lumen 118 that generally resists buckling and kinking of that portion of the EMD as the EMD is translated and / or rotated. In one embodiment, the distal portion 106a of the knob 106 is a cylindrical support tube having a lumen 118. In one embodiment, the proximal portion 106b of the knob 106 is a cylindrical cup that is open proximally and has an internal protrusion 106c that extends proximally from a distal base of the cylindrical cup. In one embodiment, the internal protrusion 106c of the knob 106 is a cylinder having a lumen 118 that has a centerline aligned with the longitudinal centerline of the torquer 100. In one embodiment, the proximal portion 106b of the knob 106 includes internal threads 106d on the inner wall of the cylindrical cup. In one embodiment, the proximal portion 106b of the knob 106 includes external threads on the outer wall of the internal projection 106c. In one embodiment, the knob 106 includes internal threads and the body 108 includes external threads. In one embodiment, the knob 106 is a single manufactured part, such as a molded part, with the lumen 118 as an internal passageway through which a portion of the shaft of the EMD passes. In one embodiment, the knob 106 is an assembled part, with the lumen 118 as an internal passageway through which a portion of the shaft of the EMD passes. In one embodiment, the passageway can accommodate elongated medical devices having diameters from 0.014 inches (0.356 mm) to 0.038 inches (0.965 mm). In one embodiment, the range of diameters of elongated medical devices that can be accommodated includes devices having diameters of 0.038 inches (0.965 mm) or less. In one embodiment, the passages can accommodate special diameter EMDs in a range such as 0.016 inches (0.406 mm) ±0.002 inches (0.051 mm).

[0048] The body 108 includes a distal portion 108a, a middle portion 108b, and a proximal portion 108c, all of which have longitudinal centerlines aligned with the longitudinal centerline of the torquer 100. In one embodiment, the body 108 is a hollow cylinder with separate inner and outer diameters at the distal portion 108a, the middle portion 108b, and the proximal portion 108c. In one embodiment, the body 108 may have portions that are not cylindrical. In one embodiment, the outer wall of the distal portion 108a includes male threads 108d. In one embodiment, the inner wall of the distal portion 108a includes female threads. In one embodiment, the inner wall of the body 108 includes a first channel 108e and a second channel 108f that are grooved in the opposing inner walls. The width of the first channel 108e is wider than the width of the first jaw 110, and the width of the second channel 108f is wider than the width of the second jaw 112. In one embodiment, the body 108 is a single manufactured part, such as a molding, with an internal passageway through which a portion of the shaft of the EMD passes. In one embodiment, the body 108 is an assembled part, with an internal passageway through which a portion of the shaft of the EMD passes.

[0049] The first jaw 110 includes a first pad 110a and a first pad base 110b, and the second jaw 112 includes a second pad 112a and a second pad base 112b. In one embodiment, the first pad base 110b is a parallelepiped-shaped member with a longitudinal axis corresponding to its longest dimension extending along the longitudinal axis of the torquer 100. In one embodiment, the first pad base 110b is a cubic-shaped member with a longitudinal axis corresponding to its longest dimension extending along the longitudinal axis of the torquer 100. In one embodiment, the first pad base has a prismatic shape. In one embodiment, the first pad base 110b includes a flat bottom surface for attaching the first pad 110a. In one embodiment, the first pad 110a is chemically bonded, mechanically attached, or attached to the first pad base 110b by other known means for attaching members to each other. In one embodiment, the second pad base 112b is a parallelepiped-shaped member having a longitudinal axis corresponding to its longest dimension extending along the longitudinal axis of the torquer 100. In one embodiment, the second pad base 112b is a cubic-shaped member having a longitudinal axis corresponding to its longest dimension extending along the longitudinal axis of the torquer 100. In one embodiment, the second pad base 112b includes a flat upper surface for attaching the second pad 112a.

[0050] 6, the first pad base 110b according to one embodiment includes a flat bottom surface 110c to which the first pad 110a is attached, a flat front side surface 110d, a flat rear side surface 110e, a sloped flat distal end surface 110f, a flat proximal end surface 110g with a protrusion 110h, and a top surface, which includes a flat distal portion 110i, a curved middle portion 110j, a sloped flat middle portion 110k, and a flat proximal portion 110m. In one embodiment, the curved middle portion 110j of the top surface of the first pad base 110b has a convex arcuate contour and is a transition surface between the flat distal portion 110i and the sloped flat middle portion 110k.

[0051] In one embodiment, the second pad base 112b is identical to the first pad base 110b and includes surfaces that correspond to the respective surfaces of the first pad base 110b. In one embodiment of the torquer 100, the second pad base 112b is rotated (flipped) 180 degrees about its longitudinal axis relative to the first pad base 110b. In other words, the flat bottom surface 110c of the first pad base 110b on which the first pad 110a described herein is mounted faces the flat top surface of the second pad base 112b on which the second pad 112a is mounted.

[0052] In one embodiment, the bottom surface of the first pad 110a of the first jaw 110 is a flat surface. In one embodiment, the bottom surface of the first pad 110a of the first jaw 110 is a flat surface that includes a concave arcuate contour (in a cross section, i.e., in the YZ plane) that extends over the entire length of the first pad 110a surface. In one embodiment, the bottom surface of the first pad 110a of the first jaw 110 is a curved surface that includes a concave arcuate contour (in a cross section, i.e., in the YZ plane) that extends over the entire length of the first pad 110a surface.

[0053] In one embodiment, the second pad 112a is identical to the first pad 110a and includes surfaces that correspond to respective surfaces of the first pad 110a. In one embodiment, the top surface of the second pad 112a of the second jaw 112 is identical to the bottom surface of the first pad 110a of the first jaw 110 and includes surfaces that correspond to respective surfaces of the first pad 110a. In one embodiment, the first pad 110a is attached to the first pad base 110b and the second pad 112a is attached to the second pad base 112b.

[0054] In one embodiment, the first pad 110a and the second pad 112a are formed from a medical biocompatible material such that when pressed by the pads, they will not scratch or penetrate the coating of an EMD such as a guidewire used in a catheter procedure. In one embodiment, the first pad 110a and the second pad 112a are formed from an elastomeric material within a durometer measurement range of 50D-75D and manufactured with a particular smoothness / roughness / texture rating such as SPI-B1, A1, C1, A2, B2, or C2. In one embodiment, the Society of Plastics Industry (SPI) ratings listed herein correspond to the following roughness parameter (Ra) values ​​in microinches (μ inches) shown in parentheses after the listed SPI rating: SPI B1 (RA 2-3), A1 (RA 0-1), A2 (RA 1-2), B2 (RA 4-5), C2 (RA 25-28). In one embodiment, the first pad 110a and the second pad 112a are formed from a natural or synthetic material that has a low modulus value and a high strain value compared to other materials, such as metallic materials.

[0055] An elastomeric material, as used herein, is a material made of a polymer having elastic or viscoelastic properties, or a rubber or rubber-like material having elastic or viscoelastic properties, or a material having flexible and / or elastic or viscoelastic properties. The first pad 110a and the second pad 112a are referred to herein as elastomeric pads. In one embodiment, each pad having flexible properties is formed from a polyurethane material or a polyether block amide (PEBA) material.

[0056] In one embodiment, the first pad base 110b and the second pad base 112b are made of a medical biocompatible material, such as a biocompatible plastic, that is harder than the material of the first pad 110a and the second pad 112a. In one embodiment, the first pad base 110b and the second pad base 112b are made of a material, such as Ultem 1000 or stainless steel. In one embodiment, the first pad base 110b and the second pad base 112b are made of a material that is stiffer than the material of the first pad 110a and the second pad 112a. In one embodiment, the first pad base 110b and the second pad base 112b are made of a material that has a modulus of elasticity equal to or greater than a value of 3.5 GPa. In one embodiment, the first pad base 110b and the second pad base 112b are made of a material that has a modulus of elasticity that is more than twice the value of the material of the first pad 110a and the second pad 112a. In one embodiment, the first pad base 110b and the second pad base 112b are formed from a material having a modulus of elasticity that is 10 times or greater than the material of the first pad 110a and the second pad 112a.

[0057] In one embodiment of the torquer 100, the female thread 106d of the knob 106 meshes with the male thread 108d of the body 108, and rotation of the knob 106 relative to the body 108 changes the longitudinal distance between the knob 106 and the body 108, and the distance increases or decreases depending on the direction of the relative rotation. The change in longitudinal distance per unit of relative rotation between the knob 106 and the body 108 is determined by the pitch of the meshing threads 106d, 108d. In one embodiment (not shown) of the torquer 100, the male thread of the internal projection 106c of the knob 106 meshes with the female thread on the inner wall of the distal portion 108a of the body 108, and rotation of the knob 106 relative to the body 108 changes the longitudinal distance between the knob 106 and the body 108, and the distance increases or decreases depending on the direction of the relative rotation. The change in longitudinal distance per unit of relative rotation between knob 106 and body 108 is determined by the pitch of the mating threads.

[0058] In one embodiment, the spring 114 is a helical compression spring. In one embodiment, the spring 114 is a helical compression spring with flat, polished ends. In one embodiment, the spring 114 is a helical compression spring with square, polished ends. In one embodiment, the spring 114 is a hollow cylindrical or another shaped flexible elastic member.

[0059] The spring housing 116 includes a distal portion 116a, a bevel gear 116b, and a proximal portion 116c, all of which have longitudinal centerlines aligned with the longitudinal centerline of the torquer 100. In one embodiment, the bevel gear 116b is intermediate the distal portion 116a and the proximal portion 116c of the spring housing 116 and is fixedly attached integrally to the portions 116a, 116c. In one embodiment, the teeth of the bevel gear 116b face in the longitudinal proximal direction 104. In one embodiment, the bevel gear is a driven member that is driven to move by a drive member of the robotic system. In one embodiment, the distal portion 116a of the spring housing 116 is a cylindrical cup that opens distally and includes an opening at its proximal base. In one embodiment, the proximal portion 116c of the spring housing 116 is a cylindrical cup that is distally open and has an internal post 116d extending distally from a proximal base of the cylindrical cup with a lumen 118 extending entirely along the central longitudinal axis of the torquer 100. In one embodiment, the internal post 116d of the spring housing 116 is a cylindrical protrusion with a chamfered distal end and a central lumen 118 with the centerline aligned with the longitudinal centerline of the torquer 100. In one embodiment, the spring housing 116 is a single manufactured part, such as a molding, with the lumen 118 as an internal passageway for a portion of the shaft of the EMD to pass through. In one embodiment, the spring housing 116 is an assembled part with the lumen 118 as an internal passageway for a portion of the shaft of the EMD to pass through. In one embodiment, the bevel gear 116b is a driven member that may be located anywhere on the exterior portion of the torquer body and / or may be located anywhere on the exterior portion of the actuator or knob 106. The driven member 116b may be other types of gears such as spur gears, worm gears, hypoid gears, or may be a surface that frictionally engages with a drive member, including but not limited to a belt drive mechanism.

[0060] In one embodiment of the assembled torquer 100, the proximal portion 108c of the body 108 snaps into the distal portion 116a of the housing 116, for example, by using a molded undercut in the portion that engages the mating engagement lip. In one embodiment of the assembled torquer 100, the proximal portion 108c of the body 108 is interference-fitted into the distal portion 116a of the housing 116, for example, by using dimensional interference of the engagement portions. In one embodiment, the proximal portion 108c of the body 108 is secured to the distal portion 116a of the housing 116 by adhesives, glues, bonding agents, laser welding, ultrasonic welding, or other means of attaching two objects together during assembly and manufacturing. In one embodiment of the torquer 100, the body 108 is removably secured to the housing 116 using fasteners (not shown). As used herein, "snap fit" refers to an assembly method for assembling flexible parts (usually plastic) in which the interlocking components of the parts are pressed together to form the final product. There are many variations of snap fits, such as cantilever, torsion, ring, etc. Snap fits are an alternative to assembly methods using nails or screws as a one-piece assembly function, and have the advantages of being quick and having no loose parts.

[0061] In one embodiment of the torquer 100, the spring 114 is constrained from longitudinal and lateral movement (i.e., movement in the YZ plane) relative to the housing 116 and prevented from buckling by being seated around a central internal post 116d that extends distally from the proximal base of the cylindrical cup of the housing 116. The internal post 116d is cylindrical with an outer diameter smaller than the inner diameter of the spring 114 and includes a central bore 118. In one embodiment, the inner diameter of the proximal portion 116c of the housing 116 or the outer diameter of the internal post 116d of the proximal portion 116c of the housing 116 is required to prevent buckling.

[0062] In one embodiment of the torquer 100, the proximal end of the spring 114 is constrained from longitudinal movement relative to the housing 116 by contacting the inner surface of a cylindrical cup base (bottom) at the proximal end of the proximal portion 116c of the housing 116. In one embodiment of the torquer 100, the distal end of the spring 114 contacts the flat proximal end surface 110g of the first pad base 110b of the first jaw 110 and the flat proximal end surface of the second pad base 112b of the second jaw 112. In one embodiment, the first pad base 110b includes a wedge-shaped protrusion 110h near the bottom surface 110c at the flat proximal end surface 110g of the first pad base 110b, and the second pad base 112b includes a corresponding wedge-shaped protrusion near the top surface at the flat proximal end surface of the second pad base 112b. The wedges project proximally and are located inside the inner diameter of spring 114 at the distal end of spring 114 .

[0063] In one embodiment of the torquer 100, the first pad base 110b moves while being constrained in the first channel 108e of the body 108, and the second pad base 112b moves while being constrained in the second channel 108f of the body 108. Specifically, in one embodiment, the sidewalls of the first channel 108e constrain the lateral movement of the first jaw 110 (by contacting the flat front side 110d and the flat back side 110e of the first pad base 110b), and similarly, the sidewalls of the second channel 108f constrain the lateral movement of the second jaw 112.

[0064] In one embodiment, a portion of the upper surface of the first pad base 110b of the first jaw 110 contacts a portion of the inner circumferential wall (bottom of the groove) of the first channel 108e of the body 108, and a portion of the bottom surface of the second pad base 112b of the second jaw 112 contacts a portion of the inner circumferential wall (bottom of the groove) of the second channel 108f of the body 108.

[0065] In one embodiment, the torquer 100 includes two jaws that act relative to one another to releasably secure a portion of the shaft of the EMD in at least one of the jaws. In one embodiment, the torquer 100 includes one jaw that acts relative to the body of the torquer 100 to releasably pinch a portion of the shaft of the EMD in the one jaw. In one embodiment, the torquer 100 includes more than two jaws that act relative to one another to releasably secure a portion of the shaft of the EMD in at least one of the jaws.

[0066] In one embodiment of the torquer 100, the spring 114 acts as a biasing member to bias one jaw against the body. In one embodiment of the torquer 100, the spring 114 acts as a biasing member to bias two jaws against the body. In one embodiment of the torquer 100, the spring 114 acts as a biasing member to bias more than two jaws against the body.

[0067] In one embodiment, two or more members acting simultaneously provide a mechanical advantage that increases the torque and / or force transmitted from the torquer to a portion of the shaft of the EMD without the shaft of the EMD moving relative to the torquer. Torquer The pinching force applied to the EMD using the torquer can be greater than the force required to create the pinch. When a portion of the shaft of the EMD is pinched, the EMD is fixed such that there is no relative movement of the torquer and that portion of the EMD throughout the acceptable operating parameters of the EMD procedure.

[0068] 7, 8, and 9, a passive torquer 100 according to one embodiment is shown in stages corresponding to a pinched state, a partial pinched state, and an unpinched state, respectively. In the pinched state, the torquer 100 is in a fully gripped state and pinches a portion of the EMD 120. In the partial pinched state, the torquer 100 is in a partially gripped state and partially pinches a portion of the EMD 120. In the unpinched state, the torquer 100 is in a released (unclipped) state and is not pinching the EMD 120. In the illustrated embodiment in all three states (pinched, partial pinched, unpinched), the female threads 106d of the knob 106 mate with the male threads 108d of the body 108. In the unpinched state, the distance between the pads in a direction perpendicular to the longitudinal axis of the torquer is greater than the diameter of the EMD.

[0069] 7, in the pinched state of the torquer 100, the knob 106 is in an open position relative to the body 108. There is no contact (i.e., a gap exists) between the proximal end surface of the internal projection 106c of the knob 106 and the inclined distal end surface 110f of the first pad base 110b of the first jaw 110, and there is no contact between the proximal end surface of the internal projection 106c of the knob 106 and the inclined distal end surface of the second pad base 112b of the second jaw 112. When the knob 106 is rotated relative to the body 108 in a direction to unscrew the knob 106 from the body 108, the knob 106 moves in the longitudinal distal direction 102 relative to the body 108, increasing the gap between the proximal end surface of the internal projection 106c and the distal end surfaces of the first jaw 110 and the second jaw 112.

[0070] In one embodiment, the knob 106 can be rotated without restriction relative to the body 108 in a direction that unscrews the knob 106 from the body 108 until the threaded engagement is broken and the knob 106 is removed from the body 108. In one embodiment, the knob 106 can be rotated without restriction relative to the body 108 in a direction that unscrews the knob 106 from the body 108 until a stop is reached that prevents the knob 106 from being removed from the body 108.

[0071] In a pinched state of the torquer 100 with the knob 106 in an open position relative to the body 108, there is no contact (i.e., a gap exists) between the inclined surface of the wedge-shaped protrusion 110h at the proximal end of the first pad base 110b and the chamfered distal end surface facing said inclined surface at the internal post 116d of the spring housing 116 (extending distally from the proximal base of the cylindrical cup), and there is also no contact between the inclined surface of the wedge-shaped protrusion at the proximal end of the second pad base 112b and the chamfered distal end surface facing said inclined surface at the internal post 116d of the spring housing 116.

[0072] In the pinched state of the torquer 100, the first pad 110a of the first jaw 110 and the second pad 112a of the second jaw 112 face each other, are parallel to each other and to a portion of the EMD 120, and pinch a portion of the EMD 120 across the entire length of each pad, i.e., the first pad 110a and the second pad 112a are in contact with a portion of the EMD 120 across their entire length.

[0073] In the pinched state of the torquer 100, the spring 114 is compressed beyond its rest length. Thus, the spring restoring force acts toward the longitudinal distal direction 102. (The spring restoring force also acts in the longitudinal proximal direction 104 in static equilibrium. However, the proximal end of the spring 114 is constrained, i.e., fixed, relative to the housing 116 and to the body 108 to which the housing 116 is assembled. Thus, the spring restoring force acts in the longitudinal distal direction 102.) Half of this force acts on the first jaw 110 through contact between the distal end of the spring 114 and the flat proximal end surface 110g of the first pad base 110b, and half of this force acts on the second jaw 112 through contact between the distal end of the spring 114 and the flat proximal end surface of the second pad base 112b.

[0074] A force (half the restoring force from the spring 114) is applied to the first jaw 110 in the longitudinal distal direction 102, but the first jaw 110 is constrained from moving in the longitudinal distal direction 102 relative to the body 108. The movement of the first jaw 110 in the longitudinal distal direction 102 is constrained by a force component equal in magnitude to and opposite to the force component of half the restoring force from the spring 114. That is, a force component acts in the longitudinal proximal direction 104, and static equilibrium of the first jaw 110 in the longitudinal direction is achieved. This longitudinal force component acts at a contact point or contact area between a curved middle portion 110j of the upper surface of the first pad base 110b of the first jaw 110 and a contoured portion of the upper inner surface of the first channel 108e of the body 108.

[0075] As described herein, an upward and downward force component also acts at a contact point or area between the curved intermediate portion 110j of the upper surface of the first pad base 110b of the first jaw 110 and the contoured portion of the upper inner surface of the first channel 108e of the body 108.

[0076] A contoured portion of the upper inner surface of the first channel 108e of the body 108 defines a cam surface that contacts a driven surface defined by a curved intermediate portion 110j of the upper surface of the first pad base 110b of the first jaw 110. The resulting force due to the contours of the cam surface and the driven surface (and the force from the spring) acts on the first jaw 110 from the body 108 with a longitudinal force component directed proximally (negative X direction) and a vertical force component directed downward (negative Z direction) at the contact point or area. The vertical force component acting on the first jaw 110 results in the first pad 110a being pressed against a portion of the EMD 120, causing the portion of the EMD 120 to contact the first pad 110a. In one embodiment, the driven surface is non-linear. In one embodiment, the driven surface is linear. In one embodiment, the driven surface is arcuate. In one embodiment, the body 108 includes a cam surface that contacts a non-linear following surface of the first pad base 110b. In one embodiment, the body 108 includes a cam surface that contacts a linear following surface of the first pad base 110b. In one embodiment, the body 108 includes a cam surface that contacts an arcuate following surface of the first pad base 110b.

[0077] The first jaw 110 can rotate and / or oscillate (in the XZ plane) about an axis at the contact point or contact area of ​​the cam surface and the driven surface. When contact occurs between a portion of the EMD 120 and the first pad 110a, the first jaw 110 rotates and / or oscillates about the contact point or contact area, dispersing the vertical force component acting on the portion of the EMD 120 and equalizing the pressure on the EMD 120 along the length of the first pad 110a. "Pivot and / or oscillate" includes both movement about an axis at a point and movement about an axis along a surface that follows a predetermined contour.

[0078] Similarly, a force (half the restoring force from the spring 114) is applied to the second jaw 112 in the longitudinal distal direction 102, but the second jaw 112 is restrained from moving in the longitudinal distal direction 102 relative to the body 108. The movement of the second jaw 112 in the longitudinal distal direction 102 is restrained by a force component equal in magnitude to and opposite to the force component of half the restoring force from the spring 114. That is, a force component acts in the longitudinal proximal direction 104, and static equilibrium of the second jaw 112 in the longitudinal direction is achieved. This longitudinal force component acts at a contact point or area between a curved middle portion of the bottom surface of the second pad base 112b of the second jaw 112 and a contoured portion of the lower inner surface of the second channel 108f of the body 108.

[0079] The vertical force component also acts at the contact point or contact area. The contoured portion of the lower inner surface of the second channel 108f of the body 108 defines a cam surface that contacts a driven surface defined by a curved intermediate portion of the bottom surface of the second pad base 112b of the second jaw 112. The resulting force due to the contours of the cam surface and the driven surface (and the force from the spring) acts on the second jaw 112 at the contact point or contact area with a longitudinal force component directed proximally (negative X direction) and a vertical force component directed upward (positive Z direction) from the body 108. The vertical force component on the second jaw 112 results in the second pad 112a being pressed against a portion of the EMD 120, bringing the portion of the EMD 120 into contact with the second pad 112a. In one embodiment, the driven surface is non-linear. In one embodiment, the driven surface is linear. In one embodiment, the following surface is arcuate. In one embodiment, the body 108 includes a cam surface that contacts a non-linear following surface of the second pad base 112b. In one embodiment, the body 108 includes a cam surface that contacts a linear following surface on the second pad base 112b. In one embodiment, the body 108 includes a cam surface that contacts an arcuate following surface on the second pad base 112b.

[0080] The second jaw 112 can rotate and / or oscillate (in the XZ plane) about the contact point or contact area of ​​the cam surface and the driven surface. When contact occurs between a portion of the EMD 120 and the second pad 112a, the second jaw 112 rotates and / or oscillates about the contact point or contact area, dispersing the vertical force component acting on the portion of the EMD 120 and equalizing the pressure on the EMD 120 along the length of the second pad 112a.

[0081] The first jaw 110 and the second jaw 112 can freely pivot and / or rock about the cam surface of the body 108 independently of one another, and the first jaw 110 and the second jaw 112 are not connected to one another. In one embodiment, the first jaw 110 and the second jaw 112 are a single manufactured part and are not directly connected to one another. In one embodiment, the first jaw 110 and the second jaw 112 are not directly connected to one another via a link. In one embodiment, as the first jaw 110 pivots about the cam surface, the distal and proximal ends of the first pad 110a move radially away from the longitudinal axis of the torquer 100. In one embodiment, the distal and proximal ends of the first pad 110a and the distal and proximal ends of the second pad 112a move radially away from the longitudinal axis of the torquer 100 as the first jaw 110 and the second jaw 112 rotate about the cam surfaces.

[0082] When the first pad 110a and the second pad 112a are pressed against each other, each pressing against the EMD 120 having a circular cross section, the first pad 110a and the second pad 112a each deform slightly around the EMD 120, such that the bottom surface of the first pad 110a contacts the peripheral surface of a portion of the EMD 120 along the length of the first pad 110a, and the top surface of the second pad 112a contacts the peripheral surface of a portion of the EMD 120 along the length of the second pad 112a. In one embodiment, pressure is equalized against the EMD 120 along the length of the elastomeric pad that contacts the portion of the EMD 120 in the fully gripped state. In one embodiment, pressure is equalized against the EMD 120 along the length of the elastomeric pad that contacts the portion of the EMD 120 in the fully gripped state. In one embodiment, pressure is equalized against the EMD 120 over a majority of the length of the elastomeric pad that is in contact with the portion of the EMD 120 at full grip. In one embodiment, pressure between the elastomeric pad and the portion of the EMD 120 is substantially equalized over the entire length of the elastomeric pad at full grip.

[0083] As first pad 110a partially deforms around EMD 120 and second pad 112a partially deforms around EMD 120, i.e., as each of the pads conforms to the arc of the circular cross section of EMD 120 in the length direction, the pads are forced toward each other from opposite directions, pinching EMD 120 between them.

[0084] 8, in the partially pinched torquer 100, the knob 106 is in a "not fully closed" position relative to the body 108. The torquer 100 is in transition from a pinched state to an unpinched state and is partially pinching the EMD 120. By rotating the knob 106 relative to the body 108 in a direction that threads the knob 106 toward the body 108, the knob 106 moves in the longitudinal proximal direction 104 relative to the body 108 until there is no gap between the proximal end face of the internal projection 106c and the distal end faces of the first jaw 110 and the second jaw 112. Specifically, the proximal end surface of the internal projection 106c of the knob 106 contacts the sloped distal end surface 110f of the first pad base 110b of the first jaw 110 (i.e., no gap), and the proximal end surface of the internal projection 106c of the knob 106 contacts the sloped distal end surface of the second pad base 112b of the second jaw 112.

[0085] When the knob 106 is screwed toward the body 108, the proximal end surface of the internal projection 106c of the knob 106 moves in the longitudinal proximal direction 104 and pushes the inclined distal end surface 110f of the first pad base 110b of the first jaw 110 in the longitudinal proximal direction 104. When the proximal end surface of the internal projection 106c pushes the inclined distal end surface 110f of the first jaw 110 in the longitudinal proximal direction 104, the distal end of the first pad 110a of the first jaw 110 opens radially away from the EMD 120 according to the inclination direction (inclination angle) of the inclined distal end surface 110f of the first jaw 110, and moves away from the EMD 120. Similarly, when the proximal end surface of the internal protrusion 106c presses the inclined distal end surface of the second jaw 112 in the longitudinal proximal direction 104, the distal end of the second pad 112a of the second jaw 112 opens radially away from the EMD 120 in accordance with the inclination direction (inclination angle) of the inclined distal end surface of the second jaw 112, and moves away from the EMD 120.

[0086] In the partially closed position, when the knob 106 is screwed toward the body 108, the proximal end face of the internal projection 106c of the knob 106 moves in the longitudinal proximal direction 104, pushing the first jaw 110 and the second jaw 112 and moving the first jaw 110 and the second jaw 112 proximally from their pinched positions. This action further compresses the spring 114 from its compression in the pinched state, increasing the spring restoring force in the longitudinal distal direction 102 to be greater than in the pinched state.

[0087] In a partially pinched state of the torquer 100 with the knob 106 in an incompletely closed position relative to the body 108, the inclined surface of the wedge-shaped protrusion 110h at the proximal end of the first pad base 110b also comes into contact (i.e., there is no gap) with the chamfered distal end surface facing said inclined surface on the internal post 116d of the spring housing 116 (extending distally from the proximal base of the cylindrical cup), and the inclined surface of the wedge-shaped protrusion at the proximal end of the second pad base 112b also comes into contact with the chamfered distal end surface facing said inclined surface on the internal post 116d of the spring housing 116.

[0088] In the partially pinched state of the torquer 100, the first pad 110a of the first jaw 110 and the second pad 112a of the second jaw 112 are misaligned with respect to the longitudinal centerline of the torquer 100. In the partially pinched state of the torquer 100, the first pad 110a of the first jaw 110 and the second pad 112a of the second jaw 112 are not parallel, partially pinching and partially unpinching a portion of the EMD 120. Specifically, being misaligned, the first pad 110a and the second pad 112a are in contact (or partially in contact) with a portion of the EMD 120 toward the proximal end, and the first pad 110a and the second pad 112a are not in contact with a portion of the EMD 120 toward the distal end. In one embodiment, either the distal or proximal end of the jaws separates from the other before the other of the distal or proximal end of the jaws.

[0089] As described above, the contoured portion of the upper inner surface of the first channel 108e of the body 108 defines the cam surface, and the curved intermediate portion 110j of the upper surface of the first pad base 110b of the first jaw 110 defines the driven surface. A longitudinal force component acts on the first pad base 110b of the first jaw 110 in the longitudinal proximal direction 104, and longitudinal static equilibrium is achieved with half the restoring force from the spring 114. This longitudinal force component is greater than the force component exerted in the pinched state. Due to the contours of the cam surface and the driven surface, a vertical force component also acts on the first pad base 110b of the first jaw 110. The longitudinal force component is directed proximally, and the vertical force component is directed downward. In the partial pinched state of the torquer 100, the force component in the vertical direction presses the proximal portion of the first pad 110a against the EMD 120. A part of the EMD 120 and the proximal portion of the first pad 110a come into contact with each other.

[0090] Similarly, a contoured portion of the lower inner surface of the second channel 108f of the body 108 defines the cam surface, and a curved intermediate portion of the bottom surface of the second pad base 112b of the second jaw 112 defines the follower surface.

[0091] A longitudinal force component acts on the second pad base 112b of the second jaw 112 in the longitudinal proximal direction 104, achieving longitudinal static equilibrium with half the restoring force from the spring 114. This longitudinal force component is greater than the force component in the pinched state. Due to the contours of the camming and driven surfaces, a vertical force component also acts on the second pad base 112b of the second jaw 112. The longitudinal force component is directed proximally and the vertical force component is directed upward. In the partially pinched state of the torquer 100, the vertical force component presses the proximal portion of the second pad 112a against the EMD 120. A portion of the EMD 120 and the proximal portion of the second pad 112a come into contact.

[0092] The proximal portion of the first pad 110a and the proximal portion of the second pad 112a each deform around a portion of the EMD 120. The proximal portions of the first pad 110a and the second pad 112a are pressed toward each other from opposite directions to partially pinch a portion of the EMD 120.

[0093] 9, in the unpinched state of the torquer 100, the knob 106 is in a closed position relative to the body 108. In the unpinched state of the torquer 100, the EMD 120 in the lumen 118 can be withdrawn in the longitudinal proximal direction 104, or the EMD 120 can be inserted in the longitudinal distal direction 102 into the lumen 118. When the knob 106 is rotated relative to the body 108 in a direction that threads the knob 106 toward the body 108 completely until it cannot move any further, the knob 106 moves to its most proximal position relative to the body 108. As in the partially pinched state, there is no gap between the proximal end face of the internal projection 106c and the distal end faces of the first jaw 110 and the second jaw 112.

[0094] In the fully unpinched state of the torquer 100, the proximal end face of the internal projection 106c of the knob 106 is at its most proximal position. The proximal end face (or the edge of the proximal end face) of the internal projection 106c of the knob 106 contacts the inclined distal end face 110f of the first jaw 110 at a portion of the inclined distal end face 110f of the first jaw 110 that is at a radially furthest position from the centerline. Due to the inclination direction (inclination angle) of the inclined distal end face 110f of the first jaw 110, the distal end of the first pad 110a of the first jaw 110 moves to its radially furthest position away from the longitudinal centerline of the torquer 100. Similarly, the proximal end face (or an edge of the proximal end face) of the internal projection 106c of the knob 106 contacts the sloped distal end face of the second jaw 112 at a portion of the sloped distal end face of the second jaw 112 that is radially furthest from the centerline. The slope direction (slope angle) of the sloped distal end face of the second jaw 112 moves the distal end of the second pad 112a of the second jaw 112 to its radially furthest position away from the longitudinal centerline of the torquer 100.

[0095] In a fully unpinched state of the torquer 100, the proximal end face (or the edge of the proximal end face) of the internal projection 106c of the knob 106 pushes the first jaw 110 and the second jaw 112 in the longitudinal proximal direction 104 to their proximal-most reachable position. The proximal-most reachable position corresponds to maximum compression of the spring 114 of the torquer 100. A maximum restoring force from the spring 114 of the torquer 100 is generated and acts on the first jaw 110 and the second jaw 112 in the longitudinal proximal direction 102.

[0096] In the fully unpinched state of the torquer 100, the inclined surface of the wedge projection 110h at the proximal end of the first pad base 110b is in its proximal-most position and presses against the chamfered distal end surface of the internal post 116d (extending distally from the proximal base of the cylindrical cup) of the spring housing 116. The inclination direction (angle of inclination) of the inclined surface of the wedge projection 110h at the proximal end of the first pad base 110b causes the proximal end of the first pad 110a of the first jaw 110 to move radially away from the longitudinal centerline of the torquer 100. Similarly, the inclined surface of the wedge projection at the proximal end of the second pad base 112b is in its proximal-most position and presses against the chamfered distal end surface of the internal post 116d of the spring housing 116. The inclination direction (inclination angle) of the inclined surface of the wedge-shaped protrusion at the proximal end of the second pad base 112b causes the proximal end of the second pad 112a of the second jaw 112 to move radially away from the longitudinal centerline of the torquer 100.

[0097] In a fully unpinched state of the torquer 100, both the proximal and distal ends of the first jaw 110 and the second jaw 112 are at their most radially distant positions from the longitudinal centerline of the torquer 100, forming a gap distance in the lengthwise direction between the opposing outermost surfaces of the first pad 110a and the second pad 112a that is greater than the diameter of the EMD 120. In other words, the first pad 110a of the first jaw 110 and the second pad 112a of the second jaw 112 are in an unpinched state and the torquer 100 is not pinching the EMD 120.

[0098] In one embodiment of the torquer 100, the torque target for a 0.014 inch (0.356 mm) guidewire is 2 mNm or greater. In other words, in one embodiment, the torquer 100 transmits or applies 2 mNm or greater without the EMD slipping relative to the torquer. In one embodiment of the torquer 100, the length of the elastomeric pads of each pad is 50 mm or less. In one embodiment of the torquer 100, the thickness of the elastomeric pads ranges from 0.5 mm to 2 mm. In one embodiment of the torquer 100, the modulus of the elastomeric pads ranges from 250 MPa to 320 MPa. In one embodiment of the torquer 100, the material of the pad base is stainless steel. In one embodiment of the torquer 100, the elastic modulus of the pads is 3 GPa or greater.

[0099] 10, a passive torquer 100 according to one embodiment includes a movable first jaw 110 and a fixed second jaw 112. In one embodiment, the passive torquer 100 includes two or more movable jaws. In one embodiment, the passive torquer 100 does not include a bevel gear 116b in the housing 116, and the housing 116 is manually operated. In one embodiment, the passive torquer 100 does not include a bevel gear 116b in the housing 116, and includes a mechanical rotation means such as a pulley.

[0100] 11, 12, and 13, an active torquer 200 according to one embodiment includes a knob 206, a body 208, a first jaw 210, a second jaw 212, a first spring 214, a second spring 216, a first pin 218, a second pin 220, a housing 222, and a fastener 224. The torquer 200 includes a lumen 226 along a longitudinal centerline thereof that extends therethrough. The lumen 226 has a diameter that is greater than the diameter of the EMD in which the torquer 200 is to be used.

[0101] In the unpinched state of the torquer 200, the END is inserted into the lumen 226 in the longitudinal proximal direction 204 from the distal end of the torquer 200 and withdrawn from the lumen 226 in the longitudinal distal direction 202 at the distal end of the torquer 200, or the EMD is inserted into the lumen 226 in the longitudinal distal direction 202 from the proximal end of the torquer 200 and withdrawn from the lumen 226 in the longitudinal proximal direction 204 at the proximal end of the torquer 200. As described above with respect to passive torquers, regardless of how the EMD was inserted into the torquer, the EMD can be removed from the torquer from either the distal or proximal end. In the pinched state of the torquer 200, a portion of the EMD is fixed relative to the torquer 200. Specifically, in the pinched state, the first jaw 210 and second jaw 212 of the torquer 200 pinch a portion of the shaft of the EMD 228 (see FIG. 14 ) such that rotation and / or translation of the torquer 200 about or along its longitudinal axis causes a corresponding rotation and / or translation of the pinched portion of the shaft of the EMD. The active torquer 200 is normally in an open or released state, with the EMD unpinched. To pinch the EMD, the operator actuates the actuator to overcome the spring bias, Torquer needs to be closed.

[0102] The knob 206 includes a distal portion 206a and a proximal portion 206b, both of which have longitudinal centerlines aligned with the longitudinal centerline of the torquer 200. In one embodiment, the knob 206 is a hollow cylinder having separate inner and outer diameters at the distal portion 206a and the proximal portion 206b. In one embodiment, the distal portion 206a of the knob 206 is a hollow cylinder. In one embodiment, the distal portion 206a of the knob 206 is a hollow cylinder having a flat outer surface arrangement on the outer wall, for example in the shape of a hexagonal nut with no internal threads. In one embodiment, the distal portion 206a of the knob 206 is a hollow cylinder having a contoured surface arrangement on the outer wall. In one embodiment, the distal portion 206a of the knob 206 is a hollow cylinder having a smooth inner wall. In one embodiment, the proximal portion 206b of the knob 206 is a hollow cylinder having an internal thread 206c, which is a thread on the inner wall of the cylinder. In one embodiment, the proximal portion 206b of the knob 206 is a hollow cylinder having an array of contoured surfaces on its outer wall. In one embodiment, the proximal portion 206b of the knob 206 is a hollow cylinder having a smooth outer wall. In one embodiment, the proximal portion 206b of the knob 206 is a hollow cylinder having a knurled outer wall. In one embodiment, the knob 206 is a single manufactured part, such as a molded part, having an internal passageway through which a portion of the shaft of the EMD passes. In one embodiment, the knob 206 is an assembled part having an internal passageway through which a portion of the shaft of the EMD passes.

[0103] The body 208 includes a distal portion 208a, an intermediate portion 208b, and a proximal portion 208c, all of which have longitudinal centerlines aligned with the longitudinal centerline of the torquer 200. In one embodiment, the body 208 is an open cylinder having individual diameters at the distal portion 208a, the intermediate portion 208b, and the proximal portion 208c. In one embodiment, the outer wall of the distal portion 208a includes male threads 208d. In one embodiment, a portion of the inner wall of the distal portion 208a includes a conical section, which is a section of linearly increasing or decreasing diameter in a plane transverse to the longitudinal axis (i.e., the YZ plane). In one embodiment, the inner wall of the distal portion 208a includes multiple portions having conical sections, which are sections of linearly increasing and decreasing diameter in a plane transverse to the longitudinal axis (i.e., the YZ plane).

[0104] In one embodiment, intermediate portion 208b of body 208 is a hollow cylinder having an array of contoured surfaces on an outer wall. In one embodiment, intermediate portion 208b of body 208 is a hollow cylinder having a smooth outer wall. In one embodiment, intermediate portion 208b of body 208 is a hollow cylinder having a knurled outer wall. In one embodiment, proximal portion 208c of body 208 includes a threaded hole in a proximal end face for receiving fastener 224. In one embodiment, body 208 is a single manufactured part, such as a molded part, having an internal passageway through which a portion of the shaft of the EMD passes. In one embodiment, body 208 is an assembled part having an internal passageway through which a portion of the shaft of the EMD passes.

[0105] The first jaw 210 includes a first pad 210a and a first pad base 210b, and the second jaw 212 includes a second pad 212a and a second pad base 212b. In one embodiment, the first pad 210a is affixed to the first pad base 210b, and the second pad 212a is affixed to the second pad base 212b. In one embodiment, the first pad base 210b is a parallelepiped-shaped member having a longitudinal axis corresponding to the longest dimension of the base along the longitudinal axis of the torquer 200. In one embodiment, the first pad base 210b is a cubic-shaped member having a longitudinal axis corresponding to the longest dimension of the base along the longitudinal axis of the torquer 200. In one embodiment, the first pad base 210b includes a flat bottom surface to which the first pad 210a is attached. In one embodiment, the second pad base 212b is a parallelepiped-shaped member having a longitudinal axis corresponding to the longest dimension of the base along the longitudinal axis of the torquer 200. In one embodiment, the second pad base 212b is a cubic-shaped member having a longitudinal axis corresponding to the longest dimension of the base along the longitudinal axis of the torquer 200. In one embodiment, the second pad base 212b includes a flat upper surface to which the second pad 212a is attached.

[0106] Referring to FIG. 14, the first pad base 210b in one embodiment includes a flat bottom surface (lower surface) 210c to which the first pad 210a is attached, a flat front side surface 210d, a flat back side surface 210e, a sloped distal end surface 210f, a proximal end surface 210g having a hole 210h extending distally through the first pad base 210b but not through to the distal end surface, and a top surface (upper surface), which includes a distal portion 210i, a first intermediate portion 210j, a second intermediate portion 210k, a third intermediate portion 210m, and a proximal portion 210n. In one embodiment, a transition portion is included between the distal portion 210i and the first intermediate portion 210j of the upper surface of the first pad base 210b, and a transition portion is included between the third intermediate portion 210m and the proximal portion 210n of the upper surface of the first pad base 210b. In one embodiment, the inclined distal end surface 210f extends beyond the distal end surface of the first pad base 210b. In one embodiment, the inclined distal end surface 210f is a portion of the distal end surface of the first pad base 210b. In one embodiment, the diameter of the hole 210h is larger than the outer diameter of the first spring 214 and larger than the outer diameter of the first pin 218. In one embodiment, the upper surface (upper surface) of each portion 210i, 210j, 210k, 210m, 210n of the first pad base 210b is curved like an arcuate surface in the circumferential direction. In one embodiment, the upper surface (upper side surface) of each of the portions 210i, 210j, 210k, 210m, and 210n of the first pad base 210b is a flat surface.

[0107] In one embodiment, the second pad base 212b is identical to the first pad base 210b and includes surfaces that correspond to the respective surfaces of the first pad base 210b. In one embodiment of the torquer 200, the second pad base 212b is rotated (flipped) 180 degrees about its longitudinal axis relative to the first pad base 210b. In other words, the flat bottom surface 210c of the first pad base 210b to which the first pad 210a is attached faces the flat top surface of the second pad base 212b to which the second pad 212a is attached.

[0108] In one embodiment, the bottom surface of the first pad 210a of the first jaw 210 is a flat surface. In one embodiment, the bottom surface of the first pad 210a of the first jaw 210 is a flat surface that includes a concave arcuate profile (in a cross section, i.e., in a YZ plane) that extends along the length of the first pad 210a surface. In one embodiment, the bottom surface of the first pad 210a of the first jaw 210 is a curved surface that has a concave arcuate profile (in a cross section, i.e., in a YZ plane) that extends along the length of the first pad 210a surface.

[0109] In one embodiment, the second pad 212a is identical to the first pad 210a and includes surfaces that correspond to respective surfaces of the first pad 210a. In one embodiment, the top surface of the second pad 212a of the second jaw 212 is identical to the bottom surface of the first pad 210a of the first jaw 210 and includes surfaces that correspond to respective surfaces of the first pad 210a. In one embodiment, the first pad 210a is attached to the first pad base 210b and the second pad 212a is attached to the second pad base 212b.

[0110] In one embodiment, the first pad 210a and the second pad 212a are formed from a medical biocompatible material that, when pressed by the pad, will not scratch or penetrate the coating of an EMD, such as a guidewire used in a catheter procedure. In one embodiment, the first pad 210a and the second pad 212a are formed from an elastomeric material within a durometer measurement range of 50D-75D and manufactured with a particular smoothness / roughness rating, such as SPI-B1, A1, C1, A2, B2, or C2. In one embodiment, the first pad 210a and the second pad 2112a are formed from a natural or synthetic material with a low modulus value and high strain value compared to other materials.

[0111] In one embodiment, the first pad base 210b and the second pad base 212b are made of a medical biocompatible material, such as a biocompatible plastic, that is harder than the material of the first pad 210a and the second pad 212a. In one embodiment, the first pad base 210b and the second pad base 212b are made of a material, such as Ultem 1000 or stainless steel. In one embodiment, the first pad base 210b and the second pad base 212b are made of a material that is stiffer than the material of the first pad 210a and the second pad 212a. In one embodiment, the first pad base 210b and the second pad base 212b are made of a material that has a modulus of elasticity equal to or greater than a value of 3.5 GPa. In one embodiment, the first pad base 210b and the second pad base 212b are made of a material that has a modulus of elasticity that is more than twice the value of the material of the first pad 210a and the second pad 212a. In one embodiment, the first pad base 210b and the second pad base 212b are formed from a material having a modulus of elasticity ten times greater than the material of the first pad 210a and the second pad 212a.

[0112] In the torquer 200 according to one embodiment, the female thread 206c of the knob 206 meshes with the male thread 208d of the body 208, and the rotation of the knob 206 relative to the body 208 changes the longitudinal distance between the knob 206 and the body 208, and the distance increases or decreases depending on the direction of the relative rotation. The change in longitudinal distance per unit of relative rotation between the knob 206 and the body 208 is determined by the pitch of the meshed threads 206d, 208d. In the torquer 200 according to one embodiment, the male thread of the knob 206 meshes with the female thread formed on the inner wall of the distal portion 208a of the body 208, and the rotation of the knob 206 relative to the body 208 changes the longitudinal distance between the knob 206 and the body 208, and the distance increases or decreases depending on the direction of the relative rotation. The change in longitudinal distance per unit of relative rotation between the knob 206 and the body 208 is determined by the pitch of the meshed threads.

[0113] In one embodiment, the first spring 214 and the second spring 216 are helical compression springs. In one embodiment, the first spring 214 and the second spring 216 are helical compression springs with flat, polished ends. In one embodiment, the first spring 214 and the second spring 216 are helical compression springs with square, polished ends. In one embodiment, the first spring 214 and the second spring 216 are hollow cylinders or other shaped flexible elastic members. In one embodiment, the first spring 214 and the second spring 216 are identical, such as having the same dimensions, being made from the same material, and having the same stiffness characteristics. In one embodiment, the first spring 214 and the second spring 216 are different, such as having different dimensions, being made from different materials, or having different stiffness characteristics.

[0114] In one embodiment, the first pin 218 and the second pin 220 are cylindrical pins with their respective longitudinal axes aligned with the longitudinal axis of the torquer 200. In one embodiment, the first pin 218 and the second pin 220 are identical, i.e., have the same dimensions and are made of the same material. In one embodiment, the first pin 218 and the second pin 220 have different dimensions or are made of different materials. In one embodiment, the outer diameter of the first pin 218 is equal to or greater than the outer diameter of the first spring 214, and the outer diameter of the second pin 220 is equal to or greater than the outer diameter of the second spring 216.

[0115] The housing 222 includes a distal portion 222a, a first intermediate portion 222b, a second intermediate portion 222c, and a proximal portion 222d, all of which have longitudinal centerlines aligned with the longitudinal centerline of the torquer 200. In one embodiment, the distal portion 222a of the housing 222 is a support tube having a distally extending lumen 226 to inhibit buckling and prevent kinking of a portion of the EMD in the length direction when the EMD is translated and / or rotated. In one embodiment, the distal portion 222a of the housing 222 is a cylindrical support tube having a lumen 226.

[0116] The first intermediate portion 222b of the housing 222 is a transitional section that integrally connects the distal portion 222a at its distal end to the second intermediate portion 22c at its proximal end, with a lumen 226 extending along the longitudinal centerline. In one embodiment, the first intermediate portion 222b is formed in a double truncated cone shape that meets at a common cone base, with the lumen 226 extending along the longitudinal centerline. In one embodiment, the diameters of the connecting cone bases of the double truncated cones are the same and are smaller than the inner diameter of the distal portion 206a of the knob 206. In one embodiment, the first intermediate portion 222b includes a distal truncated cone and a proximal truncated cone, with the distal truncated cone transitioning from the outer diameter of the distal portion 222a to the outer periphery of the second intermediate portion 222c. In one embodiment, first intermediate portion 222b includes a distal frustum having a conical surface that increases in diameter in the proximal longitudinal direction 104 and a proximal frustum having a conical surface that decreases in diameter in the proximal longitudinal direction 104 and a flat proximal end surface. In one embodiment, first intermediate portion 222b includes a double cone having an arcuate contoured conical surface.

[0117] The second intermediate portion 222c of the housing 222 integrally connects the first intermediate portion 222b and the proximal portion 222d, connecting the first intermediate portion 222b at a distal end and the proximal portion 222d at a proximal end. In one embodiment, the second intermediate portion 222c is cylindrical and includes a first pocket 222e and a second pocket 222f that are recessed into the second intermediate portion 222c and aligned with the longitudinal axis of the second intermediate portion 222c, and the second intermediate portion 222c includes a conical portion 222g at a proximal end. In one embodiment, the length of the first pocket 222e is longer than the length of the first jaw 210, and the length of the second pocket 222f is longer than the length of the second jaw 212. In one embodiment, the width of the first pocket 222e is greater than the width of the first jaw 210 and the width of the second pocket 222f is greater than the width of the second jaw 212. In one embodiment, the base of the conical portion 222g is at the proximal end of the second intermediate portion 222c of the housing 222 and the diameter of the conical surface decreases in the longitudinal distal direction 202.

[0118] In one embodiment, proximal portion 222d includes distal portion 222h and proximal portion 222i, where distal portion 222h is a disk-like cylinder having an outer diameter and an inner diameter, and proximal portion 222i is a bevel gear with proximally oriented teeth. In one embodiment, distal portion 222h and proximal portion 222i of proximal portion 222d are a single manufactured part, such as a molded part, having an internal passageway through which a portion of the shaft of the EMD passes. In one embodiment, distal portion 222h and proximal portion 222i of proximal portion 222d are assembled together as a single integral unit having an internal passageway through which a portion of the shaft of the EMD passes. In one embodiment, the proximal portion 222d of the housing 222 includes two holes extending longitudinally therethrough that are larger in diameter than the threads of the fastener 224 and are located on the periphery of the proximal portion 222d and correspond to the recessed threaded holes in the proximal portion 208c of the body 208. In one embodiment, the bevel gear is a driven member that is driven in motion by a drive member of a robotic system.

[0119] In one embodiment, housing 222 is a single manufactured part, such as a molded part, having an internal passageway through which a portion of the shaft of the EMD passes. In one embodiment, housing 222 is an assembled part, having an internal passageway through which a portion of the shaft of the EMD passes.

[0120] In one embodiment of the assembled torquer 200, the body 208 is removably secured to the housing 222 by fasteners 224 that are inserted into holes in the proximal portion 222d of the housing 222 and threaded into threaded holes recessed in the proximal portion 208c of the body 208. In one embodiment of the assembled torquer 200, the body 208 is secured to the housing 222 by adhesives, glues, bonding agents, laser welding, ultrasonic welding, or other means of attaching two objects together during assembly and manufacturing.

[0121] In one embodiment of the torquer 200, a first spring 214 is inserted in a longitudinal distal direction 202 and sits entirely in a hole 210h in the first jaw 210, and a second spring 216 is inserted in a longitudinal distal direction 202 and sits entirely in a similar hole in the second jaw 212. In one embodiment of the torquer 200, a distal end of the first spring 214 presses against a distal end of the hole 210h in the first jaw 210, and a distal end of the second spring 216 presses against a distal end of the similar hole in the second jaw 212. In one embodiment of the torquer 200, a first pin 218 is inserted in the longitudinal distal direction 202 with its distal end abutting the proximal end of the first spring 214 in a hole 210h of the first jaw 210, and a second pin 220 is inserted in the longitudinal distal direction 202 with its distal end abutting the proximal end of the second spring 216 in a similar hole of the second jaw 212.

[0122] In one embodiment of the torquer 200, the first pad base 210b is constrained for movement within a first pocket 222e of the housing 222, and the second pad base 212b is constrained for movement within a second pocket 222f of the housing 222. Specifically, in one embodiment, the walls of the first pocket 222e constrain the lateral movement of the first jaw 210 (by contacting the flat front side 210d and the flat back side 210e of the first pad base 210b), and the walls of the second pocket 222f constrain the lateral movement of the second jaw 212.

[0123] In one embodiment, a portion of an upper surface of the first pad base 210b of the first jaw 210 contacts a portion of the inner peripheral wall of the body 208, and a portion of a bottom surface of the second pad base 212b of the second jaw 212 contacts a portion of the inner peripheral wall of the body 208. In one embodiment, a portion of an upper surface of the first pad base 210b of the first jaw 210 contacts a portion of the inner peripheral wall of the body 208, a portion of an upper surface of the first pad base 210b of the first jaw 210 contacts a portion of the inner peripheral wall of the housing 222, and a portion of a bottom surface of the second pad base 212b of the second jaw 212 contacts a portion of the inner peripheral wall of the body 208, and a portion of a bottom surface of the second pad base 212b of the second jaw 212 contacts a portion of the housing 222.

[0124] In one embodiment, the torquer 200 includes two jaws that move relative to one another to releasably secure a portion of the shaft of the EMD in at least one of the jaws. In one embodiment, the torquer 200 includes one jaw that moves relative to a body of the torquer 200 to releasably secure a portion of the shaft of the EMD in the jaw. In one embodiment, the torquer 200 includes more than two jaws that move relative to one another to releasably secure a portion of the shaft of the EMD in at least one of the jaws.

[0125] In one embodiment of the torquer 200, a first spring 214 acts as a biasing member to bias one jaw against the body. In one embodiment of the torquer 100, a first spring 214 and a second spring 216 act as biasing members to bias two jaws against the body. In one embodiment of the torquer 100, more than two springs act as biasing members to bias more than two jaws against the body.

[0126] 15, 16, and 17, an active torquer 200 according to one embodiment is shown in a fully unpinch state, an unpinch transitioning to a pinch state, and a stage corresponding to a pinch state, respectively. In the unpinch state, the torquer 200 is in an ungripped (released) state and is not pinching the EMD 228. In the pinch state, the torquer 200 is in a fully gripped state and is pinching a portion of the EMD 228. In the embodiment shown in all three states (unpinch, unpinch transitioning to pinch, and pinch), the female threads 206c of the knob 206 are mated with the male threads 208d of the body 208.

[0127] 15, in a fully unpinched state of the torquer 200, the knob 206 is in an open position relative to the body 208. In the unpinched state of the torquer 200, the EMD 228 in the lumen 226 can be withdrawn in the longitudinal proximal direction 204, and the EMD 228 can be inserted into the lumen 226 in the longitudinal distal direction 202. There is no contact (i.e., a gap exists) between the third intermediate portion 210m of the top surface of the first pad base 210b of the first jaw 210 and the sloped inner wall of the distal portion 208a of the body 208, nor is there contact between the corresponding intermediate portion of the bottom surface of the second pad base 212b of the second jaw 212 and the sloped inner wall of the distal portion 208a of the body 208. By rotating the knob 206 relative to the body 208 in a direction in which the knob 206 is unscrewed from the body 208, the knob 206 moves in the longitudinal distal direction 202 relative to the body 208, increasing the gap between the third intermediate portion 210m of the upper surface of the first pad base 210b of the first jaw 210 and the sloped inner wall of the distal portion 208a of the body 208, and also increasing the gap between the corresponding intermediate portion of the bottom surface of the second pad base 212b of the second jaw 212 and the sloped inner wall of the distal portion 208a of the body 208.

[0128] In one embodiment, the knob 206 can be rotated without restriction relative to the body 208 in a direction that unscrews the knob 206 from the body 208 until the knob 206 is unscrewed and can be removed from the body 208. In one embodiment, the knob 206 can be rotated without restriction relative to the body 208 in a direction that unscrews the knob 206 from the body 208 until a stop is reached that prevents the knob 206 from being removed from the body 208.

[0129] In a fully unpinched state of the torquer 200 with the knob 206 in an open position relative to the body 208, there is contact between the proximal conical surface of the first intermediate portion 222b of the housing 222 and the sloped distal end surface 210f of the first pad base 210b of the first jaw 210, and there is also contact between the proximal conical surface of the first intermediate portion 22b of the housing 222 and the sloped distal end surface of the second pad base 212b of the second jaw 212.

[0130] In a fully unpinched state of the torquer 200, the first pad 210a of the first jaw 210 and the second pad 212a of the second jaw 212 face each other, are spaced apart from each other by a predetermined distance, are parallel to each other and to a portion of the EMD 228, if an EMD is present, and are not in contact with any portion of the EMD 228. The first pad 210a and the second pad 212a are not in contact with any portion of the EMD 228 across the entire area of ​​both pads.

[0131] In a fully unpinched state of the torquer 200, the first spring 214 and the second spring 216 are compressed to their respective rest lengths, resulting in a spring restoring force acting in the longitudinal distal direction 202 from the first spring 214 and a spring restoring force acting in the longitudinal distal direction 202 from the second spring 216. (The spring restoring force also acts in the longitudinal proximal direction 204 from the first spring 214 and from the second spring 216 during static equilibrium. However, the proximal end of the first spring 214 and the proximal end of the second spring 216 are constrained, i.e., fixed, relative to the housing 222 and to the body 208 to which the housing 222 is attached. The length of the first pin 218 and the second pin 220 are fixed, and both pins are constrained from moving relative to the housing 222 and to the body 208 because their proximal ends abut the conical portion 222g of the second intermediate portion 222c of the housing 222. Thus, the spring restoring force in this case acts in the longitudinal distal direction 202.)

[0132] A spring restoring force from the first spring 214 acts on the first jaw 210 through contact between a distal end of the first spring 214 and an inner surface at the distal end of a hole 210h in the first pad base 210b. As a result, the first jaw 210 moves in the longitudinal distal direction 202 until movement is arrested by contact between a first intermediate portion 210j of the upper surface of the first pad base 210b and the sloped inner wall of the knob 206. Similarly, a spring restoring force from the second spring 216 acts on the second jaw 212 through contact between a distal end of the second spring 216 and an inner surface at the distal end of a hole in the second pad base 212b. As a result, the second jaw 212 moves in the longitudinal distal direction 202 until movement is arrested by contact between a corresponding first intermediate portion of the bottom surface of the second pad base 212 b and the sloped inner wall of the knob 206 .

[0133] 16, in the unpinched state of the torquer 200, which is in the process of transitioning from the fully unpinched state to the fully pinched state, the knob 206 is in an incompletely closed position relative to the body 208. By rotating the knob 206 relative to the body 208 in a direction that screws the knob 206 into the body 208, the knob 206 moves in the longitudinal proximal direction 204 relative to the body 208. As a result, a third intermediate portion 210m of the top surface of the first pad base 210b of the first jaw 210 contacts the sloped inner wall of the distal portion 208a of the body 208, and a corresponding intermediate portion of the bottom surface of the second pad base 212b of the second jaw 212 contacts the sloped inner wall of the distal portion 208a of the body 208.

[0134] As the knob 206 is threaded into the body 208, the knob 206 moves in a longitudinal proximal direction 204 relative to the body 208, pushing the first jaw 210 and the second jaw 212 in the longitudinal proximal direction 204. The movement in the longitudinal proximal direction 204 compresses the first spring 214 further than it was compressed in the unpinched state, resulting in a first spring restoring force that is greater than the first spring restoring force in the unpinched state, and the second spring 216 also compresses further than it was compressed in the unpinched state, resulting in a second spring restoring force that is greater than the second spring restoring force in the unpinched state.

[0135] The angled inner walls of the knob 206 cause the knob 206 to both push the first jaw 210 down toward the longitudinal centerline of the torquer 200 and push the second jaw 212 up toward the longitudinal centerline of the torquer 200. In other words, the first pad 210a of the first jaw 210 moves radially toward a portion of the EMD 228 and the second pad 212a of the second jaw 212 also moves radially toward a portion of the EMD 228. The first pad 210a and the second pad 212a face each other parallel to each other and maintain a parallel orientation to the portion of the EMD 228 between the pads as a result of the two angled surfaces on the top surface of the first pad base 210b and the two angled surfaces on the bottom surface of the second pad base 212b. Specifically, the inclination of the first intermediate portion 210j of the upper surface of the first pad base 210b is the same as the inclination of the inner wall of the knob 206, and the inclination of the third intermediate portion 210m of the upper surface of the first pad base 210b is the same as the inclination of the inner wall of the body 208. The bottom surface 210c of the first pad base 210b is flat. Furthermore, the inclination of the first intermediate portion 210j of the upper surface of the first pad base 210b is the same magnitude and opposite sign as the inclination of the third intermediate portion 210m of the upper surface of the first pad base 210b. As a result, the first pad 210a together with the flat bottom surface 210c of the first pad base 210b remains parallel to the longitudinal centerline of the torquer 200 and moves toward the longitudinal centerline of the torquer 200 while the knob 206 is screwed into the body 208. Similarly, the second pad 212a together with the flat upper surface of the second pad base 212b remain parallel to and move toward the longitudinal centerline of the torquer 200 while the knob 206 is screwed into the body 208.

[0136] 17, in the pinched state of the torquer 200, the knob 206 is in a closed position relative to the body 208. In the pinched state of the torquer 200, the first pad 210a of the first jaw 210 and the second pad 212a of the second jaw 212 face each other, are parallel to each other, are parallel to a portion of the EMD 228, and pinch a portion of the EMD 228 over the entire length of each pad. That is, the first pad 210a and the second pad 212a contact a portion of the EMD 228 over the entire length of each pad. The knob 206 moves to its most proximal position relative to the body 208 by rotating the knob 206 all the way relative to the body 208 in a direction that screws the knob 206 into the body 208 until it cannot move any further.

[0137] With the knob 206 in its proximal-most position relative to the body 208, the knob 206 pushes the first jaw 210 and the second jaw 212 in the longitudinal proximal direction 204 to their proximal-most achievable positions corresponding to maximum compression of the first spring 214 and maximum compression of the second spring 216. A maximum restoring force from the first spring 214 is generated and acts on the first jaw 210 in the longitudinal distal direction 202, and a maximum restoring force from the second spring 216 is generated and acts on the second jaw 212 in the longitudinal distal direction 202. Thus, a maximum vertical force component acts to push the first jaw radially downward toward the longitudinal centerline of the torquer 200, and a maximum vertical force component acts to push the second jaw radially upward toward the longitudinal centerline of the torquer 200.

[0138] When the first pad 210a and the second pad 212a are pressed against each other and each is pressed against an EMD 228 having a circular cross-section, the first pad 210a and the second pad 212a each deform slightly around the EMD 228, such that the bottom surface of the first pad 210a contacts a portion of the peripheral surface of the EMD 228 along the entire length of the first pad 210a, and the top surface of the second pad 212a contacts a portion of the peripheral surface of the EMD 120 along the entire length of the second pad 212a.

[0139] When first pad 210a partially deforms around EMD 228 and second pad 212a partially deforms around EMD 228, i.e., when both pads conform across their entire length to the arc of the circular cross section of EMD 228, the pads push against each other in opposite directions and EMD 228 is pinched between them.

[0140] In one embodiment, the pad with soft characteristics has a modulus of elasticity magnitude of 200 to 400 MPa. In one embodiment, the pad with soft characteristics has a pad durometer value of 45D to 75D. In one embodiment, the pad with soft characteristics has a modulus of elasticity magnitude of 200 to 400 MPa and a pad durometer value of 45D to 75D. In one embodiment, the force applied by the jaw pad to the EMD is a magnitude of 200 to 400N. In one embodiment, the length of the pad is less than 50mm. In one embodiment, the modulus of elasticity of the pad base is a value of 3.5GPa or more. In one embodiment, the modulus of elasticity of the pad base is greater than the modulus of elasticity of the pad. In one embodiment, the modulus of elasticity of the elastomeric pad is a value of 200 to 400 MPa, the length of the elastomeric pad is less than 50mm, the elastomeric pad has a durometer value of 45D to 75D, and the modulus of elasticity of the pad base is a value of 3.5GPa or more. The jaw pads referred to in this paragraph are the jaw pads on torquer 100 and torquer 200.

[0141] As described herein, in the gripped state of the torquer 200, the shaft of the EMD is pinched in the internal passage of the torquer 200. In one embodiment, the EMD is axially loaded into the internal passage of the torquer 200. For axial loading, a portion of the shaft is loaded into the internal passage of the torquer 200 by first inserting a free end of the EMD into either the proximal or distal opening of the lumen 226.

[0142] In another embodiment, the shaft of the EMD is radially loaded into the internal passage of the torquer. Radial loading is contrasted with axial loading and is sometimes referred to as side loading or lateral loading. The EMD is loaded into the torquer 200 through a longitudinal slit or opening in the torquer, which runs from the proximal end to the distal end of the torquer on the side of the torquer. In a radial loading embodiment, access to the internal passage is gained from the torquer periphery to the internal passage by a longitudinal slit along the torquer 200.

[0143] 18, the torquer 100 is located in the device module 32 according to one embodiment. Although not shown, the torquer 200 can also be located in a device module that robotically controls an EMD. The cassette 66 of the device module 32 includes a bearing support 232 that receives the bearing surface 117 on the torquer 100. The device module's bearing support 232 provides rotational and thrust support for the torquer 100, allowing it to rotate about the longitudinal axis of the device module, but not the device module itself. The distal portion 106a of the knob 106 provides anti-buckling support for the EMD. The bearing support 232 according to one embodiment is formed by a C-shaped bracket in the cassette 66, and the bearing support 232 according to one embodiment is formed in part by a bracket in the cassette 66 and in part by a portion of a cover pivotally attached to the cassette 66.

[0144] In one embodiment, the distal free end of the distal portion 106a is immediately adjacent to the device support or flexible track 79 along the longitudinal axis of the device module to prevent the EMD from buckling between the distal end of the distal portion 106a and the track 79 when the EMD is translated and / or rotated. In one embodiment, the distance between the distal free end of the distal portion 106a and the device support or track 79 is 1 inch (25.4 mm) or less, and in one embodiment, 0.5 inch (12.7 mm) or less. In one embodiment, the distal free end of the distal portion 106a is located within a lumen defined by the device support or track 79. In one embodiment, the track 79 is formed from a flexible member that is movable from a position collinear with the longitudinal axis of the device module to a position offset from the longitudinal axis of the device module. In one embodiment, the track 79 has a longitudinal slit that extends from an outer surface of the track 79 to a lumen extending longitudinally therethrough. In the use position, the drive member (bevel gear) 116b meshes with the drive member 230. The drive member is robotically controlled to impart rotational motion to the torquer and EMD.

[0145] The distal end of distal portion 106a in one embodiment, a torquer, is used with certain EMDs, such as stent retrievers and certain coils, where it is not desirable to rotate the proximal shaft, in which case the adapter does not include a drive member. In one embodiment, the adapter includes a feature such as a tab that engages with a stop on the cassette or device module to prevent rotation of the adapter and the particular EMD.

[0146] The passive torquer 100 resembles a two-jawed collet with a preloaded spring that pinches together with an elastomeric pad. The jaws are forced open when the operator twists the knob. To reclose the jaws, the knob is loosened to release the jaws. The passive torquer does not damage EMDs, accepts all sizes of wire-like devices, and eliminates performance variability due to operator force. Variations of the invention include radial loading versus axial loading, single-sided pinching, alternative force sources, and alternative actuation mechanisms.

[0147] The use of an elastomeric material for the pads minimizes damage to the outer surface coating of the EMD as compared to jaws formed from a metallic material.

[0148] Although other types of torque devices are available, the most commonly used torque devices require the operator to tighten a knob to close the pin vice of the wire-like device. The rotational and linear grip of the torquer is determined by how tightly the operator tightens the knob. Human strength testing suggests that more than 5% of the population would not be able to provide sufficient torque on the knob to achieve the target torque performance of 2.5 mNm guidewire torque. Significantly fewer individuals would be able to provide sufficient knob torque to achieve 6.5 mNm torque on the access wire of a 0.035-0.038 inch (0.889-0.965 mm) diameter device.

[0149] Although the present invention has been disclosed in the description based on the embodiments, it is to be understood that those skilled in the art can make changes in form and detail without departing from the spirit and scope of the defined subject matter. For example, although various embodiments are described as including one or more features providing one or more benefits, it is contemplated that the described features can be interchanged with one another or can be combined with one another in the described embodiments or in other alternative embodiments. Because the technology disclosed herein is relatively complex, it is not necessarily the case that all changes in the technology are foreseeable. The above disclosure is expressly intended to be as broad as possible. For example, unless otherwise specified, a definition describing one specific element also encompasses a plurality of similar specific elements.

Claims

1. 1. A torquer for an elongated medical device, comprising: a body having a cavity defining a passage; a first jaw movable within the cavity and including a first pad having compliant properties; a biasing member separate from the first jaw for biasing the first jaw against the body; an actuator configured to rotate relative to the body to actuate the first jaw to pinch and / or unpinch an elongated medical device with the first pad within the path.

2. the first pad is formed from an elastomeric material; a second jaw movable relative to the body toward the first jaw, the second jaw having a second pad formed from an elastomeric material; 2. The torquer of claim 1, wherein each of the first and second jaws includes a pad base having a first modulus of elasticity, the first modulus of elasticity being greater than a second modulus of elasticity of the first and second pads.

3. 3. The torquer of claim 2, wherein each of the first and second jaws rotates freely independently of one another about a cam surface of the body, and the first and second jaws are not connected to one another.

4. 4. The torquer of claim 3, wherein a distal end or a proximal end of the first or second pad formed from the elastomeric material moves radially away from a torquer longitudinal axis when the first or second jaw pivots about the cam surface.

5. The torquer of claim 2 , wherein the body includes a cam surface that contacts the non-linear following surface of each of the pad bases.

6. The torquer of claim 5 , wherein the driven surface is arcuate.

7. The torquer of claim 6 , wherein the cam surface is linear.

8. the first pad is an elastomeric pad; The torquer of claim 1 , wherein pressure between the elastomeric pad and the elongated medical device is substantially equalized across the area where the elastomeric pad contacts the elongated medical device under full pinch conditions.

9. The torquer of claim 2 , wherein the biasing force of the biasing member acts in a direction that biases the first and second pads toward each other.

10. The torquer of claim 2 , wherein the biasing force of the biasing member acts in a direction to bias the first and second pads away from each other.

11. The torquer of claim 1 , wherein the biasing member comprises one or more helical compression springs having a longitudinal axis that is parallel or coaxial with a longitudinal axis of the body.

12. each of the first and second jaws having a distal end and a proximal end; The torquer of claim 2 , wherein one of the distal and proximal ends of the first and second jaws moves away from one another before the other of the distal and proximal ends of the first and second jaws.

13. The torquer of claim 1 , wherein the passageway is capable of accepting an elongated medical device having a diameter from 0.014 inches to 0.038 inches.

14. a magnitude of force applied to the elongate medical device by the first and second pads is between 200 and 400 N; The first and second pads have an elastic modulus of 200 to 400 MPa, a length of the first and second pads is 50 mm or less, and a hardness value of the first and second pads is 45D to 75D; The torquer of claim 2 , wherein the first and second pad bases each have a modulus of elasticity greater than 3.5 GPa.

15. 1. A torquer for releasably pinching an elongated medical device, comprising: a body having a cavity defining a passage; at least two jaws movable within the cavity, each having a pad base and a pad secured to the pad base, the jaws being unconnected to each other; a biasing member separate from the jaw portion for biasing the jaw portion against the body; a knob configured to rotate relative to the body to move the jaws relative to one another to pinch or unpinch an elongated medical device with the pad within the passageway.

16. The torquer of claim 15 , wherein the body includes a cam surface that contacts the non-linear following surface of each of the pad bases.

17. 17. The torquer of claim 16, wherein each of said jaws is free to rotate about said cam surface independently of the other jaws.

18. The torquer of claim 17 , wherein pressure between the pad and the elongate medical device is substantially equalized over the entire length of the pad.

19. the magnitude of force applied by the pad to the elongated medical device is between 200 and 400 N; The elastic modulus of the pad is 200 to 400 MPa, the length of the pad is 50 mm or less, and the hardness value of the pad is 45D to 75D; 16. The torquer of claim 15, wherein the modulus of elasticity of the pad base is greater than 3.5 GPa.

20. 1. A torquer for releasably gripping an elongate medical device, comprising: a body having a cavity defining a passage; at least two jaws movable within the cavity, each having an elastomeric pad and unconnected to each other; a biasing member separate from the jaw portion that biases the jaw portion against the body; a knob configured to rotate relative to the body to move the jaws relative to one another to pinch or unpinch an elongated medical device with the elastomeric pad within the passageway; A torquer, wherein pressure between the elastomeric pad and the elongate medical device is substantially equalized across the entire length of the elastomeric pad in a fully pinched condition.

Images