Load sensing of an elongated medical device in robotic actuation

Abstract

The apparatus includes a collet having a first portion with a first collet coupler connected thereto and a second portion with a second collet coupler connected thereto, an elongated medical device (EMD) removably positioned within a path defined by the collet, a drive module including a first actuator operatively coupled to the first collet coupler to operatively clamp and unclamp the EMD in the path and rotate the EMD and a second actuator operatively engaged with the second collet coupler, a first load sensor to determine a first collet coupler torque acting on the first collet coupler, and a processor to determine an EMD torque acting on the EMD from a first signal from the first load sensor.

Description

[0001] This application is a continuation of application number 202080065666.9, filed July 14, 2020, entitled LOAD SENSING OF ELONGATED MEDICAL DEVICE IN ROBOTIC ACTUATION.

[0002] Cross Reference to Related Patent Applications

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 876,489, filed July 19, 2019, and entitled LOAD SENSING OF ELONGATED MEDICAL DEVICE IN ROBOTIC ACTUATION, and claims the benefit of U.S. Provisional Patent Application No. 63 / 012,607, filed April 20, 2020, entitled LOAD SENSING OF ELONGATED MEDICAL DEVICE IN ROBOTIC ACTUATION, the entire contents of both of which are incorporated herein by reference. TECHNICAL FIELD

[0004] The present invention relates generally to the field of robotic medical procedure systems, and more specifically to apparatuses and methods for sensing a load applied to an elongated medical device in robotic actuation. BACKGROUND

[0005] Catheters and other elongated medical devices (EMDs) can be used for minimally invasive medical procedures to diagnose and treat various vascular system diseases, including neurovascular interventions (NVI) (also known as neurointerventional procedures), percutaneous coronary interventions (PCI), and peripheral vascular interventions (PVI). These procedures typically involve navigating a guidewire through the vasculature and advancing a catheter over the guidewire for treatment. Catheterization procedures first use standard percutaneous techniques to access an appropriate blood vessel, such as an artery or vein, through a guide sheath. Through the guide sheath, a sheath or guide catheter is then advanced over a diagnostic guidewire to a main location, such as the internal carotid artery for NVI, the coronary artery ostium for PCI, or the superficial femoral artery for PVI. A guidewire appropriate for the vasculature is then navigated through the sheath or guide catheter to a target location in the vasculature. In some cases, such as in tortuous anatomy, a support catheter or microcatheter is inserted over the guidewire to assist in navigating the guidewire. The physician or operator can use an imaging system (e.g., a fluoroscope) to obtain images of contrast injections and select a fixed frame to use as a roadmap to navigate the guidewire or catheter to the target location, e.g., a lesion. Contrast-enhanced images can also be obtained while the physician is delivering the guidewire or catheter so that the physician can verify that the device is moving along the correct path to the target location. While viewing the anatomy using the fluoroscope, the physician manipulates the proximal end of the guidewire or catheter to direct the distal tip into the appropriate blood vessel toward the lesion or target anatomical location and avoid advancing into side branches.

[0006] Surgical systems based on robotic catheters have been developed that can be used to assist physicians in performing catheterization 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 of acute ischemic stroke large vessel occlusion. In NVI procedures, physicians use robotic systems to obtain access to the target lesion by controlling the manipulation of a neurovascular guidewire and microcatheter, providing treatment to restore normal blood flow. The target access is obtained through a sheath or guide catheter, although intermediate catheters can also be needed for more distal regions or to provide moderate support for the microcatheter and guidewire. Depending on the lesion and type of treatment, the distal tip of the guidewire is navigated into or past the lesion. To treat an aneurysm, a microcatheter is advanced into the lesion and the guidewire is removed, and several embolic coils are deployed into the aneurysm through the microcatheter and used to block blood flow into the aneurysm. To treat an arteriovenous malformation, a liquid embolus is injected into the malformation via the microcatheter. Mechanical thrombectomy to treat a vascular occlusion can be achieved by aspiration and / or using a stent retriever. Depending on the location of the clot, aspiration is performed through an aspiration catheter or through a microcatheter for smaller arteries. Once the aspiration catheter is in place at the lesion, negative pressure is applied to remove the clot through the catheter. Alternatively, a stent retriever can be deployed through a microcatheter to remove the clot. Once the clot has been incorporated into the stent retriever, the clot is retrieved by retracting the stent retriever and microcatheter (or intermediate catheter) into the guide catheter.

[0007] In PCI, physicians use robotic systems to obtain access to the lesion by manipulating a coronary guidewire to provide treatment and restore normal blood flow. The access is obtained by placing a guide catheter in the coronary ostium. The distal tip of the guidewire is navigated past the lesion, and for complex anatomy, a microcatheter can be used to provide moderate support for the guidewire. Blood flow is restored by delivering and deploying a stent or balloon at the lesion. The lesion can require preparation before stenting, by delivering a balloon for pre-dilation of the lesion, or using, for example, a laser or rotational atherectomy catheter and a balloon over the guidewire for atherectomy. Diagnostic imaging and physiologic measurements can be performed to determine the appropriate treatment method by using an imaging catheter or fractional flow reserve (FFR) measurements.

[0008] In PVI, physicians use robotic systems to perform treatment and restore blood flow using techniques similar to NVI. The distal tip of the guidewire is navigated past the lesion, and a microcatheter can be used to provide moderate support for the guidewire for complex anatomy. Blood flow is restored by delivering and deploying a stent or balloon at the lesion. As in the case of PCI, lesion preparation and diagnostic imaging can also be used.

[0009] When support at the distal end of a catheter or guidewire is needed, for example, to navigate tortuous or calcified vessels, to reach a distal anatomical location, or to cross a hard lesion, an over-the-wire (OTW) catheter or a coaxial system is used. An OTW catheter has an inner lumen for a guidewire that extends the entire length of the catheter. This provides a relatively stable system because the guidewire is supported along the entire length. However, such a system has some disadvantages, including greater friction and longer overall length compared to a rapid exchange catheter (see below). Typically, in order to remove or exchange an OTW catheter while maintaining the position of the underlying guidewire, the exposed length of the guidewire (outside the patient) must be longer than the OTW catheter. A 300 cm long guidewire is typically sufficient for this purpose and is often referred to as an exchange length guidewire. Due to the length of the guidewire, two operators are needed to remove or exchange an OTW catheter. This becomes more challenging if a triaxial catheter, known in the art as a tri-coaxial system, is used (four-coaxial catheters are also known to be used). However, due to its stability, the OTW system is often used for NVI and PVI procedures. PCI procedures, on the other hand, often use a rapid exchange (or monorail) catheter. The guidewire lumen in a rapid exchange catheter extends only through the distal section of the catheter, also known as the monorail or rapid exchange (RX) section. In the case of an RX system, the operators manipulate the interventional devices in parallel to each other (as opposed to an OTW system, where the devices are manipulated in a serial configuration), and the exposed length of the guidewire need only be slightly longer than the RX section of the catheter. A rapid exchange length guidewire is approximately 180-200 cm long. In the case of a shorter length guidewire and monorail, an RX catheter can be exchanged by a single operator. However, when more distal support is needed, an RX catheter is often not sufficient. SUMMARY

[0010] The apparatus includes a drive module having a drive module base component and a load sensing component. An elongated medical device (EMD) is removably coupled to an isolation component. The isolation component is isolated from external loads other than actual loads acting on the EMD. The isolation component is removably coupled to the load sensing component. A load sensor is secured to the drive module base component and the load sensing component that senses the actual loads acting on the EMD.

[0011] In one embodiment, the apparatus includes a drive module having a drive module base component and a load sensing component and a cartridge removably secured to the drive module. The cartridge includes a housing and a floating member movable within the housing. The EMD is manipulated by the floating member. The floating member is isolated from external loads other than actual loads acting on the EMD. The floating member is operatively connected to the load sensing component and a load sensor is secured to the drive module base component and the load sensing component that senses the actual loads acting on the EMD.

[0012] In one embodiment, an apparatus includes a collet having a first portion with a first collet coupler connected thereto and a second portion with a second collet coupler connected thereto. An EMD is removably located within a path defined by the collet. A drive module includes a first actuator operatively coupled to the first collet coupler to operatively clamp and unclamp the EMD in the path and rotate the EMD and a second actuator operatively engaged with the second collet coupler. A first load sensor determines torque acting on the first collet coupler and a processor determines torque acting on the EMD from a first signal from the first load sensor.

[0013] In one embodiment, an apparatus for calibrating a load sensor includes a drive module including a drive module base component, a load sensing component, a load sensor, and a resilient member having a known stiffness intermediate the load sensor and the drive module base component. A cartridge is removably secured to the drive module, the cartridge including a housing and a floating member movable within the housing; the cartridge configured to receive an elongated medical device.

[0014] In one embodiment, a catheter-based surgical system includes a robotic drive through which an elongated medical device (EMD) extends and is removably located within a path of the robotic drive and is manipulated within the path of the robotic drive. The system includes one or more sensors for determining a load acting on a proximal end of the EMD as the system advances, retracts, rotates, and fixes the EMD in an interventional procedure. The load includes a force and a torque acting on the EMD. A processor determines the load acting on the EMD from signals from the one or more sensors in the system. In one embodiment, the processor determines the load acting on the EMD in the robotic drive with a reset motion of the EMD.

[0015] In one embodiment, the system includes automatically calibrating the one or more sensors with a known deflection of a resilient member. In one embodiment, the system protects the sensors from overloading. In one embodiment, the system includes a processor that determines the load acting on the EMD in the robotic drive with a reset motion of the EMD, automatically calibrates the one or more sensors with a deflection of a resilient member, and protects the one or more sensors from overloading.

[0016] In one embodiment, an apparatus includes a first drive module having a first on-device adapter operatively engaged with an elongated medical device (EMD) to operate the EMD. The drive module includes a first load sensor to measure a load applied to the EMD by the first drive module. A second drive module has a second on-device adapter releasably engaged with the EMD. A reset state includes moving the first on-device adapter relative to the second drive module between an extended position and a reset position. A second load sensor is operatively connected to the second on-device adapter and the second drive module. A processor receives a first signal from the first load sensor and a second signal from the second load sensor and determines an actual load on the EMD from the first signal, the second signal, and a state of the first on-device adapter and a state of the second on-device adapter. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1 is a schematic diagram of an exemplary catheter-based surgical system according to an embodiment.

[0018] Figure 2 is a schematic block diagram of an exemplary catheter-based surgical system according to an embodiment.

[0019] Figure 3 is an isometric view of an exemplary bedside system of a catheter-based surgical system according to an embodiment.

[0020] Figure 4A is a schematic end view of a device module having a load sensing system including an isolation component and a load sensing component.

[0021] Figure 4B is Figure 4A is a schematic end view of another embodiment of

[0022] Figure 4C is Figure 4A is a schematic end view of another embodiment of

[0023] Figure 4D is Figure 4A is a schematic end view of another embodiment of

[0024] Figure 5Ais a top view of a drive module with a load sensing system, the drive module including an actuator that rotates and / or clamps / unclamps an EMD located outside of the load sensing component and a bearing support of the load sensing component in at least one off-axis (not measured) direction.

[0025] Figure 5B is a side view of a drive module with a load sensing system, the drive module including an actuator that rotates and / or clamps / unclamps an EMD located outside of the load sensing component and a bearing support of the load sensing component in at least one off-axis (not measured) direction.

[0026] Figure 5C is an isometric view of a drive module including a load sensing component and a drive module base component.

[0027] Figure 5D is an exploded isometric view of a device module with a load sensing system and a cassette capable of receiving a device on adapter with an EMD according to an embodiment.

[0028] Figure 5E is an isometric view of a catheter with an EMD device on adapter according to an embodiment.

[0029] Figure 5F is an isometric view of a guidewire with an EMD device on adapter according to an embodiment.

[0030] Figure 5G is an exploded isometric view of a drive module with a drive module base component and a load sensing component.

[0031] Figure 5H is Figure 5A is a close-up top view showing the load sensing component connected to a load sensor within the drive module base component.

[0032] Figure 5I is an isometric view of a cassette with a device on adapter with an EMD according to an embodiment.

[0033] Figure 5J is an exploded isometric view of a cassette showing a first component and a second component of an isolation component.

[0034] Figure 5K is an exploded isometric view of the bottom side of a cassette and its connection to a drive module.

[0035] Figure 5L is Figure 5I is a partial side view of

[0036] Figure 5M is Figure 5Iis an end cross-sectional view of the cassette showing meshing of the bevel gears in the cassette.

[0037] Figure 6A is a top view of a cassette according to an embodiment, with an isolation component and a cassette housing.

[0038] Figure 6B is an end cross-sectional view of the isolation component and cassette according to an embodiment.

[0039] Figure 6C is a bottom view of the isolation component and cassette housing according to an embodiment.

[0040] Figure 7 is Figure 4D is a schematic end cross-sectional view of an exemplary embodiment of a load sensing system of

[0041] Figure 8 is a schematic top view of a load sensing system including a double bevel gear drive mechanism.

[0042] Figure 9A is Figure 8 is a schematic side view of an exemplary embodiment of a load sensing system of

[0043] Figure 9B is Figure 9A is a schematic side view of another embodiment of a load sensing system.

[0044] Figure 9C is Figure 9B is a schematic isometric view of a load sensing system of

[0045] Figure 9D is a schematic side view of an exemplary embodiment of a load sensing system of a collet mechanism with a single torque sensor.

[0046] Figure 9E is a schematic side view of an exemplary embodiment of a load sensing system for a hub drive mechanism with a single torque sensor.

[0047] Figure 9F is another embodiment of a load sensing system for measuring force and torque on an EMD. Figure 9B is a schematic side view of another embodiment of a load sensing system for measuring force and torque on an EMD.

[0048] Figure 10A is a schematic side view of another embodiment of a load sensing system for measuring force and torque on an EMD.

[0049] Figure 10B This is a schematic top view of another embodiment of a load sensing system for measuring force and torque on an EMD.

[0050] Figure 11 This is a schematic top view of an embodiment of a load sensing system that uses a tire drive on the distal side of an adapter on a first device to measure force and torque on an EMD in a robot system with reset motion.

[0051] Figure 12A This is a schematic top view of an embodiment of a load sensing system that uses a tire drive on the proximal side of an adapter on a first device to measure force and torque on an EMD in a robot system with reset motion.

[0052] Figure 12B yes Figure 12A A schematic side view of an exemplary embodiment of the load sensing system.

[0053] Figure 13A This is a schematic top view of an embodiment of a load sensing system for measuring force and torque on an EMD in a robotic system with automatic calibration and overload protection of sensors, the load sensing system being shown in a neutral (no load) position.

[0054] Figure 13B yes Figure 13A A schematic top view of an embodiment of a load sensing system, shown in a loaded position.

[0055] Figure 14A This is a schematic top view of another embodiment of a load sensing system for measuring force and torque on an EMD in a robotic system with automatic calibration and overload protection of sensors, the load sensing system being shown in a neutral (no load) position.

[0056] Figure 14B yes Figure 14A A schematic top view of an embodiment of a load sensing system, shown in a loaded position.

[0057] Figure 15A This is a schematic top view of another embodiment of a load sensing system for measuring force and torque on an EMD in a robotic system with automatic calibration and overload protection of sensors, the load sensing system being shown in a neutral (no load) position, with the drive actuator located inside the load sensing component.

[0058] Figure 15B yes Figure 15A A schematic top view of an embodiment of a load sensing system, shown in a loaded position, wherein the drive actuator is located inside the load sensing component.

[0059] Figure 16A This is a schematic top view of another embodiment of a load sensing system for measuring force and torque on an EMD in a robotic system with automatic calibration and overload protection of sensors, the load sensing system being shown in a neutral (no load) position.

[0060] Figure 16B This is a schematic top view of another embodiment of a load sensing system for measuring force and torque on an EMD in a robotic system with automatic calibration and overload protection of sensors, the load sensing system being shown in a loaded position.

[0061] Figure 17 It is a block diagram of a processor with two inputs (sensing load and parasitic load) and one output (actual load).

[0062] Figure 18 It refers to a block diagram that shows the symbol for the sum of loads combined into parasitic loads. Detailed Implementation

[0063] 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 intervention (NVI) (e.g., treatment of emergency large vessel occlusion (ELVO)), peripheral vascular intervention (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 assist in the diagnosis of a patient's condition. For example, during one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected through a catheter onto one or more arteries, and images of the patient's vascular system are acquired. 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. This can be achieved by including an accessory device 54 (such as...). Figure 2 The catheter-based surgical system 10 can improve surgical procedures by using devices such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. However, it should be noted that those skilled in the art should recognize that certain specific percutaneous interventional devices or components (e.g., guidewire type, catheter type, etc.) can be selected based on the type of procedure to be performed. The catheter-based surgical system 10 can perform any number of catheter-based medical procedures and can be adapted with minimal adjustments to accommodate the specific percutaneous interventional devices to be used during the procedure.

[0064] The catheter-based procedure system 10 includes a bedside unit 20 and a control station 26, among other elements. The bedside unit 20 includes a robotic drive 24 and a positioning system 22 placed proximate to a patient 12. The patient 12 is supported on a bed 18. The positioning system 22 is used to position and support the robotic drive 24. The positioning system 22 can be, for example, a robotic arm, an articulated arm, a holder, etc. The positioning system 22 can be attached at one end to a rail, a base, or a cart on, for example, the bed 18. The other end of the positioning system 22 is attached to the robotic drive 24. The positioning system 22 can be removed (with the robotic drive 24) to allow the patient 12 to be placed on the bed 18. Once the patient 12 is positioned on the bed 18, the positioning system 22 can be used to position or orient the robotic drive 24 relative to the patient 12 for a procedure. In embodiments, the bed 18 is operably supported by a base 17 that is fixed to the floor and / or ground. The bed 18 is movable relative to the base 17 in multiple degrees of freedom, such as roll, pitch, and yaw. The bedside unit 20 can also include controls and a display 46 (shown in Figure 2 ). For example, the controls and display can be located on a housing of the robotic drive 24.

[0065] Generally, the robotic drive 24 can be equipped with appropriate percutaneous intervention devices and accessories 48 (shown in Figure 2 ) (e.g., guide wires, various types of catheters, including balloon catheters, stent delivery systems, stent retrievers, embolic coils, liquid embolization, suction pumps, devices for delivery of contrast media, drugs, hemostasis valve adapters, syringes, stopcocks, inflation devices, etc.) to allow a user or operator 11 to perform a catheter-based medical procedure via the robotic system by operating various controls, such as controls and inputs located at the control station 26. The bedside unit 20, and particularly the robotic drive 24, can include any number of components and / or combinations of components to provide the bedside unit 20 with functionality as described herein. The user or operator 11 at the control station 26 is referred to as a control station user or control station operator and is referred to herein as a user or operator. The user or operator at the bedside unit 20 is referred to as a bedside unit user or bedside unit operator. The robotic drive 24 includes a plurality of device modules 32a-d mounted on a rail or linear member 60 (shown in Figure 3 ). The rail or linear member 60 guides and supports the device modules. Each device module 32a-d can be used to drive an EMD, such as a catheter or guide wire. For example, the robotic drive 24 can be used to automatically feed a guide wire into a diagnostic catheter and guide catheter in an artery of the patient 12. One or more devices, such as EMDs, enter the patient 12's body (e.g., a blood vessel) at the insertion point 16 via, for example, a guide sheath.

[0066] Bedside unit 20 communicates with control station 26, allowing signals generated by user input via 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 (in... Figure 2 (as shown in the diagram) or connected to the bedside unit 20 via the control computing system 34. The bedside unit 20 can also provide feedback signals (e.g., load, speed, operating conditions, warning signals, error codes, etc.) to the control station 26, control computing system 34 (as shown in the diagram). Figure 2 (as shown in the diagram) 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 location (e.g., Figure 2 The local control station 38 shown) or at a remote location (e.g., Figure 2 The remote control station and computer system 42 shown in the diagram. The catheterization system 10 can be operated by a control station located at a local location, a control station located at a remote location, or both. At the local location, the user or operator 11 and the control station 26 are located in the same room as or adjacent to the patient 12 and the bedside unit 20. As used herein, the local location is the location of the bedside unit 20 and the patient 12 or subject (e.g., animal or cadaver), and the remote location is the location of the user or operator 11 and the control station 26 used to remotely control the bedside unit 20. The control station 26 (and control computing system) at the remote location and the bedside unit 20 and / or control computing system at the local location can be operated using a communication system and service 36 (in... Figure 2 (As shown in the figure), communication is conducted, for example, via the Internet. In embodiments, the remote location and the local (patient) location are geographically distant from each other, for example, in different rooms within the same building, in different buildings within the same city, in different cities, or the remote location does not require physical access to the bedside unit 20 and / or other different locations of the patient 12 at the local location.

[0067] The control station 26 generally includes one or more input modules 28 configured to receive user input to operate various components or systems of the catheter-based procedure system 10. In the illustrated embodiment, the control station 26 allows a user or operator 11 to control the bedside unit 20 to perform a catheter-based medical procedure. For example, the input modules 28 can be configured to cause the bedside unit 20 to perform various tasks (e.g., advance, retract, or rotate a guidewire; advance, retract, or rotate a catheter; inflate or deflate a balloon positioned on a catheter; position and / or deploy a stent; position and / or deploy a stent retriever; position and / or deploy a coil; inject contrast media into a catheter; inject a liquid embolization into a catheter; inject a drug or saline into a catheter; perform suction on a catheter; or perform any other function that can be performed as part of a catheter-based medical procedure) by using a percutaneous interventional device (e.g., an EMD) interfaced with the robotic drive 24. The robotic drive 24 includes various drive mechanisms to cause movement (e.g., axial and rotational movement) of components of the bedside unit 20, including the percutaneous interventional device.

[0068] In one embodiment, the input modules 28 can include one or more touchscreens, joysticks, wheels, and / or buttons. In addition to the input modules 28, the control station 26 can use additional user controls 44 (in Figure 2The input modules 28 can include buttons, such as foot pedals and microphones for voice commands, among others. The input modules 28 can be configured to advance, retract, or rotate various components and percutaneous interventional devices, such as guide wires and one or more catheters or microcatheters. The buttons can include, for example, an emergency stop button, a multiplier button, a device selection button, and an automatic move button. When the emergency stop button is pushed, power (e.g., electrical power) to the bedside unit 20 is disconnected or removed. When in a speed control mode, the multiplier button is used to increase or decrease the speed of the associated component in response to manipulative movement of the input module 28. When in a position control mode, the multiplier button changes the mapping between input distance and output command distance. The device selection button allows the user or operator 11 to select which percutaneous interventional device the input module 28 controls is loaded into the robotic drive 24. The automatic move button is used to enable algorithmic motion that the catheter-based procedure system 10 can perform on the percutaneous interventional device without direct commands from the user or operator 11. In one embodiment, the input modules 28 can include one or more controls or icons (not shown) displayed on a touch screen (which can or can not be part of the display 30) that, when activated, cause operation of components of the catheter-based procedure system 10. The input modules 28 can also include balloon or stent controls configured to inflate or deflate balloons and / or deploy stents. Each input module 28 can include one or more buttons, dials, joysticks, touch screens, etc. that can be used to control one or more specific components dedicated to that control. In addition, one or more touch screens can display one or more icons (not shown) related to portions of the input module 28 or components of the catheter-based procedure system 10.

[0069] The control station 26 can include a display 30. In other embodiments, the control station 26 can include two or more displays 30. The display 30 can be configured to display information or patient-specific data to the user or operator 11 located at the control station 26. For example, the display 30 can 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 therapy assessment data (e.g., IVUS, OCT, FFR, etc.). In addition, the display 30 can be configured to display procedure-specific information (e.g., procedure checklists, recommendations, procedure duration, catheter or guide wire position, volume of drug or contrast delivered, etc.). In addition, the display 30 can be configured to display information to provide functionality associated with the control computing system 34 (shown in Figure 2 FIG. 1). The display 30 can include touch screen capabilities to provide certain user input capabilities of the system.

[0070] The catheter-based surgical system 10 also includes an imaging system 14. The imaging system 14 can be any medical imaging system that can be used in conjunction with a catheter-based medical procedure (e.g., non-digital X-ray, digital X-ray, CT, MRI, ultrasound, etc.). In an exemplary embodiment, the imaging system 14 is a digital X-ray imaging device in communication with the control station 26. In one embodiment, the imaging system 14 can include a C-arm (shown in Figure 1 FIG. 1), which allows the imaging system 14 to be partially or completely rotated around the patient 12 in order to obtain images at different angular positions relative to the patient 12 (e.g., sagittal view, caudal view, anteroposterior view, etc.). In one embodiment, the imaging system 14 is a fluoroscopic system including a C-arm with an X-ray source 13 and a detector 15, also referred to as an image intensifier.

[0071] The imaging system 14 can be configured to acquire X-ray images of appropriate regions of the patient 12 during a procedure. For example, the imaging system 14 can be configured to acquire one or more X-ray images of the head in order to diagnose a neurovascular condition. The imaging system 14 can also be configured to acquire one or more X-ray images (e.g., real-time images) during a catheter-based medical procedure in order to assist the user or operator 11 of the control station 26 in properly positioning a guidewire, a guide catheter, a microcatheter, a stent retriever, a coil, a stent, a balloon, etc. during the procedure. The one or more images can be displayed on the display 30. For example, the images can be displayed on the display 30 to allow the user or operator 11 to accurately move a guide catheter or guidewire into the proper position.

[0072] For orientation purposes, a rectangular coordinate system with X, Y and Z axes is introduced. The positive X-axis is oriented in the longitudinal (axial) distal direction, i.e. in the direction from proximal to distal, in other words from proximal to distal. The Y and Z axes lie in a plane transverse to the X-axis, and the positive Z-axis points upward, i.e. in the direction opposite to gravity, and the Y-axis is determined by the right-hand rule.

[0073] Figure 2 is a block diagram of a catheter-based surgical system 10 according to an exemplary embodiment. The catheter-surgical system 10 can include a control computing system 34. The control computing system 34 can be physically, for example, the control station 26 (shown in Figure 1(As shown in the diagram) Part of the control computing system 34. The control computing system 34 may be generally an electronic control unit adapted to provide the various functions described herein to 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 to have the functions 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 system 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, the bed 18, the additional medical system 50, the contrast agent 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 described above, additional controls and displays may be located on the housing of the robot actuator 24. Interventional devices and accessories 48 (e.g., leads, 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 contrast agents, etc.) whose interfaces connect to their respective accessories 54, i.e., IVUS systems, OCT systems, and FFR systems, etc.

[0074] In various embodiments, the control computing system 34 is configured based on user and (e.g., control station 26) Figure 1 The interaction with input modules 28 (such as local control station 38 or remote control station 42) and / or the generation of control signals based on information available to the control computing system 34, as shown in the diagram, allows medical procedures to be performed using the catheter-based surgical system 10. Local control station 38 includes one or more displays 30, one or more input modules 28, and additional user controls 44. Remote control stations and computing systems 42 may include components similar to local control station 38. Remote control stations 42 and local control stations 38 can be different and customized based on their required functionality. Additional user controls 44 may include, for example, one or more foot input controls. Foot input controls can be configured to allow users 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, foot input devices can be configured to allow users to select which device is mapped to a wheel included in the input module 28. Additional communication systems 40 (e.g., audio conferencing, video conferencing, telepresence, etc.) can be used to help operators interact with patients, medical staff (e.g., angiography personnel) and / or bedside devices.

[0075] The catheter-based surgical system 10 can be connected to or configured to include any other systems and / or devices not explicitly shown. For example, the catheter-based surgical system 10 can include an image processing engine, a data storage and archiving system, an automated balloon and / or stent inflation system, a medical injection system, a medical tracking and / or recording system, user records, an encryption system, a system to limit access or use of the catheter-based surgical system 10, and the like.

[0076] As noted, the control computing system 34 is in communication with the bedside unit 20, which includes the robotic drive 24, the positioning system 22, and can include additional controls and displays 46, and can provide control signals to the bedside unit 20 to control the operation of the motors and drive mechanisms used to drive the percutaneous interventional devices (e.g., guide wires, catheters, etc.). Various drive mechanisms can be provided as part of the robotic drive 24. Figure 3 is an isometric view of a robotic drive for a catheter-based surgical system 10 according to an embodiment. In Figure 3 In the embodiment shown in FIG. 1, the robotic drive 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 mounted directly to the stages 62a-d. Each stage 62a-d can be independently actuated to move linearly along the linear member 60. Thus, each stage 62a-d (and the corresponding device module 32a-d coupled to the stage 62a-d) can move independently relative to each other and relative to the linear member 60. A drive mechanism is used to actuate each stage 62a-d. In the embodiment shown in FIG. 1, the drive mechanism includes a separate stage translation motor 64a-d coupled to each stage 62a-d and a stage drive mechanism 76, e.g., a lead screw via a rotating nut, a rack via a pinion, a belt via a pulley, a chain via a sprocket, or the stage translation motor 64a-d itself can be a linear motor. In some embodiments, the stage drive mechanism 76 can be a combination of these mechanisms, e.g., each stage 62a-d can use a different type of stage drive mechanism. In embodiments where the stage drive mechanism is a lead screw and rotating nut, the lead screw can be rotated and each stage 62a-d can engage and disengage the lead screw to move, e.g., advance or retract. In embodiments where the stage drive mechanism is a rack and pinion, the rack can be translated and each stage 62a-d can engage and disengage the rack to move, e.g., advance or retract. In embodiments where the stage drive mechanism is a belt and pulley, the belt can be translated and each stage 62a-d can engage and disengage the belt to move, e.g., advance or retract. In embodiments where the stage drive mechanism is a chain and sprocket, the chain can be translated and each stage 62a-d can engage and disengage the chain to move, e.g., advance or retract. Figure 3 In the embodiment shown in FIG. 1, the robotic drive 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 mounted directly to the stages 62a-d. Each stage 62a-d can be independently actuated to move linearly along the linear member 60. Thus, each stage 62a-d (and the corresponding device module 32a-d coupled to the stage 62a-d) can move independently relative to each other and relative to the linear member 60. A drive mechanism is used to actuate each stage 62a-d. In the embodiment shown in FIG. 1, the drive mechanism includes a separate stage translation motor 64a-d coupled to each stage 62a-d and a stage drive mechanism 76, e.g., a lead screw via a rotating nut, a rack via a pinion, a belt via a pulley, a chain via a sprocket, or the stage translation motor 64a-d itself can be a linear motor. In some embodiments, the stage drive mechanism 76 can be a combination of these mechanisms, e.g., each stage 62a-d can use a different type of stage drive mechanism. In embodiments where the stage drive mechanism is a lead screw and rotating nut, the lead screw can be rotated and each stage 62a-d can engage and disengage the lead screw to move, e.g., advance or retract. In Figure 3 In the embodiment shown in FIG. 1, the robotic drive 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 mounted directly to the stages 62a-d. Each stage 62a-d can be independently actuated to move linearly along the linear member 60. Thus, each stage 62a-d (and the corresponding device module 32a-d coupled to the stage 62a-d) can move independently relative to each other and relative to the linear member 60. A drive mechanism is used to actuate each stage 62a-d. In the embodiment shown in FIG. 1, the drive mechanism includes a separate stage translation motor 64a-d coupled to each stage 62a-d and a stage drive mechanism 76, e.g., a lead screw via a rotating nut, a rack via a pinion, a belt via a pulley, a chain via a sprocket, or the stage translation motor 64a-d itself can be a linear motor. In some embodiments, the stage drive mechanism 76 can be a combination of these mechanisms, e.g., each stage 62a-d can use a different type of stage drive mechanism. In embodiments where the stage drive mechanism is a lead screw and rotating nut, the lead screw can be rotated and each stage 62a-d can engage and disengage the lead screw to move, e.g., advance or retract. In

[0077] Each device module 32a-d includes a drive module 68a-d and a cartridge 66a-d mounted on and coupled to the drive module 68a-d. In Figure 3 the embodiment shown in FIG. 26, each cartridge 66a-d is mounted to the drive module 68a-d in a vertical orientation. In other embodiments, each cartridge 66a-d can be mounted to the drive module 68a-d in other mounting orientations. Each cartridge 66a-d is configured to interface with and support a proximal portion of an EMD (not shown). In addition, each cartridge 66a-d can include elements that provide one or more degrees of freedom in addition to linear motion along the linear member 60 provided by actuation of the corresponding stage 62a-d. For example, the cartridge 66a-d can include elements that can be used to rotate the EMD when the cartridge is coupled to the drive module 68a-d. Each drive module 68a-d includes at least one coupler to provide a drive interface to mechanisms in each cartridge 66a-d to provide additional degrees of freedom. Each cartridge 66a-d also includes a channel within which a device support 79a-d is positioned, and each device support 79a-d is used to prevent the EMD from buckling. Support arms 77a, 77b, and 77c are attached to each device module 32a, 32b, and 32c, respectively, to provide a fixed support point for the proximal end of the device support 79b, 79c, and 79d, respectively. The robotic drive 24 can also include a device support connection 72 that is connected to the device support 79, the distal support arm 70, and the support arm 77o. The support arm 77o is used to provide a fixed support point for the proximal end of the distal-most device support 79a housed in the distal-most device module 32a. In addition, a guide interface support (repositioner) 74 can be connected to the device support connection 72 and the EMD (e.g., a guide sheath). The configuration of the robotic drive 24 has the advantage of reducing the volume and weight of the drive robotic drive 24 by using actuators on a single linear member.

[0078] To prevent contamination of the patient by pathogens, the medical staff uses sterile technique in the room containing the bedside unit 20 and the patient 12 or subject (shown in Figure 1 FIG. 26). The room containing the bedside unit 20 and the patient 12 can be, for example, a catheterization lab or an angiography lab. Sterile technique includes the use of sterile barriers, sterile equipment, proper patient preparation, environmental controls, and contact guidelines. Thus, all EMDs and interventional accessories are sterilized and only able to be contacted by sterile barriers or sterile equipment. In embodiments, a sterile drape (not shown) is placed over the non-sterile robotic drive 24. Each cartridge 66a-d is sterilized and used as a sterile interface between the draped robotic drive 24 and at least one EMD. Each cartridge 66a-d can be designed to be sterilized for single use, or sterilized in whole or in part for repeated use so that the cartridge 66a-d or components thereof can be used in multiple procedures.

[0079] Definitions and Terminology

[0080] EMD: The term elongated medical device (EMD) refers to, but is not limited to, catheters (e.g., guide catheters, microcatheters, balloon / stent catheters), wire-based devices (e.g., guide wires, embolic coils, stent retrievers, etc.), and medical devices comprising any combination thereof.

[0081] Load: The term load refers to a force, a torque, or a combination of force and torque. A load can include a single component of force (force along a single axis) or multiple components of force (multi-axis force) and / or a single component of torque (torque about a single axis) or multiple components of torque (multi-axis torque). A load can be static (not changing with time) or dynamic (changing with time).

[0082] Force: The term force refers to a factor that causes or attempts to cause motion of an object. A force acting on an object can change the motion of the object, stop the motion of the object, balance a force already acting on the object, and cause internal stresses in the object. Characteristics of a force include the magnitude of the force, the line of action of the force (the axis along which the force acts), the direction of the force (corresponding to a pressure or a tensile force), and the point of action of the force.

[0083] Torque: The term torque refers to a factor that causes or attempts to cause rotational motion of a physical object. A torque acting on an object can change the rotational motion of the object, stop the rotational motion of the object, balance a torque already acting on the object, and cause internal stresses in the object. Characteristics of a torque include the magnitude of the torque, the line of action of the torque, the direction of the torque (clockwise or counterclockwise about the line of action), and the point of action of the torque. The term torque also refers to moment, moment of force, rotational force, torsion, and "turning effect." A torque is a rotational equivalent of a force. The magnitude of a torque can also be determined as the product of the magnitude of the force and the perpendicular distance from the line of action of the force to the axis of rotation.

[0084] Control computing system: The term control computing system includes a processor having processing circuitry. The processor includes a central processing unit, an application-specific processor (ASIC), a circuit containing one or more processing components, a distributed set of processing components, a distributed set of computers configured to process, and the like, configured to provide the functionality of the modules or sub-system components discussed herein. A memory unit (e.g., a memory device, a storage device, and the like) is a device for storing data and / or computer code for completing and / or assisting with the various processes described in the present disclosure. The memory unit can include volatile memory and / or non-volatile memory. The memory unit can include a database component, a table component, a calendar component, and / or any other type of information structure for supporting the various activities described in the present disclosure. According to an example embodiment, any distributed and / or local memory device, past, present, or future, can be used with the systems and methods of the present disclosure. According to an example embodiment, the memory unit is communicably connected to one or more associated processing circuitries. This connection can be via circuitry or any other wired, wireless, or network connection and includes computer code for performing one or more processes described herein. A single memory unit can include various individual memory devices, chips, disks, and / or other storage structures or systems. The modules or sub-system components can be computer code (e.g., object code, program code, compiled code, script code, executable code, or any combination thereof) for performing the respective functions of each module.

[0085] Distal and proximal: The terms distal and proximal define the relative positions of two different features. With respect to a robotic drive, the terms distal and proximal are defined by the position of the robotic drive relative to the patient in its intended use.

[0086] When used to define a relative position, a distal feature is a feature of the robotic drive that is closer to the patient than a proximal feature when the robotic drive is in its intended use position. Within a patient, any blood vessel marker that is further along the path from the point of entry into the patient is considered more distal than a marker that is closer to the point of entry, where the point of entry is the point at which the EMD enters the patient. Similarly, a proximal feature is a feature of the robotic drive that is further from the patient than a distal feature when the robotic drive is in its intended use position.

[0087] When used to define a direction, a distal direction refers to the path along which something is moving or intended to move, or the path along which something is pointed or directed from a proximal feature to a distal feature and / or the patient when the robotic drive is in its intended use position. A proximal direction is the opposite direction from the distal direction. With reference to Figure 1 The robotic device is shown from the perspective of a patient-facing operator. In this arrangement, the distal direction is along the positive X coordinate axis and the proximal direction is along the negative X coordinate axis. With reference to Figure 3EMD is moved in a distal direction on a path through the guide interface support 74 defining the distal end of the robotic drive 24 toward the patient. The proximal end of the robotic drive 24 is the point farthest from the distal end along the negative X-axis.

[0088] Longitudinal axis: The term longitudinal axis of a member (e.g., an EMD or other element in a catheter-based surgical system) is a line or axis along the length of the member that passes through the center of the member cross-section in a direction from a proximal portion of the member to a distal portion of the member. For example, the longitudinal axis of a guidewire is a central axis in a direction from a proximal portion of the guidewire to a distal portion of the guidewire, although the guidewire can be non-linear over the relevant portions.

[0089] Axial and rotational motion: The term axial motion of a member refers to translation of the member along its longitudinal axis. An EMD is being advanced when its distal end is being moved axially in a distal direction into or further into the patient along its longitudinal axis. An EMD is being retracted when its distal end is being moved axially in a proximal direction out of or further out of the patient along its longitudinal axis. The term rotational motion of a member refers to a change in angular orientation of the member about its local longitudinal axis. Rotational motion of an EMD corresponds to clockwise or counterclockwise rotation of the EMD about its longitudinal axis due to an applied torque.

[0090] Axial and lateral insertion: The term axial insertion refers to inserting a first member into a second member along the longitudinal axis of the second member. The term lateral insertion refers to inserting a first member into a second member along a direction in a plane perpendicular to the longitudinal axis of the second member. This can also be referred to as radial loading or lateral loading.

[0091] Pinch / Unpinch: The term pinch refers to releasably securing an EMD to a member so that the EMD moves with the member when the member moves. The term unpinch refers to releasing an EMD from a member so that the EMD moves independently of the member when the member moves.

[0092] Clamp / Unclamp: The term clamp refers to releasably securing an EMD to a member so that motion of the EMD is constrained relative to the member. The member can be secured relative to a global coordinate system or relative to a local coordinate system. The term unclamp refers to releasing an EMD from a member so that the EMD can move independently.

[0093] Grip / Ungrip: The term grip refers to the application of force or torque by a drive mechanism to an EMD that results in motion of the EMD without slippage in at least one degree of freedom. The term un-grip refers to the release of the force or torque applied by the drive mechanism to the EMD so that the position of the EMD is no longer constrained. An EMD that is gripped between two tires rotates about its longitudinal axis when the two tires move longitudinally relative to each other. The rotational motion of the EMD is distinct from the motion of the two tires. The position of the gripped EMD is constrained by the drive mechanism.

[0094] Flex: The term flex refers to an attempt by a flexible EMD to bend away from the longitudinal axis or intended path along which it is being advanced when under axial compression. In one embodiment, axial compression occurs in response to resistance from navigating in a vasculature. The distance that an EMD can be driven unsupported along its longitudinal axis before the EMD flexes is referred to herein as the device flex distance. The device flex distance is a function of the rigidity of the device, the geometry including but not limited to the diameter, and the force applied to the EMD. Flexing can result in the EMD taking an arc that is different from the intended path. Kinking is a case of flexing in which the deformation of the EMD is inelastic, resulting in permanent deformation.

[0095] Home: The term home refers to moving a member to a defined position. An example of a defined position is a reference position. Another example of a defined position is an initial position. The term home position refers to a defined position. It is often used as a reference for subsequent linear or rotational positions.

[0096] Top / Bottom, Upper / Lower, Front / Back, Inward / Outward: The terms top, upper, and superior refer to the general direction away from the direction of gravity, and the terms bottom, lower, and inferior refer to the general direction in the direction of gravity. The term front refers to the side of a robotic drive that faces the bedside user and is away from a positioning system such as an articulated arm. The term back refers to the side of a robotic drive that is closest to a positioning system such as an articulated arm. The term inward refers to an interior portion of a feature. The term outward refers to an exterior portion of a feature.

[0097] Table: The term table refers to a member, feature, or device that is used to couple a device module to a robotic drive. For example, a table can be used to couple a device module to a rail or linear member of a robotic drive.

[0098] Drive Module: The term drive module generally refers to a portion (e.g., a major portion) of a robotic drive system that typically contains one or more motors with drive couplings that interface with a cassette.

[0099] Device Module: The term device module refers to the combination of a drive module and a cassette.

[0100] Cartridge: The term cartridge generally refers to the portion of the robotic drive system that is typically a drive module and at least one EMD (directly) or through a device adapter (indirectly) that is a sterile interface (non-essential, consumable or sterilizable unit).

[0101] Collet: The term collet refers to a device that can releasably secure a portion of an EMD. The term secure in this context means that there is no intentional relative motion between the collet and the EMD during operation. In one embodiment, the collet includes at least two members that move relative to each other rotationally to releasably secure the EMD to at least one of the members. In one embodiment, the collet includes at least two members that move relative to each other (along a longitudinal axis) axially to releasably secure the EMD to at least one of the members. In one embodiment, the collet includes at least two members that move relative to each other rotationally and axially to releasably secure the EMD to at least one of the members.

[0102] Secure: The term secure means that there is no intentional relative motion of the first member with respect to the second member during operation.

[0103] On-Device Adapter: The term on-device adapter refers to a sterile device that can releasably clamp an EMD to provide a drive interface. The on-device adapter is also referred to as an end effector or EMD capture device. In one non-limiting embodiment, the on-device adapter is a collet that is robotically controlled to cause the EMD to rotate about its longitudinal axis, clamp and / or unclamp the EMD to the collet, and / or cause the EMD to translate along its longitudinal axis. In one embodiment, the on-device adapter is a hub-drive mechanism, such as a driven gear on the hub of the EMD.

[0104] Tandem Drive: The term tandem drive refers to a drive unit or subsystem within a robotic drive that contains two or more EMD drive modules that can manipulate one or more EMDs.

[0105] Hub (proximal) drive: The term hub drive or proximal drive refers to grasping and manipulating an EMD from a proximal location (e.g., a gear adapter on the hub of a catheter). In one embodiment, hub drive refers to applying a force or torque to the hub of a catheter to cause the catheter to translate and / or rotate. Hub drive can cause the EMD to buckle and thus hub drive typically requires an anti-buckling feature. For devices that do not have a hub or other interface (e.g., a guidewire), a device adapter can be added to the device to serve as an interface for the device module. In one embodiment, the EMD does not include any mechanism to manipulate features within the catheter, such as a wire that extends from a handle to the distal end of the catheter to deflect the distal end of the catheter.

[0106] Shaft (distal) drive: The term shaft (distal) drive refers to holding and manipulating the EMD along its shaft. The on-device adapter is typically located proximal to the hub or Y-connector into which the device is inserted. If the on-device adapter is located near the point of insertion (into the body or another catheter or valve), shaft drive typically does not require an anti-kink feature. (It can include an anti-kink feature to improve driveability.)

[0107] Sterilizable unit: The term sterilizable unit refers to equipment that can be sterilized (free of pathogenic microorganisms). This includes, but is not limited to, a cassette, a consumable unit, a drape, a device adapter, and a sterilizable drive module / unit (which can include electromechanical components). A sterilizable unit can contact a patient, other sterile devices, or anything placed in the sterile field of a medical procedure.

[0108] Sterile interface: The term sterile interface refers to the interface or boundary between a sterile and a non-sterile unit. For example, a cassette can be a sterile interface between a robotic drive and at least one EMD.

[0109] Reset (drive mechanism reset): The term reset means repositioning the drive mechanism from a first position to a second position to allow continued rotation and / or axial movement of the EMD. During the reset, the drive mechanism is not actively moving the EMD. In one embodiment, the drive mechanism releases the EMD prior to repositioning the drive mechanism. In one embodiment, the clamp secures the position of the EMD during repositioning of the drive mechanism.

[0110] Continuous motion: The term continuous motion refers to motion that does not require a reset and is uninterrupted. Wheel drive linear motion is continuous motion.

[0111] Discrete motion: The term discrete motion refers to motion that requires a reset and is interrupted. Paddle drive linear motion is discrete motion.

[0112] Consumable: The term consumable refers to a sterilizable unit that is typically used once in a medical procedure. The unit can be a reusable consumable that is used in another medical procedure by a re-sterilization process.

[0113] Device support: The term device support refers to a means, feature, or device that prevents kinking of the EMD.

[0114] Double Gears: The term double gears refers to two independent driven gears operably connected to two different parts of the device. Each of the two gears has the same or different design. The term gear can be a bevel gear, a spiral bevel gear, a spur gear, a helical gear, a worm gear, a helical gear, a rack and pinion, a screw gear, an internal gear such as a bull gear, a involute spline shaft and bushing or any other type of gear known in the art. In one embodiment, double gears also include devices in which any driving connection is maintained through two different parts of the device, including but not limited to belts, frictional engagement or other couplings known in the art.

[0115] Load Sensor: The term load sensor refers to a sensor that measures one or more components of force and / or torque. For example, a single axis load sensor measures force along one axis or torque about one axis. A multi-axis load sensor measures force and / or torque in multiple mutually orthogonal axes. Load sensors typically generate an electrical signal in response to a load (e.g., a load sensor based on a strain gauge produces an electrical charge in response to a load) and typically require signal conditioning circuitry to convert the signal into force and / or torque. Thus, a load sensor is a transducer that converts one or more components of compressive and / or tensile force and / or clockwise and / or counter-clockwise torque into a measurable electrical output (e.g., voltage or current).

[0116] Motion Sensor: The term motion sensor refers to a sensor that detects a parameter of motion. Contact motion sensors include but are not limited to accelerometers, LVDTs, encoders. Non-contact motion sensors include but are not limited to CMOS sensors, optical encoders, ultrasonic sensors, standard or high speed cameras.

[0117] Zero Offset: The term zero offset refers to the bias of a load sensing system's measurement of load that indicates an apparent load when no load is applied. The process of sensor calibration corrects for zero offset so that the load sensing system indicates zero load when no load is applied.

[0118] Overload Protection: The term overload protection refers to any means of preventing a load sensor from being overloaded, that is, exposed to a force that exceeds the working range of the sensor or damaged due to a load exceeding the upper limit of the sensor's measurement specification.

[0119] Automatic Calibration: The term automatic calibration or automated calibration or auto-calibration refers to any means of calibration of a sensor or sensor system that occurs without human intervention. In automatic calibration, a known load (i.e., a load that is accurately known through another method) can be applied to a load sensor or load sensing system by non-manual means (such as a driven motor shifting a known rigid elastic member) and a processor is used to correct for any errors.

[0120] Load Sensing

[0121] To sense forces and torques acting on a mechanical component having an elongated cylindrical portion, sensors are placed in-line with the elongated cylindrical portion or strain gauges are attached to the elongated cylindrical portion. In interventional catheter and guidewire systems where the elongated cylindrical device is an elongated medical device (EMD), it can be desirable to measure forces and torques (hereafter referred to as loads) outside the patient where the sensors are not in-line with or attached to the EMD. Measuring forces outside the patient does not require placing sensors and associated electronics (e.g., cables) inside the blood vessel. While it is possible to place load sensors inside the blood vessel, for example, for larger diameter EMDs (e.g., some EP (electrophysiology) catheters having > 2 mm diameter), it can be desirable to measure loads without requiring placement of sensors inside the blood vessel when using smaller diameter EMDs with diameters between 0.2 mm and 2 mm. In manual procedures, the physician relies on his / her fingers to estimate the loads. However, since the range of forces and torques carried by the EMDs is small, it is difficult for the physician to accurately estimate the loads when the device diameter is small.

[0122] In robotic systems, it is possible to measure forces and torques acting on the EMD by using load sensors inside the robotic drive mechanism. By placing sensors inside the drive mechanism, parasitic forces and torques due to friction and inertial effects can corrupt (e.g., add to) the actual values and thereby possibly degrade the accuracy of the force and torque measurements in the EMD. Here, methods and designs are presented to implement load sensing in robotic vascular interventional systems while reducing the parasitic loads acting on the load sensors. In other words, the load sensing components are isolated from the parasitic loads so that the difference between the measured loads and the actual loads is minimized.

[0123] The load sensing systems described herein can be used in combination with the systems described in the following co-pending applications, which are entitled SYSTEMS, APPARATUS AND METHODS FOR SUPPORTING AND DRIVING ELONGATED MEDICAL DEVICES IN A ROBOTIC CATHETER-BASED PROCEDURE SYSTEM, having U.S. Provisional Application No. 62 / 874,222, filed July 15, 2019. Floating cartridge members are described herein. Buckling prevention support systems (stretchy supports, accordion-type members, fixed sheaths, etc.) used in collet drives and tubing systems can exert unexpected forces (parasitic forces) on the disposable components that can mix with (or be added to) the actual forces acting on the EMD in the load sensing measurements.

[0124] Reference is made to Figure 3 andFigure 4A-4D The device module 32 of the robot actuator 24 includes a drive module 68 and a housing 66 separated by a sterile barrier 100. In one embodiment, the sterile barrier 100 is a flexible curtain. In another embodiment, the sterile barrier 100 is a rigid sterile barrier, such as a box. In one embodiment, the drive module 68 is the main part of the device module 32, and the housing 66 and the sterile barrier 100 are disposable parts of the device module 32. The robot drive system enables the EMD 102 to move linearly along the longitudinal axis of the EMD and / or rotate about the longitudinal axis of the EMD. Linear (advance, retraction) motion and rotational (clockwise, counterclockwise) motion are the primary degrees of freedom (DOF) of the EMD 102. Additional DOFs may exist, for example, to clamp / release the EMD 102 in a collet or to pull out a self-expanding support.

[0125] The cassette 66 includes a housing 104 and a floating member 106 movable within and / or relative to the housing 104. In one embodiment, the floating member 106 is isolated from the housing 104 such that it is not fixed to the housing 104. In one embodiment, the floating member 106 is connected to a tube 110 that can be used to introduce saline, contrast agents, etc. In one embodiment, the tube 110 is connected to a hub of a Y-connector or conduit, wherein the tube 110 is anchored to the housing 104. In one embodiment, the cassette 66 is a disposable unit, wherein the housing 104, the floating member 106, and the tube 110 are disposable components.

[0126] EMD 102 is actuated by a mechanism (described below) within floating component 106. Floating component 106 is isolated from external loads other than the actual load acting on EMD 102. In one embodiment, floating component 106 of cartridge 66 is attached to housing 104 of cartridge 66, for example, by using a flexible membrane 108. In another example, floating component 106 of cartridge 66 is held together with housing 104 of cartridge 66 by using guide and slider interfaces. (See...) Figure 6B (See attached figures 150-151 and 156-157).

[0127] In one embodiment, the flexible membrane 108 does not apply a significant load to the floating member 106 in the load measurement direction. For example, the load applied by the flexible membrane 108 to the floating member 106 is less than 10% of the range of the load being measured.

[0128] In one embodiment, the float component 106 is captured, i.e., housed, in the housing 104 of the cassette 66, such that the two components of the cassette 66 (the cassette housing 104 and the float component 106) can move together and be mounted together on the drive module 68. Once mounted on the drive module 68, the float component 106 becomes non-contacting with respect to the housing 104 of the cassette 66, such that no load is applied from the housing 104 of the cassette 66 to the float component 106. This feature is described in detail in the application with U.S. Provisional Application No. 62 / 874,222, entitled SYSTEMS, APPARATUS AND METHODS FOR SUPPORTING AND DRIVING ELONGATED MEDICAL DEVICES IN A ROBOTIC CATHETER-BASED PROCEDURE SYSTEM, filed July 15, 2019.

[0129] Referring to Figure 3 , Figure 4A-4D and Figure 5D , in one embodiment, the linear DOF motion of the EMD 102 is achieved by moving the device module 32 along the table drive mechanism 76 while the EMD 102 is captured by an EMD-on-device adapter 112 that is integrally connected to the float component 106 of the cassette 66. The EMD-on-device adapter 112 is also referred to as an end effector or EMD capture device. In one embodiment, the EMD-on-device adapter 112 is a collet. In one embodiment, the EMD-on-device adapter 112 is a hub driver. In one embodiment, the table drive mechanism 76 is a lead screw, and the drive module 68 includes a table translation motor 64 that rotates a nut on the lead screw using a belt 114. The nut contacts the drive module 68 through two thrust bearings, and as the nut rotates on the lead screw, it translates the device module 32. The drive module 68 is constrained to move only linearly with respect to the table drive mechanism 76 by a guide.

[0130] The drive module 68 includes a drive module base component 116 and a load sensing component 118. The load sensing component 118 supports the float component 106 in at least one load measurement direction, and the load sensing component 118 is supported in the at least one load measurement direction by a load sensor 120 that is connected to the drive module base component 116. In one embodiment, the drive module 68 is a primary unit that makes the drive module base component 116, the load sensing component 118, and the load sensor 120 primary components.

[0131] In one embodiment, cable 122 is connected to load sensing component 118, where, for example, cable 122 contains wires to power the actuator or transmit signals to / from an encoder (e.g. Figure 14A and Figure 4C In one embodiment, cable 122 connected to load sensing component 118 is anchored on drive module base component 116 to prevent cable 122 from dragging on load sensing component 118. In one embodiment, cable 122 is connected to load sensing component 118 through an internal cavity in drive module base component 116. In one embodiment, cable 122 comprises separate cables, for example, a first portion is a cable connected to a connector on drive module base component 116, and a second portion is a separate cable connecting the connector on drive module base component 116 to load sensing component 118, where the second cable does not exert a significant load on load sensing component 118 in the load measurement direction. In one example, a load exerted by the second cable is not considered significant if it is less than 10% of the entire range of the load being measured.

[0132] In one embodiment, load sensing component 118 can be fully supported by load sensor 120. However, the load capacity of load sensor 120 against off-axis loads (e.g., force components acting along an axis other than the measurement axis, which is shown as the X-axis in the figures) can be insufficient to bear the loads of load sensing component 118 such as weight or inertial forces. Typically, the structural strength of a load sensor is proportional to the load measurement range of the sensor. Because the range of loads acting on EMD 102 can be significantly less than the weight or inertial forces of load sensing component 118, load sensor 120 can be overloaded and damaged if the weight and / or inertial forces are fully supported by the sensor. One method of supporting off-axis loads includes using a load sensor 120 with greater structural strength in the off-axis direction capable of supporting high off-axis loads. For example, in one embodiment, load sensor 120 is a flexure beam sensor with these characteristics.

[0133] In one embodiment, off-axis loads are supported by additional components such as bearing supports. Bearing supports can be used to support only off-axis loads without exerting a load in the measurement direction.

[0134] In an embodiment, load sensing can be accomplished indirectly, i.e., without explicitly using a load sensor 120. For example, in an embodiment, load sensing can be accomplished by measuring the current of the electric actuator, which can be related to the force and / or torque exerted by the actuator. In an embodiment, load sensing can be accomplished by measuring a physical property of the actuator, such as pressure, which can be related to the force and / or torque exerted. In an embodiment, the relationship between the physical property and the load can be determined by experimental calibration. In an embodiment, the relationship between the physical property and the load can be determined by a mathematical model or equation.

[0135] In an embodiment, the entire drive module 68 is load-sensed. As an example, the entire drive module 68 can be connected to the table 62 by a load sensor 120, and the load sensor 120 supports the drive module 68 in at least one direction (load measurement direction). In an embodiment, the load sensor 120 is located inside the drive module 68 in order to eliminate parasitic load sources from the load sensing components 118 and to reduce parasitic loads such as frictional loads, inertial loads, gravitational loads, etc. that corrupt the measurement of the actual load acting on the EMD 102 during measurement.

[0136] The load sensing system includes a processor (processing unit) that receives one or more signals representative of the measured load from the load sensor.

[0137] The load sensing system includes a method of correcting for parasitic loads acting on the load sensing components 118 due to parasitic load sources in the drive system, such as parasitic loads from the drive module 68, the cassette 66, the cable 122, the tubing 110, and the sterile barrier 100, that corrupt the actual load. In an embodiment, the sterile barrier 100 includes a drape. The method includes characterizing and / or measuring the parasitic loads, such as inertial loads, gravitational loads, frictional loads, and resistance loads. Resistance loads refer to loads due to the cable and / or tubing system and / or other components exerting resistive loads on the load sensing components 118. Frictional loads include, but are not limited to, frictional losses in the drive train, such as in the gears, belts, sliding components, seals. The actual force F actual and the actual torque T actual are determined as follows, respectively:

[0138] F actual = F seased - F inertia - F gravity - F friction - F drag (1)

[0139] Tactual = T seased - T inertia - T gravity - T friction - T drag (2)

[0140] where F inertia , F gravity , F friction and F drag represent parasitic inertia, gravity, friction and resistance, respectively, and T inertia , T gravity , T friction and T drag represent parasitic inertia, gravity, friction and resistance torques, respectively. F sensed and T sensed refer to the force and torque measured by a load sensor connected to the load sensing component.

[0141] With reference to the load sensing concepts discussed above Figure 4A-4D , in the indicated load sensing concept, the device module 32 comprises a drive module 68 comprising a drive module base component 116 and a load sensing component 118. The EMD 102 is removably coupled to an isolation component 106. The isolation component 106 is also referred to as an isolation interface component, as it provides an interface between the load sensing component 118 and the EMD 102. As used herein, the isolation component is also referred to as a floating member or floating component. The isolation component 106 is isolated from loads other than the actual load acting on the EMD 102. The isolation component 106 is removably coupled to the load sensing component 118. A load sensor 120 fixed to the drive module base component 116 and the load sensing component 118 senses the actual load acting on the EMD 102.

[0142] In an embodiment, the load sensor 120 is the only support for the load sensing component 118 in at least one load measurement direction. In an embodiment, the cartridge housing 104 and the isolation component 106 are internally connected such that they form one component. In an embodiment, the flexible membrane 108 connects the cartridge housing 104 and the isolation component 106, wherein the flexible membrane 108 exerts negligible forces on the isolation component 106 in the X direction (device direction). In an embodiment, the flexible membrane 108 is not a physical membrane and represents a cartridge interface.

[0143] With reference to the load sensing concepts discussed above Figure 4AThe device module 32 includes a load sensing component 118 entirely supported by the load sensor 120. In one embodiment, the load sensor 120 is a single-axis sensor that measures the reaction force to determine the actual force on the EMD 102. In one embodiment, the load sensor 120 is a multi-axis sensor that measures the components of the reaction load to determine the corresponding actual force and torque on the EMD 102. In one embodiment, there is no actuator for rotating the EMD 102 or clamping / releasing the EMD 102. In one embodiment, there is at least one actuator (not shown) for rotating the EMD 102 and / or clamping / releasing the EMD 102 located inside or integrally connected to the load sensing component 118.

[0144] refer to Figure 4B Device module 32 with load sensing system Figure 4A Another embodiment is shown with the additional feature that at least one actuator used for rotating EMD 102 and / or clamping / releasing is positioned outside the load sensing element 118. In one embodiment, the actuator 124 is moved from inside the load sensing element 118 to outside the load sensing element 118 to reduce parasitic loads (such as inertial loads) that may be applied to the load sensing element 118 by the actuator.

[0145] In one embodiment, power is transmitted from an actuator 124 located outside the load sensing component 118 via a power system to a drive component located inside the load sensing component (e.g., a pulley and / or winch used in a disposable device adapter within a drive housing), which does not apply a load to the load sensor 120 in the load measurement direction. In another embodiment, power is transmitted from the actuator 124 located outside the load sensing component 118 to the drive component located inside the load sensing component 118 using a belt 126 perpendicular to the load measurement direction. In another embodiment, power is transmitted from the actuator 124 located outside the load sensing component 118 to the drive component located inside the load sensing component 118 by other means, such as using a chain, cable, or thread perpendicular to the load measurement direction. In yet another embodiment, power is transmitted from the actuator 124 to an adapter 112 on the EMD device via a drive system that applies a load to the load sensor 120 in the load measurement direction, wherein the load can be corrected to determine the actual load on the EMD 102. In one embodiment, actuator 124 includes a second load sensor, such as torque sensor 125, to measure the reaction torque between actuator 124 and drive module base component 116. In one embodiment, actuator 124 includes an encoder for device angular position feedback.

[0146] In one embodiment, load sensor 120 is a force sensor, such as a bending beam force sensor, to measure the force acting on EMD 102. In one embodiment, load sensor 120 is a multi-axis sensor used to measure the force and torque acting on EMD 102. In one embodiment, the centerline of the power train (e.g., belt, cable, chain, etc.) used to transmit power from actuator 124 used to rotate or clamp / unclamp EMD 102 to load sensing component 118 coincides with the axis of load sensor 120, such that pre-tension in the power train does not impart torque to the torque sensor in the direction of torque measurement. In another embodiment, the power train is parallel to the EMD proximal portion engaged in floating component 106, such that pre-tension in the power train does not impart torque in the direction of torque measurement.

[0147] In one embodiment, load sensor 120 is used in the power train between actuator 124 used to rotate or clamp / unclamp EMD 102 and adapter 112 on the EMD device to determine the force acting on EMD 102 and / or the torque applied to clamp / unclamp the collet. In one embodiment, load sensor 120 is located between actuator 124 and drive module base component 116 to determine the torque acting on EMD 102 and / or the torque applied to clamp / unclamp the collet.

[0148] Referring to Figure 4C , another embodiment of device module 32 with a load sensing system is shown with additional features including a bearing 128 to support load sensing component 118 in at least one non-measurement direction. In other words, bearing support 128 does not load in the measurement direction. Referring to Figure 4A , in one embodiment, bearing support 128 is a linear bearing (pointing in the plane) that supports load sensing component 118 in all directions except the force measurement direction. Figure 4C

[0149] Referring to Figure 4D , another embodiment of device module 32 with a load sensing system is shown with additional features including a bearing 128 to support load sensing component 118 in at least one non-measurement direction. In other words, bearing support 128 does not load in the measurement direction. Referring to Figure 4A , in one embodiment, bearing support 128 is a linear bearing (pointing in the plane) that supports load sensing component 118 in all directions except the force measurement direction. Figure 4B Figure 4C Referring to Figure 4D , another embodiment of device module 32 with a load sensing system is shown with additional features including a bearing 128 to support load sensing component 118 in at least one non-measurement direction. In other words, bearing support 128 does not load in the measurement direction. Referring to , in one embodiment, bearing support 128 is a linear bearing (pointing in the plane) that supports load sensing component 118 in all directions except the force measurement direction.

[0150] Referring to​Figure 5A , Figure 5B and Figure 5C , showing a drive module 68 with a load sensing system. The drive module 68 includes a drive module base component 116 and a load sensing component 118 as separate pieces that are connected by a load sensor 120 located between the drive module base component 116 and the load sensing component 118. The bearings 128 of the load sensing component 118 support the load sensing component in at least one off-axis (unmeasured) direction.

[0151] Referring to Figure 5B , the drive module 68 with a load sensing system includes an actuator 124 located outside of the load sensing component 118 (which is used to rotate and / or clamp / unclamp the EMD 102). In one embodiment, the actuator 124 causes a first pulley to rotate, which causes a belt 126 to rotate, which causes a coupler 130 that enables engagement and disengagement of the cartridge 66 to rotate.

[0152] Referring to Figure 5A , Figure 5B , Figure 5C , Figure 5G and Figure 5H , in one embodiment, the drive module base component 116 includes the load sensing component 118 and the load sensor 120. As discussed above, the drive module 68 includes a drive module base component 116 and a load sensing component 118 as separate pieces that are connected by a load sensor 120 located between the drive module base component 116 and the load sensing component 118. The bearings 128 of the load sensing component 118 support the load sensing component in at least one off-axis (unmeasured) direction. The load sensing component 118 is located within the drive module base component 116 and is secured to the drive module base component 116 with the load sensor 120. In one embodiment, the load sensor 120 includes a first portion that is secured to the drive module base component 116 using a first fastener 115 and a second portion that is secured to the load sensing component 118 using a second fastener 119. In one embodiment, the first portion of the load sensor 120 is different than and distinct from the second portion of the load sensor 120. In one embodiment, the first fastener 115 and the second fastener 119 are bolts. In one embodiment, the first fastener 115 and the second fastener 119 are mechanical fastening components known in the art for securing mechanical connections. In one embodiment, the first fastener 115 and the second fastener 119 are replaced with adhesive means for securing mechanical connections. In one embodiment, the first fastener 115 and the second fastener 119 are magnets.

[0153] Referring to Figure 5Dwith a load sensing system is shown connected to the cassette 66 and the EMD 102. Rotation of the coupler 130 causes the on-EMD adapter 112 to rotate so as to rotate and / or clamp / unclamp the EMD 102, as described below.

[0154] The cassette 66 includes a cassette housing 104. The cassette housing 104 includes a cradle 132 that is configured to receive the on-EMD adapter 112 with the EMD 102. A cassette pinion 134 in the cassette housing 104 is freely rotatable about an axis that is aligned with the coupler axis 131 about which the coupler 130 of the drive module 68 rotates. In the assembled device module 32, the cassette 66 is positioned on a mounting surface of the drive module 68 so that the cassette pinion 134 receives the coupler 130 along the coupler axis 131 so that it is freely engaged and disengaged along the coupler axis 131 and integrally connected (not freely) about the coupler axis 131 so that rotation of the coupler 130 is identically corresponded to rotation of the cassette pinion 134. In other words, if the coupler 130 is rotated clockwise at a given speed, the cassette pinion 134 is rotated clockwise at the same given speed, and if the coupler 130 is rotated counterclockwise at a given speed, the cassette pinion 134 is rotated counterclockwise at the same given speed.

[0155] When the on-EMD adapter 112 is seated in the cradle 132 of the cassette housing 104, the cassette pinion 134 engages a driven pinion 136 that is integrally connected to the on-EMD adapter 112. In one embodiment, Figure 5D In an embodiment where the EMD 102 is a guidewire and the on-EMD adapter 112 is a collet, when power is transmitted from the coupler 130 of the drive module 68 to the cassette pinion 134, the cassette pinion 134 engages the driven pinion 136 on the collet to rotate the guidewire.

[0156] Referring to Figure 5D The device support 79 is positioned in a channel 138 in the cassette housing 104. The device support 79 and the cassette 66 are configured to move relative to one another. Details are provided in patent application 62 / 874,247 (U.S. provisional application number 62 / 874,247, filed July 15, 2019), entitled SYSTEMS, APPARATUS AND METHODS FOR ROBOTIC INTERVENTIONAL PROCEDURES USING A PLURALITY OF ELONGATED MEDICAL DEVICES, which is incorporated by reference herein.

[0157] Referring to Figure 5DIn an embodiment, the drive module 68 causes the EMD 102 to move in a first direction, the isolation component 106 separates from the cartridge housing 104 in the first direction. In an embodiment, the first direction is along a longitudinal axis of the EMD 102. In such an embodiment, the first direction corresponds to the X-axis. In an embodiment, the drive module 68 causes the EMD 102 to move in a second direction, the isolation component 106 separates from the cartridge housing 104 in the first direction and the second direction. In an embodiment, the second direction is a rotation about the longitudinal axis of the EMD in a clockwise direction and a counterclockwise direction.

[0158] Referring to Figure 5D and Figure 5I In an embodiment, the apparatus includes a cartridge 66 comprised of a cartridge housing 104 removably attached to a drive module base component 116 and a cartridge cover 105 attached to an isolation component 106.

[0159] Referring to Figure 4A-4D , Figure 5D and Figure 5I In an embodiment, the on-device adapter 112 is spaced apart from and in non-contacting relation with the cartridge housing 104 when the on-device adapter 112 is coupled to the load sensing component 118 by the isolation component 106. In an embodiment, the isolation component 106 is separated from the cartridge housing 104 in all directions. In an embodiment, the isolation component 106 is separated from and in non-contacting relation with the cartridge housing 104.

[0160] Referring to Figure 5D , Figure 5I and Figure 5J The isolation component 106 includes a first component 106a and a second component 106b attached thereto. The first component 106a is placed within a recess 143 of the cartridge housing 104 in a direction toward the drive module 68 when the cartridge 66 is in an in-use position secured to the drive module 68. The second component 106b is placed within the recess 143 in a direction away from the load sensing component 118 toward the first component 106a. The isolation component 106 is positioned within the cartridge housing 104 and separated from the cartridge housing in at least one direction when the isolation component 106 is connected to the load sensing component 118.

[0161] Referring to Figure 5G In an embodiment, the drive module base component 116 includes a recess that receives the load sensing component 118. In an embodiment, the drive module base component 116 further defines a cavity extending from the recess that receives a portion of the load sensor 120.

[0162] Referring to Figure 5I and Figure 5JThe cartridge 66 includes a cartridge housing 104 and a cartridge cover 105 connected to a first portion 106a of the isolation component 106. The cartridge housing 104 includes a cavity 132 configured to receive an EMD on adapter 112 having the EMD 102. The cavity 132 is also referred to herein as a cradle 132.

[0163] Referring to Figure 5J , Figure 5K and Figure 5L , the cartridge bevel gear 134 in a second portion 106b of the isolation component 106, where the isolation component 106 is housed within the cartridge housing 104, is freely rotatable relative to the isolation component 106 about an axis aligned with the coupler axis 131, where the coupler 130 of the load sensing component 118 rotates about the coupler axis 131, where the load sensing component 118 is housed within the drive module 68.

[0164] Referring to Figure 5I and Figure 5K , in one embodiment, the cartridge housing 104 is releasably connected to the drive module base component 116 via a quick release mechanism 121. In one embodiment, the quick release mechanism 121 includes a spring biased member in the cartridge housing 104 that is activated by a latch release 123 that releasably engages a quick release locking pin 117a secured to the drive module base component 116. In one embodiment, an alignment pin 117b secured to the drive module base component 116 aligns the cartridge housing 104 relative to the drive module base component 116.

[0165] Referring to Figure 5I and Figure 5LIn an embodiment, in the in-use position, the on-device adapter 112 is supported in a cylindrical groove positioned longitudinally towards the proximal end of the on-device adapter 112. In the in-use position, the support of the on-device adapter 112 is provided by a bottom support 133 on the distal face of the first part 106a of the isolation part 106 and a top support 135 on the interior of the closed cartridge lid 105. In an embodiment, the groove in the on-device adapter 112 that supports the on-device adapter 112 is located on the on-device adapter 112, longitudinally towards the proximal end of the on-device adapter 112 and distally from the driven bevel gear 136. In an embodiment, the on-device adapter 112 includes features such as flanges on either side of the groove that supports the on-device adapter 112. In an embodiment, the support provided by the bottom support 133 and the top support 135 at the groove of the on-device adapter 112 acts as a thrust bearing for the on-device adapter 112, allowing the on-device adapter 112 to rotate freely and constraining the longitudinal motion of the on-device adapter 112 to the translational motion of the first part 106a of the isolation part 106 and the cartridge lid 105 that are connected at the hinge 103. The bottom support 133 is also referred to as a rotational drive element carrier.

[0166] Referring to Figure 5I , Figure 5J and Figure 5M , in an embodiment, the cartridge 66 includes a cartridge lid 105 that is pivotably coupled to the isolation part 106 by a hinge 103 that is separate and in non-contact with the cartridge housing 104. In an embodiment, the cartridge lid 105 is pivotably coupled to the first part 106a of the isolation part 106 by the hinge 103. In an embodiment, the cartridge lid 105 is connected to the first part 106a of the isolation part 106 by means other than a snap, such as a screw. In an embodiment, the EMD 102 is spaced apart and in non-contact with the cartridge housing 104 when the on-device adapter 112 is coupled to the load sensing part 118.

[0167] Referring to Figure 5E , a catheter 140 embodiment of the EMD 102 is shown with the EMD on-device adapter 112 and the driven bevel gear 136. The catheter 140 includes a hub that can be connected to a rotating stopcock on the proximal end of the catheter 140, for example. In an embodiment, the hub of the catheter 140 is devoid of controls for manipulating features within the catheter 140, such as a wire that extends to the distal end of the catheter to deflect a tip. In an embodiment, the catheter 140 is devoid of any controls for manipulating features within the catheter 140, such as a wire that extends to the distal end of the catheter 140 to deflect a tip.

[0168] In one embodiment, the on-EMD device adapter 112 includes a conduit 140 integrally connected to a driven bevel gear 136 that can be removably connected to a Y-connector, shown as a hub 142 that can be removably connected to a hemostatic valve on a proximal end. One embodiment of the on-EMD device adapter 112 includes a conduit 140 removably connected to a driven bevel gear 136. The conduit 140 includes an integrally connected conduit hub 139 and a conduit shaft 141.

[0169] Referring to Figure 5F , a guidewire embodiment of the EMD 102 is shown with the on-EMD device adapter 112 and the driven bevel gear 136. In Figure 5F one embodiment, the on-EMD device adapter 112 is a collet 113 with a driven bevel gear 136 on the proximal end of the collet.

[0170] In one embodiment, the on-device adapter 112 includes a collet 113 having a collet jaw (or collet nut) at the distal end of the on-device adapter 112 and a collet body captured within an open cylindrical housing with the driven bevel gear 136 integrally connected to the housing at the proximal end of the on-device adapter 112. The inner lumen through the central longitudinal axis of the on-device adapter 112 is coaxial with the central longitudinal axis of the collet 113, allowing the guidewire EMD 102 to pass therethrough. In one embodiment, the open cylindrical housing of the on-device adapter 112 includes features such as longitudinal slits, enabling the collet body to be press fit within the cylindrical housing. In one embodiment, the cylindrical housing of the on-device adapter 112 includes an external flange that can be used to ensure kinematic engagement with the actuation member to allow translation of the on-device adapter 112. In one embodiment, rotation of the driven bevel gear 136 corresponds to rotation of the on-device adapter 112 and is thus used to rotate and / or clamp / unclamp the EMD 102.

[0171] Referring to Figure 5J and Figure 5M , the isolation component 106 is housed inside the box housing 104 by attaching the first component 106a around the rail 107 in the box housing 104 to the second component 106b of the isolation component 106. In the in-use position, the isolation component 106 does not contact the rail 107.

[0172] In one embodiment, the load sensor 120 measures the reaction force applied by the EMD 102 to the isolation component 106 of the cartridge 66. In one embodiment, the load sensor 120 measures the torque applied by the EMD 102 to the isolation component 106 of the cartridge 66. In one embodiment, the load sensor 120 measures both the reaction force and the reaction torque applied by the EMD to the isolation component 106 of the cartridge 66. In one embodiment, the actual force acting along the longitudinal axis of the EMD 102 and the torque about the longitudinal axis of the EMD 102 are determined based on the load sensor measurements.

[0173] Referring to Figure 5J and Figure 5M The first component 106a and the second component 106b of the isolation component 106 are secured to each other. The cartridge housing 104 includes two longitudinally oriented rails 107 that are located within the recess 143. The rails 107 are also referred to herein as linear guides. Prior to the cartridge 66 being attached to the drive module 68, the first component 106a is located on the top surface of the rails 107, closest to the top surface of the cartridge housing 104, and the second component 106b is located below and spaced apart from the bottom surface of the rails 107 and closest to the load sensing component 118. Note that while the assembly orientation of the first component 106a and the second component 106b of the isolation component 106 is described with respect to an in-use position, the first and second components of the isolation component 106 can be installed away from the drive module 68. In other words, the first component 106a of the isolation component 106 is inserted into the recess 143 in a direction that is generally perpendicular to the longitudinal axis of the cartridge housing 104, in a direction from the top surface of the cartridge 66 toward the bottom surface of the cartridge 66.

[0174] In one embodiment, a mechanical fastener or fasteners secure the first component 106a to the second component 106b of the isolation component 106. In one embodiment, the first component 106a and the second component 106b are secured together using magnets. In one embodiment, the first component 106a and the second component 106b of the isolation component 106 are secured using an adhesive. In one embodiment, the first component 106a and the second component 106b are releasably secured to each other without the use of a tool. In one embodiment, the first component 106a and the second component 106b are non-releasably secured to each other.

[0175] Referring to Figure 5KIn one embodiment, a fastener is used to releasably secure the second part 106b of the isolation part 106 to the load sensing part 118. In one embodiment, the fastener includes a quick release mechanism that is capable of releasably securing the second part 106b of the isolation part 106 to the load sensing part 118. In one embodiment, the fastener is a magnet. In one embodiment, the second part 106b of the isolation part 106 is releasably secured to the load sensing part 118 by a separable press fit. In one embodiment, the second part 106b of the isolation part 106 is releasably secured to the load sensing part 118 by a clearance fit. In one embodiment, the second part 106b of the isolation part 106 is releasably secured to the load sensing part 118 by an interference fit.

[0176] Referring to Figure 5M In the use position in which the second part 106b of the isolation part 106 is releasably secured to the load sensing part 118, the first part 106a and the second part 106b are spaced apart from the rails 107 of the cassette housing 104 such that the first part 106a and the second part 106b are in a non-contacting relationship with the cassette housing 104.

[0177] Referring to Figure 6A An apparatus module 32 is shown having a cassette housing 104 and a first part 106a of an isolation part 106. Also shown is a drive module base part 116. The first part 106a of the isolation part 106 is located in the cassette housing 104 and provides support for an EMD 102 (not shown) that is captured in an EMD on-device adapter 112. In one embodiment, the cassette housing 104 is a rigid (relatively stiff) support. The EMD on-device adapter 112 includes a driven bevel gear 136 in the isolation part 106 that is configured to interface with a cassette bevel gear 134 (not shown). The EMD on-device adapter 112 with the driven bevel gear 136 is supported in a rotational drive element cradle 133 of the first part 106a of the isolation part 106. In one embodiment, the EMD on-device adapter 112 with the Y-shaped connector includes a Y-shaped connector hub 142. In one embodiment, the isolation part 106 floats relative to the cassette housing 104 in the sense that there is no direct contact.

[0178] The cassette housing 104 reacts forces such as forces from a device support 79 that is connected to the cassette, resistance from fluid tubes, forces exerted by supported rail arms, and loads from other parts that connect or interact with the cassette other than the EMD 102. To reduce measurement noise of rotational forces, the rotational drive element cradle 133 that supports the driven bevel gear 136 of the EMD on-device adapter 112 can be formed of a low friction static material. In another embodiment, the rotational drive element cradle 133 can include bearings in the form of sliding or rolling bearings.

[0179] Referring to Figure 6B The isolation component 106 includes a first component 106a and a second component 106b that are connected and the isolation component 106 is decoupled from the cartridge housing 104 by a first slot 148 and a second slot 149. The isolation component 106 is loosely housed within the first slot 148 and the second slot 149 and is constrained to have a limited range of motion. The range of motion of the isolation component 106 allows the isolation component 106 to be mounted on the load sensing component 118 of the drive module 68 (not shown) while allowing for tolerances between the interface components. The first slot 148 and the second slot 149 are configured to allow limited motion of the isolation component 106 in the X and Y directions. The isolation component 106 is also floating due to the first tab 150 on the first side 152 of the cartridge housing 104 and the second tab 151 on the second side 154 of the cartridge housing 104, but is captured in the Z direction in the first slot 148 and the second slot 149. The isolation component 106 includes a first recess 156 on a first side 158 of the isolation component 106 and a second recess 157 on a second side 160 of the isolation component 106. The first tab 150 is loosely positioned in the first recess 156 of the isolation component 106 and the second tab 151 is loosely positioned in the second recess 157 of the isolation component 106. In one embodiment, the isolation component 106 and the cartridge housing 104 exist as separate components. In one embodiment, the isolation component 106 and the cartridge housing 104 exist as a single unit, rather than two completely independent pieces. In one embodiment, a contactless frictionless interface is achieved when the isolation component 106 is mounted to the drive module 68 (not shown). In one embodiment, the isolation component 106 is mounted to the drive module 68 by contact.

[0180] In one embodiment, a positioning pin 129 on the drive module load sensing component 118 engages a connection point 166 on the floating component 106. When the cartridge 66 is mounted to the drive module 68, the cartridge housing 104 is attached to the drive module base component 116. The positioning pin on the drive module 68 lifts the floating component 106 to a height relative to the cartridge housing 104 where a contactless interface is achieved. In one embodiment, the height is 1 mm. In other embodiments, the height is less than 1 mm and in other embodiments, the height is greater than 1 mm. The contactless frictionless interface between the floating component 106 and the cartridge housing 104 allows the actual load on the EMD 102 in the direction of measurement (X axis) to be supported only by the load sensing component 118 and thus prevents frictional parasitic loads from being incorporated into the load sensed by the load sensor 120. In other words, the floating component 106 that captures the cartridge 66 of the EMD 102 is directly load sensed and isolated from parasitic load sources.

[0181] Referring toFigure 6C FIG. 43 shows a bottom view of the float component 106 of the cartridge 66. The bottom surface 162 of the float component 106 is configured to couple to the drive module 68. The bottom surface 162 of the float component 106 includes connectors 164 that receive the couplers 130 of the drive module 68. The bottom surface 162 of the float component 106 also includes connection points 166 that are configured to receive connection members of the drive module 68. For example, the locating pins 129 in the drive module 68 can fit into a series of holes and slots in the bottom surface 162 of the float component 106. The locating pins 129 can be used to fully constrain the float component 106 and the drive module 68 in the X, Y, and Z directions. In one embodiment, the float component 106 is constrained in the Z direction by magnets in one or more of the connection points 166. In another embodiment, the float component 106 is constrained in the Z direction by friction with the connection points 166. In one embodiment, slots are used to interact with the locating pins 129 of the drive module 68 to constrain the float component 106.

[0182] Referring to Figure 5K and Figure 6C In one embodiment, the locating pins 129 on the load sensing component 118 of the drive module 68 rest in pockets in the connection points 166 on the second component 106b of the isolation component 106. When the cartridge 66 is installed to the drive module 68, the cartridge housing 104 is attached to the drive module base component 116. The locating pins 129 of the load sensing component 118 within the drive module 68 lift the second component 106b of the isolation component 106 relative to the cartridge housing 104 to a height at which a contactless interface is achieved between the isolation component 106 and the cartridge housing 104. In one embodiment, the isolation component 106 does not contact the cartridge housing 104 in the three orthogonal X, Y, and Z directions. In one embodiment, the gap height between the isolation component 106 and the cartridge housing 104 is 1 mm. In other embodiments, the gap height is less than 1 mm, and in other embodiments the gap height is greater than 1 mm. The contactless, frictionless interface between the isolation component 106 and the cartridge housing 104 allows the actual load acting on the EMD 102 in the measurement direction (X-axis) to be supported only by the load sensing component 118 and thus prevents frictional parasitic loads from being incorporated into the load sensed by the load sensor 120. In other words, the isolation component 106 of the cartridge 66 that captures the EMD 102 is directly load sensed and isolated from parasitic load sources.

[0183] Referring to Figure 7 FIG. 43 shows a bottom view of the float component 106 of the cartridge 66. The bottom surface 162 of the float component 106 is configured to couple to the drive module 68. The bottom surface 162 of the float component 106 includes connectors 164 that receive the couplers 130 of the drive module 68. The bottom surface 162 of the float component 106 also includes connection points 166 that are configured to receive connection members of the drive module 68. For example, the locating pins 129 in the drive module 68 can fit into a series of holes and slots in the bottom surface 162 of the float component 106. The locating pins 129 can be used to fully constrain the float component 106 and the drive module 68 in the X, Y, and Z directions. In one embodiment, the float component 106 is constrained in the Z direction by magnets in one or more of the connection points 166. In another embodiment, the float component 106 is constrained in the Z direction by friction with the connection points 166. In one embodiment, slots are used to interact with the locating pins 129 of the drive module 68 to constrain the float component 106. Figure 4DFIG. 1 is a perspective view of an exemplary embodiment of a load sensing system (e.g., the load sensing system of FIG. 1) including a disposable cartridge component and a primary drive module component. The device module 32 includes a cartridge 66 and a drive module 68, shown by dashed lines. In one embodiment, the cartridge 66 and its components are disposable, and the drive module 68 and its components are primary, i.e., reusable and non-disposable. The cartridge 66 includes a cartridge housing 104 and an isolation component 106, which is connected to a cartridge cover 105.

[0184] In one embodiment, linear DOF motion of the EMD 102 is achieved by moving the device module 32 along the table drive mechanism 76, while the EMD 102 is captured by an EMD on-device adapter 112 that is integral to the floating component 106 of the cartridge 66. The EMD on-device adapter 112 is also referred to as an end effector or on-device adapter. In one embodiment, the EMD on-device adapter 112 is a collet. In one embodiment, the EMD on-device adapter 112 is a hub driver. In one embodiment, the table drive mechanism 76 is a lead screw, and the drive module 68 includes a table translation motor 64 that rotates a nut on the lead screw.

[0185] The drive module 68 includes a load sensing component 118 and a load sensor 120. In one embodiment, the load sensor 120 is a single-axis sensor that measures a reaction force to determine the actual force on the EMD 102 that is captured by the EMD on-device adapter 112. In one embodiment, the load sensor 120 is a multi-axis sensor that measures components of a reaction force to determine corresponding actual forces and torques on the EMD 102 that is captured by the EMD on-device adapter 112. In one embodiment, at least one actuator 124 that is used to rotate the EMD 102 and / or clamp / unclamp the EMD 102 is located outside of the load sensing component 118. As shown previously, this reduces parasitic loads (such as inertial loads) that can be imposed by the actuator on the load sensing component 118.

[0186] In one embodiment, power is transmitted from the actuator 124 that is located outside of the load sensing component 118 to the drive component that is located inside of the load sensing component 118 by using a belt 126 that is perpendicular to the load measurement direction. In one embodiment, power is transmitted from the actuator 124 that is located outside of the load sensing component 118 to the drive component that is located inside of the load sensing component 118 by other means, such as using a chain or cable or wire that is perpendicular to the load measurement direction. In one embodiment, power is transmitted from the actuator 124 to the EMD on-device adapter 112 through a drive train that imposes a load on the load sensor 120 in the load measurement direction, where the load can be corrected in determining the actual load on the EMD 102. In one embodiment, the actuator 124 includes an encoder for device angular position feedback.

[0187] In one embodiment, power is transmitted from the actuator 124 located outside the load sensing component 118 to the drive component located inside the load sensing component (e.g., used to drive the pulley and / or capstan of the on-device adapter) through a power train that does not exert a load on the load cell 120 in the load measurement direction.

[0188] In one embodiment, the load cell 120 is a force sensor, such as a bending beam force sensor, to measure the force acting on the EMD 102. In one embodiment, the load cell 120 is a multi-axis sensor used to measure the force and torque acting on the EMD 102. In one embodiment, the centerline of the power train (e.g., belt, cable, chain, etc.) used to transmit power from the actuator 124 used to rotate or clamp / unclamp the EMD 102 to the load sensing component 118 coincides with the axis of the load cell 120, such that pre-tension in the power train does not exert a torque on the torque sensor in the torque measurement direction. In another embodiment, the power train is parallel to the EMD proximal portion engaged in the floating component 106, such that pre-tension in the power train does not generate a torque in the torque measurement direction.

[0189] In one embodiment, the load cell 120 is used in the power train between the actuator 124 used to rotate or clamp / unclamp the EMD 102 and the EMD device adapter 112 to determine the force acting on the EMD 102 and / or the torque applied to clamp / unclamp the collet. In one embodiment, the load cell 120 is located between the actuator 124 and the drive module base component 116 to determine the torque acting on the EMD 102 and / or the torque applied to clamp / unclamp the collet.

[0190] In one embodiment, a bearing 128 is used to support the load sensing component 118 in at least one non-measurement direction. In other words, the bearing support 128 does not exert a load in the measurement direction. In one embodiment, the bearing support 128 is a linear bearing (pointing into the plane) that supports the load sensing component 118 in all directions except the force measurement direction.

[0191] Reference Figure 7In one embodiment, the actuator that rotates the EMD 102 about its longitudinal axis is external to the load sensing component 118. In one embodiment, the actuator that clamps / unclamps the EMD 102 within the drive module is external to the load sensing component 118. In one embodiment, the drive module 68 includes a power transmission device that is driven by an actuator external to the load sensing component 118 that is used to actuate a part internal to the load sensing component 118 in order to manipulate the EMD 102. In one embodiment, the power transmission device does not exert a load on the load sensing component 118 in at least one load measuring direction. In one embodiment, the power transmission device is a flexible device that does not experience shear forces, such as a belt, cable, chain. In one embodiment, the power transmission device is perpendicular to the load measuring direction, such that it does not exert a load on the load sensing component 118 in the load measuring direction. In one embodiment, the drive module 68 includes a bearing that supports the load sensing component 118 in at least one non-measuring direction to support off-axis loads in that direction. In one embodiment, the load sensor 120 is spaced apart from the longitudinal axis of the EMD 102. Also, in one embodiment, the load sensing component 118 is spaced apart from and not collinear with the EMD. In other words, the load sensor is spaced apart from the longitudinal axis of the EMD.

[0192] Referring to Figure 8 FIG. 18 shows a top view of a load sensing system including a bevel gear drive mechanism 178. The bevel gear drive mechanism 178 is also referred to as a bevel gear collet drive. The system includes a stage translation motor 64, a stage drive mechanism 76, an EMD 102, a drive module base component 116, a load sensing component 118, a load sensor 120, a bearing 128 that supports the load sensing component 118, a first actuator 168 that rotates and / or clamps / unclamps the EMD 102, a second actuator 170 that rotates and / or clamps / unclamps the EMD 102, a first belt 172 that is used to rotate and / or clamp / unclamp the EMD 102, and a second belt 174 that is used to rotate and / or clamp / unclamp the EMD 102. In one embodiment, the load sensor 120 is fixed to the drive module base component 116 and the load sensing component 118. In one embodiment, all of the sensors described herein are fixed to the respective relevant adjacent component, as disclosed in the drawings and as is known in the art.

[0193] In the illustrated embodiment, the load sensing component 118 is a bevel gear drive mechanism 178 driven by two actuators (168 and 170) through belts (172 and 174) to effect rotation and / or clamping / unclamping of the EMD 102 via a two-part collet 180. The mechanism 178 and collet 180 are described in detail in the pending U.S. Application entitled MANIPULATION OF AN ELONGATED MEDICAL DEVICE (U.S. Provisional Application No. 62 / 874,173, filed 7 / 15 / 2019). The ‘173 application describes a dual taper collet drive mechanism.

[0194] In one embodiment, the accelerometer 176 determines the acceleration of the load sensing component 118. In one embodiment, the accelerometer 176 is a single axis accelerometer that measures the acceleration component in the longitudinal direction (i.e., in the X direction). In one embodiment, the accelerometer 176 is a multi-axis accelerometer that measures the acceleration components in the X, Y, and Z directions.

[0195] In one embodiment, other types of sensors (e.g., velocity transducers, displacement transducers, etc.) are used to determine the acceleration of the load sensing component 118. In one embodiment, more than one sensor is used to determine the acceleration of different parts, including the entire load sensing component and internal parts of the load sensing component that have motion relative to the load sensing component. In one embodiment, the acceleration of the load sensing component is determined from parameters of the actuators (e.g., actuator parameters of the table translation motor 64). The parameters of the actuators include, but are not limited to, the encoder signals of the actuators, the current of the actuators, and the voltage of the actuators.

[0196] Referring to Figure 8 In one embodiment, the acceleration of the load sensing component 118 is determined using a sensor such as the accelerometer 176 to correct for parasitic inertial loads. In one embodiment, the acceleration of the load sensing component 118 is determined using a sensor such as a velocity transducer, whereby the acceleration of the load sensing component is determined to correct for parasitic inertial loads. In one embodiment, the acceleration of the load sensing component 118 is determined using a sensor such as a displacement transducer, whereby the acceleration of the load sensing component is determined to correct for parasitic inertial loads.

[0197] The measured or determined acceleration can be used to correct the load measurements for parasitic loads caused by the inertia of the load sensing component and its internal parts, and to determine the actual load acting on the EMD. The inertial force F inertia calculated as the product of the mass of the component and the acceleration in the given direction. The actual force can be determined from the sensed force (Fsensed ) to determine.

[0198] The gravitational load on the load sensing component can be determined based on the mass of the component and the orientation as the product of the mass and the component of the gravitational force in a given direction.

[0199] The friction and drag parasitic loads can be measured and characterized to determine their values. In one embodiment, the measurement and characterization can be done by performing off-line tests. In one embodiment, the values of the friction and drag parasitic loads can be tabulated and / or formulated as a function of different parameters such as displacement and velocity.

[0200] In one embodiment, the at least one or more actuators are moved from the load sensing component 118 to the drive module base component 116 in order to reduce the parasitic inertial load. In such a case, the actuation power can be transmitted from the actuator to the device adapter through a transmission train that does not exert a load on the sensor in the load measurement direction (e.g., by using a belt / chain / cable that is perpendicular to the load measurement direction, or by a magnetic coupling). If the transmission train exerts a parasitic load on the sensor in the load measurement direction, the load measurement value needs to be further corrected for the parasitic load in order to determine the actual load on the EMD.

[0201] In the system described herein, the EMD 102 is manipulated by a mechanism within the floating component of the cartridge. The floating component of the cartridge is attached to the load sensing component of the primary device, and the reaction load exerted by the EMD to the floating component of the cartridge is measured by using sensors inside the primary device. A sterile barrier can be used between the primary unit (drive module) and the cartridge, so that the sensors or the drive module do not need to be sterilized. Any component that can generate parasitic loads (e.g., anti-buckling supports, plumbing, cables, etc.) is connected to the base sub-component of the disposable (cartridge housing) in order to isolate the load sensing component from the parasitic loads.

[0202] In one embodiment, at least two loads are measured, such as the force along the longitudinal axis of the EMD and the torque about the longitudinal axis of the EMD.

[0203] In Figure 8 In the embodiment shown, the drive mechanism is a differential collet (comprising two parts). In one embodiment, the drive mechanism is a hub drive module, which has two DOF such as linear and rotational.

[0204] Referring to Figure 9A and Figure 9BThe cartridge 66 includes a collet 180 that is actuated by the bevel gear drive mechanism 178 and removably captures the EMD 102 therewith. The cartridge 66 includes the load sensing component 118. The system also includes a drive module 68 that includes the stage translation motor 64, the stage drive mechanism 76, the drive module base component 116, a load sensor (not shown), a bearing (not shown) that supports the load sensing component 118, a first actuator 168, and a second actuator 170. The housings of the actuators 168 and 170 are integrally mounted to the drive module base component 116. The capstans (shafts) of the actuators 168 and 170 are used to rotate the EMD 102 and / or clamp / unclamp the EMD 102. A first torque sensor 182 is located on the capstan of the first actuator 168 that drives a first driver gear 186. The first torque sensor 182 measures the reaction torque between the first actuator 168 and the first driver gear 186. A second torque sensor 184 is located on the capstan of the second actuator 170 that drives a second driver gear 188. The second torque sensor 184 measures the reaction torque between the second actuator 170 and the second driver gear 188.

[0205] The EMD 102 is removably located within a path defined by the collet 180. The collet 180 has a first portion that is connected to a first collet coupler and a second portion that is connected to a second collet coupler. In one embodiment, the capstan of the first actuator 168 is operatively coupled to the first collet coupler through a pair of bevel gears, and the capstan of the second actuator 170 is operatively coupled to the second collet coupler through a pair of bevel gears. Rotation of the first collet coupler and rotation of the second collet coupler can be used independently and / or in combination to operatively clamp and unclamp the EMD 102 in the path and / or rotate the EMD 102 clockwise and counterclockwise.

[0206] The bevel gear drive mechanism 178 with the collet 180 is described in the pending U.S. Application entitled MANIPULATION OF AN ELONGATED MEDICAL DEVICE (U.S. Provisional Application No. 62 / 874,173, filed 7 / 15 / 2019), which is incorporated by reference herein. (See, in particular, the description of Figures F4.1-F4.6 in that application).

[0207] A first torque sensor 182 determines torque acting on the first collet coupler, and a second torque sensor 184 determines torque acting on the second collet coupler. The processor determines torque acting on the EMD from a first signal from the first torque sensor 182 and a second signal from the second torque sensor 184. Likewise, the processor determines differential torque applied to the bevel gear drive mechanism 178 to clamp the EMD 102 from a first signal from the first torque sensor 182 and a second signal from the second torque sensor 184. In one embodiment, the clamping force applied to the EMD is calculated using the differential torque used to tighten the bevel gear drive mechanism 178 and clamp the EMD 102. In one embodiment, the relationship between the clamping force on the EMD 102 and the differential torque applied to the two ends of the bevel gear drive mechanism 178 is determined by experimental testing. In one embodiment, such a relationship is determined by a mathematical model or equation.

[0208] The drive module 68 includes a first actuator 168 operatively coupled to the first collet coupler to operatively clamp and unclamp the EMD 102 in the path and rotate the EMD 102, and a second actuator 170 operatively engaged with the second collet coupler. A first torque sensor 182 (or more generally a first load sensor) determines a first collet coupler torque acting on the first collet coupler, and the processor determines EMD torque acting on the EMD 102 from a first signal from the first torque sensor 182 (or more generally a first load sensor).

[0209] In one embodiment, the second actuator 170 operatively engages and disengages the second collet coupler to prevent and allow rotation of the second collet coupler. In one embodiment, the second collet coupler operatively clamps and unclamps the EMD 102 in the path to rotate the EMD 102, and a second torque sensor 184 (or more generally a second load sensor) determines a second collet coupler torque acting on the second collet coupler. The processor determines EMD torque acting on the EMD 102 from a first signal from the first torque sensor 182 (or more generally a first load sensor) and a second signal from the second torque sensor 184 (or more generally a second load sensor).

[0210] In one embodiment, the processor determines a net collet torque applied to the collet to clamp and / or unclamp the EMD 102, where the net collet torque is the relative torque between the torque acting on the first collet coupler by the first actuator 168 and the torque acting on the second collet coupler by the second actuator 170.

[0211] In Figure 9AIn the illustrated embodiment, the first torque sensor 182 is mounted on and above the capstan of the first actuator 168, and the second torque sensor 184 is mounted on and above the capstan of the second actuator 170. In one embodiment, the first torque sensor 182 includes two parts, a first torque sensor rotating part mounted on the capstan of the first actuator 168 and a first torque sensor housing mounted to the housing of the first actuator 168 that is fixed to the drive module base member 116. In one embodiment, the second torque sensor 184 includes two parts, a second torque sensor rotating part mounted on the capstan of the second actuator 170 and a second torque sensor housing mounted to the housing of the second actuator 170 that is fixed to the drive module base member 116. In alternative embodiments, at least one of the two torque sensors is located in line with the capstan shaft driven by one of the actuators, with the sensor rotating with the actuator shaft.

[0212] In Figure 9B the illustrated embodiment, the first torque sensor 182 is mounted between the housing of the first actuator 168 and the drive module base member 116, and below the first actuator 168; and the second torque sensor 184 is mounted between the housing of the second actuator 170 and the drive module base member 116, and below the second actuator. In one embodiment, at least one of the torque sensors is located between the actuator and the drive module base member 116 of the drive module 68, with the torque sensor supporting the actuator in at least one direction.

[0213] Referring to Figure 9C , an isometric view of the load sensing system of Figure 9B is shown. In the illustrated embodiment, the first torque sensor 182 is mounted on and below the capstan of the first actuator 168, and the second torque sensor 184 is mounted on and below the capstan of the second actuator 170. In one embodiment, at least one of the torque sensors is located between the actuator and the drive module base member 116 of the drive module 68, with the torque sensor supporting the actuator in at least one direction.

[0214] The device module 32 includes a drive module 68 that is translated along the axial direction of the EMD 102 by actuation of a stage translation motor 64 that drives a stage drive mechanism 76, such as a leadscrew, relative to the stage 62. Alternatively, the stage drive mechanism 76, such as a leadscrew, can be stationary and the stage translation motor 64 can rotate a nut on the leadscrew either directly or by use of a belt 114 (shown in FIG. 4). The nut drives the drive module 68 through contact of two thrust bearings, and as the nut is rotated on the leadscrew it translates the device module 32. The drive module 68 is constrained to only linear movement relative to the stage drive mechanism 76 by guides. The drive module 68 includes a drive module base component 116, a cartridge 66, and a cartridge housing 104. The cartridge 66 includes a bevel gear drive mechanism 178 that includes a collet 180 (not shown) and EMD guides 190. The EMD guides 190 include pairs of guides that act as v-shaped notches and as open channels for guiding the EMD 102 through the drive system. Note that in operation the cartridge housing 104 is rotated down to a closed position. The guides act as an anti-buckling feature. In one embodiment, the EMD guides 190 include pairs of v-shaped notches or u-shaped channels that act as guides. The top of the v-shaped or u-shaped channels can be beveled to assist in loading the EMD 102. In one embodiment, one pair of EMD guides 102 is used on the proximal side of the bevel gear drive mechanism 178 and one pair of EMD guides 190 is used on the distal side of the bevel gear drive mechanism 178. In one embodiment, multiple pairs of EMD guides 190 are used on the proximal side of the bevel gear drive mechanism 178 and multiple pairs of EMD guides 190 are used on the distal side of the bevel gear drive mechanism 178.

[0215] Reference Figure 9DFigure 2 shows an embodiment of a torque sensing system that uses a first torque sensor 182 located between a first actuator 168 that locks / unlocks the collet 180 during operation and its capstan. The capstan of the first actuator 168 drives a first driver gear 186 that is in continuous engagement with a first portion 192 of a collet drive mechanism that is used to rotate the entire collet 180 with the EMD 102 when the EMD is clamped in the collet. To unclamp the EMD 102a, the locking actuator 171 engages a lock / unlock mechanism 194 to lock a second portion 196 of the collet drive mechanism to prevent rotation of that portion to allow a differential torque to be applied on the two portions of the collet 180 to clamp / unclamp the EMD 102. In one embodiment, the lock / unlock mechanism 194 is actuated by linear motion of the locking actuator 171. In one embodiment, the lock / unlock mechanism 194 is actuated by rotational motion of the locking actuator 171. In one embodiment, the lock / unlock mechanism 194 of the collet 180 is achieved by other methods such as engaging / disengaging gear teeth or keys, frictional interface connections, etc.

[0216] The second portion 196 of the collet drive mechanism is held in place by a fixture 197 that is integrally connected to the drive module base component 116. The fixture 197 allows the second portion 196 of the collet drive mechanism to freely rotate about its longitudinal axis and constrains the motion of the second portion 196 in the longitudinal (axial) direction X and the lateral directions Y and Z. In one embodiment, the fixture 197 includes a rotational bearing to allow the second portion 196 of the collet drive mechanism to freely rotate.

[0217] With the locking actuator 171 having the lock / unlock mechanism 194 disengaged from the second portion 196 of the collet 180 during operation, the torque on the EMD 102 can be determined by using one load sensor, i.e., the first torque sensor 182, that measures the reaction torque on the continuously engaged first actuator 168. The measured reaction torque is used to determine the torque on the EMD 102 when clamped in the collet 180 and to determine the tightening torque of the collet 180 during the reset state when the lock / unlock mechanism 194 is engaged with the second portion 196 of the collet 180.

[0218] The system includes a method to correct for parasitic loads that can corrupt the measurement of the actual torque acting on the EMD 102. The system includes a method to correct for the measured reaction torque due to friction, including friction due to the transmission, that can corrupt the measurement of the actual torque acting on the EMD 102 during the measurement (see equation (2)).

[0219] In one embodiment, the cables connected to the first actuator 168 and the locking actuator 171 and the first torque sensor 182 of the load sensing component are anchored to the drive module base component 116 of the main unit to isolate the load sensing component from the resistance load applied by the cables.

[0220] refer to Figure 9E An embodiment of a torque sensing system is shown, which uses a first torque sensor 182 below a first actuator 168 on an EMD hub drive mechanism 198. In the illustrated embodiment of the EMD hub drive mechanism 198, a driven bevel gear 136 is connected to the hub 142 of an adapter 112 on the EMD device, and the torque acting on the EMD is determined by measuring the reaction torque of the first actuator 168 using the torque sensor 182. In one embodiment, torque sensing can be performed indirectly, i.e., without explicitly using the torque sensor 182. For example, in one embodiment, torque sensing can be performed by measuring the current in the actuator 168, which can be correlated with the torque applied by the actuator. In one embodiment, the torque sensor 182 includes one or more force sensors that measure the reaction force and a processing unit that determines the torque based on the measured reaction force. The torque about the axis can be calculated as the cross product of the position vector of the point of force application (relative to the torque measurement axis) and the reaction force vector.

[0221] refer to Figure 9F , showing Figure 9B In one embodiment, a load sensor 120 is used between the drive module base component 116 and the load sensing component 118 to measure the force applied to the EMD 102. A first torque sensor 182 at the lower end of the first actuator 168 and a second torque sensor 184 at the lower end of the second actuator 170 are used to determine the torque applied to the EMD 102. In one embodiment, the first torque sensor 182 and the second torque sensor 184 are located in a straight line with the winch shafts of the first actuator 168 and the second actuator 170, respectively. Figure 9A As shown.

[0222] In one embodiment, a linear bearing support 128 is used to support the load sensing component 118 in a direction other than the load measurement direction.

[0223] refer to Figure 10AFIG. 1 shows an embodiment of a load sensing system for an EMD hub drive mechanism, where the force, torque, or force and torque components acting on the EMD are determined by a load sensor 120 between the drive module base component 116 and the load sensing component 118 and a first torque sensor 182 at the bottom of the first actuator 168. In one embodiment, the load sensor 120 is a multi-axis sensor that measures at least the force components and torque. In one embodiment, the load sensing component 118 is completely supported by the load sensor 120 and does not use bearings. In one embodiment, linear bearings 128 are used to support the load sensing component 118 in at least one non-measured direction.

[0224] In one embodiment, the load sensor 120 is a force sensor that measures the force acting on the EMD and a torque sensor 182 is used to determine the torque acting on the EMD. In one embodiment, the bearings 128 support the load sensing component 118 in all directions except the force measurement direction. For example, the bearings are linear slides, allowing motion parallel to the direction of motion of the table drive mechanism 76.

[0225] Referring to FIG. 2, an embodiment of a load sensing drive system is shown with a reset motion 200 that includes a first drive module 202, a first load sensor 222, a second drive module 204, and a second load sensor 224. The first drive module 202 includes a first table translation motor 206 and the second drive module 204 includes a second table translation motor 208. The first table translation motor 206 and the second table translation motor 208 operate independently and enable the first drive module 202 and the second drive module 204, respectively, to translate relative to a table drive mechanism 210. In one embodiment, the table drive mechanism 210 is a leadscrew. Figure 10B Figure 10A Referring to FIG. 2, an embodiment of a load sensing drive system is shown with a reset motion 200 that includes a first drive module 202, a first load sensor 222, a second drive module 204, and a second load sensor 224. The first drive module 202 includes a first table translation motor 206 and the second drive module 204 includes a second table translation motor 208. The first table translation motor 206 and the second table translation motor 208 operate independently and enable the first drive module 202 and the second drive module 204, respectively, to translate relative to a table drive mechanism 210. In one embodiment, the table drive mechanism 210 is a leadscrew.

[0226] Referring to FIG. 2, an embodiment of a load sensing drive system is shown with a reset motion 200 that includes a first drive module 202, a first load sensor 222, a second drive module 204, and a second load sensor 224. The first drive module 202 includes a first table translation motor 206 and the second drive module 204 includes a second table translation motor 208. The first table translation motor 206 and the second table translation motor 208 operate independently and enable the first drive module 202 and the second drive module 204, respectively, to translate relative to a table drive mechanism 210. In one embodiment, the table drive mechanism 210 is a leadscrew. Figure 11 Referring to FIG. 2, an embodiment of a load sensing drive system is shown with a reset motion 200 that includes a first drive module 202, a first load sensor 222, a second drive module 204, and a second load sensor 224. The first drive module 202 includes a first table translation motor 206 and the second drive module 204 includes a second table translation motor 208. The first table translation motor 206 and the second table translation motor 208 operate independently and enable the first drive module 202 and the second drive module 204, respectively, to translate relative to a table drive mechanism 210. In one embodiment, the table drive mechanism 210 is a leadscrew.

[0227] ​The first drive module 202 includes a first drive module base component 212 and a cartridge 214 housing a first device-on-adaptor 216 that releasably grips and can advance (i.e., translate the EMD 220 in a distal longitudinal direction), retract (i.e., translate the EMD 220 in a proximal longitudinal direction), rotate clockwise, and rotate counterclockwise the first EMD 220. In one embodiment, the first device-on-adaptor 216 is a double bevel gear drive mechanism.

[0228] Operation of the first device-on-adaptor 216 is described in U.S. Provisional Application No. 62 / 874,173 (Dkt C 130-338), which is incorporated herein by reference above. See generally sections

[0317] -

[0322] and FIGS. G2A-G2D of the ‘173 application.

[0229] In the clamped state, the first device-on-adaptor 216 clamping the first EMD 220 moves the first EMD 220 a distance in one direction and then is in a reset state, the first device-on-adaptor 216 releases the first EMD 220 and moves to a reset position in a direction opposite the one direction. For example, the first device-on-adaptor 216 clamps the first EMD 220 and then moves the first EMD 220 in a distal direction. In the reset state, the first device-on-adaptor 216 releases the first EMD 220 and then the first device-on-adaptor 216 returns to a reset position, i.e., after releasing the EMD 220, the first device-on-adaptor 216 moves in a proximal direction. In one embodiment, during the reset state, the EMD 220 is clamped by the second device-on-adaptor 218. In another embodiment, the first EMD 220 is parked in place during the reset due to friction between the first EMD 220 and the second EMD 234 and / or a hemostasis valve on the second EMD 234. Once the first device-on-adaptor 216 moves to the reset position, the first device-on-adaptor 216 re-clamps the first EMD 220. The load-sensing drive system with the reset motion 200 can repeat the sequence of the clamped state and the reset state.

[0230] A device support 230 between the first device-on-adaptor 216 and the second device-on-adaptor 218 prevents the EMD 220 from buckling.

[0231] The first device-on adapter 216 is the first load sensing component. The first load sensor 222 detects a load acting on the first device-on adapter 216, which corresponds to a load applied to the first EMD 220 at the first device-on adapter 216. The second device-on adapter 218 is the second load sensing component. The second load sensor 224 detects a load acting on the second device-on adapter 218, which corresponds to a load applied to the first EMD 220 at the second device-on adapter 218. In one embodiment, the measured load can be an axial force. In one embodiment, the measured load can be a torque. In one embodiment, the measured load can have a component of axial force and a component of torque.

[0232] In one embodiment, the first device-on adapter 216 is supported in the lateral direction by a first linear bearing 226 that integrally connects the first device-on adapter 216 and the first drive module base component 212 in all directions except the load measurement direction(s). In the load measurement direction(s), the first device-on adapter 216 is supported only by the first load sensor 222, which connects the first device-on adapter 216 and the first drive module base component 212 in the load measurement direction(s). The first load sensor 222 is oriented along the longitudinal direction of the first EMD 220 and is positioned between the first device-on adapter 216 (first load sensing component) and the first drive module base component 212. The first load sensor 222 measures the load acting on the first device-on adapter 216 when gripped by the first device-on adapter 216, and thus measures the load acting on the first EMD 220.

[0233] The second load sensor 224 is positioned between the second device-on adapter 218 and the second drive module base component 228 of the second drive module 204. The second load sensor 224 measures the load acting on the second device-on adapter 218, and thus measures the load acting on the first EMD 220 when gripped or secured by the second device-on adapter 216.

[0234] In one embodiment, the second device adapter 218 is a clamp that fixes the position of the first EMD 220 relative to the second device adapter 218 while the first device adapter 216 is in the reset state. In another embodiment, the second device adapter 218 is a driver that causes linear motion of the first EMD 220 relative to the second device adapter 218. In one embodiment, the second device adapter 218 includes two other engagement surfaces (wheels or paddles) that impart motion to the first EMD 220. In one embodiment, the second device adapter 218 enables linear and rotational movement of the EMD 220.

[0235] In one embodiment, the second device adapter 218 and the second load sensor 224 are not used, and the first EMD 220 stays in place during the reset state due to friction between the first EMD 220 and the second EMD 234 and / or the hemostatic valve.

[0236] The processor (not shown) distinguishes between the clamped state and the reset state by using state sensors in the drive mechanism, and determines the actual load on the first EMD 220. In one embodiment, the processor determines the actual load on the first EMD 220 only during clamping and does not provide load information during the reset state. In one embodiment, the processor determines the actual load on the first EMD 220 of the first device adapter from the load data from the first load sensor 222, the load data from the second load sensor 224, the state of the first device adapter 216, and the state of the second device adapter 218, where the state refers to whether the device adapter is gripping or releasing the EMD 220, rotating clockwise, counterclockwise, or not rotating, etc.

[0237] The load feedback system indicates load information to the user. In one embodiment, the load feedback system indicates the actual load on the first EMD 220 during the clamped state and the state of the first device adapter 216, and during the reset state (e.g., when the second device adapter is not used and / or the second load sensor is not used) only indicates the state of the first device adapter 216. This prevents the feedback system from indicating a false load measurement that is sensed when the EMD 220 is not clamped by the first device adapter 216. In one embodiment, the feedback system indicates the actual load on the first EMD 220 of the first device adapter 216 and the state of the first device adapter 216 during both the clamped state and the reset state.

[0238] Reference Figure 11In one embodiment of a reset load sensing system 200, the first drive module 202 includes a first device-on adapter 216 operatively engaging the EMD 220 and a second drive module 204 having a second device-on adapter 218 releasably engaging the EMD 220, wherein the reset state includes moving the first device-on adapter 216 relative to the second drive module 204 between an extended position and a reset position. In such an embodiment, a first load sensor 222 is operatively connected to the first device-on adapter 216 and the first drive module 202, and a second load sensor 224 is operatively connected to the second device-on adapter 218 and the second drive module 204. A processor (not shown) receives a first signal from the first load sensor 222 and a second signal from the second load sensor 224, and determines the actual load on the EMD from the first signal, the second signal, and the state of the first device-on adapter 216 and the state of the second device-on adapter 218. In one embodiment, the first device-on adapter includes a collet. In one embodiment, the second device-on adapter includes a clip having a pair of rolling members.

[0239] In one embodiment, the distance between the first device-on adapter 216 and the second device-on adapter 218 is greater in the reset position than in the extended position when the apparatus is advancing the EMD 220, and the distance between the first device-on adapter 216 and the second device-on adapter 218 is greater in the extended position than in the reset position when the apparatus is retracting the EMD 220. In one embodiment, the state of the first device-on adapter 216 includes a clamped state and an unclamped state, and the second device-on adapter 218 includes a grasped state and a released state.

[0240] In one embodiment, the first drive module includes a first device-on adapter and a second drive module, wherein the first device-on adapter has a first state of operatively engaging the EMD and a second state of operatively disengaging the EMD, and wherein the second device-on adapter has a third state of engaging the EMD and a fourth state of disengaging the EMD. The reset state includes moving the first device-on adapter relative to the second drive module between an extended position and a reset position. A second load sensor is operatively connected to the second device-on adapter and the second drive module. A processor receives a first signal from the load sensor and a second signal from the second load sensor, and determines the actual load on the EMD from the first signal, the second signal, and whether the first device-on adapter is in the first state or the second state and whether the second device-on adapter is in the third state or the fourth state. In one embodiment, the first state of the first device-on adapter is a clamped state and the second state of the first device-on adapter is an unclamped state, and the third state of the second device-on adapter is a grasped state and the fourth state of the second device-on adapter is a released state.

[0241] Referring to Figure 11 , the system includes a third on-device adapter 232 for grasping and manipulating a second EMD 234 coaxial with the first EMD 220. In one embodiment, the third on-device adapter 232 is supported in the lateral direction by a second linear bearing 236 that integrally connects the third on-device adapter 232 and the second drive module base component 228 for all directions other than the load measurement direction(s) for the second EMD 234. In the load measurement direction(s), the third on-device adapter 232 is supported only by a third load sensor 238 that connects the third on-device adapter 232 and the second drive module base component 228 in the load measurement direction(s). The third load sensor 238 is positioned between the third on-device adapter 232 and the second drive base component 228. The third load sensor 238 measures the load acting on the third on-device adapter 232, and thus the load acting on the second EMD 234 when grasped by the third on-device adapter 232.

[0242] Referring to Figure 12A and Figure 12B , another embodiment of a load-sensing drive system with a reset motion 200, the load-sensing drive system with a reset motion 200 includes a single drive module 240. The drive module 240 includes a stage translation motor 242 that enables the drive module 240 to translate relative to the stage drive mechanism 210. In one embodiment, the stage drive mechanism 210 is a leadscrew.

[0243] The drive module 240 includes a drive module base component 244 and a cartridge 214 that houses a first on-device adapter 216 that releasably grasps an EMD 250 and can advance the EMD 250 (i.e., translate the EMD 250 in a distal longitudinal direction), retract the EMD 250 (i.e., translate the EMD 250 in a proximal longitudinal direction), rotate the EMD 250 clockwise, and rotate the EMD 250 counterclockwise. In one embodiment, the translational degrees of freedom on the EMD 250 are achieved by moving the drive module 240 along the stage drive mechanism 210 while the EMD 250 is grasped by the first on-device adapter 216. In one embodiment, the first on-device adapter 216 is a bevel gear drive mechanism 230.

[0244] Operation of the first on-device adapter 216 is described in U.S. Provisional Application No. 62 / 874,173 (Dkt C 130-338), which is incorporated by reference herein. See generally

[0317] -

[0322] and FIGS. G2A-G2D of the ‘173 application.

[0245] The drive module base component 244 also includes a second device-on adapter 218. In Figure 12A and Figure 12B In embodiments, the second device-on adapter 218 is proximal to the first device-on adapter 216.

[0246] In the clamping state, the first device-on adapter 216 of the clamping EMD 250 causes the EMD 250 to move a distance in one direction, and then the first device-on adapter 216 releases the EMD 250 and moves to a reset position in a direction opposite the one direction. For example, in the clamping state, the first device-on adapter 216 of the clamping EMD 250 causes the EMD 250 to move in a distal direction. In an embodiment, the translational degree of freedom on the EMD 250 is achieved by moving the drive module 240 along the table drive mechanism 210 while the EMD 250 is clamped by the first device-on adapter 216. In the reset state, the first device-on adapter 216 releases the EMD 250 and then the first device-on adapter 216 returns to the reset position, i.e., the first device-on adapter 216 moves in a proximal direction after releasing the EMD 250. In an embodiment, the EMD 250 is held by the second device-on adapter during both the clamping state and the reset state. In an embodiment, the second device-on adapter 218 is one or more pairs of tires that can linearly move the EMD 250 by rotating about their axis. The two tires in each pair of tires rotate at the same rate but in opposite directions to linearly move the EMD 250 in a proximal or distal direction. In the clamping state, the second device-on adapter 218 does not cause the EMD 250 to move relative to the second device-on adapter 218. In the reset state, the EMD 250 is held by the second device-on adapter 218, and the second device-on adapter 218 causes the EMD 250 to move relative to the second device-on adapter 218 so that the absolute position of the EMD 250 is maintained as the drive module 240 moves along the table drive mechanism 210 to the reset position. Once the first device-on adapter 216 moves to the reset position, the first device-on adapter 216 re-clamps the EMD 250. The load-sensing drive system with the reset motion 200 can repeat the sequence of the clamping state and the reset state.

[0247] The first-device-on-adaptor 216 and the second-device-on-adaptor 218 are mounted on a load-sensing component 246. A load sensor 248 detects a load acting on the load-sensing component 246. In one embodiment, the load sensor 248 is oriented along a longitudinal direction of the EMD 250 and is positioned between the load-sensing component 246 and the drive module base component 244. The load sensor 248 measures the load acting on the EMD 250 in both the clamped and reset states.

[0248] In one embodiment, the load-sensing component 246 is supported in one or more directions other than the measurement direction(s) by a bearing 252.

[0249] Referring to Figure 13A and Figure 13B , a load-sensing system 260 with automatic calibration of the load sensor 262 and overload protection of the load sensor 262 includes a single drive module 264. The drive module 264 includes a stage translation motor 242 that enables the drive module 264 to translate relative to the stage drive mechanism 210. In one embodiment, the stage drive mechanism 210 is a leadscrew.

[0250] The drive module 264 includes a drive module base component 266 and a cartridge 268 that houses a first-device-on-adaptor 270 that releasably grips the EMD 250 and can advance the EMD 250 (i.e., translate the EMD 250 in a distal longitudinal direction), retract the EMD 250 (i.e., translate the EMD 250 in a proximal longitudinal direction), rotate the EMD 250 clockwise, and rotate the EMD 250 counterclockwise. In one embodiment, the first-device-on-adaptor 270 is a single bevel gear drive mechanism 272 (similar to the one used in Figure 9E .

[0251] Operation of the first-device-on-adaptor 270 is described in U.S. Provisional Application No. 62 / 874,173 (Dkt C 130-338), which is incorporated herein by reference. See generally paragraphs

[0317] -

[0322] and FIGS. G2A-G2D of the ‘173 application.

[0252] In one embodiment, the load-sensing system 260 also includes a second-device-on-adaptor 274. In the embodiment of Figure 13A and Figure 13B , the second-device-on-adaptor 274 is a retaining clip that is distal to the first-device-on-adaptor 270. The second-device-on-adaptor 274 is mounted to a second-device-on-adaptor base 276 that is fixed relative to the linear member or rail 60 (see Figure 3 ).

[0253] The device support 230 between the first device adapter 270 and the second device adapter 274 prevents the EMD 250 from buckling.

[0254] The first device adapter 270 is mounted on a load sensing member 278. The load sensor 262 detects a load acting on the load sensing member 278. In one embodiment, the load sensor 262 is oriented along the longitudinal direction of the EMD 250 and is positioned longitudinally between the load sensing member 278 and a resilient member 280. The resilient member 280 is sandwiched between the load sensor 262 and a pocket 282 in the drive module base member 266. In one embodiment, the resilient member 280 is a mechanical coil spring having a known spring rate. In one embodiment, the pocket 282 is a circular recess in the drive module base member 266 within which a mechanical coil spring having a known spring rate is mounted. In one embodiment, the resilient member 280 has a known constant spring rate. In one embodiment, the resilient member 280 has a known non-linear spring rate, i.e. its force versus displacement characteristic is known.

[0255] With reference to Figure 13A , the load sensing member 278 is supported in the load measurement direction only by the load sensor 262 and the resilient member 280. In one embodiment, the first device adapter 270 is supported in the transverse direction (non-load measurement direction) by a bearing 252 that integrally connects the load sensing member 278 and the drive module base member 266.

[0256] Integrated to the drive module base component 266 are mechanical stops 284 and 286 in the proximal and distal longitudinal directions of the load sensing component 278, respectively. In one embodiment, the mechanical stops comprise a single mechanical stop. In one embodiment, the mechanical stops comprise more than one mechanical stop. The mechanical stops 284 are on the side of the drive module base component 266 closest to the load sensor 262 and are separated from each other by a distance greater than the lateral dimension of the load sensor 262 such that they can encompass the load sensor. In one embodiment, the mechanical stops 284 and 286 are bar extensions oriented longitudinally from the drive module base component 266. In one embodiment, the mechanical stops 284 and 286 are flange extensions oriented longitudinally from the drive module base component 266. In one embodiment, the mechanical stops 284 and 286 and the drive module base component 266 are made of the same material as a single piece. In one embodiment, the mechanical stops 284 and 286 and the drive module base component 266 are made of different materials and are integrally connected to form a single piece. The purpose of the mechanical stops 284 is to protect the load sensor 262 from overload, i.e., to protect the load sensor 262 from exposure to forces beyond the working range of the sensor or damage due to forces beyond the upper limit of the sensor when a pushing force is applied to the EMD 250, which is defined herein as “sensor overload protection.” The purpose of the mechanical stops 286 is to limit the range of longitudinal motion of the load sensing component 278 relative to the drive module base component 266 when a pulling force is applied to the EMD 250.

[0257] Referring to Figure 13A , the load sensing system 260 is shown in a neutral position of the load sensing component 278, i.e., no load is applied to the load sensing component 278. In the neutral position, there is no contact between the load sensing component 278 and the mechanical stops 284. Referring to Figure 13B, the load sensing system 260 is shown in the maximum load position of the load sensing member 278, i.e., where the maximum allowable thrust load is applied to the load sensor 262, the load sensing member 278 contacts a mechanical stop 284 at the load sensor 262 of the drive module 264. In one embodiment, a second sensor can be a contact detection sensor to detect contact between the load sensing member 278 and the mechanical stop 284. Different types of sensors can be used as the contact detection sensor, including but not limited to a distance sensor, a load sensor, an optical sensor, an electronic circuit based contact detection sensor. The movement of the load sensing member relative to the mechanical stop 284 is proportional to the load applied to the EMD. With the stiffness of the spring member 280 known, the gap between the load sensing member 278 and the mechanical stop 284 in the unloaded condition, i.e., when the spring member has a neutral length, is selected such that the gap closes at the maximum allowable load due to deflection of the spring member 280. The maximum allowable load is defined as the maximum load that can be accepted to be applied to the load sensor 262.

[0258] The process of automatic calibration of load sensor 262 and overload protection of load sensor 262 includes two steps as follows. Step 1 is to eliminate zero offset. This is achieved by measuring the force from load sensor 262 when no load is applied to EMD 250; i.e. the elastic member 280 has a neutral length. The load indicated by the load sensing system should be zero because no load is applied to EMD 250, and therefore, if the indicated load is non-zero, the load measured by load sensor 262 is reduced by this non-zero value. Step 2 is to calibrate the calibration factor or relationship between the actual force acting on EMD 250 and the force measured by load sensor 262. Starting from the neutral position, the second device-on adapter 274 clamps EMD 250 so that it is stationary. In one embodiment, step 2 is to calibrate any error, if present, between the force measured by load sensor 262 and the actual force acting on EMD 250. Because EMD 250 is stationary, load sensing member 278 is also stationary. Then, force 288 is applied to EMD 250 by driving table translation motor 242 and pushing load sensing member 278, which contains first device-on adapter 270, into elastic member 280. The reaction force of force 288 is in turn applied to elastic member 280. Due to the reaction force of force 288, elastic member 280 deflects (i.e. is compressed). The amount of deflection increases with the magnitude of force 288 until there is hard contact between mechanical stop 284 on the load sensor side and drive module base member 266. A processor (not shown) then compares the measured force from load sensor 262 with force 288, which is known because the stiffness of elastic member 280 is known and the deflection of load sensing member 278 is known (i.e. the initial gap between load sensing member 278 and mechanical stop 284 is known) and applies Hooke's law, i.e. the elastic force is equal to the elastic stiffness times the deflection of the elastic member. The processor is then able to calculate any necessary correction factor to the measured data from load sensor 262 so that load sensor 262 is calibrated.

[0259] In one embodiment, load sensing system 260 does not have a second actuator and the second step of calibration is done by manually pushing load sensing member 278 towards mechanical stop 284 until they make contact. In the contact state, a processor compares the force measured by load sensor 262 with known force 288 and calculates any necessary correction factor to the measured data from load sensor 262 so that load sensor 262 is calibrated.

[0260] In one embodiment, the same method is used for the rotational degree of freedom to perform calibration and overload protection of a torque sensor. In such a system, a mechanical stop and a torsion spring are used, where the mechanical stop limits the angular displacement of load sensing member 278.

[0261] Referring to the above discussion Figure 13A and Figure 13B , a device for calibrating the load sensor 262 is shown, where the drive module 264 includes a drive module base component 266, a load sensing component (not shown), the load sensor 262, and a resilient component 280 having a known stiffness. The resilient component 280 is intermediate the load sensor 262 and the drive module base component 266. A cartridge 268 is removably secured to the drive module 264. The cartridge 268 includes a housing and an isolation component movable within the housing, and is configured to receive an elongated medical device (EMD) 250.

[0262] In one embodiment, a mechanical stop 284 limits movement of the isolation component relative to one of the housing and the drive module base component 266 in the direction of the resilient component 280, thereby limiting the maximum deflection of the resilient component 280 to a known distance between the mechanical stop 284 and the isolation component. In one embodiment, the distance between the mechanical stop 284 and the load sensing component is predetermined to limit the maximum load applied to the load sensor 262, such that the load sensor 262 is protected from overloading.

[0263] In one embodiment, the second sensor detects contact between the load sensing member and the mechanical stop 284. In one embodiment, the second sensor is a motion sensor. In one embodiment, the processor is used to determine and remove a zero offset from the measurements of the load sensor 262, where the zero offset refers to a bias in the measured load that indicates an apparent load when no load is applied. The process of sensor calibration corrects for the zero offset so that the load sensing system indicates zero load when no load is applied. In one embodiment, the processor is used to correct the calibration factor by comparing the measured load to a known load. In one embodiment, calibration of the load sensor 262 is accomplished manually by pushing the load sensing member toward one or more mechanical stops 284 until it contacts the one or more mechanical stops 284. In one embodiment, calibration of the load sensor 262 is accomplished automatically. In one embodiment, calibration of the load sensor 262 is accomplished automatically by the mechanism used to clamp the EMD 250. In one embodiment, calibration of the load sensor 262 is accomplished automatically by the mechanism used to clamp the EMD 250, where the EMD 250 is supported by the device support. In one embodiment, calibration of the load sensor 262 is accomplished automatically by using a locking mechanism to secure the load sensing member in place independent of the drive module base member 266. In one embodiment, calibration of the load sensor 262 is accomplished automatically and there is overload protection of the load sensor 262 and the load sensor 262 measures axial force on the EMD 250. In one embodiment, calibration of the load sensor 262 is accomplished automatically and there is overload protection of the load sensor 262 and the load sensor 262 measures torque about the longitudinal axis of the EMD 250 on the EMD 250. In one embodiment, calibration of the load sensor 262 is accomplished automatically and there is overload protection of the load sensor 262 and the load sensor 262 measures axial force on the EMD 250 and measures torque about the longitudinal axis of the EMD 250 on the EMD 250.

[0264] Referring to Figure 14A and Figure 14B the components of the load sensing system are the same as the components of the load sensing system of Figure 13A and Figure 13B except for the alternative embodiments of the first device adapter 270.

[0265] Referring to Figure 14A and Figure 14B, a load sensing system with automatic calibration of its load sensor and overload protection includes a first device on adapter 270 that is a tire drive mechanism 292 and a clip 294. The tire drive mechanism 292 is driven by a drive actuator 296 mounted on a drive module base component 266. The drive actuator 296 transmits power to the tire drive mechanism 292 through a power train medium 298 that does not exert a significant force on the load sensing component in the direction of measurement (e.g. no force in the direction of the X axis). In one embodiment, the power train medium 298 is a belt that is wrapped around and driven by a pulley attached to the drive actuator 296.

[0266] Referring to Figure 14A , which is an alternative embodiment of Figure 13A , the load sensing system is shown in a neutral position of the load sensing component 278, i.e. no load is applied to the load sensing component 278. Referring to Figure 14B , which is an alternative embodiment of Figure 13B , the load sensing system is shown in a maximum load position of the load sensing component 278, i.e. a maximum allowable load is applied to the load sensor 262.

[0267] Referring to Figure 14A and Figure 14B , the process for automatic calibration of the load sensor 262 and overload protection of the load sensor 262 is the same as described above for the load sensing system of Figure 13A and Figure 13B .

[0268] Referring to Figure 15A and Figure 15B , an alternative embodiment of a load sensing system with automatic calibration of its load sensor and overload protection includes the same components as the load sensing system of Figure 14A and Figure 14B . In this alternative embodiment, the tire drive mechanism 292 is driven by a drive actuator 296 mounted to the load sensing component 278. In one embodiment, the drive actuator 296 is mounted inside the load sensing component 278.

[0269] Referring to Figure 15A , which is an alternative embodiment of Figure 14A , the load sensing system is shown in a neutral position of the load sensing component 278. Referring to Figure 15B , which is an alternative embodiment of Figure 14B , the load sensing system is shown in a maximum load position of the load sensing component 278.

[0270] Referring to Figure 15A and Figure 15B, the process for automatic calibration of load sensor 262 and overload protection of load sensor 262 is the same as described above for the load sensing system of Figure 13A and Figure 13B .

[0271] Referring to Figure 16A and Figure 16B , an alternative embodiment of a load sensing system having automatic calibration and overload protection of its load sensor includes a locking member 300 that reversibly fixes the longitudinal position of load sensing member 278 relative to stage drive mechanism 210 while stage translation motor 242 translates drive module 264 along stage drive mechanism 210. Longitudinal motion of load sensing member 278 is prevented by seating locking member 300 into a pocket 302 in load sensing member 278. In one embodiment, locking member 300 is a locking pin. In one embodiment, locking member 300 is a flange. In one embodiment, locking member 300 is a protrusion or bump of a linkage. In one embodiment, locking member 300 locks load sensing member 278 by friction.

[0272] Locking member 300 is constrained for linear motion in the lateral direction (actuated and controlled by a system not shown). In one embodiment, locking member 300 is constrained for linear motion by a linear bearing. In one embodiment, locking member 300 is constrained for linear motion by a guide. In one embodiment, linear motion of locking member 300 is achieved by rotation of a screw.

[0273] Referring to Figure 16A , which is an alternative embodiment of Figure 14A , the load sensing system is shown in a neutral position of load sensing member 278. Load sensing member 278 is supported in the longitudinal direction by load sensor and spring members, and is constrained in the lateral direction by a linear bearing (not shown) that integrally connects load sensing member 278 and drive module base member 266. Referring to Figure 16B , which is an alternative embodiment of Figure 14B , the load sensing system is shown in a loaded position of load sensing member 278.

[0274] Referring to Figure 16A and Figure 16B , the process for automatic calibration of load sensor 262 and overload protection of load sensor 262 is similar to that described above for the load sensing system of Figure 13A and Figure 13B , where fixation of the position of load sensing member 278 is achieved by seating locking member 300 into pocket 302, thereby preventing longitudinal motion of load sensing member 278.

[0275] Referring toFigure 17 and Figure 18 The processor or processing unit corrects the load measurement for parasitic loads that disrupt the measurement of the actual load acting on the EMD, where the parasitic loads can include, but are not limited to, frictional loads, inertial loads, resistance loads, and gravitational loads.

[0276] While the present disclosure has been described with reference to example embodiments, it will be recognized by those of skill in the art that changes can be made in form and detail without departing from the spirit and scope of the defined subject matter. For example, although different example embodiments have been described as including one or more features, it will be recognized that such features can be interchanged or otherwise combined with one another. The described disclosure is intended to be as broad as possible. For example, unless otherwise specified, the definition of a recited term is intended to encompass both singular and plural forms of that term.

Claims

1. An apparatus for use in a medical procedure system, comprising: a collet having a first portion with a first collet coupler connected thereto; and a second portion with a second collet coupler connected thereto; an elongated medical device removably positioned within a path defined by the collet; a drive module including a first actuator operatively coupled to the first collet coupler to operatively clamp and unclamp the elongated medical device in the path and rotate the elongated medical device and a second actuator operatively engaged with the second collet coupler; a first load sensor to determine a first collet coupler torque acting on the first collet coupler; and a processor to determine an elongated medical device torque acting on the elongated medical device from a first signal from the first load sensor, and wherein the second collet coupler operatively clamps and unclamps the elongated medical device in the path to rotate the elongated medical device; and the apparatus further comprising a second load sensor to determine a second collet coupler torque acting on the second collet coupler; wherein the processor determines the elongated medical device torque acting on the elongated medical device from the first signal from the first load sensor and a second signal from the second load sensor.

2. The apparatus of claim 1, wherein the second actuator operatively engages and disengages the second collet coupler to prevent and allow rotation of the second collet coupler, respectively. Rotation of the first collet coupler and rotation of the second collet coupler can be used independently and / or in combination to operatively clamp and unclamp the elongated medical device in the path and / or rotate the elongated medical device clockwise and counterclockwise.

4. The apparatus of claim 1, wherein the processor determines a net collet torque applied to the collet for clamping and / or unclamping the elongated medical device.

3. The apparatus of claim 1, wherein, 5. The apparatus of claim 4, wherein the elongated medical device torque is related to a clamping force on the elongated medical device.

6. The apparatus of claim 5, wherein the first load sensor is positioned between the first actuator and the first collet coupler and the second load sensor is positioned between the second actuator and the second collet coupler.

7. The apparatus of claim 5, wherein the first load sensor is positioned between the first actuator and a housing of the drive module.

8. The apparatus of claim 5, wherein the second load sensor is positioned between the second actuator and a housing of the drive module. The first load sensor is mounted on a capstan of the first actuator. The first load sensor includes a first torque sensor rotating portion mounted on a capstan of the first actuator and a first torque sensor housing mounted to a housing of the first actuator, the housing of the first actuator being fixed to the drive module.

9. The apparatus of claim 1, wherein, ​ 10. The apparatus of claim 1, wherein, ​ 11. The apparatus of claim 1, wherein the second load sensor comprises a second torque sensor rotating portion and a second torque sensor housing, the second torque sensor rotating portion mounted on a capstan of the second actuator, the second torque sensor housing mounted to a housing of the second actuator, the housing of the second actuator fixed to the drive module.

12. The apparatus of claim 1, wherein the first load sensor is placed in line with a capstan shaft driven by the first actuator, wherein the first load sensor rotates with the actuator shaft.

13. The apparatus of claim 4, wherein the net collet torque is the relative torque between a first torque on the first collet coupler due to the first actuator and a second torque on the second collet coupler due to the second actuator.

14. The apparatus of claim 7, wherein, the first load sensor placed between the first actuator and a drive module base component of the drive module housing, wherein the first load sensor supports the first actuator in at least one direction.

15. The apparatus of claim 1, wherein the first actuator continuously engages the first portion of the collet and the second actuator engages a lock / unlock mechanism to lock the second portion of the collet.

Images