System and device that operate elongated medical device in robot catheter type treatment system

Abstract

To provide a system and a device that operate an elongated medical device by a robot drive device.SOLUTION: A cassette 200 used in a robot drive device of a catheter-based treatment system includes: a housing 206 including a cradle 220 configured to receive an elongated medical device having a longitudinal direction device shaft 218; a connection mechanism 210 connected to the housing 206 at a position lower than the longitudinal direction device shaft 218; and a cover 208 rotatably connected to the housing 206 by the connection mechanism 210.SELECTED DRAWING: Figure 12

Description

[Technical Field]

[0001] The present invention relates generally to the field of robotic medical procedure systems, and more particularly to systems and apparatus for manipulating elongated medical devices with robotic drives. [Background technology]

[0002] Catheters and other elongated medical devices (EMDs) are used in minimally invasive medical procedures for the diagnosis and treatment of various vascular diseases, including neurovascular intervention (NVI), also known as neurointerventional surgery, percutaneous coronary intervention (PCI), and peripheral vascular intervention (PVI). These procedures typically involve navigating a guidewire through the vascular system and advancing a catheter using the guidewire to perform the treatment. Catheter-based procedures begin with standard percutaneous techniques to gain access to an appropriate vessel, such as an artery or vein, using an introducer sheath. A sheath or guide catheter is then advanced through the introducer sheath using a diagnostic guidewire to a primary location, such as the internal carotid artery for NVI, the coronary ostia for PCI, or the superficial femoral artery for PVI. A guidewire appropriate for the vascular system is then navigated through the sheath or guide catheter to the target location within the vascular system. In situations such as tortuous anatomy, a support catheter or microcatheter is inserted over the guidewire to aid in guidewire navigation. An operator, such as a physician, can use an imaging system (e.g., a fluoroscopy device) to obtain contrast-injected cines and select a fixed frame to use as a roadmap for navigating the guidewire or catheter to a target location, e.g., a lesion. Contrast-enhanced images are also obtained while the operator advances the guidewire or catheter, allowing the operator to verify that the device is moving along the correct path toward the target location. While observing the anatomy using fluoroscopy, the operator manipulates the proximal end of the guidewire or catheter, directing the distal tip into the appropriate vessel and toward the target anatomical location (e.g., a lesion), avoiding side branches.

[0003] Robotic catheter-based treatment systems have been developed to assist physicians in performing catheter-based procedures, such as neurovascular intervention (NVI), peripheral coronary intervention (PCI), and percutaneous coronary intervention (PVI). Examples of NVI procedures include coil embolization of aneurysms, liquid embolization of arteriovenous malformations, and mechanical thrombectomy of large vessel occlusions in the setting of acute ischemic stroke. In NVI procedures, physicians use a robotic system to control the manipulation of neurovascular guidewires and microcatheters to gain access to target lesions and administer treatments that restore normal blood flow. Access to the target is enabled by a sheath or guide catheter, but intermediate catheters may be required for more distal areas or to provide adequate support for the microcatheter and guidewire. The distal tip of the guidewire is navigated into or past the lesion, depending on the lesion and type of treatment. When treating an aneurysm, a microcatheter is advanced into the lesion, the guidewire is removed, and several embolic coils are placed through the microcatheter into the aneurysm and used to occlude blood flow into the aneurysm. When treating arteriovenous malformations, liquid emboli are injected into the malformation via a microcatheter. Mechanical thrombectomy for treating vascular occlusions is accomplished by either aspiration or the use of a stent retriever. Depending on the location of the thrombus, aspiration is performed via an aspiration catheter or, in the case of small arteries, via a microcatheter. Once the aspiration catheter is in the lesion, negative pressure is applied through the catheter to remove the thrombus. Alternatively, the thrombus can be removed by placing a stent retriever through the microcatheter. After the thrombus is entangled with the stent retriever, it is retrieved by retracting the stent retriever and microcatheter (or intermediate catheter) into the guide catheter.

[0004] During PCI, physicians use a robotic system to manipulate a coronary guidewire to access the lesion, perform treatment, and restore normal blood flow. Access is achieved by seating a guide catheter in the coronary artery ostium. The distal tip of the guidewire is navigated to the lesion, and a microcatheter can be used to properly support the guidewire due to complex anatomy. Blood flow is restored by delivering and deploying a stent or balloon into the lesion. Lesions may require pre-treatment before stent placement, with a balloon delivered to pre-dilatate the lesion, or atherectomy is performed, for example, using a laser or rotational atherectomy catheter and balloon over the guidewire. Imaging and physiological measurements can be performed to determine the appropriate treatment using an imaging catheter or fractional flow reserve (FFR) measurements.

[0005] In PVI, physicians use a robotic system to perform the procedure and restore blood flow using techniques similar to NVI. The distal tip of a guidewire is navigated to the lesion, and a microcatheter is used to properly support the guidewire in complex anatomical structures. A stent or balloon is delivered and deployed at the lesion to restore blood flow. As with PCI, pre-treatment and imaging of the lesion are also used.

[0006] Over-the-wire (OTW) catheters or coaxial systems are used when support at the distal end of the catheter or guidewire is required, for example, to navigate a tortuous or calcified vasculature, reach a distal anatomical location, or cross a sclerotic lesion. OTW catheters have a guidewire lumen that extends the entire length of the catheter. This provides support for the guidewire along its entire length, resulting in a relatively stable system. However, this system has several drawbacks compared to rapid exchange catheters (described below), including increased friction and a longer overall length. Typically, to remove or exchange an OTW catheter while maintaining the position of the indwelling guidewire, the exposed length of the guidewire (exiting from the patient) must be longer than that of the OTW catheter. A 300 cm guidewire is generally sufficient for this purpose and is often referred to as an exchange-length guidewire. Due to this guidewire length, two operators are required to remove or exchange an OTW catheter. This becomes even more difficult when using triple-coaxial systems, known in the art as triaxial systems (although quadruple-coaxial catheters have also been known to be used). However, due to their stability, OTW systems are often used in NVI and PVI procedures. Meanwhile, rapid exchange (or monorail) catheters are often used in PCI procedures. The guidewire lumen of a rapid exchange catheter only runs through the distal portion of the catheter, called the monorail or rapid exchange (RX) section. Operators using RX systems manipulate the interventional devices parallel to each other (as opposed to the tandem configuration of devices in OTW systems), and the exposed length of the guidewire only needs to be slightly longer than the RX section of the catheter. Rapid exchange guidewires are typically 180–200 cm long. Given the short length of the guidewire and monorail, RX catheters can be exchanged by a single operator. However, RX catheters are often inappropriate when more distal support is needed. Summary of the Invention

[0007] In one aspect, a cassette for use with a robotic drive of a catheter-based treatment system includes a housing including a cradle configured to receive an elongated medical device having a longitudinal device axis, a connection mechanism coupled to the housing at a location below the longitudinal device axis, and a cover pivotally coupled to the housing using the connection mechanism.

[0008] In another aspect, a cassette for use with a robotic drive device of a catheter-based treatment system includes a housing having a distal end and a proximal end, the housing including a cradle configured to receive an elongated medical device having a longitudinal device axis, a saddle disposed at the proximal end of the housing and configured to receive and restrain a hemostasis valve connected to the elongated medical device, a connection mechanism connected to the housing at a position below the longitudinal device axis, and a cover pivotally connected to the housing using the connection mechanism.

[0009] In another aspect, a robotic drive system for driving one or more elongated medical devices includes a linear member, a device module coupled to the linear member, a distal support arm having a device support connection located distal to the device module, an introducer interface support coupled to the device support connection and having a flexible tube, and an introducer sheath coupled to the introducer interface support. [Brief explanation of the drawings]

[0010] The present invention will be better understood from the following detailed description taken in conjunction with the following drawings, in which like reference numerals refer to like parts and in which: [Figure 1] 1 is a perspective view of a catheter-based treatment system according to an embodiment. [Figure 2] 1 is a schematic block diagram of a catheter-based treatment system according to an embodiment. [Figure 3] FIG. 1 is a perspective view of a robotic drive unit of a catheter-based treatment system according to an embodiment. [Figure 4]1 is a diagram illustrating the operating axis of an elongated medical device and the insertion point within a patient. [Figure 5] 5A and 5B are diagrams illustrating the influence of the thickness of the robot drive unit on the loss of working length. [Figure 6] FIG. 10 is a diagram illustrating an example of an orientation that minimizes loss of working length. [Figure 7] FIG. 10 is a perspective view of a device module including a cassette mounted upright in an upright position according to an embodiment. [Figure 8] FIG. 10 is a rear perspective view of a device module with cassettes mounted upright in an upright position according to an embodiment. [Figure 9] FIG. 10 is an end view of the distal end of an embodiment of a device module with a cassette mounted upright. [Figure 10] FIG. 10 is an end view of the distal end of a device module with a horizontally mounted cassette, according to an embodiment. [Figure 11] FIG. 10 is a front view of an embodiment of a cassette and an elongated medical device. [Figure 12] FIG. 10 is a perspective view of an embodiment of a cassette configured for vertical mounting to a drive module. [Figure 13] 1 is a perspective view of an elongated medical device, according to an embodiment. [Figure 14] 1 is a perspective view of an example cassette and elongated medical device with the cover in an open position. FIG. [Figure 15] 1 is a perspective view of an example cassette with an elongated medical device positioned on the cassette cover in an open position before the elongated medical device is loaded into the cassette; FIG. [Figure 16] FIG. 10 is a front view of an example cassette with the cover in an open position and an elongated medical device loaded into the cassette. [Figure 17] 1 is a perspective view of an introducer interface support, according to an embodiment. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0011] The following definitions are used herein: An elongate medical device (EMD) refers to, but is not limited to, catheters (e.g., guide catheters, microcatheters, balloon / stent catheters), wire-over-the-wire devices (e.g., guidewires, embolic coils, stent retrievers), and devices comprising combinations thereof. Wire-over-the-wire EMDs include, but are not limited to, guidewires, microwires, proximal pushers for embolic coils, stent retrievers, self-expanding stents, and flow diverters. Typically, wire-over-the-wire EMDs do not have a hub or handle at their proximal end. In one embodiment, an EMD comprises a catheter having a hub at the proximal end of the catheter and a flexible shaft extending from the hub toward the distal end of the catheter, the shaft being more flexible than the hub. In one embodiment, the catheter includes a transition section between the hub and the shaft, the flexibility of which is softer than the hub and stiffer than the shaft. In one embodiment, the transition section is a strain relief.

[0012] "Distal" and "proximal" define the relative location of two separate parts. In the context of a robotic drive, "distal" and "proximal" are defined by the intended placement of the robotic drive relative to the patient. When used to define relative location, the distal portion is the portion of the robotic drive that is closer to the patient than the proximal portion when the robotic drive is in its intended placement. Within the patient, vascular landmarks that are farther along a path from an access point are considered more distal than landmarks closer to the access point. The access point is the point at which the EMD enters the patient. Similarly, the proximal portion is the portion of the robotic drive that is farther from the patient than the distal portion when the robotic drive is in its intended placement. When used to define direction, the distal direction refers to the path that something is moving or is moving to, or the path that something is pointing or pointing from the proximal portion toward the distal portion and / or the patient when the robotic drive is in its intended placement. The proximal direction is the opposite direction of the distal direction.

[0013] The longitudinal axis (longitudinal axis, long axis) of a member (EMD or other element of a catheter-based treatment system) is the direction from the proximal portion of the member to the distal portion of the member. For example, the longitudinal axis of a guidewire is the direction from the proximal portion of the guidewire to the distal portion of the guidewire, even if the guidewire is nonlinear in the relevant section. Axial movement of a member refers to translation (translation) of the member along its longitudinal axis. When the distal end of the EMD is axially moved distally along the longitudinal axis of the EMD, into or further into the patient, the EMD is being advanced. When the distal end of the EMD is axially moved proximally along the longitudinal axis of the EMD, out or further out of the patient, the EMD is being withdrawn. Rotational movement of a member refers to a change in the angular orientation of the member about its local longitudinal axis. The rotational motion of the EMD corresponds to the clockwise or counterclockwise rotation of the EMD about its longitudinal axis due to an applied torque.

[0014] "Axial insertion" means inserting a first member into a second member along the longitudinal axis of the second member. "Lateral insertion" means inserting a first member into a second member along a direction in a plane intersecting the longitudinal axis of the second member. Lateral insertion may also be referred to as radial loading or side loading. "Pinch" means removably securing an EMD to a member so that the EMD and member move together when the member moves. "Unpinch" means releasing an EMD from a member so that the EMD and member move independently when the member moves. "Clamp" means removably securing an EMD to a member so that movement of the EMD is constrained relative to the member. The member may be fixed with respect to a global coordinate system or a local coordinate system. "Unclamp" means releasing an EMD from a member so that the EMD can move independently.

[0015] "Grip" refers to the application of a force or torque to an EMD by a drive mechanism that moves the EMD without slip in at least one degree of freedom. "Ungrip" refers to the release of a force or torque applied to the EMD by a drive mechanism so that the position of the EMD is no longer constrained. In one example, an EMD gripped between two tires can rotate about its longitudinal axis as the tires move longitudinally relative to each other. The rotational movement of the EMD is distinct from the movement of the two tires. The position of the gripped EMD is constrained by the drive mechanism. "Buckling" refers to the tendency of a flexible EMD under axial compression to bend away from its longitudinal axis or away from the desired path of advancement. In one embodiment, axial compression occurs in response to resistance due to navigation within the vascular system. The distance an EMD can be driven along its longitudinal axis without support before buckling is referred to herein as the device buckling distance. The device buckling distance is related to the device's stiffness, shape (including but not limited to diameter), and the force applied to the EMD. Buckling can cause the EMD to form a bow that deviates from the desired path. "Kink" is an example of buckling when deformation of the EMD creates strain that is inelastic and cannot be corrected.

[0016] "Top" refers to the general direction opposite to the direction of gravity, and "bottom" refers to the general direction in the direction of gravity. "Inside" refers to a location within a specific part. "Outside" refers to a location outside a specific part. "Front" refers to the side of the robotic drive (or element of the robotic drive, or other element of a catheterization system) facing the user at the bedside and away from a positioning system such as an articulated arm. "Rear" refers to the side of the robotic drive (or element of the robotic drive, or other element of a catheterization system) closest to a positioning system such as an articulated arm. "Sterile interface" refers to the interface or boundary between a sterile unit and a non-sterile unit. For example, a cassette can be the sterile interface between the robotic drive and at least one EMD. "Sterilizable unit" refers to a device that can be sterilized (free from pathogenic microorganisms). This includes, but is not limited to, cassettes, consumable units, drapes, device adapters, and sterilizable drive modules / units (which may contain electromechanical components). Sterilizable units may come into contact with the patient, other sterile devices, or anything placed in the sterile field of a medical procedure.

[0017] "On-device adapter" means a sterile device that can releasably pinch an EMD to provide a drive interface. For example, an on-device adapter is also known as an end effector or EMD capture device. In one non-limiting example, the on-device adapter is a collet that is robotically actuated to rotate the EMD about its longitudinal axis, pinch and / or unpinch the EMD into the collet, and / or translate the EMD along its longitudinal axis. In one example, the on-device adapter is a hub drive mechanism, such as a driven gear disposed on the hub of the EMD.

[0018] FIG. 1 is a perspective view of an example of a catheter-based treatment system 10. The catheter-based treatment system 10 is used to perform catheter-based medical procedures, such as percutaneous interventional procedures such as percutaneous coronary intervention (PCI) (e.g., for treating STEMI), neurovascular interventional procedures (NVI) (e.g., for treating emergency large vessel occlusion (ELVO)), and peripheral vascular interventional procedures (PVI) (e.g., for critical limb ischemia (CLI)). Catheter-based medical procedures include diagnostic catheterization procedures that use one or more catheters or other elongated medical devices (EMDs) to assist in diagnosing a patient's disease. For example, in one example of a catheter-based diagnostic procedure, a contrast agent is injected through a catheter into one or more arteries to obtain images of the patient's vascular system. Catheter-based medical procedures also include catheter-based therapeutic procedures that use a catheter (or other EMD) to treat a disease (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, thrombectomy, treatment of arteriovenous malformations, treatment of aneurysms, etc.). The therapeutic procedure may be enhanced by the inclusion of ancillary devices 54 (shown in FIG. 2 ), such as, for example, intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. However, one of ordinary skill in the art will recognize that the particular percutaneous interventional devices or components (e.g., guidewire type, catheter type, etc.) may be selected based on the type of procedure to be performed. The catheter-based treatment system 10 can accommodate, with minor adjustments, the specialized percutaneous interventional devices used in the procedure and can perform any catheter-based medical procedure.

[0019] The catheter-based treatment system 10 includes, among other elements, a bedside unit 20 and a control station 26. The bedside unit 20 includes a robotic drive 24 and a positioning system 22 positioned next to the patient 12. The patient 12 is positioned on a patient table 18. The positioning system 22 is used to position and support the robotic drive 24. The positioning system 22 may be, for example, a robotic arm, an articulating arm, a holder, or the like. The positioning system 22 may be attached at one end to, for example, a rail, a base, or a cart of the patient table 18. The robotic drive 24 is attached to the other end of the positioning system 22. The positioning system 22 (together with the robotic drive 24) can be retracted to allow the patient 12 to be positioned on the patient table 18. After the patient 12 is positioned on the patient table 18, the positioning system 22 is used to position (secure) the robotic drive 24 relative to the patient 12 for treatment. In one embodiment, the patient table 18 is supported and operatively mounted on a pedestal 17 that is mounted to the floor and / or ground. The patient table 18 can move with multiple degrees of freedom, e.g., roll, pitch, and yaw, relative to the pedestal 17. The bedside unit 20 can also include a control and display 46 (shown in FIG. 2). For example, the control and display can be located on the housing of the robotic drive 24.

[0020] Generally, the robotic drive 24 is equipped with appropriate percutaneous interventional devices and accessories 48 (shown in FIG. 2 ) (e.g., guidewires, various catheters including balloon catheters, stent delivery systems, stent retrievers, embolization coils, liquid emboli, suction pumps, contrast and drug delivery devices, hemostasis valve adapters, syringes, stopcocks, inflation devices, etc.) to enable an operator (user) 11 to perform a catheter-based medical procedure using the robotic system by operating various controls, such as controls and input devices, located at the control station 26. The bedside unit 20, and particularly the robotic drive 24, may include any and / or combination of components to provide the bedside unit 20 with the functionality described herein. The operator 11 of the control station 26 is referred to as the control station operator (user), and is referred to herein as the operator (user). The operator (user) of the bedside unit 20 is referred to as the bedside unit operator (user). The robotic drive 24 includes multiple device modules 32a-d mounted on rails or linear members 60 (shown in FIG. 3 ). The rails or linear members 60 guide and support the device modules. Each of the device modules 32a-d can be used to drive an EMD, such as a catheter or guidewire. For example, the robotic drive 24 can be used to automatically feed a guidewire into a diagnostic catheter and into a guide catheter in an artery of the patient 12. One or more devices, such as an EMD, enter the body (e.g., a blood vessel) of the patient 12 at an insertion point 16, for example, via an introducer sheath.

[0021] The bedside unit 20 communicates with a control station 26, which transmits signals generated by user inputs at the control station 26 to the bedside unit 20, either wirelessly or via a wired connection, allowing the bedside unit 20 to control various functions. As described below, the control station 26 includes or is connected to the bedside unit 20 via a control computing system 34 (shown in FIG. 2). The bedside unit 20 may also provide feedback signals (e.g., load, speed, operating conditions, warning signals, error codes, etc.) to the control station 26 and / or the control computing system 34. Communication between the control computing system 34 and each component of the catheter-based treatment system 10 is provided via a communication link, which may be a wireless connection, a wired connection, or any other means that allows communication between the components. The control station 26 or other similar control system may be located at either a local site (e.g., local control station 38 in FIG. 2) or a remote site (e.g., remote control station and computing system 42 in FIG. 2). The catheterization system 10 can be operated by a local site control station, a remote site control station, or both a local and a remote control station simultaneously. At a local site, the operator 11 and control station 26 are located in the same room as the patient 12 and bedside unit 20 or in an adjacent room. As used herein, the local site is the location of the bedside unit 20 and patient 12 or subject (e.g., an animal or cadaver), and the remote site is the location of the operator 11 and control station 26 used to remotely control the bedside unit 20. The remote site control station 26 (and controlling computing system) and the local site bedside unit 20 and / or controlling computing system communicate over a communications system and services 36 (shown in FIG. 2), e.g., via the Internet.In one embodiment, the remote site and the local (patient) site are separate from one another, for example, in different rooms in the same building, different buildings in the same city, different cities, or other different locations where the remote site does not have physical access to the bedside unit 20 and / or patient 12 at the local site.

[0022] The control station 26 typically includes one or more input modules 28 configured to receive user inputs for operating each component or system of the catheter-based procedure system 10. In the illustrated embodiment, the control station 26 enables the operator 11 to control the bedside unit 20 to perform a catheter-based medical procedure. For example, the input module 28 is configured to cause the bedside unit 20 to perform various tasks using a percutaneous interventional device (e.g., an EMD) in conjunction with the robotic drive 24 (e.g., advance, retract, or rotate a guidewire; advance, retract, or rotate a catheter; inflate or deflate a balloon placed in the catheter; deploy and / or deploy a stent; deploy and / or deploy a stent retriever; deploy and / or deploy a coil; inject contrast into the catheter; inject a liquid embolus into the catheter; inject a drug or saline into the catheter; perform catheter aspiration; or perform any other function that may be performed as part of a catheter-based medical procedure). The robotic drive system 24 includes various drive mechanisms for moving (eg, axially and rotationally) the components of the bedside unit 20, including the percutaneous interventional devices.

[0023] In one embodiment, the input module 28 includes one or more touchscreens, joysticks, scroll wheels, and / or buttons. In addition to the input module 28, the control station 26 can use additional user controls 44 (shown in FIG. 2), such as a footswitch or a microphone for voice commands. The input module 28 is configured to advance, retract, or rotate various components and various percutaneous interventional devices, such as a guidewire and one or more catheters or microcatheters. The buttons include, for example, an emergency stop button, a magnification button, a device selection button, and an automatic activation button. When the emergency stop button is pressed, power (e.g., electrical power) is cut off or removed from the bedside unit 20. When in speed control mode, the magnification button acts to increase or decrease the speed at which the associated component moves in response to manipulation of the input module 28. When in position control mode, the magnification button changes the mapping between input distance and output commanded distance. The device selection button allows the operator 11 to select which of the percutaneous interventional devices loaded into the robotic drive 24 will be controlled by the input module 28. The automatic activation button is used to execute algorithmic operations that the catheter-based treatment system 10 can perform on the percutaneous interventional device without receiving direct commands from the operator 11. In one embodiment, the input module 28 includes one or more controllers or icons (not shown) displayed on a touchscreen (which may or may not be part of the display 30) that, when activated, activate components of the catheter-based treatment system 10. The input module 28 may also include balloon or stent controls configured to inflate or deflate a balloon and / or deploy a stent. Each of the input modules 28 includes one or more buttons, scroll wheels, joysticks, touchscreens, etc., which may be used to dedicatedly control one or more specific components.Additionally, one or more touchscreens display one or more icons (not shown) associated with each portion of the input module 28 or each component of the catheter-based treatment system 10 .

[0024] The control station 26 includes a display 30. In one embodiment, the control station 26 may include two or more displays 30. The display 30 is configured to display information or patient-specific data to the operator 11 located at the control station 26. For example, the display 30 may be configured to display image data (e.g., X-ray images, MRI images, CT images, ultrasound images, etc.), hemodynamic data (e.g., blood pressure, heart rate, etc.), patient chart information (e.g., medical history, age, weight, etc.), and lesion or treatment evaluation data (e.g., IVUS, OCT, FFR, etc.). The display 30 may also be configured to display procedure-specific information (e.g., procedure checklists, recommendations, duration of procedure, catheter or guidewire position, amount of drug or contrast delivered, etc.). The display 30 may also be configured to display information to provide functionality associated with the control computing system 34 (shown in FIG. 2 ). The display 30 may also have touchscreen capabilities to provide some of the user input functionality of the system.

[0025] The catheter-based procedure system 10 also includes an imaging system 14. The imaging system 14 may be any medical imaging system (e.g., non-digital x-ray, digital x-ray, CT, MRI, ultrasound, etc.) that may be used in conjunction with a catheter-based medical procedure. In one embodiment, the imaging system 14 is a digital x-ray imager in communication with a control station 26. In one embodiment, the imaging system 14 includes a C-arm (shown in FIG. 1 ) that allows the imaging system 14 to partially or fully rotate around the patient 12 to obtain images at various angular positions relative to the patient 12 (e.g., sagittal, caudal, anterior-posterior, etc.). In one embodiment, the imaging system 14 is a fluoroscopy system that includes a C-arm having an x-ray source 13 and a detector 15, also known as an image intensifier.

[0026] The imaging system 14 is configured to capture x-ray images of appropriate regions of the patient 12 during a procedure. For example, the imaging system 14 may be configured to capture one or more x-ray images of the head to diagnose a neurovascular condition. The imaging system 14 may also be configured to capture one or more x-ray images (e.g., real-time images) during a catheter-based medical procedure to assist the operator 11 at the control station 26 in properly positioning a guidewire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, or the like during the procedure. One or more images are displayed on the display 30. For example, the images may be displayed on the display 30 to enable the operator 11 to accurately move a guide catheter or guidewire to the appropriate position.

[0027] For clarity of orientation, a Cartesian coordinate system is presented with X, Y, and Z axes. The positive X axis points in the longitudinal (axial) distal direction, i.e., from the proximal end to the distal end, or in other words, from proximal to distal. The Y and Z axes lie in a plane transverse to the X axis, with the positive Z axis pointing upward, i.e., opposite the direction of gravity, and the Y axis being automatically determined by the right-hand rule.

[0028] FIG. 2 is a block diagram of one embodiment of a catheter-based treatment system 10. The catheter-based treatment system 10 includes a control computing system 34. The control computing system 34 may be physically part of, for example, the control station 26 (shown in FIG. 1). The control computing system 34 is typically an electronic control unit suitable for providing the catheter-based treatment system 10 with the functionality described herein. For example, the control computing system 34 may be an embedded system, a dedicated circuit, or a general-purpose system programmed with the functionality described herein. The control computing system 34 communicates with the bedside unit 20, communication systems and services 36 (e.g., the Internet, firewalls, cloud services, session managers, hospital networks, etc.), a local control station 38, additional communication systems 40 (e.g., telepresence systems), remote control stations and computing systems 42, and patient sensors 56 (e.g., electrocardiogram (ECG) devices, electroencephalogram (EEG) devices, blood pressure monitors, temperature monitors, heart rate monitors, respiratory monitors, etc.). The control computing system also communicates with the imaging system 14, the patient table 18, additional medical systems 50, a contrast injection system 52, and auxiliary devices 54 (e.g., IVUS, OCT, FFR, etc.). The bedside unit 20 includes the robotic drive 24 and the positioning system 22 and may also include additional controls and a display 46. As described above, the additional controls and displays may be located on the housing of the robotic drive 24. Interventional devices and auxiliary equipment 48 (e.g., guidewires, catheters, etc.) are connected to the bedside system 20. In one embodiment, the interventional devices and auxiliary equipment 48 include dedicated devices (e.g., IVUS catheters, OCT catheters, FFR wires, contrast diagnostic catheters, etc.) that connect to the respective auxiliary devices 54, i.e., IVUS systems, OCT systems, FFR systems, etc.

[0029] In one embodiment, the control computing system 34 is configured to generate control signals based on user interaction with an input module 28 (e.g., of a control station 26 (shown in FIG. 1 ), such as a local control station 38 or a remote control station 42) and / or based on information accessible to control the control computing system 34 to perform a medical procedure using the catheter-based treatment system 10. The local control station 38 includes one or more displays 30, one or more input modules 28, and additional user controls 44. The remote control station and the computing system 42 may include similar components to the local control station 38. The remote control station 42 and the local control station 38 may be different, tailored to the functionality desired for each. The additional user controls 44 may include, for example, one or more foot-input controllers. The foot-input controllers may be configured to allow the operator to select functions of the imaging system 14, such as turning x-rays on and off or scrolling through multiple stored images. In one embodiment, the foot-input device may be configured to allow the operator to select a device mapped to a scroll wheel included in the input module 28. Additional communication systems 40 (e.g., voice, video, telepresence, etc.) may be employed to assist the operator in communicating with the patient, medical staff (e.g., angiography suite staff), and / or equipment near the bedside.

[0030] The catheter-based treatment system 10 may be connected to or configured to include any other systems and / or devices not expressly mentioned, such as an image processing engine, a data storage and archiving system, an automated balloon and / or stent inflation system, a drug injection system, a drug tracking and / or logging system, a user log, an encryption system, a system for restricting access to or use of the catheter-based treatment system 10, etc.

[0031] As described above, the control computing system 34 communicates with the bedside unit 20, which includes the robotic drive 24 and the positioning system 22 and may include additional controls and a display 46, and provides control signals to the bedside unit 20 to operate and control motors and mechanisms used to drive percutaneous interventional devices (e.g., guidewires, catheters, etc.). Each drive mechanism may be provided as part of the robotic drive 24. FIG. 3, according to an embodiment, is a perspective view of the robotic drive of the catheter-based treatment system 10. In FIG. 3, the robotic drive 24 includes multiple device modules 32a-d coupled to a linear member 60. Each of the device modules 32a-d is coupled to the linear member 60 via a stage 62a-d movably mounted to the linear member 60. Each of the device modules 32a-d is connected to the stage 62a-d using a connector, such as an offset bracket 78a-d. In one embodiment, the device modules 32a-d are directly mounted to the stage 62a-d. Each stage 62a-d can be independently operated to move linearly along the linear member 60. Thus, each stage 62a-d (and the corresponding device modules 32a-d coupled to the stages 62a-d) can be independently operated relative to each other and the linear member 60. A drive mechanism is used to operate each stage 62a-d. In the embodiment shown in FIG. 3, the drive mechanism includes individual stage translation motors 64a-d and a stage drive mechanism 76 coupled to each stage 62a-d, or the stage translation motors 64a-d themselves can be linear motors. The stage drive mechanism 76 can be, for example, a lead screw via a rotating nut, a rack via a pinion, a belt via a pinion or pulley, or a chain via a sprocket. In one embodiment, the stage drive mechanism 76 is a combination of these mechanisms. For example, a different type of stage drive mechanism can be employed for each stage 62a-d.In embodiments in which the stage drive mechanism is a screw type (e.g., a lead screw, ball screw, or other type of screw mechanism) and a rotating nut, the lead screw is rotated to engage and disengage each stage 62a-d with respect to the lead screw, thereby moving, for example, forward or backward. In the embodiment shown in Figure 3, the stages 62a-d and device modules 32a-d are in a tandem drive configuration.

[0032] Each device module 32a-d includes a drive module 68a-d and a cassette 66a-d mounted to and coupled with the drive module 68a-d. In the embodiment shown in FIG. 3, each of the cassettes 66a-d is mounted to the drive module 68a-d by lowering the cassette 66a-d vertically downward onto the drive module 68a-d. The top (or side) of the cassette 66a-d is parallel to the top (or side) (i.e., mounting surface) of the drive module 68a-d when the cassette 66a-d is mounted to the drive module 68a-d. As used herein, the mounting orientation shown in FIG. 3 is referred to as the horizontal direction. In other embodiments, each cassette 66a-d may be attached to the drive module 68a-d in other mounting orientations. Various mounting orientations are disclosed below with reference to FIGS. 7-10. Each cassette 66a-d is configured to interface with and support a proximal portion of an EMD (not shown). Additionally, each cassette 66a-d may include elements that provide one or more degrees of freedom in addition to the linear motion provided by actuation of the corresponding stage 62a-d to move linearly along the linear member 60. For example, each cassette 66a-d may include elements used to rotate the EMD in the cassette coupled to drive modules 68a-d. Each drive module 68a-d includes at least one coupler to provide a drive interface to mechanisms within each cassette 66a-d and add an additional degree of freedom. Each cassette 66a-d also includes a channel in which device supports 79a-d are positioned, and each device support 79a-d is used to prevent buckling of the EMD. Support arms 77a, 77b, and 77c are attached to each device module 32a, 32b, and 32c, respectively, providing fixed points for supporting the proximal ends of device supports 79b, 79c, and 79d, respectively. The robotic drive 24 also includes a device support 79, a distal support arm 70, and a device support connection 72 connected to a support arm 770. The support arm 770 is used to provide a fixed point for supporting the proximal end of the distal-most device support 79a housed in the distal-most device module 32a.Additionally, an introducer interface support (redirector) 74 can be connected to the device support connection 72 and to the EMD (e.g., introducer sheath). This configuration of the robotic drive 24 has the advantage that the use of an actuator on a single linear member can reduce the volume and weight of the robotic drive 24.

[0033] To prevent patient pathogen transmission, healthcare staff use aseptic technique in the bedside unit 20 and the room housing the patient 12 or subject (shown in FIG. 1). The room housing the bedside unit 20 and patient 12 may be, for example, a catheter lab or an angio suite. Aseptic technique consists of using sterile barriers, sterile instruments, proper patient preparation, environmental controls, and contact guidelines. That is, all EMDs and interventional accessories are sterilized and are only allowed to come into contact with either the sterile barrier or sterile instruments. In one embodiment, a sterile drape (not shown) is placed over the non-sterile robotic drive 24. Each cassette 66a-d is sterilized and serves as a sterile interface between the draped robotic drive 24 and at least one EMD. Each cassette 66a-d is designed to be sterilizable for a single use or to be resterilizable in whole or in part so that the cassette 66a-d or its components can be used for multiple procedures.

[0034] As shown in FIG. 1 , one or more EMDs are introduced into a patient's body (e.g., a blood vessel) at an insertion point 16 using, for example, an introducer and introducer sheath. The introducer sheath is typically oriented at an angle, typically less than 45 degrees, relative to the axis of the vessel in the patient 120 (shown in FIGS. 4-6 ). The height difference between the height at which the EMD enters the body (the proximal opening 126 of the introducer sheath shown in FIG. 4 ) and the height of the longitudinal drive shaft of the robotic drive 124 directly affects the working length of the elongated medical device. The more elongated medical device is required to compensate for the difference in position and angle, the less elongated medical device can be introduced into the body when the robotic drive is in its most distal (forward) position. It is beneficial to have a robotic drive at the same height and angle as the introducer sheath. FIG. 4 illustrates the working axis of an elongated medical device and its point of entry into a patient. FIG. 4 illustrates the height difference (d) 123 between the height of the proximal end 126 of the introducer sheath 122 and the height of the longitudinal device axis 125, as well as the angular difference (θ) 128 between the introducer sheath 122 and the longitudinal device axis 125 of the robotic drive 124. The elongated medical device 121 is constrained to each axis, creating a curve with endpoints that are tangentially aligned. The length of this curve represents the length of the elongated medical device 121 beyond which the robotic drive 124 cannot drive it further forward and into the introducer sheath 122, which would result in misalignment. The greater the angle (θ) 128, the greater the friction of the device. In general, a smaller angle difference (θ) 128 and height difference (d) 123 will result in less friction and less loss of working length. 4 illustrates a simple example illustrating one linear and one rotational offset, it should be understood that this problem occurs in three dimensions, i.e., three linear and three rotational offsets. The thickness of the robotic drive 124 is also a factor in determining the location of the longitudinal device axis 125 relative to the introducer sheath 122.

[0035] 5A and 5B illustrate the effect of the overall thickness of the drive module, or robotic drive, on the loss of working length. FIG. 5A shows the position of the longitudinal device axis 125 of the robotic drive 124 relative to the introducer sheath 122, indicated by (d) 123, where the robotic drive 124 is thicker as indicated by the distance (X) 129 between the top and bottom surfaces of the robotic drive 124. FIG. 5B shows the position of the longitudinal device axis 125 of the robotic drive 124 relative to the introducer sheath 122, indicated by the shorter (d) 123, where the robotic drive 124 is thinner as indicated by the distance (X) 129 between the top and bottom surfaces of the robotic drive 124. Reducing the thickness of the robotic drive 124 to bring it closer to the patient and the introducer sheath shortens the distance 123 between the introducer sheath and the device axis, reducing the loss of working length of the elongated medical device. FIG. 6 illustrates an orientation for minimizing the loss of working length. 6, the robotic drive 124 is positioned so that the longitudinal device axis 125 of the robotic drive 124 is aligned with the axis of the introducer sheath 122. This eliminates the loss of working length due to angular and vertical variations in the elongated medical device. However, this orientation of the robotic drive 124 is not practical given the length and size of the robotic drive 124. Additionally, orienting the robotic drive at an acute angle makes loading and unloading the elongated medical device, as well as adjustment and handling of the robotic drive, difficult, affecting ease of use.

[0036] To reduce the distance between the robotic drive and the patient, and the distance between the longitudinal device axis of the robotic drive and the introducer sheath, cassettes 66a-d of device module 32 (shown in FIG. 3 ) are mounted to drive modules 68a-d in an orientation such that cassettes 66a-d are mounted to drive modules 68a-d by horizontally moving cassettes 66a-d onto them. FIG. 7 shows a perspective view of a device module with vertically mounted cassettes, and FIG. 8 shows a rear perspective view of a device module with vertically mounted cassettes, according to one embodiment. In FIGS. 7 and 8 , device module 132 includes cassette 138 mounted to drive module 140 such that front side (or lateral surface) 139 of cassette 138 is parallel to front side (or lateral surface) 141 (i.e., mounting surface) of drive module 140. As used herein, the mounting orientation shown in FIGS. 7 and 8 is referred to as the vertical direction. The device module 132 is connected to a stage 136 that is movably mounted on a rail or linear member 134. The drive module 140 includes a coupler 142 that is used to provide a power interface to the cassette 138 for rotating, for example, an elongated medical device (not shown) disposed within the cassette. The coupler 142 rotates about an axis 143. As previously described, the cassette 138 is mounted to the drive module 140 by horizontally moving the cassette 138 onto the mounting surface 141, thereby coupling the cassette with the coupler 142 of the drive module 140. By mounting the cassette 138 upright, the drive module 140 to which the cassette 138 is mounted is positioned off to the side and is no longer positioned between the cassette 138 and the patient. FIG. 9, according to one embodiment, is an end view of the distal end of a device module with a cassette mounted upright. 9 shows the distance 146 between the device axis of the elongated medical device 144 and the bottom surface of the device module 132. The top-to-bottom mounting of the cassette 138 eliminates the need to position the drive module 140 below the device axis between the elongated medical device 144 and the patient.Only a portion of the cassette 138 is between the elongated medical device 138 and the patient. The vertical mounting of the cassette 138 reduces the distance 146 between the elongated medical device and the bottom of the device module 132, allowing the robotic drive to be closer to the patient and reducing the loss of working length in the elongated medical device. For comparison, FIG. 10 shows an end view of the distal end of a device module with a horizontally (side-to-side) mounted cassette. In the device module 132 shown in FIG. 10, the cassette 138 is mounted horizontally to the drive module 140. The top (or side) 145 of the cassette 138 is parallel to the top (or side) 147 (i.e., mounting surface) of the drive module 140 when the cassette 138 is mounted to the drive module 140. The drive module 140 is located below or underneath the cassette 138, increasing the distance 148 between the device axis of the elongated medical device 144 and the bottom of the device module 132. This prevents the device axis from being as close as possible to the introducer (not shown here). The drive module 140, located below the cassette 138, may also interfere with the patient. In one embodiment, the cassette can be attached to the drive module at any angle. In one embodiment, the cassette can be attached horizontally to the underside of the drive module, eliminating the need to position the drive module between the device axis and the patient.

[0037] FIG. 11 is a front view of a cassette and an elongate medical device, according to one embodiment. Cassette 200 is configured for vertical mounting to a drive module and includes portions that allow cassette 200 to be vertically attached to a drive module of a robotic drive (e.g., vertical mounting as described above with reference to FIGS. 7-9 ). The cassette and drive module comprise a device module as described above with reference to FIG. 3 . Cassette 200 has a distal end 202, a proximal end 204, and a longitudinal device axis 218 that is associated with and defined by an elongate medical device (EMD) 212 disposed within cassette housing 206. In one embodiment, longitudinal device axis 218 is below or lowered below a centerline of cassette 200 to bring longitudinal device axis 218 closer to the patient. The distance 219 between the longitudinal device axis 218 and the bottom surface 217 of the device module (defined by the cassette 200) can be reduced by mounting the cassette 200 and drive module (not shown) in a top-to-bottom orientation. Top-to-bottom mounting is advantageous because the drive module is not located below the device axis and between the device axis and the patient. As a result, the longitudinal device axis 218 can be closer to the patient. Specifically, it is desirable to have the longitudinal device axis of the most distal device module (i.e., the device module closest to the patient along the linear member 60 (shown in FIG. 3 )) as close to the patient as possible. In one embodiment, the cassette 200 is configured to minimize the distance 219. In one embodiment, the EMD 212 is a catheter. The catheter 212 is coupled to a hemostasis valve (e.g., a rotary hemostasis valve (RHV)) 214, which is also disposed within the cassette housing 206. The hemostasis valve 214 includes a side port 216 for connecting tubing (not shown) for flowing fluid (e.g., saline) into and out of the hemostasis valve 214 and the catheter 212. The cassette 200 also includes a cover 208 that is coupled to the cassette housing 206 using a connection mechanism 210 (e.g., a hinge). The connection mechanism 210 is positioned below a longitudinal device axis 218. In Figure 11, the cover 208 is in a closed position.A connection mechanism 210 allows the cover 208 to be moved between a closed and an open position.

[0038] FIG. 12, according to one embodiment, is a perspective view of a cassette configured for vertical mounting to a drive module. In FIG. 12, a cover 208 connected to a housing 206 of the cassette 200 is in an open position. As described above, the cover 208 is attached to the cassette housing 206 by a connection mechanism 210 (e.g., a hinge). The connection mechanism 210 is positioned below the longitudinal device axis 218 of the cassette 200. When the cover 208 is open, a plane defined by an inner surface 221 of the cover 208 is approximately perpendicular to a plane defined by a front side 223 of the cassette housing 206 and a front side (e.g., front side or side 141 shown in FIG. 7) of a device module (not shown) to which the cassette 200 is vertically mounted. Thus, the cover 208 is horizontal in the open position. In another embodiment, the cover 208 may be angled so that an outer edge 228 of the cover 208 is below horizontal. A mechanical stop 225 is coupled to the cassette housing 206 and the cover 208 and is used to hold the cover 208 in a substantially horizontal orientation when the cover 208 is in the open position. In one embodiment, the mechanical stop 225 is coupled to the cassette housing 206 and the cover 208, and the mechanical stop 225 is used to hold the cover 208 at an angle below horizontal when the cover 208 is in the open position. In the closed position (shown in FIG. 11 ), the plane defined by the inner surface 221 of the cover 208 is substantially parallel to the plane defined by the front surface 223 of the cassette housing 206, and the cover 208 is oriented in an up-down direction. The cover 208 and / or the cassette housing 206 may include a mechanical locking mechanism or magnets to hold the cover 206 in the closed position.

[0039] Cover 208 also includes a recess 224 into which an EMD to be assembled can be placed, for example, before the EMD is loaded into cassette 200, as described below with reference to FIG. 15 . Opening 226 in cover 208 allows for the use of an EMD with a port (e.g., a side port) in the cassette and allows connection of the EMD to the port, as described below with reference to FIG. 16 . Cassette housing 206 includes a recess 250 configured to receive a side port of a hemostasis valve disposed within cassette housing 206 and / or a tube connected to the side port (e.g., side port 216 and tube 236 shown in FIG. 14 ). Cover 208 also includes a retention element 252 complementary to recess 250 and configured to retain the side port when cover 208 is in a closed position and to allow an operator to view tube 236 when cover 208 is in a closed position, as described below with reference to FIG. 14 . Cassette housing 206 includes a cradle 220 configured to receive an EMD (not shown) loaded into cassette housing 206. Saddles 222a and 222b are located at proximal end 204 of cassette housing 206. In the embodiment shown in FIG. 12 , saddles 222a and 222b are U-shaped with straight portions (straight portion 227 of saddle 222a and straight portion 229 of saddle 222b). Saddle 222a is configured to receive and restrain a groove on the distal end of a hemostasis valve of the EMD, and saddle 222b is configured to receive and restrain a proximal end of the hemostasis valve of the EMD. For example, saddles 222a and 222b can be configured to provide a snap fit with the grooves and proximal ends of hemostasis valves located on saddles 222a and 222b, as described below. Cassette 200 also includes a bevel gear 238 that engages with a coupler of a drive module and is used to engage the EMD, for example, to rotate the EMD.

[0040] As described above, an EMD can be loaded and positioned within cassette 200. FIG. 13, according to one embodiment, is a perspective view of an elongated medical device. The example EMD shown in FIG. 13 is a catheter 212. Catheter 212 is coupled to a hemostasis valve 214 (e.g., a rotary hemostasis valve) at a proximal end 234 of the EMD. A body 235 of the hemostasis valve includes a gear 232 and a groove 233 at a distal end of body 235. Gear 232 is configured to interact with a gear on the cassette (e.g., bevel gear 238 shown in FIG. 12). For example, when power is transmitted from a drive module to which the cassette is attached (e.g., via a coupler) to the gear on the cassette (e.g., gear 238), the cassette gear actuates gear 232 on catheter 212, causing catheter 212 to rotate. Additionally, the proximal end 234 (including the side port 216) of the hemostasis valve 214 is configured to remain stationary while the body 235, gear 232, and groove 233 rotate. The side port 216 of the hemostasis valve 214 is connected to a tube 236, as described above, to allow fluid (e.g., saline) to flow in and out of the hemostasis valve 214 and catheter 212. When the EMD is loaded into a cassette (e.g., cassette 200 shown in FIG. 12) of a robotic drive unit (e.g., robotic drive unit 24 shown in FIG. 3), the tube 236 is connected to a fluid source (not shown), such as a pressurized bag.

[0041] FIG. 14 , according to one embodiment, is a perspective view of a cassette and an elongated medical device with the cover in an open position. In FIG. 14 , an EMD (e.g., the EMD shown in FIG. 13 ) is loaded into and positioned within cassette 200. Specifically, the EMD is positioned within cradle 220 of cassette housing 206. As described above, the EMD may be a catheter 212 coupled to a hemostasis valve 214 having a side port 216, a gear 232, a groove 233, and a body 235. Side port 216 is oriented upward so that it faces upward when cassette 200 is installed vertically into a drive module (not shown) within a robotic drive system. As a result, tubing 236 connected to side port 216 faces upward and descends from above the robotic drive system. Recess 250 in cassette housing 206 is configured to receive side port 216 and tubing 236 connected to side port 216. When cover 208 is closed, complementary retention elements 252 hold side port 216 in place during robotic drive operations, such as advancing and retracting the device module containing cassette 200 and rotating catheter 212. In one embodiment, retention elements 252 are configured to allow an operator to view all or a portion of tubing 236 within cassette housing 206, for example, to monitor tubing 236 for air bubbles. For example, retention elements 252 have a width that is smaller than the width of side port 216 and tubing 236. Furthermore, recess 250 in cassette housing 206 and retention elements 252 in cover 208 are configured to allow side port 216 to be oriented in a desired direction (e.g., substantially up or down).

[0042] Groove 233 of hemostasis valve 214 is located in saddle 222a at proximal end 204 of cassette housing 204, and the proximal end of hemostasis valve 214 is located in saddle 222b at proximal end 204 of cassette housing 204. As described above, saddles 222a and 222b are configured to receive and restrain the hemostasis valve of the EMD. For example, saddle 222b is configured to snap-fit ​​onto the proximal end of hemostasis valve 214 located in saddle 222b. In one embodiment, groove 233 of hemostasis valve 214 is restrained by saddle 222a, for example, by a snap-fit. In one embodiment, the shape of groove 233 corresponds to the shape of saddle 222a. Saddles 222a and 222b are configured so that they do not completely retain groove 233 and the proximal end of hemostasis valve 214, but sufficiently restrain groove 233 and the proximal end of hemostasis valve 214 (e.g., 90-90% full) so that the EMD does not fall out of the cassette when cover 208 is opened or before cover 208 is closed. When cover 208 is closed, recess 224 provides additional force to hold catheter 212, hemostasis valve 214, and gear 232 in place during operation of the robotic drive, such as advancing and retracting a device module including cassette 200 and rotating catheter 212. That is, recess 224 is configured to complete saddles 222a and 222b when cover 208 is closed. Cover 208 is also configured to press groove 233 into place when cover 208 is closed (e.g., the closed state shown in FIG. 11 ). Cover 208 in a closed position (eg, as shown in FIG. 11) prevents contact with gear 232 by an operator or other elements of the system.

[0043] As described above, cover 208 of cassette 200 also includes recess 224 in which an assembled EMD can be placed, for example, before the EMD is loaded into cassette 200. FIG. 15 , according to one embodiment, is a perspective view of a cassette shown with an elongated medical device placed on the cassette cover in an open position before the elongated medical device is loaded into the cassette. In FIG. 15 , the EMD is a catheter 212 coupled to hemostasis valve 214 (including gear 232, groove 233, and body 235). Catheter 212 and hemostasis valve 214 rest in recess 224 of cover 208. That is, recess 224 functions as a shelf to temporarily and lightly hold an assembled EMD, for example, before loading into cassette 200. In one embodiment, groove 233 has a shape that corresponds to recess 224, such that groove 233 is engaged and restrained by recess 224 when placed on cover 208; for example, groove 233 may have flanges located on either side of recess 224. As described above, in one embodiment, cover 208 may include opening 226. FIG. 16 , according to one embodiment, is a front view of a cassette with its cover open and an elongated medical device loaded into the cassette. In FIG. 16 , opening 226 in cover 208 is used to enable use of EMD 240, which includes side port 242. Opening 226 in cover 208 allows access to side port 242 even when cover 208 is closed. Furthermore, opening 226 in cover 208 is configured to allow side port 242 to be oriented in a desired direction (e.g., outward, approximately vertical, etc.). The EMD shown in FIG. 16 is also coupled to a hemostasis valve 244 with side port 246.

[0044] As described above with reference to FIG. 3 , the robot drive 24 can also include a device support connector 72 and a distal support arm 70 connected to the device support 79 a. The device support connector 72 is used to support the distal end of the device support 79 a housed in the most distal device module 32 a. The distal support arm 70 extends from the robot drive 24 and is attached to a frame of the robot drive 24, such as the frame of the linear member 60. A connector at the distal end of the device support 79 a can be attached to the device support connector 72. Furthermore, an introducer interface support 74 can be connected to the device support connector 72 and the introducer sheath. FIG. 17 , according to one embodiment, is a perspective view of the introducer interface support. In FIG. 17 , an introducer interface support (or sheath connector) 272 is connected to the device support connector 270 and the introducer sheath 274. The introducer interface support 272 is configured to support an EMD (not shown) between a device support (e.g., device support 79a shown in FIG. 3 ) and an introducer sheath 274 connected to the distal end 276 of the introducer interface support 272. The introducer interface support 272 prevents the EMD from buckling or deflecting between the distal end of the device support (e.g., device support 79a shown in FIG. 3 ) and the hub of the introducer sheath 274. The introducer interface support 272 is a flexible tube. The flexible tube of the introducer interface support 272 is configured to provide a compensating curvature that helps avoid misalignment and offsets robotic drive perturbations or patient motion. In one embodiment, the introducer interface support 272 is also used to redirect the EMD from a position axially aligned with the robotic drive and device axis to a position axially aligned with the introducer sheath 274. An introducer sheath 274 is inserted into the patient's vascular system to direct the EMD to a target site (eg, a lesion) in the patient at an entry point (eg, the femoral artery).The introducer sheath 274 must be held in place to prevent it from becoming dislodged from the patient. In one embodiment, the device support connection 270 and distal support arm 70 (shown in FIG. 3) are used to fix the position of the introducer sheath 274 and react to forces on the introducer sheath 274 generated from friction between the introducer sheath 274 and the EMD moving through the introducer sheath 274.

[0045] The control computing systems described herein may include a processor having processing circuitry. A processor may include a central processing unit, an application-specific processor (ASIC), a circuit including one or more processing components, a group of distributed processing components, a group of distributed computers configured for processing, etc., configured to provide the functionality of the modules or subsystem components described herein. A memory unit (e.g., a memory device, a storage device, etc.) is a device for storing data and / or computer code to perform and / or facilitate the various processes disclosed herein. The memory unit may include volatile memory and / or non-volatile memory. The memory unit may include a database component, an object code component, a script component, and / or any other type of information structure to support the various activities disclosed herein. According to one embodiment, any past, present, or future distributed and / or local memory device may be utilized in the systems and methods disclosed herein. According to one embodiment, the memory unit is commonly connected to one or more associated processing circuits. This connection may be via a circuit or any other wired, wireless, or network connection and may contain computer code for performing one or more processes described herein. A single memory unit may include various individual memory devices, chips, disks, and / or other storage structures or systems. A module or subsystem component may be computer code (e.g., object code, program code, compiled code, script code, executable code, or any combination thereof) for performing the functionality of the module.

[0046] The written description uses examples to disclose the invention, including the best mode, and to enable any person skilled in the art to make and use the invention. The scope of the invention is defined by the claims, and includes other examples that may occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have elements that do not depart from the recitation of the claims, or if they have equivalent elements that do not differ substantially from the recitation of the claims. Any order and sequence of process or method steps may be changed or rearranged according to alternative embodiments.

[0047] Many other changes and modifications may be made to the present invention without departing from the spirit thereof, the scope of these and other modifications being apparent from the appended claims.

Claims

1. A cassette for use in a robotic drive device of a catheter-based treatment system, comprising: a housing including a cradle configured to receive an elongated medical device having a longitudinal device axis; a connection mechanism coupled to the housing at a location below the longitudinal device axis; a cover pivotally coupled to said housing using said connection mechanism.

2. 2. The cassette of claim 1, wherein the cover is movable between a closed state and an open state, and when the cover is in the open state, an axis of the cover between an outer edge of the cover and the connecting mechanism is substantially perpendicular to the housing.

3. The cassette of claim 1 , wherein the connection mechanism is a hinge.

4. The cassette of claim 1 , further comprising a mechanical locking mechanism configured to hold the cover closed.

5. The cassette of claim 1 , wherein the cover includes a recess configured to receive a hemostasis valve coupled to the elongate medical device when the cover is in an open position.

6. The cassette of claim 1 , wherein the cover includes an opening configured to receive a side port of the elongate medical device.

7. The cassette of claim 6 , wherein the opening is configured to allow a side port of the elongate medical device to be oriented generally vertically.

8. The cassette of claim 1 , wherein the housing further comprises a recess configured to receive a side port of a hemostasis valve coupled to the elongate medical device.

9. The cassette of claim 8 , wherein the cover includes a retaining element configured to orient the side port of the hemostasis valve in a generally vertical direction.

10. A cassette for use in a robotic drive device of a catheter-based treatment system, comprising: a housing having a distal end and a proximal end, the housing including a cradle configured to receive an elongated medical device having a longitudinal device axis; a saddle located at a proximal end of the housing and configured to receive and restrain a hemostasis valve coupled to the elongate medical device; a connection mechanism coupled to the housing at a location below the longitudinal device axis; a cover pivotally coupled to said housing using said connection mechanism.

11. The cassette of claim 10 , wherein the saddle includes a snap mechanism for retaining the hemostasis valve when the hemostasis valve is positioned within the saddle.

12. The cassette of claim 10 wherein the saddle is U-shaped.

13. 11. The cassette of claim 10, wherein the cover is operable between a closed state and an open state, and when the cover is in the open state, an axis of the cover between the connection mechanism and an outer edge of the cover is substantially perpendicular to the housing.

14. The cassette of claim 13 , wherein the connection mechanism is a hinge.

15. The cassette of claim 13 further comprising a magnet configured to hold the cover closed.

16. The cassette of claim 13 , wherein the cover includes an opening configured to receive a side port of the elongate medical device.

17. 17. The cassette of claim 16, wherein the opening is configured to allow a side port of the elongate medical device to be oriented generally vertically.

18. The cassette of claim 10 , wherein the housing further includes a recess configured to receive a side port of the hemostasis valve.

19. The cassette of claim 18 , wherein the cover includes a retaining element configured to orient the side port of the hemostasis valve in a generally vertical direction.

20. 1. A robotic drive system for driving one or more elongated medical devices, comprising: A straight member; a device module connected to the linear member; a distal support arm having a device support connection located distal to the device module; an introducer interface support coupled to the device support connection and including a flexible tube; an introducer sheath coupled to the introducer interface support.

Images