Torquer for an elongated medical device

Abstract

A torque wrench for an elongated medical device includes a body having a cavity defining a passageway. A first jaw is movable within the cavity. The first jaw includes a gasket having a compliant property. A biasing member, separate from the first jaw, biases the first jaw relative to the body. An actuator, movable relative to the body, moves the first jaw to clamp and / or unclamp the elongated medical device within the passageway with the first gasket.

Description

Background Technology

[0001] Catheters and other elongated medical devices (EMDs) can be used in minimally invasive medical procedures to diagnose and treat a variety of vascular system diseases, including neurovascular intervention (NVI) (also known as neurointerventional surgery), percutaneous coronary intervention (PCI), and peripheral vascular intervention (PVI). These procedures typically involve guiding a guidewire through the vascular system and advancing a catheter via the guidewire to deliver treatment. Catheter insertion begins with the use of a guide sheath to enter the appropriate vessel, such as an artery or vein, using standard percutaneous techniques. The sheath or guide catheter is then advanced over the diagnostic guidewire to the primary location, such as the internal carotid artery for NVI, the coronary ostium for PCI, or the superficial femoral artery for PVI. A guidewire adapted to the vascular system is then guided through the sheath or guide catheter to the target location within the vascular system. In some cases, such as in convoluted anatomy, a support catheter or microcatheter is inserted over the guidewire to aid in its guidance. Physicians or operators can use imaging systems (such as fluorescein microscopes) to obtain images via angiography and select fixed frames as a roadmap to guide the guidewire or catheter to the target location, such as a lesion. As the physician advances the guidewire or catheter, enhanced images are also obtained, allowing the physician to verify that the device is moving along the correct path to the target location. When using fluoroscopy to visualize anatomical structures, the physician manipulates the proximal end of the guidewire or catheter to guide the distal tip toward the lesion or target anatomical location into the appropriate vessel and avoids advancing it into branch vessels.

[0002] Robotic catheter-based surgical systems have been developed to assist physicians in performing catheter insertion procedures such as, for example, NVI, PCI, and PVI. Examples of NVI procedures include coil embolization of aneurysms, liquid embolization of arteriovenous malformations, and mechanical thrombectomy for large vessel occlusion following acute ischemic stroke. In NVI procedures, physicians use a robotic system to access the target lesion by manipulating a neurovascular guidewire and microcatheter to deliver treatment and restore normal blood flow. Target access is made possible by a sheath or guide catheter, but intermediate catheters may be needed for more distant areas or to provide adequate support for the microcatheter and guidewire. Depending on the type of lesion and the treatment, the distal tip of the guidewire enters or passes through the lesion. To treat an aneurysm, the microcatheter is advanced into the lesion, the guidewire is removed, and several embolization coils are deployed into the aneurysm via the microcatheter to block blood flow into the aneurysm. To treat an arteriovenous malformation, a liquid embolic agent is injected into the malformation via the microcatheter. Mechanical thrombectomy for vascular occlusion can be performed via aspiration and / or the use of a stent retrieval device. Depending on the location of the clot, aspiration is performed via an aspiration catheter or via a microcatheter for smaller arteries. Once the aspiration catheter is at the lesion site, negative pressure is applied to remove the clot through the catheter. Alternatively, the clot can be removed by deploying a stent retrieval device via a microcatheter. Once the clot has integrated into the stent retrieval device, it is removed by retracting the stent retrieval device and the microcatheter (or intermediate catheter) into the guiding catheter.

[0003] In PCI, physicians use robotic systems to access the lesion, manipulating a coronary guidewire to deliver treatment and restore normal blood flow. Access is made possible by placing a guiding catheter in the coronary ostium. The distal tip of the guidewire is guided through the lesion, and for complex anatomy, a microcatheter can be used to provide adequate support for the guidewire. Blood flow is restored by delivering and deploying a stent or balloon at the lesion. The lesion may require preparation before stent placement, either by delivering a balloon for pre-dilation of the lesion or by performing atherosclerosis resection using a catheter and guidewire, such as a laser or rotational atherosclerosis resection catheter. Diagnostic imaging and physiological measurements can be performed using imaging catheters or fractional flow reserve (FFR) measurements to determine appropriate treatment.

[0004] In PVI, physicians use a robotic system to deliver treatment and restore blood flow using techniques similar to NVI. The distal tip of the guidewire is guided through the lesion, and microcatheters can be used to provide adequate support for the guidewire when used in complex anatomical structures. Blood flow is restored by delivering and deploying a stent or capsule to the lesion. As with PCI, lesion preparation and diagnostic imaging can also be used.

[0005] When support at the distal end of the catheter or guidewire is required, for example, to guide a tortuous or calcified vascular system to a distal anatomical location or through a hard lesion, an over-the-wire (OTW, integral exchangeable cyst catheter) or coaxial system is used. An OTW catheter has an inner lumen for the guidewire that extends the entire length of the catheter. This provides a relatively stable system because the guidewire is supported along its entire length. However, this system has some disadvantages compared to rapid exchange catheters, including higher friction and a longer overall length (see below). Typically, to remove or replace the OTW catheter while maintaining the indwelling guidewire position, the exposed length of the guidewire (outside the patient) must be longer than the OTW catheter. For this purpose, a 300 cm guidewire is usually sufficient and is often referred to as an exchange-length guidewire. Due to the length of the guidewire, two operators are required to remove or replace the OTW catheter. This becomes even more challenging if a triaxial system (known in the art as a triaxial system) is used (quadriaxial catheters are also known to be used). However, due to its stability, the OTW system is commonly used in NVI and PVI procedures. On the other hand, PCI procedures typically use rapid-exchange (or single-rail) catheters. In a rapid-exchange catheter, the guidewire lumen extends only through the distal segment of the catheter, known as the single-rail or rapid-exchange (RX) segment. Using the RX system, the operator manipulates interventional devices parallel to each other (as opposed to the OTW system, where multiple devices are arranged in a tandem configuration), and the exposed length of the guidewire only needs to be slightly longer than the RX segment of the catheter. Rapid-exchange guidewires are typically 180–200 cm long. Given a shorter guidewire and single rail, the RX catheter can be changed by a single operator. However, the RX catheter is often insufficient when more distal support is required.

[0006] During the procedure, various linear devices (such as guidewires, stent retrieval devices, and coils) are grasped along their axes to manipulate the device within the patient's anatomy linearly and / or rotationally. EMDs are typically grasped by the operator's fingers or by pin-like devices (often called torque devices).

[0007] The operator uses a torque wrench to releasably clamp and release a portion of the EMD (such as a guidewire) during the procedure. The torque wrench is used to releasably secure a portion of the EMD to allow the user to manipulate the EMD by rotating and / or translating it.

[0008] The diameter of the devices used in the procedure varies from 0.009 to 0.038 inches (0.229 to 0.965 mm) in outer diameter (OD). Commercially available torque converters are typically designed for a specific OD device. For example, one torque converter will be used to manipulate a 0.014-inch (0.356 mm) OD device, and different torque converters will be used to manipulate a 0.038-inch (0.965 mm) OD device. Summary of the Invention

[0009] A torque converter for an elongated medical device includes a body having a cavity defining a passage. A first clamp is movable within the cavity. The first clamp includes a pad having compliant properties. A biasing member, separate from the first clamp, biases the first clamp relative to the body. An actuator movable relative to the body moves the first clamp to clamp and / or release the elongated medical device within the passage using the first pad. In one embodiment, the pad having compliant properties is formed of an elastomeric material. In one embodiment, the actuator is a knob.

[0010] In one embodiment, a torque converter for releasably engaging an elongated medical device includes a body having a cavity defining a passage. At least two clamps are movable within the cavity, each clamp having a pad base and a pad fixed thereto, wherein the clamps are not connected to each other. A biasing member, separate from the clamps, biases the clamps relative to the body. A knob movable relative to the body moves the clamps relative to each other, thereby clamping or releasing the elongated medical device within the passage using the pads.

[0011] In one embodiment, a torque converter for releasably engaging an elongated medical device includes a body having a cavity defining a passage. At least two clamps, each having an elastomeric pad, move within the cavity, wherein the clamps are not connected to each other. A biasing member, separate from the clamps, biases the clamps relative to the body. A knob movable relative to the body moves the clamps relative to each other to clamp or release the elongated medical device within the passage using the elastomeric pad, wherein in the fully clamped position, the pressure between the elastomeric pad and the elongated medical device is substantially equalized along the entire length of the elastomeric pad. Attached Figure Description

[0012] Figure 1 This is a schematic view of an exemplary catheter-based surgical system according to an embodiment.

[0013] Figure 2 This is a schematic block diagram of an exemplary catheter-based surgical system according to an embodiment.

[0014] Figure 3 This is an isometric view of an exemplary bedside system of a catheter-based surgical system according to an embodiment.

[0015] Figure 4 This is an isometric view of a passive torque converter assembly with shims.

[0016] Figure 5 yes Figure 4 An exploded view of the passive torque converter assembly.

[0017] Figure 6 yes Figure 4 Exploded view of the clamp of the passive torque converter assembly.

[0018] Figure 7 It is roughly in Figure 4 A cross-sectional view taken in the XZ plane, which shows Figure 4 The torque converter assembly has a gasket in an engagement position that engages with the guide wire (EMD).

[0019] Figure 8 It is roughly in Figure 4 A cross-sectional view (not to scale) taken in the XZ plane, showing Figure 4 The torque converter assembly has a gasket that is misaligned during disengagement from the guide wire (EMD).

[0020] Figure 9 It is roughly in Figure 4 A cross-sectional view taken in the XZ plane, which shows Figure 4 The torque converter assembly has a gasket in the disengaged position.

[0021] Figure 10 It is roughly in Figure 4 A cross-sectional view (not to scale) taken in the XZ plane, showing Figure 4 An embodiment of a torque converter assembly having a single movable clamp during disengagement from the guide wire (EMD).

[0022] Figure 11 This is an isometric view of an active torque converter assembly with shims.

[0023] Figure 12 It is shown Figure 11 An exploded view of some components of the active torque converter assembly.

[0024] Figure 13 It is shown Figure 11 An exploded view of the internal components of the active torque converter assembly.

[0025] Figure 14 yes Figure 11 An exploded view of the clamp of the active torque converter assembly.

[0026] Figure 15 It is roughly in Figure 11 A cross-sectional view taken in the XZ plane, which shows Figure 11 The torque converter assembly has a knob that is turned out and a gasket that is in the disengaged position.

[0027] Figure 16 It is roughly in Figure 11 A cross-sectional view taken in the XZ plane, which shows Figure 11 The torque converter assembly has a screw-in knob and a gasket in the disengaged position.

[0028] Figure 17 It is roughly in Figure 11 A cross-sectional view taken in the XZ plane, which shows Figure 11 A torque converter assembly having a gasket in an engaged position.

[0029] Figure 18 It is in the device module Figure 4 A view of the passive torque converter assembly. Detailed Implementation

[0030] definition

[0031] The term "elongated medical device (EMD)" refers to, but is not limited to, catheters (e.g., guiding catheters, microcatheters, capsule / stent catheters), wire-based devices (e.g., guidewires, embolization coils, stent retrieval devices, etc.), and any combination thereof. Wire-based EMDs include, but are not limited to, guidewires, microwires, proximal pushers for embolization coils, stent retrieval devices, self-deploying stents, and deflectors. Typically, wire-based EMDs do not have a hub or handle at their proximal end. In one embodiment, an EMD is a catheter having a hub at its proximal end and a flexible shaft extending from the hub toward the distal end of the catheter, wherein the shaft is more flexible than the hub. In one embodiment, the catheter includes an intermediate portion transitioning between the hub and the shaft, wherein the intermediate portion has intermediate flexibility that is less rigid than the hub and more rigid than the shaft. In one embodiment, the intermediate portion is a strain reliever.

[0032] The terms “distal” and “proximal” define the relative positions of two distinct features. Regarding the robotic actuator, the terms “distal” and “proximal” are defined by the position of the robotic actuator relative to the patient in its intended use. When used to define relative positions, when the robotic actuator is in its intended use position, a distal feature is a feature of the robotic actuator that is closer to the patient than a proximal feature. Within the patient, any vascular system landmark further away from the access point along the path is considered distal than a landmark closer to the access point, where the access point is the point where the EMD enters the patient. Similarly, when the robotic actuator is in its intended use position, a proximal feature is a feature further away from the patient than a distal feature. When used to define orientation, when the robotic actuator is in its intended use position, “distal orientation” refers to something that is moving or intended to move on it, or something that is moving along its path from the proximal feature toward or towards the distal feature and / or the patient. The proximal orientation is the opposite of the distal orientation.

[0033] The term "longitudinal axis of a component" (e.g., an EMD or other element in a catheter-based surgical system) is a line or axis along the length of the component that passes through the center of the component's transverse cross-section in a direction from the proximal portion of the component to the distal portion of the component. For example, the longitudinal axis of a guidewire is a central axis in a direction from the proximal portion of the guidewire toward the distal portion of the guidewire, even if the guidewire may be non-linear in the relevant portion.

[0034] The terms “top,” “up,” and “upper” refer to the general direction away from the direction of gravity, while the terms “bottom,” “lower,” and “lower” refer to the general direction in the direction of gravity.

[0035] The term "axial movement of a component" refers to the translation of a component along its longitudinal axis.

[0036] The term "rotational motion of a component" refers to the change in the angular orientation of a component about its local longitudinal axis.

[0037] The term "axial insertion" refers to inserting the first member into the second member along the longitudinal axis of the second member.

[0038] The term "force" refers to the factor that causes or tends to cause the motion of a body. Forces acting on a body may alter the motion of the body, impede the motion of the body, balance forces already acting on the body, and cause internal stresses within the body.

[0039] The term "torque" refers to the factor that causes or tends to cause the rotational motion of a physical body. Torque acting on a body can alter its rotational motion, impede its rotational motion, balance the torque already acting on the body, and induce internal stress within the body.

[0040] The term "fixed" means that there is no intentional relative movement between the first component and the second component during operation.

[0041] The term "clamped" refers to releasably securing the EMD to the component such that when the component moves, the EMD moves with the component. Rotational movement of the component will cause rotational movement of the EMD in the clamped state. The term "released" refers to releasing the EMD from the component such that when the component moves, the EMD and the component move independently. In the released state, the EMD can be moved / rotated relative to the component.

[0042] The term "clamp" refers to a device capable of releasably securing a portion of the EMD. The term "secured" here means that there is no intentional relative movement between the clamp and the EMD during operation.

[0043] The term "torquer" refers to a device that releasably clamps and releases a portion of an EMD (such as a guidewire). The term torquer is a commonly accepted term used by medical professionals in catheterization procedures to indicate a device used to rotate and / or translate an EMD. Torquers are also commonly referred to as clamps or pins. The torquer described herein is used for external clamping of a portion of an EMD located outside the patient's body.

[0044] Description of the Implementation Examples

[0045] Figure 1 This is a perspective view of an exemplary catheter-based surgical system 10 according to an embodiment. The catheter-based surgical system 10 can be used to perform catheter-based medical procedures, such as percutaneous interventional procedures, such as percutaneous coronary intervention (PCI) (e.g., treatment of STEMI), neurovascular interventional procedures (NVI) (e.g., treatment of emergency large vessel occlusion (ELVO)), peripheral vascular interventional procedures (PVI) (e.g., for severe limb ischemia (CLI), etc.). Catheter-based medical procedures can include diagnostic catheter insertion procedures, during which one or more catheters or other elongated medical devices (EMDs) are used to aid in the diagnosis of a patient's condition. For example, during one embodiment of a catheter-based diagnostic procedure, contrast agent is injected through a catheter onto one or more arteries, and images of the patient's vascular system are taken. Catheter-based medical procedures can also include catheter-based therapeutic procedures (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, clot removal, treatment of arteriovenous malformations, aneurysm treatment, etc.), during which a catheter (or other EMD) is used to treat the condition. It can be achieved through auxiliary devices including, for example, intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR) 54 ( Figure 2(As shown in the diagram) to enhance the treatment procedure. However, it should be noted that those skilled in the art will recognize that certain specific percutaneous interventional devices or components (e.g., the type of guidewire, the type of catheter, etc.) can be selected based on the type of procedure to be performed. The catheter-based surgical system 10 is capable of performing any number of catheter-based medical procedures with only minor adjustments to accommodate the specific percutaneous interventional device to be used in the procedure.

[0046] In addition to other components, the catheter-based surgical system 10 includes a bedside unit 20 and a control station 26. The bedside unit 20 includes a robot actuator 24 and a positioning system 22 positioned adjacent to the patient 12. The patient 12 is supported on a patient table 18. The positioning system 22 is used to position and support the robot actuator 24. The positioning system 22 may be, for example, a robotic arm, an articulated arm, a retainer, etc. One end of the positioning system 22 may be attached to, for example, a rail, base, or trolley on the patient table 18. The other end of the positioning system 22 is attached to the robot actuator 24. The positioning system 22 can be removed (along with the robot actuator 24) to allow the patient 12 to be positioned on the patient table 18. Once the patient 12 is positioned on the patient table 18, the positioning system 22 can be used to position or position the robot actuator 24 relative to the patient 12 for the procedure. In an embodiment, the patient table 18 is operatively supported by a base 17 fixed to the floor and / or ground. The patient table 18 is capable of moving relative to the base 17 with multiple degrees of freedom, such as roll, pitch, and yaw. The bedside unit 20 may also include controls and a display 46. Figure 2 (As shown in the diagram). For example, controls and displays can be located on the housing of the robot driver 24.

[0047] Typically, the robot actuator 24 may be equipped with appropriate percutaneous intervention devices and accessories 48. Figure 2 (as shown herein) (e.g., guidewires, various types of catheters, including balloon catheters, stent delivery systems, stent retrieval devices, embolization coils, liquid embolization agents, aspiration pumps, devices for delivering contrast agents, medications, hemostatic valve adapters, syringes, stopcocks, inflation devices, etc.) to allow a user or operator 11 to perform catheter-based medical procedures via a robotic system by operating various controls (such as controls and inputs located at control station 26). Bedside unit 20, and in particular robot actuator 24, may include any number and / or any combination of components to provide the functionality described herein to bedside unit 20. The user or operator 11 at control station 26 is referred to as control station user or control station operator, and is referred to herein as user or operator. The user or operator at bedside unit 20 is referred to as bedside unit user or bedside unit operator. Robot actuator 24 includes components mounted to a track or linear member 60 ( Figure 3Multiple device modules 32a-d (shown in the diagram). A track 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, a robotic actuator 24 can be used to automatically feed a guidewire into a diagnostic catheter and a guiding catheter in the patient's artery 12. One or more devices (such as EMDs) are inserted into the patient's body (e.g., a blood vessel) at insertion point 16 via, for example, a guide sheath.

[0048] Bedside unit 20 communicates with control station 26, allowing signals generated by user input from control station 26 to be transmitted wirelessly or via hardwired to bedside unit 20 to control various functions of bedside unit 20. As discussed below, control station 26 may include control computing system 34. Figure 2 (as shown in the diagram) or coupled to the bedside unit 20 via the control computing system 34. The bedside unit 20 can also provide feedback signals (e.g., load, speed, operating conditions, warning signals, error codes, etc.) to the control station 26, the control computing system 34 (as shown in the diagram) or via the control computing system 34. Figure 2 (as shown) or both. Communication between the control computing system 34 and the various components of the catheter-based surgical system 10 can be provided via a communication link, which can be a wireless connection, a cable connection, or any other means that allows communication between components. The control station 26 or other similar control system can be located at a local site (e.g., Figure 2 At the local control station 38 shown or at a remote station (e.g., Figure 2 The remote control station and computer system 42 shown are illustrated. The catheterization system 10 can be operated by a control station at a local site, a control station at a remote site, or both simultaneously. At the local site, the user or operator 11 and the control station 26 are located in the same or adjacent room as the patient 12 and the bedside unit 20. As used herein, the local site is the location of the bedside unit 20 and the patient 12 or object (e.g., animal or cadaver), and the remote site is the location of the user or operator 11 and the control station 26 for remotely controlling the bedside unit 20. The control station 26 (and control computing system) at the remote site and the control computing system at the bedside unit 20 and / or the local site can utilize communication systems and services 36. Figure 2 The remote site and the local (patient) site communicate with each other, for example, via the Internet. In an embodiment, the remote site and the local (patient) site are geographically distant from each other, for example, in different rooms in the same building, in different buildings in the same city, in different cities, or in other different locations where the remote site cannot physically access the bedside unit 20 and / or the patient 12 at the local site.

[0049] Control station 26 generally includes one or more input modules 28 configured to receive user input to operate various components or systems of catheter-based surgical system 10. In the illustrated embodiment, control station 26 allows a user or operator 11 to control bedside unit 20 to perform catheter-based medical procedures. For example, input modules 28 may be configured to cause bedside unit 20 to perform various tasks using a percutaneous interventional device (e.g., EMD) docked to robot actuator 24 (e.g., advancing, retracting, or rotating guidewires; advancing, retracting, or rotating catheters; inflating or contracting a balloon located on the catheter; positioning and / or deploying a stent; positioning and / or deploying a stent retrieval device; positioning and / or deploying a coil; injecting contrast agent into the catheter; injecting a liquid embolizing agent into the catheter; injecting medication or saline into the catheter; aspirating from the catheter; or performing any other function that may be performed as part of a catheter-based medical procedure). Robot actuator 24 includes various actuation mechanisms to cause movement (e.g., axial and rotational movement) of components of bedside unit 20, including the percutaneous interventional device.

[0050] In one embodiment, input module 28 may include one or more touchscreens, joysticks, scroll wheels, and / or buttons. In addition to input module 28, control station 26 may use additional user controls 44. Figure 2As shown in the diagram, input module 28 can be configured to advance, retract, or rotate various components and percutaneous interventional devices, such as guidewires and one or more catheters or microcatheters. Buttons may include, for example, an emergency stop button, a multiplier button, a device selection button, and an automated movement button. When the emergency stop button is pressed, power (e.g., electricity) to the bedside unit 20 is cut off or removed. In speed control mode, the multiplier button functions to increase or decrease the speed at which the associated component is moved in response to manipulation of input module 28. In position control mode, the multiplier button changes the mapping between the input distance and the output command distance. The device selection button allows the user or operator 11 to select which percutaneous interventional devices loaded into the robot actuator 24 are controlled by input module 28. The automated movement button enables algorithmic movement of the catheter-based surgical system 10 that can be performed on percutaneous interventional devices without direct commands from the user or operator 11. In one embodiment, input module 28 may include one or more controls or icons (not shown) displayed on a touchscreen (which may or may not be part of display 30), which, when activated, cause operation of components of the catheter-based surgical system 10. Input module 28 may also include a capsule or stent control configured to inflate or deflate a capsule and / or deploy a stent. Each input module 28 may include one or more buttons, scroll wheels, joysticks, touchscreens, etc., which may be used to control one or more specific components dedicated to that control. Furthermore, one or more touchscreens may display one or more icons (not shown) associated with various parts of input module 28 or various components of catheter-based surgical system 10.

[0051] Control station 26 may include display 30. In other embodiments, control station 26 may include two or more displays 30. Display 30 may be configured to display information or patient-specific data to a user or operator 11 located at control station 26. For example, 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 record information (e.g., medical history, age, weight, etc.), lesion or treatment assessment data (e.g., IVUS, OCT, FFR, etc.). Furthermore, display 30 may be configured to display information for a specific procedure (e.g., procedure list, recommendations, procedure duration, catheter or guidewire position, volume of delivered medication or contrast agent, etc.). Additionally, display 30 may be configured to display information to provide information to the control computing system 34 ( Figure 2 (As shown in the diagram) Related functionality. Display 30 may include touchscreen capability to provide some user input capabilities for the system.

[0052] The catheter-based surgical system 10 also includes an imaging system 14. The imaging system 14 can be any medical imaging system that can be used in conjunction with catheter-based medical procedures (e.g., non-digital X-ray, digital X-ray, CT, MRI, ultrasound, etc.). In an exemplary embodiment, the imaging system 14 is a digital X-ray imaging device that communicates with a control station 26. In one embodiment, the imaging system 14 may include a C-arm (…). Figure 1 As shown in the diagram, the C-arm allows the imaging system 14 to rotate partially or completely around the patient 12 to obtain images at different angular positions relative to the patient 12 (e.g., sagittal view, caudal view, anterior and posterior view, etc.). In one embodiment, the imaging system 14 is a fluorescence fluoroscopy system including a C-arm with an X-ray source 13 and a detector 15, also referred to as an image intensifier.

[0053] Imaging system 14 can be configured to capture X-ray images of appropriate areas of the patient 12 during surgery. For example, imaging system 14 can be configured to capture one or more X-ray images of the head to diagnose neurovascular conditions. Imaging system 14 can also be configured to capture one or more X-ray images (e.g., real-time images) during catheter-based medical procedures to help the user or operator 11 of control station 26 properly position guidewires, guiding catheters, microcatheters, stent retrieval devices, coils, stents, capsules, etc., during surgery. One or more images can be displayed on display 30. For example, images can be displayed on display 30 to allow the user or operator 11 to accurately move the guiding catheter or guidewire into the appropriate position.

[0054] To define directions, a Cartesian coordinate system with X, Y, and Z axes is introduced. The positive X-axis is oriented in the longitudinal (axial) direction, that is, from the proximal end to the distal end, in other words, from the proximal side to the distal side. The Y and Z axes lie in the transverse plane of the X-axis, with the positive Z-axis oriented upwards, that is, in the direction opposite to gravity, and the Y-axis is automatically determined by the right-hand rule.

[0055] Figure 2 This is a block diagram of a catheter-based surgical system 10 according to an exemplary embodiment. The catheter-based surgical system 10 may include a control computing system 34. The control computing system 34 may be physically, for example, a control station 26. Figure 1As shown in the diagram, the control computing system 34 is generally an electronic control unit adapted to provide the various functionalities described herein for the catheter-based surgical system 10. For example, the control computing system 34 may be an embedded system, a dedicated circuit, a general-purpose system programmed with the functionalities described herein, etc. The control computing system 34 communicates with the bedside unit 20, communication systems and services 36 (e.g., the Internet, firewall, cloud services, session manager, hospital network, etc.), local control station 38, additional communication systems 40 (e.g., telepresence system), remote control station and computing system 42, and patient sensors 56 (e.g., electrocardiogram (ECG) device, electroencephalogram (EEG) device, blood pressure monitor, temperature monitor, heart rate monitor, respiratory monitor, etc.). The control computing system also communicates with the imaging system 14, patient table 18, additional medical systems 50, contrast injection system 52, and auxiliary devices 54 (e.g., IVUS, OCT, FFR, etc.). The bedside unit 20 includes a robot actuator 24, a positioning system 22, and may include additional controls and a display 46. As mentioned above, additional controls and displays may be located on the housing of the robot actuator 24. Interventional devices and accessories 48 (e.g., guidewires, catheters, etc.) interface with the bedside system 20. In embodiments, interventional devices and accessories 48 may include dedicated devices (e.g., IVUS catheters, OCT catheters, FFR lines, diagnostic catheters for angiography, etc.) that interface with their respective auxiliary devices 54, i.e., the IVUS system, OCT system, and FFR system, etc.

[0056] In various embodiments, the control computing system 34 is configured to be user-based (e.g., control station 26 such as local control station 38 or remote control station 42). Figure 1 The input module 28 (shown in the diagram) interacts with and / or generates control signals based on information accessible to the control computing system 34, enabling the use of the catheter-based surgical system 10 to perform medical procedures. The local control station 38 includes one or more displays 30, one or more input modules 28, and additional user controls 44. The remote control station and computing system 42 may include components similar to the local control station 38. The remote control station 42 and the local control station 38 can be different and customized based on their required functionality. The additional user controls 44 may include, for example, one or more foot input controls. Foot input controls can be configured to allow the user to select functions of the imaging system 14, such as turning X-rays on and off and scrolling through different stored images. In another embodiment, the foot input device can be configured to allow the user to select which devices are mapped to a wheel included in the input module 28. An additional communication system 40 (e.g., audio conferencing, video conferencing, telepresence, etc.) can be used to assist the operator in interacting with patients, medical personnel (e.g., angiography room personnel), and / or bedside devices.

[0057] The catheter-based surgical system 10 may be connected to or configured to include any other systems and / or devices not explicitly shown. For example, the catheter-based surgical system 10 may include an image processing engine, a data storage and archiving system, an automated capsule and / or stent expansion system, a drug injection system, a drug tracking and / or recording system, a user log, an encryption system, a system for restricting access to or use of the catheter-based surgical system 10, etc.

[0058] As mentioned, the control computing system 34 communicates with the bedside unit 20, which includes a robot actuator 24, a positioning system 22, and may include additional controls and a display 46, and can provide control signals to the bedside unit 20 to control the operation of motors and drive mechanisms used to drive percutaneous interventional devices (e.g., guidewires, catheters, etc.). Various drive mechanisms may be configured as part of the robot actuator 24.

[0059] Figure 3 This is a perspective view of a robot actuator for a catheter-based surgical system 10 according to an embodiment. Figure 3 In this embodiment, the robot actuator 24 includes a plurality of device modules 32a-d coupled to a linear member 60. Each device module 32a-d is coupled to the linear member 60 via a stage 62a-d movably mounted to the linear member 60. The device modules 32a-d can be connected to the stages 62a-d using connectors such as offset brackets 78a-d. In another embodiment, the device modules 32a-d are directly mounted to the stages 62a-d. Each stage 62a-d can be independently actuated to move linearly along the linear member 60. Therefore, each stage 62a-d (and its corresponding device module 32a-d coupled to the stage 62a-d) can move independently relative to each other and to the linear member 60. A drive mechanism is used to actuate each stage 62a-d. Figure 3 In the illustrated embodiment, the drive mechanism includes independent stage translation motors 64a-d coupled to each stage 62a-d and a stage drive mechanism 76, such as a lead screw via a rotating nut, a rack via a pinion, a conveyor belt via a pinion or pulley, a chain via a sprocket, or the stage translation motors 64a-d themselves may be linear motors. In some embodiments, the stage drive mechanism 76 may be a combination of these mechanisms; for example, each stage 62a-d may employ a different type of stage drive mechanism. In embodiments where the stage drive mechanism is a lead screw and a rotating nut, the lead screw can be rotated, and each stage 62a-d can engage and disengage with the lead screw to move, such as advance or retract. Figure 3 In the embodiment shown, the stations 62a-d and the device modules 32a-d are in a series drive configuration.

[0060] Each device module 32a-d includes a drive module 68a-d and a housing 66a-d mounted on and connected to the drive module 68a-d. Figure 3 In the illustrated embodiment, each housing 66a-d is mounted to the drive module 68a-d in a vertical orientation. In other embodiments, each housing 66a-d may be mounted to the drive module 68a-d in other mounting orientations. Each housing 66a-d is configured to abut and support a proximal portion of the EMD (not shown). Furthermore, in addition to the linear motion provided by the actuation of the corresponding stage 62a-d to move linearly along the linear member 60, each housing 66a-d may include elements for providing one or more degrees of freedom. For example, housing 66a-d may include elements that can be used to rotate the EMD when the housing is coupled to the drive module 68a-d. Each drive module 68a-d includes at least one coupler to provide a drive interface to the mechanism in each housing 66a-d, thereby providing additional degrees of freedom. Each housing 66a-d also includes a channel therein for device supports 79a-d, and each device support 79a-d is used to prevent buckling of the EMD. Support arms 77a, 77b, and 77c are attached to each device module 32a, 32b, and 32c, respectively, to provide fixation points for supporting the proximal ends of device supports 79b, 79c, and 79d. The robot actuator 24 may also include a device support connector 72, a distal support arm 70, and a support arm 77o connected to the device support 79. The support arm 77o is used to provide fixation points for supporting the proximal end of the distal device support 79a housed in the distal device module 32a. Furthermore, a guide interface support (steering mechanism) 74 may be connected to the device support connector 72 and an EMD (e.g., a guide sheath). The configuration of the robot actuator 24 has the advantage of reducing the size and weight of the driving robot actuator 24 by using multiple actuators on a single linear member.

[0061] To prevent pathogen contamination of patients, healthcare staff will house bedside units 20 and patient 12 or other relevant facilities. Figure 1Aseptic techniques are used in the room shown. The room housing the bedside unit 20 and the patient 12 can be, for example, a catheterization lab or an angiography suite. Aseptic techniques include the use of sterile barriers, sterilization equipment, proper patient preparation, environmental control, and contact guidelines. Therefore, all EMDs and interventional accessories are sterilized and can only come into contact with sterile barriers or sterilization equipment. In an embodiment, a sterile cover (not shown) is placed over a non-sterile robotic actuator 24. Each cartridge 66a-d is sterilized and acts as a sterilization interface between the covered robotic actuator 24 and at least one EMD. Each cartridge 66a-d can be designed to be sterilized for single use or to be resterilized wholly or partially, allowing cartridge 66a-d or components thereof to be used in multiple procedures.

[0062] refer to Figure 4 and Figure 5 According to an embodiment, a passive torque converter 100 includes an actuator 106, a body 108, a first clamp 110, a second clamp 112, a spring 114, and a spring housing 116. The torque converter 100 includes an inner cavity 118 extending through it along a longitudinal centerline. The body 108 includes a cavity 109. The inner cavity 118 extends from a proximal end to a distal end of the body 108 and is in fluid communication with the cavity 109. The inner cavity 118 includes an inner cavity portion extending through a knob 106 and an inner cavity portion extending through the housing 116. The diameter of the inner cavity 118 is sized to be larger than that of an EMD (Electronic Device Modulation) used with the torque converter 100. Figure 4 and Figure 5 The diameter (not shown in the diagram). As described herein, the first clamp 110 and the second clamp 112 are movable within the cavity 109. In one embodiment, the spring 114 has a longitudinal axis collinear with the longitudinal axis of the body 108. In one embodiment, the actuator 106 is a knob movable relative to the body 108 that moves the first clamp 110 to engage and / or disengage the EMD within the cavity 109. The actuator 106 includes other known mechanisms, and the terms “actuator” and “knob” are used interchangeably herein. In one embodiment, the knob 106 movable relative to the body 108 moves the first clamp 110 and the second clamp 112 to engage and / or disengage the EMD within the cavity 109. The passive torque converter 100 is normally in the closed position, such that when the EMD is in the torque converter 100, it is clamped in the normally closed position. An operator or robotic system will need to use a biasing member to release the EMD.

[0063] In the released state of the torque converter 100, the EMD is inserted into the cavity 118 at the distal end of the torque converter 100 in the longitudinal proximal direction 104 and is withdrawn or removed from the cavity 118 at the distal end of the torque converter 100 in the longitudinal distal direction 102, or the EMD is withdrawn or removed from the cavity 118 at the proximal end of the torque converter 100 in the longitudinal proximal direction. In one embodiment, the EMD is inserted into the cavity 118 at the proximal end of the torque converter 100 in the longitudinal distal direction 102 and is withdrawn from the cavity 118 at the proximal end of the torque converter 100 in the longitudinal proximal direction 104 or at the distal end of the torque converter 100 in the longitudinal distal direction. In the clamped state of the torque converter 100, a portion of the EMD is fixed relative to the torque converter body 108. Specifically, in the clamped state, the first clamp 110 and the second clamp 112 of the torque converter 100 clamp a portion of the shaft of the EMD 120 (see...). Figure 7 This causes rotation and / or translation of the torque generator 100 about or along its longitudinal axis to induce a distributed torque and / or force along the shim, thereby imparting the same or substantially the same rotation and / or translation to that portion of the shaft of the clamped EMD. In one embodiment, when the EMD is in the clamped state, after rotating the torque generator to apply torque to the EMD, the portion of the EMD along the longitudinal length of the shim gradually increases the torsion in the EMD from the proximal end to the distal end of the torque generator. In one embodiment, the EMD is fixed in the clamped position relative to the proximal end of the shim. When torque is applied, the EMD rotates to a certain extent along the length of the shim from the proximal end to the distal end of the torque generator.

[0064] Knob 106 includes a distal portion 106a and a proximal portion 106b, wherein the longitudinal centerlines of both portions are aligned with the longitudinal centerline of torque generator 100. In one embodiment, the distal portion 106a of knob 106 is a support tube having an inner cavity 118 that extends distally to limit buckling and prevent kinking of a portion of the EMD along its length as it is being translated and / or rotated. In one embodiment, the distal portion 106a of knob 106 is a cylindrical support tube having an inner cavity 118. In one embodiment, the proximal portion 106b of knob 106 is a cylindrical cup that is open in the proximal direction and has an internal protrusion 106c extending proximally from the distal base of the cylindrical cup. In one embodiment, the internal protrusion 106c of knob 106 is a cylinder having an inner cavity 118, and its centerline is aligned with the longitudinal centerline of torque generator 100. In one embodiment, the proximal portion 106b of knob 106 includes an internal thread 106d on the inner wall of a cylindrical cup. In one embodiment, the proximal portion 106b of knob 106 includes an external thread on the outer wall of an inner protrusion 106c. In one embodiment, 106 includes an internal thread, while 108d has an external thread. In one embodiment, knob 106 is a single manufactured part, such as a molded part, wherein the cavity 118 serves as an internal passage through which a portion of the shaft of the EMD passes. In one embodiment, knob 106 is an assembled part, wherein the cavity 118 serves as an internal passage through which a portion of the shaft of the EMD passes. In one embodiment, the passage is capable of accommodating an elongated medical device having a diameter ranging from 0.014 inches (0.356 mm) to 0.038 inches (0.965 mm) and including 0.038 inches (0.965 mm). In one embodiment, the range of diameters of the elongated medical devices that can be accommodated includes devices having a diameter of 0.038 inches (0.965 mm) or less. In one embodiment, the passage is capable of accommodating an EMD with a specific diameter ranging from 0.016 inches (0.406 mm) to 0.002 inches (0.051 mm).

[0065] The body 108 includes a distal portion 108a, a middle portion 108b, and a proximal portion 108c, wherein the longitudinal centerline of all portions is aligned with the longitudinal centerline of the torque generator 100. In one embodiment, the body 108 is a hollow cylinder with different inner and outer diameters in the distal portion 108a, the middle portion 108b, and the proximal portion 108c. In one embodiment, the body 108 may have non-cylindrical features. In one embodiment, the outer wall of the distal portion 108a includes external threads 108d. In one embodiment, the inner wall of the distal portion 108a includes internal threads. In one embodiment, the inner wall of the body 108 includes a first channel 108e and a second channel 108f, which are slotted cutouts in the inner wall opposite to each other. The width of the first channel 108e is greater than the width of the first clamp 110, and the width of the second channel 108f is greater than the width of the second clamp 112. In one embodiment, the body 108 is a single manufactured part, such as a molded part, having an internal passage through which a portion of the shaft of the EMD passes. In one embodiment, the body 108 is an assembly component having an internal passage through which a portion of the EMD's shaft passes.

[0066] The first clamp 110 includes a first gasket 110a and a first gasket base 110b, and the second clamp 112 includes a second gasket 112a and a second gasket base 112b. In one embodiment, the first gasket base 110b is a parallelepiped member having a longitudinal axis corresponding to its longest dimension oriented along the longitudinal axis of the torque generator 100. In one embodiment, the first gasket base 110b is a cuboid member having a longitudinal axis corresponding to its longest dimension oriented along the longitudinal axis of the torque generator 100. In one embodiment, the first gasket base has a prism shape. In one embodiment, the first gasket base 110b includes a flat bottom surface to which the first gasket 110a is secured. In one example, the gasket 110a is chemically bonded to the gasket base 110b by mechanical attachment or by other known means of attaching components together. In one embodiment, the second gasket base 112b is a parallelepiped member having a longitudinal axis corresponding to its longest dimension oriented along the longitudinal axis of the torque converter 100. In another embodiment, the second gasket base 112b is a cuboid member having a longitudinal axis corresponding to its longest dimension oriented along the longitudinal axis of the torque converter 100. In yet another embodiment, the second gasket base 112b includes a flat top surface to which the second gasket 112a is attached.

[0067] refer to Figure 6One embodiment of the first gasket base 110b includes a flat bottom (lower) surface 110c to which a first gasket 110a is fixed, a flat front lateral surface 110d, a flat rear lateral surface 110e, a sloping flat distal surface 110f, a flat proximal surface 110g having a protrusion 110h, and a top (upper) surface including a flat distal portion 110i, a curved intermediate portion 110j, a sloping flat intermediate portion 110k, and a flat proximal portion 110m. In one embodiment, the curved intermediate portion 110j of the top surface of the first gasket base 110b has a convex arcuate profile and is a transition surface between the flat distal portion 110i and the sloping flat intermediate portion 110k.

[0068] In one embodiment, the second gasket base 112b is identical to the first gasket base 110b and includes surfaces that are congruent to those surfaces of the first gasket base 110b. In one embodiment of the torque converter 100, the second gasket base 112b is rotated (flipped) 180 degrees relative to the first gasket base 110b about its longitudinal axis. In other words, as described herein, the flat bottom surface 110c of the first gasket base 110b to which the first gasket 110a is attached faces the flat top surface of the second gasket base 112b to which the second gasket 112a is attached.

[0069] In one embodiment, the bottom surface of the first pad 110a of the first clamp 110 is a flat surface. In another embodiment, the bottom surface of the first pad 110a of the first clamp 110 is a flat surface including a recessed arcuate profile extending along the length of the surface of the first pad 110a (in the transverse plane, i.e., in the YZ plane). In yet another embodiment, the bottom surface of the first pad 110a of the first clamp 110 is a curved surface having a recessed arcuate profile extending along the length of the surface of the first pad 110a (in the transverse plane, i.e., in the YZ plane).

[0070] In one embodiment, the second gasket 112a is identical to the first gasket 110a and includes surfaces congruent to those surfaces of the first gasket 110a. In one embodiment, the top surface of the second gasket 112a of the second clamp 112 is identical to the bottom surface of the first gasket 110a of the first clamp 110 and includes surfaces congruent to those surfaces of the first gasket 110a. In one embodiment, the first gasket 110a is secured to the first gasket base 110b, and the second gasket 112a is secured to the second gasket base 112b.

[0071] In one embodiment, the first gasket 110a and the second gasket 112a are made of a medical-grade biocompatible material that will not damage or penetrate the coating on the EMD when pressed into an EMD (such as a guidewire) used in catheter-related procedures. In one embodiment, the first gasket 110a and the second gasket 112a are made of an elastomeric material with a hardness measure in the range of 50D–75D and manufactured in a specific smoothness / roughness / texture grade, such as SPI B1, A1, C1, A2, B2, or C2. In one embodiment, each SPI (Plastics Industry Association) grade identified herein corresponds to the following Ra (roughness parameter) values ​​in microinches (µin) shown in parentheses after the SPI grade identification: SPI B1 (RA 2–3), A1 (RA 0–1), A2 (RA 1–2), B2 (RA 4–5), and C2 (RA 25–28). In one embodiment, the first gasket 110a and the second gasket 112a are made of natural or synthetic materials that have a low modulus of elasticity and a high strain value compared to other materials such as metals.

[0072] The elastomer material 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 compliant properties and / or elastic or viscoelastic properties. The first gasket 110a and the second gasket 112a are referred to herein as elastomer gaskets. In one embodiment, each gasket having compliant properties is formed of a polyurethane material or a polyether block amide (PEBA) material.

[0073] In one embodiment, the first gasket base 110b and the second gasket base 112b are made of a medical-grade biocompatible material, such as a biocompatible plastic, which is harder than the material of the first gasket 110a and the second gasket 112a. In one embodiment, the first gasket base 110b and the second gasket base 112b are made of a material such as Ultem 1000 or stainless steel. In one embodiment, the first gasket base 110b and the second gasket base 112b are made of a material that is more rigid than the material of the first gasket 110a and the second gasket 112a. In one embodiment, the first gasket base 110b and the second gasket base 112b are made of a material with an elastic modulus equal to or greater than 3.5 GPa. In one embodiment, the first gasket base 110b and the second gasket base 112b are made of a material having an elastic modulus that is two or more times the elastic modulus value of the material of the first gasket 110a and the second gasket 112a. In one embodiment, the first gasket base 110b and the second gasket base 112b are made of a material having an elastic modulus that is ten times or more the elastic modulus of the material of the first gasket 110a and the second gasket 112a.

[0074] In one embodiment of the torque converter 100, the internal thread 106d of the knob 106 engages with the external thread 108d of the body 108, such that rotation of the knob 106 relative to the body 108 causes a change in the longitudinal distance between the knob 106 and the body 108, wherein this distance increases or decreases depending on the direction of relative rotation. The change in longitudinal distance per unit relative rotation of the knob 106 and the body 108 is related to the pitch of the engaging threads 106d and 108d. In another embodiment of the torque converter 100 (not shown), the external thread of the internal protrusion 106c of the knob 106 engages with the internal thread on the inner wall of the distal portion 108a of the body 108, such that rotation of the knob 106 relative to the body 108 causes a change in the longitudinal distance between the knob 106 and the body 108, wherein this distance increases or decreases depending on the direction of relative rotation. The change in longitudinal distance per unit relative rotation of the knob 106 and the body 108 is related to the pitch of the engaging threads.

[0075] In one embodiment, spring 114 is a helical compression spring. In one embodiment, spring 114 is a helical compression spring having a flat end and a ground end. In one embodiment, spring 114 is a helical compression spring having a square end and a ground end. In one embodiment, spring 114 is a compliant elastic member with a hollow cylinder or other geometry.

[0076] The spring housing 116 includes a distal portion 116a, a bevel gear 116b, and a proximal portion 116c, wherein the longitudinal centerline of all portions is aligned with the longitudinal centerline of the torque generator 200. In one embodiment, the bevel gear 116b is located between the distal portion 116a and the proximal portion 116c of the spring housing 116 and is integrally fixed to portions 116a and 116c. In one embodiment, the teeth of the bevel gear 116b are oriented in the longitudinal proximal direction 104. In one embodiment, the bevel gear is a driven member operably driven by a drive member in a robotic system. In one embodiment, the distal portion 116a of the spring housing 116 is a cylindrical cup that is open in the distal direction and includes an opening in its proximal base. In one embodiment, the proximal portion 116c of the spring housing 116 is a cylindrical cup that is open in the distal direction and has an internal post 116d extending in the distal direction from the proximal base of the cylindrical cup, having an inner cavity 118 that extends through the torque generator 100 in alignment with the longitudinal central axis. In one embodiment, the internal post 116d of the spring housing 116 is a cylindrical projection with a chamfered distal end, having a central inner cavity 118, and its centerline is aligned with the longitudinal centerline of the torque generator 100. In one embodiment, the spring housing 116 is a single manufactured part, such as a molded part, wherein the inner cavity 118 serves as an internal passage through which a portion of the shaft of the EMD passes. In one embodiment, the spring housing 116 is an assembled part, wherein the inner cavity 118 serves as an internal passage through which a portion of the shaft of the EMD passes. In one embodiment, the bevel gear 116b may be a driven member that can be located on any exterior of the torque generator body and / or may be located on the exterior of the actuator or knob 106. The driven member 116b may be another type of gear, such as a spur gear, a worm gear, a hypoid gear, or may be the surface of a friction-engaging drive member, including but not limited to a conveyor belt drive mechanism.

[0077] In one embodiment of the assembled torque converter 100, the proximal portion 108c of the body 108 snaps into the distal portion 116a of the housing 116, for example, by engaging with a mating lip on one component via a molded undercut on another component. In one embodiment of the assembled torque converter 100, the proximal portion 108c of the body 108 is press-fitted into the distal portion 116a of the housing 116, for example, using dimensional interference on the mating components. In one embodiment, the proximal portion 108c of the body 108 is secured to the distal portion 116a of the housing 116 by means of glue, adhesive, bonding agent, laser welding, ultrasonic welding, or other means of securing the two bodies during assembly and manufacturing. In one embodiment of the torque converter 100, the body 108 is removably secured to the housing 116 using fasteners (not shown). The term "snap-fit," as used herein, is an assembly method for attaching flexible components (typically plastic) to form a final product by pushing interlocking parts of the components together. Snap-fit ​​connections come in various variations, including cantilever, torsion, and ring types. As a seamless attachment feature, snap-fit ​​connections offer an alternative to screw or threaded assembly, providing advantages such as speed and the absence of loose parts.

[0078] In one embodiment of the torque converter 100, the spring 114 is constrained from lateral or transverse movement (i.e., movement in the YZ plane) relative to the housing 116 by being positioned on a central post 116d extending in a distal direction from the proximal base of the cylindrical cup of the housing 116, and buckling is prevented, wherein the central post 116d has a cylindrical shape, having an outer diameter smaller than the inner diameter of the spring 114, and includes a central cavity 118. In one embodiment, the inner diameter of the proximal portion 116c of the housing 116 or the outer diameter of the inner post 116d of the proximal portion 116c of the housing 116 is required to prevent buckling.

[0079] In one embodiment of the torque converter 100, the proximal end of the spring 114 is constrained in its longitudinal movement relative to the housing 116 by contacting the inner surface of the cylindrical cup base at the proximal end of the proximal portion 116c of the housing 116. In one embodiment of the torque converter 100, the distal end of the spring 114 contacts the flat proximal surface 110g of the first pad base 110b of the first clamp 110 and the flat proximal surface of the second pad base 112b of the second clamp 112. In one embodiment, the first pad base 110b includes a wedge-shaped protrusion 110h on the flat proximal surface 110g adjacent to the bottom surface 110c of the first pad base 110b, and the second pad base 112b includes a corresponding wedge-shaped protrusion on the flat proximal surface adjacent to the top surface of the second pad base 112b, wherein the two wedge-shaped protrusions extend proximally and both wedge-shaped protrusions are located within the inner diameter of the spring 114 at its distal end.

[0080] In one embodiment of the torque converter 100, a first gasket base 110b is kinematically constrained in a first channel 108e of the body 108, and a second gasket base 112b is kinematically constrained in a second channel 108f of the body 108. Specifically, in one embodiment, the wall of the first channel 108e constrains the lateral movement of the first clamp 110 (by contacting the flat front lateral surface 110d and the flat rear lateral surface 110e of the first gasket base 110b), and the wall of the second channel 108f constrains the lateral movement of the second clamp 112.

[0081] In one embodiment, a portion of the top surface of the first pad base 110b of the first clamp 110 contacts a portion of the inner peripheral wall 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 clamp 112 contacts a portion of the inner peripheral wall of the second channel 108f of the body 108.

[0082] In one embodiment, the torque converter 100 includes two clamps that are movable relative to each other to releasably secure a portion of the EMD's shaft to at least one of the clamps. In another embodiment, the torque converter 100 includes a clamp that is movable relative to the body of the torque converter 100 to releasably clamp a portion of the EMD's shaft to this single clamp. In yet another embodiment, the torque converter 100 includes two or more clamps that are movable relative to each other to releasably secure a portion of the EMD's shaft to at least one of these clamps.

[0083] In one embodiment of the torque converter 100, the spring 114 serves as a biasing member that biases one clamp relative to the body. In one embodiment of the torque converter 100, the spring 114 serves as a biasing member that biases two clamps relative to the body. In one embodiment of the torque converter 100, the spring 114 serves as a biasing member that biases more than two clamps relative to the body.

[0084] In one embodiment, two or more components operating together provide a mechanical advantage by increasing the torque and / or force that can be transmitted from the torque generator to a portion of the EMD's shaft, while the EMD's shaft does not move relative to the torque generator. The clamping force applied to the EMD using the torque generator can be greater than the force required to perform the clamping. When a portion of the EMD's shaft is clamped, it is fixed such that there is no relative movement between the torque generator and that portion of the EMD during acceptable operating parameters of the EMD procedure.

[0085] refer to Figure 7 , Figure 8 and Figure 9The passive torque converter 100 according to the embodiment is shown in stages corresponding to a clamped state, a partially clamped state, and a released state, respectively. In the clamped state, the torque converter 100 is in a fully engaged position and clamps a portion of the EMD 120; in the partially clamped state, the torque converter 100 is in a partially engaged position and partially clamps a portion of the EMD 120; and in the released state, the torque converter 100 is in a disengaged position and does not clamp the EMD 120. In the embodiments depicted in all three states (clamped, partially clamped, and released), the internal thread 106d of the knob 106 engages with the external thread 108d of the body 108. In the released state, the distance between the shims is greater than the diameter of the EMD in a direction perpendicular to the longitudinal axis of the torque converter.

[0086] refer to Figure 7 With the torque converter 100 clamped, the knob 106 is in the open position relative to the body 108. There is no contact (i.e., a gap) between the proximal surface of the inner protrusion 106c of the knob 106 and the inclined distal surface 110f of the first pad base 110b of the first clamp 110, and no contact between the proximal surface of the inner protrusion 106c of the knob 106 and the inclined distal surface of the second pad base 112b of the second clamp 112. Rotating the knob 106 relative to the body 108 in the direction from which it is turned out causes the knob 106 to move relative to the body 108 in the longitudinal distal direction 102, thereby increasing the gap between the proximal surface of the inner protrusion 106c and the distal surfaces of the first clamp 110 and the second clamp 112.

[0087] In one embodiment, the knob 106 rotates freely relative to the body 108 in a direction that loosens the knob 106 from the body 108 until their teeth no longer mesh and the knob 106 disengages from the body 108. In another embodiment, the knob 106 rotates freely relative to the body 108 in a direction that loosens the knob 106 from the body 108 until a stop preventing the knob 106 from disengaging from the body 108 is reached.

[0088] In the clamped state of the torque converter 100, where the knob 106 is in the open position relative to the body 108, there is no contact (i.e., a gap) between the inclined surface of the wedge-shaped protrusion 110h on the proximal end of the first gasket base 110b and the distal chamfered surface of the central post 116d of the spring housing 116 (extending in the distal direction from the proximal base of the cylindrical cup), and there is no contact between the inclined surface of the wedge-shaped protrusion on the proximal end of the second gasket base 112b and the distal chamfered surface of the central post 116d of the spring housing 116.

[0089] In the clamped state of the torque converter 100, the first pad 110a of the first clamp 110 and the second pad 112a of the second clamp 112 face each other, are parallel to each other and are parallel to a portion of the EMD 120, and clamp a portion of the EMD 120 along the length of each pad, that is, the first pad 110a and the second pad 112a are in contact with a portion of the EMD 120 along the length of each pad.

[0090] With the torque converter 100 clamped, the spring 114 is compressed relative to its rest length. As a result, the spring restoring force acts in the longitudinal distal direction 102. (The spring restoring force also acts in the longitudinal proximal direction 104 for static equilibrium. However, the proximal end of the spring 114 is constrained, i.e., fixed relative to the housing 116 and the body 108 to which the housing 116 is fixed. Therefore, the useful spring restoring force acts in the longitudinal distal direction 102.) Half of this force acts on the first clamp 110 through the contact between the distal end of the spring 114 and the flat proximal surface 110g of the first washer base 110b, and half of this force acts on the second clamp 112 through the contact between the distal end of the spring 114 and the flat proximal surface of the second washer base 112b.

[0091] Although a force (half the restoring force from spring 114) is applied to the first clamp 110 in the longitudinal distal direction 102, the first clamp 110 is prevented from moving relative to the body 108 in the longitudinal distal direction 102. The movement of the first clamp 110 in the longitudinal distal direction 102 is constrained by a component force that is equal in magnitude and opposite in direction to half the restoring force from spring 114. That is, the component force acts in the longitudinal proximal direction 104 to achieve static equilibrium of the first clamp 110 in the longitudinal direction. This longitudinal component force acts at the contact point or region between the curved intermediate portion 110j of the top surface of the first pad base 110b of the first clamp 110 and the shaped portion of the top inner surface of the first channel 108e of the body 108.

[0092] The vertical component of the force also acts at the contact point or region between the curved intermediate portion 110j of the top surface of the first pad base 110b of the first clamp 110 and the shaped portion of the top inner surface of the first channel 108e of the body 108, as described herein.

[0093] A shaped portion of the top inner surface of the first channel 108e of the body 108 defines a cam surface that contacts a curved intermediate portion 110j of the top surface of the first shim base 110b of the first clamp 110, which defines a follower surface. Due to the shaping of the cam-follower surface (and the force from the spring), a resultant force acts from the body 108 on the first clamp 110 at the point of contact or region, wherein the longitudinal component of the force points proximally (in the negative X direction) and the vertical component points downward (in the negative Z direction). As a result of the vertical component acting on the first clamp 110, the first shim 110a is pressed into a portion of the EMD 120, and contact exists between the portion of the EMD 120 and the first shim 110a. In one embodiment, the follower surface is non-linear. In one embodiment, the follower surface is linear. In one embodiment, the follower surface is arcuate. In one embodiment, the body 108 includes a cam surface that contacts the non-linear follower surface on the first shim base 110b. In one embodiment, the body 108 includes a cam surface that contacts a linear follower surface on the first shim base 110b. In another embodiment, the body 108 includes a cam surface that contacts an arcuate follower surface on the first shim base 110b.

[0094] The first clamp 110 is capable of pivoting and / or oscillating (in the XZ plane) about a contact point or area at the cam-follower surface. As contact is established between a portion of the EMD 120 and the first pad 110a, the first clamp 110 pivots and / or oscillates about the contact point or area, thereby distributing the vertical component of the force acting on the portion of the EMD 120 and balancing the pressure on the EMD 120 along the entire length of the first pad 110a. The terms “pivot” and / or “oscillate” include both movement about a single point and movement about a surface along a predetermined profile.

[0095] Similarly, a force (half of the restoring force from spring 114) is applied to the second clamp 112 in the longitudinal distal direction 102, preventing the second clamp 112 from moving relative to the torque generator body 108 in the longitudinal distal direction 102. The movement of the second clamp 112 in the longitudinal distal direction 102 is constrained by a component force that is equal in magnitude and opposite in direction to half the restoring force from spring 114. That is, the component force acts in the longitudinal proximal direction 104 to achieve static equilibrium of the second clamp 112 in the longitudinal direction. This longitudinal component force acts at the contact point or region between the curved middle portion of the bottom surface of the second pad base 112b of the second clamp 112 and the shaped portion of the bottom inner surface of the second channel 108f of the body 108.

[0096] The vertical component of the force also acts at the contact point or region. A shaped portion of the bottom inner surface of the second channel 108f of the body 108 defines a cam surface that contacts a curved intermediate portion of the bottom surface of the second pad base 112b of the second clamp 112, which defines the follower surface. Due to the shaping of the cam-follower surface (and the force from the spring), the resultant force acts from the body 108 onto the second clamp 112 at the contact point or region, wherein the longitudinal component points proximally (in the negative X direction) and the vertical component points upward (in the positive Z direction). As a result of the vertical component acting on the second clamp 112, the second pad 112a is pressed into a portion of the EMD 120, and there is contact between the portion of the EMD 120 and the second pad 112a. In one embodiment, the follower surface is non-linear. In one embodiment, the follower surface is linear. In one embodiment, the follower surface is arcuate. In one embodiment, the body 108 includes a cam surface that contacts the non-linear follower surface on the second pad base 112b. In one embodiment, the body 108 includes a cam surface that contacts a linear follower surface on the second shim base 112b. In another embodiment, the body 108 includes a cam surface that contacts an arcuate follower surface on the second shim base 112b.

[0097] The second clamp 112 is capable of pivoting and / or oscillating (in the XZ plane) around a contact point or area at the cam-follower surface. As contact is made between a portion of the EMD 120 and the second pad 112a, the second clamp 112 pivots and / or oscillates around the contact point or area, thereby distributing the vertical component of the force acting on a portion of the EMD 120 and balancing the pressure on the EMD 120 along the length of the second pad 112a.

[0098] The first clamp 110 and the second clamp 112 are independently pivotable and / or oscillating about a cam surface on the body 108, and wherein the first clamp 110 and the second clamp 112 are not connected to each other. In one embodiment, the first clamp 110 and the second clamp 112 are not directly connected to each other as a single manufactured component. In one embodiment, the first clamp 110 and the second clamp 112 are not directly connected to each other via a linkage. In one embodiment, when the first clamp 110 pivots about the cam surface, the distal and proximal ends of the first shim 110a move radially away from the longitudinal axis of the torque generator 100. In one embodiment, when the first clamp 110 and the second clamp 112 pivot about the cam surface, the distal and proximal ends of the first shim 110a and the distal and proximal ends of the second shim 112a move radially away from the longitudinal axis of the torque generator 100.

[0099] When the first gasket 110a and the second gasket 112a are pressed against each other and each enters the EMD 120 having a circular cross-section, the first gasket 110a and the second gasket 112a each slightly deform around the EMD 120, and there is contact between the bottom surface of the first gasket 110a and a portion of the periphery of the EMD 120 along the length of the first gasket 110a, and there is contact between the top surface of the second gasket 112a and a portion of the periphery of the EMD 120 along the length of the second gasket 112a. In one embodiment, the pressure on the EMD 120 is balanced along the length of the portion of the elastomeric gasket that contacts the EMD 120 in the fully engaged position. In another embodiment, the pressure on the EMD 120 is balanced along the entire length of the portion of the elastomeric gasket that contacts the EMD 120 in the fully engaged position. In yet another embodiment, the pressure on the EMD 120 is balanced along most of the length of the portion of the elastomeric gasket that contacts the EMD 120 in the fully engaged position. In one embodiment, the pressure between the elastomeric gasket and a portion of the EMD 120 is substantially uniform along the entire length of the elastomeric gasket in the fully engaged position.

[0100] When the first gasket 110a partially deforms around the EMD 120 and the second gasket 112a partially deforms around the EMD 120, that is, when each gasket conforms to the arc of the circular cross-section of the EMD 120 along its length, they are pressed against each other from opposite directions, and the EMD 120 is clamped between them.

[0101] refer to Figure 8 With the torque converter 100 partially clamped, the knob 106 is in a "partially closed" position relative to the body 108. The torque converter 100 partially clamps the EMD 120 during the transition from the clamped state to the released state. Rotating the knob 106 relative to the body 108 in the direction of turning the knob 106 toward the body 108 causes the knob 106 to move relative to the body 108 in the longitudinal proximal direction 104, such that there is no gap between the proximal surface of the inner protrusion 106c and the distal surfaces of the first clamp 110 and the second clamp 112. Specifically, there is contact (i.e., no gap) between the proximal surface of the inner protrusion 106c of the knob 106 and the inclined distal surface 110f of the first pad base 110b of the first clamp 110, and there is contact between the proximal surface of the inner protrusion 106c of the knob 106 and the inclined distal surface of the second pad base 112b of the second clamp 112.

[0102] When knob 106 is turned toward body 108, the proximal surface of the inner protrusion 106c of knob 106 moves in the longitudinal proximal direction 104 and pushes against the inclined distal surface 110f of the first pad base 110b of the first clamp 110 in the longitudinal proximal direction 104. When the proximal surface of the inner protrusion 106c pushes against the inclined distal surface 110f of the first clamp 110 in the longitudinal proximal direction 104, the distal end of the first pad 110a of the first clamp 110 moves radially away from and separates from EMD 120 due to the orientation (tilt angle) of the inclined distal surface 110f of the first clamp 110. Similarly, when the proximal surface of the internal protrusion 106c pushes against the inclined distal surface of the second clamp 112 in the longitudinal proximal direction 104, the distal end of the second pad 112a of the second clamp 112 moves radially away from and separates from the EMD 120 due to the orientation (tilt angle) of the inclined distal surface of the second clamp 112.

[0103] In the partially clamped state, when the knob 106 is turned toward the body 108, the proximal surface of the internal protrusion 106c of the knob 106 moves in the longitudinal proximal direction 104, thereby pushing and moving the first clamp 110 and the second clamp 112 proximally relative to the positive ends of the first clamp 110 and the second clamp 112 in the clamped state. The compression spring 114 is compressed further than it is in the clamped state, thereby generating a spring restoring force with a larger magnitude in the longitudinal distal direction 102 than it is in the clamped state.

[0104] In the partially clamped state of the torque converter 100, where the knob 106 is in a partially closed position relative to the body 108, there is also contact (i.e., no gap) between the inclined surface of the wedge-shaped protrusion 110h on the proximal end of the first gasket base 110b and the distal chamfered surface of the central post 116d of the spring housing 116 (extending in the distal direction from the proximal base of the cylindrical cup), and there is contact between the inclined surface of the wedge-shaped protrusion on the proximal end of the second gasket base 112b and the distal chamfered surface of the central post 116d of the spring housing 116.

[0105] In the partially clamped state of the torque converter 100, the first shim 110a of the first clamp 110 and the second shim 112a of the second clamp 112 are misaligned relative to the longitudinal central axis of the torque converter 100. In the partially clamped state of the torque converter 100, the first shim 110a of the first clamp 110 and the second shim 112a of the second clamp 112 are not parallel, and portions of the EMD 120 are partially clamped and partially released. Specifically, due to their misalignment, the first shim 110a and the second shim 112a contact (or partially contact) a portion of the EMD 120 towards their proximal ends, and do not contact a portion of the EMD 120 towards their distal ends. In one embodiment, one of the distal and proximal ends of the clamp moves away from each other before the other of the distal and proximal ends of the clamp.

[0106] As described above, the shaped portion of the top inner surface of the first channel 108e of the body 108 defines the cam surface, and the curved intermediate portion 110j of the top surface of the first pad base 110b of the first clamp 110 defines the follower surface. A longitudinal component force acts on the first pad base 110b of the first clamp 110 in the longitudinal proximal direction 104 to achieve static equilibrium with half the restoring force from the spring 114 in the longitudinal direction. This longitudinal component force has a larger magnitude than the component force generated in the clamped state. Due to the shaping of the cam-follower surface, a vertical component force also acts on the first pad base 100b of the first clamp 110. The longitudinal component force is proximal, and the vertical component force is downward. In the partially clamped state of the torque converter 100, the vertical component force presses the proximal portion of the first pad 110a into the EMD 120, and there is contact between a portion of the EMD 120 and the proximal portion of the first pad 110a.

[0107] Similarly, the shaped portion of the bottom inner surface of the second channel 108f of the body 108 defines the cam surface, and the curved middle portion of the bottom surface of the second pad base 112b of the second clamp 112 defines the follower surface.

[0108] A longitudinal component of the force acts on the base 112b of the second pad of the second clamp 112 in the longitudinal proximal direction 104 to achieve static equilibrium with half the restoring force from the spring 114 in the longitudinal direction. This longitudinal component has a larger magnitude than the component generated in the clamped state. Due to the shaping of the cam-follower surface, a vertical component of the force also acts on the base 112b of the second pad of the second clamp 112. The longitudinal component points proximal, and the vertical component points upward. In the partially clamped state of the torque converter 100, the vertical component presses the proximal portion of the second pad 112a into the EMD 120, and there is contact between a portion of the EMD 120 and the proximal portion of the second pad 112a.

[0109] The proximal portions of the first gasket 110a and the second gasket 112a are each deformed around a portion of the EMD 120. The proximal portions of the first gasket 110a and the second gasket 112a are pressed against each other from opposite directions, thereby partially clamping a portion of the EMD 120 between them.

[0110] refer to Figure 9 With the torque converter 100 in the released state, the knob 106 is in the closed position relative to the body 108. With the torque converter 100 in the released state, the EMD 120 in the cavity 118 can be withdrawn in the longitudinal proximal direction 104, or the EMD 120 can be inserted into the cavity 118 in the longitudinal distal direction 102. The knob 106 is fully rotated relative to the body 108 in the direction of turning it toward the body 108 until it is impossible for further travel to cause the knob 106 to move to its nearest position relative to the body 108. As in the partially clamped state, there is no gap between the proximal surface of the internal protrusion 106c and the distal surfaces of the first clamp 110 and the second clamp 112.

[0111] With the torque generator 100 fully released, the proximal surface of the inner protrusion 106c of the knob 106 is in its closest position. The proximal surface (or the edge of the proximal surface) of the inner protrusion 106c of the knob 106 contacts a portion of the inclined distal surface 110f of the first clamp 110, which is located at the radially furthest point of the first clamp 110 from the central axis. Due to the orientation (tilt angle) of the inclined distal surface 110f of the first clamp 110, the distal end of the first pad 110a of the first clamp 110 moves to its radially furthest position away from the central longitudinal axis of the torque generator 100. Similarly, the proximal surface (or the edge of the proximal surface) of the inner protrusion 106c of the knob 106 contacts a portion of the inclined distal surface of the second clamp 112, which is located at the radially furthest point of the second clamp 112 from the central axis. Due to the orientation (tilt angle) of the inclined distal surface of the second clamp 112, the distal end of the second pad 112a of the second clamp 112 moves to its radially furthest position away from the central longitudinal axis of the torque generator 100.

[0112] With the torque converter 100 fully released, the proximal surface (or the edge of the proximal surface) of the inner protrusion 106c of the knob 106 pushes the first clamp 110 and the second clamp 112 to their nearest achievable positions in the longitudinal proximal direction 104, corresponding to the maximum compression of the spring 114 of the torque converter 100. The maximum restoring force from the spring 114 of the torque converter 100 is generated in the longitudinal distal direction 102 and acts on the first clamp 110 and the second clamp 112.

[0113] With the torque converter 100 fully released, the inclined surface of the wedge-shaped protrusion 110h on the proximal end of the first washer base 110b is in its closest position and presses against the distal chamfered surface of the central post 116d of the spring housing 116 (extending in the distal direction from the proximal base of the cylindrical cup). Due to the orientation (tilt angle) of the inclined surface of the wedge-shaped protrusion 110h on the proximal end of the first washer base 110b, the proximal end of the first washer 110a of the first clamp 110 moves radially away from the central longitudinal axis of the torque converter 100. Similarly, the inclined surface of the wedge-shaped protrusion on the proximal end of the second washer base 112b is in its closest position and presses against the distal chamfered surface of the central post 116d of the spring housing 116. Due to the orientation (tilt angle) of the inclined surface of the wedge-shaped protrusion on the proximal end of the second pad base 112b, the proximal end of the second pad 112a of the second clamp 112 moves radially away from the central longitudinal axis of the torque generator 100.

[0114] With the torque converter 100 fully disengaged, both the proximal and distal ends of the first clamp 110 and the second clamp 112 are at their radially furthest points from the central longitudinal axis of the torque converter 100, creating a gap distance along their length between the opposing outermost surfaces of the first shim 110a and the second shim 112a, which is greater than the diameter of the EMD 120. In other words, the first shim 110a of the first clamp 110 and the second shim 112a of the second clamp 112 are in a disengaged position, and the torque converter 100 is not clamping the EMD 120.

[0115] In one embodiment of the torque converter 100, the target torque for the 0.014-inch (0.356 mm) guide wire is greater than or equal to 2 mNm. In other words, in one embodiment, the torque converter 100 transmits or applies greater than or equal to 2 mNm while the EMD does not slip relative to the torque converter. In one embodiment of the torque converter 100, the length of each elastomeric gasket is less than 50 mm. In one embodiment of the torque converter 100, the thickness of the elastomeric gasket is in the range of 0.5 mm to 2 mm. In one embodiment of the torque converter 100, the modulus of the elastomeric gasket is in the range of 250 MPa to 320 MPa. In one embodiment of the torque converter 100, the gasket base material is stainless steel. In one embodiment of the torque converter 100, the gasket modulus is greater than or equal to 3 GPa.

[0116] refer to Figure 10 An embodiment of the passive torque converter 100 includes a movable first clamp 110 and a fixed second clamp 112. In one embodiment, the passive torque converter 100 includes two or more movable clamps. In one embodiment, the passive torque converter 100 does not include a bevel gear 116b on a housing 116, and the housing 116 is manually operated. In one embodiment, the passive torque converter 100 does not include a bevel gear 116b on a housing 116 and includes a mechanical rotating component, such as a pulley.

[0117] refer to Figure 11 , Figure 12 and Figure 13 The active torque converter 200 according to an embodiment includes a knob 206, a body 208, a first clamp 210, a second clamp 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 torque converter 200 includes an inner cavity 226 extending through it along its longitudinal centerline. The diameter of the inner cavity 226 is sized to be larger than the diameter of the EMD used with the torque converter 200.

[0118] In the released state of torque converter 200, the EMD is inserted into the cavity 226 at the distal end of torque converter 200 in the longitudinal proximal direction 204 and retracted from the cavity 226 at the distal end of torque converter 200 in the longitudinal distal direction 202, or the EMD is inserted into the cavity 226 at the proximal end of torque converter 200 in the longitudinal distal direction 202 and retracted from the cavity 226 at the proximal end of torque converter 200 in the longitudinal proximal direction 204. As discussed above regarding passive torque converters, the EMD can be removed from the torque converter from either the distal or proximal end, regardless of how the EMD is inserted into the torque converter. In the clamped state of torque converter 200, a portion of the EMD is fixed relative to torque converter 200. Specifically, in the clamped state, the first clamp 210 and the second clamp 212 of torque converter 200 clamp a portion of the shaft of EMD 228 (see...). Figure 14 This causes rotation and / or translation of the torque converter 200 about or along its longitudinal axis to cause the same rotation and / or translation of that portion of the clamped EMD's shaft. The active torque converter 200 is typically in an open or disengaged position, allowing the EMD to be released. The operator needs to move the actuator to overcome the spring bias to close the torque converter and clamp the EMD.

[0119] Knob 206 includes a distal portion 206a and a proximal portion 206b, wherein the longitudinal centerlines of the two portions are aligned with the longitudinal centerline of the torque converter 200. In one embodiment, knob 206 is a hollow cylinder having different inner and outer diameters in the distal portion 206a and the proximal portion 206b. In one embodiment, the distal portion 206a of knob 206 is a hollow cylinder. In one embodiment, the distal portion 206a of knob 206 is a hollow cylinder having a flat outer surface arrangement on its outer wall, for example, in the shape of a hexagonal nut without internal threads. In one embodiment, the distal portion 206a of knob 206 is a hollow cylinder having a shaped surface arrangement on its outer wall. In one embodiment, the distal portion 206a of knob 206 is a hollow cylinder with a smooth inner wall. In one embodiment, the proximal portion 206b of knob 206 is a hollow cylinder with internal threads 206c (i.e., threads on the inner wall of the cylinder). In one embodiment, the proximal portion 206b of the knob 206 is a hollow cylinder having a shaped surface arrangement on its outer wall. In one embodiment, the proximal portion 206b of the knob 206 is a hollow cylinder with a smooth outer wall. In one embodiment, the proximal portion 206b of the knob 206 is a hollow cylinder with a knurled outer wall. In one embodiment, the knob 206 is a single manufactured part, such as a molded part, having an internal passage through which a portion of the EMD's shaft passes. In one embodiment, the knob 206 is an assembled part having an internal passage through which a portion of the EMD's shaft passes.

[0120] The body 208 includes a distal portion 208a, an intermediate portion 208b, and a proximal portion 208c, wherein the longitudinal centerline of all portions is aligned with the longitudinal centerline of the torque generator 200. In one embodiment, the body 208 is an open cylinder with different diameters in the distal portion 208a, intermediate portion 208b, and proximal portion 208c. In one embodiment, the outer wall of the distal portion 208a includes an external thread 208d. In one embodiment, a portion of the inner wall of the distal portion 208a includes a tapered section, i.e., a section with a linearly increasing diameter or a linearly 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 multiple tapered sections, i.e., multiple sections with linearly increasing diameters and multiple sections with linearly decreasing diameters in a plane transverse to the longitudinal axis (i.e., the YZ plane).

[0121] In one embodiment, the intermediate portion 208b of the body 208 is a hollow cylinder having a shaped surface arrangement on its outer wall. In one embodiment, the intermediate portion 208b of the body 208 is a hollow cylinder with a smooth outer wall. In one embodiment, the intermediate portion 208b of the body 208 is a hollow cylinder with a knurled outer wall. In one embodiment, the proximal portion 208c of the body 208 includes a threaded recess on its nearest side for receiving a fastener 224. In one embodiment, the body 208 is a single manufactured part, such as a molded part, having an internal passage through which a portion of the shaft of the EMD passes. In one embodiment, the body 208 is an assembled part having an internal passage through which a portion of the shaft of the EMD passes.

[0122] The first clamp 210 includes a first pad 210a and a first pad base 210b, and the second clamp 212 includes a second pad 212a and a second pad base 212b. In one embodiment, the first pad 210a is fixed to the first pad base 210b, and the second pad 212a is fixed to the second pad base 212b. In one embodiment, the first pad base 210b is a parallelepiped member having a longitudinal axis corresponding to its longest dimension oriented along the longitudinal axis of the torque converter 200. In one embodiment, the first pad base 210b is a cuboid member having a longitudinal axis corresponding to its longest dimension oriented along the longitudinal axis of the torque converter 200. In one embodiment, the first pad base 210b includes a flat bottom surface to which the first pad 210a is fixed. In one embodiment, the second pad base 212b is a parallelepiped member having a longitudinal axis corresponding to its longest dimension oriented along the longitudinal axis of the torque converter 200. In one embodiment, the second gasket base 212b is a cuboid member having a longitudinal axis corresponding to the longest dimension oriented along the longitudinal axis of the torquer 200. In one embodiment, the second gasket base 212b includes a flat top surface to which the second gasket 212a is attached.

[0123] refer to Figure 14One embodiment of the first gasket base 210b includes a flat bottom (lower) surface 210c to which a first gasket 210a is fixed, a flat front lateral surface 210d, a flat rear lateral surface 210e, an inclined distal surface 210f, a proximal surface 210g having a hole 210h extending distally within the first gasket base 210b but not through the distal surface of the first gasket base 210b, and a top (upper) surface including 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 top surface of the first gasket base 210b, and a transition portion is included between the third intermediate portion 210m and the proximal portion 210n of the top surface of the first gasket base 210b. In one embodiment, the inclined distal surface 210f extends across the front distal side of the first gasket base 210b. In one embodiment, the inclined distal surface 210f includes a portion of the front distal side of the first gasket base 210b. In one embodiment, the diameter of the hole 210h is larger in size than the outer diameter of the first spring 214 and larger in size than the outer diameter of the first pin 218. In one embodiment, the top (upper) surfaces of portions 210i, 210j, 210k, 210m, and 210n of the first gasket base 210b are curved, such as circumferentially arcuate surfaces. In one embodiment, the top (upper) surfaces of portions 210i, 210j, 210k, 210m, and 210n of the first gasket base 210b are flat surfaces.

[0124] In one embodiment, the second gasket base 212b is identical to the first gasket base 210b and includes surfaces that are congruent to those surfaces of the first gasket base 210b. In one embodiment of the torque converter 200, the second gasket base 212b is rotated (flipped) 180 degrees relative to the first gasket base 210b about its longitudinal axis. In other words, the flat bottom surface 210c of the first gasket base 210b to which the first gasket 210a is attached faces the flat top surface of the second gasket base 212b to which the second gasket 212a is attached.

[0125] In one embodiment, the bottom surface of the first pad 210a of the first clamp 210 is a flat surface. In another embodiment, the bottom surface of the first pad 210a of the first clamp 210 is a flat surface including a recessed arcuate profile extending along the length of the surface of the first pad 210a (in the transverse plane, i.e., in the YZ plane). In yet another embodiment, the bottom surface of the first pad 210a of the first clamp 210 is a curved surface having a recessed arcuate profile extending along the length of the surface of the first pad 210a (in the transverse plane, i.e., in the YZ plane).

[0126] In one embodiment, the second gasket 212a is identical to the first gasket 210a and includes surfaces congruent to those surfaces of the first gasket 210a. In one embodiment, the top surface of the second gasket 212a of the second clamp 212 is identical to the bottom surface of the first gasket 210a of the first clamp 210 and includes surfaces congruent to those surfaces of the first gasket 210a. In one embodiment, the first gasket 210a is secured to the first gasket base 210b, and the second gasket 212a is secured to the second gasket base 212b.

[0127] In one embodiment, the first gasket 210a and the second gasket 212a are made of a medical-grade biocompatible material that will not damage or penetrate the coating on the EMD when pressed into an EMD (such as a guidewire) used in catheter-related procedures. In another embodiment, the first gasket 210a and the second gasket 212a are made of an elastomeric material with a hardness measure in the range of 50D–75D and a specific smoothness / roughness grade, such as SPI B1, A1, C1, A2, B2, or C2. In yet another embodiment, the first gasket 210a and the second gasket 212a are made of a natural or synthetic material that has a low modulus of elasticity and a high strain value compared to other materials.

[0128] In one embodiment, the first gasket base 210b and the second gasket base 212b are made of a medical-grade biocompatible material, such as a biocompatible plastic, which is harder than the material of the first gasket 210a and the second gasket 212a. In one embodiment, the first gasket base 210b and the second gasket base 212b are made of a material such as Ultem 1000 or stainless steel. In one embodiment, the first gasket base 210b and the second gasket base 212b are made of a material with greater rigidity than the material of the first gasket 210a and the second gasket 212a. In one embodiment, the first gasket base 210b and the second gasket base 212b are made of a material with an elastic modulus equal to or greater than 3.5 GPa. In one embodiment, the first gasket base 210b and the second gasket base 212b are made of a material having an elastic modulus that is two or more times the elastic modulus value of the material of the first gasket 210a and the second gasket 212a. In one embodiment, the first gasket base 210b and the second gasket base 212b are made of a material having an elastic modulus that is ten times the elastic modulus of the materials of the first gasket 210a and the second gasket 212a.

[0129] In one embodiment of the torque converter 200, the internal thread 206d of the knob 206 engages with the external thread 208d of the body 208, such that rotation of the knob 206 relative to the body 208 causes a change in the longitudinal distance between the knob 206 and the body 208, wherein this distance increases or decreases depending on the direction of relative rotation. The change in longitudinal distance per unit relative rotation of the knob 206 and the body 208 is related to the pitch of the engaging threads 206d and 208d. In another embodiment of the torque converter 200, the external thread of the knob 106 engages with the internal thread on the inner wall of the distal portion 208a of the body 208, such that rotation of the knob 206 relative to the body 208 causes a change in the longitudinal distance between the knob 206 and the body 208, wherein this distance increases or decreases depending on the direction of relative rotation. The change in longitudinal distance per unit relative rotation of the knob 206 and the body 208 is related to the pitch of the engaging threads.

[0130] 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 a flat end and a ground end. In one embodiment, the first spring 214 and the second spring 216 are helical compression springs with a square end and a ground end. In one embodiment, the first spring 214 and the second spring 216 are compliant elastic members of a hollow cylinder or other geometry. In one embodiment, the first spring 214 and the second spring 216 are identical, such that they have the same dimensions, are made of the same material, and have the same stiffness properties. In one embodiment, the first spring 214 and the second spring 216 are different, such that they have different dimensions, are made of different materials, or have different stiffness properties.

[0131] In one embodiment, the first pin 218 and the second pin 220 are cylindrical pins, wherein their longitudinal axes are oriented along the longitudinal axis of the torque converter 200. In one embodiment, the first pin 218 and the second pin 220 are identical, such that they 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.

[0132] The housing 222 includes a distal portion 222a, a first intermediate portion 222b, a second intermediate portion 222c, and a proximal portion 222d, wherein the longitudinal centerline of all portions is aligned with the longitudinal centerline of the torque generator 200. In one embodiment, the distal portion 222a of the housing 222 is a support tube having an inner cavity 226 that extends distally to limit buckling and prevent kinking of a portion of the EMD along its length as it is being translated and / or rotated. In another embodiment, the distal portion 222a of the housing 222 is a cylindrical support tube having an inner cavity 226.

[0133] The first intermediate portion 222b of the outer casing 222 is a transition portion that integrally connects to the distal portion 222a at its distal end and to the second intermediate portion 222c at its proximal end, and has an inner cavity 226 extending through it along its longitudinal centerline. In one embodiment, the first intermediate portion 222b comprises a double cone truncated at both apexes and having a common conical base connected thereto, wherein the inner cavity 226 extends through it along its longitudinal centerline. In one embodiment, the diameter of the connected conical base of the truncated double cone is the same and smaller than the inner diameter of the distal portion 206a of the knob 206. In one embodiment, the first intermediate portion 222b comprises a distal truncated cone and a proximal truncated cone, wherein the distal truncated cone transitions from the outer diameter of the distal portion 222a to the outer circumferential surface of the second intermediate portion 222c. In one embodiment, the first intermediate portion 222b includes a distal truncated cone and a proximal truncated cone, the distal truncated cone having a conical surface with an increasing diameter in the longitudinal proximal direction 104, and the proximal truncated cone having a conical surface with a decreasing diameter in the longitudinal proximal direction 104 and a flat proximal side. In one embodiment, the first intermediate portion 222b includes a double cone having a conical surface with an arcuate profile.

[0134] The second intermediate portion 222c of the outer casing 222 integrally connects the first intermediate portion 222b and the proximal portion 222d, wherein the first intermediate portion 222b is at its distal end and the proximal portion 222d is at its proximal end. In one embodiment, the second intermediate portion 222c is cylindrical and includes a first recess 222e and a second recess 222f, both recesses being recessed within the second intermediate portion 222c and oriented along the longitudinal axis of the second intermediate portion 222c, and both including a tapered portion 222g at their proximal ends. In one embodiment, the length of the first recess 222e is greater than the length of the first clamp 210, and the length of the second recess 222f is greater than the length of the second clamp 212. In one embodiment, the width of the first recess 222e is greater than the width of the first clamp 210, and the width of the second recess 222f is greater than the width of the second clamp 212. In one embodiment, the base of the tapered portion 222g is located near the end of the second intermediate portion 222c of the housing 222, and the diameter of the tapered surface decreases in the longitudinal distal direction 202.

[0135] In one embodiment, the proximal portion 222d includes a distal portion 222h and a proximal portion 222i, wherein the distal portion 222h is a cylinder (such as a disk) having an outer diameter and an inner diameter, and wherein the proximal portion 222i is a bevel gear with its teeth facing proximally. In one embodiment, the distal portion 222h and the proximal portion 222i of the proximal portion 222d are a single manufactured part, such as a molded part, having an internal passage through which a portion of the shaft of the EMD passes. In one embodiment, the distal portion 222h and the proximal portion 222i of the proximal portion 222d are fixed together as an integral unit, having an internal passage through which a portion of the shaft of the EMD passes. In one embodiment, the proximal portion 222d of the housing 222 includes two longitudinally extending through holes, wherein the diameter of the holes is larger than the diameter of the threaded portion of the fastener 224, and wherein the holes are positioned toward the periphery of the proximal portion 222d and mate with the position of the recessed thread of the proximal portion 208c of the body 208. In one embodiment, the bevel gear is a driven member operably driven by a drive member in a robotic system.

[0136] In one embodiment, housing 222 is a single manufactured part, such as a molded part, having an internal passage through which a portion of the shaft of the EMD passes. In one embodiment, housing 222 is an assembled part, having an internal passage through which a portion of the shaft of the EMD passes.

[0137] In one embodiment of the assembled torque converter 200, the body 208 is removably secured to the housing 222 by means of a fastener 224, which is inserted into a hole in the proximal portion 222d of the housing 222 and screwed into a recessed threaded hole in the proximal portion 208c of the body 208. In another embodiment of the assembled torque converter 200, the body 208 is secured to the housing 222 by means of glue, adhesive, bonding agent, laser welding, ultrasonic welding, or other means of securing the two bodies during assembly and manufacturing.

[0138] In one embodiment of the torque converter 200, a first spring 214 is inserted in the longitudinal distal direction 202 and is completely located within a hole 210h of the first clamp 210, and a second spring 216 is inserted in the longitudinal distal direction 202 and is completely located within a similar hole of the second clamp 212. In one embodiment of the torque converter 200, the distal end of the first spring 214 presses against the distal end of the hole 210h of the first clamp 210, and the distal end of the second spring 216 presses against the distal end of a similar hole of the second clamp 212. In one embodiment of the torque converter 200, a first pin 218 is inserted in the longitudinal distal direction 202, and its distal end contacts the proximal end of the first spring 214 within the hole 210h of the first clamp 210, and a second pin 220 is inserted in the longitudinal distal direction 202, and its distal end contacts the proximal end of the second spring 216 within a similar hole of the second clamp 212.

[0139] In one embodiment of the torque converter 200, a first gasket base 210b is kinematically constrained in a first recess 222e of the housing 222, and a second gasket base 212b is kinematically constrained in a second recess 222f of the housing 222. Specifically, in one embodiment, the wall of the first recess 222e constrains the lateral movement of the first clamp 210 (by contacting the flat front lateral surface 210d and the flat rear lateral surface 210e of the first gasket base 210b), and the wall of the second recess 222f constrains the lateral movement of the second clamp 212.

[0140] In one embodiment, a portion of the top surface of the first pad base 210b of the first clamp 210 contacts a portion of the inner peripheral wall of the body 208, and a portion of the bottom surface of the second pad base 212b of the second clamp 212 contacts a portion of the inner peripheral wall of the body 208. In another embodiment, a portion of the top surface of the first pad base 210b of the first clamp 210 contacts a portion of the inner peripheral wall of the body 208, and a portion of the top surface of the first pad base 210b of the first clamp 210 contacts a portion of the inner peripheral wall of the housing 222, and a portion of the bottom surface of the second pad base 212b of the second clamp 212 contacts a portion of the inner peripheral wall of the body 208, and a portion of the bottom surface of the second pad base 212b of the second clamp 212 contacts a portion of the housing 222.

[0141] In one embodiment, the torque converter 200 includes two clamps that are movable relative to each other to releasably secure a portion of the EMD's shaft to at least one of the clamps. In another embodiment, the torque converter 200 includes a clamp that is movable relative to the body of the torque converter 200 to releasably secure a portion of the EMD's shaft to this single clamp. In yet another embodiment, the torque converter 200 includes two or more clamps that are movable relative to each other to releasably secure a portion of the EMD's shaft to at least one of the clamps.

[0142] In one embodiment of torque converter 200, the first spring 214 acts as a biasing member that biases one clamp relative to the body. In one embodiment of torque converter 100, the first spring 214 and the second spring 216 act as biasing members that bias two clamps relative to the body. In one embodiment of torque converter 100, two or more springs act as biasing members that bias two or more clamps relative to the body.

[0143] refer to Figure 15 , Figure 16 and Figure 17 According to the embodiment, the active torque converter 200 is shown in three phases, corresponding to a fully released state, a transition from the released state to a clamped state, and a clamped state, respectively. In the released state, the torque converter 200 is in a disengaged position and does not clamp the EMD 228, and in the clamped state, the torque converter 200 is in a fully engaged position and clamps a portion of the EMD 228. In the embodiments described in all three states (released, transition from the released state to clamped state, and clamped state), the internal thread 206c of the knob 206 engages with the external thread 208d of the body 208.

[0144] refer to Figure 15With the torque converter 200 fully released, the knob 206 is in the open position relative to the body 208. With the torque converter 200 released, the EMD 228 in the cavity 226 can be retracted in the longitudinal proximal direction 204, or the EMD 228 can be inserted into the cavity 226 in the longitudinal distal direction 202. There is no contact (i.e., a gap) between the third intermediate portion 210m of the top surface of the first pad base 210b of the first clamp 210 and the inclined inner wall of the proximal portion 208c of the body 208, and there is no contact between the corresponding intermediate portion of the bottom surface of the second pad base 212b of the second clamp 212 and the inclined inner wall of the proximal portion 208c of the body 208. Rotating knob 206 relative to body 208 in the direction of rotating knob 206 out of body 208 causes knob 206 to move relative to body 208 in the longitudinal distal direction 202, thereby increasing the gap between the third intermediate portion 210m of the top surface of the first pad base 210b of the first clamp 210 and the inclined inner wall of the proximal portion 208c of body 208, and between the corresponding intermediate portion of the bottom surface of the second pad base 212b of the second clamp 212 and the inclined inner wall of the proximal portion 208c of body 208.

[0145] In one embodiment, the knob 206 rotates freely relative to the body 208 in the direction in which the knob 206 is turned out of the body 208 until their teeth no longer mesh and the knob 206 separates from the body 208. In another embodiment, the knob 206 rotates freely relative to the body 208 in the direction in which the knob 206 is turned out of the body 208 until a stop preventing the knob 206 from separating from the body 208 is reached.

[0146] In the fully released state of the torque converter 200, wherein the knob 206 is in the 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 inclined distal surface 210f of the first pad base 210b of the first clamp 210, and there is contact between the proximal conical surface of the first intermediate portion 222b of the housing 222 and the inclined distal surface of the second pad base 212b of the second clamp 212.

[0147] With the torque converter 200 fully released, the first pad 210a of the first clamp 210 and the second pad 212a of the second clamp 212 face each other, are separated by a distance, are parallel to each other and parallel to a portion of the EMD 228 (if present), and do not contact any part of the EMD 228, that is, the first pad 210a and the second pad 212a do not contact a portion of the EMD 228 along the length of each pad.

[0148] In the fully released state of the torque converter 200, the first spring 214 and the second spring 216 are compressed relative to their respective rest lengths. Therefore, a spring restoring force acts from the first spring 214 in the longitudinal distal direction 202, and from the second spring 216 in the longitudinal distal direction 202. (The spring restoring force also acts from the first spring 214 and from the second spring 216 in the longitudinal proximal direction 204 for static equilibrium. However, the proximal ends of the first spring 214 and the second spring 216 are constrained, i.e., fixed relative to the housing 222 and the body 208 to which the housing 222 is fixed. The lengths of the first pin 218 and the second pin 220 are constant, and both pins are prevented from moving relative to the housing 222 and the body 208 when their proximal ends contact the tapered portion 222g of the second intermediate portion 222c of the housing 222. Therefore, a useful spring restoring force acts in the longitudinal distal direction 202.)

[0149] The spring restoring force from the first spring 214 acts on the first clamp 210 through the contact between the distal end of the first spring 214 and the inner surface at the distal end of the hole 210h of the first washer base 210b. Therefore, the first clamp 210 moves in the longitudinal distal direction 202 until it is stopped by the contact between the first intermediate portion 210j of the top surface of the first washer base 210b and the inclined inner wall of the knob 206. Similarly, the spring restoring force from the second spring 216 acts on the second clamp 212 through the contact between the distal end of the second spring 216 and the inner surface at the distal end of the hole of the second washer base 212b. Therefore, the second clamp 212 moves in the longitudinal distal direction 202 until it is stopped by the contact between the corresponding first intermediate portion of the bottom surface of the second washer base 212b and the inclined inner wall of the knob 206.

[0150] refer to Figure 16 In the released state of the torque converter 200, during the transition from fully released to fully clamped, the knob 206 is in a partially closed position relative to the body 208. Rotating the knob 206 relative to the body 208 in the direction of turning the knob 206 toward the body 208 causes the knob 206 to move relative to the body 208 in the longitudinal proximal direction 204, such that there is contact between the third intermediate portion 210m of the top surface of the first pad base 210b of the first clamp 210 and the inclined inner wall of the proximal portion 208c of the body 208, and there is contact between the corresponding intermediate portion of the bottom surface of the second pad base 212b of the second clamp 212 and the inclined inner wall of the proximal portion 208c of the body 208.

[0151] When knob 206 is turned toward body 208, causing knob 206 to move relative to body 208 in the longitudinal proximal direction 204, it pushes the first clamp 210 and the second clamp 212 in the longitudinal proximal direction 204. This movement in the longitudinal proximal direction 204 compresses the first spring 214 further than it is in the released state, thereby generating a first spring return force greater than the first spring return force value in the released state, and compresses the second spring 216 further than it is in the released state, thereby generating a second spring return force greater than the second spring return force value in the released state.

[0152] Due to the inclined inner wall of knob 206, knob 206 also pushes the first clamp 210 downward toward the longitudinal central axis of torque converter 200, and pushes the second clamp 212 upward toward the longitudinal central axis of torque converter 200. In other words, the first pad 210a of the first clamp 210 moves radially toward a portion of EMD 228, and the second pad 212a of the second clamp 212 moves radially toward a portion of EMD 228. Due to the two inclined surfaces of the upper surface of the first pad base 210b and the two inclined surfaces of the lower surface of the second pad base 212b, the first pad 210a and the second pad 212a remain parallel to each other and oriented parallel to the portion of EMD 228 between them. Specifically, the slope of the first intermediate portion 210j of the top surface of the first gasket base 210b is the same as the slope of the inner wall of the knob 206, and the slope of the third intermediate portion 210m of the top surface of the first gasket base 210b is the same as the slope of the inner wall of the body 208, as is the flat bottom lower surface 210c of the first gasket base 210b. Furthermore, the slope of the first intermediate portion 210j of the top surface of the first gasket base 210b and the slope of the third intermediate portion 210m of the top surface of the first gasket base 210b have the same magnitude but opposite signs. Therefore, the flat bottom lower surface 210c of the first gasket base 210b and the first gasket 210a remain parallel to the longitudinal central axis of the torque converter 200 and move toward the longitudinal central axis of the torque converter 200 as the knob 206 is rotated toward the body 208. Similarly, the flat top surface of the second gasket base 212b and the second gasket 212a remain parallel to the longitudinal central axis of the torque generator 200 and move toward the longitudinal central axis of the torque generator 200 as the knob 206 is turned toward the body 208.

[0153] refer to Figure 17With the torque converter 200 clamped, the knob 206 is in the closed position relative to the body 208. In the clamped state of the torque converter 200, the first pad 210a of the first clamp 210 and the second pad 212a of the second clamp 212 face each other, are parallel to each other and parallel to a portion of the EMD 228, and clamp a portion of the EMD 228 along the length of each pad; that is, the first pad 210a and the second pad 212a are in contact with a portion of the EMD 228 along the length of each pad. The knob 206 is fully rotated relative to the body 208 in the direction of turning the knob 206 toward the body 208 until it is impossible for further movement to cause the knob 206 to move to its nearest side position relative to the body 208.

[0154] With knob 206 in its closest position relative to body 208, knob 206 pushes the first clamp 210 and the second clamp 212 to their closest achievable positions in the longitudinal proximal direction 204, corresponding to the maximum compression of the first spring 214 and the second spring 216. The maximum restoring force from the first spring 214 is generated in the longitudinal distal direction 202 and acts on the first clamp 210, and the maximum restoring force from the second spring 216 is generated in the longitudinal distal direction 202 and acts on the second clamp 212. Therefore, the maximum vertical component of force acts to press the first clamp radially downward toward the longitudinal central axis of torque generator 200, and the maximum vertical component of force acts to press the first clamp radially upward toward the longitudinal central axis of torque generator 200.

[0155] When the first gasket 210a and the second gasket 212a are pressed against each other and each enters the EMD 228 having a circular cross-section, the first gasket 210a and the second gasket 212a are slightly deformed around the EMD 228, and there is contact between the bottom surface of the first gasket 210a and a portion of the periphery of the EMD 228 along the length of the first gasket 210a, and there is contact between the top surface of the second gasket 212a and a portion of the periphery of the EMD 120 along the length of the second gasket 212a.

[0156] When the first gasket 210a is partially deformed around the EMD 228 and the second gasket 212a is partially deformed around the EMD 228, that is, when each gasket conforms to the arc of the circular cross-section of the EMD 228 along its length, they are pressed against each other from opposite directions and the EMD 228 is clamped between them.

[0157] In one embodiment, the gasket with compliant properties has a modulus value between 200 and 400 MPa. In one embodiment, the gasket with compliant properties has a gasket hardness value between 45D and 75D. In one embodiment, the gasket with compliant properties has a modulus value between 200 and 400 MPa, and the gasket hardness value is between 45D and 75D. In one embodiment, the force applied to the EMD from the clamping gasket has a value between 200 and 400 N. In one embodiment, the length of the gasket is less than or equal to 50 mm. In one embodiment, the modulus of the gasket base has a value equal to or greater than 3.5 GPa. In one embodiment, the modulus of the gasket base is greater than the modulus of the gasket. In one embodiment, the modulus of the elastomeric gasket has a value between 200 and 400 MPa, the length of the elastomeric gasket has a value equal to or less than 50 mm, the hardness of the elastomeric gasket has a value between 45D and 75D, and the modulus of the gasket base has a value equal to or greater than 3.5 GPa. The clamping shims mentioned in this paragraph are the clamping shims in torque generator 100 and torque generator 200.

[0158] As described herein, with the torque converter 200 engaged, the EMD shaft is clamped within the internal passage of the torque converter 200. In one embodiment, the EMD is axially loaded into the internal passage of the torque converter 200. In axial loading, the shaft portion is loaded into the internal passage of the torque converter 200 by first inserting the free end of the EMD into the proximal or distal opening of the cavity 226.

[0159] In another embodiment, the EMD shaft is radially loaded into the internal passage of the torquer. Radial loading contrasts with axial loading and may also be referred to as lateral loading or side loading. The EMD is loaded into the torquer 200 through a longitudinal slit or opening in the torquer (i.e., one side of the torquer extending from the proximal end to the distal end). In the radially loaded embodiment, it enters the internal passage by means of a longitudinal slit along the torquer 200 from its outer periphery to the internal passage.

[0160] refer to Figure 18In one embodiment, torque generator 100 is located within device module 32. Although not shown, torque generator 200 can also be located within the device module for mechanical control of the EMD. The housing 66 of device module 32 includes a bearing support 232 that receives a bearing surface 117 on torque generator 100. The device module bearing support 232 provides rotational and thrust support for torque generator 100, allowing torque generator 100 to rotate about the longitudinal axis of the device module without the device module itself rotating. The distal portion 106a of knob 106 provides buckling-resistant support for the EMD. In one embodiment, bearing support 232 is formed by a C-shaped bracket within housing 66, and in another embodiment, bearing support 232 is partially formed by a bracket within housing 66 and partially formed by a portion of a cover pivotally attached to housing 66.

[0161] In one embodiment, the distal free end of the distal portion 106a is adjacent to the device support or flexible track 79 along the longitudinal axis of the device module, such that the EMD does not buckle 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 less than one inch (25.4 mm), and in one embodiment less than 0.5 inches (12.7 mm). In one embodiment, the distal free end of the distal portion 106a is located within a cavity defined by the device support or track 79. In one embodiment, the track 79 is formed of a flexible member that moves from a position collinear with the longitudinal axis of the device module to a position offset from the longitudinal axis of the device. In one embodiment, the track 79 has a longitudinal slit extending from the outer surface of the track 79 to a longitudinally extending cavity therethrough. In the position of use, the driven member 116b engages the drive member 230. The drive member is mechanically controlled to impart rotational motion to the torque converter and the EMD.

[0162] In one embodiment, the distal end of the distal portion 106a. In one embodiment, a torque converter for use with certain EMDs (such as bracket retrievers and certain coils) where rotation of the proximal shaft is not desired, and the adapter is not provided with a driven member. In one embodiment, the adapter includes features such as tabs that engage with stops on the housing or device module to prevent rotation of the adapter and certain EMDs.

[0163] The passive torque converter 100 is similar to a two-clamp chuck with a pre-loaded spring that clamps the elastomeric gaskets together. When the operator turns the knob in, the clamps are forced into the open position. To close the clamps again, the knob is turned out, releasing the clamps. The passive torque converter does not damage the EMD, accepts various wire device sizes, and eliminates performance variations due to user force. Variations of the invention include axial-to-radial loading, single-sided clamping, alternative force sources, and alternative actuation mechanisms.

[0164] Using elastomeric materials on the gasket minimizes damage to the outer surface coating of the EMD compared to clamps made of metallic materials.

[0165] While other types of torque devices are available, the most commonly used ones require the operator to tighten a knob to close a pin on the wire device. The rotation and linear grip of the torque device depend on how tightly the operator tightens the knob. Human strength testing indicates that more than 5% of the population will not be able to sufficiently twist the knob to achieve the target torque performance of 2.5 mNm guidewire torque. Significantly fewer individuals will be able to provide sufficient knob torque to achieve 6.5 mNm torque on access wires with diameters ranging from .035 to .038 inches (.889 to .965 mm).

[0166] Although this disclosure has been described with reference to exemplary embodiments, those skilled in the art will recognize that changes in form and detail may be made without departing from the spirit and scope of the subject matter. For example, while different exemplary embodiments may have been described as including one or more features that provide one or more benefits, it is contemplated that the described features may be interchanged or alternatively combined with each other in the described exemplary embodiments or in other alternative embodiments. Because the technology of this disclosure is relatively complex, not all changes to the technology are foreseeable. The described disclosure is obviously intended to be as broad as possible. For example, unless specifically indicated otherwise, the description of a single particular element also covers multiple such particular elements.

Claims

1. A torque wrench for an elongated medical device, comprising: a body having a cavity defining a passageway; a first jaw movable within the cavity, the first jaw including a first pad made of a medical grade biocompatible material that does not damage or penetrate a coating on the elongated medical device; a biasing member separate from the first jaw that biases the first jaw relative to the body; an actuator movable relative to the body to move the first jaw to clamp and / or unclamp the elongated medical device within the passageway with the first pad, and at least one second jaw movable relative to the body toward the first jaw, the second jaw having a second pad made of a medical grade biocompatible material that does not damage or penetrate a coating on the elongated medical device, and wherein each jaw is free to pivot about a cam surface on the body, and wherein the jaws are not connected to each other.

2. The torque wrench of claim 1, wherein, Each jaw includes a pad base having a first modulus that is greater than a second modulus of the first pad and the second pad.

3. The torque wrench of claim 2, wherein, Each jaw is free to pivot about a cam surface on the body independently of each other.

4. The torque wrench of claim 3, wherein, When the jaws pivot about the cam surface, a distal end and a proximal end of the elastomeric pad move radially away from a longitudinal axis of the torque wrench.

5. The torque device of claim 2, wherein, The body includes a cam surface that contacts a non-linear follower surface on each pad base.

6. The torque device of claim 5, wherein, The follower surface is arcuate.

7. The torque wrench of claim 6 wherein, The cam surface is linear.

8. The torque wrench of claim 1, wherein, The pads are elastomeric pads, and wherein in a fully clamped position, a pressure between the elastomeric pads and the elongated medical device is substantially uniform along an entire length of the elastomeric pads contacting the elongated medical device.

9. The torque device of claim 2, wherein, The biasing member biases the pads toward each other.

10. The torque device of claim 2, wherein, The biasing member biases the pads away from each other.

11. The torque device of claim 1, wherein, The biasing member includes one or more helical compression springs having a longitudinal axis that is parallel or collinear with a longitudinal axis of the body.

12. The torque device of claim 2, wherein, Each jaw has a distal end and a proximal end, wherein one of the distal end and the proximal end of the jaw moves away from the other of the distal end and the proximal end of the jaw before the other of the distal end and the proximal end of the jaw.

13. The torque device of claim 1, wherein, The passageway is capable of accommodating an elongated medical device having a diameter of 0.014 inches to 0.038 inches, inclusive.

14. The torque device of claim 2, wherein, A magnitude of force exerted by the pads onto the elongated medical device is between 200 and 400 N, and a modulus of the pads is between 200 and 400 MPa, and a length of the pads is less than 50 mm, and a hardness value of the pads is between 45D and 75D, and wherein a modulus of each pad base is greater than 3.5 GPa.

15. The torque wrench of claim 1 releasably clamping an elongated medical device, wherein, the at least two jaws are movable within the cavity; the biasing member is separate from the jaws that biases the jaws relative to the body; and wherein the actuator includes a knob that is movable relative to the body, the knob moving the jaws relative to each other to clamp or unclamp the elongated medical device within the passageway with the pad.

16. The torque device of claim 15, wherein, The body includes a cam surface that contacts a non-linear follower surface on each pad base.

17. The torque wrench of claim 16, wherein, Each jaw is free to pivot about the cam surface independently of the other.

18. The torque device of claim 17, wherein, Pressure between the pad and the elongated medical device is substantially uniform along the entire length of the pad.

19. The torque device of claim 15, wherein, The magnitude of force exerted from the pad to the elongated medical device is between 200 and 400 N, and the magnitude of the modulus of the pad is between 200 and 400 MPa, and the length of the pad is less than 50 mm, and the hardness value of the pad is between 45D and 75D, and wherein the magnitude of the modulus of the pad base is greater than 3.5 GPa.

20. The torque wrench of claim 1 releasably engaging an elongated medical device, wherein, the at least two jaws are movable within the cavity, each jaw having an elastomeric pad; the biasing member is separate from the jaws, biasing the jaws relative to the body; and wherein the actuator includes a knob that is movable relative to the body, the knob moving the jaws relative to each other to clamp or unclamp the elongated medical device within the passageway with the elastomeric pad; wherein in a fully clamped position, pressure between the elastomeric pad and the elongated medical device is substantially uniform along the entire length of the elastomeric pad.

Images